Method of making an introducer sheath with an inner liner

Patent metadata

Field	Value
Publication number	US-10595993-B2
Application number	US-201816150035-A
Country	US
Kind code	B2
Filing date	Oct 2, 2018
Priority date	Dec 5, 2013
Publication date	Mar 24, 2020
Grant date	Mar 24, 2020

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.

First claim

What is claimed is:

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.

Assignees

• Edwards Lifesciences Corp

Inventors

• Siegel Alexander J
• Bakis George

Classifications

• A61F2240/001

  Designing or manufacturing processes · CPC title

• A61F2210/0076

  multilayered, e.g. laminated structures · CPC title

• A61F2250/0069

  Sealing means · CPC title

• A61F2250/0039

  differing in diameter · CPC title

• A61F2/2475

  Venous valves · CPC title