Side-delivered transcatheter heart valve replacement

• US 10,595,994 B1
• Filed: 06/10/2019
• Issued: 03/24/2020
• Est. Priority Date: 09/20/2018
• Status: Active Grant

• Current Assignee: Vdyne, Inc.
• Original Assignee: Vdyne, LLC
• Inventors: Christianson, Mark, Vidlund, Robert, Saikrishnan, Neelakantan
• Primary Examiner(s): Yabut, Diane D
• Application Number:
  US16/435,687
• Publication Number:
  US 20200093589A1
• Time in Patent Office: 288 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Abstract

The invention relates to a transcatheter heart valve replacement (A61F2/2412), and in particular to a side delivered large diameter, low profile transcatheter prosthetic valve having a compressible tubular frame having a side wall and a central axial lumen, said tubular frame having a height of 8-20 mm and a diameter of 40-80 mm, an atrial sealing cuff, a subannular anchoring component, and aa flow control component comprising a leaflet structure, wherein the valve is side-delivered longitudinally to a mitral valve annulus or tricuspid valve annulus of a patient using a 22-34 Fr delivery catheter.

Claims

1. A side-delivered transcatheter prosthetic valve comprising:

a compressible tubular frame having a side wall and a central axial lumen, said tubular frame having a height of 8-20 mm and a diameter of 40-80 mm,

an atrial sealing cuff attached to a top edge of the side wall,

a subannular anchoring component attached to the tubular frame, said subannular anchoring component selected from one or more of the group consisting of a lower tension arm extending from a distal side of the tubular frame, a proximal anchoring tab extending from a proximal side of the tubular frame, a ventricular sealing collar attached to a bottom edge of the side wall, and at least one tissue anchor to connect the tubular frame to native tissue, and

a flow control component comprising a leaflet structure having three leaflets of pericardial material sewn to a leaflet frame to form a rounded cylinder mounted within the lumen of the tubular frame and configured to permit blood flow in a first direction through an inflow end of the valve and block blood flow in a second direction, opposite the first direction, through an outflow end of the valve,

wherein the valve is compressible to a compressed configuration for introduction into the body using a delivery catheter for implanting at a mitral valve annulus or tricuspid valve annulus of a patient, said delivery catheter having an internal diameter from 22 Fr (7.33 mm) to 34 Fr (11.33 mm),

said compressed configuration having a long-axis that is substantially parallel to a length-wise cylindrical axis of the delivery catheter, and substantially orthogonal to the blood flow through the flow control component mounted in the central axial lumen,

said compressed configuration having a height and a width to fit within the delivery catheter, the height and width of the compressed configuration compressed by longitudinal/length-wise rolling or folding,

wherein the valve is expandable to an expanded configuration having a long-axis substantially orthogonal to the blood flow through the flow control component mounted in the central axial lumen,

said tubular frame and said atrial sealing cuff having a polyester cover, and said tubular frame and said atrial sealing cuff made from superelastic shape-memory material selected from Ni—

Ti alloy, Cu—

Zn—

Al—

Ni alloys, Cu—

Al—

Ni alloys, a polymer composite, a composite containing one or more of carbon nanotubes, carbon fibers, metal fibers, glass fibers, and polymer fibers, a stainless steel, a cobalt chromium material, and a titanium material.

2. The valve of claim 1, wherein the at least one tissue anchor to connect the tubular frame to native tissue is an anterior leaflet clip or anchor, a posterior leaflet clip or anchor, or a septal leaflet clip or anchor.

3. The valve of claim 1, wherein said tubular frame is comprised of a braided, wire, or laser-cut wire frame, and said tubular frame is covered with a biocompatible material.

4. The valve of claim 1, wherein the tubular frame has a side profile of a flat cone shape having a diameter R of 40-80 mm, a diameter r of 20-60 mm, and a height of 8-20 mm.

5. The valve of claim 1, wherein the tubular frame has an inner surface and an outer surface, said inner surface and said outer surface covered with pericardial tissue.

6. The valve of claim 1, wherein the tubular frame has a side profile of an hourglass shape having a top diameter R1 of 40-80 mm, a bottom diameter R2 of 50-70 mm, an internal diameter r of 20-60 mm, and a height of 8-20 mm.

7. The valve of claim 1, wherein the flow control component has an internal diameter of 20-60 mm and a height of 8-20 mm.

8. The valve of claim 1, wherein the flow control component is supported with one or more longitudinal supports integrated into or mounted upon the flow control component, the one or more longitudinal supports selected from rigid or semi-rigid posts, rigid or semi-rigid ribs, rigid or semi-rigid battons, rigid or semi-rigid panels, and combinations thereof.

9. The valve of claim 1, wherein the lower tension arm extending from the distal side of the tubular frame is comprised of wire loop or wire frame, integrated frame section, or stent, and extends from about 10-40 mm away from the tubular frame.

10. The valve of claim 1, comprising (i) an upper tension arm attached to a distal upper edge of the tubular frame, the upper tension arm comprised of wire loop or wire frame extending from about 2-20 mm away from the tubular frame, and (ii) the lower tension arm extending from the distal side of the tubular frame is comprised of wire loop or wire frame, integrated frame section, or stent, and extends from about 10-40 mm away from the tubular frame.

11. A method for side delivery of implantable prosthetic valve between a ventricle and an atrium of a heart, the method comprising the steps:

advancing a delivery catheter containing the valve of claim 1 in a compressed configuration to the atrium of the heart,

and

partially releasing the valve from the delivery catheter to position a distal side wall of the tubular frame at an oblique angle against a distal portion of the native annulus and allowing blood to flow from the atrium to the ventricle both through the native valve and through the prosthetic valve,

releasing the remainder of the prosthetic valve from the delivery catheter to an expanded configuration to assess valve function at the oblique angle before seating the valve completely into the native annulus,

pushing a proximal side wall of the tubular frame into the native annulus to complete seating of the valve in the native annulus, wherein said atrial sealing cuff is disposed on the atrial floor and the tubular frame is seated within the native annulus, and

anchoring the subannular anchoring component of the valve to native annular or subannular tissue,

wherein the native valve is a tricuspid valve or a mitral valve.

12. The method of claim 11, wherein releasing the valve from the delivery catheter is selected from the steps consisting of:

(i) pulling the valve out of the delivery catheter using a rigid elongated pushing rod that is releasably connected to the distal side of the valve, wherein advancing the pushing rod away from the delivery catheter pulls the compressed valve out of the delivery catheter, or (ii) pushing the valve out of the delivery catheter using a rigid elongated pushing rod that is releasably connected to the proximal side of the valve, wherein advancing the pushing rod out of from the delivery catheter pushes the compressed valve out of the delivery catheter.

13. The method of claim 11, comprising the additional step of anchoring one or more secondary tissue anchors attached to the valve into native tissue.

14. The method of claim 11, wherein the subannular anchoring component is a lower tension arm extending from a distal side of the tubular frame.

15. The method of claim 11, comprising the additional step of rotating the heart valve prosthesis using a steerable catheter along an axis parallel to the plane of the valve annulus, wherein an upper tension arm mounted on the valve is conformationally pressure locked against supra-annular tissue, and wherein the lower tension arm mounted on the valve is conformationally pressure locked against sub-annular tissue.