Implantable drug delivery systems and methods

• US 8,216,177 B2
• Filed: 12/23/2003
• Issued: 07/10/2012
• 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
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Snyder, Melissa A
• Application Number:
  US10/746,269
• Publication Number:
  US 20040220552A1
• Time in Patent Office: 3,122 Days
• Field of Search: 604/536, 604/891.1, 604/523, 604/508, 604/506, 604/82, 604 66- 67, 604/175, 60428801-28804, 73/32.R
• US Class Current: 604/67
• 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 general flow characteristics A61M2206/10
• 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. A 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;

a reservoir switching valve assembly between the two or more implantable reservoirs and the catheter connection port via the reservoir valve switching assembly, wherein the two or more implantable reservoirs can be selectively connected to the catheter connection port, and wherein two reservoirs of the two or more reservoirs contain fluids having different densities;

an implantable density sensor configured to sense density of cerebrospinal fluid of a patient in which the sensor is implanted; and

a controller operably coupled to the reservoir switching valve assembly and to the implantable density sensor,

wherein the controller is configured to cause the reservoir switching valve assembly to alternate between (i) selectively coupling one or more of the two or more reservoirs to the catheter connection port to cause a fluid that is hypobaric relative to the density of the cerebrospinal fluid to be delivered to the catheter connection port, and (ii) selectively coupling a different one or more of the two or more reservoirs to the catheter connection port to cause a fluid that is hyperbaric relative to the density of the cerebrospinal fluid to be delivered 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 a telemetry module operably connected to the density sensor.

4. The system of claim 1, 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 based on a density measured by the density sensor.

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

6. The system of claim 5, wherein the different drugs are in drug solutions having different densities.

7. 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.

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

9. The system of claim 8, wherein the means for mixing performs the mixing before the fluids exit the catheter connection port.

10. The system of claim 8, further comprising a telemetry module operably connected to control the means for mixing.

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

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

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

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

15. 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.

16. The system of claim 15, 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.

17. The system of claim 16, further comprising a telemetry module operably connected to control the lumen switching valve assembly.

18. The system of claim 15, further comprising means for modifying the flow rate through one or both of the first lumen and the second lumen.

19. The system of claim 15, wherein the two or more reservoirs comprise a first reservoir connected to the first lumen and a second reservoir connected to the second lumen.

20. The system of claim 19, 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.

21. The system of claim 19, further comprising a telemetry module operably connected to control one or both of the first valve and the second valve.

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

33. The system of claim 1, wherein at least one of the two reservoirs of the two or more reservoirs contains a drug.

34. The system of claim 1, wherein both of the two reservoirs of the two or more reservoirs contain drugs.

35. The system of claim 34, wherein both of the two reservoirs of the two or more reservoirs contain the same drug.

23. 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, wherein two reservoirs of the two or more reservoirs contain fluids having different densities, the method comprising:

measuring density of the cerebrospinal fluid of a patient using an implanted density sensor; and

alternating between (i) selectively connecting one or more of the two or more implantable reservoirs to the catheter connection port to obtain a fluid that is hypobaric relative to the measured density of the cerebrospinal fluid; and

delivering the hypobaric fluid from the one or more reservoir of the two or more implantable reservoirs to the catheter connection port using the implantable pump assembly;

(ii) selectively connecting another one or more of the two or more implantable reservoirs to the catheter connection port to obtain a fluid that is hyperbaric relative to the measured density of the cerebrospinal fluid; and

delivering the hyperbaric fluid from the one or more reservoir of the two or more implantable reservoirs to the catheter connection port using the implantable pump assembly.

24. The method of claim 23, further comprising controlling the reservoir switching valve assembly from a location outside of the body of the patient.

25. The method of claim 23, further comprising receiving a signal from the implanted density sensor indicative of the density of the cerebrospinal fluid as measured.

26. The method of claim 23, further comprising mixing fluids delivered from at least two of the two or more reservoirs before delivering the drug.

27. The method of claim 23, wherein two reservoirs of the two or more reservoirs contain different drugs.

28. The method of claim 27, wherein the different drugs are in drug solutions having different densities.

29. The method of claim 23, wherein two reservoirs of the two or more reservoirs contain the same drug in two different drug solutions having different densities.

30. The method of claim 23, 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.

31. The method of claim 30, 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.

32. The method of claim 31, further comprising a telemetry module operably connected to control the lumen switching valve assembly.

36. The method of claim 23, wherein at least one of the two reservoirs of the two or more reservoirs contains a drug.

37. The method of claim 23, wherein both of the two reservoirs of the two or more reservoirs contain drugs.

38. The method of claim 37, wherein both of the two reservoirs of the two or more reservoirs contain the same drug.

39. An implantable drug delivery system comprising:

an implantable pump assembly;

an implantable density sensor configured to measure density of cerebrospinal fluid of a patient in which the sensor is implanted;

two or more implantable reservoirs operably connected to the implantable pump assembly, wherein the two or more reservoirs are configured to contain fluids of differing densities such that (i) selection of fluids from a first of one or more of the two or more reservoirs results in a fluid that is hypobaric relative to the density of the cerebrospinal fluid, and (ii) selection of fluids from a second of one or more of the two or more reservoirs results in a fluid that is hyperbaric relative to the density of the cerebrospinal fluid;

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

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 such that delivery of the hypobaric fluid resulting from selection of the first of the one or more reservoirs is configured to alternate with delivery of the hyperbaric fluid resulting from selection of the second of the one or more reservoirs.

40. The system of claim 39, further comprising a telemetry module operably connected to control the reservoir switching valve assembly.

41. The system of claim 39, further comprising a telemetry module operably connected to the density sensor.

42. The system of claim 39, 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.

43. The system of claim 39, wherein two reservoirs of the two or more reservoirs contain different drugs.

44. The system of claim 43, wherein the different drugs are in drug solutions having different densities.

45. The system of claim 39, wherein two reservoirs of the two or more reservoirs contain the same drug in two different drug solutions having different densities.

46. The system of claim 39, further comprising means for mixing fluids delivered from at least two of the two or more reservoirs.

47. The system of claim 46, wherein the means for mixing performs the mixing before the fluids exit the catheter connection port.

48. The system of claim 46, further comprising a telemetry module operably connected to control the means for mixing.

49. The system of claim 39, further comprising means for modifying flow rate to the catheter connection port.

50. The system of claim 39, wherein the implantable pump assembly comprises at least one programmable pump mechanism.

51. The system of claim 39, further comprising a telemetry module operably connected to control the implantable pump assembly.

52. 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:

alternating between;

(i) selectively connecting one or more of the two or more implantable reservoirs to the catheter connection port to obtain a fluid that is configured to be hypobaric relative to the density of cerebrospinal fluid, and delivering the hypobaric fluid from the one or more reservoir of the two or more implantable reservoirs to the catheter connection port using the implantable pump assembly; and

(ii) selectively connecting another one or more of the two or more implantable reservoirs to the catheter connection port to obtain a fluid that is configured to be hyperbaric relative to the density of the cerebrospinal fluid; and

delivering the hyperbaric fluid from the one or more reservoir of the two or more implantable reservoirs to the catheter connection port using the implantable pump assembly.

53. The method of claim 52, further comprising controlling the reservoir switching valve assembly from a location outside of the body of the patient.

54. The method of claim 52, further comprising receiving a signal from the implanted density sensor indicative of the density of the cerebrospinal fluid as measured.

55. The method of claim 52, further comprising mixing fluids delivered from at least two of the two or more reservoirs before delivering the drug.

56. The method of claim 52, wherein two reservoirs of the two or more reservoirs contain different drugs.

57. The method of claim 56, wherein the different drugs are in drug solutions having different densities.

58. The method of claim 52, wherein two reservoirs of the two or more reservoirs contain the same drug in two different drug solutions having different densities.