Embolization device constructed from expansile polymer

• US 9,724,103 B2
• Filed: 01/07/2016
• Issued: 08/08/2017
• Est. Priority Date: 06/15/2006
• Status: Active Grant

• Current Assignee: Microvention Incorporated (Terumo Corporation)
• Original Assignee: Microvention Incorporated (Terumo Corporation)
• Inventors: Tran, Terrance, Cruise, Gregory M., Constant, Michael J.
• Primary Examiner(s): Tran, Susan
• Assistant Examiner(s): CRAIGO, WILLIAM A
• Application Number:
  US14/990,676
• Publication Number:
  US 20160166258A1
• Time in Patent Office: 579 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. A device for occlusion of a lumen comprising:

an elongated hydrogel configured to expand upon contact with an aqueous liquid at a physiological pH to form an expanded hydrogel, wherein the hydrogel comprises a reaction product of;

a monomer including at least one ethylenically unsaturated moiety; and

a polyether macromer selected from poly(ethylene glycol) di-acrylamide, poly(ethylene glycol) di-acrylate, poly(ethylene glycol) dimethacrylate, poly(ethylene glycol) dimethacrylamide, derivatives thereof, or combinations thereof; and

a flexible carrier member having a diameter and configured to house the elongated hydrogel within the diameter, and wherein the flexible carrier member includes at least one gap configured to allow the expanded hydrogel to expand into the at least one gap,

wherein no carrier member or coil is contained within an outer surface of the elongated hydrogel.

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

3. The device according to claim 1, wherein the monomer includes at least one pH sensitive ionizable functional group.

4. The device according to claim 3, wherein the at least one pH sensitive ionizable functional group includes a basic group.

5. The device according to claim 4, wherein the basic group comprises an amine, derivatives thereof, or combinations thereof.

6. The device according to claim 5, wherein the basic functional group is configured to be deprotonated at pHs greater than the pKa or protonated at pHs less than the pKa of the functional group.

7. The device according to claim 3, wherein the at least one pH sensitive ionizable functional group includes an acidic group.

8. The device according to claim 7, wherein the acidic group comprises a carboxylic acid, derivatives thereof, or combinations thereof.

9. The device according to claim 8, wherein the acidic functional group is configured to be protonated at pHs less than the pKa or de-protonated at pHs greater than the pKa of the functional groups.

10. The device according to claim 7, wherein the monomer is acrylic acid, methacrylic acid, or a salt thereof.

11. The device according to claim 1, wherein the polyether macromer is poly(ethylene glycol) di-acrylamide.

12. The device according to claim 1, wherein the elongated hydrogel is substantially free of acrylamide.

13. The device according to claim 1, wherein the polyether macromer is cross-linked with at least one ethylenically unsaturated compound.

14. The device according to claim 1, wherein the polyether macromer is cross-linked with N,N′

-methylenebisacrylamide, derivatives thereof, or combinations thereof.

15. The device according to claim 1, wherein the elongated hydrogel comprises a reaction product of the monomer, the polyether macromer, and an initiator.

16. The device according to claim 15, wherein the initiator is selected from N,N,N′

,N′

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

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

17. The device according to claim 1, wherein the elongated hydrogel is substantially non-resorbable.

18. The device according to claim 1, wherein the flexible carrier member is metallic.

19. The device according to claim 1, wherein the flexible carrier member is polymeric.

20. The device according to claim 1, wherein the at least one gap is between 0.00025″

and 0.005″

.

21. A device for occlusion of a lumen comprising:

an elongated hydrogel configured to expand upon contact with an aqueous liquid at a physiological pH to form an expanded hydrogel, wherein the hydrogel comprises a reaction product of a prepolymer solution consisting essentially of;

a monomer including at least one ethylenically unsaturated moiety;

a polyether macromer selected from poly(ethylene glycol) di-acrylamide, poly(ethylene glycol) di-acrylate, poly(ethylene glycol) dimethacrylate, poly(ethylene glycol) dimethacrylamide, derivatives thereof, or combinations thereof;

a crosslinker;

a visualization agent; and

a flexible carrier member having a diameter and configured to house the narrow, elongated hydrogel within the diameter, and wherein the flexible carrier member includes at least one gap configured to allow the expanded hydrogel to expand into the at least one gap,

wherein no carrier member or coil is contained within an outer surface of the elongated hydrogel.