Systems and methods for monitoring muscle rehabilitation

• US 10,471,268 B2
• Filed: 10/13/2015
• Issued: 11/12/2019
• Est. Priority Date: 10/16/2014
• Status: Active Grant

• Current Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Original Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Inventors: Crosby, Peter A., Jaax, Kristen N., Rawat, Prashant B.
• Primary Examiner(s): Wilson, Kaylee R
• Application Number:
  US14/882,087
• Publication Number:
  US 20160106994A1
• Time in Patent Office: 1,491 Days
• CPC Class Codes: A61B 2505/09 Rehabilitation or training
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 2/004 specially adapted for a specific therapy
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

System and method for rehabilitating a muscle and monitoring such rehabilitation are provided, the system including a user input receiver for receiving stimulation parameter inputs from a user, a stimulator for generating stimulations to be applied to a patient'"'"'s body based on the stimulation parameter inputs, a signal receiver to receive, detect, and record a signal containing an evoked potential generated by the body in response to the stimulations, a signal processor for processing the recorded signal, for example, by amplifying, filtering, digitizing and temporal averaging the recorded signal, a trigger detector to alert the signal processor module when stimulations are generated to enable synchronization of the response signal with the stimulus for accurate temporal averaging, and an output display for providing data representative of the evoked potential to the user.

Claims

1. A method for monitoring rehabilitation of a muscle, the method comprising:

receiving from an extracorporeal source a first input defining a first stimulation protocol, the first stimulation protocol comprising a plurality of parameters for generation of an electric current or an electric voltage;

generating an electromagnetic field in accordance with the first stimulation protocol via a transcranial magnetic stimulation device and applying the electromagnetic field to a portion of a patient'"'"'s body to cause contraction of a skeletal target muscle associated with control of the lumbar spine;

generating a trigger signal via trigger detector communicatively coupled to the transcranial magnetic stimulation device upon generation of the electromagnetic field;

recording a response signal generated by the patient'"'"'s body in response to the first stimulation protocol via an implanted recording electrode implanted on, in, or a the skeletal target tissue, wherein the response signal is at least one of an electrical signal, a force signal, or a movement signal;

processing the recorded response signal to produce processed signal responsive to receiving the trigger signal;

displaying information indicative of the processed signal.

2. The method of claim 1, wherein the plurality of parameters are selected from a group of parameters consisting of:

pulse amplitude, pulse width, stimulation rate, stimulation frequency, ramp timing, cycle timing, session timing, duty cycle, contacts activated, percent of total current allocated to each contact, and location of stimulation.

3. The method of claim 1, wherein the target muscle is at least one of the lumbar multifidus, the transverse abdominus, the erector spinae, the iliocostalis, and the longissimus.

4. The method of claim 1, wherein the electric current or electric voltage of the first stimulation protocol comprises a plurality of electrical pulses.

5. The method of claim 1, wherein the recorded response signal or the processed signal is transmitted wirelessly to an external receiver.

6. The method of claim 1, wherein the response signal is recorded by a surface electrode electrically coupled to the implanted recording electrode, the surface electrode attached to the patient at the head, neck, or spine, and wherein the recorded response signal is received by a processor from the surface electrode via a wired or wireless connection.

7. The method of claim 1, wherein the response signal is an electrical signal and wherein processing the recorded response signal comprises at least one of amplifying, filtering and digitizing the recorded response signal.

8. The method of claim 1, wherein processing the recorded response signal comprises taking a temporal average of the recorded response signal.

9. The method of claim 1, further comprising:

receiving a second input from the extracorporeal source to adjust the first stimulation protocol; and

generating an electromagnetic field in accordance with an adjusted stimulation protocol.

10. The method of claim 9, wherein processing the recorded response signal comprises synchronizing the recorded response signal with the trigger signal.

11. The method of claim 9, further comprising recording a second response signal comprising an adjusted response signal generated in response to the adjusted stimulation protocol, processing the second response signal to produce a second processed signal, and displaying information indicative of the second processed signal.

12. The method of claim 1, wherein the response signal is an evoked potential.

13. The method of claim 1, wherein information indicative of the processed signal comprises:

a waveform of the processed signal, and/or one or more quantitative metrics of the processed signal selected from the group consisting of;

amplitude, width, frequency, latency relative to application of the first stimulation protocol, and slope.