Device and method for tissue engineering

• US 20020150604A1
• Filed: 04/11/2001
• Published: 10/17/2002
• Est. Priority Date: 04/11/2001
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Gosiewska, Anna, Roweton, Susan, Yi, Chin-Feng
• Granted Patent: US 6,656,488 B2
• Time in Patent Office: Days
• US Class Current: 424/426
• CPC Class Codes: A61L 27/52 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body

Abstract

A device and method for tissue engineering is disclosed. More particularly this invention relates to a bioabsorbable device and a method of its use which promotes controlled new tissue in-growth into voids or cavities occupied by the device as portions of the device are selectively absorbed within a host thereby minimizing collapse of surrounding, pre-existing host tissue into the engineered site.

Claims

1. A device for tissue engineering comprising:

a) a porous bioabsorbable bag;

b) at least two bioabsorbable materials each material having a different rate of bioabsorption, the materials being of sufficient size so as to be contained within the porous bag; and

c) a bioabsorbable binding gel which sets and binds the bioabsorbable materials in relation to each other.

2. The device of claim 1, wherein the porous bioabsorbable bag and the bioabsorbable materials are made from materials selected from the group consisting of polyesters and biopolymers.

3. The device of claim 2, wherein the size of the pores of the porous bag range from 30 to 600 micrometers.

4. The device of claim 2, wherein the bioabsorbable bag and the bioabsorbable materials are selected from the group consisting of aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, polyacetals, polyketals, polycarbonates, polyorthocarbonates, polyurethanes, poly (alkylene succinates), poly(maleic acid), poly(methyl vinyl ether), poly(maleic anhydride), tyrosine derived polycarbonates, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly (anhydrides), polyphosphazenes, polypeptides, polysaccharides, polysaccharide derivatives and mixtures thereof

5. The device of claim 4, wherein the shape of the bioabsorbable materials is selected from the group consisting of fibers, beads, pellets, granules, powders, flakes and mixtures thereof.

6. The device of claim 5, wherein the bioabsorbable materials are in the form of beads and range in size from 100 to 1000 micrometers.

7. The device of claim 1, wherein the gel is selected from the group consisting of hydrogels, fibrin or autologous plasma mixed with thrombin, extracellular matrix proteins, proteoglycans, and mixtures thereof.

8. The device of claim 7, wherein the extracellular matrix proteins are selected from the group consisting of collagen, laminin, elastin, and mixtures thereof.

9. The device of claim 1 wherein the bioabsorbable bag comprises copolymers of poly(L-lactide) and poly (glycolide) in a ratio range of about 100:

0 to about 0;

100 of L-lactide to glycolide or poly(ε

-caprolactone) and poly(glycolide) in a ratio range of about 0;

100 to about 50;

50 ε

-caprolactone to glycolide;

one of the bioabsorbable materials comprises copolymers of poly(L-lactide) and poly (glycolide) in a ratio range about 100;

0 to about 0;

100 of L-lactide to glycolide;

the other of the bioabsorbable materials comprises a material selected from the group consisting of collagen, gelatin, alginate, pectin, starch, fibrin, oxidized cellulose, chitin, chitosan, tropoelastin, hyaluronic acid and mixtures thereof; and

the binding gel comprises fibrin or autologous plasma mixed with thrombin, extracellular matrix proteins, proteoglycans, and mixtures thereof.

10. The device of claim 9 wherein the bioabsorbable bag comprises copolymers of poly(ε

-caprolactone) and poly(glycolide) in a ratio range of about 30;

70 to about 50;

50 ε

-caprolactone to glycolide, one of the bioabsorbable materials comprises copolymers of poly(L-lactide) and poly (glycolide) in a ratio of about 85;

15 of L-lactide to glycolide, the other of the bioabsorbable materials comprises collagen, and the binding gel comprises fibrin or autologous plasma mixed with thrombin.

11. The device of claim 10, wherein the bag comprises pores in the range of 30 to 100 micrometers and the bioabsorbable materials are beads having diameters in the range of 100 to 1000 micrometers.

12. The device of claim 9, wherein the bioabsorbable bag comprises copolymers of poly(L-lactide) and poly (glycolide) in a ratio of about 10:

90 of L-lactide to glycolide, one of the bioabsorbable materials comprises copolymers of poly(L-lactide) and poly (glycolide) in a ratio of about 85;

15 of L-lactide to glycolide, the other of the bioabsorbable materials comprises collagen, and the binding gel comprises fibrin or autologous plasma mixed with thrombin.

13. The device of claim 12, wherein the bag comprises average pore sizes in the range of approximately 200 micrometers and the bioabsorbable materials are beads having diameters in the range of 400 to 1000 micrometers.

14. The device of claim 1 further incorporating wound healing stimulants or cells.

18. The method of claim 17, wherein the size of the pores of the porous bag range from 30 to 600 micrometers.

19. The method of claim 17, wherein the bioresorbable bag and the bioresorbable materials are group consisting of aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, polyacetals, polyketals, polycarbonates, polyorthocarbonates, polyurethanes, poly(alkylene succinates), poly(maleic acid), poly(methyl vinyl ether), poly(maleic anhydride), tyrosine derived polycarbonates, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, polypeptides, polysaccharides, polysaccharide derivatives and mixtures thereof.

20. The method of claim 19, wherein the shape of the bioabsorbable materials is selected from the group consisting of fibers, beads, pellets, granules, powders, flakes and combinations thereof.

21. The method of claim 20, wherein the bioabsorbable materials are in the form of beads and range in size from 100 to 1000 micrometers.

22. The method of claim 20, wherein the gel is selected from the group consisting of hydrogels, fibrin or autologous plasma mixed with thrombin, extracellular matrix proteins, proteoglycans, and mixtures thereof

23. The method of claim 22, wherein the extracellular matrix proteins are selected from the group consisting of collagen, laminin, elastin, and mixtures thereof.

24. The method of claim 23, wherein the bioabsorbable bag comprises copolymers of poly(L-lactide) and poly (glycolide) in a ratio range about 100:

0 to about 0;

100 of L-lactide to glycolide or poly(ε

-caprolactone) and poly(glycolide) in a ratio range of about 0;

100 to about 50;

50 ε

-caprolactone to glycolide, one of the bioabsorbable materials comprises copolymers of poly(L-lactide) and poly (glycolide) in a ratio range of about 100;

0 to about 50;

50 of L-lactide to glycolide, the other of the bioabsorbable materials comprises a material selected from the group consisting of collagen, gelatin, alginate, pectin, starch, fibrin, oxidized cellulose, chitin, chitosan, tropoelastin, hyaluronic acid and mixtures thereof, and the binding gel comprises fibrin or autologous plasma mixed with thrombin.

25. The method of claim 24, wherein the bag comprises pores in the range of about 30 to 600 micrometers, the bioabsorbable materials comprise beads in the range of 100 to 1000 micrometers.

26. The method of claim 15 or 16, wherein the method is used in conjunction with promoting growth of soft tissue.

27. The method of claim 15 or 16, wherein the growth of tissue is promoted in a wound cavity.

28. The method of claim 15 or 16, wherein the growth of tissue is promoted in the breast.

29. The method of claim 15 or 16, wherein the growth of tissue is promoted in bone.

30. The method of claim 15 further comprising the step of placing the result of step b into a mold and forming a molded shaped before beginning step c.

15. A method for promoting in-growth of host tissue into a void within the host comprising the steps of:

a) providing a porous bioabsorbable bag comprising at least two bioabsorbable materials, each material having a different rate of bioabsorption and each material of sufficient size so as to be contained in the bag;

b) injecting into the bag a bioabsorbable binding gel capable of binding and setting the bioabsorbable materials in relation to each other; and

c) inserting the bag of step b into the void and conforming the bag to the desired shape within the void.

17. The method of claims 15 or 16, wherein the porous bioabsorbable bag and the bioabsorbable materials are made from the group consisting of polyesters and biopolymers.

16. A method for promoting in-growth of host tissue into a void within the host comprising the steps of:

a) providing a porous bioabsorbable bag comprising at least two bioabsorbable materials, each material having a different rate of bioabsorption and each material of sufficient size so as to be contained in the bag;

b) inserting the bag of step a into the void and conforming the bag to the desired shape within the void; and

c) injecting into the bag a bioabsorbable binding gel capable of binding and setting the bioabsorbable materials in relation to each other and further conforming the bag to the desired shape within the void.