METHODS AND DEVICES FOR TREATMENT OF VASCULAR DEFECTS

• US 20110022149A1
• Filed: 06/03/2008
• Published: 01/27/2011
• Est. Priority Date: 06/04/2007
• Status: Abandoned Application

• Current Assignee: Microvention Incorporated (Terumo Corporation)
• Original Assignee: Microvention Incorporated (Terumo Corporation)
• Inventors: Schaefer, Dean, Rosenbluth, Robert F., Cox, Brian J.
• Application Number:
  US12/602,997
• Publication Number:
  US 20110022149A1
• Time in Patent Office: Days
• US Class Current: 623/1.11
• 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 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• 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 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/006 : Y-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0076 : ellipsoidal or ovoid

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 include thin permeable membranes configured to occlude blood flow therethrough.

Claims

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

an expandable body support structure having;

a low profile radially constrained state with an elongated tubular configuration that includes a first end, a second end, a longitudinal axis and elongate flexible wires disposed substantially parallel to each other with first ends thereof secured to a first ring and second ends thereof secured to a second ring with the first and second rings being disposed substantially concentric to the longitudinal axis, and a middle portion of the expandable body having a first transverse dimension with a low profile suitable for delivery from a microcatheter,

an expanded relaxed state having an axially shortened configuration relative to the constrained state with the first ring disposed adjacent the second ring, both rings substantially concentric to the longitudinal axis and each wire forming a smooth arc between the first and second rings with a reverse bend at one or both ends such that the arc of each wire extends axially beyond each respective ring and such that the middle portion has a second transverse dimension substantially greater than the first transverse dimension and each wire is configured to flex radially with respect to the longitudinal axis of the expandable body; and

a permeable layer defect spanning structure disposed at and conforming to a profile of a first end of the expandable body when in the expanded relaxed state.

3. The device of claim 1 wherein the permeable layer is disposed interior to an outer surface of the expandable body.

4. The device of claim 1 wherein the permeable layer has a convex configuration that spans the first end of the expandable body in a relaxed expanded state and extends along the wires towards the first ring.

5. The device of claim 1 wherein the permeable layer spans the wires towards the second ring to a longitudinal position of about 10 percent to about 60 percent the total length of the expandable body in a relaxed expanded state.

7. The device of claim 1 wherein the permeable layer comprises microfibers.

9. The device of claim 1 wherein the permeable layer comprises an outer layer that includes an anti-thrombogenic agent and an inner layer disposed distal of the outer layer towards an interior cavity of the device with the expandable body in a deployed state that includes a thrombogenic agent.

16. The device of claim 1 wherein the total volume of permeable layer is between about 0.5 mm³ and about 4 mm³.

17. The device of claim 1 wherein the permeable layer has a porosity greater than about 60 percent.

21. The device of claim 1 wherein a spacing between the first ring and second ring in the relaxed state of the expandable body is about 10 percent to about 50 percent of the spacing between the first ring and second ring in the constrained tubular state.

109. The device of claim 1 wherein the permeable layer defect spanning structure comprises wires.

110. The device of claim 109 wherein the permeable layer defect spanning structure comprises braided wires.

111. The device of claim 109 wherein the wires of the permeable layer defect spanning structure have a thickness of about 0.015 mm to about 0.030 mm.

112. The device of claim 1 wherein the permeable layer defect spanning structure comprises multiple layers.

2. (canceled)

6. (canceled)

8. (canceled)

10-15. -15. (canceled)

18-20. -20. (canceled)

22-32. -32. (canceled)

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

an expandable body support structure, having;

a low profile radially constrained state with a first end, a second end, an elongated tubular configuration having a longitudinal axis, elongate flexible wires connected at intersections between the first end and second end forming a plurality of open cells between wires in a middle portion of the expandable body, and a first transverse dimension suitable for delivery from a microcatheter configured for navigation in cerebral vasculature,

an expanded relaxed state with a tubular configuration having a second transverse dimension substantially greater than the first transverse dimension of the tubular configuration of the constrained state; and

a permeable layer spanning at least one cell between wires of the expandable body.

34. The device of claim 33 wherein the support structure comprises wire members configured to span or cross a lumen of a parent vessel both upstream and downstream of a vascular defect and, a defect spanning structure configured to substantially block flow into the defect when positioned substantially over the defect.

35. The device of claim 33 further comprising perforations disposed in the wires of the expandable body and configured for securing the permeable layer to the expandable body.

38. The device of claim 33 wherein the permeable layer comprises microfibers.

40. The device of claim 33 wherein the permeable layer comprises an outer layer that includes an anti-thrombogenic agent and an inner layer disposed towards a cavity of an aneurysm relative to the outer layer with the expandable body in a deployed state that includes a thrombogenic agent.

44. The device of claim 33 further comprising a sealing member disposed about a perimeter of the permeable layer and configured to form a seal between the permeable layer and a surface of the patient'"'"'s vasculature.

47. The device of claim 33 wherein the total volume of permeable layer is between about 0.5 mm³ and 4 mm³.

48. The device of claim 33 wherein the permeable layer has a porosity greater than about 60 percent.

36. (canceled)

37. (canceled)

39. (canceled)

41-43. -43. (canceled)

45-46. -46. (canceled)

49-51. -51. (canceled)

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

an expandable body support structure having;

a low profile radially constrained state with an elongated tubular configuration that includes a first end, a second end, a longitudinal axis and elongate flexible wires disposed substantially parallel to each other with first ends thereof secured relative to each other, and a middle portion of the expandable body having a first transverse dimension with a low profile suitable for delivery from a microcatheter,

an expanded relaxed state having an axially shortened configuration relative to the constrained state with each wire forming a smooth arc such that the arc of each wire extends axially beyond the first transverse dimension and such that the middle portion has a second transverse dimension substantially greater than the first transverse dimension and each wire is configured to independently flex in a radial orientation with respect to the longitudinal axis of the expandable body; and

a defect spanning structure comprising a permeable layer disposed at and conforming to a profile of a second end of the expandable body when in the expanded relaxed state.

55. The device of claim 52 wherein the permeable layer has a convex configuration that spans a second end portion of the expandable body in a relaxed expanded state and extends along the wires towards the first end.

56. The device of claim 52 wherein the permeable layer spans the wires towards the first ring to a longitudinal position of about 10 percent to about 60 percent the total length of the expandable body in a relaxed expanded state.

57. The device of claim 52 wherein the permeable layer comprises a laser cut polymer membrane.

58. The device of claim 52 wherein the permeable layer comprises microfibers.

64. The device of claim 52 further comprising a sealing member which includes an elongate element configured to form a seal between the permeable layer and a tissue surface of the patient'"'"'s vasculature.

53-54. -54. (canceled)

59-63. -63. (canceled)

65-73. -73. (canceled)

74. A method of treating a vascular defect, comprising:

a) providing a vascular defect treatment device comprising a support structure with an expandable body and a defect spanning structure that includes a plurality of microfibers that are substantially parallel to each other when the support structure is in an expanded relaxed state;

b) advancing a delivery system to a position adjacent a vascular defect to be treated;

c) positioning the device inside the vascular defect; and

d) deploying the device such that the expandable body self-expands and the defect spanning structure covers at least a portion of the defect opening or neck.

75. The method of claim 74 wherein the device is positioned within the vascular defect from a distal end of the delivery apparatus releasably secured to the device and further comprising releasing the device from the delivery apparatus.

76. The method of claim 74 further comprising promoting the formation of clot within an interior space of the device.

77. The method of claim 74 further comprising delivering energy through the delivery apparatus and/or a separate catheter to facilitate fixation and/or healing of the device within the defect.

123. The method of claim 74 wherein the plurality of microfibers are braided or woven.

124. The method of claim 74 wherein the defect spanning structure comprises a plurality of layers.

125. The method of claim 74 wherein the defect spanning structure comprises a portion with low or no porosity and oriented such that the low porosity portion is substantially perpendicular to the longitudinal axis of the support structure when in an expanded state.

78-108. -108. (canceled)

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

an expandable body support structure, having;

a low profile radially constrained state with a first end, a second end, an elongated tubular configuration having a longitudinal axis, elongate flexible wires forming a plurality of open cells between wires, and a first transverse dimension suitable for delivery from a microcatheter configured for navigation in cerebral vasculature,

an expanded relaxed state with a substantially spherical or globular configuration having a second transverse dimension substantially greater than the first transverse dimension of the tubular configuration of the constrained state; and

a permeable layer secured to the expandable body which is configured to cover an aneurysm opening and having a portion with low or no porosity and oriented such that the low porosity portion is substantially perpendicular to the longitudinal axis of the expandable body support structure when in the expanded relaxed state.

114. The device of claim 113 wherein the defect spanning layer is formed from woven or braided strands of material.

115. The device of claim 113 wherein the defect spanning layer is disposed interior to an outer surface of the expandable body.

116. The device of claim 113 wherein the defect spanning layer longitudinally spans from about 10 percent to about 60 percent of the total length of the expandable body when the expandable body is in a relaxed expanded state.

117. The device of claim 113 wherein the wires are disposed substantially parallel to each other with first ends thereof secured to a first ring and second ends thereof secured to a second ring with the first and second rings being disposed substantially concentric to the longitudinal axis, and the spacing between the first end and second end in the relaxed state of the expandable body is about 10 percent to about 50 percent of the spacing between the first ring and second ring in the constrained tubular state.

118. A method of treating a vascular defect, comprising:

a) providing a vascular defect treatment device comprising a support structure with an expandable body constructed from a plurality of wires to form a plurality of open cells between the wires and a defect spanning structure that includes a plurality of filaments that are substantially parallel to each other when the support structure is in an expanded relaxed state and form a low porosity portion in the expanded relaxed state;

b) advancing a delivery system to a position adjacent a vascular defect to be treated;

c) positioning the device substantially within the vascular defect; and

d) deploying the device such that the expandable body self-expands and the defect spanning structure covers at least a portion of the defect opening or neck.

119. The method of claim 118 wherein the defect spanning structure is formed from woven or braided strands of material.

120. The method of claim 118 wherein the support structure has a substantially spherical, bulbous, globular or globe-like configuration.

121. The method of claim 118 further comprising releasing the device from the delivery system by the delivery of energy to a junction or release mechanism disposed between the device and delivery system.

122. The method of claim 118 wherein the defect spanning layer is disposed interior to an outer surface of the expandable body.