Controller for neuromuscular testing

• US 9,259,164 B2
• Filed: 08/21/2006
• Issued: 02/16/2016
• Est. Priority Date: 08/30/2004
• Status: Active Grant

• Current Assignee: Neuronetrix Solutions LLC
• Original Assignee: Neuronetrix, Inc.
• Inventors: Fadem, Kalford C.
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): LLOYD, EMILY M
• Application Number:
  US12/064,057
• Publication Number:
  US 20080312551A1
• Time in Patent Office: 3,466 Days
• Field of Search: 600/554
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0051 by applying vibrations
• CPC Class Codes: A61B 5/1106 to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/377 using evoked responses
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4047 afferent nerves, i.e. nerves that relay impulses to the central nervous system
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick

Abstract

A peripheral nervous system (PNS) neuromuscular disorder testing system incorporates a testing apparatus that is affixed to a patients skin, positioning a stimulus transducer (e.g., electrical contact(s), movable sharp point, etc.) into a nerve pathway of interest with an electrode and reference electrodes appropriately positioned relative thereto to measure the electrical signal produced. A wireless connection to a control box relays the data associated with the time of the stimulus and the sensed response to a diagnostic system that analyzes the waveform per selectable testing protocols with user tailorable view capabilities and data dissemination communication paths.

Claims

1. A kit operable to perform both evoked response potential (ERP) and peripheral nervous system (PNS) testing, the kit comprising:

a PNS testing device positionable upon a subject'"'"'s skin having a signal electrode, a reference electrode and a tactile stimulus producer;

an ERP testing device configured to perform an ERP test;

a control unit device operably configured to communicate a plurality of testing control administration parameters to the testing devices, wherein the control unit device is operable to perform both a peripheral nervous system nerve conduction test with the PNS testing device and an evoked response potential test with the ERP testing device, wherein the control unit device comprises a first port that is selectively connectable to a selected one of the PNS testing device or the ERP testing device;

a remote storage device, wherein the remote storage device is configured to store classifiers associated with a plurality of neuromuscular disorders;

a computer processor device in communication with the remote storage device, wherein the computer processor device is remote from the control unit device, wherein the computer processor device is configured to receive PNS test results and ERP test results from the control unit device, wherein the computer processor device is configured to compare the PNS test results or ERP test results from the control unit device against the classifiers stored on the remote storage device to correlate the PNS test results or ERP test results with one or more of the neuromuscular disorders, wherein the computer processor device is further configured to generate additional classifiers based at least in part on the PNS test results or ERP test results, the additional classifiers being associated with one or more neuromuscular disorders; and

a second port in communication with the control unit device, wherein the a second port is configured to;

(i) provide remote registration of the control unit device with the computer processor device via a communication network,

(ii) provide communication of one or more PNS testing protocols or ERP testing protocols from the computer processor device to the control unit device via the communication network, and

(iii) provide communication of the PNS test results or ERP test results from the control unit device to the computer processor device via the communication network,

wherein the testing control administration parameters communicated from the control unit device to the testing devices are provided in accordance with the one or more PNS testing protocols or ERP testing protocols.

2. The kit of claim 1, wherein the tactile stimulus producer comprises an electrically actuated projecting member to jab the skin.

3. The kit of claim 1, wherein the tactile stimulus producer comprises a pair of selectively electrified contacts.

4. The kit of claim 1, wherein the plurality of testing control administration parameters are selected from a group consisting of a stimuli start time, a stimuli selection, a stimuli sequence, a failure determination, and sample mode.

5. The kit of claim 1, wherein the computer processor device is further configured to perform PNS diagnostic analyses on the PNS test results.

6. The kit of claim 1, wherein the control unit device further comprises:

a memory;

a paradigm logic library, wherein the memory is configured to store paradigm logic information in the paradigm logic library;

a stimulus library database, wherein the memory is further configured to store stimulus information in the stimulus library database;

a program contained in the memory; and

a controller operatively configured to access the memory to perform the program, the program operably configured to access a selected testing paradigm contained in the paradigm logic library, to access stimuli specified by the selected testing paradigm contained in the stimulus library database, to calculate sequence and interstimulus delays between selected stimuli in accordance with the selected testing paradigm, and to output a testing stream associated with the testing paradigm.

7. The kit of claim 6, wherein the controller is further operatively configured to receive PNS test results, wherein the controller is further operatively configured to store the PNS test results in association with subject identification information and the selected testing paradigm.

8. The kit of claim 1, wherein the testing device is further operatively configured to detect an artifact contained in sensed test results, to access an epoch grouping of stimuli associated with the artifact, and to replay the associated epoch grouping.

9. The kit of claim 1, wherein each of the testing devices includes a unique registration code associated with sensed testing results acquired by each of the testing devices.

10. The kit of claim 1, wherein the testing device further comprises a user input feature that is responsive to a manual input from the subject performed in response to a stimulus, the control unit device being operatively configured to receive and store the PNS test results or ERP test results in association with the manual inputs.

11. The kit of claim 1, further comprising a computer system and a graphical user interface operatively configured to access testing results associated with subject identification information and selected testing paradigms, to generate a display of a template of a stored data manipulation parameters, and to generate a display of automatic paradigm-specific grouping.

12. The kit of claim 1, further comprising a computer system and graphical user interface operatively configured to access PNS testing results associated with subject identification information and selected testing paradigms, to access a selected digital signal processing parameter, to access a selected PNS grouping criteria, to access an algebraic combination configuration, to calculate an algebraic combination of the PNS testing results, and to pattern match the combined PNS test results against a neurological PNS model.

13. The kit of claim 12, wherein the computer system is further configured to correlate subsequent neurological diagnoses associated with subject identification information and refine a selected neurological PNS model to correlate with PNS test results associated with the neurological diagnoses.

14. The kit of claim 1, wherein the testing device is positionable at the subject'"'"'s wrist.