Systems and methods for implanting electrode leads for use with implantable neuromuscular electrical stimulator

• US 9,186,501 B2
• Filed: 06/03/2014
• Issued: 11/17/2015
• Est. Priority Date: 06/13/2012
• Status: Active Grant

• Current Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Original Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Inventors: Rawat, Prashant Brijmohansingh, Shiroff, Jason Alan, Demorett, Henry Thomas
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US14/295,153
• Publication Number:
  US 20140288616A1
• Time in Patent Office: 532 Days
• Field of Search: 607115-117, 607/126, 607/128
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset

Abstract

A system of implanting electrode leads for restoring muscle function to the lumbar spine to treat low back pain is provided. The system provides efficient implantation of the leads, including the ability to verify deployment of anchoring mechanisms on the lead using an impedance assessment, such that the implanted lead may be secured within the patient and used to restore muscle function of local segmental muscles associated with the lumbar spine stabilization system.

Claims

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

first and second electrodes configured to be implanted in or adjacent to tissue associated with control of the lumbar spine;

a lead having the first and second electrodes disposed thereon;

a fixation element coupled to the lead and disposed in proximity to the first electrode, the fixation element configured to transition from a delivery state, wherein the fixation element is positioned adjacent to the first electrode, to a deployed state, wherein the fixation element is spaced apart from the first electrode and is positioned to anchor the lead to an anchor site;

a pulse generator coupled to the first and second electrodes via the lead, the pulse generator configured to cause the first or second electrode to emit energy such that the second or first electrode, respectively, receives a portion of the emitted energy, the pulse generator further configured to transmit a signal indicative of an impedance measurement based on the energy emitted and the portion of the energy received; and

software stored on a non-transient computer readable media configured to run on an external computer operatively coupled to the pulse generator, the software configured to cause the external computer to display the impedance measurement and to indicate whether the fixation element is in the delivery state or the deployed state based on the impedance measurement.

2. The system of claim 1, further comprising a second fixation element coupled to the lead distal to the fixation element, wherein the fixation element is angled distally relative to the lead and the second fixation element is angled proximally relative to the lead, and wherein the fixation element and the second fixation element are configured to sandwich the anchor site therebetween.

3. The system of claim 1, further comprising an external programmer coupled to the external computer, the external programmer configured to receive the signal indicative of the impedance measurement from the pulse generator and to transmit the signal to the external computer.

4. The system of claim 3, wherein the external programmer is configured to transfer programming data to the pulse generator.

5. The system of claim 4, wherein the software is configured to permit selection, adjustment, and display of the programming data.

6. The system of claim 4, wherein the programming data comprises at least one of:

pulse amplitude, pulse width, stimulation rate, stimulation frequency, ramp timing, cycle timing, session timing, or electrode configuration.

7. The system of claim 4, further comprising a handheld activator configured to transfer a stimulation command to the pulse generator, wherein the stimulation command directs at least one of the first or second electrodes to stimulate the tissue in accordance with the programming data.

8. The system of claim 1, wherein the software is further configured to cause the external computer to display a second impedance measurement based on a second signal.

9. The system of claim 1, wherein the software is configured to determine whether the fixation element is in the delivery state or the deployed state.

10. The system of claim 1, wherein the impedance measurement is indicative of the fixation element being in the delivery state in a range and the impedance measurement is indicative of the fixation element being in the deployed state in a different range.

11. The system of claim 10, wherein the range is between 1501-3500 ohms, 1200-2500 ohms, 1000-2000 ohms, or 750-1750 ohms and the different range is between 500-1500 ohms, 500-1200 ohms, 500-1000 ohms, or 500-750 ohms.

12. A method of verifying deployment of a fixation element in a system for restoring muscle function to the lumbar spine, the method comprising:

implanting a lead such that an electrode disposed on the lead is positioned in or adjacent to tissue associated with control of the lumbar spine, the lead coupled to a fixation element disposed in proximity to the electrode, the fixation element configured to transition from a delivery state, wherein the fixation element is positioned adjacent to the electrode, to a deployed state, wherein the fixation element is spaced apart from the electrode and is positioned to anchor the lead to an anchor site;

causing the electrode to stimulate tissue using a pulse generator;

transmitting a signal indicative of an impedance measurement to an external display;

displaying the impedance measurement on the external display; and

determining whether the fixation element is in the delivery state or the deployed state based on the displayed impedance measurement.

13. The method of claim 12, wherein the signal is transmitted from the pulse generator to an external programmer coupled to an external computer having the external display.

14. The method of claim 12, further comprising adjusting the lead if the fixation element is determined to be in the delivery state.