Method of forming a tubular membrane on a structural frame

• US 7,270,675 B2
• Filed: 03/28/2003
• Issued: 09/18/2007
• Est. Priority Date: 05/10/2002
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Majercak, David Christopher, Chun, Iksoo, Roller, Mark B.
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US10/402,048
• Publication Number:
  US 20030209835A1
• Time in Patent Office: 1,635 Days
• Field of Search: 623/1.15, 623/1.24, 623/1.26, 623/1.42, 623/1.39, 623/1.44, 623/1.45
• US Class Current: 623/1.15
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/91583 by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: D01D 5/0084 Coating by electro-spinning, i.e. the electro-spun fibres are not removed from the collecting device but remain integral with it, e.g. coating of prostheses
• CPC Class Codes: D01F 6/32 comprising halogenated hydrocarbons as the major constituent
• CPC Class Codes: D01F 6/84 from copolyesters
• CPC Class Codes: D04H 3/07 : otherwise than in a plane, e.g. in a tubular way

Abstract

The present invention relates to a medical device and method of forming the medical device. In particular, the present invention relates to a medical device having a tubular membrane structure over a radially expandable structural frame, and to a method of forming the tubular membrane on the radially expandable structural frame. In one aspect, a structural frame is placed over a spinning mandrel and a fiber is electro-statically spun over at least a portion of the structural frame forming a membrane. A transfer sheath may be used between the mandrel and structural frame to prevent the electro-statically spun fiber from adhering to the mandrel. In another aspect, a first membrane is spun over the mandrel before the structural frame is placed over the mandrel. In this aspect, at least a portion of the structural frame is sandwiched between the membranes. The membrane or membranes and structural frame form a fiber spun frame assembly. The fiber spun frame assembly may be coated with an elastic polymer. In addition, the membrane or membranes may go through some post processing to achieve desired characteristics or configurations.

Claims

1. A medical device having a tubular membrane structure comprising:

a radially expandable structural frame, including a proximal anchor having a substantially cylindrical configurations with first and second open ends and a longitudinal axis extending there between, and a plurality of connecting members each having a first and a second end and being oriented parallel to the longitudinal axis, wherein the first end of each connecting member is attached to the proximal anchor;

a polymer fiber membrane electrostatically spun over at least a portion of the exterior surface of the connecting members; and

a polymeric outer membrane coated over the fiber membrane, the polymeric outer membrane and fiber membrane combining to form the tubular membrane structure, the tubular membrane structure terminating with a plurality of, supple valve flaps, each supple valve flap having a distally oriented leading edge defined along the circumference of the tubular membrane structure by adjacent connecting members, wherein the leading edge of the supple valve flap is frameless.

2. The medical device of claim 1 wherein the polymer fiber membrane comprises a fluoropolymer.

3. The medical deice of claim 2 wherein the fluoropolymer is a vinylidene fluoride/hexofluoropropylene having a weight to weight ratio in the range from about 75%/25% to about 100%/0%.

4. The medical device of claim 1 wherein the polymer fiber membrane is a bioabsorbable polymer.

5. The medical device of claim 4 wherein the bioabsorbable polymer is a polylactic acid/polycaprolactone having a weight to weight ratio of between 50%/50% and 70%/30%.

6. The medical device of claim 4 wherein the bioabsorbable polymer is a polyglycolic acid/polycaprolactone having a weight to weight ratio of between 50%/50% and 70%/30%.

7. The medical device of claim 1 wherein the polymer fiber membrane comprises a bioabsorbable polymer from the group consisting of homopolymers and copolymers.

8. The medical device of claim 1 wherein the polymer fiber membrane comprises a polymer from the group consisting of nonabsorbable siliconized polyurethane, non-siliconized polyurethane, siliconized polyureaurethane and natural polymers.

9. The medical device of claim 1 wherein the polymer fiber membrane comprises a therapeutic agent.

10. The medical device of claim 1 wherein the polymer fiber membrane comprises a pharmaceutic agent.

11. The medical device of claim 1 wherein the polymer fiber membrane has a wall thickness in the range from about 5 μ

m to about 100 μ

m.

12. The medical device of claim 1 wherein the outer membrane comprises a polymer.

13. The medical device of claim 12 wherein the polymer is a fluoropolymer.

14. The medical deice of claim 13 wherein the fluoropolymer is a vinylidene fluoride/hexofluoropropylene having a weight to weight ratio in the range from about 50%/50% to about 70%/30%.

15. The medical device of claim 12 wherein the polymer is siliconized polyurethane.

16. The medical device of claim 12 wherein the polymer is non-siliconized polyurethane.

17. The medical device of claim 12 wherein the polymer comprises a therapeutic agent.

18. The medical device of claim 12 wherein the polymer comprises a pharmaceutic agent.

19. The medical device of claim 1 wherein the tubular membrane structure has a wall thickness in the range from about 5 μ

m to about 100 μ

m.