DEVICES, SYSTEMS AND METHODS TO IMPROVE PLACEMENT AND PREVENT HEART BLOCK WITH PERCUTANEOUS AORTIC VALVE REPLACEMENT

• US 20180153690A1
• Filed: 01/18/2018
• Published: 06/07/2018
• Est. Priority Date: 08/03/2016
• Status: Active Grant

• Current Assignee: HBX, Inc.
• Original Assignee: HBX, Inc.
• Inventors: Spence, Paul A.
• Granted Patent: US 10,722,352 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3762 using computed tomography systems [CT]
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/0081 directly machined on the prosthetic surface, e.g. holes, grooves A61F2/30771 takes precedence
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0004 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0021 square
• CPC Class Codes: A61F 2230/0045 Omega-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0069 : Sealing means
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 25/0108 : using radio-opaque or ultrasound markers

Abstract

Devices, systems and methods to position a prosthetic heart valve such that the prosthetic valve does not compress conduction tissue and thereby produce heart block. Guide devices promote positioning the prosthetic valve within a native aortic valve to avoid the conduction tissue and, optionally, to center the prosthetic valve within the native heart valve. Prosthetic valves include one or more cut-outs, openings or recesses configured to align with the conduction tissue so that the conduction tissue is not contacted in a way that would lead to higher incidents of complete heart block.

Claims

1. A prosthetic aortic valve for mounting at an implant site associated with a native aortic valve of a patient, comprising:

a stent frame formed from wire, the stent frame including an upper margin or edge, a lower margin or edge, and an interior, wherein the stent frame includes only a single cut-out, opening or recess located along the lower margin or edge configured to align with conduction tissue below the native aortic valve to prevent contact by any structural element of the stent frame with the conduction tissue while providing more valve surface area at the lower margin for sealing blood flow after implantation, and

a plurality of prosthetic valve leaflets mounted within the interior of the stent frame to provide unidirectional flow of blood through the prosthetic aortic valve.

2. The valve of claim 1 wherein the cut-out, opening or recess is generally U-shaped or V-shaped or generally square shaped.

3. The valve of claim 1 wherein the cut-out, opening or recess is generally curved in shape.

4. The valve of claim 1, wherein the cut-out, opening or recess further comprises an indentation in the stent frame so the frame avoids compressing the conduction tissue.

5. The valve of claim 1, further comprising a covering material attached over the cut-out, opening or recess.

6. The valve of claim 1, further comprising at least one radiopaque marker placed adjacent opposite edges of the cut-out, opening or recess to aid in the correct orientation of the valve during implantation in relationship to the conduction tissue.

7. A prosthetic aortic valve for mounting at an implant site associated with a native aortic valve of a patient, comprising:

a stent frame formed from wire, the stent frame including an upper margin or edge, a lower margin or edge, and an interior, wherein the stent frame includes a plurality of spaced apart cut-outs, openings or recesses located along the lower margin or edge, wherein one of the cut-outs, openings or recesses may be aligned with conduction tissue below the native aortic valve to prevent contact by any structural element of the stent frame with the conduction tissue,

a plurality of prosthetic valve leaflets mounted within the interior of the stent frame to provide unidirectional flow of blood through the prosthetic aortic valve; and

a covering material fixed on an outside surface of the stent frame to enclose the interior, wherein the covering material includes a plurality of cut-outs respectively aligned with the plurality of cut-outs, openings or recesses in the stent frame.

8. The valve of claim 7 wherein the cut-out, opening or recess is generally U-shaped or V-shaped or generally square shaped.

9. The valve of claim 7 wherein the cut-out, opening or recess is generally curved in shape.

10. The valve of claim 7, wherein the cut-out, opening or recess further comprises an indentation in the stent frame so the frame avoids compressing the conduction tissue.

11. The valve of claim 7, further comprising at least one radiopaque marker placed adjacent opposite edges of each of the cut-outs, openings or recesses to aid in the correct orientation of the valve during implantation in relationship to the conduction tissue.

12. A prosthetic aortic valve for mounting at an implant site associated with a native aortic valve of a patient, comprising:

a stent frame formed from wire, the stent frame including an upper margin or edge, a lower margin or edge, and an interior, wherein the stent frame includes a cut-out, opening or recess located along the lower margin or edge configured to align with conduction tissue below the native aortic valve to prevent contact by any structural element of the stent frame with the conduction tissue,

at least one radiopaque marker placed adjacent opposite edges of the cut-out, opening or recess to aid in the correct orientation of the valve during implantation in relationship to the conduction tissue, and

a plurality of prosthetic valve leaflets mounted within the interior of the stent frame to provide unidirectional flow of blood through the prosthetic aortic valve.

13. A method of implanting a prosthetic aortic valve, the prosthetic aortic valve including a stent frame formed from wire, the stent frame including an upper margin or edge, a lower margin or edge, and an interior, wherein the stent frame includes a cut-out, opening or recess located along the lower margin or edge, and a plurality of prosthetic valve leaflets mounted within the interior of the stent frame to provide unidirectional flow of blood through the prosthetic aortic valve, the method comprising:

inserting the prosthetic valve into a native aortic valve, and

aligning the cut-out, opening or recess with the conduction tissue located below the native aortic annulus.

14. The method of claim 13, further comprising:

placing the prosthetic valve, in a collapsed condition, into a delivery sheath in a femoral artery of the patient with the prosthetic aortic valve in a predetermined rotational orientation for ensuring that the cut-out, opening or recess is at least substantially aligned with the conduction tissue at the native aortic valve when the prosthetic valve is delivered into the native aortic valve.

15. The method of claim 13, further comprising:

using at least one radiopaque marker placed on the prosthetic aortic valve adjacent opposite edges of the cut-out, opening or recess to align the cut-out, opening or recess with the conduction tissue.

16. A system to assist percutaneous aortic valve replacement, comprising:

a prosthetic aortic valve movable between a collapsed condition suitable for percutaneous delivery into a native aortic valve, and

a guide device configured to engage native heart tissue and guide valve deployment and expansion away from conduction tissue.

17. The device of claim 16, wherein the guide device is integrated with the prosthetic aortic valve.

18. The device of claim 16, wherein the guide device is comprised of wire and takes on the form of at least one of:

a helix, a basket, and a plurality of radiating arms.

19. A method of implanting a prosthetic aortic valve, comprising:

using a guide device to identify the nadir of the aortic valve leaflets or the left ventricular outflow tissue, and

percutaneously implanting a prosthetic aortic valve having a valve frame so that no portion of the valve frame contacts conduction tissue located below the native aortic annulus.

20. The method of claim 19, further comprising:

removing the guide device from the patient through a catheter after implanting the prosthetic aortic valve.

21. The method of claim 19, further comprising:

using at least one radiopaque marker on the guide device and at least one radiopaque marker on the prosthetic aortic valve to locate the prosthetic aortic valve relative to the guide device at the native aortic valve.

22. The method of claim 19, further comprising:

using the guide device, or a separate centering guide, to center the placement of the prosthetic aortic valve within the native aortic valve.