Abstract: The present invention provides a fully intrathoracic artificial pacemaker. The pacemaker is of sufficiently compact size to allow for implantation of both the electrode and the power source within the chest cavity. In exemplary embodiments, a screw-type electrode is used for connection to heart tissue, and a relatively short lead is used to connect the electrode to a battery unit, which can comprise electronics for control of the pacemaker. An assembly for implanting the pacemaker, as well as methods of implanting the pacemaker, are disclosed. In embodiments, the device is designed as a fetal pacemaker.

Abstract: The invention is directed to an apparatus substantially eliminating destructive low-temperature, humidity-enhanced phase transformation of yttria-stabilized zirconia in general, as well as eliminating low-temperature degradation of yttria-stabilized tetragonal zirconia polycrystalline ceramic (Y-TZP). The martensitic-type phase transformation from tetragonal to monoclinic is accompanied by severe strength degradation in a moist environment at low-temperature, specifically at room temperature as well as at body temperature. This class of materials has been chosen as the packaging material for small implantable neural-muscular sensors and stimulators because of the high fracture toughness and high mechanical strength. This destructive phase transformation has been substantially eliminated, thus ensuring the safety of long-term implants, by subjecting the sintered components to post-machining hot isostatic pressing, such that the average grain size is less than about 0.5 microns.

Abstract: In one embodiment, there is disclosed an implantable pulse generator for electrically stimulating a patient, which comprises: a housing enclosing pulse generating circuitry; a header coupled to the metallic housing, the header including an inner guide having cylindrical passages for accepting feedthrough wires such that the inner guide is slidingly coupled to the plurality of feedthrough wires, wherein the inner guide has an exterior surface which intersects a portion of each cylindrical passage to create an exposed portion of each feedthrough wire, an outer seal having an interior surface sized to support terminals against the exposed portion of the feedthrough wires, and an outer clip component fitting over at least a portion of the outer seal component.

Abstract: A cochlear implant for a cochlear stimulation system and method of assembling the implant comprising an implantable sealed housing comprising a metal feedthrough case and a metal bottom cover and containing cochlea stimulation circuitry, the feedthrough case comprising silicone enclosed feedthrough pins for connecting an electrical lead of a cochlear electrode to the stimulation circuitry, and a moisture absorbing material comprising calcium oxide secured within the housing and sufficient in quantity to absorb moisture released by the circuitry materials and leaking into the feedthrough case at leak rates of about 1×10?7 atm cc/s to maintain the cochlear implant within acceptable internal moisture limits for at least about 60 years.

Abstract: Methods and apparatuses are provided for an electrical device that employs a feedthrough including a hermetic seal that seals an interior region of the electrical device. The electrical device includes an electrical contact disposed within the interior region of the electrical device, and a wire terminal that includes an encircled portion that is encircled by the feedthrough, and a first end that electrically connects with said electrical contact. When the electrical device is constructed, the first end of the wire terminal is coated with a conductive metal that is more resistant to oxidation than the wire terminal. The first end of the wire terminal is secured to the electrical contact using a mechanical device such as a crimping connector or a spring connector.

Abstract: An active medical implantable device with at least two diagnostic and/or therapeutic functions is constructed from separate active implant modules (2 to 7) which are adapted to the respective desired functions and can be coupled to each other.

Abstract: In a medical implantable device having a hermetically sealed, radio shielded encapsulations containing an RF circuit therein and having an antenna located outside of the encapsulation, and in a method for connecting the RF circuit to the antenna, at least one hermetical feedthrough connection is provided in the form of at least one conductor passing through a wall portion of the encapsulation in a liquid-tight and gas-tight manner, with the feedthrough being electrically insulated from the encapsulation. At least one connector pin is provided on an RF circuit board, which is resiliently mounted on the RF circuit board. The RF circuit is mounted in the encapsulation so as to cause the connector pin to resiliently engage the conductor and to electrically connect the conductor with the RF circuit board.

Abstract: One example includes a battery case sealed to retain electrolyte, an electrode disposed in the battery case, the electrode comprising a framework defining open areas disposed along three axes (“3D framework”) formed of fluorinated carbon including elements that each include a conductive core at least partially surrounded by an electrochemically active portion, wherein a plurality conductive cores form an electrically conductive network, a conductor electrically coupled to the electrode in electrical communication with the conductive network and sealingly extending through the battery case to a terminal disposed on an exterior of the battery case, a further electrode disposed in the battery case, a separator disposed between the electrode and the further electrode and a further terminal disposed on the exterior of the battery case and in electrical communication with the further electrode, with the terminal and the further terminal electrically isolated from one another.

Abstract: A medical device (e.g., an implantable medical device) including a sealing apparatus (sealing element, e.g., a grommet for securing a lead to the device) that includes an element (e.g., a body) having a plasma-treated surface and methods (e.g., methods of making the device).

Abstract: Methods and apparatuses are provided for an electrical device that employs a feedthrough including a hermetic seal that seals an interior region of the electrical device. The electrical device includes an electrical contact disposed within the interior region of the electrical device, and a wire terminal that includes an encircled portion that is encircled by the feedthrough, and a first end that electrically connects with said electrical contact. When the electrical device is constructed, the first end of the wire terminal is coated with a conductive metal that is more resistant to oxidation than the wire terminal. The first end of the wire terminal is secured to the electrical contact using a mechanical device such as a crimping connector or a spring connector.

Abstract: A device for electrical stimulation of the brain, heart, and other neurons and muscles, capable of modifying the electrical activity of its environment in ways that are desirable for a better life style of a patient with brain, heart, or other problems. When used for brain stimulation, the device is able to superimpose an electrical current on the natural current that happens to occur, when the natural currents cause some undesirable effect, as in Parkinson's disease. When used for heart stimulation, the device is able to superimpose an electrical current on the natural current that happens to occur, originating at the sino-atrial node, which causes a healthy heart to pump blood to the lungs and to the body. The device offers an improvement over prior art of being capable of adjusting the position of the stimulating electrodes.

Abstract: Instrumented retrievable implantable device, including an expandable section, for placement inside a body lumen, preferably in a blood vessel. The device includes a joined sensor for monitoring one or more physiological parameter for diagnostic or therapeutic purposes. Data access is assured by a passive RF transponder, in communication with an external readout unit or an implanted device, providing as well to the energy supply of the sensor. The shape of the device allows repositioning and retrieval by micro-invasive methods, by means of a link section coupleable with a grabbing device mounted on a catheter.

Abstract: A terminal housing (14) for an electromedical implant (10) having female contacts (22.2, 22.2, 24) to receive and provide electric contact for electrode line plugs. The terminal housing has a base module (20) and a separately premanufactured cover module (40) that has a female contact (24) according to the IS-4 standard and is inserted into the base module (20) and connected thereto.

Abstract: The invention is directed to designs for capacitors of implantable medical devices (IMDs) such as implantable defibrillators, implantable cardioverter-defibrillators, implantable pacemaker-cardioverter-defibrillators, and the like. The capacitor designs can reduce capacitor volume significantly and may also improve charge holding capacity relative to conventional capacitor designs. Moreover, since capacitors typically comprise a significant portion of the volume of an IMD, significant reductions in capacitor volume can likewise significantly reduce the size of the IMD.

Abstract: An implantable medical device comprises an anti-infection agent. The implantable medical device may be configured for placement in the head of a patient and for monitoring or treatment of the brain. The implantable medical device may have a housing or it may have a housing and a member for providing a smooth interface between the device and the adjacent tissue. The anti-infection agent may be provided on or impregnated in the housing or the member. In some embodiments, the device includes a single module while in other embodiments a plurality of modules are coupled to provide a smaller profile. In some embodiments the implantable medical device may include both anti-infection and lubricious materials.

Abstract: A form for retaining a battery in implantable medical device includes outer edge and first and second opposing major surfaces. The first major surface of the form includes a recess, a ridge disposed between the recess and the outer edge, and a trough forming element disposed between the ridge and the outer edge. The ridge is configured to engage at least a portion of a major surface of the battery retained in the form. The trough forming element has first and second edge surfaces positioned to engage an edge surface of the retained battery to form a trough configured to receive adhesive. The recess is disposed adjacent the ridge and is configured to allow for expansion of the retained battery during recharge. The retention assembly is configured to secure the first major surface of the battery against the ridge to prevent adhesive from leaking from the trough into the recess.

Abstract: An implantable medical device is configured so that all of the major components including a housing and attached leads are disposed within the vasculature of a patient. A tether extends from the housing of the device to an implant location where the tether is secured to tissue outside of the vasculature. In this manner, an intravascular medical device may be implanted at a location remote from final placement, delivered via the vasculature and anchored at the initial entry point.

Abstract: A case for use with a speech processor unit including a housing configured to receive the speech processor unit and a connector configured to be connected to a connector on the speech processor unit.

Abstract: An electronic device, comprising a housing, a functional unit disposed in the housing, a terminal lead electrically connecting the functional unit to the outside of the housing, and a sealed feedthrough in the housing, the feedthrough surrounding the terminal lead and insulating it with respect to the housing, wherein the feedthrough is produced from a liquid crystal polymer.

Abstract: An implantable medical device that includes a housing having a first shield having an outwardly extending first flange and a second shield having an outwardly extending second flange. The first flange is fixedly engaged with the second flange along a seal to form a housing flange extending outward from the housing, and a surround shroud, having first recessed portions for receiving the housing flange when the shroud is positioned about the housing.

Abstract: An implantable medical device connector assembly and method of manufacture include a molded, insulative shell having a first inner surface forming a connector bore, an outer surface defining a fill port for receiving an adhesive, and a second inner surface defining a channel extending from the fill port to the first inner surface forming the connector bore; one or more conductive members positioned along the connector bore; and sealing members positioned between the conductive members. An adhesive is disposed in the channel and seals the outer surface of the sealing member to the inner surface forming the connector bore.

Abstract: An electrochemical cell for use in an implantable medical device is presented. The electrochemical cell includes a cover having a first surface and a second surface separated by an outer edge. The electrochemical cell also includes a case having a planar bottom, a side extending upwardly from the planar bottom, and an open top for receiving the cover.

Abstract: A septum for use in an implantable pulse generator. The septum includes a soft sealing material and a hard inner portion or core having a set of lips. The lips are exposed outside the soft sealing material and act to displace the sealing material when a force is applied, for example from a tool used to tighten or loosen a set screw, enlarging a slit, seam or slot into a passageway through the septum.

Abstract: Lumen-traveling biological interface devices and associated methods and systems are described. Lumen-traveling biological interface devices capable of traveling within a body lumen may include a propelling mechanism to produce movement of the lumen-traveling device within the lumen, electrodes or other electromagnetic transducers for detecting biological signals and electrodes, coils or other electromagnetic transducers for delivering electromagnetic stimuli to stimulus responsive tissues. Lumen-traveling biological interface devices may also include additional components such as sensors, an active portion, and/or control circuitry.

Abstract: One example includes a configurable power source system for an implantable device having a predetermined power requirement, the system comprising a housing for a battery and a capacitor, the housing including a distance D between a first internal face and a second internal face, the housing adapted to fit within dimensions of the implantable device, a plurality of batteries of different thicknesses, each battery adapted to fit within a perimeter of the housing, a plurality of capacitors of different thicknesses, each capacitor adapted to fit within the housing and adjacent the battery and a pick and place system adapted to assemble a selected battery from the plurality of batteries and a selected capacitor from the plurality of capacitors with the housing to form a configurable power source at least meeting the predetermined power requirement for the implantable device.

Abstract: One aspect relates to a method for producing an alloy, whereby the alloy consists of three metals and the three metals are selected from the group consisting of tantalum, tungsten, and niobium. The method according to one embodiment is characterized by a) grinding the tantalum to form a tantalum powder and grinding the tungsten to form a tungsten powder; b) mixing the tantalum powder and the tungsten powder to form a blended powder, whereby the weight fraction of tungsten powder in the blended powder is larger than in the desired alloy; c) producing a blended body from the blended powder by means of a powder metallurgical route; d) producing a pre-alloy by means of a first melting of the blended body and at least a fraction of at least one further metal by means of a melt metallurgical route; and e) producing the alloy by means of a second melting of the pre-alloy and the remaining fraction of at least one metal by means of a melt metallurgical route.

Abstract: An implantable medical device having a case with therapeutic componentry contained with the case. A module has a rail around at least a portion of a perimeter of the module and is adapted to be mechanically secured to the case. The case has a rigid fastening channel adapted to receive the rail of the module. The rigid fastening channel has an opening allowing the rail of the module to drop into the rigid fastening channel through the opening and then slide along the rigid fastening channel to be mechanically secured to the case.

Abstract: Endocardial or intravascular cardiac pacemaker having a sealed housing, in which a battery and a pacemaker controller connected to the battery, as well as at least one stimulation pulse generator, are situated, the housing being oblong and having a length of less than 70 mm and a cross-sectional area of less than 100 mm2 and carrying at least two electrodes, each of which has an outwardly directed, electrically conductive surface and is implemented as a stimulation electrode and is at least sometimes electrically connected to the stimulation pulse generator via an electrical connection situated in the interior of the housing.

Abstract: An implantable microstimulator configured for implantation beneath a patient's skin for tissue stimulation to prevent and/or treat various disorders, uses a self-contained power source. Periodic or occasional replenishment of the power source is accomplished, for example, by inductive coupling with an external device. A bidirectional telemetry link allows the microstimulator to provide information regarding the system's status, including the power source's charge level, and stimulation parameter states. Processing circuitry automatically controls the applied stimulation pulses to match a set of programmed stimulation parameters established for a particular patient. The microstimulator preferably has a cylindrical hermetically sealed case having a length no greater than about 27 mm and a diameter no greater than about 3.3 mm. A reference electrode is located on one end of the case and an active electrode is located on the other end.

Abstract: An implantable microdevice includes at least one electrode detachably connected to electronic circuitry housed in an hermetically-sealed micro housing. The micro housing has a length no more than about 10 mm. In one embodiment, the electrode is located at a distal end of an electrode lead, and a proximal end of the electrode lead is removably inserted into a connector that forms part of the micro housing.

Abstract: A micro integrated cardiac pacemaker includes a control unit for outputting a control signal according to cardiograph information, heart stimulating means for stimulating heart tissue in response to the control signal, cardiograph information extracting means for extracting cardiograph information and outputting it to the control unit, and a power supply unit for supplying drive power. The power supply unit is a biological fuel cell that takes out electrons by oxidation of a biological fuel. The biological fuel cell includes an anode and a cathode. An oxidase of a biological fuel and a mediator are immobilized on the cathode. Blood and/or body fluid are used as an electrolytic solution, and a biological fuel and oxygen in the blood and/or the fluid are used. The biological fuel cell is attached to the end of a catheter and implanted into the heart, and the catheter is withdrawn, without incising the breast.

Abstract: The present subject matter provides feedthrough or interconnect systems for components of an implantable medical device and methods for their manufacture. A feedthrough system includes a wire or nailhead having a protruded tip. The wire or nailhead extends from an aperture in an encasement of a first component and is connected to a terminal conductor adapted to electrically connect to circuitry within the encasement. A ribbon wire has a distal end adapted to electrically connect to a second component and a proximal end having a pattern adapted to fit to the protruded tip of the wire or nailhead to provide for subsequent attachment of the ribbon wire to the nailhead.

Abstract: The present invention provides a pacing device and method that allows for preferential right atrial, at or near the His bundle, and ventricular pacing, either individually or in combination, including tri-ventricular pacing. The pacing device includes a power source and one or more logic circuits allowing for programmable delivery of pacing to any combination of the right atria, the para-Hisian region, and the right and/or the left ventricles. The pacing device allows the user to select which site(s) to pace as well at the appropriate relative timing of pacing impulse delivery to any of these three previously mentioned sites. The device is constructed and arranged to be combined with an atrial sensing/pacing electrode to allow for atrio-ventricular sequential tri-ventricular pacing or variants of such. Also, a defibrillator lead can be incorporated into the device to allow for protection from ventricular arrhythmias and sudden death.

Abstract: The present invention relates to provide a catheter tube having excellent insertability into the body, excellent operability and an excellent anti-thrombogenic property, and also provide a catheter having the tube. For the purpose, a catheter tube of the present invention comprises a mixture of an isobutylene block copolymer and a thermoplastic polyurethane resin, wherein the isobutylene block copolymer is composed of a polymer block mainly comprising isobutylene and a polymer block mainly comprising a monomeric component other than isobutylene; and a catheter using the tube.

Abstract: Cardiac sensing and/or stimulation devices and methods that adapt to implant location and positioning, and may employ automated vector selection from multiple electrodes. Devices include a housing having a first face opposing a second face, and an edge extending around the perimeter. A pulse generator and controller are coupled to three or more electrodes. Electrode arrangement facilitates selection of the particular electrodes that sense cardiac activity irrespective of one or more of positioning of the device, rotation of the housing, and which of the first and second faces of the housing is orientated toward the patient's skin. A first vector may be selected that provides for sensing cardiac activity, and a second vector may sense skeletal muscle activity. The vectors may be selected based on amplitude or signal-to-noise ratio exceeding a predetermined threshold. Methods may involve delivering defibrillation or cardioversion energy and/or determining cardiac rhythm states using selected vectors.

Abstract: An implantable medical device connector assembly and method of manufacture include a molded, insulative shell having an inner surface forming a connector bore, a circuit member including a one or more traces extending through the shell; one or more conductive members positioned along the connector bore and electrically coupled to the traces; and sealing members positioned between the conductive members.

Abstract: An improved structure for an implantable medical device, such as an implantable pulse generator, is disclosed. The improved device includes a charging coil for wirelessly receiving energy via induction from an external charger. The charging coil in the device is located substantially equidistantly from the two planar sides of the device case. Because the coil is substantially equidistant within the thickness of the case of the device, the device's orientation within the patient is irrelevant, at least from the standpoint of the efficiency of charging the device using the external charger. Accordingly, charging is not adversely affected if the device is implanted in the patient with the wrong orientation, or if the device flips within the patient after implantation.

Abstract: A protective faceplate (37) for an implantable component of a tissue-stimulating prosthesis, such as a prosthetic hearing implant. The faceplate (37) comprising a first or outer surface and an opposed second or inner surface. The implantable component can be removably or non-removably mountable to the second surface and adapted to extend into a cavity formed in a bone of a recipient.

Abstract: Methods and apparatuses are provided for an electrical device that employs a feedthrough including a hermetic seal that seals an interior region of the electrical device. The electrical device includes an electrical contact disposed within the interior region of the electrical device, and a wire terminal that includes an encircled portion that is encircled by the feedthrough, and a first end that electrically connects with said electrical contact. When the electrical device is constructed, the first end of the wire terminal is coated with a conductive metal that is more resistant to oxidation than the wire terminal. The first end of the wire terminal is secured to the electrical contact using a mechanical device such as a crimping connector or a spring connector.

Abstract: A shielded three-terminal flat-through EMI/energy dissipating filter includes an active electrode plate through which a circuit current passes between a first terminal and a second terminal, a first shield plate on a first side of the active electrode plate, and a second shield plate on a second side of the active electrode plate opposite the first shield plate. The first and second shield plates are conductively coupled to a grounded third terminal. In preferred embodiments, the active electrode plate and the shield plates are at least partially disposed with a hybrid flat-through substrate that may include a flex cable section, a rigid cable section, or both.

Abstract: An implantable microstimulator includes a housing, an electronic subassembly, conductive vias, and an electrode arrangement. The housing defines an interior and an exterior with the electronic subassembly disposed in the interior of the housing. The conductive vias extend from the interior to the exterior of the housing. The electrode arrangement is disposed on the housing and includes a film substrate with electrodes disposed on the film substrate and coupled to the electronic subassembly through the plurality of vias.

Abstract: A lead coupling device adapted for coupling to a lead and methods for using the coupling devices are provided. The coupling device includes a housing assembly having a proximal opening and a distal opening. The coupling device also has a lead receiving channel that is disposed between the two openings to receive a lead therethrough. Various electronics components may also included in the coupling device that enable operations such as sensing, delivery of electrical energy and wireless communication between the coupling device and an external device.

Abstract: An implantable microdevice includes at least one electrode detachably connected to electronic circuitry housed in an hermetically-sealed micro housing. The micro housing has a length no more than about 10 mm. In one embodiment, the electrode is located at a distal end of an electrode lead, and a proximal end of the electrode lead is removably inserted into a connector that forms part of the micro housing.

Abstract: An implantable medical device comprising a housing and an ultrasonic transducer having a communication frequency coupled to a portion of the housing. The housing resonates at the communication frequency, and a casing is coupled to the housing and disposed over the ultrasonic transducer. The casing is adapted to amplify the deformation of the ultrasonic transducer in a bending mode and transfer the bending moment to the housing. An implantable medical device comprising a housing having an upper portion and a lower portion. A first ultrasonic transducer is coupled to a first connection rod and is coaxial with the first connection rod. The first ultrasonic transducer and first connection rod are interposed between the upper and lower portions such that the first ultrasonic transducer is adapted to vibrate the upper and lower portions simultaneously. A method of optimizing an ultrasonic transducer and a housing of an implantable medical device.

Abstract: An implantable medical device (IMD) provides quadripolar transthoracic impedance measurement capability by forming at least one of the two electrodes associated with the canister of the device on a lead proximate the canister.

Abstract: The present invention relates to an electrical feedthrough for insertion into an opening of an implantable electrical treatment device having an electrically insulating insulation body through which at least one electrically conductive terminal pin passes, which is connected hermetically sealed to the insulation body using a solder, the solder material being glass or glass ceramic.

Abstract: An implantable battery powered leadless pacemaker or biostimulator is provided that may include any of a number of features. One feature of the biostimulator is that it safely operates under a wide range of MRI conditions. One feature of the biostimulator is that it has a total volume small enough to avoid excessive image artifacts during a MRI procedure. Another feature of the biostimulator is that it has reduced path lengths between electrodes to minimize tissue heating at the site of the biostimulator. Yet another feature of the biostimulator is that a current loop area within the biostimulator is small enough to reduce an induced current and voltage in the biostimulator during MRI procedures. Methods associated with use of the biostimulator are also covered.

Abstract: A filtering capacitor feedthrough assembly for an implantable active medical device is disclosed. The filtering capacitor feedthrough assembly includes a capacitor having an aperture defined by an inner capacitor surface. The capacitor is electrically grounded to an electrically conductive feedthrough ferrule or housing of the implantable active medical device. A terminal pin extends into the aperture. An electrically conductive split ring sleeve is disposed within the aperture and between the terminal pin and the capacitor. The split ring sleeve includes a first end, a second end, a sleeve length therebetween. A longitudinal slit through the sleeve extends from the first end to the second end. The electrically conductive split ring sleeve mechanically securing and electrically coupling the terminal pin to the capacitor.

Abstract: A method of reforming a wet-tantalum capacitor is disclosed. The method comprises charging the capacitor to a voltage that is substantially less than one of a maximum and rated voltage for the capacitor. The method also comprises providing an open circuit condition and allowing the capacitor to at least partially discharge through leakage current.

Abstract: Embodiments of an implantable medical device includes a loop antenna wound about an inner housing. The loop antenna may form a partial winding, a complete winding, or multiple windings about the inner housing. One or more additional antennae may be capacitively coupled to the loop antenna external to the inner housing to increase efficiency and decrease Return Loss Response of the implantable device. The additional antenna may be balanced or unbalanced antennae.