Non-woven scaffold for tissue engineering

• US 20070036842A1
• Filed: 08/15/2005
• Published: 02/15/2007
• Est. Priority Date: 08/15/2005
• Status: Abandoned Application

• Current Assignee: Concordia Manufacturing Company Incorporated
• Original Assignee: Concordia Manufacturing Company Incorporated
• Inventors: Spencer, Randal
• Application Number:
  US11/204,655
• Publication Number:
  US 20070036842A1
• Time in Patent Office: Days
• US Class Current: 424/443
• CPC Class Codes: A01N 1/0231 Chemically defined matrices, e.g. alginate gels, for immobilising, holding or storing cells, tissue or organs for preservation purposes; Chemically altering or fixing cells, tissue or organs, e.g. by cross-linking, for preservation purposes
• CPC Class Codes: A01N 1/0263 Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/38 containing added animal cells organs or tissue containing native cells A61L27/36
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Scaffolds for tissue engineering, and methods and systems for manufacturing the same. The starting material used to manufacture the scaffolds may include a needled non-woven sheet, or a batt of fibers. In either case, the starting material includes a bioabsorbable polymer, such as polyglycolic acid or poly-L-lactide. This allows the scaffold to dissolve when exposed to water (e.g., when placed in the body). The starting material is needled into a three dimensional shape that is substantially seamless and then set with heat and pressure to provide substantially uniform thickness and density. This affords an improved substrate on which to place cells that will form the tissue.

Claims

1. A method of making at least a portion of a shape for receiving one or more living cells, the method comprising the steps of:

providing a piece of starting material including a first portion, a second portion, and a third portion;

covering the first portion with the second portion, neither the first portion nor the second portion covering the third portion, the third portion not covering either the first portion or the second portion;

needling at least the first and second portions to attach at least the first and second portions to each other to create a three dimensional shape that defines an interior space; and

refraining from needling at least a portion of the third portion.

2. The method of claim 1 wherein the first and second portions each include a taper.

3. The method of claim 2 wherein a combined thickness of the first and second portions is substantially equal to a thickness of the third portion.

4. The method of claim 1 wherein the providing step comprises providing a needled non-woven sheet as the piece of starting material.

5. The method of claim 1 wherein the providing step comprises providing a batt of fibers as the piece of starting material.

6. The method of claim 1 wherein the needling step results in the creation of the three dimensional shape with substantially no seams.

7. The method of claim 1 wherein the piece of starting material comprises a bioabsorbable polymer.

8. The method of claim 7 wherein the polymer comprises at least one of polyglycolic acid or poly-L-lactide.

9. The method of claim 1 further comprising the step of sterilizing the shape.

10. A method of making at least a portion of a shape for receiving one or more living cells, the method comprising the steps of:

providing a plurality of pieces of starting material, each of the pieces including a first portion and a second portion;

covering the first portion of a first one of the pieces with the first portion of a second one of the pieces;

needling at least the first portions of the first and second ones of the pieces to attach at least the first portions to each other to create at least a portion of a three dimensional shape that defines an interior space; and

refraining from needling at least a portion of the second portion of at least one of the plurality of pieces.

11. The method of claim 10 wherein each of the first portions includes a taper.

12. The method of claim 11 wherein a combined thickness of the first portions is substantially equal to a thickness of the second portion.

13. The method of claim 10 wherein the providing step comprises providing a first needled non-woven sheet as the first one of the pieces and providing a second needled non-woven sheet as the second one of the pieces.

14. The method of claim 10 wherein the providing step comprises providing a first batt of fibers as the first one of the pieces and providing a second batt of fibers as the second one of the pieces.

15. The method of claim 10 wherein the needling step results in the creation of the three dimensional shape with substantially no seams.

16. The method of claim 10 wherein the covering step comprises covering the first portion of the first one of the pieces with the first portion of the second one of the pieces such that the second portion of at least one of the first and second ones of the pieces (i) is not covered and (ii) does not cover the first portion of either the first or second ones of the pieces.

17. The method of claim 10 wherein at least one of the plurality of pieces of starting material comprises a bioabsorbable polymer.

18. The method of claim 17 wherein the polymer comprises at least one of polyglycolic acid or poly-L-lactide.

19. The method of claim 10 further comprising the step of sterilizing the shape.

20. A method of making at least a portion of a shape for receiving one or more living cells, the method comprising the steps of:

providing a plurality of pieces of starting material, each of the pieces including a first portion and a second portion, wherein each of the first portions includes a taper;

covering the first portion of a first one of the pieces with the first portion of a second one of the pieces, wherein a combined thickness of the first portions is substantially equal to a thickness of the second portion; and

needling at least the first portions of the first and second ones of the pieces to attach at least the first portions to each other to create at least a portion of a three dimensional shape that defines an interior space.

21. The method of claim 20 wherein the providing step comprises providing a first needled non-woven sheet as the first one of the pieces and providing a second needled non-woven sheet as the second one of the pieces.

22. The method of claim 20 wherein the providing step comprises providing a first batt of fibers as the first one of the pieces and providing a second batt of fibers as the second one of the pieces.

23. The method of claim 20 wherein the needling step results in the creation of the three dimensional shape with substantially no seams.

24. The method of claim 20 wherein the covering step comprises covering the first portion of the first one of the pieces with the first portion of the second one of the pieces such that the second portion of at least one of the first and second ones of the pieces (i) is not covered and (ii) does not cover the first portion of either the first or second ones of the pieces.

25. The method of claim 20 wherein at least one of the plurality of pieces of starting material comprises a bioabsorbable polymer.

26. The method of claim 25 wherein the polymer comprises at least one of polyglycolic acid or poly-L-lactide.

27. The method of claim 20 further comprising the step of sterilizing the shape.

28. A method of making at least a portion of a shape for receiving one or more living cells, the method comprising the steps of:

providing at least one batt of fibers;

manipulating the at least one batt into a three dimensional structure, the three dimensional structure defining an interior space; and

needling the at least one batt to consolidate the fibers and create the three dimensional structure.

29. The method of claim 28 wherein the needling step results in the creation of the three dimensional structure with substantially no seams.

30. The method of claim 28 wherein the at least one batt comprises a bioabsorbable polymer.

31. The method of claim 30 wherein the polymer comprises at least one of polyglycolic acid or poly-L-lactide.

32. The method of claim 28 further comprising the step of sterilizing the shape.

33. A structure for receiving one or more living cells, comprising:

a piece of starting material formed into a three dimensional structure defining an interior space, the piece of starting material including a first portion, a second portion, and a third portion, the second portion covering the first portion, neither the first portion nor the second portion covering the third portion, the third portion not covering either the first portion or the second portion;

a needled region including the first portion and the second portion and with substantially no seams; and

a non-needled region including at least a portion of the third portion.

34. The structure of claim 33 wherein the first and second portions each include a taper.

35. The structure of claim 34 wherein a combined thickness of the first and second portions is substantially equal to a thickness of the third portion.

36. The structure of claim 33 wherein the piece of starting material comprises a needled non-woven sheet.

37. The structure of claim 33 wherein the piece of starting material comprises a batt of fibers.

38. The structure of claim 33 wherein the piece of starting material comprises a bioabsorbable polymer.

39. The structure of claim 38 wherein the polymer comprises at least one of polyglycolic acid or poly-L-lactide.

40. A structure for receiving one or more living cells, comprising:

a plurality of pieces of starting material formed into a three dimensional structure defining an interior space, each of the pieces including a first portion and a second portion, the first portion of a first one of the pieces covering the first portion of a second one of the pieces;

a needled region including the first portions of the first and second ones of the pieces and with substantially no seams; and

a non-needled region including at least a portion of the second portion of at least one of the plurality of pieces.

41. The structure of claim 40 wherein each of the first portions includes a taper.

42. The structure of claim 41 wherein a combined thickness of the first portions is substantially equal to a thickness of the second portion.

43. The structure claim 40 wherein at least one of the plurality of pieces of starting material comprises a needled non-woven sheet.

44. The structure of claim 40 wherein at least one of the plurality of pieces of starting material comprises a batt of fibers.

45. The structure of claim 40 wherein at least one of the plurality of pieces of starting material comprises a bioabsorbable polymer.

46. The structure of claim 45, wherein the polymer comprises at least one of polyglycolic acid or poly-L-lactide.

47. A structure for receiving one or more living cells, comprising:

a plurality of pieces of starting material formed into a three dimensional structure defining an interior space, each of the pieces including a first portion having a taper and a second portion, the first portion of a first one of the pieces covering the first portion of a second one of the pieces, wherein a combined thickness of the first portions is substantially equal to a thickness of the second portion; and

a needled region including the first portions of the first and second ones of the pieces and with substantially no seams.

48. The structure of claim 47 wherein at least one of the plurality of pieces of starting material comprises a needled non-woven sheet.

49. The structure of claim 47 wherein at least one of the plurality of pieces of starting material comprises a batt of fibers.

50. The structure of claim 47 wherein at least one of the plurality of pieces of starting material comprises a bioabsorbable polymer.

51. The structure of claim 50, wherein the polymer comprises at least one of polyglycolic acid or poly-L-lactide.

52. A system for manufacturing a shape for receiving one or more living cells, the system comprising:

a flexible mandrel including a plurality of support ribs for receiving at least one piece of starting material, wherein one of the support ribs defines a plurality of apertures;

a plurality of barbed needles disposed proximate to the support rib having the plurality of apertures;

at least one actuator associated with at least one of the support ribs;

means for pressing and removing the plurality of barbed needles through the at least one starting material and into the plurality of apertures; and

means for moving the at least one starting material relative to the support rib having the plurality of apertures.

53. The system of claim 52 wherein the at least one starting material comprises a non-woven sheet.

54. The system of claim 52 wherein the at least one starting material comprises a batt of fibers.

55. The system of claim 52 wherein the piece of starting material comprises a bioabsorbable polymer.

56. The system of claim 55 wherein the polymer comprises at least one of polyglycolic acid or poly-L-lactide.

57. The system of claim 52 wherein the flexible mandrel is characterized at least in part by a profile corresponding to at least a portion of the shape for receiving one or more living cells.

58. The system of claim 52 further comprising a controller in communication with the flexible mandrel, the plurality of barbed needles, the at least one actuator, the means for pressing and removing the plurality of barbed needles, and the means for moving the at least one starting material.

59. A method of setting at least a portion of a needled non-woven shape for receiving one or more living cells, the method comprising the steps of:

providing a mold;

heating the mold to a predetermined temperature;

providing an expandable bladder disposed within the mold and defining a gap therebetween;

placing the shape on the expandable bladder and within the gap; and

expanding the bladder to a predetermined pressure to cause the sheet to contact the mold for a predetermined period.