Methods of using in situ hydration of hydrogel articles for sealing or augmentation of tissue or vessels

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.

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.   
   
   
       2 . The apparatus of  claim 1 , wherein the hollow tube comprises a catheter. 
   
   
       3 . The apparatus of  claim 1 , wherein the hollow tube comprises a needle. 
   
   
       4 . The apparatus of  claim 1 , wherein the hollow tube is flexible. 
   
   
       5 . The apparatus of  claim 1 , wherein the hollow tube has a length such that the proximal end remains outside the patient's body when the distal end is introduced into the patient's body to deliver the hydrogel material. 
   
   
       6 . The apparatus of  claim 1 , wherein the hydrogel material has 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. 
   
   
       7 . The apparatus of  claim 1 , wherein the preformed hydrogel is a rod. 
   
   
       8 . The apparatus of  claim 1 , wherein the preformed hydrogel is a sheet rolled from one edge to another to form a roll that is loaded within the hollow tube. 
   
   
       9 . The apparatus of  claim 1 , wherein the hydrogel material has a diameter within the hollow tube that is no more than 1.5 mm. 
   
   
       10 . The apparatus of  claim 1 , wherein the hydrogel material is biodegradable. 
   
   
       11 . The apparatus of  claim 1 , wherein the lumen or void is selected from the group consisting of a naturally occurring body passageway, a fallopian tube, an arteriovenous malformation, a bone canal, and a puncture wound, and wherein the distal end of the hollow tube is sized to be received within the naturally occurring body passageway, fallopian tube, arteriovenous malformation, bone canal, or puncture wound. 
   
   
       12 . The apparatus of  claim 1 , wherein the macromer, before polymerization, comprises a functional group polymerizable by a polymerization reaction that is selected from the group consisting of free radical, condensation, anionic, and cationic. 
   
   
       13 . The apparatus of  claim 1 , wherein the macromer is polymerized by an electrophile-nucleophile reaction. 
   
   
       14 . The apparatus of  claim 1 , wherein the hydrogel material further comprises a therapeutic bioactive molecule. 
   
   
       15 . The apparatus of  claim 14 , wherein the therapeutic bioactive molecule is selected from the group consisting of peptides, antibiotics, antitumor agents, hemostatics, and analgesics. 
   
   
       16 . The apparatus of  claim 1 , wherein the hydrogel material further comprises a contrast agent. 
   
   
       17 . The apparatus of  claim 16 , wherein the contrast agent is a radio-opaque contrast agent. 
   
   
       18 . The apparatus of  claim 1 , wherein the hydrogel material is formed from a freeze dried hydrogel. 
   
   
       19 . The apparatus of  claim 1 , wherein the hydrogel material is formed as a porous structure so as to accelerate the rate of expansion of the hydrogel material within the lumen or void. 
   
   
       20 . An apparatus for sealing a lumen or void in a body of a patient, comprising:
 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.   
   
   
       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.