Abstract: A multiple-sided medical device comprises a frame comprising wire or other resilient material and having a series of bends and interconnecting sides. The device has both a flat configuration and a second, folded configuration which a generally serpentine shape. The device is pushed from a delivery catheter into the lumen of a duct or vessel and may include one or more barbs for anchoring purposes. A full or partial covering of fabric or other flexible material such as DACRON, PTFE, or a collagen-based material such as small intestinal submucosa (SIS), may be sutured or attached to the frame to form an occlusion device, a stent graft, or an implantable, intraluminal valve such as for correcting incompetent veins in the lower legs and feet.

Abstract: Described are tissue graft constructs that include submucosa and other extracellular matrix materials that incorporate a number of exogenous proteins. Further described are methods for making tissue graft constructs that include stripping endogenous heparin binding proteins from a porcine graft material and thereafter binding one or more human growth factors to the native heparin molecules that are retained within the graft material. Such graft materials may be used in methods for the treatment of wounds in patients.

Abstract: Described, in certain aspects, are medical products comprised of uniquely prepared remodelable extracellular matrix (ECM) materials retaining at least a portion of their native bioactivity. Also described are methods for forming and using such products. In one embodiment, an inventive product comprises a layer of remodelable ECM material modified through contact with periodic acid or a salt thereof. In some forms, such a modified ECM material layer includes non-native Schiff's base crosslinks within and/or between certain components of the ECM material (e.g., between two collagen molecules, two non-collagen molecules, and/or a collagen molecule and a non-collagen molecule). Other inventive products are comprised of various gels, foams, pastes, and formed, coherent, porous bodies at least containing ECM materials that have been modified in accordance with the present invention.

Abstract: Described are purified extracellular matrix materials isolated from the abdominal wall of animals and including the subserous fascia layer of the abdominal wall. Such medical materials can find use in treating damaged tissue and in certain aspects in providing tissue support for the repair of hernias. Related methods of manufacture and use are also described.

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 implantable prosthetic valve devices comprising isolated granulation tissue. Also described are methods of treatment that include implanting at least one of these valves within a body passageway of a patient, for example, within a vein to treat venous insufficiency.

Abstract: An absorbable and expandable closure member used to occlude or exclude a body lumen or cavity, such as a blood vessel, fallopian tube, duct, aneurysmal sac, etc., comprising a closure member comprising one of more sheets of a biomaterial that are rolled, stacked, or folded to form a multilayer construct of a generally cylindrical configuration for deployment through a delivery system, either as a singularly or part of a multiplicity of closure members. The biomaterial is derived from a source material, such as small intestinal submucosa or another remodelable material (e.g., an extracellular matrix) having properties for stimulating ingrowth of adjacent tissue into the biomaterial deployed within the bodily lumen. The closure member is deployed to the bodily lumen from a delivery sheath, cartridge, and/or over a inner guiding member, such as a wire guide or catheter.

Abstract: Described are medical graft materials and devices having improved properties relating to their component profiles.

Abstract: Described are preferred prosthetic valve devices including a first extracellular matrix material having a second extracellular matrix material deposited thereon. The preferred materials are made by culturing cells in contact with an extracellular matrix graft material in a fashion to cause the cells to biosynthesize and deposit extracellular matrix components on the material. The cells are then removed to provide the extracellular matrix composite material. In preferred embodiments, the prosthetic valve devices are configured for use in vascular applications.

Abstract: A multiple-sided medical device comprises a frame comprising wire or other resilient material and having a series of bends and interconnecting sides. The device has both a flat configuration and a second, folded configuration which a generally serpentine shape. The device is pushed from a delivery catheter into the lumen of a duct or vessel and may include one or more barbs for anchoring purposes. A full or partial covering of fabric or other flexible material such as DACRON, PTFE, or a collagen-based material such as small intestinal submucosa (SIS), may be sutured or attached to the frame using heat or pressure welding crimping, adhesive, or other techniques to form an occlusion device, a stent graft, or an implantable, intraluminal valve such as for correcting incompetent veins in the lower legs and feet.

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: A biofilm-inhibiting medical product includes a carrier formed from a natural, bioremodelable material, whereby the carrier includes a biocidal bismuth thiol agent and/or one or more other biofilm-inhibiting or wound healing agents. A method for using the biofilm-inhibiting medical product to treat a wound or tissue defect in a patient's body is described.

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: An absorbable and expandable closure member used to occlude or exclude a body lumen or cavity, such as a blood vessel, fallopian tube, duct, aneurysmal sac, etc., comprising a closure member comprising one of more sheets of a biomaterial that are rolled, stacked, or folded to form a multilayer construct of a generally cylindrical configuration for deployment through a delivery system, either as a singularly or part of a multiplicity of closure members. The biomaterial is derived from a source material, such as small intestinal submucosa or another remodelable material (e.g., an extracellular matrix) having properties for stimulating ingrowth of adjacent tissue into the biomaterial deployed within the bodily lumen. The closure member is deployed to the bodily lumen from a delivery sheath, cartridge, and/or over a inner guiding member, such as a wire guide or catheter.

Abstract: This invention is directed to graft materials for implanting, transplanting, replacing, or repairing a part of a patient and to methods of making the graft materials. The present invention is also directed to stent grafts and endoluminal prostheses formed of the graft materials. More specifically, the present invention is a graft material which includes porous polymeric sheet, extracellular matrix material (ECM) disposed on at least a portion of the porous polymeric sheet and at least one polymer layer disposed on at least a portion of the ECM. The ECM may be in a gel form. The polymeric sheet and the polymer layer may be made from foam material and may comprise a polyurethane urea and a surface modifying agent such as siloxane.

Abstract: Described are medical graft materials and devices having improved properties relating to their component profiles.

Abstract: Described are medical graft materials and devices having improved properties relating to their component profiles.

Abstract: Described are methods for treating a topical wound in a patient. The methods involve applying to the wound a wound dressing including a collagenous biomaterial isolated as a sheet of tissue from urinary tract tissue of a mammal.