Abstract: The present invention automates impedance measurements between pairs of electrodes that are associated with a lead of an implanted device. Apparatus comprises a communications module and a processor, in which the processor communicates with the implanted device over a communications channel. The processor instructs the implanted device to perform a voltage measurement that is associated with a stimulation pulse between the pair of electrodes. The implanted device sends the voltage measurement to the apparatus over the communications channel from which the apparatus determines the impedance between the pair of electrodes. The apparatus initiates an impedance measurement for each pair of electrodes along the lead. With a plurality of leads, the apparatus repeats the impedance measurements for electrode pairs of the other leads. The embodiment also supports measuring a current between pairs of electrodes. The impedance measurements and current measurements are displayed to a clinician on a user interface.

Abstract: A valve repair system, preferably including an annuloplasty prosthesis and a holder for the prosthesis. The holder includes a first component having a central opening, a circumferential surface and an outwardly extending member. The annuloplasty prosthesis is located adjacent to the circumferential surface, above the outwardly extending member. The holder further includes a second component movable upwardly relative to the first holder component and includes a rigid penetrating member extending downward from the second component into the prosthesis, holding it adjacent the circumferential surface. The holder also includes a suturing guide for assisting a physician in valve repair surgery, which may be a cuttable suture extending across the central opening along a path approximating a desired line of leaflet coaption. The cuttable suture may additionally secure the first and second components to one another.

Abstract: Disclosed is a method and apparatus for configuring an external device so that may communicate with and an implantable medical device in accordance with a desired telemetry protocols. The external device utilizes a telemetry module can be loaded with a protocol driver necessary for communicating with the implantable medical device. Once the desired protocol driver has been installed, the telemetry module and its associated external device, e.g., a physician programmer, are enabled to communicate with the implantable medical device.

Abstract: Disclosed is a universal connector for connecting component devices of an implantable medical treatment system. The universal connector includes a male and a female interface adapted to connectively mate two devices of the implantable medical treatment system. A locking flange and recess are provided, as well as a locking shoulder and ridge combination, to securely connect the mated male and female interfaces. When mated and securely joined, the universal connector of the present invention allows a device of the implantable medical treatment system to interface with any other device of the implantable medical treatment system for simplified handling and bi-directional communications.

Abstract: Disclosed is a method and apparatus for configuring an external device so that may communicate with and an implantable medical device in accordance with a desired telemetry protocols. The external device utilizes a configurable telemetry module that comprises a protocol driver that interacts with a transmit driver and a receive driver, both of which can be configured to process a telemetry signal in accordance with the necessary telemetry protocol for communicating with the implantable medical device. Once the transmit and receive drivers are configured, the telemetry module and its associated external device, e.g., a physician programmer, are enabled to communicate with the implantable medical device.

Abstract: A method and system for the collection and centralized storage of medical information stored in implantable medical devices and associated programming devices. The system comprises a clinician programmer, a patient programmer, an implanted medical device, and a communication network for storing data found on these devices into a central database for report generation.

Abstract: An implantable infusion pump possesses operational functionality that is, at least in part, controlled by software operating in two processor ICs which are configured to perform some different and some duplicate functions. The pump exchanges messages with an external device via telemetry. Each processor controls a different part of the drug infusion mechanism such that both processors must agree on the appropriateness of drug delivery for infusion to occur. Delivery accumulators are incremented and decremented with delivery requests and with deliveries made. When accumulated amounts reach or exceed, quantized deliverable amounts, infusion is made to occur. The accumulators are capable of being incremented by two or more independent types of delivery requests. Operational modes of the infusion device are changed automatically in view of various system errors that are trapped, various system alarm conditions that are detected, and when excess periods of time lapse between pump and external device interactions.

Abstract: An annuloplasty system including an annuloplasty prosthesis and a holder for the prosthesis. In a preferred embodiment, the holder includes a first holder component having an upper surface, a lower surface and a circumferential surface corresponding generally to the configuration of a heart valve annulus. The anuloplasty prosthesis is located adjacent to and extending at least partially around the circumferential surface. The holder also preferably includes a second holder component, coupled to and extending above the first holder component. At least one rigid, downwardly extending penetrating member is mounted to the second component and extends into the prosthesis, holding it adjacent the circumferential surface. The circumferential surface preferably includes at least one outwardly extending member extending alongside a lower surface of the prosthesis, preventing the prosthesis from moving downward and off of the penetrating member.

Abstract: Implantable medical devices (IMDs) and their various components, including flat electrolytic capacitors for same, and methods of making and using same, particularly an improved electrolytic capacitor with optimized ESR and anode layer surface area. An electrode stack assembly and electrolyte are located within the interior case chamber of a hermetically sealed capacitor case. The electrode stack assembly comprises a plurality of capacitor layers stacked in registration upon one another, each capacitor layer comprising a cathode layer having a cathode tab, an anode sub-assembly comprising at least one anode layer having an anode tab, and a separator layer located between adjacent anode and cathode layers, whereby all adjacent cathode layers and anode layers of the stack are electrically insulated from one another by a separator layer.

Abstract: The present invention provides for an encryption apparatus, system, and method in which data from an Implantable Medical Device (IMD) and a data center could be transferred based on a differentiated encryption system. The encryption scheme allows for the differentiation, segregation, and classification of data at required or needed levels of security. Before transfer of the data, either from an IMD or any other part of a support network for the IMDs, the encryption device begins to distinguish the data. The variable data is then classified based on various levels of security having distinct encryption protocols. After classification the data is encrypted based on the data's level of security. The data is then transmitted. Upon being received the data is then segregated based on whether the data is encrypted. The encrypted data is then de-encrypted and interpreted.

Abstract: A laryngeal cutting blade has an outer blade assembly including a tubular member having a bend closer to a proximal portion than a distal end, a hollow inner blade assembly rotatably received in the outer blade assembly for mounting to a powered handpiece and having a flexible portion disposed adjacent the bend and a suction passage extending through the inner blade assembly to permit aspiration of cut tissue, the angled configuration of the laryngeal cutting blade and toothed and smooth profile cutting ends therefore are particularly effective for debulking large, firm lesions and for delicate shaving of superficial lesions of the vocal cords after removal of bulk mass.

Abstract: Structures and methods relating to electrodes for incorporation into a feedthrough with a profile adapted for subcutaneous sensing of physiologic and cardiac signals. Electrode assemblies are adapted for integration with feedthrough to enable maximal electrode spacing, minimal myopotential electrical noise and provide reliable insulation from the IMD housing. Various structures and manufacturing processes are implemented to provide a large sensing surface with a low profile. The subcutaneous sensing electrode assembly provides a leadless sensing system and further enhances installation and follow-up procedures.

Abstract: Balloons and balloon catheters with a superior overall combination of distensibility, elastic stress response and strength. The improved properties of the balloons result from the method or process used to form the balloons, as well as the polymeric materials used in said balloon forming process. Additionally, the enhanced combination of properties of the balloons will not be adversely affected by the novel sterilization process contemplated by this invention.

Abstract: A medical electrical lead, which may be useful in coupling an implantable medical device, is comprised of an elongate body having first and second spaced apart lumens. A conductor and an electrode are associated with the first lumen, and the second lumen is multi-purpose. The second lumen may be used to guide the lead and to introduce various fluids into the venous system. The second lumen may at various times be used to introduce vasodilation solutions, contrast fluids and adhesives into the venous system.

Abstract: A method and apparatus for performing self-tests on defibrillation and pacing circuits including a patient isolation switch is disclosed. Following a test of the defibrillation and pacing circuitry, the isolation switch is tested by closing certain switches within the defibrillation circuitry so as to create a circuit path, and then opening and closing the isolation switch. Alternative tests may be performed depending on whether the impedance at the output of the defibrillator is determined to be an open circuit or a short circuit. If the output is determined to be an open circuit, then the test monitors the voltage across the output of the defibrillator as indicated by the voltage of a DC offset of a preamplifier coupled to the output of the defibrillator. For the short circuit test, the voltage on the energy storage capacitor is monitored.

Abstract: Medical electrode arrangements are provided for electrotherapy and monitoring applications. In one embodiment, each electrode arrangement includes a smaller electrode that is releasably attached to the back of a larger electrode. For adult applications, the larger electrode is applied to the patient. For pediatric applications, the larger electrode is preferably removed, and the smaller electrode is applied to the patient. Face-to-face and back-to-back electrode arrangement configurations are also provided. In another embodiment, an electrode arrangement is comprised of first and second conductive regions that are separable from each other. In yet further embodiments, an electrode arrangement is comprised of two or more electrodes that are not physically or electrically connected to each other. At least one electrode from each electrode arrangement is placed on the patient. A sensor is also provided to sense which electrodes in each electrode arrangement have been placed on the patient.

Abstract: A method and apparatus for performing self-tests on defibrillation and pacing circuits including a patient isolation switch is disclosed. Tests are provided for the defibrillation and pacing circuitry as well as the isolation switch. For testing the defibrillation circuitry, the impedance drive circuits and preamplifier may be utilized such that the energy storage capacitor is not required to be charged and discharged during the test, thus conserving energy. For testing the pacing circuitry and the isolation switch, the defibrillation circuitry is utilized. For certain of the tests, the test stimulus is the output voltage on the energy storage capacitor, while for other tests the test stimulus may be the pace current as indicated by the voltage across the input to the preamplifier. Alternative tests may be performed depending on whether the impedance at the output of the defibrillator is determined to be an open circuit or a short circuit.

Abstract: A method and system for programming settings of a medical device surgically implanted within a body of a patient. The system comprises a physician programmer, a patient programmer, an external neural stimulator, and a telemetry component being in communication with the implanted medical device, the external neural stimulator, and the physician programmer. The implantable medical device may be programmed using a two-phase process, a screening phase and an implant phase. During the screening phase, the physician and patient programmers may be used to roughly test the parameters of the stimulation to determine that the treatment therapy is efficacious. During the implant phase, the same physician and patient programmers may be used to fine tune the parameters of the stimulation.

Abstract: Methods are provided for forming a coating of an immobilized biomolecule on a surface of a medical device to impart improved biocompatibility for contacting tissue and bodily fluids. A biomolecule such as a glycoprotein having an unsubstituted amide moiety is combined with an amine forming agent to form an amine-functional biomolecule. The amine-functional biomolecule is combined with a medical device surface having a chemical moiety such as aldehyde, epoxide, isocyanate, 1,2-dicarbonyl, phosphate, sulphate or carboxylate to form a chemical bond immobilizing the biomolecule on the surface. The chemical bond may be combined with a reducing agent or a stabilizing agent. The aldehyde moiety may be formed by combining a periodate with a 2-aminoalcohol moiety or a 1,2-dihydroxy moiety. Alternatively, an amine-functional medical device surface is combined with a biomolecule having a chemical moiety that reacts with an amine moiety.

Abstract: Spiral electrodes and similar structures are manufactured using a high-pressure fluid stream. Specifically, spiral electrodes are made from tubular structures by using a high-pressure water stream to precisely cut, or etch spirals of predetermined geometries to conform to a particular current distribution and conduction requirements. In an embodiment, the high-pressure water stream is tangentially and rotatably oriented against a rotating and translating tubular element. The tangential orientation enables limited cutting or etching of the tubular surface that is only in direct contact with the high pressure stream. Various geometries and spiral structures could be formed by managing the pressure and rotation of the high-pressure water stream source and the rotation and translation of the tubular element.