Method of making an introducer sheath with an inner liner

• US 10,595,993 B2
• Filed: 10/02/2018
• Issued: 03/24/2020
• Est. Priority Date: 12/05/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Siegel, Alexander J., Bakis, George
• Primary Examiner(s): Lee, Edmund H
• Application Number:
  US16/150,035
• Publication Number:
  US 20190029818A1
• Time in Patent Office: 539 Days
• Field of Search: None
• 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 pertains to new methods of making an introducer sheath with an inner liner for percutaneous insertion of a medical device into a patient. The present disclosure also discloses embodiments of catheter-based prosthetic heart valves, including, 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.

Claims

1. 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.

2. The method of claim 1, wherein the preform cylindrical polymer tube is made of nylon-12, polyethylene, or fluorinated ethylene propylene.

3. The method of claim 1, 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).

4. The method of claim 1, 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).

5. The method of claim 1, wherein pressurizing and heating the polymer tube comprises injecting heated compressed gas into the polymer tube.

6. The method of claim 1, 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.

7. The method of claim 1, wherein the metal sleeve comprises a plurality of circumferentially or helically extending slots.

8. The method of claim 1, wherein the introducer sheath is configured for percutaneous insertion of a prosthetic heart valve through the femoral artery of the patient.

9. The method of claim 1, further comprising forming an outer polymer liner on the metal sleeve.

10. A method of making an introducer sheath configured for percutaneous insertion of a prosthetic heart valve through a blood vessel of the 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, wherein pressurizing the polymer tube comprises injecting compressed gas into the polymer tube.

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 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 blood vessel is the femoral artery of the patient.

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