Abstract: Described embodiments are directed toward centrally-opening leaflet support devices having a frame and one or more support leaflets coupled to the frame forming a hinge where coupled. The described support leaflets have one or more stiffer regions that facilitate the function of a support leaflet to decrease or prevent prolapse of a native valve leaflet. Methods of making and using such valve devices are also described amongst others.

Abstract: A prosthetic heart valve, for example a tricuspid valve, may include a flexible membrane and a frame. The frame may be attached to the periphery of the tricuspid orifice. The diaphragm may be attached to the frame around a part of the perimeter of the orifice. Optionally the frame may be flexible. For example the frame may elastically flex between a substantially circular shape and/of an elliptical and/or crescent shape. Optionally there may not be a stiff cross piece crossing a central region of the orifice and connected on opposing sides of frame. In some embodiments, the diaphragm may take a dome shape during systole.

Abstract: A repair structure apparatus for cardiac surgery is disclosed. The repair structure apparatus includes a fluid reservoir and a platform comprising a porous surface in communication with the fluid reservoir, with a port in communication with the porous surface. The apparatus includes a cutting template configured to align with the platform and a slicing sled configured to engage the platform. A cutting template for constructing a repair structure for cardiac surgery is further disclosed. The cutting template includes a frame having at least one arcuate lobe; and at least one sharpened edge. A device for constructing a repair structure for cardiac surgery is also disclosed, wherein the device includes a porous platform. A repair structure for cardiac surgery is disclosed. The repair structure includes a tissue sheet, wherein the tissue sheet is folded along a free edge of the tissue sheet.

Abstract: A prosthetic heart valve may include an expandable stent, a cuff attached to an annulus section of the stent, and a plurality of leaflets disposed within an interior region of the stent and attached to at least one of the cuff or the stent. The stent may have a plurality of cells connected to one another in a plurality of annular rows around the stent. The leaflets together may have a coapted position occluding the interior region of the stent and an open position in which the interior region is not occluded. Each leaflet may include a primary leaflet material, as well as features that reinforce specific regions of the leaflet.

Abstract: A heart valve replacement device comprises a stent having a first end, a second end, an outer surface, and an inner surface, the inner surface defining a lumen; and a valve disposed within the lumen of the stent, the valve formed from a single sheet of tissue, the valve having an outer surface, an inner surface, and a thickness between the outer surface and the inner surface, the valve comprising at least three leaflets, wherein, the valve is attached to the stent with minimal sutures. The leaflets are formed with a curvilinear surface.

Abstract: An apparatus and modeling method of the present invention includes the successive steps of generating cartographic data representative of points belonging to a glenoid surface; distinguishing from among the cartographic data a first group of cartographic data corresponding to a first part of the glenoid surface, the first surface part being situated farthest down in the vertical direction in relation to the scapula; calculating from the first group of cartographic data a first ellipsoid portion that coincides substantially with the first surface part; and obtaining a theoretical glenoid surface from the first ellipsoid portion. By virtue of the theoretical glenoid surface obtained by this method, it is possible to assist the surgeon in optimizing the position of implantation of a glenoid component and to produce a glenoid component “made to measure” for the scapula that is to be fitted with a prosthesis.

Abstract: Disclosed herein is a surgical guide tool for use in total hip replacement surgery. The surgical guide tool may include a customized mating region and a resection guide. The customized mating region and the resection guide are referenced to each other such that, when the customized mating region matingly engages a surface area of a proximal femur, the resection guide will be aligned to guide a resectioning of the proximal femur along a preoperatively planned resection plane.

Abstract: Systems and methods for computer-aided alignment and positioning of a prosthesis component onto a target host bone, such as in joint resurfacing arthroplasty, are discussed. A system for can include a processor unit and a user interface unit. The processor unit can receive a target bone model including a first data set representing a target bone surface, and a prosthesis model including a second data set representing a prosthesis surface. The prosthesis, when positioned against the target bone, is configured to at least partially replace the articulation surface. The processor unit can generate an articulation interface representation that indicates spatial misalignment between one or more portions of the prosthesis surface and one or more portions of the target bone surface when the prosthesis model is positioned against the target bone model.

Abstract: Examples associated with three-dimensional model generation are disclosed. One example includes analyzing a structure of a first component of an object. The composition of the first component of the object is also analyzed. A three-dimensional model of the object is then generated. The three-dimensional model includes data based on the structure of the first component of the object and data based on the composition of the first component of the object.

Abstract: Disclosed herein is a surgical guide tool for use in total hip replacement surgery. The surgical guide tool may include a customized mating region and a resection guide. The customized mating region and the resection guide are referenced to each other such that, when the customized mating region matingly engages a surface area of a proximal femur, the resection guide will be aligned to guide a resectioning of the proximal femur along a preoperatively planned resection plane.

Abstract: A non-transitory, tangible, computer-readable storage media may contain a program of instructions that causes a computer system having a processor running the program of instructions to: receive design information indicative of the design of a three-dimensional object to be printed by a three-dimensional printer; receive test product deformation information indicative of deformation in the profiles of no more than five, three-dimensional test products that have a circular or polygonal cross section that were made by the three-dimensional printer; generate polygon product deformation information indicative of a predicted deformation of a polygon shape that the three-dimensional printer will print and that has a number of sides and a number of sizes that are both different from each of the number of sides and number of sizes that the no more than five, three-dimensional test products have; and generate adjustment information indicative of an adjustment needed to print a desired profile of the polygon shape that

Abstract: In a method and system for producing an implant, the latter is designed with one or more surfaces extending in the longitudinal direction of the implant. Two or three production stages can be used. In one stage, either a topography with a long wave pattern is produced by means of cutting work, or laser bombardment or further cutting work is used to produce a topography with an intermediate-length wave pattern. In addition, an oxidation process or shot-peening or etching is used to produce an outer layer. When using two of said production stages, said cutting work or said laser bombardment or further cutting work is followed by the oxidation process or the shot-peening or etching method. When using all three production stages, cutting work is followed by laser bombardment, or further cutting work, which in turn is followed for example by the oxidation process. The invention also relates to an implant which is produced using the method and is identified, ordered and produced using the system.

Abstract: Methods, systems, and devices are provided for guiding surgical instruments using radio frequency (RF) technology. In general, the methods, systems, and devices can allow a trajectory, e.g., an angular approach, of a surgical instrument relative to a patient to be identified during use of the instrument in a surgical procedure being performed on the patient. The trajectory can be identified using a plurality of RF modules. The methods, systems, and devices can allow the trajectory to be compared to a predetermined trajectory so as to identify whether the trajectory matches the predetermined trajectory. A result of the matching can be communicated to a user of the instrument. Based on the result, the user can maintain the trajectory, e.g., if the trajectory matches the predetermined trajectory, or can adjust the trajectory to closer align the trajectory with the predetermined trajectory, e.g., if the trajectory does not match the predetermined trajectory.

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: The present invention provides methods of improving the osteogenic and/or chondrogenic activity of a bone matrix, e.g., a dermineralized bone matrix (DBM), by exposing the bone matrix to one or more treatments or conditions. In preferred embodiments the bone matrix is derived from human bone. The treatment or condition may alter the structure of the bone matrix and/or cleave one or more specific proteins. Cleavage may generate peptides or protein fragments that have osteoinductive, osteogenic, or chondrogenic activity. Preferred treatments include collagenase and various other proteases. The invention further provides improved bone and cartilage matrix compositions that have been prepared according to the inventive methods and methods of treatment using the compositions. The invention further provides methods of preparing, testing, and using the improved bone matrix compositions.

Abstract: A stent for placement in a body lumen is fabricated by forming a tube having an un-deployed diameter sized for the tube to be placed on a deployment balloon and advanced through a body lumen to a deployment site. The tube is expandable upon inflation of the balloon to an enlarged diameter sized for the tube to be retained within the lumen at the site upon deflation and withdrawal of the balloon. The tube has a stent axis extending between first and second axial ends of the tube. The tube has an exterior surface and an interior surface. The tube is polished to polish the exterior surface to a smooth surface finish and with at least a portion of the interior surface having a rough surface finish rougher than the surface finish of the exterior surface.

Abstract: A flexible laminate formed from at least a first layer comprising a first flexible elastomer and a second layer comprising a second flexible elastomer, which are connected to one another by an intermediate layer. The intermediate layer comprises parylene and is applied to the first layer such that the intermediate layer has an irregular surface with irregularities. The second flexible elastomer or an adhesive connected to the second layer is applied in liquid form to the intermediate layer such that the irregularities the intermediate layer are at least partially filled.

Abstract: An orthopedic implant includes a first portion including at least one feature modified to be patient-specific and match the anatomy of a specific patient from a three-dimensional digital image of a patient's joint using computer modeling. The orthopedic implant includes a non-custom inner bone-engaging surface including a plurality of planar surfaces configured for engagement with non-custom bone cuts.

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: A replacement device for resurfacing a joint surface of a femur and a method of making and installing such a 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 top surface is designed so as to maintain centrally directed tracking of the patella perpendicular to the plane established by the distal end of the femoral condyles and aligned with the center of the femoral head.

Abstract: A replacement device for resurfacing a joint surface of a femur and a method of making and installing such a 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 top surface is designed so as to maintain centrally directed tracking of the patella perpendicular to the plane established by the distal end of the femoral condyles and aligned with the center of the femoral head.

Abstract: A replacement device for resurfacing a joint surface of a femur and a method of making and installing such a 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 top surface is designed so as to maintain centrally directed tracking of the patella perpendicular to the plane established by the distal end of the femoral condyles and aligned with the center of the femoral head.

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

Abstract: Medical devices, such as endoprostheses, and methods of making the devices are disclosed. The medical device can include a composite cover formed of a deposited metallic film. The cover may include one or more filaments, e.g., wires, which cooperate with the film to provide desirable mechanical properties. The wires may be integrated with the film by depositing the film over the wires.

Abstract: In one embodiment, a method for treating an infected implant area of a knee joint comprises surgically accessing the implant area, and inserting a tibial component into the tibia using an antibiotic-impregnated material. A femoral component is formed that is configured to interact with the tibial component by stable knee joint articulation and motion. The femoral component is formed of an antibiotic-impregnated material using a mold. The femoral component is attached to the femur using an antibiotic-impregnated material, and the tibial component is interfaced with the femoral component to form a stable temporary knee joint capable of reducing the spread of infection while permitting movement of the knee joint.

Abstract: An implant for repair of a cartilaginous defect in a subject includes a collagen matrix charged with synovial cells. A method preparing an implant for repair of a cartilaginous defect in a subject includes obtaining a fluid containing synovial cells and charging the synovial cells to the matrix. A device for preparing a cell-charged implant includes a first chamber and a second chamber, the first and second chambers being separated by a membrane and a perforated filter. The membrane is adapted to collect cells from a cell-containing fluid introduced into the first chamber and the perforated filter is adapted to permit passage or diffusion of the fluid through the second chamber. A method for preparing a cell-charged implant utilizes the device.

Abstract: A replacement device for resurfacing a joint surface of a femur and a method of making and installing such a 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 method for making an encapsulated stent includes providing a first seamless unsintered ePTFE tube, providing a second seamless unsintered ePTFE tube, positioning a balloon-expandable stent between the first and second ePTFE tubes to form an assembly, disposing an ePTFE interlayer member between the first and second ePTFE tubes, and joining the first ePTFE tube to the second ePTFE tube through openings in a wall of the stent by applying first pressure, and then heat, to the assembly.

Abstract: The present disclosure relates to a dynamic bioactive bone graft material and a method of handling the material to prepare an implant. In one embodiment, a method of preparing a dynamic bioactive bone graft implant is provided. The method includes the step of providing a porous, fibrous composition of bioactive glass fibers, wherein the fibers are characterized by fiber diameters ranging from about 5 nanometers to about 100 micrometers, and wherein the porosity of the matrix ranges from about 100 nanometers to about 1 millimeter. The porous, fibrous composition is introduced into a mold tray, and a shaped implant is created using the mold tray. The composition may be wetted with a fluid such as saline or a naturally occurring body fluid like blood prior to creating the shaped implant. In another embodiment, the porous, fibrous composition is provided with the mold tray as a kit.

Abstract: For use in connection with evaluating prosthetic sockets (and other objects) designed and fabricated with computer aided design and manufacturing software, the shape of a socket is accurately scanned and digitized. The scanned data are then compared to either an electronic shape data file, or to the shape of another socket, a positive model of a residual limb (or socket), or a residual limb. Differences detected during the comparison can then be applied to revise the design or fabrication of the socket, to more accurately achieve a desired shape that properly fits the residual limb of a patient and can be used to solve the inverse problem by correcting for observed errors of a specific fabricator before a socket is produced. The digitizing process is implemented using a stylus ball that contacts a surface of the socket to produce data indicating the three-dimensional shape of the socket.

Abstract: A replacement device for resurfacing a joint surface of a femur and a method of making and installing such a 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 top surface is designed so as to maintain centrally directed tracking of the patella perpendicular to the plane established by the distal end of the femoral condyles and aligned with the center of the femoral head.

Abstract: An orthopedic device includes a femoral implant having a non-custom internal bone engagement surface. The femoral implant includes at least nine parameters adjusted preoperatively to correspond to a specific patient. The parameters can include patient-specific lengths, such as, for example, medial and lateral condyle widths and notch height, and patient-specific medial and lateral angles.

Abstract: The present disclosure is directed to orthopedic implants and methods of designing orthopedic implants using in vivo data specific to an orthopedic implant or orthopedic trial. Specifically, the instant disclosure utilizes permanent orthopedic implants and orthopedic trials outfitted with pressure sensors to provide feedback regarding the position and magnitude of pressures exerted upon the devices to discern which design is preferable or which designs are preferable.

Abstract: A technique to manufacture small joint orthopedic implants includes the steps of taking standard radiographs of a pathologic joint and the corresponding non-pathologic joint. In order to provide an accurate frame of reference, a specialized marker is placed in the radiographic field. By inspection of the radiographs and by comparison with the marker, the dimensions of the cortical bone and the cancellous bone can be quickly and accurately determined. These dimensions can be used to manufacture a suitable implant and installation tool. Typically, the implant will include a stem from which a post projects. A radially extending collar is located at the intersection between the stem and the post. A mating head is attached to the post. The head closely approximates the size and shape of the natural head being replaced. The stem will be non-round in cross-section to prevent rotation of the stem in the bone.

Abstract: The present invention illustrates a method of manufacturing a surgical implant guide to increase the precision, safety and reliability of the surgery. First the present invention plans an invasive position for implanting an implant, and then, plans an invasive path for the implant to invade from the invasive position of an affected tissue, and finally, produces an implant guide based on the invasive position, the invasive path, and the shapes of the implant and the affected tissue. The surgical implant guide includes a coupling portion matching the shape the affected tissue, and a guiding portion matching the shape of the implant, the invasive position, and the invasive path. When the coupling portion is disposed on the affected tissue, the guiding portion is aligned with the invasive position, so that the implant is implanted in the affected tissue under guidance of the invasive path.

Abstract: Disclosed herein are methods and compositions for producing articular repair materials and for repairing an articular surface. In particular, methods for providing articular repair systems. Also provided are articular surface repair systems designed to replace a selected area cartilage, for example, and surgical tools for repairing articular surfaces.

Abstract: A preform for making a prosthetic limb socket includes an injection molded disk of thermoplastics material, and a peripheral portion of the disk is supported by a rigid metal ring. The ring and the peripheral disk portion have an interfitting connection which permits the disk and ring to be heated in an oven. The ring and softened disk are then inverted and stretched downwardly over a positive model of a residual limb while a vacuum is introduced through holes within the model to form a plastic socket which conforms to the model. The interfitting connection may be peripherally spaced studs on the ring and projecting into corresponding holes in the disk or may be an annular rib or arcuate rib sections on the ring which project into an annular recess or arcuate cavities within the disk. After the plastic cools, the ring is separated for reuse.

Abstract: The invention concerns methods of coating stents and stents produced in accordance therewith. The object of the invention is to provide methods of coating stents with a polysaccharide layer which has improved adhesion capacity on the substrate surface of the implant, and to afford correspondingly functionalized stents. That is achieved inter alia by covalent bonding of a non-crosslinked hyaluronic acid to a substrate surface of the stent with the formation of hyaluronic acid layer and crosslinking of the hyaluronic acid layer.

Abstract: Extruded, stretched, sintered tubular PTFE materials are produced which are suited for use in the medical field as liners and covers for expandable stents. The PTFE materials have an unusually low REC (Radial Expansion Coefficient) and RER (Radial Expansion Ratio).

Abstract: An image is captured or otherwise converted into a signal in an artificial vision system. The signal is transmitted to the retina utilizing an implant. The implant consists of a polymer substrate made of a compliant material such as poly(dimethylsiloxane) or PDMS. The polymer substrate is conformable to the shape of the retina. Electrodes and conductive leads are embedded in the polymer substrate. The conductive leads and the electrodes transmit the signal representing the image to the cells in the retina. The signal representing the image stimulates cells in the retina.

Abstract: A method for fabricating a prosthetic limb socket component includes the following steps: (a) obtaining measurements of an individual's residual limb; (b) generating electronic data representing outer dimensions of the individual's residual limb utilizing (at least in part) the obtained measurements; (c) storing the electronic data representing outer dimensions of the individual's residual limb in an electronic record, where the electronic record includes cross-reference information; (d) manufacturing a first prosthetic limb socket component utilizing, at least in part, the electronic data representing outer dimensions of the individual's residual limb; (e) placing a permanent unique indicia on the prosthetic limb socket component, where the unique indicia includes data corresponding to the cross-reference information; and (f) utilizing the unique indicia data to access, with the assistance of a computer, the electronic record via the cross-reference information.

Abstract: A one step method for drug coating an interventional device is disclosed by mixing a drug with a phosphorylcholine-linked methacrylate polymer in a liquid and applying the mixture to an interventional device, such as a stent, in a single step.

Abstract: Devices for assessing the size, shape, and topography of vessel lumens and hollow portions of organs are described. The devices are particularly adapted for determining the size, shape, topography, and compliance of the native heart valves to facilitate the later implantation of a prosthetic heart valve. The devices are typically catheter-based having an assessment mechanism fixed to a distal end of the catheter. The assessment mechanism generally includes an expandable member, such as a balloon. The assessment mechanism may also include an imaging member, a physical assessment member, an electronic mapping construction, an alignment mechanism, a valvuloplasty balloon, or any combination thereof.

Abstract: In the transplant of a living organism tissue, such as a heart valve, taken from an animal, etc. into a human body, a cell removing solution for removing original cells from the living organism tissue is provided with flow approximately equal to the bloodstream of transplant recipient living body, and the living organism tissue is placed in the flow so as to effect immersion of the living organism tissue in the cell removing solution. In the immersion, it is preferred that the living organism tissue placed in the cell removing solution, while being rotated, be irradiated with microwave. As a result, original cells can be removed from the living organism tissue uniformly and reliably, so that the biocompatibility of living organism tissue after transplant can be enhanced.

Abstract: The invention involves a submucosa tissue that has the capability of being shape formed or shape configured. The submucosa involves a purified form of submucosa tissue. Optionally, the submucosa can be packaged in such a manner to permit sterility or maintain sterility of the submucosa.

Abstract: Disclosed are implantable tissue augmentation devices, methods, and associated tools. The devices include an inflatable body, having an inner layer and an outer layer. A valve is provided for permitting the introduction of and retaining inflation media. At least one pull tab is provided on an end of the implant, to assist in positioning the implant. Kits and systems are also disclosed.

Abstract: An apparatus and method for imprinting a pattern on a medical device to provide a surface with greater surface area and improved adhesion properties.

Abstract: An orthopedic implant. The implant has a first portion including at least one patient-adjustable feature, and a second portion including at least one standard feature.

Abstract: In order to provide a bone substitution material which enables mechanical stability and long-term in-vivo biocompatibility which can also be used for guided bone healing, the invention provides a method comprising the steps of providing a starting material comprising a mixture of at least a skeleton substance (20) and at least one functional substance, and building up a skeleton from the skeleton substance, thereby producing a profiled body (30), as well as a profiled body (30) containing a skeleton substance (20) and comprising a porous structure (10) with pores (12, 15) being interconnected with each other.

Abstract: Described are methods and systems for drying remodelable materials, such that selective regions of the remodelable materials have differing properties. Also described are medical graft products having selective regions of differing material properties. Advantageous remodelable materials include collagenous extracellular matrix material, such as small intestine submucosa.