Leadless implantable sensor assembly and a cardiac emergency warning alarm

• US 5,404,877 A
• Filed: 06/04/1993
• Issued: 04/11/1995
• Est. Priority Date: 06/04/1993
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Telectronics Pacing Systems, Inc (Abbott Laboratories Incorporated)
• Inventors: Nolan, James A., Steinhaus, Bruce M., Nappholz, Tibor A.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US08/072,570
• Time in Patent Office: 676 Days
• Field of Search: 607/27, 607/32, 607/65, 607/60, 607/63, 607/2, 607/6, 607/18, 607/19, 607/20, 128/671, 128/702, 128/705, 128/695, 128/734
• US Class Current: 600/484
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts

Abstract

A leadless implantable cardiac arrhythmia alarm is disclosed which continuously assesses a patient'"'"'s heart function to discriminate between normal and abnormal heart functioning and, upon detecting an abnormal condition, generates a patient-warning signal. The alarm is capable of sensing impedance measurements of heart, respiratory and patient motion and, from these measurements, generating an alarm signal when the measurements indicate the occurrence of a cardiac arrhythmia. Because it requires no external leads or feedthrough connectors, the hermetically-sealed patient alarm is minimally invasive and results in reduced trauma to a patient.

Claims

1. A cardiac arrhythmia alarm for chronic subcutaneous implantation within a patient'"'"'s body, comprising:

a hermetically-sealed housing;

an electromagnetic sensor fully enclosed within said housing, said sensor including an antenna, means for applying measuring currents to said antenna, said measuring currents having frequency components within a range of from approximately 10 kilohertz to approximately 1000 megahertz, means for controlling said measuring current applying means to limit the frequency components of the applied measuring currents to lie within at least one predetermined subrange of frequencies such that the measured voltage within each subrange of frequencies corresponds to a measurement of physical motion within the patient'"'"'s body relating to a particular physiological function, means for measuring voltages developed at said antenna in response to the application of said measuring currents, and means for deriving at least one physiological parameter from the measured voltage corresponding to each of said at least one predetermined subrange of frequencies;

means responsive to said sensor for detecting a cardiac arrhythmia, said detecting means being fully enclosed within said housing; and

said acoustic alarm within said housing responsive to said detecting means for notifying the patient of an arrhythmia condition.

2. A cardiac arrhythmia alarm in accordance with claim 1, wherein said measuring current applying means includes means for generating measuring currents in the form of short-duration, square-wave-like current pulses having pulse durations in the range from 5 nanoseconds to 20 microseconds, wherein said controlling means includes means for limiting said measuring current applying means to generate measuring current pulses having pulse durations within at least one predetermined subrange of durations, wherein said at least one derived physiological parameter is a heart motion parameter and its associated subrange of pulse durations includes durations longer than approximately 300 nanoseconds, and wherein said cardiac arrhythmia detecting means derives a heart rate measurement on the basis of said heart motion parameter and detects a physiological condition indicative of a cardiac arrhythmia when said heart rate measurement is greater than a predetermined abnormal heart rate.

3. A cardiac arrhythmia alarm in accordance with claim 2, wherein said physiological parameter deriving means derives a second physiological parameter, wherein said second physiological parameter is a respiration parameter and its associated subrange of pulse durations includes durations from approximately 25 nanoseconds to approximately 500 nanoseconds, wherein said cardiac arrhythmia detecting means derives a metabolic indicator rate on the basis of said respiration parameter and sets said predetermined abnormal heart rate as a function of said metabolic indicator rate.

4. A cardiac arrhythmia alarm in accordance with claim 1, wherein said measuring current applying means includes means for generating measuring currents in the form of sinusoidal-like oscillating currents having frequency components in the range from 10 kilohertz to 1000 megahertz, wherein said controlling means includes means for limiting said measuring current applying means to generate measuring currents having sinusoidal-like oscillating frequencies within at least one predetermined subrange of frequencies, wherein said at least one derived physiological parameter is a heart motion parameter and its associated subrange of oscillating current frequencies includes frequencies lower than approximately 4 megahertz, and wherein said cardiac arrhythmia detecting means derives a heart rate measurement on the basis of said heart motion parameter and detects a physiological condition indicative of a cardiac arrhythmia when said heart rate measurement is greater than a predetermined abnormal heart rate.

5. A cardiac arrhythmia alarm in accordance with claim 4, wherein said physiological parameter deriving means derives a second physiological parameter, wherein said second physiological parameter is a respiration parameter and its associated subrange of oscillating current frequencies includes frequencies from approximately 2 megahertz to approximately 40 megahertz, wherein said cardiac arrhythmia detecting means derives a metabolic indicator rate on the basis of said respiration parameter and sets said predetermined abnormal heart rate as a function of said metabolic indicator rate.

6. A cardiac arrhythmia alarm for chronic subcutaneous implantation within a patient'"'"'s body, capable of communicating with an information-receiving device, comprising:

a hermetically-sealed housing;

an electromagnetic sensor fully enclosed within said housing, said sensor including an antenna, means for applying measuring currents to said antenna, said measuring currents having frequency components within a range of from approximately 10 kilohertz to approximately 1000 megahertz, means for controlling said measuring current applying means to limit the frequency components of the applied measuring currents to lie within at least one predetermined subrange of frequencies such that the measured voltage within each subrange of frequencies corresponds to a measurement of physical motion within the patient'"'"'s body relating to a particular physiological function, means for measuring voltages developed at said antenna in response to the application of said measuring currents, and means for deriving at least one physiological parameter from the measured voltage corresponding to each of said at least one predetermined subrange of frequencies;

means responsive to said sensor for determining a heart abnormality, said detecting means being fully enclosed within said housing; and

a transmitter within said housing responsive to said determining means for communicating with said information-receiving device to report on the heart abnormality.

7. A cardiac arrhythmia alarm in accordance with claim 6, wherein said transmitter includes means to initiate a communication with said information-receiving device independent of the operation of said information-receiving device.

8. A cardiac arrhythmia alarm in accordance with claim 7, wherein said transmitter includes means to report a heart abnormality in the form of a diagnostic message.

9. A cardiac arrhythmia alarm in accordance with claim 6, wherein said sensor, said determining means and said transmitter all include means to operate continuously, independently of external control by said information-receiving device.

10. A cardiac arrhythmia alarm in accordance with claim 6, wherein said measuring current applying means includes a circuit to generate a constant measuring current.

11. A cardiac arrhythmia alarm in accordance with claim 6, wherein said measuring current applying means includes a circuit to generate measuring current using a constant voltage.

12. A cardiac arrhythmia alarm in accordance with claim 6, wherein said measuring current applying means includes means for generating measuring currents in the form of short-duration, square-wave-like current pulses having pulse durations in the range from 5 nanoseconds to 20 microseconds, wherein said controlling means includes means for limiting said measuring current applying means to generate measuring current pulses having pulse durations within at least one predetermined subrange of durations, wherein said at least one derived physiological parameter is a heart motion parameter and its associated subrange of pulse durations includes durations longer than approximately 300 nanoseconds, and wherein said heart abnormality determining means derives a heart rate measurement on the basis of said heart motion parameter and detects a physiological condition indicative of a heart abnormality when said heart rate measurement is greater than a predetermined abnormal heart rate.

13. A cardiac arrhythmia alarm in accordance with claim 12, wherein said physiological parameter deriving means derives a second physiological parameter, wherein said second physiological parameter is a respiration parameter and its associated subrange of pulse durations includes durations from approximately 25 nanoseconds to approximately 500 nanoseconds, and wherein said heart abnormality determining means derives a metabolic indicator rate on the basis of said respiration parameter and sets said predetermined abnormal heart rate as a function of said metabolic indicator rate.

14. A cardiac arrhythmia alarm in accordance with claim 6, wherein said measuring current applying means includes means for generating measuring currents in the form of short-duration, square-wave-like current pulses, wherein said controlling means includes means for regulating said measuring current applying means to generate measuring current pulses having a predetermined pulse duration, said regulating means regulating, for each of said measuring current pulses, at least one subrange of sampling times with respect to the onset of the current pulse at which said measuring current applying means measures the voltage developed at said antenna by the current pulse, and wherein said at least one subrange of sampling times defines a sampling frequency which corresponds to a measurement of a physiological parameter.

15. A cardiac arrhythmia alarm in accordance with claim 14, wherein said at least one derived physiological parameter is a heart motion parameter and its associated subrange of sampling times includes times longer than approximately 300 nanoseconds, and wherein said heart abnormality determining means derives a heart rate measurement on the basis of said heart motion parameter and detects a physiological condition indicative of a heart abnormality when the heart rate parameter is greater that a predetermined abnormal heart rate.

16. A cardiac arrhythmia alarm in accordance with claim 15, wherein said physiological parameter deriving means derives a second physiological parameter, wherein said second physiological parameter is a respiration parameter and its associated subrange of sampling times includes times from approximately 25 nanoseconds to approximately 500 nanoseconds, and wherein said heart abnormality determining means derives a metabolic indicator rate on the basis of said respiration parameter and sets the predetermined abnormal heart rate as a function of said metabolic indicator rate.

17. A cardiac arrhythmia alarm in accordance with claim 6, wherein said measuring current applying means includes means for generating measuring currents in the form of sinusoidal-like oscillating currents having frequency components in the range from 10 kilohertz to 1000 megahertz, wherein said controlling means includes means for limiting said measuring current applying means to generate measuring currents having sinusoidal-like oscillating frequencies within at least one predetermined subrange of frequencies, wherein said at least one derived physiological parameter is a heart motion parameter and its associated subrange of oscillating current frequencies includes frequencies lower than approximately 4 megahertz, and wherein said heart abnormality determining means derives a heart rate measurement on the basis of said heart motion parameter and detects a physiological condition indicative of a heart abnormality when said heart rate measurement is greater that a predetermined abnormal heart rate.

18. A cardiac arrhythmia alarm in accordance with claim 17, wherein said physiological parameter deriving means derives a second physiological parameter, wherein said second physiological parameter is a respiration parameter and its associated subrange of oscillating current frequencies includes frequencies from approximately 2 megahertz to approximately 40 megahertz, and wherein said heart abnormality determining means derives a metabolic indicator rate on the basis of said respiration parameter and sets said predetermined abnormal heart rate as a function of said metabolic indicator rate.

19. A cardiac arrhythmia alarm in accordance with claim 6, wherein said measuring current applying means includes means for generating measuring currents in the form of timed pulses of sinusoidal-like oscillating currents having timed pulses of durations of at least 5 nanoseconds and having frequency components in the range of from 10 kilohertz to 1000 megahertz, and wherein said controlling means includes means for limiting said measuring current applying means to generate measuring currents having oscillating frequencies within at least one predetermined subrange of frequencies.

20. A cardiac arrhythmia alarm for chronic subcutaneous implantation within a patient'"'"'s body, capable of communicating with an information-receiving device, comprising:

a hermetically-sealed housing;

an electromagnetic sensor fully enclosed within said housing, said sensor including an antenna, means for applying measuring currents to said antenna, said measuring currents having frequency components within a range of from approximately 10 kilohertz to approximately 1000 megahertz, means for controlling said measuring current applying means to limit the frequency components of the applied measuring currents to lie within at least one predetermined subrange of frequencies such that the measured voltage within each subrange of frequencies corresponds to a measurement of physical motion within the patient'"'"'s body relating to a particular physiological function, means for measuring voltages developed at said antenna in response to the application of said measuring currents, and means for deriving at least one physiological parameter from the measured voltage corresponding to each of said at least one predetermined subrange of frequencies;

means responsive to said sensor for deriving cardiac information therefrom, said responsive means being fully enclosed within said housing; and

means within said housing responsive to said deriving means for communicating with said information-receiving device to report on the derived cardiac information.

21. A method for monitoring a patient'"'"'s heartbeat signals using a hermetically-sealed cardiac arrhythmia alarm apparatus to detect and warn of a cardiac arrhythmia condition comprising the steps of:

measuring impedance within the patient'"'"'s body, said impedance measuring step comprising the substeps of applying measuring currents to an antenna fully enclosed within the apparatus and measuring voltages developed at the antenna in response to the application of said measuring currents, said measuring currents having frequency components within a range from approximately 10 kilohertz to approximately 1000 megahertz;

controlling the frequency components of the applied measuring current to lie within at least one predetermined subrange of frequencies such that the measured voltage within each subrange of frequencies corresponds to a measurement of a physiological parameter;

deriving at least one physiological parameter from the measured voltage corresponding to each of said at least one predetermined subrange of frequencies;

analyzing the derived at least one physiological parameter to detect a physiological condition indicative of a heart abnormality; and

upon the detection of a heart abnormality, activating an acoustic alarm within said apparatus to notify the patient of said heart abnormality.

22. A method in accordance with claim 21, wherein said impedance measuring step includes the further substep of generating said measuring currents in the form of short-duration, square-wave-like current pulses having pulse durations in the range of from 5 nanoseconds to 20 microseconds, and wherein said controlling step includes the substep of regulating said impedance measuring step to generate measuring current pulses having pulse durations within at least one predetermined subrange of durations.

23. A method in accordance with claim 22, wherein said controlling step includes the substep of regulating said impedance measuring step to generate measuring current pulses having pulse durations longer than approximately 300 nanoseconds.

24. A method in accordance with claim 23, wherein said at least one derived physiological parameter is a heart motion parameter, and wherein said analyzing step includes the substeps of determining a heart rate parameter on the basis of said heart motion parameter and detecting a physiological condition indicative of a heart abnormality when said heart rate parameter is greater than a predetermined abnormal heart rate.

25. A method in accordance with claim 24, wherein said deriving step includes the substep of driving a second physiological parameter, said second physiological parameter being a respiration parameter, and wherein said controlling step includes the further substep of regulating said impedance measuring step to also generate measuring current pulses having pulse durations from approximately 25 nanoseconds to approximately 500 nanoseconds.

26. A method in accordance with claim 25, wherein said analyzing step includes the further substeps of deriving a metabolic indicator rate on the basis of said respiration parameter and setting said predetermined abnormal heart rate as a function of said metabolic indicator rate.

27. A method in accordance with claim 24, wherein said deriving step includes the substep of deriving a second physiological parameter, said second physiological parameter being a patient motion parameter, and wherein said controlling step includes the further substep of regulating said impedance measuring step to also generate measuring current pulses having pulse durations shorter than approximately 125 nanoseconds.

28. A method in accordance with claim 27, wherein said analyzing step includes the further substeps of deriving a metabolic indicator rate on the basis of said patient motion parameter and setting said predetermined abnormal heart rate as a function of said metabolic indicator rate.

29. A method in accordance with claim 21, wherein said impedance measuring step includes the further substep of generating said measuring currents in the form of oscillating measuring currents having frequency components in the range of from 10 kilohertz to 1000 megahertz, and wherein said controlling step includes the substep of limiting said impedance measuring step to generating measuring currents having oscillating current frequencies.

30. A method in accordance with claim 29, wherein said controlling step includes the substep of regulating said impedance measuring step to generate oscillating measuring currents having frequencies lower than approximately 4 megahertz.

31. A method in accordance with claim 30, wherein said at least one derived physiological parameter is a heart motion parameter, and wherein said analyzing step includes the substeps of determining a heart rate parameter on the basis of said heart motion parameter and detecting a physiological condition indicative of a heart abnormality when said heart rate parameter is greater than a predetermined abnormal heart rate.

32. A method in accordance with claim 31, wherein said deriving step includes the substep of deriving a second physiological parameter, said second physiological parameter being a respiration parameter, and wherein said controlling step includes the further substep of regulating said impedance measuring step to also generate oscillating measuring currents having frequencies from approximately 2 megahertz to approximately 40 megahertz.

33. A method in accordance with claim 32, wherein said analyzing step includes the further substeps of deriving a metabolic indicator rate on the basis of said respiration parameter and setting said predetermined abnormal heart rate as a function of said metabolic indicator rate.

34. A method in accordance with claim 31, wherein said deriving step includes the substep of deriving a second physiological parameter, said second physiological parameter being a patient motion parameter, and wherein said controlling step includes the further substep of regulating said impedance measuring step to also generate oscillating measuring currents having frequencies higher than approximately 8 megahertz.

35. A method in accordance with claim 34, wherein said analyzing step includes the further substeps of deriving a metabolic indicator rate on the basis of said patient motion parameter and setting said predetermined abnormal heart rate as a function of said metabolic indicator rate.

36. A method in accordance with claim 21, wherein said impedance measuring step includes the further substep of generating measuring currents in the form of timed pulses of sinusoidal-like oscillating currents having timed pulses of durations of at least 5 nanoseconds and having frequency components in the range from 10 kilohertz to 1000 megahertz, wherein said controlling step includes the substep of limiting said impedance measuring step to generate measuring currents having oscillating current frequencies within at least one predetermined subrange of frequencies, and wherein the measured voltage within each subrange of frequencies corresponds to a measurement of a physiological parameter.

37. A method in accordance with claim 21, further comprising the steps of:

upon the detection of a heart abnormality, initiating communication with a non-implanted message-receiving device independent of the operation of said message-receiving device; and

transmitting diagnostic messages to said message-receiving device upon initiation of communication.

38. A leadless cardiac sensor assembly for chronic subcutaneous implantation within a patient'"'"'s body, comprising:

a hermetically-sealed housing; and

an electromagnetic sensor fully enclosed within said housing, said sensor including an antenna, means for applying excitation signals to said antenna, said excitation signals having frequency components within a range of from approximately 10 kilohertz to approximately 1000 megahertz, means for controlling said excitation signal applying means to limit the frequency components of the applied excitation signals to lie within at least one predetermined subrange of frequencies such that a received signal within each subrange of frequencies corresponds to a measurement of physical motion within the patient'"'"'s body relating to a particular physiological function, means for measuring received signals developed at said antenna in response to the application of said excitation signals, and means for deriving at least one physiological parameter from the received signal corresponding to each of said at least one predetermined subrange of frequencies.

39. The leadless sensor in accordance with claim 38, wherein said excitation signal applying means includes means for generating excitation signals in the form of short-duration, square-wave-like signal pulses having pulse durations in the range from 5 nanoseconds to 20 microseconds, wherein said controlling means includes means for limiting said excitation signal applying means to generate excitation signals having pulse durations within at least one predetermined subrange of durations, and wherein said at least one derived physiological parameter is a heart motion parameter.

40. The leadless sensor in accordance with claim 39, wherein said physiological parameter deriving means derives a second physiological parameter, wherein said second physiological parameter is a respiration parameter and its associated subrange of pulse durations includes durations from approximately 25 nanoseconds to approximately 500 nanoseconds, said sensor further comprising heart rate means for deriving a heart rate on the basis of said respiration parameter.

41. A device for monitoring body organs, body tissues or fluid contents thereof, said device comprising:

a hermetically-sealed housing; and

an electromagnetic sensor fully enclosed within said housing, said sensor including;

(a) an antenna,

(b) means for applying excitation signals to said antenna, said excitation signals having frequency components exceeding 10 kilohertz,

(c) means for controlling said excitation signal applying means to limit the frequency components of the applied excitation signals to lie within at least one predetermined subrange of frequencies such that a received signal within each subrange of frequencies corresponds to a physiological parameter within the patient'"'"'s body relating to a particular physiological function,

(d) means for measuring received signals developed at said antenna in response to the application of said excitation signals, and

(e) means for deriving said parameter from the received signals.

42. The device of claim 41 wherein said physical parameter relates to the motion of said patient'"'"'s heart.

43. The device of claim 41 wherein said physical parameter relates to a tissue motion within said patient.

44. A method for monitoring a patient'"'"'s heartbeat signals using a hermetically-sealed leaderless sensor apparatus to generate a signal indicative of a cardiac parameter comprising the steps of:

measuring impedance within the patient'"'"'s body, said impedance measuring step comprising the substeps of applying measuring currents to an antenna fully enclosed within the apparatus and measuring signals developed at the antenna in response to the application of said measuring currents, said measuring currents having frequency components within a range from approximately 10 kilohertz;

controlling the frequency components of the applied measuring current to lie within at least one predetermined subrange of frequencies such that the measured signal within each subrange of frequencies corresponds to a measurement of a physiological parameter; and

deriving at least one physiological parameter from the measured voltage corresponding to said at least one predetermined subrange of frequencies.