Abstract: The invention is directed to an expandable stent for implantation in a body lumen, such as an artery, and a method for making it from a single length of tubing. The stent consists of a plurality of radially expandable cylindrical elements generally aligned on a common axis and interconnected by one or more interconnective elements. The individual radially expandable cylindrical elements consist of ribbon-like material disposed in an undulating pattern. Portions of the expanded stent project outwardly into engagement with the vessel wall to more securely attach the stent.

Abstract: A bioprosthetic stent graft is disclosed, having a stent frame and a biomaterial sheath suturelessly bonded to the stent frame. Sutureless bonding avoids sutures and substantially reducing medical complications in implantation of the stent graft.

Abstract: A bioprosthetic valve graft comprises a valve frame and valve flaps, the latter acting to open or close a valve aperture to directionally control fluid flow through the bioprosthesis. The bioprosthetic valve graft comprises a biomaterial suturelessly bonded to the valve frame, avoiding sutures and substantially reducing medical complications in implantations.

Abstract: A prosthesis is disclosed at least of the surface of which is of metal, said metal being covered by a layer of aluminium oxide which comprises phosphate and/or pores containing bioactive material, optionally with a layer of aluminium or an alloy thereof between the metal and the porous aluminium oxide layer.

Abstract: A vascular prosthesis is constructed from a well-defined pore structure to allow uninterrupted ingrowth of connective tissue into a wall of the prosthesis. Several different methods can be used to produce the prosthesis, including a vacuum impregnation technique, a paste molding technique, a paste extrusion technique, a dip coating technique, and a melt extrusion technique. Furthermore, mechanical properties of the prosthesis are matched with mechanical properties of the host vessel, thereby overcoming problems of compliance mismatch.

Abstract: A method is disclosed for making vascular prostheses from ePTFE said prostheses having a diameter which is larger, and a wall thickness which is smaller than previously achievable using ram extrusion techniques. The method consists of extruding a PTFE tube, finish processing the tube into an ePTFE tube, laterally dilating it by expansion in incremental steps, calendering the tube after each dilating step, while the tube is being maintained at an elevated temperature. Once the tube is dilated it can be sintered with another tube to form a laminate. Alternatively, a wire stent may be joined with one or more tubes, thereby biasing the laminate to a cylindrical configuration.

Abstract: A method for fabricating a foam cosmetic cover for a prosthetic component. The steps comprise selection of an appropriate prosthetic component, collecting data regarding its shape from a replica of the prosthetic component, converting the data into the dimensions of two halves of an interior cavity, and providing this data to a computer-controlled milling machine. The computer-controlled milling machine then cuts a portion of one-half of the cavity into one side of the block and a portion of the other half of the cavity on the opposed side of the block. The cutting head is then advanced longitudinally so that additional portions of the cavity can be cut into the opposing sides of the block. The block is then removed from the milling machine and cut in half longitudinally between the indentations in the sides of a block. The two halves of the block are then attached to one another to form a cavity having the general shape of the prosthetic component.

Abstract: The present invention relates generally to intervertebral disc repair devices and methods of manufacture. A method of manufacturing a dynamically responsive encapsulated intervertebral disc repair device that prevents the flow of disc material out of the disc, provides support to the anulus fibrosus, and shields the nerves of the anulus and spinal cord, is provided.

Abstract: Method for producing a medical support device from an object, using an electromagnetic field generator, whereby the method comprises of the steps of placing a formation mandrel against the object, close to a predetermined formation area, and applying the electromagnetic field to the formation area, thereby forming the object. The produced object can be made from a tubular segment, a folded sheet of material or a plurality of wires joined together.

Abstract: A framework assembly that supports a prosthesis and passively fits onto implants embedded in a bone. The framework assembly comprises a first abutment attachable to a first implant and a second abutment attachable to a second implant. The first abutment is attachable to the second abutment by a joint which causes the first abutment to be moveable relative to the second abutment. The framework assembly may also include additional abutments connected to the first and second abutments by either a rigid connecting segment or another joint.

Abstract: An implantable textile prosthesis which is anatomically curved to substantially match the natural curvature of the aortic arch in a human being or patient is provided. The first woven section is arched define an apical region and to conform generally to an aortic arch of a human patient. A plurality of elongate woven tubular extents extend vertically from a top wall portion at the apical region of the tubular main wall. These tubular extents are sutured to the first woven section to provide fluid communication between the tubular main wall and the tubular extents.

Abstract: A cortical bone implant is formed of two or more planks of bone which are connected with one or more offset pins. The pins may be right circular cylinders inserted into a corresponding offset bore which offset bends the inserted pin. The bending creates compression and tensile loads in the pin which loads creates friction compression forces on the planks connecting them to the pins by friction. The pins may have different shapes to form the offsets and different configurations for friction attachment to the planks. The implants may be formed of flat or L-shaped planks or bones formed into other shapes including interlocking arrangements. Processes and fixtures are disclosed for forming the pins, planks and implants. Various embodiments of the pins, planks, implants and processes are disclosed.

Abstract: The present invention provides synthetic, biocompatible, bioabsorbable, porous foam tissue scaffolds possessing physicochemical properties suitable for use in the repair and regeneration of dermal tissue and to methods of preparing such foam scaffolds.

Abstract: A radiopaque nitinol stent for 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 including tungsten. The added tungsten in specified amounts improve the radiopacity of the nitinol stent comparable to that of a stainless steel stent of the same strut pattern coated with a thin layer of gold. Furthermore, 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: Partially encapsulated stents are made using strips and bands of covering material. In one embodiment ringed stents are placed over an inner ePTFE tube (e.g., supported on a mandrel) and are covered by a series of longitudinal strips. A series of spaced apart ePTFE circumferential bands can then be placed over the top of the longitudinal strips and ringed stents; alternatively bands alone or strips alone may be employed. All of the components of the structure are then laminated to the inner ePTFE tube to capture the stent. By selecting the size and position of the ePTFE bands, it is possible to leave critical parts of the stent unencapsulated to facilitate flexibility and expansion. The longitudinal strips can be woven about the stent and later laminated into position to provide an anti-compression function as well as overall structural stability. Although a single stent can be used, these approaches lend themselves to use of a plurality of individual ring stents spaced apart along the inner ePTFE tube.

Abstract: A vascular implant formed of a compressible foam material has a compressed configuration from which it is expansible into a configuration substantially conforming to the shape and size of a vascular site to be embolized. Preferably, the implant is formed of a hydrophilic, macroporous foam material, having an initial configuration of a scaled-down model of the vascular site, from which it is compressible into the compressed configuration. The implant is made by scanning the vascular site to create a digitized scan data set; using the scan data set to create a three-dimensional digitized virtual model of the vascular site; using the virtual model to create a scaled-down physical mold of the vascular site; and using the mold to create a vascular implant in the form of a scaled-down model of the vascular site. To embolize a vascular site, the implant is compressed and passed through a microcatheter, the distal end of which has been passed into a vascular site.

Abstract: Intraluminal prosthesis comprising a tubular trunk element (1), which is radially expandable and compressible and which axially has a cavity (2) open at its two ends and divided into several axial channels (7, 8), and at least one branch element (13) which is radially expandable and compressible and which axially has a cavity open at its two ends, being, in its compression position, independent of the trunk element and having, in the expansion position, one end within one of the said axial channels and another end outside the trunk element.

Abstract: A method of forming an elongated graft element includes procuring a tubular tissue from a mammal, with the tubular tissue having a longitudinal axis, and a distal edge and a proximal end on opposing ends of the longitudinal axis. Thereafter, the tubular tissue is split along a line that is parallel to the longitudinal axis to form a sheet, and the distal edge and the proximal edge are approximated towards each other to form an elongated graft element. The elongated graft element has a longitudinal axis that comprises the circumferential orientation of the tubular tissue, with the circumferential orientation being transverse to the longitudinal axis of the tubular tissue.

Abstract: A preform for making a prosthetic limb socket includes an injection molded flat circular disk of rigid thermoplastics material, and the disk has a peripheral portion with an embedded reinforcing ring which was spaced as an insert within the mold cavity. The preform is heated within an oven on a flat surface support ring, and the softened disk is manually drawn and stretched downwardly over a positive model of a residual limb while vacuum is introduced through small holes within the model to form a plastic socket which conforms to the positive model. After the plastic cools, the annular base portion of the disk with the embedded reinforcing ring is trimmed from the socket, and the model is removed from the socket.

Abstract: Textured surface having micro recesses such that the outer surface overhangs the micro recesses. Embodiments of the textured surface include sharp edges for promoting bone deposition and growth within the micro recesses, protrusions of varying depth from the surface that include overhangs, and micro recesses that are at least partially defined by complex ellipsoids.

Abstract: An implantable device or endoluminal prosthesis, such as a stent, having a sheath and a method of forming the sheath are provided. The sheath may be used for the delivery of an active ingredient. The sheath may have a selected pattern of interstices for allowing a fluid to seep through the sheath in the direction of the pattern created.

Abstract: Expandable heart valves for minimally invasive valve replacement surgeries are disclosed. The valves are rolled into a first, contracted configuration for minimally invasive delivery using a catheter, and then unrolled or unfurled at the implantation site. One- and two-piece stents may be used in conjunction with a plurality of flexible leaflet-forming membranes. The stents may include an annulus section, a sinus section with the membranes attached over sinus apertures, and an outflow section. Lockout tabs and making slots secure the stents in their expanded shapes. Alignment structure ensures concentric unfurling of the stent. Anchoring elements at the stent edges or in the stent body secure the valve within the annulus. A method of manufacture includes shape setting the sheet-like stent to ensure an outward bias during deployment. The stent may also include dear tracks for engagement with a gear mechanism for deployment.

Abstract: Cermet comprising ceramic and metal components and a molten metal infiltration method and process for fabrication thereof. The light weight cermets having improved porosity, strength, durability, toughness, elasticity fabricated from presintered ceramic powder infiltrated with a molten metal or metal alloy. Alumina titanium cermets biocompatible with the human body suitable for bone and joint replacements.

Abstract: Solid free-form (SSF) techniques for making medical devices for implantation and growth of cells from polymers or polymer/inorganic composites using computer aided design are described. Examples of SFF methods include stereo-lithography (SLA), selective laser sintering (SLS), ballistic particle manufacturing (BPM), fusion deposition modeling (FDM), and three dimensional printing (3DP). The devices can incorporate inorganic particles to improve the strength of the walls forming the pores within the matrix and to provide a source of mineral for the regenerating tissue. The devices can contain tissue adhesion peptides, or can be coated with materials which reduce tissue adhesion. The macrostructure and porosity of the device can be manipulated by controlling printing parameters. Most importantly, these features can be designed and tailored using computer assisted design (CAD) for individual patients to optimize therapy.

Abstract: The present invention features a regenerative bone implant. The implant includes a biocompatible and biodegradable matrix having pores, and a biocompatible and biodegradable biopolymer disposed in the pores and covalently bonded to the matrix. Optionally, the implant can further include a bone formation promoter that is also disposed in the pores and can be covalently bonded to the matrix.

Abstract: The method for manufacturing a blood filter adapted to be disposed in a blood vessel comprises, in the invention, the steps of a) providing a thin wall comprising a biocompatible material, b) producing in said thin wall a series of essentially parallel elongated sections, for defining the elongated legs, and having the elongated legs joined to each other, at a first end of the elongated sections, wherein step b) comprises the steps of producing adjacent essentially parallel strips comprising a first strip and a second strip separated by a slot, the strips extending essentially parallel the axis and each slot being interrupted at a distance from a second end of the elongated sections, so that the first and the second strips are connected to each other at said second end, by a continuous zone of said thin wall, and having the first strip of the elongated sections joined to each other, at said first end thereof.

Abstract: The invention relates to a liquid or pasty organosiloxane based composition autopolymerizing into a permanently elastic silicon at ambient temperature. This composition is used for producing intervertebral disc implants that restore to a large extent the physiological range of movement of the intervertebral discs.

Abstract: A method for the repair of a cartilagenous tissue defect, a cartilage repair device and a method of making a cartilage repair device are disclosed. In the method for the repair of a cartilagenous tissue defect, a device comprising a scaffold, for example an extracellular matrix material, is implanted into the defect, and a biological lubricant is administered to the defect. The device comprises a scaffold, for example a naturally occurring extracellular matrix material, and a biological lubricant.

Abstract: A process of manufacturing tissue implant products with optimum use of material from irregularly shaped tissue stock. Also disclosed is a process of imaging tissue used for implant manufacture wherein data obtained from an imaging device, interfaces with a computer software system to create a production-yield analysis. By automating the evaluation and allocation processes associated with manufacture of implants, the current invention maximizes the amount of tissue recovered from donated samples, increases processing efficiency, decreases cost of production by eliminating the need for post machining sterilization, and improves the quality of product produced.

Abstract: A bifurcated stent for insertion into a bifurcated vessel such as a blood vessel. In one embodiment, a first sheet is formed into a first leg, a second sheet is formed into a second leg, a third sheet is formed into a stem, and the two legs are attached to the stem. In a second embodiment, a first sheet is formed into a member having a first leg and half of a stem, a second sheet is formed into a second member having a second leg and half of a stem, and the two stem halves are combined to form the bifurcated stent. In a third embodiment, the stent comprises two sections that are serially inserted and assembled within the vessel at the site of the bifurcation to be treated.

Abstract: A method of making a one-piece intraocular lens formed from a copolymer of a hydrophilic monomer and an alkoxy-alkylmethacrylate. The intraocular lens is foldable so as to be insertable through a small incision in the eye. Copolymers of the lens have an equilibrium water content of from about 10 to about 38 percent by weight based on the total weight of the hydrated copolymer.

Abstract: A method of cutting material for use in an implantable medical device employs a plotted laser cutting system. The laser cutting system is computer controlled and includes a laser combined with a motion system. The laser precisely cuts segments out of source material according to a predetermined pattern as designated by the computer. The segments are used in constructing implantable medical devices. The cutting energy of the laser is selected so that the cut edges of the segments are melted to discourage delamination or fraying, but communication of thermal energy into the segment beyond the edge is minimized to avoid damaging the segment adjacent the edge.

Abstract: A stent-graft assembly having a thin-walled membrane and method of preparing the same are disclosed. In a first embodiment, the assembly comprises a stent, a coating and a porous membrane, wherein the membrane is less than 0.040 inch thick or less. Portions of the coating extend into the pores of the thin membrane to sealingly engage the membrane to achieve secure adhesion. In a second embodiment the coating and thin membrane bond to form a homogenous structure. In an alternative embodiment, the assembly comprises an inner and outer thin membrane bound to one another through the interstices of the support member and a coating at the proximal and distal regions. In any of the foregoing embodiments, the proximal and distal regions of the stent-graft assembly may comprise an additional coating, whereby layers of material are sealed, thereby minimizing thrombogenic potential of free ends of the assembly.

Abstract: The invention is directed to an expandable stent for implantation in a body lumen, such as an artery, and a method for making it from a single length of tubing. The stent consists of a plurality of radially expandable cylindrical elements generally aligned on a common axis and interconnected by one or more interconnective elements. The individual radially expandable cylindrical elements consist of ribbon-like material disposed in an undulating pattern. Portions of the expanded stent project outwardly into engagement with the vessel wall to more securely attach the stent.

Abstract: A joint prosthesis (10) including a first component (12)for cooperation with a first long bone (14) and a second component (16) for cooperation with a second long bone (20) is provided. The joint prosthesis (10) also includes a bearing component (222) positionable between the first component (12) and the second component (16) and cooperable with the first (12) and second (16) components. The bearing component (222) has a reinforcing component (236) having a first end (286) and a second end (294) and a polymeric material (207). The polymeric material (207) surrounds at least 99% of the surface area of the reinforcing component (236) and is molded to the reinforcing component (236) so that the material may be sterilized by a predominately surface sterilizing technology. The bearing component (222) defines a first peripheral region (271) and a second peripheral region (282).

Abstract: A method of transplanting human body tissue. Tissue elements are obtained from a human donor and are interconnected at a location remote from an operating facility to form an article to be implanted. The article is then transported to an operating facility where it is implanted into a patient.

Abstract: A hernia repair prosthesis with an occlusive member for inserting into and/or backing the herniated tissue. The occlusive member is convertible from a first configuration with a first axial length and first major radial extent to a second configuration with a second axial length and a second major radial extent. The second axial length is less than the first axial length and the second major radial extent is larger than the first major radial extent. The occlusive member has a pair of subsections, each having an apex, lands and pleats and each flaring outwardly therefrom towards a terminal end. The apexes are disposed at opposite ends of the occlusive member with the terminal ends overlapping. The pair of subsections are conjoined proximate the overlapping terminal ends. The terminal end of one or both of the subsections may be in the form of a conic flange mimicking the lands and pleats of the other subsection providing automatic alignment and nesting to aid in the attachment of the two subsections.

Abstract: A two-layer external breast prosthesis comprising a first inner layer comprised of a self-shaping dispersion and a second outer layer comprised of an elastic material, wherein the second outer layer is relatively stiffer than the first inner layer.

Abstract: A lock adapter is adapted to connect a residual limb liner with locking pin to a transfemoral prosthetic limb. The lock adapter is formed of a bracket having a first end and a second end, and preferably has a generally S-shaped configuration. The first end of the bracket has a first mounting face against which the lock is to be secured. The second end of the bracket is provided with a second mounting face against which the prosthetic limb is to be secured. The bracket being is formed so that the first and second mounting faces are spaced apart from one another, and may optionally be angled relative to one another. Methods of forming transfemoral test and final sockets are provided.

Abstract: The surface of a device that is surgically implantable in living bone is prepared. The device is made of titanium with a native oxide layer on the surface. The method of preparation comprises the steps of removing the native oxide layer from the surface of the device and performing further treatment of the surface substantially in the absence of unreacted oxygen.

Abstract: An orthopedic implant is formed from a sheet of moldable material such as a polymer or a bioresorbable material using an instrument. The material is heated above its glass transition temperature so that it can be formed into the desired shape of the implant. Then the material is cooled below its glass transition temperature to harden the material such that it retains the implant shape. During surgery, a surgeon can form implants to fit unique orthopedic applications by using instruments having various internal and external mold forms between which the sheet of moldable material can be rolled, wound, pressed or drawn.

Abstract: The present invention relates to a method for creating shaped implants, such as intraocular lenses in vivo, as well as the novel implants themselves. Utilizing the method of the invention, it is possible to create an implant in vivo and to adjust either the physical properties such as refractive index, viscosity, etc., mechanical properties such as modulus, tensile strength, tear, etc., or the shape of the implant by noninvasive means. For example, using the method of the patent it is possible to create an intraocular lens in vivo and then adjust the shape and power of the lens through no invasion means. The novel implants are also addressed in this application.

Abstract: A method for manufacturing a prosthetic heart valve. An elastic valve body and at least one leaflet are formed on a mold. The leaflet has a free edge which is formed by the mold without cutting the leaflet at the free edge.

Abstract: A double-sheet stent for insertion into a lumen of a vessel of living being, comprises constructive elements, preliminary formed in a shape of the two mainly similar stencils I and II on the surface of the two thin sheet metallic blanks. The stencils I and II are preliminary superimposed one on another in order to be shifted for a winding outline width along the stent longitudinal axis and to form the alternating winding outlines pairs. One pair of the winding outlines is executed by a simple superimposing of the stencil I winding outline (12) on the stencil II winding outline (14), whereas the winding outlines pair, neighboring to it, is performed by the superimposing of the stencil II winding outline (15) on the stencil I winding outline (13). The stencil II winding outlines are passed through the slots between the stencil I winding outlines as to make the formed semicircles be located in turns in the stent expanded shape.

Abstract: A device which can be implanted in the body and comprises an electrically conducting support covered with a layer of electrically conducting polymer, to which layer is attached at least one biologically active substance of an anionic or cationic nature. The deposition of the polymer is carried out, in a first stage, by electropolymerization directly directly on the support or, according to an alternative form, by deposition of the polymer in solution on the support. In a second stage, electrochemical oxidation or reduction is conducted and the biologically active substance with an anionic or cationic nature is attached to the polymer.

Abstract: A method for producing a medical device, such as a prosthetic or orthotic structure which makes the procedure more widely available at less cost. The method involves making a model of the body part for which a medical structure is to be manufactured using conformable fabric impregnated with a settable resin. The model may be prepared by a physician or a prosthetist who has no direct access to an expensive digitizing scanner. The model is removed from the patient's body part and shipped to a scanning facility where a digitizing scanner is used to produce a digitized image of the model. The digitized image is shrunk to compensate for the thickness of the model and the digitized data file is preferably sent back to the physician or prosthetist who manipulates the digitized image using a customized software program to produce a modified data file.

Abstract: A donor heart valve sizer and method of sizing to increase the quality and yield of, and decrease the expense of fabricating, prosthetic heart valves. The sizer includes an axially-extending sizing portion sized to fit within the lumen of a donor heart valve. The sizing portion may be conical such that a resistance to further insertion is felt when the exterior of the sizing portion contacts the annulus of the valve. A measuring bracket attached to the sizing portion includes a scale aligned with the sizing portion that indicates the final expected valve size based on the position of the fresh donor valve on the sizing portion. The measuring bracket includes regions of acceptable valve sizes, and may also include regions of unacceptable valve sizes. A method of sizing includes utilizing the sizer in the slaughterhouse to reduce the overall number of valves shipped to the valve assembly facility to obtain a particular valve size.

Abstract: A method and apparatus for forming an impression of a socket used in a prosthetic device. The impression is formed using a blank formed of a material which is malleable at low temperatures. The blank is inserted inside the socket and heated so that the blank assumes a molded shape which conforms to the shape and size of the socket. The molded blank is then cooled and removed from the socket. The blank material has a sufficient flexibility to allow the molded blank to deflect or bend significantly during removal yet return to its molded shape. The molded blank may then be used to form a new socket.

Abstract: A process for fabricating shaped material from demineralized bone particles includes the steps of applying a liquid slurry of demineralized bone particles to a support, removing excess liquid form the demineralized bone particles to provide a cohering shaped mass of demineralized bone particles, and warming the shaped mass of demineralized bone particles at a predetermined temperature and for a predetermined time period. The resultant bone mass exhibits enhanced tensile strength and minimal bone particle disassociation upon rehydration thereby improving product handling and application at the operative site.

Abstract: A stent for occluding the human ductus arteriosus comprises a length of wire of shape memory effect or superelastic material which is expandable from a relatively straightened state for introduction into the patient to an occluding state wherein the wire defines an occluding anchor part and a spiral anchor part and a straight linking part connecting the two wherein the wire has a series of turns extending over the cross-sectional area of the occluding anchor part.