US-12616593-B2 - Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath and loading system

US12616593B2US 12616593 B2US12616593 B2US 12616593B2US-12616593-B2

Abstract

The present disclosure relates to a delivery catheter and the stepwise release of a stent from the catheter into the vasculature of a patient, as well as a loading device for a transcatheter heart valve (THV) prosthesis.

Inventors

Stefan Schreck
Hussain Rangwala
Payam SAFFARI
Makensley LORDEUS
Vincent Ming Hai Chow
Kevin Han Tang Chu

Assignees

JENAVALVE TECHNOLOGY, INC.

Dates

Publication Date: 20260505
Application Date: 20210715

Claims (13)

1 . A system for repairing a cardiac valve, the system comprising: a valve prosthesis a delivery system comprising a handle at a proximal end of the delivery system, an end region at a distal end of the delivery system, and a catheter extending between the handle and the end region of the delivery system, the end region of the delivery system comprising a distal sleeve configured to constrain a distal portion the valve prothesis and a proximal sleeve configured to constrain, together with a stent holder disposed within the proximal sleeve, a proximal portion of the valve prosthesis, the stent holder configured to be removably coupled to the proximal portion of the valve prosthesis and to selectively move with respect to the proximal sleeve, and the valve prosthesis is configured to be sequentially released using the handle in mechanical communication with the end region of the delivery system, the valve prosthesis being self-expandable, wherein the proximal sleeve of the delivery system and the distal sleeve of the delivery system are configured to constrain the valve prosthesis such that an exposed portion of the valve prosthesis extends between the proximal sleeve of the delivery system and the distal sleeve of the delivery system when the distal sleeve of the delivery system is in a proximal-most position and the proximal sleeve of the delivery system is in a distal-most position, the exposed portion self-expanding radially beyond the proximal sleeve of the delivery system and the distal sleeve of the delivery system, and wherein the distal sleeve is configured to move distally to release the distal portion of the valve prosthesis and the stent holder is configured to move distally, subsequent to the distal sleeve moving distally, to fully release the valve prosthesis from the delivery system.
2 . The system of claim 1 , wherein the valve prosthesis is configured to transition from a radially collapsed state to a radially expanded state.
3 . The system of claim 1 , wherein the valve prosthesis is stored in a liquid for transport.
4 . The system of claim 1 , further comprising a steering system, wherein the delivery system and the steering system are releasably connectable.
5 . The system of claim 1 , wherein the proximal sleeve is axially fixed with respect to the catheter.
6 . The system of claim 1 , wherein the stent holder is in mechanical communication with the distal sleeve.
7 . The system of claim 6 , wherein a cable connects stent holder to the distal sleeve.
8 . A method for preparing a system for repairing a cardiac valve, the system comprising a valve prosthesis that is self-expandable and a first segment of a delivery system comprising a handle at a proximal end of the delivery system, an end region at a distal end of the delivery system, and a catheter extending between the handle and the end region of the delivery system, the end region of the delivery system comprising a distal sleeve configured to constrain a distal portion the valve prothesis and a proximal sleeve configured to constrain, together with a stent holder disposed within the proximal sleeve, a proximal portion of the valve prosthesis, the stent holder configured to be removably coupled to the proximal portion of the valve prosthesis and to selectively move with respect to the proximal sleeve, the method comprising: engaging the stent holder of the delivery system with the valve prosthesis, engaging the distal sleeve of the delivery system with the distal portion of the valve prosthesis; and wherein the proximal sleeve of the delivery system and the distal sleeve of the delivery system are configured to contact and constrain the valve prosthesis such that an exposed portion of the valve prosthesis extends between the proximal sleeve of the delivery system and the distal sleeve of the delivery system when the distal sleeve of the delivery system is in a proximal-most position and the proximal sleeve of the delivery system is in a distal-most position, the exposed portion self-expanding radially beyond the proximal sleeve of the delivery system and the distal sleeve of the delivery system, and wherein the distal sleeve is configured to move distally to release the distal portion of the valve prosthesis and the stent holder is configured to move distally, subsequent to the distal sleeve moving distally, to fully release the valve prosthesis from the delivery system.
9 . The method of claim 8 , wherein engaging the valve prosthesis with the stent holder of the delivery system comprises coupling the valve prosthesis to the stent holder of the delivery system.
10 . The method of claim 8 , further comprising connecting the delivery system to a steering system adapted to align the valve prosthesis with the cardiac valve.
11 . The method of claim 8 , wherein the proximal sleeve is axially fixed with respect to the catheter.
12 . The method of claim 8 , wherein the stent holder is in mechanical communication with the distal sleeve.
13 . The method of claim 12 , wherein a cable connects stent holder to the distal sleeve.

Description

This application is a divisional application of U.S. patent application Ser. No. 16/099,793, filed on Nov. 8, 2018, now U.S. Pat. No. 11,065,138, which is a national stage of PCT/IB2017/052718, filed on May 10, 2017, which claims priority to U.S. Provisional Application No. 62/491,391, filed on Apr. 28, 2017, and U.S. Provisional Application No. 62/336,153, filed on May 13, 2016, the entire contents of each of which are incorporated herein by reference. This application is also related to U.S. Provisional Application No. 62/136,092, filed on Mar. 20, 2015, the entire contents of which are incorporated herein by reference. The present disclosure relates to a delivery system, a catheter system and a method for the minimally invasive application of prostheses to individuals in need thereof and a method and device for loading a prosthesis onto a catheter system and/or a delivery system. BACKGROUND The present disclosure relates to the field of medical devices, in particular to a prosthesis which is transplanted into an individual in need thereof in order to re-establish proper body functions by way of minimally invasive methods and means applicable therefor. Examples of prostheses that are placed by way of minimally invasive methods are stents and heart valves like aortic and mitral heart valves. Heart valves today are applied e.g. by the transapical, transfemoral, or subclavial route. Usually the prosthesis is delivered to the implantation site by way of a delivery system also denoted a catheter. The requirements for the catheter by way of transfemoral delivery is more complex as compared with the transapical route because for the narrower, longer and more tortuous pathway. One example of such a delivery system is disclosed in EP2387977B1. This patent describes a transfemoral catheter for the delivery of an aortic heart valve. The patent does not disclose nor suggest the features described herein. Usually the prosthesis is radially compressed onto the catheter and crimped to a small size in order pass through the vasculature of the patient and to be delivered to the implantation site. The different systems known in the prior art use catheter systems with a profile of 18 to 26 French. Because of the potential detrimental effect of long-term crimping on the properties of the tissue leaflets, the prosthesis is crimped or loaded onto the catheter in the operating room just prior to use. Typically, the loading procedure is performed in the sterile field by a trained operator using a dedicated loading tool. This adds to the complexity of the implant procedure. Another consideration is the accurate positioning of the prosthesis into the final implant location. The beating heart causes the native valve annulus to move with the cardiac cycle. This creates a non-stationary target. In some cases, the natural heart beat is interrupted during placement of the prosthesis to create a stationary target. In some cases, the prosthesis is deployed in a stepwise fashion to better control the positioning of the prosthesis. In some cases, the catheter is designed to retract the prosthesis after partial release in case re-positioning of the prosthesis is desired. Another consideration in the delivery is the maneuvering of the prosthesis by way of the catheter through the vasculature and its bends. The fact that the vasculature is typically narrow, and particularly at the aortic entry into the heart a substantive curve with a narrow angle has to be passed through, represents a substantial challenge for such a delivery procedure and device. Yet another consideration is the diameter size of catheter system. The diameter size of the crimped prosthesis in the catheter for delivery through the vasculature of the patient may affect the implantation procedure and/or functioning of the prosthesis upon implantation. Many known systems do not achieve an adequate crimping size, and often the prosthesis tissue is negatively affected in known systems during the crimping procedure. An object of the present disclosure is to provide for a simple and precisely operable delivery system for stents or prostheses, in particular heart valve prostheses which improve or avoid the disadvantages of prior art delivery systems. On the basis of the problems referenced and outlined above, certain embodiments of the present disclosure may address the issue of delivering and positioning a specialized endoprosthesis for treating a narrowed cardiac valve or a cardiac valve insufficiency which realizes optimum positioning accuracy and anchoring of the emplaced device. In addition, the treatment of the narrowed cardiac valve or cardiac valve insufficiency may be achieved by way of a relatively simple procedure to enable routine treatment of narrowed cardiac valve or cardiac valve insufficiency without major stress to the patient. EXEMPLARY OBJECTS OF THE DISCLOSURE One exemplary object of some aspects of the present disclosure includes providing a catheter system for d