US 20120059394A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2012/0059394A1 Brenner et al. (43) Pub. Date: Mar. 8, 2012
(54) CLOSURE DEVICE AND METHOD Related U.S. Application Data (75) Inventors: Jacob S. Brenner, Menlo Park, CA (60) Provisional application No. 61/153.278, filed on Feb. (US); Gregory A. Magee, Menlo 17, 2009, provisional application No. 61/220,742, Park, CA (US); Ruey Feng Peh, filed on Jun. 26, 2009, provisional application No. Singapore (SG); Erika I. Palmer, 61/266,981, filed on Dec. 4, 2009. Menlo Park, CA (US) Publication Classification (73) Assignee: THE BOARD OF TRUSTEES OF (51) Int. Cl. THE LELAND STANFORD A6B 7/28 (2006.01) JUNIOR UNIVERSITY, A6B 7/22 (2006.01) STANFORD, CA (US) (52) U.S. Cl...... 606/142: 606/158 (21) Appl. No.: 13/201,079 (57) ABSTRACT (22) PCT Fled: Feb. 17, 2010 Devices and methods for treatment of prolapsed hemor rhoidal arteries is disclosed. The devices can identify the (86) PCT NO.: PCT/US 10/00470 hemorrhoid and ligate the artery without causing significant pain or distension of the rectum. The artery can be identified S371 (c)(1), with ultrasound. The ligation can be performed using energy (2), (4) Date: Nov. 23, 2011 and/or mechanical structures, such as clips or rubber bands.
CLP Patent Application Publication Mar. 8, 2012 Sheet 1 of 46 US 2012/0059394 A1
DETECON AND GATON ERMNA ANEETSN SECTION. -i. P SECTION \ TERMINAL
DOPPLER STEERAB E DOPPER SENSOR ON SENSOR
RF- E DSTA EECTRODE | f | 5 OUTER E. c DAMETER GRADATIONS
STOPPER -- RF SECTION cy EECTRODE F.G. 1B
STOPPER HEADPHONES
SHAFT->
PROCESSOR SPEAKERS
GATON HANDE-> CONTROL
RiGGER REMOTE COMPONENT
ANDLE SPEAKER
FG. A Patent Application Publication Mar. 8, 2012 Sheet 2 of 46 US 2012/0059394 A1
Patent Application Publication Mar. 8, 2012 Sheet 3 of 46 US 2012/0059394 A1
Ck 8
Patent Application Publication Mar. 8, 2012 Sheet 5 of 46 US 2012/0059394 A1
REARPANE SUCTION PORT
FIG. 4A SUCONIVACUUM X DOPPLER SENSOR FA5, RESS REARPANE FROM HOUSN NY-PANELas RETRACTs FROM HOUSENG
FG. 4B
NTERNA
FG. 4C OUTER HOUSING Patent Application Publication Mar. 8, 2012 Sheet 6 of 46 US 2012/0059394 A1
NTERNA JAW
PN HOLE
NTERNAAW TRACK
ACUATION SLEEVE
F.G. 5A
CP CPTP
CP BASE F.G. 5B Patent Application Publication Mar. 8, 2012 Sheet 7 of 46 US 2012/0059394A1
CPTP CP ARM ARERY CPTP
Ya CP /1Y CP s CP ARM CP 3ASE F.G. 6A F.G. 6B F.G. 6C
CP CP TSSUE
ARTERY FIG. 7A FG. 7B
CPTP CLIFTP CPTP
CPTP CPP CP ARM CP ARM CP ARM ARTERY Y clip CP / CLP- YCLP
FG. 8A FIG. 8B FG. 9A FG. 9B Patent Application Publication Mar. 8, 2012 Sheet 8 of 46 US 2012/0059394 A1
Cip-Y c?, CP -r CLP-1
F.G. 10A F.G. OB FIG. OC F.G. 1 OD
1. CLP Clip
FIG. OE F.G. 10A" Patent Application Publication Mar. 8, 2012 Sheet 9 of 46 US 2012/0059394 A1
CLP v - C / 1. +l. 1 C CP CP
CP - CP
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-
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F.G. 5' Patent Application Publication Mar. 8, 2012 Sheet 12 of 46 US 2012/0059394 A1
block clip
artery
Fig. 16A
block
Fig. 16B Patent Application Publication Mar. 8, 2012 Sheet 13 of 46 US 2012/0059394 A1
BAOON DSTA UTRASOUND PORT E F-7 SRYSAS URASOUND UTRASOUND < CRYSTAL CRYSTALS
A A B B
BALOON
GRADANTS GRADANTS
SHAFT
NECTION PORT
NFLATON POR F.G. 14A F.G. 14C
A-A-N B-B- BAOON
BAOON
(?-URASOUND URASOUND CRYSTA CRYSTA FIG. 143 FIG. 4D Patent Application Publication Mar. 8, 2012 Sheet 14 of 46 US 2012/0059394 A1
to o d o is & d
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ANDLE
F.G. 6A F.G. 6B
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FIG. 6C Patent Application Publication Mar. 8, 2012 Sheet 15 of 46 US 2012/0059394 A1
NECTON PORT
HANDLE CONTRO BUTTON S.
-- OOOO
REMOTE COMPONENT
ENDOSCOPE PORT
DOPPER ENDOSCOPE SENSOR SUCON PORT 2 END PECE
-LIGHT SOURCE
DSTALEND FG. 9A OF ENDOSCOPE
RF ELECRODE
GT SOURCE y C-C RRGAON
SUCTON NSTRUMENTS
FG. 9B Patent Application Publication Mar. 8, 2012 Sheet 16 of 46 US 2012/0059394 A1
tissue
Doppler Sensor RF electrode endpiece
Distal tip of Suction port endoscope
endoscope
Fig. 9C
Doppler sensor
tissue Suction port endpiece
RF electrode Distal tip of suction port endoScope
endoscope Patent Application Publication Mar. 8, 2012 Sheet 17 of 46 US 2012/0059394 A1
REMOTE COMPONENT
CONTROL HANDLE
DOPPER SENSOR ENDOSCOPE
END PECE
SUCTION PORT
CPAPPER
F.G. O. Patent Application Publication Mar. 8, 2012 Sheet 18 of 46 US 2012/0059394 A1
RECUM
RF ELECTRODE
STEERABLE ON HEMORRHODA ARERY HEMORRHODA ARERY
NTERNA
EMORRHOD NERNA (PROLAPSING) HEMORRHOD 2 Cr? (PROLAPSING) O EXTERNALANAL 3 cm 22-WN NY SPHNCTER 2.5 Cr, & O 3 Ci Ales iNTERNAANA DENAE ad NSPHINCTER NE EXTERNA EXTERNA EEMORROD HEMORRHOD STOPPER TOUCH SENSOR
FG. A Patent Application Publication Mar. 8, 2012 Sheet 19 of 46 US 2012/0059394 A1
RECUM
STEERABLE ON
DOPPER SENSOR
HEMORRHODA ARTERY HEMORRHODA RF ELECTRODE ARTERY INTERNA NERNA HEMORRHOD HEMORRHOD NSSES - " (PROLAPSING) (PROLAPSING) Ny- -- EXTERNAL ANA SPHNCTER
NTERNA ANA SPHNCER EMORRHOD EXTERNA EMORRHOD
FIG. B Patent Application Publication Mar. 8, 2012 Sheet 20 of 46 US 2012/0059394 A1
RECTUM
HEMORRHODA GATED ARTERY -EMORRHODA ARTERY ARTERY INTERNA NTERNA- -- HEMORRHOD HEMORRHOD \ (PROLAPSING) (PROLAPSING) EXTERNAL ANA SPHNCER DENTATE LINE
NTERNAL ANA
EXERNA SPHINCER EMORRHOD EXTERNA EMORROD
F.G. 1C Patent Application Publication Mar. 8, 2012 Sheet 21 of 46 US 2012/0059394 A1
wŠ Submucosal arteria blood
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Sassa-Systiskawsuitas Fig. 12 Patent Application Publication Mar. 8, 2012 Sheet 22 of 46 US 2012/0059394 A1
RECUM
HEMORRHODA ARERY EXPANDABLEH HEMORRHODA BASKE ARTERY NTERNA ENERNAL V HEMORR-OD HEMORRHOD \ (PROLAPSING) (PROLAPSING) EXTERNAL ANA SPHNCTER DENIAE LINE
NTERNAL ANA EXTERNA SPHENCTER
EMORROD EXTERNAL EMORRHOD
F.G. 13A Patent Application Publication Mar. 8, 2012 Sheet 23 of 46 US 2012/0059394 A1
RECUM
EXPANDABLE
BASKET DOPPER SANE SALNE HEMORRHODA ARTERY HEMORRHODA ARTERY RF ELECTRODE DOPPER SENSOR RF ELECTRODE NERNA HEMORRO) HEMORRHOD "WANs-'S - (PROLAPSING) (PROLAPSING) EXTERNAL ANA Y-- SPHINCTER DENTATELNE
NTERNAL ANA EXEERNA SPHENCER EMORRHOD EXTERNA
HEMORRHO)
F.G. 13B Patent Application Publication Mar. 8, 2012 Sheet 24 of 46 US 2012/0059394 A1
RECTUM
URASOUND CRYSTA
BAOON HEMORRHODA ARERY HEVORRHODA ARTERY NTERNA NERNA HEMORRHOD EMORRHOD NSAW ify - - (PROLAPSING) (PROLAPSING) VW -. EXTERNAL ANA
Y SPHNCTER DENATE NEE
iNTERNAL ANA SPHINCER
EXTERNAL SYRNGE EMORROD kiss
NFLATON VOLUME PORT MEASUREMENT PRESSURE F.G. 15A GAUGE Patent Application Publication Mar. 8, 2012 Sheet 25 of 46 US 2012/0059394 A1
RECUM
URASOUND CRYSTAL
BA OON HEMORRHODA ARTERY HEMORRHODA ARERY NTERNA HEMORRHOD
NERNA (PROLAPSING)
HEMORRHOD "WANX&WS - (PROLAPSING) EXTERNAL ANA SPHNCTER OENTATE NE NTERNA ANA SPHNCTER
REMOTE COMPONENT SYRNGE
F.G. 15B Patent Application Publication Mar. 8, 2012 Sheet 26 of 46 US 2012/0059394 A1
RECUM
COAPSEDARERY
HEMORRHODA HEMORR-OEDAL ARTERY ARTERY
NTERNA Y HEMORRHOD HEMORRHODNERNA - \(PROLAPSING) (PROLAPSING) EXTERNALANA SPHNCER DENTATE NE NTERNA ANA SPHNCTER
EXTERNA HEMORRHOD
SYRNGE
F.G. 5C Patent Application Publication Mar. 8, 2012 Sheet 27 of 46 US 2012/0059394 A1
RECTUM
PAD STEERABLEON
ABAON SENSING HEMORRHODA PAR ARERY HEMORRHODA ARTERY HEMORRHOD NTERNA (PROLAPSENG) HEMORRHOD (PROLAPSING) EXTERNAL ANA SPHINCTER DENATELNE NTERNA ANA SPHNCTER EXERNA
HEMORRHOD EXTERNA HEMORRHOD
ANDLE REMOTE COMPONENT Y
F.G. 17 Patent Application Publication Mar. 8, 2012 Sheet 28 of 46 US 2012/0059394 A1
HEMORRHODA ARTERY
() MARTERYHEMORRHODA PAD
O
O
ABATON SENSNG PAR F.G. 18A ANDE
F.G. 18B HEMORRHODA ARTERY
HEMORRODA O O ACWAE) RF ARTERY O. O. a ELECTRODE O O O. O. O O. O. O. O. O. O C. O. O. O. O. O C. O. O. GATE) O O. o o ARTERY O O Q O
NAC WA E RF EECRODE
FG. 8) FIG. 18C Patent Application Publication Mar. 8, 2012 Sheet 29 of 46 US 2012/0059394 A1
IGATION OF HEMORRHO)AARTERES WITH STEAN WITH MNNIAL PAN
A
RECTUM
EIN 7SUCTIONCUP
HEMORR-OiDA A? N NEEDLE ARTERY EWORRODA ARTERY
NERNA HEMORRHOD HEMORRHODINTERNA a (PROLAPSING) (PROLAPSING) EXERNAL ANA
SPHINCTER DENTATE LINE al
NERNAANA SPHINCER EXTERNA EXERNA EWORRHOD HEORRHOD
STEERING MECHANESM SYRNGE «s AS SCLEROSNGAGENT DE VERY SYSTEM
SANE
REMOTE SCEROSING RESERVOR COMPONENT CONTRO FOW METER F.G. 19A Patent Application Publication Mar. 8, 2012 Sheet 30 of 46 US 2012/0059394 A1
RECTUM
SUCTION CUP HEMORRODA a; DOPPER SENSOR ARERY & HEMORRODA
NEEDE
a k. AAA NTERNA INTERNA NA: HEMORRHOD HEMORRHOD (PROLAPSING) (PROLAPSING) EXERNA ANA SP-NCTER DENTATE LINE NERNA ANA SPHINCTER EXERNAL EXERNA EMORRO) EMORROO STEERING MECHANSM SYRNGE KS CUP SCLEROSINGAGENT vX A CONTROL DELIVERY SYSTEM
S-sá REMOTE RFSANE COMPONENT SCEROSING CONTRO FOW MEER F.G. 19B Patent Application Publication Mar. 8, 2012 Sheet 31 of 46 US 2012/0059394 A1
RECTUM
IDOPPLER IISENSOR EMORRODA ARTERY NTERNA HEMORRHOD (PROLAPSING) HEMORRODA S EXTERNAL ANA ARTERY SPHNCTER iNTERNA NERNAANA EMORROD SPHNCER (PROLAPSING) A. W. SOc-4EXTERNAL DENATE HEMORRHOD NE STEERING
EXTERNA MECHANISM HEMORRHOD SCLEROSENG SYRNGE CONTRO
SCEROSNGAGENT DEVERY SYSTEM is E-SANE REMOTE RESERVOR COMPONENT MEERFOW CP CONTROL F.G. 19C Patent Application Publication Mar. 8, 2012 Sheet 32 of 46 US 2012/0059394 A1
RECTUM
(DOPPLER Y SENSOR
EMORRHODA ARTERY B.N. HEMORRHODNTERNA (PROLAPSING) HEMORRHODA EXTERNAANA ARTERY SPHNCTER NTERNA HEMORROD (PROLAPSING) NTERNA ANA OENATE SPHNCER NE EXTERNA
HEMORRHOD EXTERNA SEERNG HEMORROD MECHANSM SYRNGE YBULKING CONTROL BULKNGAGENT la DEVERY SYSTEM CYN =s SS SANE REMOTE RESERVOR FLOW COMPONEN METER CUP CONTRO F.G. 190 Patent Application Publication Mar. 8, 2012 Sheet 33 of 46 US 2012/0059394 A1
RECUM
EMSSON WNDOW TREAVEN EMORRHODA DEPTH 1.\ Tao,HEWORRHOD HEMORRHODA ARTERY N (PROLAPSING) NTERNAL SN \E N EXTERNAL ANA HEMORRHOD S. W. SPHENCTER (PROLAPSING) SS NTERNAL ANA DENTATE SPHNCTER NE
EXTERNAL EXERNA HEMORRHOD HEMORRHOD NECK
ANDE
REMOTE COMPONENT FG. 20' Patent Application Publication Mar. 8, 2012 Sheet 34 of 46 US 2012/0059394 A1
NORMA HEMORRHOD
PROAPSE) HEMORROD
DENTATE
ANAWERG FG, 20A
PEXY UNCTON
PEXED HEMORRHOD
FG. 20B Patent Application Publication Mar. 8, 2012 Sheet 35 of 46 US 2012/0059394 A1
MECHANCA PRO APS-D SCAR PRO APSE) FASTENER HEMORRHOD HEMORRHOD
PEXED EMORRO) HERSold FIG.21A FIG.21B FIG.22A ' PEATS
RJBBER PRO APSED SUCTION BAND
HEMORRHOD PEAT PORT
ROTATES, TSSUE TWSTNG MJCOSA
HESRRG65NPROAPSED PEXE) EMORRO) PEXED HEMORR-OD FG. 23A FG. 23B FG. 24A F.G. 24B
STENT STEN
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DEPOYMEN DEPLOYMENT OOL TOO FIG.24A FG. 24B' Patent Application Publication Mar. 8, 2012 Sheet 36 of 46 US 2012/0059394 A1
SUCON SUCTION PORT PORT CP TSSUE SUCTON APPER
systems | s
-EMORR-ODAL ARTERY TSSUE EMORRODA S ARTERY HEMORRHODA TSSUE F.G.G. 2525A FG.G. 2525B ARERYFG. 25C
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SUCON PORT
TSSUE -A- 7s F.G. 26A UN SUCT ON PORT TSSUE FIG. 26B
PORT TRANSLAON SUCTON
TSSUE
FIG. 26C
SUCTON PORT SUCTION PORT
FG. 26D FIG. 26E Patent Application Publication Mar. 8, 2012 Sheet 38 of 46 US 2012/0059394 A1
ARTERY
ISSUE
FG. 28 Patent Application Publication Mar. 8, 2012 Sheet 39 of 46 US 2012/0059394 A1
SAPE
FG.29A
STAPLE
ARTERY
F.G. 29B Patent Application Publication Mar. 8, 2012 Sheet 40 of 46 US 2012/0059394 A1
tisse tissue artery needle
J. needle suture receiving receiving port port
Suture artery needle needle receiver receiver needle w needle Fig. 30A driver driver Fig. 30B
reedle tissue artery tissue receiving port
suture artery
needle
Ceye needle driver Fig. 30C Fig. 30D Patent Application Publication Mar. 8, 2012 Sheet 41 of 46 US 2012/0059394 A1
needle needle Containing containing Structure receiving port
needle
CO
Suture Fig. 31B
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ar joint suturing device Fig. 31A
receiving port needle receiving port
Fig. 31C
Fig. 31 D Patent Application Publication Mar. 8, 2012 Sheet 42 of 46 US 2012/0059394 A1
receiving port
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artery
Fig. 31H suturing device Fig. 31G Patent Application Publication US 2012/0059394 A1
Patent Application Publication Mar. 8, 2012 Sheet 44 of 46 US 2012/0059394 A1
tissue tissue artery artery
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tissue artery tissue y Suufe
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Fig. 34A Fig. 34B Patent Application Publication Mar. 8, 2012 Sheet 45 of 46 US 2012/0059394 A1
tissue artery tissue
Suture
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Suture
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CLOSURE DEVICE AND METHOD emphasis currently on Stapled hemorrhoidopexy, doppler guided hemorrhoidal artery ligation (DHAL), and hemor CROSS REFERENCE TO RELATED rhoidectomy. The efficacies of these therapies are approxi APPLICATIONS mately 80% for stapled hemorrhoidopexy and 70% for DHAL. DHAL is associated with significantly less pain that 0001. This application claims priority to U.S. Provisional stapled hemorrhoidopexy or hemorrhoidectomy, but it is a Application Nos. 61/153.278, filed 17 Feb. 2009: 61/220,742, relatively new technology and is currently not widely filed 26 Jun. 2009; and 61/266,981, filed 4 Dec. 2009, which adopted. Grade IV hemorrhoids are typically treated by a are incorporated herein by reference in their entireties. surgical hemorrhoidectomy, which has an efficacy of 95% and almost no recurrence, but it causes a significant amount of BACKGROUND OF THE INVENTION post-operative pain and can risk complications such as per 0002 1. Field of the Invention manent fecal incontinence. Patients miss an average of 11 0003. The present invention relates to medical devices days of work due to the severity and duration of pain. used for closure or ligation (e.g., mechanical ligation) of 0009 Currently there is no treatment that is both highly vessels, such as arteries or veins, such as vessels in the GI effective and has a low rate of post-procedural pain and com tract, for example veins in the esophagus or arteries in the GI plications. Procedures with low invasiveness, such as rubber tract, more narrowly the hemorrhoidal arteries, More particu band ligation, are used on mild hemorrhoids with few com larly, the present invention relates to methods and apparatus plications, but have poor long-term efficacy. More invasive to treat hemorrhoids without Subjecting patients to pain, or procedures. Such as hemorrhoidectomy and stapled hemor with minimal pain. rhoidopexy, have good long-term efficacy, but are associated 0004 2. Description of the Related Art with significant pain and high complication rates. Thus, there 0005 Hemorrhoids are a network of vascular cushions is a need for a more effective way to treat Grade II, III, and IV that exist as a normal part of human anatomy present in all hemorrhoids that is effective, but produces little pain and few healthy individuals. However, the term hemorrhoids is gen complications, and has a low recurrence rate. erally used to refer to the disease process whereby a person 0010 Methods of treatment using hemorrhoidal dearteri develops symptoms when the hemorrhoids become inflamed, alization (HD) work by ligating the hemorrhoidal (aka rectal) thrombosed, or prolapsed. When a person Strains during def arteries, more specifically the Superior hemorrhoidal arteries ecation the pressure within the rectum increases and causes via hand-thrown Sutures, performed throughananoscope that engorgement of the hemorrhoids. The mechanism of action is required significant dilation of the anal canal. HD causes the believed to be due to decreased venous return and continued blood-engorged hemorrhoids to regain their normal structure arterial Supply. Additionally aging causes laxity of connective within a few weeks. Numerous studies show that HD cures tissues Supporting the hemorrhoids and, hence, increases greater than 90% of grade II-IV hemorrhoids, with almost no their ability to prolapse. post-operative pain in 95% of patients. 0006 Hemorrhoids are simply enlarged vascular struc 0011. There is also great need for a treatment that can be tures in the anal canal that produce discomfort, Soiling of performed outside the operating room (OR) by Surgeons and undergarments, intense itching, and in some patients, excru non-Surgeons alike. Meeting this need could decrease costs ciating pain. and increase the number of patients who could receive treat ment. First, costs should decrease because current treatments, 0007 Hemorrhoids are one of the most common medical such as hemorrhoidectomy, can only be performed in the OR, afflictions of older adults. The prevalence of hemorrhoids in which is tremendously expensive. Second, a new treatment the United States is approximately 13 million with a yearly performed by non-surgeons would simplify the referral path incidence of 1.5 million. With a peak prevalence in the 45-65 way, which could increase the number of hemorrhoids age range, hemorrhoids particularly impact the quality of life treated. Currently, patients must first see a primary care phy for millions of Baby Boomers. However, only about a third of sician and/or a gastroenterologist, who then refer to a Surgeon these patients seek medical treatment. This may be due to the who has the requisite skills to perform current procedures. fact that people are uncomfortable talking about this problem, The long cycle of care causes many patients to never receive that there is perception that there is no good treatment for this treatment, as patients are lost between referrals. If gastroen problem, or that there is a complicated referral pathway. The terologists had a tool to effectively treat hemorrhoids, they grading system used by physicians has 4 grades of increasing could treat the patients they diagnose, preventing patients severity. Grade I are internal hemorrhoids that bleed. Grade II hemorrhoids are those that bleed and prolapse with straining from being lost in a long referral chain. Fewer appointments but return by themselves. Grade III hemorrhoids bleed and would also decrease costs. prolapse with Straining and require manual replacement. SUMMARY OF THE INVENTION Grade IV hemorrhoids do not return to the anal canal and are chronically prolapsed. 0012 Methods, systems, and apparti of ligation (e.g., 0008 Grade I hemorrhoids are treated conservatively with mechanical ligation) of vessels, such as arteries or veins. Such dietary changes (including increasing fiber and water intake) as vessels in the GI tract, for example veins in the esophagus to soften the stool and medications to increase the lubrication or arteries in the GI tract, more narrowly the hemorrhoidal of the stool. Grade II hemorrhoids that do not resolve with the arteries are disclosed. The systems and methods can utilize above therapies are treated by a variety of methods, with hemorrhoidal dearterialization (HD) in which the arteries rubber band ligation being the most common and effective. feeding the hemorrhoids are located and then sealed off. The This method is fast and relatively pain-free, but has a recur systems and methods can utilize transanal open hemorrhoid rence rate of about 70% after 3 years and it usually requires opexy (TOH) in which the hemorrhoids are pexied (lifted and several return visits to the physician. Grade III hemorrhoids tacked up) to the more proximal anorectal canal, thereby are candidates for several different treatments as well, with an preventing their prolapse. Tools are disclosed to make HD and US 2012/0059394 A1 Mar. 8, 2012
TOH easier to perform, safer, require less anal dilation, able 360 degrees until all hemorrhoidal arteries close to the surface to be performed outside the OR, and can be performed with of the interior rectal wall are ligated. out Surgical training. 0018. The user/operator can then perform a confirmation 0013 Apparatus and methods are disclosed for treating check by rotating the device for another 360 degrees to detect hemorrhoids with minimal or no pain to the patient during any arterial blood flow and look for any hemorrhoidal artery and/or after the procedure. The disclosed treatments can be that might have been missed or not ligated previously. The performed outside an operation room (for example in a clinic procedure can be considered complete when the confirmation or office setting), rapidly without the need to have multiple check detects no arterial blood flow to the downstream hem tool exchanges (approximately 10 minutes), easily with mini orrhoid prolapsed plexus. mal training or prerequisite skills required for the operator 0019. Other embodiments of the invention include the use (Surgeons, gastroenterologists, primary care physicians, of balloon, expandable basket, mesh or other expandable nurses, and/or the patient themselves) and efficaciously with member in place of a solid probe at the distal end of the minimal reoccurrence. device. Instead of the use of radiofrequency, other energy 0014. A device is disclosed comprising two or more dis sources such as HIFU can be used in place of RF electrodes. tinct sections: a sensor component for vessel (e.g. artery) In another embodiment the hemorrhoidal artery ligation can detection and location, and a ligation component to ligate the be performed with the use of steam injected directly into the vessel. Some embodiments contain other components, for artery to reduce collateral injury. example, a fixation component to allow for easier ligation, a 0020. Other features include: a control circuit which auto stopper to ensure the working end of the device is inserted to matically determines the optimal power and time require the proper depth, and a handle. Coupled with the device is a ments, based on feedback from the artery and arterial flow vessel (e.g. artery) detection processing unit, such as a Dop sensor; and a radio frequency (RF) electrode-array controlled pler processor. by an array of Doppler ultrasound elements, such that only 0015. Some embodiments contain a ligation electrode(s), electrode elements overlying an artery are activated to ablate a shaft and a proximal handle. Coupled with some embodi underlying tissue. ments is an ablation energy generator, Such as radiofrequency, 0021. Other artery detection sensors or methods are also high intensity focused ultrasound (HIFU), laser, microwave described. First, the sensor can be laser Doppler flowmetry. or cryo. Second, the patient can receive intravenous indocyanine 0016. The device can be inserted into the anus until either green dye, followed by detection of the arteries by near the touch sensor is in contact with the external anus, or when infrared video angiography. Third, the arteries can be the stopper stops the device from being inserted further into detected by measuring absorption of electromagnetic energy the anal canal, to position the Doppler sensor and electrode from the mucosa. Fourth, the sensor can use multiple wave above the dentate line. (Interventions performed above the length bands of electromagnetic energy to differentiate arter dentate line are painless.) Next, the user/operator will turn the ies from veins, by comparing absorption at these wave distal surface of the device to be in contact with the interior lengths. Including Doppler ultrasound sensors, a wall of the rectum (e.g. by articulating a steerable joint). The combination of any of the above sensors can also be used to device is then rotated until the Doppler transducer picks up detect submucosal arterial segments with internal blood flow, signals of arterial flow beneath the rectal mucosa that the in conjunction with or incorporated into inventions described transducer is in contact with. Next, the ligation mechanism is in this document. deployed to stop flow through the artery. In some embodi 0022. The devices and methods hereincan reduce or elimi ments the mucosa is fixed in place after detection of the nate the pain of hemorrhoid treatment. Methods and appara appropriate artery and prior to deploying the ligation compo tus in this application also describe a rapid, convenient and nent. In some embodiments the ligation component is a simple way to perform minimally invasive, painless (or mini mechanical closure. mally painful) treatment of hemorrhoids as both the hemor 0017. In some embodiments the ligation component uses rhoidal artery detector, Such as the Doppler transducer, and energy that is delivered through an electrode that is adjacent the artery ligation tool, such as the RF electrode, can be in a to the Doppler transducer to the hemorrhoidal artery to ligate single device with no working channels required. No tool or ablate the artery. For example, radiofrequency energy can exchanges, such as passing Suture and needles, laser coagu be delivered to precisely increase the temperature of the hem lation device, or other energy ablation tools, through the orrhoidal artery to a temperature above 85 degrees Celsius. working channel of an anoscope or a dilator with Doppler Fibrotic closure of the artery or plexus occurs when subjected transducer sensors, is required to perform the treatment. to heat above 85 degrees Celsius. As neighboring tissue Sur Inventions described in this application also represent appa rounding the hemorrhoidal artery is mucosal or Sub-mucosal ratus and methods to access the anal canal and treat hemor tissue, any potential collateral injury (if any) due to the energy rhoids that do not require patient's anus to be dilated. This is source will be healed with minimal inflammatory response or a key advantage as excessive or prolonged anal dilation has clinical complications. Thermal or ablative energy is deliv been known to be a potential cause of fecal incontinence, a ered until the Doppler transducer does not pick up any signal possible complication that could result using other hemor of arterial flow. At this point, the hemorrhoidal artery that is rhoid treatment tools or options as described in prior art. subjected to the thermal or ablative energy would be ligated, Other advantages also include safety features to ensure thereby stopping blood flow downstream from the ligated energy delivery or ablation can only be performed when the section to the prolapsed hemorrhoidal plexus. This conse electrode is positioned above the dentate line (for manage quently over time will reduce the engorged hemorrhoid ment of pain); and obviating the need for users/operators to plexus and treat the prolapsed hemorrhoids downstream of depend on good direct visualization (often challenging due to the ligated hemorrhoidal artery definitively. The procedure obstructing tissue and poor illumination) to perform ligation can then be repeated by rotating the device circumferentially of superior hemorrhoidal artery. US 2012/0059394 A1 Mar. 8, 2012
0023 Various embodiments and methods by which HD 0047 FIG. 11C is a cross sectional side view of the anus and/or TOH is accomplished via mechanical compression of and rectum with hemorrhoidal arteries above the dentate line the hemorrhoidal artery are also described. Platforms on fully ligated and stopping blood flow to prolapsed hemor which the devices perform HD and/or TOH can include a rhoid plexus downstream. hand-held wand that can be inserted into the anus; and a 0048 FIG. 12 is a schematic diagram illustrating auto device on the end of an endoscope. matic activation of the energy source based on signals picked up by the Doppler transducer to enable rapid and precise SUMMARY OF THE DRAWINGS ligation of hemorrhoidal arteries. 0024 FIG. 1A is a side view of one embodiment of the 0049 FIG. 13A is a side view of the hemorrhoid treatment painless hemorrhoid treatment device coupled to a radiofre device with the distal expandable basket half deployed. quency energy generator and a Doppler processor. 0050 FIG. 13B is a side view of the same hemorrhoid 0025 FIGS. 2A through 2C illustrate variations of the treatment device the distal expandable basket fully deployed device. and in contact with the inner wall of the rectum above the 0026 FIGS. 3A, 3B and 3C illustrate variations of the dentate line. distal end of the device having various ligating components. 0051 FIG. 15A illustrates a variation of a method for 0027 FIGS. 4A through 4C illustrate a variation of the insertion of the deflated balloon catheter into the rectum distal end of the device during use. through the applicator. 0028 FIG. 5A illustrates a variation of a clip deployment 0052 FIG. 15B illustrates a variation of a method for mechanism that can be located inside of the housing of the inflation of the balloon catheter using a pressure and/or Vol device. ume-controlled Syringe. 0053 FIG. 15C illustrates a variation of a method for 0029 FIG. 5B illustrates a variation of the clip. removal of a deflated balloon catheter with hemorrhoidal 0030 FIGS.6A through 6Cillustrate variations of the clip. arteries in a collapsed state. 0031 FIGS. 7A and 7A illustrate undeformed variations 0054 FIG. 17 illustrates a method for insertion of the of the clip. Doppler-RF-Electrode-Array device into the anus, placing 0032 FIGS. 7B through 7E illustrate deformed variations the pad onto mucosa above the dentate line. of the clip of FIG. 7A. 0055 FIG. 18A is a rear view of a branching hemorrhoidal 0033 FIG. 8A illustrates an undeformed variation of the artery. clip. 0056 FIG. 18B is a rear view of the Doppler-RF-Elec 0034 FIGS. 8B through 8E illustrate deformed variations trode-Array being placed on top of mucosa overlying the of the clip of FIG. 8A. branching hemorrhoidal artery of FIG. 18A. 0035 FIG. 14A illustrates a variation of a balloon catheter with ultrasound crystals mounted to the exterior of the bal 0057 FIG. 18C is arear view of a variation of a method for loon. ablating the artery of FIG. 18A by activating a subset of the 0.036 FIG.14B illustrates a variation of cross-section A-A RF electrode elements in the electrode array. of FIG. 14A. 0058 FIG. 18D is a rear view of the ablated hemorrhoidal 0037 FIG. 14C illustrates a variation of a balloon catheter artery of FIG. 18A. with ultrasound crystals mounted on the internal shaft of the 0059 FIG. 19A is a side view of the hemorrhoid treatment balloon. device that utilizes steam energy inserted through the anus 0038 FIG.14D illustrates a variation of cross-section B-B without requiring dilation of the anus. of FIG. 14C. 0060 FIG. 19B is a side view of the hemorrhoid treatment 0039 FIGS. 16A and 16B are front and oblique views, device that utilizes steam energy with the Suction cup respectively, of the device with a Doppler-electrode-array. deployed. 0040 FIGS. 16C and 16D are oblique and top view, 0061 FIG. 19C is side view of the hemorrhoid treatment respectively, of the device with a Doppler-electrode-array and device utilizing steam energy to ligate Superior hemorrhoidal ultrasound waves emanating from the array. arteries with Suction cup providing stabilization during the 0041 FIG. 9A illustrates a variation of the treatment treatment. device attached to video endoscope with an radio frequency 0062 FIG. 19D illustrates a method of using the hemor electrode. rhoid treatment device for injecting a bulking agent to tam 0.042 FIG.9B illustrates a variation of cross-section C-C ponade the hemorrhoidal arteries. of FIG.9A. 0063 FIG. 20' illustrates a variation of the hemorrhoid 0043 FIGS.9C and 9D are close-up views of variations of treatment device emitting infrared radiation in a circular pat the distal end of the endoscope and the endpiece Suctioning tern in the rectum. tissue. 0064 FIGS. 20A and 20B illustrate a prolapsed hemor 0044 FIG.10 illustrates a variation of the treatment device rhoid and apexied hemorrhoid, respectively. attached to a video endoscope using a clip. 0065 FIGS. 21A and 21B illustrate a variation of a 004.5 FIG. 11A is a side view of the hemorrhoid treatment method of hemorrhoid treatment by peXying by Scarring. device locating a Superior hemorrhoidal artery above the den 0066 FIGS. 22A and 22B illustrate a variation of a tate line and ligating said hemorrhoidal artery non-invasively method of hemorrhoid treatment by peXying with a mechani with radio frequency energy. cal fastener. 0046 FIG. 11B is a side view of the hemorrhoid treatment 0067 FIGS. 23A and 23B illustrate a variation of a device rotated about the anal canal/inferior rectum, locating method of hemorrhoid treatment by pexying with a pleat. and ligating another hemorrhoidal artery above the dentate 0068 FIGS. 24A and 24B illustrate a variation of a line non-invasively. method of hemorrhoid treatment by pexying with a pleat. US 2012/0059394 A1 Mar. 8, 2012
0069 FIGS. 24A and 24B' illustrate a variation of a electrode, for example to deliver energy to ligate the artery method for treating hemorrhoids by peXying with a radially detected by the Doppler signal. expandable stent. 0086. The distal section can have a distal outer diameter 0070 FIGS. 25A through 25C illustrate a variation of a that is Small enough to not require a patient's anal canal to be method for using a clip. dilated before said invention can be inserted. For example, the (0071 FIGS. 26A through 26D illustrate a variation of a distal outer diameter can be about equal to or Smaller than the method for using a clip. diameter of an average adult human finger. The distal outer 0072 FIG. 28 illustrates a variation of using a clip in a diameter can be Smaller than about 2 cm, more narrowly section of tissue. smaller than about 1.5 cm, yet more narrowly smaller than 0073 FIGS. 29A and 29B illustrate a variation of a about 1 cm. method for using a staple. I0087. The section connecting the distal artery and ligation 0074 FIGS. 30A through 30D illustrate a variation of section to the mid-shaft section can be made of one or more ligating a hemorrhoidal artery. steerable joints or links, for example covered by a flexible 0075 FIGS. 31A through 31H illustrate a variation of case, housing or boot. The steerable joints or links can enable ligating a hemorrhoidal artery. the distal detection and ligation section to be articulated at an 0076 FIGS. 32A through 32D illustrate a variation of angle to access and be in contact with the rectal wall. The ligating a hemorrhoidal artery. articulating joint can be made from pull wires, pinned links, 0077 FIG. 32E illustrates a variation of the device of laser cut extrusions, double durometer extrusions, or combi FIGS. 32A through 32.D. nations thereof. 0078 FIGS. 33A through 33B illustrate a variation of I0088 Proximal to the steerable joints, the device can have ligating a hemorrhoidal artery. an insertion stopper. The insertion stopper can have at least 0079 FIGS. 34A through 34E illustrate a variation of about two different outer diameters along the longitudinal ligating a hemorrhoidal artery. profile, the first distal diameter can be approximately the 0080 FIGS. 35A through 35C illustrate a methodofpexy diameter of the artery detection and ligation section, and the ing a prolapsed hemorrhoid. second outer diameter, proximal to the first diameter, is of an I0081 FIGS. 36A through 36C illustrate a methodofpexy outer diameter at least two times that of said first outer diam ing a prolapsed hemorrhoid. eter. The insertion stopper can prevent the hemorrhoid treat ment device from being inserted too deep into the anal canal DETAILED DESCRIPTION (e.g., greater than about 8 cm from anal Verge) and potentially 0082. This application discloses devices (i.e., appara damaging the middle or Superiorrectum or the sigmoid colon. tuses) and methods that provide a way to treat patients Suf The insertion stopper can have depth measurement gradia fering from hemorrhoids. The apparatuses and methods can tions or markings longitudinally along the insertion stopper, treat hemorrhoids with minimal or no pain to the patient for example, to inform the user/operator length of the device during and/or after the procedure. The treatment can be per that is inserted into the anal canal. The visible gradiations can formed outside an operation room (for example in a clinic or be checked during insertion of the device into the anus. The office setting), rapidly without the need to have multiple tool gradiations can be used to increase the likelihood that the exchanges, in approximately 10 minutes, easily with minimal ablation component, such as the RF electrode, has been training or prerequisite skills required for the operator (e.g., inserted into the colon above the dentate line before perform Surgeon, gastroenterologist, primary care physician, nurse, ing a Substantially painless (e.g., performed Superior to the and/or the patient themselves), efficaciously with minimal dentate line) ligation, for example inserted about 2-3 cm. reoccurrence, or combinations thereof. I0089 FIG. 1A illustrates that for example, when the 0083. As seen in FIG. 1A, the device can have about four device is fully inserted through the hemorrhoid patient's anus, distinct sections: a distal artery detection and ligation section, the Doppler transducer and ablative electrode can be posi an insertion stopper section, a shaft, and a proximal handle. tioned approximately 6 cm (e.g., plus-minus 1 cm) above the Coupled with the device is an ablation energy generator. Such anal verge, or approximately 1 cm to 2 cm above the dentate as radiofrequency, high intensity focused ultrasound (HIFU), line. This position represents a pain-free position for the laser, microwave energy generation or cryogeneration com device to locate Superior hemorrhoidal arteries and to ligate ponent, and the artery detection processing unit, Such as a the hemorrhoidal arteries by the ablative energy source, such Doppler processor. as radiofrequency, via the electrode around the Doppler trans 0084. The distal artery detection and ligation section ducer. ("distal section’) can have a traumatic or atraumatic terminal 0090 The device can have multiple touch sensors posi tip. For example, the terminal tip can be soft, such as by being tioned circumferentially around the insertion stopper at the covered with a soft elastomer, and comfortable for use during transition between first distal smaller outer diameter and the insertion into the anus. second proximal largerouter diameter. Said touch sensors can I0085 FIGS. 1A and 1B illustrate that the distal tip can be a safety mechanism, for example to ensure ablative energy have an ligation element, Such as a monopolar or bipolar RF can only be activated when the electrode is placed above the ablation electrode, mounted on the exterior surface of the dentate line. When the touch sensors are in contact with the distal section. A Doppler sensor/transducer can be positioned external anoderm, the device is fully inserted with the elec in the middle of the electrode. The RF electrode can surround trode and Doppler transducer at least 5 cm from the anal the Doppler transducer, for example to maximize ablation of verge, thereby being at least 2 cm above the dentate line. (The the area sensed by the Doppler transducer (e.g., to ablate to dentate line is about 2.5-3 cm above the anal verge.) Deliv fully stop the blood flow or otherwise ligate the hemorrhoidal ering of ablative energy or heat above the dentate line is artery detected by the Doppler transducer). The Doppler important as therapy on the interior wall of the rectum is transducer can be positioned in the middle of the ablation painless if it is above the dentate line. US 2012/0059394 A1 Mar. 8, 2012
0091. The stopper can have a dial, for example at the For example the Suction Source can be a syringe coupled to the proximal end of the stopper. Rotating the dial can control handle (as shown) or central suction (delivered from a wall rotating of the device, for example to rotate the electrode and port in a health care facility's room). The suction port can be Doppler sensor about 360° or more with respect to the extended from and retracted into the distal section of the remainder of the device proximal to the stopper. device. 0092. The third section of the device is a cylindrical shaft 0096. When the probe has located the artery, the physician connecting the insertion stopper section and the proximal can turn on the Suction Source (e.g., press a control button or handle section. Said shaft can be rigid or flexible. If said shaft draw on the syringe). The suction delivered by the suction is flexible, it will be at a durometer that allows proper force port can fix to and/or pull the rectal tissue containing the transmission along the shaft such that the device can be easily hemorrhoidal artery of interest into the distal section of the inserted into the anus and apply decent contact pressure on the device. The physician can then activate the clip applier, rectal wall for the Doppler transducer to effectively locate and thereby sealing or collapsing the hemorrhoidal artery and/or detect arterial flow and for the electrode to effectively deliv turn on the radiofrequency energy from the RF electrodes, ery heat or other ablative energy (such as cryo) to ligate the sealing or collapsing the hemorrhoidal artery. hemorrhoidal artery. Between the shaft and the insertion stop 0097. The Doppler sensor, which can be continuously on per is also a rotation dial that tracks the rotation of the device. during a Surgical procedure, can determine if the artery has Hence, if the device is rotated over, for example 30 deg, the been sealed off when it no longer detects blood flow through dial located on the proximal side of the insertion stopper the artery. If the radiofrequency energy is used, the radiofre (distal to the shaft) will indicate a colored arc showing that the quency energy can be automatically turned off (or the physi device has been rotated for 30 degrees as a way to help cian can determine when to turn it off) when the Doppler user/operator keep track. The purpose of said rotation dial is sensor no longer detects blood flow through the artery. This to ensure that the user/operator has rotated the device a full procedure will be repeated until all six of the hemorrhoidal 360 degrees to thoroughly locate all hemorrhoidal arteries arteries are collapsed. In place of a clip applier, this same circumferentially to ligate. device can also use any of the other methods of mechanical 0093. The device can have a handle section (“handle') ligation described below, or other mechanicalligation mecha proximal to the shaft section. The handle section can be the nisms. The handle can have a Doppler control. Such as a most proximal section of the device. The handle can comprise switch to turn the Doppler sensor on and off of a squeeze trigger that steers the steerable section of the 0098. The distal section can be non-articulating and have a distal tip, a ligation control such as an ablation start/stop rigid neck. button to manually activate or override the energy source used 0099 FIG. 2B shows a variation of the device that can use for ablation or ligation, an audio handle speaker to playback a rubber band, or other mechanical mechanism to pinch Doppler audio signals when an artery is located. The audio closed the hemorrhoidal artery. The device can use Doppler handle speakers can be built in to the handle and broadcast ultrasound to locate the hemorrhoidal artery and Suction to Sound corresponding to the detected vascular (e.g., arterial) isolate the tissue of interest in the distal end of the device. The flow. The trigger can have a locking mechanism to fix the device can have a mechanical mechanism, such as a rubber angle of the steerable section of the distal tip at an angle. band applicator, that can seal off the hemorrhoidal artery. 0094. The device can be coupled from the handle to an Additionally, in this variation, the handle of the device can energy generator, such as a radio frequency, HIFU, micro have a trigger that can have a lever mechanism by which the wave, laser or cryogenerator. The device can be coupled to a mechanical seal can be activated. The mechanical sealing Doppler ultrasound signal processor, or a processor of an mechanism could be performed in numerous ways, including alternative sensor that can be used in place of Doppler to via rubber bands, staples or clips. locate and detect hemorrhoidal arteries. More of such alter 0100. The remote component and/or suction device (e.g., native sensors that can be used in place or in conjunction with Syringe, as shown) can have a clip. The remote component Doppler are disclosed in the later part of this application. The and/or suction device can be removably attached to the Doppler or alternative processor can deliver output to visual handle. (e.g., video monitor) and/or audible (e.g., processor speakers 0101 FIG. 2C illustrates that the distal section can have a and/or headphones) components. The processor and/or gen distal lip proximal of the terminal tip. The distal lip can be erator can be within the housing of the handle and/or attached proximal of the sensing component, such as the Doppler to a remote component. sensor, and ligation component, such as the RF electrode. The 0095 FIG. 2A illustrates that the device can be a hand distal lip can be distal of the stopper. The distal lip configu held, stand alone device. The device can have a Doppler ration can bend sharply toward the longitudinal axis of the ultrasound sensor, Suction, an energy-based ligation compo neck proximal to the distal lip. The Doppler sensor and RF nent Such as a radiofrequency (RF) energy applier Such as one electrode can be positioned laterally away from the longitu or more RF electrodes, and/or a mechanical ligation compo dinal axis of the neck of the device. During use, the distallip nent such as a clip applier. Initially, the physician can place can be inserted past the prolapsed hemorrhoid and then pulled the device into the patient's anus until the stopper or device back partially toward the anus. The distal lip can be used to cuff comes in contact with the external anus, for example to pull the prolapsed hemorrhoid down (i.e., inferiorly) to posi position the sensing and ligating components of the device tion the hemorrhoid adjacent to the Doppler sensor and RF above the dentate line. Once the device is positioned at the electrode and inferior to the terminal tip. FIG. 3A illustrates target site, the physician can turn on the Doppler sensor the distal end of the mechanical sealing device using rubber allowing the physician to locate the hemorrhoidal artery (of bands to seal the hemorrhoidal artery. As shown, a cartridge which there are approximately six). The distal tip can have a of rubber bands can be circumferentially located around the Suction port in fluid communication with a section source. distal window. In this embodiment, the tissue can be pulled The suction source can be located away from the distal tip. into the distal window of the device via suction and then the US 2012/0059394 A1 Mar. 8, 2012
physician can deploy the rubber band by pulling on the lever, (0.108 FIG. 5B illustrates a variation of the clip. The clip shown in FIG. 2A. By pulling on the lever, the mechanism can have a clip tip and a clip base. When compressed, the clip holding the rubber bands in place can retract, thereby pushing tip can be closed before the clip base, for example to prevent the most distal rubber band and releasing said rubber band tissue within the clip from being pushed out of the clip during around the base of the tissue. The pinching effect on the tissue clamping and clip compression. The clip can be plastically fold can mechanically occlude the hemorrhoidal arteries. deformed when closed or the clip can be elastic and held open 01.02 FIG. 3B shows the distal end of the mechanical until deployed. sealing device using staples to seal the hemorrhoidal artery. In 0109 FIG. 6A illustrates that the clip tips at the terminal this variation, two rows of staples will be located inside the ends of the clip arms (i.e., clip legs) can be traumatic. For mouth of the anvil at the distal end of the device. Once the example, the clip tips can be barbed. The barbs pierce through artery has been located via Doppler and Suction applied to the mucosa to the Submucosa, thereby fixing the clip to the pull tissue into the device, the physician will pull the lever at tissue. The barbs are offset (different clip arm lengths), so that the proximal end of the device (as shown in FIG. 2A). This when the clip is closed (goes from U-shaped to I-shaped), the action will force the anvil to close and drive a row of staples barbs can flatten out better with increased interaction area. into the tissue, thereby sealing the artery. Additionally, the medial surfaces of the clips should be flat 0103 FIG. 3C shows another variation of the mechanical (rather than rounded), which can prevent Scissoring of the sealing invention by which clips are used to collapse the clip. A cross-section of an artery shows a placement of the artery. In this embodiment, the artery is again located via vessel within the clip during use. Doppler, and Suction is applied to pull tissue into the distal 0110 FIG. 6B illustrates that the clip base can be end of the device. The physician will then activate the lever V-shaped, which can aid in the clip being easier to close located at the proximal end of the device to push a clip out of completely. The clip tips can be atraumatic. The clip tips can the device. Upon deploying said clip off the device onto the be configured to reduce puncture of tissue by the tips. The clip tissue fold, the clip will collapse into a closed configuration tips can be configured as spheres with larger cross-section around the isolated tissue, thereby sealing the artery. (The clip diameters than the clip arms. applicator is shown in-plane for illustrative purposes, but can 0111. The lengths of the opposed clip arms can be differ be out-of-plane compared to the figure as shown.) ent (as shown) or the same. 0104 FIG. 4A illustrates a device that has a suction port or 0112 FIG. 6C illustrates that the cross section of the clip aperture that can be flush with the bottom of the housing can be square. The clip can be configured to reduce the motion during the initial stage of suction. The Suction port can have a of the arms of the clip to scissor or move out of plane with the Suction port cover. remainder of the clip. 0105 FIG. 4B illustrates that after the tissue is sucked into 0113 FIG. 7A illustrates a naturally curled clip help in an the Suction port, the Suction port cover can be retracted into open C-shaped configuration and inserted into the tissue the housing of the distal section as a rear panel attached to the around the artery. FIG. 7B illustrates that the clip can be Suction port cover is elevated away from the opposite side of released and relax into a closed configuration, compressing the housing from the suction port. The tissue that has been and ligating the artery. Sucked into the Suction port can be drawn into the housing. 0114 FIGS. 8A and 8B illustrate that the clip tips can be 01.06 FIG. 4C illustrates that the distal end of the device directed inward and out of plane with the clip legs. The clip can have a clamping mechanism located within the housing. arms can be different lengths. The clip tips can point in The clamping mechanism can have opposed internal jaws that opposite directions when out of plane. can clamp a clip onto tissue that has been Sucked into the 0115 FIGS. 9A and 9B illustrate that the clip arms can be housing. When the suction port cover retracts into the hous the same length. The clip tips can abut each other in a staple ing, the tissue mound drawn into the housing by the Suction port cover can be positioned adjacent to, and between, the like fashion when closed and press downward. The clip tips internal jaws. can be out of plane and not abut each other when closed. 0116 FIGS. 10A and 10A illustrate variations of the clip 0107 FIG. 5A illustrates that the jaws, which lie just in an undeformed configuration. The clip arms can be sym inside the device housing, close on the tissue mound, thereby metric (e.g., have the same length) or asymmetric (e.g., have placing a clip across the tissue mound. The proximal ends of different lengths). FIGS. 10B through 10E illustrate varia the internal jaws can be slidably attached by pins inserted tions of the clip of FIG. 10A in deformed configurations. The through pinholes in the jaws to tracks in an actuation sleeve. clips can be symmetrically barbed. The interaction area and The tracks can control and limit the jaw closure and opening by interference fitting against the pins. The actuation sleeve forces can be high and the clips can be configured to Scissor. can encompass the length of the internal jaws positioned 0117 FIG. 11A illustrates a variation of the clip in an within the actuation sleeve. The width of the actuation sleeve undeformed configuration. The legs of the clip can be asym can be less than the width between the opposed internal jaws metric or offset (e.g., have different lengths). FIGS. 11B when the jaws are in a relaxed configuration. The internal through 11E illustrate variations of the clip of FIG. 11A in jaws can form a natural spring biased to be in an open con deformed configurations. The clips can be offset barbed. The figuration, and/or the internal jaws can have a spring attached interaction area can be high. The clips can have a flattening between the jaws to bias the jaws outward from each other. As interaction area. The clips can be configured to reduce of the actuation sleeve is slid distally with respect to the jaws, the prevent Scissoring. jaws compress toward each other, compressing a clip posi 0118 FIGS. 12A and 12B' illustrate that the clip arms can tioned between the jaws and clamping any tissue located be rotatably attached at a hinge. between the jaws. The jaws can be configured to close the clip 0119 FIGS. 13A and 13B' illustrate that a staple can be tip before closing the clip base. inserted around the artery. The head of the staple can remain US 2012/0059394 A1 Mar. 8, 2012
outside of the surface of the mucosal tissue. The staple arms ers to the environment radially exterior to the balloon, such as can be bent around the artery, compressing and ligating the mucosa and/or hemorrhoidal arteries. artery. 0129 FIGS. 16A and 16B illustrate that the radiofre 0120 FIG. 14' illustrates a W-shaped clip being bent and quency (RF) electrodes, or other ablation component, can be deformed towards its center to encompass and ligate an artery. divided into an electrode-array controlled by an array of 0121 FIG. 15 illustrates three variations of barbed needle sensing components, such as Doppler ultrasound sensors. clips that can be used to ligate the artery. The barbs can Each ablation-sensing pair can have an RF electrode located prevent backing out once the clip is deployed in the tissue. immediately adjacent to and/or within a Doppler sensor. The 0122 FIGS. 16A and 16B' illustrate a clip in an opened ablation-sensing pairs can be configured in an orthogonal and closed configuration. The clip can be a Nitinol clip which grid, for example about eight pairs wide by about nine pairs remains closed in a relaxed configuration. The clip can have long. bioabsorbable toothed blocks at the ends of the clip arms. 0.130. When a Doppler sensor in the array detects arterial Once released from a deployment tool, the clip arms can flow, for example by detecting a pulsatile acoustic waveform, angularly close and compress the artery between the bioab the RF electrode in the same ablation sensing pair (i.e., cor Sorbable blocks, ligating the artery. The clip arms can be relating with the position of the aforementioned, artery flow removed. The blocks can be bioaborbed over time. detecting Doppler sensor) can be activated to ablate underly ing tissue. The electrodes can ablate when located directly 0123. The devices and elements for performing HD and/or over the artery. The array can provide for a resolution for the TOH can be located on the end of or along a flexible endo ablation pattern corresponding to the density of the array. Scope. I0131 The device can have a distal pad connected via a 012.4 FIGS. 14A and 14B show a device that can ablate pivoting joint to a proximal handle, which is in turn connected with ultrasound energy. The energy can be applied with a to a central control system. The distal pad can have an array of balloon catheter that can have an inflated balloon. The device ablation-sensing pairs. The distal pad can be a Substrate for can comprise an applicator and the balloon catheter for inser the ablation-sensing pairs. The distal pad can be made from a tion into the anal canal for the purpose of ablating the hem rigid material. Such as a plastic or metal, or a resilient or orrhoidal arteries, such as the superior or middle hemor non-resilient expandable balloon. The central control system rhoidal arteries. The applicator can have a hollow core which can include a generator to generate the RF energy, circuitry can contain the deflated balloon catheter. The applicator can and other electronics to generate and process Doppler signals, insert the balloon catheter into the anal cavity, minimizing the and a control circuit that can interpret Doppler signals to discomfort that may be caused when components of the cath control which elements in the electrode array are turned on. eter pass through the sensitive area below the dentate line. I0132 FIG.16A illustrates that the pad can be substantially 0.125 FIGS. 14A and 14B illustrate that the balloon cath flat or planar. FIG.16B illustrates that the pad can be a partial eter can be comprised of a hollow shaft with an inflatable or complete cylinder (i.e., having a semi-circular or circular member, Such as a balloon, at the distal end. The proximal end cross-section), and/or a partial arc (i.e., having a round cross of the shaft can have an inflation port for inflation of the section, but not necessarily having a constant radius). inflatable member and/or an injection port for injection of (0.133 FIGS. 16C and 16D illustrate that the cylindrical or material through a distal port of the catheter. The device can otherwise arc shape of the electrodes can cause the Doppler have one or more ultrasound transducers, such as ultrasound ultrasound energy to emanate from all points underneath the crystals mounted to the radial exterior or interior of the exter electrode array. The Doppler ultrasound can detect arteries nal wall of the balloon. The ultrasound transducers can be which underlie the tissue placed under the distal pad. high frequency ultrasound (HIFU) transducers. The ultra I0134. The array of ultrasound elements can generate a Sound transducers can be located at one or more longitudinal virtual image of the arteries underlying the mucosa onto lengths along the balloon. The ultrasound transducers can be which the pad is placed. The central control system can select aligned at one or more angles, with respect to the longitudinal subsets of RF electrode elements to turn on, thus ablating only axis of the balloon. tissue underneath activated electrode elements. 0126 The inflatable member can be made of polyure 0.135 FIG. 9A illustrates an endoscopic device that can thane, nylon or any number of polymeric materials. The shape achieve HD and/or TOH via a combination of a Doppler of the inflatable member can be a single, cylindrical or spheri sensor to detect the hemorrhoidal artery, and an RF electrode cal balloon. The balloon in an inflated configuration can to ablate (e.g., heat-seal) the artery. The device can have a obstruct the anal canal. The shaft of the balloon catheter can distal endpiece that can be fixedly or removably attached to have gradiations or markings, for example, to indicate the the distal working end of an endoscope, and a remote com depth of insertion of the catheter into the anal canal, which in ponent, such as a control box that is connected to the controls turn can result in the user knowing how far the inflatable on the endscope. The endpiece can be clipped, glued, welded, balloon portion is inserted above the dentate line and in the screwed, or snapped to the distal end of the endoscope. The region of interest to apply energy and collapse the hemor endoscope can have an endoscope handle. The handle can rhoidal arteries. have a steering mechanism that can control the angular 0127 HIFU can be used to ablate the arteries concurrentor deflection of the distal terminal tip of the endoscope and the Subsequent to Doppler ultrasound being used to locate and endpiece. The endoscope, for example on the handle, can check for arterial flow. have an endoscope port. The RF electrode and wires connect 0128 FIGS. 14C and 14D illustrate that the ultrasound ing the electrode to the remote component can be slid through crystals can be mounted internal to the inflatable member on the endoscope port toward the distal end of the endoscope. the shaft of the balloon catheter. The balloon can be filled with 0.136 FIG. 9B illustrates that the endoscope can have a liquid, for example Saline solution or water. The liquid can lumen or channels for fluid irrigation, fluid aspiration, a light transmit the ultrasound energy from the ultrasound transduc Source, fiber optic camera or other visualization tools, and US 2012/0059394 A1 Mar. 8, 2012
one or more instruments or tooling. The leads or wires for the normally forward looking endoscope to look about 90° later ablation tool and/or sensor (e.g., Doppler sensor) can be ally. Alternatively, the endpiece could have a port on the tip slidably received in the instrument lumen. The light source that allows normal forward visualization through the end can emit light at the distal end of the endoscope. The ablation scope. Alternatively, the mirror could be adjustable, thus tool can be one or more RF electrodes, other heat sources allowing the user to look forward through the scope, until the (e.g., electrical resistive heating coil or pad, Peltier junction), Scope is in place, at which point the mirror is adjusted so that a freezing component (e.g., Peltier junction, cooling tube the scope looks about 90° laterally. filled with circulating fluid at sub 0°), or combinations 0.143 FIG. 10 depicts another endoscope-based embodi thereof. Although RF electrodes are described throughout, ment, which achieves HD and/or TOH by using mechanical any of the alternative ablation components can be used with or devices to seal hemorrhoidal arteries and/or pexy hemor in place of the RF electrodes. rhoids. The device can have an endpiece which is attached to 0.137 The endpiece can have a Doppler sensor to locate the working end of the endoscope, and a control box that is the hemorrhoidal artery; a Suction port that can grab, hold and connected to the controls on the endoscope. evaginate the tissue containing the artery into the port, 0144. The endpiece can have a Doppler sensor to locate wherein the suction port is connected with and powered by the hemorrhoidal artery; a Suction port that can evaginates the the suction channel of the endoscope; an RF electrode(s) to tissue containing the artery into the port; and any of a variety heat the artery in order to seal the artery to prevent blood flow: of embodiments to mechanically produce HD and/or TOH, or combinations thereof. The Doppler sensor, Suction port, for example the variations of FIGS. 3A through 3C, which RF electrode(s), or combinations thereof, can be on the lateral include rubber band applicators, clip appliers, and Staplers. side of the endpiece. The endpiece can be in data and energy The endpiece can communicate with the control box, with communication with the control box, with leads, wires or wires or tubing that either are contained in the working instru tubing that can be contained in the working channels of the ment channels of the endoscope, or along the outer diameter endoscope, and/or along the outer diameter of the endoscope. of the endoscope. A control handle can be attached to the 0138 FIG. 9C illustrates that the suction port can apply wires. The control handle can be configured to release the Suction, as shown by arrows, and draw tissue into the end mechanical sealing device. Such as rubber bands, staples, piece through the open distal end of the endpiece. The Suction clips or combinations thereof. port can be located on the distal terminal end of the endo 0145 The control box can contain a Doppler processor Scope. The Suction port can be positioned adjacent to the which takes the signal from the Doppler sensor in the end Doppler sensor and the RF electrode. The Doppler sensor and piece, and converts it into sound, thereby allowing the phy the RF electrode can be on the radially inner side of the wall sician to hear the pulsatile flow of an artery, via a speaker on of the endpiece. The tissue can be suctioned to be adjacent to the box or headphones. The device can have one or more and/or in contact with the Doppler sensor and the RF elec components, such as actuators for example Solenoids, can aid trode. The endpiece can attach coaxially (i.e., with collinear the mechanical force generation in the endpiece, and a com longitudinal axes) with the endoscope. puterized control system that can sense the Doppler signal to 0139 FIG.9B illustrates that the suction port can be on the control mechanical components in the endpiece. The physi lateral wall of the endpiece. The Doppler sensor and the RF cian can control the device via the variation and elements electrode can be positioned immediately adjacent to the Suc described above for FIG.9A. Visualization can be achieved tion port. The Suction port can apply suction to hold the tissue via variations and elements similar to those described for against the radial outside wall of the endpiece. The tissue can FIG.9A. be adjacent to and/or in contact with the Doppler sensor and 0146 Method of Use the RF electrode. The endpiece can attach off-axis to the 0147 As shown in FIG. 11A, the rectum has hemorrhoidal endoscope, for example with the later wall of the endoscope arteries, classified as Superior, middle and inferior hemor aligned with the lateral wall of the endpiece. The endpiece can rhoidal arteries. The hemorrhoidal arteries are also known as have a larger (as shown), Smaller or same outer diameter as rectal arteries. The arteries targeted by the devices described the endoscope. herein are usually the longitudinal Submucosal branches of 0140. The control box can have a Doppler processor which the rectal arteries, also known as the Superior hemorrhoidal can receive a signal from the Doppler sensor positioned in the arteries, and for simplicity, are often referred to as the hem end piece and converts the signal into Sound, thereby allowing orrhoidal arteries herein. The dentate line, superior/orad to the physician to hear the pulsatile flow of an artery via a which the mucosa does not register pain, is usually about 2-3 speaker on the box and/or headphones. The control box can cm into the rectum past the entrance to the anal sphincter. have an RF generator, which can produce the RF energy (The anal sphincter can be classified as the internal anal which is transmitted through the RF electrodes in the end sphincter and the external anal sphincter.) Hemorrhoids are piece. The control box can have a computerized control sys located at the juncture between the hemorrhoidal arties and tem that will sense the Doppler signal to control the timing the veins. External hemorrhoids are located exterior to the and intensity of the RF signal. anus. Internal hemorrhoids are located within the rectum. 0141. The physician can control the device via control 0148 FIGS. 11A and 11B illustrates the method of treat buttons on the endoscope to control the two working channels ing hemorrhoids with minimal or no pain. As shown in FIG. and Suction channel could be used to control the Suction and 11A, the device can be inserted into the anus until at least one RF; the physician could control the RF and suction with foot of a pressure-sensing touch sensor attached to the distal end of pedals; the RF & suction could be controlled via buttons on the stopper is in contact with the external anus, or when the the box. insertion stopper stops the device from being further inserted 0142. The Doppler sensor, suction port, and RF electrode into the anus. The Doppler sensor and RF electrode can be can be on the lateral side of the endpiece, with visualization about 2-3 cm above or superior to the dentate line at this part achieved via a mirror within the endpiece that allows the of the procedure. Next, the user/operator can articulate the US 2012/0059394 A1 Mar. 8, 2012
steerable joint to enable the distal surface of the device to be blood flow is detectable beneath the mucosa on which the in contact with the interior wall of the rectum. The device is ablating member sits. If blood flow is detected, the physician then rotated until the Doppler transducer picks up signals of is alerted (e.g., with an acoustic signal through a speaker or arterial flow beneath the rectum that the transducer is in headphones) to the presence of arterial blood flow, and the contact with. ablation component can be activated and ablation energy can 0149. At this point, the device has successfully located a be applied to the region of mucosa under which blood flow hemorrhoidal artery, such as a Superior hemorrhoidal artery. was detected. If blood flow is not detected, the physician is Next, ablation energy is delivered through the electrode that is alerted to the absence of arterial blood flow (e.g., with an adjacent to the Doppler transducer to the hemorrhoidal artery acoustic signal through a speaker or headphones different to ligate or ablate the artery. For example, radiofrequency energy can be delivered to precisely increase the temperature from the signal when blood flow is detected, or with the of the hemorrhoidal artery to a temperature above 85 deg absence of an acoustic signal), and no ablation energy is Celsius. Fibrotic closure of the artery or plexus occurs when applied. A loop continues in this manner until no blood flow subjected to heat above 85 degrees Celsius. As neighboring is detected or a safety shutoff is activated. tissue surrounding the hemorrhoidal artery is mucosal or 0154 The safety shut-off can be a timer mechanism in Sub-mucosal tissue, any potential collateral injury (if any) due which ablation energy is shut offbecause the ablation energy to the energy source may be healed with minimal inflamma has been Supplied for a length of time meeting or exceeding a tory response or clinical complications. Thermal or ablative safety threshold, such as the threshold length of time that has energy is delivered until the Doppler transducer does not pick been found to be safe. The safety shut-off can employ a up any signals. sensor, Such as an impedance sensor, which shuts off the 0150. At this point, the hemorrhoidal artery that is sub ablation energy if the sensed variable (e.g., time, temperature, jected to the thermal or ablative energy would be ligated, or combinations thereof) enters a range that is considered thereby stopping blood flow downstream from the ligated unsafe or undesirable. The safety shutoff can be a physician section to the enlarged and engorged hemorrhoidal plexus. operated over-ride Switch, which the physician or operator This consequently over time will reduce the engorged hem can flip or otherwise activate at any time during the proce orrhoidal plexus and definitively treat the prolapsed hemor dure. rhoids downstream of the ligated hemorrhoidal artery. 0155 The device illustrated in FIG. 13A is a variation of 0151. As shown in FIG. 11B, the procedure can then be the device that can have an expandable member at the distal repeated while slowly rotating, as shown by arrows, the section. The expandable member can be inserted into a device circumferentially for the fully 360 degrees until all patient's anal canal while in a narrow profile so as to minimize hemorrhoidal arteries close to the surface of the interiorrectal or prevent the need for dilation of the anus. wall are ligated. There are often six and sometimes up to ten 0156 FIG. 13B illustrates that once the device is inserted hemorrhoidal arteries (there is a natural variation within the to the specified length, a plunger on the proximal end is population), any or all of which can be ligated. The user/ pushed, which opens the expandable unit at the distal end of operator can then perform a confirmation check by rotating the device inside the rectum. The expandable unit can be a the device for another 360 degrees to detect any blood flow basket, balloon, mesh, etc. The basket has several struts that detected by the Doppler sensor indicating any hemorrhoidal expand such that it conforms to the rectal wall circumferen artery that might have been missed and not ligated previously. tially. This provides support to keep the device in a fixed The confirmation check can be performed until the Doppler position once properly positioned. When the distal end is not sensor detects no blood flow to the downstream engorged completely expanded it can be rotated about its axis until the hemorrhoidal prolapsed plexi, as shown in FIG. 11C. The Doppler picks up signal so as to localize the hemorrhoidal ligated artery will no longer deliver blood to the hemorrhoid. arteries. One or more of the basket struts can have an irriga 0152 Methods described in FIGS. 11A through 11C tion port on the distal end to infuse cold saline to cool the describe a rapid, convenient and simple way to perform mini tissue electrode interface. Proximal to the infusion port is the mally invasive, painless (or minimally painful) hemorrhoids RF electrode, which ablates the hemorrhoidal artery. When treatment as both the hemorrhoidal artery detector, such as the the user locates the artery by Doppler, the expandable mem Doppler transducer, and the artery ligation tool. Such as the ber is fully expanded and the saline irrigation and RF elec RF electrode, are built into a single device with no working trode are turned on at the same time. Ablation occurs until channels required. No tool exchanges. Such as passing Suture there is no more Doppler signal. The device can then be and needles, laser coagulation device, or other energy abla rotated until the Doppler picks up another artery, which will tion tools, through the working channel of an anoscope or a be ablated in a similar fashion. The procedure can be per dilator with Doppler transducer sensors, is required to per formed until no further arteries are located. form the treatment. Apparati and methods to access the anus 0157. The expandable basket can be made out of heat and treat hemorrhoids that do not require apatient's anal canal shaped metal such as Nitinol. The wires for the RF electrode to be dilated before said invention can be inserted are dis and the Doppler transducer as well as the irrigation catheter is closed. The device and method herein minimize prolonged contained within a sheath Surrounding the exterior of one or anal dilation, which has been known to be a potential cause of more of the basket struts. These components are then con fecal incontinence and anal fissure. tained within body of the device and exit individually at the 0153. The system illustrated in FIGS. 11A through 11C handle. The Doppler transducer is located beneath the RF can comprise a control circuit which can automatically deter transducer so that it can be used to determine that that the mine how long to keep activated the ablation energy source artery has been completely ablated. When there is no further and the optimal power requirements, based on feedback from flow as measured by the Doppler it will automatically turn off the artery and arterial flow sensor. As shown in FIG. 12, the the RF transducer. The expandable member can be removed system can begin by detecting (i.e., measuring) if arterial from and reinserted into the body of the device. US 2012/0059394 A1 Mar. 8, 2012
0158. The device does not require anal dilation, and pre or all arteries in a ring of mucosa above the dentate line. The cisely allows for a more precise method to ablate tissue and ablation-sensing pairs can remain active as the pad is rotated. spare surrounding structures. This will eliminate the dangers If desired, ablation can occur concurrent with the rotation of of suturing the internal anal sphincter, which can cause severe the pad along the mucosa. The Doppler-RF Electrode-Array spasm and pain and can lead to fecal incontinence. The device can minimize or completely prevent Substantial col expandable member allows for insertion of a small diameter lateral damage by only emitting RF energy directly on top of device that conforms to the rectal wall and keeps the device in arteries. the proper location. 0163 The Doppler array can create a virtual image of the 0159 FIG.15A illustrates that the catheter can be inserted, underlying arteries. The Doppler array can be an array of as shown by arrow, through an applicator into a region of Doppler ultrasound elements directed perpendicularly to the interest in the rectum. The applicator can be rigid and placed distal pad surface. The Doppler array can also be fewer Dop in the anus. For example, the applicator can be a disposable pler ultrasound elements directed at an acute angle to the hollow cylinder similar to a tampon applicator, with the cath distal pad surface, with the entire plane of the ultrasound eter running through the lumen of the applicator. The appli signal providing Doppler information, as in the operation of cator can dilate the anus. The applicator is not required. The transthroacic ultrasound images of the blood flows in the distal end of the catheter can have a balloon. The balloon can heart. The Doppler array can also be smaller set of ultrasound be deflated when placed through the anus. The balloon can elements which move or pivot periodically to survey more have ultrasound crystals, for example on the radially outer Surface area. surface of the balloon wall. Other artery sealing technologies 0164 Said distal pad's array of RF electrode elements can described herein (e.g., radiofrequency electrodes, Sclerosant be a unipolar RF ablation lead with a grounding pad placed on delivery needles, etc) could be on the outer surface of the a remote site on the patient. Alternatively, each RF electrode, balloon wall as well. The inflation port can be in fluid com or pixel, can be bipolar itself, containing both a positive and munication with a Syringe. The Syringe can have demarcated negative lead within the element. Alternatively, the adjacent Volume measurements and can have a pressure gauge that can RF electrodes within the array can alternate between positive indicate (e.g., digitally) the pressure of fluid delivery from the and negative leads. Syringe. 0.165. The distal pad can be a cylinder so that a complete, (0160 FIG. 15B illustrates that once the catheter has been 360-degree ring of mucosa is simultaneously contacted by the inserted into the region of interest, the balloon can be inflated pad. Said 360-degree-ring distal pad can be radially expand using the Syringe that can register pressure and/or Volume able to press the surface of the pad flush against the mucosa. readings. The balloon can be inflated with saline, contrast (0166 FIG. 19A illustrates that the device can emit steam medium or other liquid materials, or gas such as air, oxygen, as the energy source, a Sclerosing agent for hemorrhoidal or carbon dioxide. The balloon can be inflated until there is a artery ligation (e.g., as opposed to RF). The Steam can be Sudden increase in pressure, indicating that the balloon is in delivered into or adjacent to the artery and used to ablate the contact with the walls of the anal canal. The user can then artery. Alternatively, instead of steam or in combination with activate the ultrasound, or other artery-sealing modality, steam, the Sclerosing agent can be alcohol Such as ethanol, which applies energy through the walls of the rectum, thereby phenol, methanol, isopropyl alcohol, butanol, ethylene gly collapsing the hemorrhoidal artery Supply that lies beneath. col; aldehydes such as formaldehyde; acids, such as hydro (0161 FIG. 15C illustrates that the catheter can then be chloric acid, hydrofluoric acid, acetic acid, Sulfuric acid; deflated using the Syringe and removed from the anus through strongly alkaline (base) materials such as urea, lye, hydrogen the applicator. The user can then remove the applicator from perchlorate; quinine, urea hydrochloride, hypertonic salt the anal canal. solution, vegetable oil, or combinations thereof. The scleros 0162 FIG. 17 illustrates that the distal pad of an artery ing agent can be delivered into or adjacent to the target artery. sealing device can be inserted into the rectum. The pad can The distal section of the device can comprise a collapsable have an array of ablation-sensing pairs. The pad can be placed Suction cup attached to an articulating joint with a needle firmly on the mucosa of a first region in the rectum, with firm protected inside the collapsed or contracted Suction cup. The placement aided by the pivoting steerable joint between the distal edge of the Suction cup can have a Doppler sensor. A distal pad and handle. The Doppler element array then can Sclerosing agent delivery system, such as a Sclerosing agent creates a virtual image of the arteries underlying the mucosa reservoir and pump can be in controllable fluid communica onto which the pad is placed (shown in FIGS. 18A and 18B). tion with the needle. The Sclerosing agent delivery system can The virtual image of the artery geometry is sent to the central be replaced with or used in conjunction with a steam genera control system (e.g., in the remote component), which can tor in regulated fluid communication with the needle. A scle then activate only the RF electrode elements which overlie an rosing control can regulate the Sclerosing agent delivered to artery. FIG. 18C illustrates that the RF electrodes overlying the needle. A Saline reservoir (e.g., bag) can also be in fluid arteries are activated RF electrodes and the RF electrodes communication with the needle. A flow meter can measure overlying non-arterial tissue are inactive RF electrodes. The and regulate the delivery of saline. RF energy emanating from each activated RF electrode can (0167 FIG. 19B illustrates that the device can be inserted ablate underlying arteries, producing coagulation, collapse, into the patient's rectum to a specified length. The Suction cup scarring, and cessation of blood flow through the affected can be mechanically connected to a cup control. Such as a artery segments. FIG. 18D illustrates that the hemorrhoidal knob. The cup control can then be pulled, as shown by arrow, artery can be ligated where treated by the RF electrodes, but or otherwise manipulated to open or expand the collapsed or not elsewhere. Likewise, tissue Surrounding the artery can be contracted Suction cup. The steering mechanism can be substantially unaffected by the ablation. The device can then manipulated (e.g., rotated—as shown by arrow pulled, rotated along its long axis repeatedly so that the pad comes pushed, levered) to angularly articulate or rotate the Suction into contact with a 360-degree ring of mucosa, ablating most Cup. US 2012/0059394 A1 Mar. 8, 2012
(0168 FIG. 19C illustrates that the articulating lever at the 0173 FIG. 19D illustrates that a bulking agent can be proximal end of the device can be turned to actuate the articu injected or a bulking device can be implanted adjacent to the lating joint at the distal end of the device, thereby directing the hemorrhoidal artery. FIG. 19D illustrates that the device can Suction cup toward the target tissue. The Doppler sensor can be configured to tamponade the hemorrhoidal artery by deliv be located radially inside the Suction cup, and can locate the ering a bulking or tamponading agent below the Surface of the hemorrhoidal arteries. The wires for the Doppler transducer mucosal tissue and adjacent to the hemorrhoidal artery. The wires run the length of the interior of the device and exit at the bulking or tamponading agent can be delivered by the bulking proximal end where they can be connected to a remote com agent delivery system. The flow of bulking agent can be ponent and/or speakers or headphones. Once the distal end of controlled by the bulking control, for example a valve. The the device is in the correct location, Suction is applied to hold bulking agent can be abolus of hardening or otherwise curing it in place against the tissue. Suction is applied through a hole polymer or other material or device described herein. The located inside the Suction cup connected to anon-collapsible bulking agent can be exposed to curing energy (e.g., IR tubing that runs the length of the interior of the device and energy) after being injected or implanted. The bulking agent exits at the proximal end of the device. This tubing is con can compress or tamponade the hemorrhoidal artery. nected to a vacuum source. Such as a Syringe. 0.174 FIG. 20' illustrates that the distal end of the device 0169. The needle, heretofore being protected from the tis can have an emission window. The emission window can Sue, can then be slowly advanced into or adjacent to the located around part or all of the lateral surface of the device. hemorrhoidal artery by turning or otherwise operating the cup For example, the emission window can be located around part control at the proximal end of the device. The needle can be of or the entire circumference of the device. The device can connected to a lumen, channel or tubing running along the have an infrared radiation transducer inside of the emissions interior of the device throughout the length of the handle and window. exiting at the proximal end where the tubing can be attached (0175 When the emissions window is orad to the dentate to a flow meter running to a low-pressure saline (or empty) line, the infrared transducer can emit infrared (IR) energy in reservoir or bag. The flow meter can regulate the blood flow to Some or all (e.g.)360° angles, as shown by arrows, out from the saline reservoir and/or the saline flow from the saline the emissions window. For example, IR energy can be emitted reservoir to the needle. For example the blood flow to the in a circular plane perpendicular to the longitudinal axis of the needle can occur only once the needle tip is inside the artery, neck at the emissions window. indicating that the needle is in position to deliver Steam and/or 0176 The IR energy can be received treat a treatment line sclerosing agent(s) into the artery. The tubing can also be around part or all of the perimeter or circumference of the connected to a Sclerosing agent delivery system and/or steam mucosal tissue surface of the rectum at the level of the emis generator, which can be turned on once the needle tip is in the sion window. The IR energy can transmit into the tissue artery by a Sclerosing control (e.g., a button) located on the underlying the muscosal tissue Surface. The IR energy can tubing. The Sclerosing agent or steam can thereby be injected reach a treatment depth, for example deep enough to transmit into or adjacent to the artery, optionally in combination with energy to Some or all of the hemorrhoidal arteries. the saline (the flow meter can have a pump), causing thermal 0177. The IR energy can induce blood clotting and/or damage and collapse. ablation of vessels. The IR energy can cause Substantially 0170 When the Doppler sensor stops reading arterial flow, concurrent ligation of all the hemorrhoidal arteries in the the steam can be automatically turned off, for example for rectum with a single, uninterrupted delivery of energy. The safety. The Suction can then be removed from the Suction cup, energy delivered can be IR energy, RF energy, HIFU energy, releasing the Suction cup from the rectal mucosa, and the thermal energy, electro-cautery energy (i.e., plasma), or com device can then be rotated around the circumference of the binations thereof. The energy can be delivered from the bas rectum and all hemorrhoidal arteries can be ablated in a ket, balloon, or any other variation shown herein. similar fashion. When no further arteries are located by the 0.178 The device can have a stopper on the neck and/or Doppler sensor, the articulating joint can be put back into the handle. The stopped can prevent the terminal distal end of the original configuration (e.g., coaxially aligned with the device from advancing more than about 8 cm into the rectum. handle) and the device can be removed from the rectum. The stopper can have a radius configured to abut the outside of 0171 The device can be made with a multi-lumen polymer the anus. The length from the stopper to the emission window extrusion, such that the tubes are wires are contained with the can be from about 4 cm to about 6 cm. interior of the device and exit individually at the proximal (0179 FIGS. 20A through 24B illustrate achieving TOH end. The articulating joint can be made from pull wires and using tools and methods described herein. pinned links or laser cut extrusions that is connected to the 0180 FIG. 20A shows typical normal hemorrhoids and articulating lever. The Doppler is located inside the suction prolapsed hemorrhoids. The device can pexy (i.e., lift and cup so that it can measure arterial flow at the same time as the secure) the hemorrhoids so that the hemorrhoids are higher in steam is injected, thereby allowing a feedback mechanism to the anorectal canal and no longerprolapsed, as shown in FIG. stop steam injection when flow has ceased. The Suction cup 20B. The pexied hemorrhoid can be less obstructive of the can be rotated about the entire circumference of the rectum rectum and reduce symptoms. The peXied hemorrhoid can be when suction is relieved. attached to the rectal wall at apexy junction. The device can 0172. The device allows for precise ablation of the hem pexy with any of the devices described herein, either those orrhoidal arteries with little to no damage to Surrounding with a wand or those on the end of a flexible endoscope. structures. The device can avoid or minimize damaging the 0181 FIG. 21A illustrates that the device can be used to internal anal sphincter, which causes severe spasm and pain create a scar in the anorectal canal proximal to (above) the and can lead to fecal incontinence. Similarly, it does not cutor hemorrhoid. The tissue of the scar can shrink, pulling up the remove any tissue, thereby will lead to significantly less and hemorrhoid, as shown in FIG. 21B. The scar can be created potentially no post-operative pain. with ablation, such as with RF energy, rubberbanding the US 2012/0059394 A1 Mar. 8, 2012 mucosa, injecting Sclerosant, cryo (cold), or other energy FIG. 25 illustrates that a spring clamp can be placed across sources. The size of the scar can correlate to the size of the the tissue. The spring clamp can have opposing clamp arm prolapsed. and a spring connected to both clamp arms. The spring clamp 0182 FIG. 22A illustrates a prolapsed hemorrhoid. FIG. can be extended and placed on the tissue. The spring can then 22B illustrates that a mechanical fastener can be used to contract and compress the tissue, as shown by arrows. A clip attach the hemorrhoid to the proximal inner diameter of the can then be applied to the tissue mound as shown in FIG. 25C. anorectal canal. The mechanical fasteners could include (0189 FIG. 26A illustrates that the mucosal surface can be clips, tacks, brads, and Staples, Suturing devices, or combina Substantially flat before the Suction port applies a vacuum or tions thereof. suction. FIGS. 26A through 26D illustrate a similar device to 0183 FIG. 23A illustrates a prolapsed hemorrhoid. FIG. the device shown in FIGS. 25B and 25C, but the device in 23B illustrates that a tissue fold or pleat above the hemorrhoid FIGS. 26B through 26D demonstrates that after the suction can be formed to pull the hemorrhoid up, as shown in FIG. port grabs hold of the mucosa by the application of suction, as 22B. This tissue fold could be created using the clip applier, shown by arrows, the Suction port can be translated, as shown Stapler, or any mechanical coupling elements described by arrow, and elevated away from the, in order to lengthen the herein or combinations thereof. exposed neck of the tissue mound, and provide room for the 018.4 FIG.24A illustrates that the mucosatissue above the clip applier to apply a clip across the exposed neck of the hemorrhoid can be twisted. The tissue can be sucked into a tissue mound (the hemorrhoidal artery is not shown). The clip Suction port. The Suction port can then rotate about the lon can compress and ligate the hemorrhoidal artery. gitudinal axis through the middle of the opening of the Suction 0.190 FIG. 28 illustrates that a clip can pierce the mucosal port. FIG. 24B illustrates that a rubber band can be placed tissue and surround the hemorrhoidal artery. The clip can be over the twisted mucosa to hold it in place. The twisted tissue compressed (going from an “open' U-shape to a "closed can form pleats. A scar will form that can hold the twisted I-shape), thus compressing and collapsing the artery. mucosa in place over the long term. Other clips herein can be 0191 The clip can pierce the mucosa in a variety of ways. used in addition to or in lieu of the rubber band. For example, the clip can be inside a jaw that is sharp and 0185 FIG.24A illustrates that an expandable stent can be pierces the mucosa. The clip tips can be sharp, and exposed mounted on a deployment tool. Such as a catheter. The stent beyond the jaws. This clipping mechanism can be combined can be a wireframe or mesh scaffold. The stent can be self with any of a variety of mechanisms for holding the mucosa expandable (i.e., elastically biased to in an expanded configu in place. Such as vacuum Suction, hooks, chemical adhesive, ration, but restrained in a contracted configuration on the or combinations thereof. deployment tool), and restrained by a sheath on the deploy 0.192 FIG. 29A illustrates a C-shaped staple that pierces ment tool. The stent can be balloon-expandable (i.e., plasti the mucosa so that it surrounds the hemorrhoidal artery, and is cally deformable from a contracted configuration to an then further compressed to form an O-shape, thus compress expanded configuration) and mounted on a balloon in the ing and collapsing the artery. There can be an anvil at the end deployment tool. The stent can be inserted into the rectum of the stapler (shown as two prongs receding up from the adjacent to the prolapsed hemorrhoid. image that hold the staple base in place). In order to over-drive 0186 FIG. 24B' illustrates that the stent can be radially the staple into the Smallest O-shape possible, a second pliers expanded in the rectum. The stent can be radially expanded, like mechanism can be used. FIG. 29B illustrates the staple as shown by arrows, for example by removing a restraining deployed around an artery. sheath over the stent and/or inflating a balloon onto which the 0193 The ligation mechanism could be, for example, a stent is mounted. The expanded stent can compress the hem clip, staple, automatic Suture, band, energy delivery, radiation orrhoids radially outward. All of the pexied hemorrhoids delivery, Sclerosant, tamponading agent, embolizing agent, around the circumference of the rectum can be concurrently and/or drug(s). Additional features could include a fixation pexied by a single stent. component (e.g. mucosal fixation), method to navigate 0187 FIG. 25A illustrates the surface of the mucosal tis around the bulk of the tissue (e.g. hemorrhoid), method to lift sue covering a hemorrhoidal artery. FIG. 25B illustrates that the tissue (e.g. hemorrhoid), the use of bio-absorbable mate the Suction port can apply Suction to draw up and hold the rials, features to reduce pain, features to prevent prolapse (e.g. mucosal tissue in place, forming a tissue mound. FIG. 25C primary or recurrent prolapse), and other methods to block illustrates that the clip applier can then apply a clip to the flow (e.g. blood flow) through a vessel. Additionally, various resulting tissue mound, thereby clamping off the hemor medical applications for this device are described. rhoidal artery that runs through the tissue mound. The clip 0194 For example, mechanical ligation devices can does not go completely across the mucosa, since clipping include clips. Clips for ligating vessels cause compression of across the full diameter of the tissue mound would cause the the vessel and terminate flow through the vessel where the mound to necrose. The clip can be applied Such that the long clip is applied. Clips for this purpose can come is various axis of the clip is perpendicular to the long-axis of the tissue forms, such as: clips with two or more prongs, clips with mound. However, the clip can also be applied at any angle sharp tips so that they pierce tissue and then clamp (for with respect to the long-axis of the tissue mound; for example a clip that pierces the tissue, clamps around a vessel, example, the clip can be applied parallel to the tissue mound's and is buried under the tissue), clips that clamp externally long-axis, and at the tissue-mound's peak. around a mound of tissue and thereby clamp underlying ves 0188 FIG. 25A illustrates that one, two or more hooks sels, clips that approach the vessel parallel (0 degrees) to the can be attached to the mucosal tissue. FIG. 25B" illustrates long axis of the vessel (or tissue) or clips that approach the that the hooks can be translated away from the surface of the vessel perpendicular (90 degrees) to the vessel. The clip could mucosal tissue, raising the tissue and the hemorrhoidal artery approach and/or ligate the vessel at any orientation (0-90 in a tissue mound. A clip can then be applied partially or degrees) with respect to the long axis of the vessel and still completely across the tissue mound as shown in FIG. 25C. occlude flow. Clips could have different length prongs. The US 2012/0059394 A1 Mar. 8, 2012 clips could have barbs on the prongs. The clips could have prongs that have alligator teeth. This could, for example, teeth on the prongs, for example, alligator teeth prongs (show allow the staple to fall out of the tissue as the bio-absorbable figure). The clips could be made wholly or partially of bio housings dissolve in the tissue. absorbable (resorbable) materials, such as described below. 0199 The vessels (e.g. hemorrhoidal arteries) can be The clips could be made such that they are biased closed and sealed by automatically placing Sutures to ligate the vessels held open until deployment (e.g. Nitinol clips). The clips (e.g. arteries). Automatic Suturing ligation can include the could be compressed to close around the vessel (or tissue). placement of Sutures, Suture-like materials around and/or The clips could start in different shapes, such as V-shaped near the vessel (e.g. hemorrhoidal artery) in order to compress clips, W-shaped clips, etc. The clips could be combined with the vessel (e.g. artery), and the placement of the Suture or other mechanisms included here. Such as clips to localize mechanical ligation device is automated in that it does not radiation, Sclerosing agents, drug delivery, energy delivery, or require all the steps of hand-suturing tissue as usually per to pexy (i.e. lift) tissue. formed by a physician. For example, the device could have at 0.195 The clips could be introduced through a flexible or its working end a miniature sewing machine, that with the rigid endoscope. Examples of clips that are introduced press of a button places one or more loops of Suture through through endoscopes include, the InScope TM Multi-Clip the tissue (e.g. mucosa) and around the vessel (e.g. hemor Applier (INSCOPE, A Division of Ethicon Endo-Surgery, rhoidal arteries), thereby Squeezing shut the vessels (e.g. Inc.), the ResolutionTM Hemostasis Clipping Device (Boston arteries). Automatic Suturing ligation devices could include Scientific Corporation), the Endoscopic Multi-Fire Clip components that pass the Suture through the tissue, devices Applier (Syntheon, LLC), the Rotatable Clip Fixing Device that tie or bring together or seal the ends of the Suture, and HX-5/6-1 (Olympus Optical Co., Ltd.), the Long Clip devices that both pass Suture through tissue and bring together HX-600-090L (Olympus Medical Systems Corporation), the the ends of the suture. QuickClip2, HX-201LR-135 & HX-201UR-135 (Olympus 0200. There are various components and methods by Medical Systems Corporation), the QuickClip2 Long, which one can pass the Suture through the tissue (e.g. mucosa) HX-201LR-135L & HX-201UR-135L (Olympus Medical and around the vessel (e.g. hemorrhoidal arteries). For Systems Corporation), the TriClip Endoscopic Clipping example, the device can pass a needle beneath a mound of Device (Wilson-Cook Medical Inc., Winston-Salem, N.C.), tissue containing the vessel (e.g. hemorrhoidal artery). however, these clips are inadequate for intended purpose as 0201 FIG.30A shows the mound of tissue surrounded by they typically require numerous clips to adequately occlude a the two arms of the device. One arm is the needle driver vessel. holding the needle that enters the tissue roughly perpendicu 0196. The clips could include any combination of the lar to the long axis of the mound of tissue. The needle is above variations, for example a clip that is biased open (e.g. attached to a Suture at the end opposite its tissue-piercing end. using Nitinol) that has a bio-absorbable housing around the The other device arm is the needle receiver which can grab the prongs that have alligator teeth. This could, for example, needle once the needle emerges from the other side of the allow the clip to fall out of the tissue as the bio-absorbable tissue mound. housings dissolve in the tissue. (0202 FIG. 30B shows the needle driver moving towards 0.197 Mechanical ligation devices can include staples. the tissue mound so that the needle punctures the tissue Staples for ligating vessels cause compression of the vessel mound, and engages the needle receiver on the opposite side and terminate flow through the vessel where the staple is of the mound. The needle receiver holds onto the end (or near applied. Staples for this purpose can come in various forms, the end) of the needle, while the needle driver disengages the Such as: Staplers with or without an anvil, staples that over needle (lets it go). The two arms, especially the needle close (i.e. over compress tissue), staples with barbs, staples receiver, are then withdrawn away from the tissue mound, as that pierce the tissue (e.g. staples that pierce the tissue, clamp shown in FIG. 30C. The suture then lies deep to the artery, around a vessel, and are buried under the tissue), staples at with its free ends hanging out well above the mucosal Surface that wholly or partially made from bio-absorbable (resorb as shown in FIG.30D. The free ends of the suture can then be able) materials (for example bio-absorbable prongs, or more crossed over each other, tied, and thus apply pressure to specifically, bio-absorbable prongs that pierce the tissue), compress the artery, sealing off its blood flow and ligating the Staples that have different length prongs, Staples that have artery. teeth (e.g. teeth on the prongs, e.g. alligator teeth), Staples that (0203 The devices shown in FIG. 31A through 31D can are bias closed (e.g. Nitinol), staples that pexy (i.e. lift up) have several variations. The needle can be straight or curved. tissue (e.g. to perform a mucopexy or hemorrhoidopexy), The suture can have barbs on it. The needle driver and needle Staples that localize other therapies (e.g. radiation, Sclerosing receiver arms can hold and release the needle using a variety agents, drug delivery, or energy delivery). There could be one of mechanisms: forceps, tweezers, clamps, magnets, adhe or more staples deployed at a time such as, one or more rows sives, or combinations thereof. The free ends of the suture can of Staples, such as anastomosis staplers (e.g. bowel anasto be re-passed through the tissue multiple times, crossed over mosis staplers, vascular anastomosis staplers, or airway anas multiple times, and tied together or locked together using any tomosis staplers), or staplers for the PPH procedure (proce of the mechanisms described below. dure for prolapsed hemorrhoids), closure staplers (for 0204 The suturing device shown in FIG. 31A can place example bowel closure staplers or vascular closure Staplers), Sutures to form what Surgeons call a “figure-of-eight Stitch. or staplers to close tissue (e.g. skin). The staples could start in The device has two arms that are joined at their proximal ends different shapes, such as C-shaped Staples, D-shaped Staples, by a flexible joint. On the distal ends of each arm can be a M-shaped Staples, W-shaped Staples, etc. needle containing Suture (diagrammed as a shaft with a cone 0198 The staples could include any combination of the on it), and a receiving port to grab the needle. above variations, for example a staple that is biased open (e.g. 0205 The needle is shown in FIG. 31B: The needle is using Nitinol) that has a bio-absorbable housing around the similar in mechanism to a harpoon. The tip of the needle is a US 2012/0059394 A1 Mar. 8, 2012
cone, with the base of the cone attached to a suture. The suture nisms that do not involve a hollow cylindrical shaft with the runs through a hollow cylindrical shaft that is joined to the Suture running through it; for example, the Suture could run cone such that the cone can disengage the shaft at a time next to the cylindrical shaft. determined by the device and/or operator. 0214. Once the suture is pulled through the path, the two 0206 FIG. 31C shows the needle moving towards the free ends of the Suture can be tightened and tied, compressing receiving port. In FIG.31D, the needle has passed through the and ligating the artery. receiving port. At this stage, the cone of the needle becomes 0215. There are various components that can tie or bring disengaged from the hollow cylindrical shaft. The cylindrical together or seal the free ends of the suture. For example, the shaft can be withdrawn over the suture that is attached to the suture free ends could be hand-tied. The free ends of the cone. Then, as shown in FIG. 31E, the cone of the needle is suture could be tied to small weights or hooks so that it would now on the opposite side of the receiving port. be easy for the device or operator to grab them. 0207 FIG.31F illustrates that during the treatment proce 0216. The suture free ends could be tied via a zip-tie dure (e.g. hemorrhoids treatment procedure), a mound of mechanism. FIG. 33A shows an example of a zip-tie device. tissue containing the vessel (e.g. hemorrhoidal artery) is The Suture has been passed through the mound of tissue so placed between the distal ends of the two arms. The flexible that it is deep to the vessel (e.g. hemorrhoidal artery). The free joint at the proximal end of the two arms is narrowed, bring end of the suture is then passed through the eyelet of the ing together the two distal ends (Squeezing the device shut). zip-tie, as shown in FIG. 33B. This can form a lasso. The This squeezing causes the needles to pass through the tissue, zip-tie eyelet is designed such that the free end of the suture deep to the vessel (e.g. artery). can move through the eyelet in only one direction. Therefore, 0208 After the cones emerge from the other side of a once the free end is passed through the eyelet, pulling on the tissue mound, the cones enter the receiving ports, and disen free end of the Suture tightens the lasso loop, and pressure gage, as shown in FIGS. 31 B through 31E. This leaves two within the lasso loop is unable to cause the free end to move Sutures having passed through the tissue. If the two coned the other direction within the eyelet. Thus, once the free end ends are now joined (through a lock-and-key mechanism, is passed through the eyelet, pulling on the free end tightens hand tied, etc), this leaves a single continuous line of Suture the lasso loop in a manner that does not allow the lasso loop that has been passed deep to the artery, in a pattern that to be loosened. A variety of embodiments can accomplish this surgeons call a “figure-of-eight stitch.” The free ends of the one-way locking Zip-tie mechanism: For example, similar to Suture (hanging out the back ends of each shaft) can then be plastic Zip-ties for commercial goods, the free end of the tied together, completing a figure-of-eight stitch, as shown in suture can have barbs on it, and the eyelet can have a ratchet FIG. 31H. The sutures can emerge from openings in the side that only allows the barbs to move in one direction through the of each receiving port. eyelet. Alternatively, the suture can have no barbs but the 0209. Other methods of tying the ends of the suture can be zip-tie eyelet can be selectively tightened around the suture used; Such as tying the cone ends to the free ends first. There which passes through it, such that once the lasso is tightened are also numerous methods by which the cone of the needle to a sufficient level, the zip-tie eyelet can be tightened so that can become disengaged from the needle shaft, such as for the Suture cannot move through it anymore. ceps-like grabber that grabs the needle tip, a magnet, etc. 0217. At least one end of the suture can be a T-anchor 0210. The device shown in FIG. 32A uses a helical needle integrated with the suture or pledget slidably attached to the (e.g., corkscrew-shaped needle) to drive a helical line of Suture. The T-anchor functions similarly to T-anchors on plas Sutures around an artery. One end (e.g., distal end) of the tic clothing tags. For our treatment device (e.g. hemorrhoids helical needle is the tissue-piercing end. The opposite end treatment device), the T-anchor can be a bar that has a Suture (e.g., proximal end) of the helical needle is attached to a attached near the middle of the bar. One or both ends of the suture, which runs through a hollow cylindrical shaft called T-anchor can be sharp so that the T-anchor can pierce through the needle driver. The needle is attached to the hollow cylin tissue if the sharp tip is presented so that the bar is perpen drical shaft in a manner that allows the needle to become dicular to the mucosal surface. FIG. 34A shows the T-anchor disengaged at the desired time. The helical needle is placed positioned next to a mound of tissue with the vessel (e.g. next to the mucosal Surface, and is rotated on its long axis so hemorrhoidal artery) running through the tissue mound. The that it drives a helical path through the tissue, as shown in T-anchor is pushed through the mound of tissue so that the FIG.32B. T-anchor emerges on the opposite side of the tissue mound, as shown in FIG.34B. This can ensure that the suture runs deep 0211. The helical needle can be positioned so that the to the vessel (e.g. artery). The Suture can then be looped hemorrhoidal artery runs through the helix’s lumen. The tis around the tissue mound and passed through the tissue again Sue-piercing end of the needle can then be grabbed by a so that the Suture forms a loop around the vessel (e.g. artery), needle receiver arm, while the needle driver becomes disen as shown in FIG. 34C. The T-anchor can then change its angle gaged from the helical needle, as shown in FIG. 32C. with respect to the suture, as shown in FIG. 34D. The T-an 0212. The needle receiver arm rotates the needle out of the chor can then lie with its flat side parallel to the tissue (e.g. tissue, leaving two free ends of Suture on either side of a mucosal surface). When the suture is tightened, the T-anchor segment of Suture that makes ahelical path through the tissue, is pressed more firmly against the tissue (e.g. mucosal Sur as shown in FIG. 32D. face). Then a sliding fastener/clamp can be applied to the free 0213 FIG.32E illustrates that the suture could be attached end of suture, as shown in FIG. 34E. This fastener can be to the needle near the distal tip (i.e., the tissue-piercing end) of pushed along the free end of suture until it fits tightly against the needle. The receiving arm can engage the Suture, and the the tissue (e.g. mucosal Surface), thus tightening the Suture needle driver can reverse the direction of rotation to withdraw loop, and preventing the Suture loop from loosening. The the needle before the entire needle exits the tissue. Addition sliding fastener/clamp can then be locked in place onto the ally, the suture could be attached to needle through mecha suture position on which it resides. The T-anchor can have US 2012/0059394 A1 Mar. 8, 2012
several variations. For example, the T-anchor's bar could be a to the vessel through the use of radiation. The radiation can disc, or could be attached to the Suture after looping the Suture create an area of inflammation that can lead to Scaring and around the vessel (e.g. artery). necrosis (i.e. death of tissues) that could eliminate flow 0218. The suture free ends can be sealed together with a through the vessels that are targeted. The radiation can several twist-tie mechanism. The suture free ends can be sealed forms such as external beam radiotherapy, Stereotactic radia together by heating them until they become sealed (e.g. melt tion (e.g. Cyberknife or Gamma Knife), virtual simulation, ing the ends together). The Suture free ends can be sealed 3-dimensional conformal radiotherapy, and intensity-modu together with a lock-and-key mechanism. This can take Vari lated radiotherapy, particle therapy, radioisotope therapy ous forms, such as that similar to a Snap on a coat, the sealing (RIT), brachytherapy, or radioimmunotherapy. part of a Ziploc plastic bag, or combinations thereof. 0224. Historically, the three main divisions of radio 0219. The suture used in the automatic suturing ligation therapy are external beam radiotherapy (EBRT or XBRT) or devices can have barbs (similar to Quill SRS by Angiotech teletherapy, brachytherapy or sealed source radiotherapy, and Pharmaceuticals) that only allow it to be passed through systemic radioisotope therapy or unsealed Source radio tissue in one direction, can excrete or be coated with an therapy. The differences relate to the position of the radiation adhesive, so that it can hold tightly within the tissue it passes Source: external is outside the body, brachytherapy uses through, can be absorbent of water, Such that the Suture diam sealed radioactive sources placed precisely in the area under eter expands in tissue, with the resulting increased pressure treatment, and systemic radioisotopes are given by infusion holding the suture within the tissue, or combinations thereof. or oral ingestion. Brachytherapy can use temporary or per 0220 Additionally other mechanical mechanisms to manent placement of radioactive sources. The temporary occlude flow through a vessel, include, but are not limited to, Sources are usually placed by a technique called afterloading. a tight-fitting band (e.g. rubberband) that Squeezes the tissue In afterloading a hollow tube or applicator is placed Surgically captured inside it sufficiently to occlude flow, a small clamp in the organ to be treated, and the Sources are loaded into the around the vessel (e.g. clamp locked in place, e.g. a clamp that applicator after the applicator is implanted. This minimizes is locked in place with a ratchet mechanism, by a latch, or by radiation exposure to health care personnel. Particle therapy magnets), magnets that Squeeze the tissue between them (e.g. is a special case of external beam radiotherapy where the rare earth magnets), a tourniquet mechanism (e.g. a suction particles are protons or heavier ions. Intraoperative radio cup that creates high pressure between the tissue that is suc therapy is a special type of radiotherapy that is delivered tioned and can stay in place for several weeks, or twisting immediately after Surgical removal of the tissue (e.g. vessel, tissue to kink the vessel). Additionally, any of the mecha lesion, or cancer). This method has been employed in breast nisms could include barbs to provide additional purchase of cancer (TARGeted Introperative radioTherapy), brain tumors the tissue and keep the device in place for the desired length and rectal cancers. of time. Examples include a barbed clip, barbed staple or 0225. The radiation source could be from external beam barbed suture (e.g. Quill SRS by Angiotech Pharmaceuti radiotherapy; more specifically it could be from conventional cals). For example, barbs could be used for sutures to secure external beam radiotherapy (2DXRT), which is delivered via them in place without requiring knots. two-dimensional beams using linear accelerator machines. 0221) The vessels (e.g. hemorrhoidal arteries) can be 2DXRT mainly consists of a single beam of radiation deliv sealed by delivering a variety of types of energy tofaround the ered to the patient from several directions: often front or back, vessel (e.g. hemorrhoidal arteries). For example, radiofre and both sides. The word “conventional” refers to the way the quency energy can be delivered to the vessel, thereby heating treatment is planned or simulated on a specially calibrated the tissue locally, causing the vessel walls to shrink and seal to diagnostic X-ray machine known as a simulator because it each other, and thereby occlude blood flow. Various embodi recreates the linear accelerator actions (or sometimes by eye), ments of an energy-deploying device are depicted in FIGS. and to the usually well-established arrangements of the radia 2A, 14A, and elsewhere herein. tion beams to achieve a desired plan. The aim of simulation is 0222 Many types of energy can be applied to seal the to accurately target or localize the volume that is to be treated. vessels (e.g. hemorrhoidal arteries), including: radiofre This technique is well established and is generally quick and quency electrical energy, bipolar or unipolar diathermy, reliable. The worry is that some high-dose treatments may be direct-current electrotherapy. direct heat from a conducting limited by the radiation toxicity capacity of healthy tissues element. For example, a wire/filament can be heated and that lay close to the target (e.g. tissue, vessel, or tumor) placed on/near the vessel (e.g. hemorrhoidal artery) or over volume. An example of this problem is seen in radiation of the lying tissue (e.g. mucosa), Cryo (tissue can be cooled to a low prostate gland, where the sensitivity of the adjacent rectum enough temperature that it causes tissue damage, and vessel limited the dose that could be safely prescribed using 2DXRT thrombosis), phototherapy, such as with infrared light. For planning to Such an extent that tumor control may not be example, infrared light penetrates tissue and heats the under easily achievable. Prior to the invention of the CT, physicians lying structures, causing inflammation and vessel thrombo and physicists had limited knowledge about the true radiation sis. Additional wavelengths of photons can be used, such as dosage delivered to both cancerous and healthy tissue. For ultraviolet. Laser energy can be used, such as photons deliv this reason, 3-dimensional conformal radiotherapy is becom ered via a laser to have similar effects as non-laser-based ing the standard treatment for a number of sites (e.g. for phototherapy. Ultrasound energy can be used, for example tissues, vessels, or tumors). The radiation source could be HIFU (high frequency ultrasound). Argon beam coagulator from Stereotactic radiation. Stereotactic radiation is a special energy can be used. Radioactive sources, for example in low ized type of external beam radiation therapy that uses focused dosage, can be used. Combinations of any energy sources radiation beams targeting a well-defined location (e.g. tissue, listed herein can also be used. vessel, or tumor) using extremely detailed imaging scans. 0223) Another embodiment could include a mechanism to Radiation oncologists perform Stereotactic treatments, often occlude flow through the vessel by causing Sufficient damage with the help of a neurosurgeon for tumors in the brain or US 2012/0059394 A1 Mar. 8, 2012
spine. There are two types of stereotactic radiation. Stereo ment outcomes than even3DCRT. 3DCRT is still used exten tactic radioSurgery (SRS) is when doctors use a single or sively for many body sites but the use of IMRT is growing in several stereotactic radiation treatments, typically for the more complicated body sites such as CNS, head and neck, brain or spine. Stereotactic body radiation therapy (SBRT) prostate, breast and lung. Currently, IMRT is limited by its refers to one or several stereotactic radiation treatments with need for additional time from experienced medical personnel. the body, such as the lungs. A potential advantage to stereo This is because currently, physicians must manually delineate tactic treatments are they deliver the right amount of radiation the regions of interest (e.g. tissues, Vessels, lesions, or to the specific location of interest (e.g. tissues, vessels, or tumors) one CT image at a time through the entire disease site, cancer) in a shorter amount of time than traditional treat which can take much longer than 3DCRT preparation. Then, ments, which can often take six to 11 weeks. Additionally, medical physicists and dosimetrists must be engaged to create treatments are given with extreme accuracy, which should a viable treatment plan. Also, the IMRT technology has only limit the effect of the radiation on healthy tissues. One poten been used commercially since the late 1990s even at the most tial issue with Stereotactic treatments is that they are usually advanced cancer centers, so radiation oncologists who did not only suitable for Small Volumes of tissues (e.g. vessels or learnitas part of their residency program must find additional tumors). Stereotactic treatments can be confusing because sources of education before implementing IMRT. Proof of many hospitals call the treatments by the name of the manu improved benefit from either of these two techniques over facturer rather than calling it SRS or SBRT. Brand names for conventional radiotherapy (2DXRT) is growing for many these treatments include Axesse, Cyberknife, Gamma Knife, tissue sites, but the ability to reduce toxicity is generally Novalis, Primatom, Synergy, X-Knife, TomoTherapy and accepted. Both techniques enable dose escalation, potentially Trilogy. This list changes as equipment manufacturers con increasing usefulness. Overconfidence in the accuracy of tinue to develop new, specialized technologies (e.g. to treat imaging may increase the chance of missinglesions that are tissues, vessels, or cancers). invisible on the planning scans (and therefore not included in 0226. The radiation could be from virtual simulation, 3-di the treatment plan) or that move between or during a treat mensional conformal radiotherapy, and intensity-modulated ment (for example, due to respiration or inadequate patient radiotherapy. The planning of radiotherapy treatment has immobilization). New techniques are being developed to bet been revolutionized by the ability to delineate the tissue of ter control this uncertainty—for example, real-time imaging interest (e.g. vessels or tumors) and adjacent normal struc combined with real-time adjustment of the therapeutic tures in three dimensions using specialized CT and/or MRI beams. This new technology is called image-guided radiation scanners and planning software. Virtual simulation, the most therapy (IGRT) or four-dimensional radiotherapy. The radia basic form of planning, allows more accurate placement of tion could be from particle therapy. In particle therapy (aka radiation beams than is possible using conventional X-rays, proton therapy), energetic ionizing particles (protons or car where soft-tissue structures are often difficult to assess and bon ions) are directed at the target tissues (e.g. vessel, lesion, normal tissues difficult to protect. An enhancement of virtual or tumor). The dose increases while the particle penetrates the simulation is 3-Dimensional Conformal Radiotherapy tissue, up to a maximum (the Bragg peak) that occurs near the (3DCRT), in which the profile of each radiation beam is end of the particle's range, and it then drops to (almost) Zero. shaped to fit the profile of the target from a beam's eye view The advantage of this energy deposition profile is that less (BEV) using a multileaf collimator (MLC) and a variable energy is deposited into the healthy tissue Surrounding the number of beams. When the treatment volume conforms to target tissue. the shape of the tissue of interest (e.g. vessel, lesion, or 0228. The radiation could be from radioisotope therapy tumor), the relative toxicity of radiation to the Surrounding (RIT). Systemic radioisotope therapy is a form of targeted normal tissues is reduced, allowing a higher dose of radiation therapy. Targeting can be due to the chemical properties of the to be delivered to the tissue of interest than conventional isotope such as radioiodine which is specifically absorbed by techniques would allow. Intensity-modulated radiation the thyroid gland a thousand-fold better than other bodily therapy (IMRT) is an advanced type of high-precision radia organs. Targeting can also be achieved by attaching the radio tion that is the next generation of 3DCRT, IMRT also isotope to another molecule or antibody to guide it to the improves the ability to conform the treatment volume to con target tissue. The radioisotopes are delivered through infusion cave shapes, for example when the tissue of interest (e.g. (into the bloodstream)oringestion. Examples are the infusion vessel, lesion, or tumor) is wrapped around a Vulnerable of metaiodobenzylguanidine (MIBG) to treat neuroblastoma, structure Such as the spinal cord or a major organ or blood of oral iodine-131 to treat thyroid cancer or thyrotoxicosis, vessel. Computer-controlled X-ray accelerators distribute and of hormone-bound lutetium-177 and yttrium-90 to treat precise radiation doses to region of interest (e.g. vessel, neuroendocrine tumors (peptide receptor radionuclide lesion, malignant tumors, or specific areas within a tumor). therapy). Another example is the injection of radioactive glass 0227. The pattern of radiation delivery is determined using or resin microspheres into the hepatic artery to radioembolize highly-tailored computing applications to perform optimiza liver tumors or liver metastases; and this method could be tion and treatment simulation (Treatment Planning). The used for example to target any tissue of interest (e.g. hemor radiation dose is consistent with the 3-D shape of the tumor by rhoidal arteries). Other isotopes commonly used (for example controlling, or modulating, the radiation beam’s intensity. in the treatment of bone metastasis) are strontium-89 and The radiation dose intensity is elevated near the gross tumor samarium (153Sm) lexidronam. Volume while radiation among the neighboring normal tissue 0229. The radiation could be delivered by the technique of is decreased or avoided completely. The customized radiation radioimmunotherapy. In 2002, the United States Food and dose is intended to maximize the dose to the region of interest Drug Administration (FDA) approved ibritumomab tiuxetan (e.g. tissue, vessel, lesion, or tumor) while simultaneously (Zevalin), which is an anti-CD20 monoclonal antibody con protecting the Surrounding normal tissue. This may result in jugated to yttrium-90. In 2003, the FDA approved the to situ better targeting, lessened side effects, and improved treat momab/iodine (1311) to situmomab regimen (Bexxar), which US 2012/0059394 A1 Mar. 8, 2012
is a combination of an iodine-131 labeled and an unlabeled tion, leading to local thrombosis, inflammation, and variable anti-CD20 monoclonal antibody. These medications were the tissue necrosis, fibrosis, and contraction. Sclerosing agents first agents of what is known as radioimmunotherapy, and have for many years been injected into the hemorrhoid itself they were approved for the treatment of refractory non (i.e., the hemorrhoidal cushion or vascular plexus within the Hodgkins lymphoma. Using this technique, radioactive mol hemorrhoid). However, delivering the Sclerosing agent in a ecules are delivered through the bloodstream attached to anti targeted manner intofaround the hemorrhoidal arteries can be bodies to the targeted tissue of interest (e.g. vessels, lesions, more effective, less painful, and produce less collateral dam or tumors). To localize a specific region of interest that does not have a unique antigen, a foreign or unique antigen could age. be placed in the region of interest (for example by injection). 0233. There are many sclerosing agents, including: pow 0230. The radiation could be delivered by the technique ders, detergents, acids and bases, boiling water, hypertonic known as brachytherapy. Brachytherapy (also known as inter saline, hypertonic glucose, talc, acetic acid, alcohols (e.g., nal radiotherapy, sealed source radiotherapy, curietherapy or ethanol, isopropanol, methanol, etc), bleomycin, OK-432, endocurietherapy) is a form of radiotherapy where a radiation Ethibloc, sodium tetradecyl sulfate, phenol oil, vegetable oil, Source is placed inside or next to the area requiring treatment. quinine, urea hydrochloride, monoethanolamine oleate, poli Brachytherapy is commonly used as an effective treatment docanol, invert Sugar, calcium dobesilate, and several other for cervical, prostate, breast, and skin cancer and can also be irritating agents and mixtures thereof. used to treat tissues (e.g. vessels, lesions, or tumors) in many 0234. There are various possible methods to deliver the other body sites. Brachytherapy can be used alone or in com Sclerosing agent in order to occlude flow in the vessel (e.g. bination with other therapies such as Surgery, external beam blood flow in the hemorrhoidal arteries) (in no particular radiotherapy (EBRT) and chemotherapy. In contrast to EBRT, order): 1) Delivery via needles. The sclerosing agent can be brachytherapy involves the precise placement of radiation directly injected into the lumen of the vessel. One method of Sources directly at the site of the region of interest (e.g. tissue, direct injection could use a Doppler ultrasound sensor to vessel, lesion, or tumor). A key feature of brachytherapy is locate the vessel (e.g. artery), Suction to hold the overlying that the irradiation only affects a very localized area around tissue (e.g. mucosa) in place, Doppler to estimate the depth the radiation sources. Exposure to radiation of healthy tissues below the Surface (e.g. mucosal Surface), and moving the further away from the sources is therefore reduced. In addi needle forward until the tip lies within the vessel lumen. Such tion, if the patient moves or if there is any movement of the a system would be similar to that diagrammed in FIG. 19C. A region of interest (e.g. tissue, vessel, lesion, or tumor) within similar system could be used to deliver the needle tip so that the body during treatment, the radiation sources retain their it is within a few millimeters of the vessel (e.g. artery), as correct position in relation to the region of interest. These Sclerosants can occlude the vessel without being placed characteristics of brachytherapy provide advantages over directly into the vessel's lumen. Additionally, the needle may EBRT the region of interest can be treated with very high inject without the use of Doppler guidance or Suction to hold doses of localized radiation, while reducing the probability of the tissue (e.g. mucosa) in place. Multiple needles could be unnecessary damage to Surrounding healthy tissues. A course used to simultaneously target multiple vessels (e.g. arteries), of brachytherapy can be completed in less time than other or simply to inject enough sclerosant in the vicinity of the radiotherapy techniques. This can help reduce the chance of vessels (e.g. arteries) to ensure all vessels are sealed off 2) Surviving cells dividing and growing in the intervals between Topical delivery of the sclerosant applied to the overlying each radiotherapy dose. Patients typically have to make fewer tissue (e.g. mucosa). The Sclerosant could be held in place by visits to the radiotherapy clinic compared with EBRT, and the mixing the Sclerosant with any of various materials that treatment is often performed on an outpatient basis. This adhere to the tissue (e.g. mucosa). Such as petroleum jelly, makes treatment accessible and convenient formany patients. cyanoacrylate, etc. 3) Needle-free transmucosal delivery. A These features of brachytherapy reflect that most patients are variety of needle-free transdermal systems are available for able to tolerate the brachytherapy procedure very well. In the delivery of drugs transcutaneously. A similar approach addition, brachytherapy is associated with a low risk of seri can be used on the tissue (e.g. mucosa) overlying the vessel(s) ous adverse side effects. Brachytherapy could also be deliv (e.g. hemorrhoidal arteries). The needle-free delivery sys ered by electronic brachytherapy, which involves placement tems include high-velocity streams of fluid that penetrate the of miniature low energy X-ray tube sources into a pre-posi skin/mucosa (e.g. using piezoelectric actuators), creation of tioned applicator within body cavities (e.g. tissue, vessel, micropores on the mucosa (e.g. using electric current), and lesion, or tumor) to rapidly deliver high doses to targettissues many more. 4) A Suppository pill that is placed into the rectum while maintaining low doses to distant non-target tissues. The and elutes the Sclerosant. commonly used radiation Sources (radionuclides) for brachy 0235 Another way to occlude flow through a vessel (e.g therapy are: Caesium-137 (137Cs), Cobalt-60 (60Co), Iri blood flow in the hemorrhoidal arteries) is to tamponade the dium-192 (192Ir), Iodine-125 (1251), Palladium-103 vessel (e.g. hemorrhoidal arteries) with chemicals delivered (103Pd), Ruthenium-106 (106Ru). below the tissue (e.g. mucosa), which increase the pressure 0231 Radiation therapy can be combined with other around the vessel (e.g. hemorrhoidal arteries). For example, a mechanisms described here, such as with a mechanical clo solution of silicone microbeads could be delivered beneath Sure device (e.g. clips, staple, Suture, etc.) to localize the the tissue (e.g. mucosa) at a high enough Volume that the radiotherapy (e.g. clip with brachytherapy) to the region of pressure in the low tissue layers (e.g. Submucosal tissue) interest. increases, since the tissue surface (e.g. mucosal Surface) can 0232 Another way to occlude flow through a vessel (e.g. only expand a fixed amount. This increased submucosal pres blood flow in the hemorrhoidal arteries) is to deliver scleros Sure could tamponade the vessel(s) (e.g. hemorrhoidal arter ing agents into or nearby the vessel (e.g. hemorrhoidal arter ies) compressing them Sufficiently to occlude flow (e.g. blood ies). Sclerosing agents are Substances that cause tissue irrita flow) and/or induce thrombosis. US 2012/0059394 A1 Mar. 8, 2012
0236 Tamponading agents could include: all Sclerosing than ethanol. However, it does cause hemolysis and renal agents as above, saline solutions, bio-compatible injectable failure in large doses.), Sotradecol (This agent is used for bulking agents such as those used in procedures to ameliorate superficial lower extremity varicose veins. It has been around urinary incontinence (carbon-coated microbeads, autologous for a very long time and is a proven remedy. However, it does fat, teflon paste, collagen, silicone elastomer), cyanoacrylate, cause hyperpigmentation of the region in 30% of patients. It heterologous tissues (fat, etc) that cause tamponade and/or is less painful than ethanol.), particulate embolic agents cause an inflammatory reaction, and similar agents that can (These agents are typically used for precapillary arterioles or remain in the tissue (e.g. Submucosa) for a few days. Tam small arteries. These are also very good for AVMs deep within ponading agents can be delivered using any of the methods the body. The disadvantage is that they are not easily targeted described above for Sclerosing agents. in the vessel. None of these are radioopaque So it makes 0237 Another embodiment could include a mechanism to radiologic imaging difficult to see them unless they were occlude flow through the vessel by purposely putting a soaked in contrast prior to injection.), gelfoam (This agent blocker into the vessel either from a proximal or distal loca temporarily occludes vessels for 5 weeks. They work by tion or directly at the desired location. The blocker could absorbing liquid and plugging up the vessel. These are water travel spontaneously to the desired location due to the flow insoluble gelatin so the particles may travel distally and within the vessel or the blocker could be placed directly at the occlude Smaller capillaries. A way to localize the injection of desired location by a device such as a wire or catheter that gelfoam is to make a gelfoam sandwich. A coil is placed at a could travel internally in the vessel. The blocker could be precise location, then gelfoam is injected and lodged into the expanded to a sufficient size once it was a the desired location, coil.), polyvinyl alcohol (PVA) (These are permanent agents. such as, by a balloon that is inflated or by a absorbent material They are tiny balls 50-1200 micrometers in size. The particles that when put in contact with liquid (such as liquid with a are not meant to mechanically occlude a vessel. Instead they vessel) expands to a larger desired size, or it could be cause an inflammatory reaction. They have a tendency to expanded in a larger caliber vessel and moved to a smaller clump together since the balls are not perfectly round. The caliber vessel such that it occluded flow past the blocker. The clump can separate a few days later failing as an embolic blocker could be an embolizing agent that is introduced (for agent.), acrylic gelatin microspheres (This is a Superior form example by a needle or catheter) into the vessel at a location of permanent particulate embolic agent. They are similar to that is proximal (with orientation to flow) to the desired site of PVA but they are perfectly round, thus they do not clump occlusion. The blocker could, for example, be inserted into together. The balls are fragile so they may crack inside Small the vessel directly through the rectum orthrough a catheterin, catheters.), mechanical occlusion devices (These fit in all for example, the femoral artery). The blocker could be an vessels, and have the advantage of accuracy of location as embolizing agent made out of various compounds, including, they are deployed exactly where the catheter ends.), coils but not limited to, liquid embolic agents (these are used for (These are often used forateriovenous fistulas (AVFs), aneu ateriovenous malformations (AVMs). These agents are able rysms, or trauma. They are very good for fast flowing vessels to flow through complex vascular structures so the Surgeon because they immediately clot the vessel. They are usually does not need to target his catheter to every single vessel.), made from platinum or stainless steel, and they induce clot nbca (n-butyle-2-cyanoacrylate) (This agent is a permanent because of the dacron wool tails around the wire. The coil rapidly acting liquid that will polymerize immediately on itself will not cause mechanical occlusion. Because it is made contact with ions, aka Superglue. It also has an exothermic of metal, it is easily seen in radiographic images. The disad reaction that destroys the vessel wall. Since the polymeriza Vantage is that large coils can disrupt the radiographic image. tion is so rapid, it requires skill of the Surgeon when using. The coil may also lose its shape if the catheteriskinked. There During the procedure, the Surgeon must flush the catheter is a Small risk of dislodging from the deployed location.), before and after injecting the nbca or the agent will polymer and/or a detachable balloon (These are used to treat AVFs and ize within the catheter. Also the catheter must be withdrawn aneurysms. These balloons are simply implanted in a target quickly or it will be stuck to the vessel. Oil can be mixed with vessel then filled with saline through a one-way valve. The nbca to slow the rate of polymerization.), ethiodol (This is blood stops and endothelium grows around the balloon until made from iodine and poppy seed oil, and is a highly viscous the vessel fibroses. The balloon may be hypertonic relative to agent. It is usually used for chemembolizations, especially for blood and cause the balloon to rupture and fail, or the balloon hepatomas. This is because these types of tumors have a may be hypotonic and cause the balloon to shrink and migrate characteristic of absorbing iodine. Halflife is 5 days so it only Somewhere else.) temporarily embolizes vessels.), Sclerosing agents (These 0238. The vessel(s) (e.g. hemorrhoidal arteries) can be will harden the endothelial lining of vessels. They have been sealed by locally delivering a variety of drugs. These drugs around for a long time and need more time to react than the can work by any of the following actions: induce intra-arterial liquid embolic agents. Therefore, they are less appropriate for coagulation, induce contraction or spasm of the arterial wall, high flow vessels or large vessels.), ethanol (This permanent etc. These drugs can include Fibrin, Thrombin, Alpha-1-adr agent is very good for treating AVMs. The alcohol does need energic agonists such as phenylephrine, Epinephrine, Prosta Some time to denaturize proteins of the endothelium and cyclin pathway inhibitors, Nitric oxide pathway inhibitors, activate the coagulation system which causes a blood clot. 5-HT pathway activators, TXA-2 pathway activators, Cal Therefore, some Surgeons will use a balloon occlusion cath cium channel activators, Ethanol, Interferon, Cocaine, eter to stop the blood flow and allow time for ethanol to work. Amphetamine, Ergot derivatives (e.g., ergotamine). These The disadvantage of this is that it is toxic to the system in large drugs can be delivered via any of the mechanisms described quantities and may cause compartment syndrome, and addi for Sclerosing agents above. tionally, the injections are painful.), ethanolamine oleate 0239. In any of the processes used to seal the vessel (e.g. (This permanent agent is used for Sclerosing esophageal hemorrhoidal artery), it may be advantageous to hold the varices. It is made of 2% benzyl alcohol so it is less painful overlying tissue (e.g. mucosa) in place during the procedure US 2012/0059394 A1 Mar. 8, 2012
(hereafter referred to as “mucosal fixation'). For example, in that lies in an internal shaft of the device and that is inserted FIG. 19C, a suction cup is used to hold the mucosa in place into the vessel-sealing end of the device. while a needle is delivered into the hemorrhoidal artery to seal 0244. There can be multiple bends/angles between the it with steam. In this case, mucosal fixation is provided by a handle and vessel-sealing ends of the device. vacuum created in a Suction cup that prevents the mucosal and 0245 Another method is to place between the handle and vessel (e.g. hemorrhoidal artery) from moving out of position vessel-sealing end of the device a shaft that is curved. The during placement of the needle. Mucosal fixation is useful curvature of this shaft can be any series of smooth curves. The because the mucosa is slippery, billowy, and elastic, and exact curvature can be selected based on actual tissue mea because the underlying vessel (e.g. hemorrhoidal artery) is Surements (e.g. hemorrhoid measurements) in humans. For able to move around under the mucosal Surface. example, the curvature could just be a smooth curve taking 0240 Mucosal fixation techniques include (in no particu the angles mentioned above for a fixed angle/bend. This lar order): 1) Suction of the tissue surface (e.g. mucosal curved shaft can be malleable, so the operator can inspect a Surface) with a Suction cup that creates a vacuum between the patient's anus and hemorrhoids and pre-bend the shaft so that Suction cup and tissue Surface (e.g. mucosal Surface). Our it will easily arc around the patient's hemorrhoids without tests suggest that the port size on the Suction cup that works exerting much pressure on the hemorrhoids. well is a circular (or elliptical) port that has a diameter of 0.5-3 0246 FIGS. 35A through 35C shows a method for pexy cm, or more narrowly 0.5-2 cm, or more narrowly 0.5-1 cm. ing prolapsed tissue (e.g. hemorrhoids) using a Support 2) A port that is shaped such that the mucosal evaginates into attachment, especially after vessels (e.g. hemorrhoidal arter the port. For example, a port that is conically-shaped would ies) are ligated. Said Support attachment consists of an adhe cause the compliant mucosa to form a cone shape that might sive ring member on the proximal circumferential end of the not slip away as easily. The port artery sealing mechanism Support attachment. Distal to the adhesive ring member is an (e.g. RF) could be positioned nearlin the port. 3) Movable elastic tubular member that wraps around and Supports the hooks to grab the mucosa. These hooks could be shaped like prolapsed hemorrhoid. The elastic tubular member can be curved Suture needles, have barbs, serrated edges, have adhe constructed from elastomeric membrane Such as polyure sive on them, and more. The hooks can be retractable, steer thane, latex, or can be a mesh made from the same materials. able, and more. 4) Pressing against the tissue (e.g. mucosa) Said tubular member in its un-stretched configuration will be firmly with a force orthogonal to the plane of the tissue of smaller Volume and longitudinal length as compared to the Surface (e.g. mucosal Surface). Pressing against the tissue tissue of interest (e.g. prolapsed hemorrhoids). (e.g. mucosal wall) could be done by having the operator 0247 The support attachment can be deployed from an press against, for example, the rectal wall with the device, or endoscope or a handheld device similar to the embodiment having an actuating mechanism on the device which allows described in FIG. 3. The adhesive circumference proximal the device to create its own force against the rectal wall. 5) An end, when deployed, will adhere to the anal wall around the adhesive. Adhesives include tissue glue (e.g. cyanoacrylate), base of the tissue (e.g. prolapsed hemorrhoid). Said tissue dry materials that wick up moisture from the mucosa (e.g. (e.g. prolapsed hemorrhoid) will be compactly wrapped and Whatman filter paper), and more. These adhesives could be supported by the tubular elastic member as shown in FIG. selectively inactivated (e.g. applying a jet of water to the S6-B. Additionally, the tubular elastic member applies pres Whatman filter paper). Sure on the tissue (e.g. prolapsed hemorrhoid) proximally 0241. In order for a device (e.g. transanal device) to seal a toward the anal wall and will promote the tissue (e.g. pro vessel (e.g. the hemorrhoidal arteries), it could be useful to lapsed hemorrhoids) to retract, as shown in FIG.S6-C. Said have a feature of the device that allows the vessel-sealing end Support attachment is particularly useful in promoting recov of the device to easily navigate arounda bulk of tissue (e.g. the ery especially after vessel closure (e.g. hemorrhoidal Deart bulk of the hemorrhoid). Many hemorrhoids are very large erialization) is performed by inventions disclosed in this and bulky, and external pressure on the hemorrhoid can cause application. Recovery is promoted because the tissue (e.g. pain. Therefore, it can be difficult to insert a device into the prolapsed hemorrhoids) when peXy-ed in place will reduce anus of a conscious patient without causing pain. strain to the vessel(s) (e.g. hemorrhoidal vasculature) and/or 0242 To minimize the amount of pressure exerted on the Supporting tissues (e.g. hemorrhoidal Supporting muscles) hemorrhoid and anus by inserting this device, there are vari during strain on the tissue, for example, during a bowel move ous features that can be included. One method is to have the ment, consequently preventing further damage and worsen vessel-sealing end of the device (e.g. the region of the device ing of the condition. Disclosed support attachment can also be with the clip-applier or vessel-sealing energy source) distal to used as a stand-alone (instead of a post-op) treatment if a bend/angle in the device. For example, FIG. 1A shows a desired by the physician. device with an angled bend between the handle and vessel 0248 FIG. 36A through 36C shows a variation of a Sup sealing ends of the device. The angle between these two ends port attachment (e.g. hemorrhoids Support attachment). can be a fixed angle, with the angle (between the two arms) Instead of an adhesive and elastic tubular member as approximately 90 to 180 degrees, more narrowly 135 to 170 described in FIG. 35A through 35C, a shape-memory coil, degrees, more narrowly 135 to 165 degrees, for example constructed from shape memory wires such as Nitinol, can be 150 to 165 degrees. attached to the tissue (e.g. prolapsed hemorrhoid(s)). The 0243 This bend/angle can be adjustable (having similar shape-memory Support coil is pre-heated and shaped into a angle ranges to those listed for fixed angle). The angle can be spiral coil that will be able to attach itself through axial adjusted either with a dial/slider on the device, by having the pressure (pinching motion) to the tissue (e.g. prolapsed hem operator hand-bend a malleable joint, etc. This angle can be orrhoids). As the coil is configured to remain flat (FIG. 36A) adjusted before and/or during the treatment procedure (e.g. in its un-stretched position, the coil when applied to the tissue hemorrhoids treatment procedure). The internal mechanism (e.g. a prolapsed hemorrhoid) is able to guide and promote the for controlling the bend could include pulling on a guidewire tissue (e.g. prolapsed hemorrhoid) to retract proximally US 2012/0059394 A1 Mar. 8, 2012 20 towards the wall (e.g. anal wall). Similar to the Support attach ening agent, more specifically a Sclerosing agent), or by fixa ment in FIG. 35B and 35C, the shape-memory support coil tion of the tissue (e.g. by using a band (e.g. rubberband), Stent, will promote recovery and can be deployed from an endo glue, or adhesive. scope or a handheld device as described in FIG. 3, after 0253. An additional feature that could be included with procedure (e.g. hemorrhoidal dearterialization procedure) is any of the previously described embodiments could be a performed, or as a stand-alone treatment as desired by the method to tack the tissue of interest (e.g. hemorrhoid) in place physician. The axial pressure (pinching effect) generated by by inverting and Stapling or clipping the tissue (e.g. hemor the shape-memory Support coil will provide additional forces rhoid) upwards, creating tissue fold to reduce tissue redun to ligate vessels (e.g. arteries) feeding the tissue (e.g. pro dancy (e.g. by Suturing tissue upwards), inserting an implant lapsed hemorrhoid). in the tissue to reduce redundancy, using liposuction tools to reduce tissue redundancy and pull up or tighten the tissue of 0249. Any of the above embodiments (e.g. clip, staple, interest (e.g. hemorrhoids), creating new Suspensory liga rubberband, suture, etc.) could be made wholly or partially ments, or injecting a sheet under the tissue (e.g. mucosa) to out of bio-absorbable (resorbable) materials. Bio-absorbable tighten the tissue. materials slowly degrade inside the body. Examples of bio 0254. An additional feature that could be included with absorbable materials that could be used include, but are not any of the previously described embodiments could be a limited to: ethenylbenzene (e.g. LactomerTM absorbable method to correct an engorged plexus (e.g. hemorrhoid or copolymer, e.g. Poly SurgiclipTM by Covidien), catgut (plain hemorrhoidal plexus). This could be achieved by injecting a or chormic), polyglycolic acid (e.g. Dexon), polyglactin (e.g. cross-linking agent, using heat (e.g. steam) to tighten tissues Vicryl), polydioxanone (PDS) (e.g. ABSOLOK EXTRA (e.g. hemorrhoids), pexy (e.g. anopexy or mucopexy) to lift Single Clip by Ethicon), polyglyconate (e.g. Maxon), or the tissues (e.g. hemorrhoids), deflating the vein via Suction, Purasorb (by Purac Biomaterials). a mesh or net around the hemorrhoids, rubberband support 0250. An additional feature that could be included with and spikes to drain blood from hemorrhoids, injection of any of the previously described embodiments could be a Sclerosing agents (e.g. ethanol) or lipids into the vein (e.g. method to decrease any pain or discomfort. Different meth hemorrhoidal veins), or stent to push hemorrhoids back in ods that could be used to minimize pain include, but are not place (e.g. barbs on a stent, spring on a stent, or drugs on a limited to, cooling the tissues of interest, a pudendal nerve stent (e.g. fenoafern or injection ports for drug delivery). block (e.g. an injection, plug, or implant), an epidural or 0255. An additional feature that could be included with spinal block, or using local anesthetics to the tissues of inter any of the previously described embodiments could be a est Such as esters (e.g. Procaine, Benzocaine, Chlorop method to block the blood supply. This could be achieved by rocaine, Cocaine, Cyclomethycaine, Dimethocaine/ an expanding ring pressing on or above the tissue of interest (e.g. hemorrhoids), a valve in the artery or vein or funnel in Larocaine, Propoxycaine, Procaine/Novocaine, the artery or vein to decrease blood Supply, injecting thrombin Proparacaine, or Tetracaine/Amethocaine), amides (e.g. or gel foam into the blood stream of the tissue of interest, Lidocaine, Articaine, Bupivacaine, Cinchocaine/Dibucaine, suction to the tissue of interest, ablation of thearteries or veins Etidocaine, Levobupivacaine, Lidocaine/Lignocaine, Mepi with an probe using, for example, energy, for example UV vacaine, Piperocaine, Prilocaine, Ropivacaine, or Tri light, near infrared light, or argon beam, or laser therapy. mecaine), combinations (e.g. Lidocaine/prilocaine 0256 This device could be used for several different medi (EMLA)), or natural local anesthetics (e.g. Saxitoxin or Tet cal purposes, such as ligation of vessels (such as arteries, rodotoxin). Other methods to decrease pain in the region of veins, or lymphatics), ducts, sinus tracts, and fistulae. More interest include injection of botox (as anti-spasmodic), an specifically it could be used to ligate vessels hard to reach implantable anesthetic or anesthetic delivery device, anti locations, or locations where it is difficult to locate the vessel, inflammatory drugs (e.g. Tylenol or NSAIDs), injection of a Such as in the gastrointestinal tract, more specifically it could toxin (e.g. spider Venom) to digest the area of the nerve, be used to ligate hemorrhoidal (or rectal) arteries (or varices) destruction of the nerves by radiofrequency ablation, electric or esophageal varices. Other medical problems this device ity, ice, or capsacin, injection of the painkiller used by mos could be used for include, but are not limited to, endoscopic quitoes, a stimulation probe to build tolerance, reducing pain procedures (for example: to ligate vessels in and around receptors (e.g. anti-opiate or Narcan), or injection of a col bleeding ulcers, such as gastric ulcers, duodenal ulcers, and lagen cross link in the tissue (e.g. to push nerves away from marginal ulcers (from anastomoses), to ligate esophageal, tissue edge). gastric, or rectal (hemorrhoidal) varices, to stop bleeding 0251 An additional feature that could be included with from bleeding vessels the small bowel (for example from any of the previously described embodiments could be a AVMs), to ligate bleeding vessels the colon (for example method to prevent prolapse. This could be a sleeve around the from angiodysplasia, bleeding diverticulae, or rectal or hem anus to prevent or reduce shearing forces. The sleeve could be orrhoidal varices), endoscopic marking, closure of mucosec held in place, for example, by a device fixed to the pelvic inlet. tomy (for example for cancer or a suspicious lesion), closure Alternatively, it could be lubricating stool and the rectal wall, of a perforation (for example, caused by endoscopy), for fiber for softer stool, nitroglycerin, or creating a second skin diverticular disease (for example, for closure of diverticulum, over the hemorrhoid. or to stop bleeding from diverticular disease), to perform a 0252. An additional feature that could be included with polypectomy (ligation of polyps), as an anchoring (for any of the previously described embodiments could be a example, to fix jejunal feeding tube to the wall of the small method to prevent recurrent prolapse (protrusion of tissue, for bowel).) The device could be used for surgical procedures, example, prolapse of hemorrhoids). The method to prevent Such as for a neck dissection (for example for ligation of recurrence of prolapse could be to either strengthen the tis vessels or lymph nodes), lymph node dissection (for example Sues (e.g. with electro-stimulation or injection of a strength in the breast, neck, or in the groin), for gynecological proce US 2012/0059394 A1 Mar. 8, 2012
dures, such as uterine artery ligation for the treatment of number of other sensors, which can be incorporated into or uterine fibroid disease, for bleeding following a Caesarean used in conjunction with the inventions described in this section, for fallopian tubal ligation, for urological procedures, document. Such as vasectomy (for example for the purpose of ligating a 0263. The sensor can be laser Doppler flow metry. The structure and specifically avoiding ligation of a vessel), for patient can receive intravenous indocyanine green dye, fol closure of urine leaks from kidneys, ureters, bladder, and/or lowed by detection of the arteries by near-infrared video urethra, for ligation of vessels (such as lacerated arteries angiography. The arteries can be detected by measuring and/or veins) in trauma situations (for example to stop rapid absorption of electromagnetic energy from the mucosa. Sev arterial bleeding without isolating the artery, more specifi eral wavelength bands should suffice for submucosal arterial cally to enable those untrained in medicine to stop bleeding in detection, such as infrared which is well absorbed by blood the field), to stop bleeding from AVMs, to close an aneurysm vessels. Fourth, the sensor can use multiple wavelength bands of electromagnetic energy to differentiate arteries from veins. (for example for Small aneurysm sacs), for closure of arteries Oxygenated hemoglobin absorbs more light at 910 nm and (such as hemorhhoidal arteries, the gastroduodenal artery, deoxygenated hemoglobin absorbs more light at 660 nm. By and/or bleeding ulcers), for closure of veins (such as veins in comparing absorption at these wavelengths it is possible to the esophagus), for closure of lymphatic vessels (such as the differentiate veins from arteries. Including dopper ultrasound lymphatic duct, lymph vessels causing a lymphocele, and/or sensors, a combination of any of the above sensors can also be lymph nodes), for closure of ducts, such as the pancreatic used to detect Submucosal arterial segments with internal duct, biliary ducts (for example for post-Surgical leaks, for blood flow, in conjunction with or incorporated into inven example the cystic duct, intra- or extra-hepatic ducts, com tions described in this document. mon hepatic duct, and or common bile duct), Sebaceous ducts, 0264. Any or all elements of the clips, clamps, staples, mucous ducts, and/or salivary ducts, closure of sinus tracts, stents, or other implantable devices or tools for delivering the closure of fistulae, such as vascular fistulae and/or enteric treating devices or directly treating hemorrhoids disclosed fistulae, for aneurysms (for example aneurysms in the brain, herein (collectively the “treatment devices”) and/or other aorta, iliac, femoral, popliteal artery, or other peripheral devices or apparatuses described herein can be made from, artery), for venous aneurysms (for example, popliteal vein for example, a single or multiple stainless steel alloys, nickel aneurysms). It could also be use for closure of airways (e.g. titanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g., bronchi airways, e.g. for air leaks). ELGILOYR from Elgin Specialty Metals, Elgin, Ill.: CON 0257. The devices and methods disclosed here can effec ICHROME(R) from Carpenter Metals Corp., Wyomissing, tively treat hemorrhoids with minimal pain. The device is Pa.), nickel-cobalt alloys (e.g., MP35NR) from Magellan minimally invasive and can involve no cutting, Suturing, and Industrial Trading Company, Inc., Westport, Conn.), molyb extensive anal dilation. The device can require only 1.5 cm denum alloys (e.g., molybdenum TZMalloy, for example as dilation of the anus (the same as a finger exam of the rectum) disclosed in International Pub. No. WO 03/082363 A2, pub and the use of precision energy delivery to collapse the tar lished 9 Oct. 2003, which is herein incorporated by reference geted arteries. in its entirety), tungsten-rhenium alloys, for example, as dis 0258. The methods described herein can be performed in a closed in International Pub. No. WO 03/082363, polymers clinic or office. The methods described are minimally inva such as polyethylene teraphathalate (PET)/polyester (e.g., sive and do not require anesthesia (which requires previously DACRONR) from E. I. Du Pont de Nemours and Company, existing treatments to be performed in the operating room Wilmington, Del.), polypropylene, (PET), polytetrafluoroet (OR), which is typically more expensive). hylene (PTFE), expanded PTFE (ePTFE), polyether ketone (PEK), polyether ether ketone (PEEK), poly ether ketone 0259. The devices and methods described herein can be ketone (PEKK) (also poly aryl ether ketone ketone), nylon, usable by gastroenterologists. Gastroenterologists currently polyether-block co-polyamide polymers (e.g., PEBAX(R) diagnose hemorrhoids but are unable to effectively treat the from ATOFINA, Paris, France), aliphatic polyether polyure hemorrhoids because they lack the necessary tools. thanes (e.g., TECOFLEX(R) from Thermedics Polymer Prod 0260 Many patients do not receive treatment because they ucts, Wilmington, Mass.), polyvinyl chloride (PVC), poly fear the painful treatments, or get lost in the referral chain. urethane, thermoplastic, fluorinated ethylene propylene The devices and methods described herein can expand the (FEP), absorbable or resorbable polymers such as polygly treated population by providing an effective treatment that is colic acid (PGA), polylactic acid (PLA), polycaprolactone painless and can be performed by the physicians who first (PCL), polyethyl acrylate (PEA), polydioxanone (PDS), and diagnose the hemorrhoids. pseudo-polyamino tyrosine-based acids, extruded collagen, 0261. The devices and methods described herein will silicone, Zinc, echogenic, radioactive, radiopaque materials, a effectively treat hemorrhoids with minimal procedural and biomaterial (e.g., cadaver tissue, collagen, allograft, post-procedural pain. The devices and methods herein autograft, Xenograft, bone cement, morselized bone, osteo improve upon HD in several respects: the massive anal dila genic powder, beads of bone) any of the other materials listed tion (>6 cm) required by HD causes severe anal fissures herein or combinations thereof. Examples of radiopaque (tears) in 4% of patients, while our invention requires mini materials are barium sulfate, Zinc oxide, titanium, stainless mal dilation (1.5 cm); the presently disclosed procedure can steel, nickel-titanium alloys, tantalum and gold. be performed by gastroenterologists and will allows a much 0265 Any or all elements of the treatment devices and/or faster and easier procedure. The device has the efficacy and other devices or apparatuses described herein, can be, have, minimal pain of HD. and/or be completely or partially coated with agents and/or a 0262 Alternative or in addition to the use of ultrasound matrix for cell ingrowth or used with a fabric, for example a Doppler sensors, detection of Submucosal arterial segments covering (not shown) that acts as a matrix for cell ingrowth. with internal blood flow can also be accomplished using a The matrix and/or fabric can be, for example, polyester (e.g., US 2012/0059394 A1 Mar. 8, 2012 22
DACRONR) from E. I. Du Pont de Nemours and Company, device ligating hemorrhoids in the rectum means that the Wilmington, Del.), polypropylene, PTFE, ePTFE, nylon, device is controlled by elements operated by the user outside extruded collagen, silicone or combinations thereof. of the rectum. 0271 "Immobilizing herein refers to actively holding 0266 The treatment devices and/or elements of the treat steady, not merely being placed next to a loose object or tissue ment devices and/or other devices or apparatuses described that may continue to move about. herein and/or the fabric can be filled, coated, layered and/or 0272 “Ligating herein refers to a method of stopping otherwise made with and/or from cements, fillers, glues, and/ flow within a lumen. Ligating can include, but is not limited or an agent delivery matrix known to one having ordinary to, mechanical constriction or otherwise compressing or tam skill in the art and/or a therapeutic and/or diagnostic agent. ponading, Sclerosing, ablating, or combinations thereof. Any of these cements and/or fillers and/or glues can be osteo 0273. The devices and methods discussed above are not genic and osteoinductive growth factors. limited to certain treatments or regions of the body, but may 0267 Examples of such cements and/or fillers includes include any number of other treatments and areas of the body. bone chips, demineralized bone matrix (DBM), calcium sul Modification of the above-described methods and devices for fate, coralline hydroxyapatite, biocoral, tricalcium phos carrying out the invention, and variations of aspects of the phate, calcium phosphate, polymethyl methacrylate invention that are obvious to those of skill in the arts are (PMMA), biodegradable ceramics, bioactive glasses, hyalu intended to be within the scope of this disclosure. Any ele ronic acid, lactoferrin, bone morphogenic proteins (BMPs) ments described herein as singular can be pluralized (i.e., Such as recombinant human bone morphogenetic proteins anything described as "one can be more than one). Any (rhBMPs), other materials described herein, or combinations species element of a genus element can have the characteris thereof. tics or elements of any other species element of that genus. 0268. The agents within these matrices can include any The above-described configurations, elements or complete agent disclosed herein or combinations thereof, including assemblies and methods and their elements for carrying out radioactive materials; radiopaque materials; cytogenic the invention, and variations of aspects of the invention can be agents; cytotoxic agents; cytostatic agents; thrombogenic combined and modified with each other in any combination. agents, for example polyurethane, cellulose acetate polymer Moreover, various combinations of aspects between mixed with bismuth trioxide, and ethylene vinyl alcohol: examples are also contemplated and are considered to be lubricious, hydrophilic materials; phosphor cholene; anti-in within the scope of this disclosure as well. flammatory agents, for example non-steroidal anti-inflamma We claim: tories (NSAIDs) such as cyclooxygenase-1 (COX-1) inhibi 1. A method for treating a hemorrhoid comprising: tors (e.g., acetylsalicylic acid, for example ASPIRINR) from locating a hemorrhoidal artery; Bayer AG, Leverkusen, Germany; ibuprofen, for example immobilizing the hemorroidal artery; and ADVILR) from Wyeth, Collegeville, Pa.; indomethacin: automatedly sealing the hemorrhoidal artery. mefenamic acid), COX-2 inhibitors (e.g., VIOXXOR) from 2. The method of claim 1, wherein automatedly sealing Merck & Co., Inc., Whitehouse Station, N.J., CELEBREX(R) comprises mechanically ligating the hemorrhoidal artery. from Pharmacia Corp., Peapack, N.J.; COX-1 inhibitors); 3. The method of claim 2, wherein mechanically ligating immunosuppressive agents, for example Sirolimus (RAPA comprises compressing the hemorrhoidal artery. MUNE(R), from Wyeth, Collegeville, Pa.), or matrix metallo 4. The method of claim 1, wherein immobilizing comprises proteinase (MMP) inhibitors (e.g., tetracycline and tetracy applying Suction. cline derivatives) that act early within the pathways of an 5. The method of claim 1, wherein immobilizing comprises inflammatory response. Examples of other agents are pro inserting a hook into tissue adjacent to the hemorrhoidal vided in Walton et al. Inhibition of Prostoglandin E. Synthe artery. sis in Abdominal Aortic Aneurysms, Circulation, Jul. 6, 1999, 6. The method of claim 1, wherein immobilizing comprises 48-54; Tambiah et al. Provocation of Experimental Aortic applying an adhesive adjacent to the hemorrhoidal artery. Inflammation Mediators and Chlamydia Pneumoniae, Brit. J. 7. A method for treating a hemorrhoid comprising: Surgery 88 (7), 935-940; Franklin et al, Uptake of Tetracy locating a hemorrhoidal artery; cline by Aortic Aneurysm Wall and Its Effect on Inflammation immobilizing the hemorroidal artery; and and Proteolysis, Brit. J. Surgery 86 (6), 771-775; Xuetal, Sp1 automatedly sealing the hemorrhoidal artery; wherein Increases Expression of Cyclooxygenase-2 in Hypoxic Vas automatedly sealing comprises sensing flow in the cular Endothelium, J. Biological Chemistry 275 (32) 24583 artery, and triggering the sealing when flow is detected. 24589; and Pyo et al. Targeted Gene Disruption of Matrix 8. The method of claim 7, wherein automatedly sealing Metalloproteinase-9 (Gelatinase B) Suppresses Development comprises compressing the artery. of Experimental Abdominal Aortic Aneurysms, J. Clinical 9. The method of claim 8, wherein compressing the artery Investigation 105 (11), 1641-1649 which are all incorporated comprises Suctioning the tissue adjacent to the artery to form by reference in their entireties. a tissue mound, and delivering a clip onto the tissue mound. 0269. Automated' or “automatedly' herein refers to con 10. The method of claim 7, wherein automatedly sealing trolling a device to perform the function desired. Automatic comprises ablating the artery when flow in the artery is implies that the operators hands have no direct mechanical detected. control over the tool. The operator of an automated tool can 11. The method of claim 10, wherein ablating comprises press a button, a lever, knob, and/or use other controls to delivering RF energy to the artery. control a working element, but does not have a grasp on the 12. The method of claim 10, wherein ablating comprises working element performing the resulting action itself. delivering steam into or onto the artery. (0270. “Remote' or “remotely”herein refers to controlling 13. The method of claim 10, wherein ablating comprises a device away from the target site. Notably, remotely using a freezing the artery. US 2012/0059394 A1 Mar. 8, 2012
14. The method of claim 7, wherein automatedly sealing 33. The device of claim29, wherein the ligating component comprises Sclerosing the artery when flow in the artery is comprises a clip. detected. 34. The device of claim29, wherein the ligating component 15. The method of claim 14, wherein sclerosing the artery comprises an ablating component. comprises delivering a Sclerosing agent into or onto the artery. 35. The device of claim 34, wherein the ablating compo 16. The method of claim 7, wherein locating comprises nent comprises an electrode. locating using Doppler ultrasound. 36. The device of claim 35, wherein the ablating compo 17. A method for treating a hemorrhoid comprising: nent comprises a HIFU transducer. locating a hemorrhoidal artery; 37. The device of claim29, wherein the ligating component immobilizing the hemorroidal artery; and comprises a tamponading agent remotely sealing the hemorrhoidal artery. 38. The device of claim29, wherein the ligating component 18. The method of claim 17, wherein remotely sealing comprises a Sclerosing agent. comprises activating a sealing device to close the hemor 39. The device of claim29, wherein the ligating component rhoidal artery, wherein activating comprises controlling the comprises an ionizing radiation source. device outside of the rectum. 40. The device of claim29, wherein the fixation component 19. The method of claim 17, wherein the device comprises comprises a Suction source. an ablator, and wherein the ablator ablates the hemorrhoidal 41. The device of claim 40, wherein the suction source is in artery, and whereinactivating the device comprises activating fluid communication with a suction port adjacent to the the ablator. remote locating component and the ligating component. 20. The method of claim 17, wherein the device comprises 42. The device of claim 41, wherein the suction source is a compressor deployer, and wherein the compressor deployer translatable with respect to the remainder of the device. deploys a compressor that compresses the hemorrhoidal 43. The device of claim 29, wherein the remote locating artery. component comprises a Doppler sensor. 21. The method of claim 20, wherein the compressor 44. The device of claim 29, wherein the remote locating deployer comprises a Suture deployer. component comprises a flow detector. 22. The method of claim 20, wherein the compressor 45. The device of claim 44, wherein the remote locating deployer comprises a clip applier. component is configured to emit an acoustic signal when the 23. The method of claim 20, wherein the compressor flow detector detects flow. deployer comprises a stapler. 46. A device for treating hemorrhoidal arteries comprising: 24. The method of claim 17, wherein locating comprises an orthogonal grid of ligating-locating pairs, wherein each locating using Doppler ultrasound. ligating-locating pair comprises an artery ligator adja 25. A method for treating a hemorrhoid comprising: cent to or within an artery locator, and wherein the grid applying Suction to tissue Superficial to a hemorrhoidal comprises two rows and two columns of ligating-locat artery. ing pairs. 26. The method of claim 25, further comprising locating 47. The device of claim 46, wherein the artery ligator the hemorrhoidal artery; and fixing a treatment device to the comprises an RF electrode. hemorroidal artery, and wherein fixing comprises the apply 48. The device of claim 46, wherein the artery locator ing of Suction to tissue Superficial to the hemorrhoidal artery. comprises a Doppler sensor. 27. A device for treating hemorrhoidal arteries comprising: 49. A method of ligating a hemorrhoidal artery comprising: a distal end comprising a remote locating component; a inserting a device into the anus, wherein the device com ligating component; and a fixation component; prises a sensing element and a ligating element; a handle proximal to the distal end; and advancing the device so that the sensing and ligating com a neck between the handle and the distal end, wherein the ponents are Superior to the dentate line; neck is non-linear. ligating the hemorrhoidal artery not using hand Suturing; 28. A device for treating hemorrhoidal arteries comprising: and a distal end comprising a remote locating component; a done without direct visualization ligating component; and a fixation component; 50. The method of claim 49, wherein the inserting further a handle proximal to the distal end; and comprises dilating the anus less than about 2 cm. a neck between the handle and the distal end, wherein the 51. The method of claim 50, wherein advancing comprises neck is angularly articulatable. advancing the device so the sensing and ligating components 29. A device for treating hemorrhoidal arteries comprising: are superior to about 1 cm above the dentate line. a distal end comprising a remote locating component; a 52. A method for treating hemorrhoidal arteries compris ligating component; and a fixation component; wherein ing: the distal end has a distal end diameter less than about 3 concurrently ligating all the hemorrhoidal arteries. cm; and 53. The method of claim 52, wherein the ligation comprises a stopper proximal to the distal end, wherein the stopper circumferentially ablating tissue in the rectum. has a stopper diameter greater than about 3 cm. 54. The method of claim 53, further comprising inserting a 30. The device of claim 29, wherein the distal end diameter ligation device into the rectum and past the dentate line. is less than about 2 cm. 55. The method of claim 54, wherein inserting comprises 31. The device of claim 29, wherein the distal end diameter prohibiting the device from insertion of the ligation device is less than about 1.5 cm. more than about 8 cm into the rectum. 32. The device of claim 29, wherein the distal end diameter 56. The method of claim 54, wherein prohibiting the device is less than about 1 cm. comprises abutting the anus. US 2012/0059394 A1 Mar. 8, 2012 24
57. The method of claim 52, wherein ligation comprises ligating said hemorrhoidal artery thermally with the energy applying energy to the hemorrhoidal arteries. probe. 58. The method of claim 57, wherein the energy comprises 76. The method according to claim 75, wherein ligating the infrared energy. hemorrhoidal artery comprises making no incisions. 59. The method of claim 57, wherein the energy comprises 77. The method according to claim 76, wherein ligating the RF energy. hemorrhoidal artery comprises increasing the temperature of 60. The method of claim 57, wherein the energy comprises a wall of the hemorrhoidal artery to above about 70 degrees HIFU energy. Celsius. 61. The method of claim 57, wherein the energy comprises 78. The method according to claim 76, wherein ligation the thermal energy. hemorrhoidal artery occurs after positioning the energy above 62. The method of claim 57, wherein the energy comprises the dentate line. electro-cautery energy. 79. An apparatus for ligating hemorrhoidal arteries for 63. An apparatus for treating hemorrhoids comprising: treatment of hemorrhoids comprising: a sensor for locating hemorrhoidal arteries; a tubular housing: an energy probe for thermally ligating said hemorrhoidal a suction chamber at the distal end of the tubular housing arteries; defining an open cavity for creating a tissue fold through a safety mechanism to position the sensor and the energy Suction, wherein the Suction chamber having means for probe at least 1 cm above the dentate line; receiving compression clips deployable to at least par a processing unit coupled to the sensor, and tially pinch the base of said tissue fold: an energy generator coupled to the energy probe. a Doppler ultrasound sensor proximal to the Suction cham 64. apparatus of claim 63, wherein the safety mechanism ber and the clip deployment mechanism; a handle at the comprises a stopper. proximal end of the tubular housing with mechanisms to 65. apparatus of claim 63, wherein the stopper has a larger activate Suction in the Suction chamber and to deploy diameter than the diameter of the remainder of the device. clips to at least partially pinch the base of said tissue 66. The apparatus of claim 63, wherein said sensor is an fold. ultrasound Doppler transducer. 80. The apparatus of claim 79, wherein compression clip 67. The apparatus of claim 63 wherein said energy probe is comprises barbs with tips of differing lengths. a radiofrequency electrode, a high intensity ultrasound abla 81. The apparatus of claim 79, wherein the compression tion probe, a steam delivery port and/or a laser transmitter. clip comprises wirestock. 68. The apparatus of claim 63, wherein said sensor is placed in the middle of or adjacent to said energy probe. 82. A method for ligating hemorrhoidal arteries for treat 69. The apparatus of claim 63, wherein said sensor and/or ment of hemorrhoids, comprising: energy probe is placed on an expandable member. placing a Doppler ultrasound sensor on a tissue surface of 70. The apparatus of claim 69, wherein the expandable a tissue; member comprises a balloon. moving said ultrasound sensor along the tissue surface 71. The apparatus of claim 69, wherein the expandable until an artery is located; member comprises a basket. pinching the tissue perpendicularly to create a tissue fold 72. The apparatus of claim 69, wherein the expandable that disrupts blood flow through said detected artery; and member comprises a mesh. delivering a compression clip to at least partially pinch the 73. The apparatus of claim 63, wherein said safety mecha base of said tissue fold to stop blood flow through the nism is a touch sensor and/or an insertion depth indicator. detected artery. 74. The apparatus of claim 63, wherein the processing unit 83. The method of claim 82, further comprising confirming and the energy generator are configured to exchange infor cessation of blood flow through the artery after the compres mation to optimize the artery ligation process without requir sion clip is delivered, wherein comfirming cessation of blood ing direct visualization of the hemorrhoidal artery. flow comprises using a Doppler ultrasound sensor. 75. A method of treating hemorrhoids comprising: 84. The method of claim 82, wherein pinching comprises inserting a treatment device through the anus, wherein the applying Suction to the tissue, and wherein delivering com treatment device comprises a sensor and an energy prises delivering the compression clip perpendicular to the probe; direction of Suction. positioning the sensor and energy probe to at least 1 cm 85. The method of claim 82, wherein placing the Doppler above the dentate line; ultrasound sensor comprises advancing a treatment device expanding or articulating the distal end said treatment through the rectum, wherein the device comprises a measur device to allow treatment device to be in contact with the ing device; and measuring the advancing of the treatment interior rectal tissue; device to confirm that a working end of the treatment device articulating said treatment device until at least one hemor is above the dentate line of the rectum. rhoidal artery is located, wherein articulating comprises turning and/or translating; and c c c c c