Medical device for repairing a fistula

Abstract

A closure element applying medical device for repairing a fistula is described. The closure element applying medical device can be configured for repairing any type of fistula that provides an abnormal channel from one body part to another body part (e.g., organ to organ, organ to vessel, and/or vessel to vessel). Examples of fistulas that can be repaired with the present invention include anorectal fistulas, enteroenteral fistulas, enterocutaneous fistulas, vesicovaginal fistulas, arteriovenous fistulas, perilymph fistulas, rectovaginal fistulas, ureterocolon fistulas, and the like. The medical device can include a closure element, a shaft, a carrier assembly, and controller systems. The medical device can also include a locator assembly. Additionally, the closure element applying medical device can include endoscope components so as to function also as an endoscope.

What is claimed is: 
     
         1 . A medical device for delivering a closure element to tissue within and/or adjacent to a fistula to repair the fistula, the medical device comprising:
 a closure element having at least one tissue-grabbing member;   a carrier assembly having a garage for retaining the closure element, said carrier assembly having a flexible portion being configured to bend so as to be capable of directing the closure element toward the tissue;   a carrier assembly controller system operatively coupled to the flexible portion of the carrier assembly and being configured for controlling the delivery of the carrier assembly to the fistula; and   a closure element deployment controller system operatively coupled to the carrier assembly and being configured for deploying the closure element to the tissue to repair the fistula.   
     
     
         2 . A medical device as in  claim 1 , wherein an outer diameter of the carrier assembly is larger than about 0.17 inches. 
     
     
         3 . A medical device as in  claim 2 , wherein the length of the carrier assembly is longer than about 11 cm. 
     
     
         4 . A medical device as in  claim 3 , further comprising endoscope components configured such that the medical device is capable of functioning as an endoscope. 
     
     
         5 . A medical device as in  claim 3 , wherein the flexible portion is configured to be capable of being bent to an angle of at least about 45 degrees. 
     
     
         6 . A medical device as in  claim 5 , wherein the closure element is one of a star closure element, collapsible tubular closure element, self-rolling closure element, reverse closure element, clam closure element, or combinations thereof. 
     
     
         7 . A medical device as in  claim 6 , further comprising a locator assembly operably coupled to the carrier assembly. 
     
     
         8 . A medical device as in  claim 7 , wherein the locator assembly includes a locator having a length of at least about 0.25 cm. 
     
     
         9 . A medical device as in  claim 8 , wherein the locator includes at least two locator wings, said locator wings having an expanded diameter of at least about 0.25. 
     
     
         10 . A medical device as in  claim 9 , wherein the locator assembly is configured to collapse and withdraw from the fistula as the closure element is deployed. 
     
     
         11 . A medical device for delivering a closure element to tissue within and/or adjacent to a fistula to repair the fistula, the medical device comprising:
 a closure element;   a carrier assembly having a garage for retaining the closure element, said carrier assembly having a flexible portion being configured to bend at least about 45 degrees;   locator assembly having a locator configured to be capable of locating the fistula;   a carrier assembly controller system operatively coupled to the flexible portion of the carrier assembly and being configured for controlling the delivery of the carrier assembly to the fistula; and   a closure element deployment controller system operatively coupled to the carrier assembly and being configured for deploying the closure element to the tissue to repair the fistula.   
     
     
         12 . A medical device as in  claim 11 , wherein the outer diameter of the carrier assembly is larger than about 0.17 inches. 
     
     
         13 . A medical device as in  claim 12 , wherein the length of the carrier assembly is longer than about 11 cm. 
     
     
         14 . A medical device as in  claim 13 , further comprising endoscope components configured such that the medical device is capable of functioning as an endoscope. 
     
     
         15 . A medical device as in  claim 13 , wherein the flexible portion is capable of selectively bending to an angle of at least about 90 degrees. 
     
     
         16 . A medical device as in  claim 15 , wherein the closure element is one of a star closure element, collapsible tubular closure element, self-rolling closure element, reverse closure element, clam closure element, or combinations thereof. 
     
     
         17 . A medical device as in  claim 16 , wherein the locator has a length of at least about 0.25 cm. 
     
     
         18 . A medical device as in  claim 17 , wherein the locator includes at least two locator wings, said locator wings having an expanded diameter of at least about 0.25 cm. 
     
     
         19 . A medical device as in  claim 18 , wherein the locator assembly is configured to collapse and withdraw from the fistula as the closure element is deployed. 
     
     
         20 . A method for delivering a closure element to tissue within and/or adjacent to a fistula to repair the fistula, the method comprising:
 inserting a distal end of a medical device into a natural body opening in a subject, said distal end having a garage retaining a closure element and having a flexible portion capable of being selectively bent to at least about 45 degrees;   delivering the distal end of the medical device to the fistula;   bending the flexible portion at least about 45 degrees; and   deploying the closure element into tissue within and/or adjacent to a fistula to repair the fistula.   
     
     
         21 . A method as in  claim 20 , wherein the medical device includes at least one of the following:
 a closure element having at least one tissue-grabbing member;   a carrier assembly having a garage for retaining the closure element, said carrier assembly having a flexible portion being configured to bend so as to be capable of directing the closure element toward the tissue;   a carrier assembly controller system operatively coupled to the flexible portion of the carrier assembly and being configured for controlling the delivery of the carrier assembly to the fistula; and   a closure element deployment controller system operatively coupled to the carrier assembly and being configured for deploying the closure element to the tissue to repair the fistula.   
     
     
         22 . A method as in  claim 21 , wherein the outer diameter of the carrier assembly is larger than about 0.17 inches. 
     
     
         23 . A method as in  claim 22 , wherein the length of the carrier assembly is longer than about 11 cm. 
     
     
         24 . A method as in  claim 23 , the medical device further comprising endoscope components configured such that the medical device is capable of functioning as an endoscope. 
     
     
         25 . A method as in  claim 23 , further comprising bending the flexible portion to an angle of at least about 90 degrees. 
     
     
         26 . A method as in  claim 25 , wherein the closure element is one of a star closure element, collapsible tubular closure element, self-rolling closure element, reverse closure element, clam closure element, or combinations thereof. 
     
     
         27 . A method as in  claim 26 , further comprising:
 inserting a locator into the fistula;   expanding locator wings of the locator such that the locator wings contact the tissue within and/or adjacent to the fistula; and   identifying the locator to be at or within the fistula.   
     
     
         28 . A method as in  claim 27 , wherein the locator has a length of at least 0.25 cm. 
     
     
         29 . A method as in  claim 28 , wherein the locator wings have an expanded diameter of at least 0.25 cm. 
     
     
         30 . A method as in  claim 27 , further comprising:
 collapsing the locator wings; and   withdrawing the locator from the fistula as the closure element is deployed.