IMPLANTABLE SENSOR METHOD AND SYSTEM

• US 20130079608A1
• Filed: 09/19/2012
• Published: 03/28/2013
• Est. Priority Date: 09/27/2002
• Status: Abandoned Application

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Shah, Rajiv, Miller, Michael E
• Application Number:
  US13/622,927
• Publication Number:
  US 20130079608A1
• Time in Patent Office: Days
• US Class Current: 600/323
• 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 non-vascular implant of a sensor comprising

implanting an implant unit in an area of a body;

allowing a foreign body capsule to form around the area of the implant unit; and

directing the sensor into the foreign body capsule.

2. The method of claim 1, wherein implanting an implant unit comprises incising an area of the body large enough for the implant unit.

3. The method of claim 1, further comprising placing a material around the implant unit for promoting growth characteristics.

4. The method of claim 1, wherein the implant unit comprises electronics.

5. The method of claim 1, wherein the implant unit comprises a pump.

6. The method of claim 1, wherein allowing a foreign body capsule to form comprises inserting materials around the implant unit to promote growth characteristics.

7. The method of claim 1, further comprising attaching the sensor to the implant unit.

8. The method of claim 7, wherein the sensor is attached to the implant unit prior to formation of the foreign body capsule.

9. The method of claim 7, wherein the sensor is attached to the implant unit subsequent to formation of the foreign body capsule.

10. The method of claim 1, further comprising incising an area of the body large enough for the sensor.

11. The method of claim 10, wherein the incised area of the body large enough for the sensor is smaller than an incised area of the body large enough for the implant unit.

12. A method for non-vascular implant of a sensor comprising:

incising an area of a body large enough for inserting an implant unit;

incising an area remote from a sensor location for inserting a sensor;

directing the sensor into a body cavity;

connecting the sensor to the implant unit; and

inserting the implant unit into the body.

13. The method of claim 12, wherein inserting the implant unit into the body comprises inserting the implant unit into a pocket formed when incising an area of the body large enough for inserting the implant unit.

14. The method of claim 12, further comprising fixing the sensor in place using suture.

15. A non-vascular implant system comprising

an implant unit;

a sensor for detecting a physiological parameter, the sensor being separate from and connectable to the implant unit,

wherein the sensor is placed in a non-vascular area of the human body.

16. The system of claim 15, wherein the implant unit comprises a pump.

17. The system of claim 15, wherein the implant unit comprises electronics.

18. The system of claim 15, wherein the implant unit delivers drug to a human body.

19. The system of claim 18, wherein the drug is insulin.

20. The system of claim 15, wherein the sensor comprises a biomolecule.

21. The system of claim 15, wherein the sensor comprises a lead.

22. The system of claim 15, wherein the sensor comprises a sensing element.

23. The system of claim 22, wherein the sensing element is a biomolecule.

24. The system of claim 23, wherein the biomolecule is a glucose oxidase enzyme.

25. The system of claim 15, wherein the physiological parameter is oxygen.

26. The system of claim 15, wherein the physiological parameter is glucose.

27. The system of claim 15, wherein the non-vascular area of the human body is the peritoneum.

28. The system of claim 15, wherein the non-vascular area of the human body is subcutaneous tissue.

29. A method for non-vascular implant of a sensor comprising:

incising an area of a body large enough for inserting an implant unit;

creating a tunnel in subcutaneous tissue;

directing the sensor through the tunnel;

connecting the sensor to the implant unit; and

inserting the implant unit into the body.

30. The method of claim 29, wherein the tunnel is created using a blunt instrument.

31. The method of claim 30, wherein the blunt instrument causes minimal trauma to the subcutaneous tissue.

32. The method of claim 30, wherein the blunt instrument is a trocar.

33-68. -68. (canceled)

69. A structure for defining an in vivo implant site comprising:

a cylinder having a hollow area in an interior portion thereof,

wherein a portion of the cylinder is covered with a coating.

70. The structure of claim 69, wherein the coating is silicone rubber.

71. The structure of claim 69, wherein the cylinder is a right circular cylinder.

72. The structure of claim 69, wherein the hollow area is sufficiently large to accept a sensor.

73. The structure of claim 69, wherein the cylinder has at least one hole in an outer surface thereof.

74. A multi-analyte measuring device comprising:

a substrate;

an electrode array on a first side of the substrate; and

an integrated circuit on a second side of the substrate.

75. The multi-analyte measuring device of claim 74, wherein the electrode array and the integrated circuit are electrically connected.

76. The multi-analyte measuring device of claim 74, wherein the integrated circuit processes signals.

77. The multi-analyte measuring device of claim 74, wherein the integrated circuit monitors signals.

78. The multi-analyte measuring device of claim 74, wherein the electrode array includes an agent.

79. The multi-analyte measuring device of claim 78, wherein the agent is an enzyme.

80. The multi-analyte measuring device of claim 74, wherein the substrate comprises channels.

81. The multi-analyte measuring device of claim 74, further comprising a connector for providing access to the integrated circuit.

82. The multi-analyte measuring device of claim 81, wherein the connector connects to a display device.

83. The multi-analyte measuring device of claim 81, wherein the connector connects to a monitoring device.

84. The multi-analyte measuring device of claim 74, further comprising a power supply.

85. The multi-analyte measuring device of claim 84, wherein the power supply is a battery.

86. The multi-analyte measuring device of claim 84, wherein the power supply is a capacitor.