Fistula grafts and related methods and systems useful for treating gastrointestinal and other fistulae
View Patent ↗Described are medical products, systems, and methods useful for treating fistulae, particularly enterocutaneous fistulae. Certain inventive products are configured to have portions residing in and around a primary fistula opening in a wall of the alimentary canal. One product includes a graft body which is configured to block at least the primary opening. The graft body includes a capping member connected to an elongate plug member. The capping member is configured to contact portions of the alimentary canal wall adjacent to the primary opening, with the elongate plug member extending into at least a portion of the fistula. A product of this sort may be particularly adapted to allow a portion of the capping member to be positioned alongside an exterior, lateral surface of the plug member, e.g., when placed in a delivery device lumen. Such a capping member may be hingedly or non-hingedly coupled to the elongate plug member.
1. A medical product useful for blocking an opening in a wall of a bodily structure in a body of a patient, the medical product comprising:
an implantable device that includes a deformable anchoring member positionable at the opening for placing a sheet-form covering over the opening, said implantable device also including a three-dimensional plug body that is formed separately from the sheet-form covering but attached to the sheet-form covering, the three-dimensional plug body comprised of a material receptive to tissue ingrowth, the implantable device being implantable with the sheet-form covering positioned over said opening and with the three-dimensional plug body extending from the sheet-form covering through the opening,
wherein the deformable anchoring member includes a resilient wire support frame defining a central opening across which the sheet-form covering extends, the resilient wire support frame configured to extend around the opening in the wall of the bodily structure when the implantable device is implanted;
wherein the deformable anchoring member further includes a radiopaque component positioned in the central opening and discretely spaced from the resilient wire support frame;
wherein the radiopaque component has a first face having a width, a second face opposite the first face, and a thickness between the first face and second face, the thickness less than the width;
wherein the radiopaque component is connected to the resilient wire support frame by the sheet-form covering, the radiopaque component movable relative to the resilient wire support frame;
wherein said resilient wire support frame and said radiopaque component can be visualized under x-ray or sonography subsequent to implantation, and
wherein the resilient wire support frame and said radiopaque component of said deformable anchoring member are arranged such that upon deformation of the deformable anchoring member from a first condition to a second condition, the position of the radiopaque component changes to the resilient wire support frame so that deformation of the deformable anchoring member can be visualized from outside of the body; and
wherein said three-dimensional plug body has a length of about 1 to 8 inches.
2. The medical product of claim 1 , wherein the resilient wire support frame is formed with Nitinol.
3. The medical product of claim 1 , wherein the three-dimensional plug body comprises a synthetic polymeric material.
4. The medical product of claim 1 , wherein the three-dimensional plug body comprises a collagen-containing material.
5. The medical product of claim 1 , wherein the three-dimensional plug body comprises a remodelable material.
6. The medical product of claim 1 , wherein the three-dimensional plug body comprises an extracellular matrix material.
7. The medical product of claim 6 , wherein said extracellular matrix material comprises submucosa, serosa, pericardium, dura mater, peritoneum, or dermal collagen.
8. The medical product of claim 6 , wherein said radiopaque component includes a metallic material.
9. The medical product of claim 1 , wherein the sheet-form covering is positionable over said opening such that deforming the deformable anchoring member from the first condition to the second condition conforms the sheet-form covering to tissue at the opening so as to substantially seal off the opening.
10. The medical product of claim 1 , wherein the sheet-form covering is positionable over said opening such that deforming the deformable anchoring member from the first condition to the second condition provides a convex surface of the sheet-form covering contacting tissue at said opening, the convex surface having a first portion residing externally of the opening and a second portion residing within the opening.
11. The medical product of claim 1 , wherein the resilient wire support frame includes a closed circumference frame member lying within a single generally flat plane.
12. The medical product of claim 11 , wherein the radiopaque component is positioned to the interior of said closed circumference frame member when the deformable anchoring member is in the first condition.
13. The medical product of claim 11 , wherein the sheet-form covering material includes a synthetic polymeric layer extending between outer portions of said closed circumference frame member.
14. The medical product of claim 1 , wherein the three-dimensional plug body is of sufficient size to generally fill the opening.
15. The medical product of claim 1 , wherein the three-dimensional plug body comprises a resorbable material.
16. The medical product of claim 1 , further comprising an actuating member connected to and extending from the deformable anchoring member, wherein the actuating member is configured to extend through the opening when the implantable device is implanted and is actuatable to convert the deformable anchoring member from the first condition to the second condition.
17. The medical product of claim 1 , wherein said resilient wire support frame and said radiopaque component are configured for visualization under x-ray subsequent to delivery of the implantable device to the implantation site.
18. The medical product of claim 1 , wherein said resilient wire support frame and said radiopaque component are spaced a distance from one another.
19. A method for blocking an opening in a wall of a bodily structure, comprising:
providing an implantable medical device that includes a deformable anchoring member positionable at the opening for placing a sheet-form covering over the opening, said implantable medical device also including a three-dimensional plug body that is formed separately from the sheet-form covering but attached to the sheet-form covering, the three-dimensional plug body comprised of a material receptive to tissue ingrowth, the implantable device being implantable with the sheet-form covering positioned over said opening and with the three-dimensional plug body extending from the sheet-form covering through the opening,
wherein the deformable anchoring member includes a resilient wire support frame defining a central opening across which the sheet-form covering extends, the resilient wire support frame configured to extend around the opening in the wall of the bodily structure when the implantable device is implanted;
wherein the deformable anchoring member further includes a radiopaque component positioned in the central opening and discretely spaced from the resilient wire support frame;
wherein the radiopaque component has a first face having a width, a second face opposite the first face, and a thickness between the first face and second face, the thickness less than the width;
wherein the radiopaque component is connected to the resilient wire support frame by the sheet-form covering, the radiopaque component movable relative to the resilient wire support frame;
wherein said resilient wire support frame and said radiopaque component can be visualized under x-ray or sonography subsequent to implantation, and
wherein the resilient wire support frame and said radiopaque component of said deformable anchoring member are arranged such that upon deformation of the deformable anchoring member from a first condition to a second condition, the position of the radiopaque component changes relative to the resilient wire support frame so that deformation of the deformable anchoring member can be visualized from outside of the body; and
wherein said three-dimensional plug body has a length of about 1 to 8 inches;
delivering the implantable medical device to an implantation site which includes said opening so that the sheet-form covering is positioned over said opening and the three-dimensional plug body extends from the sheet-form covering through the opening;
deforming the deformable anchoring member from the first condition to the second condition, wherein the radiopaque component changes position relative to the resilient wire frame; and
visualizing the change in position of the radiopaque component relative to the resilient wire support frame.