ANATOMICALLY-ORIENTATED AND SELF-POSITIONING TRANSCATHETER MITRAL VALVE

• US 20160206424A1
• Filed: 10/14/2014
• Published: 07/21/2016
• Est. Priority Date: 10/15/2013
• Status: Active Grant

• Current Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Original Assignee: Cedars-Sinai Medical Center (Cedars Sinai Health System)
• Inventors: Al-Jilaihawi, Hasanian, Makkar, Rajendra
• Granted Patent: US 10,226,333 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

Described herein is a mitral valve and systems and methods for implanting the same. The mitral valve device is designed to easily orient to and conform to the mitral orifice natural morphology. This mitral valve system may be implanted using a system of 2 guide wires that facilitate orientation of the flat portion of the stent properly with the flat portion of the mitral valve that is adjacent to the aortic valve. Additionally, the disclosed valve may have multiple mounds distributed across the outer surface of the valve/stent complex so as to prevent or reduce paravalvular leak after implantation.

Claims

1. A system for mitral valve replacement in a subject in need thereof comprising:

a mitral valve

a D-shaped stent frame connected to the mitral valve;

an anchor comprising a right arm and a left arm, wherein the right arm of the anchor is connected to the D-shaped stent frame and the right and the left arm of the anchor are connected;

a cylindrical sheath, comprising;

a proximal end, a distal end and an elongated body, wherein the cylindrical sheath is configured to be advanced transapically into the left ventricle;

a first guide wire, comprising a proximal end and a distal end, wherein

the first guide wire is configured to be advanced through the cylindrical sheath and through the aortic valve into the aorta;

a second guide wire comprising a proximal end and a distal end, wherein the second guide wire is configured to be advanced through the cylindrical sheath, mitral valve and the left atrium into the right upper pulmonary vein, and wherein the second and first guide wires are configured to be advanced and retracted independently of each other;

a first catheter, comprising;

a hollow proximal end, a conical closed distal end and an elongated central shaft with a hollow central lumen configured to advance over the first guide wire, wherein the hollow proximal end of the first catheter is expandable and collapsible and wherein the first catheter is configured to carry the left arm of the anchor;

a second catheter, comprising;

a hollow proximal end, a conical closed distal end and an elongated central shaft with a hollow central lumen configured to advance over the second guide wire, wherein the hollow proximal end of the second catheter is expandable and collapsible and wherein the second catheter is configured to carry the right arm of the anchor; and

a third catheter comprising;

a proximal end, a distal end, an elongated hollow body wherein the third catheter makes contact with the first and second catheters and the first, second and third catheters are designed to be advanced as one in vivo.

2. The system of claim 1, wherein the anchor is U-shaped.

3. The system of claim 1, wherein the first and second catheters are configured so that they may be advanced and retracted independently of each other.

4. The system of claim 1, wherein the mitral valve has mounds that are configured to prevent paravalvular leaks.

5. The system of claim 4, wherein the mounds are coated with therapeutic agents.

6. The system of claim 5, wherein the therapeutic agents are any one or more of but are not limited to pro-coagulant agents or materials such fibrinogen or collagen, antibodies or chemoattractants that may recruit cells, such as CD34 or interleukins.

7. The system of claim 1, wherein the mitral valve comprises one, two or three leaflets.

8. A method for replacing a diseased mitral valve in a subject in need thereof comprising:

providing the system of claim 1;

loading the left and right arms of the anchor into the first and second catheters respectively;

positioning the third catheter, so that the proximal end of the third catheter surrounds the proximal end of the first and second catheters;

inserting a cylindrical sheath into the left ventricle of the subject;

inserting a first guide wire through the cylindrical sheath into the aorta of the subject;

inserting a second guide wire through the cylindrical sheath and into the right upper pulmonary vein through the left atrium of the subject;

simultaneously advancing the first, second and third catheters through the cylindrical sheath into the left ventricle;

advancing the first catheter across the aortic valve over the first guide wire so that the left arm of the anchor contacts the LVOT aspect of the anterior mitral leaflet and the aortic mitral continuity below the aortic valve;

deploying the anchor and retracting the first catheter;

advancing the second catheter such that the right arm of the anchor contacts the atrial aspect of the anterior mitral leaflet and the aortic mitral continuity and the D-shaped valve is aligned with the subject'"'"'s mitral valve;

deploying the D-shaped valve;

retracting the second and third catheter; and

retracting the guide wires and the cylindrical shaft.

9. The method of claim 8, wherein the replacement valve is inserted transapically.

10. The method of claim 8, wherein the subject is a mammal.

11. The method of claim 8, wherein the subject is a human.

12. The method of claim 8, wherein the anchor is U-shaped.

13. A device comprising:

a mitral valve;

a D-shaped stent frame containing the mitral valve; and

an anchor comprising a right arm and a left arm so as to anchor the stent frame to the aortic mitral continuity and the anterior mitral leaflet.

14. The device of claim 13, wherein the right arm of the U-shaped anchor is integrated with the D-shaped stent frame.

15. The device of claim 13, wherein the anchor is U-shaped or V-shaped.

16. The device of claim 13, wherein the mitral valve has mounds so as to prevent paravalvular leaks.

17. The device of claim 13, wherein the flat portion of the D-shaped stent frame is in close proximity to the connection between the right arm and the left arm of the anchor.

18. The device of claim 14, wherein the mounds are coated with therapeutic agents.

19. The device of claim 18, wherein the therapeutic agents are any one or more of but are not limited to pro-coagulant agents or materials such fibrinogen or collagen, antibodies or chemo-attractants that may recruit cells, such as CD34 or interleukins.

20. The device of claim 13, wherein the mitral valve comprises one, two or three leaflets.