METHODS OF USING IN SITU HYDRATION OF HYDROGEL ARTICLES FOR SEALING OR AUGMENTATION OF TISSUE OR VESSELS

• US 20010046518A1
• Filed: 08/14/1998
• Published: 11/29/2001
• Est. Priority Date: 08/14/1998
• Status: Active Grant

• Current Assignee: Incept LLC
• Original Assignee: Incept LLC
• Inventors: SAWHNEY, AMARPREET S.
• Granted Patent: US 6,605,294 B2
• Time in Patent Office: Days
• US Class Current: 424/486
• 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 for anchoring an implant in a lumen or void in a body comprising:

providing a member comprising a pharmaceutically acceptable crosslinked hydrogel, the member having a first state wherein the hydrogel is at substantially less than an equilibrium level of hydration, and a second state wherein the hydrogel is substantially at the equilibrium level of hydration, the member undergoing volumetric expansion while transitioning to the second state;

positioning the member in the lumen or void in the first state; and

hydrating the member to transition the hydrogel to the second state so that the member undergoes sufficient volumetric expansion to become anchored within and occlude the lumen or void.

2. The method of

claim 1

wherein providing a member comprising a pharmaceutically acceptable crosslinked hydrogel comprises providing a member comprising a pharmaceutically acceptable crosslinked hydrogel having a shape selected from the group consisting of rods, spheres, blocks, sheets, tubes and irregularly shaped particles.

3. The method of

claim 1

wherein providing a member comprising a pharmaceutically acceptable crosslinked hydrogel further comprises providing a member comprising a pharmaceutically acceptable crosslinked hydrogel that is biodegradable in vivo.

4. The method of

claim 1

wherein providing a member comprising a pharmaceutically acceptable crosslinked hydrogel further comprises providing a member comprising a pharmaceutically acceptable crosslinked hydrogel having a tensile strength in excess of 10 kPa.

5. The method of

claim 1

wherein providing a member comprising a pharmaceutically acceptable crosslinked hydrogel further comprises:

providing a member comprising a pharmaceutically acceptable crosslinked hydrogel containing a therapeutic bioactive molecule; and

after hydrating the member, eluting the therapeutic bioactive molecule from the hydrogel.

6. The method of

claim 1

wherein the lumen or void is a needle track formed by a biopsy device and positioning the member in the lumen or void comprises positioning the member in the needle track after retrieval of a biopsy sample.

7. The method of

claim 1

wherein the lumen or void is a naturally occurring body passageway and positioning the member in the lumen or void comprises positioning the member in the naturally occurring body passageway.

8. The method of

claim 7

wherein the naturally occurring body passageway forms a portion of reproductive system of a mammal and hydrating the member renders the mammal sterile.

9. The method of

claim 8

wherein the naturally occurring body passageway is a fallopian tube and positioning the member comprises inserting the member into the fallopian tube using a catheter.

10. The method of

claim 8

wherein providing a member comprising a pharmaceutically acceptable crosslinked hydrogel further comprises providing a member comprising a pharmaceutically acceptable crosslinked hydrogel that is biodegradable in vivo.

11. The method of

claim 1

wherein the lumen or void is an arteriovenous malformation and positioning the member in the lumen or void comprises positioning the member in the arteriovenous malformation.

12. The method of

claim 1

wherein lumen or void provides an access site to a vessel through a puncture, the method further comprising:

providing a pledget coupled to the member;

positioning the pledget to occlude the puncture,

wherein hydrating the member to transition the hydrogel to the second state causes the member to become lodged within and occlude the lumen or void while retaining the pledget in position.

13. The method of

claim 1

wherein the lumen or void is a bone canal and positioning the member in the lumen or void comprises positioning the member in the bone canal.

14. The method of

claim 1

wherein providing a member comprising a pharmaceutically acceptable crosslinked hydrogel further comprises:

providing a first hydrogel component;

providing a second hydrogel component;

instilling the first and second hydrogel components into the lumen or void; and

polymerizing the first and second hydrogel components to form the member.

15. The method of

claim 14

wherein the first hydrogel component comprises a foaming agent, the method further comprising:

activating the foaming agent while polymerizing the first and second hydrogel components to create a controlled amount of porosity in the hydrogel.

16. The method of

claim 1

wherein providing a member comprising a pharmaceutically acceptable crosslinked hydrogel further comprises providing a member comprising a pharmaceutically acceptable crosslinked hydrogel that, in the first state, contains an excipient that assists in rehydration.

17. A method of augmenting tissue in a mammalian body comprising:

providing a member comprising a pharmaceutically acceptable crosslinked hydrogel, the member having a first state wherein the hydrogel is at substantially less than an equilibrium level of hydration, and a second state wherein the hydrogel is substantially at the equilibrium level of hydration, the member undergoing volumetric expansion while transitioning to the second state;

creating a cavity in the tissue;

positioning the member in the cavity in the first state; and

hydrating the member to transition the hydrogel to the second state so that the member expands the tissue and becomes lodged within the cavity.

18. The method of

claim 17

wherein wherein providing a member comprising a pharmaceutically acceptable crosslinked hydrogel comprises providing a member comprising a pharmaceutically acceptable crosslinked hydrogel having a shape selected from the group consisting of rods, spheres, blocks, sheets, tubes and irregularly shaped particles.

19. The method of

claim 17

wherein providing a member comprising a pharmaceutically acceptable crosslinked hydrogel further comprises providing a member comprising a pharmaceutically acceptable crosslinked hydrogel that is biodegradable in vivo.

20. The method of

claim 17

wherein providing a member comprising a pharmaceutically acceptable crosslinked hydrogel further comprises:

providing a member comprising a pharmaceutically acceptable crosslinked hydrogel containing a therapeutic bioactive molecule; and

after hydrating the member, eluting the therapeutic bioactive molecule from the hydrogel into tissue surrounding the cavity.

21. The method of

claim 17

wherein the cavity is formed in sphincter tissue and hydrating the member augments the volume of a sphincter.

22. The method of

claim 17

wherein providing a member comprising a pharmaceutically acceptable crosslinked hydrogel further comprises:

providing a first hydrogel component;

providing a second hydrogel component;

instilling the first and second hydrogel components into the cavity; and

polymerizing the first and second hydrogel components to form the member.

23. The method of

claim 22

wherein the first hydrogel component comprises a foaming agent, the method further comprising:

activating the foaming agent while polymerizing the first and second hydrogel components to create a controlled amount of porosity in the hydrogel.

24. The method of

claim 17

wherein providing a member comprising a pharmaceutically acceptable crosslinked hydrogel further comprises providing a member comprising a pharmaceutically acceptable crosslinked hydrogel that, in the first state, contains an excipient that assists in rehydration.

25. A method of anchoring a medical device within a mammalian body comprising:

providing an medical device;

providing a pharmaceutically acceptable crosslinked hydrogel, the hydrogel having a first state wherein the hydrogel is at substantially less than an equilibrium level of hydration, and a second state wherein the hydrogel is substantially at the equilibrium level of hydration, the hydrogel undergoing volumetric expansion while transitioning to the second state;

coating an exterior surface of the medical device with the hydrogel;

positioning the medical device in the mammalian body in the first state; and

hydrating the hydrogel to transition the hydrogel to the second state so that the hydrogel undergoes volumetric expansion and anchors the medical device within the mammalian body.

26. The method of

claim 25

wherein providing a pharmaceutically acceptable crosslinked hydrogel further comprises providing a pharmaceutically acceptable crosslinked hydrogel that is biodegradable in vivo.

27. The method of

claim 25

wherein providing a pharmaceutically acceptable crosslinked hydrogel further comprises:

providing a pharmaceutically acceptable crosslinked hydrogel containing a therapeutic bioactive molecule; and

after hydrating the hydrogel, eluting the therapeutic bioactive molecule from the hydrogel into the mammalian body.

28. The method of

claim 25

wherein providing a pharmaceutically acceptable crosslinked hydrogel further comprises providing a pharmaceutically acceptable crosslinked hydrogel that, in the first state, contains an excipient that assists in rehydration.

29. The method of

claim 25

wherein the medical device comprises a suture disposed through a needle hole and hydrating the hydrogel causes the hydrogel to seal the needle hole.

30. The method of

claim 25

wherein the medical device comprises a stent graft system and hydrating the hydrogel causes the hydrogel to seal the stent graft vessel against bypass flow.