Abstract: An bioelastomeric intraluminal stent comprising fibrin and elastin is capable of providing a treatment of restenosis.

Abstract: Methods for coating a prosthetic surface with anti-thrombogenic, or anti-coagulant, proteins are disclosed. The methods involve contacting a surface of a prosthetic material with a composition containing multimers of fibrin degradation products. These multimers, preferably D-dimers, have cross-linked D-domains. The methods of the invention are useful for providing an anti-thrombogenic coating on prosthetic implants which are exposed to a patient's blood after implantation, for example vascular grafts and artificial heart valves.

Abstract: An intraluminal stenting graft for implantation in a blood vessel and a method for making same wherein the intraluminal stenting graft includes a collapsible tube member having a first end and a second end. An outer layer and an inner layer extend between the ends. The outer layer is more flexible than the inner layer. The outer layer is joined to the inner layer to form a plurality of cylinders longitudinally extending between the first end and the second end. The method of the present invention including the steps of: placing a first layer of material on a substantially flat surface; placing a second layer of material on a shaped surface; maintaining the second layer on said shaped surface by use of reverse pressure; moving the second layer to the first layer; joining the second layer to the first layer to form a plurality of longitudinally extending cylinders; and shaping the first and second layers to form a tube member.

Abstract: An intraluminal stent comprising fibrin and an elutable drug is capable of providing a treatment of restenosis.

Abstract: The present invention is directed to a sheath for use with vascular prostheses derived from donor blood vessels, particularly mammalian blood vessels. A vascular prosthesis of the present invention employs an external sheath around a donor blood vessel. The sheath prevents access to the donor vessel wall by host cells originating from perigraft tissue. While resistant to host cell ingrowth, the external sheath is permeable to the flux of macromolecules across its thickness. The exclusion of host cells by the external sheath and the bi-directional flow of macromolecules through the external sheath assists in maintaining the original function of the underlying donor vascular tissue of the prosthesis.

Abstract: An intraluminal stent comprising fibrin and heparin is capable of providing a treatment of restenosis.

Abstract: A radially self-expanding implantable intraluminal device formed from a hollow tubular braid. The intraluminal device may be used in a variety of medical procedures which require a passageway to be maintained in an open position or which require reinforcement, support or a bypass conduit such as in blood vessels weakened by disease. The intraluminal device is longitudinally expanded or radially collapsed for ease of insertion into a lumen and upon alignment within the lumen, the intraluminal device radially self-expands to come into intimate contact with the inner surface of the lumen.

Abstract: An intraluminal stent comprising fibrin and heparin is capable of providing a treatment of restenosis.

Abstract: A novel cell seeded hollow fiber bioreactor is described as a potential bioartificial kidney. Renal cells are seeded along a hollow fiber in a perfused bioreactor to reproduce the ultrafiltration function and transport function of the kidney. Maintenance of tissue specific function and ultrastructure suggest that this bioreactor provides an economical device for treating renal failure as well as studying renal tubululogenesis in vitro.

Abstract: An artificial blood vessel which has excellent long-term patency and can be used stably in a living body for a long time. The artificial blood vessel has improved durability under pulsation and can withstand puncturing. The artificial blood vessel is made of an elastomer containing a multiplicity of cells throughout the structure thereof and comprises a layer (A) containing closed cells having no communicability therebetween; and a layer (B) containing open cells having mutual communicability therebetween. The surface of the layer (B) which is contiguous to the inner surface of the layer (A) and the wall surfaces of the open cells are coated with a thin film of crosslinked protein of biological origin. The layer (A) may be incorporated with a knitted or woven fabric which is not degradable in a living body. The layer (B) may further contain a synthetic resin short fiber distributed throughout the layer.

Abstract: A tissue press for shaping or compressing a piece of tissue comprises first and second members movable relative to each other. Tissue removed from a human body is placed in the press. The press is operated to apply pressure against the human tissue. The human tissue is maintained in a viable living condition during operation of the press. Means are preferably provided for monitoring and controlling the amount of pressure applied to the piece of tissue, in order to maintain the tissue in a viable living condition. Means may also be provided for draining off fluid from compressed tissue, so that the tissue can be implanted in a compressed state and imbibe fluid from the host site. A retainer, which may be expandable, can be used to maintain the tissue graft in a compressed condition.

Abstract: An apparatus and method for culturing living endothelial cells is provided. The apparatus comprises a cell growth container, which in a preferred embodiment is a synthetic graft, heat crimped at both ends. The apparatus further comprises a rotation container that may contain the cell growth container and is attached to a rotation apparatus. The apparatus further comprises fixturing apparatus, which in a preferred embodiment is a pair of o-ring members, that enhances a separated condition of the cell growth container within the rotation container. The method of the present invention comprises providing a culture that includes living cells and a growth medium, introducing the culture into a cell growth container, heat crimping the cell growth container to substantially seal the cell growth container, and positioning fixturing apparatus upon the external surface of the cell growth container. This assembly is inserted into a rotation container, which is rotated by a rotation apparatus.

Abstract: A vascular prosthesis is disclosed which excels in expansibility and allows satisfactory attachment thereto of cells and tissues. This vascular prosthesis is obtained by air-jet entangling a mass of yarns containing in at least a part thereof an elastic bulked yarn in order to get an entangled yarn furnished with fine crimps formed in fiber thereof, and fabricating a tubular fabric of the entangled fiber by one treatment selected from among weaving, knitting, and braiding treatments.

Abstract: A method for surgical correction of vascular occlusions involving replacement of the affected portion of the vessel with a vascular autotransplant grown in the patient's tissues around the modelled preform from a magnetic alloy which speeds up killing, reduces the risk of thromboses, infection and rejection and forestalls the development of the destructive processes in the wall of the autotransplant.

Abstract: A resilient tubular graft is delivered into place within a body passage by elongating the graft to reduce its diameter and then directing the graft to the desired position while in the elongated condition. The graft is carried into position by a pair of elongate members mounted for longitudinal movement relative to one other. Flexible lines secure opposite ends of the graft to the respective elongate members whereby relative longitudinal movement of the members functions to elongate the graft and reduce its diameter. The lines extend around the graft to impart radial compression thereto simultaneously with elongation of the graft. Upon placement of the graft at the desired location within a body passage, the lines are released to permit the graft to expand into engagement with the passage. Barbs on the graft provide for secure engagement of the graft with a body passage.

Abstract: An implantable porous expanded polytetrafluoroethylene material having a microstructure of nodes interconnected by fibrils wherein a surface of the material has been modified by the removal of fibrils from the surface so that under magnification the surface has the appearance of freestanding node portions not interconnected by fibrils but rather having open valleys disposed between the freestanding node portions. Unmodified material beneath the surface maintains the original microstructure of nodes interconnected by fibrils. The modification is preferably done by exposing the surface to radio frequency gas plasma discharge with a reactive etching gas for a lengthy amount of time such as about ten minutes. The depth of fibril removal from the surface is substantially a function of the duration and amount of energy applied to the surface.

Abstract: Porous expanded polytetrafluoroethylene material having a microstructure of nodes interconnected by fibrils wherein a surface of the material has been modified to have increased hydrophobicity as indicated by having a water droplet roll-off angle of less than about 10 degrees in comparison to a typical roll-off angle of greater than about 12 degrees for the unmodified material. Under magnification, the surface morphology may be indistinguishable from that of the unmodified precursor material. The modification is preferably done by exposing the surface to radio frequency gas plasma discharge with a reactive etching gas for a lengthy amount of time such as about ten minutes. If surface etching is continued beyond a time adequate to produce the highly hydrophobic behavior, then the surface morphology includes the appearance of broken fibrils.

Abstract: A vascular graft fabricated of a polyester fiber, the surface of which is impregnated with biodegradable blood-compatible materials, characterized in that the surface of the said vascular graft comprises carboxylate groups and is impregnated with polysaccharides or their derivatives. The vascular graft is manufactured by treating the hydrophobic surface of a vascular graft fabricated of a polyester fiber to render it more hydrophilic and then impregnating the vascular graft with above polysaccharides or their derivatives by chelate bond with metal ions or physical adsorption in order to increase the adhesion properties and adding glycerin to the impregnated polysaccharides or their derivatives in order to increase the softness so that the impregnated substances may turn into the state of gel by blood at the time of use.

Abstract: A vascular graft fabric containing air jet textured yarns. The woven, knitted or braided fabric possesses a beneficial combination of strength, tissue infiltratability, handling and permeability.

Abstract: The invention relates to three-layer vascular prostheses comprising an internal layer 1, a middle layer 2 and an external layer 3 which is characterized in that the middle layer 2 is made from a physiologically non-resorbable, porous material, and the internal layer 1 and the external layer 3 are self-supporting and are made from a physiologically resorbable, fibrillar material, and are tanned. The internal layer 1 and the external layer 3 preferably consist of collagen, but have different resorbability. The middle layer 2 is preferably made from inert fibers, preferably synthetic fibers, by means of textile technology. The biologically resorbable layers preferably comprise chemically or physically bonded or incorporated pharmacologically active substances.

Abstract: An implantable prosthetic device for sustained release of a bioactive material into a fluid flow pathway of a patient comprises a body adapted for attachment to the fluid flow pathway. The body defines a primary lumen for accommodating fluid flow therethrough and at least one secondary lumen at least a portion of which is separated from the primary lumen by a wall sufficiently permeable to permit a bioactive material disposed in the lumen to diffuse through the wall and into the primary lumen. The bioactive material can be either a therapeutic or diagnostic agent. In a particular embodiment of the invention, the device comprises a tubular body consisting of stretched and/or expanded polytetrafluoroethylene and is adapted for attachment to a blood vessel of a patient.

Abstract: The invention relates to a vascular prosthesis wherein, fragments of biological tissues such as vascular tissues, connective tissues, fat tissues and muscular tissues and/or cells composing vascular walls such as vascular endothelial cells, smooth muscle cells and fibroblast cells are deposited and captured within the wall of a vascular prosthesis substrate; a manufacturing method comprising the steps of immersing a vascular prosthesis substrate into a dispersed solution of fragments of biological tissues such as vascular tissues, connective tissues, fat tissues and muscular tissues and/or cells composing vascular walls such as vascular endothelial cells, smooth muscle cells and fibroblast cells, and depositing and capturing the cells and/or tissue fragments on the inner wall and within the wall of the vascular prosthesis from one side to the other side of the vascular prosthesis substrate wall by providing a pressure differential between the outside and the inside of the vascular prosthesis substrate; and a

Abstract: The present invention provides vascular prostheses free of any substance that counteracts an anticoagulant comprising a base material, the base material having inner and outer surfaces, wherein the outer surface has a layer of a material capable of reducing the porosity of said prosthesis to blood or body fluid and a coating of compounded heparin bound thereon, and the inner surface has a coating of compounded heparin bound thereon, the compounded heparin comprising heparin and a cationic surfactant. The present invention also provides a method for forming a vascular prosthesis. The vascular prostheses of the present invention exhibit low porosity at the time of implantation of the prosthesis thereby obviating the need for pre-clotting the prosthesis to avoid leakage or hemorrhaging of blood through the prosthesis.

Abstract: The present invention provides a soft tissue prosthesis which is formed from a three-dimensional braided structure. The three-dimensional braided structure preferably may be made in the form of a solid three-dimensional braid, a three-dimensional braid having at least one interlocking yarn coupling contiguous layers or in the form of a plurality of two-dimensional braided layers adhesively laminated, separately sewn or otherwise connected together to form the three-dimensional braided prosthesis.

Abstract: Preparing chemically cross-linked collagenous biological graft material by preparation processes which include the step of altering the locations and/or orientations of chemical cross-linkages formed during the collagen cross-linking process. Embodiments of the method include various processes whereby physical force, stress or movement is applied to alter the relative positioning of the collagen fibers within the graft materials during at least the initial period of exposure to the collagen cross-linking reagent.

Abstract: A solid woven tubular prosthesis having sufficient inherent wall stiffness so as to be radially self-supporting. The solid woven prosthesis is capable of being formed with a smooth, continuous inner wall that improves the hemodynamic flow with respect to conventional woven prosthesis, thereby facilitating the flow of fluid therethrough.

Abstract: A polylumenal implantable device comprises a body defining a plurality of capillary lumina. The prosthetic device is suitable for implantation in a patient as an arterial or venous bypass graft or shunt, or intra-organ implant as well as other purposes. The improved prosthetic device has increased surface area and preferably a three-dimensional porosity for encouraging the harboring of, for example, endothelial cells, as well as for receiving organized deposition of material such as genetically enhanced cell types. A method for providing a bioactive material to a patient includes the steps of providing a polyluminal implantable organ comprising an implantable body defining a plurality of capillary lumina, treating the interior surfaces of the lumina with a bioactive material or plasma polymerization, and implanting the prosthetic device in the patient so that bodily fluids of the patient come into contact with the treated interior surfaces.

Abstract: A method of treating heart valve dysfunction in a human patient in which the dysfunctioning valve is replaced with a novel bioprosthesis. The novel bioprosthesis comprises a porcine pulmonary valve, which has preferably been treated to fix and also sterilize the valve tissue. The porcine pulmonary valve may either be stent mounted to facilitate its surgical implantation into the patient, or it may be unstented to reduce the possibility of embolism and thrombosis.

Abstract: An anti-turbulent, anti-thrombogenic intravascular stent of a helically shaped titanium or aluminum strip having an airfoil on internal surfaces thereof for increasing blood flow through the stent without creating areas of stagnant or turbulent flow therein. Also, a method for cleaning the stent for optimum performance in the intended application, and the stents which are cleaned by the process, and novel devices for introducing the stents of the invention into the body of a patient.

Abstract: Genetically engineered endothelial cells which exhibit enhanced cell migration and enhanced urokinase-type plasminogen activator (u-PA) activity are provided. The cells are modified by incorporation of the coding sequence for the c-src gene so that the cells express elevated levels of the tyrosine kinase protein, pp60.sup.c-src. The C-src gene is a naturally occurring gene which appears to be present in all animal species and is highly conserved. Because of their enhanced migration rates, the modified cells can be used to efficiently seed denuded segments of vessels or natural or synthetic grafts prior to implantation. Because of their enhanced u-PA activity, the cells can reduce the probability of thrombus formation at sites of vessel damage, such as that produced during such surgical procedures as coronary angioplasty and vessel reconstruction with grafts, stents, or the like.

Abstract: A tissue press for shaping or compressing a piece of tissue comprises first and second members movable relative to each other. A first forming element of a predetermined shape is selectively engageable on the first member. A second forming element of predetermined shape is selectively engageable on the second member. The first and second forming elements are positionable on opposite sides of the piece of tissue. The first and second members are relatively movable between a first spaced apart condition and a second condition in which the piece of tissue is held between the first and second forming elements. Means are preferably provided for monitoring and controlling the amount of pressure applied to the piece of tissue, in order to maintain the tissue in a viable living condition. Means may also be provided for draining off fluid from compressed tissue, so that the tissue can be implanted in a compressed state and imbibe fluid from the host site.

Abstract: Surfaces of polymeric materials are coated with a layer of thermally denatured fibrinogen. The fibrinogen may be treated with thrombin to produce fibrin, and additional fibrinogen and factor XIII added to produce a cross-linked fibrin coating. The resulting coated surface is stable, anti-thrombotic and resistant to platelet adhesion. Polymeric materials coated in this way are useful in constructing vascular grafts and prosthetic devices, and provide test systems useful in the study of thrombogenesis.

Abstract: A method of inhibiting cell proliferation in mammals which comprises the local delivery of an inhibitory amount of dipyridamole. Inhibiting cell proliferation is useful for the treatment of proliferative diseases such as vascular restonesis, scleroderma, psoriasis, and rheumatoid arthritis. This method includes the local delivery of dipyridamole to the proliferative site by various techniques including local delivery catheters, site specific carriers, implants, direct injection, or direct application.

Abstract: A piezoelectric medical device and a process for preparing the same by electrostatically spinning a copolymer of vinylidene fluoride and a second fluorinated hydrocarbon, and collecting the spun fibers on a suitable receiver is disclosed.

Abstract: An organ preservative solution containing a low molecular weight dextran in a pharmacologically acceptable storage solution is suitable for storage and preservative of organs for transplantation.

Abstract: A method for inhibiting decomposition and/or degradation of an implantation polymeric material in the living body, which comprises allowing dipyridamole and/or a salt or a derivative thereof as an active component to exist in the vicinity of an implantation polymeric material implanted in the living body; an inhibitor effective for inhibiting biological decomposition and/or degradation of a polymeric material implanted in the living body, which comprises dipyridamole and/or a salt or a derivative thereof as an active component; and an implantation polymeric material which contains dipyridamole and/or a salt or a derivative thereof as an active component.

Abstract: A device for holding a tendon graft in position as the tendon is scraped and sutured is described. The device includes a pair of tension arms that can be moved in both a horizontal and vertical plane. Horizontal movement of the tension arms can be used to adjust the amount of tension that is applied to a tendon graft. Vertical movement of the tension arms can be used to position the tendon graft in a location which enables medical personnel to more easily suture parallel lengths of a graft together.

Abstract: Self-restrained stent for use in a lumen of a vessel of a patient having a body with the vessel therein, comprising a substantially cylindrical member formed of a plastic material having a built-in elastic predetermined diameter and having a memory provided therein of a diameter greater than the predetermined diameter. The plastic is characterized in that it will attempt to assume the greater diameter in its memory upon occurrence of one or more of the following conditions:(a) adsorption of heat by the plastic material;(b) adsorption of a liquid by the plastic material; and(c) a change in the pH in the liquid in which the plastic member is disposed.

Abstract: The present invention provides a synthetic or naturally occurring implant, such as a vascular graft, for implantation into a human patient. Uncultured, microvascular endothelial cells, isolated from microvascular endothelial cell rich tissue are disposed on at least one surface of the implant to provide at least about 50% confluence of the cells on the surface of the implant prior to implantation. In a preferred embodiment, the microvascular endothelial cells are obtained from fat tissue. Because of the large number of fresh microvascular endothelial cells that may be obtained from such tissue, sufficient cells may be placed on the implant so that they attach to provide at least 50% confluent coverage of the implant surface prior to the time of implantation.

Abstract: An aortic graft and system and method for implanting the aortic graft are provided. The aortic graft comprises a substantially cylindrical graft material with attachment means which comprise a plurality of post and hook assemblies which are implanted with a double catheter system to penetrate the aorta wall above and below the aneurysm to provide firm attachment of the aortic graft and, thereby, exclude the aneurysm from the circulatory system.

Abstract: The method of generating a homograft includes preparing a prosthesis composed of a tubular substrate. The substrate is open at each end to permit blood to flow along the length of the substrate inside wall. The substrate is selected to have at least one thrombogenic surface or a thrombogenic mesh material supported by the substrate. The prosthesis is inserted in the lumen of a blood vessel, either a vein or artery, of a living body and anchored in the lumen of the vessel to prevent the substrate from moving along the vessel with the blood flow. The body generates collagenous growth on the thrombogenic surface of the substrate while the substrate is freely suspended in the blood flow of the vessel. The substrate is then removed from the vessel after which a tubular homograft of collagenous tissue is removed from the substrate.

Abstract: This invention relates to a method for improving the resistance of biomaterial to thrombosis and infection and for improving tissue ingrowth, by eliminating undissolved gasses therefrom and by incorporation of therapeutic agents therein via the application of hydrostatic pressure.

Abstract: The invention relates to a vascular prosthesis wherein, fragments of biological tissues such as vascular tissues, connective tissues, fat tissues and muscular tissues and/or cells composing vascular walls such as vascular endothelial cells, smooth muscle cells and fibroblast cells are deposited and captured within the wall of a vascular prosthesis substrate; a manufacturing method comprising the steps of immersing a vascular prosthesis substrate into a dispersed solution of fragments of biological tissues such as vascular tissues, connective tissues, fat tissues and muscular tissues and/or cells composing vascular walls such as vascular endothelial cells, smooth muscle cells and fibroblast cells, and depositing and capturing the cells and/or tissue fragments on the inner wall and within the wall of the vascular prosthesis from one side to the other side of the vascular prosthesis substrate wall by providing a pressure differential between the outside and the inside of the vascular prosthesis substrate; and a

Abstract: A method is disclosed for preparing a transplantable tissue which has been cryopreserved with an intracellular cryoprotectant and then thawed. After thawing, the tissue is treated with a diluent (or eluent) solution to reduce the level of cryoprotectant in the cells to a substantially non-toxic level. This is conducted using a single dilution step. Cryoprotectants which are removable in this manner include dimethylsulfoxide, glycerol, propanediol and other compounds which penetrate the cells.The dilution step does not require end point titration and can be conducted over a time period greater than about 5 minutes.

Abstract: An antithrombogenic material having its surface modified by ion implantation is disclosed. This antithrombogenic material may, for example, be a silicone material which has its surface modified by introducing functional groups on its surface by ion implantation. The material exhibits improved compatibility to blood due to introduction of the functional groups by ion implantation and the doping effect of the implanted elements.

Abstract: A stent is made from a thermoplastic material having a glass transition temperature below the normal temperature of the human body. Therefore the thermoplastic polymer may be necked in situ. The stent is made with a series of circumferential strips.

Abstract: A novel implantable prosthesis for implantation in human patients is disclosed which comprises a synthetic substrate and a Type IV/V collagen surface layer seeded with a confluent monolayer of autologous endothelial cells. In the preferred embodiment, a base layer of interstitial collagen is adhered to the substrate. The Type IV/V collagen surface layer is provided in a laminate comprising an intermediate layer of interstitial collagen which is covalently bound to the aforementioned base layer. A cross linking agent, such as glutaraldehyde, is utilized to covalently bind the interstitial collagen base layer to the substrate, and the collagen intermediate layer to the base layer. The cross linking agent is subsequently deactivated with a soluble peptide, such as lysine. Autologous endothelial cells, such as microvascular endothelial cells derived from adipose tissue, are then seeded at high densities on the pretreated graft material.

Abstract: Arteries and veins of umbilical cords are treated by processes described, fitted with a biodegradable mesh support and used as tubular prosthesis for vascular reconstructive surgery.

Abstract: A device for use in cryopreservation of blood vessels comprising a pair of stylets insertable into the ends of a dissected blood vessel segment. The stylets are mountable on a support track whereby the blood vessel can be distended and supported during cryopreservation procedures. Also disclosed is a freezing and thawing profile capable of maximizing endothelial cell survival. The use of chondroitin sulfate or similar compound is discussed as a novel cryoprotectant.

Abstract: A unique method (10) for preparing protein-impacted grafts (22) wherein an untreated graft (22) is impacted and impregnated with a protein solution, ideally a collagen suspension (14) utilizing a dynamic flow soaking process (24). After soaking in the dynamic flow (24), the collagen-impacted graft is thermally and chemically fixed (26). Following a water wash (30) and glycine wash (34), the graft (22) is softened with a plastification procedure (36), after which it is air dried (38) and placed in a package and sterilized. With the method of the present invention, storable, surgically-ready collagen-impacted grafts can be reliably and rapidly prepared with a high degree of control and uniformity of characteristics in each graft than has heretofore been possible.