SLEEVE FOR MEDICAL DEVICE ASSEMBLY

• US 20140120287A1
• Filed: 10/29/2013
• Published: 05/01/2014
• Est. Priority Date: 10/30/2012
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Jacoby, Russell L., Sloan, Andrew W.
• Granted Patent: US 10,010,654 B2
• Time in Patent Office: Days
• US Class Current: 428/36.91
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: B29C 2053/365 provided with a string
• CPC Class Codes: B29C 53/20 of tubes
• CPC Class Codes: B29C 53/56 Winding and joining, e.g. winding spirally winding in general B65H
• CPC Class Codes: B29D 23/00 Producing tubular articles B29D24/00 takes precedence
• CPC Class Codes: B65B 11/00 Wrapping, e.g. partially or wholly enclosing, articles or quantities of material, in strips, sheets or blanks, of flexible material bundling articles by applying narrow strips or bands of flexible material B65B13/00
• CPC Class Codes: Y10T 428/1393 Multilayer [continuous layer]
• CPC Class Codes: Y10T 428/24777 Edge feature

Abstract

The present disclosure describes a medical device assembly comprising an expandable medical device wrapped with an improved constraining sleeve. The sleeve in accordance with various embodiments of the present disclosure is thin walled and translucent, having reduced edge sharpness. The sleeve in accordance with the present disclosure exhibits resistance to ripping and delamination. Various embodiments of the present disclosure provide methods of making sheet material usable for constraining sleeves from flattened film tubes. Methods for making improved constraining sleeves and medical device assemblies that comprise an improved constraining sleeve are also disclosed herein.

Claims

1. A method of manufacturing a constraining sleeve comprising:

applying at least one first layer of film around an outer surface of a longitudinally extending mandrel;

orienting at least one reinforcing fiber longitudinally along said mandrel and against said at least one first layer of film;

applying at least one additional layer of film around said mandrel over both of said first layer of film and said at least one reinforcing fiber;

forming a film tube by bonding said layers;

removing said film tube from said mandrel;

flattening said film tube into a sheet material having generally parallel opposing edges; and

shaping said flattened film tube into a tubular shape by bringing said opposing edges into proximity.

2. The method of claim 1, wherein said at least one reinforcing fiber is disposed along at least one of said opposing edges and embedded within said sheet material.

3. The method as in any one of claim 1, further comprising at least two reinforcing fibers, wherein at least one of said at least two reinforcing fibers is disposed along each of said opposing parallel edges and embedded within said sheet material.

4. The method as in any one of claim 1, further comprising two reinforcing fibers, wherein each one of the said two fibers is disposed along each one of said opposing parallel edges, with each of said fibers embedded within said sheet material.

5. The method as in any one of claim 1, wherein said sheet material has a thickness of less than about 0.12 mm and a visible light transmission of about 80% or greater.

6. The method as in any one of claim 1, wherein said sheet material has a thickness of less than about 0.10 mm.

7. The method as in any one of claim 1, wherein said sheet material has a thickness of from about 0.08 mm to about 0.10 mm.

8. The method as in any one of claim 1, wherein said sheet material has a visible light transmission of about 90% or greater.

9. The method as in any one of claim 1, wherein said sheet material has a visible light transmission of about 95% or greater.

10. The method as in any one of claim 1, further comprising piercing a row of openings along each of said opposing edges.

11. The method as in any one of claim 1, wherein said sheet material comprises expanded polytetrafluoroethylene.

12. A sheet material comprising:

a laminate of at least four bonded layers of expanded polytetrafluoroethylene film; and

at least one length of reinforcing fiber embedded between any of said bonded layers,

wherein said sheet material is from about 0.08 mm to about 0.10 mm thick, having a burst strength of 400 psi or greater.

13. The sheet material of claim 12, further comprising at least two lengths of reinforcing fiber, wherein said sheet material includes two generally parallel and opposing edges with one of said lengths of reinforcing fiber disposed along each of said two opposing edges.

14. The sheet material of claim 12 having a visible light transmission of about 80% or greater.

15. The sheet material of claim 12 having a visible light transmission of about 90% or greater.

16. The sheet material of claim 12 having a visible light transmission of about 95% or greater.

25. A method of manufacturing a medical device assembly comprising:

wrapping the sheet material as in claim 13 circumferentially around an expandable medical device compressed into a outer peripheral dimension suitable for introduction into a body conduit;

piercing two rows of openings along each of said opposing edges; and

coupling said opposing edges by stitching an elongated coupling member through said openings to produce a releasable seam.

17. A constraining sleeve comprising:

at least one layer of expanded polytetrafluoroethylene film; and

at least one reinforcing fiber,

wherein said sleeve has a burst strength of equal to or greater than 400 psi and a wall thickness of less than about 0.12 mm.

18. The constraining sleeve of claim 17, wherein said sleeve is tubular, having a longitudinal axis, and wherein said at least one reinforcing fiber is embedded in said sleeve, disposed substantially parallel to said longitudinal axis.

19. The constraining sleeve of claim 17, further comprising two reinforcing fibers.

20. The constraining sleeve of claim 17, having a wall thickness of less than about 0.10 mm.

21. The constraining sleeve of claim 17, having a wall thickness of from about 0.08 mm to about 0.10 mm.

22. The constraining sleeve of claim 17, having a visible light transmission of about 80% or greater.

23. The constraining sleeve of claim 17, having a visible light transmission of about 90% or greater.

24. The constraining sleeve of claim 17, having a visible light transmission of about 95% or greater.

26. A method of manufacturing a constraining sleeve comprising:

applying at least one first layer of film around an outer surface of a longitudinally extending mandrel;

orienting two parallel reinforcing fibers longitudinally along said mandrel and against said at least one first layer of film, the two reinforcing fibers disposed on opposite sides of the mandrel having an approximate 180°

separation from one another along the length of the mandrel;

applying at least one additional layer of film around said mandrel over both of said first layer of film and said at least one reinforcing fiber;

forming a film tube by bonding said layers;

removing said film tube from said mandrel;

flattening said film tube into a sheet material having generally parallel opposing edges, the parallel reinforcing fibers being disposed essentially along the parallel opposing edges, said sheet having an excess film material extending to a length beyond a boundary of one of the reinforcing fibers, wherein the excess film material extended length is less than about 0.5 mm; and

shaping said flattened film tube into a tubular shape by bringing said opposing edges into proximity.

27. The method of claim 26 wherein said sheet material has a thickness of less than about 0.12 mm and a visible light transmission of about 80% or greater.

28. The method of claim 26 further comprising piercing two rows of openings along each of said generally opposing opposing edges;

and

coupling said opposing edges by stitching an elongated coupling member through said openings to produce a tubular form with a releasable seam.

29. The method of claim 28 wherein said tubular form has a wall thickness from about 0.08 mm to about 0.10 mm thick and having a burst strength of 400 psi or greater.