Biocompatible foams, systems, and methods

• US 20090093550A1
• Filed: 09/19/2008
• Published: 04/09/2009
• Est. Priority Date: 09/19/2007
• Status: Active Grant

• Current Assignee: Surmodics Incorporated
• Original Assignee: Surmodics Incorporated
• Inventors: Reed, Pamela J., Chudzik, Stephen J., Rolfes, Emily R.
• Granted Patent: US 8,999,377 B2
• Time in Patent Office: Days
• US Class Current: 514/772.7
• CPC Class Codes: A61K 9/122 Foams; Dry foams edible foams A61K9/0056
• CPC Class Codes: A61L 15/28 Polysaccharides or their derivatives A61L15/225 takes precedence
• CPC Class Codes: A61L 15/425 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 15/62 Compostable, hydrosoluble or hydrodegradable materials
• CPC Class Codes: A61L 26/0023 Polysaccharides
• CPC Class Codes: A61L 26/0085 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 26/009 Materials resorbable by the body
• CPC Class Codes: C08J 2201/024 Preparation or use of a blowing agent concentrate, i.e. masterbatch in a foamable composition
• CPC Class Codes: C08J 2303/02 Starch; Degradation products thereof, e.g. dextrin
• CPC Class Codes: C08J 2303/14 Amylose derivatives; Amylopectin derivatives
• CPC Class Codes: C08J 2305/00 Characterised by the use of polysaccharides or of their derivatives not provided for in groups C08J2301/00 or C08J2303/00
• CPC Class Codes: C08J 2305/16 Cyclodextrin; Derivatives thereof
• CPC Class Codes: C08J 2371/02 Polyalkylene oxides
• CPC Class Codes: C08J 2403/00 Characterised by the use of starch, amylose or amylopectin or of their derivatives or degradation products
• CPC Class Codes: C08J 2405/00 Characterised by the use of polysaccharides or of their derivatives not provided for in groups C08J2401/00 or C08J2403/00
• CPC Class Codes: C08J 2471/00 Characterised by the use of polyethers obtained by reactions forming an ether link in the main chain of polyacetals C08J2459/00; of epoxy resins C08J2463/00; of polythioether-ethers C08J2481/02; of polyethersulfones C08J2481/06; Derivatives of such polymers
• CPC Class Codes: C08J 9/0004 Use of compounding ingredients, the chemical constitution of which is unknown, broadly defined, or irrelevant
• CPC Class Codes: C08J 9/0061 characterized by the use of several polymeric components
• CPC Class Codes: C08J 9/08 developing carbon dioxide

Abstract

Biocompatible foams having excellent physical and chemical properties are described. The biocompatible foams can be formed in situ or applied as a pre-formed foam for the treatment of tissue. The invention provides biocompatible degradable foams formed with a poly-α(1→4)glucopyranose macromer. The invention also provides biostable foams formed with a poly(alkylene oxide) macromer.

Claims

1. A system for forming a biocompatible biodegradable foam comprising:

a covalently crosslinkable polymer comprising poly-α

(1→

4)glucopyranose and pendent polymerizable groups;

a polymerization initiator; and

a gas-producing component.

2. The system of claim 1 wherein the polymerizable groups are pendent from the poly-α

(1→

4)glucopyranose in an amount in the range of 0.05 mmol/gram to 0.4 mmol/gram (polymerizable group s/poly-α

(1→

4)glucopyranose).

3. The system of claim 2 wherein the polymerizable groups are pendent from the poly-α

(1→

4)glucopyranose in an amount in the range of 0.1 mmol/gram to about 0.35 mmol/gram of polymer.

4. The system of claim 1 wherein the covalently crosslinkable polymer comprising poly-α

(1→

4)glucopyranose has a molecular weight of 500,000 Da or less.

5. The system of claim 1 further comprising a second covalently crosslinkable polymer comprising a biocompatible polymer that is biocompatible, hydrophilic, and biostable and that comprises pendent polymerizable groups.

6. The system of claim 5 wherein the second covalently crosslinkable polymer comprises an alkylene oxide polymer.

7. The system of claim 5 having a ratio of covalently crosslinkable polymer comprising poly-α

(1→

4)glucopyranose to the second covalently crosslinkable polymer in the range of 1;

1 to 3;

1 by weight.

8. The system of claim 1 wherein the polymerization initiator comprises an activating component selected from the group consisting of ferrous gluconate, ferrous ascorbate, ferrous acetylacetonate, and ferrous lactate.

9. The system of claim 1 wherein the polymerization initiator comprises a peroxide-based initiator.

10. The system of claim 1 further comprising a poloxamer surfactant.

11. A method for forming a biocompatible biodegradable foam comprising a step of:

providing a composition comprising a covalently crosslinkable polymer comprising poly-α

(1→

4)glucopyranose and pendent polymerizable groups, a polymerization initiator, and a gas-producing component, wherein the a gas-producing component reacts to produce gas and the polymerization initiator is activated to cause polymerization and formation of a foam.

12. The method of claim 11 wherein the step of providing, the composition is placed in contact with a tissue.

13. The method of claim 12 wherein the step of providing, the composition is placed in contact with tissue in a dermal wound.

14. The method of claim 11 wherein the foam is formed within a period of 20 seconds or less.

15. The method of claim 11 wherein the composition comprising a covalently crosslinkable polymer comprising poly-α

(1→

4)glucopyranose has a polymer concentration in the range of 200 mg/mL to 1000 mg/mL.

16. The method of claim 15 wherein the composition comprising a covalently crosslinkable polymer comprising poly-α

(1→

4)glucopyranose has a polymer concentration in the range of 400 mg/mL to 700 mg/mL.

17. The method of claim 11 wherein the polymerization initiator comprises a first member and a second member of a redox pair which are individually present in the composition prior to reaction at a concentration in the range of 2.0 mM to 25 mM.

18. The method of claim 11 wherein the gas-producing component comprises a biocompatible acid and a bicarbonate salt which are individually present in the composition prior to reaction at a concentration in the range of 20 mg/mL to 80 mg/mL.

19. A biocompatible biodegradable foam comprising poly-α

(1→

4)glucopyranose segments covalently crosslinked via polymerized groups.

20. The biocompatible biodegradable foam of claim 19 having pore volume in the range of 1.5 to 7.5.

21. The biocompatible biodegradable foam of claim 19 having a compressive modulus in the range of 0.5 kPa to 50 kPa.

22. The biocompatible biodegradable foam of claim 19 having a 50% compressive force in the range of 0.5 N to 20 N.