Abstract: According to the invention there is provided surgical instrumentation for implanting an orthopedic prosthesis comprising a handle having opposed longitudinal ends and a head assembly situated at one end of the handle. The head assembly includes an external impact surface for transmitting force to an orthopedic instrument or prosthesis. A spring and sliding shaft arrangement are disposed within the head assembly for dampening the force from the impact surface. The head assembly is adjustable for varying the force absorbed by the spring and sliding shaft arrangement.

Abstract: According to the invention there is provided an intravascular catheter and thrombectomy procedure utilizing the catheter. The catheter comprises a flexible jacket with a distal working head having a canalizing tip rotatable at high speeds for removing thrombus from the lumen of a vessel. A flexible drive assembly extends through the jacket to rotate the tip and a plurality of infusion ports are formed adjacent the distal end of the jacket, capable of delivering a fluid contrast media at relatively high volumetric flow rates into the lumen of the vessel to locate the site of the thrombus. The canalizing tip is then rotated at high speed to homogenize and remove the thrombus from the lumen.

Abstract: According to the invention there is provided an intravascular catheter comprising an elongated flexible jacket having opposed proximal and distal ends and a central passageway extending between and interconnecting the ends. A rotating working head is located at the distal end of the jacket. A flexible drive cable extends through the passageway of the jacket, having a driving end operatively connected to the working head for rotating it, and a driven end operatively connected to a high-speed motor. The working head is rotatably mounted in a bearing sleeve which is further attached to the catheter jacket. The working head is actuated, by a actuator which adjust the a pair of tip portions from an at least initial retracted position with a first effective working diameter to an extended position with a second effective working diameter greater than the first effective diameter. Centrifugal forces generated by rotation of the cable cause the tip portions to assume the greater effective working diameter.

Abstract: According to the invention, there is provided a trial implant comprising a modular bracket defining a structure having an internal surface adapted to be seated on the distal aspect of a resected femur bone and an external surface with a shape resembling the normal distal condyle of the femur. The bracket has an elongated central opening appointed to expose the resected bone of the femur, including a pair of tracks for guiding a tool along a predetermined path for controlled shaping of a patellar groove in the bone exposed through the opening. An end mill guide cooperates with the bracket to receive another tool to form a deep recess for accommodating a posterior-stabilizing housing. After the recess is formed, the guide is replaced with an insert having a posterior-stabilizing housing which covers the opening of the bracket and articulates with a proximal aspect of the tibia during interoperative trial reduction of the knee joint.

Abstract: According to the invention, there is provided an implantable prosthetic device inflatable by a self-contained resealable valve in combination with an external locator for determining the position of the valve. The prosthesis includes a flexible outer envelope defining a closed lumen and having a valve attached to an area of the envelope with indicia on the valve responsive to the external locator for determining the position of the valve. A plurality of spaced sensors are each fixedly arrayed on the locator so that when the sensors are in a certain non-juxtaposed relationship with the indicia the sensors orientate with one another, signifying a true location of the valve. A multi-compartmental design having a tethered valve for selective inflation of an inner lumen is also disclosed. The tissue-contacting surface of the outer envelope is micro-textured to minimize tissue capsule contracture.

Abstract: An intravascular catheter comprises an elongated flexible jacket having opposed proximal and distal ends and a central passageway extending between the ends. A working head is located at the distal end, including a canalizing tip and a bearing for rotatably supporting the tip on the working head to remove occlusions from the lumen of a vessel. A drive cable extends through the central passageway and has a driving portion operatively located adjacent the distal end and a driven portion for releasably engaging the working head located opposite the driving portion. A power-driven motor is coupled to the driven end for rotating the cable. The jacket segments are disconnected and the canalizing tip removed with the drive cable from the catheter and replaced with a guide wire which is inserted through the central passageway.

Abstract: The present invention provides a modular hip prosthesis, and instrumentation for implanting the same, which has provision for varying the angulation between the stem portion and the trochanteral module portion by provision of connection means between the neck and stem which can be positioned or attached together in a variety of rotational positions. Variation of the angulation or anteversion is made possible in accordance with the present invention by virtue of the fact that the axis of the connection portion of the stem and neck is angularly offset from the axis of the body of the stem and neck, respectively. A further aspect of this invention is the provision of instrumention for formation of a cavity for implantation of a prosthesis of this invention which is provided with indication means for indicating to the surgeon the optimum angle for assembly of the prosthesis of invention for implantation into a particular proximal femur.

Abstract: According to the invention, there is provided a trial implant comprising a modular bracket defining a structure having an internal surface adapted to be seated on the distal aspect of a resected femur bone and an external surface with a shape resembling the normal distal condyle of the femur. The bracket has an elongated central opening appointed to expose the resected bone of the femur, including a pair of tracks for guiding a tool along a predetermined path for controlled shaping of a patellar groove in the bone exposed through the opening. A replaceable insert covers the opening and articulates with a proximal aspect of the tibia during interoperative trial reduction of the knee joint, whereby prior removal of the bracket from the resected bone is unnecessary following shaping of the patellar groove. Preferably, the insert and guide tracks cooperate together to securely position the insert within the opening during trial reduction. A surgical method is also provided using the described trial implant guide.

Abstract: Modular surgical instrumentation and a method of using same is provided, according to the invention. The instrumentation comprises a first bracket defining a generally U-shaped structure having an internal surface adapted to be seated on the distal aspect of a resected femur bone and an elongated central opening appointed to expose a selected area of the resected femur, including a curved track for guiding a first shaping tool along a predetermined path for controlled shaping of a curved patellar groove in a portion of the selected area exposed through the opening. A second bracket defines a linear slotted bore extending generally parallel to the long axis of the femur for guiding a second shaping tool to form a relatively deep recess accommodating an intercondylar stabilizing housing of a knee implant.

Abstract: There is described a surgical tool and method for implanting a condylar prosthesis onto a femur using the tool. The prosthesis is of the type having a pair of posterior condyles which define an intercondylar notch opening including a distal internal contact surface extending anteriorly from the notch toward an anterior condylar flange. The tool comprises an elongated handle having a proximal end adapted for contact with the prosthesis and a distal end with an anvil for driving the prosthesis onto the distal aspect of the resected femur. One or more arms are attached to the proximal end of the shaft, including one or more anteriorly projecting fingers which are moved within the notch to engage the proximal internal contact surface. A pair of abutment pads are actuated to engage an external surface of the proximal condyle and exert a force opposite to the gripping finger(s) to securely lock and hold the prosthesis and tool together during implantation.

Abstract: A catheter having a distal working head carried by a tubular sheath. A bearing fixed to the tubular sheath forms fluid delivery passageways in fluid communications with the center of the sheath. The fluid delivery passageways open into a vessel via radially extending ports that open out into the vessel through an end face of the bearing.

Abstract: A surgical device for accurately positioning and cutting a patellar groove in a resected distal femur to receive a patellar track portion of a prosthesis, including a guide element adapted to fit over the distal end of a resected femur, having a central opening which exposes the central, distal an anterior aspects of the femur, each side of the opening being provided with a track, extending the length of the patella track, and, a cutting tool having a cutting surface, perferably convex, adapted to fit into the central opening for the purpose of cutting or abrading a groove into the femur as the tool is moved along the opening. The tool, which is preferably a rotary cutter provided with independently rotatable track-engaging surfaces on each side of the opening is adapted to engage and move along the track.

Abstract: A tissue expander and a method of making a tissue expander which includes (a) a fluid-tight envelope which is inflatable by a single means for inflation and which has an expandable upper section formed of (i) a first elastic portion and (ii) a second elastic portion formed of a material having a lower modulus of elasticity than that of the material forming the first portion, so that during the inflation of said envelope the modulus of elasticity of each portion at least partially controls the amount of expansion of each portion, thereby allowing the envelope to assume a complex shape. The tissue expander also has a means for inflating the envelope with a biocompatible fluid.

Abstract: A composite metal/plastic patellar prosthesis for implantation in the human body to replace the articulating surface of the patella is provided. The prosthesis includes a polymeric articulating surface portion and a metal backing having an anterior surface adapted to be attached to the posterior surface of a resected patella, and a dome or conically shaped posterior surface to which the polymeric articulating surface portion is heat and pressure molded. The metal backing portion has at least one aperture extending therethrough which has a greater cross-sectional area on the anterior side than on the posterior side into which an anchoring peg integral with the antrior surface of the polymeric articulating surface portion is molded. The metal and plastic components of the composite are coextensive in size and shape.

Abstract: The present invention provides a modular hip prosthesis, and instrumentation for implanting the same, which has provision for varying the angulation between the stem portion and the trochanteral module portion by provision of connection means between the neck and stem which can be positioned or attached together in a variety of rotational positions. Variation of the angulation or anteversion is made possible in accordance with the present invention by virtue of the fact that the axis of the connection portion of the stem and neck is angularly offset from the axis of the body of the stem and neck, respectively. A further aspect of this invention is the provision of instrumentation for formation of a cavity for implantation of a prosthesis of this invention which is provided with indication means for indicating to the surgeon the optimum angle for assembly of the prosthesis of invention for implantation into a particular proximal femur.

Abstract: The present invention provides a shaping guide to permit accurate shaping of the tibial plateau while saving the anterior cruciate ligament. An alignment rod is located anterior to the anterior cruciate ligament and along the anterior cortex of the intermedullary canal of the tibia provides points of reference for all shaping operations. The shaping guide of the present invention is adjustable with respect to the handle portion of the rod so that the amount of resection of the tibial plateau can be controlled readily by the surgeon by raising or lowering of the cutting guide surfaces for resection of the tibia.

Abstract: A method of making a permeation-resistant silicone elastomer-containing laminate useful for making fluid-containing implants such as mammary prostheses and gastric balloons. The method is accomplished by (a) applying a layer of an unvulcanized heat-curable silicone elastomer composition to a cured silicone elastomer substrate, (b) applying a layer of a solvent dispersion of a permeation-resistant elastomer and a solvent on the layer of unvulcanized silicone elastomer composition to form a three-layered laminate, and (c) exposing the three-layered laminate to heat until the unvulcanized silicone elastomer composition is vulcanized.

Abstract: A process is provided for preparing a three dimensional object such as a mandrel for forming envelopes for mammary prostheses or other implantable medical device by dipping the mandrel, etc. The envelopes are provided with micropillars on the exterior surface which resembles the mandrel surface in negative relief. According to the process a workpiece of solid stock material such as polymer is provided in the shape of the desired prostheses. It is positioned for rotation on a supporting shaft or other holding mechanism. A pulsing laser beam, directed at the workpiece is moved in a plane parallel to the axis of rotation of the workpiece while the beam is maintained approximately perpendicular to the workpiece surface. The rate of pulsing of the laser beam and the speed of rotation of the workpiece are controlled to produce patterns of blind micro-holes onthe surface of the workpiece.

Abstract: The present invention relates to a distal femoral surface shaping guide for mounting on an intramedullary alignment which references the central long axis of the femur in shaping the distal femoral surface and a method for shaping the distal femur using that shaping guide with particular applicability for shaping one condyle for attachment of a unicondylar prosthesis. The alignment guide of the present invention is adjustable relative to the surface of the condyle to insure that the distal femoral condyle is resected relative to that surface. The alignment guide of the present invention utilizes visual sighting studs and provides a main body which remains attached to the intramedullary alignment guide throughout the entire shaping of the distal femur.

Abstract: The invention provides an improved prosthetic toe joint adapted for replacement of a human toe joint which includes at least one one-piece member for implantation into the bone of the joint. The implant has a concave articulating surface which articulates against another one-piece component having a mating convex surface or against a mating convex bone surface. This one part component is provided with a flexible hinge section at the junction of its stem and the enlarged head portions. The hinge section is formed from a section of the stem which extends laterally outwardly on both sides of the stem portion adjacent the junction with the head. The laterally enlarged section is provided with a longitudinal channel extending through its midsection to form a hinge. Each of the one-piece components is preferably molded of a flexible elastomeric, physiologically inert material, for example medical grade silicone rubber.