Implantable drug delivery systems and methods

• US 20040220552A1
• Filed: 12/23/2003
• Published: 11/04/2004
• Est. Priority Date: 12/23/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Heruth, Kenneth T., Lent, Mark S., Blanco, Justin A.
• Granted Patent: US 8,216,177 B2
• Time in Patent Office: Days
• US Class Current: 604/891.1
• CPC Class Codes: A61M 2025/0007 Epidural catheters
• 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 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow
• CPC Class Codes: A61M 2202/0464 Cerebrospinal fluid
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407

Abstract

Devices, systems and methods for delivering one or more drugs to one or more internal body locations (such as the cerebrospinal fluid) are disclosed. In various aspects, the systems and methods may involve catheters having infusion sections with permeable membranes that develop significant back pressure to enhance uniform delivery of the drug over an infusion section; catheters that have two or more infusion sections spaced apart along the length of the same catheter, catheters that include two or more infusion sections serviced by independent lumens (such that, e.g., different drug solutions can be delivered to the different infusion sections); implantable drug delivery systems with pumps and multiple reservoirs from which drugs can be delivered; systems that are capable of delivering drug solutions with selected densities; etc.

Claims

1. An implantable drug delivery system comprising:

an implantable pump assembly;

two or more implantable reservoirs operably connected to the implantable pump assembly;

a catheter connection port adapted to attach a catheter to the drug delivery system; and

a reservoir switching valve assembly between the two or more implantable reservoirs and the catheter connection port, wherein the two or more implantable reservoirs can be selectively connected to the catheter connection port.

2. The system of claim 1, further comprising a telemetry module operably connected to control the reservoir switching valve assembly.

3. The system of claim 1, further comprising an implantable density sensor.

4. The system of claim 3, further comprising a telemetry module operably connected to the density sensor.

5. The system of claim 3, further comprising means for mixing fluids delivered from at least two of the two or more reservoirs, wherein the density sensor is operably connected to the means for mixing, whereby a mixed fluid having a selected density can be obtained based on a density measured by the density sensor.

6. The system of claim 1, wherein two reservoirs of the two or more reservoirs contain different drugs.

7. The system of claim 6, wherein the different drugs are in drug solutions having different densities.

8. The system of claim 1, wherein two reservoirs of the two or more reservoirs contain the same drug in two different drug solutions having different densities.

9. The system of claim 1, further comprising means for mixing fluids delivered from at least two of the two or more reservoirs.

10. The system of claim 9, wherein the means for mixing performs the mixing before the fluids exit the catheter connection port.

11. The system of claim 9, further comprising a telemetry module operably connected to control the means for mixing.

12. The system of claim 1, further comprising means for modifying flow rate to the catheter connection port.

13. The system of claim 1, wherein the implantable pump assembly comprises at least one programmable pump mechanism.

14. The system of claim 1, further comprising a telemetry module operably connected to control the implantable pump assembly,

15. The system of claim 1, wherein the implantable pump assembly comprises two or more pump mechanisms.

16. The system of claim 1, further comprising a catheter that comprises a proximal end connected to the catheter connection port, wherein the catheter comprises a first lumen extending from the proximal end of the catheter to a first infusion section and a second lumen extending from the proximal end of the catheter to a second infusion section.

17. The system of claim 16, further comprising a lumen switching valve assembly between the two or more reservoirs and the catheter, wherein the two or more reservoirs can be selectively connected to one or both of the first lumen and the second lumen.

18. The system of claim 17, further comprising a telemetry module operably connected to control the lumen switching valve assembly.

19. The system of claim 16, further comprising means for modifying the flow rate through one or both of the first lumen and the second lumen.

20. The system of claim 16, wherein the two or more reservoirs comprise a first reservoir connected to the first lumen and a second reservoir connected to the second lumen.

21. The system of claim 20, further comprising a first valve between the first reservoir and the first lumen and a second valve between the second reservoir and the second lumen.

22. The system of claim 20, further comprising a telemetry module operably connected to control one or both of the first valve and the second valve.

23. The system of claim 20, further comprising means for modifying the flow rate through one or both of the first lumen and the second lumen.

24. A method of delivering one or more drugs to at least one internal body location using a drug delivery system implanted in the body of a patient, wherein the drug delivery apparatus comprises an implantable pump assembly, two or more implantable reservoirs operably connected to the implantable pump assembly, a catheter connection port adapted to attach a catheter to the drug delivery system, and a reservoir switching valve assembly between the two or more implantable reservoirs and the catheter connection port, the method comprising:

selectively connecting at least one reservoir of the two or more implantable reservoirs to the catheter connection port; and

delivering a drug from at least one reservoir of the two or more implantable reservoirs to the catheter connection port using the implantable pump assembly.

25. The method of claim 24, further comprising controlling the reservoir switching valve assembly from a location outside of the body of the patient.

26. The method of claim 24, further comprising measuring density of the cerebrospinal fluid of a patient using an implanted density sensor.

27. The method of claim 26, further comprising receiving a signal from the implanted density sensor indicative of the density of the cerebrospinal fluid as measured.

28. The method of claim 24, further comprising mixing fluids delivered from at least two of the two or more reservoirs before delivering the drug.

29. The method of claim 24, wherein two reservoirs of the two or more reservoirs contain different drugs.

30. The method of claim 29, wherein the different drugs are in drug solutions having different densities.

31. The method of claim 24, wherein two reservoirs of the two or more reservoirs contain the same drug in two different drug solutions having different densities.

32. The method of claim 24, wherein the drug delivery system further comprises a catheter comprising a proximal end connected to the catheter connection port, wherein the catheter comprises a first lumen extending from the proximal end of the catheter to a first infusion section and a second lumen extending from the proximal end of the catheter to a second infusion section, and wherein the method further comprises passing the drug delivered from the at least one reservoir of the two or more implantable reservoirs to the catheter connection port to at least one of the first infusion section and the second infusion section.

33. The method of claim 32, wherein the drug delivery system comprises a lumen switching valve assembly between the two or more reservoirs and the catheter, wherein the two or more reservoirs can be selectively connected to one or both of the first lumen and the second lumen.

34. The method of claim 33, further comprising a telemetry module operably connected to control the lumen switching valve assembly.

35. An implantable drug delivery system comprising:

an implantable pump assembly comprising two or more pump mechanisms;

two or more implantable reservoirs operably connected to the implantable pump assembly; and

a catheter connection port adapted to attach a catheter to the drug delivery system.

36. The system of claim 35, further comprising means for modifying flow rate to the catheter connection port.

37. The system of claim 35, wherein at least one of the two or more pump mechanisms comprises a programmable pump mechanism.

38. The system of claim 35, further comprising a telemetry module operably connected to control the implantable pump assembly.

39. The system of claim 35, further comprising a reservoir switching valve assembly between the two or more implantable reservoirs and the catheter connection port, wherein the two or more implantable reservoirs can be selectively connected to the catheter connection port, and a telemetry module operably connected to control the reservoir switching valve assembly.

40. The system of claim 35, further comprising an implantable density sensor located outside of a fluid path between the two or more reservoirs and the catheter connection port, wherein the implantable density sensor is adapted for implantation within a bodily fluid of a patient.

41. The system of claim 40, further comprising a telemetry module operably connected to the density sensor.

42. The system of claim 40, further comprising means for mixing fluids delivered from at least two of the two or more reservoirs, whereby a mixed fluid having a selected density can be obtained.

43. The system of claim 35, further comprising a density sensor located between the two or more reservoirs and the catheter connection port, wherein the density of fluid delivered to the catheter connection port can be determined by the density sensor.

44. The system of claim 43, further comprising means for mixing fluids delivered from at least two of the two or more reservoirs, wherein a mixed fluid can be obtained.

45. The system of claim 44, wherein the density sensor is operably connected to the means for mixing, wherein the means for mixing can be operated to obtain the mixed fluid with a selected density as measured by the density sensor.

46. The system of claim 35, wherein two reservoirs of the two or more reservoirs contain different drugs.

47. The system of claim 46, wherein the different drugs are in drug solutions having different densities.

48. The system of claim 35, wherein two reservoirs of the two or more reservoirs contain the same drug in two different drug solutions having different densities.

49. The system of claim 35, further comprising a catheter that comprises a proximal end connected to the catheter connection port, wherein the catheter comprises a first lumen extending from the proximal end of the catheter to a first infusion section and a second lumen extending from the proximal end of the catheter to a second infusion section.

50. The system of claim 49, further comprising a lumen switching valve assembly between the two or more reservoirs and the catheter, wherein the two or more reservoirs can be selectively connected to one or both of the first lumen and the second lumen.

51. The system of claim 50, further comprising a telemetry module operably connected to control the lumen switching valve assembly.

52. The system of claim 49, further comprising means for modifying the flow rate through one or both of the first lumen and the second lumen.

53. The system of claim 49, wherein the two or more reservoirs comprise a first reservoir connected to the first lumen and a second reservoir connected to the second lumen.

54. The system of claim 53, further comprising a first valve between the first reservoir and the first lumen and a second valve between the second reservoir and the second lumen.

55. The system of claim 54, further comprising a telemetry module operably connected to control one or both of the first valve and the second valve.

56. A method of delivering one or more drugs to at least one internal body location using a drug delivery system implanted in the body of a patient, wherein the drug delivery apparatus comprises an implantable pump assembly comprising two or more pump mechanisms, two or more implantable reservoirs operably connected to the implantable pump assembly, and a catheter connection port adapted to attach a catheter to the drug delivery system, the method comprising:

selectively operating the two or more pump mechanisms of the implantable pump assembly; and

delivering a drug from at least one reservoir of the two or more implantable reservoirs to the catheter connection port using the implantable pump assembly.

57. The method of claim 56, further comprising controlling the implantable pump assembly using a telemetry module operably connected to the pump assembly.

58. The method of claim 56, further comprising measuring density of the cerebrospinal fluid of a patient using an implanted density sensor.

59. The method of claim 58, further comprising receiving a signal from the implanted density sensor indicative of the density of the cerebrospinal fluid as measured.

60. The method of claim 56, further comprising mixing fluids delivered from at least two of the two or more reservoirs before delivering the drug.

61. The method of claim 56, wherein two reservoirs of the two or more reservoirs contain different drugs.

62. The method of claim 61, wherein the different drugs are in drug solutions having different densities.

63. The method of claim 56, wherein two reservoirs of the two or more reservoirs contain the same drug in two different drug solutions having different densities.

64. The method of claim 56, wherein the drug delivery system further comprises a catheter comprising a proximal end connected to the catheter connection port, wherein the catheter comprises a first lumen extending from the proximal end of the catheter to a first infusion section and a second lumen extending from the proximal end of the catheter to a second infusion section, and wherein the method further comprises passing the drug delivered from the at least one reservoir of the two or more implantable reservoirs to the catheter connection port to at least one of the first infusion section and the second infusion section.

65. An implantable drug delivery system comprising:

an implantable controller;

an implantable pump assembly operably connected to the controller;

two or more implantable reservoirs operably connected to the implantable pump assembly;

at least one density sensor operably connected to the controller;

a telemetry module operably connected to the controller; and

a catheter connection port adapted to attach a catheter to the drug delivery system.

66. The system of claim 65, further comprising means for mixing fluids delivered from at least two of the two or more reservoirs, whereby a mixed fluid having a selected density can be obtained.

67. The system of claim 65, wherein the at least one density sensor comprises an internal density sensor located between the two or more reservoirs and the catheter connection port, wherein the density of fluid delivered to the catheter connection port can be determined by the density sensor.

68. The system of claim 67, further comprising means for mixing fluids delivered from at least two of the two or more reservoirs, wherein a mixed fluid can be obtained.

69. The system of claim 68, wherein the internal density sensor is operably connected to the means for mixing, wherein the means for mixing can be operated to obtain the mixed fluid with a selected density as measured by the density sensor.

70. The system of claim 65, wherein the at least one density sensor comprises an implantable density sensor located outside of a fluid path between the two or more reservoirs and the catheter connection port, wherein the implantable density sensor is adapted for implantation within a bodily fluid of a patient.

71. The system of claim 70, wherein the at least one density sensor comprises an internal density sensor located between the two or more reservoirs and the catheter connection port, wherein the density of fluid delivered to the catheter connection port can be determined by the internal density sensor.

72. The system of claim 71, further comprising means for mixing fluids delivered from at least two of the two or more reservoirs, wherein a mixed fluid can be obtained.

73. The system of claim 71, wherein the internal density sensor is operably connected to the means for mixing, wherein the means for mixing can be operated to obtain the mixed fluid with a selected density as measured by the internal density sensor.

74. The system of claim 65, wherein the implantable pump assembly comprises two or more pump mechanisms.

75. The system of claim 65, wherein two reservoirs of the two or more reservoirs contain different drugs.

76. The system of claim 75, wherein the different drugs are in drug solutions having different densities.

77. The system of claim 65, wherein two reservoirs of the two or more reservoirs contain the same drug in two different drug solutions having different densities.