Swellable hydrogel matrix and methods

• US 20090123519A1
• Filed: 11/12/2008
• Published: 05/14/2009
• Est. Priority Date: 11/12/2007
• Status: Abandoned Application

• Current Assignee: Surmodics Incorporated
• Original Assignee: Surmodics Incorporated
• Inventors: Chudzik, Stephen J., Reed, Pamela J., Rolfes, Emily R.
• Application Number:
  US12/291,622
• Publication Number:
  US 20090123519A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61K 47/00 Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
• CPC Class Codes: A61K 9/1641 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
• CPC Class Codes: A61K 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids

Abstract

The invention provides biocompatible polymeric hydrogel matrices having excellent durability and swellability. The matrices are formed from a macromer and photo-polymer combination. The matrices can be used in association with a medical device or alone. In some methods the polymeric matrix is placed or formed at a target site in which the matrix swells and occludes the target area.

Claims

1. A medical implant comprising:

a biocompatible swellable or swollen polymeric matrix comprising first and second polymer-containing segments covalently linked via reacted groups, wherein the first polymer-containing segment comprises a hydrophilic polymer comprising pendent polymerized groups, and the second polymer-containing segment comprises a hydrophilic polymer comprising pendent reacted photogroups, and

a non-porous article having a surface which the biocompatible swellable or swollen polymeric matrix is associated with.

2. The medical implant of claim 1 wherein the first polymer-containing segment comprises two pendent polymerized groups.

3. The medical implant of claim 1 wherein the first polymer-containing segment comprises an oxyalkylene polymer.

4. The medical implant of claim 1 wherein the first polymer-containing segment has a molecular weight in the range of 250 Da to 20 kDa.

5. The medical implant of claim 1 wherein the first polymer-containing segment having a linear structure comprises a polymer selected from the group consisting of poly(ethylene oxide) (PEO), poly(ethyloxazoline), poly(propylene oxide) (PPO), poly(ethylene glycol) (PEG), copolymers of polyethylene glycol and polypropylene oxide (PEG-PPO), and polyvinyl alcohol.

6. The medical implant of claim 1 wherein the first polymer-containing segment has a branched structure, or the polymeric matrix further comprises a third polymer-containing segment having a branched structure.

7. The medical implant of claim 6 wherein the branched structure comprises poly(ethylene glycol) portions.

8. The medical implant of claim 6 wherein the branched structure is selected from the group consisting of:

wherein X is C or S, or a homo- or heterocyclic ring;

Y₁, Y₂, and Y₃ are independently, —

C_n—

O—

, wherein n is 0 or an integer of 1 or greater;

R₁, R₂, and R₃, are independently hydrophilic polymeric portions, which can be the same or different, and R₁, R₂, and R₃ independently have one or more pendent polymerized group(s); and

Z is a non-polymeric group;

wherein X is C or S, or a homo- or heterocyclic ring;

Y₁, Y₂, Y₃, and Y₄ are independently, —

C_n—

O—

, wherein n is 0 or an integer of 1 or greater;

R₁, R₂, R₃, and R₄, are independently hydrophilic polymeric portions, which can be the same or different, and R₁, R₂, R₃, and R₄ independently have one or more pendent polymerized group(s); and

wherein X is selected from N, C—

H, or S—

H, or a homo- or heterocyclic ring;

Y₁ and Y₂ are —

C_n—

O—

, wherein n is 0 or an integer of 1 or greater; and

R₁, R₂, and R₃, are independently hydrophilic polymeric portions, which can be the same or different, and R₁, R₂, and R₃ independently have one or more pendent polymerized group(s).

9. The medical implant of claim 1 wherein the second polymer-containing segment comprises non-oxyalkylene monomeric units.

10. The medical implant of claim 1 wherein the second polymer-containing segment comprises monomeric units selected from (meth)acrylamide, vinyl pyrrolidone, and (meth)acrylic acid.

11. The medical implant of claim 9 wherein the second polymer-containing segment comprises copolymer comprising oxyalkylene and non-oxyalkylene monomeric units.

12. The medical implant of claim 1 wherein the second polymer-containing segment comprises amphiphilic monomeric units selected from the group consisting of diacetone acrylamide (DAA), vinyloxyethanol (VOE), 2-acrylamido-2-methylpropane (AMPS), and methyl acryloyl lactate (ALM).

13. The medical implant of claim 1 wherein the molecular weight of the first polymer-containing segment is less than the second polymer-containing segment.

14. The medical implant of claim 1 wherein the first polymer-containing segment and the second polymer-containing segment are present in the matrix at a weight ratio in the range of 9:

1 to 1;

3, respectively.

15. The medical implant of claim 14 wherein the first polymer-containing segment and the second polymer-containing segment are present in the matrix at a weight ratio in the range of 4:

1 to 1;

2, respectively.

16. The medical implant of claim 1, wherein the biocompatible swellable or swollen polymeric matrix is in the form of an overmold on the non-porous article.

17. The medical implant of claim 1 comprising a radiopaque agent.

18. A method for occluding a target site in the body comprising steps of:

placing at a target site in the body a biocompatible swellable matrix comprising first and second polymer-containing segments covalently linked via reacted groups, wherein the first polymer-containing segment comprises a hydrophilic polymer comprising pendent polymerized groups, and second polymer-containing segment comprises a hydrophilic polymer comprising pendent reacted photogroups; and

allowing the matrix to swell at the target site, which occludes the target site.

19. The method of claim 18, wherein the matrix swells at the target site to a weight of 1.5 times or greater a weight of the matrix in a dehydrated form.

20. The method of claim 18, wherein the matrix exerts a swelling force of 100 g/cm² or greater upon swelling.

21. The method of claim 18, wherein the matrix swells to a size that is at least 25% greater than its size in a dehydrated form.