Systems and methods for enhanced implantation of electrode leads between tissue layers
AssigneeMainstay Medical Limited
InventorsJason Alan SHIROFF, Henry DEMORETT, John BECK, Sidney HAUSCHILD
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Abstract
Systems and methods for enhanced implantation of an electrode lead for neuromuscular electrical stimulation of tissue associated with control of the lumbar spine for treatment of back pain, in a midline-to-lateral manner are provided. 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 without disruption of the electrode lead post-implantation due to anatomical structures.
Claims20
A method for implanting a device for restoring muscle function to a lumbar spine, the method comprising:
- selecting a guide needle having a longitudinal axis and a distal tip;
- selecting a lead having a distal region including one or more electrodes;
- locating a target vertebrae of the lumbar spine;
- inserting the distal tip of the guide needle percutaneously at a first insertion site a lateral distance from a midline of the target vertebrae to a depth;
- locating a second insertion site along the midline of the target vertebrae based on the depth;
- and
- implanting the lead at the second insertion site with the distal region angled relative to the longitudinal axis of the guide needle, so that the lead traverses naturally occurring fascicle planes and the one or more electrodes are disposed in or adjacent to a tissue associated with control of the lumbar spine.
A kit for implanting a device for restoring muscle function to a lumbar spine, the kit comprising:
- a guide needle configured for percutaneous insertion at a first insertion site, the guide needle having a distal tip and a longitudinal axis;
- a delivery needle configured for percutaneous insertion at a second insertion site such that a longitudinal axis of the delivery needle is angled relative to the longitudinal axis of the guide needle, the delivery needle having a distal tip and a lumen extending therethrough;
- a guidewire configured to be inserted through the lumen of the delivery needle;
- an introducer assembly having a distal tip and a lumen extending therethrough configured to receive the guidewire;
- and
- a lead having one or more electrodes disposed at a distal region of the lead, the lead configured for implantation through the lumen of the introducer assembly to position the one or more electrodes in or adjacent to a tissue associated with control of the lumbar spine.
Dependencies are inferred from the claim text.