Disclosed herein are delivery systems and delivery assemblies comprising a co-extruded elongated polymeric sleeve comprising an inner polymer layer and an outer polymer layer, which form two lumens having a different diameter, wherein the inner polymer layer comprises a fluoropolymer; and wherein the outer polymer layer comprises a polyamide, or a polyether block amide, or a combination thereof. Also disclosed are methods of making and using the same.

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 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 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.

The present disclosure includes a device for reshaping a heart valve. The device may include a central ring about a central axis and a plurality of arms coupled to the central ring, each of the arms coupled to the central ring at a pivot point at a first end of the arm, the arm comprising an attachment feature at a second point along the arm, the pivot point configured to allow movement of the arm about the pivot point through a plane extending radially from the central axis through the arm. Additionally, the plurality of arms may be contractable and may be extendable such that the hooks extend beyond a dilated heart valve. The present disclosure also includes associated methods and systems.

The present disclosure includes a device for reshaping a heart valve. The device may include a central ring about a central axis and a plurality of arms coupled to the central ring, each of the arms coupled to the central ring at a pivot point at a first end of the arm, the arm comprising an attachment feature at a second point along the arm, the pivot point configured to allow movement of the arm about the pivot point through a plane extending radially from the central axis through the arm. Additionally, the plurality of arms may be contractable and may be extendable such that the hooks extend beyond a dilated heart valve. The present disclosure also includes associated methods and systems.

The disclosure provides insertion tools and articles that facilitate entry of a medical device, such as a balloon catheter, into the body. In embodiments the insertion tools have an elongate hollow body (50) that is able to protect a portion of a medical device, such as a balloon of a balloon catheter, during an insertion procedure. In one embodiment the insertion tool has an elongate hollow body (131), a tapered distal end (135), and a locking mechanism (133) at the proximal end which can secure a portion of a balloon catheter. An opening at the distal end can allow passage of the balloon in a folded uninflated state.

A constricting cord can be delivered to the vicinity of an annulus using an apparatus that includes a set of support arms, with a respective anchor launcher supported by each of the support arms. An inflatable first balloon is configured to push the support arms away from each other when the first balloon is inflated. An inflatable second balloon is mounted to a shaft and is configured for inflation when the second balloon is disposed distally beyond the first balloon. In some embodiments, the distal balloon is inflated while it is in a ventricle. In some embodiments, the distal balloon is inflated while it is in a pulmonary artery.

A venous stent may be used to maintain or enhance patency of a blood vessel. By using multiple, separate stent elements that are balloon expandable, the multi-element stent may be stronger than a traditional self-expanding stent but may also be more flexible, due to its multiple-element configuration, than a traditional balloon-expandable stent. The stent elements are formed from a bioresorbable polymer material. The stent elements may have thick and/or wide struts and may be deployed oversized so as to overcome venous elastic recoil and anatomic compression.

Apparatus for progressively dilating the lumen of a narrow natural vessel such as an iliac artery and implanting a tubular device enabling access through the dilated lumen to conduct subsequent procedures via the dilated lumen, includes an inflatable integrated balloon locatable at least partially within the tubular device, the tubular device having a length L1 providing a self-expanding tubular body having at least a portion including stents, so that when the integrated balloon is removed the dilated lumen of the natural vessel remains dilated and supported by the tubular device.