Systems and methods for enhanced implantation of electrode leads between tissue layers
First Claim
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1. 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;
measuring the depth attained by the distal tip of the guide needle;
locating a second insertion site along the midline of the target vertebrae based on the depth, the second insertion site located a distance from the first insertion site approximately equal to 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.
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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.
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Citations
30 Claims
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1. A method for implanting a device for restoring muscle function to a lumbar spine, the method comprising:
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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; measuring the depth attained by the distal tip of the guide needle; locating a second insertion site along the midline of the target vertebrae based on the depth, the second insertion site located a distance from the first insertion site approximately equal to 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A method for implanting a device for restoring muscle function to a lumbar spine, the method comprising:
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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, the first insertion site located at a superior articular process of the target vertebrae; 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. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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29. A method for implanting a device for restoring muscle function to a lumbar spine, the method comprising:
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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, wherein implanting the lead at the second insertion site comprises; selecting a delivery needle having a distal tip, a lumen and a longitudinal axis; inserting the distal tip of the delivery needle percutaneously at the second insertion site such that the longitudinal axis of the delivery needle is angled approximately 45 degrees relative to the longitudinal axis of the guide needle; advancing a guidewire through the lumen of the delivery needle; removing the delivery needle; advancing an introducer assembly over the guidewire; removing the guidewire; advancing the lead through the introducer assembly so that the one or more electrodes are disposed in or adjacent to the tissue associated with control of the lumbar spine; and retracting the introducer assembly.
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30. A method for implanting a device for restoring muscle function to a lumbar spine, the method comprising:
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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, wherein implanting the lead at the second insertion site comprises; selecting a delivery needle having a distal tip, a lumen and a longitudinal axis; inserting the distal tip of the delivery needle percutaneously at the second insertion site such that the longitudinal axis of the delivery needle is angled relative to the longitudinal axis of the guide needle, and advancing the distal tip of the delivery needle approximately 3-5 mm beyond the distal tip of the guide needle, thereby penetrating an intertransversarii; advancing a guidewire through the lumen of the delivery needle; removing the delivery needle; advancing an introducer assembly over the guidewire; removing the guidewire; advancing the lead through the introducer assembly so that the one or more electrodes are disposed in or adjacent to the tissue associated with control of the lumbar spine; and retracting the introducer assembly.
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Specification