Systems and methods for restoring muscle function to the lumbar spine

• US 10,016,603 B2
• Filed: 10/20/2016
• Issued: 07/10/2018
• Est. Priority Date: 03/09/2007
• Status: Active Grant

• Current Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Original Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Inventors: Sachs, Dan, Rawat, Prashant Brijmohansingh, Shiroff, Jason Alan, Crosby, Peter Andrew
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US15/299,399
• Publication Number:
  US 20170036025A1
• Time in Patent Office: 628 Days
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• 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 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 2/008 for pain treatment or analgesia
• CPC Class Codes: A61N 2/06 using magnetic fields produced by permanent magnets A61N2/12 takes precedence

Abstract

A system for restoring muscle function to the lumbar spine to treat low back pain is provided. The system may include electrodes coupled to an implantable pulse generator (IPG), a handheld activator configured to transfer a stimulation command to the IPG, and an external programmer configured to transfer programming data to the IPG. The stimulation command directs the programmable controller to stimulate the tissue in accordance with the programming data. The system may include a software-based programming system run on a computer such that the treating physician may program and adjust stimulation parameters.

Claims

1. A system for restoring muscle function to the lumbar spine to treat back pain, the system comprising:

a plurality of electrodes configured to be implanted in or adjacent to tissue associated with control of the lumbar spine;

a pulse generator operatively coupled to the plurality of electrodes, the pulse generator configured to deliver a neuromuscular electrical stimulation therapy to cause at least one of the plurality of electrodes to emit electrical energy to stimulate the tissue to cause contraction of one or more muscles associated with control of the lumbar spine for restoring muscle function to the lumbar spine to treat back pain, and to run a routine to measure impedance of the plurality of electrodes; and

a non-transitory computer readable medium with instructions that, when executed by a processor of a computer operatively coupled to the pulse generator, cause a graphical user interface displayed on the computer to generate at least one user interface screen configured to display to the user an impedance screen comprising an impedance matrix area, an identification and status area, an electrode configuration area, and a sessions parameters area,

wherein the impedance matrix area is configured to populate an impedance matrix having a plurality of columns and rows to permit the user to monitor impedance and permit adjustments to the neuromuscular electrical stimulation therapy based on the measured impedance, each column and row associated with a respective electrode of the plurality of electrodes such that an intersection of a column and row displays a measured impedance between the respective electrodes associated with the column and row.

2. The system of claim 1, wherein the system is configured to communicate with the pulse generator via an external programmer.

3. The system of claim 1, wherein the identification and status area is configured to permit the user to enter an ID for a subject having the pulse generator implanted therein, and to activate and deactivate operation of the pulse generator, the identification and status area further configured to display remaining battery power of a power supply of the pulse generator, and a serial number assigned to the pulse generator.

4. The system of claim 1, wherein the electrode configuration area is configured to permit the user to select a bilateral mode where the pulse generator delivers neuromuscular electrical stimulation via the plurality of electrodes on two separate electrode leads at the same time or a unilateral mode where the pulse generator delivers neuromuscular electrical stimulation via the at least one or electrode on only one electrode lead.

5. The system of claim 1, wherein the electrode configuration area is configured to permit the user to select a stimulation rate within a range of 1-40 Hz.

6. The system of claim 1, wherein the electrode configuration area is configured to display a representation of the plurality of electrodes implanted within a subject,

wherein the electrode configuration area permits the user to allocate a polarity of at least one of the plurality of electrodes, and

wherein the electrode configuration area permits the user to select at least one of the plurality of electrodes such that the pulse generator delivers neuromuscular electrical stimulation via the selected at least one electrode.

7. The system of claim 1, wherein the electrode configuration area is configured to permit the user to adjust at least one of pulse amplitude or pulse width of the neuromuscular electrical stimulation delivered by the pulse generator.

8. The system of claim 1, wherein the sessions parameters area is configured to permit the user to adjust the timing of at least one of session, cycle on, cycle off, on ramp, or off ramp parameter.

9. The system of claim 1, wherein the at least one user interface screen is further configured to display to the user a main program screen comprising an impedance logging area, a settings area, and one or more buttons.

10. The system of claim 9, wherein the electrode configuration area is configured to permit the user to command the pulse generator to run the routine to measure impedance of the plurality of electrodes, the electrode configuration area further configured to display the measured impedance of at least one of the plurality of electrodes.

11. The system of claim 10, wherein the impedance logging area is configured to permit the user to command the pulse generator to run the routine to measure impedance of the plurality of electrodes at predetermined intervals, wherein the measured impedance is stored in a memory of the computer.

12. The system of claim 11, wherein the measured impedance is stored in the memory in matrix form, and wherein the impedance logging area is configured to permit the user to command the pulse generator to store the measured impedance in matrix form.

13. The system of claim 9, wherein the settings area is configured to permit the user to select a maximum cumulative stimulation session minutes in a day, to set a number of hours or minutes that a stimulation session may not be initiated, to select a number of seconds that a session will be delayed after the pulse generator receives a command to start a session, to adjust a time between stimulation pulses, and to adjust a maximum voltage that may be supplied from a power source to the plurality of electrodes.

14. The system of claim 9, wherein the one or more buttons are configured to permit the user to request information indicative of at least one of an actual value of stimulation parameter programmed in the pulse generator, a battery voltage remaining in the pulse generator, data stored in a memory of the pulse generator, or pulse generator status data, wherein the requested information is displayed by the graphical user interface.

15. The system of claim 1, wherein the at least one user interface screen is further configured to display to the user a temporary program screen, the temporary program screen configured to permit the user to adjust stimulation parameters on a temporary basis.

16. The system of claim 1, wherein the at least one user interface screen is configured to display to the user information retrieved from the pulse generator.

17. The system of claim 1, wherein the at least one user interface screen is configured to display to the user a data review screen comprising a daily log area and a data matrix area.

18. The system of claim 17, wherein the daily log area is configured to permit the user to view, on a day-by-day basis, at least one of number of daily sessions, total daily session time, daily impedance, or voltage.

19. The system of claim 18, wherein the daily log area comprises a date button, the date button configured to permit the user to select a day and time such that the user may view stored data from the selected day and time.

20. The system of claim 1, wherein the at least one user interface screen is configured to display to the user a data graphs screen comprising at least one of a session time graph or an impedance graph.