Methods of using in situ hydration of hydrogel articles for sealing or augmentation of tissue or vessels
First Claim
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1. A medical implant to seal a lumen or void in a body of a patient comprising:
- a sterilized pharmaceutically acceptable covalently crosslinked hydrogel polymerized from at least one synthetic hydrophilic polyethylene glycol macromer,the hydrogel having a substantially less than equilibrium level of hydration for undergoing a volumetric expansion of at least about 50% after swelling with physiological fluid andhaving a size and a swellability to press against tissue surrounding the lumen or void upon swelling to seal and thereby occlude the lumen or void upon swelling from exposure to a fluid from the body,wherein the hydrogel, at the substantially less than equilibrium level of hydration, has a shape selected from the group consisting of a rod and a sheet rolled from one edge to another to form a roll, with the rod or roll outer diameter being no more than 1.5 mm.
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Abstract
Pharmaceutically acceptable hydrogel polymers of natural, recombinant or synthetic origin, or hybrids thereof, are introduced in a dry, less hydrated, or substantially deswollen state and rehydrate in a physiological environment to undergo a volumetric expansion and to affect sealing, plugging, or augmentation of tissue, defects in tissue, or of organs. The hydrogel polymers may deliver therapeutic entities by controlled release at the site. Methods to form useful devices from such polymers, and to implant the devices are provided.
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Citations
22 Claims
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1. A medical implant to seal a lumen or void in a body of a patient comprising:
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a sterilized pharmaceutically acceptable covalently crosslinked hydrogel polymerized from at least one synthetic hydrophilic polyethylene glycol macromer, the hydrogel having a substantially less than equilibrium level of hydration for undergoing a volumetric expansion of at least about 50% after swelling with physiological fluid and having a size and a swellability to press against tissue surrounding the lumen or void upon swelling to seal and thereby occlude the lumen or void upon swelling from exposure to a fluid from the body, wherein the hydrogel, at the substantially less than equilibrium level of hydration, has a shape selected from the group consisting of a rod and a sheet rolled from one edge to another to form a roll, with the rod or roll outer diameter being no more than 1.5 mm. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. A medical implant to seal a lumen or void in a body of a patient comprising:
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a sterilized pharmaceutically acceptable covalently crosslinked hydrogel polymerized from at least one synthetic hydrophilic polyethylene glycol macromer, the hydrogel having a substantially less than equilibrium level of hydration for undergoing a volumetric expansion of at least about 50% after swelling with physiological fluid and having a size and a swellability to press against tissue surrounding the lumen or void upon swelling to seal and thereby occlude the lumen or void upon swelling from exposure to a fluid from the body, wherein the hydrogel, at the substantially less than equilibrium level of hydration, has a shape selected from the group consisting of a rod and a sheet rolled from one edge to another to form a roll, with the rod or roll outer diameter being about 1.5 mm. - View Dependent Claims (19, 20, 21, 22)
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Specification