Retaining mechanisms for prosthetic valves

• US 10,722,355 B2
• Filed: 10/11/2017
• Issued: 07/28/2020
• Est. Priority Date: 06/20/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rowe, Stanton J., Maisano, Francesco, Meiri, Oded
• Primary Examiner(s): Tyson, Melanie R
• Application Number:
  US15/729,986
• Publication Number:
  US 20180028313A1
• Time in Patent Office: 1,021 Days
• Field of Search: 623 211, 623 238
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 2017/32004 having a laterally movable cutting member at its most distal end which remains within the contours of said end
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Prosthetic valve systems for replacing a native valve exhibiting regurgitation include a support structure and a transcatheter heart valve (THV) that is separate from the support structure. The support structure can be configured to be positioned such that it extends annularly around the native valve leaflets. After the support structure is deployed around the native valve leaflets, the THV can be expanded within the support structure such that the native valve leaflets are engaged between the support structure and the THV.

Claims

1. An assembly comprising:

a prosthetic heart valve comprising an annular frame that is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, and a valve structure positioned within the frame; and

a support structure separate from the prosthetic heart valve configured to be positioned such that the support structure extends annularly around the native mitral valve leaflets within the left ventricle of a patient'"'"'s heart;

wherein the prosthetic heart valve is configured to be deployed within the native mitral valve leaflets after the support structure is deployed around the native mitral valve leaflets such that the native mitral valve leaflets are positioned between and engaged by the support structure and the prosthetic heart valve;

a delivery system configured to deliver and implant the prosthetic heart valve and the support structure within the heart of the patient;

wherein the delivery system comprises;

a first loop delivery catheter having a distal end portion configured to be advanced into the left ventricle;

a second loop delivery catheter having a distal end portion configured to be advanced into the left ventricle; and

a guidewire configured to be inserted through the first loop delivery catheter and the second loop delivery catheter so as to form a loop in the left ventricle for delivering and positioning the support structure around the native mitral valve leaflets.

2. The assembly of claim 1, wherein the distal end portion of the first loop delivery catheter is configured to extend substantially around the exterior of one half of the chordae tendineae of the patient and the distal end portion of the second loop delivery catheter is configured to extend substantially around the exterior of the other half of the chordae tendineae of the patient.

3. The assembly of claim 2, wherein the distal end portion of the first loop delivery catheter is configured to engage the distal end portion of the second loop delivery catheter to form a contiguous junction between the first and second loop delivery catheters.

4. The assembly of claim 1, wherein the first and second loop catheters are configured to be advanced through the patient'"'"'s arch, the native aortic valve, and into the left ventricle.

5. The assembly of claim 1, wherein the delivery system further comprises:

a first catheter delivery sheath having a curved distal end region, wherein the first loop delivery catheter is configured to be advanced through the first catheter delivery sheath into the left ventricle; and

a second catheter delivery sheath having a curved distal end region, wherein the second loop delivery catheter is configured to be advanced through the second catheter delivery sheath into the left ventricle.

6. The assembly of claim 5, wherein the delivery system further comprises:

an introducer having a distal end portion configured to be inserted into the heart;

wherein the first and second catheter delivery sheaths are configured to be advanced through the introducer and into the heart.

7. The assembly of claim 6, wherein the first catheter delivery sheath and the second catheter delivery sheath are configured such that they arc outwardly away from each other as they are advanced distally from the introducer sheath.

8. An assembly comprising:

a first loop delivery catheter having a distal end portion configured to be advanced into a patient'"'"'s left ventricle;

a second loop delivery catheter having a distal end portion configured to be advanced into the left ventricle; and

a guidewire configured to be inserted through the first loop delivery catheter and the second loop delivery catheter so as to form a loop in the left ventricle for delivering and positioning a support structure around the patient'"'"'s native mitral valve leaflets.

9. The assembly of claim 8, wherein the distal end portion of the first loop delivery catheter is configured to extend substantially around the exterior of one half of the patient'"'"'s chordae tendineae, the second loop delivery catheter is configured to extend substantially around the exterior of the other half of the patient'"'"'s chordae tendineae, and the distal end of the first and second loop delivery catheters are configured to engage each other to form a contiguous junction between them.

10. The assembly of claim 8, further comprising:

a first catheter delivery sheath having a curved distal end region, wherein the first loop delivery catheter is configured to be advanced through the first catheter delivery sheath into the left ventricle; and

a second catheter delivery sheath having a curved distal end region, wherein the second loop delivery catheter is configured to be advanced through the second catheter delivery sheath into the left ventricle.

11. The assembly of claim 10, further comprising:

an introducer having a distal end portion configured to be inserted into the heart;

wherein the first and second catheter delivery sheaths are configured to be advanced through the introducer and into the heart.

12. An assembly comprising:

a prosthetic heart valve comprising an annular frame that is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, and a valve structure positioned within the frame; and

a support member separate from the prosthetic heart valve configured to be positioned annularly around the native mitral valve leaflets within the left ventricle of a patient'"'"'s heart;

wherein the support member comprises a hollow first end and a second end configured to extend into the hollow first end to form an annular band configured to extend around and engage the native mitral valve leaflets and support the prosthetic heart valve when the prosthetic heart valve is deployed within the native mitral valve leaflets.

13. The assembly of claim 12, wherein the first end comprises a shoulder and the second end comprises an angled collar that forms a snap-fit connection with the shoulder.