Apparatus for contracting, loading or crimping self-expanding and balloon expandable stent devices

• US 6,915,560 B2
• Filed: 05/23/2003
• Issued: 07/12/2005
• Est. Priority Date: 09/22/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Austin, Michael
• Primary Examiner(s): JIMENEZ, MARC QUEMUEL
• Application Number:
  US10/444,807
• Publication Number:
  US 20030192164A1
• Time in Patent Office: 781 Days
• Field of Search: 292/831.5, 297/51, 295/16, 292/37, 292/43, 295/17, 295/08, 292/835, 724/02, 606/1
• US Class Current: 29/722
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9524 Iris-type crimpers
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: Y10T 29/4981 Utilizing transitory attached element or associated separate material
• CPC Class Codes: Y10T 29/49865 by temperature differential [e.g., shrink fit]
• CPC Class Codes: Y10T 29/49908 Joining by deforming
• CPC Class Codes: Y10T 29/49913 by constricting outer annulus
• CPC Class Codes: Y10T 29/49925 Inward deformation of aperture or hollow body wall
• CPC Class Codes: Y10T 29/49927 Hollow body is axially joined cup or tube
• CPC Class Codes: Y10T 29/53096 including means to provide a controlled environment
• CPC Class Codes: Y10T 29/5367 Coupling to conduit
• CPC Class Codes: Y10T 29/53717 Annular work
• CPC Class Codes: Y10T 29/53987 Tube, sleeve or ferrule
• CPC Class Codes: Y10T 29/53996 by deforming

Abstract

An apparatus for manipulating a medical device is formed of at least three coupled movable blades which are disposed about a reference circle to form an aperture whose size may be varied. The aperture capable of being sized to contain a medical device. Each blade is in communication with an actuation device which is capable of moving the blade to alter the size of the aperture. Each blade includes a single radial point which a) lies on the circumference of the reference circle prior to movement of the blade, and b) may be moved only along a radius of the reference circle on movement of the blade.

Claims

1. A stent crimper comprising:

a plurality of movable dies arranged to form an iris having a longitudinal axis, the iris defining an aperture, the dies disposed about the aperture and between stationary end-walls which are disposed about the longitudinal axis, at least one of the stationary end-walls operatively engaged to the dies at distinct connection locations such that the number of distinct connection locations and the number of dies are the same;

each die having a first straight side and a second straight side, the first straight side and the second straight side convering to form a tip;

wherein a portion of the first straight side of each die faces the aperture, each first straight side parallel to the second side of an adjacent die.

2. The stent crimper of claim 1 having a rotatable actuation device coupled to the dies, rotation of the actuation device causing the dies to move inward and reduce the size of the aperture or outward so as to increase the size of the aperture.

3. The stent crimper of claim 1 the dies are cooled below ambient temperature.

4. The stent crimper of claim 3 including a stent within the aperture.

5. The stent crimper of claim 4 wherein the stent is made of nitinol.

6. The stent crimper of claim 1 wherein at least 8 dies are provided.

7. The stent crimper of claim 1 wherein at least 16 dies are provided.

8. The stent crimper of claim 1 wherein the dies are moved cooperatively inward during the moving step.

9. The stent crimper of claim 1 wherein the dies are wedge-shaped.

10. A stent crimper comprising:

a plurality of movable dies arranged to form an iris, the dies disposed about an aperture, the aperture having a longitudinal axis and a substantially regular polygonal shape, each of the dies having an inward facing straight side which faces the longitudinal axis of the aperture, both when the dies move to maximize the aperture and when the dies move to minimize the aperture, the dies between two stationary end-walls disposed about the longitudinal axis, the longitudinal axis passing through a point substantially centered on the end-walls,

a rotatable actuation device coupled to the dies, rotation of the actuation device causing the inward facing straight sides of the dies to move inward and reduce the size of the aperture or outward so as to increase the size of the aperture.

11. The stent crimper of claim 10 wherein a stent is disposed about a medical balloon, the medical balloon disposed about a catheter.

12. The stent crimper of claim 11 having a stent, wherein the stent is made of nitinol.

13. The stent crimper of claim 10 wherein a stent is cooled below ambient temperature prior to reducing the size of the aperture.

14. The stent crimper of claim 10 wherein the dies are wedge-shaped.

15. The stent crimper of claim 10 wherein at least 8 dies are provided.

16. The stent crimper of claim 10 wherein at least 16 wedge-shaped dies are provided.

17. The stent crimper of claim 10 wherein an entire stent is disposed in the aperture.

18. A stent crimper comprising:

eight or more movable dies arranged to form an iris, the iris defining an aperture of a substantially regular polygonal shape, the aperture having a longitudinal axis, each die having an inward facing flat portion which faces the longitudinal axis of the aperture both when the dies move to maximize the aperture and when the dies move to minimize the aperture, the dies between stationary end walls and operatively engaged to at least one of the stationary end-walls, the stationary end-walls disposed about the longitudinal axis,

the iris comprising at least eight of the inward facing flat portions, the aperture being reducible in size by moving the inward facing flat portions toward the longitudinal axis of the aperture,

a rotatable actuation device coupled to the dies, rotation of the actuation device causing the inward facing straight sides of the dies to move inward and reduce the size of the aperture or outward so as to increase the size of the aperture.

19. The stent crimper of claim 18 wherein a stent is disposed about a medical balloon, the medical balloon disposed about a catheter.

20. The stent crimper of claim 18 wherein the dies are cooled below ambient temperature.

21. The stent crimper of claim 20 including a stent in the aperture, wherein the stent is made of nitinol.

22. A stent crimping assembly comprising a stent crimper as in claim 20 and a loading device for loading a stent in the aperture.

23. The stent crimper of claim 18 wherein the dies are wedge-shaped.

24. The stent crimper of claim 18 wherein at least 16 dies are provided.

25. The stent crimper of claim 18 wherein the dies are moved cooperatively inward during the moving step.

26. The stent crimper of claim 18 wherein an entire stout is disposed in the aperture.

27. A stent crimper comprising:

an aperture with a plurality of movable blades disposed thereabout, the aperture having a longitudinal axis and being substantially polygonal, the blades between stationary end-walls substantially centered about the longitudinal axis, the blades coupled to one another so as to be movable inward or outward simultaneously, movement of the blades outward increasing the size of the aperture, movement of the blades inward decreasing the size of the aperture, the aperture remaining substantially regular polygonal when it is sized to receive a stent therein and when the blades minimize the aperture.

28. The stent crimper of claim 27 further comprising a rotatable actuation device coupled to the blades, rotation of the actuation device causing the blades to move inward or outward.

29. The stent crimper of claim 28 wherein the dies arc cooled below ambient temperature.

30. The stent crimper of claim 29 including a stent, wherein the stent is made of nitinol.

31. The stent crimper of claim 28 wherein the dies are wedge-shaped.

32. The stent crimper of claim 28 wherein at least 16 dies are provided.

33. The stent crimper of claim 28 wherein the dies are moved cooperatively inward during the moving step.

34. The stent crimper of claim 28 wherein an entire stent is disposed in the aperture.

35. The stent crimper of claim 27 wherein a stent is disposed about a medical balloon, the medical balloon disposed about a catheter.

36. A stent crimper comprising:

an aperture with a plurality of movable blades disposed thereabout, the aperture being substantially polygonal, the blades coupled to one another so as to be movable inward or outward simultaneously, movement of the blades outward increasing the size of the aperture, movement of the blades inward decreasing the size of the aperture, the aperture remaining substantially regular polygonal when it is sized to receive a stent therein and when the blades minimize the aperture;

a cryogenic source, the cryogenic source in fluid communication with the stent crimper so as to cool the blades.

37. A stent crimper comprising:

a plurality of overlapping movable dies arranged to form an iris, the dies disposed about an aperture, the aperture having a longitudinal axis, the dies between stationary end-walls disposed about the longitudinal axis, the dies operatively engaged to at least one of the stationary end-walls;

each die having a first straight side and a second straight side, the first straight side and the second straight side converging to form a tip;

wherein a portion of the first straight side of each die faces the aperture, each first straight side parallel to the second side of an adjacent die.

38. A stent crimper comprising:

a plurality of movable dies and a thermal cooling unit for cooling the dies, the plurality of moveable dies arranged to form an iris disposed about an aperture, the aperture having a longitudinal axis, the plurality of movable dies between stationary end-walls substantially centered about the longitudinal axis, at least one stationary end-wall operatively engaged to the dies at distinct connection locations such that the number of distinct connection locations and the number of dies are the same, each die in communication with an actuation device, the actuation device constructed and arranged such that rotational motion of the actuation device opens or closes the aperture.

39. A stent crimper comprising:

a plurality of movable dies arranged to form an iris disposed about an aperture, the aperture having a center and a first opening and a second opening, the dies constructed and arranged to have a length exceeding the length of a stent with a longitudinal axis passing through both the first opening and the second opening, each die in communication with an actuation device, the actuation device constructed and arranged such that rotational motion of the actuation device opens or closes the aperture;

each die having a first straight side and a second straight side, the first straight side and the second straight side converging to form a tip;

wherein a portion of the first straight side of each die faces the aperture, each first straight side parallel to the second side of an adjacent die.

40. A stent crimper comprising:

a plurality of movable dies arranged to form an iris disposed about an aperture, the aperture having a longitudinal axis, the plurality of movable dies between stationary plates disposed about the longitudinal axis, each die in communication with an actuation device, the actuation device constructed and arranged such that rotational motion of the actuation device opens or closes the aperture, the dies operatively engaged to at least one of the stationary plates;

each die having a first straight side and a second straight side, the first straight side and the second straight side convering to form a tip;

wherein a portion of the first straight side of each die faces the aperture, each first straight side parallel to the second side of an adjacent die.