Implantable device for vital signs monitoring

• US 20070016089A1
• Filed: 07/15/2005
• Published: 01/18/2007
• Est. Priority Date: 07/15/2005
• Status: Abandoned Application

• Current Assignee: Hi-Tronics Designs, Inc. (Abbott Laboratories Incorporated), Angel Medical Systems, Inc.
• Original Assignee: Hi-Tronics Designs, Inc. (Abbott Laboratories Incorporated), Angel Medical Systems, Inc.
• Inventors: Johnson, Steven, Harwood, Jonathan, Fischell, Tim, Fischell, David, Turi, Gregg
• Application Number:
  US11/181,969
• Publication Number:
  US 20070016089A1
• Time in Patent Office: Days
• US Class Current: 600/509
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle

Abstract

An implantable medical device is provided for subcutaneous implantation within a human being. The implantable medical device includes a pair of electrodes for sensing electrical signals from the human being'"'"'s heart. Electronic circuitry having digital memory is provided with the electronic circuitry designed to record the electrical signals from the heart. The electronics of the electronic circuitry are housed in a case having a tapered shape to facilitate implantation and removal of the implantable medical device.

Claims

1. A implantable medical device for subcutaneous implantation within the body of a human patient the device including:

at least two electrodes for sensing the electrical signals from the patient'"'"'s heart;

electronic circuitry including digital memory designed to record the electrical signals from the heart;

the electronics being housed in a case having a tapered shape to facilitate implantation and removal of the device.

2. The device of claim 1 where the case is tapered in thickness with the ends being thinner than the middle.

3. The device of claim 1 where the case is tapered in width with the ends being thinner than the middle.

4. The device of claim 1 where the case is tapered in both width and thickness.

5. The device of claim 1 further including a detachable subcutaneous lead.

6. The device of claim 5 where the detachable lead is less than 1 inch long.

7. The device of claim 5 where the detachable lead is between 1 and 6 inches long.

8. The device of claim 5 where the detachable lead is greater than 6 inches in length.

9. The device of claim 5 where the detachable lead has exactly one electrode.

10. The device of claim 5 where the detachable lead has two or more electrodes.

11. The device of claim 1 further including a blood oxygen level sensor.

12. The device of claim 11 where the blood oxygen level sensor is a photoplesmography sensor.

13. The device of claim 1 further including a temperature sensor.

14. The device of claim 1 further including means to calculate and store R-R interval variability data.

15. The device of claim 1 further including a blood pressure sensor.

16. The device of claim 1 further including patient alerting means.

17. The device of claim 16 where the patient alerting means is located within the device.

18. The device of claim 16 where the patient alerting means is located external to the device.

19. The device of claim 16 also including patient alerting means located within the device. and a separate patient alerting means external to the device.

20. The device of claim 1 further including telemetry means, the telemetry means being designed to communicate with external equipment at a distance of greater than six inches.

21. A implantable medical device for subcutaneous implantation within the body of a human patient the device including:

a shell housing containing the electronics and battery for the implantable medical device;

at least two electrodes for sensing the electrical signals from the patient'"'"'s heart where one electrode is located on the shell housing and the other electrode is located on a detachable subcutaneous lead, the detachable subcutaneous lead having one of at least two different lengths.

22. The device of claim 21 where the detachable lead is less than 1 inch long.

23. The device of claim 21 where the detachable lead is between 1 and 6 inches long.

24. The device of claim 21 where the detachable lead is greater than 6 inches in length.

25. The device of claim 21 where the detachable lead has exactly one electrode.

26. The device of claim 21 where the detachable lead has two or more electrodes.

27. The device of claim 21 further including a blood oxygen level sensor.

28. The device of claim 27 where the blood oxygen level sensor is a photoplesmography sensor.

29. The device of claim 21 further including a temperature sensor.

30. The device of claim 21 further including means to calculate and store R-R interval variability data.

31. The device of claim 21 further including patient alerting means.

32. The device of claim 31 where the patient alerting means is located within the device.

33. The device of claim 31 where the patient alerting means is located external to the device.

34. The device of claim 31 also including patient alerting means located within the device and a separate patient alerting means external to the device.

35. The device of claim 21 further including telemetry means, the telemetry means being designed to communicate with external equipment at a distance of greater than six inches.

42. The method of claim 25 where the medical device includes electrodes for sensing electrical signals from the human heart, the timing of beats being measured from the electrical signals.

36. A method of calculating the spectrum of R-R interval variability, the method including the steps of:

a. implanting a medical device within the body of a human patient, the medical device being part of a system including at least one processor designed to measure the timing of beats of a patient'"'"'s heart from a signal sensed within the patients body;

b. having the at least one processor measure the R-R interval for a multiplicity of beats during the preset time period;

c. having the at least one processor calculate average R-R interval for the multiplicity of beats during the preset time period;

d. having the at least one processor calculate the R-R interval variability as the difference between the R-R interval and average R-R interval for the multiplicity of beats during the preset time period.

37. The method of claim 36 further including the steps:

e. having the at least one processor construct a time history of R-R interval variability;

f. having the at least one processor calculate the amplitude and duration of each half wave formed between maxima and minima of the time history of R-R interval variability.

g. having the at least one processor construct a power spectrum of R-R interval variability from the amplitude and duration data of the half waves.

38. The method of claim 37 further including a step h of having the processor compare the R-R interval variability power spectrum at a given time to the spectrum of R-R interval variability from an earlier time.

39. The method of claim 38 further including a step i of alerting the patient if the comparison indicates a change in the R-R interval variability power spectrum exceeds a preset threshold.

40. The method of claim 39 where the patient is alerted by an alerting signal produced by the implanted medical device.

41. The method of claim 39 where the patient is alerted by an alerting signal produced by the external equipment.

43. The method of claim 36 where the medical device includes a photoplesmography sensor for sensing oxygen levels from the patient'"'"'s vasculature, the timing of beats of the patient'"'"'s heart being measured from the signal produced by the photoplesmography sensor.

44. The method of claim 36 where there is at least one processor located in the implanted medical device 45. The method of claim 36 where there is at least one processor located in external equipment 46. The method of claim 45 where there are at least two processors with at least one processor being located in the implanted medical device and at least one processor being located in the external equipment.