Implantable medical devices and related methods

• US 20050245971A1
• Filed: 04/28/2005
• Published: 11/03/2005
• Est. Priority Date: 04/28/2004
• Status: Abandoned Application

• Current Assignee: Transoma Medical, Inc.
• Original Assignee: Transoma Medical, Inc.
• Inventors: Foster, Arthur J., Brockway, Brian P., Lambert, Scott, Mills, Perry A., Sherwood, Kathy Lynn
• Application Number:
  US11/119,358
• Publication Number:
  US 20050245971A1
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/3727 characterised by the modulation technique
• CPC Class Codes: A61N 1/37276 characterised by means for reducing power consumption during telemetry
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3785 generated by biological activity or substance, e.g. body movement
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Implantable medical devices and associated methods are disclosed. In one implementation, the implantable medical device comprises a conductive housing and a remote electrode that is mechanically coupled to the conductive housing by a lead body. An amplifier is electrically connected to the remote electrode and the conductive housing for providing a signal representative of a voltage difference between the remote electrode and the conductive housing. In some methods in accordance with the present invention, the implantable medical device is implanted in an implant site overlaying one half of a rib cage of a human body. The implantable medical device produces a signal representative of the voltage difference between the remote electrode and the conductive housing and the signal is transmitted to a receiver located outside the human body.

Claims

1. A method comprising the steps of:

forming a pocket in an implant site overlaying a rib cage of a human body;

inserting an implantable monitoring device into the pocket;

removing the implantable monitoring device from the pocket; and

inserting an implantable therapy device into the pocket.

2. The method of claim 1, wherein the implantable monitoring device has a size and shape that is similar to a size and shape of the implantable therapy device.

3. The method of claim 2, further including the steps of:

detecting a voltage difference between a conductive housing of the heart monitor and a remote electrode of the heart monitor.

producing a signal representative of the voltage difference between the remote electrode and the conductive housing; and

transmitting the signal to a receiver located outside the human body.

4. The method of claim 1, wherein the implant site extends between a skin and a rib cage of the human body.

5. The method of claim 1, wherein the implant site extends between a left-most extent of a sternum of the human body and a left-most extent of a rib cage of the human body.

6. The method of claim 1, wherein the implant site extends between a right-most extent of a sternum of the human body and a right-most extent of a rib cage of the human body.

7. The method of claim 1, wherein the implant site extends between a lower-most surface of a clavicle of the human body and a lower-most extent of a sternum of the human body.

8. The method of claim 1, wherein the heart monitor is placed between a skin and a rib cage of the human body.

9. The method of claim 1, wherein the heart monitor is placed between a left-most extent of a sternum of the human body and a left-most extent of a rib cage of the human body.

10. The method of claim 1, wherein the heart monitor is placed between a right-most extent of a sternum of the human body and a right-most extent of a rib cage of the human body.

11. The method of claim 1, wherein the heart monitor is placed between a lower-most surface of a clavicle of the human body and a lower-most extent of a sternum of the human body.

12. A method comprising the steps of:

placing an implantable medical device comprising a conductive housing and a remote electrode in an implant site proximate a left arm of a human body;

detecting a voltage difference between the remote electrode and the conductive housing;

producing a signal representative of the voltage difference between the remote electrode and the conductive housing; and

transmitting the signal to a receiver located outside the human body.

13. The method of claim 12, wherein the step of placing the implantable medical device in the implant site comprises the steps of:

forming a pocket in the implant site; and

inserting the conductive housing into the pocket.

14. The method of claim 13, further including the steps of:

removing the implantable medical device from the pocket; and

inserting a heart therapy device into the pocket.

15. The method of claim 12, wherein the step of placing the remote electrode and the conductive housing in the implant site comprises the steps of:

forming a pocket in the implant site;

forming a channel in the implant site such that the channel communicates with the pocket;

placing the remote electrode in the channel;

connecting the remote electrode to the conductive housing; and

placing the conductive housing in the pocket.

16. The method of claim 12, wherein the implant site extends between a skin and a rib cage of the human body.

17. The method of claim 12, wherein the implant site extends between a left-most extent of a sternum of the human body and a left-most extent of a rib cage of the human body.

18. The method of claim 12, wherein the implant site extends between a right-most extent of a sternum of the human body and a right-most extent of a rib cage of the human body.

19. The method of claim 12, wherein the implant site extends between a lower-most surface of a clavicle of the human body and a lower-most extent of a sternum of the human body.

20. The method of claim 12, wherein the remote electrode and the conductive housing are both placed between a skin and a rib cage of the human body.

21. The method of claim 12, wherein the remote electrode and the conductive housing are both placed between a left-most extent of a sternum of the human body and a left-most extent of a rib cage of the human body.

22. The method of claim 12, wherein the remote electrode and the conductive housing are both placed between a right-most extent of a sternum of the human body and a right-most extent of a rib cage of the human body.

23. The method of claim 12, wherein the remote electrode and the conductive housing are both placed between a lower-most surface of a clavicle of the human body and a lower-most extent of a sternum of the human body.

24. The method of claim 12, wherein the remote electrode and the conductive housing are placed so that the remote electrode and the conductive housing are separated by a center-to center distance that is pre-selected for fitting the remote electrode and the conductive housing within the implant site.

25. The method of claim 24, wherein the pre-selected distance is greater than about 4.0 centimeters and less than about 10.0 centimeters.

26. The method of claim 25, wherein the pre-selected distance is greater than about 5.0 centimeters and less than about 7.0 centimeters.

27. The method of claim 12, wherein the remote electrode and the conductive housing are placed so that the remote electrode and the conductive housing define an overall length of the implantable medical device that is pre-selected for fitting the remote electrode and the conductive housing within the implant site.

28. The method of claim 27, wherein the overall length is greater than about 4.0 centimeters and less than about 13.0 centimeters.

29. The method of claim 25, wherein the overall length is greater than about 5.0 centimeters and less than about 10.0 centimeters.

30. The method of claim 12, further comprising the steps of receiving the transmitted signal and re-transmitting the signal.

31. The method of claim 30, further comprising the steps of receiving the re-transmitted signal and communicating the signal over a network.

32. The method of claim 31, wherein the network comprises the internet.

33. The method of claim 31, further including the step of analyzing the signal.

34. The method of claim 33, wherein the signal is analyzed after the signal is communicated over the network.

35. The method of claim 12, wherein the signal is transmitted substantially in real time.

36. The method of claim 12, wherein the signal transmitted at a given point in time is representative of the voltage difference being detected at the given point time.

37. The method of claim 12, wherein the signal is a function of the voltage difference between the remote electrode and the conductive housing.

38. The method of claim 12, wherein the step of producing a signal representative of the voltage difference between the remote electrode and the conductive housing comprises the step of amplifying the voltage difference between the remote electrode and the conductive housing.

39. The method of claim 12, further comprising the step of filtering the signal.

40. An implantable medical device, comprising:

a conductive housing;

a remote electrode mechanically coupled to the conductive housing by a lead body;

an amplifier electrically connected to the remote electrode and the conductive housing for providing a signal representative of a voltage difference between the remote electrode and the conductive housing.

41. The implantable medical device of claim 40, wherein further including a battery disposed in the conductive housing.

42. The implantable medical device of claim 41, wherein further including a battery disposed in the conductive housing.

43. The implantable medical device of claim 42, wherein the implantable power source comprises a means for generating power from a human body.

44. The implantable medical device of claim 40, wherein the lead body separates remote electrode and the conductive housing by a center to center distance that is selected so that the conductive housing, the remote electrode, and the lead body will all be received in an implant site overlaying one half of a rib cage of a human body.

45. The implantable medical device of claim 44, wherein the implant site extends between a skin and a rib cage of the human body.

46. The implantable medical device of claim 44, wherein the implant site extends between a left-most extent of a sternum of the human body and a left-most extent of a rib cage of the human body.

47. The implantable medical device of claim 44, wherein the implant site extends between a right-most extent of a sternum of the human body and a right-most extent of a rib cage of the human body.

48. The implantable medical device of claim 44, wherein the implant site extends between a lower-most surface of a clavicle of the human body and a lower-most extent of a sternum of the human body.

49. The implantable medical device of claim 44, wherein the pre-selected distance is greater than about 4.0 centimeters and less than about 10.0 centimeters.

50. The implantable medical device of claim 44, wherein the pre-selected distance is greater than about 5.0 centimeters and less than about 7.0 centimeters.

51. The implantable medical device of claim 40, wherein the remote electrode is detachably attached to the conductive housing by the lead body.

52. The implantable medical device of claim 40, further comprising a transmitter for transmitting a signal produced by the amplifier.

53. The implantable medical device of claim 40, wherein the lead body has sufficient lateral flexibility to allow relative motion between the electrode and the conductive housing in response to muscle movements of the human body.

54. The implantable medical device of claim 40, wherein the lead body has sufficient longitudinal stiffness to maintain spacing between the electrode and the conductive housing.

55. The implantable medical device of claim 40, wherein the remote electrode has a generally circular lateral cross section.

56. The implantable medical device of claim 40, wherein the remote electrode comprises a generally cylindrical body portion.

57. The implantable medical device of claim 40, wherein the remote electrode comprises a rounded tip portion.

58. The implantable medical device of claim 57, wherein the remote electrode comprises a generally hemispherical tip portion.

59. The implantable medical device of claim 40, wherein the remote electrode is free of anchors.

60. The implantable medical device of claim 40, wherein the lead body is free of anchors.

61. In combination:

a charging device comprising a first coil and a first battery coupled to the first coil for exciting the first coil;

an implantable medical device comprising a second battery and a second coil coupled to the second battery for charging the second battery;

the first coil and the second coil being inductively coupled to one another so that the second battery is charged while the first battery is depleted.

62. The combination of claim 61, wherein the implantable medical device is disposed inside a human body and the charging device is disposed outside of the human body.

63. The combination of claim 61, wherein the charging device comprises a housing defining a cavity.

64. The combination of claim 63, wherein the first battery is disposed within the cavity defined by the housing of the charging device.

65. The combination of claim 61, wherein the first battery is capable of satisfying the power requirements of the charging device.

66. The combination of claim 61, wherein the first battery is larger than the second battery.

67. The combination of claim 66, wherein the first battery is sufficiently larger than the second battery so that the first battery has sufficient capacity for fully charging the second battery and compensating for energy lost during the charging of the second battery.

68. The combination of claim 61, wherein the first battery is the sole source of power for the charging device.

69. The combination of claim 61, further comprising a garment for holding the charging device proximate the implanted medical device.

70. The combination of claim 69, wherein the garment comprises a pocket that is dimensioned to receive the charging device.

71. An implantable medical device, comprising:

a first energy storage element;

a first coil and a first regulator coupled to the first energy storage element for charging the first energy storage element at a first charging rate;

a second energy storage element coupled to the first energy storage element; and

a second regulator interposed between the first energy storage element and the second energy storage element for charging the second energy storage element at a second charging rate.

72. The implantable medical device of claim 71, wherein the second charging rate is different from the first charging rate.

73. The implantable medical device of claim 72, wherein the second charging rate is slower than the first charging rate.

74. The implantable medical device of claim 71, wherein the first energy storage element comprises one or more capacitors.

75. The implantable medical device of claim 71, further comprising a housing defining a cavity.

76. The implantable medical device of claim 75, wherein the housing comprises a metallic material.

77. The implantable medical device of claim 76, wherein the metallic material comprises titanium.

78. The implantable medical device of claim 75, wherein the first coil is disposed in the cavity defined by the housing.

79. The implantable medical device of claim 71, wherein the second energy storage element comprises a battery.

80. An implantable medical device, comprising:

a first energy storage element;

a coil coupled to the first energy storage element for charging the first energy storage element;

a second energy storage element coupled to the first energy storage element; and

a regulator interposed between the first energy storage element and the second energy storage element for charging the second energy storage element at a second charging rate.

81. The implantable medical device of claim 80, further including a diode connected between the coil and the first energy storage element.

82. The implantable medical device of claim 80, wherein the first energy storage element comprises one or more capacitors.

83. The implantable medical device of claim 80, further comprising a housing defining a cavity.

84. The implantable medical device of claim 83, wherein the housing comprises a metallic material.

86. The implantable medical device of claim 83, wherein the first coil is disposed in the cavity defined by the housing.

87. The implantable medical device of claim 80, wherein the second energy storage element comprises a battery.

85. The implantable medical device of claim 85, wherein the metallic material comprises titanium.

88. A method for placing an implantable medical device in a body, comprising the steps of:

providing an implantable medical device disposed in a lumen defined by a placement tool;

inserting a distal end of the placement tool into the body; and

moving a shaft distally within the lumen of the placement tool for urging the implantable medical device to exit the distal end of the placement tool.

89. In combination:

a placement tool having a proximal end, a distal end, and a lumen extending therebetween;

a shaft disposed in sliding engagement with the lumen of the placement tool;

the shaft being partially disposed within the lumen of the placement tool; and

an implantable medical device disposed in the lumen of the delivery tool.

90. The combination of claim 89, wherein a distal end of the shaft is disposed in the lumen of the placement tool and a proximal end of the shaft is disposed outside of the lumen of the placement tool.

91. The combination of claim 89, wherein the implantable medical device is disposed proximate a distal end of the placement tool.

92. The combination of claim 89, wherein the implantable medical device is disposed proximate a distal end of the shaft.

93. The combination of claim 92, wherein a distal end of the shaft contacts the implantable medical device.

94. The combination of claim 89, wherein the implantable medical device comprises a first electrode, a second electrode, and an amplifier electrically connected to the first electrode and the second electrode for providing a signal representative of a voltage difference between the first electrode and the second electrode.

95. The combination of claim 94, wherein the first electrode and the second electrode are capable of contacting a tissue of a body.

96. The combination of claim 89, wherein the implantable medical device is capable of detecting a physiological parameter of a human body.

97. The combination of claim 96, wherein the physiological parameter is selected from the group consisting of ECG, pressure, patient activity, patient posture, impedance, respiratory rate, respiratory effort, and glucose.