Fistula grafts and related methods and systems useful for treating gastrointestinal and other fistulae

摘要

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.

主权项

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.