Catheters incorporating valves and permeable membranes

• US 20050137578A1
• Filed: 06/22/2004
• Published: 06/23/2005
• 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 8,043,281 B2
• Time in Patent Office: Days
• US Class Current: 604/536
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• 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 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 2039/224 of the slide-valve type
• CPC Class Codes: A61M 2202/0464 Cerebrospinal fluid
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 39/223 Multiway valves
• 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 and one or more valves that control flow to the infusion sections.

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 elongated body to an infusion section spaced from the proximal end of the elongated 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; and

a valve located between the proximal end of the elongated body and the one or more openings within the infusion section, wherein the valve controls flow through the lumen to the infusion section.

2. The catheter of claim 1, wherein the valve is located closer to the infusion section than to the proximal end of the elongated body.

3. The catheter of claim 1, wherein the valve is located closer to the proximal end of the elongated body than to the infusion section.

4. The catheter of claim 1, wherein the valve comprises a linear valve.

5. The catheter of claim 1, wherein the valve comprises a rotary valve.

6. The catheter of claim 1, wherein the one 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 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.

7. 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.

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

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

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

11. The catheter of claim 1, 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 a distal end;

a plurality of infusion sections located along the elongated body, wherein each infusion section of the plurality of infusion sections comprises a permeable membrane through which a drug passes during delivery;

a valve located between the plurality of infusion sections and the proximal end of the elongated body, wherein the valve comprises a plurality of outlets;

a plurality of lumens in the catheter, wherein each lumen of the plurality of lumens extends from one outlet of the plurality of outlets on the valve to one infusion section of the plurality of infusion sections.

13. The catheter of claim 12, wherein each lumen extending from one outlet of the valve to one infusion section comprises a fluid volume, and wherein the fluid volumes of each lumen of the plurality of lumens are balanced.

14. The catheter of claim 12, wherein the valve is located closer to the plurality of infusion sections than to the proximal end of the elongated body.

15. The catheter of claim 12, wherein the valve is located closer to the proximal end of the elongated body than to the plurality of infusion sections.

16. The catheter of claim 12, wherein the valve comprises a linear valve.

17. The catheter of claim 12, wherein the valve comprises a rotary valve.

18. The catheter of claim 12, wherein each infusion section of the plurality of infusion sections comprises one or more openings in the lumen leading to the infusion section, and wherein the permeable membrane of the infusion section creates a back pressure in the lumen such that the drug exits the infusion section 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.

19. The catheter of claim 12, wherein the permeable membrane in each infusion section of the plurality of infusion sections creates a back pressure of 300 pascals or more in the lumen leading to the infusion section when the drug is delivered to the infusion section through the lumen at a continuous rate of 2 microliters per hour.

20. The catheter of claim 12, wherein the permeable membrane comprises a molecular weight cut-off of 80 kiloDaltons or less.

21. The catheter of claim 12, wherein each infusion section of the plurality of infusion sections comprises an axial length of 20 mm or more.

22. The catheter of claim 12, wherein each infusion section of the plurality of infusion sections comprises an axial length of 320 mm or less.

23. The catheter of claim 12, wherein the plurality of infusion sections comprises at least a first infusion and a second infusion section, and wherein the first infusion section is spaced apart from the second infusion section along the elongated body by an axial distance of 20 mm or more.

24. The catheter of claim 12, wherein the plurality of infusion sections comprises at least a first infusion and a second infusion section, and wherein the first infusion section is spaced apart from the second infusion section along the elongated body by an axial distance of one human vertebral level or more.

25. A drug delivery catheter comprising:

an elongated body comprising a proximal end and a distal end;

a plurality of infusion sections located along the elongated body, wherein each infusion section of the plurality of infusion sections comprises a permeable membrane through which a drug passes during delivery;

a plurality of valves, wherein each valve of the plurality of valves is located between one infusion section of the plurality of infusion sections and the proximal end of the elongated body;

a plurality of lumens in the catheter, wherein each lumen of the plurality of lumens extends from one valve of the plurality of valves to one infusion section of the plurality of infusion sections.

26. The catheter of claim 25, wherein each lumen extending from one valve to one infusion section comprises a fluid volume, and wherein the fluid volumes of each lumen of the plurality of lumens are balanced.

27. The catheter of claim 25, wherein each valve is located closer to the plurality of infusion sections than to the proximal end of the elongated body.

28. The catheter of claim 25, wherein each valve is located closer to the proximal end of the elongated body than to the plurality of infusion sections.

29. The catheter of claim 25, wherein each valve comprises a linear valve.

30. The catheter of claim 25, wherein each valve comprises a rotary valve.

31. The catheter of claim 25, wherein each infusion section of the plurality of infusion sections comprises one or more openings in the lumen leading to the infusion section, and wherein the permeable membrane of the infusion section creates a back pressure in the lumen such that the drug exits the infusion section 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.

32. The catheter of claim 25, wherein the permeable membrane in each infusion section of the plurality of infusion sections creates a back pressure of 300 pascals or more in the lumen leading to the infusion section when the drug is delivered to the infusion section through the lumen at a continuous rate of 2 microliters per hour.

33. The catheter of claim 25, wherein the permeable membrane comprises a molecular weight cut-off of 80 kiloDaltons or less.

34. The catheter of claim 25, wherein each infusion section of the plurality of infusion sections comprises an axial length of 20 mm or more.

35. The catheter of claim 25, wherein each infusion section of the plurality of infusion sections comprises an axial length of 320 mm or less.

36. The catheter of claim 25, wherein the plurality of infusion sections comprises at least a first infusion and a second infusion section, and wherein the first infusion section is spaced apart from the second infusion section along the elongated body by an axial distance of 20 mm or more.

37. The catheter of claim 25, wherein the plurality of infusion sections comprises at least a first infusion and a second infusion section, and wherein the first infusion section is spaced apart from the second infusion section along the elongated body by an axial distance of one human vertebral level or more.

38. 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 proximal end and distal end;

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

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

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

a valve located between the proximal end of the elongated body and the one or more openings within the infusion section, wherein the valve controls flow through the lumen to the infusion section.

39. The system of claim 38, wherein the valve is located closer to the infusion section than to the proximal end of the elongated body.

40. The system of claim 38, wherein the valve is located closer to the proximal end of the elongated body than to the infusion section.

41. The system of claim 38, wherein the one 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 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.

42. The system of claim 38, 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.

43. The system of claim 38, wherein the permeable membrane comprises a molecular weight cut-off of 80 kiloDaltons or less.

44. The system of claim 38, wherein the infusion section comprises an axial length of 20 mm or more.

45. The system of claim 38, wherein the infusion section comprises an axial length of 320 mm or less.

46. The system of claim 38, wherein the drug delivery apparatus comprises an implantable drug delivery apparatus.

47. 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 proximal end and a distal end;

a plurality of infusion sections located along the elongated body, wherein each infusion section of the plurality of infusion sections comprises a permeable membrane through which a drug passes during delivery;

a valve located between the plurality of infusion sections and the proximal end of the elongated body, wherein the valve comprises a plurality of outlets;

a plurality of lumens in the catheter, wherein each lumen of the plurality of lumens extends from one outlet of the plurality of outlets on the valve to one infusion section of the plurality of infusion sections.

48. The system of claim 47, wherein each lumen extending from one outlet of the valve to one infusion section comprises a fluid volume, and wherein the fluid volumes of each lumen of the plurality of lumens are balanced.

49. The system of claim 47, wherein the valve is located closer to the plurality of infusion sections than to the proximal end of the elongated body.

50. The system of claim 47, wherein the valve is located closer to the proximal end of the elongated body than to the plurality of infusion sections.

51. The system of claim 47, wherein each infusion section of the plurality of infusion sections comprises one or more openings in the lumen leading to the infusion section, and wherein the permeable membrane of the infusion section creates a back pressure in the lumen such that the drug exits the infusion section 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.

52. The system of claim 47, wherein the permeable membrane in each infusion section of the plurality of infusion sections creates a back pressure of 300 pascals or more in the lumen leading to the infusion section when the drug is delivered to the infusion section through the lumen at a continuous rate of 2 microliters per hour.

53. The system of claim 47, wherein the permeable membrane comprises a molecular weight cut-off of 80 kiloDaltons or less.

54. The system of claim 47, wherein each infusion section of the plurality of infusion sections comprises an axial length of 20 mm or more.

55. The system of claim 47, wherein each infusion section of the plurality of infusion sections comprises an axial length of 320 mm or less.

56. The system of claim 47, wherein the plurality of infusion sections comprises at least a first infusion and a second infusion section, and wherein the first infusion section is spaced apart from the second infusion section along the elongated body by an axial distance of 20 mm or more.

57. The system of claim 47, wherein the plurality of infusion sections comprises at least a first infusion and a second infusion section, and wherein the first infusion section is spaced apart from the second infusion section along the elongated body by an axial distance of one human vertebral level or more.

58. The system of claim 47, wherein the drug delivery apparatus comprises an implantable drug delivery apparatus.

59. 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 proximal end and a distal end;

a plurality of infusion sections located along the elongated body, wherein each infusion section of the plurality of infusion sections comprises a permeable membrane through which a drug passes during delivery;

a plurality of valves, wherein each valve of the plurality of valves is located between one infusion section of the plurality of infusion sections and the proximal end of the elongated body;

a plurality of lumens in the catheter, wherein each lumen of the plurality of lumens extends from one valve of the plurality of valves to one infusion section of the plurality of infusion sections.

60. The system of claim 59, wherein each lumen extending from one valve to one infusion section comprises a fluid volume, and wherein the fluid volumes of each lumen of the plurality of lumens are balanced.

61. The system of claim 59, wherein each valve is located closer to the plurality of infusion sections than to the proximal end of the elongated body.

62. The system of claim 59, wherein each valve is located closer to the proximal end of the elongated body than to the plurality of infusion sections.

63. The system of claim 59, wherein each infusion section of the plurality of infusion sections comprises one or more openings in the lumen leading to the infusion section, and wherein the permeable membrane of the infusion section creates a back pressure in the lumen such that the drug exits the infusion section 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.

64. The system of claim 59, wherein the permeable membrane in each infusion section of the plurality of infusion sections creates a back pressure of 300 pascals or more in the lumen leading to the infusion section when the drug is delivered to the infusion section through the lumen at a continuous rate of 2 microliters per hour.

65. The system of claim 59, wherein the permeable membrane comprises a molecular weight cut-off of 80 kiloDaltons or less.

66. The system of claim 59, wherein each infusion section of the plurality of infusion sections comprises an axial length of 20 mm or more.

67. The system of claim 59, wherein each infusion section of the plurality of infusion sections comprises an axial length of 320 mm or less.

68. The system of claim 59, wherein the plurality of infusion sections comprises at least a first infusion and a second infusion section, and wherein the first infusion section is spaced apart from the second infusion section along the elongated body by an axial distance of 20 mm or more.

69. The system of claim 59, wherein the plurality of infusion sections comprises at least a first infusion and a second infusion section, and wherein the first infusion section is spaced apart from the second infusion section along the elongated body by an axial distance of one human vertebral level or more.

70. The system of claim 59, wherein the drug delivery apparatus comprises an implantable drug delivery apparatus.

71. 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 valve located between the proximal end of the elongated body and the infusion section, and wherein the catheter further comprises a lumen extending from the valve to the infusion section; and

passing the drug out of the infusion section through 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 passing the drug through the valve located within the catheter between the proximal end of the elongated body and the infusion section.

72. The method of claim 71, wherein the infusion section is located within the cerebrospinal fluid of a patient.

73. The method of claim 72, wherein the infusion section is located proximate the spinal cord.

74. The method of claim 71, wherein the reservoir is implanted within the body of a patient.

75. 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;

a plurality of infusion sections located along the elongated body, wherein each infusion section of the plurality of infusion sections comprises a permeable membrane through which a drug passes during delivery;

a valve located between the plurality of infusion sections and the proximal end of the elongated body, wherein the valve comprises a plurality of outlets; and

a plurality of lumens in the catheter, wherein each lumen of the plurality of lumens extends from one outlet of the plurality of outlets on the valve to one infusion section of the plurality of infusion sections; and

passing the drug through the valve and out of at least one infusion section of the plurality of infusion sections through the permeable membrane in the at east one infusion section.

76. The method of claim 75, wherein the at least one infusion section is located within the cerebrospinal fluid of a patient.

77. The method of claim 76, wherein the at least one infusion section is located proximate the spinal cord.

78. The method of claim 75, wherein the reservoir is implanted within the body of a patient.

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

delivering a drug from a reservoir to at least one infusion section of a catheter, wherein the catheter comprises;

an elongated body comprising a proximal end and a distal end;

a plurality of infusion sections located along the elongated body, wherein each infusion section of the plurality of infusion sections comprises a permeable membrane through which a drug passes during delivery;

a plurality of valves, wherein each valve of the plurality of valves is located between one infusion section of the plurality of infusion sections and the proximal end of the elongated body; and

a plurality of lumens in the catheter, wherein each lumen of the plurality of lumens extends from one valve of the plurality of valves to one infusion section of the plurality of infusion sections; and

passing the drug out of at least one infusion section through the permeable membrane of the at least one infusion section, wherein the drug passes through the valve connected to the at least one infusion section.

80. The method of claim 79, wherein the infusion section is located within the cerebrospinal fluid of a patient.

81. The method of claim 80, wherein the infusion section is located proximate the spinal cord.

82. The method of claim 79, wherein the reservoir is implanted within the body of a patient.