Systems and methods for compound motor action potential monitoring with neuromodulation of the pelvis and other body regions

• US 9,603,526 B2
• Filed: 10/31/2014
• Issued: 03/28/2017
• Est. Priority Date: 11/01/2013
• Status: Expired due to Fees

• Current Assignee: CMAP Technology,llc
• Original Assignee: CMAP Technology,llc
• Inventors: Benson, Kevin D., Lucente, Vincent R., Miklos, John R.
• Primary Examiner(s): Stout, Michael C
• Assistant Examiner(s): Kolderman, Nicholas E
• Application Number:
  US14/530,211
• Publication Number:
  US 20150126894A1
• Time in Patent Office: 879 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/391 of genito-urinary organs
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

An electromyography muscle sensing system including a sensor platform and a cloud-based data analysis and storage platform. The sensor platform has an electromyography muscle sensor having sensing electrodes and a signal processing circuit having a sensor output, an analog-to-digital converter having a digital output, a memory, a communications device, a display indicating a status and an indication of CMAP presence, a microcontroller maintaining a record of a current procedure, transmitting in real-time the record, determining if CMAP is being achieved, and displaying a status or indication of CMAP. The data analysis and storage platform has a database, organizes and stores the output data, maintains a history of each procedure, analyzes the output data and defines a successful CMAP outcome, predicts an outcome of the current procedure if the output data correlates with stored output data of a successful CMAP outcome, and real-time communicates the outcome of the current procedure.

Claims

1. An electromyography muscle sensing system, comprising:

a sensor platform having;

an electromyography muscle sensor having;

sensing electrodes with patient contacts at which electrical energy is at least one of measured and supplied; and

a signal processing circuit electrically connected to the sensing electrodes and having a sensor output;

an analog-to-digital converter electrically connected to the sensor output and having a digital output at which is supplied a signal representing an electromyogram waveform;

a memory;

a communications device sending output data from the sensor platform and receiving input data into the sensor platform;

a display displaying information to a user to indicate at least one of a status of the sensor platform and an indication of CMAP presence or absence; and

a microcontroller electrically connected to the sensor, the analog-to-digital converter, the memory, the display, and the communications device, the microcontroller;

receiving from the digital output the signal and storing at least a portion of the signal in the memory;

maintaining a record of a current procedure being performed by the sensor platform;

providing communication directives to the communications device to transmit in real-time at least portions of the record to and/or from the sensor platform;

determining if CMAP is being achieved in the current procedure; and

providing at the display at least one of the status of the sensor platform and the indication of CMAP presence or absence; and

a cloud-based data analysis and storage platform communicatively connected at least to the communications device of the sensor platform to receive the output data from the sensor platform and to send the input data to the sensor platform, the cloud-based data analysis and storage platform;

having a database;

centrally organizing and storing the output data from the sensor platform in the database;

maintaining a history of each procedure of the sensor platform in the database;

analyzing the stored output data and the history to define stored output data of a successful CMAP outcome;

storing the output data in the database and asking the user to tag that data as achieving one of a successful CMAP and an unsuccessful CMAP every time a CMAP procedure is undertaken with the sensor platform;

predicting an outcome of the current procedure by comparing at least a portion of the output data in the current procedure with output data in the database to determine if the portion of the current output data correlates with the stored output data of the successful CMAP outcome; and

communicating in real time the outcome of the current procedure.

2. The electromyography muscle sensing system according to claim 1, wherein at least one of the electromyography muscle sensor and the communications device of the sensor platform is a wireless handheld sensor platform.

3. The electromyography muscle sensing system according to claim 1, wherein the sensor platform is one of a laptop, a smart phone, and a tablet.

4. The electromyography muscle sensing system according to claim 1, wherein the sensor platform is a plurality of sensor platforms.

5. The electromyography muscle sensing system according to claim 1, wherein the sensing electrodes comprise a positive electrode, a negative electrode, and a ground electrode.

6. The electromyography muscle sensing system according to claim 1, wherein the signal processing circuit includes:

an amplification circuit having an input connected to at least one of the electrodes and a first amplification output;

a rectification circuit connected to the first amplification output of the amplification circuit having a rectified output at which is provided a rectified signal;

a smoothing circuit connected to the rectified output, smoothing the rectified signal, and having a smoothed output; and

a publication circuit amplifying the smoothed output and publishing the output signal.

7. The electromyography muscle sensing system according to claim 1, wherein a voltage of the output signal supplied to the analog-to-digital converter represents the electromyogram waveform.

8. The electromyography muscle sensing system according to claim 1, wherein:

the signal includes values of at least one of date, time, and session identifier; and

the microcontroller stores the values in the memory.

9. The electromyography muscle sensing system according to claim 1, wherein the communications device is a wireless radio.

10. The electromyography muscle sensing system according to claim 1, wherein the communications device is a Bluetooth radio.

11. The electromyography muscle sensing system according to claim 1, wherein the signal processing circuit includes at least one of:

a filter having settings for gain, high cut, and low cut;

a trigger threshold sensitivity;

a time base with a trigger window; and

a selective audio filter.

12. The electromyography muscle sensing system according to claim 1, wherein the user and default settings of the sensor include at least one of voltage, signal gain, sample frequency, and amplitude.

13. The electromyography muscle sensing system according to claim 1, wherein the record of the current procedure includes a patient'"'"'s demographic information, a procedure duration, and EMG event data.

14. The electromyography muscle sensing system according to claim 1, wherein CMAP is achieved according to the formula Delta EMG=ABS(E1−

E2), where a time between E1 and E2 is in milliseconds and EMG is a value of the digital output.

15. The electromyography muscle sensing system according to claim 1, wherein a graphical mapping is indicated at the display by at least one of sound, lights, graphics, and tactile measures.

16. The electromyography muscle sensing system according to claim 1, wherein the cloud platform is a centralized computer server connected to the Internet.

17. The electromyography muscle sensing system according to claim 1, wherein the cloud platform stores data stored securely to comply with health information privacy laws.

18. The electromyography muscle sensing system according to claim 1, wherein the microcontroller is programmed to:

receive from the digital output the signal at a sampling rate frequency and store the sampled digital output in the memory;

control user and default settings of the sensor;

record the settings in the memory for each procedure conducted by the user of the sensor platform; and

map a value of the sensor output and communicate to the user whether or not CMAP is being achieved.

19. The electromyography muscle sensing system according to claim 1, wherein the cloud-based data analysis and storage platform:

authenticates and authorizes use of the sensor platform and, upon authorization, records demographic information of the patient, identifies candidate historical procedures, and populates the database with the demographic information and the candidate historical procedures; and

receives and handles individual events of the sensor platform and evaluates a status of the current procedure based upon the individual events.

20. An electromyography muscle sensing system, comprising:

a sensor platform having;

an electromyography muscle sensor having;

sensing electrodes with patient contacts at which electrical energy is at least one of measured and supplied; and

a signal processing circuit electrically connected to the sensing electrodes and having a sensor output;

an analog-to-digital converter electrically connected to the sensor output and having a digital output at which is supplied a signal representing an electromyogram waveform;

a memory;

a communications device sending output data from the sensor platform and receiving input data into the sensor platform;

a display displaying information to a user to indicate at least one of a status of the sensor platform and an indication of CMAP presence or absence; and

a microcontroller electrically connected to the sensor, the analog-to-digital converter, the memory, the display, and the communications device, the microcontroller;

receiving from the digital output the signal and storing at least a portion of the signal in the memory;

maintaining a record of a current procedure being performed by the sensor platform;

providing communication directives to the communications device to transmit in real-time at least portions of the record to and/or from the sensor platform;

determining if CMAP is being achieved in the current procedure; and

providing at the display at least one of the status of the sensor platform and the indication of CMAP presence or absence; and

a cloud-based data analysis and storage platform communicatively connected at least to the communications device of the sensor platform to receive the output data from the sensor platform and to send the input data to the sensor platform, the cloud-based data analysis and storage platform;

having a database;

centrally organizing and storing the output data from the sensor platform in the database;

maintaining a history of each procedure of the sensor platform in the database;

analyzing the stored output data and the history to define stored output data of a successful CMAP outcome;

authenticating and authorizing use of the sensor platform and, upon authorization, recording demographic information of the patient, identifying candidate historical procedures, and populating the database with the demographic information and the candidate historical procedures;

receiving and handling individual events of the sensor platform and evaluating a status of the current procedure based upon the individual events;

predicting an outcome of the current procedure by comparing at least a portion of the output data in the current procedure with output data in the database to determine if the portion of the current output data correlates with the stored output data of the successful CMAP outcome; and

communicating in real time the outcome of the current procedure.

21. The electromyography muscle sensing system according to claim 20, wherein the sensor platform is a wireless handheld sensor platform.

22. The electromyography muscle sensing system according to claim 20, wherein the sensor platform is one of a laptop, a smart phone, and a tablet.

23. The electromyography muscle sensing system according to claim 20, wherein the sensor platform is a plurality of sensor platforms.

24. The electromyography muscle sensing system according to claim 20, wherein the sensing electrodes comprise a positive electrode, a negative electrode, and a ground electrode.

25. The electromyography muscle sensing system according to claim 20, wherein the signal processing circuit includes:

an amplification circuit having an input connected to at least one of the electrodes and a first amplification output;

a rectification circuit connected to the first amplification output of the amplification circuit having a rectified output at which is provided a rectified signal;

a smoothing circuit connected to the rectified output, smoothing the rectified signal, and having a smoothed output; and

a publication circuit amplifying the smoothed output and publishing the output signal.

26. The electromyography muscle sensing system according to claim 20, wherein a voltage of the output signal supplied to the analog-to-digital converter represents the electromyogram waveform.

27. The electromyography muscle sensing system according to claim 20, wherein:

the signal includes values of at least one of date, time, and session identifier; and

the microcontroller stores the values in the memory.

28. The electromyography muscle sensing system according to claim 20, wherein the communications device is a wireless radio.

29. The electromyography muscle sensing system according to claim 20, wherein the communications device is a Bluetooth radio.

30. The electromyography muscle sensing system according to claim 20, wherein the signal processing circuit includes at least one of:

a filter having settings for gain, high cut, and low cut;

a trigger threshold sensitivity;

a time base with a trigger window; and

a selective audio filter.

31. The electromyography muscle sensing system according to claim 20, wherein the user and default settings of the sensor include at least one of voltage, signal gain, sample frequency, and amplitude.

32. The electromyography muscle sensing system according to claim 20, wherein the record of the current procedure includes a patient'"'"'s demographic information, a procedure duration, and EMG event data.

33. The electromyography muscle sensing system according to claim 20, wherein CMAP is achieved according to the formula Delta EMG=ABS(E1−

E2), where a time between E1 and E2 is in milliseconds and EMG is a value of the digital output.

34. The electromyography muscle sensing system according to claim 20, wherein a graphical mapping is indicated at the display by at least one of sound, lights, graphics, and tactile measures.

35. The electromyography muscle sensing system according to claim 20, wherein the cloud platform is a centralized computer server connected to the Internet.

36. The electromyography muscle sensing system according to claim 20, wherein the cloud platform stores data stored securely to comply with health information privacy laws.

37. The electromyography muscle sensing system according to claim 20, wherein the microcontroller is programmed to:

receive from the digital output the signal at a sampling rate frequency and store the sampled digital output in the memory;

control user and default settings of the sensor;

record the settings in the memory for each procedure conducted by the user of the sensor platform; and

map a value of the sensor output and communicate to the user whether or not CMAP is being achieved.

38. The electromyography muscle sensing system according to claim 20, wherein, every time a CMAP procedure is undertaken with the sensor platform, the cloud-based data analysis and storage platform stores the output data in the database and asks the user to tag that data as achieving one of a successful CMAP and an unsuccessful CMAP.