Heart valve pinch devices and delivery systems

• US 10,357,361 B2
• Filed: 09/13/2017
• Issued: 07/23/2019
• Est. Priority Date: 09/15/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rafi, Hamid, Joseph, Russell T., Bowes, Robert, Trinh, Uy D., Karapetian, Emil, Bak-Boychuk, Gregory
• Primary Examiner(s): Sweet, Thomas
• Assistant Examiner(s): Zimmerman, Rebecca Lynee
• Application Number:
  US15/703,888
• Publication Number:
  US 20180071085A1
• Time in Patent Office: 678 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0063 Three-dimensional shapes
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

Pinch devices and access systems that can be used to secure a prosthetic heart valve to a heart valve annulus and to treat valvular insufficiency. A pinch device can be a separate expandable element from the prosthetic heart valve that is first advanced to the annulus and deployed, after which an expandable prosthetic heart valve can be advanced to within the annulus and deployed. The two elements can clamp/pinch the heart valve leaflets to hold the prosthetic heart valve in place. The pinch device can have a flexible, expandable annular frame. A combined delivery system can deliver the pinch device and prosthetic heart valve with just a single access point and aid more accurate coaxial deployment. The pinch device can be mounted near distal end of an access sheath, and a catheter for delivering the prosthetic heart valve can be passed through a lumen of the same access sheath.

Claims

1. A prosthetic heart valve and delivery system, comprising:

an expandable prosthetic heart valve having a constricted diameter and an expanded diameter;

a delivery catheter having a distal end on which the heart valve is mounted;

a pinch device separate from the heart valve that has an expanded state defining an annular frame formed around a central axis and having peaks and valleys extending in opposite axial directions around its periphery, the pinch device including an inner body covered with a biocompatible fabric covering, with a plurality of buckles integrated with the inner body and projecting from a proximal end without being covered by the fabric covering, the pinch device in its expanded state being sized slightly smaller than the expanded diameter of the heart valve;

and an access system including a proximal handle and a distal access sheath, the handle and sheath defining a common lumen sized to allow passage therethrough of the distal end of the delivery catheter with the heart valve in its constricted diameter thereon, and the handle having one or more hemostatic seals to prevent blood leakage proximally past the distal end of the delivery catheter during use, the access system including a plurality of deployment arms, wherein at least one of the plurality of deployment arms and the sheath are axially movable relative to the other, wherein each of the plurality of deployment arms is coupled to one of the buckles of the pinch device, and wherein, prior to delivery, the pinch device is positioned in a constricted state within a distal end of the access sheath and is distal with respect to the distal end of the delivery catheter, such that the pinch device can be expelled from the access sheath and self-expand prior to expansion of the heart valve while connected to the plurality of deployment arms,

wherein the system is configured such that the distal access sheath can be introduced into the heart and advanced so that the distal end thereof is proximate a native heart valve, whereupon the pinch device can be expelled therefrom and positioned around native heart valve leaflets and the delivery catheter can be advanced to position the heart valve within the native heart valve leaflets such that expansion of the heart valve pinches the leaflets between the heart valve and pinch device,

wherein the proximal handle of the access system includes an advancement mechanism for axially displacing the deployment arms, and a release mechanism for decoupling each deployment arm from its corresponding buckle, and

wherein the release mechanism includes a filament extending from the proximal handle to a distal end of each deployment arm that nominally locks the deployment arm to the corresponding buckle, and an end sleeve on the proximal grip portion to which each filament is attached, wherein relative axial movement of the end sleeve with respect to the proximal grip portion pulls the filaments in a proximal direction.

2. A prosthetic heart valve system, comprising:

an expandable prosthetic heart valve having a constricted diameter and an expanded diameter;

a delivery catheter having a distal end on which the heart valve is mounted;

a pinch device separate from the heart valve that has an expanded state defining an annular frame formed around a central axis and having peaks and valleys extending in opposite axial directions around its periphery, the pinch device including an inner body, the pinch device in its expanded state being sized slightly smaller than the expanded diameter of the heart valve; and

an access system including a proximal handle and a distal access sheath, the handle and sheath defining a common lumen sized for passage therethrough of the distal end of the delivery catheter with the heart valve in its constricted diameter thereon, the access system including a plurality of deployment arms each coupled to the pinch device, wherein at least one of the sheath and the plurality of deployment arms is axially movable relative to the other, wherein the pinch device is positioned, prior to delivery, in a constricted state within a distal end of the access sheath and distal with respect to the distal end of the delivery catheter, such that the pinch device can be expelled from the access sheath and self-expand prior to expansion of the heart valve, the proximal handle having an advancement mechanism for axially displacing the deployment arms in a distal direction and/or retracting the sheath, and a release mechanism for decoupling each deployment arm from the pinch device,

wherein the system is configured such that the distal access sheath can be introduced into the heart and advanced so that the distal end thereof is proximate a native heart valve, whereupon the pinch device can be expelled therefrom and positioned around native heart valve leaflets and the delivery catheter can be advanced to position the heart valve within the native heart valve leaflets such that expansion of the heart valve pinches the leaflets between the heart valve and pinch device, and

wherein the release mechanism includes a filament extending from the proximal handle to a distal end of each deployment arm that nominally locks the deployment arm to the corresponding buckle, and an end sleeve on the proximal grip portion to which each filament is attached, wherein relative axial movement of the end sleeve with respect to the proximal grip portion pulls the filaments in a proximal direction.

3. The system of claim 2, wherein the pinch device has a plurality of buckles integrated with the inner body and projecting from a proximal end without any fabric covering, and the buckles on the pinch device are located at terminal ends of three fingers extending in a proximal direction from the pinch device and distributed evenly around a periphery of the pinch device, and wherein the deployment arms are each coupled to one of the buckles of the pinch device.

4. The system of claim 3, wherein the peaks of the pinch device project in a distal direction and the valleys project in a proximal direction, and the fingers extend proximally from three of the peaks of the pinch device.

5. The system of claim 3, wherein the peaks of the pinch device project in a proximal direction and the valleys project in a distal direction, and the fingers extend from three of the peaks distributed evenly around a periphery of the pinch device.

6. The system of claim 2, wherein the inner body includes circumferential struts connecting each two adjacent peaks and valleys each of which is generally S-shaped, with two curvatures separated by a point of inflection.

7. The system of claim 6, wherein each of the circumferential struts terminates at its corresponding peak and valley in an asymptotic manner such that it is nearly aligned with the vertical Z-axis.

8. The system of claim 2, wherein the advancement mechanism comprises a thumb wheel mounted for rotation on the proximal grip portion that engages a gear rack fixed to the distal housing so as to advance the proximal grip portion.

9. The system of claim 2, wherein the end sleeve is prevented from relative axial movement prior to rotational movement with respect to the proximal grip portion.

10. The system of claim 9, further including a pair of opposed locking tabs on the end sleeve that prevent rotational movement with respect to the proximal grip portion prior to depressing both locking tabs radially inward.

11. The system of claim 2, wherein the proximal handle includes a distal housing and the advancement mechanism comprises a proximal grip portion slidably mounted over the distal housing in a telescoping fashion.