Fistula closure devices and methods
View Patent ↗Described are methods and systems for treating fistulae and other passageways and openings in the body. In certain aspects, an anchored suture is provided that extends from at or near a first fistula opening and through a fistula tract toward a second fistula opening. Various modes of anchoring may be used in this regard including, in some modes, having the suture extend from a deployed anchoring member positioned in and/or around the first opening. The anchored suture, which has a more slender cross sectional dimension relative to the fistula tract through which it extends, is capable of receiving an optional fill substance therealong in the tract. A fill substance can be or include a variety of biodegradable and/or non-biodegradable objects and materials including flowable and non-flowable materials.
1. A method for treating a fistula having first opening, a second opening and a fistula tract having a fistula tract wall extending therebetween, the method comprising:
providing an anchored three-dimensional graft member proximate the first fistula opening and extending therefrom through the fistula tract toward the second fistula opening, the anchored three-dimensional graft member capable of receiving one or more plug bodies therealong for filling a substantial portion of the tract; and
inserting one or more plug bodies through the second opening, along the anchored three-dimensional graft member and into the fistula tract, wherein the one or more plug bodies comprise rolled or folded sheet material, wherein the one or more plug bodies each include a first end face and a second end face opposite the first end face, wherein the first end face and the second end face each present a plurality of exposed edges of the rolled or folded sheet material; and
further wherein during said inserting, the first end face and the second end face of the one or more plug bodies are oriented transverse to a longitudinal axis of the fistula tract so as to face toward the fistula tract wall.
2. The method of claim 1 , wherein said anchored three-dimensional graft member has a diameter in the range of about 2 mm to about 7 mm.
3. The method of claim 1 , wherein said anchored three-dimensional graft member comprises an ECM material.
4. The method of claim 3 , further comprising delivering an ECM fill material into the fistula tract around the anchored three-dimensional graft member.
5. The method of claim 1 , wherein said providing includes deploying an anchoring member proximate the first fistula opening, the anchored three-dimensional graft member connected to and extending from the anchoring member.
6. The method of claim 5 , wherein said deploying includes said anchoring member urging the first fistula opening toward a closed position.
7. The method of claim 5 , wherein said anchoring member comprises a fillable body.
8. The method of claim 1 , further comprising injecting a flowable material into the fistula tract.
9. The method of claim 1 , wherein said plug body comprises a volumetrically expandable material.
10. The method of claim 1 , further comprising delivering two or more of said plug bodies into the fistula tract over the anchored three-dimensional graft member.
11. The method of claim 10 , wherein said two or more plug bodies includes a first plug body and a second plug body having substantially the same dimensions.
12. The method of claim 10 , wherein said two or more plug bodies includes a first plug body formed with a first material and a second plug body formed with a second material.
13. The method of claim 1 , wherein said anchored three-dimensional graft member comprises an expandable material.
14. The method of claim 13 , further comprising positioning two or more of said plug bodies in the fistula tract over the three-dimensional graft member.
15. The method of claim 1 , wherein the sheet material comprises an extracellular matrix sheet material.
16. The method of claim 15 , wherein the extracellular matrix sheet material comprises growth factors retained from a source tissue for the sheet material.
17. The method of claim 16 , wherein the extracellular matrix sheet material retains at least a portion of a collagen microarchitecture of a source tissue for the sheet material.
18. The method of claim 17 , wherein the one or more plug bodies are cylindrical plug bodies having a cylindrical side wall extending between said first end face and said second end face.
19. The method of claim 15 , wherein the extracellular matrix sheet material retains at least a portion of a collagen microarchitecture of a source tissue for the sheet material.
20. The method of claim 1 , wherein the one or more plug bodies are cylindrical plug bodies having a cylindrical side wall extending between said first end face and said second end face.
21. A method for treating a void extending through soft tissue of a patient, the void including a first opening, a second opening and a passageway having a passageway wall extending therebetween, the method comprising:
providing an elongate three-dimensional graft member extending through the passageway;
advancing one or more plug bodies through the second opening and over the graft member to fill a substantial portion of the passageway, wherein the one or more plug bodies comprise rolled or folded sheet material, wherein the one or more plug bodies each include a first end face and a second end face opposite the first end face, wherein the first end face and the second end face each present a plurality of exposed edges of the rolled or folded sheet material; and
further wherein during said advancing, the first end face and the second end face of the one or more plug bodies are oriented transverse to a longitudinal axis of the passageway so as to face toward the passageway wall.
22. The method of claim 21 , wherein said advancing comprises advancing at least two of said plug bodies over the graft member.
23. The method of claim 21 , wherein said one or more plug bodies includes a first plug body and a second plug body having different lengths.
24. The method of claim 21 , wherein the sheet material comprises an extracellular matrix sheet material.
25. The method of claim 24 , wherein the extracellular matrix sheet material comprises growth factors retained from a source tissue for the sheet material.
26. The method of claim 25 , wherein the extracellular matrix sheet material retains at least a portion of a collagen microarchitecture of a source tissue for the sheet material.
27. The method of claim 26 , wherein the one or more plug bodies are cylindrical plug bodies having a cylindrical side wall extending between said first end face and said second end face.
28. The method of claim 24 , wherein the extracellular matrix sheet material retains at least a portion of a collagen microarchitecture of a source tissue for the sheet material.
29. The method of claim 21 , wherein the one or more plug bodies are cylindrical plug bodies having a cylindrical side wall extending between said first end face and said second end face.