Abstract: Medical devices are described herein. More particularly, the disclosure relates to medical devices, systems, and methods for the visualization and treatment of bodily passages, such as an airway, sinus cavity, or sinus passages. An exemplary medical device comprises an elongate member, an actuator moveable between an actuator first position and an actuator second position, and a wire member. The elongate member has a first straight, or substantially straight configuration, when the actuator is in the actuator first position and a second curved configuration when the actuator is in the actuator second position.

Abstract: Tissue adjustment implants useful for adjusting a position of tissue in a patient are described. In an embodiment, a tissue adjustment implant includes a main body having a series of outwardly-extending projections. The tissue adjustment implants can be used in a variety of treatments, such as in the treatment of Obstructive Sleep Apnea and snoring.

Abstract: An apparatus which includes a closure member and delivery systems for closing vessels in the body of a patient is disclosed. In one embodiment, the closure member is a hemostatic closure member having a cylindrical shape and an expandable volume on contact with fluids. The hemostatic member includes a functional passageway through the length of the member so that it may be mounted over a delivery catheter or wire guide for delivery against a vessel puncture or into another vacuslar environment, such as to fill an aneurysm sac. In another embodiment the closure member is a fallopian tube closure member which is deployed into the fallopian tube over a guide wire to prevent conception. The fallopian tube member includes a loop-shaped frame having barbs, a first layer of material, a binding wire, a second layer of material, and an expandable volume on contact with fluids.

Abstract: Lung volume reduction by isolating a target lung portion from the rest of the lung with a mass of extracellular matrix (“ECM”) material. The procedure can be performed by locating a tube within the lumen of an airway to be obstructed and depositing an amount of flowable or other ECM in the open space until the lumen is occluded. Optionally, the procedure may be performed by delivering a plug substantially comprised of ECM material into the lumen of an airway to be obstructed. Further optionally, the ECM plug may include a one-way valve to allow air and mucous to escape from the isolated lung portion.

Abstract: Described are devices and methods for medically sealing a perivalvular leak associated with implanted valves. For example, a bioresorbable tissue infiltratable sheet is provided for insertion through a perivalvular leak. A filament extending through the sheet is also provided which when pulled causes the sheet to gather around the filament on either side of the perivalvular leak. The gathered position of the sheet may be secured by a series of stops and/or use of a capping member.

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 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 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 medical graft products, systems, and methods for treating fistulae. Certain products of the invention are configured to have portions residing in and around a primary fistula opening, e.g., one occurring 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, which is configured to contact portions of the alimentary canal wall adjacent to the primary opening, and an elongate plug member extending from the capping member, which is configured to extend into at least a portion of the fistula. In certain embodiments, a graft body component has the capacity to expand or otherwise change form to provide a suitable capping arrangement. Such a component can include a resilient wire frame, e.g., one that is self-expandable or one that requires at least some manipulation in order to expand.

Abstract: Described, in certain respects, are unique methods and systems for treating fistulae and other passageways and openings in the body. In some embodiments, treatment will be performed on fistulae that include a passage extending through a subcutaneous wall or wall-like structure. Illustratively, such a passage can extend through a subcutaneous tissue wall that includes, at a minimum, portions of an intestinal wall, and in this regard, such a wall can have a first side that is provided by the luminal side of the intestines and a second subcutaneous side that is provided, for example, by the abluminal side of the intestines and/or by other subcutaneous tissues adhered to this abluminal side. Some inventive products and methods involve sealing off the passage from both sides of the wall, for example, where a sealing element is placed on each side of the wall over an opening to the passage.

Abstract: Described are packaged, sterile medical graft products containing controlled levels of a growth factor such as Fibroblast Growth Factor-2 (FGF-2). Also described are methods of manufacturing medical graft products wherein processing, including sterilization, is controlled and monitored to provide medical graft products having modulated, known levels of a extracellular matrix factor, such as a growth factor, e.g. FGF-2. Preferred graft materials are extracellular matrix materials isolated from human or animal donors, particularly submucosa-containing extracellular matrix materials. Further described are ECM compositions that are or are useful for preparing gels, and related methods for preparation and use.

Abstract: Described are tissue graft constructs that include an extracellular matrix material in combination with added endothelial cells and at least one additional added exogenous cellular population. The additional exogenous cellular population desirably includes muscle cells, such as smooth muscle cells, fibroblasts, or a combination thereof. Tubular constructs seeded with such cell combinations can be beneficially used as vascular grafts. Also described are methods for preparing and using such grafts.

Abstract: 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.

Abstract: Some aspects of the present invention are directed to unique products and methods for treating fistulae and other passageways and openings in the body. In some preferred forms, an inventive construct will include an elongate graft body that incorporates a plurality of sheet or sheet-like segments. The plurality of sheet or sheet-like segments, in some arrangements, will be stacked in a generally longitudinal direction along the length of the plug body, and optionally, the segments will be received over one or more elongate elements. Elongate elements of this sort can take a variety of forms including a suture, wire, filament, or other relatively thin-bodied elongate member, although in some forms, an elongate element will be or include a somewhat heftier structure such as a biodegradable or non-biodegradable three-dimensional body.

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: 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: Described are devices, methods and systems useful for achieving occlusion of vascular vessels. Percutaneous procedures are used to occlude and obliterate the greater saphenous vein, for example in the treatment of varicose vein condition caused by venous reflux. Certain embodiments encompass the deployment of one or more vascular occlusion devices via a through-and-through percutaneous procedure that leaves the vascular occlusion device or devices in a through-and-through condition.

Abstract: Described are embodiments of a multilaminate or multiple layer implantable surgical graft with an illustrative graft comprising a remodelable collagenous sheet material, the graft including one or more interweaving members to stitch together the graft to help prevent the layers from delaminating or separating during handling and the initial stages of remodeling. The interweaving members may comprise lines of suture, thread, individual stitches, strips of material, etc. that are woven through the layers of biomaterial in a desired pattern. In one embodiment, the interweaving members comprise a pharmacologically active substance, such as a drug, growth factors, etc. to elicit a desired biological response in the host tissue. In another embodiment, the graft further comprises a reinforcing material, such as a synthetic mesh, within the layers of remodelable biomaterial and stitched together by one or more interweaving members.

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: 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.