Patent Publication Number: US-11660451-B2

Title: Functional electrical stimulation ergometer including automatic spasm control

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. patent application Ser. No. 16/242,624, entitled “Functional Electrical Stimulation Ergometer Including Automatic Spasm Control,” filed Jan. 8, 2019, which is a continuation of U.S. patent application Ser. No. 15/804,441, entitled “Functional Electrical Stimulation Ergometer Including Automatic Spasm Control,” filed Nov. 6, 2017, now U.S. Pat. No. 10,173,058, which claims priority to and the benefit of U.S. Provisional Application No. 62/417,477, filed Nov. 4, 2016, the disclosures of which are hereby incorporated herein in their entireties and for all purposes. 
    
    
     FIELD OF THE INVENTION 
     The invention relates to functional electrical stimulation (FES) systems for rehabilitation of individuals suffering from neurological injuries. More particularly, the present invention relates to a device that utilizes both mechanical and electrical stimulation of individual&#39;s muscles. 
     BACKGROUND OF THE INVENTION 
     Spinal cord injured patients gain great benefit from riding on FES enabled ergometers. However, when a patient&#39;s limbs are set in motion and/or when stimulation is applied at the start of a session many patients suffer from muscle spasms. This spasm often prevents the patients from riding for several minutes until the spasms have subsided. This can cause time to be lost by both the patient and therapist/care-giver and results in reducing the benefits that the patient receives from the FES ergometer. 
     Current techniques to minimize spasm include: 
     1. Stretching the patient&#39;s legs prior to riding. The problem with this approach is that it is labor intensive and does not always achieve the desired results. 
     2. Having the therapist observe the patient as stimulation is being applied and manually prevent the stimulation from increasing when the patient is showing early signs of spasm. The problem with this approach is that it requires a well-trained therapist to be present when the patient cycles. This is not always practical. 
     3. Setting the FES ergometer to increase the stimulation levels on the subject very slowly so that the patient&#39;s muscles accommodate the stimulation. The problem with this solution is that a therapist needs to be trained to know how to set-up the FES ergometer for a patient known to have spasms. Another problem is that it takes longer for the patient to receive the maximum benefit of FES cycling because the stimulation ramps up slowly. The patient may only occasionally suffer from spasm in which case it would be better to ramp up stimulation more quickly when the patient is not suffering from spasm. 
     BRIEF DESCRIPTION OF THE INVENTION 
     According to the invention, there is provided a functional electrical stimulation device having a left extremity support and a right extremity support, wherein both extremity supports are connected to a primary drive motor that causes the extremity supports to move in a reciprocal motion; the left extremity support is connected to a left extremity support servo motor and the right extremity support is connected to a right extremity support servo motor, wherein each of said right and left extremity support servo motors causes its respective extremity support to rotate about an axis. The device further has a control unit connected to the left and right extremity support servo motors which controls the actuation of the left and right extremity support servo motors. The control unit may also include functional electrical stimulation leads attached to skin adhesive electrodes which deliver electrical stimulation to a patient&#39;s muscles. 
     The device also includes an automatic spasm control system including a monitor which continuously monitors the torque required to rotate one or both of the left and right extremity supports and a controller configured to calculate a rate of change of said torque, and to calculate a maximum electrical stimulation, a maximum stimulation ramp-up rate, a maximum servo-motor speed and a maximum servo-motor ramp-up rate. 
     According to further embodiments, the functional electrical stimulation system has two drive arms connecting the primary drive motor to each of said left and right extremity supports, the drive arms optionally having various attachment points for connecting to corresponding right and left cranks at different attachment positions. According to further embodiments, the extremity supports are attached to the drive arms by the corresponding left and right cranks. 
     According to further embodiments of the invention, the controller of said automatic spasm control system is configured to identify a possible onset of spasm when a monitored amount of torque or rate of change of torque exceeds a predetermined value, and when a monitored amount of torque or rate of change of torque exceeds said predetermined value, to compare a current level of electrical stimulation to said calculated maximum stimulation and to compare a current crank speed to said calculated maximum crank speed and to send instructions to said control unit connected to the left and right extremity support servo motors and to said functional electrical stimulation leads to reduce the amount of electrical stimulation and crank speed. 
     According to further embodiments of the invention, there is provided a therapeutic muscle exercise device having a cycling base configured to accept a subject&#39;s upper or lower extremities and assist a subject in exercising the subject&#39;s muscles; the cycling base having a first extremity support and a second extremity support, wherein said extremity supports are driven or resisted by a motor controlled by a controller, the device further including a functional electrical stimulation controller, wherein the functional stimulation controller and the first and second extremity supports and cycling base are configured to assist a subject in moving his or her upper or lower extremities; said device further including an automatic spasm control system comprising a monitor configured to continuously monitor a torque required to rotate one or both of said left and right extremity supports, said controller configured to calculate a rate of change of said torque, a maximum servo-motor speed and a maximum servo-motor ramp-up rate, said functional electrical stimulation controller configured to calculate a maximum electrical stimulation, a maximum stimulation ramp-up rate. 
     According to further embodiments of the invention the controller manages isometric functional electrical stimulation to the subject&#39;s muscles. 
     According to further embodiments of the invention there is provided a method of exercising a subject&#39;s extremities comprising: placing the subject&#39;s extremities in an extremity support of a device described herein, placing electrical stimulation electrodes on the subject&#39;s extremities, and exercising the subject&#39;s extremities. 
     According to further embodiments of the invention, the exercising step includes actively assisting the subject in moving the subject&#39;s extremities by rotating the extremity supports around an extremity support pivot point. 
     According to further embodiments of the invention, the method includes assisting the subject to exercise the subject&#39;s extremities through isometric functional electrical stimulation. 
     According to further embodiments of the invention, the method includes increasing muscle electrical stimulation and reducing motor assistance. 
     According to further embodiments of the invention, electrical stimulation evokes coordinated muscle contractions and the extremity supports&#39; do not drive rotation. 
     According to further embodiments of the invention, the method includes increasing motor assistance and decreasing electrical stimulation. 
     According to further embodiments of the invention, the automatic spasm controller is configured to identify a possible onset of spasm when a monitored amount of torque or rate of change of torque exceeds a predetermined value, and when a monitored amount of torque or rate of change of torque exceeds said predetermined value, and to compare a current crank speed to said calculated maximum crank speed and said electrical stimulation controller configured to compare a current level of electrical stimulation to said calculated maximum stimulation. 
    
    
     
       DESCRIPTION OF THE DRAWINGS 
       The subsequent description of the preferred embodiments of the present invention refers to the attached drawings, wherein: 
         FIG.  1    shows an RT300™ Functional Electrical Stimulation cycling system by Restorative Therapies, with an automatic spasm control system of the invention installed in the RT300™&#39;s controller. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The invention summarized above may be better understood by referring to the following description, the accompanying drawings, and the claims listed below. This description of an embodiment, set out below to enable one to practice an implementation of the invention, is not intended to limit the preferred embodiment, but to serve as a particular example thereof. Those skilled in the art should appreciate that they may readily use the conception and specific embodiments disclosed as a basis for modifying or designing other methods and systems for carrying out the same purposes of the present invention. Those skilled in the art should also realize that such equivalent assemblies do not depart from the spirit and scope of the invention in its broadest form. While the invention is described herein in the context of an RT300-SLSA cycling system, it may be used in conjunction with any FES system, including the systems described in U.S. Pat. Nos. 8,905,951 and 9,511,256, the disclosures of which are incorporated herein in their entirety. 
     As shown in  FIG.  1   , one embodiment of the present invention comprises a therapeutic muscle exercise device  100  used to treat patients who may have partial or entire paralysis of the arms and/or legs. The device  100  comprises a cycling base  105  that is mounted on a mobile support  103 . 
     The cycling base  105  has a first extremity support  108  and a second extremity support  109 . It is contemplated that in some embodiments a single extremity support may be included to facilitate treatment of subjects who have lost a limb. Each extremity support  108  and  109  are attached to the cycling base by a first rotating arm  114  and a second rotating arm  115 , respectively. 
     The rotating arms  114  and  115  attach to the extremity supports  108  and  109  at a extremity support pivot point  130  and  131 . The configuration allows the foot of the subject to rotate as normally as it would when performing a cycling motion naturally. The rotating arms connect to the cycling base  105  at a base pivot point  140 . In a preferred embodiment, the base pivot point  140  comprises a shaft that passes through a channel that extends through the base; the shaft connects the base end of the first rotating arm  114  to the base end of the second rotating arm  115 . In such embodiment, the shaft then rotates uniformly around the base pivot point  140 . In other embodiments, the rotating arms  114 ,  115  may connect to two independently rotatable shafts at the base pivot point  140  allowing the extremity supports  108  and  109  to rotate independently of one-another. 
     The cycling base  105  also includes two calf supports  148 ,  149 . In some embodiments, the calf supports  148  and  149  are connected to the extremity supports  108  and  109  though an attachment link  153 ,  154 . In other embodiments, the calf supports  148  and  149  may not be linked to the extremity supports  108  and  109 . 
     The device  100  also includes a functional electrical stimulation controller  175 . The controller  175  manages the electrical impulses provided to the subject&#39;s muscles through a series of leads  159 , which are connected to the controller  175  through a lead cable  156 . The controller  175  also controls a motor (not shown) that controls the speed of rotation of the rotating arms  114  and  115 . The controller  175  coordinates the rotation of the rotating arms  114  and  115  in conjunction with functional electrical stimulation through the leads  159  depending on the level of need of the subject. In some instances, the controller  175  will direct full movement of the rotating arms  114  and  115  in conjunction with electrical stimulation resulting in fully FES evoked movement. In the alternative, the controller  175  may reduce the level of assistance provided by the motor and the electrical stimulation allowing volitional movement by the subject. In yet a further embodiment, the controller  175  will not provide any assistance in order to allow the subject to rotate the extremity supports  108 ,  109  without assistance. The controller  175  provides such assistance as needed by the subject and directed by the user. 
     Likewise, wrist and hand supports  208  and  209  may be provided and configured to attach to rotating arms  214  and  215  at base pivot point  240 , and subsequent attachment to wrist and hand supports  208  and  209 . 
     In one embodiment, a method for exercising a subject&#39;s extremities is provided. According to this embodiment, the system continuously rotates at the set speed and it either assists or resists the patient&#39;s efforts. The patient&#39;s efforts are either volitional or evoked by FES. In a first step of the method the system&#39;s motor moves the subject&#39;s extremities and the controller provides initial muscle electrical stimulation. This first step can be referred to as a warm up step. In a subsequent step, referred to as active transition, the controller increases muscle electrical stimulation and reduces motor assistance until the muscle takes over movement of the extremity supports or 100% stimulation threshold is reached. In a subsequent step, referred to as the active step, electrical stimulation evokes coordinated muscle contractions as the rotating arms  114  and  115  (and/or  214  and  215 ) turn around the pivot point  140  (and/or  240 ) resulting in the subject&#39;s muscles performing the cycling motion. The combination of the rotating arms  114  and  115  (and/or  214  and  215 ) connected at the pivot point  140  (and/or  240 ) is also referred to herein as the crank. Once muscle fatigue is reached and/or detected by the controller, electrical stimulation is reduced and the motor of the cycling base takes over for cycling motion. In a final step, referred to as cool down, the motor completely takes over cycling motion allowing subject&#39;s muscles to rest while permitting movement through the range of motion. 
     According to a further embodiment, an automatic spasm control feature of the present invention monitors the amount of torque required to move the patient&#39;s arms or legs from the beginning of the therapy session. The system also monitors the pattern and rate of change, or smoothness, of the required torque through each rotation of the ergometer crank. The automatic spasm control system of the invention uses increases in required torque as well as decreases in the smoothness of the required torque to detect muscle tone and to detect if a muscle spasm is occurring. 
     For each amount of muscle tone detected, the automatic spasm control system of the invention sets a maximum stimulation level, a maximum stimulation ramp-up rate, a maximum crank speed, and a crank ramp-up rate. If a full muscle spasm occurs, then the automatic spasm control system inhibits the motor from rotating the crank for a period of time, and then tries to start the therapy session again. 
     The following example follows a patient starting a leg therapy session and the stimulation level is increasing. If the patient experiences the onset of a spasm, the torque required to assist leg rotation will begin to fluctuate which fluctuation in torque will be detected by the automatic spasm control system. Similarly, if the patient starts to exhibit high muscle tone, the motor torque required to assist the leg crank rotation will increase and the automatic spasm control system will detect this increase. In either event, automatic spasm control system will calculate the maximum stimulation level and cycling cadence appropriate to prevent the muscle tone from increasing or developing into a muscle spasm. 
     If the current therapy is stimulating at a higher level than the calculated maximum stimulation level appropriate to prevent the muscle tone from increasing or developing into a spasm, the automatic spasm control system will cause the stimulation level to be decreased accordingly. Likewise, if the current leg therapy cadence is currently going faster than the maximum cycling cadence to prevent the muscle tone from increasing or developing into a spasm, the automatic spasm control system will cause the cadence rate to be reduced. 
     Conversely, if the current stimulation level is lower than the calculated maximum stimulation value, then the system will calculate the maximum stimulation level ramp up rate that is appropriate to prevent the muscle tone from increasing or a muscle spasm from developing. The system will allow the stimulation level to increase at a rate no greater than this maximum. 
     If the cadence is lower than the calculated maximum cycling cadence value, then the system will calculate the maximum speed ramp up rate that is appropriate to prevent the muscle tone from increasing or a muscle spasm from occurring. The system will allow the cadence to increase at a rate no greater than this calculated maximum rate. 
     If the muscle tone continues to increase, then all of these maximum levels will be further reduced. This acts to allow the patient&#39;s muscles to accommodate the stimulation so that eventually the muscle tone will reduce. As the muscle tone reduces, the system will increase all these maximum levels. Once there is no or minimal muscle tone, no limits are imposed by the system. At this point the FES therapy session will continue using its preset stimulation level and cadence parameters. 
     In the event that the detected muscle tone does not decrease over time, indicating that the muscles are either not accommodating the prescribed cadence or stimulation levels, the automatic spasm control system will slowly allow a higher cadence and stimulation level. This allows a patient to progress to active cycling even though he/she is exhibiting tone. In this case it is likely that the detected tone was caused not by spasm, but by another factor such as myotatic reflex. According to various different embodiments of the invention, the system may make adjustments to cadence and stimulation levels appropriately for spasm and myotatic reflex. 
     The invention has been described with references to a preferred embodiment. While specific values, relationships, materials and steps have been set forth for purposes of describing concepts of the invention, it will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the invention as shown in the specific embodiments without departing from the spirit or scope of the basic concepts and operating principles of the invention as broadly described. It should be recognized that, in the light of the above teachings, those skilled in the art can modify those specifics without departing from the invention taught herein. Having now fully set forth the preferred embodiments and certain modifications of the concept underlying the present invention, various other embodiments as well as certain variations and modifications of the embodiments herein shown and described will obviously occur to those skilled in the art upon becoming familiar with such underlying concept. It is intended to include all such modifications, alternatives and other embodiments insofar as they come within the scope of the appended claims or equivalents thereof. It should be understood, therefore, that the invention may be practiced otherwise than as specifically set forth herein. Consequently, the present embodiments are to be considered in all respects as illustrative and not restrictive.