Implantable medical device

• US 20070078391A1
• Filed: 09/28/2006
• Published: 04/05/2007
• Est. Priority Date: 09/30/2005
• Status: Abandoned Application

• Current Assignee: AngioDynamics, Inc.
• Original Assignee: AngioDynamics, Inc.
• Inventors: di Palma, Giorgio, Wortley, Ronald, King, Eric
• Application Number:
  US11/536,363
• Publication Number:
  US 20070078391A1
• Time in Patent Office: Days
• US Class Current: 604/116
• CPC Class Codes: A61M 2039/0036 characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
• CPC Class Codes: A61M 2039/0054 Multiple layers
• CPC Class Codes: A61M 2039/0238 having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers
• CPC Class Codes: A61M 2039/0244 having means for detecting an inserted needle
• CPC Class Codes: A61M 2205/0205 Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
• CPC Class Codes: A61M 2205/0233 Conductive materials, e.g. antistatic coatings for spark prevention
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

A medical device suitable for subcutaneous implantation, generally including a housing having a reservoir, a septum positioned within and supported by the housing, at least one light emitting element placed in position defining relation to the septum, and a pressure actuated, light activating circuitry associated with the at least one light emitting element. The light element(s) may be positioned, for instance, in at least partially surrounding relation around the septum, embedded within or below a translucent housing that supports the septum, positioned within the reservoir and adapted to emit its light through a translucent septum, or positioned on the exterior of the supporting housing. The medical device can be adapted to receive high pressure fluid injections and if so adapted, will include a light emitting element that will provide a visual indication this capacity.

Claims

1. A medical device suitable for subcutaneous implantation, comprising:

a. a housing;

b. a septum positioned in supported relation within said housing;

c. at least one light emitting element; and

d. light activating circuitry associated with said at least one light emitting element, wherein said circuitry is actuated by pressure applied to the medical device.

2. The medical device according to claim 1, further comprising a reservoir.

3. The medical device according to claim 2, further comprising a lumen extending outwardly from said reservoir.

6. The medical device according to claim 1, wherein said septum is composed of at least first and second portions having first and second material durometers, respectively.

7. The medical device according to claim 6, wherein said first material durometer is lower than said second material durometer.

8. The medical device according to claim 7, wherein said first portion is radially surrounded by said second portion.

9. The medical device according to claim 7, wherein said first and second portions are layered relative to one another.

10. The medical device according to claim 9, wherein said first portion is positioned vertically above said second portion.

11. The medical device according to claim 9, wherein said first portion is positioned vertically below said second portion.

12. The medical device according to claim 1, further comprising at least one button associated with said housing and adapted for being depressed and activating said light activating circuitry when depressed.

13. The medical device according to claim 12, further comprising first and second buttons associated with said housing and adapted for being depressed.

14. The medical device according to claim 13, wherein said light activating circuitry is actuated upon depression of either of said first and second buttons.

15. The medical device according to claim 13, wherein said light activating circuitry is actuated upon depression of both of said first and second buttons.

16. The medical device according to claim 13, wherein said first and second buttons are positioned on opposing sides of said housing.

17. The medical device according to claim 1, wherein said light activating circuitry is selectively, manually actuable from an open position to a closed position by application of a transversely directed force.

18. The medical device according to claim 1, wherein said circuitry is selectively, manually actuable between an open position and a closed position by application of perpendicularly directed force.

19. The medical device according to claim 1, further comprising a switch operably associated with said light activating circuitry movable from an open position to a closed position.

20. The medical device according to claim 19, wherein said switch is movable between its open and closed positions by conductive coupling.

21. The medical device according to claim 20, wherein said conductive coupling comprises a first layer of conductive material associated with said septum and a second layer of conductive material in at least one of said septum and said housing, wherein said first and second layers of conductive material are electrically connected to said at least one light emitting element and are coupled by a conductive needle inserted through said septum.

22. The medical device according to claim 21, wherein said at least one light emitting element is adapted to emit light of a first color when actuated by said light activating circuitry and a second color when actuated by said switch.

23. The medical device according to claim 1, wherein said at least one light emitting element comprises at least a first light emitting element adapted to emit light of a first color, and a second light emitting element adapted to emit light of a second color.

24. The medical device according to claim 1, wherein said at least one light emitting element is adapted to blink upon being actuated.

25. The medical device according to claim 1, further comprising a power source for supplying power to said light activating circuitry.

26. The medical device according to claim 25, wherein said power source comprises a kinetic energy holding cell actuated by the body movement of the patient.

27. The medical device according to claim 25, wherein said power source is external to the patient and is adapted to induce current in said light activating circuitry.

28. The medical device according to claim 25, wherein said power source comprises at least one battery.

29. The medical device according to claim 28, wherein said at least one battery is positioned within said device to extend in a plane essentially parallel to that in which said septum extends.

30. The medical device according to claim 28, wherein said at least one battery is positioned within said device to extend in a plane that is transverse to that in which said septum extends.

31. The medical device according to claim 1, wherein said housing is composed of a material that permits light transmittance therethrough.

32. The medical device according to claim 31, wherein said at least one light emitting element is positioned relative to said housing such that it is adapted to emit light through said housing.

33. The medical device according to claim 1, wherein said light activating circuitry comprises:

a first portion that extends in a first plane and that includes a conductive pathway formed thereon;

a second portion that extends in a second plane parallel to said first plane; and

a third portion that extends between and interconnects said first portion and said second portion.

34. The medical device according to claim 33, wherein said light emitting elements are mounted on said first portion and in electrical communication with said conductive pathway.

35. The medical device according to claim 34, further comprising positive and negative terminals attached to said second portion.

36. The medical device according to claim 35, further comprising a power source adapted for placement between said first portion and said second portion and in operable association with said positive and negative terminals.

37. The medical device according to claim 1, wherein said light activating circuitry comprises:

a light supporting member that extends in a first plane and includes a conductive pathway formed thereon; and

a first panel extending in a first plane transverse and in connected relation to said first portion.

38. The medical device according to claim 37, wherein said at least one light emitting element is positioned on said light supporting member in electrical communication with said conductive pathway.

39. The medical device according to claim 37, further comprising a second panel connected to said light supporting member and extending in a third plane that is spaced from and parallel to said second plane.

40. The medical device according to claim 39, wherein said first and second panels each include respective conductive pathways formed thereon, each of which is electrically connected with said conductive pathway formed on said light supporting member.

41. The medical device according to claim 40, further comprising first and second power sources positioned in parallel relation adjacent to said first and second panels, respectively.

42. The medical device according to claim 41, further comprising a housing that includes first and second buttons formed thereon that are positioned outwardly adjacent said first and second panels, respectively.

43. The medical device according to claim 42, wherein said first and second buttons are movable by manually applied force thereto.

44. The medical device according to claim 1, wherein said light activating circuitry comprises:

a first portion that extends about said septum and includes a conductive pathway formed thereon; and

a second portion connected to said first portion and that includes positive and negative terminals mounted thereon.

45. The medical device according to claim 44, further comprising first and second pressure switches formed on said first portion.

46. The medical device according to claim 45, further comprising an upper housing positioned in surrounding relation to said housing, and with said first portion being positioned between said upper housing and said housing.

47. The medical device according to claim 46, wherein said upper housing includes first and second buttons formed thereon and positioned outwardly of and adjacent to said first and second pressure switches, respectively.

48. The medical device according to claim 1, wherein the medical device is a vascular access port.

49. The medical device according to claim 1, further comprising a second septum supported by said housing.

50. The medical device according to claim 1, wherein said light activating circuitry is adapted to illuminate said at least one light emitting element for a predetermined duration.

51. The medical device according to claim 1, wherein said light activating circuitry is adapted to illuminate said at least one light emitting element when the medical device becomes impaired.

52. The medical device according to claim 51, further comprising an impedance-based sensor associated with the medical device and adapted to monitor and compare fluid-generated impedance within the medical device and externally of the medical device in the tissue immediately surrounding the medical device.

53. The medical device according to claim 51, further comprising a pressure transducer located within the medical device and adapted to sense pressure levels within the medical device and, whereby if a predetermined pressure level is exceeded, said light activating circuitry is activated causing said at least one light emitting component to emit light.

54. The medical device according to claim 1, wherein said at least one light emitting element is an LED.

4. The medical device according to clam 1, wherein said light activating circuitry comprises a light supporting member on which said at least one light emitting element is positioned.

5. The medical device according to claim 4, wherein said light supporting member is an at least partially annular track.

55. A medical device suitable for subcutaneous implantation, comprising:

a. a housing;

b. a septum positioned within and supported by said housing;

c. at least one light emitting element positioned in position defining relation to said septum;

d. light activating circuitry associated with said at least one light emitting element; and

e. a first switch operably associated with said light activating circuitry movable from an open position to a closed position by manually applied pressure.

56. A method for non-invasively determining the location of a medical device implanted subcutaneously in a patient, wherein the medical device comprises a housing, a septum positioned within and supported by said housing, at least one light emitting element, and light activating circuitry associated with said at least one light emitting element, the method comprising the step of applying pressure to the medical device, wherein the applied pressure actuates the at least one light emitting element.

57. The method according to claim 56, comprising the further step of identifying the position of the septum based upon visual identification of the position of the actuated light emitting element.

58. The method according to claim 57, comprising the further step of inserting a needle through said septum.

59. The method according to claim 56, comprising the further step of determining whether the medical device is adapted to receive an injection of high pressure fluid.

60. The method according to claim 56, wherein the step of applying pressure is done by applying force to the medical device in a direction that is transverse relative to the medical device.

61. The method according to claim 56, wherein the step of applying pressure is done by applying force to the medical device in a direction that is perpendicular relative to said septum.

62. The method according to claim 56, comprising the further step of determining whether the device is impaired.

63. The method according to claim 62, wherein the device includes a pressure transducer incorporated therein, and the step of determining whether the device has been impaired includes the step of actuating the at least one light emitting element in response to the pressure transducer determining that the pressure within the device exceeds a predetermined threshold.

64. The method according to claim 62, wherein the device includes an impedance-based sensor incorporated therein and the step of determining whether the device has been impaired includes the step of actuating the at least one light emitting element in response to an impedance differential between the interior of and exterior to the device exceeding a predetermined threshold.

65. The method according to claim 56, wherein the device includes a pressure transducer incorporated therein, comprising the further step of determining whether the device has received an injection of fluid at a pressure above a predetermined threshold and if it said threshold is exceeded, then actuating the light activating circuitry to cause the at least one light emitting element to emit light.

66. The method according to claim 56, comprising the further step of determining whether the device can safely receive high pressure fluid injections.

67. The method according to claim 66, wherein the step of determining whether the device can safely receive high pressure fluid injections includes including a second light emitting element that is actuable by the light activating circuitry and exhibits a distinct characteristic that distinguishes it from the at least one light emitting element.

68. A medical device suitable for subcutaneous implantation, comprising:

a. a housing;

b. a septum positioned within and supported by said housing and adapted to receive an injection of high pressure fluid therethrough;

c. a first light emitting element adapted for identifying the capacity of the medical device to receive high pressure fluid injections and emitting light of a first distinctive character;

d. a second light emitting element adapted for placement in position defining relation to said septum and emitting light of a second distinctive character; and

e. light activating circuitry associated with said first and second light emitting elements, wherein said circuitry is actuated by manually applied pressure.

69. The medical device according to claim 68, wherein said septum is composed of at least first and second portions having first and second durometers, respectively.

70. The medical device according to claim 69, wherein said first durometer is lower than said second durometer.

71. The medical device according to claim 70, wherein said first portion is radially surrounded by said second portion.

72. The medical device according to claim 70, wherein said first portion is layered on top of said second portion.

73. The medical device according to claim 70, wherein said first portion is layered below said second portion.

74. The medical device according to claim 68, wherein said housing is composed of a material that permits light to transmit therethrough.

75. The medical device according to claim 74, wherein said second light emitting element is positioned relative to said housing such that it is adapted to emit light therethrough.

76. The medical device according to claim 68, wherein said light activating circuitry is actuated by transversely directed force.

77. The medical device according to claim 68, wherein said light activating circuitry is actuated by force perpendicularly applied relative to said septum.

78. The medical device according to claim 68, wherein the medical device is a vascular access port.

79. The medical device according to claim 68, wherein said first distinctive character is a light of a first color.

80. The medical device according to claim 79, wherein said second distinctive character is a light of a second color.

81. A medical device suitable for a predetermined use and for subcutaneous implantation, comprising:

a. a housing;

b. a septum positioned within and supported by said housing, and having the capacity to be used for the predetermined use;

c. at least one first light emitting element associated with said housing and adapted to identify the capacity of the medical device to be used for the predetermined use; and

d. light activating circuitry.

82. The medical device according to claim 81, wherein said light activating circuitry is actuated by pressure.

83. The medical device according to claim 82, wherein said housing includes at least one button as a part thereof that upon being depressed actuates said light activating circuitry.

84. The medical device according to claim 83, wherein said light activating circuitry is actuated by transversely directed force applied to said at least one button.

85. The medical device according to claim 81, further comprising at least one second light emitting element associated with said housing and positioned in proximity to said septum to enable visual identification of said septum'"'"'s location upon actuation of said at least one second light emitting element.

86. The medical device according to claim 82, wherein said septum is composed of at least first and second portions having first and second durometers, respectively.

87. The medical device according to claim 86, wherein said first durometer is lower than said second durometer.

88. The medical device according to claim 87, wherein said first portion is radially surrounded by said second portion.

89. The medical device according to claim 87, wherein said first portion is layered on top of said second portion.

90. The medical device according to claim 87, wherein said first portion is layered below said second portion.

91. A method for determining whether a medical device adapted for subcutaneous implantation in a patient has been impaired, wherein the medical device comprises a housing, a septum positioned within and supported by the housing, a reservoir positioned adjacent to the septum and adapted to receive a fluid therein, at least one light emitting element, and light activating circuitry operably coupled to the at least one light emitting element, the method comprising the steps of:

a. incorporating a predetermined sensor in the housing that is adapted to quantitatively measure a predetermined physical condition and compare said quantitative measurement to a predetermined threshold; and

b. actuating the light activating circuitry in the event said predetermined threshold has been exceeded, thereby causing the at least one light emitting element to emit light.

92. The method according to claim 91, wherein said predetermined sensor comprises a pressure transducer.

93. The method according to claim 91, wherein said predetermined sensor comprises an impedance-based sensor that compares the impedance of the fluid within the medical device to the impedance outside the medical device.