Abstract: A method for increasing the rate of thrombus formation and/or proliferative cell growth of a selected region (21) of cellular tissue (22) including the step of endovascularly irradiating the selected region (21) with radiation, having a dose range of endovascular radiation of about 1 Gy to about 600 Gy at a low dose rate of about 1 cGy/hr to about 320 cGy/hr, to increase thrombus formation and/or cell proliferation of the affected selected region (21). Preferably, the delivery means includes a deformable endovascular prosthesis (25) adapted for secured positioning adjacent to the selected region (21) of cellular tissue (22), and a radioactive source. This source cooperates with the deformable endovascular device (25) in a manner endovascularly irradiating the selected region with radiation, having the above-indicated dose range and low dose rate of endovascular radiation to increase thrombus formation and/or cell proliferation of the affected selected region (21).

Abstract: A stent crimping apparatus for crimping a deformable radioactive stent onto a deployment device which includes a first jaw member defining a shielded first compression surface, and an opposed, second jaw member defining a shielded second compression surface oriented opposite the first compression surface. The first and second compression surfaces are adapted to collectively form an elongated guide bore formed for axial receipt of the deformable stent and the deployment device therein. To protect against exposure to the radioactive stent, a shield assembly is provided defining an opening into a bore therein which is formed and dimensioned for longitudinal receipt of the deformable stent in an uncrimped condition. A shield assembly defines an opening into the bore, and cooperates with the first and second jaw members to substantially prevent radioactive particles emitted by the radioactive stent from passing out of the crimping apparatus.

Abstract: A method for increasing the rate of thrombus formation and/or proliferative cell growth of a selected region (21) of cellular tissue (22) including the step of endovascularly irradiating the selected region (21) with radiation, having a dose range of endovascular radiation of about 1 Gy to about 600 Gy at a low dose rate of about 1 cGy/hr to about 320 cGy/hr, to increase thrombus formation and/or cell proliferation of the affected selected region (21). Preferably, the delivery means includes a deformable endovascular prosthesis (25) adapted for secured positioning adjacent to the selected region (21) of cellular tissue (22), and a radioactive source. This source cooperates with the deformable endovascular device (25) in a manner endovascularly irradiating the selected region with radiation, having the above-indicated dose range and low dose rate of endovascular radiation to increase thrombus formation and/or cell proliferation of the affected selected region (21).

Abstract: A method for increasing the rate of thrombus formation and/or proliferative cell growth of a selected region (21) of cellular tissue (22) including the step of endovascularly irradiating the selected region (21) with radiation, having a dose range of endovascular radiation of about 1 Gy to about 600 Gy at a low dose rate of about 1 cGy/hr to about 320 cGy/hr, to increase thrombus formation and/or cell proliferation of the affected selected region (21). Preferably, the delivery means includes a deformable endovascular prosthesis (25) adapted for secured positioning adjacent to the selected region (21) of cellular tissue (22), and a radioactive source. This source cooperates with the deformable endovascular device (25) in a manner endovascularly irradiating the selected region with radiation, having the above-indicated dose range and low dose rate of endovascular radiation to increase thrombus formation and/or cell proliferation of the affected selected region (21).

Abstract: Disclosed is a balloon on a distal portion of a balloon angioplasty catheter. The section of the balloon onto which a stent can be mounted has a central segment that is substantially cylindrical in shape that is centered between two segments each having the shape of a sector of a prolate spheroid. This shape for a balloon for a stent delivery catheter provides a more cylindrical shape for the stent after it is implanted in an artery that has a typical distribution of plaque in an arterial stenosis, which distribution of plaque is greatest for some limited length at a central region of the stenosis and then decreases somewhat uniformly as one approaches the edges of the stenosis. Another embodiment of the invention utilizes two segments that are frustums of a cone instead of sectors of a prolate spheroid, which conical segments surround the central cylindrical segment. Also disclosed is a balloon whose compliance decreases continuously as a function of the distance away from either end of the central segment.

Abstract: A radiation shield assembly (30) for a radioactive stent (11) mounted onto a deployment portion (20) of a delivery apparatus (12) including a relatively thin, elongated tube member (69) having a wall (70) defining a receiving passage (72) formed and dimensioned for axial receipt of the stent mounted onto the deployment portion therein to substantially prevent direct contact with the stent (11). A removal structure (71) cooperating with the wall (70) of the tube member (69) for longitudinal severing thereof to enable selective removal of the tube member from the delivery apparatus (12) for deployment use thereof.

Abstract: Disclosed is a stent delivery catheter system for placing a radioactive stent within a blockage in a vessel of a human body. The stent delivery catheter system consists of a radioactive stent that is placed onto an angioplasty balloon that is located at the distal portion of a stent delivery catheter. Just proximal and just distal to the stent there is a proximal radioactive band and a distal radioactive band, respectively, each of which are generally thin walled and cylindrical. The radioactive stent located on the balloon at the distal portion of the stent delivery catheter is advanced over a flexible guide wire until the non-deployed radioactive stent is placed at the site of a vessel blockage such as an arterial stenosis. The balloon is inflated and the radioactive stent and the distal and proximal radioactive bands are pushed radially outward in apposition to the wall of the artery, resulting in dilatation of the stenosis.

Abstract: A radiation shield assembly (30) for a radioactive stent (11) which includes a first shield member (31) having a first mating surface (32) and a second shield member (33) having an opposed second mating surface (35). When the two shield members are removably coupled to one another, the first mating surface (32) cooperates with the opposing second mating surface (35) to substantially radially enclose the stent (11) therebetween, and substantially prevent the direct passage of radioisotopes emitted from the stent radially out of the shield assembly (30).

Abstract: Disclosed is a stent delivery system consisting of a stent delivery catheter, a guide wire over which the stent delivery catheter is advanced and a balloon angioplasty catheter that is placed over the guide wire and within the stent delivery catheter. The stent delivery catheter is an elongated cylindrical tube with a radioisotope stent placed at a distal section of the tube. Just proximal and just distal to the stent there is a proximal radioactive marker band and a distal radioactive marker band each of which are fixedly attached to the delivery catheter. After the stent has been properly positioned at the site of a vascular blockage such as an arterial stenosis, a balloon angioplasty catheter can be advanced over the guide wire and inside the delivery catheter. The balloon at a distal section of the balloon angioplasty catheter is then inflated which expands the stent and both radioactive marker bands radially outward against the wall of the blood vessel.

Abstract: A radioisotope stent that is made radioactive for most of the stent's length at a center section of the stent, but is not radioactive for a limited length at each end section of the stent. Such a stent design would have a negligible radiation level at the extreme ends of the stent. Therefore, there will not be any portion of the dilated stenosis that has no mechanical support from the stent and is also exposed to a moderate level of radiation. Furthermore, all portions of the dilated stenosis that are exposed to a high or moderate level of radiation will be mechanically supported by the stent so as to preclude the phenomena of late vascular contraction. Thus it is an object of this invention to have a stent that is designed with a comparatively high level of radioactivity at a longitudinally central section of the stent and would be free of any radioactivity at each of the two end sections of the stent.

Abstract: A stent loading apparatus for loading a self-expanding radioactive stent into a bore of a deployment device in a compressed condition including a storage device defining an elongated first passage formed and dimensioned for sliding receipt of the stent therein. The first passage extends through the storage device and terminates at a stent transfer opening of a proximal coupling end thereof. A radiation shield defines an elongated second passage which terminates at a distal opening of a distal coupling end thereof. The distal coupling end of the radiation shield and the proximal coupling end of the storage device cooperate to align the distal opening of the shield in receiving communication with the stent transfer opening of the storage device. The second passage of the shield is formed and dimensioned for receipt of the deployment device therein in a manner positioning a mouth of the deployment device bore substantially adjacent the stent transfer opening of the storage device.

Abstract: A stent loading apparatus for loading a deformable stent onto a deployment device. The stent loading apparatus includes an elastic member defining a passage therein formed for longitudinal receipt of the deformable stent in an uncrimped condition. A first member includes a first compression region; and a second member includes a second compression region positioned substantially adjacent the first compression region at a first position. At this first position, the elastic member and the deformable stent in the uncrimped condition may be received between the opposed first and second compression regions. The first compression region and the second compression region are further configured to provide rolling support and compression of the elastic member during relative movement between the first position and a second position for rolling radial compression of the deformable stent onto the deployment device.

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: Disclosed herein is a thin-walled cylindrical stent in which one or more of the sets of strut members are more radially rigid after stent expansion as compared to other sets of strut members. Each set of strut members consists of a multiplicity of structural struts that are connected together with the struts extending circumferentially when the stent is outwardly radially deployed within a vessel of a human body. The sets of strut members are those parts of the stent which unfold during radial expansion and provide the radially rigid structure which maintains vessel patency. This invention is a stent structure specifically designed to have enhanced radial rigidity either at the ends or the center of the stent. More radially rigid end struts reduce injury to the vessel from over expansion at the ends of the stent. The embodiment of the present invention with enhanced rigidity in the center would be particularly useful for the treatment of calcified obstructions.

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 utilizes a balloon with three or more folds to more evenly distribute the frictional forces on the inside of a stent during stent deployment thus improving the uniformity of stent cell expansion. Ideally one would like to have the same number of balloon folds as the number of stent cells distributed circumferentially around the stent. Matching the number of balloon folds to the number of cells of each cylindrical segment of the stent provides better size uniformity for the stent cells after they are expanded against the wall or other vessel within a human body.

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: One aspect of the present invention envisions two radiopaque marker bands located within the balloon of the balloon angioplasty catheter for balloon expandable stents, or located at a distal portion of a stent delivery catheter designed for self-expanding stents. When the balloon is expanded to its nominal diameter, the proximal marker band (of the two bands) is positioned to indicate the proximal extremity of the stent and the distal marker band is used to indicate the distal extremity of the stent. A second aspect of this invention envisions one or more radiopaque marker bands placed onto a distal portion of a stent delivery catheter with each radiopaque marker band indicating the position of a special expandable cell of the stent, which cell can be placed at the ostium of a side branch artery where that side branch enters into a main artery. The interventionalist would align such a radiopaque marker band with the ostium of the side branch prior to stent deployment.

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.