Prosthesis Seals and Methods for Sealing an Expandable Prosthesis

Abstract

Embodiments of the present disclosure are related to devices and techniques for para-valve sealing of an expandable stent-valve implanted using a catheter. In some embodiments, a stent-valve is provided which comprises a seal sleeve/cuff containing material that swells when contacted by blood. A piercing tool may be included and used to permit a user to puncture the sleeve/cuff prior to introduction into a patient's body. In some embodiments, the sleeve/cuff has an integral tubular structure configured to withstand balloon expansion of the stent-valve during or after implantation.

Description

RELATED APPLICATIONS[0001]This application claims benefit under 35 U.S.C. §119(e) of U.S. provisional patent application No. 61 / 779,744, entitled, “Prosthesis Seals and Methods for Sealing and Expandable Prosthesis”, filed on Mar. 13, 2013, the entire disclosure of which is herein incorporated by reference.FIELD OF THE DISCLOSURE[0002]The present disclosure relates to the field of stents implantable in the body. Embodiments have been devised to address problems encountered in the field of stent-valves, for example cardiac stent-valves (e.g., prosthetic heart valves). However, the concepts disclosed herein may have broader application to any stent or stented prosthesis where a seal is desired at an exterior surface of a stent.BACKGROUND OF THE DISCLOSURE[0003]Transcatheter valve implantation (for example, transcatheter aortic valve implantation (TAVI)) is an evolving technology for replacement valve therapy that (i) avoids the trauma of conventional open-chest surgery, and (ii) avoid...

AI Technical Summary

Benefits of technology

[0042]In some embodiments, using an integral tubular structure for the sleeve/cuff may enable the sleeve/cuff to achieve the otherwise conflicting requirements of desirably thin wall thickness, and good strength against bursting. Risk of bursting is often highest at join-lines of non-integral structures. Forming an integral tubular structure reduces the need for extensive join lines, in particular, a join line extending circumferentially around the prosthesis (in some embodiments, substantially around).

[0043]In some embodiments, in which the stent-valve is configured to be expanded to an operative configuration by expansion by an inflatable expansion balloon, providing a stent-valve with a seal sleeve/cuff comprising an integral tubular structure may be highly advantageous in enabling the seal sleeve/cuff to made desirably thin, yet have good strength and resistance to bursting should the seal be subject to the forces applied during the balloon-expansion, especially against the irregular or sharp contours of a calcified native anatomy

[0044]Although not immediately intuitive, some embodiments of the present disclosure provide a technique of post-implantation balloon-expansion of an implanted prosthesis stent-valve carrying a swellable seal. Providing a stent-valve

Problems solved by technology

Despite the successes of transcatheter stent-valves, technological challenges remain.

One such challenge is preventing retrograde leakage of blood around the stent-valve (so called para-valve leakage).

Moreover, heavy calcification of the native anatomy may obstruct full deployment of any stent and make the native anatomy even more irregular.

Thus, it can sometimes be difficult to provide a perfectly sealing fit between the stent-valve and the surrounding anatomy.

Para-valve leakage is believed to be one of the factors affecting the long-term efficacy of the prosthetic

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