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

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