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.

Abstract: An ergonomic vascular access needle (10) is provided which has a transparent body (20) having an extended and small diameter capillary lumen (22) through which blood may be observed. The extended capillary lumen (22) is in fluid communication on opposing ends with a variable volume chamber (25) and a needle lumen (32). A movable plunger (40) within the transparent body (20) is displaceable to create the variable volume chamber (25). The distal end of the needle (30) is then pushed through the patient's skin and the plunger (40) is displaced from a forward position to create a suction within the capillary lumen (22), the needle lumen (32) and the variable volume chamber (25). The needle (30) is then advanced until the needle distal opening (33) is within the venous lumen and blood is observable in the capillary lumen (22).

Abstract: It is well known that radiation therapy can reduce the proliferation of rapidly growing cancer cells is a malignant tumor. The present invention utilizes a radioisotope which is integral to a stent which can irradiate the tissue in close proximity to the implantation site of the stent in order to reduce the rapid growth of malignant cells in a vessel, such as a bile duct while simultaneously maintaining vessel patency. The radioisotope could be place inside the stent, alloyed into the metal from which the stent is made, or preferably, it can be coated onto the stent's exterior surface.

Abstract: A sheath for percutaneous insertion into an artery includes a manually insertable sealing tab having a flexible hinge molded onto the sheath near its proximal end. The tab includes a cylindrically shaped stopper that can be inserted into the sheath's proximal end to prevent blood loss when there is no catheter inserted into the sheath. The stopper design allows a guide wire to remain in place or be advanced or pulled out of the sheath when the stopper is in place to seal the sheath's proximal end.

Abstract: An expandable transluminal atherectomy catheter system (10) is provided which includes an expandable transluminal atherectomy catheter (ETAC) (20), a balloon-on-a-guide wire (30), a sheathing catheter (40) and a rotator unit (60). The balloon-on-a-guide wire (30) is advanced through an arterial system to a predetermined point. The ETAC (20) within a sheathing catheter (40) is advanced over the guide wire cylinder (32). Prior to injection of a medium the sheathing catheter (40) is pulled back to allow spokes (24) of ETAC (20) to expand. The system (10) removes atheromatous plaque to a larger diameter than the diameter of the catheter (20) where it percutaneously penetrates the skin by the anterograde transluminal catheter whose distal end can be expanded after insertion of the catheter (20) into an artery.

Abstract: Intra-arterial stents are frequently used subsequent to balloon angioplasty to maintain arterial patency. The most frequent cause for failure to maintain patency is the rapid growth of the injured arterial tissue through the openings in the stent, which rapid growth is called "intimal hyperplasia." Since irradiation from a radioisotope source is capable of selectively inhibiting the growth of hyperproliferating cells as compared with normal cells, a radioisotope material which forms part of the stent can be used to decrease the rate of arterial reclosure. The radioisotope could be placed inside the stent, alloyed into the metal from which the stent is made, or preferably, it can be coated onto the stent's exterior surface. Beta emitting radioisotopes having a half-life between 1 and 100 days would be best suited as a stent coating because of their comparatively short range of action within human tissue, and because of their comparatively short half-life.

Abstract: An Endoluminal Tissue Excision Catheter (ETEC) is described which is capable of excising obstructive tissue from a vessel in a living body. The ETEC system operates by first passing a guide wire through the vessel and beyond the obstructive tissue. The ETEC catheter is then advanced over the guide wire until its distal end lies beyond the obstructive tissue. A closing catheter portion of ETEC is then pulled back from a cut/collect catheter portion of the ETEC thus exposing a cutting edge located at the proximal end of a cylindrical cutting blade located at a distal portion of the cut/collect catheter. A rotating means is then attached to the cut/collect catheters'3 s proximal end. The cut/collect catheter is then pulled back in a retrograde direction while rotating, thus cutting and collecting the excised obstructive tissue into a tissue collection chamber that is formed within the cylindrical cutting blade.

Abstract: An atherectomy catheter is advanced over a guide wire in the anterograde direction to the site of an arterial stenosis. The distal end of the catheter is centered around the guide wire which has been previously advanced through the stenotic lumen. The catheter is then advanced over the guide wire with its sharpened distal end cutting through the stenosis. The atherectomy catheter can also employ rotation or vibration or an electrocautery current to enhance the catheter's cutting action. Suction applied at the catheter's proximal end is used to enhance the collection of plaque cut from the stenosis at the catheter's distal end so that the cut plaque enters a single passageway that lies between the outer surface of the guide wire and the inner surface of the cylindrical catheter.

Abstract: Disclosed is an Expandable Pullback Atherectomy Catheter (EPAC) comprising a distal tip portion capable of assuming two diameters. The distal tip portion includes an expandable cutting means and an expandable tissue collecting means. The catheter is guided in an artery to the stenosis and the distal tip is urged past the stenosis while being maintained in a compressed state by a sheathing catheter. The sheathing catheter is withdrawn allowing the cutting means and collecting means to expand. The stenotic tissue is removed by pulling the distal tip back in a retrograde direction while the cut tissue is captured in the collecting means. Additional structural details are provided to prevent injury to the inner wall of an artery and to avoid total obstruction of the artery during the antherectomy procedure.

Abstract: This invention is in the field of percutaneous insertion catheters that are used for placing a coil spring stent into a vessel of a living body for the purposes of enhancing luminal dilation, preventing arterial restenosis and preventing vessel blockage resulting from intimal dissection following balloon and other methods of angioplasty. The stent can also be used for the maintaining patency of many different ducts or vessels within a living body.