Implantable sensor method and system

• US 8,292,808 B2
• Filed: 09/16/2008
• Issued: 10/23/2012
• 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
• Primary Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US12/211,783
• Publication Number:
  US 20090030297A1
• Time in Patent Office: 1,498 Days
• Field of Search: 600/347, 600/365
• US Class Current: 600/309
• 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 5/145 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 5/6847 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 intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material 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. A method for sensing a physiological parameter comprising:

implanting an implant unit in a non-vascular area of a body;

allowing a foreign body capsule to form around the implant unit to surround the implant unit;

providing a sensor lead, a first sensor element on the sensor lead for detecting a physiological parameter, the first sensor element configured to sense a first individual amount of the physiological parameter, and a second sensor element on the sensor lead for detecting the physiological parameter, the second sensor element configured to sense a second individual amount of the physiological parameter, wherein the sensor lead is separate but connectable to the implant unit;

implanting the sensor lead with the first sensor element and second sensor element in a non-vascular area of the body and connecting the sensor lead to the implant unit;

sensing the first individual amount and the second individual amount of the physiological parameter and generating a signal representing the first and second individual sensed amounts of the physiological parameter; and

determining an overall amount of the physiological parameter by calculating a total statistical measurement of the first and second individual sensed amounts from the signals generated from the sensor elements.

2. The method of claim 1, wherein the physiological parameter is at least one of oxygen and glucose.

3. The method of claim 1, wherein the calculating the statistical measurement includes using at least one algorithm that employs values associated with the signal generated from the sensor.

4. The method of claim 1, the method further comprising:

securing a site housing to the body at a reusable sensor site, the site housing configured for use with the sensor lead.

5. The method of claim 4, the site housing having a cavity for receiving an analyte and a conduit for providing fluid communication between the cavity of the site housing and subcutaneous tissue in the body.

6. The method of claim 5, the site housing comprising a material for allowing the analyte to pass through the material into the cavity of the site housing.

7. The method of claim 5, the conduit having a predetermined length to substantially inhibit trauma to subcutaneous tissue approximately adjacent the conduit.

8. The system of claim 5, the system further comprising:

a layer of fluid provided on at least a portion of the cavity of the site housing.

9. The method of claim 1, wherein the first sensor element and the second sensor element are comprised in a plurality of spatially separated sensing elements, each of the plurality of spatially separated sensing elements for detecting a sensed amount of a physiological parameter at that spatially separated sensing element and generating a signal representing the sensed amount at that spatially separated sensing element, wherein the sensed amounts from the signals generated from the plurality of spatially separated sensing elements includes the first and second individual sensed amounts;

and

wherein determining the overall amount of the physiological parameter includes calculating the total statistical measurement of the sensed amounts from the signals generated from the plurality of spatially separated sensing elements.

10. The method of claim 9, the plurality of spatially separated sensing elements being 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.

11. The method of claim 9, wherein the total statistical measurement is at least one of a maximum amount for the sensed amounts, an average amount of the sensed amounts, a median of the sensed amount, an arithmetic mean of the-sensed amounts, and a weighted arithmetic mean of the sensed amounts.

12. The method of claim 9, wherein the computing element is 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.

13. The method of claim 1, the method further comprising:

providing a pump for delivering a drug to the body.

14. The method of claim 13, wherein the providing the pump comprises implanting the pump in the body.

15. The method of claim 1, wherein the non-vascular area of the body includes

subcutaneous tissue.

16. The method of claim 1, wherein the sensor lead is approximately 9 inches long.

17. The method of claim 1, wherein the distance between the first sensing element and the second sensing element is approximately 5 or 6 inches.

18. The method of claim 1, wherein the first sensing element is located near an end of the sensor lead that is connectable to the implant unit and the second sensing element is located near an end of the sensor lead that is furthest away from the end that is connectable to the implant unit.

19. The method of claim 1, wherein the sensor lead and implant unit are both implanted in the peritoneum.

20. The of claim 1, wherein the implant unit includes a pump operable to deliver a drug to the body.