Filamentary devices for treatment of vascular defects

• US 9,955,976 B2
• Filed: 04/10/2015
• Issued: 05/01/2018
• 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, Patterson, William R, Thompson, James M, Plaza, Claudio, Tran, Hung P
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US14/684,079
• Publication Number:
  US 20160249934A1
• Time in Patent Office: 1,117 Days
• 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 17/12145 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 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• 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 2017/00862 elastic or resilient for sutures A61B2017/0618
• 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

Devices and methods for treatment of a patient'"'"'s vasculature are described. The devices include implants made of woven braided mesh having a variable mesh density, i.e., the average size of pores in one region are a different than the average size of pores in another region. Additionally, there is a transition zone between the two regions. The implants have a low profile radially constrained state and an expanded state that is axially shortened. Methods of using the device to treat a cerebral aneurysm are also described. Methods of forming a tubular braid are also described. Methods of forming a tubular braid with variable braid densities are described. Methods of forming a tubular braid using a castellated mandrel are also described.

Claims

1. A device for treating a cerebral aneurysm, comprising:

an implant comprising a single layer of woven braided mesh, the implant having a proximal end with a hub, a distal end, and a longitudinal axis extending from the proximal end to the distal end, and a length;

the implant having a distal region having a plurality of pores having an average diameter, a proximal region having a plurality of pores having an average diameter, and a transition region that lies substantially perpendicular to the longitudinal axis of the implant and extends between the distal and proximal regions and has a length;

the implant having an expanded globular configuration when deployed, the expanded implant having a region of maximum diameter that extends from a proximal portion of the distal region through the transition region and to a distal portion of the proximal region,

wherein the average diameter of the plurality of pores in the distal region is greater than the average diameter of the plurality of pores in the proximal region, and wherein the length of the transition region is about 0.5% to about 20% of the length of the implant.

2. The device of claim 1, wherein the average diameter of the plurality of pores in the distal region is greater than 250 μ

m.

3. The device of claim 1, wherein the average diameter of the plurality of pores in the distal region is greater than 400 μ

m.

4. The device of claim 1, wherein the average diameter of the plurality of pores in the distal region is between about 250 μ

m to about 500 μ

m or between about 300 μ

m to about 600 μ

m.

5. The device of claim 1, wherein the average diameter of the plurality of pores in the proximal region is 200 μ

m or less.

6. The device of claim 1, wherein the average diameter of the plurality of pores in the proximal region is between about 50 μ

m to about 200 μ

m.

7. The device of claim 1, wherein the average diameter of the plurality of pores in the proximal region is between about 100 μ

m to about 200 μ

m.

8. The device of claim 1, wherein the length of the transition region is about 1% to about 15% of the length of the implant.

9. The device of claim 1, wherein the length of the transition region is about 1% to about 10% of the length of the implant.

10. The device of claim 1, wherein the length of the transition region is about 3% to about 8% of the length of the implant.

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

providing an implant comprising a single layer of woven braided mesh, the implant having a proximal end with a hub, a distal end, and a longitudinal axis extending from the proximal end to the distal end, and a length,

wherein the implant has a distal region having a plurality of pore having an average diameter, a proximal region having a plurality of pore having an average diameter, and a transition region that lies substantially perpendicular to the longitudinal axis of the implant and extends between the distal and proximal regions and has a length;

wherein the implant has an expanded globular configuration when deployed, the expanded implant having a region of maximum diameter that extends from a proximal portion of the distal region through the transition region and to a distal portion of the proximal region,

wherein the average diameter of the plurality of pores in the distal region is greater than the average diameter of the plurality of pores in the proximal region, and wherein the length of the transition zone may be about 0.5% to about 20% of the length of the implant;

advancing the implant in the low profile radially constrained state within a microcatheter to a region of interest within a cerebral artery;

deploying the implant within the cerebral aneurysm, wherein the distal and proximal permeable shells expand to their expanded shapes; and

withdrawing the microcatheter from the region of interest after deploying the implant.

12. The method of claim 11, wherein the average diameter of the plurality of pores in the distal region is greater than 250 μ

m.

13. The method of claim 11, wherein the average diameter of the plurality of pores in the distal region is greater than 400 μ

m.

14. The method of claim 11, wherein the average diameter of the plurality of pores in the distal region is between about 250 μ

m to about 500 μ

m or between about 300 μ

m to about 600 μ

m.

15. The method of claim 11, wherein the average diameter of the plurality of pores in the proximal region is 200 μ

m or less.

16. The method of claim 11, wherein the average diameter of the plurality of pores in the proximal region is between about 50 μ

m to about 200 μ

m.

17. The method of claim 11, wherein the average diameter of the plurality of pores in the proximal region is between about 100 μ

m to about 200 μ

m.

18. The method of claim 11, wherein the length of the transition region is about 1% to about 15% of the length of the implant.

19. The method of claim 11, wherein the length of the transition region is about 1% to about 10% of the length of the implant.

20. The method of claim 11, wherein the length of the transition region is about 3% to about 8% of the length of the implant.