Abstract: A stent-graft assembly is provided for a variety of medical treatments. The stent-graft assembly comprises an inner graft, an outer graft, and at least one stent disposed circumferentially between the inner graft and outer graft. The inner graft is attached directly to the outer graft circumferentially at a first location proximal to a first stent, and further attached directly to the outer graft circumferentially at a second location distal to the first stent, thereby forming a first pocket that houses the first stent. Neither the inner graft nor the outer graft is attached directly to the stent, permitting improved stent flexibility and reducing manufacturing complexity.

Abstract: The present invention concerns methods for joining flexible polymer workpieces using light energy. These methods, referred to as laser welding, can be used to join thermoplastic or thermoset polymers. The laser welding method of the invention is applicable to the creation or repair of any article requiring the bonding of two flexible polymer components or a flexible polymer component and an inflexible polymer component.

Abstract: A prefabricated tympanic membrane prosthesis includes a piece of collagen sheet processed with a diluted solution of formalin. The piece of collagen sheet is molded on a forming surface of a tool having a shape resembling a natural tympanic membrane of a human subject. The piece of collagen sheet is processed with a diluted solution of formalin so that the resulting tympanic membrane prosthesis retains the shape of the forming surface. The tympanic membrane prosthesis is semi-rigid, yet flexible, and is packaged in a substantially rigid container to protect it shape during shipment and storage.

Abstract: A method of sizing, resizing or reshaping the interior of a prosthetic device includes placing a lightweight moldable or shape assuming, pliable material that adheres and hardens on the interior sides of a socket of a prosthetic device. An end of a residual limb is placed into the socket causing the moldable material to conform to the shape of the residual limb. The limb is maintained in position for a few minutes in the socket until the moldable material has sufficiently hardened. After hardening, the molded material is dressed down, sanded or feathered to remove any burrs or sharp edges. Low spots or holes may be filled in with more moldable material and the fitting process repeated.

Abstract: A method of socket design and fabrication for Below-the-Knee (BK) amputees that utilizes manual measurements. This method, known as BK by Measurement, utilizes a manual measurement procedure where predetermined points are identified and measurements are taken of a patient's residual limb. These measurements are recorded and thereafter entered into a software package enabling customization by the fabrication facility. Prosthetic components fabricated in accordance with the present invention provide a custom fit, while not relying on more expensive digital imaging technology. The invention also provides a method and associated system for recording and retrieving fabrication and/or fitting data associated with a prosthetic component for use with a particular patient, which can include affixing to the prosthetic component a strip debossed with indicia unique to the particular patient or prosthetic component.

Abstract: A method for making a bioprosthetic heart valve includes providing a non-contact cutting apparatus and a layer of tissue. The non-contact cutting apparatus may include a laser cutting system or high pressure water jet system. A leaflet is cut from the layer of tissue using a predefined template, and a plurality of alignment holes in the leaflet are created in the leaflet, e.g., along a peripheral edge. A support structure is provided having a plurality of alignment holes corresponding to alignment holes in the leaflet. The leaflet is secured to the support structure by securing one or more sutures through corresponding alignment holes in the leaflet and the support structure to provide a leaflet subassembly. A bioprosthetic heart valve is made by securing a set of leaflet subassemblies to a frame.

Abstract: A high density microwall ePTFE structure and a method for making, involving the manipulation of a standard extruded ePTFE graft. The final product has the desired characteristics of high density, reduced wall-thickness, above-average radial strength and enhanced suture retention.

Abstract: A method for stitching thread onto the wall of a tubular medical implant (preferably a graft) employs a sewing machine with an elongate bobbin or a needle on an elongate element, depending on whether it is desired to sew from the outside-in or the inside-out. A motor rotates and translates the implant, which is mounted on a hollow drum, relative to the needle.

Abstract: A method of manufacturing a metallic blank into a shaped article useful as an enclosure for an implantable medical device is described. The method entails a plurality of steps in a particular order to obtain certain finish characteristics. Some of them are a surface roughness for bond ability and/or a uniform surface finish on the drawn section of the blank. The preset steps must be completed in a particular order; otherwise the desired characteristics are not provided.

Abstract: A system and method for manufacturing a custom prosthetic liner. The system may include a shape capture device for capturing the shape of a residual limb. The captured shape may be used to generate a 3-dimensional electronic liner model using a processor and specialized software. A 3-dimensional electronic model of the residual limb may also be produced. Preferably, an interface is provided that allows a user of the system to alter the shape and/or size of the 3-dimensional model(s) to allow the subsequently-produced liner to accommodate particular features of the residual limb. Data associated with at least the resulting 3-dimensional liner model is provided to a manufacturing facility equipped to produce a custom liner therefrom. The data may be remotely transmitted to the manufacturing facility. A positive likeness of the residual limb is created from the data associated with the 3-dimensional model(s), and is subsequently used as a mold core in the liner molding process.

Abstract: A coiled-sheet stent includes a tubular body having a longitudinal axis, a circumference, and a thickness, and having a size configured for introduction into a body lumen. The tubular body includes a plurality of cylindrical bands, each band including a generally zig-zag pattern defined by a series of sequential arcuate-shaped diagonal elements connected to one another and extending about the circumference. Longitudinal connectors extend between adjacent cylindrical bands. Slots are formed in the tubular body oriented about the circumference of the tubular body, thereby providing reduced thickness regions in the longitudinal connectors that have a thickness that is substantially smaller than the thickness of the cylindrical bands of the tubular body.

Abstract: An implant designing method to be applied to a body of bone which has a bone deficient portion, wherein the bone being substantially symmetric with respect to a plane of symmetry, includes generating three-dimensional data of the bone based on a plurality of pieces of tomographic data of the bone, and estimating a shape of a bone that is to exist at the bone deficient portion using part of the three-dimensional data corresponding to a symmetrical part of the bone deficient portion.

Abstract: A prosthetic socket casting device includes a base with a forward side from which an expandable bladder surrounding a central casting area extends. The bladder includes a plurality of inner expandable chambers that generally extend along the length of the bladder interior and peripherally surround the central casting area. The inner walls of the chambers are formed of a pliable, fluid impermeable relatively thin sheet material that is distendable upon pressurization of the chamber volumes. The bladder further includes an outer covering or wall formed of a material or construction that limits distention of the bladder outwardly. The chambers may be expanded using pressurized air or other fluid to constrict the central casting area in which a residuum having a settable prosthetic socket material thereon may be placed for molding and curing under pressure. The multiple expandable chambers create a desirable pressure distribution circumferentially around the central casting area.

Abstract: A method of making an ophthalmological implant by applying a layer of pharmaceutical agent and an overlying layer of a bioerodible material, a biodegradable material, a bloavailable material or a mixture thereof, the overlying layer having variable thickness and being dimensioned for prolonged release of the pharmaceutical agent from the implant as the overlying layer degrades.

Abstract: The present invention relates to a method of making a tissue graft material. The method includes placing body tissue and a blood component in a chamber and extruding the body tissue and blood component from an opening in the chamber to form the tissue graft material.

Abstract: A prosthesis, and method for forming same, are provided which includes expanded polytetrafluoroethylene (ePTFE) tubes having angularly offset node and fibril configurations. Also, the node and fibril configurations are angularly offset from the longitudinal axes of the respective tubes, providing resistance against failure in the longitudinal direction.

Abstract: A breast prosthesis may be formed by forming an outer layer on a mold, and filling the mold with a polymerizable foaming composition. The mold may be formed by forming a computer model of the prosthesis based on scanning a patient. The computer model may be used to form a solid model. A prosthesis may be coupled to the patient by coupling at least one metallic insert to the prosthesis and at least one magnet to the patient. Alternately, the prosthesis may be formed with a retaining harness integral to the prosthesis. In still another method, the prosthesis may be coupled to a retaining device surgically implanted in the patient.

Abstract: A method for modeling an implant to be applied to a defect of a bone comprises the steps of obtaining a plurality of tomographic image data of the bone based on measurement data by MRI, producing three-dimensional image data of the bone based on the plurality of tomographic image data, and estimating a shape of a missing born that was previously present or should have been present in the defect of the bone to obtain three-dimensional data of the implant. The estimating step comprises the steps of estimating a provisional shape of the implant which has a contour conformable with the shape of a contour of periphery of the side walls of the defect at the distal surface of the bone and has a predetermined thickness; and deleting data of portions of the provisional shape of the implant that overlap the bone from the data of the provisional shape of the implant so that the three-dimensional data of the implant has an outer peripheral shape that is conformable with the shape of the side walls of the defect.

Abstract: In order to be able to ascertain the position of the bone in the body without complicated procedures in a process for the preoperative determination of the positioning data of endoprosthetic parts of a central joint relative to the bones forming the central joint, a respective outer articular point is determined by way or movement of the bones about a respective outer joint which is located at the end of the two bones facing away from the central joint. An articular point is determined for each of the two bones in the area of the central joint, and a direction characteristic for each of these bones is determined by way of a straight-line connection of the two articular points obtained in this manner for the two bones. The orientation of the endoprosthetic parts relative to this characteristic direction is then determined. Apparatus for carrying out the process is also provided.

Abstract: A prosthetic socket is made by wrapping water-soaked plaster bandages around a residual limb or around a prosthetic liner within which is disposed a residual limb, and positioning a vacuum wick in overlying relation to the plaster bandages. The residual limb, prosthetic liner, plaster bandages, and vacuum wick means are then inserted into a vacuum bladder. The vacuum bladder is sealed and a predetermined vacuum is applied internally to the bladder until the plaster hardens into a negative cast. The residual limb is manipulated through the vacuum bladder to modify the geometry of the plaster before the plaster hardens. The negative cast is removed from the residual limb and a positive cast is produced by pouring plaster into the negative cast. A thermoplastic sheet is thermoformed over the positive cast or a carbon-epoxy matrix is laminated over the positive cast. This eliminates reduction and modification of a hard positive cast.

Abstract: The present invention provides a method of forming a drug-polymer coated stent. A polymeric coating is applied onto at least a portion of a stent framework and dried. A jet of heated gas is directed towards excess coating portions of the dried polymeric coating. The excess coating portions, which extend into apertures of the stent framework, are removed from the apertures of the stent framework by reflowing the polymeric coating with the directed jet of heated gas. A drug-polymer coated stent with a reflowed drug-polymer coating and a system for treating a vascular condition are also disclosed.

Abstract: Disclosed herein is a flexible self-expandable stent using shape memory alloy for expanding stenosal portions and method and apparatus for fabricating the same.

Abstract: Provided are crosslinked polymer compositions that include a first synthetic polymer containing multiple nucleophilic groups covalently bound to a second synthetic polymer containing multiple electrophilic groups. The first synthetic polymer is preferably a synthetic polypeptide or a polyethylene glycol that has been modified to contain multiple nucleophilic groups, such as primary amino (—NH2) or thiol (—SH) groups. The second synthetic polymer may be a hydrophilic or hydrophobic synthetic polymer, which contains or has been derivatized to contain, two or more electrophilic groups, such as succinimidyl groups. The compositions may further include other components, such as naturally occurring polysaccharides or proteins (such as glycosaminoglycans or collagen) and/or biologically active agents.

Abstract: An orthopedic implant device and method is disclosed. Specifically, a knee mold system is disclosed, including elastic tibial and femoral molds, each of which may be configured and dimensioned as a unitary mold for in situ placement during a surgical procedure. Each mold may be manufactured from an elastic material that may be disposable. The tibial mold may further comprise a sidewall forming a cavity, markings for relative depth measurement, and depth rings for use as a guide for scoring, cutting, and/or trimming and tearing away an excess portion of the tibial mold. The femoral mold may further comprise a sidewall defining a cavity, two legs extending from a body of the femoral mold for forming the artificial condyles, and an eyelet for aiding in placement and removal of the femoral mold. The resulting prosthetic tibial and femoral components may form an articulation surface that mimics, at least in part, the natural articulation surface of the knee.

Abstract: A stent having marker tabs formed from a micro-alloyed combination of materials provides for more precise placement and post-procedural visualization in a vessel, by increasing the radiopacity of the stent under X-ray fluoroscopy. A unique micro-alloying process is utilized to form the tabs, comprising a first alloy and a second alloy, wherein one of these alloys is radiopaque. This substantially eliminates the possibility of galvanic action between the tab and the stent. This process is also applicable to other medical devices.

Abstract: An implant is generated which is functionally and aesthetically adapted to the patient with a greater degree of precision, irrespective of the size, form and complexity of the defect, whereby the implant can be produced and operatively inserted into the patient over a short time period and in a simple manner. A virtual three-dimensional model of the patient which is formed from existing recorded (two-dimensional) image data of the patient is compared with real medical reference data. The comparison which is, for example, carried out using a data bank with test person data enables a reference model object which is most suited to the patient or closest to the patient model to be selected or formed and a virtual implant model is generated accordingly. Computer numeric control data is directly generated from the implant model which is generated virtually in the computer for program-assisted production of the implant.

Abstract: A method for manufacturing an endovascular support device comprises positioning a generally tubular member made of an implantable metal and having a generally cylindrical wall in a working relationship with a laser beam. A desired pattern is cut in the generally cylindrical wall in order to produce a stent having a plurality of openings and a plurality of edges. The stent is tumbled in a medium to round its edges and, in turn, to produce more rounded cross-sections of stent elements.

Abstract: A method for forming an implantable medical device, such as a stent, is provided, in which electric discharges are applied to a metal surface of the implantable medical device. The electric discharges pit the surface. The pitted surface improves retention of a coating on the device and increases the amount of coating that can be carried by the device. An electric discharge machining process is described for applying electric discharges to the surface of the implantable medical device or portion thereof.

Abstract: The use of a flexible, foldable or rollable and heatable mat for the manufacture of an orthosis, in which a flat sheet of a thermoplastic material is heated on a flat-laid mat to a temperature at which the sheet softens and can be readily shaped, whereafter the sheet is applied to and shaped on part of a patient's body and then allowed to cool on the patient so as to form a supporting orthosis. The mat can be transported in a rolled-up state or a folded state and laid out on a supporting surface, such as a floor surface in the proximity of the patient. The mat includes a heating element disposed over the area of the mat and functioning to deliver heat uniformly to the sheet.

Abstract: A replacement device for resurfacing a joint surface of a femur and a method of making and installing such a 5 device is provided. The custom replacement device is designed to substantially fit the trochlear groove surface, of an individual femur. Thereby creating a “customized” replacement device for that individual femur and maintaining the original kinematics of the joint. The replacement device may be defined by four boundary points, and a first and a second surface. The first of four points is 3 to 5 mm from the point of attachment of the anterior cruciate ligament to the femur. The second point is near the bottom edge of the end of the natural articulatar cartilage. The third point is at the top ridge of the right condyle and the fourth point at the top ridge of the left condyle of the femur.

Abstract: A graft is provided with a flexible sheet of graft material to which is sewn a reinforcing wire, preferably of shape-memory alloy. Sewing of the wire is carried out while the sheet is substantially planar, thus by conventional embroidery machines. The sheet is subsequently rolled into a tubular shape.

Abstract: An ankle block for a leg prosthesis comprising an insert having a body with an upper mounting surface and a bottom interface surface opposite from the upper mounting surface. The insert body defines a central coaxial hole therethrough. An over mold is formed about an exterior of the body and extends upwardly therefrom defining a central cavity above the insert and above the upper mounting surface.

Abstract: A stent includes a main body of a generally tubular shape for insertion into a lumen of a vessel of a living being. The tubular main body includes a substantially biodegradable matrix having collagen IV and laminin that enclose voids within the matrix. The tubular main body also includes a biodegradable strengthening material in contact with the matrix to strengthen the matrix. The tubular main body is essentially saturated with drugs.

Abstract: A prosthetic ligament and its method of manufacture is provided by which the prosthetic ligament is comprised of a plurality of strands aligned in a parallel lengthwise relationship to form a bundle, with the strands being interwoven at their respective ends while the middle portion of the strands remain unattached to adjacent strands. A predetermined torsion is applied to each strand prior to forming the bundle to create natural coiling in either a clockwise or counter-clockwise orientation. The prosthetic ligament may be used for a posterior or anterior cruciate ligament of the knee joint.

Abstract: A hybrid stent is formed which exhibits both high flexibility and high radial strength. The expandable hybrid stent for implantation in a body lumen, such as a coronary artery, consists of radially expandable cylindrical rings generally aligned on a common longitudinal axis and interconnected by one or more links. In one embodiment, a dip-coated covered stent is formed by encapsulating cylindrical rings within a polymer material. In other embodiments, at least some of the rings and links are formed of a polymer material which provides longitudinal and flexural flexibility to the stent. These polymer rings and links are alternated with metallic rings and links in various configurations to attain sufficient column strength along with the requisite flexibility in holding open the target site within the body lumen. Alternatively, a laminated, linkless hybrid stent is formed by encapsulating cylindrical rings within a polymer tube.

Abstract: A tubular vascular prosthesis with a uniform velour outer layer has an elementary unit of tubing composed of a double velour outer layer, made from polyester yarn, the middle layer, made from two polyester yarns, positioned between two strained polyurethane monofilament yarns and four polyurethane yarn monofilaments, the smooth inner surface and linking of all three layers made of polyester wefts, the between filaments filled with aqueous gelatin-glycerol solution.

Abstract: A method of tissue grafting. Tissue elements are obtained from at least one human body and are enclosed within a retaining structure. The tissue elements with the retaining structure are shaped to form a grafting material having a predetermined configuration. The grafting material is then implanted into a patient.

Abstract: A radiopaque nitinol medical device such as a stent for use with or implantation in a body lumen is disclosed. The stent is made from a superelastic alloy such as nickel-titanium or nitinol, and includes a ternary element selected from the group of chemical elements consisting of iridium, platinum, gold, rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, or hafnium. The added ternary element improves the radiopacity of the nitinol stent comparable to that of a stainless steel stent of the same size and strut pattern coated with a thin layer of gold. The nitinol stent has improved radiopacity yet retains its superelastic and shape memory behavior and further maintains a thin strut/wall thickness for high flexibility.

Abstract: A process for producing implants made of a bioresorbable metal, particularly magnesium alloys or zinc alloys, in which the material properties of the magnesium or the zinc are changed and the processing and utilization properties are improved by combining process steps for adjusting the properties of the material and subsequent machining. In this way it is possible to produce thin-walled tubular implants, particularly blood vessel support stents, from bioresorbable magnesium or zinc alloys, which are readily deformable without the risk of fracture during implantation.

Abstract: The present invention is directed to the field of prosthetic devices. More particularly, one embodiment of the present invention is directed to an artificial disc that can be used as a replacement for an intervertebral disc (e.g., a human intervertebral lumbar disc, a human intervertebral cervical disc and/or a human intervertebral thoracic disc).

Abstract: The present invention provides improvements in methods for the manufacture of stents. Specifically, the invention provides methods wherein stents are placed on jigs of various designs which facilitate manufacture, stents carried by the jigs are immersed in liquid baths which contain an electrolyte, the stents are urged into contact with their associated electrodes while current is applied to those electrodes, and wherein the positions of contact between the stents and their respective electrodes are altered during processing without removing the stents from the jig. The method is applicable for electropolishing and electroplating.

Abstract: A method of forming prosthetic limbs is disclosed. A preferred embodiment of practicing the invention comprises the basic steps of scanning a portion of a residual limb on which a prosthetic device is to be attached, creating a digital representation of a socket portion of the prosthetic device using the scanned information, and creating the socket out of physical material using a digitally controlled layered manufacturing technique driven by the digital representation of the socket.

Abstract: A prosthetic socket having a self-contained vacuum reservoir chamber includes a rigid, load-bearing inner socket member for receiving a residual limb and an outer, rigid, load-bearing wall section attached to the inner wall section in a manner providing a vacuum reservoir chamber between the inner wall and the outer wall section. The vacuum reservoir chamber communicates with the inner volume of the inner wall through a vacuum transfer port and the vacuum reservoir chamber may be evacuated via an evacuation port having an appropriate one-way check valve permitting withdrawal of air from the vacuum reservoir chamber while preventing ingress of air into the chamber. A method for making the prosthetic socket is disclosed.

Abstract: The invention concerns a metal object for medical or surgical use, such as a prosthesis, for example an endovascular prosthesis (called stent) for percutaneous transluminal coronary angioplasty, comprising a metal substrate whereof the surface is coated partly at least with a polysaccharide compound. The invention is characterised in that the polysaccharide compound is covalently bound, via a plurality of grafting arms, comprising each at least a silane unit, bound on one side to the metal substrate by an —O— metal bond, and on the other side, directly or indirectly, by a covalent —NH— bond, with the polysaccharide compound.

Abstract: The stent with improved surface adhesion of the present invention increases adhesion between a stent and a coating by including a silane layer between the stent and the coating. The silane layer improves the wettability of the stent for application of a liquid coating and increases the coating adhesion. A coated stent can be manufactured by applying a silane solution to a stent by spraying or dipping the stent to form a silane layer on the stent surface, curing the resulting silane layer in an inert atmosphere, and applying a coating to the silane layer. In one embodiment, an amino silane can be used with a stainless steel stent.

Abstract: A method of manufacturing a bearing component for use in arthroplasty for cooperation with a first and a second component includes the step of providing a non-linear support of a durable material having. The method further includes providing a molding die for manufacturing the bearing component having first and second mold portions. The first mold portion provides a first surface for cooperation with the first joint component and the second mold portion provides a second surface for cooperation with the second joint component. The method includes positioning the support in a desired position within the molding die with the first end or the second end located in the first mold portion, adding moldable material into the molding die, surrounding the support with the moldable material, heating and pressurizing the moldable material, permitting the moldable material to cool, and removing the component from the molding die.

Abstract: An implantable endoluminal device which is fabricated from materials which present a blood or body fluid and tissue contact surface which has controlled heterogeneities in material constitution. An endoluminal stent which is made of a material having controlled heterogeneities in the stent material along the blood flow surface of the stent and the method of fabricating the stent using vacuum deposition methods.

Abstract: The present invention provides monofocal ophthalmic lenses that exhibit extended depth of field while providing sufficient contrast for resolution of an image over a selected range of defocus distances. In some embodiments, a lens of the invention can include a refractive surface having controlled surface modulations relative to a base profile. The surface modulations are designed to extend a depth of field of the lens such that a single image can be resolved, albeit with somewhat less contrast, over a range of distances greater than the focal region of a conventional lens. The ophthalmic lenses of the invention can be employed in various vision correction applications, including, but not limited to, intraocular lenses, contact lenses, instrastromal implants and other refractive devices.

Abstract: An implant is provided for replacing a portion of an articular surface. The implant includes a body portion having a recess. An insert is disposed in the recess. The body portion and insert provide a load bearing surface of the implant, with the load bearing surface including regions of the insert and regions of the body portion. The insert may be formed from a lubricious and shock absorbing material, providing a low friction and shock absorbing region of the load bearing surface.

Abstract: There is disclosed a method of making an intraocular lens having first and second viewing elements. The viewing elements are interconnected by a plurality of translation members extending from a periphery of the first viewing element. At least one of the translation members comprises a plurality of arms, and at least one of the viewing elements includes an optic having refractive power. The method comprises providing a first outer mold and a second outer mold, and an inner mold therebetween. The first outer mold and the inner mold define a first mold space, and the second outer mold and the inner mold define a second mold space. The method further comprises molding the viewing elements, the plurality of arms and the optic as a single piece by filling the first and second mold spaces with a material, such that the first viewing element and the plurality of arms are formed in the first mold space and the second viewing element is formed in the second mold space.