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: 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 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: This invention provides a non-kinking and thin-walled introducer sheath (10) having a flat wire metal coil (12) that lies within a plastic covering (20) fitted onto the exterior surface of the flat wire metal coil (12) and extends into a space between adjacent turns of the flat wire metal coil (12) without covering the interior surface. Each turn of the flat wire metal coil (12) has a thickness within the range between 0.75-3.0 mils with a width to thickness ratio lying between 12 and 80. A plastic adapter (30) is provided and is located at a proximal end of the sheath (10) for inserting guide wires through the sheath (10) into a vessel.

Abstract: The invention is a system for reducing blood loss when placing a guiding catheter into an artery of a human subject. The system consists of a guiding catheter, a sealing means to be placed on the guiding catheter's proximal end and a guide wire that can be placed through both the guiding catheter and the sealing means to assist in placing the guiding catheter into a specific artery. The sealing means is typically a cap consisting of a male Luer lock fitting that includes a hemostasis valve that is designed to seal around the guide wire. The cap can be a separate component or it can be joined to the guiding catheter's proximal end by means of a flexible hinge. After the guiding catheter has been placed at a desired location in the arterial system, the cap and guide wire can be removed and a "Y" adaptor would then be placed onto the guiding catheter's proximal end. If desired the flexible hinge could also be removed from the guiding catheter.

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.

Abstract: An introducer sheath (10) is provided for percutaneous insertion of catheters into a blood vessel. The introduction of the sheath (10) through a wall of blood vessel causes an opening to be formed through which blood may pass from the blood vessel. The sheath(10) includes an inflatable collar (20) which may be expanded under pressurized inflation of fluid inserted within the inflatable collar (20) to expand into contiguous contact with a periphery of the opening formed by the sheath (10) to prevent blood leakage through the blood vessel wall opening.

Abstract: This invention is directed to a vascular access needle (20) for insertion of a sharpened end of a needle (28) into the lumen of a blood vessel. The vascular access needle (20) includes both a hollow needle (28) and an elongated cylindrical body (22) having respective central passageway lumen (27) and capillary lumen (26) extending through the entire vascular access needle (20). The elongated cylindrical body includes a planar angled surface (21) which plane is oriented parallel to the plane of the needle distal opening (29), which provides the capability for proper orientation of the needle (28) for insertion into the blood vessel lumen. The elongated cylindrical body (22) further includes a pair of parallel flat surfaces (23) for stabilization and proper orientation of the needle distal opening (29) when inserting into the blood vessel lumen.

Abstract: The present invention is a means for accessing blood vessels for the insertion of a guide wire while preventing the free release of blood. Specifically, a hollow, thin-walled metal tube typically having a sharp point at its distal end is joined at its proximal end to a transparent viewing section. The viewing section has a distal narrow lumen and a proximal chamber which has a cap at its proximal end. The cap encloses a pressure sealing means through which a guide wire can be passed. After the distal end of the metal tube is placed in an artery, blood will rush through the metal tube and into the viewing section. The air in the air-tight proximal chamber will alternatively be compressed between diastolic and systolic blood pressure. Feedback to the operator that the distal end of the metal tube is properly placed within an artery can be achieved by observing the reciprocating pulsatile motion of the blood column within the distal narrow lumen of the viewing section.