IMPLANTABLE SENSOR METHOD AND SYSTEM

• US 20090030297A1
• Filed: 09/16/2008
• Published: 01/29/2009
• Est. Priority Date: 09/27/2002
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Miller, Michael E., Shah, Rajiv
• GRANTED PATENT: US 8,292,808 B2
• Time in patent office: 0 Days
• US Class Current: 600/345
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/04 Measuring bioelectric signals of the body or parts thereof
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61M 1/1698 Blood oxygenators with or without heat-exchangers A61M1/1678 takes precedence; membranes therefor B01D67/00, B01D69/00, B01D71/00
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

Systems and methods for non-vascular sensor implantation and for measuring physiological parameters in areas of a body where the physiological parameters are heterogeneous. An implant unit is implanted in an area of a body and a foreign body capsule is allowed to form around the implant unit area. A sensor may be directed into a body cavity such as, for example, the peritoneal space, subcutaneous tissues, the foreign body capsule, or other area. A subcutaneous area of the body may be tunneled for sensor placement. Spatially separated sensing elements may be used for detecting individual amounts of the physiological parameter. An overall amount of the physiological parameter may be determined by calculating a statistical measurement of the individual sensed amounts in the area. Another embodiment of the invention, a multi-analyte measuring device, may include a substrate having an electrode array on one side and an integrated circuit on another side.

Claims

1-14. -14. (canceled)

16-24. -24. (canceled)

26-36. -36. (canceled)

38-45. -45. (canceled)

47-58. -58. (canceled)

59. A sensor system comprising:

a sensor for detecting a physiological parameter, the sensor configured to detect an individual sensed amount of the physiological parameter and configured to generate a signal representing the individual sensed amount; and

a computing element configured to determine an amount of the physiological parameter by calculating a statistical measurement of the individual sensed amount from the signal generated from the sensor.

15. The system of claim 59, the system further comprising

a medical device adapted to be implanted in an area of a human body;

the sensor being separate from and connectable to the medical device.

25. The system of claim 59, the physiological parameter is being at least one of oxygen and glucose.

37. The system of claim 87, the plurality of spatially separated sensing elements configured in at least one of a one-dimensional array of sensing elements a two-dimensional array of sensing elements, and a three-dimensional array of sensing elements.

46. The system of claim 87,

the computing element configured to detect a first signal representing a first individual sensed amount of the physiological parameter from one of the plurality of spatially spaced sensing elements;

and

the computing element configured to detect a second signal representing a second individual sensed amount of the physiological parameter from another of the plurality of spatially spaced sensing elements.

60. The system of claim 87, wherein the total statistical measurement is at least one of a maximum amount for the individual sensed amounts, an average amount of the individual sensed amounts, a median of the individual sensed amounts, an arithmetic mean of the individual sensed amounts, and a weighted arithmetic mean of the individual sensed amounts.

61. The system of claim 87, the computing element configured to calculate the total statistical measurement using at least one algorithm that employs values associated with the signals generated from the plurality of spatially separated sensing elements.

62. The system of claim 87, the system further comprising a sensor lead, the plurality of spatially separated sensing elements being located along at least a portion of a length of the lead.

74. The system of claim 59, the sensor comprising:

an electrode; and

an integrated circuit electrically connected to the electrode.

82. The system of claim 59, the sensor adapted to connect to at least one of a display device and a monitoring device.

87. The system of claim 59, the sensor comprising:

a plurality of spatially separated sensing elements, each of the plurality of spatially separated sensing elements for detecting an individual sensed amount of a physiological parameter and generating a signal representing the individual sensed amount;

the computing element for determining an overall amount of the physiological parameter by calculating a total statistical measurement of the individual sensed amounts from the signals generated from the plurality of spatially separated sensing elements.

88. The system of claim 59, the computing element configured to calculate the statistical measurement using at least one algorithm that employs values associated with the signal generated from the sensor.

89. The system of claim 59, the sensor adapted for use in subcutaneous tissue in a human body.

90. The system of claim 59, the sensor adapted for use external to a human body.

91. The system of claim 59, the system further comprising:

a medical device for delivering a drug to a human body.

92. The system of claim 91, the medical device adapted to be implanted in the human body.

93. The system of claim 59, the system further comprising:

a base adapted to be secured to a human body, the base configured for use with the sensor, the base having a housing.

94. The system of claim 93, the housing having a cavity for receiving an analyte and a conduit for providing fluid communication between the cavity of the housing and subcutaneous tissue in a case where the base is secured to the human body.

95. The system of claim 94, the housing comprising a material for allowing the analyte to pass through the material into the cavity of the housing.

96. The system of claim 94, the conduit having a predetermined length to substantially inhibit trauma to subcutaneous tissue approximately adjacent the conduit in a case where the base is secured to the human body.

97. The system of claim 94, the system further comprising:

a layer of fluid provided on at least one of at least a portion of the sensor and the cavity of the housing.

98. The system of claim 74, the electrode and the integrated circuit arranged to operate in two different environments.

105. The method of claim 93, the method further comprising:

adapting a base to be secured to a human body, the base having a housing, the housing having a cavity for receiving an analyte and a conduit for providing fluid communication between the cavity of the housing and subcutaneous tissue in a case where the base is secured to the human body.

63-73. -73. (canceled)

75-81. -81. (canceled)

83-86. -86. (canceled)

99. A method for sensing a physiological parameter comprising:

providing a sensor for detecting a physiological parameter;

detecting an individual sensed amount of the physiological parameter and generating a signal representing the individual sensed amount; and

determining an amount of the physiological parameter by calculating a total statistical measurement of the individual sensed amount from the signal generated from the sensor.

100. The method of claim 99, providing a sensor comprising:

providing a plurality of spatially separated sensing elements, each of the plurality of spatially separated sensing elements for detecting an individual sensed amount of a physiological parameter and generating a signal representing the individual sensed amount; and

determining an overall amount of the physiological parameter by calculating a total statistical measurement of the individual sensed amounts from the signals generated from the plurality of spatially separated sensing elements.

101. The method of claim 99, the method further comprising:

implanting a medical device in an area of a human body, the sensor being separate from and connectable to the implant unit.

102. The method of claim 99, the method further comprising:

providing a pump for delivering a drug to a human body.

103. The method of claim 102, providing the pump comprising implanting the pump in the human body.

104. The method of claim 99, the method further comprising:

adapting the sensor for use in subcutaneous tissue in a human body.

106. A sensor system, the system comprising:

a sensor configured to detect an individual sensed amount of a physiological parameter; and

a base adapted to be secured to a human body, the base configured for use with the sensor;

at least one of the base and the sensor configured to receive an analyte having the physiological parameter;

the base having a conduit for providing fluid communication between the base and subcutaneous tissue in a case where the base is secured to the human body.