Abstract: A graft anchor includes an anchor member for placement in bone tissue. The anchor member defines an opening. An inner member is insertably securable into the anchor member opening. A fastener is configured such that insertion and securing of the inner member into the anchor member opening results in a holding force being applied to the graft. The anchor member is of limited length to maintain its distal end within the bone. The anchor member includes a distal drive opening for receiving a drive tool and the inner member includes a proximal drive opening for receiving the drive tool. The fastener includes channels for containing the graft, a fastener body with protrusions extending from the fastener body for penetrating bone tissue, and a reinforcing member contained within the fastener body.

Abstract: A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one layer 18 of a bioactive material posited on one surface of structure 12; and at least one porous layer 20 posited over the bioactive material layer 18 posited on one surface of structure (12) and the bioactive-material-free surface. Preferably, the structure 12 is a coronary stent. The porous layer 20 is comprised of a polymer applied preferably by vapor or plasma deposition and provides a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, merely by condensation of a monomer vapor. Also disclosed is the method of manufacture of the device 10, as well as a method of using it in medical treatments.

Abstract: A bone prosthesis has a growth enhancement coating recessed in and protected by its surface topography. The topographic features define gaps under a few millimeters which are readily spanned by new bone growth, while the features protect the coating from abrasion or physical damage. The topographic features substantially surround the coated regions, and prevent migration of flakes spalled during implantation or microparticles shed by the coating as it is resorbed or incorporated in new bone over time. In a preferred embodiment, edge features cast in the surface of a metal prosthesis include dovetail, undercut or skewed faces which firmly interlock with newly-growing bone to form a strong and shear-free, substantially rigid attachment. The prosthesis may be cast in a mold having a complex surface interlock texture, and these molds may be mass produced by an iterative three-dimensional printing technique to build each mold up in layers in the form of a suitable casting negative.

Abstract: A surgical device for implantation of deformable intraocular lens into the eye through a relatively small incision made in the ocular tissue including a holder with receiver for a lens holder. A lens holder for a surgical device for implantation of deformable intraocular lens into the eye including a split tubular member having a fixed tubular portion and a moveable tubular portion connected together at a hinge. A method for implantation of deformable intraocular lens into the eye using the above-described surgical devices.

Abstract: Heart valve leaflet selection methods and apparatuses which subject individual leaflets to loads and measure the resulting deflection to more reliably group leaflets of similar physical characteristics for later assembly in prosthetic heart valves. The deflection testing may be accomplished using a variety of test set ups which are designed to impart a load on the leaflet which simulates the actual loading within a heart valve. The results from a number of deflection tests are used to categorize individual leaflets, which data can be combined with other data regarding the characteristics of the leaflet to better select leaflets for assembly into a multi-leaflet heart valve. In one embodiment, the deflection test is combined with an intrinsic load test, and leaflets having similar deflection and intrinsic load values used in the same heart valve.

Abstract: An absorbent article comprises a liquid permeable topsheet, a liquid impermeable backsheet attached to the topsheet, an absorbent core of a combination of airlaid material, wetlaid material and superabsorbant, the core being positioned between the topsheet and the backsheet to absorb fluid, and wherein the core includes an elongated, cylindrical, raised portion for improved contact with a user, and a scrim material surrounding at least a portion of the raised portion of the core.

Abstract: A wearable peritoneal dialysis device providing continuous removal of waste metabolites from the blood using a small volume (250-1000 mls) of protein-containing dialysate having an overall flow rate of about 2-3 liters per hour. The device may be worn in several places on the torso and limbs. Included are methods for peritoneal dialysis having improved efficiency, as well as methods for providing hormones, nutrients or therapeutic agents to a patient.

Abstract: Pull-on garments provided with an intermittent lap seam joining the front region and the back region together at spaced apart locations to provide a breathable seam. In a preferred embodiment, the pull-on garment includes a chassis layer comprising a continuous sheet that defines a front region, a back region, and a crotch region; a first belt layer joined to the chassis layer in the front region; a second belt layer joined to the chassis layer in the back region; elastic panel members positioned between the belt layers and the chassis layers which laminate is mechanically stretched to form elastically extensible stretch laminates in both the front region and the back region in the side panels; and intermittent lap seams joining the front region to the back region at spaced apart locations so as to form the leg openings and waist openings.

Abstract: A spinal fixation device includes a threaded stud having an open-ended axial slot to straddle a rod of a vertebral support, and a bracket which is rotatable on the stud. A vertebra bone screw passes through an opening in a distal end of the bracket. The stud and bracket are locked in position relative to the rod by a nut. An insert within the slot bears against the rod and prevents the stud from being deformed by the force of the nut on the stud segments. The bracket can be rotated around the stud; and the stud can be rotated around and slid along the rod, to afford great adjustability and ease of attachment.

Abstract: A permanent, biocompatible material for soft tissue augmentation. The biocompatible material comprises a matrix of smooth, round, finely divided, substantially spherical particles of a biocompatible ceramic material, close to or in contact with each other, which provide a scaffold or lattice for autogenous, three dimensional, randomly oriented, non-scar soft tissue growth at the augmentation site. The augmentation material can be homogeneously suspended in a biocompatible, resorbable lubricious gel carrier comprising a polysaccharide. This serves to improve the delivery of the augmentation material by injection to the tissue site where augmentation is desired. The augmentation material is especially suitable for urethral sphincter augmentation, for treatment of incontinence, for filling soft tissue voids, for creating soft tissue blebs, for the treatment of unilateral vocal cord paralysis, and for mammary implants. It can be injected intradermally, subcutaneously or can be implanted.

Abstract: A radially expansible lumenal prosthesis comprises one or more body segments which include struts and hinge regions between the struts. Certain of the hinge regions are weakened relative to others so that the expansion characteristics of the prosthesis may be programmed. In particular, by distributing the weakened hinge regions circumferentially about the body segment, uniform expansion of the prosthesis can be improved, even when the prosthesis is only partially deployed.

Abstract: A resorbable, flexible implant in the form of a continuous macro-porous sheet is disclosed. The implant is adapted to protect biological tissue defects, especially bone defects in the mammalian skeletal system, from the interposition of adjacent soft tissues during in vivo repair. The membrane has pores with diameters from 20 microns to 3000 microns. This porosity is such that vasculature and connective tissue cells derived from the adjacent soft tissues including the periosteum can proliferate through the membrane into the bone defect. The thickness of the sheet is such that the sheet has both sufficient flexibility to allow the sheet to be shaped to conform to the configuration of a skeletal region to be repaired, and sufficient tensile strength to allow the sheet to be so shaped without damage to the sheet. The sheet provides enough inherent mechanical strength to withstand pressure from adjacent musculature and does not collapse.

Abstract: An improved artificial mechanical heart valve prosthesis having an improved leaflet hinge mechanism which improves washing of the hinge recess, reduces leaflet closing impact force and decreases noise and wear. A generally annular valve body having an annular interior surface extending between an inflow rim and an outflow rim thereof defines an annular orifice therethrough. A pair of leaflets are supported on said annular valve body for alternately blocking blood flow in an inflow direction when seated against the annular interior side wall in a closed position and then allowing the flow of blood through said annular orifice in a predetermined blood outflow direction when rotated into an open position. Each leaflet is supported for pivotal movement by a pair of hinge mechanisms comprising a pair of convexly extending leaflet ears that each fit within a hinge recess formed in parallel planar surfaces of the annular interior side wall.

Abstract: The invention provides an article of manufacture comprising a substantially native xenogeneic knee meniscal cartilage heterografts for implantation into humans. The invention further provides a method for preparing a substantially native xenogeneic knee meniscal heterograft by removing at least a portion of a meniscus from a non-human animal to provide a heterograft; and washing the heterograft in saline and alcohol. In accordance with the invention the heterograft has substantially the same mechanical properties as the native xenogeneic meniscus.

Abstract: A method for implanting a stent within a body passageway defined by a body wall. The method includes the step of fabricating the stent in an initial orientation in which the stent has an initial diameter and an initial length. The method also includes the step of collapsing the stent radially inward from the initial orientation to a collapsed orientation in which the stent has a collapsed length and a collapsed diameter. The stent is collapsed by deforming a portion of the stent beyond the elastic limit of the portion of the stent. The method further includes the step of positioning the collapsed stent at a desired location within the body passageway. Additionally, the method includes the step of expanding the stent radially outward from the collapsed orientation to a deployed orientation in which the stent has a deployed diameter and a deployed length. The deployed diameter and the deployed length are respectively substantially equal to the initial diameter and the initial length.

Abstract: A prosthetic heart valve is shown which incorporates a valve body design and leaflet pivot arrangements that minimize turbulence and shear stresses having a tendency to generate thrombosis. A valve body having an axially curved entrance that is smoothly joined to a generally cylindrical body of extended axial length provides excellent fluid flow characteristics when combined with leaflets that can assume orientations perfectly aligned with the downstream flow of blood. By constructing such a pyrocarbon valve body which receives a metal ring at an appropriate location, suture rings that permit the tissue annulus to directly contact the exterior surface of the cylindrical valve body are accommodated.

Abstract: Continuously flat-woven implantable tubular prostheses have seamless woven sections which gradually change the number of warp yarns to smoothly transition, i.e., taper, from one diameter to another. Multi-diameter endoluminal grafts having a variety of shapes and configurations are made using a seamless weaving process without unacceptable voids or gaps in the tubular wall.

Abstract: This invention relates to bioprosthetic heart valve stents that are fashioned of bioresorbable materials. Such stents may be configured as sheaths or frames contoured to the shape of a valvular graft. The stents are eventually resorbed by the patent, leaving a functional "stentless" valve with improved hemodynamic characteristics compared to stented valve implants.

Abstract: A surgical implant for securing ligament grafts into a joint. The implant has back-biting threads that allow the implant to be advanced into bone by impaction. If necessary, the implant can be removed from the bone by rotation. The implant is used, for example, for knee ligament repair by forming a longitudinal socket in a bone. The socket is intersected by a transverse pin. A flexible strand is drawn with the pin through the bone. A looped portion of the flexible strand is diverted so as to protrude out of the entrance to the longitudinal socket. The ends of the flexible strand remain accessible on either side of the bone. The ligament graft is captured within the strand loop protruding from the entrance to the socket. The strand is retracted into the socket, drawing the graft into the socket by pulling on the accessible ends of the flexible strand. The graft is fixed in the socket using the transverse implant.

Abstract: A surgical device for implantation of deformable intraocular lens into the eye through a relatively small incision made in the ocular tissue including a holder with receiver for a lens holder. A lens holder for a surgical device for implantation of deformable intraocular lens into the eye including a split tubular member having a fixed tubular portion and a moveable tubular portion connected together at a hinge. A method for implantation of deformable intraocular lens into the eye using the above-described surgical devices.