Abstract: A tissue modification apparatus includes a first and a second guide, a first and a second set of mounts, and a first and a second actuator. The first guide defines a first axis, and the second guide defines a second axis intersecting the first axis. The mounts of the first set of mounts are movable relative to one another along the first axis, and the mounts of the second set of mounts are movable relative to one another along the second axis. The first actuator and the second actuator are each settable to a stress load, with the first actuator and the second actuator movable, respectively, along the first axis and the second axis to transmit each respective stress load to a piece of tissue mechanically coupled to the first and second set of mounts.

Abstract: A medical device with an outer surface prepared to reduce crystalline growth or surface fowling thereon is provided. The device includes an elongate member that extends between a distal end and a proximal end, and a lumen defined through at least a central portion of the member. The member is defined from a wire that is coiled to define the lumen therethrough, the coils of the wire are configured such that a plurality of the neighboring coils define a small space therebetween. The coiled wire includes a central metallic core that extends along the entire length of the wire defining the member and a polymeric jacket is wrapped around the core, wherein the polymeric jacket is configured to retain an electric charge disposed therethrough.

Abstract: The invention provides methods, compositions, and devices for promoting adhesion or migration of endothelial cell.

Abstract: The present invention aims to provide a surface modification method for a rubber vulcanizate or a thermoplastic elastomer, which can impart various functions such as sliding properties and biocompatibility according to its use. The present invention relates to a surface modification method for modifying a rubber vulcanizate or a thermoplastic elastomer as an object to be modified, the method including: Step 1 of forming polymerization initiation points on a surface of the object to be modified; Step 2 of radical polymerizing monomers starting from the polymerization initiation points to grow polymer chains on the surface of the object to be modified; and Step 3 of functionalizing the polymer chains.

Abstract: An intravascular cuff acts as a lining between a native vessel and an intravascular prosthetic device. During deployment, the ends of the cuff curl back upon themselves and are capable of trapping native tissue, such as valve leaflet tissue, between the ends. The cuff creates a seal between the vessel and the prosthetic, thereby preventing leakage around the prosthetic. The cuff also traps any embolic material dislodged from the vessel during expansion of the prosthetic.

Abstract: Embodiments of the present invention relate to devices and methods for detecting opsonophagocytotic antibodies using detection particles having product-specific detection reagents and having a characteristic spectral feature. Detection substrates, include microwells. Phagocytic cells are grown in the microwells, and a sample of serum or other bodily fluid from a patient is introduced into the wells, along with a set of detection particles, each set having an antigen recognized by opsonophagocytotic antibodies. The detection particles bind to the antibodies present in the sample and the phagocytic cells then take up the detection particles, labeling the phagocytic cells. The cells are then visualized via image analysis, thereby detecting the presence of, and the types of the opsonophagocytotic antibodies in the sample.

Abstract: Methods and devices are disclosed for supporting and holding open a tubular structure in the body of an animal or human. In one form, the device is a manually adjustable variable outside diameter stent that can be repositioned or removed. The stent includes an elastic tubular body and an adjustment mechanism for the moving two ends of the body toward or away from each other. The elastic tubular body comprises a braiding of two groups of spaced apart helically wound elastic strands. The adjustment mechanism includes a bracket, a tension adjustor, and a tensioning wire attached to the bracket and the tension adjuster. The bracket and the tension adjuster are attached to one or more of the elastic strands of the two groups. Using the adjustment mechanism, the distance between the bracket and the tension adjustor can be decreased causing the outside diameter of the body to increase, or vice versa.

Abstract: A tissue modification apparatus includes a first and a second guide, a first and a second set of mounts, and a first and a second actuator. The first guide defines a first axis, and the second guide defines a second axis intersecting the first axis. The mounts of the first set of mounts are movable relative to one another along the first axis, and the mounts of the second set of mounts are movable relative to one another along the second axis. The first actuator and the second actuator are each settable to a stress load, with the first actuator and the second actuator movable, respectively, along the first axis and the second axis to transmit each respective stress load to a piece of tissue mechanically coupled to the first and second set of mounts.

Abstract: A device and a method for preparing adipose tissue for transplantation from lobular fat extracted, for instance by liposuction, the fat including a fluid component that have an oily component, a blood component and/or sterile solutions, and a solid component including cell fragments, cells and one or more cell macroagglomerates of heterogeneous size, wherein the device includes at least one washing and separating container having a washing chamber, the container has an inlet and an outlet for the liposuctioned material to enter the washing chamber through the inlet and for at least part of the material to exit the washing chamber through the outlet, the washing chamber including stirring means for forming an emulsion of fluid components.

Abstract: A fabric cutting system and/or method can include a mandrel having a body and first and second legs, a centered chuck, and an offset chuck, each chuck configured to receive either one of the legs or body to rotatingly support the mandrel between the chucks. When one of the legs is inserted into the centered chuck and the mandrel body is inserted into the offset chuck, the mandrel can be rotated and the fabric mounted on the mandrel can be cut about the leg at a location beyond the end of the other leg. One of the legs can include a leg extension removable from a leg base that when removed allows the other leg to be cut beyond the end of the leg base. The fabric can be cut with a cutting laser, which may be a multi-axis laser, and/or have low power.

Abstract: A system for visualizing an anatomical target includes a scope (102) for internal imaging having a field of view less than a region to be imaged. A planning module (104) is configured to receive video from the scope such that field of view images of the scope are stitched together to generate a composite image of the region to be imaged. An image guidance module (016) is configured to move the scope along the anatomical target during a procedure such that an image generated in the field of view of the scope is displayed as live video overlaid on a field of the composite image.

Abstract: A contoured biological tissue for a bioprostheses, such as a cardiac/vascular patch or a bioprosthetic heart valve, and methods of contouring the tissue, are described. A predetermined pattern is provided on the tissue, comprising a plurality of ridges or depressions that are configured to facilitate cellular migration in a first direction and discourage cellular migration in a second direction. The biological tissue can be used in connection with a bioprosthetic heart valve comprising a biological tissue leaflet structure coupled to a supporting frame.

Abstract: Devices, systems, and methods for determining isometric and isotonic activity of luminal organs. In an exemplary method for detecting a luminal organ response to mechanical stimulation of the present disclosure, the method comprises the steps of maintaining a luminal organ at a first internal pressure, increasing the first internal pressure of the luminal organ, and measuring a first organ parameter change in response to the increase in internal pressure.

Abstract: An endoscopic harvesting device removes a vessel from a body. The vessel has an anterior side closest to the skin. A sheath extends in a longitudinal direction with a dissector tip for advancing along the vessel substantially along the anterior side to create a flanking tunnel spaced away from the vessel. A ring-shaped blade is mounted to the sheath and is disposed in a plane substantially perpendicular to the longitudinal direction and proximal of the dissector tip. The blade forms a lateral loop to encircle the vessel from the flanking tunnel and to make a vasiform cut including a pedicle around the vessel as the sheath advances.

Abstract: Disclosed is the use of serous tissue, such as pericardium, as a component of intracorporeal implants. Particularly, disclosed is a jacketed stent assembly comprising an expandable stent provided with a jacket of processed serous tissue which, in some embodiments, is impregnated with a therapeutic or diagnostic agent. In a preferred embodiment, the jacket of the expandable stent is formed of pericardial tissue, preferably bovine or porcine pericardial tissue.

Abstract: A tissue illumination system and a method for harvesting a section of a blood vessel from a patient's body for further use. The tissue illumination system includes a light catheter inserted into a lumen of the blood vessel section to illuminate the vessel section and vessel side branches with an intensity which is visible to the physician from an exterior of the vessel section and also includes a viewing element insertable into the lumen and capable of viewing the illuminated vessel section. The tissue illumination system also includes at least one tool insertable into the lumen and used to harvest the vessel section.

Abstract: A vessel harvesting system that is suitable for harvesting target vessels such as the saphenous vein or radial artery for cardiac artery bypass graft surgery. The system includes a vessel harvesting tool with an elongated cannula and a plurality of surgical instruments therein for separating the target vessels from the surrounding tissue and side branches. The harvesting tool includes a modular handle unit with a base attached to the elongated cannula and a sled that can adapt the base to various types of vessel severing/securing tools, such as tissue welders, bipolar scissors, and bipolar bisectors. The handle unit may be relatively rigid and integrated with the various tool movement controls to facilitate one-handed operation by a user. A severing/securing tool rotation mechanism may be incorporated within the handle and operated by a thumbwheel or other such mechanism. The vessel harvesting system may also provide distal CO2 insufflation for enhanced maintenance of the operating cavity.

Abstract: Blood vessel preservation technology is disclosed wherein harvested blood vessels are attached to stationary attachment fixtures at one end, and to a non-stationary (freely extending) fixture at the other end. The vessel and fixtures are placed within a container. Thereafter, a stream of pulsatile blood is directed through the fixtures and the lumen of the vessel causing the vessel to assume full natural length and aligning the vessel with the container. The pulsatile blood then completely bathes the outside surface of the vessel before being re-circulated. The methods disclosed include those wherein the patient's own circulatory system is part of the circulatory path flowing through the vessel and methods in which the circulatory path is outside and apart from the patient. A pulsatile pump, blood heater and pressure regulator may all be utilized in preferred embodiments of the disclosed methods and devices.

Abstract: Apparatus, systems, and methods for endoscopic dissection of blood vessels and control over cavity pressure within an endoscopic procedure are described herein. Apparatus, systems, and methods for harvesting of blood vessels are also described herein.

Abstract: Apparatus for marking a blood vessel for use as a bypass graft in a patient includes a preparation plate for supporting an isolated blood vessel that is in a state for anastomosing to the patient. A stencil plate is configured for overlying the blood vessel and preparation plate, wherein the stencil plate has an opening adapted to expose a portion of the blood vessel to a dye applied through the opening. The stencil plate around the opening is adapted to shield the blood vessel from the dye. A dye applicator is configured to direct a metered amount of the dye through the opening and onto the exposed portion of the blood vessel, preferably as a mist. Preferably, the opening is a lineal slot for creating a guide line extending longitudinally along an outer wall of the blood vessel.

Abstract: Methods for the conditioning of bioprosthetic material employ bovine pericardial membrane. A laser directed at the fibrous surface of the membrane and moved relative thereto reduces the thickness of the membrane to a specific uniform thickness and smoothes the surface. The wavelength, power and pulse rate of the laser are selected which will smooth the fibrous surface as well as ablate the surface to the appropriate thickness. Alternatively, a dermatome is used to remove a layer of material from the fibrous surface of the membrane. Thinning may also employ compression. Stepwise compression with cross-linking to stabilize the membrane is used to avoid damaging the membrane through inelastic compression. Rather, the membrane is bound in the elastic compressed state through addition cross-linking. The foregoing several thinning techniques may be employed together to achieve strong thin membranes.

Abstract: Articles made of a porous material having a fibrillar microstructure of bent fibrils and provided with a fracturable coating whereby the physical size of the article may be changed by the application of force to the article in a direction substantially parallel to a direction of orientation of the fibrils. The application of a tensile force to such an article in a direction substantially parallel to orientation of the bent fibrils results in fracturing of the fracturable material and straightening of the bent fibrils. Methods of making such articles are also described. The articles may include implantable articles such as vascular grafts and stent-grafts; such devices may, for example, be forcibly increased in diameter or in length wherein the force results in fracturing of the coating. One such coated material is porous expanded polytetrafluoroethylene provided with a coating of fluorinated ethylene propylene.

Abstract: A tissue modification apparatus includes a first and a second guide, a first and a second set of mounts, and a first and a second actuator. The first guide defines a first axis, and the second guide defines a second axis intersecting the first axis. The mounts of the first set of mounts are movable relative to one another along the first axis, and the mounts of the second set of mounts are movable relative to one another along the second axis. The first actuator and the second actuator are each settable to a stress load, with the first actuator and the second actuator movable, respectively, along the first axis and the second axis to transmit each respective stress load to a piece of tissue mechanically coupled to the first and second set of mounts.

Abstract: A method for making a radially expandable stent-graft, including positioning a radially expandable stent member concentrically over a first polymeric member, locating a second polymeric member concentrically over the stent member and first polymeric member, and joining the first polymeric member to the second polymeric member through interstices of the stent member at selective locations to form slip planes between the first and second polymeric members. The slip planes accommodate movement of the stent between the polymeric members to facilitate compression of the stent graft to a low profile.

Abstract: Compositions and methods are provided for modulating the growth, development and repair of bone, cartilage or other connective tissue. Devices and stimulus waveforms are provided to differentially modulate the behavior of osteoblasts, chondrocytes and other connective tissue cells to promote proliferation, differentiation, matrix formation or mineralization for in vitro or in vivo applications. Continuous-mode and pulse-burst-mode stimulation of cells with charge-balanced signals may be used. Bone, cartilage and other connective tissue growth is stimulated in part by nitric oxide release through electrical stimulation and may be modulated through co-administration of NO donors and NO synthase inhibitors. Bone, cartilage and other connective tissue growth is stimulated in part by release of BMP-2 and BMP-7 in response to electrical stimulation to promote differentiation of cells.

Abstract: A tissue illumination system and a method for harvesting a section of a blood vessel from a patient's body for further use. The tissue illumination system includes a light catheter inserted into a lumen of the blood vessel section to illuminate the vessel section and vessel side branches with an intensity which is visible to the physician from an exterior of the vessel section and also includes a viewing element insertable into the lumen and capable of viewing the illuminated vessel section. The tissue illumination system also includes at least one tool insertable into the lumen and used to harvest the vessel section.

Abstract: A platform for creating an artificial blood brain barrier including a functional, perfused artificial vessel lined with endothelial cells embedded in a physiologically relevant three-dimensional extracellular matrix is described.

Abstract: A method for constructing a vascular connector configured to bypass an occluded vessel which comprises a primary graft stem and a venous outflow stem. In general, the primary graft stem accepts a blood flow from an occluded vessel to bypass the occlusion. The venous outflow stem may extend from a wall of the primary graft stem and divert a portion of the blood flow to a native vein or other vessel of the vascular system. This configuration is beneficial in ensuring adequate blood flow at the vascular connector to inhibit the formation of clots and to extend the patency of the vascular connector.

Abstract: A tubular woven implantable graft having a tapered section is provided. The graft comprises a first diameter and a second diameter and has a generally constant number of warp yarns per inch adjacent both the first diameter and the second diameter. A method for producing an implantable woven graft is also provided. The method includes weaving a first section having a first diameter and a tapered diameter tapering from the first diameter to a second diameter. During weaving of the tapered section a number of warp yarns are dropped from the weave and compressive forces are applied to the fabric to narrow the width of the fabric.

Abstract: An endothelial scaffold may used to form a graft with an endothelial lining or endothelium. The scaffold allows a natural vessel or other endothelial lumen to line a channel of the scaffold to provide an endothelial layer which enhances blood flow through the channel. The channel may have a narrowed section to provide a stenosis. One or more conduits may extend from an exterior portion of the scaffold to an inner surface of the channel. Air may be withdrawn from between the natural vessel and inner surface of the channel via the conduits to cause the endothelial lumen to conform to the inner surface of the channel. A valve may be used to prevent air from reentering the conduits. The graft, including the endothelial lumen, may be implanted into a patient.

Abstract: The invention provides method of fabricating a scaffold comprising a fluidic network, including the steps of: (a) generating an initial vascular layer for enclosing the chamber and providing fluid to the cells, the initial vascular layer having a network of channels for fluid; (b) translating the initial vascular layer into a model for fluid dynamics analysis; (c) analyzing the initial vascular layer based on desired parameters selected from the group consisting of a characteristic of a specific fluid, an input pressure, an output pressure, an overall flow rate and combinations thereof to determine sheer stress and velocity within the network of channels; (d) measuring the sheer stress and the velocity and comparing the obtained values to predetermined values; (e) determining if either of the shear stress or the velocity are greater than or less than the predetermined values, and (f) optionally modifying the initial vascular layer and repeating steps (b)-(e).

Abstract: A method for perfusion of a porous implant which achieves efficient interpenetration of desired factors into and removal of undesirable factors from the pores of the implant, cleaning of the implant, efficient passivation of the implant, and the implant produced by such treatment. A system wherein the rate of pressure cycling, the fact of pressure cycling, and the amplitude of pressure cycling, results in highly cleaned tissues and other implants. Goals include between about a one to twelve log reduction in bacterial contamination, between about a one to fifteen log reduction in enveloped virus contamination, up to about a five log reduction in non-enveloped virus contamination, between about a two to tenfold reduction in endotoxin, maintenance of implant or graft biologic and biomechanical properties, absence of tissue toxicity due to cleaning solutions used, and reduced implant antigenicity.

Abstract: A system for applying a fiber matrix on a tubular member is provided. A mandrel, configured for atraumatic placement within the tubular member, is included. Methods for atraumatic placement of a mandrel into a tubular member are also provided.

Abstract: A method of forming an implantable medical device includes providing an implantable microstimulator. The microstimulator includes a body with a first end and an opposing second end. The microstimulator further includes internal circuitry that is disposed in the body and that provides stimulation energy. The microstimulator additionally includes a first microstimulator electrode that is electrically coupled to the internal circuitry and that is disposed along the first end portion of the body. The method further includes providing a first lead assembly that includes an insulated conductor with at least one first remote electrode disposed at a distal end of the insulated conductor, and a first connector disposed at a proximal end of the insulated conductor. The first connector is disposed over the first microstimulator electrode to completely cover the first microstimulator electrode. The first connector also electrically couples the insulated conductor to the first microstimulator electrode.

Abstract: A cartridge device is provided for applying a fiber matrix to a tubular member such as a saphenous vein graft. The cartridge includes a housing, a tubular member holder, a rotational drive, and a polymer delivery assembly. The housing defines a chamber which surrounds the tubular member holder. The rotational drive rotates the tubular member during the fiber application process.

Abstract: An implantable prosthesis can comprise a strut having a lumen, radiopaque particles within the lumen, and a polymer binder. The polymer binder retains the radiopaque particles within the lumen. The strut may have side holes through which a therapeutic agent may pass and through which the radiopaque particles are incapable of passing. The polymer binder may be absent or optional. The radiopaque particles can have sizes that prevent them from escaping out of the lumen through the side holes. The radiopaque particles placed within the lumen can improve visualization of the prosthesis during an implantation procedure.

Abstract: The invention relates to an assembly comprising on the one hand a graft vessel and on the other hand an anastomosis has connector. The connector comprises a ring and two pins. Each pin has a free end and a fixed end connected to the ring. The pins extend, viewed from the fixed end towards the free end, next to and set apart from each other. Each pin has an overlap section where the pin, viewed in axial direction of the ring, overlaps the plane bounded by the outer contour of the ring. The axial axis of the ring extends transverse to the wall of the graft vessel. The connector is attached to the graft vessel and the ring lies, with its full circumference, against the wall of the graft vessel. The invention further relates to a method of providing such an assembly and a method of attaching such an assembly to a recipient vessel.

Abstract: A fabric cutting system and/or method can include a mandrel having a body and first and second legs, a centered chuck, and an offset chuck, each chuck configured to receive either one of the legs or body to rotatingly support the mandrel between the chucks. When one of the legs is inserted into the centered chuck and the mandrel body is inserted into the offset chuck, the mandrel can be rotated and the fabric mounted on the mandrel can be cut about the leg at a location beyond the end of the other leg. One of the legs can include a leg extension removable from a leg base that when removed allows the other leg to be cut beyond the end of the leg base. The fabric can be cut with a cutting laser, which may be a multi-axis laser, and/or have low power.

Abstract: An apparatus is provided for applying a restrictive fiber matrix to a conduit to create a graft device. A rotating assembly rotates the conduit, and a polymer delivery assembly delivers the restrictive fiber matrix. A controller controls the polymer deliver assembly and the rotating assembly.

Abstract: A system and method for tissue repair employing a continuous loop of suture attached to a free floating needle. The free floating needle is not swaged on the suture so that, after passing the suture loop construct through the tissue to be treated, the needle may be recentered if the suture strands are uneven.

Abstract: Compositions comprising aortic material and methods for using harvested blood vessels (e.g., arteries or veins e.g., aortae) graft procedures, e.g., for restoring and repairing luminal structures (e.g., in the aerodigestive tract, such as the larynx, pharynx, and esophagus); as tissue fillers (e.g., injectable morselized blood vessel tissues, for use in cosmetic applications and functional sphincter enhancement); and as biological structural supports (e.g., intact portions of aortae, for use in repairing abdominal wounds, anastomoses, bony repairs, and the heart).

Abstract: A fabric cutting system and/or method can include a mandrel having a body and first and second legs, a centered chuck, and an offset chuck, each chuck configured to receive either one of the legs or body to rotatingly support the mandrel between the chucks. When one of the legs is inserted into the centered chuck and the mandrel body is inserted into the offset chuck, the mandrel can be rotated and the fabric mounted on the mandrel can be cut about the leg at a location beyond the end of the other leg. One of the legs can include a leg extension removable from a leg base that when removed allows the other leg to be cut beyond the end of the leg base. The fabric can be cut with a cutting laser, which may be a multi-axis laser, and/or have low power.

Abstract: The present invention discloses a composite yarn comprising at least one wear-resistant polymeric fiber and at least one flexible polymeric fiber. The present invention also discloses a co-extruded filament comprising a polymeric inner core and a polymeric outer sheath. The polymeric inner core comprises a flexible polymeric material and the polymeric outer sheath comprises a wear-resistant polymeric material. The composite yarn and the co-extruded filament synergistically combine durability and flexibility, and thereby are particularly useful for the construction of graft materials. The present invention further discloses a reinforced fiber graft comprising wear-resistant beads and weaves of flexible polymeric fibers. In another aspect, the present invention discloses a process for assembling a graft device without suture knots by using the inventive co-extruded filament.

Abstract: Unitary surgical devices for tissue harvesting are disclosed. Such devices may include an elongated body extending between a proximal end and a distal end, and having one or more lumens extending through the elongated body and a tip disposed at the distal end of the elongated body. The harvesting device may further include a first gripping element disposed about the dissection tip and a second gripping element disposed about the dissection tip distally of the first gripping member. The second gripping member may be moveable with respect to the first gripping member for capturing a blood vessel between the first gripping member and the second gripping member. The blood vessel captured between first gripping member and the second gripping member may then be sealed and, subsequently, severed by a cauterizing element disposed between the first gripping member and the second gripping member.

Abstract: The invention is directed to methods for preparing artificial blood vessels by preconditioning a matrix seeded with endothelial cells to fluid flow conditions that mimic blood flow.

Abstract: Unitary surgical devices are disclosed. Such devices may include an elongated body extending between a proximal end and a distal end, and having one or more lumens extending through the elongated body and a tip disposed at the distal end of the elongated body. The harvesting device may further include a first gripping element disposed about the dissection tip and a second gripping element disposed about the dissection tip distally of the first gripping member. The second gripping member may be moveable with respect to the first gripping member for capturing a blood vessel between the first gripping member and the second gripping member. The blood vessel captured between first gripping member and the second gripping member may then be sealed and, subsequently, severed by a cauterizing element disposed between the first gripping member and the second gripping member.

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: Photochemical tissue boding methods for bonding neural tissues include the application of a photosensitizer to a tissue and/or tissue graft, followed by irradiation with electromagnetic energy to produce a tissue seal. The methods are useful for tissue adhesion, such as in wound closure, tissue grafting, skin grafting, musculoskeletal tissue repair, ligament or tendon repair, neural repair, blood vessel repair and corneal repair.

Abstract: Implantable medical grafts fabricated of metallic or pseudometallic films of biocompatible materials having a plurality of microperforations passing through the film in a pattern that imparts fabric-like qualities to the graft or permits the geometric deformation of the graft. The implantable graft is preferably fabricated by vacuum deposition of metallic and/or pseudometallic materials into either single or multi-layered structures with the plurality of microperforations either being formed during deposition or after deposition by selective removal of sections of the deposited film. The implantable medical grafts are suitable for use as endoluminal or surgical grafts and may be used as vascular grafts, stent-grafts, skin grafts, shunts, bone grafts, surgical patches, non-vascular conduits, valvular leaflets, filters, occlusion membranes, artificial sphincters, tendons and ligaments.

Abstract: A method for bonding a graft material to a support element employing a silane coupling agent, and a medical device obtainable by said method. A medical device including a graft material bound to a support element by a plurality of silane linkages is also described.