Self-expanding endoprosthesis

• US 6,051,021 A
• Filed: 05/26/1998
• Issued: 04/18/2000
• Est. Priority Date: 05/27/1997
• Status: Expired due to Term

• Current Assignee: Medicorp R&D Benelux, S.A.
• Original Assignee: Medicorp, S.A.
• Inventors: Frid, Noureddine
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US09/083,974
• Time in Patent Office: 693 Days
• Field of Search: 623/1, 623/12, 606/195, 606/198
• US Class Current: 623/1.2
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes

Abstract

A luminal endoprosthesis comprising a framework made up of braided filaments. The framework is self-expanding, that is to say that after it has been radially compressed for positioning of the endoprosthesis, it automatically recovers its nominal diameter. The metal of the framework has undergone a thermal treatment bringing about a state transition, at a temperature close to that of the organism, and this confers upon it a suitable rigidity after it has been positioned in an anatomical conduit.

Claims

1. A luminal endoprosthesis, adapted for introduction into an anatomical conduit of an organism, comprising:

a self-expandable braided framework of filaments, radially expandable to a nominal diameter, said filaments including a temperature transitionable material;

said temperature transitionable material of said framework being adapted to experience a phase transition in which a rigidity of said transitionable material changes from a first rigidity to a second rigidity, greater than said first rigidity, at a temperature equal to or lower than a temperature of said organism; and

said framework being compressible to a reduced diameter for introduction into said anatomical conduit of said organism, and upon release of compression, said framework being adapted to spontaneously adopt said nominal diameter independent of a temperature surrounding said framework and said phase transition.

2. An endoprosthesis according to claim 1, wherein at its nominal diameter, the braided filaments form between each other, along at least a section of the braid, an angle .sub.α

between 30° and

95°

.

3. An endoprosthesis according to claim 2, wherein the angle .sub.α

is between 50 and 90°

.

4. An endoprosthesis according to claim 2, wherein the angle .sub.α

varies along the length of the braid.

5. An endoprosthesis according to claim 1, wherein the metal of the filaments is superelastic.

6. An endoprosthesis according to claim 5, wherein the metal of the filaments is chosen from the group consisting in the nickel/titanium alloys and the nickel/titanium/cobalt alloys.

7. An endoprosthesis according to claim 6, wherein the alloy comprises between 52 and 56% by weight of nickel.

8. Method for manufacturing an endoprosthesis according to claim 1, comprising the following operations:

producing filaments made of an elastic metal on which it is possible to confer a transition of atomic structure, causing it to change from a given rigidity to a greater rigidity,

braiding these filaments around a mandrel in such a way as to obtain a braid, of a given nominal diameter,

subjecting sections of this braid, at their nominal diameter, to a thermal treatment establishing a phase transition at a temperature equal to or lower than the temperature of a warm-blooded organism,

placing an optional coating on the said framework,

cutting the sections of braid into segments of suitable length.

9. Method according to claim 8, wherein

the braiding is effected using cold-hammered nickel/titanium filaments from the die, and in that

the thermal treatment comprises at least one heating operation in a zone between 400°

and 600°

C., and air cooling.

10. Method according to claim 9, wherein the thermal treatment is carried out at 500°

C. for 10 minutes.

11. Method according to claim 8, wherein the braiding is carried so that the filaments form between each other at least along a section of the braid, an angle .sub.α

of between 30° and

95°

.

12. An endoprosthesis as claimed in claim 1, wherein said nominal diameter of said framework varies along a length of said framework.

13. An endoprosthesis as claimed in claim 1, wherein said temperature at which said temperature transitionable material of said framework experiences said phase transition is 37°

C.

14. A method of placing a self-expanding endoprosthesis in an anatomical conduit of an organism, said endoprosthesis being radially expandable to a nominal diameter and including a temperature transitionable material, said method comprising the steps of:

placing said endoprosthesis in an environment having a temperature at or below a transition temperature at which said endoprosthesis experiences a phase transition in which a rigidity of said transitionable material changes from a first rigidity to a second rigidity, greater than said first rigidity, said transition temperature being a temperature equal to or lower than a temperature of said organism;

compressing said endoprosthesis to reduce a diameter of said endoprosthesis from said nominal diameter to a reduced diameter for introduction into said anatomical conduit of said organism;

introducing said compressed endoprosthesis into said anatomical conduit; and

releasing compression from said endoprosthesis to enable said endoprosthesis to spontaneously adopt said nominal diameter independent of a temperature surrounding said endoprosthesis and said phase transition.

15. A method as claimed in claim 14, further comprising the step of:

exposing said endoprosthesis to said temperature of said organism to enable said endoprosthesis to experience said phase transition in which said rigidity of said transitionable material changes to said second rigidity.

16. A method as claimed in claim 14, wherein said endoprosthesis includes a braided framework of filaments.

17. A method as claimed in claim 14, wherein said transition temperature is 37°

C.

18. A luminal endoprosthesis, adapted for introduction into an anatomical conduit of an organism, comprising:

a self-expandable framework, radially expandable to a nominal diameter and including a temperature transitionable material;

said temperature transitionable material of said framework being adapted to experience a phase transition in which a rigidity of said transitionable material changes from a first rigidity to a second rigidity, greater than said first rigidity, at a transition temperature within a predefined temperature range; and

said framework being compressible to a reduced diameter for introduction into said anatomical conduit of said organism, and upon release of compression, said framework being adapted to spontaneously adopt said nominal diameter independent of a temperature surrounding said framework and said phase transition.

19. A luminal endoprosthesis as claimed in claim 18, wherein said framework includes a braided framework of filaments.

20. A luminal endoprosthesis as claimed in claim 18, wherein said predefined temperature range is between 30°

C. and 40°

C.

21. A luminal endoprosthesis as claimed in claim 18, wherein said transition temperature is 37°

C.