Embolic devices

Patent metadata

Field	Value
Publication number	US-9456823-B2
Application number	US-201213450287-A
Country	US
Kind code	B2
Filing date	Apr 18, 2012
Priority date	Apr 18, 2011
Publication date	Oct 4, 2016
Grant date	Oct 4, 2016

Abstract

Described herein are apparatus, compositions, systems and associated methods to occlude structures and malformations of the vasculature with radiopaque hydrogel filaments with delayed controlled rates of expansion. Further described is a device for implantation in an animal comprising a difunctional, low molecular weight ethylenically unsaturated shapeable macromer; an ethylenically unsaturated monomer; and a radiopaque element, wherein said device contains no support members. Methods of forming such devices are also disclosed.

First claim

We claim:

1. An expansile device for implantation comprising:
a polymeric filament including about 25% w/w poly (ethylene glycol) 10,000 macromer; about 11% w/w of an ethylenically unsaturated monomer; and about 63% w/w barium sulfate;
an introducer configured to be connected to a catheter;
a first pressurized liquid configured to flush the polymeric filament out of the introducer and into the catheter, wherein the first pressurized liquid has a pressure of between about 50 psi and about 200 psi; and
a second pressurized liquid configured to flush the polymeric filament out of the catheter, wherein the second pressurized liquid has a pressure of between about 60 psi and about 140 psi,
wherein the expansile device includes no metal support members.

2. The expansile device according to claim 1 , further comprising a multifunctional, ethylenically unsaturated cross-linker.

3. The expansile device according to claim 1 , wherein the expansile device has reduced beam hardening artifacts when imaged using computed tomography.

4. The expansile device according to claim 1 , wherein the expansile device has a diameter of less than about 0.03 inches.

5. The expansile device according to claim 1 , wherein the expansile device is substantially non-resorbable.

6. The expansile device according to claim 1 , wherein the expansile device is biodegradable.

7. The expansile device according to claim 1 , wherein the ethylenically unsaturated monomer is pH sensitive.

8. The expansile device according to claim 1 , including about 11% w/w sodium acrylate, about 1% w/w N,N-methylenebisacrylamide, about 63% w/w barium sulfate, and about <1% w/w 2,2′-azobis(2-methylpropionaamidine)dihydrochloride.

9. The expansile device according to claim 1 , wherein the polymeric filament consists essentially of about 25% w/w poly(ethylene glycol) 10,000 diacrylamide, about 11% w/w sodium acrylate, about 1% w/w N,N-methylenebisacrylamide, about 63% barium sulfate, and about <1% 2,2′-azobis(2-methylpropionaamidine)dihydrochloride.

10. The expansile device according to claim 1 , wherein the bending resistance of the polymeric filament in a wet state is about 2 mg to about 50 mg.

11. An expansile device for implantation comprising:
a polymeric filament including about 29% w/w poly (ethylene glycol) 10,000 macromer; about 12% w/w of an ethylenically unsaturated monomer; and about 58% w/w barium sulfate;
an introducer configured to be connected to a catheter;
a first pressurized liquid configured to flush the polymeric filament out of the introducer and into the catheter, wherein the first pressurized liquid has a pressure of between about 50 psi and about 200 psi; and
a second pressurized liquid configured to flush the polymeric filament out of the catheter, wherein the second pressurized liquid has a pressure of between about 60 psi and about 140 psi,
wherein the expansile device includes no metal support members; and
wherein a bending resistance of the polymeric filament in a wet state is about 2 mg to about 50 mg.

12. The expansile device according to claim 11 , further comprising a multifunctional, ethylenically unsaturated cross-linker.

13. The expansile device according to claim 11 , wherein the expansile device has reduced beam hardening artifacts when imaged using computed tomography.

14. The expansile device according to claim 11 , wherein the expansile device has a diameter of less than about 0.03 inches.

15. The expansile device according to claim 11 , wherein the expansile device is substantially non-resorbable.

16. The expansile device according to claim 11 , wherein the expansile device is biodegradable.

17. The expansile device according to claim 11 , wherein the ethylenically unsaturated monomer is pH sensitive.

18. The expansile device according to claim 11 , including about 12% w/w sodium acrylate, about 1% w/w N,N-methylenebisacrylamide, about 58% w/w barium sulfate, and about <1% w/w 2,2′-azobis(2-methylpropionaamidine)dihydrochloride.

19. The expansile device according to claim 11 , wherein the polymeric filament consists essentially of about 29% w/w poly(ethylene glycol) 10,000 diacrylamide, about 12% w/w sodium acrylate, about 1% w/w N,N-methylenebisacrylamide, about 58% barium sulfate, and about <1% 2,2′-azobis(2-methylpropionaamidine)dihydrochloride.

Assignees

• Constant Michael
• Garretson Josh
• Cruise Gregory M
• Terumo Corp

Inventors

• Constant Michael
• Garretson Josh
• Cruise Gregory M

Classifications

• A61M2025/0042

  Microcatheters, cannula or the like having outside diameters around 1 mm or less · CPC title

• A61L31/048 Primary

  obtained by reactions only involving carbon-to-carbon unsaturated bonds (A61L31/041 takes precedence) · CPC title

• A61B17/1215

  comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated · CPC title

• A61L2430/36

  for embolization or occlusion, e.g. vaso-occlusive compositions or devices · CPC title

• A61L31/06 Primary

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)} · CPC title