Filamentary devices for treatment of vascular defects

• US 9,198,670 B2
• Filed: 06/18/2015
• Issued: 12/01/2015
• Est. Priority Date: 08/16/2013
• Status: Active Grant

• Current Assignee: Microvention Incorporated (Terumo Corporation)
• Original Assignee: Sequent Medical, Inc. (Terumo Corporation)
• Inventors: Hewitt, Todd J, Merritt, Brian E, Patterson, William R
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US14/743,627
• Publication Number:
  US 20150283363A1
• Time in Patent Office: 166 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/12031 complete occlusion
• 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 17/12172 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 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12068 detachable by heat
• CPC Class Codes: A61B 2017/1209 detachable by electrical current or potential, e.g. electroactive polymer
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image

Abstract

Methods for treatment of a cerebral aneurysm are described. Embodiments may include a self-expanding resilient permeable shell having a radially constrained elongated state configured for delivery within a catheter lumen, an expanded state with a globular and longitudinally shortened configuration relative to the radially constrained state, and a plurality of elongate filaments which are woven together, which define a cavity of the permeable shell. The permeable shell includes at least some filaments consisting of nitinol and at least some composite filaments. The composite filaments include drawn filled tube wires having an external nitinol tube and a highly radiopaque material concentrically disposed within the external tube.

Claims

1. A method for treating a cerebral aneurysm, comprising the steps of:

providing a resilient self-expanding permeable shell, the permeable shell including a radially constrained elongated state configured for delivery within a catheter lumen, an expanded state with a globular and longitudinally shortened configuration relative to the radially constrained state, and a plurality of elongate filaments which are woven together and define a cavity of the permeable shell, the permeable shell comprising at least some filaments consisting of nitinol and at least some composite filaments, the composite filaments comprising drawn filled tube wires each comprising an external nitinol tube and a highly radiopaque material concentrically disposed within the external tube, and wherein the permeable shell has at least about 40% composite filaments relative to a total number of filaments, and wherein a total number of filaments is about 70 to about 300;

advancing the permeable shell in the radially constrained state within a catheter to a region of interest within a cerebral artery;

deploying the permeable shell within the cerebral aneurysm, wherein the permeable shell expands to the expanded state within the cerebral aneurysm; and

withdrawing the catheter from the region of interest after deploying the permeable shell, wherein the permeable shell is in the expanded state with the globular configuration after the catheter is withdrawn.

2. The method of claim 1, wherein the plurality of elongate filaments are secured relative to each other at a distal end of the permeable shell.

3. The method of claim 1, wherein the plurality of elongate filaments are secured relative to each other at a proximal end of the permeable shell.

4. The method of claim 1, wherein the drawn filled tube wires have a fill ratio of cross sectional area of between about 25% and about 35%.

5. The method of claim 1, wherein the highly radiopaque material of the composite filaments comprises platinum.

6. The method of claim 1, wherein a ratio of a number of the at least some filaments consisting of nitinol to the number of at least some composite filaments is selected from the group consisting of 1:

1, 1;

1.5, and 1.5;

1.

7. The method of claim 1, wherein each of the composite filaments has a diameter selected from the group consisting of 0.00075″

, 0.001″

, and 0.00125″

.

8. A method for treating a cerebral aneurysm, comprising the steps of:

providing a resilient self-expanding permeable shell, the permeable shell including a radially constrained elongated state configured for delivery within a catheter lumen, an expanded state with a globular and longitudinally shortened configuration relative to the radially constrained state, and a plurality of elongate filaments which are woven together and define a cavity of the permeable shell, the plurality of filaments having a total cross sectional area, the permeable shell comprising at least some filaments consisting of nitinol and at least some composite filaments, the composite filaments comprising drawn filled tube wires each comprising an external nitinol tube and a highly radiopaque material, and wherein the permeable shell has at least about 40% composite filaments relative to a total number of filaments, and wherein a total number of filaments is about 70 to about 300, and wherein the total cross sectional area of the highly radiopaque material is between about 11% and about 30% of the total cross sectional area of the plurality of elongate elements;

advancing the permeable shell in the radially constrained state within a catheter to a region of interest within a cerebral artery;

deploying the permeable shell within the cerebral aneurysm, wherein the permeable shell expands to the expanded state within the cerebral aneurysm; and

withdrawing the catheter from the region of interest after deploying the permeable shell, wherein the permeable shell is in the expanded state with the globular configuration after the catheter is withdrawn.

9. The method of claim 8, wherein the total cross sectional area of the highly radiopaque material is between about 15% and about 30% of the total cross sectional area of the plurality of elongate elements.

10. The method of claim 8, wherein the total cross sectional area of the highly radiopaque material is between about 15% and about 22% of the total cross sectional area of the plurality of elongate elements.

11. The method of claim 8, wherein the total cross sectional area of the highly radiopaque material is between about 19% and about 30% of the total cross sectional area of the plurality of elongate elements.

12. The method of claim 8, wherein the total cross sectional area of the highly radiopaque material is between about 11% and about 18.5% of the total cross sectional area of the plurality of elongate elements.

13. The method of claim 8, wherein the plurality of elongate filaments are secured relative to each other at a distal end of the permeable shell.

14. The method of claim 8, wherein the plurality of elongate filaments are secured relative to each other at a proximal end of the permeable shell.

15. The method of claim 8, wherein the drawn filled tube wires have a fill ratio of cross sectional area of between about 25% and about 35%.

16. The method of claim 8, wherein the highly radiopaque material comprises platinum.

17. The method of claim 8, wherein a ratio of a number of the at least some filaments consisting of nitinol to the number of at least some composite filaments is selected from the group consisting of 1:

1, 1;

1.5, and 1.5;

1.

18. The method of claim 8, wherein each of the composite filaments has a diameter selected from the group consisting of 0.00075″

, 0.001″

, and 0.00125″

.

19. A method for treating a cerebral aneurysm, comprising the steps of:

providing a resilient self-expanding permeable shell, the permeable shell including a radially constrained elongated state configured for delivery within a catheter lumen, an expanded state with a globular and longitudinally shortened configuration relative to the radially constrained state, and a plurality of elongate filaments which are woven together and define a cavity of the permeable shell, the permeable shell comprising at least some filaments consisting of nitinol and at least some composite filaments, the composite filaments comprising drawn filled tube wires each comprising an external nitinol tube and a highly radiopaque material concentrically disposed within the external tube, and wherein a total number of filaments is about 70 to about 300, and wherein the permeable shell has either at least 40% composite filaments or has a total number of composite filaments between about 40 and 190;

advancing the permeable shell in the radially constrained state within a catheter to a region of interest within a cerebral artery;

deploying the permeable shell within the cerebral aneurysm, wherein the permeable shell expands to the expanded state within the cerebral aneurysm; and

withdrawing the catheter from the region of interest after deploying the permeable shell, wherein the permeable shell is in the expanded state with the globular configuration after the catheter is withdrawn.

20. The method of claim 19, wherein the plurality of elongate filaments are secured relative to each other at a distal end of the permeable shell.

21. The method of claim 19, wherein the plurality of elongate filaments are secured relative to each other at a proximal end of the permeable shell.

22. The method of claim 19, wherein the highly radiopaque material of the composite filaments comprises platinum.

23. The method of claim 19, wherein a ratio of a number of the at least some filaments consisting of nitinol to the number of at least some composite filaments is selected from the group consisting of 1:

1, 1;

1.5, and 1.5;

1.

24. The method of claim 19, wherein each of the composite filaments has a diameter selected from the group consisting of 0.00075″

, 0.001″

, and 0.00125″

.

25. A method for treating a cerebral aneurysm, comprising the steps of:

providing a resilient self-expanding permeable shell, the permeable shell including a radially constrained elongated state configured for delivery within a catheter lumen, an expanded state with a globular and longitudinally shortened configuration relative to the radially constrained state, and a plurality of elongate filaments which are woven together and define a cavity of the permeable shell, the plurality of filaments having a total cross sectional area, the permeable shell comprising at least some filaments consisting of nitinol and at least some composite filaments, the composite filaments comprising drawn filled tube wires each comprising an external nitinol tube and a highly radiopaque material, and wherein a total number of filaments is about 70 to about 300, and wherein the permeable shell has either at least 40% composite filaments or has a total number of composite filaments between about 40 and 190, and wherein the total cross sectional area of the highly radiopaque material is between about 11% and about 30% of the total cross sectional area of the plurality of elongate elements;

advancing the permeable shell in the radially constrained state within a catheter to a region of interest within a cerebral artery;

deploying the permeable shell within the cerebral aneurysm, wherein the permeable shell expands to the expanded state within the cerebral aneurysm; and

withdrawing the catheter from the region of interest after deploying the permeable shell, wherein the permeable shell is in the expanded state with the globular configuration after the catheter is withdrawn.

26. The method of claim 25, wherein the plurality of elongate filaments are secured relative to each other at a distal end of the permeable shell.

27. The method of claim 25, wherein the plurality of elongate filaments are secured relative to each other at a proximal end of the permeable shell.

28. The method of claim 25, wherein the highly radiopaque material of the composite filaments comprises platinum.

29. The method of claim 25, wherein a ratio of a number of the at least some filaments consisting of nitinol to the number of at least some composite filaments is selected from the group consisting of 1:

1, 1;

1.5, and 1.5;

1.

30. The method of claim 25, wherein each of the composite filaments has a diameter selected from the group consisting of 0.00075″

, 0.001″

, and 0.00125″

.