Implantable graft to close a fistula

Abstract

Abstract of the Disclosure An implantable graft, which may be inserted into a fistula tract to occlude the primary opening of the fistula, is provided. The graft may have a curved, generally conical shape with a trumpet-like head end that continuously tapers to a smaller tail end. The graft may be an integral unit made of a single material, such as a heterograft material. Methods of closing single and multiple fistulae are also provided.

1.  An implantable graft for closing a fistula, comprising a curved, generally conical body having a first end with a first diameter and a second end with a second diameter that is smaller than the first diameter, where the body comprises a continuous taper between the first end and the second end, and where the graft comprises a biological material selected from the group consisting of a cadaveric material from a human donor and a heterograft material from a non-human donor. 
   
   
       2.  The graft of  claim 1  where the body has a length of about 5 to about 10 centimeters. 
   
   
       3.  The graft of  claim 2  where the first diameter is about 2 to about 15 millimeters and the second diameter is about 0.5 to about 3.5 millimeters. 
   
   
       4.  The graft of  claim 1  where the graft is made of a single material. 
   
   
       5.  The graft of  claim 1  where the graft is an integral unit. 
   
   
       6.  (Canceled). 
   
   
       7.  The graft of  claim 1  where the graft comprises an extracellular matrix material. 
   
   
       8.  The graft of  claim 7  where the graft comprises small intestinal submucosa. 
   
   
       9.  The graft of  claim 4  where the graft comprises small intestinal submucosa. 
   
   
       10.  The graft of  claim 1  where the graft comprises an injectable heterograft material. 
   
   
       11.  The graft of  claim 1  further comprising protrusions on an external surface of the body. 
   
   
       12.  The graft of  claim 1  where the graft comprises a material having a portion that remains intact to allow for ingrowth of host cells. 
   
   
       13.  The graft of  claim 1  where the graft comprises a material that promotes angiogenesis. 
   
   
       14.  The graft of  claim 1  where the graft comprises a material that promotes site-specific tissue remodeling. 
   
   
       15.  The graft of  claim 1  where the graft comprises a material that resists infection. 
   
   
       16.  The graft of  claim 1  where the graft further comprises a drug. 
   
   
       17.  An implantable plug for closing a fistula, comprising a generally conical body having a continuous taper between a head end with a first diameter and a tail end with a smaller second diameter, where the body has a length of about 5 to about 10 centimeters. 
   
   
       18.  The plug of  claim 17  where the plug is made of a single heterograft material from a non-human donor. 
   
   
       19.  The plug of  claim 18  where the heterograft material is small intestinal submucosa. 
   
   
       20.  The plug of  claim 17  where the body is curved. 
   
   
       21.  A method for closing a fistula having a first end and a second end, the method comprising:  providing a plug having an elongate plug body, the elongate plug body having a length sufficient to extend from the first end of the fistula to the second end of the fistula, the plug body having a tail end portion and a head end portion; and inserting the tail end portion of the plug into the fistula through the first end of the fistula until the tail end portion of the plug protrudes from the second end of the fistula and the head end portion of the plug contacts the first end of the fistula. 
   
   
       22.  The method of  claim 21  further comprising securing the tail end portion of the plug, the head end portion of the plug, or both end portions of the plug with suture. 
   
   
       23.  The method of  claim 21  further comprising providing a securing device having a central lumen, placing the securing device over the tail end portion of the plug, and securing the securing device into position at skin level. 
   
   
       24.  The method of  claim 21  where the elongate plug body comprises small intestinal submucosa. 
   
   
       25.  The method of  claim 21 , where the plug is pulled into the fistula with a probe or scope. 
   
   
       26.  The method of  claim 25 , where the tail end portion of the plug is attached to the probe or scope. 
   
   
       27.  The method of  claim 25 , further comprising introducing an adhesive into the fistula. 
   
   
       28.  A method of surgically treating an anorectal fistula of a human patient, the anorectal fistula having a tract with a primary opening, the method comprising inserting a plug in the primary opening of the tract, wherein said plug is comprised of a bioremodelable material that promotes cellular invasion and ingrowth in the patient. 
   
   
       29.  The method of  claim 28 , wherein said bioremodelable material is an allograft extracellular matrix material. 
   
   
       30.  The method of  claim 28 , wherein the bioremodelable material is a heterograft extracellular matrix material. 
   
   
       31.  The method of  claim 28 , wherein the bioremodelable material retains growth factors native to a source tissue from which it was obtained. 
   
   
       32.  The method of  claim 31 , wherein the growth factors comprise one or more of fibroblast growth factor-2, transforming growth factor-beta, epidermal growth factor, and platelet derived growth factor. 
   
   
       33.  The method of  claim 32 , wherein the bioremodelable material comprises submucosa. 
   
   
       34.  The method of  claim 32 , wherein the bioremodelable material comprises dermal collagen. 
   
   
       35.  The method of  claim 28 , wherein the bioremodelable material incorporates an antibiotic agent. 
   
   
       36.  The method of  claim 28 , wherein the bioremodelable material is angiogenic. 
   
   
       37.  An implantable graft for closing an anorectal fistula in a human patient, comprising a tapered plug graft sized and configured to close an anorectal fistula, said tapered plug graft comprising a bioremodelable material that promotes cellular invasion and ingrowth in the patient. 
   
   
       38.  The implantable graft of  claim 37 , wherein said bioremodelable material is an allograft extracellular matrix material. 
   
   
       39.  The implantable graft of  claim 37 , wherein the bioremodelable material is a heterograft extracellular matrix material. 
   
   
       40.  The implantable graft of  claim 37 , wherein the bioremodelable material retains growth factors native to a source tissue from which it was obtained. 
   
   
       41.  The implantable graft of  claim 40 , wherein the growth factors comprise one or more of fibroblast growth factor-2, transforming growth factor-beta, epidermal growth factor, and platelet derived growth factor. 
   
   
       42.  The implantable graft of  claim 41 , wherein the bioremodelable material comprises submucosa. 
   
   
       43.  The implantable graft of  claim 42 , wherein the bioremodelable material comprises dermal collagen. 
   
   
       44.  The implantable graft of  claim 37 , wherein the bioremodelable material incorporates an antibiotic agent. 
   
   
       45.  The implantable graft of  claim 10 , wherein the biological material is angiogenic. 
   
   
       46.  The method of  claim 21 , wherein the fistula is an anorectal fistula. 
   
   
       47.  The method of  claim 46 , wherein the elongate plug body comprises a bioremodelable extracellular matrix material. 
   
   
       48.  The method of  claim 34 , wherein the bioremodelable material comprises acellular dermal tissue from a human cadaveric donor. 
   
   
       49.  The implantable graft of  claim 37 , wherein the bioremodelable material comprises acellular dermal tissue from a human cadaveric donor. 
   
   
       50.  The method of  claim 21  where the elongate plug body is made of a single material.