Abstract: A venous valve with a frame and a cover on the frame for unidirectional flow of a liquid through the valve.

Abstract: In one embodiment, a balloon catheter is provided for use during annuloplasty. Preferably, the balloon includes a distal, noncompliant portion and a proximal semi-compliant portion which allows for sequential inflation, reliable positioning, and compliance measurement.

Abstract: A balloon catheter is used for dilating tubular members of the body such as dilating stenotic aortic valve leaflets found in the aortic root, and measuring the shape and dimensions of the annulus. The balloon has two larger diameter bulbous regions; one is positioned in the left ventricular outflow tract (LVOT) and the other in the aortic sinus; a smaller diameter waist region is positioned across the aortic annulus. During inflation of the balloon, the balloon waist expands in diameter until it comes into contact with the aortic annulus. The balloon pressure and inflation volume is monitored during inflation so that an inflection point in the dP/dV curve is seen at the point of contact of the waist with the annulus. Radiopaque rings and/or marker bands in the device allow the size and orientation of the elliptical annulus to be calculated.

Abstract: A device is disclosed for providing an indication as to the relative position of a vessel or artery opening thereby facilitating the choice of which several closure techniques to use. A disclosed device includes an outer tube and a collapsible foot slidably disposed within a distal end of the outer tube. The device may further include one or more threaded suture needles, a biodegradable plug or other wound closing device that is connected to another shaft. The collapsed or folded foot is pushed distally out of the tube and through the opening in the vessel whereupon the foot expands. Pulling the expanded foot in the proximal direction provides an indication as to the orientation of the opening in the vessel, which assists in determining the type of closing procedure to be carried out.

Abstract: A balloon catheter is used for dilating tubular members of the body such as dilating stenotic aortic valve leaflets found in the aortic root, and measuring the shape and dimensions of the annulus. The balloon has two larger diameter bulbous regions; one is positioned in the left ventricular outflow tract (LVOT) and the other in the aortic sinus; a smaller diameter waist region is positioned across the aortic annulus. During inflation of the balloon, the balloon waist expands in diameter until it comes into contact with the aortic annulus. The balloon pressure and inflation volume is monitored during inflation so that an inflection point in the dP/dV curve is seen at the point of contact of the waist with the annulus. Radiopaque rings and/or marker bands in the device allow the size and orientation of the elliptical annulus to be calculated.

Abstract: A bulbous valvuloplasty balloon is described that maintains its bulbous shape in its final deployed configuration along with the method of use for post dilation of a TAVR device. The bulbous balloon has two larger diameter bulb segments located on each side of a smaller diameter waist and can be used to post dilate a TAVR device that has been implanted at the site of a stenotic aortic valve. The post dilation causes deformation of the underlying tissues residing outside of the TARV stent structure.

Abstract: A balloon catheter is used for dilating tubular members of the body such as dilating stenotic aortic valve leaflets found in the aortic root, and measuring the shape and dimensions of the annulus. The balloon has two larger diameter bulbous regions; one is positioned in the left ventricular outflow tract (LVOT) and the other in the aortic sinus; a smaller diameter waist region is positioned across the aortic annulus. During inflation of the balloon, the balloon waist expands in diameter until it comes into contact with the aortic annulus. The balloon pressure and inflation volume is monitored during inflation so that an inflection point in the dP/dV curve is seen at the point of contact of the waist with the annulus. Radiopaque rings and/or marker bands in the device allow the size and orientation of the elliptical annulus to be calculated.

Abstract: Various configurations of systems that employ leadless electrodes to provide pacing therapy are provided. In one example, a system that provides multiple sites for pacing of myocardium of a heart includes wireless pacing electrodes that are implantable at sites proximate the myocardium using a percutaneous, transluminal, catheter delivery system. Each of the electrodes contains a source of electrical energy for pacing the myocardium and is adapted to receive electromagnetic energy from a source outside the myocardium. The system also includes a source adapted for placement outside the myocardium and that uses locally measured electrocardiograms to synchronize pacing of the heart by sending electromagnetic commands to the electrodes to pace the myocardium surrounding the electrodes. Also disclosed is various configurations of such systems, wireless electrode assemblies, and delivery catheters for delivering and implanting the electrode assemblies.

Abstract: The invention is direction to an alignment apparatus comprising a central sheath, an alignment sheath, and at least one stent. The central sheath and the alignment sheath each have a wall and a distal end where the wall of the alignment sheath is engaged to the wall of the central sheath. The wall of the central sheath defines a central lumen that has a central guide wire extending therethrough and the wall of the alignment sheath defines an alignment lumen that has an alignment guide wire extending therethrough. The distal end of the alignment sheath is positioned proximally to the distal end of the central sheath. The alignment apparatus has at least one stent disposed about one of the alignment guide wire or the central guide wire. The at least one stent has a pre-delivered state so that when the at least one stent is in the pre-delivered state, it is contained within at least one of the central sheath and the alignment sheath.

Abstract: A filter system, comprising an elongate filter body defining a lumen and having a proximal end and a distal end. A valve can be provided defining a lumen and having a reversibly sealable opening for unidirectional flow of a fluid through the lumen. The valve can be adjoined proximal the distal end of the elongate filter body, wherein the elongate filter body filters the unidirectional flow of the fluid passing through the lumen of the valve and the lumen of the elongate filter body.

Abstract: A balloon catheter is used for dilating tubular members of the body such as dilating stenotic aortic valve leaflets found in the aortic root, and measuring the shape and dimensions of the annulus. The balloon has two larger diameter bulbous regions; one is positioned in the left ventricular outflow tract (LVOT) and the other in the aortic sinus; a smaller diameter waist region is positioned across the aortic annulus. During inflation of the balloon, the balloon waist expands in diameter until it comes into contact with the aortic annulus. The balloon pressure and inflation volume is monitored during inflation so that an inflection point in the dP/dV curve is seen at the point of contact of the waist with the annulus. Radiopaque rings and/or marker bands in the device allow the size and orientation of the elliptical annulus to be calculated.

Abstract: A cardiac valve with a support frame having a first end member and a second end member opposing the first end member in a substantially fixed distance relationship, and a cover extending over the support frame to allow for unidirectional flow of a liquid through the valve.

Abstract: A measuring balloon has an inner bulbous balloon formed from a non-compliant or semi-compliant material and has a central smaller diameter inner waist and two larger diameter bulbs on each side of the inner waist. A compliant outer waist bladder is located on the outside of the inner bulbous balloon adjacent to the inner waist and is inflated via a separate inflation lumen. The inner balloon is inflated at a higher pressure to dilate stenotic aortic valve leaflets, and provide alignment and positioning of the measuring balloon across the aortic annulus. The bladder waist is inflated to a lower pressure to make contact with the aortic valve annulus. Marker bands positioned on the outside of the measuring balloon provide determination of annulus diameter and ovality.

Abstract: A thrombectomy system may include an elongate shaft that defines a high pressure lumen and a low pressure lumen. The high pressure lumen may terminate near an end of the low pressure lumen. An expandable capture basket may be disposed near the end of the low pressure lumen. A thrombectomy apparatus may include an elongate shaft, an evacuation lumen extending within the elongate shaft and a high pressure lumen extending within the elongate shaft. A capture apparatus may be disposed within a wire lumen that extends within the elongate shaft such that the capture apparatus extends distally from the wire lumen.

Abstract: A cardiac valve with a support frame having a first end member and a second end member opposing the first end member in a substantially fixed distance relationship, and a cover extending over the support frame to allow for unidirectional flow of a liquid through the valve.

Abstract: Apparatuses, systems, and methods for use in a vascular system. The apparatus include a circulatory valve having a valve frame in which frame members define frame cells. Frame cells include joints in opposing relationship, where the joints transition from a first stable equilibrium state through an unstable equilibrium state to a second stable equilibrium state as the joints are drawn towards each other.

Abstract: A thrombectomy system may include an elongate shaft that defines a high pressure lumen and a low pressure lumen. The high pressure lumen may terminate near an end of the low pressure lumen. An expandable capture basket may be disposed near the end of the low pressure lumen. A thrombectomy apparatus may include an elongate shaft, an evacuation lumen extending within the elongate shaft and a high pressure lumen extending within the elongate shaft. A capture apparatus may be disposed within a wire lumen that extends within the elongate shaft such that the capture apparatus extends distally from the wire lumen.

Abstract: Embodiments for a device, system and method for occluding an opening in a septum. Embodiments of the device can include a first control component, a first elongate member that extends from the first control component, a second elongate member, a connecting member that positions the first elongate member adjacent the second elongate member and a retraction member releasably coupled to the first control component. The retraction member can be used to change a relative position of the first elongate member and the second elongate member of the device.

Abstract: Apparatuses, systems, and methods for use in a vascular system. The apparatus include a circulatory valve having a valve frame in which frame members define frame cells. Frame cells include joints in opposing relationship, where the joints transition from a first stable equilibrium state through an unstable equilibrium state to a second stable equilibrium state as the joints are drawn towards each other.

Abstract: An apparatus and method for closing an opening in a blood vessel wall is disclosed. The apparatus includes at least one member which is extended through a tissue tract formed through the epidermis and subcutaneous layer of skin and through the opening in the blood vessel. The member includes a proximal end and a distal end with the distal end being positionable proximate to the opening in the blood vessel wall. A positive electrode is positioned next to the distal end with a negative electrode being positioned next to the proximal end When the electrodes are energized an electric field is created therebetween, blood cells are attracted to the positive electrode, and a thrombus is formed at the opening in the blood vessel wall. The member may include a balloon at the distal end to temporarily occlude blood flow from the blood vessel to the tissue tract to facilitate formation of the thrombus.