Abstract: Disclosed is a system for the detection of cardiac events that includes an implanted device called a cardiosaver, a physician's programmer and an external alarm system. The system is designed to provide early detection of cardiac events such as acute myocardial infarction or exercise induced myocardial ischemia caused by an increased heart rate or exertion. The system can also alert the patient with a less urgent alarm if a heart arrhythmia is detected. Using different algorithms, the cardiosaver can detect a change in the patient's electrogram that is indicative of a cardiac event within five minutes after it occurs and then automatically warn the patient that the event is occurring. To provide this warning, the system includes an internal alarm sub-system (internal alarm means) within the cardiosaver and/or an external alarm system (external alarm means) which are activated after the ST segment of the electrogram exceeds a preset threshold.

Abstract: A method for implanting a balloon expandable stent at a site within a passageway of a curved coronary article. The stent includes at least two longitudinally spaced apart circumferential rings. At least one longitudinally extending connector extends between adjacent rings. The connector has at least one turn back portion that can expand or contract in length while being passed through a curved passageway. The stent is disposed on a stent delivery catheter having an inflatable balloon. The stent delivery catheter and the stent is delivered through the passageway to the site of implementation with the connector member expanding or contracting in length to facilitate delivery and placement of the stent. The stent is expanded at the site of implantation by inflating the balloon to force the stent radially outward against the wall of the coronary artery.

Abstract: Disclosed is a system for the detection of cardiac events that includes an implanted device called a cardiosaver, a physician's programmer and an external alarm system. The system is designed to provide early detection of cardiac events such as acute myocardial infarction or exercise induced myocardial ischemia caused by an increased heart rate or exertion. The system can also alert the patient with a less urgent alarm if a heart arrhythmia is detected. Using different algorithms, the cardiosaver can detect a change in the patient's electrogram that is indicative of a cardiac event within five minutes after it occurs and then automatically warn the patient that the event is occurring. To provide this warning, the system includes an internal alarm sub-system (internal alarm means) within the cardiosaver and/or an external alarm system (external alarm means) which are activated after the ST segment of the electrogram exceeds a preset threshold.

Abstract: Disclosed is a system for the detection of cardiac events that includes an implanted device called a cardiosaver, a physician's programmer and an external alarm system. The system is designed to provide early detection of cardiac events such as acute myocardial infarction or exercise induced myocardial ischemia caused by an increased heart rate or exertion. The system can also alert the patient with a less urgent alarm if a heart arrhythmia is detected. Using different algorithms, the cardiosaver can detect a change in the patient's electrogram that is indicative of a cardiac event within five minutes after it occurs and then automatically warn the patient that the event is occurring. To provide this warning, the system includes an internal alarm sub-system (internal alarm means) within the cardiosaver and/or an external alarm system (external alarm means) which are activated after the ST segment of the electrogram exceeds a preset threshold.

Abstract: The present device has increased longitudinal flexibility in a stent by having some curved sections of each circumferential set of strut members being unconnected to the curved sections of the adjacent circumferential set of strut members with the other curved sections being connected by highly flexible, undulating longitudinal connecting links. The present device prevents flaring of the unconnected strut members by having a shorter longitudinal length for the unconnected strut members, and may have generally shorter longitudinal lengths for all the strut members in the circumferential sets of strut members at the stent ends to reduce the tendency for end flaring of the stent. Finally, the stent demonstrates that the flexible longitudinal connecting links of the curved sections of the sets of strut members are connected at a point that is close to the line where the diagonal sections join the curved sections, thus further reducing the propensity for end flaring.

Abstract: Disclosed is an ostial stent positioner that has the form of a wire for most of its length and having a short cylinder with expandable legs situated at the positioner's distal end. The cylinder with its attached wire acts as an introducer sheath to introduce a stent delivery system with a stent into the artery that is to be stented. A second aspect of the present invention is a method for accurately placing a stent at the ostium of an artery that would have an ostial stenosis. Examples of such arteries that have ostial stenoses are the right and left main coronary arteries, a saphenous vein graft as used in coronary bypass surgery and the renal arteries. Also disclosed are designs for the short cylinder that have a variable diameter so as to fit snugly within guiding catheters having different inside diameters.

Abstract: A first aspect of the present invention is an ostial stent positioner that has the form of a wire for most of its length and having a cylinder with expandable legs situated at the positioner's distal end. The cylinder with its attached wire acts as an introducer sheath to introduce a stent delivery system with a stent into the artery that is to be stented. A second aspect of the present invention is a method for accurately placing a stent at the ostium of an artery that would have an ostial stenosis. Examples of such arteries that have ostial stenoses are the right and left main coronary arteries, a saphenous vein graft as used in coronary bypass surgery and the renal arteries. Each of these arteries has an ostium situated at the aorta.

Abstract: The present invention uses sets of strut members where the most distal set of strut members is similar to that of most stents in that the plane of the distal set of strut members is perpendicular to the stent's longitudinal axis. The present invention has a multiplicity of circumferential sets of strut members, but only the distal set of strut members has its plane perpendicular to the stent's longitudinal axis. The more proximal sets of strut members are angulated, so that the plane of the most proximal set of strut members has a preset angle such as 30°, 45° or 60° relative to the stent's longitudinal axis. The stent could also be formed from or coated with a highly radiopaque material. Alternately, a radiopaque marker could be placed at the most proximal point of the angulated, side branch stent, for the stent has to be rotated by the clinician until the plane of the most proximal angulated set of strut members is situated to be approximately parallel to the plane of the ostium of the side branch.

Abstract: Disclosed is a cytostatic drug attached to a sterile sheet that is designed to be placed between internal body tissues to prevent the formation of post-operative adhesions, which adhesions are really scar tissue formation. This sheet onto or into which the drug is placed may be either a permanent implant or it may be biodegradable. By impregnating an existing product such as the Johnson & Johnson SURGICEL™ absorbable hemostat gauze-like sheet with an anti-proliferative drug such as sirolimus, the biodegradable, drug impregnated mesh would act as a barrier to cell proliferation and hence be a deterrent to the formation of adhesions or scar tissue. Another embodiment of this invention is a cytostatic drug attached to a sheet that is placed at the site of an anastamosis to decrease scar tissue formation from within the vessel at the site of the anastomosis.

Abstract: A system for the detection of cardiac events occurring in a human patient is provided. At least two electrodes are included in the system for obtaining an electrical signal from a patient's heart. An electrical signal processor is electrically coupled to the electrodes for processing the electrical signal and a patient alarm means is further provided and electrically coupled to the electrical signal processor. The electrical signal is acquired in the form of electrogram segments, which are categorized according to heart rate, ST segment shift and type heart rhythm (normal or abnormal). Baseline electrogram segments are tracked over time.

Abstract: A thin-walled guide wire tube is fixedly and sealably attached to both a proximal section and a distal section of a balloon angioplasty catheter. A stent is co-axially mounted onto the inflatable balloon of the balloon angioplasty catheter. Because the guide wire tube forms an inner liner for the balloon angioplasty catheter, the fluid inflation lumen of the catheter is sealed so the inflation liquid that pressurizes the balloon will not leak as it would be if there were no “inner liner” and the balloon angioplasty catheter were attached to the guide wire itself. By not having a traditional inner shaft through which a conventional guide wire slides, the deflated balloon on which the stent is mounted can have a reduced diameter.

Abstract: The present device has increased longitudinal flexibility in a stent by having some curved sections of each circumferential set of strut members being unconnected to the curved sections of the adjacent circumferential set of strut members with the other curved sections being connected by highly flexible, undulating longitudinal connecting links. The present device prevents flaring of the unconnected strut members by having a shorter longitudinal length for the unconnected strut members, and may have generally shorter longitudinal lengths for all the strut members in the circumferential sets of strut members at the stent ends to reduce the tendency for end flaring of the stent. Finally, the stent demonstrates that the flexible longitudinal connecting links of the curved sections of the sets of strut members are connected at a point that is close to the line where the diagonal sections join the curved sections, thus further reducing the propensity for end flaring.

Abstract: An implantable medical device is provided for subcutaneous implantation within a human being. The implantable medical device includes a pair of electrodes for sensing electrical signals from the human being's heart. Electronic circuitry having digital memory is provided with the electronic circuitry designed to record the electrical signals from the heart. The electronics of the electronic circuitry are housed in a case having a tapered shape to facilitate implantation and removal of the implantable medical device.

Abstract: The present invention describes various devices and methods wherein a cytostatic antiproliferative drug, either alone or in combination with other drugs, is placed between internal body tissues to prevent the formation of scar tissue and/or adhesions during healing of a wound or surgical site. Specific devices to achieve this administration include, but are not limited to, a permanent implant or a biodegradable material having an attached antiproliferative drug such as sirolimus. These antiproliferative drugs may be combined with other drugs including, but not limited to, antiplatelets, antithrombotics or anticoagulants. The present invention also contemplates methods to a reduce scar tissue and/or adhesions or adhesion formation at an anastomosis site. In particular, a cytostatic antiproliferative drug is administered to an arteriovenous shunt anastomoses in patients having end-stage renal disease.

Abstract: A programmer is provided for an implantable medical device capable of detecting cardiac events in a human patient. The programmer has a two-way wireless data communication mechanism with the implantable medical device and a graphical user interface is included which has a display and input mechanism designed for use in programming patient specific parameters for the detection of ST shift related cardiac events.

Abstract: Disclosed are a means and method for rapidly and accurately positioning a toroidal balloon with its distal surface placed tightly against the endocardial surface of the left atrium at a location that is close to the ostium of a pulmonary vein. On the exterior surface of the toroidal balloon can be an electrically conducting wire that is capable of causing rf energy to be placed into the tissue of the left atrium so as to ablate that tissue to alter the conduction of aberrant electrical signals of the heart that are associated with atrial fibrillation. The toroidal balloon is wrapped circumferentially around a tapered balloon that is placed into the pulmonary vein. This system can be applied successively to at least one or as many as all four of the pulmonary veins that enter the left atrium to treat the patient's atrial fibrillation.

Abstract: A hybrid stent that is defined as having a central section that is balloon expandable and end sections that are self-expanding. The entire stent is mounted on a balloon of a balloon angioplasty catheter. One way to retain the self-expanding portion of the stent onto a balloon onto which it has been nested is to place a cylindrical elastomer tube around each of the self-expanding end sections of the stent.

Abstract: The present invention is a stent delivery system that uses a short section of a guide wire that is fixedly attached to a distal section of a balloon angioplasty catheter. By not having a guide wire that slides through the balloon of the balloon angioplasty catheter, the balloon on which the stent is mounted can have a reduced diameter. Therefore, the outside diameter of the undeployed stent mounted onto that balloon is also minimized. This provides a minimum profile, i.e., a minimum outside diameter, for the stent. A minimum profile at the distal section of the stent delivery system is highly advantageous for improving the percentage of cases that can be treated by means of direct stenting; i.e., without requiring pre-dilation of a stenosis.

Abstract: Disclosed is a system for detecting an acute myocardial infarction (i.e., a heart attack) at the earliest possible time and promptly warning the patient that he should immediately seek medical care. The present invention includes an implantable electronic system that can sense a change in the patient's electrogram that is indicative of a heart attack. If a heart attack is sensed, the device would then cause an implantable and/or externally located alarm to be actuated to warn the patient of his condition and a medical practitioner at a remote diagnostic center would receive the patient's electrogram for analysis. The patient or a caretaker would then be informed to self-inject medication through a subcutaneous, pass-through drug port that can be a separate device or integrated into the implanted device that is designed for the early detection of a heart attack.

Abstract: An anti-proliferative drug, such as rapamycin or taxol, is placed onto or within a sheet of material or mesh. The strands onto or into which the drug is placed may be either a permanent implant or it may be biodegradable. Surgical sutures or staples may also be coated and used for connecting human tissues (i.e., for example, an anastomosis).