Abstract: This invention provides, in certain aspects, unique devices and methods for treating fistulae. In one embodiment, an inventive device includes an elongate graft body having a proximal end and a distal end. The graft body is configurable to a first condition and a second condition, the second condition including the distal end deflected laterally relative to its position in the first condition of the body. The device also includes a tether, which is connected to the graft body, and is configured to traverse proximally along the body. The tether is manipulable to convert the graft body from the first condition to the second condition. Such a device may also include one or more additional tethers connected to the graft body. For instance, a second tether can be configured to extend distally from the distal end of the graft body, and may be effective in pulling the graft body along a fistula tract.

Abstract: An implantable graft, which may be inserted into a fistula tract to occlude the primary opening of the fistula, is provided. To prevent unintentional displacement of the graft or extrusion of the graft from the fistula of a patient, the graft may be provided with a cap that extends laterally from at least one end of the body of the graft, where the cap may be integral with the body of the graft, attachable to at least one end of the body of the graft, and/or moveable along the body of the graft. The graft may also have a tail that extends from one end of the body of the graft to assist in placement of the graft in a fistula tract. The graft may be an integral unit made of a single material, such as a heterograft material, or may include distinct components made of the same or different materials. Methods for closing a fistula tract are also provided.

Abstract: Tissue augmentation devices, as well as methods of manufacturing and using the same, are disclosed. In certain embodiments, a tissue augmentation device comprises an elongate tissue penetrating member and an amount of remodelable material, wherein at least a portion of the elongate member is cannulated, and at least a portion of the amount of material is received within at least a portion of the cannulated portion of the elongate member. The elongate tissue penetrating member may provide at least one deformation that is configured to constrict portions of the amount of remodelable material received within the elongate member. In alternate embodiments, a flexible covering over an implantable biomaterial provides protection and allows an easier delivery of the biomaterial to a tissue tract.

Abstract: 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.

Abstract: Described are devices, methods, and systems useful in the treatment of fistulae, and in certain embodiments those having openings extending into the alimentary canal, such as anorectal fistulae. Illustratively, an anorectal fistula can be treated by placing a volumetric construct within the primary opening of the fistula. In certain embodiments, the volumetric construct can include a rolled remodelable material processed to form a substantially unitary body. Advantageous such remodelable materials can include collagenous extracellular matrix materials, such as small intestine submucosa.

Abstract: Among other things, there are disclosed apparatuses and methods for medically sealing an opening in a vessel or wall. For example, in medical applications, a delivery tube is provided for insertion through a sheath into a vessel (e.g. a blood vessel). A dome-shaped seal fixed to a filament, an absorbent and/or compressible buffer, and a locking member are provided in the delivery tube. The delivery tube is configured so that it can be inserted into the vessel through a sheath. Tension is maintained on the filament to hold the seal against the tube or sheath. The sheath is pulled out, which pulls out the tube at the same time, leaving the seal over the opening in the vessel wall. The locking member compresses the buffer against the outside of the vessel and with the filament holds the seal in place against the inside of a vessel.

Abstract: This invention relates in one aspect to the treatment of a vascular vessel with a biomaterial. The biomaterial can be a remodelable material that strengthens and/or supports the vessel walls. Additionally the biomaterial can include a variety of naturally occurring or added bioactive agents and/or viable cellular populations.

Abstract: This invention relates in one aspect to the treatment of a vascular vessel with a biomaterial. The biomaterial can be a remodelable material that strengthens and/or supports the vessel walls. Additionally the biomaterial can include a variety of naturally occurring or added bioactive agents and/or viable cellular populations.

Abstract: An implantable graft, which may be inserted into a fistula tract to occlude the primary opening of the fistula, is provided. To prevent unintentional displacement of the graft or extrusion of the graft from the fistula of a patient, the graft may be provided with a cap that extends laterally from at least one end of the body of the graft, where the cap may be integral with the body of the graft, attachable to at least one end of the body of the graft, and/or moveable along the body of the graft. The graft may also have a tail that extends from one end of the body of the graft to assist in placement of the graft in a fistula tract. The graft may be an integral unit made of a single material, such as a heterograft material, or may include distinct components made of the same or different materials. Methods for closing a fistula tract are also provided.

Abstract: The embodiments described include graft devices for reinforcing patient tissue structures and methods of making and using the graft devices. In certain embodiments the graft devices have a remodelable extracellular matrix material graft body defining a slot and having a portion receivable through the slot to form a closed loop. Such graft devices can be used in encircling reinforcement of patient tissue structures such as anal sphincters or anastomosed vessel segments.

Abstract: This invention relates in one aspect to the treatment of a vascular vessel with a biomaterial. The biomaterial can be a remodelable material that strengthens and/or supports the vessel walls. Additionally the biomaterial can include a variety of naturally occurring or added bioactive agents and/or viable cellular populations.

Abstract: Provided by certain aspects of the invention are methods for treating fistulae and various fistula graft assemblages useful in this regard. Illustratively, some inventive methods are useful in treating fistulae having at least a first fistula opening, a second fistula opening and a fistula tract extending therebetween. In one step, a first capping member is positioned over the first fistula opening such that a first pulling member, which extends from the first capping member, passes through the fistula tract. In another step, a second capping member is positioned over the second fistula opening such that a second pulling member, which extends from the second capping member, passes through the fistula tract. A first pulling force is applied to the first pulling member, and a second pulling force is applied to the second pulling member, for maintaining the first capping member over the first fistula opening and for maintaining the second capping member over the second fistula opening, respectively.

Abstract: An implantable graft, which may be inserted into a fistula tract to occlude the primary opening of the fistula, is provided. To prevent unintentional displacement of the graft or extrusion of the graft from the fistula of a patient, the graft may be provided with a cap that extends laterally from at least one end of the body of the graft, where the cap may be integral with the body of the graft, attachable to at least one end of the body of the graft, and/or moveable along the body of the graft. The graft may also have a tail that extends from one end of the body of the graft to assist in placement of the graft in a fistula tract. The graft may be an integral unit made of a single material, such as a heterograft material, or may include distinct components made of the same or different materials. Methods for closing a fistula tract are also provided.

Abstract: Tissue augmentation devices, as well as methods of manufacturing and using the same, are disclosed. In certain embodiments, a tissue augmentation device comprises an elongate tissue penetrating member and an amount of remodelable material, wherein at least a portion of the elongate member is cannulated, and at least a portion of the amount of material is received within at least a portion of the cannulated portion of the elongate member. The elongate tissue penetrating member may provide at least one deformation that is configured to constrict portions of the amount of remodelable material received within the elongate member. In alternate embodiments, a flexible covering over an implantable biomaterial provides protection and allows an easier delivery of the biomaterial to a tissue tract.

Abstract: Tissue augmentation devices, as well as methods of manufacturing and using the same, are disclosed. In certain embodiments, a tissue augmentation device comprises an elongate tissue penetrating member and an amount of remodelable material, wherein at least a portion of the elongate member is cannulated, and at least a portion of the amount of material is received within at least a portion of the cannulated portion of the elongate member. The elongate tissue penetrating member may provide at least one deformation that is configured to constrict portions of the amount of remodelable material received within the elongate member. In alternate embodiments, a flexible covering over an implantable biomaterial provides protection and allows an easier delivery of the biomaterial to a tissue tract.

Abstract: Described are devices, methods, and systems useful in the treatment of fistulae, and in certain embodiments those having openings extending into the alimentary canal, such as anorectal fistulae. Illustratively, an anorectal fistula can be treated by placing a volumetric construct within the primary opening of the fistula. In certain embodiments, the volumetric construct can include a rolled remodelable material processed to form a substantially unitary body. Advantageous such remodelable materials can include collagenous extracellular matrix materials, such as small intestine submucosa.

Abstract: Certain aspects of the present invention provide devices for occluding vascular vessels. In some preferred forms, these devices are able to move from a first condition to a less compact, second condition in a vascular vessel so as to fully or partially prevent fluid from passing through the vessel. One such device includes a frame and a flexible sheet material. The device also includes an occluding material that is located in an interior region of the frame. The flexible sheet material and frame are associated with one another such that when the device is in the second condition in the vascular vessel, the sheet material is positioned in the vessel lumen so as to block fluid flow through the lumen.

Abstract: Described are devices, methods, and systems useful in the treatment of fistulae, and in certain embodiments those having openings extending into the alimentary canal, such as anorectal fistulae. Illustratively, an anorectal fistula can be treated by placing a volumetric construct within the primary opening of the fistula. In certain embodiments, the volumetric construct can include a rolled remodelable material processed to form a substantially unitary body. Advantageous such remodelable materials can include collagenous extracellular matrix materials, such as small intestine submucosa.

Abstract: Described are expanded collagenous materials and methods for their preparation and use. Certain expanded collagenous materials can be prepared by treating a first collagenous material with an alkaline substance under conditions effective to expand the first collagenous material, and recovering the expanded material. Expanded materials can exhibit beneficial persistence and tissue generation characteristics when implanted, and can be used in the formation of highly porous medical implant bodies which can be compressed to fractions of their original volume and will thereafter substantially recover their original volume.

Abstract: Described are medical graft products, systems, and methods useful for treating fistulae, particularly enterocutaneous fistulae. Certain products of the invention are configured to have portions residing in and around a primary fistula opening in a wall of the alimentary canal. One such product includes a biocompatible 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, and the elongate plug member is configured to extend into at least a portion of the fistula. A graft 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.