Embolization device constructed from expansile polymer

• US 8,377,091 B2
• Filed: 06/15/2007
• Issued: 02/19/2013
• 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
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): CRAIGO, WILLIAM A
• Application Number:
  US11/764,111
• Publication Number:
  US 20070299464A1
• Time in Patent Office: 2,076 Days
• Field of Search: None
• US Class Current: 606/192
• 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 in an animal comprising:

a narrow, elongated, flexible expansile element comprising a hydrogel configured to expand upon contact with an aqueous liquid at a physiological pH, wherein the hydrogel comprises a reaction product of;

a monomer having a pH sensitive ionizable functional group and an 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; and

a polymerization initiator; and

wherein a cylindrical sample of the hydrogel having a diameter of about 0.02 inches and a length of about 1 inch has an unexpanded bending resistance of about 0.1 mg to about 50 mg; and

a flexible carrier member, composed of a non-hydrogel material, configured to assist the delivery of the expansile element through a body lumen for occlusion of the lumen by expansion of the expansile element.

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

3. A device according to claim 1 wherein said with pH sensitive ionizable functional groups comprise basic groups.

4. A device according to claim 3 wherein said basic groups comprise an amine, derivatives thereof, or combinations thereof.

5. A device according to claims 4 wherein said basic functional groups can be deprotonated at pHs greater than the pKa or protonated at pHs less than the pKa of said functional groups.

6. A device according to claim 1 wherein said pH sensitive ionizable functional groups comprise acidic groups.

7. A device according to claim 6 wherein said acidic groups comprise a carboxylic acid, derivatives thereof, or combinations thereof.

8. A device according to claim 7 wherein said acidic functional groups can be protonated at pHs less than the pKa or de-protonated at pHs greater than the pKa of said functional groups.

9. A device according to claim 1 wherein said hydrogel further comprises vinyl, acrylates, acrylamides, methacrylates, derivatives thereof, or combinations thereof.

10. A device according to claim 1 wherein said polyether macromer comprises poly(ethylene glycol) di-acrylamide.

11. A device according to claim 1 wherein said hydrogel is substantially free of acrylamide.

12. A device according to claim 1 wherein said polyether macromer is cross-linked with at least one ethylenically unsaturated compound.

13. A device according to claim 1 wherein said polyether macromer is cross-linked with N,N′

-methylenebisacrylamide, derivatives thereof, or combinations thereof.

14. A device according to claim 1 wherein said hydrogel is polymerized using a polymerization initiator selected from N,N,N′

,N′

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

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

15. A device according to claim 1 wherein said hydrogel is substantially non-resorbable.

16. A device according to claim 1, wherein the monomer having a pH sensitive ionizable functional group and an ethylenically unsaturated moiety is acrylic acid, methacrylic acid, or a salt thereof.

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

18. The device according to claim 1, wherein the flexible carrier member includes at least one gap configured to allow the expansile element to expand through the at least one gap.