Abstract: Devices and methods are provided for forming a vascular graft by axially distending a blood vessel to induce growth. In one embodiment, a device for distending a blood vessel of a human or animal is provided which comprises a stretching mechanism attachable directly to a blood vessel at at least two attachment positions thereon, and a means for operating the stretching mechanism to cause the blood vessel portion between said at least two attachment positions to be stretched axially. The distended portion can then be excised and used as a graft.

Abstract: Bioprosthetic tissues are treated by immersing or otherwise contacting fixed, unfixed or partially fixed tissue with a glutaraldehyde solution that has previously been heat-treated or pH adjusted prior to its contact with the tissue. The prior heat treating or pH adjustment of the glutaraldehyde solution causes its free aldehyde concentration to decrease by about 25% or more, preferably by as much as 50%, and allows a “stabilized” glutaraldehyde solution to be obtained at the desired concentration and pH for an optimal fixation of the tissue at high or low temperature. This treatment results in a decrease in the tissue's propensity to calcify after being implanted within the body of a human or animal patient.

Abstract: The present invention relates to a method of preparing a tissue graft material. The invention also relates to a multipurpose tissue graft material and to methods of using same as a replacement for vascular and non-vascular tissue.

Abstract: A medical device such as a stent made from single or double-butted tubing is disclosed. The butted tubing may be made from stainless steel or a nickel-titanium (nitinol) alloy. The butted tubing is created by thinning the material in between the ends of the tube through machining, drawing, cold working, laser cutting, or chemical etching. A strut pattern for a stent is laser cut into the butted tubing. The strut pattern for the stent includes rings connected by links. The end rings of the stent coincide with the double-butted ends of the tubing thereby increasing the hoop strength of those end rings.

Abstract: A prosthetic valve for replacing a cardiac valve includes an expandable support member and at least two valve leaflets made of a first layer of biological material selected from peritoneal tissue, pleural tissue or pericardial tissue. A second layer of biological material is attached to the support member. The second layer is also made from peritoneal tissue, pleural tissue or pericardial tissue. The second layer includes a radially inwardly facing surface that defines a conduit for directing blood flow. The valve leaflets extend across the conduit to permit unidirectional flow of blood through the conduit. Methods for making and implanting the prosthetic valve are also provided.

Abstract: A method for preparing a graft vessel for anastomosis to a target vessel includes making at least one incision in the graft vessel, such as to form a flap at an end thereof. The graft vessel and/or a fixture, such as a clamp, may be positioned relative to one another, such as to form an angle relative to one another, prior to making the incision or incisions. The position of the graft vessel relative to the fixture may be based on the size of the opening in the target vessel at the anastomosis site.

Abstract: A method is provided for enhancing hematopoiesis. The method includes transplanting at least a therapeutically effective portion of an isolated vascular tissue into a subject, wherein the vascular tissue enhances hematopoiesis. A method is also provided for detecting an agent that affects hematopoiesis. The method includes transplanting a portion of an isolated vascular tissue into a subject, wherein the portion of the isolated vascular tissue is sufficient to enhance hematopoiesis. The vascular tissue is treated with an agent, and hematopoiesis is detected in the subject. Hematopoiesis in the subject is compared with hematopoietic in a control. A change in hematopoiesis in the subject as compared to the control indicatives that the agent affects hematopoiesis. A method is provided for isolating a hematopoiesis growth factor using the method of the invention. In addition, a method is provided for isolating a hematopoietic stem cell using the method of the invention.

Abstract: The invention provides a system for treating a vascular condition, comprising a catheter and a stent. The catheter includes an inflatable balloon. The stent is removably coupled to the balloon. The stent includes at least one elongated opening oriented generally perpendicular to the longitudinal axis of the stent. A portion of the balloon is positioned within the elongated opening to aid in retaining the stent to the balloon.

Abstract: A graft preparation board that enables an exact tensioning of soft tissue grafts. The graft preparation board allows the amount of tensile load to be easily determined so that the operator can precisely control the amount of tension to be applied. The graft preparation board also enables higher tensions to be placed on graft tissues to be used in surgery.

Abstract: A graft vessel preparation device and a method for using the graft vessel preparation device is provided. The graft vessel preparation device establishes and maintains a critical dimension on a graft vessel which corresponds to a dimension of an anastomosis site on a target vessel. One example of a graft vessel preparation device which prepares a graft vessel for a vascular anastomosis procedure includes a parallelogram linkage, a first spreader arm and a second spreader arm. The first spreader arm and the second spreader arm mount on opposing members of the parallelogram linkage in a parallel configuration. The spreader arms are configured in order to allow the placement of an end of a graft vessel over the spreader arms. The spreader arms are also configured to separate within an interior of the graft vessel once the graft vessel is placed over the spreader arms in order to establish a critical dimension. The critical dimension is established using a critical dimension locator.

Abstract: The invention is directed to use of fibrin as an extracellular matrix and, together with cells, its use in forming engineered tissue. The engineered tissue can include the synthetic manufacture of specific organs or “organ-like” tissue. A preferred embodiment is a plasma-derived fibrin matrix containing cells.

Abstract: A system and a method for harvesting a section of a blood vessel from a patient's body for further use. The system includes an expandable hood that creates a workspace for the dissection and removal of the vessel and a telescoping device that has tools at its distal end. The blood vessel is cut at a distal location and a light catheter inserted to illuminate the area of dissection. The system can remove a section of the saphenous vein for use in coronary bypass surgery.

Abstract: An improved ePTFE material and method of preparing the improved ePTFE material provides a tubular structure with enhanced axial elongation, radial expansion, and physical recovery characteristics.

Abstract: An implant device including a tubular matrix made of a biocompatible and bioresorbable biopolymeric material. The matrix has a first end and a second end, a wall of a homogeneous thickness; a plurality of ridges on the wall; and a channel which is defined by the wall and extends from the first end to the second end of the tubular matrix.

Abstract: A system and a method for harvesting a section of a blood vessel from a patient's body for further use. The system includes an expandable hood that creates a workspace for the dissection and removal of the vessel and a telescoping device that has tools at its distal end. The blood vessel is cut at a distal location and a light catheter inserted to illuminate the area of dissection. The system can remove a section of the saphenous vein for use in coronary bypass surgery.

Abstract: Methods and apparatus are provided for forming a vascular graft in vitro by axially distending a blood vessel to induce growth. The apparatus comprises a chamber containing a tissue culture medium, an inlet cannula, an outlet cannula, and a means for moving the inlet cannula, the outlet cannula, or both, to axially stretch a donor blood vessel secured between the inlet cannula and the outlet cannula in a submerged position in the tissue culture medium, wherein the inlet cannula, the outlet cannula, and the donor blood vessel are secured together to form a conduit through which the tissue culture medium can flow.

Abstract: A fluid flow system for preparing an implantable substrate is provided having a fluid permeable container that is capable of retaining a biocompatible, implantable substrate, and a driver mechanism for subjecting fluid to a constant force to induce a selected, controlled flow rate of the fluid through a substrate disposed in the container. The system can include a fluid reservoir having an inlet and an outlet, and being effective to selectively retain a fluid. The reservoir is preferably disposed upstream of the container. The system can also optionally include a fluid recycling conduit that is effective to recirculate fluid from the container to the reservoir.

Abstract: The invention is directed to an implantable stent prosthesis comprising a sidewall and at least one channel for containing a biologically active material. A method for making such stent prosthesis is also disclosed. In the method, at least one tube or mandrel is placed in contact with a covering material on a stent and surrounded by the covering material to form a channel. Alternatively, a channel can be formed by covering the tube or mandrel with a channel material and exposing the covered tube or mandrel to an appropriate treatment. The channel can be attached to a sidewall of a stent or attached to a strut material to form a stent wire. A method of treating an afflicted area of a body lumen by implanting the stent prosthesis is also disclosed.

Abstract: A method for making a curved implantable sheath includes placing a sheet of flexible material into engagement with a member having a curved surface having a desired configuration. The sheet and member are placed in a fixation solution so that the sheet assumes the configuration of the surface engaged thereby.

Abstract: A method of increasing the rate of expansion of tissue area and volume, either in vivo or in vitro, which comprises preparing a tissue for expansion and subjecting the tissue to stretching forces, wherein the stretching forces are alternatively increased and decreased to provide alternating periods of stretch and relax cycles.

Abstract: Devices and methods are provided for forming a vascular graft by axially distending a blood vessel to induce growth. The device preferably comprises a stretching mechanism which includes (i) a rigid body; (ii) a pair of posts comprising a first post and a second post which are connected to the body; (iii) a driver element slidably secured to the body and disposed between the pair of posts; and (iv) a device for sliding the driver element away from the pair of posts to axially distend a blood vessel positioned between the pair of posts and the driver element. Preferably, the device is implanted, for example using endoscopic techniques, for use in vivo, although the device also can be used in vitro.

Abstract: A universal, surgical prosthesis for hernia repair is provided in the form of a foldable sheet. The prosthesis includes a barrier layer formed of a material adapted to prevent biological adherence thereto, such as polytetrafluoroethylene, and a second surface layer formed of a material adapted to promote biological tissue adherence thereto, such as polypropylene. The second surface may be formed of a series of spaced projections. The prosthesis is adapted to be manipulated into an operative position to exhibit an appropriate exterior when in the operative position. In this manner, the universal, surgical prosthesis can be utilized for a wide range of surgical procedures.

Abstract: Devices and methods are provided for forming a vascular graft by axially distending a blood vessel to induce growth. The device preferably comprises a stretching mechanism which includes (i) a stabilization rod, (ii) a pair of rotatable elements, wherein each rotatable element is rotatably attached to the elongated body and has a channel substantially perpendicular to the axis of rotation, and (iii) a means for rotating each rotatable element to axially distend a blood vessel positioned in the channels of the rotatable elements. The elements can be rotated intermittently, cyclically, or continuously, over a period to distend or elongate the donor vessel. Preferably, the device is implanted, for example using endoscopic techniques, for use in vivo, although the device also can be used in vitro.

Abstract: Disclosed are tissue implant materials for use in grafting procedures. More particularly non-vascular tissue for use as vascular graft material and a method of vascular grafting using non-vascular tissue is disclosed. The tissue is preferably autologous relative to the recipient of the graft and is conveniently prepared around or on a molding support inserted into a body cavity of the intended recipient of the graft. These tissues and methods are particularly useful in the treatment or prophylaxis of diseased or damaged blood vessels such as in atherosclerosis.

Abstract: A system and a method for harvesting a section of a blood vessel from a patient's body for further use. The system includes an expandable hood that creates a workspace for the dissection and removal of the vessel and a telescoping device that has tools at its distal end. The blood vessel is cut at a distal location and a light catheter inserted to illuminate the area of dissection. The system can remove a section of the saphenous vein for use in coronary bypass surgery.

Abstract: A graft vessel preparation device and a method for using the graft vessel preparation device is provided. The graft vessel preparation device establishes and maintains a critical dimension on a graft vessel which corresponds to a dimension of an anastomosis site on a target vessel. One example of a graft vessel preparation device which prepares a graft vessel for a vascular anastomosis procedure includes a parallelogram linkage, a first spreader arm and a second spreader arm. The first spreader arm and the second spreader arm mount on opposing members of the parallelogram linkage in a parallel configuration. The spreader arms are configured in order to allow the placement of an end of a graft vessel over the spreader arms. The spreader arms are also configured to separate within an interior of the graft vessel once the graft vessel is placed over the spreader arms in order to establish a critical dimension. The critical dimension is established using a critical dimension locator.

Abstract: The present invention is directed to methods for obtaining heart valves from a donor animal that have a reduced tendency to cause inflammation when implanted into a human patient. The valves produced by this method should be less likely to undergo post-surgical degeneration.

Abstract: Fibrointimal proliferation, neointimal hyperplasia and other vascular lesions or injuries are reduced by ex vivo irradiation of the autologous coronary bypass conduit, especially the saphenous vein, as an adjunct in cardiovascular surgery or other treatment, in anyone of a variety of suitable devices.

Abstract: The present invention provides an ex vivo vascular remodeling methods and system by which an excised, small diameter blood vessel can be harvested and expanded to provide viable vascular grafts, as demonstrated at the physical and molecular levels, and as optimized in vivo. The tissue-engineered vessels generated by the present invention closely resemble native vessels in terms of structure, histologically, including endothelial coverage and intricate structural components such as the internal elastic lamina, viability (as measured with the MTT assay and TUNEL analysis), and function (vasoactivity, mechanical and biomechanical properties). Thus, the resulting vascular grafts behave in a manner similar to native arteries in terms of mechanical integrity, and provide clinically relevant patency rates when implanted in vivo.

Abstract: A method and system for removing body vessels from a patient is provided. An embodiment of the method includes a method for harvesting a vessel for subsequent use in a grafting procedure, such as, for example, saphenous vein graft harvesting for a coronary bypass surgical operation. A quantity of a solution is infused into tissue surrounding the portion of the vessel to be removed. An external device is used to apply an energy field to the tissue to loosen the intercellular connections between the tissue and the vessel to be removed. One such device is an ultrasonic instrument having an ultrasonic transducer comprised of a composite of ultrasonic crystal transducers. Once the energy field has been applied, the portion of the vessel to be removed is separated from surrounding tissue and tributary vessels are ligated. The portion of the vessel is then transected and removed from the body.

Abstract: A method for treating fixed biological tissue inhibits calcification of the biological tissue following implantation thereof in a mammalian body. The method includes placing the biological tissue in contact with glutaraldehyde and then heating the glutaraldehyde. Alternatively, methods other than heating (e.g., chemical or mechanical means), for effecting polymerization of the glutaraldehyde may also be utilized. Alternatively, the tissue may be heat treated prior to fixing thereof. Alternatively, methods other than glutaraldehyde may also be used for fixing the tissue. The biological tissue may be so treated at any time prior to implantation thereof in a mammalian body.

Abstract: A cerebral interface system has a housing mechanism configured to be at least partially spaced in a cavity formed in the subject's skull; an attaching mechanism for attaching the housing mechanism to the subject's skull; a sealing mechanism for providing a fluid-tight seal between the housing mechanism and the subject's skull; a control mechanism spaced within the housing mechanism; a communication mechanism with one or more sensors embedded in the subject's brain connecting the control mechanism to the subject's brain; and a power source spaced within the housing mechanism.

Abstract: A system and a method for harvesting a section of a blood vessel from a patient's body for further use. The system includes an expandable hood that creates a workspace for the dissection and removal of the vessel and a telescoping device that has tools at its distal end. The blood vessel is cut at a distal location and a light catheter inserted to illuminate the area of dissection. The system can remove a section of the saphenous vein for use in coronary bypass surgery.

Abstract: Methods and apparatus for delivering and installing a new length of tubing between two sections of a patient's existing body organ tubing and at least partly outside of that existing structure. For example, the new length of tubing may be for the purpose of providing the patient with a coronary bypass. The new tubing may be an artificial graft, a natural graft (harvested elsewhere from the patient), or both. The new tubing is delivered to and installed at the operative site primarily by working through the patient's existing tubular body organ structure. This avoids the need for any significant surgery on the patient.

Abstract: A graft vessel preparation device and a method for using the graft vessel preparation device is provided. The graft vessel preparation device establishes and maintains a critical dimension on a graft vessel which corresponds to a dimension of an anastomosis site on a target vessel. One example of a graft vessel preparation device which prepares a graft vessel for a vascular anastomosis procedure includes a parallelogram linkage, a first spreader arm and a second spreader arm. The first spreader arm and the second spreader arm mount on opposing members of the parallelogram linkage in a parallel configuration. The spreader arms are configured in order to allow the placement of an end of a graft vessel over the spreader arms. The spreader arms are also configured to separate within an interior of the graft vessel once the graft vessel is placed over the spreader arms in order to establish a critical dimension. The critical dimension is established using a critical dimension locator.

Abstract: A graft preparation board that enables an exact tensioning of soft tissue grafts. The graft preparation board allows the amount of tensile load to be easily determined so that the operator can precisely control the amount of tension to be applied. The graft preparation board also enables higher tensions to be placed on graft tissues to be used in surgery.

Abstract: A method for polishing radially expandable surgical stents is disclosed where fluid abrasive media M flows over surfaces of the stent 10 causing the surfaces of the stent 10 to be polished and streamlined. The stent 10 is temporarily provided with cylindrical support ends 20, which are not radially expandable to support the stent 10 during the polishing process. An interior polishing fixture 100 is provided which has cylindrical chambers 135 therein adapted to receive a stent 10 therein. Fluid abrasive media M then flows into bores 108 in the fixture 100 leading to the cylindrical chambers 135 and adjacent the inner diameter surfaces of the stent 10. Surfaces of the stent 10 forming the outer diameter are polished by placing the stent 10 within an exterior polishing fixture 200 which has a cylindrical recess 220 therein.

Abstract: An apparatus for sealing a passage through tissue includes a plug including external threads, a lumen extending between its proximal and distal ends, and an annular collet slidably disposed within the lumen. The plug is carried on a distal end of a handle device that includes an inner member with a distal end that is slidable axially within the lumen of the body for moving the collet into a reduced cross-sectional region of the lumen, thereby compressing the collet to seal the lumen, and for deploying the plug from the handle device. During use, the plug is threaded into a passage through tissue over a guide wire. Once a desired location is reached, the plug is deployed from the handle device, thereby compressing the collet and sealing the lumen. The guide wire and handle device are removed, leaving the plug to seal the passage.

Abstract: Methods and apparatus for delivering and installing a new length of tubing between two sections of a patient's existing body organ tubing and at least partly outside of that existing structure. For example, the new length of tubing may be for the purpose of providing the patient with a coronary bypass. The new tubing may be an artificial graft, a natural graft (harvested elsewhere from the patient), or both. The new tubing is delivered to and installed at the operative site primarily by working through the patient's existing tubular body organ structure. This avoids the need for any significant surgery on the patient.

Abstract: The symptoms of congenital heart failure are addressed in this surgical procedure for mounting a patch in the ventricle of the heart to reduce ventricular volume. Placement of the patch is facilitated by palpating a beating heart to identify akinetic, although normal appearing, tissue. The patch has an oval configuration facilitating return of the heart to a normal apical shape which enhances muscle fiber efficiency and a normal writhing pumping action. The patch includes a semi-rigid ring, and a circumferential rim to address bleeding. Patch placement is further enhanced by creating a Fontan neck and use of pledged sutures. Intraoperative vascularization and valve replacement is easily accommodated. Increased injection fraction, reduced muscle stress, improved myocardial protection, and ease of accurate patch placement are all achieved with this procedure.

Abstract: A method for screening candidate antimicrobial compounds is described that utilizes a human vaginal xenograft engrafted in a non-human host. The method may be performed by using pathogen inoculated human vaginal xenografts in order to screen a wide range of candidate antimicrobials administered topically or systemically.

Abstract: A method for screening candidate antimicrobial compounds is described that utilizes a human vaginal xenograft engrafted in a non-human host. The method may be performed by using pathogen inoculated human vaginal xenografts in order to screen a wide range of candidate antimicrobials administered topically or systemically.

Abstract: Fibrointimal proliferation, neointimal hyperplasia and other vascular lesions or injuries are reduced by ex vivo irradiation of the autologous coronary bypass conduit, especially the saphenous vein, as an adjunct in cardiovascular surgery or other treatment, in anyone of a variety of suitable devices.

Abstract: The present invention relates to a method of preparing a tissue graft material. The invention also relates to a multipurpose tissue graft material and to methods of using same as a replacement for vascular and non-vascular tissue.

Abstract: A method for screening candidate antimicrobial compounds is described that utilizes a human vaginal xenograft engrafted in a non-human host. The method may be performed by using pathogen inoculated human vaginal xenografts in order to screen a wide range of candidate antimicrobials administered topically or systemically.

Abstract: A method of cross-linking a tissue, comprising treating the tissue under effective cross-linking conditions with a fluid comprising a compound comprising P(CH2OH)3Xn, wherein X is selected from C1-C10 carboxyl, sulfonic acid, sulfonic acid salts, C1-C10 alcohol, or halogens, and n is an integer from 0 to 2, inclusive, and all —X and —CH2OH groups are bonded to the phosphorus atom. In one embodiment, the compound is &bgr;-(tris(hydroxymethyl)phosphino)proprionic acid (THPP).

Abstract: Disclosed and claimed are compositions, devices, methods and kits that are useful in surgical procedures, specifically to induce adhesions for the purposes of stabilizing implants, closing apertures, and otherwise promoting the adhesion of implants and anatomical structures to one another. The invention pertains to a composition containing specific particulate components, wherein the particulates promote an inflammatory reaction that results in the formation of an adhesion.

Abstract: A one-way valve suitable for implant in the human vascular system is disclosed. The valve is formed by a tube of braided filaments and has an upstream end supported in an open configuration by a radial support. The valve has a downstream portion formed by a plurality of flexible leaflets resiliently biased into a closed configuration sealing the valve. The leaflets separate under pressure to allow fluid flow downstream but close in response to back pressure to prevent retrograde flow. The leaflets are biased by internal elastic forces within the filaments or by means of a resilient flexible membrane. To prevent collapse of leaflets under relatively high back pressure, elongated support columns are arranged lengthwise along the tube. A second radial support is provided downstream to support the columns. Fasteners are positioned circumferentially around the tube to anchor the valve within the lumen of the vascular vessel.

Abstract: A device and method for removing a generally cylindrical tissue structure such as a blood vessel from the body of a human or animal. The device includes a body portion having distal and proximal ends with at least one lumen extending longitudinally through the body portion. The lumen is sized to accommodate the vessel and at least one tool used in removing the vessel. Means is provided for isolating the vessel from the tools used in the removal procedure.

Abstract: In accordance with the present invention, there is provided a stent for implantation into a vessel of a patient. The stent has at least two plastically deformable and expandable tubular graft members for expansion within a vessel. Each of the graft member has a first end, a second end, a wall section disposed therebetween and a lumen extending therethrough. The stent further includes at least one articulation connecting the first end of one of the graft members with the second end of the other graft member. Wherein the articulation is made from a superelastic material.