Transcutaneous monitor & method of use, using therapeutic output from an implanted medical device

• US 20030004554A1
• Filed: 04/30/2002
• Published: 01/02/2003
• Est. Priority Date: 04/30/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Willenbring, James E., Linden, Gregory J., Riff, Kenneth M.
• Granted Patent: US 7,272,433 B2
• Time in Patent Office: Days
• US Class Current: 607/62
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation

Abstract

An external physiologic or implanted device monitor/controller (“monitor”) designed to be attached to the body, as for example, to the skin of the patient. The monitor is designed to detect the therapeutic outputs actually produced by the implanted medical device. Having knowledge of the operation of the implanted medical device, the monitor may then deduce, or decode, the physiologic conditions and/or devices conditions sensed by the implanted medical device. The monitor is then able to perform an action appropriate to the sensed condition and the specific implementation.

Claims

1. A monitoring system for monitoring a patient, comprising:

an implantable medical device configurable to be implanted into said patient, said implantable medical device being capable, when implanted, of generating a therapeutic effect to said patient according to known parameters in response to a physiologic condition of said patient, said implantable medical device having an output indicative of said therapeutic effect; and

a monitor, externally attachable to said patient, containing a sensor for monitoring said output, deducing an underlying condition from said output and acting in response to thereto.

2. A monitoring system as in claim 1 wherein said output is a therapeutic stimulus.

3. A monitoring system as in claim 2 wherein said therapeutic stimulus is an electrical signal.

4. A monitoring system as in claim 3 wherein said implanted medical device is configured to generate said therapeutic stimulus to said patient according to known predetermined parameters in response to said physiologic condition.

5. A monitoring system as in claim 4 wherein said monitor is attachable to said patient with a skin patch electrode.

6. A monitoring system as in claim 5 wherein said skin patch electrode is attached to said skin of said patient through the use of an adhesive.

7. A monitoring system as in claim 1 wherein said monitor acts in response thereto by communicating said underlying condition externally from said monitor using a signaling device.

8. A monitoring system as in claim 7 wherein said signaling device utilizes radio-telemetry communication to an external receiver.

9. A monitoring system as in claim 7 wherein said monitor communicates via a visual indication.

10. A monitoring system as in claim 1 wherein said monitor acts in response thereto by controlling a secondary medical device.

11. A monitoring system as in claim 1 wherein said underlying condition is indicative of said physiologic condition.

12. A monitoring system as in claim 1 wherein said underlying condition is of a condition of said implantable medical device.

14. A monitoring device as in claim 13 wherein said output is a therapeutic stimulus.

15. A monitoring device as in claim 14 wherein said patient has skin and wherein said monitor is externally attachable to said skin of said patient.

16. A monitoring device as in claim 15 wherein said monitor is attachable to said patient with a skin patch electrode.

17. A monitoring device as in claim 16 wherein said skin patch electrode is attached to said skin of said patient through the use of an adhesive.

18. A monitoring device as in claim 14 wherein said therapeutic stimulus is an electrical signal.

19. A monitoring device as in claim 18 wherein said implanted medical device is configured to generate said electrical signal to said patient according to known predetermined parameters in response to said physiologic condition.

20. A monitoring device as in claim 13 wherein said output is a magnetic signal.

21. A monitoring device as in claim 13 wherein said output is an acoustic signal.

22. A monitoring device as in claim 13 wherein said monitor acts in response thereto by communicating said underlying condition externally from said monitor using a signaling device.

23. A monitoring device as in claim 22 wherein said signaling device utilizes radio-telemetry communication to an external receiver.

24. A monitoring device as in claim 22 wherein said monitor communicates via a visual indication.

25. A monitoring device as in claim 13 wherein said monitor acts in response thereto by controlling a secondary medical device.

26. A monitoring device as in claim 13 wherein said underlying condition is indicative of said physiologic condition

27. A monitoring device as in claim 13 wherein said underlying condition is of a condition of said implantable medical device.

29. A physiologic monitoring device as in claim 28 wherein said patient has skin and wherein said monitor is externally attachable to said skin of said patient.

30. A physiologic monitoring device as in claim 29 wherein said monitor is attachable to said patient with a skin patch electrode.

31. A physiologic monitoring device as in claim 30 wherein said skin patch electrode is attached to said skin of said patient through the use of an adhesive.

32. A physiologic monitoring device as in claim 28 wherein said therapeutic stimulus is an electrical signal.

33. A physiologic monitoring device as in claim 28 wherein said implanted medical device is configured to generate said therapeutic stimulus to said patient according to known predetermined parameters in response to said physiologic condition.

34. A physiologic monitoring device as in claim 28 wherein said monitor acts in response thereto by communicating said underlying condition externally from said monitor using a signaling device.

35. A physiologic monitoring device as in claim 34 wherein said signaling device utilizes radio-telemetry communication to an external receiver.

36. A physiologic monitoring device as in claim 34 wherein said monitor communicates via a visual indication.

37. A physiologic monitoring device as in claim 28 wherein said monitor acts in response thereto by controlling a secondary medical device.

39. A physiologic monitor as in claim 38 wherein said therapeutic stimulus is an electrical signal.

40. A physiologic monitor as in claim 38 wherein said implanted medical device is configured to generate said therapeutic stimulus to said patient according to known predetermined parameters in response to said physiologic condition.

41. A physiologic monitor as in claim 38 wherein algorithm decoder is programmable via an external programming device.

42. A physiologic monitor as in claim 38 wherein said signaling device utilizes radio-telemetry communication to an external receiver.

43. A physiologic monitor as in claim 38 wherein said signaling device comprises a visual indicator.

13. A monitoring device for monitoring a patient having an implanted medical device configured to generate a therapeutic effect to said patient according to known parameters in response to said physiologic condition of said patient, said implanted medical device having an output indicative of said therapeutic effect, comprising a monitor, externally attachable to said patient, a sensor for monitoring said output, deducing an underlying condition from said output and acting in response thereto.

28. A physiologic monitoring device for monitoring a physiologic condition of a patient having an implanted medical device configured to generate a therapeutic stimulus to said patient according to known parameters in response to said physiologic condition of said patient, comprising a monitor, externally attachable to said patient, a sensor for monitoring said therapeutic stimulus, deducing said physiologic condition from said therapeutic stimulus and acting in response thereto.

38. A physiologic monitor, externally attachable to a patient having skin, for monitoring a physiologic condition of said patient having an implanted medical device configured to generate a therapeutic stimulus to said patient according to known parameters in response to said physiologic condition of said patient, comprising:

a skin patch electrode attached to said skin of said patient for sensing said therapeutic stimulus;

an algorithm decoder, operatively coupled to said skin patch electrode, for deducing said physiologic condition from said therapeutic stimulus; and

signaling device, operatively coupled to said algorithm decoder, communicating said physiologic condition externally from said physiologic monitor.

44. A method of monitoring a patient, comprising the steps of:

implanting a medical device into said patient, said implantable medical device being capable, when implanted, of generating a therapeutic effect to said patient according to known parameters in response to said physiologic condition of said patient, said implantable medical device having an output indicative of said therapeutic effect; and

externally attaching a monitor to said patient, said monitor containing a sensor for monitoring said output, deducing an underlying condition from said output and acting in response thereto.

45. A method of monitoring as in claim 44 wherein said output is a therapeutic stimulus.

46. A method of monitoring as in claim 45 wherein said therapeutic stimulus is an electrical signal.

47. A method of monitoring as in claim 46 wherein said implanted medical device is configured to generate said therapeutic stimulus to said patient according to known predetermined parameters in response to said physiologic condition.

48. A monitoring system as in claim 44 wherein said monitor acts in response thereto by communicating said underlying condition externally from said monitor using a signaling device.

49. A method of monitoring as in claim 48 wherein said signaling device utilizes radio-telemetry communication to an external receiver.

50. A method of monitoring as in claim 48 wherein said monitor communicates via a visual indication.

51. A method of monitoring as in claim 44 wherein said monitor acts in response thereto by controlling a secondary medical device.

52. A method of monitoring as in claim 44 wherein said underlying condition is indicative of said physiologic condition

53. A method of monitoring as in claim 44 wherein said underlying condition is of a condition of said implantable medical device.

54. A method of monitoring a physiologic condition of a patient having an implanted medical device configured to generate a therapeutic effect to said patient according to known parameters in response to said physiologic condition of said patient, said implanted medical device having an output indicative of said therapeutic effect, comprising the steps of:

sensing said output;

deducing said physiologic condition from said output; and

acting in response thereto.

55. A method of monitoring as in claim 54 wherein said output is a therapeutic stimulus.

56. A method of monitoring as in claim 55 wherein said therapeutic stimulus is an electrical signal.

57. A method of monitoring as in claim 56 wherein said implanted medical device is configured to generate said therapeutic stimulus to said patient according to known predetermined parameters in response to said physiologic condition.

58. A method of monitoring as in claim 57 wherein said sensing step is accomplished via a skin patch attached to said skin of said patient.

59. A method of monitoring as in claim 54 wherein said output is a magnetic signal.

60. A method of monitoring as in claim 54 wherein said output is an acoustic signal.

61. A method of monitoring as in claim 54 wherein said monitor acts in response thereto by providing a visual indication.

62. A method of monitoring as in claim 54 wherein said monitor acts in response thereto by controlling a secondary medical device.