Devices and methods for the treatment of vascular defects

• US 8,974,512 B2
• Filed: 09/12/2011
• Issued: 03/10/2015
• Est. Priority Date: 09/10/2010
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Medina Medical, Inc. (Medtronic Plc)
• Inventors: Aboytes, Maria, Rosqueta, Arturo S.
• Primary Examiner(s): Dornbusch, Dianne
• Assistant Examiner(s): LYNCH, ROBERT A
• Application Number:
  US13/230,628
• Publication Number:
  US 20120239074A1
• Time in Patent Office: 1,275 Days
• Field of Search: 606/157, 606/158, 606/191, 606/194, 606/195, 606/198, 606/200, 623/1.11, 623/1.15, 623/1.16, 623/1.18, 623/1.2, 623/1.21
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

Devices and methods for treating vascular defects, such as, for example, balloon-type aneurysms, are described herein. In one embodiment, an apparatus includes an insertion portion and an expandable implant. The expandable implant is configured to be deployed in an aneurysm and is coupled to the insertion portion. The expandable implant has a first portion and a second portion coupled to the first portion. The expandable implant is movable between a first configuration in which the first portion and the second portion are substantially linearly aligned and a second configuration in which the second portion at least partially overlaps the first portion.

Claims

1. An apparatus, comprising:

an expandable implant, configured to be deployed in a sac of an aneurysm, the expandable implant having a first portion and a second portion coupled to the first portion, the expandable implant being movable between a first configuration in which the first portion and the second portion are linearly aligned along an axis and a second configuration in which the second portion at least partially overlaps the first portion,

wherein the first portion and the second portion are configured to assume a non-linear pre-determined configuration when deployed within the sac of the aneurysm and the expandable implant is in the second configuration, the first portion and the second portion collectively forming at least a portion of an outer boundary that defines an interior volume of the expandable implant when in the second configuration, at least the first portion or the second portion being completely offset from the axis in the second configuration,

wherein the first portion and the second portion each have a concave surface and a convex surface, the convex surface of one of the first portion and the second portion being in apposition with the concave surface of the other of the first portion and the second portion when in the second configuration,

a first porous portion having

a collapsed configuration for insertion through a blood vessel, wherein, in its collapsed configuration, the first porous portion has a first width and is symmetrical about a first porous portion axis, and

an expanded configuration for occupying at least a portion of a sac of an aneurysm, wherein, in its expanded configuration, the first porous portion has a second width greater than the first width and is asymmetrical about the first porous portion axis; and

a second porous portion coupled to the first porous portion, the second porous portion having

a collapsed configuration for insertion through the blood vessel, wherein, in its collapsed configuration, the second porous portion has a third width and is symmetrical about a second porous portion axis, and

an expanded configuration for occupying at least a portion of the sac of the aneurysm, wherein, in its expanded configuration, the second porous portion has a fourth width greater than the third width and is asymmetrical about the second porous portion axis; and

wherein the first porous portion and the second porous portion are configured to expand independently of each other; and

wherein the first portion and the second portion are each formed of a flattened two-layer ribbon-shaped strand formed of tubular mesh material.

2. The apparatus of claim 1, wherein the first portion and the second portion each include a porous mesh, the porous mesh having a first porosity when in the first configuration and a second porosity when in the second configuration.

3. The apparatus of claim 1, wherein the expandable implant in the first configuration is configured for insertion through a blood vessel, and in the second configuration is configured to occupy at least a portion of the sac of the aneurysm.

4. The apparatus of claim 1, further comprising an insertion portion removably coupled to the expandable implant.

5. The apparatus of claim 4, wherein the insertion portion is a guide wire.

6. The apparatus of claim 1, wherein the first portion and the second portion are configured such that they are biased in the second configuration.

7. The apparatus of claim 1, wherein the first portion includes a first layer of porous mesh and a second layer of porous mesh, the first layer and the second layer having one of the same or different porosities.

8. The apparatus of claim 1, wherein the first portion includes a first layer of porous mesh and a second layer of porous mesh, the first layer being offset from the second layer.

9. The apparatus of claim 1, wherein the expandable implant has a first width in the first configuration and a second width in the second configuration, the second width being greater than the first width.

10. The apparatus of claim 1, wherein the first portion of the expandable implant includes a first end and a second end different than its first end, the second portion of the expandable implant includes a first end and a second end different than its first end, the first end of the first portion is coupled to the first end of the second portion.

11. The apparatus of claim 1, wherein the first portion and the second portion each include a porous mesh, the porous mesh of the first portion having a multi-dimensional shape with a first width when the expandable implant is in the second configuration, the porous mesh of the second portion having a multi-dimensional shape with a second width less than the first width when the expandable implant is in the second configuration.

12. The apparatus of claim 1, wherein the first portion and the second portion each include a porous mesh, the porous mesh of at least one of the first portion and the second portion including a plurality of braided wires braided to form the porous mesh, the braided wires including an electropositive metal.

13. The apparatus of claim 1, wherein at least one of the first portion or the second portion includes a porous mesh formed of at least one of nitinol, platinum, tantalum, drawn filled tubing, or a combination thereof.

14. The apparatus of claim 1, wherein at least one of the first portion or the second portion includes a radiopaque marker coupled to the at least one of the first portion or the second portion.

15. The apparatus of claim 1, wherein at least one of the first portion or the second portion includes a porous mesh, at least a portion of the porous mesh configured to be positioned across at least a portion of a neck of the aneurysm when the expandable implant is in the second configuration, the portion of the porous mesh being a scaffold for endothelial cell attachment at the neck of the aneurysm.

16. The apparatus of claim 1, wherein at least a portion of at least one of the first portion or the second portion of the expandable implant is positioned across at least a portion of a neck of the aneurysm when the expandable implant is deployed in the aneurysm, the portion positioned across at least a portion of the neck of the aneurysm configured to disrupt flow of a bodily fluid into the aneurysm from a vessel.

17. The apparatus of claim 1, wherein a portion of the first portion, that is spaced apart from the second portion when the first portion and the second portion are in the first configuration, contacts the second portion when the first portion and the second portion are in the second configuration.

18. The apparatus of claim 1, wherein at least a portion of the first portion and at least a portion of the second portion are configured to directly contact the aneurysm when in the second configuration.

19. The apparatus of claim 1, wherein the first portion and the second portion are coupled by an articulating segment, the first portion and second portion each having a concave surface and a convex surface, the convex surface of one of the first portion and the second portion being in apposition with the concave surface of the other of the first portion and the second portion when in the second configuration.

20. The apparatus of claim 19, wherein when in the second configuration, the first portion and the second portion each have a first cross-sectional dimension that is greater than a first cross-sectional dimension of the articulating segment and the first portion and the second portion each have a second cross-sectional dimension that is substantially the same as a second cross-sectional dimension of the articulating segment.

21. The apparatus of claim 1, further comprising a delivery catheter, the expandable implant configured to be received within a lumen of the delivery catheter when the expandable implant is in the collapsed configuration.

22. The apparatus of claim 1, wherein the expandable implant in the second configuration is compliant allowing contact with at least a portion of a wall of an irregularly shaped sac of the aneurysm.

23. An apparatus, comprising:

a first porous portion having

a collapsed configuration for insertion through a blood vessel, wherein, in its collapsed configuration, the first porous portion has a first width and is symmetrical about a first porous portion axis, and

an expanded configuration for occupying at least a portion of a sac of an aneurysm, wherein, in its expanded configuration, the first porous portion has a second width greater than the first width and is asymmetrical about the first porous portion axis; and

a second porous portion coupled to the first porous portion, the second porous portion having

a collapsed configuration for insertion through the blood vessel, wherein, in its collapsed configuration, the second porous portion has a third width and is symmetrical about a second porous portion axis, and

an expanded configuration for occupying at least a portion of the sac of the aneurysm, wherein, in its expanded configuration, the second porous portion has a fourth width greater than the third width and is asymmetrical about the second porous portion axis; and

wherein the first porous portion and the second porous portion are configured to expand independently of each other, and

wherein at least one of the first porous portion or the second porous portion is formed of a flattened two-layer ribbon-shaped strand formed of a tubular mesh material.

24. The apparatus of claim 23, wherein the first porous portion has a first end and a second end and the second porous portion has a first end and a second end, and wherein

in the collapsed configuration, the first end of the first porous portion is spaced apart from the second end of the first porous portion by a first distance, and

in the expanded configuration, the first end of the first porous portion is spaced apart from the second end of the first porous portion by a second distance less than the first distance.

25. The apparatus of claim 23, wherein at least one of the first porous portion and the second porous portion includes a weave or a braid of a plurality of electropositive metal filaments.

26. The apparatus of claim 23, wherein at least one of the first porous portion and the second porous portion is biased towards its expanded configuration.

27. The apparatus of claim 23, wherein, when the first porous portion and the second porous portion are both in their respective expanded configurations, a first portion of the first porous portion and a first portion of the second porous portion are overlapped.

28. The apparatus of claim 23, wherein, when in the expanded configuration, at least a portion of at least one of the first porous portion and the second porous portion is configured to be positioned across at least a portion of a neck of the aneurysm to facilitate endothelial cell attachment at the neck of the aneurysm.

29. The apparatus of claim 23, wherein:

the first porous portion is configured to

occupy a first volume in its collapsed configuration, and

occupy a second volume in its expanded configuration, wherein the second volume is greater than the first volume; and

the first porous portion and the second porous portion are each configured to curve into a three-dimensional configuration when in their respective expanded configurations and deployed within the aneurysm such that the first porous portion and the second porous portion collectively form a portion of a boundary that defines an interior region configured to receive at least a portion of the first porous portion in its expanded configuration.

30. The apparatus of claim 23, wherein

when in the expanded configuration, the first porous portion has a thickness less than the second width of the first porous portion and less than a length of the first porous portion, and

when in the expanded configuration, the second porous portion has a thickness less than the fourth width of the second porous portion and less than a length of the second porous portion.

31. The apparatus of claim 23, wherein at least one of the first porous portion or the second porous portion is formed with a shape memory material.

32. The apparatus of claim 31, wherein the shape memory material is nitinol.

33. The apparatus of claim 23, wherein the first porous portion and the second porous portion are coupled by an articulating segment.

34. The apparatus of claim 33, wherein, when in their expanded configurations, the first porous portion and the second porous portion each have a first cross-sectional dimension that is greater than a first cross-sectional dimension of the articulating segment and a second cross-sectional dimension that is substantially the same as a second cross-sectional dimension of the articulating segment.

35. The apparatus of claim 23, wherein, in their respective expanded configurations, the first porous portion and the second porous portion are each compliant allowing contact with at least a portion of a wall of an irregularly shaped sac of the aneurysm.

36. The apparatus of claim 23, further comprising a delivery catheter, each of the first porous portion and the second porous portion are configured to be received within a lumen defined by the delivery catheter when in their respective collapsed configurations.

37. The apparatus of claim 23, further comprising an insertion portion configured to be removably coupled to at least one of the first porous portion or the second porous portion.

38. The apparatus of claim 37, wherein the insertion portion is a guide wire.

39. An apparatus, comprising:

an expandable implant configured to be deployed within an aneurysm and occupying at least a portion of a volume defined by a sac of the aneurysm and at least a portion of the expandable implant configured to be positioned across at least a portion of a neck of the aneurysm, the expandable implant having a collapsed configuration for insertion through a blood vessel and a three-dimensional expanded configuration when deployed within the aneurysm;

the expandable implant having a first porous portion and a second porous portion, wherein at least one of the first porous portion or the second porous portion are formed of a flattened two-layer ribbon-shaped strand formed of tubular mesh material;

the first porous portion having a collapsed configuration for insertion through a blood vessel and an expanded configuration, the first porous portion being elongate in its collapsed configuration;

the second porous portion having a collapsed configuration for insertion through the blood vessel and an expanded configuration for occupying the sac of the aneurysm, the second porous portion being elongate in its collapsed configuration,

the first porous portion and the second porous portion each configured to assume a nonlinear pre-determined configuration when deployed within the aneurysm and in their respective expanded configurations, the first porous portion and the second porous portion collectively forming at least a portion of an outer boundary that defines an interior region of the expandable implant when the expandable implant is in the three-dimensional expanded configuration; and

the first porous portion and the second porous portion each having a concave surface and a convex surface, the convex surface of at least one of the first porous portion and the second porous portion being in apposition with the concave surface of at least one of the other of the first porous portion and the second porous portion when the first porous portion and the second porous portion are each in their respective expanded configurations.

40. The apparatus of claim 39, wherein the first porous portion and the second porous portion are coupled by an articulating segment and, when in their expanded configurations, the first porous portion and the second porous portion each have a first cross-sectional dimension that is greater than a first cross-sectional dimension of the corresponding articulating segment and a second cross-sectional dimension that is substantially the same as a second cross-sectional dimension of the corresponding articulating segment.

41. The apparatus of claim 39, wherein at least one of the first porous portion and the second porous portion includes a shape memory material.

42. The apparatus of claim 41, wherein the shape memory material is nitinol.

43. The apparatus of claim 39, further comprising a delivery catheter, wherein the expandable implant is configured to be received within a lumen defined by the delivery catheter when the expandable implant is in the collapsed configuration.

44. The apparatus of claim 39, further comprising an insertion portion configured to be removably coupled to the expandable implant.

45. The apparatus of claim 44, wherein the insertion portion is a guide wire.

46. The apparatus of claim 39, wherein in the expanded configuration the three-dimensional expandable implant is compliant allowing contact with at least a portion of a wall of an irregularly shaped sac of the aneurysm.