US008197552B2

(12) United States Patent (10) Patent No.: US 8,197.552 B2 Mandpe (45) Date of Patent: Jun. 12, 2012

(54) EUSTACHIANTUBE DEVICE AND METHOD (58) Field of Classification Search ...... 623/10, 623/23.7; 604/8: 606/108–109 (76) Inventor: Aditi H. Mandpe, San Francisco, CA See application file for complete search history. US (US) (56) References Cited (*) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S. PATENT DOCUMENTS U.S.C. 154(b) by 9 days. 2006/0198869 A1* 9, 2006 Furst et al...... 424/426 2006/0206189 A1* 9, 2006 Furst et al...... 623,111 (21) Appl. No.: 12/901,932 * cited by examiner (22) Filed: Oct. 11, 2010 Primary Examiner — David Isabella Assistant Examiner — Andrew Iwamaye (65) Prior Publication Data (74) Attorney, Agent, or Firm — Louis L. Wu US 2011 FOO2898.6 A1 Feb. 3, 2011 (57) ABSTRACT O O Devices are provided for insertion into a Eustachian tube of Related U.S. Application Data an animal, e.g., a human being. The devices include an insert (62) Division of application No. 1 1/678,919, filed on Feb. able member. The member has opposing Surfaces and is 26, 2007, now Pat. No. 7,833,282. formed at least in part from a biocompatible material that is degradable. The device may comprise a hole that is effective (60) Provisional application No. 60/767,020, filed on Feb. to provide sufficient fluid communication between the oppos 27, 2006. ing surfaces of the insertable member to effect pressure equilibration therebetween. The device is able to be immobi (51) Int. Cl. lized within the Eustachian tube for a predetermined period. A6 IF 2/04 (2006.01) Also provided are kits that include the device and methods for A6 IF II/00 (2006.01) inserting the device into a Eustachian tube. A6M5/00 (2006.01) (52) U.S. Cl...... 623/23.7; 604/8: 606/108;606/109 24 Claims, 3 Drawing Sheets

83

U.S. Patent Jun. 12, 2012 Sheet 1 of 3 US 8,197.552 B2

a U.S. Patent Jun. 12, 2012 Sheet 2 of 3 US 8,197.552 B2

F.G. 5 U.S. Patent Jun. 12, 2012 Sheet 3 of 3 US 8,197.552 B2

Step (a): loading onto an insertion apparatus a device Comprising an insertable member and a fluid-COmmunication providing means

Step (b): using the insertion apparatus to insert the device through a nostrilor mouth of the animal into the animal's Eustachian tube

Step (c): releasing the device from the apparatus to immobilize the device within and rendering patent the Eustachian tube for a predetermined time period

F.G. 6 US 8,197.552 B2 1. 2 EUSTACHIANTUBE DEVICE AND METHOD after placement. The invasiveness of Surgical procedures to the eardrum or tympanic membrane also represents a poten CROSS REFERENCE TO RELATED tial source of complications APPLICATIONS Some long-term solutions have been proposed. U.S. Pat. No. 3,807.409 to Paparella et al. and U.S. Pat. No. 4,695.275 This application is a divisional of U.S. patent application to Bruce etal. describe eardrum-based methods and modified Ser. No. 1 1/678,919, entitled “Eustachian Tube Device and ventilation tube flanges to promote lengthier tube retention Method,” filed on Feb.26, 2007, by inventor Aditi H. Mandpe, periods. U.S. Pat. No. 3,982.545 to Silverstein and U.S. Pat. now U.S. Pat. No. 7,833,282 B2, which claims priority to U.S. No. 5,047,053 to Jahn describe methods of ventilation tube Provisional Patent Application Ser. No. 60/767,020, entitled 10 insertion by modifying the ear canal. The materials used for “Eustachian Tube Dilator and Stent filed on Feb. 27, 2006, ventilation tube construction for U.S. Pat. No. 3,982,545 is by inventor Aditi H. Mandpe, the disclosures of which are silicone and U.S. Pat. No. 5,047,053 is biointegratable incorporated by reference in their entirety. hydroxyapatite. These prostheses may be extruded at variable 15 times and require complex office or operating room proce BACKGROUND dures to clear debris that surrounds the ventilation tubes. Direct stenting of the Eustachian tube through the middle 1. Technical Field ear orifice have been proposed. Devices for carrying out Such The invention generally relates to devices for insertion into Eustachian tube stenting have been described, for example, in a Eustachian tube. In particular, the invention relates to U.S. Pat. No. 4,015,607 to Wright, III, U.S. Pat. No. 6,589, devices that include an insertable member, a means for immo 286 to Litner and PCT/JP2005/020014. As a short-term solu bilizing the device, a means for providing sufficient fluid tion, Litner describes an elongated, drug-eluting stent communication between opposing Surfaces of the insertable designed to be secured at the tympanic orifice as a short-term member to effect pressure equilibration therebetween, and to Solution to maintain the patency of the Eustachian tube. In methods for using Such devices. 25 contrast, the Wright apparatus is designed as a long-term 2. Background Art Solution. Long-term Eustachian tube stenting via the middle The Eustachian tube is a hollow lined tube that connects a ear have resulted in unplanned tube extrusion, mucosal middle ear to the nasopharynx. The middle ear portion of the inflammation of the Eustachian tube and blockage. In any tube can only be accessed by incising the eardrum or earcanal case, these apparatuses are placed through either a myringo skin. The nasal portion of the tube is surrounded by cartilage 30 tomy or incision into the ear canal. that regulates opening and closing actions (torus tubarius). In Myringotomy can lead to persistent abnormalities with the its resting state, the Eustachian tube is in the closed position. eardrum. In the pediatric age group where myringotomy with Eustachian tube opening action is mediated by contraction of ventilation tube insertion is a common procedure, the most Surrounding muscles that impinge upon the tube and torus concerning complication is permanent eardrum perforation. tubarius. An opened tube ventilates and drains the middle ear 35 and maintains proper pressure relationships among the ear When eardrums heal after myringotomy, many are clearly drum, middle ear, and nasopharynx. abnormal. Such as, formation of retraction pockets, thin atro Eustachian tube dysfunction has been implicated in the phic membranes, and tympanosclerosis. The impact of these development of various otologic diseases. The etiology of undesirable changes is hearing loss that ranges from 3-5 acute otitis media is hypothesized to be due to bacteria trav 40 decibels (dB). Incision into the ear canal is a more technically eling into the middle ear from the nasal cavity in a setting of complex Surgical process. Bleeding in the ear canal and scar inflammation, which prevents the middle ear from draining ring of the eardrum are common outcomes. properly. Chronic otitis media occurs when the Eustachian While previous methods of relieving Eustachian tube dys tube fails to ventilate the middle ear over an extended period. function and associated problems have been focused on the In these cases, fluid and thickened mucosa accumulate in the 45 middle ear component, there is recent indication that treat middle ear, causing hearing loss. As difficulty ventilating the ment at the nasopharynx component is promising. A success middle ear continues, skin may become entrapped (choleste ful method and apparatus for the treatment of Eustachian tube atoma), and cause chronic infection and destruction of the dysfunction at the torus tubarius location would be free of ossicles, inner ear and mastoid air cell system. undesirable outcomes associated with eardrum and ear canal Eustachian tube dysfunction is especially problematic for 50 based surgical procedures. Poe et al. (2003), “Laser Eusta patients who are unable to clear their ears when flying and chian Tuboplasty: A Preliminary Report. LARYNGOSCOPE, 113 diving. In the setting of rapidly changing barometric condi (4):583-91, describes a surgical procedure which involves tions, as in flying and diving, inability to ventilate the middle partial excision of the cartilaginous portion of the torus ear Sufficiently can lead to barotrauma with accumulation of tubarius to increase the opening size. This Surgical procedure fluid or blood in the middle ear. On occasion, Eustachian tube 55 dysfunction patients can experience eardrum rupture, deep has been effective in preventing the need to replace ventila hearing loss and dizziness. tion tubes in 70% of patients with chronic otitis media. Treatment of Eustachian tube dysfunction has mainly been A non-Surgical device that acts to enlarge the torus tubarius directed at ventilation of the middle ear via the eardrum or aperture on a temporary basis appears to be effective in tympanic membrane. Typically, a myringotomy or incision 60 chronic otititis media. The EarPopperTM delivers a pressure through the Substance of the eardrum is created, and a venti controlled constant volume velocity of air through the nose to lation tube is placed within the incision. These ventilation the Eustachian tube orifice in the nasopharynx. As disclosed tubes or grommets have been commercially available for over in Aricket al. (2005), “Nonsurgical hometreatment of middle 50 years. ear effusion and associate hearing loss in children. Part I: Such treatments are associated with numerous drawbacks. 65 Clinical trial.” EAR, NOSE, THROAT JOURNAL,85(10): 1-13, such a For example, ventilation tubes are typically spontaneous and device has been used to restore hearing to normal in 85% of uncontrollably extruded from the eardrum about 4-9 months patients without antibiotics or ventilation tubes over 7 weeks. US 8,197.552 B2 3 4 Nevertheless, opportunities exist to overcome disadvan FIG. 2 depicts in side view the device shown in FIG. 1. tages associated with known technologies associated with the FIG. 3 shows in perspective view of the device shown in treatment of disorders associated with an obstructed Eusta FIG 1. chian tube. FIGS. 4a and 4b, collectively referred to as FIG. 4, show SUMMARY cross sectional views near the bottom and top, respectively, of the device shown in FIG. 1. In a first embodiment, a device is provided for insertion FIG. 5 depicts the placement of the device of FIG. 1 in into a Eustachian tube of an animal, e.g., a human. The device position in the Eustachian tube at the torus tubarius. includes, in some instances consists essentially of an insert FIG. 6 is a flow chart that shows various steps of an exem able member, an immobilizing means and a fluid-communi 10 plary embodiment of the inventive method. cation providing means. The member has opposing Surfaces and is formed at least in part from a biocompatible material DETAILED DESCRIPTION OF THE INVENTION that is degradable in the Eustachian tube at a predetermined degradation rate. The fluid-communication providing means Definitions and Overview is effective to provide sufficient fluid communication 15 Before describing the present invention in detail, it is to be between the opposing surfaces of the insertable member to effect pressure equilibration therebetween. The immobilizing understood that the invention is not limited to devices and means is effective to immobilize the device within the Eus methods that provide pressure equilibration in any specific tachian tube, typically at a location closer to a nasopharynx manner, for particular fluids and/or for treatment any specific than an eardrum, for a predetermined period of time that disorders, as such may vary. It is also to be understood that the corresponds to the predetermined degradation rate. terminology used herein is for the purpose of describing Typically, the predetermined period is selected to allow particular embodiments only, and is not intended to be limit Eustachian tube function to be restored without having ing. trauma to the Eustachian tube mucosa that potentially may In addition, as used in this specification and the appended lead to Scarring. For example, the immobilization means may 25 claims, the singular article forms “a,” “an and “the include have a construction Such that degradation of the biocompat both singular and plural referents unless the context clearly ible material of the device after the predetermined period dictates otherwise. Thus, for example, reference to “an appa within the Eustachian tube leads to a substantially complete ratus' includes a single apparatus as well as an assembly of extraction of the member from the Eustachian tube. Such apparatuses, reference to “a hole' includes a plurality of holes extraction may be carried out with or without Surgical inter 30 as well as a single hole, and reference to “a material” includes vention. a single material as well as a combination of materials, and the Member geometry may vary. Typically, at least one oppos like. ing exterior Surface is associated with a member length and In this specification and in the claims that follow, reference member width and the peripheral Surface is associated a will be made to a number of terms that shall be defined to have member thickness Such that the member length is greater than 35 the following meanings, unless the context in which they are the member thickness. In some instances, the member may have a geometry effective to allow the peripheral surface of employed clearly indicates otherwise: the member to engage a Surface of the Eustachian tube, The term “biocompatible' refers to the ability of the com thereby substantially immobilizing the device within the Eus positions of the present invention to be applied to tissues tachian tube upon insertion therein. In Such a case, at least one 40 without eliciting significant inflammation, fibrosis, or tissue exterior Surface may have a substantially triangular shape that responses that are toxic, injurious or otherwise adverse. corresponds to a cross sectional area of the Eustachian tube. The term “fluid as used herein in its ordinary sense and Optionally, the member geometry may exhibit mirror sym refers to an at least partially gaseous and/or liquid Substance metry. In addition, the fluid-communication-providing means that easily changes its shape. A fluid may contain a solid that may include or consistessentially of a hole extending through 45 is minimally, partially, or fully solvated, dispersed, or Sus the member between the opposing exterior surfaces, the hole pended. Examples of fluids include, without limitation, gases being substantially dimensionally stable for at least the pre (such as oxygen, nitrogen, carbon dioxide, water vapor, and determined period after the device is inserted into the Eusta mixtures such as air), aqueous liquids (including water perse, chian tube. salt water, and physiologic Saline Solutions), nonaqueous liq The device may be provided in a kit that also includes an 50 uids (such as organic solvents, oils and the like), fluid emul insertion apparatus, e.g., a spring-loaded hand-held endo sions, Suspensions, and/or solutions such as mucus, blood, scopic apparatus, in an optional container with optional plasma, lymph, interstitial fluids, etc. instructions for using the apparatus. The insertion apparatus Accordingly, the term “fluid-communication, unless the may be releasably engageable with the device. For example, context of its usage clearly indicates to the contrary, generally the device may be constructed to engage the device via the 55 encompasses terms such as 'air-communication, and fluid-communication-providing means. “mucus-communication.” In another embodiment, a method is for inserting a device “Optional' or “optionally’ means that the subsequently into a Eustachian tube of an animal. The device may be described circumstance may or may not occur, so that the inserted, using an optionally insertion apparatus, through a description includes instances where the circumstance occurs nostril or mouth of the animal into the Eustachian tube. The 60 and instances where it does not. device may then be released manner effective to allow the The term “polymer and “polymeric' refer to a molecule device to immobilize itself within the Eustachian tube. consisting of individual chemical moieties, which may be the same or different, but are preferably the same, that are joined BRIEF DESCRIPTION OF THE DRAWINGS together. As used herein, the term “polymer refers to indi 65 vidual chemical moieties that are joined end-to-end to form a FIG. 1 depicts in front view an exemplary device of the linear molecule, as well as individual chemical moieties invention in the form of a Eustachian tube dilator and stent. joined together in the form of a branched structure. US 8,197.552 B2 5 6 The term “resorbable' is used herein in its ordinary sense ciated with treatment methods that involve an incision in the and describes a degradable material that can be both dissolved ear canal or eardrum, or entry into the middle ear space. In in and biologically assimilated by a patient. addition, such placement of the device in the Eustachian tube The terms “substantial and “substantially are referred to may provide immediate relief from fluid in the ear and pres herein in their ordinary sense and are used to describe matters Sure related maladies. that are, e.g., considerable in importance, value, degree, As the device renders the Eustachian tube patent, the amount, and/or extent. For example, a device that is “substan device may aerate the middle ear, become a portal to drain tially immobilized in the Eustachian tube is neither required fluid and infection from the middle ear, treat retracted ear nor precluded from absolute immobilization as long as mov drums and ear congestion, and prevent pressure related dam ability of the device in the Eustachian tube is reduced to a 10 age to the ear associated with activities such as, airplane generally trivial degree that does not compromise the travel, diving, and high altitude activities. The device may intended functionality of the device within the Eustachian also enable diagnostic microendoscopy of Eustachian tube tube. Other uses of the term “substantially involve an analo and the middle ear, and serve as a conduit for the diagnosis gous definition. and assessment of middle and inner earfunctions, integrity of In general, the invention pertains to devices, apparatus and 15 the ossicles, chronic ear infection and cholesteatoma. Further, method for inserting a device into a Eustachian tube of an the device may serve as a stent and protective dressing for any animal. Typically, the device is used to dilate, provide hard and Soft palate, nasopharyngeal, or Eustachian tube Sur mechanical Support, and/or stent the Eustachian tube at loca gery. tion closer to a nasopharynx than an eardrum, e.g., the torus An Exemplary Device tubarius orifice, which in turn, maintains patency of the Eus The invention provides, in an exemplary embodiment, a tachian tube. The method of placement of the apparatus is via device constructed from biocompatible and bioresorbable the nasal and/or oral passages and nasopharyngeal opening of implantable materials with biomechanical properties that the Eustachian tube and does not require incision of the ear provide opening forces necessary to keep the Eustachian tube drum, ear canal or entry into the middle ear. orifice patent. The device includes an insertable member that In some instances, the device includes an insertable mem 25 has a triangular shaped arch with a central opening that dilates ber, an immobilizing means and a fluid-communication pro and stents the Eustachian tube, and ventilates the middle ear. viding means. The member has opposing Surfaces and is The insertable member has a contoured lip that allows the formed at least in part from a biocompatible material that is device to be Snapped into position at the nasopharyngeal degradable in the Eustachian tube at a predetermined degra orifice of the Eustachian tube. The device has structural dation rate. The fluid-communication providing means is 30 memory to maintain its shape and a central hole to ventilate effective to provide sufficient fluid communication between the middle ear. the opposing surfaces of the insertable member to effect FIGS. 1-4 show Such an embodiment of the invention in the pressure equilibration therebetween. form of a device 1 that may serve as Eustachian tube dilator The construction of the inventive device may vary depend and stent for a human patient. As is the case with all figures ing on the functionality desired. As an initial matter, the 35 referenced herein, in which like parts are referenced by like device should be constructed according to the physiology of numerals, FIGS. 1-4 are not necessarily to Scale, and certain the animal into whose Eustachian tube is intended to receive. dimensions may be exaggerated for clarity of presentation. As As the invention may be used for any animal having a Eusta shown in FIG. 1, the device 1 includes an insertable member chian tube, the invention may be constructed for humans 10 having a first exterior major Surface 12 having a shape (e.g., patients who are infants, children, teenagers, adults, and 40 generally corresponding to an acute isosceles. Such a shape seniors), domesticated animals such as dogs, cats, horses, also generally corresponds to the cross sectional area of the cattle, and pigs, and nondomesticated animals. torus tubarius opening for a Eustachian tube of an ordinary The predetermined rate may be selected according to a human patient. The device has a width indicated by A, which plurality of selection criteria, singly and in combination. For corresponds to the widest dimension of the member's bottom example, when the device is constructed to treat a disorder 45 end 3. Width. A may range from about 3 mm to about 8 mm, associated with the Eustachian tube, the rate may be chosen to but is typically about 5 mm. As shown, the bottom portion of ensure restoration of proper Eustachian tube function within the device exhibits a generally flanged geometry. The device a predetermined period without having trauma to the Eusta has a length indicated by B, which corresponds to the distance chian tube mucosa that potentially may lead to Scarring. In between the top end 2 and the bottom end 3 of the member 10. Some instances, the predetermined rate may correspond to a 50 Length B may extend about 6 mm to about 12 mm, but is predetermined period of about 2-8 weeks to allow fluid to typically about 9 mm. sufficiently drain from an acute infection and allow the Eus FIG. 2 depicts the device of FIG. 1 in side view. As shown tachian tube function to be restored. In some instances, the in FIG. 2, the device also has a second major exterior surface predetermined period may be closer to about 2-3 weeks. In 14. Surfaces 12 and 14 are both planar, have a substantially addition, once the tube is properly functioning, keeping the 55 identical shape, and are parallel to each other. The thickness opening stented for an excessive time period may lead to an of the device is generally uniform and indicated by C, which unexpected problem with an echo in the ear while speaking. represents the distance between surfaces 12 and 14. Though Accordingly, the predetermined period typically does not thickness C may range from about 2 mm to about 4 mm, C is exceed about one year. On occasion, the device may be Sur typically about 2 mm. gically removed. 60 As shown in FIGS. 1 and 2, a central ventilating hole 20 When placed in the Eustachian tube at the torus tubarius, having a generally circular shape serves as a means for pro e.g., through a minimally invasive procedure that results in viding fluid communication between major Surfaces 12 and device placement through the nasal passages or through the 14. Hole 20 has a diameter D that is typically about 3 mm, but oropharynx under the palate, the device confers a number of may range from about 2 mm to about 4 mm. The dotted lines advantages previously unknown in the art. For example, the 65 of FIG. 2 represent side walls of the hole 20 carried from FIG. benefits of a nasopharyngeal-based therapy may be achieved 1 and serves to indicate the upper and lower extent of the without the disadvantages of the undesirable outcomes asso central ventilation hole 20. As shown, the hole 20 extends in US 8,197.552 B2 7 8 a Substantially perpendicular orientation relative to Surfaces Typically, the member and the immobilization means have 12 and 14. Four optional protrusions 40 extend from first an integrated construction. For example, the member may Surface 12 and may serve as insertion flanges. have a geometry effective to allow the peripheral surface of The overall geometry of the device 1 in perspective view is the member to engage a surface of the Eustachian tube, represented in FIG. 3. As shown, the device member 10 has a thereby substantially immobilizing the device within the Eus triangular arched shaped structure with the central ventilating tachian tube upon insertion therein. In such a case, the device hole 20. The first surface 12 and the second surface (not may have mechanical properties that provide forces neces shown) are connected by a peripheral surface 50, which gen sary to render the device immobile, e.g., the member may be erally encircle the device 1. at least partially elastically deformable before immobiliza 10 tion. Optionally, the insertable device itself may be formed FIG. 4 represents cross-sectional views of the device along from a material compounded with one or more adhesives. a-a and b-b lines in FIG.1. As shown in FIG.4, the peripheral Optionally, nonintegrated immobilization means may be surface 50 takes the form of a concave groove bounded by used. For example, adhesives may be used containing com contoured lips 30. In some instances, contoured lips 30 start positions that allow the insertable member to become from one lateral aspect of device 1 near its bottom 3, cross the 15 anchored in place by mechanical and/or chemical means. In top 2 and terminate at the corresponding opposing lateral Some instances, an adhesive may be applied as an interfacial aspect of the device 1. The groove and lip construction may composition between the insertable member and the Eusta serve as a means for immobilizing the device. chian tube. FIG. 5 shows the device 1 in context with for proper posi In any case, at least one exterior Surface may have a Sub tioning in the torus tubarius 120 of a human patient to achieve stantially triangular shape that corresponds to a cross sec Eustachian tube patency. FIG. 5 contains a cross-sectional tional area of the Eustachian tube. For example, when the representation of the ear along the external auditory canaland Eustachian tube includes a torus tubarius defined at least in length of the Eustachian tube 90. The external ear or pinna 60 part by anterior and posterior pillars meeting at a top portion is the most lateral structure. The eardrum 70 and middle ear of the torus tubarius, the member may exhibit a geometry space 80 are not violated in the insertion process. The Eusta 25 Such that the peripheral Surface is effective to engage at least chian tube orifice or torus tubarius 120 resides within the a portion of the torus tubarius so as to immobilize the device nasopharynx 100. When the device 1 is properly positioned, in the Eustachian tube. In particular, the member geometry the lips 30 and groove 50 allows the device 1 to be snapped may be effective to allow a vertex portion of the peripheral into the anterior and posterior lips of the torus tubarius 120. Surface to engage the top portion of the torus tubarius and/or Device Geometry and Construction 30 allow side portions of the peripheral Surface to engage ante As discussed above, device geometry and construction rior and posterior pillars of the torus tubaris. may vary according to its functionality. In general, the device While in some rare instances the inventive device may be includes or consists essentially of an insertable member, an considered a permanent implant, the immobilization means is immobilizing means and a fluid-communication providing typically be provided in a manner that allows for the device to means. The member has opposing Surfaces and is formed at 35 be engaged with the Eustachian tube temporarily for a prede least in part from a biocompatible material. The fluid-com termined period of time and to be disengaged from the Eus munication providing means is effective to provide Sufficient tachian tube in a controlled manner. Typically, the immobili fluid communication between the opposing Surfaces of the Zation means has a construction Such that degradation of the insertable member to effect pressure equilibration therebe biocompatible material of the device after the predetermined tWeen. 40 period within the Eustachian tube leads to a substantially The opposing Surfaces may be connected by a peripheral complete extraction of the member from the Eustachian tube. Surface. Typically, at least one of the opposing Surfaces rep Such extraction may be carried out with or without surgical resents a major Surface of the member. In such a case, the intervention. Typically, the predetermined period corre major Surface is associated with a member length and mem sponds to the predetermined degradation rate of the device ber width and the peripheral surface is associated a member 45 material. thickness. In addition, at least one exterior major Surface may As is the case with the immobilization means, the fluid have a shape that Substantially corresponds to a cross sec communication providing means may vary in construction as tional area of the Eustachian tube. Though surfaces of the well. In general, the fluid-communication-providing means invention may be generally smooth, it may be possible to may be effective to equilibrate any fluid-generated pressure produce devices such that any surface may have any desired 50 between the opposing Surfaces, regardless whether the pres contour, e.g., jagged, undulated, etc. Sure is generated from gases and/or liquids. However, in some A number of optional features may be incorporated into the instances, the fluid-communication providing means may be construction of the inventive device to address certain manu selective for fluid type. For example, such means may be facturing and/or functionality concerns. For example, to effective to equilibrate at least partially gas-generated or at facilitate ease in manufacturing, the opposing Surfaces may 55 least partially liquid generated pressure between the opposing be rendered substantially planar and parallel to each other. As Surfaces. a result, the insertable member may have a uniform thickness. When provided as an integrated component of the insert In the alternative, the device may assume agentle curvilinear able member, the fluid-communication providing means contour in the front to back and top to bottom dimensions and extend through any portion of the opposing Surfaces so as to have a non-uniform thickness profile. 60 allow for pressure equilibration therebetween. In some The member length is typically greater than the member instances, such means may be centrally located through the thickness. Typically, the device length exceeds the thickness member. In the alternative, the means may be eccentric to the by at least 50%. In some instance, the device width is greater top, bottom or side. than the thickness as well. In any case, when a device is In a number of embodiments, the fluid-communication constructed for insertion into the Eustachian tube for either 65 providing means may include or consist essentially of a hole ear, left or right, the device may have a member geometry that extending through the member between the opposing exterior exhibits mirror symmetry. Surfaces. The hole may have any cross-sectional shape, US 8,197.552 B2 10 including, for example, circle, oval, square, triangular, hex due to its known biocompatibility. Various forms of PEG are agonal, etc. For ease in construction, the hole may have a extensively used in the modification of biologically active constant cross-sectional area and shape along its length. Simi molecules because PEG can be formulated to have a wide larly, the hole may extend in a Substantially perpendicular range of Solubilities and because it is low in toxicity, antige orientation relative to the opposing Surfaces. In any case, the 5 nicity, immunogenicity, and does not typically interfere with member should have a construction Such that a hole, when the enzymatic activities and/or conformations of peptides. present as a fluid-communication providing means, is Sub Further, PEG monomers are generally non-biodegradable stantially dimensionally stable for at least the predetermined and is easily excreted from most living organisms, including period after insertion into the Eustachian tube. Were the hole humans. Other synthetic polymeric materials suitable for use to be reduced in size in the Eustachian tube environment, the 10 include, for example, polyvinyl alcohols, polyacrylic acids, hole may lose its pressure equilibration functionality. polyglycolic acids, polydioxanones. Device Materials In some instances, naturally occurring compounds may be The inventive device may be formed in part or in whole employed to form the insertable member. Suitable naturally from a number of materials. Device materials are typically occurring compounds include, but are not limited to: polysac selected so as to ensure optimal device performance given the 15 charides such as hyaluronic acid, cyclodextrin, hydroxymeth particular construction and/or geometry of the device. ylcellulose, cellulose ether, and Starch; glycans such gly Optionally, the device materials may be tailored to the envi cosaminoglycan and proteoglycan; and various proteins. ronmental conditions to which the device may be exposed Proteins such as collagen and other collagenic (collagen when inserted into the Eustachian tube. It is expected that the like) materials may be Suited for use in the present invention. environmental conditions of the Eustachian tube may vary 20 Collagen, in its native form, is typically a rigid, rod-shaped according to a number of factors, e.g., the particular tempera molecule approximately 300 nm long and 1.5 nm in diameter. ture of the animal whose Eustachian is to receive the device, It is composed of three collagen polypeptides, which together whether the Eustachian tube is healthy or diseased, whether form a tight triple helix. The collagen polypeptides are each pus or other bodily fluids are present, etc. characterized by a long midsection having the repeating In some instances, the insertable member may be substan- 25 sequence —Gly—X Y—, where X and Y are often proline tially uniform in composition. However, the insertable mem or hydroxyproline, bounded at each end by the “telopeptide' ber may be comprised of a plurality of regions that form an regions, which constitute less than about 5% of the molecule. integrated whole. For example, the member, in some embodi The telopeptide regions of the collagen chains are typically ments, may be comprised of an interior region and a periph responsible for the crosslinking between chains, and for the eral region, wherein the regions exhibit different composi- 30 immunogenicity of the protein, and when removed, may tions. In Such a case, at least the peripheral region may be allow collagenic compounds to serve as a biocompatible formed from a biocompatible and resorbable or degradable device member material. material. The bulk and microstructure of the materials used Collagen occurs in several types, having distinct physical with the invention should be controlled in order to produce an properties. Suitable collagenic materials include all types of insertable member of controlled mechanical properties (e.g., 35 pharmaceutically useful collagen, e.g., types I, II, and III. tensile strength, elasticity) and resorption properties. In Such Collagens may be fibrillar or non-fibrillar, e.g., methylated or a case, the dual layer functionality may provide greater con Succinylated. In some instances, collagen crosslinked and/or trol over device performance. conjugated using heat, radiation, or chemical agents such as Typically, the insertable member is formed in large part or glutaraldehyde may be employed. entirely from a biocompatible and optionally resorbable 40 The invention may be used in conjunction with pharma material that is non-toxic, noninflammatory and nonimmu ceutical technologies known in the art. For example, the nogenic. The material is typically synthetic or man-made. device member may include a pharmacologically active con However, a naturally occurring composition may be used as stituent. Such constituents may be bound to the device mem well. Biocompatibility typically requires a material purity of ber or may be eludable. Such pharmacologically active con a pharmaceutically acceptable grade. 45 stituents may promote post-operative healing and may Materials for use with the invention may be selected in a include, for example, antibiotics, antifungal agent, anti-in manner to provide precise control over device resorption/ flammatory, or the like. In the alternative, the biocompatible enzymatic degradation rate. Often, materials are employed material may be free from any pharmacologically active con comprising one or more hydrophilic compound, mixtures stituents. thereof, copolymers of the forgoing, and combinations of the 50 The device according to the present invention may be pro aforementioned. Polymeric materials may be employed duced in a number of ways. One simple method involves because the resorption rate may be established by controlling pouring a sterile Solution of a precursor member material into the molecular weight and/or the degree of crosslinking asso a sterile mold cavity to harden. The mold cavity may be ciated with the polymeric material. Suitable hydrophilic composed of stainless steel, elastomeric orthermoplastic tub polymers used herein include polyethylene glycol, polyoxy- 55 ing, glass, or other Substances. Optionally, a releasing agentis ethylene, polymethylene glycol, polytrimethylene glycols, interposed between the mold and the solution. While the polyvinylpyrrolidones, and derivatives thereof. In some lim device member according to the present invention may be cast ited instances, polylactic acids may be employed as well. The with a fluid-communication providing means extending the polymers can be linear or multiply branched and will not be member, the member may be cast solid and bored to produce substantially crosslinked. Other suitable polymers include 60 a hollow communication passage therethrough. polyoxyethylene-polyoxypropylene block polymers and Extrusion may be employed as well to form the inventive copolymers. Polyoxyethylene-polyoxypropylene block device. Most if not all of the above-described materials may polymers having an ethylene diamine nucleus (and thus hav be formulated for extrusion through a suitable orifice. ing four ends) are also available and may be used in the Depending on the particular formulation, crosslinking may practice of the invention. 65 occur during or after extrusion. One suitable material for use in the present invention com Generally, the microstructure of the materials used with the prises a polyethylene glycol (PEG) containing compound, invention should be controlled in order to produce an insert US 8,197.552 B2 11 12 able member of controlled mechanical properties (e.g., ten infectious Eustachian tube dysfunction may also be treated. sile strength, elasticity) and resorption properties. For Both chronic and acute Eustachian tube dysfunction may be example, increasing the degree of crosslinking in the member treated. compositions tends to increase the device's tensile strength, Insertion Apparatuses and Kits rigidity, and resistance to resorption. As discussed above, an insertion apparatus may be used to Eustachian Tube Methods place the device into and/or extract the device from the Eus In another embodiment, the invention also provides a tachian tube. The insertion apparatus may have any of a method for inserting a device into a Eustachian tube of an number of designs and construction. The insertion apparatus, animal. The method involves inserting the device as described in some embodiments, is endoscopic and hand held in con 10 struction. The apparatus should provide a user Sufficient above through a nostril or mouth of the animal into the Eus degree of control over the insertion and/or extraction of the tachian tube. Optionally, the device is inserted solely through device in a minimally invasive manner So as to minimize the nasopharyngeal opening of the Eustachian tube through trauma or discomfort to a patient. Thus, the apparatus may the nose or the oropharynx in a manner that does not involve provide for precisely and accurately controlled translational making any incision to an eardrum or ear canal skin. The 15 (e.g., X-Y-Z) and/or, rotational (0-(p) movement capabilities. device may then be released manner effective to allow the The apparatus may allow for one, two, three, four, five, six, or device to immobilize itself within the Eustachian tube at its more degrees of freedom. opening in the nasopharynx. The method may be performed For example, the apparatus may have a device-interfacing with local anesthesia or sedation as appropriate. terminus and a manipulation terminus. The device-interfac Depending on the particulars of the nasal cavity configu ing terminus may have a construction specific to the inventive ration, the device may be inserted into the mouth or which device or may be used to interface with devices other than ever nostril that allows for greater ease for device placement those described herein. For example, the interfacing terminus in either the right or left Eustachian tube. In particular, the may have a solid or hollow geometry specific to the inventive device may be placed through the nasal passages or through device. In some instances, the interfacing terminus may also the oropharynx under the palate. Advantageously, the method 25 provide for functionality associated with the practice of the does not require an incision in the ear canal or eardrum, or inventive method. Exemplary functionality include Suction, entry into the middle ear space. aspiration, delivery of air or medications to the middle ear. The method may involve the use of an insertion apparatus. The manipulation terminus may house a means for releas For example, the method may involve loading onto an inser ing any device engaged therewith. The releasing means may tion apparatus and using the insertion apparatus to insert the 30 have a spring-loaded mechanism, or manual release mecha device through a nostril or mouth of the animal into the nism that allows the inventive device to be releasably engage Eustachian tube. Once the device is in place, the device may able with device-interfacing terminus of the apparatus. be released from the apparatus in a manner effective to allow Optionally, the device may be controllably slid from the inser the device to immobilize itself within the Eustachian tube. tion apparatus into the Eustachian tube. 35 In some instances, the inventive device may be constructed Once the device has been properly positioned and immo with a means for interfacing with the insertion apparatus. In bilized, the Eustachian tube remains patent. During the Some instances. Such means serve no other purpose than to device-induced patency of the Eustachian tube, the middle interface with the insertion apparatus. For example, the inter ear is aerated. The device effectively becomes a portal to drain facing means may include at least one protrusion extending fluid and infection from the middle ear. 40 from an exterior surface by which the insertion device may The inventive method may be carried out, optionally grab. As another example, one or more tabs or fenestrations through endoscopy, in conjunction with Surgery or in the may be located on either or both front and back surfaces of the absence of any incision. Regardless whether the Eustachian device around the fluid-communication providing means. tube into which the device is inserted is surgically unaltered In the alternative, the interfacing means may serve a plu or altered, the method may be effective to dilate the Eusta 45 rality of purposes. For example, the fluid-communication chian tube temporarily or permanently. Furthermore, the providing means may have a construction effective to serve as method may be effective to prevent collapse of the Eustachian means for engaging with the insertion apparatus. When a hole tube and/or involve insertion of the device into an enlarged is provided as the fluid-communication providing means, the Eustachian tube. insertion apparatus may be constructed to engage the device The inventive method and device may be used to treat 50 via the fluid-communication-providing means through a fric certain types of hearing loss, tinnitus, ear discomfort and tion fitting. headache. The method can treat dysfunction of the Eusta As another alternative, the interfacing means may be used chian tube due to Scarring from Surgery, radiation treatment, to make adjustments to the device to be inserted and/or infection and inflammation affecting the Eustachian tube. extracted. For example, the interfacing means may be used to The device also enables diagnostic microendoscopy of Eus 55 adjust the fluid-communication providing means. When the tachian tube and the middle ear, and serves as a conduit for the fluid-communication providing means is in the form of a diagnosis and assessment of middle and inner ear functions, central hole, the hole may be made Smaller or larger through integrity of the ossicles, chronic ear infection and choleste the insertion device. Such sizing may be carried out mechani atoma. Further, the device serves as a stent and protective cally and/or remotely. For example, the central hole can be dressing for any hard and soft palate, nasopharyngeal, or 60 made larger through laser ablation, or, in the alternative, be Eustachian tube Surgery. made Smaller through controlled thermal activation or heat Still further, the invention may be effective to treat regulation. retracted eardrums and ear congestion. By dilating and stent The device may be packaged with the insertion apparatus ing the Eustachian tube, barometric Eustachian tube dysfunc to form a kit. Typically, the kit also includes container for tion may be treated, and pressure related damage to the ear 65 containing the insertion apparatus and the device. Optionally, associated with activities such as, airplane travel, diving, and instruction for using the apparatus with the device may be high altitude activities may be prevented. Allergic and/or included. US 8,197.552 B2 13 14 Variations of the present invention will be apparent to those device within the Eustachian tube for the predetermined of ordinary skill in the art in view of the disclosure contained period of time that corresponds to the predetermined degra herein. For example, while the geometry of the inventive dation rate. device has been described in detail for use with a living 5. The method of claim 4, wherein the predetermined human patient, one of ordinary skill in the art may take 5 period is about two to about eight weeks. measurements from nonhuman animal cadavers to determine 6. The method of claim 4, wherein the member is formed the geometry required for Such animals. Similarly, while the entirely from the biocompatible material. fluid-communication providing means has been generally 7. The method of claim 4, wherein the member has an described as a single hole extending through the opposing interior region and a peripheral region, and the regions com Surfaces of the insertable member, Such means may include a 10 plurality of holes as well as no holes. Instead, a membrane prise different materials. that is selectively permeable to specific fluids may be used as 8. The method of claim 7, wherein the peripheral region is a fluid-communication providing means. Other variations of formed from the biocompatible material. the invention may be discovered upon engage in routine 9. The method of claim 4, wherein the biocompatible mate experimentation during the ordinary course of the practice of 15 rial is free from any pharmacologically active constituent. the invention. 10. The method of claim 4, wherein the biocompatible It is to be understood that, while the invention has been material includes a pharmacologically active constituent. described in conjunction with the preferred specific embodi 11. The method of claim 10, wherein the pharmacologi ments thereof, the foregoing description merely illustrates cally active constituent is elutable from the biocompatible and does not limit the scope of the invention. Numerous material. alternatives and equivalents exist which do not depart from 12. The method of claim 4, wherein the member and the the invention set forth above. In general, any particular immobilization means have an integrated construction Such embodiment of the invention may be modified to include or that the device is at least partially elastically deformable exclude features of other embodiments. Other aspects, advan before immobilization. tages, and modifications within the scope of the invention will 25 13. The method of claim 4, wherein the member includes be apparent to those skilled in the art to which the invention the immobilization means and has a construction Such that pertains. degradation of the biocompatible material of the device after All patents, patent applications, and publications men the predetermined period within the Eustachian tube leads to tioned herein are hereby incorporated by reference in their a substantially complete extraction of the member from the entireties to an extent not inconsistent with the disclosure 30 Eustachian tube without Surgical intervention. provided above. 14. The method of claim 1, wherein the member has a I claim: geometry effective to allow the peripheral surface of the 1. A method for inserting a device into a Eustachian tube of member to engage a Surface of the Eustachian tube, thereby an animal, comprising: 35 substantially immobilizing the device within the Eustachian (a) loading a device onto an insertion apparatus, the device tube upon insertion therein. comprising an insertable member that is sized for inser 15. The method of claim 14, wherein the Eustachian tube tion within the Eustachian tube that defines a cross sec includes a torus tubarius defined at least in part by anterior tional area, the member having a preinsertion form that and posterior pillars meeting at a top portion of the torus includes 40 tubarius, and the member has a geometry Such that the periph opposing exterior Surfaces connected by a peripheral eral Surface is effective to engage at least a portion of the torus Surface, tubarius so as to immobilize the device in the Eustachian tube. wherein at least one opposing exterior Surface defines 16. The method of claim 14, wherein the width is greater a member length and member width, and than the thickness. the opposing exterior Surfaces define a member thick 45 17. The method of claim 14, wherein the length exceeds the ness Such that the member length is greater than the thickness by at least 50%. member thickness, 18. The method of claim 1, wherein the fluid-communica means for immobilizing the device within the Eusta tion-providing means includes a hole extending through the chian tube upon insertion therein, and member between the opposing exterior Surfaces. means for providing fluid communication between the 50 19. The method of claim 18, wherein the member has a opposing Surfaces of the member to effect pressure construction Such that the hole is Substantially dimensionally equilibration therebetween: stable for at least the predetermined period after insertion into (b) using the insertion apparatus to insert the device the Eustachian tube. through a nostril or mouth of the animal into the Eusta 20. The method of claim 1, further comprising (d) extract chian tube; and 55 ing the device from the Eustachian tube after the predeter (c) releasing the device from the apparatus in a manner mined time period. effective to allow the device to immobilize itself within 21. A method for inserting a device into a Eustachian tube the Eustachian tube while maintaining its preinsertion of an animal, comprising: form, thereby rendering patent the Eustachian tube for a (a) loading a device onto an insertion apparatus, the device predetermined time period. 60 comprising 2. The method of claim 1, carried out in a manner without an insertable member that is sized for insertion within incising any ear drum or ear canal skin. the Eustachian tube that defines a cross sectional area, 3. The method of claim 1, wherein the animal is human. the member having a preinsertion form that includes 4. The method of claim 2, wherein the member is formed at opposing exterior Surfaces connected by a peripheral least in part from a biocompatible material that is degradable 65 Surface, at least one of the exterior Surfaces having in the Eustachian tube at a predetermined degradation rate, a triangular shape and size that corresponds to the and the immobilizing means is effective to immobilize the cross sectional area of the Eustachian tube, and US 8,197.552 B2 15 16 means for providing fluid communication between (c) releasing the device from the apparatus in a manner the opposing Surfaces of the member to effect pres effective to allow the device to immobilize itself within sure equilibration therebetween; the Eustachian tube, thereby rendering patent the Eus (b) using the insertion apparatus to insert the device tachian tube for a predetermined time period. through a nostril or mouth of the animal into the Eusta 5 23. A method for inserting a device into a Eustachian tube chian tube; and of an animal, comprising: (c) releasing the device from the apparatus in a manner (a) loading a device onto an insertion apparatus, the device effective to allow the device to immobilize itself within consisting essentially of an insertable member that is the Eustachian tube, thereby rendering patent the Eus sized for insertion within the Eustachian tube that tachian tube for a predetermined time period. 10 defines a cross sectional area, the member having a 22. The method of claim 21, wherein the member has a preinsertion form that includes geometry that exhibits mirror symmetry. opposing exterior Surfaces connected by a peripheral A method for inserting a device into a Eustachian tube of an Surface, the exterior Surfaces each having a triangular animal a human, comprising: shape and size that corresponds to the cross sectional (a) loading a device onto an insertion apparatus, the device 15 area of the Eustachian tube, and consisting essentially of an insertable member that is means for providing fluid communication between the sized for insertion within the Eustachian tube that opposing Surfaces of the member to effect pressure defines a cross sectional area, the member having a equilibration therebetween: preinsertion form that includes (b) using the insertion apparatus to insert the device opposing exterior Surfaces connected by a peripheral through a nostril or mouth of the animal into the Eusta Surface, the exterior Surfaces each having a triangular chian tube; and shape and size that corresponds to the cross sectional (c) releasing the device from the apparatus in a manner area of the Eustachian tube, and effective to allow the device to immobilize itself within means for providing fluid communication between the the Eustachian tube, thereby rendering patent the Eus opposing Surfaces of the member to effect pressure 25 tachian tube for a predetermined time period. equilibration therebetween: 24. The method of claim 23, wherein the opposing surfaces (b) using the insertion apparatus to insert the device are substantially planar. through a nostril or mouth of the animal into the Eusta chian tube; and k k k k k