Abstract: Described are components, component combinations, kits and methods useful for creating reconstructed tissue structures such as reconstructed nipple structures. Novel combinations are described involving surgical marking templates, implants having features correlated to the templates, and/or post-surgical shields.

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 devices useful for applying a bolster material to a surgical fastening device such as a stapler, and related methods of manufacture and use. The devices include an applicator element for receipt between arms of the stapler, and a bolster material, desirably a remodelable extracellular matrix material, coupled to the applicator element. In certain embodiments, the bolster material is held by the applicator element, for example having at least a portion looped around or received through or over a portion of the applicator element. Also described are unique implantable materials including coatings of dried, reversible adhesive.

Abstract: Described are preferred extracellular matrix composites 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.

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.

Abstract: Described are medical grafting materials that include a base substrate material and an adherent fibrous mass of extracellular matrix components received upon the substrate material. Also described are methods of preparing and using such materials.

Abstract: The invention involves a submucosa tissue that has the capability of being shape formed or shape configured. The submucosa involves a purified form of submucosa tissue. Optionally, the submucosa can be packaged in such a manner to permit sterility or maintain sterility of the submucosa.

Abstract: Described are methods, cell growth substrates, and devices that are useful in preparing cell-containing graft materials for administration to patients. Tubular passages can be defined in cell growth substrates to promote distribution of cells into the substrates. Also described are methods and devices for preparing cell-seeded graft compositions, methods and devices for preconditioning cell growth substrates prior to application of cells, and cell seeded grafts having novel substrates, and uses thereof.

Abstract: Described are methods and apparatuses for delivering fistula plugs into fistulae having at least a primary fistula opening, a secondary fistula opening, and a fistula tract extending therebetween. Illustratively, some inventive methods involve delivering a fistula plug into a fistula tract through a primary fistula opening and toward a secondary fistula opening, while others involve delivering a fistula plug into a fistula tract through a secondary fistula opening and toward a primary fistula opening. In certain aspects, a fistula plug is pushed and/or pulled through a fistula tract along a guidewire or other plug-guiding device, potentially protected by a protective delivery device such as a sheath, capsule or other suitable delivery vehicle.

Abstract: One aspect of the present invention provides a device for occluding a body cavity. In one embodiment, the occlusion device includes include a hub extending from an upstream end to a downstream end and along a central axis. A number of struts are attached to the upstream end and extend upstream from the hub. An expandable balloon is attached to the downstream end and extending downstream from the hub. Another aspect of the present invention provides a method for occluding fluid flow within in a body cavity including placing an occlusion device within the body cavity.

Abstract: Disclosed is a medical device (5) and more particularly, an implantable biomaterial. The biomaterial comprises a radiopaque (22) collagenous biomaterial (10).

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: 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 embolization devices having unique bioactive coatings, as well as methods for their manufacture and use. An illustrative embolization device of the invention comprises an embolic body and a coating material comprising biotropic extracellular matrix material immobilized on a surface of the embolic body. The biotropic extracellular matrix material comprises a network of self-assembled collagen fibrils, and comprises at least one bioactive agent retained in the extracellular matrix material, wherein the bioactive agent is selected from the group consisting of a proteoglycan, a growth factor, a glycoprotein, and a glycosaminoglycan. In certain forms, such an extracellular matrix material comprises a remodelable, angiogenic extracellular matrix material, for example, a submucosa material such as but not limited to porcine small intestinal submucosa.

Abstract: The present invention provides, in certain aspects, medical systems that are useful for applying bolster material to patient tissue. One such system includes a surgical fastening apparatus that is comprised of a first arm having a first arm working surface; and a cutting element operable along a cutting path. This system also includes at least one piece of bolster material having a portion received in the cutting path, and a retaining element retaining the at least one piece of bolster material in association with the first arm working surface, wherein the retaining element has one or more segments received in the cutting path and includes portions residing between the first arm working surface and the at least one piece of bolster material. The invention also provides medical devices that are useful for applying bolster materials to surgical fastening apparatuses, as well as methods for preparing and using such devices.

Abstract: The present invention provides, in certain aspects, devices and methods for plugging passageways and other open spaces in the body. In one embodiment, a plugging assembly comprises a first plug member and a second plug member, wherein the second plug member is configured to contact and move a portion of the first plug member in plugging a body passageway. These plug members may be formed with one or more of a variety of biocompatible materials including some that are naturally derived and some that are non-naturally derived. In another embodiment, such a plugging assembly is combined with a device that is suitable for delivering the assembly into a body passageway.

Abstract: Described are medical devices useful for applying a bolster material to a surgical fastening device such as a stapler, and related methods of manufacture and use. The devices include an applicator element for receipt between arms of the stapler, and a bolster material, desirably a remodelable extracellular matrix material, coupled to the applicator element. In certain embodiments, the bolster material is held by the applicator element, for example having at least a portion looped around or received through or over a portion of the applicator element. Also described are unique implantable materials including coatings of dried, reversible adhesive.

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: 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: Described are medical devices useful for applying a bolster material to a surgical fastening device such as a stapler, and related methods of manufacture and use. The devices include an applicator element for receipt between arms of the stapler, and a bolster material, desirably a remodelable extracellular matrix material, coupled to the applicator element. In certain embodiments, the bolster material is held by the applicator element, for example having at least a portion looped around or received through or over a portion of the applicator element. Also described are unique implantable materials including coatings of dried, reversible adhesive.