Abstract: A device and method for compressing a renal artery prior to delivery of radiofrequency ablative energy to the renal nerves. The device includes a stent structure with a focal region that expands outwards to place the RF electrodes located on the stent structure in close proximity to the renal nerves. A covering is applied to the stent structure to prevent intimal hyperplasia.

Abstract: Anatomical wall crossing systems, devices and related methods are disclosed in this patent document. A transseptal system, for example, can include a guidewire, a dilator, and a deflectable sheath configured to safely deliver a puncture needle through a septal wall associated with the fossa ovalis and into a central region of the left atrium of a heart. The dilator can include a dilator nose having a first outer diameter and a dilator beveled segment, extending proximal of the dilator nose, tapering from a second, greater outer diameter to the first outer diameter. The length and interplay of the puncture needle and the dilator nose can be configured such that the puncture needle is inhibited from bending and impinging upon the left side of the atrial septum of the heart during use. A body of the guidewire can include at least one loop segment to provide stable support in the left atrium for delivery of a diagnostic or therapeutic device along its more proximal portions.

Abstract: A head covering to reduce the force from an external surface on the head of an individual. The head covering is formed from thin polymeric tubes that are inflated by blowing via lung exhalation. The head covering is light weight and can be folded into a small in volume such that it is easily carried in a shirt or pant pocket.

Abstract: A method for transcatheter delivery to a native heart valve needing replacement. A first component is attached to the native annulus upstream of the native leaflets maintaining native leaflet function, and is held to the native annulus by barbs that are activated by a torus balloon after the first component is fully expanded. The torus balloon can be implanted along with the support frame. A limiting cable restricts further expansion of the first component and holds a second component that contains the replacement leaflets.

Abstract: A method for providing blood flow across a surface of a mitral stent-valve frame. A portion of the stent-valve frame is placed into the left atrium and into the left ventricle with a securement band located intermediate that is attached to either the annulus or to a second support frame that is placed initially and above the mitral annulus without affecting native leaflet function. Portions of the frame above the securement band allow blood flow radially inwards to reduce stagnation regions in the atrium or outwards below the securement band to help cleanse native leaflets.

Abstract: A method for placing a transcatheter stent-valve having replacement leaflets that are attached along their free edges. The stent-valve frame has supports that extend distally of the replacement leaflets to fastening sites. The replacement leaflets are attached along a leaflet base forming a linear attachment to the stent-valve frame. The free edges of the leaflets have cords attached; the cords attach the leaflets to the supports. The stent-valve can be a single component stent-valve or it can be a second component that attaches to a first component or dock.

Abstract: An occlusion device intended for blocking perivalvular leak channels that are found following heart valve implantation between the heart valve and the surrounding tissue. The occlusion device has a stent and a covering that is attached to the stent surface. A blocking fabric extends across the lumen of the stent to block blood flow. The stent pattern and wall structure provide for small radius of curvature bends to fill narrow channels that cause the perivalvular leaks.

Abstract: A method for transcatheter delivery to a native heart valve needing replacement. A first component is attached to the native annulus upstream of the native leaflets maintaining native leaflet function, and is held to the native annulus by barbs that are activated by a torus balloon after the first component is fully expanded. The torus balloon can be implanted along with the support frame. A limiting cable restricts further expansion of the first component and holds a second component that contains the replacement leaflets.

Abstract: Disclosed are a puncture sealing system and methods of locating a depth of an arteriotomy. The systems can include elongated catheters that are configured to identify the depth within a vessel so that the depth relative to a distal end of the catheter is known during or after a puncture sealing procedure.

Abstract: A method for providing blood flow across a surface of a mitral stent-valve frame. A portion of the stent-valve frame is placed into the left atrium and into the left ventricle with a securement band located intermediate that is attached to either the annulus or to a second support frame that is placed initially and above the mitral annulus without affecting native leaflet function. Portions of the frame above the securement band allow blood flow radially inwards to reduce stagnation regions in the atrium or outwards below the securement band to help cleanse native leaflets.

Abstract: Pigtail catheters and relates methods for measuring a pressure gradient across a bodily narrowing are disclosed. A pigtail catheter can comprise a proximal shaft segment and a distal shaft segment. The proximal shaft segment can include double lumen tubing defining a proximal pressure lumen and a non-coaxial, distal pressure lumen. In an example, the distal pressure lumen has a generally circular cross-sectional shape, and the proximal pressure lumen has a generally crescent or kidney cross-sectional shape that wraps partially around the distal pressure lumen. The distal shaft segment can include at least one distal orifice positionable distal to the bodily narrowing and at least one proximal orifice positionable proximal to the bodily narrowing. Each orifice can have a diameter of at least about 0.018 inches, for example.

Abstract: A transcatheter stent-valve having replacement leaflets that are attached along their free edges. The stent-valve frame has supports that extend distally of the replacement leaflets to two fastening sites. The replacement leaflets are attached along a leaflet base forming a linear attachment to the stent-valve frame. The free edges of the leaflets have cords attached; the cords attach the free edges of the leaflets to the fastening sites located on the supports. The stent-valve can be a single component stent-valve or it can be a second component of a dual component stent-valve.

Abstract: A mitral valve system comprising a first docking component and a second valvular component that are delivered via a single delivery catheter. The first component is located distal to the second component and provides a detachable rail to allow the second component to accurately position and lock with the first component. The first component has fixation members that are activated by either by a torus balloon or via fiber that does not restrict blood flow during delivery or during fixation member activation.

Abstract: A head covering to reduce the force from an external surface on the head of an individual. The head covering is formed from thin polymeric tubes that are inflated by blowing via lung exhalation. The head covering is light weight and can be folded into a small in volume such that it is easily carried in a shirt or pant pocket.

Abstract: A device and method for compressing a renal artery prior to delivery of radiofrequency ablative energy to the renal nerves. The device includes a stent structure with a focal region that expands outwards to place the RF electrodes located on the stent structure in close proximity to the renal nerves. A covering is applied to the stent structure to prevent intimal hyperplasia.

Abstract: An implantable cardiac annulus support device formed from a Nitinol stent frame that expands into contact with the annulus above the native leaflets. A torus balloon activates fixation elements along the perimeter to fasten the stent frame to native tissues of the heart valve near the native annulus. The stent frame reduces in perimeter to reduce the perimeter of the annulus. A cinch ring placed under tension can reduce the perimeter of the stent frame.

Abstract: A device for compressing a renal artery prior to delivery of radiofrequency ablative energy to the renal nerves. The device includes a stent structure with a focal region that expands outwards to place the RF electrodes located on the stent structure in close proximity to the renal nerves. A covering is applied to the stent structure to prevent intimal hyperplasia.

Abstract: A method for providing blood flow across a surface of a mitral stent-valve frame. A portion of the stent-valve frame is placed into the left atrium and into the left ventricle with a securement band located intermediate that is attached to either the annulus or to a second support frame that is placed initially and above the mitral annulus without affecting native leaflet function. Portions of the frame above the securement band allow blood flow radially inwards to reduce stagnation regions in the atrium or outwards below the securement band to help cleanse native leaflets.

Abstract: An annuloplasty device formed from a Nitinol stent frame that expands into contact with the annulus above the native leaflets. A torus balloon activates barbs along the perimeter to fasten the stent frame to the annulus. A cinch ring is placed under tension to reduce the perimeter of the stent frame. The cinch ring and torus balloon are implanted along with the stent frame.

Abstract: A two component system for replacing mitral valves using a transcatheter approach. The first component uses a torus balloon to activate barbs into the mitral annulus after the first component stent frame has been delivered. A closed ring in the first component provides a landing site for delivery of a second component that contains replacement leaflets. The second component straddles the mitral annulus such that impingement upon the left ventricular outflow track does not occur. The second component frame contains open regions that help to prevent blood stagnation.