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: The present invention is a system that utilizes optimized high pass or band pass filtering to provide accurate detection of changes in the ST segment of an electrogram as detected by an implanted cardiosaver system, which ST segment changes are indicative of coronary ischemia. To accurately detect changes in the ST segment of the electrogram, the cardiosaver system uses either analog or digital high pass filtering having an electrogram voltage reduction of 6 dB at some frequency between 0.05 Hz and 1.0 Hz with less than 6 dB of attenuation at frequencies above 1.0 Hz. and more than 6 dB of attenuation for frequencies below 0.05 Hz. The optimized filter would include attenuation of electric power generation frequencies of either 50 Hz or 60 Hz to reduce electromagnetic interference. The system also includes both implanted and external portions that provide a patient alarm if coronary ischemia is sensed.

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: The method for use of the present invention stent and stent delivery system is to insert a first guidewire into the branch vessel and advance the stent delivery system until the marker at the distal end of the split proximal end is aligned with the downstream edge of the sidebranch ostium. The balloon is then inflated to deliver the stent into the sidebranch. If the two zone balloon is being used as a stent delivery system, the initial inflation will cause the split proximal end to flare apart. If the stent is delivered on a standard balloon angioplasty catheter, then a second balloon of larger diameter would be used to post-dilate the proximal end of the split end stent. A stent is then advanced into the main branch and deployed, further spreading the split proximal and of the split end sidebranch stent outward against the wall of the main branch. A guidewire is then placed through the main branch stent and the opening into the sidebranch is enlarged using balloon inflation.

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 preferred embodiment of this invention is a stent that is coated with an anti-restenosis drug that is selected from the group that includes, Alkeran, Cytoxan, Leukeran, Cis-platinum, BiCNU, Adriamycin, Doxorubicin, Cerubidine, Idamycin, Mithracin, Mutamycin, Fluorouracil, Methotrexate, Thoguanine, Toxotere, Etoposide, Vincristine, Irinotecan, Hycamptin, Matulane, Vumon, Hexalin, Hydroxyurea, Gemzar, Oncovin, Etophophos, tacrolimus (FK506), and the following analogs of sirolimus: SDZ-RAD, CCI-779, 7-epi-rapamycin, 7-thiomethyl-rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-thiomethyl-rapamycin, 7-demethoxy-rapamycin, 32-demethoxy, 2-desmethyl and proline.

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: The present invention consists of a main artery stent (the main stent) that is placed in the main artery and a second stent that is placed into the side branch (the side branch stent), the two stents constituting a complete treatment for a stenosed arterial bifurcation. Both stents are preferably drug eluting. The main stent would optimally be one that has a reasonably small area of each cell after the stent is deployed, but also has a large perimeter length for each cell. The stent delivery system for the side branch stent has an attached main guide wire tube that can be advanced over a main guide wire and a central lumen that is advanced over a guide wire placed into the side branch. The structure of the side branch stent delivery system allows the side branch stent to achieve the correct angular orientation and longitudinal position when it is advanced over the two guide wires.

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 a catheter that has the form of an introducer sheath having an expandable radiopaque flange situated at the sheath's distal end. The distal end of the flange is adapted to be placed at the ostial plane of a stenosed artery. Also disclosed 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. The sheath is placed within a guiding catheter that has its distal end located close to the ostium of an artery where there is a stensosis. When the introducer sheath is advanced beyond the distal end of the guiding catheter, a flange expands at the end of the sheath. The flange is then pushed forward until its distal end is at the ostial plane of the ostium of the stenosed artery.

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 stent which is adapted for placement in the vessels of a human body is provided. The stent may be in the form of a thin-walled metal cylinder having a longitudinal axis. The stent has a proximal end and a distal end and includes a number of circumferentially relatively rigid portions. The relatively rigid portions are joined to each other by one or more longitudinals which extend in a substantially longitudinal direction. At least a portion of at least one of the longitudinals has an undulating shape where a first relatively rigid portion is located at the proximal end of the stent and a second relatively rigid portion is located at the distal end of the stent.

Abstract: Disclosed is a system for the detection of cardiac events (a guardian system) 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 one or more detection 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 guardian system includes an internal alarm sub-system (internal alarm means) within the cardiosaver and/or an external alarm system (external alarm means).

Abstract: Disclosed is an open cell stent that has adjacent sets of circumferential struts connected by means of highly flexible, undulating, connecting struts. To decrease outward flaring of the circumferential struts when the pre-deployed stent is advance through highly curved vessels, each unconnected strut of the sets of circumferential struts has a decreased longitudinal length as compared to the longitudinal length of the circumferential struts that are connected by the flexible connecting struts. To decrease the propensity for outward flaring of the end set of circumferential struts, the longitudinal length of the end set of circumferential struts is shorter than the longitudinal length of the interior set of circumferential struts. Enhanced features of the circumferential sets of strut members of the stent are also disclosed.

Abstract: The present invention describes the application of sirolimus and analogs of sirolimus to treat wound healing and reduce scar tissue formation. Also contemplated are non-sirolimus compounds believed to interact with the mTOR protein that have similar effects. Specifically, various medium are contemplated to create, for example, microparticles, foams, gels, sprays and bioadhesives that may be administered during surgical procedures involving either open or closed surgical site. Coating medical devices for long-term implantation is contemplated as one method of use of the above compositions.

Abstract: This invention is an anti-proliferative drug placed onto or within a sterile sheet or mesh 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 mesh or gauze 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 Rapamycin or Taxol, the biodegradable, drug impregnated mesh would act as a barrier to cell proliferation and hence be a deterrent to the formation of adhesions. Another embodiment of this invention is an anti-proliferative drug attached to a bandage that is placed onto a cut in the skin to decrease scar tissue formation.

Abstract: Heart disease is the leading cause of death in the United States. A heart attack (also known as an Acute Myocardial Infarction (AMI)) typically results from a thrombus that obstructs blood flow in one or more coronary arteries. The extent of damage to the myocardium from an AMI is strongly dependent upon the length of time prior to restoration of blood flow to the heart muscle. Acute myocardial infarction and ischemia may be detected from a patient's electrocardiogram (ECG) by noting an ST segment shift (i.e., voltage change) over a relatively short (less than 5 minutes) period of time. The present invention is a guardian system including electrodes, a cardiosaver device having AMI detection capability and an alarm means to warn the patient that they have had an AMI or other serious cardiac event and should immediately seek medical attention. Such a warning would facilitate getting medical treatment quickly to restore blood flow to the patient's heart muscle.

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: Disclosed are methods 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.