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

• US 7,780,980 B2
• Filed: 04/19/2006
• Issued: 08/24/2010
• Est. Priority Date: 08/14/1998
• Status: Expired due to Term

• Current Assignee: Incept LLC
• Original Assignee: Incept LLC
• Inventors: Sawhney, Amarpreet S.
• Primary Examiner(s): Eyler; Yvonne L
• Assistant Examiner(s): LEA, CHRISTOPHER RAYMOND
• Application Number:
  US11/406,791
• Publication Number:
  US 20060193899A1
• Time in Patent Office: 1,588 Days
• Field of Search: None
• US Class Current: 424/443
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12104 in an air passage
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61K 6/19 Self-expanding, e.g. for filling teeth
• CPC Class Codes: A61K 6/52 Cleaning; Disinfecting
• CPC Class Codes: A61K 6/54 Filling; Sealing
• CPC Class Codes: A61K 6/69 Medicaments
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0036 Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
• CPC Class Codes: A61K 9/0085 Brain, e.g. brain implants; Spinal cord
• CPC Class Codes: A61K 9/2027 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61L 2300/418 Agents promoting blood coagulation, blood-clotting agents, embolising agents
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/0031 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 33/0064 : Hydrogels or hydrocolloids
• CPC Class Codes: C08L 33/14 : of esters containing halogen, nitrogen, sulfur, or oxygen atoms in addition to the carboxy oxygen
• CPC Class Codes: C08L 39/06 : Homopolymers or copolymers of N-vinyl-pyrrolidones
• CPC Class Codes: C08L 71/02 : Polyalkylene oxides

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.

Claims

1. A method of preventing bleeding via a percutaneous puncture site comprising:

providing a hydrogel article in a substantially deswollen state preformed as a rolled sheet;

deploying the hydrogel article into the percutaneous puncture site; and

allowing the hydrogel article to hydrate and expand within the puncture site to prevent bleeding via the percutaneous puncture site.

2. The method of claim 1, wherein the hydrogel article is formed from a freeze dried hydrogel.

3. The method of claim 1, wherein the expansion of the hydrogel article anchors the hydrogel article within the percutaneous puncture site.

4. The method of claim 1, wherein the hydrogel article is bioabsorbable.

5. The method of claim 1, wherein the hydrogel article is delivered to the puncture site via a sheath.

6. The method of claim 1, wherein the hydrogel article is formed as a porous structure so as to accelerate the rate of expansion of the hydrogel article within the puncture site.

7. The method of claim 1, wherein the hydrogel article comprises a sterilized pharmaceutically acceptable covalently crosslinked hydrogel polymerized from at least one synthetic hydrophilic polyethylene glycol macromer.

8. The method of claim 1, wherein the hydrogel article has an outer diameter of no more than 1.5 mm.

9. The method of claim 1, wherein the hydrogel article is biodegradable.

10. A method for closure of a percutaneous puncture site, comprising:

positioning a sheath through a puncture wound to provide access to an artery;

removing the sheath from the puncture wound after completing a procedure;

introducing a bioabsorbable, freeze dried hydrogel comprising a preformed rolled sheet into the puncture wound via a tubular device;

exposing the hydrogel to fluids within the puncture wound, the hydrogel hydrating and expanding within the puncture wound to seal the puncture wound.

11. The method of claim 10, wherein the hydrogel comprises pores formed during the freeze drying process.

12. The method of claim 10, wherein the puncture wound communicates with a femoral artery.

13. The method of claim 10, wherein the hydrogel article comprises a sterilized pharmaceutically acceptable covalently crosslinked hydrogel polymerized from at least one synthetic hydrophilic polyethylene glycol macromer.

14. The method of claim 10, wherein the hydrogel is biodegradable.