Method and apparatus for percutaneously accessing an implanted port

• US 6,120,492 A
• Filed: 09/25/1998
• Issued: 09/19/2000
• Est. Priority Date: 07/18/1997
• Status: Expired due to Term

• Current Assignee: Vasca Inc.
• Original Assignee: Vasca Inc.
• Inventors: Brugger, James M., Burbank, Jeffrey H., Finch, Charles David
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Blyveis, Deborah
• Application Number:
  US09/161,068
• Time in Patent Office: 725 Days
• Field of Search: 604/264, 604/167, 604/175, 604/4, 604/93, 604/263-265, 604/502, 604/506-508, 604/510, 604/523, 604/1-3
• US Class Current: 604/502
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2039/0081 Means for facilitating introduction of a needle in the septum, e.g. guides, special construction of septum
• CPC Class Codes: A61M 2205/195 by the needle tip shape
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

Methods and apparatus for percutaneously accessing an implanted port use an access cannula which is periodically introduced to an aperture on the implanted port so that the cannula passes through the same tissue tract. It has been found that repeated passage of the cannula through the same tissue tract reduces patient trauma, with minimized bleeding, reduction in sensitivity. The tract may be initially formed by percutaneously placing a penetrating element through intact skin to the port and leaving the element in place for a time sufficient to created the tract.

Claims

1. A method for percutaneously accessing an implanted port, said method comprising:

locating a preformed access tract from a skin entry point to the port; and

percutaneously introducing a cannula through the preformed access tract to establish a flow path through the cannula to the port, wherein the port has an internal valve that inhibits bleed back into the tissue tract after the cannula is withdrawn.

2. A method as in claim 1, wherein the port comprises an aperture and the locating step comprises manually aligning the cannula with a line from the skin entry point of the access tract to the aperture on the port.

3. A method as in claim 2, wherein the aperture has dimensions which correspond to the cannula.

4. A method as in claim 2, wherein the locating step further comprise annularly feeling the port to determine the position of the aperture.

5. A method as in claim 1, wherein the introducing step comprises orienting the cannula generally vertically with respect to the skin surface.

6. A method as in claim 1, wherein the cannula is introduced through a skin layer having a thickness in the range from 3 mm to 20 mm.

7. A method as in claim 1, wherein the cannula dilates the access tract as it is introduced therethrough.

8. A method as in claim 7, wherein the cannula has a bore size of at least 1.16 mm.

9. A method as in claim 1, wherein the cannula comprises a needle.

10. A method as in claim 1, wherein the cannula comprises a blunt tube.

11. A method as in claim 10, wherein the cannula further comprises a stylet removably received in the blunt tube.

24. A kit comprising:

a cannula;

instructions for use setting forth a method according to claim 1; and

a package containing the cannula and the instructions for use.

25. A kit as in claim 24, further comprising a catheter connected or connectable to the cannula.

12. A method for forming a percutaneous access tract to an implanted port, said method comprising:

percutaneous introducing a cannula to define an access tract having a skin entry point and extending to the port; and

repeatedly accessing the port with a cannula through the same access tract at intervals of at least twice a week for a period of at least three months.

13. A method as in claim 12, wherein the accessing step comprises introducing a cannula at intervals of at least twice a day for a period of at least three months.

14. A method as in claim 12, wherein the introducing step comprises orienting the cannula generally vertically with respect to the skin surface.

15. A method as in claim 12, wherein the cannula is introduced through a skin layer having a thickness in the range from 3 mm to 20 mm.

16. A method as in claim 12, wherein the port has an internal valve that inhibits bleed back into the tissue tract after the cannula is withdrawn.

17. A method as in claim 12, wherein the cannula dilates the access tract as it is introduced therethrough.

18. A method as in claim 17, wherein the cannula has a bore size of at least 1.16 mm.

19. A method as in claim 12, wherein the cannula comprises a needle.

20. A method as in claim 12, wherein the cannula comprises a blunt tube.

21. A method as in claim 20, wherein the cannula further comprises a stylet removably received in the blunt tube.

26. A kit comprising:

a cannula;

instructions for use setting forth a method according to claim 12; and

a package containing the cannula and the instructions for use.

27. A kit as in claim 26, further comprising a catheter connected or connectable to the cannula.

22. A method for aligning an access cannula, said method comprising:

observing an access site on skin at the proximal end of a preformed access tract, wherein said access site overlies an implanted port capable of removably receiving the access cannula through the access tract having an internal valve that inhibits bleed back into the tissue tract after the access tube is removed; and

aligning an access cannula with the access site and at an angle coaxial with that of the access tract.

23. A method as in claim 22, wherein the angle is generally normal relative to the patients skin at the access site.

28. A method comprising (1) advancing and inserting an access cannula into an implantable vascular or peritoneal access port to gain access to the port while simultaneously opening a closure valve of said port which is normally biased closed;

(2) exchanging fluid between said cannula and said port; and

(3) withdrawing said needle from the port and allowing said valve to close;

characterized in that steps 1 to 3 are repeated with the cannula travelling along the same access tract.

29. The method of use of an implantable access port having an actuatable valve biased in a closed position wherein access cannulas repeatedly access said port along the same access tract, in a therapeutic process wherein the port is connected to a blood vessel and the process comprises removing blood through a port from a patient, processing said blood, and returning the blood through a port to the patient.

30. The method of use of an implantable access port having an actuatable valve biased in a closed position wherein access cannulas repeatedly access said port along the same access tract, in a therapeutic process wherein the port is connected to the peritoneum and the process comprises introducing dialysate to the patient through the port and thereafter removing dialysate from the patient through the port.

31. A method for percutaneously accessing an implanted port having an aperture, said method comprising:

locating a preformed access tract from a skin entry point to the port;

annularly feeling the port to determine the position of the aperture;

manually aligning the cannula with a line from the skin entry point of the access tract to the aperture on the port; and

percutaneously introducing a cannula through the preformed access tract into the aperture to establish a flow path through the cannula to the port.

32. A method as in claim 31, wherein the aperture has dimensions which correspond to the cannula.

33. A method as in claim 31, wherein the introducing step comprises orienting the cannula generally vertically with respect to the skin surface.

34. A method as in claim 31, wherein the cannula is introduced through a skin layer having a thickness in the range from 3 mm to 20 mm.

35. A method as in claim 31, wherein the port has an internal valve that inhibits bleed back into the tissue tract after the cannula is withdrawn.

36. A method as in claim 34, wherein the cannula dilates the access tract as it is introduced therethrough.

37. A method as in claim 36, wherein the cannula has a bore size of at least 1.16 mm.

38. A method as in claim 34, wherein the cannula comprises a needle.

39. A method as in claim 34, wherein the cannula comprises a blunt tube.

40. A method as in claim 34, wherein the cannula further comprises a stylet removably received in the blunt tube.

53. A kit comprising:

a cannula;

instructions for use setting forth a method according to claim 31; and

a package containing the cannula and the instructions for use.

59. A kit as in claim 53, wherein the penetrating element comprises an access cannula.

41. A method for forming a percutaneous access tract to an implanted port, said method comprising:

percutaneous introducing a cannula to define an access tract having a skin entry point and extending to the port, wherein the port has an internal valve that inhibits bleed back into the tissue tract after the cannula is withdrawn; and

repeatedly accessing the port with a cannula through the same access tract at intervals and over a time period sufficient to cause scar tissue formation over the access tract.

42. A method as in claim 41, wherein the accessing step comprises introducing a cannula at intervals of at least twice a week for a period of at least three months.

43. A method as in claim 41, wherein the accessing step comprises introducing a cannula at intervals of at least twice a day for a period of at least three months.

44. A method as in claim 41, wherein the introducing step comprises orienting the cannula generally vertically with respect to the skin surface.

45. A method as in claim 41, wherein the cannula is introduced through a skin layer having a thickness in the range from 3 mm to 20 mm.

46. A method as in claim 41, wherein the cannula dilates the access tract as it is introduced therethrough.

47. A method as in claim 46, wherein the cannula has a bore size of at least 1.16 mm.

48. A method as in claim 41, wherein the cannula comprises a needle.

49. A method as in claim 41, wherein the cannula comprises a blunt tube.

50. A method as in claim 49, wherein the cannula further comprises a stylet removably received in the blunt tube.

55. A kit comprising:

a cannula;

instructions for use setting forth a method according to claim 41; and

a package containing the cannula and the instructions for use.

61. A method as in claim 55, wherein the port comprises an aperture and the locating step comprises manually aligning the cannula with a line from the skin entry point of the access tract to the aperture on the port.

62. A method as in claim 61, wherein the aperture has dimensions which correspond to the cannula.

63. A method as in claim 61, wherein the locating step further comprise annularly feeling the port to determine the position of the aperture.

64. A method as in claim 55, wherein the introducing step comprises orienting the cannula generally vertically with respect to the skin surface.

65. A method as in claim 55, wherein the cannula is introduced through a skin layer having a thickness in the range from 3 mm to 20 mm.

66. A method as in claim 55, wherein the port has an internal valve that inhibits bleed back into the tissue tract after the cannula is withdrawn.

67. A method as in claim 55, wherein the cannula comprises a needle.

68. A method as in claim 55, wherein the cannula comprises a blunt tube.

69. A method as in claim 68, wherein the cannula further comprises a stylet removably received in the blunt tube.

51. A method for creating an access tract to a subcutaneously implanted port, said method comprising:

implanting a port in a subcutaneous tissue pocket, wherein an access cannula-receiving aperture of the port is disposed beneath an intact region of skin; and

introducing a penetrating element through the intact region of skin into the aperture, wherein the element remains anchored in the aperture for at least one week.

52. A method as in claim 51, wherein the penetrating element is an access cannula, said method further comprising introducing or removing fluids through the access cannula while said cannula remains anchored in the aperture.

54. A kit as in claim 52, further comprising a catheter connected or connectable to the cannula.

57. A kit comprising:

a subcutaneously implantable port;

instructions for implanting the port in accordance with the method of claim 51; and

a package containing the port and the instructions for use.

58. A kit as in claim 57, further comprising a penetrating element.

56. A kit as in further comprising a catheter connected or connectable to the cannula.

60. A method for percutaneously accessing an implanted port, said method comprising:

locating a preformed access tract from a skin entry point to the port; and

percutaneously introducing a cannula through the preformed access tract to establish a flow path through the cannula to the port, wherein the cannula has a bore size of at least 1.16 mm and dilates the access tract as it is introduced therethrough.

79. A kit comprising:

a cannula;

instructions for use setting forth a method according to claim 60; and

a package containing the cannula and the instructions for use.

80. A kit as in claim 79, further comprising a catheter connected or connectable to the cannula.

70. A method for forming a percutaneous access tract to an implanted port, said method comprising:

percutaneous introducing a cannula to define an access tract having a skin entry point and extending to the port, wherein the cannula has a bore size of at least 1.16 mm and dilates the access tract as it is introduced therethrough; and

repeatedly accessing the port with a cannula through the same access tract at intervals and over a time period sufficient to cause scar tissue formation over the access tract.

71. A method as in claim 70, wherein the accessing step comprises introducing a cannula at intervals of at least twice a week for a period of at least three months.

72. A method as in claim 70, wherein the accessing step comprises introducing a cannula at intervals of at least twice a day for a period of at least three months.

73. A method as in claim 70, wherein the introducing step comprises orienting the cannula generally vertically with respect to the skin surface.

74. A method as in claim 70, wherein the cannula is introduced through a skin layer having a thickness in the range from 3 mm to 20 mm.

75. A method as in claim 70, wherein the port has an internal valve that inhibits bleed back into the tissue tract after the cannula is withdrawn.

76. A method as in claim 70, wherein the cannula comprises a needle.

77. A method as in claim 70, wherein the cannula comprises a blunt tube.

78. A method as in claim 77, wherein the cannula further comprises a stylet removably received in the blunt tube.

81. A kit comprising:

a cannula;

instructions for use setting forth a method according to claim 70; and

a package containing the cannula and the instructions for use.

82. A kit as in claim 81, further comprising a catheter connected or connectable to the cannula.

83. A method for percutaneously accessing an implanted port, said method comprising:

locating a preformed access tract from a skin entry point to the port; and

percutaneously introducing a cannula comprising a blunt tube having a stylet removably received therein through the preformed access tract to establish a flow path through the cannula to the port.

84. A method as in claim 83, wherein the port comprises an aperture and the locating step comprises manually aligning the cannula with a line from the skin entry point of the access tract to the aperture on the port.

85. A method as in claim 84, wherein the aperture has dimensions which correspond to the cannula.

86. A method as in claim 84, wherein the locating step further comprise annularly feeling the port to determine the position of the aperture.

87. A method as in claim 83, wherein the introducing step comprises orienting the cannula generally vertically with respect to the skin surface.

88. A method as in claim 83, wherein the cannula is introduced through a skin layer having a thickness in the range from 3 mm to 20 mm.

89. A method as in claim 83, wherein the port has an internal valve that inhibits bleed back into the tissue tract after the cannula is withdrawn.

90. A method as in claim 83, wherein the cannula dilates the access tract as it is introduced therethrough.

91. A method as in claim 90, wherein the cannula has a bore size of at least 1.16 mm.