Abstract: The disclosed subject matter describes systems and methods of delivering a therapeutic agent, such as a sclerosing agent, to the walls of a blood vessel to perform sclerotherapy. In an exemplary embodiment a catheter includes a balloon having an inner and outer surface defining a wall, and an interior volume with an unexpanded and expanded configuration and a plurality of fibers extending from the outer surface of the balloon wall. In another exemplary embodiment, a balloon catheter comprises a catheter having a balloon with an unexpanded and an expanded configuration, and a retractable sheath disposed on the exterior surface of the balloon, wherein the sheath has an inner surface and an outer surface, and further wherein a plurality of fibers outwardly extend from the outer surface of the sheath.

Abstract: An endoprosthesis for treating a bifurcated lumen. The distal end of the endoprosthesis can include at least two wings and at least two troughs so the endoprosthesis can adequately scaffold the ostium of a bifurcated lumen by at least partially straddling the carina of the lumen bifurcation. The distal end of the endoprosthesis can also be configured to have increased expandability to help allow conformity to the anatomy of a bifurcated lumen.

Abstract: The disclosed subject matter describes systems and methods of electrospinning a fiber for a variety of applications. An exemplary embodiment includes a medical device application for delivering a therapeutic agent, such as a sclerosing agent, to the walls of a blood vessel to perform sclerotherapy. A method of fabricating a medical balloon comprises charging a polymer material with an electric voltage, dispensing the charged polymeric material through a nozzle, collecting the charged polymeric material on a grounded mandrel, wherein the mandrel includes a tubular body having a plurality of openings extending through the tubular body, and forming an electrospun medical balloon defined by a body having a varied thickness.

Abstract: Device shields for packaging and protecting medical devices during storage and deployment. A device shield includes a housing configured to maintain a medical device and at least a portion of a medical device delivery apparatus within the housing, and a limit element having a first constraining position and a second open position.

Abstract: Apparatus and methods are disclosed for supporting ischemic tissue of the heart using scaffolds that may be placed within the heart percutaneously. A scaffold assembly may include a layer of biocompatible material detachably secured to a placement rod, such that the placement rod may be used to urge the layer of biocompatible material through a catheter to adjacent an area of ischemic tissue. Anchors may secure the layer of material to the myocardium. Multiple layers of biocompatible material may be placed in the ventricle separately to form the scaffold. In some embodiments, a scaffold is formed or reinforced by injecting a polymer, such as a visco-elastic foam, around an inflatable member inflated within a ventricle.

Abstract: The disclosed subject matter describes systems and methods of delivering a therapeutic agent, such as a sclerosing agent, to the walls of a blood vessel to perform sclerotherapy. In an exemplary embodiment a catheter includes a balloon having an inner and outer surface defining a wall, and an interior volume with an unexpanded and expanded configuration and a plurality of fibers extending from the outer surface of the balloon wall. In another exemplary embodiment, a balloon catheter comprises a catheter having a balloon with an unexpanded and an expanded configuration, and a retractable sheath disposed on the exterior surface of the balloon, wherein the sheath has an inner surface and an outer surface, and further wherein a plurality of fibers outwardly extend from the outer surface of the sheath.

Abstract: The disclosed subject matter describes systems and methods of electrospinning a fiber for a variety of applications. An exemplary embodiment includes a medical device application for delivering a therapeutic agent, such as a sclerosing agent, to the walls of a blood vessel to perform sclerotherapy. A method of fabricating a medical balloon comprises charging a polymer material with an electric voltage, dispensing the charged polymeric material through a nozzle, collecting the charged polymeric material on a grounded mandrel, wherein the mandrel includes a tubular body having a plurality of openings extending through the tubular body, and forming an electrospun medical balloon defined by a body having a varied thickness.

Abstract: Systems and methods are disclosed for reinforcing ischemic tissue of a heart. A reinforcing element is initially positioned within a lumen of a delivery needle. The delivery needle is urged into the ischemic tissue and the reinforcing element is urged out of the needle into the ischemic tissue. The reinforcing element may be embodied as a coiled, undulating, or arcuate spring and may include a shape-memory material. A bioabsorbable material may maintain the reinforcing element in a deformed state. The reinforcing element may be tensioned as it is positioned within the myocardium in order to provide a cinching force by means of a cord lock selectively releasing the reinforcing element. The reinforcing element may be embodied as a number of spiral portions secured to a hub and urged outwardly by rotation of the hub.

Abstract: Device shields for packaging and protecting medical devices during storage and deployment. A device shield includes a body or housing configured to maintain a medical device and at least a portion of a medical device delivery apparatus within the body or housing, and a limit element having a first constraining position and a second open position.

Abstract: Apparatus and methods are disclosed for supporting ischemic tissue of the heart using scaffolds that may be placed within the heart percutaneously. A scaffold assembly may include a layer of biocompatible material detachably secured to a placement rod, such that the placement rod may be used to urge the layer of biocompatible material through a catheter to adjacent an area of ischemic tissue. Anchors may secure the layer of material to the myocardium. Multiple layers of biocompatible material may be placed in the ventricle separately to form the scaffold. In some embodiments, a scaffold is formed or reinforced by injecting a polymer, such as a visco-elastic foam, around an inflatable member inflated within a ventricle.

Abstract: An endoprosthesis for treating a bifurcated lumen. The distal end of the endoprosthesis can include at least two wings and at least two troughs so the endoprosthesis can adequately scaffold the ostium of a bifurcated lumen by at least partially straddling the carina of the lumen bifurcation. The distal end of the endoprosthesis can also be configured to have increased expandability to help allow conformity to the anatomy of a bifurcated lumen.

Abstract: Device shields for packaging and protecting medical devices during storage and deployment. A device shield includes a housing configured to maintain a medical device and at least a portion of a medical device delivery apparatus within the housing, and a limit element having a first constraining position and a second open position.

Abstract: The invention is directed to a catheter assembly and the method for forming the same. The catheter includes an elongated shaft having proximal and distal sections, and further includes an inflatable balloon on a portion of the distal shaft section and in surrounding relation thereto. The balloon has proximal and distal tapered regions and an intermediate region longitudinally disposed therebetween. The proximal and distal tapered regions each has a first end adjacent the intermediate region and a second end opposite the first end. The wall thickness of the proximal and distal tapered regions, may, increase from the first end to the second end. A fluid-tight bond is formed between the catheter shaft and at least a section of at least one of the proximal and distal tapered regions at the second end thereof. The bond is preferably a fusion bond. At least a portion of the either or both the proximal and distal tapered regions in the bond interface is at least partially crystalline.

Abstract: A balloon catheter system generally having an elongated catheter shaft with enhanced flexibility to facilitate more distal advancement within a patient's body lumen. The catheter shaft has a relatively stiff proximal shaft section, a relatively flexible distal shaft section and an intermediate shaft section which provides a smooth, flexible transition between the proximal and distal shaft sections. The intermediate shaft section has an improved construction with a tubular reinforcing member secured by its proximal end to the distal extremity of the proximal shaft section and a distal end secured within the proximal end of the distal shaft section. The tubular reinforcing member preferably has an inner tubular support member which has a proximal end secured to the distal end of the proximal shaft section. Preferably, the proximal shaft section has an outer jacket which extends over the tubular reinforcing member of the intermediate shaft section.

Abstract: The invention is directed to a catheter assembly and the method for forming the same. The catheter includes an elongated shaft having proximal and distal sections, and further includes an inflatable balloon on a portion of the distal shaft section and in surrounding relation thereto. The balloon has proximal and distal tapered regions and an intermediate region longitudinally disposed therebetween. The proximal and distal tapered regions each has a first end adjacent the intermediate region and a second end opposite the first end. The wall thickness of the proximal and distal tapered regions, may, increase from the first end to the second end. A fluid-tight bond is formed between the catheter shaft and at least a section of at least one of the proximal and distal tapered regions at the second end thereof. The bond is preferably a fusion bond. At least a portion of the either or both the proximal and distal tapered regions in the bond interface is at least partially crystalline.

Abstract: The invention is generally directed to an intraluminal catheter systems including an elongated shaft having proximal and distal shaft sections, and an inflatable member disposed on the distal shaft section and having an interior chamber. A guidewire receiving lumen extends along at least a portion of the proximal shaft section and at least a portion of the distal shaft section and extends distally to the shaft distal end. An inflation lumen extends along at least a portion of the proximal shaft section and at least a portion of the distal shaft section to a point proximal to a shaft distal end and is in fluid communication with the inflatable member interior chamber. The proximal shaft section has multiple non-concentric lumens with at least one lumen forming at least a portion of the guidewire receiving lumen and at least one lumen forming at least a portion of the inflation lumen.

Abstract: The invention is generally directed to an intraluminal catheter systems including an elongated shaft having proximal and distal shaft sections, and an inflatable member disposed on the distal shaft section and having an interior chamber. A guidewire receiving lumen extends along at least a portion of the proximal shaft section and at least a portion of the distal shaft section and extends distally to the shaft distal end. An inflation lumen extends along at least a portion of the proximal shaft section and at least a portion of the distal shaft section to a point proximal to a shaft distal end and is in fluid communication with the inflatable member interior chamber. The proximal shaft section has multiple non-concentric lumens with at least one lumen forming at least a portion of the guidewire receiving lumen and at least one lumen forming at least a portion of the inflation lumen.

Abstract: The invention is directed to a method of forming a distal tip on a catheter. The method includes defining an area on the distal end of a polymeric tube, creating at least one void by removing at least some of the material within the area, and sealing the cut edge closed. The area is defined by a boundary, which includes a first location on the distal tip, a second location on the distal tip radially spaced apart from the first location, and a third location proximal to the distal tip. The preferred area is a cut having a V-shape. This method creates a superior catheter tip profile, specifically for soft tips.

Abstract: A balloon catheter system generally having an elongated catheter shaft with enhanced flexibility to facilitate more distal advancement within a patient's body lumen. The catheter shaft has a relatively stiff proximal shaft section, a relatively flexible distal shaft section and an intermediate shaft section which provides a smooth, flexible transition between the proximal and distal shaft sections. The intermediate shaft section has an improved construction with a tubular reinforcing member secured by its proximal end to the distal extremity of the proximal shaft section and a distal end secured within the proximal end of the distal shaft section. The tubular reinforcing member preferably has an inner tubular support member which has a proximal end secured to the distal end of the proximal shaft section. Preferably, the proximal shaft section has an outer jacket which extends over the tubular reinforcing member of the intermediate shaft section. Dual lumen and concentric distal shaft sections are describes.

Abstract: A balloon catheter system generally having an elongated catheter shaft with enhanced flexibility to facilitate more distal advancement within a patient's body lumen. The catheter shaft has a relatively stiff proximal shaft section, a relatively flexible distal shaft section and an intermediate shaft section which provides a smooth, flexible transition between the proximal and distal shaft sections. The intermediate shaft section has an improved construction with a tubular reinforcing member secured by its proximal end to the distal extremity of the proximal shaft section and a distal end secured within the proximal end of the distal shaft section. The tubular reinforcing member preferably has an inner tubular support member which has a proximal end secured to the distal end of the proximal shaft section. Preferably, the proximal shaft section has an outer jacket which extends over the tubular reinforcing member of the intermediate shaft section.