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: 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: Disclosed are products having animal tissue packed within the lumen of a device such as a needle cannula and being therein impregnated with a cryopreservation medium. The needle cannula or other device can be received in a capsule and/or other container, which in some forms can contain additional amounts of the cryopreservation medium occurring external of the lumen. Methods of use of the products are also described and can include ejecting the animal tissue from the lumen of device using pressurized liquid passed through the lumen, potentially to deliver the animal tissue directly into a patient. Methods of manufacture of the products are also described.

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: Various compositions of matter, methods of making compositions of matter, and methods of using compositions of matter, e.g. for inducing hemostasis, are disclosed. In some embodiments, a starting fibrin material is subjected to controlled hydrolysis, desirably base-catalyzed, to prepare a fibrin hydrolysate material with increased water sorption capacity. Such fibrin hydrolysate materials, alone or combined with one or more additional substances, can be used in the preparation of hemostasis promoting foams, powders or gels. In some embodiments, a starting dialdehyde starch material is subjected to controlled hydrolysis to prepare a dialdehyde starch hydrolysate material. Such dialdehyde starch hydrolysate materials, alone or combined with one or more additional substances, in some cases combined with a fibrin hydrolysate material, can be used in the preparation of hemostasis promoting foams, powders or gels.

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: A filamentous graft has an elongate filament body including one or more intact segments of a decellularized collagenous tissue membrane. The graft can have a length of at least about 20 cm. The graft can be cut from a laminate of two or more decellularized collagenous tissue membranes. The graft can have a generally rectangular cross-section and can have substantially uniform dimensions and tensile strength along at least a substantial portion of its length. Methods for preparing and using filamentous grafts are also described.

Abstract: The present invention provides, in certain aspects, medical devices deliverable into passageways and other open spaces in the body. In one embodiment, the invention provides a fistula plug for delivery into a fistula tract. This fistula plug includes an elongate plug body, and a removable core material that is received in the plug body and effective to increase the column strength of the plug body. The plug body 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. The present invention also provides apparatuses and methods for delivering these and other medical devices into the body. One such apparatus includes a fistula plug having a plug body, and a removable delivery device received in the plug body, wherein the delivery device is effective to deliver the plug body into a fistula tract when advanced therethrough.

Abstract: Devices, kits, and methods useful in the treatment of Obstructive Sleep Apnea (OSA) are described. Example devices include a jig, a first needle, a second needle, and a third needle. An example jig comprises a drill guide and a tongue depressor. A first needle comprises an elongate shaft that defines a bend and a curve. A second needle comprises an elongate shaft that defines a curve. A third needle comprises an elongate shaft that defines a curve.

Abstract: There are disclosed various dispensing mechanisms for dispensing filamentary material through a catheter into a treatment site of a patient, for example into an aneurysm sack in a patient's vessel. In one embodiment the assembly includes a conical material carrier which is substantially aligned with the dispensing direction, thereby avoiding the need to have a rotating carrier. Another embodiment has a carrier which is at least partially cylindrical. The carrier provides for efficient dispensation of filamentary material at substantial dispensing speeds.

Abstract: Certain aspects of this disclosure relate to uniquely constructed medical implants that incorporate an electronic or other medical device. Some illustrative pocket-like implants provide an interior space for receipt of an electronic medical device, and are implantable in a patient with the electronic medical device positioned in the interior space. In one form, an inventive construct includes a remodelable material component that is effective upon implantation to promote cellular invasion and ingrowth into the remodelable material so that it becomes replaced by new patient tissue and so that the electronic medical device becomes surrounded by a new pocket structure comprised of newly generated, functional patient tissue. The electronic medical device will be a pacing device or other cardiac rhythm management (CRM) device in select embodiments.

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 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: The present embodiments generally relate to containers having utility in the lypohilization of fluids to form powers and to methods of using such containers. One embodiment provides a side-ported syringe. Another embodiment provides a two-part container.

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: 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: There are disclosed various dispensing mechanisms for dispensing filamentary material (24) through a catheter (12) into a treatment site of a patient, for example into an aneurysm sack (20) in a patient's vessel (22). In one embodiment the assembly (100) includes a conical material carrier (150) which is substantially aligned with the dispensing direction, thereby avoiding the need to have a rotating carrier. Another embodiment has a carrier (340) which is at least partially cylindrical. The carrier (150, 340) provides for efficient dispensation of filamentary material at substantial dispensing speeds.

Abstract: Described are medical products, systems, and methods for treating fistulae having a primary opening, such as in the alimentary canal. Certain methods of the invention include providing an implantable material including a compliant sheet form biocompatible material, and forcing this sheet form biocompatible material into the primary opening so as to deform the sheet form biocompatible material to conform to and block the primary opening. The biocompatible material preferably comprises a remodelable material, for example, a remodelable extracellular matrix material such as submucosa.

Abstract: Described are medical graft materials and devices which can be usefully modified with liquid additives such as cell suspensions, bioactive agents, or combinations of these. The medical graft materials and devices can have a first outer surface and a second outer surface and can define an internal chamber between the first outer surface and the second outer surface. The medical graft materials and devices can also have at least one region of the graft material interrupting the chamber and surrounded by the chamber. Also described are methods for making and using these medical graft materials and devices.

Abstract: Disclosed are electrostimulative grafts that include at least one galvanic couple with an anode spaced from a cathode. The anode and cathode can be made from biodegradable metals. The graft can include a porous graft matrix material receptive to tissue ingrowth that occurs between the anode and cathode. The electrostimulation provided by the galvanic couple after implantation of the graft can impact the development of tissue within and/or around the porous graft matrix material. Also disclosed are methods for making electrostimulative grafts and for galvanically electrostimulating tissue growth in a porous graft matrix material.