Drug solution density adjustment systems and methods

• US 20040220518A1
• Filed: 12/23/2003
• Published: 11/04/2004
• Est. Priority Date: 12/23/2002
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Heruth, Kenneth T., Lent, Mark S., Blanco, Justin A.
• Application Number:
  US10/745,963
• Publication Number:
  US 20040220518A1
• Time in Patent Office: Days
• US Class Current: 604/82
• 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:

a drug delivery apparatus comprising a pump assembly and two or more reservoirs operably connected to the pump assembly;

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

means for mixing fluids from at least two reservoirs of the two or more reservoirs at or before delivering the fluids to the catheter connection port.

2. The system of claim 1, further comprising an implantable density sensor operably connected to the drug delivery apparatus.

3. The system of claim 2, further comprising a telemetry module operably connected to the density sensor.

4. The system of claim 2, wherein the density sensor is operably connected to the drug delivery apparatus, 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 fluids.

6. The system of claim 5, wherein the different fluids comprise different densities.

7. The system of claim 1, wherein a first reservoir of the two or more reservoirs contains a first fluid comprising a low density, a second reservoir of the of the two or more reservoirs contains a second fluid comprising an intermediate density, and a third reservoir contains a third fluid comprising a high density.

8. The system of claim 7, wherein the second fluid comprises a drug.

9. The system of claim 8, wherein the first fluid and the third fluid are substantially free of the drug.

10. The system of claim 7, wherein at least two fluids of the first fluid, the second fluid, and the third fluid comprise the same drug.

11. 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.

12. The system of claim 1, further comprising a thermal control device for controlling the temperature of the drug.

13. The system of claim 1, wherein the pump assembly comprises an implantable pump assembly, and wherein the two or more reservoirs comprise implantable reservoirs operably connected to the implantable pump assembly, and further wherein the means for mixing comprises implantable means for mixing.

14. A drug delivery system comprising:

a drug delivery apparatus comprising a pump assembly and one or more reservoirs operably connected to the pump assembly;

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

a thermal control device for controlling the temperature of the drug.

15. The system of claim 14, wherein the thermal control device controls the temperature of the drug before the drug is delivered to the catheter connection port.

16. The system of claim 14, wherein the thermal control device controls the temperature of the drug after the drug passes through the catheter connection port.

17. The system of claim 16, wherein the thermal control device is located within a catheter connected to the catheter connection port.

18. The system of claim 14, further comprising an implantable density sensor operably connected to the drug delivery apparatus.

19. The system of claim 18, further comprising a telemetry module operably connected to the density sensor.

20. The system of claim 18, wherein the density sensor is operably connected to the drug delivery apparatus, whereby a fluid having a selected temperature can be obtained based on a density measured by the density sensor.

21. The system of claim 14, wherein the pump assembly comprises an implantable pump assembly, and wherein the one or more reservoirs comprise implantable reservoirs operably connected to the implantable pump assembly, and further wherein the thermal control device comprises an implantable thermal control device.

22. A method of adjusting the density of a drug solution to be delivered to an internal body location of a patient, the method comprising:

determining a selected density for the drug solution;

formulating the drug solution from two or more components to obtain the selected density for the drug solution; and

infusing the drug solution to an internal body location at a continuous rate of no more than 50 ml per hour for a period of five minutes or more.

23. The method of claim 22, wherein the infusing is performed for a period of at least 8 hours within a twenty four hour period.

24. The method of claim 22, where the infusion is performed for a duty cycle of at least 25% within a time period of 8 hours or more.

25. The method of claim 24, wherein the duty cycle is at least 50% or more.

26. The method of claim 25, wherein the time period is 12 hours or more.

27. The method of claim 22, wherein determining the selected density comprises determining the density of the cerebrospinal fluid of a patient.

28. The method of claim 27, wherein determining the density of the cerebrospinal fluid comprises locating a density sensor within the cerebrospinal fluid of a patient in vivo.

29. The method of claim 27, wherein determining the density of the cerebrospinal fluid comprises measuring the density of the cerebrospinal fluid after removing the cerebrospinal fluid from the patient.

30. The method of claim 22, wherein formulating the drug solution comprises formulating the drug solution outside of the body of the patient.

31. The method of claim 22, wherein formulating the drug solution comprises formulating the drug solution within the body of the patient.

32. The method of claim 31, wherein the two or more components are obtained from two or more reservoirs implanted within the patient.

33. The method of claim 22, further comprising delivering the drug solution to the patient.

34. The method of claim 33, further comprising obtaining feedback regarding efficacy of the drug solution after delivering the drug solution to the patient.

35. The method of claim 34, further comprising adjusting the density of the drug solution based on the feedback.

36. A method of adjusting the density of a drug solution to be delivered to an internal body location of a patient, the method comprising:

determining a selected density for the drug solution; and

controlling the temperature of the drug solution to increase or decrease the density of the drug solution to reach the selected density.

37. The method of claim 36, further comprising infusing the drug solution to an internal body location at a continuous rate of no more than 50 ml per hour for a period of five minutes or more.

38. The method of claim 37, wherein the infusing is performed for a period of at least 8 hours within a twenty four hour period.

39. The method of claim 37, where the infusion is performed for a duty cycle of at least 25% within a time period of 8 hours or more.

40. The method of claim 39, wherein the duty cycle is at least 50% or more.

41. The method of claim 40, wherein the time period is 12 hours or more.

42. The method of claim 36, wherein determining the selected density comprises determining the density of the cerebrospinal fluid of a patient.

43. The method of claim 42, wherein determining the density of the cerebrospinal fluid comprises locating a density sensor within the cerebrospinal fluid of a patient in vivo.

44. The method of claim 42, wherein determining the density of the cerebrospinal fluid comprises measuring the density of the cerebrospinal fluid after removing the cerebrospinal fluid from the patient.

45. The method of claim 36, wherein controlling the temperature of the drug solution comprises heating the drug solution within a catheter used to deliver the drug solution.

46. The method of claim 36, wherein controlling the temperature of the drug solution comprises heating the drug solution before delivering the drug solution to a catheter used to deliver the drug solution to the patient.

47. The method of claim 36, wherein the drug solution is obtained from one or more reservoirs implanted within the patient.

48. The method of claim 36, further comprising delivering the drug solution to the patient.

49. The method of claim 48, further comprising obtaining feedback regarding efficacy of the drug solution after delivering the drug solution to the patient.

50. The method of claim 49, further comprising adjusting the density of the drug solution based on the feedback.