METHOD AND APPARATUS FOR APPLICATION OF A FRESH COATING ON A MEDICAL DEVICE

• US 20090047414A1
• Filed: 07/30/2008
• Published: 02/19/2009
• Est. Priority Date: 09/28/2004
• Status: Active Grant

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: HENRICH, Georgette, MARTAKOS, Paul, KARWOSKI, Theodore, SUNTER, Brian, CORBEIL, Scott E., HERWECK, Steve A., CONROY, Suzanne, BROMANDER, Edward, LABRECQUE, Roger
• Granted Patent: US 8,312,836 B2
• Time in Patent Office: Days
• US Class Current: 427/2.250
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08

Abstract

A method, a kit, and an apparatus provide a coating on an implantable medical device. The apparatus includes housing, a sealed reservoir chamber disposed in the housing, a reducing template, and a reservoir access port. The sealed reservoir contains the coating material. The reducing template is sized to receive a medical device therethrough for application of the coating material. A seal breaching mechanism can be provided and adapted to breach the sealed reservoir upon activation of the apparatus. The reservoir access port, which is disposed in the housing, is adapted to fluidly couple the reducing template with the reservoir chamber upon activation of the apparatus for coating the medical device.

Claims

1. An apparatus for coating a medical device comprising:

a housing;

a sealed reservoir chamber disposed in the housing, the reservoir chamber containing a coating material in a sealed manner;

a reducing template disposed in the housing, the reducing template having a first end and a second end, and sized to receive the medical device therethrough for application of the coating material; and

a reservoir access port disposed in the housing and adapted to fluidly couple the reducing template with the reservoir chamber upon activation of the apparatus for coating the medical device.

2. The apparatus of claim 1, wherein the reservoir chamber forms a preserving reservoir.

3. The apparatus of claim 1, wherein the reservoir chamber contains a preserving reservoir.

4. The apparatus of claim 3, wherein the preserving reservoir comprises a sealed pod containing the coating material.

5. The apparatus of claim 3, wherein the preserving reservoir is formed of a reservoir wall comprised of a soft non-liquid layer of gelatin or cellulose.

6. The apparatus of claim 1, wherein the coating material comprises a bio-absorbable liquid.

7. The apparatus of claim 1, wherein the coating material comprises a bio-absorbable liquid and at least one therapeutic agent.

8. The apparatus of claim 1, wherein the first end of the reducing template is flared and has a cross-sectional area greater than a cross-sectional area of at least a remaining portion of the reducing template.

9. The apparatus of claim 1, wherein the first end of the reducing template is necked down and has a cross-sectional area less than a cross-sectional area of at least a remaining portion of the reducing template.

10. The apparatus of claim 1, wherein the first end of the reducing template has a land that is dimensioned to deposit a consistent coating weight or thickness on a device.

11. The apparatus of claim 1, wherein the reducing template is sized and dimensioned to fit over the medical device providing a clearance between an inner wall of the reducing template and the medical device for receiving the coating liquid for application of the coating liquid to the medical device.

12. The apparatus of claim 1, wherein the reducing template is expandable to fit over the medical device providing a clearance between an inner wall of the reducing template and the medical device for receiving the coating liquid for application of the coating liquid to the medical device.

13. The apparatus of claim 1, wherein the reducing template is expandable to fit over the medical device contacting the medical device while still leaving a nominal clearance between an inner wall of the reducing template and the medical device for receiving the coating liquid for application of the coating liquid to the medical device.

14. The apparatus of claim 1, wherein the reservoir access port has a first end and a second end, the second end of the reservoir access port having at least one sharp point adapted to puncture a preserving reservoir containing the coating material.

15. The apparatus of claim 1, further comprising a plunger disposed in the housing adjacent to the reservoir chamber and adapted to apply a compression force to the coating material to move the coating material in the direction of the reservoir access port when depressed.

16. The apparatus of claim 1, wherein the reservoir chamber is disposed within a dispenser disposed in the housing.

17. The apparatus of claim 1, further comprising a first seal and a second seal, wherein the first seal seals a first end of the reducing template and the second seal seals a second end of the reducing template and wherein the first seal and second seal are adapted to maintain the sterile integrity of an interior of the reducing template

18. The apparatus of claim 1, wherein the volume of the reservoir chamber is sized to contain a volume of coating material at least sufficient to coat one medical device.

19. The apparatus of claim 1, wherein the housing further comprises a grip for holding the housing during use.

20. The apparatus of claim 1, wherein the coating material comprises an oil containing at least one form of lipid, at least one form of essential fatty acid, or both.

21. The apparatus of claim 1, wherein the coating material comprises a partially cured oil.

22. The apparatus of claim 1, wherein the medical device comprises a stent, a catheter, or a balloon.

23. The apparatus of claim 1, further comprising a seal breaching mechanism disposed in the housing and adapted to breach the sealed reservoir chamber upon activation of the apparatus.

24. A kit for coating a medical device comprising:

a coating material;

a dispenser comprising;

a housing;

a sealed reservoir chamber containing the coating material;

a reducing template disposed in the housing, the reducing template having a first end and a second end, and sized to receive the medical device therethrough for application of the coating material; and

a reservoir access port disposed in the housing and adapted to fluidly couple the reducing template with the reservoir chamber upon activation of the apparatus;

the medical device; and

instructions for use.

25. The kit of claim 24, wherein the reservoir chamber forms a preserving reservoir.

26. The kit of claim 24, wherein the reservoir chamber contains a preserving reservoir.

27. The kit of claim 26 wherein the preserving reservoir comprises a sealed pod containing the coating material.

28. The kit of claim 26, wherein the preserving reservoir is formed of a reservoir wall comprised of a soft non-liquid layer of gelatin or cellulose.

29. The kit of claim 24, wherein the coating material comprises a bio-absorbable liquid.

30. The kit of claim 24, wherein the coating material comprises a bio-absorbable liquid and at least one therapeutic agent.

31. The kit of claim 24, wherein the first end of the reducing template is flared and has a cross-sectional area greater than a cross-sectional area of at least a remaining portion of the reducing template.

32. The kit of claim 24, wherein the first end of the reducing template is necked down and has a cross-sectional area less than a cross-sectional area of at least a remaining portion of the reducing template.

33. The kit of claim 24, wherein the first end of the reducing template has a land that is dimensioned to deposit a consistent coating weight on a device.

34. The kit of claim 24, wherein the reducing template is sized and dimensioned to fit over the medical device providing a clearance between an inner wall of the reducing template and the medical device for receiving the coating liquid for application of the coating liquid to the medical device.

35. The kit of claim 24, wherein the reducing template is expandable to fit over the medical device providing a clearance between an inner wall of the reducing template and the medical device for receiving the coating liquid for application of the coating liquid to the medical device.

36. The kit of claim 24, wherein the reducing template is expandable to fit over the medical device contacting the medical device while still leaving a nominal clearance between an inner wall of the reducing template and the medical device for receiving the coating liquid for application of the coating liquid to the medical device.

37. The kit of claim 24, wherein the reservoir access port has a first end and a second end, the second end of the reservoir access port having at least one sharp point adapted to puncture a preserving reservoir containing the coating material.

38. The kit of claim 24, further comprising a plunger disposed in the housing adjacent to the reservoir chamber and adapted to apply a compression force to the coating material to move the coating material in the reservoir chamber in the direction of the reservoir access port when depressed.

39. The kit of claim 24, wherein the reservoir chamber containing coating material is disposed within a dispenser disposed in the housing.

40. The kit of claim 24, further comprising a first seal and a second seal, wherein the first seal seals a first end of the reducing template and the second seal seals a second end of the reducing template and wherein the first seal and the and second seal are adapted to maintain the sterile integrity of an interior of the reducing template

41. The kit of claim 24, wherein the volume of the reservoir chamber is sized to contain a volume of coating material at least sufficient to coat one medical device.

42. The kit of claim 24, wherein the coating material comprises an oil containing at least one form, of lipid, at least one form of essential fatty acid, or both.

43. The kit of claim 24, wherein the coating material comprises a partially cured oil.

44. The kit of claim 24, wherein the medical device comprises a stent, a catheter, or a balloon.

45. The kit of claim 24, further comprising a seal breaching mechanism disposed in the housing and adapted to breach the sealed reservoir chamber upon activation of the apparatus.

46. A method for using an apparatus to coat a medical device with a coating material, the method comprising the steps of:

providing the apparatus having;

a housing;

a sealed reservoir chamber disposed in the housing containing the coating material;

a reducing template disposed in the housing, the reducing template having a first end and a second end, and sized to receive the medical device therethrough for application of the coating material; and

a reservoir access port disposed in the housing and adapted to fluidly couple the reducing template with the reservoir chamber upon activation of the apparatus for coating the medical device; and

conveying the coating material from the reservoir chamber to the medical device through the reservoir access port to coat the medical device.

47. The method of claim 46, wherein the reservoir chamber forms a preserving reservoir.

48. The method of claim 46, further comprising the step of:

inserting a dispenser containing the reservoir chamber into the housing.

49. The method of claim 46, wherein the reservoir chamber contains a preserving reservoir.

50. The method of claim 46, wherein the preserving reservoir comprises a sealed pod containing the coating material.

51. The method of claim 50, wherein the preserving reservoir is formed of a reservoir wall comprised of a soft non-liquid layer of gelatin or cellulose.

52. The method of claim 50, further comprising the step of:

inserting the preserving reservoir into the reservoir chamber prior to activating the coating apparatus.

53. The method of claim 46, further comprising the step of:

withdrawing the medical device from the reducing template uniformly coating the medical device.

54. The method of claim 53, wherein the medical device is rotated relative to the reducing template along an axis of the reducing template as the medical device is withdrawn from the reducing template.

55. The method of claim 46, further comprising the step of:

activating the coating apparatus by releasing the coating materials from the reservoir chamber.

56. The method of claim 55, wherein the step of activating the coating apparatus by releasing the coating material from the reservoir chamber comprises the step of depressing a plunger, turning a screw, turning a crank, pulling a lever, pushing a button, pulling a cord, engaging a snap fit, pressurizing with a gas, pressurizing with a fluid, depressing a reservoir, activating a spring, or the like.

57. The method of claim 55, wherein the step of activating the coating apparatus by releasing the coating material from the reservoir chamber comprises the step of piercing a preserving reservoir containing the coating material with a portion of the reservoir access port.

58. The method of claim 55, wherein the medical device is inserted into the reducing template before the coating apparatus is activated.

59. The method of claim 55, wherein the medical device is inserted into the reducing template after the coating apparatus is activated.

60. The method of claim 46, wherein the coating material comprises a bio-absorbable liquid.

61. The method of claim 46, wherein the coating material comprises a bio-absorbable liquid and at least one therapeutic agent.

62. The method of claim 46, wherein the first end of the reducing template is flared and has a cross-sectional area greater than a cross-sectional area of at least a remaining portion of the reducing template.

63. The method of claim 46, wherein the first end of the reducing template is necked down and has a cross-sectional area less than a cross-sectional area of at least a remaining portion of the reducing template.

64. The method of claim 46, wherein the first end of the reducing template has a land that is dimensioned to deposit a consistent coating weight on a device.

65. The method of claim 46, wherein the reducing template is sized and dimensioned to fit over the medical device providing a clearance between an inner wall of the reducing template and the medical device for receiving the coating liquid for application of the coating liquid to the medical device.

66. The method of claim 46, wherein the reducing template is expandable to fit over the medical device providing a clearance between an inner wall of the reducing template and the medical device for receiving the coating liquid for application of the coating liquid to the medical device.

67. The method of claim 46, wherein the reducing template is expandable to fit over the medical device contacting the medical device while still leaving a nominal clearance between an inner wall of the reducing template and the medical device for receiving the coating liquid for application of the coating liquid to the medical device.

68. The method of claim 46, further comprising the step of removing sterile packaging containing the apparatus.

69. The method of claim 46, wherein the step of conveying the coating material from the reservoir chamber to the reducing template through the reservoir access port comprises the step of applying a force to at least one wall of the reservoir chamber causing the coating material to flow toward the reducing template.

70. The method of claim 46, wherein the apparatus further comprises a first seal and a second seal, wherein the first seal seals a first end of the reducing template and the second seal seals a second end of the reducing template and wherein the first seal and the second seal are adapted to maintain the sterile integrity of an interior of the reducing template

71. The method of claim 70, further comprising the step of removing the first seal and the second seal from the reducing template.

72. The method of claim 46, wherein the reservoir access port has a first end and a second end, the second end of the reservoir access port having at least one sharp point adapted to puncture a preserving reservoir.

73. The method of claim 46, wherein the apparatus further comprises a plunger disposed in the housing adjacent to the reservoir chamber and adapted to apply a compression force to the coating material to move the coating material in the reservoir chamber in the direction of the reservoir access port when depressed.

74. The method of claim 46, wherein the apparatus further comprises a plunger disposed in the housing adjacent to the reservoir chamber and adapted to apply a compression force to the coating material to move the coating material in the reservoir chamber in the direction away from the reservoir access port when depressed.

75. The method of claim 46, wherein the volume of the reservoir chamber is sized to contain a volume of coating material at least sufficient to coat one medical device.

76. The method of claim 46, wherein the coating material comprises an oil containing at least one form of lipid, at least one form of essential fatty acid, or both.

77. The method of claim 46, wherein the coating material comprises a partially cured oil.

78. The method of claim 46, wherein the medical device comprises a stent, a catheter, or a balloon.

79. The method of claim 46, further comprising a seal breaching mechanism disposed in the housing and adapted to breach the sealed reservoir chamber upon activation of the apparatus.