Therapeutic device including acoustic sensor

• US 9,955,938 B2
• Filed: 06/25/2014
• Issued: 05/01/2018
• Est. Priority Date: 06/26/2013
• Status: Active Grant

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Inventors: Kaib, Thomas E.
• Primary Examiner(s): Johnson, Nicole F
• Application Number:
  US14/314,799
• Publication Number:
  US 20150005588A1
• Time in Patent Office: 1,406 Days
• Field of Search: 600372, 600528
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 7/04 Electric stethoscopes microphones, acoustic transducers therefor H04R
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: G10L 25/48 specially adapted for particular use

Abstract

Disclosed herein are methods and apparatus including medical devices having features for monitoring sounds and motions indicative of a state of health or administration of CPR to a subject. In one embodiment, a therapeutic device such as a therapy electrode comprises a layer configured to deliver a therapy to a subject and an acoustic sensor on the therapeutic device and coupled to the layer.

Claims

1. A therapeutic device comprising:

a therapy electrode comprising;

a substrate;

a conductive layer disposed on a lower surface of the substrate and configured to deliver a therapy to a subject; and

an acoustic sensor disposed within the therapy electrode and mechanically coupled to the conductive layer, the acoustic sensor configured to acoustically couple to a body of a subject to which the therapy electrode is applied, the acoustic sensor comprising

a multi-channel accelerometer,

wherein a first channel of the multi-channel accelerometer is configured to monitor sounds produced by a heart of the subject, and

a second channel of the multi-channel accelerometer is configured to monitor at least one additional parameter associated with a state of the subject, the at least one additional parameter including one or more of a parameter associated with respiration of the subject, gastrointestinal sounds of the subject, snoring of the subject, body position of the subject, and body movement of the subject.

2. The therapeutic device of claim 1, wherein the acoustic sensor comprises a MEMS accelerometer.

3. The therapeutic device of claim 1, wherein the acoustic sensor comprises a three-channel accelerometer.

4. The therapeutic device of claim 1, wherein the acoustic sensor is a three axis multiple-channel accelerometer.

5. The therapeutic device of claim 4, wherein the acoustic sensor and associated electronics is configured to provide an indication of whether the therapeutic device has been correctly oriented on the subject.

6. The therapeutic device of claim 4,

wherein the therapy electrode further comprises an electrically conductive gel reservoir configured to release an electrically conductive gel onto a surface of the conductive layer;

and

wherein the acoustic sensor is acoustically coupled to the surface of the conductive layer through a cap housing the conductive gel reservoir.

7. The therapeutic device of claim 6, wherein the acoustic sensor is adhered to an internal surface of the cap.

8. The therapeutic device of claim 7, wherein the acoustic sensor is adhered to an upper wall of the cap.

9. The therapeutic device of claim 1, wherein the acoustic sensor is coupled to a system configured to record signals indicative of sounds produced by a heart of the subject.

10. The therapeutic device of claim 1, including an adhesive layer configured to adhere the conductive layer to the subject.

11. The therapeutic device of claim 1, wherein the therapy electrode is configured to selectively apply at least one of a defibrillation shock to the subject, electrical current as a part of Transcutaneous Electrical Nerve Stimulation (TENS) therapy, and electrical pacing of a heart of the subject.

12. The therapeutic device of claim 1, wherein the therapy electrode is configured to selectively apply a plurality of forms of therapy to the subject.

13. The therapeutic device of claim 1, wherein the therapy electrode is configured to monitor an ECG of the subject.

14. The therapeutic device of claim 1, further comprising a signal conductor electrically coupling the acoustic sensor to a circuit board coupled to the therapy electrode, the signal conductor being coupled to the therapy electrode with sufficient slack to provide for the therapeutic device to flex.

15. The therapeutic device of claim 14, wherein the signal conductor extends along a multidimensional route to supply the slack to the signal conductor when the therapeutic device is flexed.

16. The therapeutic device of claim 1, further comprising a controller configured to prompt the subject to provide a verbal response prior to delivery of a therapy, and to halt delivery of the therapy responsive to a voice of the subject being detected by the acoustic sensor.

17. The therapeutic device of claim 16, wherein the controller is configured to differentiate between the voice of the subject and a voice of a person other than the subject detected by the acoustic sensor.

18. The therapeutic device of claim 17, wherein the controller is configured to perform different actions responsive to detection of the voice of the subject by the acoustic sensor and detection of the voice of the person other than the subject by the acoustic sensor.

19. The therapeutic device of claim 1, wherein the parameter associated with respiration of the subject includes one of sounds of respiration of the subject and movement of a chest of the subject.

20. The therapeutic device of claim 1, wherein the therapeutic device is configured to warn the subject responsive to sounds produced by a heart of the subject being indicative of an abnormal cardiac condition of the subject.

21. The therapeutic device of claim 1, wherein the therapeutic device is configured to provide an electric current to the subject in response to an activation signal, and wherein the therapeutic device further comprises an impedance reduction system configured to dispense an electrically conductive gel onto a first surface of the conductive layer in response to the activation signal.

22. A medical device assembly comprising:

a substrate;

a layer disposed on the substrate, the layer forming a therapeutic device portion of the medical device assembly, the layer having a first surface configured to be placed adjacent a patient'"'"'s skin and to selectively apply a therapy to the patient in response to an activation signal; and

an acoustic sensor acoustically coupled to the layer, the acoustic sensor including a multi-channel accelerometer, a first channel of the multi-channel accelerometer being configured to monitor sounds produced by a heart of the patient, and a second channel of the multi-channel accelerometer being configured to monitor at least one additional parameter associated with a state of the patient, the at least one additional parameter including one or more of a parameter associated with respiration of the patient, gastrointestinal sounds of the patient, snoring of the patient, body position of the patient, and body movement of the patient.

23. The medical device assembly of claim 22, wherein the acoustic sensor includes a MEMS accelerometer.

24. The medical device assembly of claim 22, wherein the acoustic sensor includes a three axis multi-channel accelerometer.

25. The medical device assembly of claim 24, wherein the acoustic sensor includes a three-channel accelerometer.

26. The medical device assembly of claim 25, wherein a second channel of the three-channel accelerometer is configured to monitor the respiration of the patient, and a third channel of the three-channel accelerometer is configured to monitor movement of the patient.

27. The medical device assembly of claim 22, wherein the acoustic sensor is configured to be electrically coupled to a system configured to record signals indicative of sounds produced by a heart of the patient.

28. The medical device assembly of claim 27, wherein the system is further configured to analyze the signals indicative of the sounds produced by the heart of the patient.

29. The medical device assembly of claim 28, wherein the system is further configured to warn the patient responsive to the sounds produced by the heart of the patient being indicative of an abnormal cardiac condition of the patient.

30. The medical device assembly of claim 22, further comprising an impedance reduction system including a conductive gel reservoir configured to releasably store an amount of electrically conductive gel to be dispensed onto the first surface of the layer in response to the activation signal, and wherein the acoustic sensor is acoustically coupled to the layer through a cap enclosing the conductive gel reservoir.

31. The medical device assembly of claim 30, wherein the acoustic sensor is mechanically coupled to an internal wall of the cap.

32. The medical device assembly of claim 31, wherein the acoustic sensor is disposed on an upper internal wall of the cap.

33. The medical device assembly of claim 22, wherein the layer comprises an electrically conductive layer forming an electrode portion, wherein the therapy comprises providing an electric current to the patient in response to the activation signal, and wherein the medical device assembly further comprises an impedance reduction system configured to dispense an electrically conductive gel onto the first surface of the layer in response to the activation signal.

34. The medical device assembly of claim 22, further comprising at least one ECG sensing electrode configured to monitor an ECG of the patient.

35. A therapeutic device comprising:

a therapy electrode including;

a substrate;

a conductive layer disposed on a lower surface of the substrate;

an electrically conductive gel reservoir configured to release an electrically conductive gel onto a surface of the conductive layer; and

an acoustic sensor disposed within the therapy electrode and configured to acoustically couple to a body of a subject to which the therapy electrode is applied, the acoustic sensor being acoustically coupled to the conductive layer through a cap housing the conductive gel reservoir.