Abstract: An embolic protection device for use in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region to capture any embolic material which may be created and released into the bloodstream during the procedure. The device includes a filtering assembly having a self-expanding strut assembly and a filter element attached thereto. In one embodiment, the filtering assembly is attached to the distal end of a guidewire and is deployed within the patient's vasculature as the guidewire is manipulated into the area of treatment. A restraining sheath placed over the filtering assembly in a coaxial arrangement maintains the filtering assembly in its collapsed position until it is ready to be deployed by the physician. Thereafter, the sheath can be retracted to expose the filtering assembly which will then self-expand within the patient's vasculature.

Abstract: An embolic protection device for use in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region to capture any embolic material which may be created and released into the bloodstream during the procedure. The device includes a filtering assembly having a self-expanding strut assembly and a filter element attached thereto. In one embodiment, the filtering assembly is attached to the distal end of a guidewire and is deployed within the patient's vasculature as the guidewire is manipulated into the area of treatment. A restraining sheath placed over the filtering assembly in a coaxial arrangement maintains the filtering assembly in its collapsed position until it is ready to be deployed by the physician. Thereafter, the sheath can be retracted to expose the filtering assembly which will then self-expand within the patient's vasculature.

Abstract: An embolic protection device for use in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region to capture any embolic material which may be created and released into the bloodstream during the procedure. The device includes a filtering assembly having a self-expanding strut assembly and a filter element attached thereto. In one embodiment, the filtering assembly is attached to the distal end of a guide wire and is deployed within the patient's vasculature as the guide wire is manipulated into the area of treatment. A restraining sheath placed over the filtering assembly in a coaxial arrangement maintains the filtering assembly in its collapsed position until it is ready to be deployed by the physician. Thereafter, the sheath can be retracted to expose the filtering assembly which will then self-expand within the patient's vasculature.

Abstract: The present invention relates to a stent comprising a structural support and a polymeric film or sheet or tube. The structural support comprises an outer surface that is roughened patterned. The polymeric film or sheet or tube is retained to the structural support by the roughened or patterned outer surface of the structural support.

Abstract: An embolic protection device for use in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region to capture any embolic material which may be created and released into the bloodstream during the procedure. The device includes a filtering assembly having a self-expanding strut assembly and a filter element attached thereto. In one embodiment, the filtering assembly is attached to the distal end of a guidewire and is deployed within the patient's vasculature as the guidewire is manipulated into the area of treatment. A restraining sheath placed over the filtering assembly in a coaxial arrangement maintains the filtering assembly in its collapsed position until it is ready to be deployed by the physician. Thereafter, the sheath can be retracted to expose the filtering assembly which will then self-expand within the patient's vasculature.

Abstract: A catheter apparatus includes a lesion dilating member disposable at a lesion position in a vessel (e.g. a patient's artery) which is dilatable to open the vessel at the lesion position. An emboli-capturing assembly having a perfusion member and filter is displaced downstream from the lesion dilating member to capture embolic debris released in the fluid flow. The perfusion member may illustratively have peaks and channels formed between adjacent peaks which cooperate with the filter to create trapping pockets that capture embolic debris. The filter may be made from any flexible and porous material with dimensions to pass the fluid and block the emboli. The perfusion member is thereafter deflated to provide for emboli retention in the perfusion member.

Abstract: Methods for forming low profile balloons for use with a catheter by providing a polymeric tube, removing material from the outer surface of the polymeric tube around at least one of its end portions, and inflating a region of the polymeric tube between the two end portions to form the balloon. Low profile balloons having end portions with an outer diameter below 30 mils are also disclosed.

Abstract: An embolic protection device for use in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region to capture any embolic material which may be created and released into the bloodstream during the procedure. The device includes a filtering assembly having a self-expanding strut assembly and a filter element attached thereto. In one embodiment, the filtering assembly is attached to the distal end of a guide wire and is deployed within the patient's vasculature as the guide wire is manipulated into the area of treatment. A restraining sheath placed over the filtering assembly in a coaxial arrangement maintains the filtering assembly in its collapsed position until it is ready to be deployed by the physician. Thereafter, the sheath can be retracted to expose the filtering assembly which will then self-expand within the patient's vasculature.

Abstract: Porous vascular grafts and stent covers are formed of open-celled microcellular polymeric foams having a porosity that can be modified to be adapted for carrying and delivering different types of therapeutic drugs. A stent cover is formed of a tubular member including at least one layer of a porous, microcellular foam formed from a polymeric material capable of absorbing and releasing therapeutic drugs at predictable rates for delivery of the therapeutic drugs in localized drug therapy in a blood vessel. A composite metal and polymer vascular graft is formed of an interior structural stent member, and an outer layer or coating of the porous, microcellular foam.

Abstract: An embolic protection device includes a filtering assembly having a self-expanding strut assembly and a filter element. The filtering assembly can be attached to a guidewire and deployed within the patient's vasculature into an area of treatment. A restraining sheath maintains the filtering assembly in its collapsed position until it is ready to be deployed by the physician. Interventional devices can be delivered over the guidewire and any embolic debris created and released into the blood stream will enter the filtering assembly. The filtering assembly can be rotatably mounted on the guide wire and may include a dampening element which helps to prevent some shock force that may be transmitted along the guide to the deployed filtering assembly.

Abstract: The present invention is directed to apparatus and method for forming balloons with improved dimensional stability and balloons formed by the same. The method of the present invention provides for a very accurate control of the temperature profile of the balloon material during its making. The attributes of the balloon can be affected by how the balloon is treated during the blowing stage and after the initial blowing, i.e., heat-setting. Using the present method, the balloon will form more uniformly and evenly (e.g., wall thickness and outer diameter of the balloon). The present method significantly increases the dimensional stability of the balloon which provides a balloon that is more predictable, in use. The present heat-set process also provides the means for the working length to be located more accurately on dilation catheters and stent delivery systems.

Abstract: A catheter apparatus includes a lesion dilating member disposable at a lesion position in a vessel (e.g. a patient's artery) which is dilatable to open the vessel at the lesion position. An emboli-capturing assembly having a perfusion member and filter is displaced downstream from the lesion dilating member to capture embolic debris released in the fluid flow. The perfusion member may illustratively have peaks and channels formed between adjacent peaks which cooperate with the filter to create trapping pockets that capture embolic debris. The filter may be made from any flexible and porous material with dimensions to pass the fluid and block the emboli. The perfusion member is thereafter deflated to provide for emboli retention in the perfusion member.

Abstract: A method for medical balloon fabrication comprising the steps of securing a balloon with a mold by inflating it and then enlarging the inner diameter of the balloon. The devices of the invention comprise a fixture with a mold configured to hold the inflated balloon and a drill that can be centered with the mold to enlarge the inner diameter of the balloon.

Abstract: A catheter apparatus includes a lesion dilating member disposable at a lesion position in a vessel (e.g. a patient's artery) which is dilatable to open the vessel at the lesion position. An emboli-capturing assembly having a perfusion member and filter is displaced downstream from the lesion dilating member to capture embolic debris released in the fluid flow. The perfusion member may illustratively have peaks and channels formed between adjacent peaks which cooperate with the filter to create trapping pockets that capture embolic debris. The filter may be made from any flexible and porous material with dimensions to pass the fluid and block the emboli. The perfusion member is thereafter deflated to provide for emboli retention in the perfusion member.

Abstract: A system used in a blood vessel when an interventional procedure is being performed in a stenosed or occluded region, which is capable of treating an entire affected area in a blood vessel while preventing adverse effects for healthy tissue. The system includes a catheter which is positionable in a blood vessel at the interventional procedure site. The system further includes an expandable interventional instrument such as an expandable stent which is expandable and which may be deployed in the blood vessel at the interventional procedure site, which includes an unexpanded axial dimension. The system also includes an expandable member such as an expandable balloon, for expanding the expandable stent. The expandable balloon is capable of expanding so as to expand and deploy the expandable stent, and to substantially retain the unexpanded axial dimension of the expandable stent.

Abstract: A catheter system for removably securing a stent which generally includes an inner tubular member and an outer tubular member with an expandable member disposed about the inner tubular member. A foamed cover is disposed between the expandable member and the inner tubular member. An expandable stent is crimped onto the expandable member and is retained in place by compressing the foamed cover. Used with a stent delivery system, the catheter system is inserted into a body lumen such as an artery. The stent is secured in place while advancing the system through tortuous body lumen passages. The stent is advanced to the desired location in the body lumen and implanted by inflating the expandable member and thereby expanding the stent into the body lumen. The stent is released from the system by deflating the expandable member and withdrawing the catheter system from the body.

Abstract: The present invention is directed to apparatus and method for forming balloons with improved dimensional stability and balloons formed by the same. The method of the present invention provides for a very accurate control of the temperature profile of the balloon material during its making. The attributes of the balloon can be affected by how the balloon is treated during the blowing stage and after the initial blowing, i.e., heat-setting. Using the present method, the balloon will form more uniformly and evenly (e.g., wall thickness and outer diameter of the balloon). The present method significantly increases the dimensional stability of the balloon which provides a balloon that is more predictable in use. The present heat-set process also provides the means for the working length to be located more accurately on dilation catheters and stent delivery systems.

Abstract: The present invention includes a stent. The stent comprises a structural support and a polymeric film or sheet or tube that overlays the structural support. The stent also includes a tacky portion that adheres the polymeric film or sheet or tube to the structural support. The tacky portion comprises sugar or starch or polyvinylalcohol or degradation products of these materials.