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Publication Number
US-11752331-B2
Publication Date
2023-09-12
Expiration Date
Abstract
Nerve cuff deployment apparatuses and methods of using them to deliver a nerve cuff electrode to a target nerve trunk.
Core Innovation
The invention provides a minimally invasive nerve cuff deployment system and method for attaching a nerve cuff electrode to a patient's nerve root region. A cannula is inserted into the patient's tissue to the nerve root region, and a nerve cuff deployment tool is advanced distally through the cannula. The nerve cuff electrode is removably attached at a distal end of the nerve cuff deployment tool and is self-curling or hinged so that it wraps around the patient's nerve root after deployment.
The method includes disengaging the nerve cuff electrode from the nerve cuff deployment tool so the nerve cuff electrode wraps around the patient's nerve root. The disclosed securing includes looping a suture through suture holes in two regions of the nerve cuff electrode, where the suture holds the two regions together around the patient's nerve root. The system claim further recites a nerve cuff deployment apparatus with an elongated body and a distal nerve cuff engagement region configured to secure to the nerve cuff electrode and release it near the patient's nerve root.
The deployment apparatus is engineered to withstand compressive loading during constrained delivery, including an elongated body having sufficient column strength to resist buckling under compressive forces. The description further characterizes deployment engagement and release structures, such as a two-part capsule enclosure and hinged or bifurcated end engagement, while maintaining the core sequence of removably carrying the cuff, releasing it near the nerve root, and securing it with suturing.
Claims Coverage
The document includes three independent claims, each covering a different aspect: a minimally invasive attaching method, a nerve cuff deployment system, and a nerve cuff electrode construction. Across the independent claims, the coverage is organized around an elongated deployment apparatus with a distal engagement and release region, a self-curling or hinged nerve cuff electrode that encircles a nerve root, and suture holes in two regions to secure the cuff after deployment.
Minimally invasive cannula-based deployment and release to wrap a nerve root
Inserting a cannula into the patient's tissue to a nerve root region; advancing a nerve cuff deployment tool distally through the cannula to the nerve root region, wherein the nerve cuff electrode is removably attached at a distal end of the nerve cuff deployment tool, wherein the nerve cuff electrode is self-curling or hinged to wrap around the patient's nerve root; disengaging the nerve cuff electrode from the nerve cuff deployment tool and causing the nerve cuff electrode to wrap around the patient's nerve root.
Suture-hole securing of two regions around the nerve root
Securing the nerve cuff electrode to the patient's nerve root by looping a suture through suture holes in two regions of the nerve cuff electrode, wherein the suture holds the two regions together around the patient's nerve root.
Self-curling or hinged nerve cuff electrode with two suture-hole regions
The nerve cuff electrode is self-curling or hinged to wrap around the patient's nerve root, and includes two regions comprising suture holes arranged to loop a suture therethrough so that the suture can hold the two regions together around the patient's nerve root.
Elongated deployment apparatus with distal engagement region configured to secure and release near the nerve root
A nerve cuff deployment apparatus comprising an elongated body and a nerve cuff engagement region at a distal end of the elongated body, the nerve cuff engagement region configured to secure to the nerve cuff electrode and to release the nerve cuff electrode near the patient's nerve root.
Hinged first and second halves transitioning open and closed to encircle the nerve root
A nerve cuff body comprising a first half and a second half joined by a hinge, wherein the hinge is configured to transition the first and second halves between an open state and a closed state, wherein when in the closed state, the first and second halves are configured to encircle the patient's nerve root.
Suture-hole regions on the hinged halves to hold the cuff closed around the nerve root
Each of the first and second halves includes a region comprising suture holes, wherein the suture holes are arranged to loop a suture therethrough so that the suture can hold the first and second halves together in the closed state.
First and second leads coupled to respective halves of the hinged cuff body
A first lead coupled to and extending longitudinally from the first half of the nerve cuff body; and a second lead coupled to and extending longitudinally from the second half of the nerve cuff body.
Overall, claim coverage is centered on a minimally invasive cannula-based deployment sequence that removably carries a self-curling or hinged nerve cuff electrode, releases the electrode near the nerve root so it wraps or encircles the nerve root, and secures it with suturing via suture holes in two regions. The coverage also includes an electrode construction with hinged first and second halves and corresponding lead coupling, plus a deployment apparatus with an elongated body and a distal engagement region configured to secure and release the cuff near the nerve root.
Stated Advantages
Minimally invasive attachment of a nerve cuff electrode to a patient's nerve root.
Documented Applications
Peripheral nerve stimulation and high frequency nerve block, including clinical context for peripheral nerve stimulation and pain therapy as described in the document.
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