Embolization device constructed from expansile polymer

• US 10,499,925 B2
• Filed: 12/19/2017
• Issued: 12/10/2019
• Est. Priority Date: 06/15/2006
• Status: Active Grant

• Current Assignee: Microvention Incorporated (Terumo Corporation)
• Original Assignee: Microvention Incorporated (Terumo Corporation)
• Inventors: Cruise, Gregory M., Constant, Michael, Tran, Terrance, Gulachenski, Joseph
• Primary Examiner(s): Tran, Susan T
• Assistant Examiner(s): Craigo, William
• Application Number:
  US15/847,745
• Publication Number:
  US 20180110527A1
• Time in Patent Office: 721 Days
• Field of Search: None
• 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 17/12154 having stretch limiting means
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61L 2400/04 Materials for stopping bleeding
• CPC Class Codes: A61L 31/00 Materials for other surgical articles , e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices shape or structure of stent-grafts A61F2/07, of stents A61F2/82, of surgical gloves A61B42/00, of surgical drapes A61B46/00, of occluding devices A61B17/12022
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/041 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 71/02 Polyalkylene oxides

Abstract

Devices for the occlusion of body cavities, such as the embolization of vascular aneurysms and the like, and methods for making and using such devices. The devices may be comprised of novel expansile materials, novel infrastructure design, or both. The devices provided are very flexible and enable deployment with reduced or no damage to bodily tissues, conduits, cavities, etceteras.

Claims

1. An occlusion device comprising:

an elongated, expansile element having a solid mass, that is flexible in an untreated state, consisting essentially of a poly(ethylene glycol) macromer and a pH sensitive monomer; and

a carrier element comprising a plurality of loops forming a helical shape disposed around the expansile element,

wherein the plurality of loops are spaced to form at least one gap and the at least one gap is between about 0.00025 inches and about 0.2 inches.

2. The occlusion device of claim 1, wherein the carrier element is between about 0.005 inches and about 0.035 inches in diameter.

3. The occlusion device of claim 1, wherein the carrier element is between about 0.0005 inches and about 0.01 inches in diameter.

4. The occlusion device of claim 1, wherein the carrier element is between about 0.008 inches and about 0.016 inches in diameter.

5. The occlusion device of claim 1, wherein the carrier element is between about 0.00075 inches and about 0.004 inches in diameter.

6. The occlusion device of claim 1, wherein the expansile element is between about 0.001 inches and about 0.03 inches in diameter before expansion.

7. The occlusion device of claim 1, wherein the expansile element is between about 0.002 inches and about 0.25 inches in diameter after expansion.

8. The occlusion device of claim 1, wherein the pH sensitive monomer is sodium acrylate.

9. The occlusion device of claim 1, wherein the expansile element is secured to the carrier element in a stretched configuration that is between about 125% and about 600% of its initial length.

10. The occlusion device of claim 1, wherein at least one gap is configured to allow the expansile element to expand through the at least one gap.

11. The occlusion device of claim 1, wherein the at least one gap has a distance of about 0.00025 inches to about 0.005 inches.

12. The occlusion device of claim 1, wherein the at least one gap is about 0.0013 inches.

13. The occlusion device of claim 1, wherein the carrier element is formed of a material including polyimide, nylon, polyester, polyglycolic acid, polylactic acid, PEEK, Teflon, carbon fiber or pyrolytic carbon, silicone, platinum, steel, tungsten, Nitinol, tantalum, titanium, or chromium-cobalt alloy.

14. The occlusion device of claim 1, wherein the carrier element is formed of platinum.

15. The occlusion device of claim 1, wherein the carrier element is formed of tungsten.

16. The occlusion device of claim 1, further including a stretch resistant member.

17. The occlusion device of claim 1, wherein the stretch resistant member is formed of a material including steel, nickel titanium, PET, PEEK, nylon, polytetrafluoroethylene, polyethylene, polyolefin, polyolefin elastomer, polypropylene, polylactic acid, or polyglycolic acid.

18. The occlusion device of claim 1, wherein the stretch resistant member is formed of PET.

19. The occlusion device of claim 1, wherein the stretch resistant member is formed of polyethylene.