TECHNICAL FIELD

The present disclosure pertains to medical devices and methods for manufacturing and/or using medical devices. More particularly, the present disclosure pertains to configurations of a replacement heart valve implant.

BACKGROUND

A wide variety of intracorporeal medical devices have been developed for medical use, for example, surgical and/or intravascular use. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., for stents, grafts, replacement valves, occlusive devices, etc.), and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and/or using medical devices.

SUMMARY

In a first aspect, a seal member for use with a replacement heart valve implant may comprise a tubular polymeric seal element configured to be disposed on an outer surface of a replacement heart valve implant, the tubular polymeric seal element defining a central longitudinal axis; and a reinforcement strip fixedly attached to the tubular polymeric seal element proximate a first end of the tubular polymeric seal element, the reinforcement strip extending circumferentially around the central longitudinal axis. The reinforcement strip may include a radiopaque element extending circumferentially around the central longitudinal axis.

In addition or alternatively, and in a second aspect, the radiopaque element is at least partially embedded in the reinforcement strip.

In addition or alternatively, and in a third aspect, radiopaque element includes a polyurethane spray coating doped with radiopaque nanoparticles.

In addition or alternatively, and in a fourth aspect, the polyurethane spray coating is disposed on the reinforcement strip.

In addition or alternatively, and in a fifth aspect, the polyurethane spray coating is intermingled with the reinforcement strip.

In addition or alternatively, and in a sixth aspect, the radiopaque nanoparticles include one or more of the following: tungsten, platinum, tantalum, cobalt, chromium, nickel, titanium, gold, and palladium.

In addition or alternatively, and in a seventh aspect, the reinforcement strip is formed from an electrospun polyester matrix doped with radiopaque nanoparticles.

In addition or alternatively, and in an eighth aspect, the reinforcement strip is formed from a chopped radiopaque fiber-polyurethane matrix.

In addition or alternatively, and in a ninth aspect, a replacement heart valve implant may comprise a tubular metallic support structure defining a central longitudinal axis; a plurality of valve leaflets disposed within the tubular metallic support structure; and a seal member comprising a tubular polymeric seal element disposed on an outer surface of the tubular metallic support structure and a reinforcement strip fixedly attached to the tubular polymeric seal element proximate a first end of the tubular polymeric seal element, the reinforcement strip extending circumferentially around the central longitudinal axis at an inflow end of the tubular metallic support structure. The reinforcement strip may include a radiopaque element extending circumferentially around the central longitudinal axis.

In addition or alternatively, and in a tenth aspect, the reinforcement strip is fixedly attached to the inflow end of the tubular metallic support structure.

In addition or alternatively, and in an eleventh aspect, the tubular metallic support structure is configured to shift between a collapsed delivery configuration and an expanded deployed configuration.

In addition or alternatively, and in a twelfth aspect, an overall length of the tubular metallic support structure in the expanded deployed configuration is less than in the collapsed delivery configuration.

In addition or alternatively, and in a thirteenth aspect, the seal member is configured to engage and seal against an annulus of a native heart valve in the expanded deployed configuration.

In addition or alternatively, and in a fourteenth aspect, the reinforcement strip includes a scalloped downstream edge.

In addition or alternatively, and in a fifteenth aspect, the radiopaque element extends completely around the central longitudinal axis.

In addition or alternatively, and in a sixteenth aspect, a method of locating a replacement heart valve implant during an implantation procedure may comprise advancing the replacement heart valve implant through a vasculature toward a native heart valve in a delivery configuration, the replacement heart valve implant comprising an expandable tubular support structure defining a central longitudinal axis, a plurality of valve leaflets disposed within the tubular support structure, and a seal member comprising: a tubular polymeric seal element disposed on an outer surface of the tubular support structure and a reinforcement strip fixedly attached to the tubular polymeric seal element proximate a first end of the tubular polymeric seal element, the reinforcement strip extending circumferentially around the central longitudinal axis at an inflow end of the tubular support structure. The reinforcement strip may include a radiopaque element extending circumferentially around the central longitudinal axis in a first plane. The method may further comprise imaging the replacement heart valve implant within the vasculature and the native heart valve concurrently as the replacement heart valve implant approaches the native heart valve, wherein the imaging identifies a reference plane extending through an annulus of the native heart valve generally perpendicular to a direction of fluid flow through the native heart valve; and expanding the tubular support structure within the native heart valve with the first plane positioned substantially parallel to the reference plane and offset less than 4 mm from the reference plane.

In addition or alternatively, and in a seventeenth aspect, the first plane is offset less than 2 mm from the reference plane.

In addition or alternatively, and in an eighteenth aspect, the first plane is positioned substantially coplanar with the reference plane.

In addition or alternatively, and in a nineteenth aspect, the radiopaque element includes radiopaque nanoparticles embedded in the reinforcement strip.

In addition or alternatively, and in a twentieth aspect, the reinforcement strip is fixedly attached to tubular support structure at the inflow end.

The above summary of some embodiments, aspects, and/or examples is not intended to describe each embodiment or every implementation of the present disclosure. The figures and the detailed description which follows more particularly exemplify these embodiments.

