Systems and methods for treating chronic lower back pain

Abstract

In some embodiments, a system includes a wearable garment that can be coupled to an electrode panel to secure the electrode panel in place to contract transverse abdominal muscles and lumbar multifidus muscles. In some embodiments, the system includes a controller coupled to the at least one electrode panel to deliver power to the electrodes. In some embodiments, the controller executes program instructions that may independently contract the transverse abdominal muscle and the multifidus lumbar muscle or may simultaneously contract the transverse abdominal muscle and the multifidus lumbar muscle. In some embodiments, the controller executes the NMES and TENS programs simultaneously. In some embodiments, the NMES and TENS are performed by the same electrode.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 325,470, filed on March 30, 2022, which is incorporated herein by reference in its entirety. Background Art

[0003] Commonly referred to as low back pain, it includes localized pain, muscle tension or stiffness in the lumbar area and above the gluteal groove, with or without sciatica. If the low back pain lasts for 12 weeks or longer, it is defined as chronic low back pain. About 20% of patients with acute low back pain will develop chronic low back pain one year after the initial symptoms, and the symptoms persist. Figure 1 The area of ​​the back affected by chronic lower back pain ("CLBP") is illustrated.

[0004] CLBP is most frequently diagnosed in the 40-69 age group and is the leading cause of work-related disability and the most common reason for absence from work in people under 45. Lower back pain is the fifth most common reason for doctor visits, and the CLBP treatment market was valued at $6.29 billion in 2018. Figure 2 A graphic representation of the causes, risk factors, diagnosis, and current treatments of CLBP is shown. In 2017, more than 34 million people (about 6% of the adult population) in the United States alone suffered from CLBP. However, only about 5 million of those patients (about 15%) are eligible for surgery.

[0005] CLBP is mainly due to mechanical instability of the spine, which is caused by problems in one or more of the neural control, passive elements (e.g., vertebral position, spinal locators, and spinal motion), and / or active elements (e.g., spinal muscle activation patterns). The spinal structure is designed to maintain an upright posture, absorb shock, and accommodate bipedal gait through three normal curvatures (cervical lordosis, thoracic kyphosis, and lumbar lordosis). Spinal alignment also depends on stabilizing structures such as facet joints, spinal ligaments, and intervertebral discs, as well as muscles that provide dynamic stability by absorbing spinal loads during activity. The core muscles including the transverse abdominal muscle (TrA), i.e., the deepest abdominal muscle, provide key dynamic stability for the lumbar spine. In the back, the erector spinae muscles span multiple levels of the spine and provide an upright posture. The deepest compartment in the back is composed of the lumbar multifidus (LM), which provides segmental stability for each vertebra and increases the stiffness of the spine during function. These deep compartment muscles are essential for providing the necessary stability for the spine.

[0006] Factors associated with CLBP include compromised dynamic and segmental stability of the lumbar spine and altered muscle activity to compensate for reduced stability. Patients with CLBP are unable to adequately activate the deep lumbar stabilizing muscles of the TrA and LM, which are critical for lumbar spine stability. Atrophic changes and motor control impairments affecting the TrA and LM result in dynamic and segmental instability of the lumbar spine. This, in turn, may cause or perpetuate CLBP.

[0007] Atrophic changes affecting the LM and TrA muscle groups contribute to segmental and dynamic instability of the lumbar spine and the development of CLBP. Approximately 80% of patients with CLBP will experience multifidus muscle atrophy. Spinal instability can lead to low back pain, defective neural activation of the LM and TrA muscles, joint overload, and re-injury, resulting in a perpetuating cycle of chronic low back pain.

[0008] Electrical stimulation via implanted lead electrodes to induce LM contraction has previously been found to be effective in reducing back pain intensity and improving functional outcome scores in patients with LBP. However, there is a need in the art for a non-invasive solution to relieve CLBP without resorting to more invasive procedures. Summary of the invention

[0009] In some embodiments, the present disclosure relates to a system for relieving chronic lower back pain. In some embodiments, the system includes a wearable garment and / or a plurality of electrodes. In some embodiments, the plurality of electrodes are positioned on the wearable garment so that a neuromuscular electrical stimulation (NMES) pulse reaching each of the plurality of electrodes will simultaneously contract the transverse abdominal (TrA) muscle and the lumbar multifidus (LM) muscle. In some embodiments, the wearable garment is configured so that one or more of the plurality of electrodes can be repositioned.

[0010] In some embodiments, the system further comprises a panel. In some embodiments, the panel comprises at least one electrode of the plurality of electrodes. In some embodiments, the panel is configured to be electrically coupled to at least one electrode of the plurality of electrodes. In some embodiments, the panel is configured to add rigidity to at least one electrode of the plurality of electrodes. In some embodiments, the wearable garment is configured to secure the panel in place such that when the NMES pulse is applied to at least one electrode of the plurality of electrodes, at least one electrode of the plurality of electrodes contracts at least one of the TrA muscle and the LM muscle.

[0011] In some embodiments, the system includes a plurality of panels. In some embodiments, each of the plurality of panels includes an electrical contact configured to be physically coupled to at least one of the plurality of electrodes. In some embodiments, each of the plurality of panels is configured to be electrically coupled to at least one of the plurality of electrodes. In some embodiments, the wearable garment is configured to secure each of the plurality of panels in position such that the NMES pulses contract the TrA muscle and / or the LM muscle.

[0012] In some embodiments, the plurality of panels include one or more electrode panels. In some embodiments, the electrode panel includes electrical and / or mechanical connections for two or more electrodes. In some embodiments, the mechanical connection is configured to position the two or more electrodes so that a neuromuscular electrical stimulation (NMES) pulse to each of the two or more electrodes will contract the transverse abdominal (TrA) muscle. In some embodiments, the mechanical connection is configured to position the two or more electrodes so that a neuromuscular electrical stimulation (NMES) pulse to each of the two or more electrodes will contract the lumbar multifidus (LM) muscle.

[0013] In some embodiments, the controller is configured to perform one or more program steps, including: executing TrA pulses by one or more processors; stopping TrA pulses by one or more processors; executing LM pulses by one or more processors; stopping LM pulses by one or more processors; and executing TrA pulses and LM pulses simultaneously by one or more processors.

[0014] In some embodiments, the electrode panel includes a rigidity property and a flexibility property. In some embodiments, the rigidity property enables the electrode panel to maintain substantially the same shape under the influence of gravity when it is rotated to various positions. In some embodiments, the flexibility property enables the electrode panel to bend enough to ensure that each of the two or more electrodes contacts the skin to contract the transverse abdominal (TrA) muscle and / or the lumbar multifidus (LM) muscle when two or more electrodes are connected to the electrode panel. In some embodiments, the electrode panel includes a circuit configured to deliver electrical pulses to each of the two or more electrodes. In some embodiments, the electrode panel includes a base configured to enable the controller to be connected to the docking plate. In some embodiments, the system includes one or more of the controller and the clothing. In some embodiments, the controller is configured to be electrically coupled to the electrode panel. In some embodiments, the clothing includes one or more mechanical couplings configured to removably fix the controller and / or the electrode panel in place.

[0015] In some embodiments, a system for relieving chronic lower back pain includes a plurality of electrodes and / or a controller. In some embodiments, the controller is configured to execute a neuromuscular electrical stimulation (NMES) program configured to generate one or more NMES pulses to each of the plurality of electrodes. In some embodiments, the one or more NMES pulses include a transverse abdominal (TrA) muscle pulse configured to contract the TrA muscle. In some embodiments, the one or more NMES pulses include a lumbar multifidus (LM) muscle pulse configured to contract the LM muscle.

[0016] In some embodiments, the controller is configured to perform one or more program steps, including: executing TrA pulses by one or more processors; stopping TrA pulses by one or more processors; executing LM pulses by one or more processors; and stopping LM pulses by one or more processors. In some embodiments, the controller is configured to perform transcutaneous electrical stimulation (TENS) and NMES programs. In some embodiments, the controller is configured to perform transcutaneous electrical stimulation (TENS) and NMES programs on the same electrode at the same time.

[0017] In some embodiments, the system comprises a garment and / or one or more panels. In some embodiments, the controller is configured to electrically couple to at least one of the one or more panels. In some embodiments, the garment comprises one or more mechanical couplings configured to removably secure the one or more panels in one or more positions. In some embodiments, the one or more positions are configured to deliver TrA pulses and / or LM pulses. In some embodiments, the one or more panels comprise circuits configured to deliver electrical pulses to each of a plurality of electrodes. In some embodiments, the one or more panels comprise a base configured to enable the controller to connect to a docking plate to perform one or more procedural steps. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 Illustration of the areas of the back affected by chronic lower back pain (CLBP).

[0019] Figure 2 A graphic representation of the causes, risk factors, diagnosis, and current treatments of CLBP is shown.

[0020] Figure 3 The role of a system in helping to relieve pain and restore function associated with CLBP is illustrated in accordance with some embodiments.

[0021] Figure 4-8 System electrode placement for CLPB treatment of a patient is shown in accordance with some embodiments.

[0022] Fig. 9 and Fig.10 A wearable garment according to some embodiments of the system is shown, the garment including a unique wrap, strap and / or belt design for use as Figure 4-8 as shown in the figure placed on the user.

[0023] Fig.11 An electronic system overview is illustrated in accordance with some embodiments.

[0024] Fig.12 An electrode wiring diagram according to some embodiments is shown.

[0025] Fig.13 Depicted are rendered views of assembled electrode panels and thermoformed panel configurations according to some embodiments.

[0026] Fig.14 Options for connecting a docking plate to a flex circuit are shown, along with a rendering of the flex circuit material, in accordance with some embodiments.

[0027] Fig.15 NMES waveform parameters utilized in the ActivCore Therapy treatment protocol for the CLBP device described herein are shown, according to some embodiments.

[0028] FIG. 16 illustrates NMES / TENS combination waveform parameters according to some embodiments.

[0029] Fig.17 Additional NMES / TENS combination waveform parameters are depicted according to some embodiments.

[0030] Fig.18 Depicted is the change in transverse abdominis muscle thickness from rest to stimulation, according to some embodiments.

[0031] Fig.19 Shown is the change in lumbar multifidus muscle thickness from rest to stimulation in accordance with some embodiments.

[0032] Fig. 20 A computer system enabling or including the systems and methods described herein is illustrated according to some embodiments.

[0033] Fig.21 Flowchart showing how the system can achieve personalized dose of NMES therapy by measuring the patient's muscle strength, disease stage and / or by using patient database analysis and / or machine learning. DETAILED DESCRIPTION

[0034] In some embodiments, the system includes a non-invasive neuromuscular electrical stimulation (NMES) device including surface electrodes configured to provide pain relief and therapeutic effects without surgical intervention. In some embodiments, the system is configured to provide lumbar pelvic stabilization rehabilitation to enhance muscle strength and prevent muscle atrophy. In some embodiments, the system is configured to increase the strength of the deep lumbar stabilizing muscles. The muscle activation achieved by the system has been demonstrated to result in clinical improvement in CLBP patients.

[0035] The LM and TrA are the deepest muscles in the abdominal and back regions, and they can be difficult to activate from the surface of the skin. In some embodiments, the system is configured to deliver one or more high intensity waveforms and wide electrical stimulation pulses to stimulate and activate one or more of these muscles. In some embodiments, the system includes a controller configured to implement one or more of the procedural steps described herein. In some embodiments, the procedural steps include steps to achieve co-contraction and / or simultaneous stimulation of the LM and TrA muscles.

[0036] In some embodiments, the system (controller) is configured to implement a unique NMES waveform using skin contact electrodes as a non-invasive intervention. In some embodiments, the system is configured to target the deep muscles of the TrA and LM to overcome the difficulties associated with voluntary activation of these deep spinal stabilizing muscle groups. Fig.18 and 19 Activation of the TrA and LM muscles according to some embodiments is illustrated. In some embodiments, the controller is configured to implement a unique NMES waveform that includes a high intensity, monophasic waveform with a long pulse duration, and a unique polarization shape.

[0037] In some embodiments, the controller is configured to implement a co-contraction program that is configured to stimulate the TrA and LM muscles independently and then simultaneously to provide a co-contraction effect of the core and lumbar spine. In some embodiments, over time, stimulation of the TrA and LM muscles can strengthen the muscles, stabilize the spinal structure, and / or promote effective pain relief associated with CLBP. In some embodiments, the co-contraction program is configured to provide the necessary dynamic and segmental stability to the spine. Figure 3 The role of a co-contraction program protocol in helping to alleviate CLBP is illustrated in accordance with some embodiments.

[0038] Figure 4-8Illustrated is an electrode placement method for delivering a co-contraction program and / or CLPB treatment to a patient in accordance with some embodiments. In some embodiments, the method steps include placing one or more electrodes in the abdominal region above the iliac crest and on the lower back in the L2 to L5 region. In some embodiments, activation of the electrodes in this region stimulates the TrA and LM muscles responsible for spinal core strength and stability. In some embodiments, the system includes right and / or left side activation of the TrA and LM muscles to treat instability in CLBP patients, as previously described. In some embodiments, the system includes one or more program steps for activating the electrodes in a pattern that includes approximately 5 minutes of activation of the abdominal region, approximately 5 minutes of activation of the back region, and / or approximately 5 minutes of co-contraction of the abdominal and back regions.

[0039] In some embodiments, the system is configured to achieve bilateral, independent and / or concurrent muscle electrical stimulation of the abdominal TrA and / or the LM of the lower back. In some embodiments, the co-contraction program is configured to provide a unique NMES pulse sequence, which includes about 5 minutes of bilateral and independent TA muscle stimulation, about 5 minutes of bilateral and independent LM muscle stimulation, and about 5 minutes of bilateral and concurrent TrA / LM muscle stimulation. Although on average, it was found that 5 minutes can achieve the desired results, according to some embodiments, it was found that a range of 2 minutes to 8 minutes is sufficient. In some embodiments, the system is configured to repeat the pattern for a specified number of programmings and / or a specified duration.

[0040] In some embodiments, the system is configured to perform an NMES activation protocol and a TENS activation protocol in a single treatment session. In some embodiments, the NMES activation protocol provides long-term benefits for core muscle (TA and LM) strengthening, restoration of muscle control, and pain relief. In some embodiments, the TENS activation protocol provides short-term and immediate benefits of pain relief by blocking pain signal transmission from the brain to the lower back region (i.e., the gate control theory of pain).

[0041] In some embodiments, the system includes a heating element. In some embodiments, the panel includes a heating element. In some embodiments, the garment includes a heating element. In some embodiments, the system is configured to perform a (dry) heat therapy program for lower back pain to provide immediate comfort. In some embodiments, the heating element is configured to emit infrared light, wherein the system employs far infrared radiation (FIR) heat therapy, either alone or in combination with the co-contraction program and / or hybrid NMES / TENS protocol described herein.

[0042] Fig. 9 and Fig.10A back and core wearable garment 901 is shown that includes a unique wrap, strap, or belt configured to ensure proper placement of one or more electrodes on the user to achieve bilateral, independent, and / or concurrent electrical muscle stimulation of the abdominal TrA and / or LM of the lower back. Fig. 9 Depicted is an exterior surface view showing panel placement and / or controller base 1250 location when viewing the garment from a third person perspective when the garment is worn. Fig.10 An inner surface view of the garment is shown. In some embodiments, the inner surface view shows transverse abdominis electrodes 1001 coupled to abdomen panels 1002, which are adjustably positioned at the extremities of the garment 901. In some embodiments, the inner surface view shows one or more back panels 1010, which include one or more rectus femoris electrodes 1011 configured to activate the LM muscle. In some embodiments, one or more electrodes are secured to the garment 901 to position the one or more electrodes on the user, such as Figure 4-8 In some embodiments, garment 901 is configured to secure one or more back panels in place while allowing adjustment of one or more abdominal panels.

[0043] In some embodiments, the wearable garment 901 includes one or more snap-on electrodes (e.g., up to 6) configured to be placed over the TrA muscles of the abdomen and the LM muscles of the lower back. In some embodiments, the wearable and / or panel includes: a unique electrode template including 3 or more electrodes for the abdominal area, configured to activate the right TrA, the left TrA, and / or a common portion; and / or a unique electrode template for the lower back, configured to activate the right LM, the left LM, and / or a common portion. In some embodiments, the wearable garment includes a magnetic self-aligning electrode snap that is configured to hold one or more electrodes and / or one or more panels in place while enabling power transfer.

[0044] In some embodiments, the system includes a removable panel, also referred to herein as a smart panel. In some embodiments, the ability to remove the panel provides the benefit of allowing the garment 901 to be washed without damaging the panel and / or electrodes. In some embodiments, each panel position is adjustable above the wearable device (e.g., a waistband). In some embodiments, the panel includes a foam construction substrate (e.g., In some embodiments, the panel includes a unique electrode template including pre-positioned electrodes for NMES and / or TENS for abdominal and / or lower back stimulation.

[0045] In some embodiments, the panel and / or garment 901 includes a conductive textile electrode integrated in the panel assembly. In some embodiments, the garment 901 includes a garment circuit system configured to link one or more panels to a single controller 1304. In some embodiments, the system includes a detachable panel including an electronic device, an electrode, and a sensor. In some embodiments, the position of each panel in the one or more panels is adjustable. In some embodiments, the system includes a wired or wireless snap-on pulse generator for electrical stimulation therapy and / or thermal therapy. In some embodiments, the system includes one or more embedded dynamometers, accelerometers, electromyograms (EMGs), and pressure gauges in a package or smart panel to detect the activation force of deep TrA muscles and back LM muscles. In some embodiments, the system includes a graphical user interface (GUI) configured to display the activation level of TrA and LM muscles. In some embodiments, the GUI is visible to the user. In some embodiments, the controller is configured to calculate the minimum, maximum, and / or required NMES stimulation intensity of TrA and MF muscles based on the activation force of TrA and LM muscles obtained from one or more sensors.

[0046] Some embodiments include systems and methods for predicting disease progression and changes in spine and core health by measuring muscle strength, and / or using patient database analysis and / or machine learning to provide co-contraction therapy to slow CLBP disease progression.

[0047] In some embodiments, the system is configured to perform an estimated NMES calculation configured to estimate a personalized dose (intensity and / or duration) of NMES therapy. In some embodiments, the estimated calculation includes measuring the patient's muscle strength, disease stage, and / or using patient database analysis and / or machine learning. Fig.21 A non-limiting training workflow for machine learning for any of the NMES, TENS, and / or co-contraction programs described herein is shown in accordance with some embodiments.

[0048] In some embodiments, the system is configured to estimate correlations between patient demographics, NMES intensity, NMES duration, muscle strength, EMG, and / or CLBP pain levels by applying a training workflow of a machine learning algorithm. Fig.21 ).

[0049] Some further embodiments include a biofeedback system for simultaneously detecting biofeedback signals of TrA and LM muscle activation via EMG, movement or contraction detection using wearable wireless EMG sensors, pressure sensors, PZT sensors, force sensitive sensors, strain gauges, etc.

[0050] In some embodiments, the system includes an integrated biofeedback platform that provides interactive real-time monitoring and / or visualization of muscle contractions and may include a portable control module configured to couple to a wearable garment to deliver wireless EMS, control EMS channels and intensity, collect, store, and display detected biofeedback signals (EMG, pressure, and movement). In some embodiments, the portable control module includes an application (App) on a computer such as a mobile device.

[0051] In some embodiments, the system is configured to display the user's compliance with the co-contraction program schedule and / or is configured to associate one or more sensed parameters (e.g., elevated heart rate, muscle contraction) with pain intensity for analysis. In some embodiments, the system is configured to calculate a quality of life score. In some embodiments, the system is configured to track data, review data, and share data with one or more providers. In some embodiments, the data can be analyzed in real time, and feedback can be provided to the user based on the analysis. In some embodiments, the analysis can be used to change the user's behavior and / or therapy. In some embodiments, the system is configured to change controller program instructions based on the application of collected health data and / or recommendations of a machine learning algorithm to achieve a personalized therapy dose (e.g., intensity and / or duration) for NMES and / or TENS.

[0052] Fig.11 A non-limiting system overview according to some embodiments is illustrated. In some embodiments, the panel includes one or more pre-positioned detachable electrodes. In some embodiments, the panel includes 3 rows of electrodes. In some embodiments, the first row includes a single elongated electrode. In some embodiments, the second row includes a single elongated electrode. In some embodiments, the third row includes two electrodes, wherein the two electrodes have the same size and shape. In some embodiments, each of the two electrodes includes equal sides and / or radii.

[0053] Fig.12 1200 according to some embodiments. In some embodiments, the front view 1201 and the side view 1202 depict non-limiting configurations of the electrode panel 1203. In some embodiments, the panel 1203 includes a flexible circuit 1210, which includes one or more flexible PCB fingers 1211. In some embodiments, the flexible circuit 1210 includes a The flexible circuit 1210 may be positioned on the user side (eg, the user side) of the panel 1290. Foam) panel 1291 and body side ( In some embodiments, the adhesive is configured to provide mechanical pull elasticity. In some embodiments, the mechanical pull is configured to restore the panel to its original shape after bending. In some embodiments, the finger 1211 does not contain a mark. In some embodiments, the shape of the finger 1211 is configured to allow bending without bunching.

[0054] In some embodiments, the front view 1201 depicts a circuit material 1220 including a circuit path 1230 connecting electrodes 1281-1283 represented by dashed boxes. In some embodiments, the flexible circuit 1210 includes a ring terminal hole 1240 in the flexible circuit that is configured to enable connection to a snap-on socket 1270. In some embodiments, the snap-on socket 1270 is installed via, for example, swaging or pressing, and / or does not require any welding or adhesives. In some embodiments, a rear post 1271 of the snap-on socket 1270 clamps the flexible circuit and fabric together and provides an electrical and / or mechanical connection. In some embodiments, the flexible circuit 1210 includes a base 1250 that is bent to an interface with a base plate 1251 on a user-side foam plate 1291.

[0055] Fig.13 Depicted are rendered views of assembled electrical panels 1203, 1303 and thermoformed panels 1293, 1393. In some embodiments, base 1250 is configured to couple to controller 1304 and / or removably secure controller 1304 in a fixed position. Fig.14 Options for connecting the docking plate to the flex circuit are shown, along with a rendering of the flex circuit material 1413. In some embodiments, a first option 1411 for connecting the docking plate includes fusing the docking plate to the flex circuit. In some embodiments, a second option 1412 includes a detachable docking plate connection. In some embodiments, advantages of the system include: no welding required, no sewing required, no use of thermoplastic elastomers, low profile, bends / forms over and around joints, provides structure / rigidity to support electronic components through a modular system including garments and / or straps, and therapeutic applications across multiple joints (over or around joints).

[0056] Fig.15NMES waveform parameters for the CLBP device described herein are shown according to some embodiments. In some embodiments, the NMES waveform includes pulses of a unique, asymmetric, complex, wide, and monophasic shape designed to provide improved therapeutic benefits. In some embodiments, the duty cycle includes a combination of five contraction and rest periods during the treatment cycle. In some embodiments, the contraction time is the actual stimulation contraction period. In some embodiments, the rest time is the period of waiting between contractions to oscillate the stimulation between the two channels. In some embodiments, the relaxation time is the period of no stimulation between the duty cycles. In some embodiments, the treatment duration includes a range of 10-30 minutes, where 20 minutes has been found to produce the desired results. In some embodiments, the frequency of the duty cycle includes a range of 25 to 75 pulses per second, where 50 pulses per second have been shown to produce the desired results. In some embodiments, the duty cycle includes a range of 15-35%, where about 25% has been shown to achieve particularly desired results. In some embodiments, the duty cycle including a set of pulses includes a range of 8 to 16 seconds, where about 12 seconds have been found to produce particularly desired results. In some embodiments, the relaxation time including the time between duty cycles includes a range of 7 to 13 seconds, where about 10 seconds have been shown to produce particularly desired results. In some embodiments, the contraction time and / or rest time comprises a range of 3-7 cycles, with approximately 5 cycles having been found to produce particularly desirable results.

[0057] In some embodiments, the system provides NMES concurrent stimulation. In some embodiments, the system provides bilateral, independent and concurrent muscle electrical stimulation of the transverse abdominal muscle of the abdomen and the multifidus muscle of the lower back. In some embodiments, the system includes 5 minutes of bilateral and independent TA muscle stimulation, 5 minutes of bilateral and independent LM muscle stimulation, and 10 minutes of bilateral and concurrent TrA / LM muscle stimulation. In some embodiments, concurrent stimulation is provided by means of high-frequency channel switching through pulse generator firmware updates. In some embodiments, the design fully supports 4-channel (4 electrodes) alternating stimulation.

[0058] FIG. 16 illustrates NMES / TENS combination waveform parameters according to some embodiments. In some embodiments, the CLBP device pulse generator provides a combined NMES protocol and TENS protocol in a single treatment session. In some embodiments, the NMES protocol provides long-term benefits of core muscle (TrA and LM) strengthening, restoration of muscle control, and pain relief by stimulating motor neurons in the lower back and abdomen. In some embodiments, the TENS protocol provides short-term and immediate benefits of pain relief by stimulating sensory neurons in the lower back, blocking pain signals from the brain to the lower back region (the gate control theory of pain).

[0059] Fig.17Additional NMES / TENS combination waveform parameters are depicted in accordance with some embodiments. In some embodiments, a single treatment session includes a total of 25 minutes of combined NMES and TENS. First, in some embodiments, a 20-minute TrA / LM NMES therapy session is applied. Second, in some embodiments, the pulse generator switches to a TENS program that provides only 10 minutes of TENS therapy to the lower back. In some embodiments, TENS therapy is applied during the "relaxation" cycles of NMES therapy (each relaxation time is 10 seconds), thereby providing an interleaved therapy of NMES and TENS programs.

[0060] In some embodiments, the system includes a single printed control board (PCB) or other electronic assembly capable of generating NMES, heat output, and / or TENS output. In some embodiments, heat output is generated using a heating element or resistive heating element integrated into the back portion of a lower back strap configured to apply electrodes and / or heating elements to the L4 / L5 region of the lower back. In some embodiments, the heating element(s) are positioned away from the LM electrodes. In some embodiments, the heating element(s) at least partially overlap the LM electrodes.

[0061] In some embodiments, the system includes a controller with program instructions that configure the controller to implement a single treatment course that includes a total of 30 minutes of combined NMES or TENS and heat therapy, which treatment course can be programmed by the user according to some embodiments. In some embodiments, the controller is configured to apply 20 minutes of NMES and / or TENS therapy to the TrA / LM area as a first step. In some embodiments, the controller is configured to turn off the NMES / TENS pulse generator and the same printed control board assembly (PCBA) generates heat using a thermal element and / or thermal sensor to provide 10 minutes of heat therapy for lower back pain as a second step. In some embodiments, the system includes one or more thermistor sensors to safely measure and apply temperature. In some embodiments, the system is configured to apply heat to the lower back area that is 37 degrees Celsius above average skin temperature, and according to some embodiments, the temperature range is 32 to 42 degrees Celsius.

[0062] Some embodiments of the system were tested on three subjects with the following characteristics: body mass index (BMI) up to 31.5, males and females, CLBP and healthy subjects. In some embodiments, activation of the TrA and LM muscles was confirmed with ultrasound. In some embodiments, stimulation of the TrA and LM muscles was feasible for high BMI subjects (2 of the 3 had a BMI of 29 and 31.5). In some embodiments, stimulation of the abdominal and lower back regions was felt to be comfortable for all three subjects. In some embodiments, an increase in the thickness of the TrA and LM muscles was observed for all three subjects during NMES application. Fig.18 Depicted is the change in TrA thickness from rest to stimulation, according to some embodiments. Fig.19 The change in LM thickness from rest to stimulation is shown according to some embodiments.

[0063] Fig. 20 A computer system 1010 is illustrated that enables or includes systems and methods according to some embodiments of the system. In some embodiments, the computer system 1010 can operate and / or process computer executable code of one or more software modules of the above-described systems and methods. In addition, in some embodiments, the computer system 1010 can operate and / or display information within one or more graphical user interfaces (e.g., HMIs) that are integrated or coupled with the system.

[0064] In some embodiments, the computer system 1010 may include at least one processor 1032. In some embodiments, the at least one processor 1032 may reside in or be coupled to one or more conventional server platforms (not shown). In some embodiments, the computer system 1010 may include a network interface 1035a and an application interface 1035b coupled to at least one processor 1032 capable of processing at least one operating system 1034. In addition, in some embodiments, the interfaces 1035a, 1035b coupled to the at least one processor 1032 may be configured to process one or more of the software modules (e.g., such as enterprise applications 1038). In some embodiments, the software application module 1038 may include server-based software and may be operable to host at least one user account and / or at least one client account and to transfer data between one or more of these accounts using the at least one processor 1032.

[0065] In view of the above embodiments, it can be understood that the system can employ various computer-implemented operations involving data stored in a computer system. In addition, according to various embodiments, the above databases and models described throughout the present disclosure can store analytical models and other data on a computer-readable storage medium within the computer system 1010 and on a computer-readable storage medium coupled to the computer system 1010. In addition, in some embodiments, the above applications of the system can be stored on a computer-readable storage medium within the computer system 1010 and on a computer-readable storage medium coupled to the computer system 1010. In some embodiments, these operations are operations that require physical manipulation of physical quantities. Typically, but not necessarily, in some embodiments, these quantities take the form of one or more of electrical, electromagnetic, magnetic, optical, or magneto-optical signals that can be stored, transmitted, combined, compared, and otherwise manipulated. In some embodiments, the computer system 1010 may include at least one computer-readable medium 1036 coupled to at least one of at least one data source 1037a, at least one data storage device 1037b, and / or at least one input / output 1037c. In some embodiments, the computer system 1010 can be implemented as computer-readable code on a computer-readable medium 1036. In some embodiments, computer readable medium 1036 may be any data storage device that can store data that can subsequently be read by a computer (such as computer 1040). In some embodiments, computer readable medium 1036 may be any physical or material medium that can be used to tangibly store desired information, data, or instructions and can be accessed by computer 1040 or processor 1032. In some embodiments, computer readable medium 1036 may include a hard drive, a network attached storage device (NAS), a read-only memory, a random access memory, a FLASH-based memory, a CD-ROM, a CD-R, a CD-RW, a DVD, a magnetic tape, other optical and non-optical data storage devices. In some embodiments, various other forms of computer readable media 1036 may transmit or carry instructions to a remote computer 1040 and / or at least one user 1031 (including routers, private or public networks or other wired and wireless transmissions or channels). In some embodiments, the software application module 1038 may be configured to send and receive data from a database (e.g., from a computer-readable medium 1036 including a data source 1037a and a data storage 1037b that may include a database), and the software application module 1038 may receive data from at least one other source. In some embodiments, at least one software application module 1038 may be configured within the computer system 1010 to output data to at least one user 1031 via at least one graphical user interface rendered on at least one digital display.

[0066] In some embodiments, the computer readable medium 1036 can be distributed over a conventional computer network via a network interface 1035a, where a system implemented by computer readable code can be stored and executed in a distributed manner. For example, in some embodiments, one or more components of the computer system 1010 can be coupled to send and / or receive data via a local area network ("LAN") 1039a and / or an Internet-coupled network 1039b (e.g., such as wireless Internet). In some embodiments, the network 1039a, 1039b can include a wide area network ("WAN"), a direct connection (e.g., via a universal serial bus port), or other forms of computer readable medium 1036, or any combination thereof.

[0067] In some embodiments, components of the networks 1039a, 1039b may include any number of personal computers 1040, including, for example, desktop computers and / or laptop computers, or any fixed, typically non-mobile Internet appliances coupled via the LAN 1039a. For example, some embodiments include one or more of the personal computers 1040, databases 1041, and / or servers 1042 coupled via the LAN 1039a, which may be configured for any type of user, including an administrator. Some embodiments may include one or more personal computers 1040 coupled via the network 1039b. In some embodiments, one or more components of the computer system 1010 may be coupled to send or receive data via an Internet network (e.g., such as the network 1039b). For example, some embodiments include at least one user 1031a, 1031b, which is wirelessly coupled and accesses one or more software modules of the system, including at least one enterprise application 1038, via input and output ("I / O") 1037c. In some embodiments, the computer system 1010 may enable at least one user 1031a, 1031b to be coupled via a LAN 1039a to access enterprise applications 1038 via I / O 1037c. In some embodiments, the user 1031 may include a user 1031a coupled to the computer system 1010 using a desktop computer and / or laptop computer or any fixed, typically non-mobile Internet appliance coupled via the Internet 1039b. In some embodiments, the user may include a mobile user 1031b coupled to the computer system 1010. In some embodiments, the user 1031b may use any mobile computer 1031c to connect to wirelessly couple to the computer system 1010, including but not limited to one or more personal digital assistants, at least one cellular phone, at least one mobile phone, at least one smart phone, at least one pager, at least one digital tablet, and / or at least one fixed or mobile Internet appliance.

[0068] The subject matter described herein is intended to make technical improvements in the field of lower back pain relief through new arrangements and applications of NMES. The present disclosure describes the details of how a machine including one or more computers (the computer including one or more processors and one or more non-transitory computer-readable media) implements the system, as well as its improvements over the prior art. The instructions executed by the machine cannot be executed in the human brain, nor can they be exported by a person using pen and paper, but require a machine to convert process input data into useful output data. In addition, the claims presented herein do not attempt to link judicial exceptions to known conventional steps implemented by general-purpose computers; nor do they attempt to link judicial exceptions by simply associating judicial exceptions with technical fields. In fact, the systems and methods described herein were unknown and / or did not exist in the public domain at the time of filing, and they provide technical improvements and advantages that are not known in the prior art. In addition, the present system includes unconventional steps that limit the claims to useful applications.

[0069] It should be understood that the system is not limited in its application to the details of the construction and arrangement of the components set forth in the foregoing description or shown in the accompanying drawings. The systems and methods disclosed herein fall within the scope of many embodiments. The foregoing discussion is presented to enable those skilled in the art to make and use embodiments of the system. Any portion of the structures and / or principles included in some embodiments may be applied to any and / or all embodiments: it should be understood that features from some embodiments presented herein may be combined with other features according to some other embodiments. Therefore, some embodiments of the system are not intended to be limited to what is shown, but to be given the widest scope consistent with all the principles and features disclosed herein.

[0070] Some embodiments of the system have specific values ​​and / or set points. These values ​​and set points are not intended to be limiting, but are merely examples of higher and lower configurations, and are intended to help those of ordinary skill in the art to make and use the system.

[0071] Furthermore, as Applicant's own lexicographer, Applicant assigns clear meanings and / or disclaims claim scope to the following terms:

[0072] Applicants define any use of "and / or", such as, for example, "A and / or B" or "at least one of A and / or B", to refer to element A only, element B only, or elements A and B together. Additionally, for example, the statement "at least one of A, B, and C", the statement "at least one of A, B, or C", or the statement "at least one of A, B, or C or any combination thereof" are each defined to refer to element A only, element B only, element C only, or any combination of elements A, B, and C, such as AB, AC, BC, or ABC.

[0073] When used in connection with values, "substantially" and "approximately" include differences of 5% or less of the same unit and / or scale being measured.

[0074] As used herein, "simultaneously" includes the lag and / or latency associated with conventional and / or proprietary computers, such as processors and / or networks described herein, that attempt to process multiple types of data simultaneously. "Simultaneously" also includes the time it takes for a digital signal to be transmitted from one physical location to another, whether over a wireless and / or wired network, or within a processor circuit system.

[0075] As used herein, "can" or "may" or their derivatives (e.g., the system display is able to show X) are used for descriptive purposes only and should be understood to be synonymous and / or interchangeable with "configured to" (e.g., the computer is configured to execute instruction X) in defining the boundaries and scope of the system.

[0076] Furthermore, the term "configured to" means that the limitations stated in the specification and / or claims must be arranged in a manner to perform the stated functions: "configured to" does not include structures in the art that are "capable" of being modified to perform the stated functions, but the disclosure associated with the art does not explicitly teach to do so. For example, the statement "configured to receive fluid from structure X located at the top and deliver the fluid to a container of structure Y from the bottom" is limited to systems in which structure X, structure Y, and the container are all disclosed as being arranged to perform the stated functions. The statement "configured to" excludes elements that may be "capable" of performing the stated functions solely by virtue of their construction, but the associated disclosure (or lack thereof) does not provide teaching to make such modifications to satisfy the functional limitations between all of the stated structures. Another example is "a computer system configured or programmed to execute a series of instructions X, Y, and Z." In this example, the instructions must be present on a non-transitory computer-readable medium such that the computer system is "configured to" and / or "programmed to" perform the stated instructions: "configured to" and / or "programmed to" excludes techniques that teach a computer system having a non-transitory computer-readable medium that is merely "capable of" storing the stated instructions thereon, but without the teaching of instructions X, Y, and Z being programmed and stored thereon. "Configured to" may also be interpreted as being synonymous with being operably connected when used in conjunction with a physical structure.

[0077] It should be understood that the words and terms used herein are for description and should not be considered limiting. As used herein, "including," "comprising," or "having" and variations thereof are intended to encompass the items listed thereafter and their equivalents as well as additional items. Unless otherwise specified or limited, the responsible terms "mounted," "connected," "supported," and "coupled" and variations thereof are used broadly and encompass direct and indirect mountings, connections, supports, and couplings. Additionally, "connected" and "coupled" are not limited to physical or mechanical connections or couplings.

[0078] The foregoing detailed description is read with reference to the drawings, wherein like elements in different drawings have like reference numerals.The drawings, which are not necessarily drawn to scale, depict some embodiments and are not intended to limit the scope of embodiments of the system.

[0079] Any operation that forms part of the system described herein is a useful machine operation. The system also relates to equipment or devices for performing these operations. The device can be specially constructed for the desired purpose, such as a special-purpose computer. When defined as a special-purpose computer, the computer can also perform other processing, program execution or routines that do not belong to the special purpose, while still being able to operate for the special purpose. Alternatively, operations can be processed by a general-purpose computer that is selectively activated or configured by one or more computer programs stored in a computer memory, a cache or obtained through a network. When data is obtained through a network, the data can be processed by other computers on the network (e.g., a cloud of computing resources).

[0080] The embodiment of the system can also be defined as a machine that transforms data from one state to another. Data can represent an article, which can be represented as an electronic signal and electronically processes data. In some cases, the transformed data can be visually depicted on a display, thereby representing a physical object generated by the transformation of the data. The transformed data can be saved in a storage device generally or in a specific format that enables the construction or depiction of physical and tangible objects. In some embodiments, the manipulation can be performed by a processor. In such an example, the processor thus transforms data from one thing to another. Further, some embodiments include methods that can be processed by one or more machines or processors that can be connected through a network. Each machine can transform data from one state or thing to another state or thing, and can also process data, save data to a storage device, transmit data through a network, display results, or transmit results to another machine. As used herein, computer-readable storage media refers to physical or tangible storage devices (as opposed to signals), and includes but is not limited to volatile and non-volatile, removable and non-removable storage media implemented by any method or technology for tangible storage of information (such as computer-readable instructions, data structures, program modules or other data).

[0081] Although method operations are presented in a particular order according to some embodiments, execution of these steps does not necessarily occur in the order listed unless explicitly specified. In addition, other housekeeping operations may be performed between operations, operations may be adjusted so that they occur at slightly different times, and / or operations may be distributed in a system that allows processing operations to occur at various intervals associated with the processing, as long as the processing covering the operations is performed in the desired manner and produces the desired system output.

[0082] Those skilled in the art will recognize that, although the system has been described above in conjunction with specific embodiments and examples, the system is not necessarily limited thereto, and many other embodiments, examples, uses, modifications and deviations from the embodiments, examples and uses are intended to be covered by the appended claims. The entire disclosure of each patent and publication cited herein is incorporated by reference as if each such patent or publication was individually incorporated by reference herein. Various features and advantages of the system are set forth in the following claims.

Claims

1. A system for relieving chronic lower back pain, comprising: Wearable clothing, and Multiple electrodes; The plurality of electrodes are positioned on the wearable garment such that a neuromuscular electrical stimulation (NMES) pulse reaching each of the plurality of electrodes will simultaneously contract the transverse abdominal (TrA) muscle and the lumbar multifidus (LM) muscle.

2. The system according to claim 1, Wherein the wearable garment is configured to enable repositioning of one or more of the plurality of electrodes.

3. The system of claim 1, further comprising: panel; wherein the panel comprises at least one electrode of the plurality of electrodes; and Wherein the panel is configured to be electrically coupled to at least one electrode of the plurality of electrodes.

4. The system according to claim 3, Wherein the panel is configured to add rigidity to at least one electrode of the plurality of electrodes.

5. The system according to claim 3, The wearable garment is configured to secure the panel in place such that when NMES pulses are applied to at least one of the plurality of electrodes, the at least one of the plurality of electrodes contracts at least one of the TrA muscle and the LM muscle.

6. The system of claim 1, further comprising: Multiple panels; wherein each panel of the plurality of panels comprises an electrical contact configured to be physically coupled to at least one electrode of the plurality of electrodes; wherein each panel of the plurality of panels is configured to be electrically coupled to at least one electrode of the plurality of electrodes; and The wearable garment is configured to secure each of the plurality of panels in position such that the NMES pulses contract the TrA muscle and / or the LM muscle.

7. A system for relieving chronic lower back pain, comprising: Electrode panel; The electrode panel includes electrical and / or mechanical connections of two or more electrodes.

8. The system of claim 7, Wherein the mechanical connection is configured to position the two or more electrodes such that a neuromuscular electrical stimulation (NMES) pulse reaching each of the two or more electrodes will contract the transverse abdominis (TrA) muscle.

9. The system of claim 8, Wherein the mechanical connection is configured to position the two or more electrodes such that a neuromuscular electrical stimulation (NMES) pulse reaching each of the two or more electrodes will contract a lumbar multifidus (LM) muscle.

10. The system of claim 9, further comprising: The controller is configured as: Executing the TrA pulses via one or more processors; stopping, by the one or more processors, the TrA pulse; executing, by the one or more processors, LM pulses; stopping, by the one or more processors, LM pulses; as well as The TrA pulses and the LM pulses are performed simultaneously by the one or more processors.

11. The system according to claim 7, wherein the electrode panel comprises a rigid property and a flexible property; wherein the rigidity property enables the electrode panel to maintain substantially the same shape under the influence of gravity when rotated to various positions; and Wherein the flexible property enables the electrode panel to bend a sufficient amount to ensure that when the two or more electrodes are connected to the electrode panel, each of the two or more electrodes contacts the skin to contract the transverse abdominal (TrA) muscle and / or the lumbar multifidus (LM) muscle.

12. The system of claim 7, wherein the electrode panel includes circuitry configured to deliver electrical pulses to each of the two or more electrodes; The electrode panel includes a base configured to enable connection of a controller to a docking plate.

13. The system of claim 12, further comprising: controller, and clothing; wherein the controller is configured to be electrically coupled to the electrode panel; and Wherein the garment comprises one or more mechanical couplings configured to removably secure the controller and / or the electrode panel in place.

14. A system for relieving chronic lower back pain, comprising: Multiple electrodes, and Controller; wherein the controller is configured to execute a neuromuscular electrical stimulation (NMES) program configured to generate one or more NMES pulses to each of the plurality of electrodes; wherein the one or more NMES pulses include a transverse abdominis (TrA) pulse configured to contract a TrA muscle; and Wherein the one or more NMES pulses include lumbar multifidus (LM) pulses configured to contract LM muscles.

15. The system of claim 14, The controller is configured as follows: Executing the TrA pulses via one or more processors; stopping, by the one or more processors, the TrA pulse; executing, by the one or more processors, LM pulses; and The LM pulses are stopped by the one or more processors.

16. The system of claim 14, The controller is configured as follows: executing, by the one or more processors, TrA pulses; stopping, by the one or more processors, the TrA pulse; executing, by the one or more processors, LM pulses; stopping, by the one or more processors, LM pulses; as well as The TrA pulses and the LM pulses are performed simultaneously by the one or more processors.

17. The system of claim 14, Wherein the controller is configured to perform transcutaneous electrical stimulation (TENS) and NMES programs.

18. The system of claim 14, Wherein the controller is configured to simultaneously perform transcutaneous electrical stimulation (TENS) and NMES programs on the same electrode.

19. The system of claim 14, further comprising: Clothing, and one or more panels; wherein the controller is configured to be electrically coupled to at least one of the one or more panels; wherein the garment comprises one or more mechanical couplings configured to removably secure the one or more panels in one or more positions; and Wherein the one or more locations are configured to deliver TrA pulses and / or LM pulses.

20. The system of claim 19, wherein the one or more panels include circuitry configured to deliver electrical pulses to each of the plurality of electrodes; and Wherein the one or more panels include a base configured to enable the controller to be connected to the docking plate.

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