US2022039802A1PendingUtilityA1

Embolization Device Constructed From Expansile Polymer

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Assignee: MICROVENTION INCPriority: Jun 15, 2006Filed: Oct 26, 2021Published: Feb 10, 2022
Est. expiryJun 15, 2026(expired)· nominal 20-yr term from priority
Inventors:Gregory M. CruiseMichael J. ConstantTerrance TranJoseph Gulachenski
A61L 31/146A61B 17/12145A61L 31/145A61L 31/14A61L 31/06A61B 17/1214A61B 17/12168A61B 17/12154A61B 17/1219A61L 33/06A61L 31/041A61B 17/22A61L 31/048A61L 2400/04A61B 17/12113A61L 31/022A61L 31/00A61L 31/04
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Claims

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 are described.

Claims

exact text as granted — not AI-modified
We claim: 
     
         1 . A device for implantation in an animal, comprising:
 a hydrogel having ionizable functional groups wherein said hydrogel comprises at least one macromer, further wherein said hydrogel is environmentally-responsive, and further wherein said hydrogel has an unexpanded bending resistance of about 0.1 mg to about 85 mg.   
     
     
         2 . A device according to  claim 1 , wherein said 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 hydrogel comprises polyethers, polyurethanes, derivatives thereof, or combinations thereof. 
     
     
         4 . A device according to  claim 1 , wherein said with ionizable functional groups comprise basic groups. 
     
     
         5 . A device according to  claim 4 , wherein said basic groups comprise an amine, derivatives thereof, or combinations thereof. 
     
     
         6 . A device according to  claim 5 , 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. 
     
     
         7 . A device according to  claim 1 , wherein said with ionizable functional groups comprise acidic groups. 
     
     
         8 . A device according to  claim 7 , wherein said acidic groups comprise a carboxylic acid, derivatives thereof, or combinations thereof. 
     
     
         9 . A device according to  claim 8 , 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. 
     
     
         10 . A device according to  claim 1 , wherein said hydrogel comprises vinyl, acrylates, acrylamides, methacrylates, derivatives thereof, or combinations thereof. 
     
     
         11 . A device according to  claim 1 , wherein said macromer comprises poly(ethylene glycol), derivatives thereof, or combinations thereof. 
     
     
         12 . A device according to  claim 1 , wherein said macromer comprises poly(ethylene glycol) di-acrylamide, poly(ethylene glycol) di-acrylate, poly(ethylene glycol) dimethacrylate, derivatives thereof, or combinations thereof. 
     
     
         13 . A device according to  claim 12 , wherein said macromer comprises poly(ethylene glycol) di-acrylamide. 
     
     
         14 . A device according to  claim 1 , wherein said hydrogel is substantially free of acrylamide. 
     
     
         15 . A device according to  claim 1 , wherein said macromer is cross-linked with at least one ethylenically unsaturated compound. 
     
     
         16 . A device according to  claim 1 , wherein said macromer is cross-linked with N, N′-methylenebisacrylamide, derivatives thereof, or combinations thereof. 
     
     
         17 . 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. 
     
     
         18 . A device according to  claim 1 , wherein said hydrogel is substantially non-resorbable. 
     
     
         19 . A method for preparing an environmentally-responsive hydrogel for implantation in an animal, comprising:
 a) combining at least one ethylenically unsaturated macromer, at least one macromer or monomer comprising at least one ionizable functional group, at least one polymerization initiator, and at least one solvent to prepare a hydrogel;   b) treating said hydrogel to prepare an environmentally-responsive hydrogel that is responsive at physiological conditions.   
     
     
         20 . A method according to  claim 19 , wherein said at least one ionizable functional group comprises an acidic group. 
     
     
         21 . A method according to  claim 20 , wherein said treating comprises incubating said hydrogel in an acidic environment to protonate said acidic groups. 
     
     
         22 . A method according to  claim 20 , wherein said acidic group comprises a carboxylic acid, a derivative thereof, or combinations thereof. 
     
     
         23 . A method according to  claim 19 , wherein said at least one ionizable functional group comprises a basic group. 
     
     
         24 . A method according to  claim 23 , wherein said treating comprises incubating said hydrogel in a basic environment to de-protonate said basic group. 
     
     
         25 . A method according to  claim 24 , wherein said basic group comprise an amine, derivatives thereof, or combinations thereof. 
     
     
         26 . A method according to  claim 19 , wherein said solvent comprises water, ethyl alcohol, or combinations thereof. 
     
     
         27 . A method according to  claim 26 , wherein said solvent comprises water. 
     
     
         28 . A method according to  claim 19 , wherein said at least one macromer or monomer comprising at least one ionizable functional group comprises a vinyl group, an acrylate, a methacrylate, an acrylamide, derivatives thereof, or combinations thereof. 
     
     
         29 . A method according to  claim 19 , wherein said at least one ethylenically unsaturated macromer comprises poly(ethylene glycol), derivatives thereof, or combinations thereof. 
     
     
         30 . A method according to  claim 19 , wherein said at least one ethylenically unsaturated macromer comprises poly(ethylene glycol) di-acrylamide, poly(ethylene glycol) di-acrylate, derivatives thereof, or combinations thereof. 
     
     
         31 . A method according to  claim 30 , wherein said at least one ethylenically unsaturated macromer comprises poly(ethylene glycol) di-acrylamide. 
     
     
         32 . A method according to  claim 19 , wherein said ethylenically unsaturated macromer is at a concentration of about 5% to about 40% by weight. 
     
     
         33 . A method according to  claim 19 , wherein said solvent is at a concentration of about 20% to about 80% by weight. 
     
     
         34 . A method according to  claim 19 , wherein said combining further comprises adding at least one cross-linking agent comprising a compound with a plurality of ethylenically unsaturated moieties. 
     
     
         35 . A method according to  claim 19 , wherein said polymerization initiator comprises a reduction-oxidation polymerization initiator. 
     
     
         36 . A method according to  claim 19 , wherein said polymerization initiator comprises N,N,N′,N′-tetramethylethylenediamine, ammonium persulfate, azobisisobutyronitrile, benzoyl peroxides, 2,2′-azobis(2-methylpropionaminide) dihydrochloride, derivatives thereof, or combinations thereof. 
     
     
         37 . A method according to  claim 19 , wherein said combining further comprises adding a porosigen. 
     
     
         38 . A method according to  claim 21 , wherein said acidic groups are capable of being de-protonated after implantation in an animal. 
     
     
         39 . A method according to  claim 24 , wherein said basic groups are capable of being protonated after implantation in an animal. 
     
     
         40 . A method according to  claim 19 , wherein said ethylenically unsaturated macromer comprises poly(ethylene glycol) di-acrylamide, said at least one macromer or monomer comprising at least one ionizable functional group comprises sodium acrylate, said at least one polymerization initiator comprises ammonium persulfate and N,N,N,′,N′ tetramethylethylenediamine, and said solvent comprises water. 
     
     
         41 . A method according to  claim 19  wherein said ethylenically unsaturated macromer has a molecular weight of about 400 grams/mole to about 35,000 grams/mole. 
     
     
         42 . A method according to  claim 19  wherein said environmentally-responsive hydrogel is substantially non-resorbable. 
     
     
         43 . A method according to  claim 19  wherein said environmentally-responsive hydrogel is substantially free of acrylamide. 
     
     
         44 . A method according to  claim 19  wherein said at least one ethylenically unsaturated macromer is non-ionic. 
     
     
         45 . A method according to  claim 19  wherein said environmentally-responsive hydrogel has an unexpanded bending resistance of from about 0.1 mg to about 85 mg.

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