EP-4739258-A1 - SYSTEMS AND METHODS FOR DEPLOYING CARDIAC THERAPEUTIC DEVICES

Abstract

This disclosure relates to transcatheter delivery systems, including cardiac therapeutic devices (e.g., implants), and related methods for deploying the cardiac therapeutic devices to the heart. For example, some embodiments described herein can provide improved transcatheter delivery in an efficient, repeatable, and effective manner for structural heart intervention devices to treat regurgitation at the mitral valve and the tricuspid valve.

Inventors

• SCHWEICH, JR., CYRIL J.
• MORTIER, Todd James

Assignees

• ARCOS INTERVENTIONAL INC.

Dates

Publication Date

20260513

Application Date

20240703

Claims (20)

1. 1. A deployment tool for deploying a therapeutic device to a heart, the deployment tool comprising: a guide catheter configured to enter the heart and defining a lumen through which the therapeutic device is movable to a selected position within the heart; and a frame coupled to the guide catheter and configured to stabilize a distal portion of the deployment tool within the heart when a distal portion of the frame is exposed from the distal end of the guide catheter.
2. 2. The deployment tool of claim 1, wherein the frame is disposed within the guide catheter along a majority of a length of the frame.
3. 3. The deployment tool of any one of claims 1 to 2, wherein one or more components of the frame are slidable axially along the guide catheter.
4. 4. The deployment tool of any one of claims 1 to 3, wherein one or more components of the frame are rotatable with respect to the guide catheter.
5. 5. The deployment tool any one of claims 1 to 4. wherein the lumen extends along a central axis of the guide catheter.
6. 6. The deployment tool of any one of claims 1 to 5, wherein the lumen has a maximum width of about 2.6 mm to about 4. 1 mm.
7. 7. The deployment tool of any one of claims 1 to 6, wherein the frame comprises a stabilization rail that is configured to limit a first movement of the frame in a first direction when the distal portion of the frame is exposed from the distal end of the guide catheter.
8. 8. The deployment tool of claim 7, wherein the lumen comprises a first lumen that extends along a central axis of the guide catheter, wherein the guide catheter further defines a second lumen extending along a first side of the central axis, and wherein the stabilization rail is disposed within the second lumen.
9. 9. The deployment tool of claim 8, wherein the stabilization rail is a first stabilization rail, wherein the frame further comprises a second stabilization rail that is configured to limit a second movement of the frame in a second direction when the distal portion of the frame is exposed from the distal end of the guide catheter.
10. 10. The deployment tool of claim 9, wherein the guide catheter further defines a third lumen extending along a second side of the central axis, and wherein the second stabilization rail is disposed within the third lumen.
11. 11. The deployment tool of claim 8, wherein the guide catheter comprises a first wall portion having a first maximum thickness and a second wall portion having a second maximum thickness that is less than the first maximum thickness, and wherein the first lumen extends within the first wall portion.
12. 12. The deployment tool of claim 7, wherein the frame is configured such that at least a portion of the stabilization rail is disposed within an atrium of the heart when the distal portion of the frame is exposed from the distal end of the guide catheter.
13. 13. The deployment tool of claim 7, wherein the frame is configured such that at least a portion of the stabilization rail is disposed within a ventricle of the heart when the distal portion of the frame is exposed from the distal end of the guide catheter.
14. 14. The deployment tool of claim 7, wherein the stabilization rail has a thickness of about 0.38 mm to about 0.64 mm.
15. 15. The deployment tool of claim 7, wherein the stabilization rail comprises one or more of nitinol or stainless steel.
16. 16. The deployment tool of claim 7, wherein the stabilization rail is constructed as a wire or a ribbon.
17. 17. The deployment tool of claim 7, wherein the frame comprises a hub to which the stabilization extends distally.
18. 18. The deployment tool of claim 17, wherein the stabilization rail and the hub are secured to each other at a threaded arrangement.
19. 19. The deployment tool of claim 8, wherein the frame further comprises a guiderail disposed within the first lumen and providing a path along which the therapeutic device is movable to the selected position within the heart.
20. 20. The deployment tool of claim 8, wherein the guide catheter defines a third lumen, and wherein the frame further comprises a guidewire disposed within the third lumen and configured to be extended from the distal end of the guide catheter into a ventricle of the heart.

Description

Systems and Methods for Deploying Cardiac Therapeutic Devices CLAIM OF PRIORITY This application claims the benefit of U.S. Provisional Patent Applications Serial Nos. 63/525,420, filed on July 7, 2023, and 63/532.508, filed on August 14, 2023. The entire contents of the foregoing are hereby incorporated by reference. TECHNICAL FIELD This disclosure relates to tools, systems, cardiac therapeutic devices, and related methods for deploying cardiac therapeutic devices to the heart for treating pathologies of the heart. BACKGROUND A number of cardiac interventions have been performed via a catheter, including the delivery' of replacement valves and valve clip devices intended to treat valve regurgitation, which can be a significant contributor to cardiovascular morbidity and associated mortality. The transcatheter delivery of devices for such structural heart interventions can be extraordinarily complex, especially since the heart is beating during the procedure. Even if the implant or other interventional device is satisfactorily designed for its final use within the heart, not all such devices can be accurately and efficiently delivered in a transcatheter procedure. For example, many devices used in structural heart interventions require proper alignment with anatomical features in the heart or the ability to track a particular path/be steered at a particular angle through an atrium/ventricle toward the final implantation site. In such cases, a clinically effective delivers’ of the interventional device might depend on one or more of the ability to navigate to an intended location within the three- dimensional space of the heart, stability to perform remote action after reaching a particular chamber within the heart, and the ability to evaluate the progress or placement via imaging in various planes. SUMMARY In general, this disclosure relates to transcatheter delivery systems, including cardiac therapeutic devices (e.g., implants), and related methods for deploying the cardiac therapeutic devices to the heart. For example, some embodiments described herein can provide improved transcatheter delivery in an efficient, repeatable, and effective manner for structural heart intervention devices to treat regurgitation at the mitral valve and the tricuspid valve. In some embodiments, a transcatheter delivery system includes a deployment tool, an implantation system, and a manipulation tool. In some implementations, the transcatheter delivery system may be operated to deploy a mitral valve implant or a tricuspid valve implant to a selected position within the heart and to respectively implant the valve implant at the mitral valve or the tricuspid valve. In one aspect, a deployment tool for deploying a therapeutic device to a heart includes a guide catheter and a frame coupled to the guide catheter. The guide catheter is configured to enter the heart and defines a lumen through which the therapeutic device is movable to a selected position within the heart. The frame is configured to stabilize a distal portion of the deployment tool within the heart when a distal portion of the frame is exposed from the distal end of the guide catheter. Embodiments may include one or more of the following features. In some embodiments, the frame is disposed within the guide catheter along a majority of a length of the frame. In some embodiments, one or more components of the frame are slidable axially along the guide catheter. In some embodiments, one or more components of the frame are rotatable with respect to the guide catheter. In some embodiments, the lumen extends along a central axis of the guide catheter. In some embodiments, the lumen has a maximum width of about 2.6 mm to about 4. 1 mm. In some embodiments, the frame includes a stabilization rail that is configured to limit a first movement of the frame in a first direction when the distal portion of the frame is exposed from the distal end of the guide catheter. In some embodiments, the lumen includes a first lumen that extends along a central axis of the guide catheter, wherein the guide catheter further defines a second lumen extending along a first side of the central axis, and wherein the stabilization rail is disposed within the second lumen. In some embodiments, the stabilization rail is a first stabilization rail, wherein the frame further includes a second stabilization rail that is configured to limit a second movement of the frame in a second direction when the distal portion of the frame is exposed from the distal end of the guide catheter. In some embodiments, the guide catheter further defines a third lumen extending along a second side of the central axis, wherein the second stabilization rail is disposed within the third lumen. In some embodiments, the guide catheter includes a first wall portion having a first maximum thickness and a second wall portion having a second maximum thickness that is less than the first maximum thickness, wherein the first l