SCAFFOLD AND METHOD FOR IMPLANTING CELLS

• US 20080051624A1
• Filed: 10/29/2007
• Published: 02/28/2008
• Est. Priority Date: 06/07/2002
• Status: Abandoned Application

• Current Assignee: P TECH, LLC
• Original Assignee: P TECH, LLC
• Inventors: Bonutti, Peter
• Application Number:
  US11/926,609
• Publication Number:
  US 20080051624A1
• Time in Patent Office: Days
• US Class Current: 600/36
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61L 24/0015 Medicaments; Biocides
• CPC Class Codes: A61L 24/08 Polysaccharides A61L24/043 takes precedence
• CPC Class Codes: C12N 2501/10 Growth factors
• CPC Class Codes: C12N 2501/105 Insulin-like growth factors [IGF]
• CPC Class Codes: C12N 2501/11 Epidermal growth factor [EGF]
• CPC Class Codes: C12N 2501/135 Platelet-derived growth factor [PDGF]
• CPC Class Codes: C12N 2501/155 Bone morphogenic proteins [BMP]; Osteogenins; Osteogenic factor; Bone inducing factor
• CPC Class Codes: C12N 2513/00 3D culture
• CPC Class Codes: C12N 2533/54 Collagen; Gelatin
• CPC Class Codes: C12N 2533/90 Substrates of biological origin, e.g. extracellular matrix, decellularised tissue
• CPC Class Codes: C12N 5/0062 General methods for three-dimensional culture
• CPC Class Codes: C12N 5/0068 General culture methods using substrates for specific animal cell type C12N5/06
• CPC Class Codes: C12N 5/0654 Osteocytes, Osteoblasts, Odontocytes; Bones, Teeth
• CPC Class Codes: C12N 5/0691 : Vascular smooth muscle cells; 3D culture thereof, e.g. models of blood vessels
• CPC Class Codes: Y10S 623/92 : Method or apparatus for preparing or treating prosthetic

Abstract

An improved method of implanting cells in the body of a patient includes positioning viable cells on a support structure. One or more blood vessels may be connected with the support structure to provide a flow of blood through the support structure. A support structure may be positioned at any desired location in a patient'"'"'s body. The support structure may be configured to replace an entire organ or a portion of an organ. An organ or portion of an organ may be removed from a body cells and/or other tissue is removed to leave a collagen matrix support structure having a configuration corresponding to the configuration of the organ or portion of an organ. Alternatively, a synthetic support structure may be formed. The synthetic support structure may have a configuration corresponding to a configuration of an entire organ or only a portion of an organ.

Claims

1. A method of performing an anastomotomy, which comprises:

providing a tubular implant having a support structure with a plurality of pores formed therein for receiving cells;

depositing viable cells in said pores of said cylindrical support;

providing a blood vessel segment opening at an annular connector;

providing a body part opening at an annular connector;

positioning said tubular implant between said blood vessel segment and said body part with each of said connectors of said tubular implant aligned with a respective one of said annular connectors;

attaching said annular connector of said first blood vessel to a first of said annual connectors of said tubular implant; and

attaching said annular connector of said body part to a second of said annual connectors of said tubular implant.

2. The method according to claim 1, which further comprises enclosing said support structure in an outer layer, said outer layer at least partially blocking a radially outward flow of blood.

3. The method according to claim 1, wherein the attaching step includes stitching at least one of said annular connectors to said tubular implant.

4. The method according to claim 1, wherein the attaching step includes adhering at least one of said annular connectors to said tubular implant.

5. The method according to claim 1, wherein said viable cells include cells selected from the group consisting of endothelial cells, mesenchymal cells, and smooth muscle cells.

6. The method according to claim 1, which further comprises providing tissue growth induction materials on said support structure.

7. The method according to claim 1, which further comprises exposing said viable cells to a flow of blood through said tubular implant after said tubular implant has been attached to said blood vessel segments.

8. The method according to claim 1, which further comprises providing a check valve in said tubular implant for directing blood flow in only one direction through said tubular implant.

9. The method according to claim 8, wherein said forming said check valve includes:

providing a valve support structure in said tubular implant, said valve support structure having pores formed therein; and

depositing smooth muscle cells in said pores of said valve support structure.

10. The method according to claim 1, wherein said body part is a further blood vessel segment.

11. The method according to claim 1, wherein said body part is an organ.

12. The method according to claim 11, wherein said body part is a heart.

13. The method according to claim 1, wherein said aligning step includes:

placing an expandable member against said tubular implant while said expandable member is in an unexpanded state; and

expanding said expandable member to align said tubular implant with at least one of said annular connectors.

14. The method according to claim 13, wherein:

said placing step includes inserting said expandable member within said tubular implant in an unexpanded state; and

said expanding step includes expanding said expandable member to extend into at least one of said annular connectors.

15. The method according to claim 13, which further comprises contracting said expandable member after said attaching step.

16. The method according to claim 13, which further comprises:

inserting said expandable member remotely from said tubular implant; and

moving said expandable member to said tubular implant via said blood vessel segment.

17. The method according to claim 16, which further comprises:

contracting said expandable member after said attaching step; and

subsequently removing said expandable member from said tubular implant via said blood vessel segment.

18. The method according to claim 13, wherein said expandable member expands by fluid pressure.

19. The method according to claim 13, wherein said expandable member expands mechanically.

20. The method according to claim 13, wherein said expandable member is a balloon.

21. The method according to claim 14, wherein said expandable member spans said tubular implant and extends into both of said annular connectors.

22. The method according to claim 14, which further comprises:

inserting a further expandable member within said tubular implant in an unexpanded state; and

expanding said further expandable member to extend into the other of said annular connectors.

23. A method of performing an anastomotomy, which comprises:

providing tubular implant having two annular connectors;

providing a blood vessel segment opening at an annular connector;

providing a body part opening at an annular connector;

positioning said tubular implant between said blood vessel segment and said body part with each of said annular connectors of said tubular implant aligned with a respective one of annular connectors;

inserting an expandable member within said tubular implant in an unexpanded state;

expanding said expandable member to extend into at least one of said annular connectors;

attaching said annular connector of said first blood vessel to a first of said annual connectors of said tubular implant;

attaching said annular connector of said body part to a second of said annual connectors of said tubular implant.

24. A tubular implant for connecting to at least one blood vessel segment, comprising:

a support structure having a plurality of pores for receiving cells said having two annular connectors, each of said connectors being configured to connect to at least one of an annular connector of a blood vessel segment and an annular connector of an organ; and

viable cells deposited in said openings of said cylindrical support.

25. The tubular implant according to claim 24, further comprising an outer layer enclosing said support structure, said outer layer at least partially blocking a radially outward flow of blood.

26. The tubular implant according to claim 24, wherein said support structure is cylindrical.

27. The tubular implant according to claim 24, wherein said viable cells include cells selected from the group consisting of endothelial cells, mesenchymal cells, and smooth muscle cells.

28. The tubular implant according to claim 24, further comprising tissue growth induction materials disposed on said support structure.

29. The tubular implant according to claim 24, further comprising a check valve disposed within said support structure and directing blood flow in only one direction through said tubular implant.

30. The tubular implant according to claim 29, wherein said check valve includes:

a valve support structure connected to said tubular implant and having pores formed therein; and

smooth muscle cells deposited on said valve support structure.

31. A method of replacing at least a portion of an organ, which comprises:

forming a mold of an organ to be replaced;

removing said organ from said mold;

forming a support structure within said mold, said support structure having pores formed therein;

disposing viable cells in said pores of said support structure to form a replacement organ, said viable cells performing a function of said organ to be replaced; and

placing said replacement organ into a patient to replace said organ.

32. A replacement organ for reproducing a function of an organ to be replaced, comprising:

a support structure shaped like an organ to be replaced, said support structure having pores formed therein; and

viable cells disposed in said pores of said support structure to form a replacement organ, said viable cells performing a function of the organ to be replaced.

33. A matrix corresponding to at least a portion of an organ, the portion having a function, the matrix comprising a support structure having pores formed therein for receiving viable cells and being shaped like the at least a portion of the organ.

34. The matrix according to claim 33, wherein said support structure is a collagen matrix.

35. The matrix according to claim 33, wherein said collagen matrix is an autograft taken from the at least a portion of an organ to be replaced.

36. The matrix according to claim 33, wherein said collagen matrix is an allograft taken from an at least a portion of an organ to be replaced of a donor.

37. The matrix according to claim 33, further comprising a growth factor disposed on said support structure.

38. The matrix according to claim 33, further comprising pluripotent cells disposed on said support structure.

39. The matrix according to claim 38, further comprising growth factors disposed on said matrix, said growth factors causing said pluripotent cells to differentiate.

40. The matrix according to claim 38, further comprising a means for attaching said pluripotent cells to said support structure.

41. A replacement for at least a portion of an organ having a function, the replacement comprising:

a support structure having pores formed therein;

viable cells of a first tissue type disposed in said pores; and

viable cells of a second tissue type disposed in said pores.

42. A method for making a support structure of at least a part of an organ to be replaced, which comprises:

removing at least a part of an organ having a support structure and cells connected to said support structure from a donor; and

removing said cells from said support structure.

43. The method according to claim 42, wherein said removing step includes treating said cells in a cytotoxic solution.

44. The method according to claim 42, wherein said removing step includes irradiating said cells.

45. The method according to claim 42, wherein said removing step includes exposing said cells to an environmental condition.

46. The method according to claim 42, wherein said support structure is made of collagen.

47. An artificial support structure, comprising a polymeric matrix with a configuration corresponding to a configuration of an organ to be replaced.

48. The artificial support structure according to claim 47, wherein said polymeric matrix has at least a biodegradable portion.

49. The artificial support according to claim 47, wherein said polymeric matrix is a material selected from the group consisting of cellulose, petroylglutamic acid, carboxymethylcellulose, and polylactide.

50. The artificial support according to claim 47, further comprising an additive selected from the group consisting of a plasticizer, a citrate ester, a hexamethosebacate, an antibiotic, and a growth factor.

51. The artificial structure according to claim 47, wherein said polymeric matrix includes:

a first biodegradable portion, said first biodegradable portion degrading at a slower rate; and

a second biodegradable portion, said second biodegradable portion degrading at a faster rate.

52. A replacement organ performing a function, comprising:

a support structure having pores formed therein;

a first type of cells disposed in said pores of said support structure, said first type of cells being selected from the group consisting of renal cells, stromal cells, fibroblasts, osteoblasts, mesodermal cells. osteocondral cells, myoblasts, endothelial cells, mesenchymal cells, and smooth muscle cells; and

a second type of cells disposed in said pores of said support structure, said second type of cells being selected from the group consisting of renal cells, stromal cells, fibroblasts, osteoblasts, mesodermal cells. osteocondral cells, myoblasts, endothelial cells, mesenchymal cells, and smooth muscle cells;

said second type of cells being different.

53. A cardiac implant for insertion within a heart, comprising:

a support structure having pores formed therein; and

endothelium cells disposed in said pores of said support structure.

54. An implant for at least partially replacing an organ, comprising:

a support structure having pores formed therein;

viable cells disposed in said pores of said support structure;

an outer layer surrounding said support structure and at least inhibiting blood flow from within;

an afferent blood vessel connected to said outer layer and configured to supply blood to said viable cells; and

an efferent blood vessel connected to said outer layer and configured to receive blood from said viable cells.

55. The implant according to claim 54, which further comprises a means for distributing the blood to all of said viable cells.

56. An implant assembly, comprising:

a first implant according to claim 54;

and

a second implant according to claim 54 connected to said first implant.

57. The implant assembly according to claim 56, wherein said implants are connected in series.

58. The implant assembly according to claim 57, further comprising a manifold interconnecting said afferent blood vessel of said first implant and said afferent blood vessel of said second implant, said first implant and said second implant being connected in parallel.

59. A method for minimally-invasive introduction of a scaffold for at least partially replacing an organ, which comprises:

providing a ductile support structure having pores for receiving formed therein;

drawing said support structure into a wire-like shape;

inserting a cannula to a location for receiving said support structure; and

feeding said support structure to the location while in said wire-like shape.

60. The method according to claim 59, which further comprises using a collagen matrix as said ductile support structure.

61. The method according to claim 60, which further comprises removing cells from an organ to produce said collagen matrix.

62. The method according to claim 59, which further comprises locating said ductile support structure during said feeding step by using a means for non-invasive imaging.

63. The method according to claim 59, which further comprises imaging the location for receiving said receiving said support structure during the feeding step.

64. A method for minimally-invasive introduction of a replacement for at least part of an organ, which comprises:

providing a ductile support structure having pores for receiving formed therein;

drawing said support structure into a wire-like shape;

inserting a cannula to a location for receiving said support structure;

feeding said support structure to the location while in said wire-like shape;

reshaping said support structure at the location; and

depositing via cells on said support structure located at the location by feeding said viable cells via said cannula to said support structure.

65. The method according to claim 64, further comprising:

providing a ductile outer layer;

forming said ductile outer layer into a wire-like shape;

feeding said ductile outer layer to the location via said cannula; and

enclosing said ductile support structure within said ductile outer layer at the location before the depositing step.

66. An implant for insertion in a kidney, comprising:

a support structure having pores formed therein;

kidney cells disposed in said pores of said support;

an outer layer enclosing said support structure said outer layer at least partially blocking a radially outward flow of blood;

an afferent blood vessel segment connected to said outer layer and being configured to supply blood to said kidney cells and being configured to connect to a renal artery;

an efferent blood vessel segment connected to said outer layer and being configured to remove blood from said kidney cells and being configured to connect to a renal vein; and

a conduit connected to said outer layer configured to connect to a ureter.

67. The implant according to claim 66, further comprising stromal cells disposed on said support structure.

68. The implant according to claim 66, further comprising fibroblasts disposed on said support structure.

69. The implant according to claim 66, further comprising endothelial cells disposed on said support structure.

70. An implant for inserting in a bone, comprising:

a support structure having pores formed therein;

bone cells disposed in said pores of said support, said bone cells being selected from the group consisting of osteoblasts and mesodermal cells;

an outer layer enclosing said support structure, said outer layer at least partially blocking a radially outward flow of blood;

an afferent blood vessel segment connected to said outer layer and being configured to supply blood to said bone cells and being configured to connect to a renal artery; and

an efferent blood vessel segment connected to said outer layer and being configured to remove blood from said bone cells and being configured to connect to a renal vein.

71. The implant according to claim 70, wherein said outer layer is configured to fill a portion of bone to be replaced.

72. The implant according to claim 70, further comprising osteochondral cells disposed in said pores of said support structure.

73. The implant according to claim 70, further comprising myoblasts for promoting growth of muscle tissue.

74. An implant for inserting in a pancreas, comprising

a support structure having pores formed therein;

viable cells disposed in said pores of said support, said viable cells being selected from the group consisting of endocrine cells, exocrine cells, and islets of Langerhans; and

an outer layer enclosing said support structure, said outer layer at least partially blocking a radially outward flow of blood.

75. An implant for at least partially replacing an organ performing a function, comprising:

a support structure having pores formed therein;

viable cells disposed in said pores of said support, said viable cells performing the function of the organ;

an outer layer enclosing said support structure, said outer lawyer at least partially blocking a radially outward flow of blood; and

a means for distributing blood flow within said outer layer to sustain said viable cells.

76. An implant for at least partially replacing an organ performing a function, comprising:

a support structure having pores formed therein;

a first type of viable cells disposed in said pores of said support;

a second type of viable cells disposed in said pores of said support; and

a third type of viable cells disposed in said pores of said support;

said first type, said second type, and said third type of cells performing the function of the organ.