Abstract: The present invention provides for an expandable stent (10 or 20) for use in an artery or other vessel of a human body. The stent structure (10 or 20) maintains the patency of the vessel within which the stent (10 or 20) is expanded radially outward. One embodiment of the present invention is a stent (10) having a multiplicity of frames (12) joined together by at least two undulating longitudinal structures (14L and 14R) which can readily change their length in the longitudinal direction so as to provide increased longitudinal flexibility for the stent (10) for easy passage through and placement within a curved vessel such as a coronary artery. The stent (20) is an embodiment of the present invention having frames (22) joined with longitudinal structures (24B, 24T and 24R) and formed from a single, thin-walled piece of metal by laser cutting or chemical etching.

Abstract: The present invention is an injection port assembly for subcutaneous delivery of medication. A single molded body has a soft cannula extending downward from a generally flat bottom surface and a self-sealing septum mounted at the center of a top surface which is generally of a concave shape sloping downward towards its outer perimeter at which point the single body is very thin. The single body also has a tubular extension which is directed outward parallel to the skin's surface. A metal needle which penetrates through the septum and through the lumen of the soft cannula is used for inserting the cannula through the skin. Once the soft cannula is placed subcutaneously, the needle is removed and an adhesive tape is placed over the single body and onto the skin beyond the body's outer perimeter.

Abstract: The temporary radioisotope stent catheter system of the present invention includes a temporary radioisotope stent that is situated at a distal portion of two, co-axially situated, thin-walled tubes. The catheter system can be delivered into a vessel of a human body either as a stand-alone device or it can be used in conjunction with an elongated cylindrical sheath which is a form of delivery catheter. If used as a stand-alone device, the temporary radioisotope stent is first percutaneously advanced through a guiding catheter and is then placed at the site of a stenotic dilatation. An operating means located at a proximal portion of the catheter system is then used to increase the diameter of the temporary radioisotope stent to be approximately equal to the inside diameter of the dilated stenosis.

Abstract: The present invention is a stent delivery catheter system for placing a stent within a stenosis in a vessel of a human body. The stent delivery catheter system utilizes a slideable sheath with a thin-walled distal portion that is situated coaxially over a stent that is placed onto a balloon located at the distal portion of a balloon angioplasty catheter. The distal end of a central portion of the sheath has an interior shoulder which is capable of exerting a distally directed push force on the balloon angioplasty catheter at a point that is just proximal to the stent. This push force is then transferred through the non-deployed stent to a gradually tapered, highly flexible, lubricity coated distal tip of the balloon angioplasty catheter.

Abstract: The present invention is a stent delivery catheter system for placing a stent within a stenosis in a vessel of a human body. The stent delivery catheter system utilizes a slideable sheath with a thin-walled distal portion that is situated coaxially over a stent that is placed onto a balloon located at the distal portion of a balloon angioplasty catheter. The distal end of a central portion of the sheath has an interior shoulder which is capable of exerting a distally directed push force on the balloon angioplasty catheter at a point that is just proximal to the stent. This push force is then transferred through the non-deployed stent to a gradually tapered, highly flexible, lubricity coated distal tip of the balloon angioplasty catheter.

Abstract: A balloon catheter for irradiation with or without dilatation of an arterial stenosis has an inflatable balloon and a generally cylindrical, thin-walled, elastic radioactive source both located coaxially at a distal section of the balloon catheter. The elastic radioactive source is moved radially outward as a result of injection of an inflation fluid into the inflatable balloon thus placing the radioactive source in close proximity to the wall of a vessel of the human body into which the balloon catheter has been inserted.

Abstract: The present invention provides for an expandable stent (10 or 20) for use in an artery or other vessel of a human body. The stent structure (10 or 20) maintains the patency of the vessel within which the stent (10 or 20) is expanded radially outward. One embodiment of the present invention is a stent (10) having a multiplicity of frames (12) joined together by at least two undulating longitudinal structures (14L and 14R) which can readily change their length in the longitudinal direction so as to provide increased longitudinal flexibility for the stent (10) for easy passage through and placement within a curved vessel such as a coronary artery. The stent (20) is an embodiment of the present invention having frames (22) joined with longitudinal structures (24B, 24T and 24R) and formed from a single, thin-walled piece of metal by means of laser cutting or chemical etching.

Abstract: Disclosed is a radioisotope stent that has increased radioactivity at the end regions of the stent as compared to the stent's central region. To minimize the neointimal hyperplasia that may exist to a greater extent at the ends of a stent that is implanted into an artery of a human body, the amount of radioactivity placed at or near the ends of the stent should be increased as compared to the amount of radioactivity over the remainder of the stent. It is an additional object of this invention to increase the radiation field at the end of a radioisotope stent by placing additional metal surfaces at the ends of the stent so as to have additional surfaces onto which a radioisotope can be placed.

Abstract: The present invention is a balloon angioplasty catheter that combines a catheter shaft having increased pushability with an elongated, gradually tapered, highly flexible, lubricity coated, distal tip that is specifically designed to penetrate through a tight stenosis. The distal end of the tip is formed as a very thin-walled, tapered, frustrum of a cone that is capable of following a guide wire through even the most tortuous coronary arteries. The proximal end of the tip has a diameter that is equal to or slightly larger than the diameter of an angioplasty balloon that is wrapped around a catheter shaft at a distal section of the balloon angioplasty catheter. One embodiment of the invention includes a thin-walled tube located at the proximal end of the distal tip which extends over the distal end of the angioplasty balloon. This design can prevent the distal end of the wrapped pre-deployed balloon from engaging the arterial wall as it is pushed through a tight stenosis.

Abstract: The present invention is a stent delivery catheter system for placing a stent within a stenosis in a vessel of a human body. The stent delivery catheter system utilizes a slideable sheath with a thin-walled distal portion that is situated coaxially over a stent that is placed onto a balloon located at the distal portion of a balloon angioplasty catheter. The distal end of a central portion of the sheath has an interior shoulder which is capable of exerting a distally directed push force on the balloon angioplasty catheter at a point that is just proximal to the stent. This push force is then transferred through the non-deployed stent to a gradually tapered, highly flexible, lubricity coated distal tip of the balloon angioplasty catheter.

Abstract: An expandable external radiopaque marker band is situated external to the balloon of a balloon angioplasty catheter typically at the balloon's longitudinal center. When the balloon is inflated to dilate an arterial stenosis, the external radiopaque marker band is moved radially outward by the balloon thereby forcing the external radiopaque marker band into the arterial wall. When the balloon is then deflated, the external radiopaque marker band remains in place against the wall of the dilated stenosis. The balloon angioplasty catheter can then be removed from the artery while the expanded external radiopaque marker band remains in place to indicate (typically) the center position of the dilated stenosis. The external radiopaque marker band is typically made from a dense, radiopaque metal such as tantalum, gold, platinum or an alloy of those dense metals.

Abstract: A stent delivery catheter system for the treatment of stenoses at an arterial bifurcation consists of a main guide wire, a side branch guide wire, a unique design balloon angioplasty catheter which includes a side branch tube and a stent that can be deployed to a larger diameter in the main artery leading to the arterial bifurcation, and deployed to a smaller diameter within one of the branch arteries at an arterial bifurcation. The balloon angioplasty catheter used to deploy the dual diameter stent has a proximal section that has a larger diameter as compared to the diameter of a distal section which distal section is designed to be placed in a branch artery of the bifurcation. An opening in the wall of the stent allows for the passage of the side branch tube that provides angular orientation of the pre-deployed stent relative to the two branches of the bifurcation. The side branch tube is also used to help assure proper longitudinal placement of the stent relative to the saddle point of the bifurcation.

Abstract: A single, integrated catheter is capable of performing balloon angioplasty followed by delivery of a stent without removing the catheter from the patient's body. In one embodiment, a balloon placed near the catheter's distal end is first used for pre-dilatation of a vascular stenosis. The catheter is then advanced until a stent placed within a stent containment cavity located just proximal to the balloon is placed within the dilated stenosis. An outer sheath is then pulled back which allows a self-expanding stent to be deployed radially outward. The balloon is then pulled back inside the stent and reinflared to embed the stent into the dilated stenosis. An alternative embodiment of the invention uses a side opening in the catheter located just proximal to the stent containment cavity as an entry port for a flexible guide wire thus providing a "rapid exchange" capability for the integrated catheter.

Abstract: The present invention is a device and method for securing and releasing the distal end of a thin-walled sheath to and from a distal section of a stent delivery catheter. The invention comprises a stent delivery catheter system which includes a sheath which is releasably attached to a distal section of a stent delivery catheter. When the stent delivery system has been advanced into the body so that the stent (which is situated coaxially within the sheath) is placed at the site of an arterial stenosis where it is to be deployed, the sheath is released from the stent delivery catheter and then the sheath is pulled back in a proximal direction thereby uncovering the stent. Self-deploying stents will automatically deploy when the sheath is pulled back. Balloon expandable stents can be deployed by balloon inflation after the sheath has been pulled back.

Abstract: An expandable temporary stent system (10) is provided for creating a temporary stent within a vessel of a human body and includes an over-the-wire balloon angioplasty catheter (20) having a central lumen (26) and a distal section having an inflatable balloon (23). The balloon angioplasty catheter (20) has a proximal section that remains outside the body. A stent assembly (30) is slidably mounted on the balloon angioplasty catheter (20) in a coaxial manner and has a proximal section as well as a distal section where a temporary stent (31) is located at the distal section. The distal end of the stent assembly (30) is fixed to the distal section of the balloon angioplasty catheter (20). The proximal end of the temporary stent (31) is fixed to a distal end of a pusher tube (32).

Abstract: Disclosed is a coating material which has both antithrombogenic properties and contains an embedded radioisotope that makes the coating material radioactive As phosphorous 32 is emerging as the preferred isotope for vascular radioisotope stents, and phosphorylcholine has shown promise as an antithrombogenic stent coating, it is envisioned here to produce a stent with a phosphorylcholine coating with some of the phosphorous in the coating being phosphorous 32 rather than the naturally occurring, non-radioactive element phosphorous 31. In this manner one has a stent which has a single stent coating which is both antithrombogenic and radioactive. The stent could also utilize an inner layer which is both antithrombogenic and radioactive and an outer layer which is only antithrombogenic. A preferred embodiment of the invention is to produce a phosphorylcholine coated stent where some of the phosphate groups contain the radioisotope phosphorous 32.

Abstract: The present invention is a multi-cell stent having at least two different types of cells with each type of cell accomplishing a different purpose. For example, a first type of cell is intended to provide a maximum radial rigidity after stent deployment. A second type of cell is designed to provide increased longitudinal flexibility prior to stent deployment and after stent deployment into a main artery, the second type of cell can be readily balloon expanded at the ostium of a side branch artery to a comparatively large diameter without breaking any of the struts of the stent cell. By this technique, unobstructed blood flow into the side branch can be provided.

Abstract: The present invention is designed to overcome several disadvantages of prior art balloon expandable stents. Specifically, the Butterfly Expandable To Honeycomb (BETH) stent described herein consists of a collection of circumferential (or vertical) arc structures and diagonal struts. These arcs and struts form a butterfly shape before the stent is expanded and a hexagonal, honeycomb type of structure is created when the stent is fully expanded. Until the nominal stent diameter is reached, the deployed length of the stent is actually longer than the non-deployed length. At the nominal fully-deployed diameter, the deployed stent is exactly the same length as the non-deployed length. This characteristic provides better assurance of completely covering a dilated stenosis as compared to a stent that shortens in length when deployed as is typical of all prior art balloon expandable stents.

Abstract: The present invention provides for an expandable stent (1) for use in an artery or other vessel of a human body which forms a plurality of spaced apart generally circular rings (2). The stent structure (1) maintains patency of a vessel within which the stent (1) is inserted and is formed by a plurality of closed and generally circular rings (2) where the plane of each ring (2) is substantially parallel to the plane of an adjacent ring (2). The rings (2) have a common longitudinal axis generally perpendicular to the plane of each ring (2) with the longitudinal axis passing through the geometric center of each of the rings (2). A plurality of elongated wire structures forming longitudinals (4T, 4B, 4R, 4L) are fixedly secured to the rings (2) and extend in a direction generally parallel to the longitudinal axis of the rings (2). The stent (1) formed of the generally circular rings (2) optimizes hoop strength and minimizes elastic recoil of a vessel into which the stent (1) is inserted.

Abstract: This invention is directed to an integrated catheter system (60) including a stent catheter (65) and a balloon angioplasty catheter (20). The balloon angioplasty catheter (20) has an inflatable balloon (23) mounted near the catheter's distal end which is initially used for dilation of a vessel at a low balloon pressure to partially inflate the balloon (23). The stent catheter (65) contains a stent (15) within a stent containment cavity (69) and the stent (15) is displaced over the balloon (23). The stent (15) is held in place over the partially inflated balloon (23) and an outer tube (62) of the stent catheter (65) is pulled back. The stent (15) is deployed and the balloon (23) is reinflated to a higher pressure to embed the stent (15) into the wall of the vessel.