Assimilable hydrophilic prosthesis

• US 4,181,983 A
• Filed: 08/29/1977
• Issued: 01/08/1980
• Est. Priority Date: 08/29/1977
• Status: Expired due to Term

• Current Assignee: R. K. Kulkarni
• Original Assignee: R. K. Kulkarni
• Inventors: Kulkarni, R. K.
• Primary Examiner(s): Padgett, Benjamin R.
• Assistant Examiner(s): Gron, T. S.
• Application Number:
  US05/828,659
• Time in Patent Office: 862 Days
• Field of Search: 32/1, 3/1, 3/1.9, 128/334 R, 128/335.5, 128/156, 128/296, 128/325, 521/61, 521/88, 521/90, 521/98, 264/48, 264/41, 264/86, 264/87
• US Class Current: 424/423
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: C08L 67/00 Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain of polyester-amides C08L77/12; of polyester-imides C08L79/08; Compositions of derivatives of such polymers

Abstract

A porous, hydrophilic, assimilable prosthesis is formed by the removal of solvent, without substantial dimensional change, from a solution of (a), an assimilable polymer composed primarily of polymerized units of an alpha or beta hydroxy carboxylic acid, preferably but not necessarily those having 1 to 4 carbon atoms, and (b), a small amount of a physiologically acceptable wetting agent that is sufficient to impart hydrophilicity to the prosthesis. The preferred assimilable polymer is a polylactic acid. The preferred process for making the prosthesis involves the lyophilization of a solution of polylactic acid having a molecular weight of at least 100,000, weight average, at a concentration of at least 31/2% by weight of the solution of the polylactic acid. A variety of physiologically acceptable wetting agents is useful, a preferred class being the alkali metal soaps of fatty acids or of alkyl aryl sulfonic acids.

Claims

1. An assimilable prosthesis than can be implanted in a body cavity, comprising a porous hydrophilic body formed by the removal of solvent by lyophilization or selective leaching, without substantial volume change, from a substantially homogeneous solution in liquid organic solvent of (a), an assimilable normally hydrophobic polymer composed primarily of polymerized units of a saturated, aliphatic hydroxy carboxylic acid, and (b), a small amount of a physiologically acceptable wetting agent, which amount remains in the polymer and is sufficient to impart hydrophilicity to said body.

2. A prosthesis in accordance with claim 1 that is formed from a solution containing at least 3.5% by weight of the assimilable polymer.

3. A prosthesis in accordance with claim 1 wherein the polymer is a lactic acid polymer having a molecular weight of at least 100,000, weight average.

4. A prosthesis in accordance with claim 1 wherein the carboxylic acid polymer is polylactic acid having a molecular weight of at least 100,000, weight average.

5. A prosthesis in accordance with claim 1 wherein the carboxylic acid contains not more than four carbon atoms and the polymer has a molecular weight of at least 100,000, weight average.

6. An assimilable prosthesis in accordance with claim 1 comprising a porous hydrophilic body formed of a polymer of repeating units of the formula:

##STR3## where;

n is 0 or 1;

one of -X and -Y is oxygen, ie, --O--, for connection to another repeating unit, and the other, if present, is R; and

R is H or alkyl up to 18 carbon atoms.

7. A prosthesis in accordance with claim 6 wherein the total number of carbons in the R substituents is 18.

8. A prosthesis in accordance with claim 6 wherein the wetting agent is a nonionic, cationic, or anionic synthetic wetting agent.

9. An assimilable prosthesis in accordance with claim 1 comprising a hydrophilic body that is at least 90% porous and that is formed from an assimilable polymer of an alpha or beta hydroxy carboxylic acid having not more than four carbon atoms, the molecular weight of the polymer being at least 100,000, weight average, and said polymer having intimately distributed therein the small amount of physiologically acceptable wetting agent.

10. A prosthesis in accordance with claim 9 wherein the concentration of the polymer in the solution is at least 3.5% by weight.

11. An assimilable prosthesis in accordance with claim 9, for insertion in a dry socket to facilitate healing, comprising a hydrophilic body formed by the lyophilization of a solution of at least 3.5% by weight concentration of a polylactic acid that has a molecular weight of at least 100,000, weight average, which solution contains a physiologically acceptable wetting agent in a small amount up to 5% based on the weight of the polymer, which amount is effective to impart hydrophilicity of the body.

12. A prosthesis in accordance with claim 11 wherein the wetting agent is an alkali metal soap of a fatty acid having from 8 to 18 carbon atoms, inclusive.

13. A prosthesis in accordance with claim 12 wherein the soap is sodium oleate.

14. A process for making an assimilable, porous, hydrophilic article that can be implanted in a body cavity, comprising

preparing a substantially homogeneous solution in a liquid organic solvent of a normally hydrophilic polymer formed of repeating units of the formula:

##STR4## where, n is 0 or 1;

one of --X and --Y is oxygen, ie, --O--, for connection to another repeating unit, and the other, if present, is R; and

R is H or alkyl up to 18 carbon atoms;

said solution containing a small amount, homogeneously distributed therein, and sufficient to impart hydrophilicity to the article, of a physiologically acceptable wetting agent, and then

removing the solvent from the solution by lyophilization or selective leaching, without substantial change in volume, to produce the desired porous article, the wetting agent remaining in the polymer and imparting hydrophilicity to the article.

15. A process in accordance with claim 14 wherein the concentration of polymer in the solution is at least 3.5% by weight.

16. A process for making an assimilable, porous, hydrophilic article that can be implanted in a body cavity, comprising

admixing a solution of a normally hydrophobic polymer of an aliphatic, saturated, alpha or beta hydroxy carboxylic acid having up to four carbon atoms with a small amount of a physiologically acceptable wetting agent, and

removing the solvent from the solution without substantial volume change thereof, by lyophilization or selective leaching, to produce the desired porous article, the wetting agent remaining in the polymer and imparting hydrophilicity to the article.

17. A process in accordance with claim 16 wherein the concentration of the polymer in the solution is at least 3.5% by weight.

18. A process in accordance with claim 17 wherein the polymer is a lactic acid polymer having a molecular weight of at least 100,000.

19. A process for making an assimilable, porous, hydrophilic article that can be implanted in a body cavity, comprising

admixing a solution of normally hydrophobic polymer of lactic acid having a molecular weight of at least 100,000, weight averge, with a small amount of a physiologically acceptable wetting agent, and

freeze-drying the admixture to obtain the desired porous article, the wetting agent remaining in the polymer and imparting hydrophilicity to the article.

20. A process in accordance with claim 19 wherein the concentration of the polymer in the solution is at least 3.5% by weight.

21. A process in accordance with claim 19 wherein the wetting agent is a synthetic wetting agent.

22. A process in accordance with claim 19 wherein the wetting agent is the salt of an alkali metal with a fatty acid having 8 to 18 carbon atoms.