Abstract: A method of making a polymeric body having a porous surface by (a) applying a fluid polymeric composition to a mold surface of a leachable foam having open pores thereon, (b) curing the composition to form the polymeric body, and (c) leaching the foam from the polymeric body with a suitable solvent which does not dissolve the polymeric body. The method is especially suitable for making porous silicone elastomer bodies by using polystyrene foam as the mold material and the method is useful for forming hollow, porous-surfaced polymeric bodies, e.g. mammary and vascular prostheses.

Abstract: A tissue expander and a method for 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 method of forming hollow, porous elastomeric bodies and hollow, duo-layered elastomeric bodies wherein one layer is porous and contiguous with the other layer which is solid by (a) coating a surface of a mandrel with a coating liquid, (b) adhering a layer of water-elutable particles onto the coated mandrel surface, (c) applying a layer of fluid elastomer composition to the particle-coated mandrel surface wherein the elastomeric composition is capable of forming a water-insoluble elastomer, (d) causing said elastomeric composition to form a cohesive mass while in contact with the particle-coated mandrel surface, (e) dissolving said elutable particles from the cohesvie mass with a water-based solvent, and (f) removing the cohesive mass from the mandrel. The coating liquid comprises water and may also further comprise a wetting agent and/or a sugar. The invention also relates to the method wherein the water-elutable particles are adhered to the mandrel surface by heating the mandrel surface.

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 (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: Described herein is an improved injection reservoir of the type which is employed to permit subcutaneous inflation of inflatable, implantable prostheses such as tissue expanders. The improved injection reservoir has a lozenge shape when viewed from above which permits this injection reservoir to be more easily inserted and removed subcutaneously. In a more preferred embodiment, the injection reservoir has a low profile shape such that its height is no more than forth percent of its width.

Abstract: This invention provides a multiple lumen implant in which the inner lumen is of a substantially spherical shape and is unattached or free-floating. The invention provides a construction which is able to provide and maintain a high projection and to simulate the natural flow of breast tissue during a variety of activities in which the patient may participate on a daily basis.

Abstract: A prosthesis for replacing the proximal end of a tibia, installable without bone cement which includes a tibial plateau portion adapted to receive an articulation insert. Integral with the underside of the plateau is an intermedullary fixation stem to which is attached a medial-lateral fin. Attached to each end of the fin is a transverse fin which provides a dual "T" configuration, which provides superior anchoring of the prosthesis.

Abstract: An instrument for subcutaneously inserting an injection reservoir attached to an inflatable prosthesis by means of an elongated fluid conduit is disclosed. The instrument has a hollowed end which holds the injection reservoir to be inserted in a mating, releasable fashion and that end is attached to a handle for guiding the hollowed end to the desired site. Desirably, but optionally, the end of the handle of the instrument is provided with a shaped tapered portion to act as a dilator to create a subcutaneous pocket prior to insertion of the injection reservoir.

Abstract: A prosthetic shim and a method for use of prosthetic shims to provide level support and increase the effective thickness of a femoral knee joint component having at least one fixation peg extending from the face which is to seat against the distal end of a femur. The shim is for placement between the femoral component and the femur and comprises a platform having a first surface to cooperatively engage the joint component face and a second surface to engage the distal end of the femur. The shim preferably has a means for securing the shim in place, such as spikes extending from the second surface to be driven into the femur. The platform preferably is shaped and dimensioned to be effective if placed centrally relative to the joint component face, covers a majority of the joint component face, and has an opening corresponding to each peg of the joint component so that the shim can be placed over each peg.

Abstract: The present invention relates to a distal femoral surface shaping guide for mounting on an intramedullary alignment guide 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. The alignment guide of the present invention is adjustable relative to the surface of the anterior femoral cortex to insure that the anterior aspect of the distal femoral condyles is resected relative to that surface and, preferably, at the same level as that surface. The alignment guide of the present invention provides a main body which remains attached to the intramedullary alignment guide throughout the entire shaping of the distal femur. It thus requires fewer cutting guides and alignment steps than other shaping guides while allowing greater accuracy in shaping the distal femur relative to the central long axis of the femur.

Abstract: The present invention relates to a surgical apparatus for providing an accurately placed recess in a distal femoral surface for the intercondylar stabilizing housing of a posterior-stabilized knee implant prosthesis which apparatus comprises (a) a template having (1) a bottom surface which is adapted to be placed in an aligning relationship with the flat surface of a distal femur which has been partially shaped to receive the femoral component of a posterior-stabilized knee implant prosthesis and (2) a U-shaped slot passing through the template where the slot is of substantially the same size and shape as the outer periphery of the intercondylar stabilizing housing present on the femoral component to be implanted and (b) a drilling means, preferably in the form of an end-mill cutter, having a stop means thereon and the drilling means closely engages the sides of the U-shaped slot in the template so that the drilling means can be passed through the U-shaped slot until the stop means contacts a surface of the g

Abstract: This invention provides an improved implantable tibial component comprising an implantable tibial base containing two separate, opposed raised walls which engage oppositely configured recesses in the lower surface of a removable hard polymeric condylar articulating surface insert. The locking mechanism which holds the insert within the base provides a means by which the insert can be locked within the base in a secure fashion. The locking mechanism further provides a means by which the insert can be removed from the implanted tibial base in a simple fashion by raising the anterior end of the insert over the top of the anterior wall on the edge of the tibial base and sliding the insert anteriorly out of the posterior raised walls which also extend along the medial and lateral edges of the tibial base.

Abstract: A ball-and-socket joint prosthesis, e.g. a hip joint prosthesis, which comprises an outer shell element, a ball component, and a replaceable bearing insert element positioned between the shell and the ball component. The bearing insert has a generally spherical inside surface which encompasses more than half of the ball component to thereby retain it. The insert has an outside surface shaped to mate with the inside surface of the shell, and the shell element and the insert element have a locking mechanism consisting of a protruding portion which extends a major distance around a side surface of one element which locks into a mating depression in the other element.

Abstract: This invention relates to a femoral trial prosthesis/rasp assembly for use in hip implant surgery. The novel handle assembly grips the combination trial prosthesis/rasp in a secure manner by clamping over and locking onto a post on the trial prosthesis/rasp which later serves as a mounting piece for a femoral prosthesis head used in trial reductions. The handle assembly preferably comprises a straight member which has a recess for reception of one half of the post and a pivotable lever which contains an opposing recess which fits over the remainder of the post when a screw is tightened to bring the two recesses together over the post. The trial prosthesis/rasp is cooperatively engaged by a projection located at the end of the handle assembly to hold the trial prosthesis/rasp in a preselected orientation with respect to the handle assembly during use. The trial prosthesis/rasp is easily released from the handle by turning the screw to permit the lower portion of the straight member and lever to separate.

Abstract: There is disclosed a surgically implantable prosthetic joint implant adapted for length adjustment after initial surgery to compensate, for example, for growth of a juvenile patient. A stem for bone implantation has a flange for overlying the bone end and a threaded portion for adjusting axially with respect to an overlying sleeve which carries at its extremity an articulating component of the joint. A pin in the sleeve and elongated slot in the stem restrain relative rotation but allow axial relative movement as the stem is urged into or out of the sleeve by rotation of a nut coacting with the threads on the stem while being axially restrained by the sleeve. The nut is described as having a ring of gear teeth to be actuated by an insertable gear-carrying key. An alternative embodiment uses an accessible recessed bolt for moving the stem into or out of the sleeve.