Abstract: Bioprosthetic devices made of collagen-based material having collagen amine groups and collagen carboxyl groups are provided as well as methods for their formation. The methods comprise combining an epoxy functionalized crosslinking agent with the collagen-based material in an aqueous medium at an acidic pH to react a portion of the collagen carboxyl groups with the epoxy functionalized crosslinking agent to form crosslinked collagen-based material comprising residual collagen carboxyl groups.

Abstract: An ambulatory device having a case with an integral splash cover about the area of the catheter input ports is described. Moreover, the ports are angled such that when the device is carried in its intended manner by a patient, the ports are angled downwards. Through the case design, in combination with the angle of the ports, the device is relatively more resistant to splash-related problems as compared to prior devices.

Abstract: A method and apparatus for providing electrical stimulation of the gastrointestinal tract. The apparatus features an implantable pulse generator which may be coupled to the gastric system through one or more medical electrical leads. In the preferred embodiment the leads couple to the circular layer of the stomach. The pulse generator preferably features sensors for sensing gastric electrical activity, and in particular, whether peristaltic contractions as occurring. One embodiment particularly solves the problem of accurately detecting gastric arrhythmias by periodically reverting into a sensed intrinsic gastric rhythm mode. In this mode the output of electrical stimulation is adjusted to only occur at an exceedingly slow rate. This slow rate of stimulation thus permits the gastro-intestinal tissues to undergo an intrinsic depolarization so that the underlying intrinsic slow wave rate may be detected.

Abstract: An implantable medical device having a hermetic canister a battery positioned within the hermetic canister; a pulse generator system positioned within the hermetic canister and electrically coupled to the battery; a receiver positioned within the hermetic canister and electrically coupled to the battery and the pulse generator system; a transmitter positioned within the hermetic canister and electrically coupled to the battery and the pulse generator system; and an antenna positioned outside the hermetic canister and coupled to the pulse generator by a feedthrough. The antenna is constructed of a series of planar windings enclosed by an enclosure; each winding is between 1-100 microns wide, wherein each winding is between 1-1000 microns thick and wherein each winding is spaced apart from each of the other windings between 1-100 microns.

Abstract: An ambulatory recorder which features an enhance technique for sampling. The ambulatory recorder has a programmable number of channels, each channel having a programmable sampling frequency rate. The multi channel ambulatory recorder is fashioned so as to sample and records data only from each channel as desired at the frequency as desired. The recorder examines the frequencies on the channels for which data is to be sampled and recorded, and selects a common tick frequency for the microprocessor to awaken, sample and sleep again. Moreover, the microprocessor is directed to only sample at each tick on each channels as needed reducing the amount of required memory and shortening the time it is consuming power.

Abstract: There is provided an implanted system and method for delivering subsonic mechanical waves to one or more selected patient areas, the areas including the patient's heart and/or lungs. The mechanical waves are delivered for the purpose of treating fibrillation or like arrhythmias, for enhancing lung gas exchange, enhancing cardiac muscle fiber relaxation, and enhancing coronary perfusion. Mechanical waves are generated in a frequency range of about 1-100,000 Hz, and preferably 1-50,000 Hz. The waves may be delivered continuously for short or long time periods, or may be controlled in timing either with respect to detected portions of a patient's heartbeat signal or in response to a detected event such as fibrillation. In one preferred embodiment, the implantable system includes a defibrillation shock generator and control for responding to a defibrillation event by first delivering a sequence of mechanical waves and then delivering an electrical defibrillation shock.

Abstract: An ambulatory recording system, for medical and especially diagnostic purposes, is described having a communication watchdog between two processors. The two processors may be of differing types. For example, the first processor may be real time processor ("RTP") which handles the sampling function, while the second processor may be a non real time processor ("NRTP") which handles the operating system function. This dual processor design permits relatively low power consumption for data recording (which is handled by the relatively lower power consuming RTP), while also providing a graphical user interface for user simple user operation (which is handled by the relatively higher power consuming NRTP). A communication watchdog between the two processors is provided to reset the device upon the detection of a processor failure or communication failure between the two processors.

Abstract: A system and method for providing medical electrical stimulation to a portion of the nervous system. The system includes a rigid hollow needle having a lumen, a flexible lead body disposed within the lumen of the needle, the lead body having a insulated coiled proximal section and an electrode section, the proximal section comprising a conductor which is coiled and insulated, the electrode section comprises a portion of the coiled conductor which is not insulated. In an alternative embodiment the electrode section features a crimp core around which a distal end of the coiled conductor which is not insulated is crimped, the rigid hollow needle is metal but which is partially covered along its outer surface with an insulation. In still further embodiments the flexible lead body has a stylet lumen therein and the lead body also has a connector pin for electrically connecting the electrical conductor to a pulse generator.

Abstract: A device and method useful in the diagnosis and treatment of congestive heart failure. Specifically the present invention senses the trans-thoracic impedance as well as patient posture. By correlating changes in posture with trans-thoracic impedance changes, the present invention is able to diagnose and assess the degree of congestive heart failure. The present invention is described in the context of an implantable pulse generator system, but it may also be practiced in conjunction with various types of implantable devices.

Abstract: A method and apparatus for providing electrical stimulation of the gastrointestinal tract. The apparatus features an implantable pulse generator which may be coupled to the gastric system through one or more medical electrical leads. In the preferred embodiment the leads couple to the circular layer of the stomach. The pulse generator preferably features sensors for sensing gastric electrical activity, and in particular, whether peristaltic contractions as occurring. One embodiment particularly solves the problem of accurately detecting gastric arrhythmias by periodically reverting into a sensed intrinsic gastric rhythm mode. In this mode the output of electrical stimulation is adjusted to only occur at an exceedingly slow rate. This slow rate of stimulation thus permits the gastrointestinal tissues to undergo an intrinsic depolarization so that the underlying intrinsic slow wave rate may be detected.

Abstract: There is provided a system and method for directly stimulating the LES of a patient in order to normally maintain it in a closed state, thereby preventing reflux and treating the symptoms of GERD. The stimulation is inhibited in response to patient swallowing, by monitoring esophageal motility and timing out an inhibition period following detection of motility representative of swallowing. The system utilizes an implanted stimulator which is programmed to deliver a train of stimulus pulses to one or more electrodes fixed around the gastro-esophageal junction and connected to the stimulator by one or more leads. The motility sensing is done by a sensor for sensing mechancial wave movement or electrical signals representative of high motility following swallowing. The motility sensor and stimulating electrodes are attached laproscopically, and are preferably carried by a common stent carrier which is sutured around the lower esophagus.

Abstract: There is provided an implantable system and method for monitoring pancreatic beta cell electrical activity in a patient in order to obtain a measure of a patient's insulin demand and blood glucose level. A stimulus generator is controlled to deliver stimulus pulses so as to synchronize pancreatic beta cell depolarization, thereby producing an enhanced electrical signal which is sensed and processed. In a specific embodiment, the signal is processed to determine the start and end of beta cell depolarization, from which the depolarization duration is obtained. In order to reduce cardiac interference, each stimulus pulse is timed to be offset from the QRS signal which can interfere with the pancreas sensing. Additionally, the beta cell signals are processed by a correction circuit, e.g., an adaptive filter, to remove QRS artifacts, as well as artifacts from other sources, such as respiration.

Abstract: A method and apparatus for providing electrical stimulation of the gastrointestinal tract. The apparatus features an implantable pulse generator which may be coupled to the gastric system through one or more medical electrical leads. In the preferred embodiment the leads couple to the circular layer of the stomach.

Abstract: A programmable pacemaker system, having a programmer which has the capability of making software control modifications to a family of pacemakers types which can be software modified with different control functions. The programmer carries manual data relating to the manual corresponding to each pacemaker type. Whenever a new control software release is loaded into the programmer, an accompanying new manual portion is also loaded into programmer memory; the programmer can determine what manual portion or portions are superseded if the new control software is downloaded into any one of the respective different pacemaker types of the family. Whenever a programmer is used to download a new control routine into an implanted pacemaker, the programmer automatically provides the option to display and/or print a new applicable manual portion; superseded manual portions due to downloading operations; and/or the entire manual corresponding to the pacemaker as modified by the downloading operation.

Abstract: A system to provide cardiac assistance to a patient's heart. The system includes a pulse generator adapted to be coupled to patient's heart and adapted to be coupled to a skeletal muscle ventricle (SMV). The system further includes a sewing ring adapted to be coupled to the SMV and adapted to be coupled to the patient's circulatory system, the sewing ring has a flexible cylindrical sleeve having a distal end and a proximal end, the flexible cylindrical sleeve defining a lumen therewithin, the ring further features a means for maintaining the patency of the lumen, the means for maintaining the patency positioned on the proximal end. In the preferred embodiment the means for maintaining the patency of the lumen is a reinforcing ring mounted to the proximal end of the flexible cylindrical sleeve, preferably a silicone ring.

Abstract: The present invention provides a pacing system with a lead having a fixation element for providing stable fixation relative to the patient's SVC, preferably providing for positioning of the atrial electrodes near the sinus node. In a first embodiment, an adjustable loop is provided for engaging the inside wall of the SVC so as to obtain fixation of the lead just above the sinus node. Other embodiments utilize tine arrangements for providing the fixation relative to the SVC.

Abstract: Method and apparatus for providing on-demand stimulation of the gastrointestinal tract. The apparatus features an implantable pulse generator which may be coupled to the gastric system through one or more medical electrical leads. In the preferred embodiment the leads couple to the circular layer of the stomach. The pulse generator preferably features sensor for sensing abnormalities in gastric electrical activity. The pulse generator further features means for recognizing the type of gastric abnormality sensed. That is means for detecting whether gastric arrhythmia, bradygastria, dysrhythmia, tachygastria or retrograde propagation or uncoupling are present. If any of these gastric rhythm abnormalities are detected, then the pulse generator features means for emitting stimulation pulse trains to the gastric system to treat the detected gastric rhythm abnormalities. The stimulation pulse trains may take many forms and may be emitted for various periods of time.

Abstract: An ambulatory data recorder having a selectable device control interface. The selectable device control interface permitting a selection to be made between a first device control interface, in which the full device control set is accessible, and a second control interface, in which only a partial amount of the device control set is accessible. Typically the first control interface is intended for use by physicians and the second control interface is intended for use by patients. The selectable device control interface is provided by a combination of device controls and a moveable device cover. The cover moveable from a first opened position in which the full device control set is accessible and a second closed position in which only a partial amount of the device control set is accessible. Preferably the cover permits operation of at least one of the device controls regardless of its position.

Abstract: The present invention is directed to a medical electrical lead having active fixation which features an improved fixation helix. In particular the present invention is a medical electrical lead having a fixation helix which features microgrooves. The microgrooves are dimensioned so as to minimize the foreign body response of the tissue into which the helix is implanted. The microgrooves preferably consist of a series of grooves parallel to the longitudinal axis of the helix, each groove has a depth of between approximately 0.1 to 30 microns, preferably between approximately 0.1 and 3, with 1 micron preferred; a width of between approximately 0.1 to 30 microns, preferably between approximately 0.1 and 3, with 1 micron preferred; and is spaced apart from every other groove by a distance of between approximately 0.1 to 30 microns, preferably between approximately 0.1 and 3, with 1 micron preferred.

Abstract: The present invention provides a cardiac pacing system with a DDD lead with pre-stressed curvilinear portions, the lead being able to adapt to heart movement and size so as to provide more stable positioning with respect to the atrium. The lead has at least three such pre-stressed curvilinear portions positioned to adapt to the patient's heart and to absorb movement due to contractions so as to maintain atrial electrodes in a stable position with respect to the atrial wall.