Fecal incontinence device, system and method

Abstract

A device for treating fecal incontinence in a subject is provided. The device includes a plug configured for positioning mostly within an anal canal of the subject.

1 .- 78 . (canceled) 
     
     
         79 . A device for inserting into an anal canal extending from a rectal neck surrounded by a rectal wall downward to an anal orifice to treat incontinence, said device comprising:
 an anchoring element connected to a biasing element by an elastically stretchable elongated body, wherein said anchoring element is positionable within the rectal neck and said biasing element engages an external surface of the anus and applies a force through said elastically stretchable elongated body to said anchoring element thereby biasing said anchoring element downward against the rectal neck.   
     
     
         80 . A device as in  claim 79 , wherein the anchoring element does not apply any substantial radial forces to the rectal wall when said anchoring element is biased against said rectal neck. 
     
     
         81 . A device as in  claim 79 , wherein the anchoring element comprises a flexible disc. 
     
     
         82 . A device as in  claim 81 , wherein the disc has a surface hardness below Shore A 40. 
     
     
         83 . A device as in  claim 82 , wherein the disc has a thickness from 10 microns to 3000 microns. 
     
     
         84 . A device as in  claim 83 , wherein the disc is flat and has a diameter in the range from 0.5 cm to 5 cm. 
     
     
         85 . A device as in  claim 79 , wherein the elongated body is cylindrical and has a length in the range from 0.5 cm to 6 cm and a diameter in the range from 0.1 cm to 1 cm. 
     
     
         86 . A device as in  claim 85 , wherein said elastically stretchable elongated body is axially flimsy and radially elastic. 
     
     
         87 . A device as in  claim 86 , further comprising a removable rod for stiffening the elongated body during insertion. 
     
     
         88 . A device as in  claim 87 , wherein said elastically stretchable elongated body is hollow and the rod is removably insertable into the hollow elongated body. 
     
     
         89 . A device as in  claim 79 , wherein said biasing element has a surface hardness below Shore A 40. 
     
     
         90 . A device as in  claim 79 , wherein said biasing element comprises a concave disc having an upper surface attached to a lower end of the elongated body. 
     
     
         91 . A device as in  claim 90 , wherein the biasing element comprises a disc having a diameter of 2.5 cm. 
     
     
         92 . A device as in  claim 79 , wherein the device comprises a soft polymer. 
     
     
         93 . A device as in  claim 79 , wherein the device has a surface hardness below Shore A 40. 
     
     
         94 . A device as in  claim 93 , wherein the device has a surface hardness of Shore A 3. 
     
     
         95 . A system for treating fecal incontinence, said system comprising:
 a plug comprising an anchoring element capable of engaging a portion of a rectal neck and an elongated body joined to the anchoring element and having a hollow internal bore; and   an applicator comprising (a) a rod having a distal portion removably inserted in the internal bore of the elongated body and (b) a finger hold on a proximal end of the rod to allow the user to maneuver the plug using a single finger.   
     
     
         96 . A system as in  claim 95 , wherein the finger hold includes a spring-loaded tab to engage an inserted finger. 
     
     
         97 . A system as in  claim 95 , wherein the finger hold is angled relative to an axis of the rod. 
     
     
         98 . A system as in  claim 95 , further comprising a sleeve within the elongated body made from material which is harder than that of the elongated body, said sleeve providing the internal bore which receives the applicator rod. 
     
     
         99 . A system as in  claim 95 , wherein the plug further comprises a biasing element joined to the elongated body for engaging an external surface of an anus while the anchoring element is over the rectal neck and the elongated body is in an anal canal. 
     
     
         100 . A system as in  claim 96 , wherein the plug is composed of a soft polymer with a hardness below shore A40 and the anchoring element comprises a flexible disc. 
     
     
         101 . A method for treating fecal incontinence in a patient, said method comprising:
 positioning a soft cap against a rectal neck without deforming a rectal wall; and   biasing said cap downward against the rectal neck with a force sufficient to inhibit the passage of solid and liquid fecal matter into an anal canal.   
     
     
         102 . A method as in  claim 101 , wherein the cap allows the passage of gas while inhibiting the passage of solid and liquid fecal matter. 
     
     
         103 . A method as in  claim 102 , wherein the gas passes around a periphery of the soft cap while said soft cap is biased downward against the rectal neck. 
     
     
         104 . A method as in  claim 101 , wherein the soft cap has a surface hardness below Shore A 40. 
     
     
         105 . A method as in  claim 101 , wherein biasing comprises positioning a biasing element against an external surface of the anus, wherein said soft cap is attached to said biasing element by an elastically stretchable elongated body such that said biasing element applies a force through said elastically stretchable elongated body to said soft cap thereby biasing said soft cap downward against the rectal neck. 
     
     
         106 . A method as in  claim 101 , wherein said soft cap is capable of passing through the anal canal when the patient has a bowel movement. 
     
     
         107 . A method for introducing a plug into an anal canal of a patient, said method comprising:
 providing a plug removably placed over an insertion rod;   coupling the insertion rod to a single finger of the patient;   maneuvering the single finger to advance a soft cap of the plug through the anal canal and into a rectum;   pulling the insertion rod from the plug to leave the plug in place with said soft cap biased against a rectal neck.   
     
     
         108 . A method as in  claim 107 , wherein coupling comprises placing said single finger in a finger hold on the insertion rod. 
     
     
         109 . A method as in  claim 108 , wherein said single finger is held in place within said finger hold by a spring-loaded tab. 
     
     
         110 . A method as in  claim 107 , wherein pulling said insertion rod comprises pulling with said single finger which remains coupled to the rod. 
     
     
         111 . A method as in  claim 107 , wherein maneuvering said single finger to advance said soft cap of the plug through the anal canal and into a rectum elastically elongates an elongated body attached to said soft cap to apply a biasing force to said soft cap which seats said soft cap against a neck region of a rectum. 
     
     
         112 . A method as in  claim 111 , wherein a biasing element on a lower end of said elongated body seats against the external surface of the anus and applies a biasing force to said elongated body that retains the soft cap in place over the neck region of a rectum. 
     
     
         113 . A method for treating fecal incontinence, said method comprising:
 positioning a soft compliant cap over a neck region of rectum to cover a top opening of the anal canal, and   applying a biasing force to said soft compliant cap to anchor said cap in place against the neck region of the rectum.   
     
     
         114 . A method as in  claim 113 , further comprising positioning a soft compliant stem from a lower surface of said soft compliant cap through the anal canal. 
     
     
         115 . A method as in  claim 114 , wherein applying a biasing force to said soft compliant cap comprises anchoring an external end of an elongated body attached to said soft compliant cap against the external surface of an anus to elastically stretch the elongated body. 
     
     
         116 . A method for treating fecal incontinence, said method comprising:
 positioning a soft compliant cap over a neck region of a rectum to cover the top opening of an anal canal, wherein said cap seals against the neck region of a rectum to inhibit the leakage of fecal matter while permitting said cap to be defecated during a bowel movement; and   applying a downward biasing force to said soft compliant cap to position said cap in place over the neck region of a rectum.   
     
     
         117 . A method as in  claim 116 , further comprising positioning a soft compliant stem from a lower surface of said soft compliant cap through the anal canal. 
     
     
         118 . A method as in  claim 117 , wherein applying a biasing force to said soft compliant cap comprises anchoring an external end of an elongated body attached to said soft compliant cap against an external surface of the anus to elastically stretch said elongated body. 
     
     
         119 . A method for introducing a plug into an anal canal between a rectal neck and an external anal surface, said method comprising:
 providing a plug having an anchoring element connected to a biasing element by an elastically stretchable elongated body; and   inserting the plug into the anal canal to position said anchoring element against a bottom surface of the rectal neck and said biasing element against an external anal surface, thereby stretching said stretchable elongated body to maintain said anchoring element biased downward against said bottom surface of the rectal neck and said biasing element upwardly against said external anal surface.   
     
     
         120 . A method as in  claim 119 , wherein said anchoring element comprises a soft cap. 
     
     
         121 . A method as in  claim 120 , wherein said soft cap comprises a disc. 
     
     
         122 . A method as in  claim 121 , wherein the disc folds backwards axially as the plug is inserted. 
     
     
         123 . A method as in  claim 122 , wherein the disc seats concave up against the bottom surface of the rectal neck. 
     
     
         124 . A method for introducing a plug into an anal canal between a rectal neck and an external anal surface, said method comprising:
 providing a plug removably placed over an insertion rod, said plug including an anchoring element connected to a biasing element by an elastically stretchable elongated body which is removably positioned over the insertion rod;   advancing said insertion rod to position the anchoring element through said anal canal into a rectum and position the biasing element against an external anal surface;   further advancing the insertion rod to stretch the elongated body and extend said anchoring element above said rectal neck;   removing said insertion rod from the anal plug to allow the elongated body to elastically shorten and apply a downward force on said anchoring element and bias said anchoring element against a bottom surface of the rectal neck.   
     
     
         125 . A method as in  claim 124 , wherein said anchoring element comprises a soft cap. 
     
     
         126 . A method as in  claim 125 , wherein said soft cap comprises a disc. 
     
     
         127 . A method as in  claim 126 , wherein the disc folds backwards axially over said elongated body as said plug is inserted into the anal canal. 
     
     
         128 . A method as in  claim 127 , wherein the disc seats concave up against the bottom surface of the rectal neck as the elongated body shortens. 
     
     
         129 . A method as in  claim 124 , wherein the biasing element seats concave down against the external anal surface as the elongated body shortens.