Catheter for cell delivery

• US 20080058763A1
• Filed: 08/29/2007
• Published: 03/06/2008
• Est. Priority Date: 08/29/2006
• Status: Abandoned Application

• Current Assignee: Tissue Genesis, Inc.
• Original Assignee: Tissue Genesis, Inc.
• Inventors: Williams, Stuart, Kosnik, Paul, Boland, Eugene
• Application Number:
  US11/897,389
• Publication Number:
  US 20080058763A1
• Time in Patent Office: Days
• US Class Current: 604/522
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

A cell delivery system and method for delivering cells locally to a tissue, body cavity, or joint is described. The cell delivery system comprises a catheter configured to deliver stem cells in a pressure controlled manner. The catheter may comprise an inner bladder and an outer perforated bladder. The inner bladder may be expanded through the use of a pressure conduit in order to deploy a stent. Cells, such as endothelial cells derived from adipose tissue, may be introduced between the inner and outer bladder. The inner bladder may be further expanded in order to exert pressure on the outer perforated bladder to advance the stems cells though the apertures of the outer bladder. The inner bladder may remain pressurized to hold the outer bladder against the vessel wall, thereby directing the stem cells to specific target sites. The system may be used to deliver stem cells with or without other therapeutic agents. The system may be used with or without a stent. The system may further comprise a pressure gauge that permits measurement and regulation of pressure within the catheter.

Claims

1. A cell delivery system for localized delivery of cells, the cell delivery system comprising a tube with a distal portion configured to deliver cells to a tissue in a pressure controlled manner, wherein the distal portion has a sheath comprising a plurality of apertures.

2. The system of claim 1, wherein the apertures have a diameter of about 2 microns to about 1000 microns.

3. The system of claim 1, wherein the sheath comprises a material selected from the group consisting of polytetrafluoroethylene, expanded polytetrafluoroethylene, polyurethane, polypropylene, polyethylene, polyamides, nylon, elastin, polyethylene terephthalate, polycarbonate, silicone, and combinations thereof.

4. The system of claim 1, wherein the sheath comprises an outer surface, inner surface, and a vertical surface that are surface treated to reduce cell adhesion.

5. The system of claim 1, wherein the sheath is hydrophilic.

6. The system of claim 1, wherein the cells are of mammalian origin.

7. The system of claim 1, wherein the cells are derived from adipose tissue.

8. The system of claim 1, wherein the cells are mesenchymal stem cells.

9. The system of claim 1, wherein the cells are derived from bone marrow.

10. The system of claim 1, wherein the cells are derived from blood.

11. The system of claim 1, wherein the cells are endothelial cells derived from adipose tissue.

12. The system of claim 1, wherein the cells are stem cells.

13. The system of claim 1 further comprising a pressure conduit configured to increase the pressure within the distal portion to advance the stem cells through the apertures of the sheath.

14. The system of claim 13, wherein the pressure conduit is configured to apply a pressure of between about 0.001 PSI to about 25 PSI.

15. The system of claim 1, wherein:

the catheter has a proximal end and a distal end defining a lumen therebetween;

the proximal end of said catheter comprises a fluid reservoir; and

the distal end of said catheter comprises a sheath having a plurality of apertures.

16. The system of claim 15, further comprising a pressure conduit configured to increase the pressure within the fluid reservoir to advance the contents of the fluid reservoir into the lumen of the catheter.

17. The system of claim 16, wherein the sheath is configured to expand upon application of pressure from the pressure conduit.

18. The system of claim 16, wherein the sheath is configured to deflate upon removal of pressure from the pressure conduit.

19. The system of claim 16, wherein the pressure conduit is further configured to sustain the pressure on the sheath such that a pressure gradient is maintained between the lumen of the catheter and the luminal surface of the tubular tissue, whereby the cells from the catheter are delivered to the luminal surface of the tubular tissue through the apertures of the sheath.

20. The system of claim 16, wherein the pressure conduit is a syringe.

21. The system of claim 15, wherein the proximal end of the catheter further comprises a pressure reservoir.

22. The system of claim 21, further comprising a pressure conduit configured to apply pressure to the pressure reservoir, whereby the contents of the pressure reservoir is advanced into the lumen of the catheter.

23. The system of claim 15, wherein the fluid reservoir comprises a pressure gauge.

24. The system of claim 21, wherein the pressure reservoir comprises a pressure gauge.

25. The system of claim 15, wherein the catheter is a dual lumen catheter, comprising a first tube and a second tube.

26. The system of claim 25, wherein the proximal end of the catheter further comprises a pressure reservoir and the distal end of the catheter further comprises an inner bladder and wherein the inner bladder is connected to the pressure reservoir through the first tube of the lumen of the catheter.

27. The system of claim 25, wherein the fluid reservoir is connected to the sheath through the second tube of the lumen.

28. The system of claim 15, wherein the fluid reservoir is removably attached to the catheter.

29. The system of claim 21, wherein the pressure reservoir is removably attached to the catheter.

30. The system of claim 28, wherein the catheter is configured to maintain pressure on the sheath upon removal of the fluid reservoir.

31. The system of claim 29, wherein the catheter is configured to maintain pressure on the inner bladder upon removal of the pressure reservoir

32. The system of claim 2, wherein the sheath is configured to deflate upon the release of pressure.

33. A method of delivering cells locally to a tubular tissue, the method comprising deploying a biocompatible catheter into a tubular tissue, the catheter being sized and shaped to conform to and expand the tubular tissue, and applying pressure to a catheter in a controlled manner.

34. The method of claim 33 wherein the catheter comprises a distal tip having an inner bladder and an outer perforated bladder, the method further comprising:

applying a pressure to the inner bladder causing the inner bladder to expand; and

expanding of the inner bladder, thereby advancing the stem cells through the perforations of the outer bladder.

35. The method of claim 33, wherein the catheter comprises a proximal end and a distal end defining a lumen therebetween, the proximal end comprises a fluid reservoir filled with stem cells and the distal end comprises a outer sheath having a plurality of apertures, and further comprising:

applying pressure to the fluid reservoir, thereby advancing the stem cells into the lumen of the catheter;

expanding the outer perforated bladder to be in communication with the tubular tissue; and

advancing the stem cells through the apertures of the outer bladder to target sites of the tubular tissue.

36. The method of claim 33, further comprising performing an atherectomy.

37. The method of claim 33, further comprising performing an angioplasty.

38. The method of claim 34, further comprising deploying a stent.

45. The method of claim 33, wherein the cells are of mammalian origin.

46. The method of claim 33, wherein the cells of mammalian origin are of human origin.

47. The method of claim 33, wherein the cells have been derived from adipose tissue.

48. The method of claim 33, wherein the cells are of mesenchymal origin.

49. The method of claim 33, wherein the cells have been derived from bone marrow.

50. The method of claim 33, wherein the cells have been derived from blood.

51. The method of claim 33, wherein the cells have been genetically modified to produce a protein product.

52. The method of claim 33, wherein the surface of the catheter is hydrophobic.

53. The method of claim 33, wherein the catheter is configured to prevent cell attachment.

54. The method of claim 33, wherein the pressure conduit is a syringe.

55. The method of claim 33, further comprising sustaining the pressure between about 0.001 PSI and about 25 PSI.

39. A method of delivering stem cells to the lumenal surface of a tubular tissue, comprising:

providing a catheter having a proximal end and a distal end, defining a lumen therebetween, the proximal end of said catheter comprising a fluid reservoir, the distal end of said catheter comprising an expandable balloon having a plurality of apertures;

filling the fluid reservoir with cells and fluid;

applying pressure to proximal end of the catheter;

advancing the cells from the fluid reservoir to the lumen of the catheter;

expanding the balloon proximate the luminal surface of the tubular tissue;

delivering the cells and fluid through the apertures of the balloon to the luminal surface of the tubular tissue;

sustaining the pressure on the balloon, thereby maintaining a pressure gradient between the lumen of the catheter and the luminal surface of the tubular tissue and advancing the cells from the lumen of the catheter onto the luminal surface of the tubular tissue;

releasing the pressure on the lumen of the catheter; and

deflating the balloon.

40. The method of claim 39, further comprising filling the fluid reservoir with a therapeutic agent.

41. The method of claim 39, further comprising providing a pressure conduit that increases the pressure within the fluid reservoir, thereby advancing the contents of the fluid reservoir into the lumen of the catheter.

42. The method of claim 39 further comprising automatically regulating the pressure within the fluid reservoir.

43. The method of claim 39 further comprising detaching the fluid reservoir from the catheter.

44. The method of claim 43, further comprising maintaining the pressure on the balloon while detaching the fluid reservoir from the catheter.

56. The method of claim 39, wherein the balloon comprises a material selected from the group consisting of expanded polytetrafluoroethylene, polyurethane, polypropylene, polyethylene, polyamides, nylon, elastin, polyethylene terephthalate, polycarbonate, silicone, and combinations thereof.

57. The method of claim 39, wherein the apertures of the balloon are between about 2 microns and 1000 microns in diameter.

58. The method of claim 39, wherein the balloon is surfaced treated to reduce cell attachment.

59. The method of claim 39, wherein the balloon is hydrophilic.

60. The method of claim 39, in which said method is used as a primary treatment for stenosis.

61. The method of claim 39, in which said method is used to treat injury resulting from prior intervention.

62. The method of claim 61, wherein said prior intervention is balloon angioplasty.

63. The method of claim 61, wherein said prior intervention is atherectomy.

64. The method of claim 61, wherein said prior intervention is stenting.

65. A catheter configured to deliver cells to the lumenal surface of a tubular tissue comprising:

dual coaxially mounted tubes;

a double layered balloon in communication with the tubes, said balloon having an inner chamber concentrically positioned within an outer chamber in a spaced apart relationship defining an annular lumen therebetween;

wherein the outer chamber of the balloon comprises a plurality of apertures;

wherein cells are disposed within the annular lumen of the balloon; and

wherein the balloon is configured to deliver cells to the lumenal surface of a tubular tissue through the apertures of the outer chamber.

66. The catheter of claim 65, wherein the inner chamber comprises a material selected from the group consisting of polyurethane, silicone, polyethylene, polycarbonate, and combinations thereof.

67. The catheter of claim 65, wherein a first lumen of the dual lumen tube is contiguous with the outer chamber.

68. The catheter of claim 65, wherein a second lumen of the dual lumen tube is contiguous with the inner chamber.