EMBOLIZATION DEVICE CONSTRUCTED FROM EXPANSILE POLYMER

• US 20190150932A1
• Filed: 01/17/2019
• Published: 05/23/2019
• 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 J., Tran, Terrance
• Granted Patent: US 11,160,557 B2
• Time in Patent Office: Days
• 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. A device for implantation in an animal comprising:

an expansile hydrogel having ionizable functional groups formed from a solution including a monomer and a macromer, and

a carrier member configured to coaxially house the expansile hydrogel.

2. The device of claim 1, wherein the expansile hydrogel has an unexpanded bending resistance of about 0.1 mg to about 85 mg.

3. The device of claim 1, wherein the macromer has a molecular weight of about 400 grams/mole to about 35,000 grams/mole.

4. The device of claim 1, wherein the macromer includes polyethers, polyurethanes, derivatives thereof, or combinations thereof.

5. The device of claim 1, wherein the ionizable functional groups comprise basic groups.

6. The device of claim 5, wherein the basic groups comprise an amine, derivatives thereof, or combinations thereof.

7. The device of claim 6, wherein the basic functional groups are deprotonated at pHs greater than the pKa or protonated at pHs less than the pKa of the functional groups.

8. The device of claim 1, wherein the ionizable functional groups comprise acidic groups.

9. The device of claim 8, wherein the acidic groups comprise a carboxylic acid, derivatives thereof, or combinations thereof.

10. The device of claim 9, wherein the acidic functional groups are protonated at pHs less than the pKa or de-protonated at pHs greater than the pKa of the functional groups.

11. The device of claim 1, wherein the monomer includes vinyl, acrylates, acrylamides, methacrylates, derivatives thereof, or combinations thereof.

12. The device of claim 1, wherein the macromer comprises poly(ethylene glycol), derivatives thereof, or combinations thereof.

13. The device of claim 1, wherein the macromer comprises poly(ethylene glycol) di-acrylamide, poly(ethylene glycol) di-acrylate, poly(ethylene glycol) dimethacrylate, derivatives thereof, or combinations thereof.

14. The device of claim 1, wherein the expansile hydrogel is substantially free of acrylamide.

15. The device of claim 1, wherein the solution includes N,N′

-methylenebisacrylamide, derivatives thereof, or combinations thereof.

16. The device of claim 1, wherein the solution includes N,N,N′

,N′

-tetramethylethylenediamine, ammonium persulfate, azobisisobutyronitrile, benzoyl peroxides, 2,2′

-azobis(2-methylpropionamidine) dihydrochloride, derivatives thereof, or combinations thereof.

17. The device of claim 1, wherein the expansile hydrogel is substantially nonresorbable.

19. A method for preparing the expansile hydrogel of claim 1, the method comprising:

polymerizing the solution to form the expansible hydrogel in a continuous length.

20. A method of treatment, the method comprising:

implanting the device of claim 1 in a vessel in need thereof.