FILAMENTARY DEVICES FOR TREATMENT OF VASCULAR DEFECTS

• US 20090275974A1
• Filed: 05/01/2009
• Published: 11/05/2009
• Est. Priority Date: 05/02/2008
• Status: Active Grant

• Current Assignee: Microvention Incorporated (Terumo Corporation)
• Original Assignee: Sequent Medical, Inc. (Terumo Corporation)
• Inventors: Marchand, Philippe, Rosenbluth, Robert F., Cox, Brian J.
• Granted Patent: US 9,597,087 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12068 detachable by heat
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Devices and methods for treatment of a patient'"'"'s vasculature with some embodiments configured for delivery with a microcatheter for treatment of the cerebral vasculature of a patient. Some embodiments may include a permeable shell configured to occlude blood flow therethrough.

Claims

1. A device for treatment of a patient'"'"'s vasculature, comprising:

a self-expanding resilient permeable shell having a proximal end, a distal end, a longitudinal axis and further comprising;

a plurality of elongate resilient filaments with a woven structure secured relative to each other at proximal ends and distal ends thereof,

a radially constrained elongated state configured for delivery within a microcatheter with the thin woven filaments extending longitudinally from the proximal end to the distal end radially adjacent each other along a length of the filaments, and

an expanded relaxed state with a globular and longitudinally shortened configuration relative to the radially constrained state with the woven filaments forming the self-expanding resilient permeable shell in a smooth path radially expanded from the longitudinal axis between the proximal end and distal end including a plurality of openings in the shell formed between the woven filaments, the largest of said openings being configured to allow blood flow through the openings at a velocity below a thrombotic threshold velocity.

2. The device of claim 1 wherein at least the distal end includes a reverse bend in a recessed configuration such that the secured distal ends of the filaments are disposed axially within a nominal contour of the permeable shell structure in the expanded state.

3. The device of claim 2 wherein the proximal end of the shell further comprises a reverse bend in a recessed configuration such that the secured proximal ends of the filaments are withdrawn axially within the nominal permeable shell structure in the expanded state.

4. The device of claim 1 wherein the filaments of the permeable shell are secured relative to each other at proximal ends and distal ends thereof by one or more methods selected from the group consisting of welding, soldering, adhesive bonding, and epoxy bonding.

5. The device of claim 1 further comprising a distal hub secured to the distal ends of the filaments of the permeable shell.

6. The device of claim 1 further comprising a proximal hub secured to the proximal ends of the filaments of the permeable shell.

7. The device of claim 6 wherein the proximal hub further comprises a cylindrical member that extends proximally beyond the proximal ends of the filaments forming a cavity for securing a detachment tether.

8. The device of claim 7 further comprising a detachment tether having a distal end secured within the cavity of the proximal hub.

9. The device of claim 1 wherein the filaments of the permeable shell have a transverse dimension of about 0.0005 inch to about 0.005 inch.

10. The device of claim 1 wherein the permeable shell comprises about 70 to about 300 filaments extending from the first end to the second end.

11. The device of claim 1 wherein the largest openings formed between adjacent filaments of a defect spanning portion of the permeable shell are about 0.005 inches to about 0.04 inches.

12. The device of claim 1 wherein the largest openings formed between adjacent filaments in a defect spanning portion of the permeable shell are up to about 0.016 inch.

13. The device of claim 1 wherein the permeable shell further comprises bioactive agent selected from the group consisting of a thrombogenic agent, an anti-platelet agent, an anti-thrombogenic agent and a healing promotion agent.

14. The device of claim 1 wherein a spacing between the proximal end and distal end of the permeable shell in the relaxed expanded state is about 25% percent to about 75% percent of the spacing between the proximal end and distal end in the constrained cylindrical state.

15. The device of claim 1 wherein the filaments of the permeable shell comprise a superelastic material.

16. The device of claim 15 wherein the superelastic material comprises a shape memory metal.

17. The device of claim 1 wherein the filaments of the permeable shell comprise a shape memory material that is heat set in a configuration of the relaxed expanded state.

18. The device of claim 17 wherein the shape memory metal comprises a NiTi alloy.

19. A device for treatment of a patient'"'"'s vasculature, comprising:

a self-expanding resilient permeable shell having a proximal end, a distal end, a longitudinal axis and further comprising

a plurality of elongate resilient filaments including large filaments and small filaments of at least two different transverse dimensions with a woven structure secured relative to each other at proximal ends and distal ends thereof,

a radially constrained elongated state configured for delivery within a microcatheter with the thin woven filaments extending longitudinally from the proximal end to the distal end radially adjacent each other along a length of the filaments, and

an expanded relaxed state with a globular and longitudinally shortened configuration relative to the radially constrained state with the woven filaments forming the self-expanding resilient permeable shell in a smooth path radially expanded from the longitudinal axis between the proximal end and distal end including a plurality of openings in the shell formed between the woven filaments.

20. The device of claim 19 wherein at least the distal end has a reverse bend in a recessed configuration such that the secured distal ends of the filaments are disposed axially within the nominal permeable shell structure in the expanded state.

21. The device of claim 19 wherein the large filaments of the permeable shell comprise a transverse dimension or diameter that is about 0.001 inches to about 0.004 inches.

22. The device of claim 19 wherein the small filaments of the permeable shell comprise a transverse dimension or diameter that is about 0.0004 inches to about 0.001 inches.

23. The device of claim 19 wherein the ratio of the number of small filaments of the permeable shell relative to the number of large filaments of the permeable shell may be about 2 to 1 to about 15 to 1.

24. The device of claim 19 wherein the difference in transverse dimension or diameter between the small filaments and the large filaments is less than about 0.0035 inches.

25. The device of claim 19 wherein the permeable shell comprises about 70 to about 300 filaments extending from the first end to the second end.

26. The device of claim 19 wherein the largest openings formed between adjacent filaments in a defect spanning portion of the permeable shell are about 0.005 inches to about 0.04 inches.

27. The device of claim 19 wherein the largest openings formed between adjacent filaments of a defect spanning portion of the permeable shell are up to about 0.016 inches.

28. The device of claim 19 wherein at least some of the openings formed between adjacent filaments of the defect spanning portion of the device are configured to allow blood flow through the openings at a velocity below a thrombotic threshold velocity.

29. The device of claim 19 wherein a major transverse dimension of the permeable shell in a relaxed expanded state is about 4 mm to about 30 mm.

30. A device for treatment of a patient'"'"'s vasculature, comprising:

a self-expanding resilient permeable shell having a proximal end, a distal end, a longitudinal axis and further comprising;

a plurality of elongate resilient filaments with a woven structure secured relative to each other at proximal ends and distal ends thereof,

a radially constrained elongated state configured for delivery within a microcatheter with the woven filaments extending longitudinally from the proximal end to the distal end radially adjacent each other along a length of the filaments, and

an expanded relaxed state with a globular and longitudinally shortened configuration relative to the radially constrained state with a major transverse diameter, the woven filaments forming the self-expanding resilient permeable shell in a smooth path radially expanded from the longitudinal axis between the proximal end and distal end, and including a plurality of openings in the shell formed between the woven filaments; and

wherein the diameter of the permeable shell in an expanded state, number and diameter of large filaments and number and diameter of small filaments are configured such that the permeable shell in an expanded state has a radial stiffness of about 0.014 lbf to about 0.284 lbf defined by the expression (1.2×

10⁶ lbf/D⁴)(N_ld_l⁴+N_sd_s⁴) where D is a diameter of the permeable shell in the expanded state in inches, N_l is the number of large filaments in the permeable shell, N_s is the number of small filaments in the permeable shell, d_l is the diameter of the largest filaments in inches, and d_s is the diameter of the smallest filaments in inches.

31. The device of claim 30 wherein at least the distal end has a reverse bend in a recessed configuration such that the secured distal ends of the filaments are disposed axially within the nominal permeable shell structure in the expanded state.

32. The device of claim 30 wherein the permeable shell comprises about 70 to about 300 filaments extending from the proximal end to the distal end of the permeable shell.

33. The device of claim 30 wherein a major transverse diameter of the permeable shell in a relaxed expanded state is about 4 mm to about 30 mm.

34. The device of claim 30 wherein the large filaments of the permeable shell comprise a transverse dimension or diameter that is about 0.001 inches to about 0.004 inches.

35. The device of claim 30 wherein the small filaments of the permeable shell comprise a transverse dimension or diameter that is about 0.0004 inches to about 0.001 inches.

36. The device of claim 30 wherein the ratio of the number of small filaments of the permeable shell relative to the number of large filaments of the permeable shell may be about 2 to 1 to about 15 to 1.

37. The device of claim 30 wherein the difference in transverse dimension or diameter between the small filaments and the large filaments is less than about 0.0035 inches.

38. The device of claim 30 wherein the largest openings formed between adjacent filaments of a defect spanning portion of the permeable shell are about 0.005 inches to about 0.04 inches.

39. The device of claim 30 wherein the largest openings formed between adjacent filaments of a defect spanning portion of the permeable shell are up to about 0.016 inches.

40. The device of claim 30 wherein the filaments of the permeable shell further comprise large filaments and small filaments of different transverse diameters.

41. A device for treatment of a patient'"'"'s vasculature, comprising:

a self-expanding resilient permeable shell having a proximal end, a distal end, a longitudinal axis and further comprising

a plurality of elongate resilient filaments with a woven structure secured relative to each other at proximal ends and distal ends thereof,

a radially constrained elongated state configured for delivery within a microcatheter with the thin woven filaments extending longitudinally from the proximal end to the distal end radially adjacent each other along a length of the filaments, and

an expanded relaxed state with a globular and longitudinally shortened configuration relative to the radially constrained state with a major transverse diameter, the woven filaments forming the self-expanding resilient permeable shell in a smooth path radially expanded from the longitudinal axis between the proximal end and distal end, and including a plurality of openings in the shell formed between the woven filaments; and

wherein the diameter of the permeable shell in an expanded state, number of all filaments and diameter of the small filaments are configured such that the average opening size of the permeable shell in an expanded state is less than about 0.016 inches with the average opening size defined by the expression (1.7/N_T)(π

D−

N_T/2×

d_w) where D is a diameter of the permeable shell in the expanded state in inches, N_T is the total number of filaments in the permeable shell, and d_W is the diameter of the smallest filaments in inches.

42. The device of claim 41 wherein at least the distal end has a reverse bend in a recessed configuration such that the secured distal ends of the filaments are disposed axially within the nominal permeable shell structure in the expanded state.

43. The device of claim 41 wherein the permeable shell comprises about 70 to about 300 filaments extending from the proximal end to the distal end of the permeable shell.

44. The device of claim 41 wherein a major transverse diameter of the permeable shell in a relaxed expanded state is about 4 mm to about 30 mm.

45. The device of claim 41 wherein the large filaments of the permeable shell comprise a transverse dimension or diameter that is about 0.001 inches to about 0.004 inches.

46. The device of claim 41 wherein the small filaments of the permeable shell comprise a transverse dimension or diameter that is about 0.0004 inches to about 0.001 inches.

47. The device of claim 41 wherein the ratio of the number of small filaments of the permeable shell relative to the number of large filaments of the permeable shell may be about 2 to 1 to about 15 to 1.

48. The device of claim 41 wherein the difference in transverse dimension or diameter between the small filaments and the large filaments is less than about 0.0035 inches.

49. The device of claim 41 wherein the largest openings formed between adjacent filaments in a defect spanning portion of the permeable shell are about 0.005 inches to about 0.04 inches.

50. The device of claim 41 wherein the largest openings formed between adjacent filaments in a defect spanning portion of the permeable shell are up to about 0.016 inches.

51. The device of claim 41 wherein the filaments of the permeable shell further comprise large filaments and small filaments of different transverse diameters.

52. A device for treatment of a patient'"'"'s vasculature, comprising:

a self-expanding resilient permeable shell having a proximal end, a distal end, a longitudinal axis and further comprising

a plurality of elongate resilient filaments with a woven structure secured relative to each other at proximal ends and distal ends thereof,

a radially constrained elongated state configured for delivery within a microcatheter with the woven filaments extending longitudinally from the proximal end to the distal end radially adjacent each other along a length of the filaments, and

an expanded relaxed state with a globular and longitudinally shortened configuration relative to the radially constrained state with a major transverse diameter, the woven filaments forming the self-expanding resilient permeable shell in a smooth path radially expanded from the longitudinal axis between the proximal end and distal end, and including a plurality of openings in the shell formed between the woven filaments; and

wherein the diameter of the permeable shell in an expanded state, number and diameter of large filaments and number and diameter of small filaments are configured such that the permeable shell in a constrained state has an outer transverse diameter of less than about 0.04 inches defined by the expression 1.48((N_ld_l²+N_sd_s²))^1/2 where N_l is the number of largest filaments in the permeable shell, N_s is the number of smallest filaments in the permeable shell, d_l is the diameter of the largest filaments in inches, and d_s is the diameter of the smallest filaments in inches.

53. The device of claim 52 wherein at least the distal end has a reverse bend in a recessed configuration such that the secured distal ends of the filaments are disposed axially within the nominal permeable shell structure in the expanded state.

54. The device of claim 52 wherein the permeable shell comprises about 70 to about 300 filaments extending from the proximal end to the distal end of the permeable shell.

55. The device of claim 52 wherein a major transverse diameter of the permeable shell in a relaxed expanded state is about 4 mm to about 30 mm.

56. The device of claim 52 wherein the large filaments of the permeable shell comprise a transverse dimension or diameter that is about 0.001 inches to about 0.004 inches.

57. The device of claim 52 wherein the small filaments of the permeable shell comprise a transverse dimension or diameter that is about 0.0004 inches to about 0.001 inches.

58. The device of claim 52 wherein the ratio of the number of small filaments of the permeable shell relative to the number of large filaments of the permeable shell may be about 2 to 1 to about 15 to 1.

59. The device of claim 52 wherein the difference in transverse dimension or diameter between the small filaments and the large filaments is less than about 0.0035 inches.

60. The device of claim 52 wherein the openings formed between adjacent filaments of a defect spanning portion of the permeable shell are about 0.005 inches to about 0.04 inches.

61. The device of claim 52 wherein the openings formed between adjacent filaments of a defect spanning portion of the permeable shell are up to about 0.016 inches.

62. The device of claim 52 wherein the filaments of the permeable shell further comprise large filaments and small filaments of different transverse diameters.

63. A method of treating a vascular defect of a patient, comprising:

a) providing a device for treatment of a patient'"'"'s vasculature comprising a self-expanding resilient permeable shell of woven filaments, the permeable shell having a proximal end, a distal end, a longitudinal axis, a radially constrained elongated state configured for delivery within a microcatheter with the woven filaments extending longitudinally from the proximal end to the distal radially adjacent each other, and an expanded relaxed state with a globular and axially shortened configuration relative to the constrained state with the woven filaments forming the self-expanding resilient permeable shell in a smooth path radially expanded from the longitudinal axis between the proximal end and distal end and a plurality of openings in the shell formed between the woven filaments;

b) advancing a delivery system within a patient'"'"'s body such that a distal end of the delivery system is disposed at a position adjacent or within a vascular defect to be treated;

c) axially advancing the device for treatment of a patient'"'"'s vasculature within the delivery system while in a radially constrained state with an elongate delivery apparatus which has a distal end releasably secured to a proximal end of the device for treatment of the patient'"'"'s vasculature;

d) axially advancing the device until the device emerges distally from a distal end of the delivery system and deploying the device such that the woven filaments of the device radially expand from their radially constrained state, and expand into a globular configuration of the permeable shell which covers and acutely occludes at least a portion of an opening or neck of the vascular defect due to the pore size of the permeable shell which slows a flow of blood therethrough to a velocity below a thrombotic threshold velocity.

64. The method of claim 63 further comprising releasing the device from the distal end of the elongate delivery apparatus.

65. The method of claim 63 wherein the device for treatment of the patient'"'"'s vasculature is positioned within the vascular defect by manipulation of a proximal end of the elongate delivery apparatus prior to release of the device.

66. The method of claim 65 further comprising withdrawing the device partially or wholly back within the delivery system by axial retraction of the elongate delivery apparatus prior to release of the device.

67. The method of claim 63 further comprising inhibiting the attachment of platelets to the permeable shell while promoting the formation of clot within an interior space of the permeable shell of the device.

68. The method of claim 63 further comprising implanting a stent support device in the parent vessel such that it spans across the vascular defect prior to or after deployment of the device.

69. The method of claim 63 further comprising delivering an embolic device or material into the vascular defect behind or within the permeable shell after deployment of the device.

70. The method of claim 63 further comprising imparting elongation of the permeable shell in response to radial constraint due to constriction of the vascular defect.

71. The method of claim 63 further comprising selecting a device for treatment of a patient'"'"'s vasculature having a permeable shell in an expanded state with a transverse outer dimension which is oversize relative to a transverse dimension of the patient'"'"'s vascular defect.

72. The method of claim 71 wherein the amount of oversizing of the transverse dimension is at least about 10% greater than the largest transverse dimension of the vascular defect.

73. A method of occluding a vascular defect of a patient'"'"'s vasculature comprising

providing an expandable, porous vascular occlusion device formed from a woven shell of a plurality of filamentary members that are connected to each other on at least the proximal ends of the members forming a substantially closed globular structure with a shape that approximates a size and shape of the vascular defect;

collapsing the device for delivery into the vascular system of the patient;

inserting the collapsed device through an incision in the patient'"'"'s body;

releasing and expanding the device at the vascular defect such that an outer surface contour of the device substantially fills the vascular defect;

substantially occluding the vascular defect acutely with the device that is substantially covered with clotted blood.

74. The method of claim 73 wherein the filamentary members have at least two different transverse dimensions or diameters.

75. The method of claim 74 wherein the woven shell of the occlusion device includes at least two different sizes of filamentary member and the difference between the transverse dimensions or diameters of the filamentary members is less than about 0.004 inches.

76. The method of claim 73 wherein the velocity of blood in the vascular defect is slowed to below a thrombotic threshold velocity after deployment of the device and thrombus forms within an interior volume of the shell of the device.

77. The method of claim 73 further comprising measuring a volume of the vascular defect and selecting a device with a volume that will fill at least a portion of the vascular defect.

78. The method of claim 77 wherein the selected device has approximately the same volume as the measured volume of the vascular defect.

79. The method of claim 77 wherein the measured volume is less than the total volume of the vascular defect to yield a truncated volume and the selected device substantially fills the truncated volume.

80. The method of claim 73 further comprising measuring a largest transverse dimension of the vascular defect and selecting a device having a transverse dimension that is at least about 10% larger than the largest transverse dimension of the vascular defect when the device is in a relaxed expanded state.

81. A delivery system for deployment of a device for treatment of a patient'"'"'s vasculature, comprising:

a microcatheter having an inner lumen extending a length thereof;

a device for treatment of a patient'"'"'s vasculature disposed within the inner lumen of the microcatheter and comprising a self-expanding resilient permeable shell of thin filaments, the permeable shell having a proximal end, a distal end, a longitudinal axis, a radially constrained elongated state configured for delivery within a microcatheter with the thin woven filaments extending longitudinally from the proximal end to the distal radially adjacent each other, and an expanded relaxed state with a globular and axially shortened configuration relative to the constrained state with the woven filaments forming the self-expanding resilient permeable shell in a smooth path radially expanded from the longitudinal axis between the proximal end and distal end and a plurality of openings in the shell formed between the woven filaments, the permeable shell further having a portion when in the expanded relaxed state that is configured to span an opening of a patient'"'"'s vascular defect; and

an elongate delivery apparatus having a proximal end and a distal end releasably secured to a proximal hub of the device.

82. A method of manufacturing a device for treatment of a patient'"'"'s vasculature, comprising

braiding a plurality of elongate resilient filaments over a cylindrically shaped mandrel forming a braided tubular member;

heat setting the elongate filaments of the braided tubular member in an expanded relaxed state with a globular and axially shortened configuration relative to a constrained state with the woven filaments forming the self-expanding resilient permeable shell in a smooth path radially expanded from a longitudinal axis of the device between a proximal end and a distal end of the device with the shell having a reverse bend at the distal end in an everted configuration such that a hub at the distal end is withdrawn axially within the permeable shell structure and a plurality of openings in the shell are formed between the woven filaments;

securing the proximal ends of the filaments together; and

securing the distal ends of the filaments together.

83. The method of claim 82 wherein the proximal end of the device further comprises a proximal hub secured to the proximal ends of the filaments, said proximal hub including a cylindrical member that extends beyond the proximal ends of the filaments forming a cavity.

84. The method of claim 83 further comprising securing a detachment tether within the cavity of the cylindrical member of the proximal hub.

85. The method of claim 82 further comprising securing a proximal hub to the proximal ends of the filaments, securing a distal hub to the distal ends of the filaments, and inserting radio-opaque material within the proximal and distal hubs.

86. The method of claim 82 wherein braiding a plurality of elongate filaments over a cylindrically shaped mandrel comprises braiding large filaments and small filaments having at least two different transverse dimensions.

87. The method of claim 86 wherein braiding a plurality of large and small filaments over a cylindrically shaped mandrel comprises braiding filaments wherein the ratio of the number of small filaments to large filaments is about 2 to 1 to about 15 to 1.