Implantable multi-parameter sensing system and method

• US 8,086,323 B2
• Filed: 09/23/2003
• Issued: 12/27/2011
• Est. Priority Date: 09/23/2003
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Reghabi, Bahar, Gottlieb, Rebecca, Shah, Rajiv, Enegren, Bradley
• Primary Examiner(s): Getzow, Scott
• Assistant Examiner(s): PATTON, AMANDA K
• Application Number:
  US10/669,426
• Publication Number:
  US 20050065556A1
• Time in Patent Office: 3,017 Days
• Field of Search: 607/6, 607 21- 23, 607 17- 18, 607/116, 607/119, 600300-302, 600/323
• US Class Current: 607/116
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor

Abstract

A system and method of sensing multiple parameters. The method may include implanting an implantable sensor in a patient and reading an output from at least one of the implantable sensing elements. The implantable sensor may have a housing within which are disposed a plurality of implantable sensing elements. At least one of the implantable sensing elements may respond to lactate. In addition, a medical professional may administer to the patient for myocardial ischemia, myocardial infarction angina, sepsis based on the output read. A medical professional may also administer to the patient having an implantable cardiovascular defibrillator or who is receiving extracorporeal membrane oxygenation. The method may be used in a surgical or intensive care environment.

Claims

1. A method of sensing multiple parameters, the method comprising:

implanting an implantable sensor at a single site in a patient, the implantable sensor including a housing having an interior volume within which are disposed a plurality of implantable sensing elements, each implantable sensing element of the plurality of implantable sensing elements operable through electrical communication with an external controller via a respective interconnect of a plurality of interconnects, each respective interconnect of the plurality of interconnects independently connected to a respective implantable sensing element of the plurality of implantable sensing elements, each implantable sensing element of the plurality of implantable sensing elements located within the interior volume of the housing of the implantable sensor, each implantable sensing element of the plurality of implantable sensing elements for sensing within the interior volume of the housing of the implantable sensor at least one of a respective biological parameter, a respective physiological parameter, and a respective analyte; and

reading an output from at least one implantable sensing element of the plurality of implantable sensing elements;

wherein a plurality of parameters are read from the implantable sensor at the single site;

wherein the output read from the at least one implantable sensing element of the plurality of implantable sensing elements is a quantifiable value; and

wherein the plurality of interconnects are equal in number to the plurality of implantable sensing elements.

2. The method of claim 1, wherein at least one particular implantable sensing element of the plurality of implantable sensing elements is a biological parameter sensor.

3. The method of claim 1, wherein at least one particular implantable sensing element of the plurality of implantable sensing elements is a physiological parameter sensor.

4. The method of claim 1, wherein at least one particular implantable sensing element of the plurality of implantable sensing elements is an analyte sensor.

5. The method of claim 1, wherein reading an output from the at least one implantable sensing element of the plurality of implantable sensing elements comprises reading an output from an implantable sensing element of the plurality of implantable sensing elements that responds to lactate.

6. The method of claim 1, wherein reading an output from the at least one implantable sensing element of the plurality of implantable sensing elements comprises reading an output from an implantable sensing element of the plurality of implantable sensing elements that responds to blood oxygen saturation.

7. The method of claim 1, wherein reading an output from the at least one implantable sensing element of the plurality of implantable sensing elements comprises reading an output from an implantable sensing element of the plurality of implantable sensing elements that responds to blood pressure.

8. The method of claim 1, wherein reading an output from the at least one implantable sensing element of the plurality of implantable sensing elements comprises reading an output from an implantable sensing element of the plurality of implantable sensing elements that responds to glucose.

9. The method of claim 1, wherein reading an output from the at least one implantable sensing element of the plurality of implantable sensing elements comprises reading an output from an implantable sensing element of the plurality of implantable sensing elements that responds to temperature.

10. The method of claim 1, wherein reading an output from the at least one implantable sensing element of the plurality of implantable sensing elements comprises reading an output from an implantable sensing element of the plurality of implantable sensing elements that responds to potassium.

11. The method of claim 1, wherein reading an output from the at least one implantable sensing element of the plurality of implantable sensing elements comprises reading an output from at least one implantable sensing element of the plurality of implantable sensing elements that responds to pH.

12. The method of claim 1, further comprising administering therapy to the patient based on the output read from the at least one implantable sensing element of the plurality of implantable sensing elements.

13. The method of claim 12, wherein administering therapy comprises administering therapy for myocardial ischemia.

14. The method of claim 12, wherein administering therapy comprises administering therapy for myocardial infarction.

15. The method of claim 12, wherein administering therapy comprises administering therapy for angina.

16. The method of claim 12, wherein administering therapy comprises adjusting a function of an implantable cardiovascular defibrillator disposed within the patient.

17. The method of claim 12, wherein administering therapy comprises adjusting a placement of an implantable cardiovascular defibrillator disposed within the patient.

18. The method of claim 12, wherein administering therapy comprises administering therapy for sepsis.

19. The method of claim 12, wherein administering therapy comprises administering therapy for septic shock.

20. The method of claim 12, wherein administering therapy comprises administering therapy for a patient receiving extracorporeal membrane oxygenation.

21. The method of claim 12, wherein administering therapy comprises administering therapy for a patient undergoing cardiac bypass.

22. The method of claim 12, wherein administering therapy comprises administering therapy for a patient during dialysis.

23. The method of claim 1, further comprising classifying a severity of a condition of the patient based on the output read from the at least one implantable sensing element of the plurality of the implantable sensing elements.

24. The method of claim 1, wherein the patient is in a surgical environment.

25. The method of claim 1, wherein the patient is in an intensive care environment.

26. The method of claim 1, wherein each respective interconnect of the plurality of interconnects between each implantable sensing element of the plurality of implantable sensing elements and the external controller does not pass through any other implantable sensing element of the plurality of implantable sensing elements.

27. The method of claim 1,

wherein the external controller is external to the housing of the implantable sensor;

and

wherein each respective interconnect of the plurality of interconnects between each implantable sensing element of the plurality of implantable sensing elements and the external controller is separate from all other interconnects for every other implantable sensing element of the plurality of implantable sensing elements on a corresponding communication path from each implantable sensing element of the plurality of implantable sensing elements to the external controller.

28. A method of claim 1, wherein each implantable sensing element of the plurality of implantable sensing elements is coupled by wire for electrical communication with the external controller.

29. The method of claim 1,

wherein each implantable sensing element of the plurality of implantable sensing elements of the comprises a respective power supply of a plurality of power supplies;

and

wherein the respective power supply of each implantable sensing element of the plurality of implantable sensing elements is for powering the implantable sensing element.

30. The method of claim 1, the housing having an aperture for allowing each implantable sensing element of the plurality of implantable sensing elements to sense within the housing of the implantable sensor the at least one of a respective biological parameter, a respective physiological parameter, and a respective analyte.

31. The method of claim 30, the aperture for allowing fluid to pass into a volume inside the housing of the implantable sensor to allow each implantable sensing element of the plurality of implantable sensing elements to sense within the housing of the implantable sensor the at least one of a respective biological parameter, a respective physiological parameter, and a respective analyte.

32. The method of claim 1, wherein each implantable sensing element of the plurality of implantable sensing elements is disposed completely within the housing of the implantable sensor.

33. The method of claim 1, wherein each respective interconnect of the plurality of interconnects connects with the respective implantable sensing element inside the housing of the implantable sensor.

34. The method of claim 1, wherein the plurality of interconnects are equal in number to the plurality of implantable sensing elements in the interior volume of the housing of the implantable sensor.

35. The method of claim 1, wherein all of the implantable sensing elements are located in the interior volume of the housing.

36. The method of claim 1, wherein the exterior surface of the housing of the implantable sensor is free of the plurality of implantable sensing elements.

37. A method of evaluating a patient, the method comprising:

implanting an implantable sensor in a patient, the implantable sensor including a housing having an interior volume within which are disposed a plurality of implantable sensing elements, each implantable sensing element of the plurality of implantable sensing elements operable through electrical communication with an external controller via a respective interconnect of a plurality of interconnects, each respective interconnect of the plurality of interconnects independently connected to a respective implantable sensing element of the plurality of implantable sensing elements, each implantable sensing element of the plurality of implantable sensing elements located within the interior volume of the housing of the implantable sensor, each implantable sensing element of the plurality of implantable sensing elements for sensing within the interior volume of the housing of the implantable sensor at least one of a respective biological parameter, a respective physiological parameter, and a respective analyte;

reading an output from at least one implantable sensing element of the plurality of implantable sensing elements; and

evaluating the patient based on the output read from the at least one implantable sensing element;

wherein a plurality of parameters are read from the implantable sensor at a single site;

wherein the output read from the at least one implantable sensing element of the plurality of implantable sensing elements is a quantifiable value; and

wherein the plurality of interconnects are equal in number to the plurality of implantable sensing elements.

38. The method of claim 37, wherein evaluating the patient comprises evaluating the patient based on an output from a particular implantable sensing element of the plurality of implantable sensing elements that responds to lactate.

39. The method of claim 37, wherein evaluating the patient comprises evaluating the patient based on an output from a particular implantable sensing element of the plurality of implantable sensing elements that responds to blood oxygen saturation.

40. The method of claim 37, wherein evaluating the patient comprises evaluating the patient based on an output from a particular implantable sensing element of the plurality of implantable sensing elements that responds to blood pressure.

41. The method of claim 37, wherein evaluating the patient comprises evaluating the patient based on an output from a particular implantable sensing element of the plurality of implantable sensing elements that responds to glucose.

42. The method of claim 37, wherein evaluating the patient comprises evaluating the patient based on an output from a particular implantable sensing element of the plurality of implantable sensing elements that responds to temperature.

43. The method of claim 37, wherein evaluating the patient comprises evaluating the patient based on an output from a particular implantable sensing element of the plurality of implantable sensing elements that responds to potassium.

44. The method of claim 37, wherein evaluating the patient comprises evaluating the patient based on an output from a particular implantable sensing element of the plurality of implantable sensing elements that responds to pH.

45. The method of claim 37, wherein evaluating the patient comprises evaluating the patient for myocardial ischemia.

46. The method of claim 37, wherein evaluating the patient comprises evaluating the patient for myocardial infarction.

47. The method of claim 37, wherein evaluating the patient comprises evaluating the patient for angina.

48. The method of claim 37, wherein evaluating the patient comprises evaluating the patient having an implantable cardiovascular defibrillator.

49. The method of claim 37, wherein evaluating the patient comprises evaluating the patient for sepsis.

50. The method of claim 37, wherein evaluating the patient comprises evaluating the patient receiving extracorporeal membrane oxygenation.

51. The method of claim 37, wherein evaluating the patient comprises evaluating the patient while the patient is undergoing a cardiac bypass.

52. The method of claim 37, wherein evaluating the patient comprises evaluating the patient during dialysis.

53. The method of claim 37, wherein each respective interconnect of the plurality of interconnects between each implantable sensing element of the plurality of implantable sensing elements and the external controller does not pass through any other implantable sensing element of the plurality of implantable sensing elements.

54. The method of claim 37,

wherein the external controller is external to the housing of the implantable sensor;

and

wherein each respective interconnect of the plurality of interconnects between each implantable sensing element of the plurality of implantable sensing elements and the external controller is separate from all other interconnects for every other implantable sensing element of the plurality of implantable sensing elements on a corresponding communication path from each the implantable sensing element of the plurality of implantable sensing elements to the external controller.

55. A method of claim 37, wherein each implantable sensing element of the plurality of implantable sensing elements is coupled by wire for electrical communication with the external controller.

56. The method of claim 37,

wherein each implantable sensing element of the plurality of implantable sensing elements of the comprises a respective power supply of a plurality of power supplies;

and

wherein the respective power supply of each implantable sensing element of the plurality of implantable sensing elements is for powering the implantable sensing element.

57. A method of sensing multiple parameters, the method comprising:

implanting an implantable sensor at a single site in a patient, the implantable sensor including a housing having an interior volume within which are disposed a plurality of implantable sensing elements, each implantable sensing element of the plurality of implantable sensing elements operable through electrical communication with an external controller via a respective one of a plurality of interconnects, each respective interconnect of the plurality of interconnects independently connected to a respective implantable sensing element of the plurality of implantable sensing elements, each of the implantable sensing element of the plurality of implantable sensing elements located within the interior volume of the housing of the implantable sensor, each implantable sensing element of the plurality of a parameter implantable sensing elements for sensing within the interior volume of the housing of the implantable sensor at least one of a respective biological parameter, a respective physiological parameter, and a respective analyte; and

reading an output from at least one implantable sensing element of the plurality of implantable sensing elements;

wherein a plurality of parameters are read from the implantable sensor at the single site;

wherein the output read from the at least one implantable sensing element of the plurality of implantable sensing elements is a quantifiable value; and

wherein the plurality of interconnects are equal in number to the plurality of implantable sensing elements.

58. The method of claim 57, wherein each implantable sensing element of the plurality of implantable sensing elements is operable through electrical communication with an external controller via a respective individual interconnect of a plurality of individual interconnects.

59. The method of claim 57, wherein each implantable sensing element of the plurality of implantable sensing elements allows for sensing at least one of a respective biological parameter, a respective physiological parameter, and a respective analyte.

60. A method of claim 57, wherein each implantable sensing element of the plurality of implantable sensing elements is electrically connected to an electrical conductor that extends out of the housing of the implantable sensor.

61. A method of claim 57, wherein each implantable sensing element of the plurality of implantable sensing elements is electrically connected to an electrical conductor that is electrically connectable to a remote device outside of the housing of the implantable sensor.

62. A method of claim 57, wherein each implantable sensing element of the plurality of implantable sensing elements is electrically connected to an electrical conductor that is electrically connectable to a controller.

63. The method of claim 57,

wherein each implantable sensing element of the plurality of implantable sensing elements of the comprises a respective power supply of a plurality of power supplies;

and

wherein the respective power supply of each implantable sensing element of the plurality of implantable sensing elements is for powering the implantable sensing element.

64. A method of sensing multiple parameters, the method comprising:

implanting an implantable sensor at a single site in a patient, the implantable sensor including a housing having an interior volume within which are disposed a plurality of implantable sensing elements, each implantable sensing element of the plurality of implantable sensing elements operable through electrical communication with an external controller having a plurality of interconnects, each respective interconnect of the plurality of interconnects independently connected to a respective implantable sensing element of the plurality of implantable sensing elements, each implantable sensing element of the plurality of implantable sensing elements located within the interior volume of the housing of the implantable sensor, each implantable sensing element of the plurality of implantable sensing elements for sensing within the interior volume of the housing at least one of a respective biological parameter, a respective physiological parameter, and a respective analyte; and

reading an output from at least one implantable sensing element of the plurality of implantable sensing elements;

wherein a plurality of parameters are read from the implantable sensor at the single site;

wherein the output read from said at least one implantable sensing element of the plurality of implantable sensing elements is a quantifiable value;

wherein the plurality of implantable sensing elements comprises at least one of a lactate sensing element for measuring a parameter for blood lactate level, a blood oxygen saturation sensing element for measuring a parameter for blood oxygen level, and a pH level sensing element for measuring a parameter for pH level; and

wherein the plurality of interconnects are equal in number to the plurality of implantable sensing elements.

65. The method of claim 64, further comprising administering therapy for myocardial ischemia to the patient based on the output read from the at least one implantable sensing element.

66. The method of claim 64, further comprising administering therapy for myocardial infarction or angina to the patient based on the output read from the at least one implantable sensing element of the plurality of implantable sensing elements.

67. The method of claim 64, further comprising implanting an implantable cardiovascular defibrillator (ICD) into the patient and administering defibrillation on the patient based on the output read from the at least one implantable sensing element of the plurality of implantable sensing elements.

68. The method of claim 64, further comprising administering therapy for sepsis or septic shock to the patient based on the output read from the at least one implantable sensing element of the plurality of implantable sensing elements.

69. The method of claim 64, further comprising the step of administering therapy for extracorporeal membrane oxygenation (ECMO) to the patient based on the output read from the at least one implantable sensing element of the plurality of implantable sensing elements.

70. The method of claim 64,

wherein the external controller is external to the housing of the implantable sensor;

and

wherein each respective interconnect of the plurality of interconnects between each implantable sensing element of the plurality of implantable sensing elements and the external controller is separate from all other interconnects of the plurality of individual interconnects on a corresponding communication path from each implantable sensing element of the plurality of implantable sensing elements to the external controller.

71. A method of claim 64, wherein each implantable sensing element of the plurality of implantable sensing elements is coupled by wire for electrical communication with the external controller.