Thick foams for biomedical application and methods of making

• US 20100247598A1
• Filed: 03/31/2009
• Published: 09/30/2010
• Est. Priority Date: 03/31/2009
• Status: Abandoned Application

• Current Assignee: Endo-Surgery, Inc.
• Original Assignee: Endo-Surgery, Inc.
• Inventors: Hyland, Thomas Patrick, Vyakamam, Murty N., Chun, Iksoo, Shetty, Dhanuraj S.
• Application Number:
  US12/415,260
• Publication Number:
  US 20100247598A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61L 15/26 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof A61L15/225 takes precedence
• CPC Class Codes: A61L 15/425 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08J 2201/0482 the liquid phase being organic
• CPC Class Codes: C08J 2201/0484 the liquid phase being aqueous
• CPC Class Codes: C08J 2207/10 Medical applications, e.g. biocompatible scaffolds
• CPC Class Codes: C08J 2367/04 Polyesters derived from hydroxy carboxylic acids, e.g. lactones C08J2367/06 takes precedence
• CPC Class Codes: C08J 9/26 by elimination of a solid phase from a macromolecular composition or article, e.g. leaching out
• CPC Class Codes: C08J 9/28 by elimination of a liquid phase from a macromolecular composition or article, e.g. drying of coagulum
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: Y10T 83/04 Processes

Abstract

A novel method of manufacturing thick foams, especially molded thick foams useful as tissue scaffolds and other medical devices. Also disclosed are novel thick foams made using the process of the present invention, wherein such thick foams may be used as medical devices or components of medical devices.

Claims

1. A method of making a thick polymer foam, comprising the steps of:

providing a thermoreversible polymer solution, said solution comprising a biocompatible, biodegradable polymer and a solvent;

cooling the solution until the solution gels; and

.

removing the solvent by lyophilization to yield a thick foam member having inter-connected pores.

2. The method of claim 1,wherein the biocompatible, biodegradable polymer comprises a polymer selected from the group consisting of aliphatic polyester is selected from the group consisting of homopolymers and copolymers of lactide, lactic acid, glycolide, glycolic acid), ε

-caprolactone, p-dioxanone (1,4-dioxan-2-one), trimethylene carbonate (1,3-dioxan-2-one), alkyl derivatives of trimethylene carbonate, δ

-valerolactone, β

-butyrolactone, γ

-butyrolactone, ε

-decalactone, hydroxybutyrate, hydroxyvalerate, 1,4-dioxepan-2-one, 1,5,8,12-tetraoxacyclotetradecane-7,14-dione), 1,5-dioxepan-2-one, 6,6-dimethyl-1,4-dioxan-2-one and polymer blends thereof.

3. The method of claim 1, wherein the solvent is 1,4-dioxane.

4. The method of claim 1, wherein the solution is placed into a mold prior to cooling.

5. The method of claim 1, wherein the lyophilization comprises a first freezing step and first drying step, and at least one subsequent additional drying step.

6. The method of claim 1, wherein the solution additionally comprises a leachable solid selected from the group consisting of sodium chloride, potassium chloride, calcium chloride, sodium tartrate, sodium citrate, glucose, fructose, dextrose, maltose, lactose, sucrose and combinations thereof.

7. The method of claim 1, wherein the solution additionally comprises a thereapeutic agent selected from the group consisting consisting of antiinfectives, hormones, analgesics, anti-inflammatory agents, growth factors, chemotherapeutic agents, anti-rejection agents, prostaglandins, RDG peptides and combinations thereof.

8. The method of claim 1, wherein the foam member has a thickness of greater than about 1 cm.

9. The method of claim 1, wherein the pores have a uniform morphology.

10. A foam member, comprising:

a foam member having inter-connected pores, wherein the foam member has a thickness of greater than about 1 cm, and wherein the foam member is manufactured by a process, comprising;

providing a thermoreversible polymer solution, said solution comprising a biocompatible, biodegradable polymer and a solvent;

cooling the solution until the solution gels; and

,

removing the solvent by lyophilization to yield a thick foam member having inter-connected pores.

11. The foam member of claim 10, wherein the biocompatible, biodegradable polymer comprises a polymer selected from the group consisting of aliphatic polyester is selected from the group consisting of homopolymers and copolymers of lactide, lactic acid, glycolide, glycolic acid), ε

-caprolactone, p-dioxanone (1,4-dioxan-2-one), trimethylene carbonate (1,3-dioxan-2-one), alkyl derivatives of trimethylene carbonate, δ

-valerolactone, β

-butyrolactone, γ

-butyrolactone, ε

-decalactone, hydroxybutyrate, hydroxyvalerate, 1,4-dioxepan-2-one, 1,5,8,12-tetraoxacyclotetradecane-7,14-dione), 1,5-dioxepan-2-one, 6,6-dimethyl-1,4-dioxan-2-one and polymer blends thereof.

12. The foam member of claim 10, wherein the solvent is 1,4-dioxane.

13. The foam member of claim 10, wherein the solution is placed into a mold prior to cooling.

14. The foam member of claim 10, wherein the lyophilization comprises a first freezing step and first drying step, and at least one subsequent additional drying step.

15. The foam member of claim 10, wherein the solution additionally comprises a leachable solid selected from the group consisting of sodium chloride, potassium chloride, calcium chloride, sodium tartrate, sodium citrate, glucose, fructose, dextrose, maltose, lactose, sucrose and combinations thereof.

16. The foam member of claim 10, wherein the solution additionally comprises a thereapeutic agent selected from the group consisting consisting of antiinfectives, hormones, analgesics, anti-inflammatory agents, growth factors, chemotherapeutic agents, anti-rejection agents, prostaglandins, RDG peptides and combinations thereof.

17. The foam member of claim 10, wherein the pores have a uniform morphology.

18. A method of making a medical device comprising the steps of:

providing the foam member of claim 10;

cutting the foam member into a medical device.