Abstract: A method and apparatus for reducing the incident of infection proximate to an exit site where a prosthesis fastener, e.g., a bone screw, percutaneously penetrates a patient's skin/soft tissue. Infection reduction is achieved in accordance with the invention by growing a tissue integrating seal around the fastener proximate to the exit site.

Abstract: A fully implantable hearing aid system comprised of an implantable sound generator module and an implantable sound receiver module connected by an implantable electric cable. The system includes: a) a sound generator module configured for implantation in subcutaneous tissue to place an output electric/acoustic (E/A) transducer, e.g., a speaker, immediately adjacent to, or preferably, extending percutaneously into, a patient's outer ear canal; b) a sound receiver module configured for implantation proximate to a patient's pinna to place an input acoustic/electric (AJE) transducer, e.g., a microphone, so that it is acoustically isolated from the E/A transducer; and c) an electric cable configured for implantation in subcutaneous tissue for directly electrically connecting said sound receiver module and said sound generator module.

Abstract: A medical apparatus and method of use for implanting a percutaneous catheter in a patient's body which catheter can be easily positioned, repositioned, and replaced. The apparatus includes an elongate sleeve having a tapered forward portion to facilitate its insertion through an undersized incision. The sleeve provides an interior elongate passageway which extends from a sleeve proximal end to a sleeve distal end. The sleeve is intended to be percutaneously implanted through an incision in the patient's skin so that the sleeve distal end resides subcutaneously. The sleeve outer peripheral surface carries a layer of porous material intended to be placed under the patient's outer skin layer in contact with the dermis to promote tissue ingrowth for anchoring the sleeve and forming an infection resistant barrier. The sleeve passageway is dimensioned to snugly accommodate the outer surface of catheter while permitting the catheter to slide relative to the sleeve.

Abstract: A hearing aid system (10) including an implantable device (60), and a surgical instrument (134) for enabling a physician to install the implant (60) in a patient's body in a simple office procedure using only local anesthesia.

Abstract: A method and apparatus for reducing the incident of infection proximate to an exit site where a prosthesis fastener, e.g., a bone screw, percutaneously penetrates a patient's skin/soft tissue. Infection reduction is achieved in accordance with the invention by growing a tissue integrating seal around the fastener proximate to the exit site.

Abstract: A medical apparatus and method of use for implanting a catheter in a patient's body which catheter can be easily positioned, repositioned, and replaced. The apparatus includes an elongate sleeve intended to be subcutaneously implanted. The sleeve comprises a wall surrounding an interior elongate passageway which extends from a sleeve proximal end to a sleeve distal end. The sleeve outer peripheral surface carries a layer of porous material intended to be placed just under the patient's outer skin layer in contact with the dermis to promote tissue ingrowth for anchoring the sleeve and forming an infection resistant barrier. The sleeve passageway includes a sealing nib dimensioned to engage the outer surface of the catheter while permitting the catheter to slide relative to the sleeve. The sealing nib prevents deleterious material from migrating into the patient's body along the catheter outer surface.

Abstract: A medical apparatus and method of use for implanting a percutaneous catheter in a patient's body which catheter can be easily positioned, repositioned, and replaced. The apparatus includes an elongate sleeve comprising a wall surrounding an interior elongate passageway. The passageway extends from a sleeve proximal end to a sleeve distal end. The sleeve is intended to be percutaneously implanted through an incision in the patient's skin so that the sleeve distal end resides subcutaneously. The sleeve outer peripheral surface carries a layer of porous material intended to be placed just under the patient's outer skin layer in contact with the dermis to promote tissue ingrowth for anchoring the sleeve and forming an infection resistant barrier. The sleeve passageway is dimensioned to snugly accommodate the outer surface of catheter while permitting the catheter to slide relative to the sleeve.

Abstract: A medical apparatus and method of use for implanting a catheter in a patient's body which catheter can be easily positioned, repositioned, and replaced. The apparatus includes an elongate sleeve comprising a wall surrounding an interior passageway extending from a sleeve proximal end to a sleeve distal end. The sleeve is intended to be percutaneously implanted through an incision in the patient's skin to place the sleeve distal end subcutaneously. The sleeve distal end outer surface carries porous material intended to contact the patient's dermis to promote tissue ingrowth. The sleeve passageway is dimensioned to snugly accommodate the outer surface of the catheter while permitting the catheter to slide relative to the sleeve. A split ring locking member is selectively operable in an unlocked state for permitting axial and rotational movement of said catheter relative to said sleeve and operable in a locked state for preventing such relative movement.

Abstract: An implantable device including a housing having a stud projecting percutaneously through an incision in the patient's skin. The stud defines a peripheral surface extending longitudinally inwardly from the stud outer end. The longitudinal peripheral surface is used as a substrate to carry a peripheral fibrous layer which extends longitudinally along the stud from its outer end adjacent to the skin incision to below the patient's epidermal and dermal skin layers for promoting laterally directed soft tissue ingrowth. The housing also defines a lateral shoulder surface oriented substantially perpendicular to the longitudinal peripheral surface. The shoulder surface also carries a porous layer conducive to promoting tissue ingrowth. The porous layers on the device allows tissue ingrowth into the interstices of both porous layers to form an enhanced infection resistant barrier while also providing improved device anchoring.

Abstract: A medical apparatus and method of use for implanting a percutaneous catheter in a patient's body which catheter can be easily positioned, repositioned, and replaced. The apparatus includes an elongate sleeve having a tapered forward portion to facilitate its insertion through an undersized incision. The sleeve provides an interior elongate passageway which extends from a sleeve proximal end to a sleeve distal end. The sleeve is intended to be percutaneously implanted through an incision in the patient's skin so that the sleeve distal end resides subcutaneously. The sleeve outer peripheral surface carries a layer of porous material intended to be placed under the patient's outer skin layer in contact with the dermis to promote tissue ingrowth for anchoring the sleeve and forming an infection resistant barrier. The sleeve passageway is dimensioned to snugly accommodate the outer surface of catheter while permitting the catheter to slide relative to the sleeve.

Abstract: A method and apparatus for facilitating the management of indwelling conduits to avoid and/or treat infections associated with long term implantation. A sleeve carrying a layer of porous material on its outer surface is percutaneous implanted to place the layer of porous material just under the patient's outer skin in contact with the patient's dermis where it functions to promote soft tissue ingrowth. A catheter passes through the sleeve passageway and along an interior body path to an interior destination site, e.g., an opening into a vein, i.e., venotomy site. Within about 3-6 weeks after implantation, the patient's dermal tissue integrates sufficiently with the sleeve porous material to physically anchor the sleeve and create an infection resistant barrier. Further, a tunnel, characterized by an epithelialized capsule, typically forms around the catheter along the interior body path extending to the interior destination site.

Abstract: A fully implantable hearing aid system comprised of an implantable sound generator module and an implantable sound receiver module connected by an implantable electric cable. The system includes: a) a sound generator module configured for implantation in subcutaneous tissue to place an output electric/acoustic (E/A) transducer, e.g., a speaker, immediately adjacent to, or preferably, extending percutaneously into, a patient's outer ear canal; b) a sound receiver module configured for implantation proximate to a patient's pinna to place an input acoustic/electric (AJE) transducer, e.g., a microphone, so that it is acoustically isolated from the E/A transducer; and c) an electric cable configured for implantation in subcutaneous tissue for directly electrically connecting said sound receiver module and said sound generator module.

Abstract: A hearing aid system including an implant (60) configured for insertion into a recess (40) formed under the skin of the retro-auricular space (50), which implant does not occlude the ear canal (30). The implant includes electronic circuitry (72), a transducer (65, e.g., speaker), antenna (64), and power source (66). The hearing aid also includes an external module (70), which module includes a microphone (163), electronics (172), antenna (164), and power source (166). A telemetry link (76) between the external module antenna and the implant antenna allows transmissions between the microphone module and the implant.

Abstract: An implantable device including a housing having a stud projecting percutaneously through an incision in the patient's skin. The stud defines a peripheral surface extending longitudinally inwardly from the stud outer end. The longitudinal peripheral surface is used as a substrate to carry a peripheral fibrous layer which extends longitudinally along the stud from its outer end adjacent to the skin incision to below the patient's epidermal and dermal skin layers for promoting laterally directed soft tissue ingrowth. The housing also defines a lateral shoulder surface oriented substantially perpendicular to the longitudinal peripheral surface. The shoulder surface, when implanted, is located just inwardly from the patient's outer skin surface. The shoulder surface also carries a porous layer conducive to promoting tissue ingrowth. The provision of both lateral and longitudinal porous layers on the device allows tissue ingrowth, i.e.

Abstract: A hearing aid system including an implant (60) configured for insertion into a recess (40) formed under the skin of the retro-auricular space (50), which implant does not occlude the ear canal (30). The implant includes electronic circuitry (72), a transducer (65, e.g., speaker), antenna (64), and power source (66). The hearing aid also includes an external module (70), which module includes a microphone (163), electronics (172), antenna (164), and power source (166). A telemetry link (76) between the external module antenna and the implant antenna allows transmissions between the microphone module and the implant.

Abstract: An optical fiber carries a light beam through a cardiovascular catheter and projects the beam into the patient's bloodstream. Two other fibers, spaced in a very carefully controlled configuration from the first, receive light scattered by corpuscles (and blood-vessel walls) and transmit this reflected light back through the catheter to respective detectors outside the patient's body. If preferred, two input fibers and a single output fiber--or other techniques for providing differential geometry--may be used instead. Electronic instrumentation finds the ratio of the two light fluxes, thus cancelling out unknown variables such as input light intensity and optical--connector attenuation. The known differential geometry between the two light paths permits calibration of the ratio measurement in terms of corpuscular concentration--i.e., hematocrit. Light at only one wavelength suffices for the measurement. Advanced forms of the invention correct for proximity of blood-vessel walls.

Abstract: The catheter tip fits into a cavity in the boot and is held gently (in the longitudinal direction) by a detent formed within the cavity. A calibration substance faces the tip in a mechanically and optically standardized calibration relationship, to reflect light from within the catheter back into the catheter. The calibration substance is held in constant, precise contact with the tip--but passively, not by springs or other longitudinally forcible devices but by close fit between the tip and the precision-molded internal surfaces of the cavity. In the lateral direction the boot may tightly grip the tip, at a point where the optic fibers are protected against such force. To provide a reflection standard for calibration, the calibration substance is of standardized character and quality: it is preferably a homogeneous suspension of reflecting particles in translucent or transparent polymer.

Abstract: Cardiac output, blood oxygen saturation, and oxygen consumption are measured using only two lumens of a catheter that has no interlumen crossover. Therefore this construction avoids costly techniques for modifying the catheter, as well as leakage risk at crossover points. Cardiac output is measured by thermodilution, and venous blood oxygen by optical scattering measurements through optic fibers; oxygen consumption is then claculable from the cardiac output and venous oxygen saturation--and independently measured arterial saturation. Cold-bolus injection uses on lumen. The thermal-sensor leads (electrical or otherwise) and optic fibers share the other lumen, through which they are drawn together: this method of installation effects yet a further economy by saving an expensive labor step, and tends to prevent the leads and fibers from damaging one another.

Abstract: A continuous automatic calibration system and fault detection method for analytical instruments of the kind used for measuring constituents of a fluid sample which system includes a memory for storing reference information, a comparator circuit for continuously comparing the instrument output to the stored reference information, and a sample-and-hold circuit charged positive or negative by the comparator, depending whether or not the instrument output exceeds the value of the reference information. The output of the sample-and-hold circuit in turn is coupled to the instrument continuously to adjust its output to correct value. Where the maximum allowed corrective range of the sample-and-hold circuit is exceeded by the signal from the comparator circuit beyond a predetermined time period, the system displays fault, warning the operator.