Stent crimping apparatus and method

• US 6,629,350 B2
• Filed: 06/08/2001
• Issued: 10/07/2003
• Est. Priority Date: 06/08/2000
• Status: Active Grant

• Current Assignee: Machine Solutions, Inc.
• Original Assignee: Machine Solutions, Inc.
• Inventors: Motsenbocker, Tom
• Primary Examiner(s): Vidovich, Gregory
• Assistant Examiner(s): Cozart, Jermie E.
• Application Number:
  US09/877,469
• Publication Number:
  US 20020138966A1
• Time in Patent Office: 851 Days
• Field of Search: 295/05, 295/06, 295/08, 295/16, 295/17, 295/20, 292/435.17, 292/37, 292/835, 292/82, 724/02
• US Class Current: 29/283.5
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9526 using a mandrel
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: B21F 45/008 of medical instruments, e.g. stents, corneal rings medical science A61
• CPC Class Codes: B25B 27/10 inserting fittings into hoses
• 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 29/53 Means to assemble or disassemble
• CPC Class Codes: Y10T 29/5367 Coupling to conduit
• CPC Class Codes: Y10T 29/53835 having wedge operator
• CPC Class Codes: Y10T 29/53987 Tube, sleeve or ferrule
• CPC Class Codes: Y10T 29/53996 by deforming

Abstract

An apparatus for crimping a stent by segmental radial compression, comprising a stationary base member; a rotatable drive hub which is moveable in relation to the stationary base member; and a crimping head aligned with respect to the stationary base member and to the rotatable drive hub. The crimping head includes at least ten segments. The segments each have a proximal end and an angled distal end with at least one angled side face terminating in an edge of a predetermined length, each segment having a centerline between the proximal and distal ends, each segment having a proximal point and a distal point, the distal point being disposed on the centerline and the proximal point being disposed off the centerline, and the proximal point being pivotally coupled by pins to the stationary base member and the distal point being pivotally coupled by pins to the rotatable hub member. The segments are arranged so that the segment distal ends are disposed adjacent to and a predetermined distance away from a central point and defining a central aperture with a cylindrical dimension. Also, the segment centerlines extend therefrom toward the segment distal ends and are oriented away from the central point. The segment distal ends move closer to the central point upon rotation of the rotatable hub member in a predetermined direction, whereby the stent is disposed around a base substrate, aligned in the central aperture and crimped round the base substrate upon rotation of the rotatable hub.

Claims

1. An apparatus for engaging an article, comprising:

at least one stationary member;

at least one rotatable member which is moveable in relation to the stationary member;

a plurality of segments, each having a predetermined shape with a proximal end and a distal end, each segment having a centerline between the proximal and distal ends, each segment having a proximal point and a distal point, one said point being disposed on the centerline and one said point being disposed off the centerline, and one said point being pivotally coupled to the stationary member and one said point being pivotally coupled to the rotatable member;

the segments being arranged so that the segment distal ends are disposed adjacent to and a predetermined distance away from a central point, and that the segment centerlines extending therefrom toward the segment distal ends are oriented away from the central point; and

the segment distal ends moving closer to the central point upon rotation of the rotatable member in a predetermined direction to engage the article.

2. The apparatus of claim 1, wherein there is one stationary member.

3. The apparatus of claim 1, wherein there are two stationary members.

4. The apparatus of claim 1, wherein there is one stationary member and one rotatable member.

5. The apparatus of claim 1, wherein there are two stationary members and two rotatable members.

6. The apparatus of claim 1, wherein the stationary member has an aperture aligned with the central point.

7. The apparatus of claim 1, wherein the rotatable member has an aperture aligned with the central point.

8. The apparatus of claim 1, wherein each stationary member and each rotatable member has an aperture aligned with the central point.

9. The apparatus of claim 1, wherein the stationary member is a base.

10. The apparatus of claim 1, wherein the stationary member is a hub.

11. The apparatus of claim 1, wherein the rotatable member is a base.

12. The apparatus of claim 1, wherein the rotatable member is a hub.

13. The apparatus of claim 1, wherein the stationary member is a base and the rotatable member is a hub.

14. The apparatus of claim 1, wherein the stationary member is a hub and the rotatable member is a base.

15. The apparatus of claim 1, wherein there are at least 3 segments.

16. The apparatus of claim 15, wherein there are 10 segments.

17. The apparatus of claim 15, wherein there are 15 segments.

18. The apparatus of claim 1, wherein the segments have an angled distal end with at least one angled side face, terminating in an edge.

19. The apparatus of claim 18, wherein the distal edge has a predetermined length.

20. The apparatus of claim 18, wherein the distal edge is flat.

21. The apparatus of claim 18, wherein the segments have a pair of angled side faces.

22. The apparatus of claim 18, wherein each segment contacts at least two adjacent segments, and wherein one angled side face contacts at least one adjacent segment, and wherein the angled face has an incut portion for minimizing contact with the adjacent segment.

23. The apparatus of claim 1, wherein each segment has a raised front face portion.

24. The apparatus of claim 1, wherein the segment proximal point is disposed off the segment centerline and the segment distal point is disposed on the segment center line.

25. The apparatus of claim 1, wherein the segment proximal point is disposed on the segment centerline and the segment distal point is disposed off the segment centerline.

26. The apparatus of claim 1, wherein the one said point disposed off the center line is disposed a predetermined distance off the centerline, and wherein the predetermined distance is a function of tolerance for movement of the distal end segments towards the central point.

27. The apparatus of claim 1, wherein the segments are pivotally coupled to the stationary member and to the rotatable member by pins.

28. The apparatus of claim 27, wherein at least one pin is pivotally captured in a bore in the stationary member.

29. The apparatus of claim 27, wherein at least one pin is pivotally captured in a bore in the rotatable member.

30. The apparatus of claim 27, wherein at least one pin is pivotally captured in a bore in the segment.

31. The apparatus of claim 27, wherein the pins are pivotally captured in bores in the stationary member, the rotatable member, and the segments.

32. The apparatus of claim 1 wherein each segment is pivotally coupled to the rotatable member by a pin contacting an exterior surface of the segment.

33. The apparatus of claim 1, wherein the stationary member is connected to each segment at said proximal point and the rotatable member is connected to each segment at said distal point.

34. The apparatus of claim 1, wherein the stationary member is connected to each segment at said distal point and the rotatable member is connected to each segment at said proximal point.

35. The apparatus of claim 1, wherein the segment distal ends define a central aperture of a predetermined configuration disposed about the central point.

36. The apparatus of claim 35, wherein the central aperture configuration is circular.

37. The apparatus of claim 36, wherein the central aperture is cylindrical.

38. The apparatus of claim 35, wherein the segment centerlines are tangentially oriented with respect to the central aperture.

39. The apparatus of claim 38, wherein the segment centerlines become radially aligned with respect to the central point and the aperture closes upon rotation of the rotatable member in the predetermined direction.

40. The apparatus of claim 35, wherein the central aperture closes upon rotation of the rotatable member in the predetermined direction.

41. The apparatus of claim 40, wherein the central aperture opens upon rotation of the rotatable member in an opposing direction.

42. The apparatus of claim 35, having a first state wherein the segment centerlines are tangentially oriented with respect to the central aperture, and a second state wherein the segment centerlines become radially aligned with respect to the central point and the aperture closes upon rotation of the rotatable member in the predetermined direction.

43. The apparatus of claim 1, wherein said one point is disposed off the centerline in a predetermined direction, and wherein the rotation in the predetermined direction is towards the centerline offset predetermined direction.

44. The apparatus of claim 1, wherein said one point is disposed off the centerline in a predetermined direction, and wherein the rotation in the predetermined direction is against the centerline offset predetermined direction.

45. The apparatus of claim 1, whereby the article is aligned at the central point and the segment distal ends engage the article upon rotation of the rotatable member in the predetermined direction.

46. The apparatus of claim 1, whereby the article is aligned at the central point and the segment distal ends exert a radial compressive force on the article upon rotation of the rotatable member in the predetermined direction.

47. The apparatus of claim 46, wherein the article is a stent disposed around a base, and whereby the stent is aligned at the central point and the stent is crimped on the base upon rotation.

48. The apparatus of claim 1, wherein there are at least 3 segments, each segment:

a. having an angled distal end with at least one angled side face, terminating in an edge of a predetermined length;

b. is pivotally coupled to the stationary member and to the rotatable member by pins;

c. distal end thereof defines a central aperture with a cylindrical dimension.

49. The apparatus of claim 48, having a first state wherein the segment centerlines are tangentially oriented with respect to the central aperture, and a second state wherein the segment centerlines become radially aligned with respect to the central point and the aperture closes upon rotation of the rotatable member in the predetermined direction.

50. The apparatus of claim 1, further comprising an actuator connected to the rotatable member and an article handling system arranged to handle the article at the central point.

51. The apparatus of claim 1, wherein the segment distal point is on the center line and coupled to the rotatable member, and the segment proximal point is disposed off the centerline and coupled to the stationary member.

52. The apparatus of claim 51, wherein there is one stationary member and one rotatable member.

53. The apparatus of claim 51, wherein there are two stationary members and two rotatable members.

54. The apparatus of claim 1, wherein the segment distal point is on the center line and coupled to the stationary member, and the segment proximal point is disposed off the centerline and coupled to the rotatable member.

55. The apparatus of claim 54, wherein there is one stationary member and one rotatable member.

56. The apparatus of claim 54, wherein there are two stationary members and two rotatable members.

57. The apparatus of claim 1, wherein the segment distal point is off the center line and coupled to the rotatable member, and the segment proximal point is disposed on the centerline and coupled to the stationary member.

58. The apparatus of claim 57, wherein there is one stationary member and one rotatable member.

59. The apparatus of claim 57, wherein there are two stationary members and two rotatable members.

60. The apparatus of claim 1, wherein the segment distal point is off the center line and coupled to the stationary member, and the segment proximal point is disposed on the centerline and coupled to the rotatable member.

61. The apparatus of claim 60, wherein there is one stationary member and one rotatable member.

62. The apparatus of claim 60, wherein there are two stationary members and two rotatable members.

63. An apparatus for radially compressing an article, comprising:

a. at least one stationary member;

b. at least one rotatable member which is moveable in relation to the stationary member; and

c. at least three segments;

i. with a proximal end and an angled distal end with at least one angled side face terminating in an edge of a predetermined length, each segment having a centerline between the proximal and distal ends, each segment having a proximal point and a distal point, one said point being disposed on the centerline and one said point being disposed off the centerline, and one said point being pivotally coupled by pins to the stationary member and one said point being pivotally coupled by pins to the rotatable member;

ii. the segments being arranged so that the segment distal ends are disposed adjacent to and a predetermined distance away from a central point and defining a central aperture with a cylindrical dimension, and that the segment centerlines extending therefrom toward the segment distal ends are oriented away from the central point; and

iii. the segment distal ends moving closer to the central point upon rotation of the rotatable member in a predetermined direction for compressing the article.

64. The apparatus of claim 63, having a first state wherein the segment centerlines are tangentially oriented with respect to the central aperture, and a second state wherein the segment centerlines become radially aligned with respect to the central point and the aperture closes upon rotation of the rotatable member in the predetermined direction.

65. The apparatus of claim 63, wherein the segment distal point is on the central line and coupled to the rotatable member, and the segment proximal point is disposed off the centerline and coupled to the stationary member.

66. The apparatus of claim 65, wherein there is one stationary member and one rotatable member.

67. The apparatus of claim 65, wherein there are two stationary members and two rotatable members.

68. The apparatus of claim 63, wherein the segment distal point is on the center line and coupled to the stationary member, and the segment proximal point is disposed off the centerline and coupled to the rotatable member.

69. The apparatus of claim 68, wherein there is one stationary member and one rotatable member.

70. The apparatus of claim 68, wherein there are two stationary members and two rotatable members.

71. The apparatus of claim 63, wherein the segment distal point is off the center line and coupled to the rotatable member, and the segment proximal point is disposed on the centerline and coupled to the stationary member.

72. The apparatus of claim 71, wherein there is one stationary member and one rotatable member.

73. The apparatus of claim 71, wherein there are two stationary members and two rotatable members.

74. The apparatus of claim 63, wherein the segment distal point is off the center line and coupled to the stationary member, and the segment proximal point is disposed on the centerline and coupled to the rotatable member.

75. The apparatus of claim 74, wherein there is one stationary member and one rotatable member.

76. The apparatus of claim 74, wherein there are two stationary members and two rotatable members.

77. An apparatus for crimping a stent by segmental radial compression, comprising:

a. a stationary base member;

b. a rotatable drive hub which is moveable in relation to the stationary base member; and

c. a crimping head aligned with respect to the stationary base member and to the rotatable drive hub, and including at least ten segments;

i. the segments each having a proximal end and an angled distal end with at least one angled side face terminating in an edge of a predetermined length, each segment having a centerline between the proximal and distal ends, each segment having a proximal point and a distal point, the distal point being disposed on the centerline and the proximal point being disposed off the centerline, and the proximal point being pivotally coupled by pins to the stationary base member and the distal point being pivotally coupled by pins to the rotatable hub member;

ii. the segments being arranged so that the segment distal ends are disposed adjacent to and a predetermined distance away from a central point and defining a central aperture with a cylindrical dimension, and that the segment centerlines extending therefrom toward the segment distal ends are oriented away from the central point; and

iii. the segment distal ends moving closer to the central point upon rotation of the rotatable hub member in a predetermined direction, whereby the stent is disposed around a base substrate, aligned in the central aperture and crimped round the base substrate upon rotation of the rotatable hub.

78. An apparatus for crimping a stent by segmental radial compression, comprising:

a. a pair of aligned, stationary base members separated a predetermined distance;

b. a pair of aligned rotatable drive hubs which are moveable in relation to the stationary base member and in synchronization with each other; and

c. a crimping head aligned with respect to the base members and the drive hubs, and including at least ten segments;

i. the segments each having a proximal end and an angled distal end with at least one angled side face terminating in an edge of a predetermined length, each segment having a centerline between the proximal and distal ends, each segment having a proximal point and a distal point, the distal point being disposed on the centerline and the proximal point being disposed off the centerline, and the proximal point being pivotally coupled by pins to the stationary base members and the distal point being pivotally coupled by pins to the rotatable hub members;

ii. the segments being arranged so that the segment distal ends are disposed adjacent to and a predetermined distance away from a central point and defining a central aperture with a cylindrical dimension, and that the segment centerlines extending therefrom toward the segment distal ends are oriented away from the central point; and

iii. the segment distal ends moving closer to the central point upon rotation of the rotatable hub members in a predetermined direction, whereby the stent is disposed around a base substrate, aligned in the central aperture and crimped round the base substrate upon rotation of the rotatable hub.