Valve replacement systems and methods

• US 10,285,810 B2
• Filed: 07/28/2016
• Issued: 05/14/2019
• Est. Priority Date: 04/19/2012
• Status: Active Grant

• Current Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Original Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Inventors: Schweich, Jr., Cyril J., Mortier, Todd J.
• Primary Examiner(s): Louis, Richard G
• Application Number:
  US15/221,873
• Publication Number:
  US 20160331526A1
• Time in Patent Office: 1,020 Days
• 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 2/2409 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: F04C 2270/041 Controlled or regulated

Abstract

Systems and methods for medical interventional procedures, including approaches to valve implant. In one aspect, the methods and systems involve a modular approach to treatment.

Claims

1. A percutaneous mitral valve replacement system configured to be implanted at a mitral valve site within a heart having a mitral valve annulus and native leaflets, comprising:

an expandable frame structure that is percutaneously deliverable to the heart and having a central orifice and an inlet upper end configured to extend to a supra-annular position above the mitral valve annulus in the left atrium;

multiple sub-annular anchoring feet extending from an outlet a lower end of the expandable frame structure to engage sub-annular tissue below the annulus in the left ventricle;

a flexible sealing skirt mounted along an outer circumferential periphery of the expandable frame structure to seal against the mitral valve annulus and positioned above the multiple sub-annular anchoring feet and below the inlet upper end of the expandable frame structure, the flexible sealing skirt comprising a material to receive tissue ingrowth; and

a set of leaflets coupled to the expandable frame structure between the flexible sealing skirt and the inlet end of the expandable frame structure, the set of leaflets configured to occlude the central orifice during systole and to be open to flow during diastole.

2. The system of claim 1, wherein the flexible sealing skirt expands outwardly in response to pressures within the heart.

3. The system of claim 2, wherein the flexible sealing comprises a polyester skirt.

4. The system of claim 1, further comprising a delivery catheter having a catheter tip, wherein the sub-annular anchoring feet are configured to exit the delivery catheter while the catheter tip resides in the left atrium.

5. The system of claim 1, wherein the expandable frame structure is movable between a compressed configuration for percutaneous delivery to the heart and an expanded configuration.

6. The system of claim 5, wherein the expandable frame structure comprises a nitinol frame and a covering material over at least a portion of the nitinol frame.

7. The system of claim 6, wherein the flexible sealing skirt is configured to seal against tissue of the mitral valve annulus to prevent peri-valvular flow.

8. The system of claim 7, wherein the multiple sub-annular anchoring feet comprise commissural feet deployable behind the anterior and posterior leaflets to provide direct mechanical holding of the frame structure.