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.

Abstract: An integrated catheter system utilizes a balloon angioplasty catheter placed through a central passageway of a stent delivery catheter to enable balloon angioplasty and stent delivery to be accomplished with a single device. The integrated catheter system is able to perform dilatation of an arterial stenosis, placement of the stent at the site of the stenosis and then the angioplasty catheter balloon can be used to further embed the stent into the arterial wall. Balloon angioplasty, stent placement and stent embedding into the arterial wall are all accomplished while the catheter's angioplasty balloon remains situated at the site of the stenosis. A conically shaped distal portion of the stent delivery catheter allows stent placement over the deflated balloon after balloon angioplasty even when intimal dissection causes an intimal flap to be pushed inwardly against the deflated balloon.

Abstract: A stent (10) is plated with a high density, radiopaque metal (or alloy) such as gold or tantalum. Specifically, the stent (10) is plated to a sufficient thickness (15) on its longitudinal wires (12) to make it clearly radiopaque in fluoroscopy, but the generally circumferential wires (11) are plated to a much lesser thickness (14) so that they are not distinctly radiopaque. Before the stent (10) is deployed radially outward in a vessel of the human body, the longitudinal wires (12) are very close together so the implanting physician can easily discern the proximal and distal extremities of the stent (10). Furthermore, the physician can readily discern that the stent (10) has been deployed because the longitudinals (12) will separate to an increased distance from each other after proper deployment.

Abstract: There is provided a radiation shield for protecting a health care worker from ionizing radiation prior to and during delivery of a radioisotope stent into a patient's blood vessel. The radiation shield is placed coaxially over at least a distal portion of a stent delivery catheter assembly carrying or having formed therein a radioactive stent. The radiation shield is maintained about the distal portion of the catheter assembly until delivery of the radioactive stent is to occur. During the stent's delivery, the catheter assembly is axially displaced relative to the radiation shield to pass therethrough, then into the patient's blood vessel. A protective barrier is thus continually maintained between the health care worker and the radioactive stent he or she is delivering.

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 present invention is a method for using an improved guiding catheter that eliminates the need for an introducer sheath or a separate Tuohy-Borst "Y" adaptor, thus reducing the time and expense for performing artery opening procedures. Furthermore, the guiding catheter with straightening dilator as described herein allows the hole in the wall of the femoral artery in the groin, or even more advantageously, the radial artery in the arm to be approximately 2 French sizes smaller in diameter as compared to the hole that would be created if an introducer sheath is also used. The advantages of the present invention are accomplished by utilizing a guiding catheter with a dilator that has a stiffened and/or curved distal section that can be used to straighten the distal section of the guiding catheter as it is advanced through the arterial system.

Abstract: An introducer sheath for insertion into a patient's vascular system is provided having an irregular, undulating outer surface to interface with the irregular surface formed by the invasive procedure of inserting the sheath into a blood vessel. The sheath includes a helical coil member formed of continuous turns of spiral wound flat wire and a plastic sleeve surrounding the coil. Each turn of the coil is spaced apart from a next adjacent turn sufficiently to define therebetween an interstice wide enough to allow the plastic sleeve to be constricted into the interstices between the turns. A corresponding undulating outer surface is thereby formed to interface with a wall of blood vessel to minimize blood leakage therefrom. In the preferred embodiment, a lubricated inner plastic tube is proved, and a distal portion of the sheath surface has a smooth configuration.

Abstract: A catheter is disclosed which is capable of cutting obstructive tissue from a vessel of a living body while shielding a portion of the wall of the vessel from being exposed to the cutting blade at the catheter's distal end. An essentially continuous outer surface at the catheter's distal end allows it to be readily advanced through an introducer sheath and through a tight stenosis in an artery. The shield at the catheter's distal end could subtend an arc from as little as 45 degrees to as large as 270 degrees depending on the extent of the vessel wall that is to be protected from being cut. A vacuum source at the catheter's proximal end can cause a suction to exist at a cutout at the catheter's distal end in order to pull obstructive tissue into the cutout as the cutting cylinder is pulled back in a retrograde direction, this suction being capable of enhancing the removal of the obstructive tissue.

Abstract: A guiding catheter system (10) is provided that includes a Tuohy-Borst fitting (20) attached as a one-piece construction to a guiding catheter tube (11). The guiding catheter system (10) can also include a dilator (16) and a guide wire 15. The Tuohy-Borst fitting (20) can have a side arm (14) onto which a stop cock (30) can be attached. With the stop cock (30) in its closed position, fluid flow through the side arm (14) is prevented. When the nut (22) on the Tuohy-Borst fitting (20) is tightened down so that the gland (24) in the Tuohy-Borst fitting (20) seals against the guide wire (15) and the stop cock (30) is closed, blood loss through the proximal end of the guiding catheter system (10) can be essentially eliminated. Since the Tuohy-Borst fitting (20) is integrally joined to the proximal end of the guiding catheter tube (11), the need for a separately packaged and sterilized Tuohy-Borst fitting to be screwed onto the guiding catheter's proximal end is eliminated.

Abstract: A balloon angioplasty catheter system comprising a flexible guide wire, balloon catheter and slide handle. The balloon catheter has a shaft with a guide wire lumen that includes a guide wire removal slit which extends along a portion of the shaft. The slide handle is configured to open the slit as the handle slides along the catheter. The handle includes a separate passage for the catheter and guide wire and is provided with a fitting for connecting the handle to the "Y" adaptor of a guide catheter. The system provides a arrangement with the advantages of both an over-the-wire and monorail catheter.