Patent Application
20220203087
Various embodiments described and disclosed herein relate to the field of neurostimulation, and more particularly to delivering electrical stimulation therapy to the spinal stabilization muscles and lower back of a patient, including, but not limited to, for the purposes of rehabilitating and strengthening spinal stabilization muscles and alleviating lower back pain.
Chronic low back pain (LBP) is the number one total cost burden to the U.S. healthcare system at approximately $600,000,000 per year according to ScienceDaily and a Johns Hopkins University health economics study published in September, 2012 in the Journal of Pain. LBP treatments can span the gamut from low cost over-the-counter pharmaceuticals and opioids all the way to costly spinal interventions. Frequently, marginal clinical results and/or unwanted drug dependencies result from these strategies.
Chronic LBP sufferers frequently have pain resulting from unidentified causes, and are referred to as Non-Specific Chronic Low Back Pain (NSCLBP) patients, of whom there are some 60 million such patients annually in the U.S. NSCLBP is a sub-category of LBP. NSCLBP is clinically determined by exclusion, and is defined as unmitigated chronic low back pain lasting longer than 120 days that is not attributable to a recognizable known specific pathology (e.g., infection, tumor, osteoporosis, lumbar spine fracture, disk deterioration, congenital or structural deformities, inflammatory disorders, radicular syndromes, nerve diseases or cauda equina syndrome).
NSCLBP patients suffer from a recurrent cycle of intense unidentified chronic low back pain and muscle atrophy, creating long-term spinal instability.
What is needed are improved means and methods of treating NSCLB patients, such as an acute, low cost, least invasive, Peripheral Nerve Stimulation (PNS) system that can provide relief, rehabilitation and restoration early in the patient treatment continuum.
The present disclosure is directed to devices, systems, and methods that address one or more deficiencies in the prior art.
In some embodiments, there are provided methods of rehabilitating or strengthening one or more spinal stabilization muscles in a patient, and reducing pain sensed by the patient in the patient's lower back. Such methods comprise positioning one or more medical electrical leads comprising one or more electrodes adjacent to, in contact with, or in operative positional relationship to, one or more target peripheral nerves or nerve fibers located in, adjacent to, near, or associated with, the one or more spinal stabilization muscles of the patient, the one or more target peripheral nerves comprising motor nerve fibers and sensory nerve fibers; delivering, over a first electrical stimulation period of time ranging between about 2 seconds and about 20 seconds, first electrical stimulation signals having frequencies ranging between about 10 Hz and about 30 Hz, and pulse widths ranging between about 50 microseconds and about 1,000 microseconds, through the one or more electrodes of the one or more medical electrical leads to the one or more target peripheral nerves, the first stimulation signals being configured to recruit and activate at least some alpha motor nerve fibers associated with the one or more spinal stabilization muscles, and to induce one or more tetanic contractions in the one or more spinal stabilization muscles of the patient during at least portions of the first period of time; delivering, over a second electrical stimulation period of time ranging between about 2 and about 30 seconds, second stimulation signals having frequencies ranging between about 20 Hz and about 200 Hz through the one or more electrodes of the one or more medical electrical leads to the one or more target peripheral nerves, the second electrical stimulation period of time following or preceding the first electrical stimulation period of time, the second stimulation signals being configured to recruit, activate, or block at least some alpha and gamma sensory nerves or sensory nerve fibers associated with the one or spinal stabilization muscles; repeating delivery of the first and second stimulation signals through the one or more electrodes of the one or more medical electrical leads to the one or more target peripheral nerves during subsequent first and second electrical stimulation periods of time, respectively; wherein the one or more target peripheral nerves are located near, or are associated with, at least one of: (a) one or more medial branches of one or more dorsal rami nerves or nerve fibers of the patient, and (b) one or more dorsal rami nerves or nerve fibers located proximally from at least one of first bifurcations of one or more dorsal rami nerves of the patient; and further wherein: (c) the first stimulation signals are configured to rehabilitate or strengthen the one or more spinal stabilization muscles of the patient; (d) the second stimulation signals are configured to reduce lower back pain sensed by the patient, and (e) delivery of the first and second electrical stimulation signals during repeating first and second periods of time occurs collectively over a third period of time ranging between about 10 minutes and about 90 minutes in length, the third period of time comprising a spinal stabilization muscle rehabilitation session.
Various embodiments of some embodiments of the methods may further comprise one or more of: (a) wherein the one or more spinal stabilization muscles include one or more of at least one multifidus muscle, at least one erector spinae muscle, at least one spinalis muscle, at least one longissimus muscle, and at least one iliocostalis muscle; (b) wherein the first stimulation signal further recruits and activates, in addition to one or more multifidus muscles, at least some alpha motor nerves or nerve fibers associated with one or more erector spinae muscles, spinalis muscles, longissimus muscles, iliocostalis muscles, quadratus labrum muscles, and transverse abdominus muscles; (c) wherein the one or more target nerves are the one or more dorsal rami nerves or nerve fibers located proximally from the first bifurcations of the one or more dorsal rami nerves of the patient; (d) wherein the one or more target nerves are the one or more medial branches of the one or more dorsal rami nerves of the patient; (e) wherein the first stimulation signals are further configured to disrupt arthrogenic inhibition of the one or more spinal stabilization muscles; (f) wherein the second stimulation signals are configured to engage gate mechanisms associated with the one or more sensory nerves or nerve fibers, thereby to reduce or alleviate lower back pain sensed by the patient; (g) wherein the pain is non-specific chronic lower back pain (NSCLBP); (h) wherein the second stimulation signals promote reducing non-specific chronic lower back pain; (i) wherein the third period of time ranges between one or more of: (1) about 5 minutes and about 60 minutes; (2) about 5 minutes and about 40 minutes; (3) about 10 minutes and about 30 minutes; and (4) between 10 minutes and about 20 minutes; (j) wherein the first period of time ranges between one or more of: (1) about 4 seconds and about 16 seconds; (2) about 4 seconds and about 12 seconds; and (3) about 4 seconds and about 10 seconds; (k) wherein the second period of time ranges between one or more of: (1) 2 seconds and about 20 seconds; (2) about 2 seconds and about 15 seconds; and (3) about 2 seconds and about 10 seconds; (l) wherein the first electrical stimulation signals have frequencies ranging between about 12 Hz and about 25 Hz; (m) wherein the second electrical stimulation signals have frequencies ranging between about 70 Hz and about 130 Hz; (n) wherein the first stimulation signals have one or more of: (1) pulse widths ranging between about 100 microseconds and about 500 microseconds, or between about 100 microseconds and about 300 microseconds; (2) amplitudes ranging between about 1 mA and about 20 mA, between about 2 mA and about 10 mA, or between about 2 mA and about 5 mA, and (3) amplitudes ranging between about 0.5 V and about 10 V, between about 1 V and about 10 V, or between about 1 V and about 2.5 V; (o) wherein the second stimulation signals have one or more of: (1) pulse widths ranging between about 50 microseconds and about 1000 microseconds, between about 100 microseconds and about 500 microseconds, or between about 100 microseconds and about 200 microseconds; (2) current amplitudes ranging between about 1 mA and about 20 mA, between about 2 mA and about 10 mA, or between about 2 mA and about 5 mA, and (3)
voltage amplitudes ranging between about 0.5 V and about 10 V, between about 1 V and about 5 V, and between about 1 V and about 2.5 V;
(p) wherein the patient can activate the second stimulation signal outside of the spinal stabilization muscle rehabilitation session to reduce lower back pain; (q) wherein the spinal stabilization muscle rehabilitation session is repeated at least one of: (a) a plurality of times during a 24-hour period, and (b) between 2 and 10 times during a 24-hour period; (r) wherein the first stimulation signals are: (1) interleaved with the second stimulation signals; (2) overlap with the second stimulation signals; and (3) at least partially superimposed upon and delivered simultaneously with the second stimulation signals; (r) wherein delivery of the first stimulation signals is separated from delivery of the second stimulation signals by a period of time ranging between: (1) about 0 seconds and about 60 seconds; (2) about 5 seconds and about 30 seconds; and (3) about 1 second and about 10 seconds; (s) wherein the one or more medical electrical leads are percutaneous leads; (t) wherein the one or more medical electrical leads comprise at least one of a unipolar electrode, a bipolar electrode, a ground electrode, a cathode, an anode, a coiled electrode, a cuff electrode, a wire electrode, and a hook-shaped electrode; (u) wherein ultrasound or fluoroscopy are employed to guide placement of a needle to locate the one or more target peripheral nerves; (v) wherein the needle is hollow and used to deliver one of the medical electrical leads to the one or more target peripheral nerves percutaneously; (w) wherein one of an MRI technique and an ultrasound technique is used to image one or more spinal stabilization muscles in the patient to assess the strength or degree of atrophy of the muscles before the medical electrical lead is implanted in the patient; (x) wherein an MRI is used to image one or more spinal stabilization muscles in the patient after therapy has been delivered to the patient by the first and second stimulation signals and after the medical electrical lead has been implanted in the patient.
In some other embodiments, there are provided systems for rehabilitating or strengthening one or more spinal stabilization muscles in a patient, and reducing pain sensed by the patient in the patient's lower back, where the systems comprise one or more medical electrical leads comprising distal portions or ends comprising one or more electrodes configured for implantation adjacent to, in contact with, or in operative positional relationship to, one or more target peripheral nerves or nerve fibers located in, adjacent to, near, or associated with, one or more spinal stabilization muscles of the patient, the one or more target peripheral nerves comprising motor nerve fibers and sensory nerve fibers; an external pulse generator (EPG) configured for operable connection to the one or more medical electrical leads, and further being configured to deliver first stimulation signals over a first electrical stimulation period of time ranging between about 2 seconds and about 20 seconds, the first electrical stimulation signals having frequencies ranging between about 10 Hz and about 30 Hz, and pulse widths ranging between about 50 microseconds and about 1,000 microseconds, and being delivered through the one or more electrodes of the one or more medical electrical leads to the one or more target peripheral nerves, the first stimulation signals being configured to recruit and activate at least some alpha motor nerve fibers associated with the one or more spinal stabilization muscles, and to induce one or more tetanic contractions in the one or more spinal stabilization muscles of the patient during at least portions of the first period of time; the EPG further being configured to deliver second stimulation signals over a second electrical stimulation period of time ranging between about 2 and about 30 seconds, the second stimulation signals having frequencies ranging between about 20 Hz and about 200 Hz and being delivered through the one or more electrodes of the one or more medical electrical leads to the one or more target peripheral nerves, the second electrical stimulation period of time following or preceding the first electrical stimulation period of time, the second stimulation signals being configured to recruit, activate, or block at least some alpha and gamma sensory nerves or sensory nerve fibers associated with the one or spinal stabilization muscles; the EPG further being configured to repeat delivery of the first and second stimulation signals through the one or more electrodes of the one or more medical electrical leads to the one or more target peripheral nerves during subsequent first and second electrical stimulation periods of time, respectively; wherein the one or more target peripheral nerves are located near, or are associated with, at least one of: (a) one or more medial branches of one or more dorsal rami nerves or nerve fibers of the patient, and (b) one or more dorsal rami nerves or nerve fibers located proximally from at least one of first bifurcations of one or more dorsal rami nerves of the patient; and further wherein: (c) the first stimulation signals are configured to rehabilitate or strengthen the one or more spinal stabilization muscles of the patient; (d) the second stimulation signals are configured to reduce lower back pain sensed by the patient, and (e) delivery of the first and second electrical stimulation signals during repeating first and second periods of time occurs collectively over a third period of time ranging between about 10 minutes and about 90 minutes in length, the third period of time comprising a spinal stabilization muscle rehabilitation session.
Various embodiments of some systems may further comprise one or more of: (a) wherein the one or more spinal stabilization muscles include one or more of at least one multifidus muscle, at least one erector spinae muscle, at least one spinalis muscle, at least one longissimus muscle, and at least one iliocostalis muscle; (b) wherein the first stimulation signal is further configured to recruit and activate, in addition to one or more multifidus muscles, at least some alpha motor nerves or nerve fibers associated with one or more erector spinae muscles, spinalis muscles, longissimus muscles, and iliocostalis muscles; (c) wherein the one or more target nerves are the one or more dorsal rami nerves or nerve fibers located proximally from the first bifurcations of the one or more dorsal rami nerves of the patient; (d)
wherein the one or more target nerves are the one or more medial branches of the one or more dorsal rami nerves of the patient; (e) wherein the first stimulation signals are further configured to disrupt arthrogenic inhibition of the one or more spinal stabilization muscles; (f) wherein the second stimulation signals are configured to engage gate mechanisms associated with the one or more sensory nerves or nerve fibers, thereby to reduce or alleviate lower back pain sensed by the patient; (g) wherein the pain is non-specific chronic lower back pain (NSCLBP); (h) wherein the second stimulation signals promote reducing non-specific chronic lower back pain; (i) wherein the third period of time ranges between one or more of: (1) about 5 minutes and about 60 minutes; (2) about 5 minutes and about 40 minutes; (3) about 10 minutes and about 30 minutes; and (4) between 10 minutes and about 20 minutes; (j) wherein the first period of time ranges between one or more of: (1) about 4 seconds and about 16 seconds; (2) about 4 seconds and about 12 seconds; and (3) about 4 seconds and about 10 seconds; (j) wherein the second period of time ranges between one or more of: (1) 2 seconds and about 20 seconds; (2) about 2 seconds and about 15 seconds; (3) about 2 seconds and about 10 seconds; (k) wherein the first electrical stimulation signals have frequencies ranging between about 12 Hz and about 25 Hz; (l) wherein the second electrical stimulation signals have frequencies ranging between about 70 Hz and about 130 Hz; (m) wherein the first stimulation signals have one or more of: (1) pulse widths ranging between about 100 microseconds and about 500 microseconds, or between about 100 microseconds and about 300 microseconds; (2) amplitudes ranging between about 1 mA and about 20 mA, between about 2 mA and about 10 mA, or between about 2 mA and about 5 mA, and (3) voltage amplitudes ranging between about 0.5 V and about 10 V, between about 1 V and about 5 V, and between about 1 V and about 2.5 V; (n) wherein the second stimulation signals have one or more of: (1) pulse widths ranging between about 50 microseconds and about 1000 microseconds, between about 100 microseconds and about 500 microseconds, or between about 100 microseconds and about 200 microseconds; (2) current amplitudes ranging between about 1 mA and about 20 mA, between about 2 mA and about 10 mA, or between about 2 mA and about 5 mA, and (3) voltage amplitudes ranging between about 0.5 V and about 10 V, between about 1 V and about 5 V. and between about 1 V and about 2.5 V; (o) wherein the patient can activate the second stimulation signal outside of the spinal stabilization muscle rehabilitation session to reduce lower back pain; (p) wherein the spinal stabilization muscle rehabilitation session is repeated at least one of: (1) a plurality of times during a 24-hour period, and (2) between 2 and 10 times during a 24-hour period; (q) wherein the first stimulation signals are: (1) interleaved with the second stimulation signals; (2) overlap with the second stimulation signals; and (3) at least partially superimposed upon and delivered simultaneously with the second stimulation signals; (r) wherein delivery of the first stimulation signals is separated from delivery of the second stimulation signals by a period of time ranging between: (1) about 0 seconds and about 60 seconds; (2) about 5 seconds and about 30 seconds; and (3) about 1 second and about 10 seconds; (s) wherein the one or more medical electrical leads are percutaneous leads; (t) wherein the one or more medical electrical leads comprise at least one of a unipolar electrode, a bipolar electrode, a ground electrode, a cathode, an anode, a coiled electrode, a cuff electrode, a wire electrode, and a hook-shaped electrode; (u) wherein ultrasound or fluoroscopy are employed to guide placement of a needle to locate the one or more target peripheral nerves; (v) wherein the needle is hollow and used to deliver one of the medical electrical leads to the one or more target peripheral nerves percutaneously; (w) wherein one of an MRI technique and an ultrasound technique is used to image one or more spinal stabilization muscles in the patient to assess the strength or degree of atrophy of the muscles before the medical electrical lead is implanted in the patient, and (x) wherein an MRI is used to image one or more spinal stabilization muscles in the patient after therapy has been delivered to the patient by the first and second stimulation signals and after the medical electrical lead has been implanted in the patient.
Further embodiments are disclosed herein or will become apparent to those skilled in the art after having read and understood the claims, specification and drawings hereof.
Different aspects of the various embodiments will become apparent from the following specification, drawings and claims in which:
The drawings are not necessarily to scale. Like numbers refer to like parts or steps throughout the drawings.
Described herein are various embodiments of systems, devices, components and methods for treating pain and muscle disorders in a patient's body using neurostimulation techniques.
One emphasis of the present disclosure relates to various embodiments of systems, devices, components, methods and therapies directed to a dual or combined electrical stimulation regime delivered from an external pulse generator (EPG) through percutaneous medical electrical leads to a patient's dorsal rami nerves for the purpose of both rehabilitating and strengthening the patient's multifidus muscles and reducing the patient's lower back pain. Other applications and embodiments for stimulating other nerves and muscles are contemplated, however, such as those employing fully implantable IPGs and/or leads, or those which stimulate muscles and sensory nerves other than the multifidus muscles and the dorsal rami nerves, more about which is said below.
Other non-limiting examples of medical electrical leads 18 and/or 20 suitable for use in some embodiments include leads used in conjunction with one or more ground electrodes, leads having arrays of cathodes employed in various configurations respecting corresponding anodes (all serving as electrodes 39), wire electrodes 39, hook-shaped electrodes 39, and barb-shaped electrodes 39. In a case where a lead 18 or 20 comprises three or more electrodes 39, EPG 12 can be configured to controllably switch and control one or more specific pairs or other groupings of electrodes 39 to which electrical stimulation is delivered in various combinations as anodes and/or cathodes. Likewise, pairs or other groups of electrodes 39 in different leads 18 and 20 (by way of non-limiting example) can be controllably switched or controlled so that the electrical fields emitted by electrodes 39 extend at least some distance between the different leads 18 and 20. In such a manner, optimum electrode pairings or groupings tailored to the specific patient 22, lead(s) placement, nerve location, etc., can be achieved to deliver the best therapy to patient 22.
In some embodiments, each of leads 18 and 20 comprises at least one cathode (electrode 39) that can be placed near a portion of the dorsal ramus nerve that contains motor and sensory components, allowing both pain blocking and muscle stimulation. Alternatively, more than one cathode (electrode 39) can be utilized, placing one cathode near a sensory component and one cathode near a motor component of the dorsal ramus nerve. Pain reduction stimulation signals are then delivered via the sensory-placed electrode, while motor stimulation of the multifidus muscle is effected via the other cathode. Both such electrodes can be mounted on a single lead, or on separate leads. As one of the electrodes is being used as a cathode for stimulation, the other electrode can be used as an anode for a return path to complete the electrical circuit. Alternatively, both stimulation electrodes could utilize a(n) additional electrode(s) as the anode. This anode could be on the one or more leads described above, a separate lead, or an external ground pad or other grounding device.
The lead examples and embodiments shown in
For purposes of rehabilitating a multifidus muscle and other muscles involved in spinal stabilization, including but not limited to, the erector spinae, spinalis, longissimus, and iliocostalis muscles, and also of suppressing or reducing lower back pain using a dual or combined stimulation regime as described above and below, it has been discovered that in some embodiments one or more stimulation electrodes 39 are most beneficially positioned such that the one or more electrodes 39 are positioned proximally or just proximally from what we refer to herein as “the first bifurcations of the medial and distal branches of the primary dorsal rami nerves” at locations 49/52 as illustrated in
Consistent with the improved efficacy of some embodiments of dual or combined electrical stimulation therapy regimes as described and disclosed herein both above and below, and in accordance with our research and investigations, the dorsal primary nerves 52 are believed to contain greater numbers or proportions of mixtures or bundles of intertwined and/or interpositioned combinations of motor and sensory nerves, nerve fibers, and neurons than are to be found separately in either the medial branches of the dorsal ramus nerves 44, or in the distal branches of the dorsal ramus nerves 46. Indeed, our research and investigations, which include testing in human subjects (more about which is said below), have revealed that the medial branches of the dorsal rami nerves appear to contain principally motor nerves, nerve fibers, and/or neurons, while the lateral branches of the dorsal rami nerves appear to contain principally sensory nerves, nerve fibers, and/or neurons. Stimulating one or the other of the medial and lateral branches of the dorsal rami nerves will therefore provide different—and sometimes inadequate—results to the patient (more about which is also said below).
Contrariwise, it has been discovered that stimulating at or near locations 49/52 can provide improved results to the patient, as both motor and sensory nerves, nerve fibers, and/or neurons are being stimulated, which helps “break the cycle,” as further discussed in detail below. Moreover, stimulating at or near locations 49/52 has other advantages, such as a reduced amount of electrical power being required to effectively stimulate, contract, and/or reduce pain associated with the multifidus and other spinal stabilization muscles, and the significantly enhanced ability to recruit, stimulate, and/or contract spinal stabilization muscles other than the multifidus muscle. Consequently, in some embodiments, delivery of the dual or combined electrical stimulation therapy regimes described and disclosed both above and below to locations 49 (see, e.g.,
We now describe in detail further embodiments of providing dual and/or combined stimulation regimes to a patient's spinal stabilization muscles, where in some embodiments methods of rehabilitating or strengthening one or more spinal stabilization muscles in a patient, and reducing pain sensed by the patient in the patient's lower back, comprise the following: positioning one or more medical electrical leads comprising one or more electrodes adjacent to, in contact with, or in operative positional relationship to, one or more target peripheral nerves or nerve fibers located in, adjacent to, near, or associated with, the one or more spinal stabilization muscles of the patient, the one or more target peripheral nerves comprising motor nerve fibers and sensory nerve fibers; delivering, over a first electrical stimulation period of time ranging between about 2 seconds and about 20 seconds, first electrical stimulation signals having frequencies ranging between about 10 Hz and about 30 Hz, and pulse widths ranging between about 50 microseconds and about 1,000 microseconds, through the one or more electrodes of the one or more medical electrical leads to the one or more target peripheral nerves, the first stimulation signals being configured to recruit and activate at least some alpha motor nerve fibers associated with the one or more spinal stabilization muscles, and to induce one or more tetanic contractions in the one or more spinal stabilization muscles of the patient during at least portions of the first period of time; delivering, over a second electrical stimulation period of time ranging between about 2 and about 30 seconds, second stimulation signals having frequencies ranging between about 20 Hz and about 200 Hz through the one or more electrodes of the one or more medical electrical leads to the one or more target peripheral nerves, the second electrical stimulation period of time following or preceding the first electrical stimulation period of time, the second stimulation signals being configured to recruit, activate, or block at least some alpha and gamma sensory nerves or sensory nerve fibers associated with the one or spinal stabilization muscles; repeating delivery of the first and second stimulation signals through the one or more electrodes of the one or more medical electrical leads to the one or more target peripheral nerves during subsequent first and second electrical stimulation periods of time, respectively; wherein the one or more target peripheral nerves are located near, or are associated with, at least one of: (a) one or more medial branches of one or more dorsal rami nerves or nerve fibers of the patient, and (b) one or more dorsal rami nerves or nerve fibers located proximally from at least one of first bifurcations of one or more dorsal rami nerves of the patient; and further wherein: (c) the first stimulation signals are configured to rehabilitate or strengthen the one or more spinal stabilization muscles of the patient; (d) the second stimulation signals are configured to reduce lower back pain sensed by the patient, and (e) delivery of the first and second electrical stimulation signals during repeating first and second periods of time occurs collectively over a third period of time ranging between about 10 minutes and about 90 minutes in length, the third period of time comprising a spinal stabilization muscle rehabilitation session.
In such embodiments, the one or more spinal stabilization muscles may include one or more of at least one multifidus muscle, at least one erector spinae muscle, at least one spinalis muscle, at least one longissimus muscle, at least one iliocostalis muscle, at least one quadratus labrum muscle, and at least one transverse abdominus muscle; the first stimulation signal is further configured to recruit and activate, in addition to one or more multifidus muscles, at least some alpha motor nerves or nerve fibers associated with one or more erector spinae muscles, spinalis muscles, longissimus muscles, iliocostalis muscles, quadratus labrum muscles, and transverse abdominus muscles. In some embodiments, the one or more target nerves may be one or more dorsal rami nerves or nerve fibers located proximally from the first bifurcations of the one or more dorsal rami nerves of the patient. In some embodiments, the one or more target nerves may be the one or more medial branches of the one or more dorsal rami nerves of the patient. In some embodiments, the first stimulation signals may further be configured to disrupt arthrogenic inhibition of the one or more spinal stabilization muscles. In some embodiments, the second stimulation signals may be configured to engage gate mechanisms associated with the one or more sensory nerves or nerve fibers, thereby to reduce or alleviate lower back pain sensed by the patient. In some embodiments, the pain that treated in such embodiments may non-specific chronic lower back pain (NSCLBP). In some embodiments, the second stimulation signals may also be configured to promote reducing non-specific chronic lower back pain. In some embodiments, the third period of time may range between one or more of: (a) about 5 minutes and about 60 minutes; (b) about 5 minutes and about 40 minutes; (c) about 10 minutes and about 30 minutes; and (d) between 10 minutes and about 20 minutes. In some embodiments, the first period of time may further range between one or more of: (a) about 4 seconds and about 16 seconds; (b) about 4 seconds and about 12 seconds; and (c) about 4 seconds and about 10 seconds. In some embodiments, the second period of time may further range between one or more of: (a) 2 seconds and about 20 seconds; (b) about 2 seconds and about 15 seconds; (c) about 2 seconds and about 10 seconds. In some embodiments, the first electrical stimulation signals may have frequencies ranging between about 12 Hz and about 25 Hz. In some embodiments, the second electrical stimulation signals may have frequencies ranging between about 70 Hz and about 130 Hz. In some embodiments, the first stimulation signals may have one or more of: (a) pulse widths ranging between about 100 microseconds and about 500 microseconds, or between about 100 microseconds and about 300 microseconds; (b) amplitudes ranging between about 1 mA and about 20 mA, between about 2 mA and about 10 mA, or between about 2 mA and about 5 mA, and (c) amplitudes ranging between about 0.5 V and about 40 V, between about 1 V and about 20 V, or between about 1 V and about 10 V. In some embodiments, the second stimulation signals may have one or more of: (a) pulse widths ranging between about 50 microseconds and about 1000 microseconds, between about 100 microseconds and about 500 microseconds, or between about 100 microseconds and about 200 microseconds; (b) current amplitudes ranging between about 1 mA and about 20 mA, between about 2 mA and about 10 mA, or between about 2 mA and about 5 mA, and (c) voltage amplitudes ranging between about 0.5 V and about 40 V, between about 1 V and about 20 V, and between about 1 V and about 10 V. In some embodiments, the patient can activate the second stimulation signal outside of the spinal stabilization muscle rehabilitation session to reduce lower back pain. In some embodiments, the spinal stabilization muscle rehabilitation session may be repeated at least one of: (a) a plurality of times during a 24-hour period, and (b) between 2 and 10 times during a 24-hour period. In some embodiments, the first stimulation signals may be: (a) interleaved with the second stimulation signals; (b) overlap with the second stimulation signals; and (c) at least partially superimposed upon and delivered simultaneously with the second stimulation signals. In some embodiments, delivery of the first stimulation signals is separated from delivery of the second stimulation signals by a period of time ranging between: (a) about 0 seconds and about 60 seconds; (b) about 5 seconds and about 30 seconds; and (c) about 1 second and about 10 seconds.
Testing of some of the foregoing stimulation parameters and methods was carried out in a number of human subjects in a pilot study. One purpose of the pilot study was to determine if it was possible to stimulate at the distal portion of the dorsal ramus just prior to the first bifurcation described above, and to compare this stimulation site with activation at the medial branch of the dorsal ramus. The stimulation amplitudes required to activate the multifidus muscle at or near the root of the dorsal ramus were to be compared to the activation energies required at the medial branch. The study was also designed to evaluate the optimal site (medial branch of the dorsal root or proximal thereto at the distal portion of the dorsal ramus) for activation of the deep multifidus muscle in addition to sensory stimulation to reduce pain The pilot study was a prospective, single center, acute feasibility study. Subjects selected to participate in the trial had low back pain, had been evaluated as candidates for dorsal root nerve ablation, and agreed to undergo a temporary investigational stimulation prior to ablation.
After the subjects consented to the study, he or she was enrolled in the pilot study and underwent a baseline evaluation. A standard Stryker radiofrequency ablation needle was inserted one vertebral level above each subject's painful region under fluoroscopic guidance. The nerve branch was then stimulated with the appropriate pulse width, frequency and amplitude to achieve motor activation of the multifidus muscle. Once successful motor activation was achieved, the nerve branch was stimulated with the appropriate pulse width, frequency and amplitude to achieve optimal pain reduction.
The results obtained in the pilot study are summarized as follows:
As employed herein, and consistent with their commonly understood meanings by those skilled in the arts of neurophysiology and medicine, the term “tetanus” means the prolonged contraction of a muscle caused by the delivery of appropriate electrical stimulation signals to or near target peripheral nerves associated therewith, and “tetanic contractions” are muscle contractions induced and sustained by the delivery of appropriate electrical stimulation signals to or near target peripheral nerves associate with the muscle(s).
Nevertheless, and depending upon where electrodes 39 are positioned and programmed for stimulation, other locations close to or adjoining one or more of nerves 52, 44 and 46 may also be employed beneficially and efficaciously to rehabilitate or strengthen a multifidus and/or other spinal stabilization muscle, and suppress or reduced lower back pain. As shown in
Once one or both needle(s) 130 and/or 132 have been guided to a desired location near the one or more mixed target nerves of interest, at step 104 the target nerve(s) are electrically stimulated by operably attaching the proximal ends of needles 130 and 32 to EPG 12 and activating a desired output stimulation pattern or regime for delivery to needles 130 and/or 132. Different stimulation parameters can be tested at this time by varying any one or more of the voltage, current, frequency, pulse width, amplitude, amount or degree of overlap, interleaving, and separate delivery of the first and second stimulation signals, as well as other electrical stimulation parameters.
In addition to experimenting with different stimulation parameters, needles 130 and/or 132 can be repositioned or their locations changed as required or desired at step 106 so that optimum stimulation results are obtained (e.g., maximum, sufficient, or acceptable multifidus muscle movement in response to the first signals, and a reduction, lowering, blocking or paresthesia as regards pain in the lower back in response to the second signal). Once step 106 has been completed, at step 108 an introducer is inserted over each needle, and at step 110 needle(s) 130 and/or 132 are withdrawn from the patient. Distal ends 47 of lead(s) 18 and/or 20 are then inserted through the introducers to their respective target nerve locations at step 112. Alternatively, needles 130 and 132 are hollow needles having inner diameters sufficiently large (e.g., 0.5 mm or more) to accept therein percutaneous leads 18 and 20 having diameters less than the inner diameters of needles 130 and 132. Other techniques for implanting percutaneous leads 18 and 20 near dorsal rami 52 are also contemplated.
At step 114, the proximal ends of leads 18 and/or 20 are operably connected to EPG 12. Further refinement and adjustment of electrical stimulation and EPG programming instructions may then be carried out at step 116.
As an example, patient 22 with chronic lower back pain is implanted with a lead or leads 18 and/0r 20 to be situated near the dorsal rami for blocking both pain and stimulating the stabilizing muscles 68 and 70 of spine 42. An appropriate nerve target is identified using a percutaneous needle stick and demonstrating activation of the target muscle as viewed using an ultrasound apparatus. Once the target nerve and location have been established, percutaneous lead(s) 18 and/or 20 are inserted using standard techniques. Lead(s) 18 and/or 20 are operably connected to EPG 12. System 10 and EPG 12 are then programmed using a clinician programmer app in CP 14 to determine appropriate stimulation parameters (e.g., amplitude, frequency, pulse width, time between delivery of the first and second signals, etc.) for patient 22.
In addition, an MRI can be used to image one or more multifidus or other spinal stabilization muscles in the patient to assess the strength or degree of atrophy of the multifidus muscles 68 and 70 before the leads 18 and/or 20 are implanted in patient 22. An MRI may also be used to image one or more multifidus or other spinal stabilization muscles, such as muscle 68 and 70, in patient 22 after therapy has been delivered to patient 22 by the first and second stimulation signals 140 and 142, and after the leads 18 and/or 20 have been implanted in patient 22.
Referring now to
Referring now to
In potential combinations of waveform parameters in the various embodiments, however: (a) the first stimulation signals have a first range of frequencies, pulse widths and/or amplitudes; and (b) the second stimulation signals have a second range of frequencies, pulse widths and/or amplitudes, as discussed above; (c) the first and second stimulation signals are delivered to the same, related, or nearby one or more target peripheral nerves; and (d) the first and second stimulation signals may be delivered at the same time, overlap one another, and/or be delivered separately but sequentially through the same, separate or multiple lead(s).
To avoid potential confusion, note that the terms “first stimulation signal” and “second stimulation signal” are not intended to mean, for example, limiting delivery of the first stimulation signal to be first in time with respect to the second stimulation signal; either signal can be delivered first, second or at some other point in time. Additionally, the generation and delivery of signals that could be classified according to their frequency, pulse width and/or amplitude as first or second stimulation signals, but that are modified or different in some respect with respect thereto (e.g., frequency, pulse width, amplitude, phase, etc.), which have been or will be generated and/or delivered at some previous or later point(s) in time, are also contemplated. Thus, the generation and delivery of more than first and signal stimulation signals is contemplated. Additionally, in some embodiments the frequencies of the first and second stimulation signals may the same or substantially the same, may differ from one another, or may alternate and change over time.
Continuing to refer to
Continuing to refer to
Also note that in
Referring now to
Continuing to refer to
In one embodiment, the first electrical stimulation periods of time provided during sessions 150 range between about 2 seconds and about 20 seconds, the first electrical stimulation signals have frequencies ranging between about 10 Hz and about 30 Hz and pulse widths ranging between about 50 microseconds and about 1,000 microseconds, and the second electrical stimulation periods of time provided during sessions 150 range between about 2 and about 30 seconds, and the second stimulation signals have frequencies ranging between about 20 Hz and about 200 Hz.
In further embodiments corresponding to
Other stimulation parameters are contemplated for the first and second stimulation signals and sessions 150. For example, frequencies above 200 Hz up to about 800 Hz are contemplated for the second stimulation signal 142; however, such higher frequencies for the second stimulation signal 142 have been discovered not to provide any enhanced benefit (or indeed degraded and inferior performance) as regards pain relief relative to lower frequencies at and below 200 Hz, and thus represent a waste of valuable EPG 12 power. Roughly the same holds true for first stimulation signals 140, where frequencies exceeding the optimal ranges that have been discovered (and that are described above) can be employed (e.g., up to about 200 Hz), but to gradually worsening effect on the patient and rapidly increasing waste of power from EPG 12.
Note that in some embodiments the electrical stimulation regimes described and disclosed herein may be provided by an implantable pulse generator (IPG) instead of an EPG 12, which IPG may or may not be battery-less, and which IPG may or may not be provided electrical energy wirelessly through transcutaneous inductive coupling means and an external power provision device or its own internal battery. See, for example, U.S. Pat. No. 10,898,719 to Pivonka et al., which describes and discloses an implantable stimulator that is battery-less, and which is hereby incorporated by reference herein in its entirety. IPGs with internal battery power sources, many of them rechargeable, are well known in the art, and can easily be programmed to provide the first and second signals described and disclosed herein.
Referring now to
In the non-limiting and illustrative examples of
Note that first and second stimulation signals 140 and 142, and combined first and second signals 140/142, are not necessarily to scale in
In still further embodiments, stimulation signals can be generated and delivered that comprise more than first and second stimulation signals, such as third, fourth, fifth, sixth and/or more stimulation signals, where each such combined and/or overlapping stimulation signal is characterized by a different combination or modification of stimulation parameters (e.g., frequency, pulse width, amplitude, phase, etc.). For example, a second pain stimulation signal having a first set of stimulation parameters associated therewith can be generated and delivered, followed by the generation and delivery of a first muscle stimulation signal having a second set of stimulation parameters associated therewith, followed by the generation and delivery of a second pain stimulation signal having a third set of stimulation parameters associated therewith, followed by the generation and delivery of a first muscle stimulation signal having a fourth set of stimulation parameters associated therewith, and so on. Pain stimulation signals can follow one after the other, and likewise muscle stimulation signals can follow one after the other. Single or multiple pain and muscle stimulation signals can be provided in any order or sequence that provides beneficial results to the patient.
The first and second stimulation signals may also be provided as constant voltage signals, constant current signals, triangular signals, biphasic signals, biphasic non-symmetrical signals (see, e.g.,
In various embodiments, the first and/or other stimulation signals are delivered to the one or more target nerves in bursts ranging between about 20 seconds and about 60 seconds in duration, and/or the second and/or other stimulation signals are delivered to the one or more bundles of target nerves in bursts ranging between about 20 seconds and about 120 seconds in duration. Such bursts can be delivered sequentially.
Therapy sessions 150 can be adjusted or modified as required over the multi-day or multi-month time period over which the first and second stimulation signals are delivered to the patient. For example, the stimulation parameters of combined pain and/or muscle rehabilitation therapy sessions 150 can be changed or modified as a day, or the multi-day or multi-month time period, progresses. Pain therapy sessions corresponding to second signals 142 can be shortened as the patient's pain is reduced and the multifidus and other spinal stabilization muscles become stronger. In some embodiments, the initial focus on treatment and therapy is to reduce the patient's lower back pain first so that the patient can resume or increase physical activity, which in turn permits subsequent therapy to focus increasingly on multifidus and/or other spinal stabilization muscle strengthening, thereby breaking the cycle (as described in further detail below). Many different modifications, combinations, and permutations of pain and muscle rehabilitation therapy sessions are contemplated, as those skilled in the art will understand after having read and understood the present specification and claims.
In one embodiment, the electrically stimulated motor nerves are associated with myelinated alpha (or A-fiber) afferent neurons, and the electrically stimulated sensory nerves are associated with myelinated alpha (or A-fiber, or Aσ-fiber) efferent neurons and unmyelinated gamma (or C-fiber) neurons. See, for example, the publication “General Pathways of Pain Sendation and the Major Neurotransmitters Involved in Pain Regulation,” Mun Fei Yam et al., Int. J. Mol. Sci., 2018, 19, 2164; doi:10.3390/ijms19082164, the entirety of which is incorporated by reference herein pursuant to an Information Disclosure Statement and accompanying copy thereof filed on even date herewith.
In one embodiment, the sensory nerves or nerve fibers and their associated myelinated alpha (or A-fiber, or Aσ-fiber) efferent neurons are stimulated by the first stimulation signals to reduce at least partially the pain sensed by the patient, while the sensory nerves associated with unmyelinated gamma (or C-fiber) neurons are stimulated by the second stimulation signals to provide further or a different type of pain relief sensed by the patient.
In some embodiments, the first stimulation signal provides motor nerve, nerve fiber, and/or neuron stimulation for multifidus and/or other spinal stabilization muscle rehabilitation, while the second stimulation signal provides sensory nerve, nerve fiber and/or neuron stimulation to lessen or reduce pain sensed by the patient. In such an embodiment, and if the first and second stimulation signals are delivered simultaneously or overlap one another, the patient may sense activation of the motor nerves and/or neurons resulting in muscle contraction, but may also not sense, or at least not sense very strongly, the second stimulation signals (e.g., as indicated by perceiving tingling at or near the sensory nerve and/or neuron stimulation site). This is because sensing of the second stimulation signals is overwhelmed by the patient sensing the stronger and more dominant first stimulation signals.
Note that in such an embodiment, while the first and second stimulation signals may have the same or nearly the same frequencies and pulse widths associated therewith, the amplitudes of the first and second stimulation signals may differ, where the amplitudes of the first stimulation signals exceed those of the second stimulation signals. Similar differences in the pulse widths of the first and second stimulation signals can also be employed to effect muscle rehabilitation (greater pulse width of the first stimulation signal) and pain relief (lesser pulse width of the second stimulation signal). It will now be seen that in some embodiments the frequencies, pulse widths, and/or amplitudes of the first and second stimulation signals can be the same or nearly the same, or may differ, or differ slightly, from one another.
In still further embodiments, electrodes 39 on leads 18 and/or 20 may also be employed not only to stimulate targeted nerve bundles or nerves, but also to sense depolarization and repolarization signals originating from the targeted nerve bundles or tissue in proximity thereto. These sensed signals may in turn be employed by programming instruction loaded and circuitry disposed in EPG 12 to process the sensed signals, and then determine whether or not the stimulation parameters of the first and/or second stimulation signals should be adjusted, thereby forming a feedback control loop for peripheral nerve stimulation.
Referring now to
The top portion of
The bottom portion of
Continuing to refer to
Referring now to
Some articles and technical papers describing and disclosing certain selected aspects of multifidus muscle rehabilitation and lower back pain systems, devices, methods, and therapies described and disclosed herein include the following publications: (a) Peripheral Nerve Stimulation for Chronic Low Back Pain: Prospective Case Series With 1 Year of Sustained Relief Following Short-Term Implant, Gilmore Calif. et al, Pain Practice 2020 March; 20(3):310-320; (b) Gilmore Calif., et al., Percutaneous Peripheral Nerve Stimulation for Chronic Low Back Pain: Prospective Case Series with 1 Year of Sustained Relief following Short-term Implant., Neuromodulation, vol. 22, issue 5, July, 2019; (c) Muscle Control for Non-specific Chronic Low Back Pain, Russo et al., Neuromodulation 2018: vol. 21, pp. 1-9; (d) Deckers, K et al, New Therapy for Refractory Chronic Mechanical Low Back Pain-Restorative Neurostimulation to Activate the Lumbar Multifidus: One Year Results of a Prospective Multicenter Clinical Trial. Neuromodulation, 2018 January; 21(1):48-55; (e) Gilmore, C, et al., Reduction in Opioid Consumption Reported among Chronic Low Back Pain Patients Following Percutaneous Peripheral Nerve Stimulation (PNS) of the Medial Branch Nerve for up to 60 days, ASRA November 2019; (f) Gilmore Calif., et al., Percutaneous 60-day Peripheral Nerve Stimulation Implant Provides Sustained Relief of Chronic Pain Following Amputation: 12-month Follow-up of a Randomized, Double-Blind, Placebo-Controlled Trial, Regional Anesthesia and Pain Medicine, 2019; (g) Deyo, Low Back Pain, N Engl J Med, 2001 Vol 344, No. 5. 363-370; (h) Burton et al., European Guidelines for Prevention in Back Pain, 2004, Eur Spine J (2006) 15 (Suppl. 2): S136-S168 (i) Hestbaek, Low back pain: what is the long-term course?A review of studies of general patient populations, Eur Spine J 2003, 12: 149-165; (j) Chou, Diagnosis and Treatment of Low Back Pain: A joint clinical practice guideline from the American College of Physicians and the American Pain Society., Ann Intern Med. 2007. 147: 478-491; (k) Hall et al., The role of radiofrequency facet denervation in chronic back pain, Jacksonville Medicine, October, 1998; (l) U.S. Pat. No. 4,026,301 to Friedman entitled “Apparatus and method for optimum electrode placement in the treatment of disease syndromes such as spinal curvature;” (m) U.S. Pat. No. 6,505,075 to Weiner entitled “Peripheral nerve stimulation method;” (n) U.S. Pat. No. 7,167,756 to Torgerson et al. entitled “Battery recharge management for an implantable medical device;” (o) U.S. Pat. No. 8,606,358 to Sachs entitled “Muscle stimulator;” (p) U.S. Pat. No. 8,700,177 to Strother et al. entitled “Systems and methods for providing percutaneous electrical stimulation;” (q) U.S. Patent Publication No. 2004/0122482 to Tung et al. entitled “Nerve Proximity Method and Device;” (r) U.S. Patent Publication No. 2010/0036454 to Bennett et al. entitled “Systems and methods to place one or more leads in muscle for providing electrical stimulation to treat pain,” and (s) U.S. Patent Publication No. 2013/0296966 to Wongsarnpigoon et al. entitled “Systems and methods related to the treatment of back pain.” Each of the foregoing publications is hereby incorporated by reference herein, each in its respective entirety pursuant to one or more previously filed Information Disclosure Statements filed in the parent '326 patent application or the parent '032 patent application containing citations or complete copies, as the case may be, of such publications.
Referring now to
Continuing to refer to
It will now be seen that the various systems, devices, components and methods disclosed and described herein are capable of rehabilitating and strengthening atrophied muscles, and reducing or eliminating pain sensed by a patient.
What have been described above are examples and embodiments of the devices and methods described and disclosed herein. It is, of course, not possible to describe every conceivable combination of components or methodologies for purposes of describing the invention, but one of ordinary skill in the art will recognize that many further combinations and permutations of the devices and methods described and disclosed herein are possible. Accordingly, the devices and methods described and disclosed herein are intended to embrace all such alterations, modifications and variations that fall within the scope of the appended claims. In the claims, unless otherwise indicated, the article “a” is to refer to “one or more than one.”
The terms “nerve” or “nerves,” “neuron” or “neurons,” “nerve bundle” or “nerve bundles,” “nerve fascicle or nerve fascicles,” and “nerve fiber” or “nerve fibers” as employed herein, and in the context of electrical stimulation and lead placement or positioning, can be considered to be essentially synonymous and basically mean the same thing. Thus, and by way of an illustrative but not limiting example, electrically stimulating a nerve means the same thing as electrically stimulating a nerve bundle, a nerve fascicle, a nerve fiber, or a “neuron,” and so on.
The foregoing description and disclosure outline features of several embodiments so that those skilled in the art may better understand the detailed description set forth herein. Those skilled in the art will now understand that many different permutations, combinations and variations of the systems, devices, components, and methods described and disclosed herein fall within the scope of the various embodiments. Those skilled in the art should appreciate that they may readily use the present disclosure as a basis for designing or modifying other processes and structures for carrying out the same purposes and/or achieving the same advantages of the embodiments introduced herein. Those skilled in the art should also realize that such equivalent constructions do not depart from the spirit and scope of the present disclosure, and that they may make various changes, substitutions and alterations herein without departing from the spirit and scope of the present disclosure.
After having read and understood the present specification, those skilled in the art will now understand and appreciate that the various embodiments described herein provide solutions to long-standing problems in the effective use of neurostimulation systems.
This application is a continuation-in-part of, and claims priority and other benefits from: (a) U.S. patent application Ser. No. 16/917,326 entitled “Systems, Devices, Components and Methods for the Delivery of First and Second Electrical Stimulation Signals to Motor and Sensory Peripheral Target Nerves” to Stylos et al. filed on Jun. 30, 2020 (“the '326 patent application”); and (b) U.S. patent application Ser. No. 17/377,032 entitled “Systems, Devices, Components and Methods for the Delivery of Electrical Stimulation Signals to Motor and Sensory Peripheral Target Nerves” to Stylos et al. filed on Jul. 15, 2021, 2020 (“the '032 patent application”), the respective entireties of which are hereby incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16917326 | Jun 2020 | US |
| Child | 17577324 | US | |
| Parent | 17377032 | Jul 2021 | US |
| Child | 16917326 | US |
