Abstract: A dual-chamber implantable pacemaker configured to operate in the DDD or DDDR mode automatically adjusts its AV (or PV) interval to an amount just less than the natural conduction time of a patient, thereby assuring that ventricular pacing occurs in a patient's cardiac cycle at a time near when a natural ventricular contraction (an R-wave) would occur. The pacemaker includes a pulse generator that generates ventricular stimulation pulses (V-pulses) at the conclusion of a pacemaker-defined AV (or PV) interval if no natural ventricular activity (an R-wave) is sensed during such AV (or PV) interval. The AV (or PV) intervals are automatically adjusted by the pacemaker to be just less than the natural conduction time sensed by the pacemaker, where the natural conduction time is the time between atrial activity (a sensed P-wave or a delivered A-pulse) and the subsequent natural ventricular activity (R-wave).

Abstract: A low-power band-pass filter for use in a cardiac pacer includes a single operational amplifier connected in circuit relationship with a plurality of switched capacitors that function as bilinear resistors. Each bilinear resistor comprises a switch for coupling a first lead of a capacitive element to a first terminal and for coupling a second lead of the capacitive element to a second terminal in response to a first state of a control signal, and for coupling the first lead of the capacitive element to the second terminal and for coupling the second lead of the capacitive element to the first terminal in response to a second state of the control signal. Thus, the bilinear resistor switches or oscillates the electrical orientation of the capacitive element between the first terminal and the second terminal in response to the first and second states of the control signal. The invention also includes a method of operating such an implantable filter circuit.

Abstract: A universal cable connector includes a plurality of different sized connectors adapted to mate with the proximal connectors of different sized implantable leads. The cable connector attaches to a system analyzer and enables the system analyzer to interface with whatever implantable leads are connected to the connector block, thereby allowing the system analyzer to perform desired tests, such as threshold-determining tests, using the implanted leads. An adapter cable and clamp is also provided that allows an electrical connection of the proper polarity to be established between an implantable cardioverter-defibrillator (ICD) and the cable connector block while the ICD is connected to a patient and is operating, thereby permitting the system analyzer to monitor the performance of the ICD.

Abstract: A dual-chamber implantable pacemaker automatically adjusts its AV interval so that any ventricular stimulation pulses generated by the pacemaker at the conclusion of the pacemaker-defined AV interval occur at a time in the cardiac cycle that avoids fusion with the natural ventricular depolarization of a patient's heart. The AV interval is set using a search sequence that sets the AV interval value to be on one side or the other of the natural conduction time of the heart, and incrementally changes the AV interval value until it crosses over the natural conduction time interval. The cross-over point is manifest by the occurrence of an R-wave, where an R-wave had previously been absent, or the absence of an R-wave, where an R-wave had previously been present. A final AV interval value is then set as the AV interval value at the cross-over point, adjusted by appending an AV margin thereto.

Abstract: A defibrillator patch lead having a connecting element interconnecting an electrical conductor and a wire mesh electrode pad. The connecting element includes a body portion which has a slot cut therein into which a portion of the wire mesh electrode is inserted and securely bonded, preferably by laser welding. The connecting element further includes a female connector portion which is designed to mate with a male core sleeve. The core sleeve includes a channel for receiving a first conductor therein, which is then electrically and mechanically connected (e.g., by either welding or crimping). The core sleeve also includes an orifice for receiving a second conductor, which is subsequently electrically and mechanically connected (e.g., by either welding or crimping) between the core sleeve and the connecting element. Advantageously, the combination of the core sleeve, two conductors, and the connecting element have superior pull strength over conventional methods of attachment.

Abstract: A porous electrode for pacemakers is comprised of a plurality of platinum globules sintered together to form a porous mass of semi-hemispherical shape at the end of a platinum electrode stem. The globules, which are themselves made by sintering together spherically-shaped particles of approximately one micron diameter, provide the globules with an irregular outer surface of high total surface area. The globules have diameters within a critical range of 40-200 microns. The large total surface area of the globules improves the sensing function of an electrode configuration of given size and surface area, while the globule diameters of 40-200 microns have been found to beneficially accommodate tissue ingrowth within the electrode. In a preferred method of making the electrode, the platinum globules, which are formed by sintering together platinum particles of much smaller size, are mixed with organic solvent and organic binder to form a paste.

Abstract: An implantable pacing lead for use with a cardiac pacemaker having a multilumen tubing for the lead body and at least one ring electrode or electrical contact located between the distal and proximal ends of the pacing lead. The ring electrode includes axially aligned bores therethrough, the bores corresponding to the locations of the lumens within the multilumen tubing. A stabilizing element assures that the interconnection between the multilumen tubing and the cylindrical electrode is secure.

Abstract: A bifurcated lead adapter or lead used with an implantable stimulation device, such as a pacemaker, forms part of a stimulation system and method that senses depolarization of the ventricular muscle tissue, and in response thereto, generates a stimulus (composed of a single pulse or multiple closely-spaced pulses) that is delivered to translocated muscle tissue wrapped around the ventricle of the heart, thereby causing the translocated muscle tissue to contract in synchrony with the sensed ventricular depolarization. In one embodiment, a pacemaker operates in the single-chamber triggered stimulation mode analogous to VVT mode. A bifurcated bipolar lead adapter has a proximal connector that is connected to the pacemaker's bipolar female input/output connector. The adapter couples the anode electrode of the pacemaker's bipolar input/output connector to a first female distal connector, and couples the cathode electrode of such bipolar input/output connector to a second female distal connector.

Abstract: Apparatus located in an implantable medication infusion pump for quickly and easily detecting a condition adversely affecting medication delivery in the implantable medication infusion pump is disclosed which can reliably detect occurrences including an occluded catheter, the presence of air in the pumping mechanism, and the failure of the pumping mechanism. The system uses the amplitude of an acoustic signal generated by operation of the pumping mechanism as compared with a baseline signal to detect an encapsulated or occluded catheter or air in the fluid line. In addition, the system can detect a partially encapsulated or occluded catheter by detecting repeated downward slope patterns during repetitive, closely spaced pumping cycles.

Abstract: A lead for delivering electrical stimulation pulses to pace the cardiac muscle and for sensing electrical signals occurring in the cardiac muscle is disclosed which as a rigid helix disposed at the extreme distal end thereof which rigid helix may be operated by the implanting physical to extend the tip of the rigid helix from a stored position within the distal end of the lead to a deployed position projecting from the distal end of the lead. The rigid helix pierces and engages the heart tissue to anchor the lead in place within the heart. The tip of the rigid helix has an axial bore therein which is filled with a therapeutic medication such as a steroid or steroid-based drug for inhibiting inflammation and promoting tissue growth. After the tip of the helical screw is disposed in the heart tissue, the therapeutic medication will be slowly eluted into the surrounding tissue, thereby minimizing the trauma of implantation and assisting in the anchoring of the lead.

Abstract: An implantable stimulation lead having an anti-inflammatory coating on the exposed surface area of the distal tip electrode. The coating is a semi-viscous or gelatinous material having the ability to absorb physiological fluids to provide electrical conductivity through the coating. The coating preferably has a matrix having an innate hypo-inflammatory property which can be combined with drugs and therapeutic agents to deliver the drugs and agents by co-dissolution or diffusion, or alternatively the matrix material can be used as a coating to keep the electrode surface electrochemically clean prior to and during implant.

Abstract: An electrical conductor assembly utilized, for example, in a defibrillator patch lead to interconnect a pulse generator and monitoring unit, and a wire mesh electrode pad. The electrical conductor includes a Teflon insulated drawn brazed stranded (DBS) wire cable which is wrapped in a drawn filled tube (DFT) wire multifilar coil encased in a biocompatible insulative tubing.

Abstract: A compact connector assembly for an implantable medical device includes a receptacle for receiving the proximal end of a coaxial bipolar lead having a distal end attachable to a desired tissue location. The receptacle includes an open end for receiving the proximal end of the lead and a closed end carrying a conductive pin. The pin has a portion inside the receptacle projecting toward the open end thereof and adapted to make electrical contact with one of the lead conductor terminals. The proximal end of the lead has a conductive socket for receiving the projecting portion of the pin inside the receptacle. An adapter terminal may be used to convert the proximal end of the lead to the industry VS-1 standard.

Abstract: A pacing lead having a porous electrode of platinum-iridium with recessed areas or grooves formed into the surface. The grooves allow for acute electrode stabilization as a result of clot formation and endocardial tissue capture during insertion and immediate immobilization upon implant. At least one layer of a porous coating of 20-200 micron diameter spherical particles are deposited on the surface of the base electrode to obtain a porous macrostructure for promoting chronic tissue ingrowth. Additionally, a microstructure surface coating is applied to increase the active surface area and enhance electrical efficiency by lowering electrochemical polarization and increasing electrical capacitance.

Abstract: An implantable cardioverter-defibrillator (ICD) provides a tiered therapy designed to automatically terminate tachyarrhythmias using the least aggressive therapy possible while reducing the "time-to-therapy." The tiered therapy first applies a first tier of therapy (e.g., antitachycardia). If unsuccessful, the tiered therapy next applies a second tier of therapy (e.g., cardioversion pulse with a pulse of moderate energy). If unsuccessful, the tiered therapy finally applies a third tier of therapy (e.g., a high energy pulse). So that more aggressive (higher energy) tiered therapies may be applied as early as possible following the failure of a less aggressive (lower energy) therapy, the ICD begins charging one or more high voltage capacitors of the ICD in parallel with the application of the less aggressive therapy, and/or in parallel with the verification interval immediately following a prior therapy attempt during which the ICD attempts to verify the successful termination of the tachyarrhythmia.

Abstract: A sense amplifier adapted for use with a cardiac pacer or the like includes a constant gain filter, a window comparator circuit and a programmable threshold reference generator circuit. The reference generator circuit generates a programmable window (reference) voltage used by the window comparator circuit to determine whether an input signal, amplified by the constant gain filter, exceeds the window voltage. The reference generator circuit is based on a bipolar junction device having an adjustable emitter area through which a constant current flows. The emitter area is adjusted in response to a control signal. As the emitter area changes as controlled by the control signal, the voltage across the device changes. In a preferred embodiment, a parallel combination or network of switched bipolar junction devices is used to realize the adjustable emitter area.

Abstract: A method and system for monitoring the behavior of an implanted pacemaker counts (records) the number of times that a given internal event or state change of the pacemaker occurs, and also determines the rate at which each event or state change thus counted occurs. The event counts and their associated rate are stored (recorded) in appropriate memory circuits housed within the pacemaker device. At an appropriate time, the stored event count and rate data are downloaded to an external programming device. The external programming device processes the event count and rate data, and displays a distribution of the event count data as a function of its rate of occurrence, as well as other statistical information derived therefrom. The displayed information, and its associated statistical information, allows a baseline recording to be made that establishes the implanted pacemaker's behavior for a given patient under known conditions.

Abstract: An in-line, multipolar proximal connector assembly for an implantable stimulation lead is provided which incorporates at least one sensor. Advantageously, the present invention uses straight conductive rods, or wires, to electrically connect the proximal terminals to a multilumen lead body. The straight conductive rods enable the diameter of the lead assembly to remain small. Additional terminals can easily be added by simply decreasing the spacing between terminals and adding additional conductive rods. In one embodiment, insulating spacers are premolded to include protruding portions which interlock with the ring terminals. Recesses within the insulating spacers are dimensioned to self-position the ring terminals a precise distance from the pin terminal according to precise dimensions defined by the VS-1 (or other) standards. In another embodiment, the terminals are injection molded.

Abstract: A system and method for preventing atrial competition during sensor-driven operation of a dual-chamber pacemaker includes means for sensing atrial activity during an atrial refractory period. Atrial competition is avoided by either: (1) generating an atrial competition prevention (ACP) interval upon the detection of any atrial activity during the relative refractory portion of an atrial refractory period, and preventing any atrial stimulation pulses from being generated for the duration of such ACP interval; or (2) shortening the atrial refractory period in the event that the sensor-driven rate of the pacemaker begins to approach a rate that might place atrial stimulation pulses near the end of the unshortened atrial refractory period.

Abstract: A rate-responsive pacing system and method allows the inter-related sensor operating parameters associated with the physiological sensor of a rate-responsive pacemaker to be automatically and/or optimally set for a particular patient. The system includes both a pacemaker and an external programming device. The pacemaker includes appropriate memory circuits for recording a sensor indicated rate (SIR) signal in a histogram. The external programming device retrieves the SIR histogram data, as well as other data associated with the operation of the pacemaker, and selectively processes and displays such data in a prescribed manner. An Auto-Set sequence or routine, carried out by the external programming device, sets all of the rate-responsive operating parameters to a known initial value and places the pacemaker in a passive mode. In the passive mode the SIR signal does not control the pacing rate. The Auto-Set routine then displays instructions for the physician that cause diagnostic data to be collected.