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: The invention includes a medical device and more specifically relates to a valve found generally within a frame. In a preferred device, the frame preferably comprises a self-expanding stent frame, and the valve has at least one expandable and contractible pocket member within the stent frame for resisting and permitting fluid flow, respectively.

Abstract: A collagenous biomaterial medical device comprising a molded sponge material formed from comminuted submucosa fragments that have not been cross-linked with a cross-linking agent, wherein said submucosa has at least one biotropic agent, and wherein said biotropic agent is a growth factor is disclosed.

Abstract: Described are hemostasis devices useful for implantation in biopsy tracts, which device comprise highly compact, dried hemostatic sponge elements. Preferred devices also include compacted sponge matrices exhibiting high density and rigidity in combination with high volumetric expandability when wetted. Also described are methods for making and using such devices.

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: 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: Described are medical devices configured for use in cosmetic surgery. The medical devices include an elongate body member having a proximal end, a distal end, and a plurality of gaps defined therebetween. At least a portion of the body member is associated with one or more layers of a collagenous extracellular matrix (ECM) material. The elongate member can include one or more tissue engaging members. In preferred embodiments, the collagenous extracellular matrix material includes one or more native or non-native bioactive components.

Abstract: A graft prostheses (11), materials and method for implanting, transplanting, replacing, or repairing a part of a patient. The graft prosthesis includes a purified, collagen-based matrix structure removed from a submucosa tissue source. The submucosa tissue source is purified by disinfection and removal steps to deactivate and remove contaminants, thereby making the purified structure biocompatible and suitable for grafting on and/or in a patient.

Abstract: An implantable tissue reinforcement device useful for treating or preventing the formation of parastomal hernias forming about a surgically created stoma. The tissue reinforcement device can comprise a synthetic or mammalian-derived sheet-like graft member, such as a resorbable material that promotes tissue ingrowth, wherein a sizing pattern is included that comprises linear indicia radiating outward from a stomal aperture. The linear indicia facilitate creation of a resized stomal opening in the graft member sufficiently large to allow passage of the resected bowel portion. A series of cuts made along the indicia create a plurality of flaps about the resized opening that are configured to abut the bowel portion and enhance reinforcement the stomal region after implantation. In one embodiment, the linear indicia comprises a series of weakened (e.g., perforated) lines that facilitate the cutting of the material by a scalpel, scissors, etc.

Abstract: A graft and method of using a graft are described that should decrease the incidence of abnormal placentation and uterine rupture that result from cesarean section and restore the anatomic integrity of the uterus at a hysterotomy surgical site, while not disturbing the involution of the postpartum uterus.

Abstract: Described are devices, methods, and systems for grafting tissues or organs that are exposed to bacterial or mammalian enzymes that degrade collagenous materials. Illustrative medical grafts are processed by contacting a collagenous extracellular matrix (ECM) material with a mono-carboxylic acid having from four to about twelve carbon atoms, or mixtures of two or more such acids.

Abstract: A method for forming an extracellular matrix material (ECM) material includes providing at least an ECM composition containing ECM particles varying in their capacity for migration through a fluid medium, including at least one population of expanded ECM particles. The ECM composition is combined in a fluid medium to form a flowable ECM composition. The flowable ECM composition is subjected to a centrifugal force in a mold for a period of time sufficient to distribute the ECM particles according to differences in their physical characteristics. The ECM composition is dried to form a dried ECM material having a density gradient extending from a less dense region to a more dense region. The dried ECM material may formed as a porous, substantially acellular ECM material expandable in an aqueous fluid environment by at least 100% in volume.

Abstract: Described in certain aspects are composite extracellular matrix material products including expanded collagenous materials in combination with non-expanded collagenous materials. Methods for their preparation and use are also disclosed. 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 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: A graft prostheses (11), materials and method for implanting, transplanting, replacing, or repairing a part of a patient. The graft prosthesis includes a purified, collagen-based matrix structure removed from a submucosa tissue source. The submucosa tissue source is purified by disinfection and removal steps to deactivate and remove contaminants, thereby making the purified structure biocompatible and suitable for grafting on and/or in a patient.

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: Described, in certain aspects of the invention, are multilaminate medical graft products, as well as methods for preparing and using the same. An illustrative multilaminate medical graft product of the invention comprises a first layer of remodelable extracellular matrix (ECM) material bonded to a second layer of remodelable ECM material, wherein the first material layer is enriched with a growth factor relative to the second material layer. Such a remodelable ECM material may be comprised of submucosa from a warm-blooded vertebrate, for example, porcine small intestinal submucosa (SIS).

Abstract: Described, in certain inventive embodiments, are unique devices and methods for introducing implants into soft tissue of a patient. One of these devices includes a tissue-penetrating member that is configured to pass in its entirety through a volume of patient tissue. The tissue-penetrating member has a leading end and a trailing end, and provides a receiving space for receipt of an implant body portion for carrying the implant body portion into the volume of patient tissue. The device also includes an implant that has an implant body portion removably received in the receiving space of the tissue-penetrating member. The implant body portion is configured for deployment from the receiving space in the volume of patient tissue so as to remain deployed there along a passageway traversed by the tissue-penetrating member.

Abstract: Described are medical devices which are or can be used to form tubular medical devices, and related methods. Preferred devices include tubular grafts of biomaterial having lumen walls which present no seam edge that traverses the entire length of the lumen, illustratively including devices having lumen walls which have a discontinuous seam presenting multiple seam edges. Such a device may include a tubular structure formed by inserting a plurality of extensions of a biomaterial sheet through a plurality of corresponding apertures of the sheet.

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.