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

This patent describes a device that can hold swellable material and allow it to expand and contract. The device has a hollow space or multiple pouches for the material. The pouches can communicate with each other or be closed. The pouches can also have internal partitions that allow for limited movement of the material between them. The device can be implanted without needing to break open the pouch. The material can be exposed to liquid while being constrained from expanding, which makes it easier to use in the body. Overall, this device helps to control the expansion of swellable material in a safe and effective way.

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 valve, and possibly the life expectancy of the patient.

Therefore, addressing para-valve leakage is a significant challenge.

However, a disadvantage is that such skirts add to the bulk of the stent-valve.

A thick skirt makes the stent-valve problematic to compress to a desirably small size for implantation.

While different arrangements of dispensing capsules are proposed, reliable containment of the agent when the prosthesis is implanted at the heart likely are not ensured, especially in view of the constant movement and cyclic compression experienced by heart valves.

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