Abstract: A cervical collar assembly to immobilize the neck and head of a user. The assembly includes an adjustable and conformable shell member having a pad member secured on its interior to engage the skin of the user. The shell member is comprised of a front member, a back member and means to adjustable join the front and back members. A chin support member is adjustably secured to the front member and an occipital support member is secured to the back member. The front and back members are provided with a plurality of elongated slits which permit the shell member to conform to the neck and head areas of the user. Further, the front member is provided with opposing upwardly extending tab members to engage the mandibula of a user's jaw to aid in the immobilization of the neck and head of the user.

Abstract: A connector assembly and method for electrically connecting an implantable electrode having an electrical lead array to monitoring equipment. The connector assembly includes a lead holder, an electrical conductor array, and a base holding the electrical conductor array, and a resilient element. The lead holder is moveable with respect to the base from a first position to an operating position. The resilient element is adapted to bias the lead holder from the first position to the operating position.

Abstract: A valve cover for a prosthetic implant. The valve cover is adhered to the prosthetic implant and covers the fill valve. The valve cover has a flexible body having an upper portion, a central portion and a lower portion. A plug extends from the bottom surface of the central portion of the valve cover body. A continuous textured peripheral area is disposed on the bottom surface of the flexible body and which extends through the upper portion and to the lower portion through an axis intersecting the valve entrance. The continuous peripheral area is adhered to the prosthetic implant body whereby the plug is aligned with the fill valve entrance. Lifting of the lower portion of the valve cover provides access to the fill valve of the prosthetic implant.

Abstract: A hybrid skull pin to adjust and hold a cervical fixation device to the skull of a patient. The hybrid skull pin is constructed of at least two different materials and arranged to permit cervical fixation devices to be used in MRI procedures. The hybrid skull pin has an elongated body with exterior threads and a tip portion for engaging the skull of the patient. A nonconductive coating extends over the tip portion of the skull pin body. The hybrid skull pin further includes an insert secured in the elongated body. The insert is constructed of a second material and secured in a cavity of the pin. The insert reduces the mass of the skull pin thereby reducing or eliminating the radio frequency energy conducted through the pin during MRI procedures. The insert also acts as a heat capacitor which absorbs the radio frequency energy and the magnetic field vibrations generated in the MRI environment.

Abstract: An implantable electrode for monitoring tissue electrical activity and for tissue electrical stimulation comprises a flexible electrode body for contacting human body tissue, a connector portion having a plurality of connectors for connection to external monitoring equipment, the connector portion connected to the electrode body, both the electrode body and the connector portion being comprised of a thin, flexible, non-conducting backing material, a printed circuit etched onto the flexible backing material, the printed circuit further comprising a plurality of electrical contact areas of a conductive material for contacting the tissue, and a plurality of electrical leads connecting the electrical contact areas to the connectors, and a flexible, non-conducting covering material covering the printed circuit, the electrical contact areas extending through the covering material. A method of manufacture of the electrode is also disclosed.

Abstract: An implantable body including an outer membrane forming an enclosure for receiving a filler material. The surface of the outer membrane is characterized by a random distribution of peaks separated by valleys. The peaks and valleys are separated by gradual contoured slopes with a smooth transition between the peaks and valleys which are substantially free from indentation. The enhanced surface provides improved anchoring of the implant, yet reduces host reaction. The enhanced surface is formed by depositing a distribution of cured polymeric particles on an uncured tacky surface. This intermediate surface is then cured, followed by application of a layer of uncured elastomeric material. The entire surface is then cured to form the enhanced surface.

Abstract: An improved mammary prosthesis for implantation in humans comprising: a soft, flexible outer membrane forming an enclosure for receiving a filler material; an enhanced, undulating, random sculptured, irregular, substantially smooth surface of peaks, valleys, slopes and terraces without interstices disposed over at least a portion of said outer membrane; an internal structure within said membrane for supporting said outer membrane and providing an enhanced, life-like look and feel to the prosthesis; and a soft, partially-deformable, elastic filler material received within said outer membrane and cooperating with said internal structure to support said outer membrane.

Abstract: A tissue-conformable electrode for monitoring tissue electrical activity of the type having a plurality of contacts embedded in a flexible matrix material and custom built to conform to the contours of a portion of the tissue to be monitored consists of a flexible matrix pre-shaped to conform to the contour of a portion of the tissue to be monitored; a plurality of contacts embedded in the matrix and protruding through the matrix to contact the tissue; and lead wires engaging the electrical contacts and exiting the electrode for making electrical connection with monitoring equipment.

Abstract: A bandage in the form of a reinforced silicone gel sheet for the treatment of scar tissue is disclosed. The bandage consists of a first layer of silicone adapted to adhere to the skin, a second layer of polyester mesh fabric with a plurality of holes therethrough, which contacts the first layer, and a third layer of silicone. The third layer acts as a sealant and an adhesive when applied to the mesh fabric by projecting through the holes in the mesh fabric to seal the second layer and to laminate the second layer between the first layer and the third layer. The sealant effect of the third layer provides a non-adherent surface which enables the bandage to be worn underneath clothing. A method of manufacture is also disclosed.

Abstract: An improved tissue electrode for monitoring tissue electrical activity and for tissue electrical stimulation and adapted to conform closely to the tissue, thereby optimizing tissue electrical contact. The electrode consists of an elongated electrode body with a polygonal cross-section with a tissue-engaging surface having a pair of tissue-engaging members confronting each other at an obtuse angle and a non-tissue-engaging surface meeting each of the tissue-engaging members at an acute angle. In one embodiment, the non-tissue-engaging surface is substantially flat, and the electrode thus is a half-rhombus in cross-section. In a second embodiment, the non-tissue-engaging surface is also a half-rhombus, so that the electrode is a rhombus in cross-section. An improved electrical connector for connecting lead wires from the electrode to external monitoring equipment is also disclosed.

Abstract: The invention relates to a mechanical tissue expansion device for use in the reconstruction or augmentation of a portion of an individual's body. The invention includes a pair of tissue expansion plates which may be substantially flat or which may include an arcuate curved shape. Each of the tissue expansion plates has a plurality of apertures therethrough in order to facilitate the ingrowth of natural tissue within an enlarged cavity. The tissue expansion plates are mechanically separated by a means for expansion which preferably includes a cylinder having three telescopically expanding rods engaged thereto. The means for expansion is incrementally regulated by an operating means. The operating means preferably includes tubing engaged to the cylinder and to a port having a silicone membrane, for receipt of incremental portions of saline solution or water for telescopic expansion of the rods from the cylinder.

Abstract: An implantable body including an outer membrane forming an enclosure for receiving a filler material. The surface of the outer membrane is characterized by a random distribution of peaks separated by valleys. The peaks and valleys are separated by gradual contoured slopes with a smooth transition between the peaks and valleys which are substantially free from indentation. The enhanced surface provides improved anchoring of the implant, yet reduces host reaction. The enhanced surface is formed by depositing a distribution of cured polymeric particles on an uncured tacky surface. This intermediate surface is then cured, followed by application of a layer of uncured elastomeric material. The entire surface is then cured to form the enhanced surface.

Abstract: An elastomeric valve assembly designed for use in an inflatable surgical implant to provide a self sealing means for filling the implant. The valve assembly incorporates vulcanized elastomeric strips molded between two larger silicone sheets, wherein the strips form a collapsible self-sealing channel through which a fill needle may be inserted through slits in the strips and sheets.

Abstract: The present invention relates to a torque limiting device for use in the affixation of a halo-type traction tool to the skull of a person. The torque limiting device has a shaft or shank embedded in a handle member which rotatably engages a skull pin during the fixation of a halo-type traction device to an individual. The torque limiting device has a first shear point at a reduced shank intermediate portion which prevents rotational torque forces in excess of a predetermined level from being applied to a skull pin during the attachment procedure of a medical cervical traction brace or tool. The present invention also includes a second shear point at the shank-handle interface which acts as a second safety mechanism to ensure that excessive pressure is not applied, and undesirable skull penetration does not occur, during the attachment procedure of a skull pin and halo to an individual's skull. The torque limiting device further includes a skull pin engaging end.

Abstract: The process and apparatus for an autologous dermal graft transfer provides for the easy and accurate placement of dermal grafts during plastic surgery, typically for the filling of wrinkles or scars.

Abstract: A warmer used to warm fluids, such as blood or the like, passed into the human body. Air is introduced through an opened windowed membrane to expose chemicals in a container. A chemical reaction with the air causes a heat reaction of the chemicals. A tube engages in a trough in the container adjacent where the chemical reaction takes place, thereby absorbing the heat of the chemical reaction for warming the fluids, such as blood, saline solution, injectable solutions in trauma, pre-surgical, intra-surgical, post-surgical and any other solutions through the tube.

Abstract: A nerve expander used in plastic reconstruction surgery for lengthening damaged nerves which facilitates reattachment of damaged nerves to facilitate nerve operation and function after reconstruction. One or more saddles on an inflatable expansion member positionally accommodates a nerve in a saddle trough. The nerve expander with the saddle mounted nerve is subsequently inflated with saline solution injected into a self-sealing injection port causing the inflatable expansion member to expand and the nerve thereabout to be stretched and lengthened.

Abstract: A process for manufacturing an expandable member such as a tissue expander or like product for use in plastic, reconstructive, and other surgery. A compression mold with a desired initial, predetermined geometrical configuration shape is filled partially with a layer of unvulcanized flexible material, such as silicone, a thin layer of Teflon or like non-stick substance, and followed by another layer of unvulcanized material. The Teflon is "sandwiched" between the unvulcanized material and cured in an oven or by other suitable means. The non-stick material provides a separation region for subsequent expansion by injection of suitable material, air, fluid, etc. The non-stick material can be shaped to provide expansion only in the desired regions. Single, multiple, or overlapped layers of non-stick material may be employed to manufacture a variety of expandable products in the fields of medicine, surgery, consumer and industrial applications.

Abstract: Widely adjustable anterior posterior headblock in a halo vest fixation system of graphite and other material for fixation of a head about an orthopedic jacket with respect to the cervical region, such as for spinal trauma. A slotted adjustment carrier member with ball, sockets and clamping screws at each end of the carrier fits over and between pairs of upright rods. Clamping screws and a slot in the carrier member provide for anterior and posterior movement of a saddle and an attached vertically aligned halo ring traction plate to position an attached halo ring. The halo ring traction plate moves vertically in a slot via an independent-acting, internally-captured adjustment screw to provide for vertical traction or distraction as applied to the halo ring. The halo ring rotates pivotally about a pitch axis to provide for flexion or extension adjustment of the halo ring.