Inflatable medical devices and methods for making and using the same are disclosed. The devices can be medical invasive balloons, such as those used for transcutaneous heart valve implantation, such as balloons used for transcatheter aortic-valve implantation. The balloons can have high strength, fiber-reinforced walls.

A bioprosthetic valve for repairing a deep venous insufficiency in a subject includes a single leaflet from a xenogeneic heart valve attached at natural margins of attachment to a patch of valve wall tissue. The patch may extend axially above and below the leaflet and circumferentially on either side of the leaflet to provide a region for attaching the patch to a fenestration in a host vein. A bioprosthetic valve may be manufactured by excising a portion of a xenogeneic heart valve including a single leaflet and contiguous wall tissue, and may further comprise shaving off excess leaflet tissue from adjacent leaflets. A method of replacing a malfunctioning venous valve in a subject includes providing a bioprosthetic valve as described above and inserting it to the host vein.

Prosthetic ring valve assemblies are disclosed. A prosthetic valve ring assembly includes an outer tube and a plurality of anchors. The outer tube includes a plurality of windows. The plurality of anchors are positioned inside the outer tube and about a perimeter of the outer tube. The plurality of anchors are configured to be emitted from the plurality of windows in order to anchor the prosthetic valve ring assembly to annulus tissue of a patient.

Systems, devices and methods for repairing a native heart valve. In one embodiment, a repair device for repairing a native mitral valve having an anterior leaflet and a posterior leaflet between a left atrium and a left ventricle comprises a support having a contracted configuration and an extended configuration, and an appendage, such as a flap or apron extending from the support. In the contracted configuration, the support is sized to be inserted under the posterior leaflet between a wall of the left ventricle and chordae tendineae. In the extended configuration, the support is configured to project anteriorly with respect to a posterior wall of the left ventricle by a distance sufficient to position at least a portion of the posterior leaflet toward the anterior leaflet, and the appendage is configured to extend beyond an edge of the posterior leaflet toward the anterior leaflet.

Suture locking clamps for securing prostheses such as heart valves or annuloplasty rings with sutures and without using knots improve the ease of implantation. The clamps have opposed clamp halves separated by a slot opening to one side and surrounded by a biasing member such as one or more C-clip springs. Sutures pass laterally into the slot which is held open by a retention member positioned between the clamp halves. The locking clamp slides along the sutures into position, the tension of the sutures is adjusted, and the retention member removed to allow the biasing member to clamp the sutures between the clamp halves. A delivery tool used to deliver and deploy the locking clamps contains a number of clamps within a delivery tube in a stack and bonded together for safety and a common retention member. The tool has a longitudinal channel on one side for entry of sutures.

A method for manufacturing a personalized naturally designed mitral valve prosthesis to precisely fit a specific patient for which the valve prosthesis is made for is provided. The method includes measuring size and shape of a mitral valve of the specific patient by using imaging methods, calculating geometry and dimensions of annular ring, leaflets and chords per the specific patient based on validated algorithms, and cutting and connecting the annular ring, leaflets and chords to form a personalized prosthesis mitral valve.

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.

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.

An active annuloplasty ring holder having a template that can be folded or pivoted to the side allowing the template to align longitudinally with the handle and enter the patient's chest through a small incision. The holder may include a mechanism to remotely detach sutures fastening the ring to the holder, thereby detaching the ring while avoiding the risk associated with introducing a scalpel into the operating field. A detachment mechanism may include a movable pin actuated by a pull wire that releases a plurality of holding sutures, or a hot wire, knives, or pull wire that severs the sutures. The holder may have a built-in light source for better visualization of the ring inside the heart. The holder may also have an optical means of visualizing the inside of the heart from the proximal end of the handle.

A prosthetic heart valve configured to replace a native heart valve and having a support frame configured to be reshaped into an expanded form in order to receive and/or support an expandable prosthetic heart valve therein is disclosed, together with methods of using same. The prosthetic heart valve may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace a native valve (or other prosthetic heart valve), but to assume a generally expanded form when subjected to an outward force such as that provided by a dilation balloon or other mechanical expander.