Abstract: An implantable medical interventional device is adapted to provide therapy to a patient in whom the device is implanted to treat cardiac dysrhythmias including tachyarrhythmia. The device performs a plurality of functions corresponding to different levels of therapy for treatment of sensed dysrhythmias, including an electric shock waveform of predetermined energy content for delivery to the patient's heart to terminate at least one type of tachyarrhythmia. In response to cessation of the tachyarrhythmia after delivery of the electric shock waveform, the device promptly thereafter applies post-shock pacing pulses to the heart for a period of time sufficient to allow the heart to recover from the shock and to resume substantially normal sinus rhythm. The device may be upgraded by programming to select among the various functions as necessary to provide designated therapy by suppressing some functions and activating others.

Abstract: A medical interventional device is structured for implantation in a human patient, to respond to detection of cardiac activity of the patient indicative of cardiac dysrhythmias. The device includes a cardiac therapy system responsive to a detected arrhythmia in either the atrial or ventricular chambers for automatic therapeutic treatment by selective application of an appropriate therapy regimen consisting of pacing, cardioverting or defibrillating waveforms of predetermined type and energy content to the chamber diagnosed as that in which the dysrhythmia originated. The device incorporates a DDD or DDD-R pacemaker for dual chamber sensing of electrical (ECG) activity, and for constant pacing of the atrium and atrioventricular synchronization. A fuzzy logic subsystem is used for diagnosis including identification of the originating heart chamber.

Abstract: An implantable cardiac pacemaker is adapted to be selectively non-invasively upgraded from time to time after implantation to provide a plurality of different diagnostic, functional, and pacing operational modes in the form of respective combinations of single and dual chamber sensing and pacing and rate-adaptive pacing of a patient's heart to correct any of various cardiac arrhythmias attributable to cardiac pacing or cardiovascular disorders, and of extended memory and physiological monitoring functions. The pacemaker is implemented to make available the plurality of different pacing operational and other functional modes, and is programmable to selectively enable current operation of at least one of the available pacing operational modes according to current needs of the patient while inhibiting current operation of all other available pacing operational modes and any other non-selected functional modes.

Abstract: A self-cooling transcutaneous energy transfer system is provided for transmitting power to an implantable medical device, such as a defibrillator. The system includes a housing that is supported above the human body by a base so as to define a space between the housing and the body. A primary induction coil is disposed within the housing for transferring electromagnetic energy to the implantable medical device. A cooling fan is attached to the housing for providing forced convective heat transfer from the body. Various power and control circuitry are provided. The system can transfer away heat generated by eddy currents induced in the implantable device by the magnetic flux produced by the induction coil.

Abstract: An implantable medical device for electrically stimulating the heart to beat generally includes a processor, a plurality of electrodes, a sense amplifier, a pulse generator, and a heart status monitor. The processor can determine when the patient has entered an environment of high electromagnetic interference. When this occurs, the processor forces the implantable device into a safe noise mode. While in the same noise mode (which preferably continues while the patient is experiencing the electromagnetic interference), the implantable device paces the heart on demand and inhibits pacing during the vulnerable period. The processor determines when the vulnerable period is occurring and when the heart needs to be paced by monitoring a status signal from the heart status monitor.

Abstract: A printed circuit board substrate includes cavities in which electronic components, such as integrated circuits, are mounted and encapsulated. Once the electronic components are encapsulated, other electronic components can be mounted above the encapsulated component on the top surface of the substrate, thereby increasing the number of components that can be mounted to a circuit board of a given area. The encapsulated components are mounted using any one of a variety of techniques. The substrate may include multiple conductive layers for electrically interconnecting the encapsulated components to other components.

Abstract: A defibrillator is designed for implantation in a patient and for programming certain of its parameters after implantation, including energy content of a shock waveform and timing of delivery of the shock waveform. A shock waveform generator of the device is responsive to a trigger signal for timed production of a shock waveform having a programmable shape and energy content designed for terminating atrial or ventricular fibrillation (AF or VF) of the patient. A detection circuit processes a sensed cardiac signal of the patient to determine the relative timing of various portions of the cardiac signal, including the P-wave and the T-wave.

Abstract: An implantable medical device for electrically stimulating the heart to beat generally includes a processor, a plurality of electrodes, a sense amplifier, a pair of comparators, inner and outer target logic units, and pulse generator. The processor controls the magnitudes of inner and outer target reference signals which are generated by the inner and outer target logic units, respectively. The outer target is adjusted to be approximately equal to the peak amplitude of the cardiac signal. The processor stores representations of the outer target reference in memory. Alternatively or additionally, the processor computes a histogram of the relative or absolute number of cardiac cycles that occur over a given period of time for each outer target setting. The processor can be directed to retrieve the outer target representations and/or the histogram from memory and transmit that information to an external programmer for use by a physician.

Abstract: An electromagnetic accelerometer includes a rigid shell with a cavity in which two magnets are fixed at either and of the rigid shell and one magnet is allowed to move between the fixed magnets. The three magnets are arranged so that the movable magnet is suspended between the fixed magnets by magnetic forces from the fixed magnets. A coil of wire surrounds the shell and magnets. An acceleration of the accelerometer causes a displacement of the movable magnet with the cavity. As a result, an electrical current is induced in the coil of wire. The voltage in the coil of wire is proportional to the acceleration experienced by the accelerometer. The electromagnetic accelerometer is particular useful in an implantable pacemaker or defibrillator and can be included in either or both a lead or the housing of the pacemaker. Further, the accelerometer generates its own voltage in response to acceleration and the resulting electrical energy can be used as a power source.

Abstract: A method is disclosed for rapidly removing electrically insulative coating material from a portion of the titanium housing of an implantable cardiac pulse generator. Pulsed excimer laser radiation ablates an organic coating, such as parylene or a similar polymer, to micromachine a conductive window having sharply defined boundaries or edges. An implantable cardiac pulse generator having an electrically conductive window produced according to the method is also disclosed. The method is suitable for high volume automated production of face or edge window pulse generators, and is also applicable for removal of biomolecular films from other medical articles.

Abstract: A lead assembly adapted for endocardial fixation to a human heart is provided. The lead assembly includes a lead body that has a proximal end provided with a connector for electrical connection to a cardiac stimulator. The cardiac stimulator may be a pacemaker, a cardioverter/defibrillator, or a sensing instrument. The distal end of the lead body is connected to a tubular electrode housing. The lead body consists of a noncoiled conductor cable surrounded by a coextensive insulating sleeve. In contrast to conventional leads, the lead body of the present invention does not require coiled conductor wires or an internal lumen. Manipulation of the lead body is via an external guide tube. Lead body diameters of 0.25 mm or smaller are possible.

Abstract: A method of implanting small diameter conductive leads for an artificial cardiac pacemaker or other body-implantable medical device includes inserting the lead to be implanted into a predetermined path within the patient's body with the assistance of a stylet for guiding the lead along the path. At least a portion of the stylet which is to traverse the path has an enhanced radiopaque characteristic attributable to the application or addition to the material of which the stylet is composed, of a substance having such radiopaque characteristic. When viewed under fluoroscopy external to the patient's body as the lead is maneuvered along the path, although the thin lead itself may be difficult to see, the stylet is readily discernible by virtue of its enhanced radiopacity, thereby enabling the physician to position the lead at a desired location within the patient's body. For various reasons, the thin lead itself may not be amenable to similar enhancement, which makes the stylet a suitable solution.

Abstract: An implantable medical device electrically stimulates the heart to beat and senses electrical activity in the heart. The medical device generally includes a processor, a plurality of electrodes, and a sense amplifier. The medical device is capable of performing a variety of diagnostic tests, such as a sensing test in which a suitable sensitivity setting is computed for the sense amplifier. An external programmer is also provided to initiate the diagnostic tests. The programmer transmits a start signal to the implantable medical device and the medical device's processor initiates the diagnostic test specified by the programmer via the start signal. The implantable device is capable of completing the diagnostic test without further communication from the programmer or may initiate communication with the programmer during a refractory period in which signals from the programmer will not interfere with the diagnostic test. In the latter case, the programmer responds before the refractory period ends.

Abstract: A training unit generally includes a processor, a magnetic field sensor, a plurality of control switches, and a message and data output device. Placing a PEIS magnet, constructed in accordance with the ISOWD 14994 standard, adjacent to or in contact with the training unit activates the magnetic field sensor, a condition detectable by the processor. Activation of the switches determines which of three modes the training unit will operate. In an instructional mode, the process provides instructional messages to the operator via the message and data output device, which preferably includes a display and an audio speaker. In a coached mode, the training unit informs the operator when to place the magnet adjacent to or in contact with the training unit and when to remove the magnet in accordance with the timing intervals of the PEIS entry code. In a practice mode, the operator initiates and completes the entry code using a PEIS magnet without coaching.

Abstract: A method and apparatus for classifying and treating tachyarrhythmias. A cardiac stimulator includes an algorithm that uses dual chamber sensing to determine the type of tachyarrhythmia detected. If the tachyarrhythmia is of a type that responds well to ventricular therapy, such as a tachyarrhythmia originating in the ventricle rather than the atrium, the tachyarrhythmia is grouped into a treatable category. Accordingly, the cardiac stimulator applies therapy, or therapies, to the ventricle to remedy the ventricular tachyarrhythmia.

Abstract: A lead assembly for fixation to a human heart via thoracoscopy is provided. The lead assembly includes a lead that has a connector for connection to a cardiac stimulator, such as a pacemaker, a cardioverter/defibrillator, or a sensing instrument. A fixation mechanism is coupled to the lead that includes a tubular housing and a proximally projecting hook that is adapted to engage heart tissue. The hook is pivotable between a retracted position and an extended position. The lead and the hook are manipulated by a stylet. The lead assembly also includes a tubular introducer that is passed through the chest wall of a patient and used to place the lead proximate the epicardium.

Abstract: An implantable device for providing pacing and defibrillating stimuli to a heart, comprises: a power source, at least one electrode electrically connected to said power source, a sensor capable of providing data that can be used to determine a physiological pacing demand, and a control device. The control device controls the application of electrical stimuli to the heart. The control device calculates an adjusted pacing interval based on said demand, calculates an adjusted ventricular pace refractory period (VPRP.sub.current) that is a function of said pacing interval, and calculates a T-wave monitoring window. The end time, and optionally the start time also, of the T-wave window is a function of the pacing interval. The control device is also capable of adjusting the sensitivity of an amplifier based on signals received during the T-wave window.

Abstract: A lead assembly adapted for endocardial fixation to a human heart is provided. The lead assembly includes a lead body that has a proximal end provided with a connector for electrical connection to a cardiac stimulator. The cardiac stimulator may be a pacemaker, a cardioverter/defibrillator, or a sensing instrument. The distal end of the lead body is connected to a tubular electrode housing. The lead body consists of a noncoiled conductor cable surrounded by a coextensive insulating sleeve. In contrast to conventional leads, the lead body of the present invention does not require coiled conductor wires or an internal lumen. Manipulation of the lead body is via an external guide tube. Lead body diameters of 0.25 mm or smaller are possible.

Abstract: An implantable medical device for electrically stimulating the heart to beat includes a sense circuit for detecting cardiac electrical activity. The sense circuit includes a band pass filter with an adjustable frequency response. The frequency response can be repeatedly adjusted after implantation of the medical device and preferably is adjusted upon detection of the loss of normal sinus rhythm (NSR) in the heart's atria. The loss of NSR often indicates atrial fibrillation (AF), and the filter's frequency response is adjusted to increase the sensitivity of the sense circuit to the cardiac electrical activity typical during AF. The medical device is calibrated during implantation or at subsequent doctor visits with the aid of a calibration device external to the body. Cardiac electrical activity in the form of an electrogram is transmitted from the medical device to the external calibration device. The transmitted electrogram preferably includes both NSR and AF rhythms.

Abstract: Magnetically alterable material, such as magnetostrictive material, is used in combination with a suitable substrate and a suitable magnetic field to produce a stylet and lead assembly that curves in response to a suitable magnetic field.