Abstract: Embodiments of the present invention provide medical devices and methods for treating a target site within the body, such as for treating vascular abnormalities. For example, one embodiment provides an occlusion device including an occlusive material having proximal and distal ends and a central axis extending therebetween. The occlusive material has a preset, overlapping configuration including at least three inverted overlapping layers folded over one another, wherein the at least three inverted overlapping layers are aligned with the central axis within about 45 degrees or less and are configured to be separated and disposed within a catheter in a non-overlapping configuration and return to the preset, overlapping configuration when deployed from the catheter.

Abstract: Forming a proximal anastomosis on an aortic wall includes method and instrumentation and apparatus for forming an aortic puncture and inserting into the vessel through the puncture a fluid-impervious sealing element with a protruding retainer. An anastomosis of a graft vessel over the puncture is partially completed with the retainer of the sealing element protruding through the partial anastomosis. The retainer facilitates removal of the sealing element from the partial anastomosis prior to completion of the procedure.

Abstract: A circumcision instrument used to perform a circumcision procedure. The circumcision instrument generally includes a housing having a chamber configured to receive a glans penis and an outer surface configured to be enveloped by a prepuce. An annular groove is disposed in the outer surface. A conductive ring is located at the bottom of the annular groove. A clamp has a pair of jaws that are moveable from an open position to a closed position surrounding the prepuce. In the closed position the jaws are disposed at least partially within the annular groove. A conductive inner cutting edge is located on the jaws. The clamp and the housing are connectable to a source of diathermy energy such that diathermy energy can flow between the inner cutting edge and the conductive ring, thereby cutting the prepuce.

Abstract: A device for delivering a prosthesis to a damaged body vessel includes first and second generally elongated members joined to each other along a length thereof. A distal end of each of the elongated members is insertable through an outer layer of skin to access the vessel. The distal ends are cooperatively maneuverable between a closed position for retaining the prosthesis during delivery to the vessel and an open position for releasing the prosthesis upon delivery. Each of the elongated members has a prosthesis retaining member disposed at a distal tip. The retaining members are configured for retaining the prosthesis in a constricted condition when the distal ends are in the closed condition for delivery of the prosthesis to the damaged vessel.

Abstract: The present invention provides for an implantable medical device comprising a hybrid composite material including a first biological component such as an acellular tissue matrix and a second non-biological component for strengthening the device after implantation.

Abstract: An endoscopic surgical rotary capture instrument is used in minimally invasive laparoscopic surgery for closing a gastric band having a buckle end a free end. The rotary capture instrument includes a pusher end that has a stationary jaw and a movable jaw. The movable jaw is actuated by rotary motion of an inner shaft. The jaws are used to gasp securely and push the tube end of the gastric band after it has been threaded through the buckle end of the band. A hook instrument is used to hold the buckle end securely while the rotary capture instrument is used to push the free end of the gastric band.

Abstract: Methods and devices are provided for anastomosing tissue in the body. In one exemplary embodiment, an anastomotic device is provided having an elongate tubular body that is disposable through a body lumen and that includes proximal and distal portions. The proximal and distal portions can each include a plurality of asymmetrical s-shaped slits and can each be adapted to expand upon rotation to form proximal and distal wings. The proximal and distal wings can extend toward one another to engage tissue therebetween and thereby form a passageway through the tissue.

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: A system for sealing a hole in a body, comprising a generally cylindrical mesh formed from a plurality of helical strands which is inserted into the hole, with at least one end of the cylindrical mesh being moved least partially through an interior portion of the cylindrical shaped mesh such that the mesh expands radially outwards against sides of the hole.

Abstract: A sheath is configured for elongation from a first length to a second, longer length and a retention member retains the sheath at the first length. A portion of the retention member is removed or disengaged, the sheath is released and expands in situ to the second longer length. A method for releasing the retention member is also disclosed.

Abstract: A filter device assembly and a method of using such a device to capture and remove embolic material from a body lumen or blood vessel are provided. The filter device assembly generally includes a structure having a collapsed state and an expanded state with first, second, and optionally N additional filter members circumferentially attached thereto. Each filter member forms an annulus chamber with the first filter member having porosity P1; the second filter member circumferentially having porosity P2; and the N additional filter members each having porosity [P3 . . . P(2+N)]. The magnitude of the porosity for the first, second, and N additional filter members follows the relationship P1>[P3>. . . >P(2+N)]>P2. The first, second, and N additional filter portions are configured in the expanded state to allow blood to flow there through and to capture emboli in the annulus chambers.

Abstract: The present invention includes a method and apparatus for adhering tissue to one another. In an embodiment of the present invention the two tissues to be joined, for example the lower esophagus and the fundus of the stomach, are first placed adjacent to one another. Next a first restraint is placed near the outside surface of one of the tissues and a second restraint is placed near the outside surface of the other tissue. An irritant is then placed between the two adjacent tissues. The restraints, and consequently the tissue surfaces, are then drawn together. As the touching irritated tissue surfaces heal they will become bonded to one another and their need for the mechanical fastening of the restraints, to secure them together, will be diminished.

Abstract: Devices, systems and methods for passing a suture. In general, described herein are suturing devices, such as suture passers, as well as methods of suturing tissue. These suture passing devices may include dual deployment suture passers in which a first distal jaw member is moveable at an angle with respect to the longitudinal axis of the elongate body of the device and the second distal jaw member is retractable proximally to the distal end region of the elongate body and/or the first jaw member. Also described herein are suture passers in which the tissue penetrator passing the suture travels in an approximately sigmoidal pathway, with the distal end of the tissue penetrator extending distally from one jaw of the device.

Abstract: Embodiments of the present invention provide medical devices and methods for treating a target site within the body, such as for treating vascular abnormalities. For example, one embodiment provides a stent graft including an occlusive material having a preset, overlapping configuration comprising at least three inverted overlapping layers that are folded over one another. The at least three inverted overlapping layers are configured to be separated and disposed within a catheter in a non-overlapping configuration and return to the preset, overlapping configuration when deployed from the catheter.

Abstract: A hernia patch supporting tissue in-growth conforms to a tissue wall upon surgical installation and fixation within a patient. The hernia patch can include a base and positioning straps. The base is formed of two layers that are affixed to each other around the perimeter of the patch, for example by stitching. A stabilizing washer is provided between the two layers, and the stitch is provided peripherally around the stabilizing washer, keeping the washer free-floating between the layers. The base, positioning straps, and stabilizing washer are formed of a structure that does not separate the layers of the implant or form a space in the form of a pocket, and promotes more uniform and confluent tissue incorporation or in-growth after implantation. The hernia patch may further include a hydrolysable bioabsorbable cross-linked coating of a fatty acid based material, such as an omega-3 fatty acid based material.

Abstract: A system for mixing or reconstituting agents including engageable syringe barrels, one of which having a male engagement region and the other a female engagement region. Each of the male and female engagement regions is provided with a screen. The screens are closely spaced from one another when the first and second syringe barrels are engaged with one another. The screens may take the form of a mesh, a plurality of protuberances, or cantilevered wedges having tapering thicknesses.

Abstract: A tissue prosthesis 100 comprises an envelope 38 of a biologically inert, elastically deformable material capable of being expanded to conform to an interior surface of a cavity 36 formed at a site 10 in a patient's body. A filler material 60 is received in a fluent state in the envelope 38. The filler material 60 is of the same class of material as the envelope 38 to form, when cured, together with the envelope 38, a unified structure.

Abstract: The present invention is a device for pre-surgical treatment of cleft lip and cleft palate. The device is extraoral thus reducing the risk associated with existing devices and technologies that are intraoral, such as, for example utilizing a Nasoalveolar Molding (NAM) appliance. The adjustable extraoral nasal molding appliance of the present invention consists of an adjustable and securable head fastener, a front connector with a forehead rest pad, a rod support having an aperture through which a rod is slidably connected, a fastener for locking a rod in a set position, the rod, a spring and at least one nasal bulb. Different shaped springs can be attached for treating unilateral as well as bilateral cleft lip and palate patients. Different nasal bulbs can be attached for treating unilateral as well as bilateral cleft lip and palate patients.

Abstract: In general, in an aspect, an annulus of a heart valve is caused to dilate to a predetermined configuration by pushing a delivery tool distally through the annulus from one heart chamber to another heart chamber. A valve support is attached to the delivery tool. The valve support has a plurality of barbs or hooks attached thereon. While the annulus is dilated, the valve support is attached to tissue at locations along the annulus by attaching the barbs or hooks to the tissue. After attachment, the support is caused to contract.

Abstract: Drug eluting vascular closure devices and methods for closing a blood vessel puncture site disposed at a distal end of a tissue tract are described. The devices and methods rely on a combination of the body's own natural mechanism to achieve hemostasis with chemical and/or biological agents to accelerate the hemostatic process. One method includes the steps of introducing a closure device through the tissue tract and deploying an expansible member at a distal end of the device within the blood vessel to occlude the puncture site. A chemical and/or biological sealing member disposed proximal the expansible member is then displaced so as to expose a chemical and/or biological region or release region of the device. At least one chemical and/or biological agent is thereafter released from the device and into the tissue tract to accelerate the occlusion process in the tract.