Embolization device constructed from expansile polymer

• US 9,993,252 B2
• Filed: 10/25/2010
• Issued: 06/12/2018
• Est. Priority Date: 10/26/2009
• Status: Active Grant

• Current Assignee: Microvention Incorporated (Terumo Corporation)
• Original Assignee: Microvention Incorporated (Terumo Corporation)
• Inventors: Keeley, E. Michael, Cruise, Gregory M., Constant, Michael J., Warner, Sheila, Walker, Maricela
• Primary Examiner(s): YABUT, DIANE D
• Application Number:
  US12/911,562
• Publication Number:
  US 20110184455A1
• Time in Patent Office: 2,787 Days
• Field of Search: 606200
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• 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 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61L 31/041 Mixtures of macromolecular compounds
• 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 31/145 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 include 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, or similar structures.

Claims

1. A device for implantation in an animal comprising:

a carrier member having a distal end and a proximal end, wherein the carrier member includes helical coils close to each other at the distal end and at the proximal end and having larger gaps between the distal end and the proximal end, and wherein the proximal end includes laterally a first larger coil diameter, a second smaller coil diameter, and a third larger coil diameter;

a hydrogel filament having ionizable functional groups wherein said hydrogel filament comprises a macromer of about 48% poly(ethylene glycol) di-acrylamide and a pH sensitive component of about 52% sodium acrylate, and wherein the hydrogel filament includes a proximal end, a distal end, and a pathway along a center of the hydrogel filament,

a stretch resistant member disposed within the pathway and wrapped around at least a portion of the distal end and the proximal end of the carrier member, and

an adhesive at the distal end and the proximal end that encapsulates the proximal end and the distal end of the hydrogel filament, the carrier member, and the stretch resistant member.

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

3. The device according to claim 1 wherein said macromer is cross-linked with N,N′

-methylenebisacrylamide, derivatives thereof, or combinations thereof.

4. The device according to claim 1 wherein said hydrogel includes pores created by a porosigen.

5. The device according to claim 4 wherein said porosigen is about 0.4 g/g sodium chloride.

6. The device according to claim 5 wherein said sodium chloride has a particle size of about 10 microns.

7. The device according to claim 1 wherein said larger gaps range from about 0.0015″

to about 0.00750″

.

8. The device according to claim 7 wherein said larger gaps comprise 0.003″

.

9. The implant device of claim 1 wherein said hydrogel expands from a diameter of about 0.006″

-0.007″

to a diameter of about 0.02″

after expansion.

10. The device of claim 1 wherein the stretch resistant member is wrapped around two separate helical coils at the proximal end of the carrier member.

11. A device for implantation in an animal comprising:

a carrier member having a distal end and a proximal end, wherein the carrier member includes helical coils close to each other at the distal end and at the proximal end and have larger gaps between the distal end and the proximal end, wherein the proximal end includes laterally a first larger coil diameter, a second smaller coil diameter, and a third larger coil diameter, and wherein the larger gaps range from about 0.0015″

to about 0.00750″

; and

a hydrogel filament comprising at least a macromer of about 48% poly(ethylene glycol) di-acrylamide and a pH sensitive component of about 52% sodium acrylate, and wherein the hydrogel filament includes a proximal end, a distal end, and a pathway along a center of the hydrogel filament,

a stretch resistant member disposed within the pathway and wrapped around at least a portion of the distal end and the proximal end of the carrier member, and

an adhesive at the distal end and the proximal end that encapsulates the proximal end and the distal end of the hydrogel filament, the carrier member, and the stretch resistant member.

12. The implant device of claim 11, wherein said hydrogel includes pores created by a porosigen.

13. The implant device of claim 12, wherein said porosigen is about 0.4 g/g sodium chloride.

14. The implant device of claim 13, wherein said sodium chloride has a particle size of about 10 microns.

15. The device according to claim 11 wherein said larger gaps comprise 0.003″

.

16. The implant device of claim 11 wherein said hydrogel expands from a diameter of about 0.006″

-0.007″

to a diameter of about 0.02″

after expansion.

17. The device of claim 11 wherein the stretch resistant member is wrapped around two separate helical coils at the proximal end of the carrier member.

18. An implant device comprising:

a carrier member having a distal end and a proximal end, wherein the carrier member includes helical coils close to each other at the distal end and at the proximal end and have larger gaps between the distal end and the proximal end, wherein the proximal end includes laterally a first larger coil diameter, a second smaller coil diameter, and a third lamer coil diameter, and wherein the larger spaces have a gap of about 0.003″

;

a hydrogel member including a proximal end, a distal end, and a pathway along a center of the hydrogel member, wherein the hydrogel member is disposed within said carrier member;

a stretch resistant member disposed within the pathway of said hydrogel member and wrapped around at least a portion of the distal end and the proximal end of said carrier member; and

,

an adhesive at the distal end and the proximal end that encapsulates the proximal end and the distal end of the hydrogel member, the carrier member, and the stretch resistant member,

wherein said hydrogel comprises a macromer of about 48% poly(ethylene glycol) di-acrylamide and a pH sensitive component of about 52% sodium acrylate.

19. The implant device of claim 18 wherein said hydrogel expands from a diameter of about 0.006″

-0.007″

to a diameter of about 0.02″

after expansion.

20. The implant device of claim 18 wherein the stretch resistant member is wrapped around two separate helical coils at the proximal end of the carrier member.