Filamentary devices for treatment of vascular defects

• US 9,492,174 B2
• Filed: 03/16/2016
• Issued: 11/15/2016
• 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:
  US15/071,632
• Publication Number:
  US 20160192941A1
• Time in Patent Office: 244 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. Methods include providing a self-expanding 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 that are woven together, which define a cavity of the permeable shell. The permeable shell includes composite filaments. The composite filaments may have a diameter of 0.00075″, 0.001″, 0.0015″, and/or 0.00125″. The permeable shell is advanced in the constrained state within a catheter. The permeable shell is then deploying the permeable shell within the cerebral aneurysm, wherein the permeable shell expands to the expanded state within the cerebral aneurysm. The catheter is then withdrawn after deploying the permeable shell.

Claims

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

providing a resilient self-expanding permeable shell, the permeable shell having to distal end and a proximal end and 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 composite filaments, the composite filaments comprising drawn filled tube wires comprising an external nitinol tube and a highly radiopaque material concentrically disposed within the external nitinol tube, 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 each of the composite filaments has a diameter selected from the group consisting of 0.00075″

, 0.001″

, 0.0015″

, and 0.00125″

;

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 the 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 the 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 10% and about 50%.

5. The method of claim 1, wherein the drawn filled tube wires have a fill ratio of cross sectional area of between about 20% and about 40%.

6. 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%.

7. The method of claim 1, wherein the highly radiopaque material of the at least some composite filaments comprises tantalum.

8. The method of claim 1, wherein the highly radiopaque material of the at least some composite filaments comprises platinum.

9. The method of claim 1, wherein the highly radiopaque material of the at least some composite filaments comprises gold.

10. The method of claim 1, wherein the plurality of elongate filaments have a total cross sectional area, and wherein a 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 filaments.

11. The method of claim 10, 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 filaments.

12. The method of claim 11, 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 filaments.

13. The method of claim 11, 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 filaments.

14. The method of claim 10, 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 filaments.

15. The method of claim 1, wherein each of the elongate filaments of the plurality of elongate filaments comprises a first end and a second end, and wherein the first ends and second ends of the elongate filaments are secured relative to each other at the proximal end of the permeable shell.

16. The method of claim 15, wherein each of the elongate filaments of the plurality of elongate filaments comprises a center portion between its first end and second end, the center portion forming a curved apex at the distal end of the permeable shell.

17. The method of claim 16, wherein the distal end of the permeable shell comprises a closed distal apex.

18. The method of claim 1, wherein the permeable shell has composite filaments having diameters of 0.0015″

and 0.001″

.

19. The method of claim 1, wherein the woven elongate filaments form a first average braid material density BDavg1 at a distal portion of the permeable shell and a second average braid material density BDavg2 at a proximal portion of the permeable shell, the second average braid material density BDavg2 greater than the first average braid material density BDavg1.

20. The method of claim 1, wherein the woven elongate filaments comprise a first subset of filaments each having a first transverse dimension and a second subset of filaments each having a second transverse dimension, the second transverse dimension greater than the first transverse dimension.