PROSTHETIC HEART VALVE AND DELIVERY APPARATUS

• US 20150157455A1
• Filed: 12/04/2014
• Published: 06/11/2015
• Est. Priority Date: 12/05/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Bakis, George, Hoang, Lien-Huong T., Siegel, Alexander J.
• Granted Patent: US 10,098,734 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2/2415 Manufacturing methods
• 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: B29C 2049/2404 inside the article
• CPC Class Codes: B29C 49/24 Lining or labelling
• CPC Class Codes: B29C 49/26 : inner lining of tubes
• CPC Class Codes: B29C 63/34 : using tubular layers or sheathings
• CPC Class Codes: B29K 2101/12 : Thermoplastic materials
• CPC Class Codes: B29K 2705/00 : Use of metals, their alloys or their compounds, for preformed parts, e.g. for inserts

Abstract

The present disclosure is directed to embodiments of catheter-based prosthetic heart valves, and in particular, prosthetic heart valves having sealing members configured to seal the interface between the prosthetic valve and the surrounding tissue of the native annulus in which the prosthetic valve is implanted. The present disclosure also discloses new methods of making an introducer sheath with an inner liner for percutaneous insertion of a medical device into a patient.

Claims

1. A prosthetic heart valve, comprising:

a collapsible and expandable annular frame that is configured to be collapsed to a radially collapsed state for mounting on a delivery apparatus and expanded to a radially expanded state inside the body, the frame having an inflow end, an outflow end, and a longitudinal axis extending from the inflow end to the outflow end, the frame comprising a plurality of struts defining a plurality of rows of a plurality of cells;

a collapsible and expandable valve member mounted within the annular frame;

a collapsible and expandable skirt assembly mounted within the annular frame and comprising an upper skirt, a lower skirt, and a sealing skirt, wherein the upper and lower skirts prevent the sealing skirt from contacting the valve member, and wherein when the annular frame is expanded to its radially expanded state, portions of the sealing skirt protrude outwardly through cells of the frame.

2. The prosthetic heart valve of claim 1, wherein the sealing skirt is made of loop yarn.

3. The prosthetic heart valve of claim 1, wherein the sealing skirt is mounted within the annular frame of the prosthetic heart valve by sutures that secure the sealing skirt and the lower skirt to the frame of the prosthetic heart valve.

4. The prosthetic heart valve of claim 1, wherein the sealing skirt extends beyond the inflow end of the prosthetic heart valve.

5. The prosthetic heart valve of claim 1, wherein the sealing skirt comprises an upper edge and a lower edge shaped to correspond to the shape of a lower most row of cells of the frame.

6. The prosthetic heart valve of claim 1, wherein the upper skirt comprises an upper edge shaped to correspond to the shape of an upper boundary of the second most lower row of cells of the frame.

7. The prosthetic heart valve of claim 1, wherein, from the longitudinal axis:

the valve member is positioned radially outward from the lower skirt,

the upper skirt is positioned radially outward from the valve member; and

the sealing skirt is positioned radially outward from the upper skirt.

8. The prosthetic heart valve of claim 1, wherein the lower skirt, the valve member, and the upper skirt are coupled to each other by sutures.

9. The prosthetic heart valve of claim 1, wherein the

an outflow portion of the lower skirt is sutured to an inflow portion of the valve member;

and

the inflow portion of the valve member is sutured to an inflow portion of the upper skirt.

10. A method of making an introducer sheath with an inner liner for percutaneous insertion of a medical device into a patient, comprising:

inserting a metal sleeve into a mold;

inserting a polymer tube comprising a closed end and an open end into the metal sleeve;

pressurizing and heating the polymer tube to cause the polymer tube to expand against an inner surface of the metal sleeve so as to form the inner liner of the sheath.

11. The method of claim 10, wherein the preform cylindrical polymer tube is made of nylon-12, polyethylene, or fluorinated ethylene propylene.

12. The method of claim 10, wherein the polymer tube has a radial wall thickness in the range of from about 0.025 mm (about 0.001 inch) to about 0.075 mm (about 0.003 inch).

13. The method of claim 10, wherein the metal sleeve has a radial wall thickness in the range of from about 0.05 mm (about 0.002) to 0.15 mm (about 0.006 inch).

14. The method of claim 10, wherein pressurizing and heating the polymer tube comprises injecting heated compressed gas into the polymer tube.

15. The method of claim 10, wherein pressurizing the polymer tube comprises injecting compressed gas into the polymer tube and wherein heating the polymer tube comprises heating with a heat source separate from the pressurized gas.

16. The method of claim 10, wherein the metal sleeve comprises a plurality of circumferentially or helically extending slots.

17. The method of claim 10, wherein the introducer sheath is configured for percutaneous insertion of a prosthetic heart valve through the femoral artery of the patient.

18. The method of claim 10, further comprising forming an outer polymer liner on the metal sleeve.