RETAINING MECHANISMS FOR PROSTHETIC VALVES

• US 20090319037A1
• Filed: 02/10/2009
• Published: 12/24/2009
• Est. Priority Date: 06/20/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Maisano, Francesco, Rowe, Stanton, Meiri, Oded
• Granted Patent: US 8,323,335 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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

Disclosed herein are representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support stent is delivered to a position on the surface of the outflow side of a native heart valve of a patient, the support stent defining a support-stent interior. An expandable prosthetic heart valve is delivered into the native heart valve from the inflow side of the native heart valve and into the support-stent interior. The expandable prosthetic heart valve is expanded while the expandable prosthetic valve is in the support-stent interior and while the support stent is at the position on the surface of the outflow side of the heart valve, thereby causing one or more of the native leaflets of the native heart valve to be frictionally secured between the support stent and the expanded prosthetic heart valve.

Claims

1. A method, comprising:

delivering a support structure to a position on or adjacent to the surface of the outflow side of a native heart valve of a patient, the support structure defining a support-structure interior;

delivering an expandable prosthetic heart valve into the native heart valve and into the support-structure interior; and

expanding the expandable prosthetic heart valve while the expandable prosthetic heart valve is in the support-structure interior and while the support structure is at the position on or adjacent to the surface of the outflow side of the native heart valve, thereby causing one or more native leaflets of the native heart valve to be frictionally secured between the support structure and the expanded prosthetic heart valve.

2. The method of claim 1, wherein the expandable prosthetic heart valve is delivered from the inflow side of the native heart valve.

3. The method of claim 1, wherein the expandable prosthetic heart valve is delivered from the outflow side of the native heart valve.

4. The method of claim 1, wherein the native heart valve is an aortic valve, and wherein the act of delivering the expandable prosthetic heart valve comprises delivering the prosthetic heart valve through the left ventricle of the patient'"'"'s heart.

5. The method of claim 1, wherein the native heart valve is an aortic valve, and wherein the act of delivering the expandable prosthetic heart valve comprises delivering the prosthetic heart valve through the patient'"'"'s aorta.

6. The method of claim 1, wherein the native heart valve is an aortic valve, wherein the support structure is a support stent, and wherein the act of delivering the support structure comprises:

advancing a first catheter through the aortic arch of the patient so that a distal end of the first catheter is near the aortic valve of the patient, the first catheter at least partially enclosing a stent-delivery catheter, an inner catheter, and the support stent in a compressed state; and

advancing the stent-delivery catheter and the inner catheter through the first catheter, thereby causing the support stent to be deployed from the distal end of the first catheter and to expand into a decompressed state.

7. The method of claim 1, wherein the native heart valve is a mitral valve, wherein the support structure is a support band, and wherein the act of delivering the support structure comprises:

advancing a first loop delivery catheter into the left ventricle of the patient so that a first distal end of the first loop delivery catheter extends around a first portion of the chordae tendineae;

advancing a second loop delivery catheter into the left ventricle of the patient so that a second distal end of the second loop delivery catheter extends around a second portion of the chordae tendineae, the second portion of the chordae tendineae being opposite the first portion of the chordae tendineae, and so that the second distal end of the second loop delivery is adjacent to the first distal end of the first loop delivery catheter;

advancing a support band material through an interior of the first loop delivery catheter and an interior of the second loop delivery catheter;

attaching a locking member to portions of the support band material; and

advancing the locking member along the portions of the support band material and into the left ventricle of the patient, thereby forming the support band around the chordae tendineae.

8. The method of claim 1, wherein the act of delivering the support structure comprises guiding the support structure to the position on or adjacent to the surface of the outflow side of the native heart valve and into a desired orientation, wherein the desired orientation aligns peaks of the support structure with either the tips or the commissures of the one or more native leaflets.

9. The method of claim 1, further comprising disconnecting the support structure from at least a delivery catheter once the one or more native leaflets of the native heart valve are fictionally secured between the support structure and the expanded prosthetic heart valve.

10. The method of claim 9, wherein the disconnecting comprises retracting an inner catheter relative to a stent-delivery catheter, thereby retracting inner prongs coupled to the inner catheter from corresponding apertures in retaining arms of the support stent.

11. The method of claim 9, wherein the disconnecting comprises cutting through material used to form the support structure, thereby releasing the support structure from a catheter.

12. The method of claim 1, wherein the act of expanding the expandable prosthetic heart valve comprises inflating a balloon of a balloon catheter, the expandable prosthetic heart valve being disposed around the balloon of the balloon catheter.

13. A method, comprising:

advancing a guide catheter through the aortic arch of a patient so that a distal end of the guide catheter is near the aortic valve of the patient, the guide catheter at least partially enclosing a stent-delivery catheter and a compressed support stent releasably connected to the stent-delivery catheter;

advancing the stent-delivery catheter through the guide catheter, thereby causing the support stent to be deployed from the distal end of the guide catheter and to become uncompressed;

positioning the uncompressed support stent adjacent to or on a surface of the aortic side of the aortic valve such that the leaflets of the aortic valve are circumscribed by the uncompressed support stent; and

disconnecting the uncompressed support stent from the stent-delivery catheter.

14. The method of claim 13, wherein the act of disconnecting comprises retracting an inner catheter positioned in the interior of the stent-delivery catheter.

15. The method of claim 13, further comprising advancing a distal end of a THV-delivery catheter through a puncture in the left ventricle of the patient and into both the aortic valve and an interior of the uncompressed support stent.

16. The method of claim 13, further comprising:

removing the stent-delivery catheter from the aortic arch of the patient; and

advancing a distal end of a THV-delivery catheter through the aortic arch of the patient and into both the aortic valve and an interior of the uncompressed support stent.

17. An apparatus, comprising:

a support stent having an annular body that defines one or more peaks and one or more valleys along its circumference,

the support stent being radially compressible into a compressed state and self expandable into an uncompressed state,

the support stent being sized such that it can be positioned within the aorta of a patient at a location adjacent to the aortic valve and thereby circumscribe the aortic valve,

the support stent further comprising at least one retaining arm at or near a respective one of the peaks, the retaining arm comprising an aperture.

18. The apparatus of claim 17, wherein the support stent is formed from a single annular member.

19. The apparatus of claim 17, wherein the support stent consists of three peaks and three valleys.

20. The apparatus of claim 19, wherein the shape formed by the three peaks and the three valleys approximates the shape of the leaflets of the aortic valve when the aortic valve is fully opened.

21. The apparatus of claim 17, wherein the support stent is made of a shape-memory alloy.

22. The apparatus of claim 17, wherein a projection of the annular body onto a first plane is ring shaped or starfish shaped, and wherein the annular body defines the one or more peaks and the one or more valleys in a direction perpendicular to the first plane.

23. The apparatus of claim 17, wherein the annular body is sinusoidal or saw-tooth shaped along its circumference.

24. An apparatus, comprising:

a support stent having an annular main body portion and an annular, generally U-shaped rim portion at one end of the main body portion,

the support stent being radially compressible into a compressed state and self expandable into an uncompressed state, and

the rim portion having a diameter that is greater than a diameter of the annular main body portion and that is sized so that an outer perimeter of the rim portion will engage the walls surrounding the aortic valve of a patient when the support stent is positioned within the aorta of the patient at a location adjacent to the aortic valve.

25. The apparatus of claim 24, wherein the support stent is made of a shape-memory alloy.

26. The apparatus of claim 24, wherein the annular main body portion is sinusoidal or saw-tooth shaped along its circumference.

27. The apparatus of claim 24, wherein the rim portion is located around a bottom region of the main body portion.

28. The apparatus of claim 24, wherein the support stent is made of multiple elements forming a criss-cross pattern.

29. The apparatus of claim 24, further comprising at least one retaining arm at or near a top region of the main body portion.