HEAT-TREATED BRAIDED INTRAVASCULAR DEVICES AND METHODS

• US 20160081825A1
• Filed: 10/09/2015
• Published: 03/24/2016
• Est. Priority Date: 01/04/2012
• Status: Abandoned Application

• Current Assignee: Rapid Medical Ltd.
• Original Assignee: Rapid Medical Ltd.
• Inventors: SUDIN, Yuri, ECKHOUSE, Ronen, FRIEDMAN, Aharon
• Application Number:
  US14/879,167
• Publication Number:
  US 20160081825A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2240/00 Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: D04C 1/06 Braid or lace serving particular purposes
• CPC Class Codes: D06C 7/00 Heating or cooling textile fabrics
• CPC Class Codes: D10B 2401/046 Shape recovering or form memory
• CPC Class Codes: D10B 2509/06 Vascular grafts; stents

Abstract

A process for making a product including an expandable member is provided. The process can include braiding a plurality of wires to form a tubular structure that is capable of being manipulated such that a region of the tubular structure changes in diameter from a first dimension to a second dimension different from the first dimension. The process can also include initially heat-treating the tubular structure while the region is in the first dimension, changing the diameter of the tubular structure such that the region achieves the second dimension, and subsequently heat-treating the tubular structure while the region is in the second dimension.

Claims

1. A product made by a process, the process comprising:

braiding a plurality of wires to form a tubular structure that is capable of being manipulated such that a region of the tubular structure changes in diameter from a first dimension to a second dimension different from the first dimension;

initially heat-treating the tubular structure while the region is in the first dimension;

changing the diameter of the tubular structure such that the region achieves the second dimension; and

subsequently heat-treating the tubular structure while the region is in the second dimension.

2. The product of claim 1, wherein the tubular structure is an intravascular device.

3. The product of claim 2, wherein the tubular structure is non-uniform in diameter.

4. The product of claim 2, wherein the tubular structure has opposing ends and wherein a tube diameter tapers at at least one of the opposing ends.

5. The product of claim 2, wherein the first dimension is greater than the second dimension.

6. The product of claim 2, wherein the initial heat-treating and the subsequent heat-treating occur for a period sufficient to enable the product to achieve an expansion ratio of at least about three.

7. The product of claim 2, the process further comprising enabling the tubular structure to cool between the initial heat treating and the subsequent heat treating.

8. The product of claim 2, the process further comprising at least one additional heat treatment of the tubular structure when the region is in a dimension different from the first dimension and the second dimension.

9. The product of claim 2, wherein the plurality of wires that form the tubular structure also form a guide wire.

10. The product of claim 2, wherein the plurality of wires are constructed of at least one metal, and wherein at least one of an initial heat treatment temperature and a subsequent heat treatment temperature exceeds 450 degrees Celsius.

11. The product of claim 2, wherein at least one of an initial heat treatment temperature and a subsequent heat treatment temperature is between 480 and 550 degrees Celsius.

12. The product of claim 10, wherein the at least one metal includes Nitinol.

13. The product of claim 5, wherein the subsequent heat treatment process biases the region to a contracted position of the second dimension, expandable to the first dimension via an application of force.

14. The product of claim 5, wherein the subsequent heat treatment biases the tubular structure to retain a contracted shape.

15. The product of claim 2, wherein the initial heat treatment and the subsequent heat treatment permit the region of the tubular structure to be controllably expanded and contracted between the first dimension and the second dimension.

16. The product of claim 1, wherein braiding is performed on a mandrel.

17. The product of claim 16, wherein initially heat-treating the tubular structure occurs while the tubular structure is on the mandrel.

18. The product of claim 1, wherein heat treating occurs by conveying hot air to the tubular structure while the tubular structure is retained on a mandrel.

19. The product of claim 1, wherein the first heat treating occurs with the tubular structure retained on a mandrel and the second heat treating occurs after the tubular structure is removed from the mandrel.

20. The product of claim 19, wherein prior to the second heat treating, at least one force is exerted on the tubular structure to thereby cause the diameter of the tubular structure to diminish.