Heart valve prosthesis

• US 9,801,715 B2
• Filed: 09/15/2016
• Issued: 10/31/2017
• Est. Priority Date: 08/13/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kovalsky, Igor
• Primary Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US15/266,924
• Publication Number:
  US 20170000605A1
• Time in Patent Office: 411 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0036 differing in thickness

Abstract

A heart valve prosthesis configured for deployment within a native heart valve. The heart valve prosthesis includes a tubular stent and a prosthetic valve component disposed within and secured to the stent. In addition, at least two positioning elements are coupled to a distal end of the stent to position and anchor the prosthesis within the native heart valve. Each positioning element transforms from a compressed configuration in which the positioning elements distally extend from the distal end of the stent to a deployed configuration in which the positioning elements proximally extend from the distal end of the stent. Each positioning element includes at least one U-shaped or V-shaped support arm that bends radially outward and then towards an outer surface of the stent such that it translates more than ninety degrees from the compressed configuration. Each positioning element may include an outer support arm and an inner support arm.

Claims

1. A method of percutaneously delivering and deploying a valve prosthesis within a native heart valve comprising:

tracking a prosthetic valve delivery system through the vasculature to the native heart valve, wherein the prosthetic valve delivery system includes a valve prosthesis having a tubular stent, a prosthetic valve component disposed within and secured to the tubular stent, and at least one positioning element coupled to a distal end of the tubular stent, the at least one positioning element having an outer support arm having first and second ends and an inner support arm having first and second ends, the outer and inner support arms extending distally from the distal end of the tubular stent when the tubular stent is in a compressed configuration for delivery, the outer and inner support arms extending along the same plane and the inner support arm being disposed within the outer support arm such that portions of the inner and outer support arms are aligned and the first and second ends of the outer support arm being coupled to the tubular stent at a circumferentially spaced apart location from the respective first and second ends of the inner support arm;

retracting an outer sheath of the prosthetic valve delivery system to expose the at least one positioning element, wherein each of the outer support arm and the inner support arm bends radially outward and then towards an outer surface of the tubular stent such that it translates more than ninety degrees from the compressed configuration to proximally extend from the distal end of the tubular stent and press against the native heart valve and/or a heart wall in order to position the valve prosthesis within the native heart valve; and

further retracting the outer sheath to expose the tubular stent, thereby allowing the tubular stent to self-expand into a deployed configuration.

2. The method of claim 1, wherein the native heart valve is percutaneously accessed by a transseptal antegrade approach.

3. The method of claim 1, wherein the step of tracking the prosthetic valve delivery system through the vasculature to the native heart valve includes advancing the prosthetic valve delivery system into an atrium until the valve prosthesis is centered within the native heart valve with the at least one positioning element contained within the outer sheath and distally extending into a ventricle.

4. The method of claim 1, wherein the tubular stent is contained within the outer sheath during the step of retracting the outer sheath to expose the at least one positioning element.

5. The method of claim 1, wherein the at least one positioning element rotates in a radial direction between 135 degrees and 180 degrees from the compressed configuration during deployment of the valve prosthesis.

6. The method of claim 1, wherein the outer support arm is connected to the inner support arm by two curved legs, wherein first ends of the two curved legs extend from a peak of the inner support arm and the two curved legs flare away from each other such that second ends of the two curved legs extend from opposing sides of a peak of the outer support arm.

7. The method of claim 6, wherein the distance between the peaks of the inner support arm and the outer support arm decreases when the at least one positioning element rotates from the compressed configuration to the deployed configuration.

8. The method of claim 1, wherein the at least one positioning element includes an intermediate U-shaped or V-shaped support arm between the outer support arm and the inner support arm.

9. The method of claim 1, wherein the inner and outer support arms are generally U-shaped or V-shaped.

10. The method of claim 1, wherein the inner and outer support arms each have a peak formed between their first and second ends, wherein the peak of the outer support arm is coupled to the peak of the inner support arm via a connector to ensure that the outer and inner support arms remain in the same plane.

11. A method of percutaneously delivering and deploying a valve prosthesis within a native heart valve comprising:

tracking a prosthetic valve delivery system through the vasculature to the native heart valve, wherein the prosthetic valve delivery system includes a valve prosthesis having a tubular stent, a prosthetic valve component disposed within and secured to the tubular stent, and at least one positioning element coupled to a distal end of the tubular stent, the at least one positioning element distally extending from the distal end of the tubular stent when the tubular stent is in a compressed configuration and the at least one positioning element including an outer support arm having a first end and a second end coupled to the distal end of the tubular stent with a peak formed between the first and second ends and an inner support arm having a first end and a second end coupled to the distal end of the tubular stent with a peak formed between the first and second ends, the outer and inner support arms extending along the same plane and the inner support arm being disposed within the outer support arm such that the peaks of the inner and outer support arms are aligned and each of the first and second ends of the outer support arm is coupled to the tubular stent at a circumferentially spaced apart location from the respective first and second ends of the inner support arm;

retracting an outer sheath of the prosthetic valve delivery system to expose the at least one positioning element, wherein each of the outer and inner support arm bends radially outward and then towards an outer surface of the tubular stent such that it translates more than ninety degrees from the compressed configuration to proximally extend from the distal end of the tubular stent and press against a portion of the native heart valve and/or a portion of a native heart wall in order to position the valve prosthesis, wherein the peak of the outer support arm is coupled to the peak of the inner support arm via a connector to ensure that the outer and inner support arms remain in the same plane; and

further retracting the outer sheath to expose the tubular stent, thereby allowing the tubular stent to self-expand into a deployed configuration.

12. The method of claim 11, wherein the native heart valve is percutaneously accessed by a transseptal antegrade approach.

13. The method of claim 11, wherein the step of tracking the prosthetic valve delivery system through the vasculature to the native heart valve includes advancing the prosthetic valve delivery system into an atrium until the valve prosthesis is centered within the native valve with the at least one positioning element contained within the outer sheath and distally extending into a ventricle.

14. The method of claim 11, wherein the tubular stent is contained within the outer sheath during the step of retracting the outer sheath to expose the at least one positioning element.

15. The method of claim 11, wherein the at least one positioning element rotates in a radial direction between 135 degrees and 180 degrees from the compressed configuration during deployment of the valve prosthesis.

16. The method of claim 11, wherein the connector that couples the peaks of the outer and inner support arms together includes two curved legs, wherein first ends of the two curved legs extend from the peak of the inner support arm and the two curved legs flare away from each other such that second ends of the two curved legs extend from opposing sides of the peak of the outer support arm.

17. The method of claim 16, wherein the distance between the peaks of the inner support arm and the outer support arm decreases when the at least one positioning element rotates from the compressed configuration to the deployed configuration.

18. The method of claim 11, wherein the at least one positioning element includes an intermediate support arm between the outer support arm and the inner support arm, the intermediate support arm having a first end and a second end coupled to the distal end of the tubular stent with a peak formed between the first and second ends.

19. The method of claim 18, wherein the intermediate support arm extends along the same plane as the outer and inner support arms and is disposed between the outer support arm and the inner support arm such that the peaks of the inner, outer, and intermediate support arms are aligned.

20. The method of claim 11, wherein the outer and inner support arms are generally U-shaped or V-shaped.

21. The method of claim 11, wherein the at least one positioning element is approximately parallel with a longitudinal axis of the tubular stent and distally extends from the distal end of the tubular stent when the tubular stent is in the compressed configuration.

22. The method of claim 11, wherein the tubular stent and the at least one positioning element are formed as a unitary structure.