METHODS OF USING IN SITU HYDRATION OF HYDROGEL ARTICLES FOR SEALING OR AUGMENTATION OF TISSUE OR VESSELS
First Claim
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1. An apparatus for sealing a lumen or void in a body of a patient, comprising:
- a preformed hydrogel material; and
a hollow tube comprising a proximal end, a distal end sized for introduction into a patient'"'"'s body, and a distal opening in the distal end, the tube carrying the hydrogel material such that the hydrogel material is delivered from a distal end to seal a lumen or void in the patient'"'"'s body,wherein the hydrogel material comprises a sterilized pharmaceutically acceptable covalently crosslinked hydrogel polymerized from at least one synthetic hydrophilic polyethylene glycol macromer, and having a substantially less than equilibrium level of hydration for undergoing a volumetric expansion of at least about 50% after swelling with physiological fluid.
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Abstract
Pharmaceutically acceptable hydrogel polymers of natural, recombinant or synthetic origin, or hybrids thereof, are introduced in a thy, 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.
98 Citations
21 Claims
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1. An apparatus for sealing a lumen or void in a body of a patient, comprising:
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a preformed hydrogel material; and a hollow tube comprising a proximal end, a distal end sized for introduction into a patient'"'"'s body, and a distal opening in the distal end, the tube carrying the hydrogel material such that the hydrogel material is delivered from a distal end to seal a lumen or void in the patient'"'"'s body, wherein the hydrogel material comprises a sterilized pharmaceutically acceptable covalently crosslinked hydrogel polymerized from at least one synthetic hydrophilic polyethylene glycol macromer, and having a substantially less than equilibrium level of hydration for undergoing a volumetric expansion of at least about 50% after swelling with physiological fluid. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
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20. An apparatus for sealing a lumen or void in a body of a patient, comprising:
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a bioabsorbable, freeze dried hydrogel material comprising a sterilized pharmaceutically acceptable covalently crosslinked hydrogel polymerized from at least one synthetic hydrophilic polyethylene glycol macromer; and a hollow tube comprising a proximal end, a distal end sized for introduction into a patient'"'"'s body, and a distal opening in the distal end, the hydrogel material loaded in the tube as a preformed rolled sheet such that the hydrogel material is delivered, from a distal end to seal a lumen or void in the patient'"'"'s body.
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21. A medical implant for use in a lumen or void of a body of a patient comprising:
a pharmaceutically acceptable covalently crosslinked hydrogel polymerized from at least one 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 shape to occlude the lumen or void upon swelling from exposure to a fluid from the body after implantation in the lumen or void.
Specification