Abstract: A medical device system and method allows an arterial bypass graft to be proximally anastomosed to an aorta during a beating heart procedure without substantial loss of blood by use of an endolumenal aorta isolation assembly provided along the distal end portion of an elongate catheter body. The aorta isolation assembly includes proximal and distal portions that are separated by an isolation region and that are adjustable to first and second extended positions, respectively, which are adapted to circumferentially engage the aortic wall and isolate upstream and downstream aspects of an exterior space between the elongate body and the aortic wall. The intermediate region is adapted to be positioned along the proximal anastomosis site such that the distal and proximal portions when adjusted to the first and second extended positions circumferentially engage the aortic wall on upstream and downstream sides of the proximal anastomosis site.

Abstract: A medical device assembly is adapted to isolate the heart from systemic circulation while perfusing oxygenated blood to the systemic arterial circulation during a minimally invasive bypasss procedure. An arterial catheter with an external shunt valve forms a funnel which shunts antegrade aortic blood flow from the aortic root, into a distal flow port and through an internal flow lumen in the catheter, out an intermediate flow port along the catheter proximally of the anchor, and into the systemic arterial circulation. A distal internal valve selectively occludes the shunted antegrade aortic blood flow between the distal flow port and the intermediate flow port and isolates the left heart chambers from the systemic arterial circulation. Oxygenated blood may then flow from a cardiopulmonary bypass pump, distally through the internal flow lumen, out the intermediate port.

Abstract: Disclosed here within is the method of manufacture of a reinforced and flexible tube or catheter that can be used in a variety of applications. The first method of embedding the metallic coil or braided wire comprises the steps of engaging the metallic structure over the outer surface of the tubular member, applying heat through an appropriately sized mold to the outer surface of the tubular member while creating a pressure differential between the inner lumen and the outside surface of the tubular member for a specified period of time.

Abstract: The present invention is directed to an expandable stent which is relatively flexible along its longitudinal axis to facilitate delivery through tortuous body lumens, but which is stiff and stable enough radially in an expanded condition to maintain the patency of a body lumen such as an artery when implanted therein. The struts of the present invention have a specific trapezoidal, triangular or a reduced radii configuration projecting radially outward that functions to reduce the forces necessary to penetrate the vessel wall thereby minimizing trauma or damage imparted to the wall during deployment. In addition, this design feature of the present invention helps secure the expanded stent so that it does not move once it is implanted and furthermore, minimizes projections into the blood stream. The invention generally includes a plurality of radially expandable loop elements which are relatively independent in their ability to expand and to flex relative to one another.

Abstract: A device for folding a balloon of a balloon catheter during balloon deflation includes a band and a plurality of elongated fingers that are attached to the band. The band is formed with a tab and a notch and the length of the band corresponds to the diameter of the catheter tube. The band is folded into an annulus to interlock the tab with the notch. The annulus is attached to the catheter tube of the balloon catheter with the fingers extending over the balloon in a substantially same axial direction. In operation, the fingers are moveable between an unstressed configuration, when the balloon is deflated, and a stressed configuration, when the balloon is inflated. In a stressed configuration, the fingers urge against the balloon and are biased toward the stressed configuration to return to an unstressed configuration.

Abstract: The present invention is directed to an expandable stent which is relatively flexible along its longitudinal axis to facilitate delivery through tortuous body lumens, but which is stiff and stable enough radially in an expanded condition to maintain the patency of a body lumen such as an artery when implanted therein. The struts of the present invention have a specific trapezoidal, triangular or a reduced radii configuration projecting radially outward that functions to reduce the forces necessary to penetrate the vessel wall thereby minimizing trauma or damage imparted to the wall during deployment. In addition, this design feature of the present invention helps secure the expanded stent so that it does not move once it is implanted and furthermore, minimizes projections into the blood stream.

Abstract: A medical instrument which is insertable into a vascular system to incise a stent embedded within a stenosis is provided herein and includes a multi-luminal catheter with a distal expandable balloon mounted with a reciprocating cutting member. The cutting member is selectively activated by an external reciprocating mechanism which is transmitted through the catheter to the cutting member mounted on the balloon's surface. The cutting member is designed to have the characteristics necessary to cut the metallic struts of a stent. In operation, the device is placed within the stenosis having an embedded stent and the expandable balloon is inflated. Preferably, the cutting member will be facing the myocardium. Then reciprocating motion is activated and the cutting member proceeds to sever the struts of the stent and make an incision in the stenosis. It is anticipated that more than one cutting member may be mounted on the balloon's surface.

Abstract: The present invention is a device and a method for boring a perfusion channel from a coronary artery into a cardiac muscle of a patient. Structurally, the present invention includes a positioning catheter, anchor means and a cutting catheter. The cutting catheter includes a plurality of blades and is advanceable through a deployment lumen of the positioning catheter. Advancement of the cutting catheter through the deployment lumen causes a distal end of the cutting catheter to project laterally from the positioning catheter. In use, the positioning catheter is positioned within the coronary artery. The anchor means is then expanded to anchor the positioning catheter within the artery. The cutting catheter is then advanced through the deployment lumen to bore one or more perfusion channels in the myocardial tissue.

Abstract: The present invention is a device for incision and dilation of stenotic segments within the vascular system of a patient. Structurally, the present invention includes a rigid ellipsoidal dilation probe mounted at the distal end of a catheter. A series of longitudinally oriented blades project radially from the surface of the probe. A tapered inflatable balloon is also mounted on the catheter in a position that is proximal to the dilation probe. In use, the probe and catheter are advanced over a guidewire to reach the targeted stenotic segment. The probe and blades are then advanced through the stenotic segment to incise the stenosis. The balloon may then be inflated to adopt a tapering fusiform shape, allowing the balloon to be advanced through the stenosis to further dilate the stenosis. Alternatively, the balloon may be positioned across the stenosis and inflated to dilate the stenosis.

Abstract: A medical device system and method allows an arterial bypass graft to be proximally anastomosed to an aorta during a beating heart CABG procedure without substantial loss of blood by use of an endolumenal aorta isolation assembly provided along the distal end portion of an elongate catheter body. The aorta isolation assembly includes proximal and distal portions that are separated by an intermediate isolation region and that are adjustable to first and second extended positions, respectively, which are adapted to circumferentially engage the aortic wall and isolate upstream and downstream aspects of an exterior space between the elongate body and the aortic wall. Blood flowing within the aorta is thereby isolated from the proximal anastomosis site along the intermediate region and is shunted from an upstream region of the aorta, through the distal port into the flow lumen, proximally along the flow lumen, out from the flow lumen through the proximal port, and into a downstream region of the aorta.

Abstract: A method and device for injecting fluid into a treatment area of a vessel wall is provided herein. A first version of the device includes an inflatable balloon mounted on a catheter and a plurality of dispensers extending outwardly and moving with the balloon. At least one fluid passageway connects each injector in fluid communication with a fluid source. During use of the device, the balloon is first positioned in a vessel proximate the treatment area. Next, the balloon is inflated to embed the dispensers into the vessel wall. Subsequently, the fluid from the fluid source is introduced into the fluid passageway and through the dispensers into the treatment area. A second version of the device includes a plurality of flexible tubes mounted between a multi-lumen catheter and a grommet. A push-pull wire is connected to the grommet and passed through a lumen of the multi-lumen catheter. The dispensers are mounted on each of the flexible tubes. During use, the device is first positioned in a vessel.

Abstract: The present invention is a device and a method for boring a perfusion channel from a coronary artery into a cardiac muscle of a patient. Structurally, the present invention includes a positioning catheter, anchoring structure and a cutting catheter. The cutting catheter includes a plurality of blades and is advanceable through a deployment lumen of the positioning catheter. Advancement of the cutting catheter through the deployment lumen causes a distal end of the cutting catheter to project laterally from the positioning catheter. In use, the positioning catheter is positioned within the coronary artery. The anchoring structure is then expanded to anchor the positioning catheter within the artery. The cutting catheter is then advanced through the deployment lumen to bore one or more perfusion channels in the myocardial tissue.

Abstract: A method and device for injecting fluid into a treatment area of a vessel wall is provided herein. A first version of the device includes an inflatable balloon mounted on a catheter and a plurality of dispensers extending outwardly and moving with the balloon. At least one fluid passageway connects each injector in fluid communication with a fluid source. During use of the device, the balloon is first positioned in a vessel proximate the treatment area. Next, the balloon is inflated to embed the dispensers into the vessel wall. Subsequently, the fluid from the fluid source is introduced into the fluid passageway and through the dispensers into the treatment area. A second version of the device includes a plurality of flexible tubes mounted between a multi-lumen catheter and a grommet. A push-pull wire is connected to the grommet and passed through a lumen of the multi-lumen catheter. The dispensers are mounted on each of the flexible tubes. During use, the device is first positioned in a vessel.

Abstract: Guidewire comprising an elongated core element manufactured from a martensitic alloy that is heat-treated to render a fully hardened core throughout its cross sectional area. The core has a constant taper or step-down decreasing cross sectional area in a direction towards the distal end which is fully hardened throughout its longitudinal length. A single coil, or two coils are carried by and secured to said core element near the distal end.

Abstract: Disclosed herewithin is a method of fabricating a stent which involves processing a tubular member whereby no connection points to join the edges of a flat pattern are necessary. The method includes the steps of a) removing contaminates from a tubular member, b) coating the outside surface of the tubular member with a photo-sensitive resist material, c) placing the tubular member in an apparatus designed to simultaneously rotate the tubular member while passing a specially configured photographic frame negative between a UV light source and the tubular member, thereby exposing a specified pattern of UV light to the resist coated tubular member, d) exposing the outside surface of the tubular member to a photoresist developer for a specified period of time, e) rinsing the excess developer and uncured resist from the outside surface of the tubular member, f) treating the tubular member with a electro-chemical process to remove uncovered metal.

Abstract: The present invention is a device and a method for boring a perfusion channel into the myocardial tissue of a patient. Structurally, the present invention includes a positioning catheter and a cutting catheter. The positioning catheter is formed with an inflation lumen and a deployment lumen and has an inflatable balloon mounted at its distal end. The cutting catheter has a sharpened distal end and is advanceable through the deployment lumen of the positioning catheter. Advancement of the cutting catheter through the deployment lumen causes the distal end of the cutting catheter to be directed radially outward from the positioning catheter. In use, the positioning catheter is positioned within a target vessel. The inflatable balloon is then expanded to anchor the distal end of the positioning catheter.

Abstract: A balloon activated force concentrator for use in cooperation with an inflatable angioplasty balloon includes at least one elongated flexible panel, an elongated cutting blade mounted on the outside surface of the elongated flexible panel, and an elastic circular band attached to each end of the elongated flexible panel for securing the elongated flexible panel to an angioplasty balloon. Use of this balloon activated force concentrator requires mounting the device on an inflatable angioplasty balloon by inserting the distal end of the angioplasty balloon through one of the circular bands. The balloon activated force concentrator is then advanced over the balloon until the second circular band reaches the distal end of the balloon. At that point, the elasticity of the circular bands straddle the balloon to retain the activated force concentrator securely against the outer surface of the angioplasty balloon.

Abstract: A method of manufacturing polymeric material having enhanced structural integrity includes heating the material to a temperature between the material's glass transition temperature and the material's melt temperature. Once heated, the material is highly overstretched in a first direction and moderately overstretched in a second direction. The material is then held in the overstretched condition while it is allowed to cool to room temperature. Cooling is followed by reheating to a curing temperature. After curing for a predetermined period, the material is again allowed to cool. The completed material has high polymeric orientation in the first direction and moderate polymeric orientation in the second direction. Therefore, the material is characterized by enhanced structural integrity and absence of pinhole defects common to highly oriented polymeric materials.

Abstract: A device for injecting medication into a vessel wall includes an inflatable balloon mounted on a catheter. Additionally, a tubular sleeve surrounds the balloon to create an infusion chamber between the sleeve and the balloon, and a plurality of injectors are mounted on the sleeve in fluid communication with the infusion chamber. During use of the device, the balloon is first positioned in a vessel and then inflated to embed the injectors into the vessel wall. Next, a fluid medicament is introduced into the infusion chamber for further infusion from the chamber and through the injectors into the vessel wall.

Abstract: A method for manufacturing an atherectomy cutter having a positive angle of attack which includes the following steps: forming a rod having a longitudinal axis into a cutter blank having a first cylindrical section, a second cylindrical section, and a uniformly tapered section therebetween; boring an axial passageway through the cutter blank to create walls of substantially similar thickness in each section of the cutter blank; grinding a pair of diametrically opposed flats on the external surface of the uniformly tapered section of the cutter blank; and removing the wall portions of the tapered section between the flats to create a pair of blades.