Permeable membrane catheters, systems, and methods

• US 20040220548A1
• 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: Blanco, Justin A., Heruth, Kenneth T., Lent, Mark S.
• Application Number:
  US10/745,965
• Publication Number:
  US 20040220548A1
• Time in Patent Office: Days
• US Class Current: 604/523
• 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 catheter comprising:

an elongated body comprising a proximal end and distal end;

a lumen extending from the proximal end of the body to an infusion section spaced from the proximal end of the body;

two or more openings in the lumen within the infusion section; and

a permeable membrane covering the two or more openings in the infusion section;

and wherein the two or more openings and the permeable membrane covering them create a back pressure in the lumen such that the drug exits the infusion section through all of the two or more openings in the infusion section when a drug is delivered to the infusion section through the lumen at a continuous rate of 1 milliliter per hour or less.

2. The catheter of claim 1, wherein the permeable membrane creates a back pressure of 300 pascals or more in the lumen when the drug is delivered to the infusion section through the lumen at a continuous rate of 2 microliters per hour.

3. The catheter of claim 1, wherein the permeable membrane comprises a molecular weight cut-off of 80 kiloDaltons or less.

4. The catheter of claim 1, wherein the infusion section comprises an axial length of 20 mm or more.

5. The catheter of claim 1, wherein the infusion section comprises an axial length of 40 mm or more.

6. The catheter of claim 1, wherein the infusion section comprises an axial length of 320 mm or less.

61. A method of locating a catheter in the spinal region, the method comprising:

providing a catheter according to claim 1, wherein the catheter further comprises a guidewire lumen;

advancing the catheter to a selected location within the spinal region using a guidewire located within the guidewire lumen.

62. The method of claim 61, wherein the selected location comprises the dorsal side of the spinal cord.

63. The method of claim 61, wherein the selected location comprises the ventral side of the spinal cord.

64. The method of claim 61, wherein the guidewire comprises a bent tip guidewire.

7. A drug delivery catheter comprising:

an elongated body comprising a proximal end and distal end;

a lumen extending from the proximal end of the body to an infusion section spaced from the proximal end of the body;

one or more openings in the lumen within the infusion section; and

a permeable membrane covering the one or more openings in the infusion section, wherein the one or more openings and the permeable membrane covering them create a back pressure of 300 pascals or more in the lumen when the drug is delivered to the infusion section through the lumen at a continuous rate of 2 microliters per hour.

8. The catheter of claim 7, wherein the permeable membrane comprises a molecular weight cut-off of 80 kiloDaltons or less.

9. The catheter of claim 7, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 20 mm or more.

10. The catheter of claim 7, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 40 mm or more.

11. The catheter of claim 7, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 320 mm or less.

12. A drug delivery catheter comprising:

an elongated body comprising a proximal end and distal end;

a lumen extending from the proximal end of the body to an infusion section spaced from the proximal end of the body;

one or more openings in the lumen within the infusion section; and

a permeable membrane covering the one or more openings in the infusion section, wherein the permeable membrane comprises a molecular weight cut-off of 80 kiloDaltons or less.

13. The catheter of claim 12, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 20 mm or more.

14. The catheter of claim 12, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 40 mm or more.

15. The catheter of claim 12, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 320 mm or less.

16. A drug delivery system comprising:

a drug delivery apparatus comprising a pump and a drug reservoir; and

a catheter comprising;

an elongated body comprising a distal end and a proximal end adapted for connection to the drug delivery apparatus;

a lumen extending from the proximal end of the body to an infusion section spaced from the proximal end of the body;

two or more openings in the lumen within the infusion section; and

a permeable membrane covering the two or more openings in the infusion section;

wherein the two or more openings and the permeable membrane covering them create a back pressure in the lumen such that the drug exits the permeable membrane through all of the two or more openings in the lumen wall when a drug is delivered to the infusion section through the lumen at a continuous rate of 1 milliliter per hour or less.

17. The system of claim 16, wherein the permeable membrane creates a back pressure of 300 pascals or more in the lumen when the drug is delivered to the infusion section through the lumen at a continuous rate of 2 microliters per hour.

18. The system of claim 16, wherein the permeable membrane comprises a molecular weight cut-off of 80 kiloDaltons or less.

19. The system of claim 16, wherein the infusion section comprises an axial length of 20 mm or more.

20. The system of claim 16, wherein the infusion section comprises an axial length of 40 mm or more.

21. The system of claim 16, wherein the infusion section comprises an axial length of 320 mm or less.

22. The system of claim 16, wherein the drug delivery apparatus comprises an implantable drug delivery apparatus.

23. A drug delivery system comprising:

a drug delivery apparatus comprising a pump and a drug reservoir; and

a catheter comprising;

an elongated body comprising a distal end and a proximal end adapted for connection to the drug delivery apparatus;

a lumen extending from the proximal end of the body to an infusion section spaced from the proximal end of the body;

one or more openings in the lumen within the infusion section; and

a permeable membrane covering the one or more openings in the infusion section;

wherein the one or more openings and the permeable membrane covering them create a back pressure of 300 pascals or more in the lumen when the drug is delivered to the infusion section through the lumen at a continuous rate of 2 microliters per hour.

24. The system of claim 23, wherein the permeable membrane comprises a molecular weight cut-off of 80 kiloDaltons or less.

25. The system of claim 23, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 20 mm or more.

26. The system of claim 23, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 40 mm or more.

27. The system of claim 23, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 320 mm or less.

28. The system of claim 23, wherein the drug delivery apparatus comprises an implantable drug delivery apparatus.

29. A drug delivery system comprising:

a drug delivery apparatus comprising a pump and a drug reservoir; and

a catheter comprising;

an elongated body comprising a distal end and a proximal end adapted for connection to the drug delivery apparatus;

a lumen extending from the proximal end of the body to an infusion section spaced from the proximal end of the body;

one or more openings in the lumen within the infusion section; and

a permeable membrane covering the one or more openings in the infusion section;

wherein the permeable membrane comprises a molecular weight cut-off of 80 kiloDaltons or less.

30. The system of claim 29, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 20 mm or more.

31. The system of claim 29, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 40 mm or more.

32. The system of claim 29, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 320 mm or less.

33. The system of claim 29, wherein the drug delivery apparatus comprises an implantable drug delivery apparatus.

34. A method of infusing a drug to an internal body location, the method comprising:

delivering a drug from a reservoir to an infusion section of a catheter, wherein the catheter comprises an elongated body comprising a proximal end and a distal end, and wherein the catheter comprises a lumen extending from the proximal end of the body to the infusion section; and

passing the drug out of the infusion section through two or more openings in the lumen within the infusion section, wherein the drug passes through a permeable membrane covering the two or more openings;

wherein delivering the drug comprises creating sufficient back pressure in the lumen such that the drug passes through all of the two or more openings in the infusion section when the drug is delivered to the infusion section through the lumen at a continuous rate of 1 milliliter per hour or less.

35. The method of claim 34, wherein the permeable membrane creates a back pressure of 300 pascals or more in the lumen when the drug is delivered to the infusion section through the lumen at a continuous rate of 2 microliters per hour.

36. The method of claim 34, wherein the permeable membrane comprises a molecular weight cut-off of 80 kiloDaltons or less.

37. The method of claim 34, wherein the infusion section comprises an axial length of 20 mm or more.

38. The method of claim 34, wherein the infusion section comprises an axial length of 40 mm or more.

39. The method of claim 34, wherein the infusion section comprises an axial length of 320 mm or less.

40. The method of claim 34, wherein the infusion section is located within the cerebrospinal fluid of a patient.

41. The method of claim 40, wherein the infusion section is located proximate the spinal cord.

42. The method of claim 34, wherein the reservoir is implanted within the body of a patient.

43. A method of infusing a drug to an internal body location, the method comprising:

delivering a drug from a reservoir to an infusion section of a catheter, wherein the catheter comprises an elongated body comprising a proximal end and distal end, and wherein the catheter comprises a lumen extending from the proximal end of the body to the infusion section; and

passing the drug out of the infusion section through all of one or more openings in the lumen within the infusion section, wherein the drug passes through a permeable membrane covering the one or more openings;

wherein delivering the drug comprises creating a back pressure of 300 pascals or more in the lumen when the drug is delivered to the infusion section through the lumen at a continuous rate of 2 microliters per hour.

44. The method of claim 43, wherein the permeable membrane comprises a molecular weight cut-off of 80 kiloDaltons or less.

45. The method of claim 43, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 20 mm or more.

46. The method of claim 43, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 40 mm or more.

47. The method of claim 43, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 320 mm or less.

48. The method of claim 43, wherein the infusion section is located within the cerebrospinal fluid of a patient.

49. The method of claim 48, wherein the infusion section is located proximate the spinal cord.

50. The method of claim 43, wherein the reservoir is implanted within the body of a patient.

51. A method of infusing a drug to an internal body location, the method comprising:

delivering a drug from a reservoir to an infusion section of a catheter, wherein the catheter comprises an elongated body comprising a proximal end and distal end, and wherein the catheter comprises a lumen extending from the proximal end of the body to the infusion section; and

passing the drug out of the infusion section through all of one or more openings in the lumen within the infusion section, wherein the drug passes through a permeable membrane covering the one or more openings, and wherein the permeable membrane comprises a molecular weight cut-off of 80 kiloDaltons or less.

52. The method of claim 51, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 20 mm or more.

53. The method of claim 51, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 40 mm or more.

54. The method of claim 51, wherein the one or more openings in the infusion section comprise a plurality of openings distributed within the infusion section, and wherein the infusion section comprises an axial length of 320 mm or less.

55. The method of claim 51, wherein the infusion section is located within the cerebrospinal fluid of a patient.

56. The method of claim 55, wherein the infusion section is located proximate the spinal cord.

57. The method of claim 51, wherein the reservoir is implanted within the body of a patient.

58. A method of manufacturing a drug delivery catheter, the method comprising:

providing an elongated body comprising a proximal end and distal end, the elongated body comprising a lumen extending from the proximal end of the body to an infusion section spaced from the proximal end of the body and two or more openings in the lumen within the infusion section; and

covering the two or more openings in the infusion section with a permeable membrane, wherein the two or more openings and the permeable membrane covering them are capable of creating sufficient back pressure in the lumen such that the drug exits the permeable membrane through all of the one or more openings in the infusion section when a drug is delivered to the infusion section through the lumen at a continuous rate of 1 milliliter per hour or less.

59. A method of manufacturing a drug delivery catheter, the method comprising:

providing an elongated body comprising a proximal end and distal end, the elongated body comprising a lumen extending from the proximal end of the body to an infusion section spaced from the proximal end of the body and one or more openings in the lumen within the infusion section; and

covering the one or more openings in the infusion section with a permeable membrane, wherein the one or more openings and the permeable membrane covering them are capable of creating a back pressure of 300 pascals or more in the lumen when the drug is delivered to the infusion section through the lumen at a continuous rate of 2 microliters per hour.

60. A method of manufacturing a drug delivery catheter, the method comprising:

providing an elongated body comprising a proximal end and distal end, the elongated body comprising a lumen extending from the proximal end of the body to an infusion section spaced from the proximal end of the body and one or more openings in the lumen within the infusion section; and

covering the one or more openings in the infusion section with a permeable membrane, wherein the permeable membrane comprises a molecular weight cut-off of 80 kiloDaltons or less.