Radially expanding stents

• US 7,214,229 B2
• Filed: 06/25/2002
• Issued: 05/08/2007
• Est. Priority Date: 03/18/1999
• Status: Expired due to Fees

• Current Assignee: Fossa Medical, Inc.
• Original Assignee: Fossa Medical, Inc.
• Inventors: Mitchell, Michael, Kolb, Gloria Ro, Manasas, Mark
• Primary Examiner(s): McDermott; Corrine
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US10/179,902
• Publication Number:
  US 20030040754A1
• Time in Patent Office: 1,778 Days
• Field of Search: 623/1.16, 623/1.22, 623/1.3, 623/1.31, 623 2364- 2366, 623/23.69, 623/23.7, 606/127, 606/159, 606/200, 606106-114, 606170-180, 606/198
• US Class Current: 606/127
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/2217 single wire changing shape to a gripping configuration
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0058 X-shaped
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61M 2210/1089 Urethra
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

The present disclosure is directed to embodiments of devices for capturing obstructions within passageways. The devices disclosed herein may include a flexible tubular body forming multiple flexible members arranged in a helical pattern. These flexible members may be expandable to form one or more cages when the tubular body is expanded to an increased diameter state. The cages may be generally centered around the longitudinal axis of the tubular body between the two ends of the body. Also disclosed herein are methods for capturing obstructions within passageways, methods for obtaining tissue samples from body passages, and methods for making devices for capturing obstructions within passageways.

Claims

1. A device for capturing an obstruction within a passageway, the device comprising:

a flexible tubular body having;

a proximal end;

a distal end; and

at least two expandable portions separated from each other along the length of the body;

wherein each of the at least two expandable portions of the tubular body comprises a plurality of flexible elongate members defined by a plurality of slits cut in the wall of the tubular body that are helically oriented relative to a longitudinal axis of the tubular body such that, when the tubular body is in a contracted state, adjacent ones of the flexible elongate members so touch that the tubular body forms an internal lumen and a smooth exterior surface, the flexible elongate members being expandable to form a cage when the expandable portion is expanded to an increased diameter state, in which adjacent members are so spaced apart as to form apertures through which the obstruction can enter the cage, the cage being generally centered about the longitudinal axis of the tubular body between the proximal end and the distal end, and flanked on either side along the longitudinal axis by unslitted portions of the flexible tubular body;

wherein the at least two expandable portions are separated by a first unslitted portion, so that the tubular body has at least three unslitted portions alternating with at least two expandable portions along the longitudinal axis of the tubular body; and

wherein the flexible tubular body is formed from a material so flexible that twisting the tubular body in a first direction transitions the tubular body to the expanded state, and twisting the tubular body in a second direction opposite to the first direction transitions the tubular body to the contracted state.

2. The device of claim 1, wherein the flexible tubular body is made of a polymer.

3. The device of claim 2, wherein the polymer is reinforced with fibers.

4. The device of claim 2, wherein the polymer comprises polyurethane.

5. The device of claim 1, wherein the plurality of flexible elongate members are helically oriented at a ±

45°

angle relative to the longitudinal axis of the tubular body.

6. The device of claim 1, wherein the plurality of flexible elongate members are helically oriented at an angle greater than 0°

but less than 90°

relative to the longitudinal axis of the tubular body.

7. The device of claim 1, wherein the tubular body comprises two or more flexible elongate members that are expandable to form a three-dimensional cage.

8. The device of claim 1, wherein the tubular body comprises three or more flexible elongate members that are expandable to form a three-dimensional cage.

9. The device of claim 1, wherein the device is configured for insertion into a body passage.

10. The device of claim 9, wherein the device is made of a bioabsorbable material.

11. The device of claim 9, wherein the device is coated or impregnated with an anti-inflammatory substance.

12. The device of claim 9, wherein the device is coated or impregnated with a substance capable of treating an obstruction.

13. The device of claim 9, wherein the device is coated or impregnated with a topical anesthetic substance.

14. The device of claim 9, wherein the device has an outer diameter of approximately 7.0 FR (0.092″

) to facilitate insertion into a ureter.

15. The device of claim 9, wherein the device has an outer diameter of approximately 1.0 FR (0.0125″

) to facilitate insertion into a breast duct.

16. The device of claim 9, wherein the device has an outer diameter between 3.0 FR (0.039″

) and 7.0 FR (0.092″

) to facilitate insertion into a pancreaticobiliary duct.

17. The device of claim 9, wherein the device has an outer diameter of approximately 14.0 FR (0.184″

) to facilitate insertion into a fallopian tube.

18. The device of claim 9, wherein the device has an outer diameter of approximately 18 mm (0.71″

) to facilitate insertion into an esophagus.

19. The device of claim 9, wherein the device has an outer diameter between 25 mm (1.0″

) and 35 mm (1.4″

) to facilitate insertion into a colon.

20. The device of claim 1, wherein the device is made of silicone.

21. The device of claim 1, wherein the device is coated or impregnated with an antimicrobial substance.

22. The device of claim 1, wherein the cage is marked with a marking substance to allow in vivo visualization.

23. The device of claim 22, wherein the marking substance is radiopaque.

24. The device of claim 22, wherein the marking substance is non-ferromagnetic in order to be visualized using magnetic resonance imaging.

25. The device of claim 1, wherein at least one flexible elongate member has an abrading edge.

26. The device of claim 25, wherein the abrading edge comprises a metal insert attached to the flexible member.

27. The device of claim 25, wherein the abrading edge comprises a honed edge of the flexible elongate member.

28. The device of claim 25, wherein the abrading edge comprises a serrated edge of the flexible elongate member.

29. The device of claim 25, wherein the abrading edge comprises a scored edge of the flexible elongate member.

30. The device of claim 25, wherein the abrading edge comprises brushes.

31. The device of claim 25, wherein the abrading edge comprises teeth.

32. The device of claim 1, wherein the device is configured for insertion into tubing connected to a subject.

33. The device of claim 1, wherein the device is treated with a surface coating.

34. The device of claim 33, wherein the surface coating is a hydrophilic coating.

35. The device of claim 33, wherein the surface coating is a vacuum-deposited polymer coating.

36. The device of claim 35, wherein the vacuum-deposited polymer coating comprises Parylene.

37. The device of claim 35, wherein the vacuum-deposited polymer coating comprises PTFE.

38. The device of claim 33, wherein the surface coating comprises a lubricious coating.

39. The device of claim 38, wherein the lubricious coating comprises a gel.

40. The device of claim 38, wherein the lubricious coating comprises silicone.

41. The device of claim 1, further comprising a pusher sized and shaped to press longitudinally against an end of the tubular body.

42. A method for capturing an obstruction within a passageway, the method comprising:

(a) guiding the device of claim 1 through the passageway;

(b) twisting the device in the first direction to expand the flexible elongate members and create at least one cage; and

(c) capturing an obstruction within the cage.

43. The method of claim 42, wherein an endoscope is used to facilitate insertion of the device into the passageway.

44. The method of claim 42, wherein the device is inserted using a guidewire.

45. The method of claim 42, wherein the device is inserted using a sleeve.

46. The method of claim 42, further comprising extracting the obstruction by removing the device from the passageway.

47. The method of claim 42, further comprising displacing the obstruction within the passageway.

48. The method of claim 47, further comprising treating the displaced obstruction within the passageway.

49. The method of claim 42, further comprising twisting the device in the second direction to contract the device prior to removing the device from the passageway.

50. The method of claim 42, wherein the plurality of flexible elongate members are oriented at a ±

45°

angle relative to the longitudinal axis of the tubular body.

51. The method of claim 42, wherein the cage is defined by three or more flexible elongate members.

52. The method of claim 42, wherein the passageway comprises a body passage.

53. The method of claim 52, wherein the body passage comprises a ureter.

54. The method of claim 53, wherein the device is guided in a retrograde manner through the ureter.

55. The method of claim 53, wherein the device is guided in an anterograde manner through the ureter.

56. The method of claim 52, wherein the body passage comprises at least one of a pancreaticobiliary duct, an esophagus, a blood vessel, an airway, a urethra, a fallopian tube, a breast duct, and a bowel passage.

57. The method of claim 42, wherein the passageway comprises tubing connected to a subject.

58. The method of claim 57, wherein the tubing comprises at least one of an external drainage tube, a feeding tube, an intravenous tube, and a chest tube.

59. The method of claim 42, further comprising anchoring a distal end of the device within the passageway.

60. The method of claim 59, further comprising anchoring the distal end of the device before twisting.

61. The method of claim 59, further comprising unanchoring the device releasing the anchor before removing the device from the passageway.

62. A method for capturing an obstruction within a passageway, the method comprising:

(a) guiding the device of claim 1 through the passageway;

(b) twisting the device in the first direction to expand the flexible elongate members and create a plurality of cages; and

(c) capturing an obstruction with two or more cages.

63. The method of claim 62, wherein the obstruction is captured within two or more cages.

64. The method of claim 62, wherein the obstruction is captured between two or more cages.

65. A method for capturing an obstruction within a passageway, the method comprising:

(a) guiding the device of claim 1 through the passageway;

(b) twisting the device in the first direction to expand the flexible elongate members and create at least one cage;

(c) capturing an obstruction within one or more of the cages; and

(d) rotating the device in the first direction to displace the obstruction through the device in a direction away from a distal end of the device.

66. The method of claim 65, further comprising rotating the device until the obstruction exits the device.

67. The method of claim 65, further comprising treating the displaced obstruction within the passageway.

68. The method of claim 65, wherein the passageway comprises a body passage.

69. The method of claim 68, wherein the body passage comprises a ureter.

70. The method of claim 69, wherein the device is guided in a retrograde manner through the ureter.

71. The method of claim 69, wherein the device is guided in an anterograde manner through the ureter.

72. The method of claim 68, wherein the body passage comprises at least one of a pancreaticobiliary duct, an esophagus, a blood vessel, an airway, a urethra, a fallopian tube, a breast duct, and a bowel passage.

73. The method of claim 65, wherein the passageway comprises tubing connected to a subject.

74. The method of claim 73, wherein the tubing comprises at least one of an external drainage tube, a feeding tube, an intravenous tube, and a chest tube.

75. A method for capturing an obstruction within a passageway, the method comprising:

(a) guiding the device of claim 1 through the passageway;

(b) twisting the device in the first direction to expand the flexible elongate members and create a plurality of cages;

(c) capturing an obstruction with two or more cages; and

(d) rotating the device in the first direction to displace the obstructions through the device in a direction away from a distal end of the device.

76. The method of claim 75, wherein the obstruction is captured within two or more cages.

77. The method of claim 75, wherein the obstruction is captured between two or more cages.

78. A method for making the device of claim 1, the method comprising:

(a) securing an end of a flexible tubular body;

(b) twisting the flexible tubular body about a longitudinal axis of the body;

(c) creating a plurality of longitudinal apertures in a body wall of the twisted tubular body, the apertures penetrating a cross-section of the body wall and defining flexible elongate members in the body wall; and

(d) releasing the twisted tubular body.

79. The method of claim 78, further comprising sharpening an edge of at least one flexible elongate member by honing the edge.

80. The method of claim 78, further comprising sharpening an edge of at least one flexible elongate member by attaching a metal insert to the edge.

81. The method of claim 78, wherein the apertures are circumferentially spaced about the body wall.

82. The method of claim 78, further comprising heating the device to a temperature sufficient to induce a shape memory of the untwisted state.

83. The method of claim 78, further comprising:

(a) expanding the flexible elongate members to a partially expanded state; and

(b) heating the device to a temperature sufficient to induce a shape memory of the partially expanded state.

84. The method of claim 78, further comprising:

(a) expanding the flexible elongate members to a fully expanded state; and

(b) heating the device to a temperature sufficient to induce a shape memory of the fully expanded state.

85. A method for obtaining tissue samples from a body passage, the method comprising:

(a) guiding the device of claim 1 through a body passage, wherein at least one of the flexible elongate members has an abrading edge;

(b) twisting the device in the first direction to expand the flexible elongate members and create at least one cage;

(c) rotating the device to bring the abrading edge into contact with an inner surface of the body passage and to scrape a tissue sample from the inner surface of the body passage;

(d) twisting the device in the second direction to contract the device and capture the tissue sample within the cage; and

(e) removing the device from the body passage.

86. The method of claim 85, wherein an endoscope is used to facilitate insertion of the device into the passageway.

87. The method of claim 85, wherein the device is inserted using a guidewire.

88. The method of claim 85, wherein the device is inserted using a sleeve.

89. The method of claim 85, wherein the body passage comprises at least one of a pancreaticobiliary duct, an esophagus, a blood vessel, an airway, a ureter, a urethra, a fallopian tube, a breast duct, and a bowel passage.

90. A method for obtaining tissue samples from a body passage, the method comprising:

(a) guiding the device of claim 1 through a body passage, wherein a plurality of the flexible elongate members have abrading edges;

(b) twisting the device in the first direction to expand the flexible elongate members and create a plurality of cages;

(c) rotating the device to bring the abrading edges into contact with an inner surface of the body passage and to scrape tissue samples from multiple locations on the inner surface of the body passage;

(d) twisting the device in the second direction to contract the device and capture the tissue samples within the cages; and

(e) removing the device from the body passage.