Balloon folding technology

• US 20020163104A1
• Filed: 03/26/2002
• Published: 11/07/2002
• Est. Priority Date: 03/26/2001
• Status: Active Grant

• Current Assignee: Machine Solutions, Inc.
• Original Assignee: Machine Solutions, Inc.
• Inventors: Motsenbocker, Tom, Goff, Edward, Kasprzyk, Daniel J.
• Granted Patent: US 6,988,881 B2
• Time in Patent Office: Days
• US Class Current: 264/320
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: B29C 53/086 bending radially, i.e. deformig the cross-section of the tube
• CPC Class Codes: Y10T 29/5367 Coupling to conduit

Abstract

An apparatus for folding a catheter balloon comprises a stationary base member; a rotatable drive hub which is moveable in relation to the stationary base member; and a pleating head aligned with respect to the stationary base member and to the rotatable drive hub. The pleating head includes at least three 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 has a centerline between the proximal and distal ends, each segment having a proximal point and a distal point, 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 spiral-pleat dimension having at least three channels in communication with a central aperture. 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 balloon is disposed around a shaft substrate, aligned in the central aperture and pleated around the shaft substrate upon rotation of the rotatable hub. A method of pleating and folding a catheter balloon is also disclosed.

Claims

1. An apparatus for pleating 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 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.

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 5 segments.

17. The apparatus of claim 15, wherein there are 8 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 of a curvilinear structure.

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 each segment having a proximal point and a distal point, one said point being disposed on the segment centerline and one said point being disposed off the segment centerline.

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

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

27. The apparatus of claim 24, 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.

28. The apparatus of claim 1, wherein each segment having a proximal point and a distal point, both said points being disposed off the segment centerline.

29. The apparatus of claim 28, wherein the both said points disposed off the center line are 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.

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

31. The apparatus of claim 30, wherein at least one pin is pivotally captured in a bore in the stationary member.

32. The apparatus of claim 30, wherein at least one pin is pivotally captured in a bore in the rotatable member.

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

34. The apparatus of claim 30, wherein the pins are pivotally captured in bores in the stationary member, the rotatable member, and the segments.

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

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

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

38. The apparatus of claim 1, wherein each segment distal end includes stop surfaces limiting movement of the segment distal end toward the central point.

39. The apparatus of claim 38, wherein each segment includes at least two stop surfaces.

40. The apparatus of claim 38, wherein each segment stop surface abuts a stop surface of an adjacent segment.

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

42. The apparatus of claim 41, wherein the central aperture configuration includes at least three channels in communication with the central aperture disposed about the central point.

43. The apparatus of claim 42, wherein said at least three channels in communication with the central aperture form upon stop surfaces of a segment abutting a stop surface of an adjacent segment.

44. The apparatus of claim 42, wherein said at least three channels are evenly radially positioned about the central aperture.

45. The apparatus of claim 42, wherein said at least three channels curve in a common direction.

46. The apparatus of claim 42, wherein said at least three channels in communication with the central aperture are evenly radially positioned about the central aperture and curve in a common direction, providing a spiral-pleat dimension.

47. The apparatus of claim 41, wherein the segment centerlines are tangentially oriented with respect to the central aperture.

48. The apparatus of claim 47, wherein the segment centerlines become radially aligned with respect to the center point and the aperture closes upon rotation of the rotatable member in the predetermined direction.

49. The apparatus of claim 47, wherein the central aperture closes upon rotation of the rotatable member in the predetermined direction.

50. The apparatus of claim, 49, wherein the central aperture opens upon rotation of the rotatable member in an opposing direction.

51. The apparatus of claim 41 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 center point and the aperture closes upon rotation of the rotatable member in the predetermined direction.

52. 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.

53. 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.

54. 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.

55. 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.

56. The apparatus of claim 55, wherein the article is a balloon disposed around a shaft, and whereby the balloon is aligned at the central point and the balloon is spiral-pleated on the shaft upon rotation.

57. 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; and

c. distal end thereof defines a central aperture with a spiral-pleat dimension.

58. The apparatus of claim 57, 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 center point and the aperture closes upon rotation of the rotatable member in the predetermined direction.

59. 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.

60. 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.

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. 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.

64. The apparatus of claim 63, wherein there is one stationary member and one rotatable member.

65. The apparatus of claim 63, wherein there are two stationary members and two rotatable members.

66. 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.

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

68. The apparatus of claim 66, wherein there are two stationary members and two rotatable members.

69. 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.

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

71. The apparatus of claim 69, wherein there are two stationary members and two rotatable members.

72. 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 off the centerline and coupled to the stationary member.

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

74. The apparatus of claim 72, wherein there are two stationary members and two rotatable members.

75. 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 off the centerline and coupled to the rotatable member.

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

77. The apparatus of claim 75, wherein there are two stationary members and two rotatable members.

79. The apparatus of claim 78, 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 center point and the aperture closes upon rotation of the rotatable member in the predetermined direction.

80. The apparatus of claim 78, wherein the segment distal point is disposed 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.

81. The apparatus of claim 80, wherein there is one stationary member and one rotatable member.

82. The apparatus of claim 80, wherein there are two stationary members and two rotatable members.

83. The apparatus of claim 78, wherein the segment distal point is disposed 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.

84. The apparatus of claim 83, wherein there is one stationary member and one rotatable member.

85. The apparatus of claim 83, wherein there are two stationary members and two rotatable members.

86. The apparatus of claim 78, 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.

87. The apparatus of claim 86, wherein there is one stationary member and one rotatable member.

88. The apparatus of claim 86, wherein there are two stationary members and two rotatable members.

89. The apparatus of claim 78, 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.

90. The apparatus of claim 89, wherein there is one stationary member and one rotatable member.

91. The apparatus of claim 89, wherein there are two stationary members and two rotatable members.

92. The apparatus of claim 78, wherein the segment distal point is off 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.

93. The apparatus of claim 92, wherein there is one stationary member and one rotatable member.

94. The apparatus of claim 92, wherein there are two stationary members and two rotatable members.

95. The apparatus of claim 78, wherein the segment distal point is off 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.

96. The apparatus of claim 95, wherein there is one stationary member and one rotatable member.

97. The apparatus of claim 95, wherein there are two stationary members and two rotatable members.

78. An apparatus for pleating 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 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 spiral-pleat dimension having at least three channels in communication with a central aperture, 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.

98. An apparatus for pleating a balloon 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 pleating head aligned with respect to the stationary base member and to the rotatable drive hub, and including at least three 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 off 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 spiral-pleat dimension having at least three channels in communication with a central aperture, 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 balloon is disposed around a shaft substrate, aligned in the central aperture and pleated around the shaft substrate upon rotation of the rotatable hub.

99. An apparatus for pleating a balloon 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 pleating head aligned with respect to the base members and the drive hubs, and including at least three 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 off 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 spiral-pleat dimension having at least three channels in communication with a central aperture, 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 balloon is disposed around a shaft substrate, aligned in the central aperture and pleated around the shaft substrate upon rotation of the rotatable hub.

100. A method of pleating an article comprising the steps of 1

a. providing an arrangement of a plurality of segments, each having a predetermined shape 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 pivotally coupled by pins to the stationary member and one said point being pivotally coupled by pins 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 defining a central aperture with a spiral-pleat dimension, and that the segment centerlines extending therefrom toward the segment distal ends are oriented away from the central point;

b. placing a balloon on a shaft substrate;

c. inserting the balloon and shaft substrate into the central aperture; and

d. rotating the rotatable member in a predetermined direction so that the segment distal ends move closer to the central point, whereby the central aperture contacts, compresses and pleats the balloon on the shaft substrate.

101. The method of claim 100, wherein each segment having a proximal point and a distal point, one said point being disposed on the segment centerline and one said point being disposed off the segment centerline.

102. The method of claim 100, wherein each segment having a proximal point and a distal point, both said points being disposed off the segment centerline.

103. The method of claim 102 wherein each segment is pivotally coupled to the stationary member by a pin contacting an exterior surface of the segment.

104. The method of claim 100, wherein the pleated balloon has wings in a curved configuration.

105. The method of claim 104, wherein the balloon wings have bases which are angled.

106. The method of claim 100, further including the step of pressurizing the balloon during the pleating step.

107. The method of claim 100, further including the step of applying a vacuum to the pleated balloon following the pleating step.

108. The method of claim 100, further including the step of applying heat to the pleated balloon following the pleating step to impart a set shape thereto.

109. A method of pleating and folding an article comprising the steps of:

a. providing a first arrangement of a plurality of segments, each having a predetermined shape 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 pivotally coupled by pins to the stationary member and one said point being pivotally coupled by pins 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 defining a central aperture with a spiral-pleat dimension, and that the segment centerlines extending therefrom toward the segment distal ends are oriented away from the central point;

b. providing a second arrangement of a plurality of segments, each having a predetermined shape 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, 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, 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;

c. placing a balloon on a shaft substrate;

d. inserting the balloon and shaft substrate into the first arrangement central aperture;

e. rotating the rotatable member of the first arrangement in a predetermined direction so that the segment distal ends move closer to the central point, whereby the central aperture contacts, compresses and pleats the balloon onto the shaft substrate to form a pleated balloon;

f. rotating the rotatable member of the first arrangement in an opposite direction and removing the pleated balloon from the first arrangement;

g. inserting the pleated balloon and shaft substrate into the second arrangement central aperture;

h. rotating the rotatable member of the second arrangement in a predetermined direction so that the segment distal ends move closer to the central point, whereby the central aperture contacts, radially compresses and folds the pleated balloon onto the shaft substrate to form a folded balloon; and

i. rotating the rotatable member of the second arrangement in an opposite direction for removing the folded balloon from the second arrangement.

110. The method of claim 109, wherein each segment of said first arrangement having a proximal point and a distal point, one said point being disposed on the segment centerline and one said point being disposed off the segment centerline.

111. The method of claim 109, wherein each segment of said first arrangement having a proximal point and a distal point, both said points being disposed off the segment centerline.

112. The method of claim 109, wherein each segment of said second arrangement having a proximal point and a distal point, one said point being disposed on the segment centerline and one said point being disposed off the segment centerline.

113. The method of claim 109, wherein each segment of said second arrangement having a proximal point and a distal point, both said points being disposed off the segment centerline.

114. The method of claim 109 wherein each segment of said first arrangement is pivotally coupled to the stationary member by a pin contacting an exterior surface of the segment.

115. The method of claim 109 wherein each segment of said second arrangement is pivotally coupled to the stationary member by a pin contacting an exterior surface of the segment.

116. The method of claim 109, wherein the pleated balloon has wings in a curved configuration.

117. The method of claim 116, wherein the balloon wings have bases which are angled.

118. The method of claim 109, further including the step of pressurizing the balloon during the pleating step.

119. The method of claim 109, further including the step of applying a vacuum to the pleated balloon following the pleating step.

120. The method of claim 109, further including the step of applying heat to the pleated balloon following the pleating step to impart a set shape thereto.

121. The method of claim 109, further including the step of applying a vacuum to the pleated balloon during the folding step.

122. The method of claim 109, further including the step of applying heat to the folded balloon following the folding step to impart a set shape thereto.

123. An system for pleating and folding a balloon by segmental radial compression, comprising:

A. a balloon pleating head device including;

a. a stationary base member;

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

c. a pleating head aligned with respect to the stationary base member and to the rotatable drive hub, and including at least three 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 off 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 spiral-pleat dimension having at least three channels in communication with a central aperture, 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 balloon is disposed around a shaft substrate, aligned in the central aperture and pleated around the shaft substrate upon rotation of the rotatable hub; and

B. a pleated balloon folding device including;

a. a stationary base member;

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

c. a folding 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 off 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 pleated balloon disposed around a shaft substrate, is aligned in the central aperture and folded around the shaft substrate upon rotation of the rotatable hub.