Body worn physiological sensor device having a disposable electrode module

• US 10,159,422 B2
• Filed: 01/26/2018
• Issued: 12/25/2018
• Est. Priority Date: 11/01/2006
• Status: Active Grant

• Current Assignee: Welch Allyn Incorporated
• Original Assignee: Welch Allyn Incorporated
• Inventors: Baker, Steven D., McAdams, Eric T., Welch, James P.
• Primary Examiner(s): Johnson, Nicole F
• Application Number:
  US15/880,712
• Publication Number:
  US 20180146877A1
• Time in Patent Office: 333 Days
• Field of Search: 600372, 600508-509
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/0214 Capacitive electrodes
• CPC Class Codes: A61B 2562/182 Electrical shielding, e.g. using a Faraday cage
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/274 using snap or button fasteners
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/301 providing electrical separation, e.g. by using isolating transformers or optocouplers
• CPC Class Codes: A61B 5/303 Patient cord assembly, e.g. cable harness
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/68335 including release sheets or liners
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 : Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B

Abstract

A body worn patient monitoring device includes a flexible substrate having a plurality of electrical connections adapted to be coupled to a skin surface to measure physiological signals. The flexible substrate is adapted to be directly and non-permanently affixed to a skin surface of a patient and configured for single patient use. A communication-computation module, removably attached to an upper surface of the flexible substrate, is configured to receive physiological signals from the flexible substrate and includes a microprocessor that is configured to process and analyze the physiological signals. A series of resistive traces screened onto the flexible substrate are configured as at least one series current-limiting resistor to protect the communication-computation module.

Claims

1. A method for manufacturing a body-worn physiological sensor, the method comprising:

providing a disposable substrate made from an insulating material, said substrate comprising;

a flexible printed circuit board layer made from the insulating material;

at least two electrodes disposed on the disposable substrate; and

conductive traces defined between the at least two electrodes;

providing a computation-communication module, said module comprising;

a housing;

a processor disposed in the housing; and

attaching the computation-communication module to the disposable substrate.

2. The method of claim 1, further comprising:

providing conductive traces in the flexible circuit layer.

3. The method of claim 2, in which the conductive traces are configured on the flexible circuit layer to electrically couple with the attached computation-communication module.

4. The method of claim 1, further comprising:

providing a plurality of openings in the flexible printed circuit board layer, the openings being sized for receiving electrode gels.

5. The method of claim 1, in which the computation-communication module is releasably attached to the disposable substrate.

6. The method of claim 1, further comprising:

providing a radio circuit in the computation-communication module.

7. The method of claim 3, further comprising:

at least partially covering the conductive traces with an insulating covering.

8. The method of claim 7, in which the insulating covering is a fabric.

9. The method of claim 1, further comprising:

integrating at least two electrodes into the flexible printed circuit board layer of the disposable substrate.

10. The method of claim 3, further comprising:

screening the conductive traces onto the flexible printed circuit board layer.

11. The method of claim 9, in which each electrode includes an electrode gel and a conductive surface defining a half cell.

12. The method of claim 11, in which the disposable substrate is crescent shaped and in which the body-worn physiological sensor is worn on the chest of a patient.

13. The method of claim 3, further comprising:

providing a pacer circuit in the flexible printed circuit board layer of the disposable substrate.

14. A body-worn physiological sensor made by the process of:

providing a disposable substrate made from an insulating material, said substrate comprising;

a flexible printed circuit board layer made from an insulating material;

at least two electrodes disposed on the disposable substrate; and

conductive traces defined between the at least two electrodes;

providing a computation-communication module, said module comprising;

a housing;

a processor disposed in the housing; and

attaching the computation-communication module to the disposable substrate.

15. The body-worn physiological sensor of claim 14, wherein the process further comprises:

providing the conductive traces in the flexible printed circuit board layer.

16. The body-worn physiological sensor of claim 15, in which the process further comprises:

configuring the conductive traces in the flexible printed circuit board layer to electrically couple with the attached computation-communication module.

17. The body-worn physiological sensor of claim 14, in which the computation-communication module is releasably attached to the disposable substrate.

18. The body-worn physiological sensor of claim 14, wherein the process further comprises:

providing the computation-communication module with a radio circuit.

19. The body-worn physiological sensor of claim 16, in which the process further comprises:

at least partially covering the conductive traces with an insulating covering.

20. The body-worn physiological sensor of claim 14, in which the process further comprises:

integrating at least two electrodes into the flexible printed circuit board layer of the disposable substrate.