Embolization device constructed from expansile polymer

• US 9,877,731 B2
• Filed: 08/12/2016
• Issued: 01/30/2018
• 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
• Assistant Examiner(s): CRAIGO, WILLIAM A
• Application Number:
  US15/236,135
• Publication Number:
  US 20160345978A1
• Time in Patent Office: 536 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 consisting essentially of:

an elongated, solid expansile element, 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 elongated, solid, flexible expansile element is secured to the carrier element in a stretched configuration that is between about 125% and about 600% of its initial length.

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 pH sensitive monomer is sodium acrylate.

4. The occlusion device of claim 1, wherein the plurality of loops are spaced by gaps.

5. The occlusion device of claim 4, wherein at least one gap is configured to allow the elongated expansile element to expand through the at least one gap.

6. The occlusion device of claim 5, wherein the at least one gap has a distance of about 0.00025 inches to about 0.2 inches.

7. The occlusion device of claim 6, wherein the at least one gap has a distance of about 0.00025 inches to about 0.005 inches.

8. The occlusion device of claim 5, wherein the at least one gap has a distance of about 0.0013 inches.

9. A method of treating a lesion comprising:

providing an occlusion device consisting essentially of

a carrier member, and

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

wherein the elongated, solid expansile element is secured to the carrier member in a stretched configuration that is between about 125% and about 600% of its initial length and the carrier member is formed into a secondary configuration that is approximately the same diameter as the lesion.

10. The method of claim 9, wherein the poly(ethlyene glycol) macromer has a molecular weight of about 400 grams/mole to about 35,000 grams/mole.

11. The method of claim 9, wherein the carrier element is between about 0.005 inches and about 0.035 inches in diameter.

12. The method of claim 9, wherein the pH sensitive monomer is sodium acrylate.

13. The method of claim 9, wherein the carrier element comprises a plurality of loops forming a helical shape disposed around the expansile element.

14. The method of claim 13, wherein the plurality of loops are spaced by gaps.

15. The method of claim 14, wherein at least one gap is configured to allow the elongated, solid, expansile element to expand through the at least one gap.

16. The method of claim 15, wherein the at least one gap has a distance of about 0.00025 inches to about 0.2 inches.

17. The method of claim 16, wherein the at least one gap has a distance of about 0.00025 inches to about 0.005 inches.

18. The method of claim 15, wherein the at least one gap has a distance of about 0.0013 inches.