CN-121987389-A - Mitral or tricuspid valve repair system with multidirectional anchor

CN121987389ACN 121987389 ACN121987389 ACN 121987389ACN-121987389-A

Abstract

The present disclosure discloses a prosthetic valve ring assembly comprising an outer tube comprising an interior lumen and a plurality of windows, and a plurality of anchors positioned inside the outer tube and around a perimeter of the outer tube, wherein the plurality of anchors are configured to be ejected from the plurality of windows in order to anchor the prosthetic valve ring assembly to annular tissue of a patient, characterized in that the plurality of anchors are configured to be ejected in different directions, and wherein a first portion of the plurality of anchors are configured to be ejected to a ventricular side of the annular tissue and a second portion of the plurality of anchors are configured to be ejected to an atrial side of the annular tissue.

Inventors

Nadav Ihering
Guy Rogol
Oav Rosen
Rafi Ben Ali
Joshua Porras
Samuel M Shaw

Assignees

沃卡尔医药有限公司

Dates

Publication Date: 20260508
Application Date: 20170616
Priority Date: 20170317

Claims (12)

1. A prosthetic valve annulus assembly, comprising: An outer tube comprising an inner lumen and a plurality of windows, and An anchor assembly comprising a first plurality of anchors and a second plurality of anchors, the anchor assembly configured to be positioned within the interior lumen of the outer tube and around a perimeter of the outer tube, wherein the first plurality of anchors and the second plurality of anchors are configured to be ejected from the plurality of windows in different directions so as to anchor the prosthetic valve annulus assembly to annulus tissue of a patient, and wherein the first plurality of anchors are configured to be ejected outwardly and downwardly relative to a plane of the outer tube to a ventricular side of the annulus tissue, the second plurality of anchors are configured to be ejected outwardly and upwardly relative to a plane of the outer tube to an atrial side of the annulus tissue; A closure device configured to lock the distal and proximal sides of the prosthetic valve annulus assembly; a first end anchor extending outwardly from a distal side of the prosthetic valve ring assembly and a second end anchor extending outwardly from a proximal side of the prosthetic valve ring assembly, and A release pin configured to unlock the closure device to separate the distal and proximal ends of the prosthetic valve ring assembly to enable repositioning of the prosthetic valve ring assembly through a catheter or retrieval of the prosthetic valve ring assembly from a patient.
2. The prosthetic valve annulus assembly of claim 1, wherein the anchor assembly is created using a laser cutting technique.
3. The prosthetic valve annulus assembly of claim 1, wherein the plurality of windows of the outer tube are created using a laser cutting technique.
4. The prosthetic valve ring assembly of claim 1, further comprising a posterior adjustment mechanism comprising a flexible connection configured to move an anterior portion of the prosthetic valve ring assembly relative to a posterior portion of the prosthetic valve ring assembly, thereby changing at least one of a size and a geometry of the prosthetic valve ring assembly.
5. The prosthetic valve ring assembly of claim 1, further comprising one or more protrusions positioned on a perimeter of the prosthetic valve ring assembly and configured to apply additional pressure to a triangle of annular tissue of a patient, thereby providing improved anchoring to the prosthetic valve ring assembly.
6. A prosthetic valve annulus assembly, comprising: an outer tube comprising an interior lumen and a plurality of windows, and A plurality of anchors positioned inside and around a perimeter of the outer tube, wherein the plurality of anchors are configured to be ejected from the plurality of windows to anchor the prosthetic valve ring assembly to a patient's ring tissue, Wherein the plurality of anchors are configured to eject in different directions, and wherein a first portion of the plurality of anchors are configured to eject to a ventricular side of the ring tissue and a second portion of the plurality of anchors are configured to eject to an atrial side of the ring tissue.
7. The prosthetic valve annulus assembly of claim 6, wherein the plurality of anchors are created using a laser cutting technique.
8. The prosthetic valve annulus assembly of claim 7, wherein the laser cutting technique comprises cutting according to a laser cutting pattern to define a plurality of windows from which the plurality of anchors are configured to be ejected.
9. The prosthetic valve ring assembly of claim 6, further comprising a closure device configured to lock distal and proximal sides of the prosthetic valve ring assembly.
10. The prosthetic valve ring assembly of claim 6, further comprising a posterior adjustment mechanism comprising a flexible connection configured to move an anterior portion of the prosthetic valve ring assembly relative to a posterior portion of the prosthetic valve ring assembly, thereby changing at least one of a size and a geometry of the prosthetic valve ring assembly.
11. The prosthetic valve ring assembly of claim 6, further comprising: A closure device configured to lock the distal and proximal sides of the valve annulus assembly, and An unlocking mechanism configured to unlock the closure device, thereby enabling repositioning of the prosthetic valve ring assembly through a catheter or retrieval of the prosthetic valve ring assembly from a patient.
12. The prosthetic valve ring assembly of claim 6, further comprising one or more protrusions positioned on a perimeter of the prosthetic valve ring assembly and configured to apply additional pressure to a triangle of annular tissue of a patient, thereby providing improved anchoring to the prosthetic valve ring assembly.

Description

Mitral or tricuspid valve repair system with multidirectional anchor The present application is a divisional application of the application patent application with the application number 201710459034.0, entitled "mitral valve or tricuspid valve repair System with Multi-directional Anchor", filed on 6 th and 16 th 2017. Technical Field The present disclosure relates to implantable prosthetic devices. More particularly, the present disclosure relates to an improved prosthetic device implantable through a catheter for mitral or tricuspid valve regurgitation treatment. Background Mitral regurgitation is a valve dysfunction that causes blood volume to flow from the left ventricle to the left atrium during systole (during systole of the left ventricle). In contrast, in a healthy heart, this flow direction is blocked by the mitral valve. Reverse flow during systole causes pressure to rise in the left atrium, and maintaining normal cardiac output causes pressure to rise in the left atrium. Treatment of patients with MR (mitral regurgitation) or TR (tricuspid regurgitation) may require valve (valve) replacement in order to reduce or eliminate regurgitation. For many years, a commonly accepted treatment has been surgical repair or replacement of native valves during open heart surgery. In recent years, transvascular techniques have been developed that introduce and implant prosthetic heart valves using flexible catheters in a manner that is less invasive than open heart surgery. In transvascular techniques, when the prosthetic valve is crimped (crimped) into a small diameter shaft, the valve is delivered through a catheter to a target site (e.g., aortic, mitral, tricuspid or other valve). Then, when the valve is in the correct position, it is expanded/deployed to a functional size. Examples of such prosthetic valves and related procedures for delivering the valve through a catheter are described in U.S. patent No. 8,518,107, the entire contents of which are incorporated herein by reference. Advancing the catheter to the target site may be accomplished by (a) advancing the catheter from the femoral vein/artery or any other vessel that allows access to the target site to the vascular system of the target site, (b) passing the catheter through a small incision made in the chest wall and then through the apex of the heart (trans-apically), or (c) passing the catheter through a small incision made in the chest wall and then through the left atrium or right atrium (trans-atrially). Disclosure of Invention Embodiments herein relate to a plurality of prosthetic valve annulus assemblies for repairing heart valves having regurgitation, such as mitral or tricuspid valves. A prosthetic valve annulus assembly is described herein. In particular embodiments, a prosthetic valve annulus assembly may include an outer tube including a plurality of windows, and a plurality of anchors positioned inside the outer tube and around a perimeter of the outer tube. The plurality of anchors are configured to be ejected (emit) from the plurality of windows to anchor the prosthetic valve ring assembly to ring (annulus) tissue of the patient. In some embodiments, the anchor portion is configured to eject in a different direction. For example, a first portion of the anchor portion is configured to eject to the ventricular side of the patient's annular tissue and a second portion of the anchor portion is configured to eject to the atrial side of the patient's annular tissue. In some embodiments, the anchor is created using a laser cutting technique. In an embodiment, the laser cutting technique includes cutting according to a laser cutting pattern to define a plurality of windows through which the plurality of anchors are configured to be ejected. In some embodiments, the prosthetic valve ring assembly further comprises a closure device configured to lock the distal and proximal sides of the prosthetic valve ring assembly. In some embodiments, the prosthetic valve ring assembly further comprises a posterior adjustment mechanism comprising a flexible connection configured to move an anterior portion of the prosthetic valve ring assembly relative to a posterior portion of the prosthetic valve ring assembly, thereby altering at least one of a size and geometry of the prosthetic valve ring assembly. In some embodiments, the prosthetic valve ring assembly further comprises a closure device configured to lock the distal and proximal sides of the prosthetic valve ring assembly, and an unlocking mechanism configured to unlock the closure device to enable repositioning of the valve ring assembly or retrieval of the valve ring assembly from a patient through a catheter. In some embodiments, the prosthetic valve ring assembly further includes one or more protrusions positioned on a perimeter of the prosthetic valve ring assembly and configured to apply additional pressure to a triangle (trigone) of the patient's annulus tissue, thereby providing improved anchor