System for treating involuntary muscle contractions
The wearable interface with energy applicators addresses the limitations of current tremor treatments by using inflation, vibration, and electrical stimulation to manage involuntary muscle contractions effectively and adaptively, reducing shaking without side effects.
Patent Information
- Application Number
- JP2023037577
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2018-05-23
- Filing Date
- 2023-03-10
- Publication Date
- 2025-07-11
- Estimated Expiration
- 2038-08-27
AI Technical Summary
Current treatments for tremors, such as surgeries and pharmacological means, often come with undesirable side effects and do not effectively manage involuntary muscle contractions causing shaking or periodic movements in various body parts.
A wearable interface with an energy applicator that applies multiple types of energy, including inflation, vibration, and electrical stimulation, controlled by a sensing module to detect muscle contractions and adjust energy application accordingly.
The wearable system provides effective tremor management by reducing involuntary muscle movements without the side effects associated with traditional treatments, offering customizable and adaptive neuromodulation based on individual tremor symptoms.
Smart Images

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Abstract
Description
Technical Field
[0001]
[0001] Embodiments of the present invention relate to systems and methods for controlling the effects of tremors.
Summary of the Invention
[0002]
[0002] In a first embodiment of the present disclosure, a system for treating involuntary muscle contractions includes a wearable interface having an internal contact surface and configured to at least partially surround a first portion of a subject's limb, and an energy applicator supported by the wearable interface and configured to apply two or more types of energy to the subject's limb. In some embodiments, the system for treating involuntary muscle contractions further includes a control unit configured to control the operation of the energy applicator.
Brief Description of the Drawings
[0003]
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DETAILED DESCRIPTION OF THE INVENTION
[0004]
[0033] Tremor is an involuntary muscle contraction that causes shaking or periodic movement in one or more parts of the body. Muscle contractions often follow a rhythmic pattern. Tremor generally affects the area of the patient's hand or wrist, but can also affect the arms, legs, head, torso, and even the vocal cords. Tremor may be intermittent or, in some cases, persistent. In some cases, tremor may be concurrent with or accompanied by one or more other disorders. The effects of tremor can range from partial to severe impairment and are often a cause of confusion. Some forms of tremor include essential tremor, restless legs syndrome (RLS), Parkinsonian tremor, dystonic tremor, cerebellar tremor, rest tremor, action tremor, psychogenic tremor (associated with psychological disorders), enhanced physiological tremor, and orthostatic tremor. In some cases, surgeries such as deep brain stimulation (DBS) or thalamotomy may be performed to treat tremor. Although improvement is seen after these treatments, the treatments can sometimes cause subsequent speech or balance problems in the patient.
[0005]
[0034] Some of the pharmacological means currently used to treat types of tremors include anti-seizure drugs, which include topiramate or gabapentin, beta blockers such as propranolol, atenolol, metoprolol, nadolol, sotalol, benzodiazepine tranquilizers such as alprazolam and clonazepam, drugs for Parkinson's disease such as levodopa and carbidopa, and in some cases, drugs such as botulinum toxin (BTX). All of these drugs may have certain side effects that are not desirable for certain patients with tremors.
[0006]
[0035] Essential tremor (or familial tremor) is typically a shaking that occurs in one or both of the patient's arms, wrists, or hands. However, the patient's head and voice may also be affected. Figure 1 shows a wearable tremor control system 10 configured to be placed on the patient's wrist. The wearable tremor control system 10 includes a housing 12 and a band 14 coupled to the lower side 16 of the housing 12. The wearable tremor control system 10 is shown in a state not fixed in Figure 1. The band 14 is fixed to the lower side 16 of the housing 12 by an epoxy or adhesive 18. In other embodiments, the housing 12 may be overmolded or insert molded with the band 14. In other embodiments, the band 14 may be fixed by a fixture, sewing, fusing, or may slide through a slit or elongated space in the housing 12. The band 14 is configured to be slidable (e.g., longitudinally along its own axis) within a groove or slot to adjust the position of the band 14 relative to the housing 12. The band 14 is configured to wrap around the user / patient's wrist and secure itself using a hook and loop (Velcro® type) system 20. The loop surface 20a inside a portion of the band 14 is fixed to the hook surface 20b of the outer portion of the band 14. An inflatable cuff 22 extends around a circumferential path 24 surrounding the interior 26 of the band 14. In some embodiments, the band 14 may be configured to be worn like a watch or bracelet and may be configured to partially or fully surround a limb (arm, leg) at a particular part (wrist, ankle, etc.). The hook and loop system 20 may be replaced in alternative embodiments with a button closure, snap closure, loop closure, adhesive closure, or magnetic closure.
[0007]
[0036] Figure 2 shows the wearable tremor control system 10 in a fixed state, where the loop surface 20a is fixed to the hook surface 20b. To better show the activity of the inflatable cuff 22, the user's arm is not shown in FIGS. 2-4. The sensor 28 is mounted on the inner surface 30 of the band 14 and is configured to detect disturbances caused by muscle activity. In some embodiments, the sensor 28 may include an ultrasonic transducer. In some embodiments, the sensor 28 may include an accelerometer configured to measure acceleration (e.g., of a limb during tremor), and may further include a piezoelectric accelerometer, a piezoresistive accelerometer, or a capacitive accelerometer. In some embodiments, the sensor 28 may include a gyroscope. The gyroscope may be configured to measure angular velocity (e.g., of a limb during tremor). In some embodiments, the sensor 28 may include an electrical goniometer configured to provide a signal related to the angle over time (e.g., the elbow joint angle). In some embodiments, the sensor 28 may include a force gauge or a strain gauge. In some embodiments, the sensor 28 may include an electromyogram (EMG) sensor. In some embodiments, the sensor 28 may include two or more different types of sensors such as those described above. Thus, multimodal sensing is possible. The controller 32 within the housing 12 is configured to receive signals from the sensor 28. The controller 32 may include a microcontroller and is electrically coupled to the sensor 28. The controller 32 is also electrically coupled to the transceiver 34, which is configured to wirelessly communicate with a mobile phone, smartphone, or other personal communication device. The personal communication device may include a chip (e.g., an integrated circuit) embedded in the user's body, or a chip supported by a part of the user's body or clothing. The transceiver 34 may include a WiFi antenna in some embodiments. The actuator 36 coupled to the controller 32 is configured to receive a signal from the controller 32 and inflate the inflatable cuff 22. The actuator 36 may include a number of different mechanical, hydraulic, or pneumatic devices for inflating the cuff 22 or otherwise causing inflation.The inflatable cuff 22 is shown in Figure 2 in a substantially non-inflated state. The inflatable cuff 22 in Figure 3 is shown in a partially inflated state. The inflatable cuff 22 in Figure 4 is shown in a substantially inflated state. In the partially inflated state of Figure 3, the inflatable cuff 22 can begin to apply pressure to the limb or increase the pressure applied to the limb. In the substantially inflated state of Figure 4, the inflatable cuff 22 can apply sufficient pressure to the limb to produce or optimize the effect. Although the power unit is not shown in Figures 2-4, a battery can be included within the housing to supply power to the electrical components. The battery may be rechargeable, removable, or disposable. Alternative power supply means for the battery, such as inductive coupling power circuits or wirelessly rechargeable capacitors, can be used.
[0008]
[0037] Figure 5 shows a wearable tremor control system 10 in use at a fixed position on the wrist 38 of the arm 40 of user 42. The band 14 may be fixed very close to the hand 44 of user 42, or may be attached around the wrist 38 (or other part of the arm 40) at a distance d from the hand 44, for example, 0.5 cm, 1 cm, 2 cm, 5 cm, 10 cm, or 15 cm, or at a distance between 0 cm and 15 cm. Alternatively, the band 14 may be fixed around a part of the upper arm (not shown). Turning to FIG. 6, user 42 experiences tremors (bidirectional displacement arrows 50) caused at least in part by involuntary activity 46 of one or more muscles 52 near the sensor 28. The sensor 28 outputs a signal 48 proportional to the activity 46, and the signal 48 is received by the controller 32 (e.g., via conductor 47). In some embodiments where the sensor 28 includes a piezoelectric sensor, the sensor 28 can output a signal 48 of about 0.1 millivolts to about 10 volts when responding to displacement caused by limb movement. In FIG. 7, the controller 32 commands the actuator 36 to inflate the inflatable cuff 22 against the wrist 38 of user 42. The controller 32 can command the actuator 36 to inflate the inflatable cuff 22 based at least in part on data received from the sensor 28 via the signal 48. For example, if the signal 48 exceeds a particular threshold amplitude, or if the signal 48 persists longer than a particular threshold duration, the controller 32 can command the actuator 36 to inflate the inflatable cuff 22. The inflation pressure of the inflatable cuff 22 may be based on an algorithm that includes parameters of the signal 48.
[0009]
[0038] FIG. 8 shows a wearable tremor control system 100 configured to be disposed on a patient's wrist 38. The wearable tremor control system 100 includes a housing 102 and a band 104 coupled to the lower side 105 of the housing 102. To better illustrate the features of the wearable tremor control system 100, the wearable tremor control system 100 is shown in FIG. 8 in a fixed state where the user 42's arm 40 is not visible. A loop 106 is fixed to a first portion 108 of the band 104, and a series of rubber wedges 110 are supported by a second portion 112 of the band 104. The wedges 110 may be made of any compressible or semi-compressible material, may be adhered or otherwise fixed to the band 104, may be directly molded onto the band 104, or may be an integral or integral part of the band 104. To attach the wearable tremor control system 100 to the user's wrist 38, the user 42 (or a person assisting the user 42) slides the first end 114 of the band 104 through the opening 116 of the loop 106 and pulls one or more wedges 110 through the opening 116 of the loop 106 while applying a pulling force to the first end 114 until the band 104 is comfortably snug around the user's wrist 38. A flat edge 118 of one of the wedges 110a abuts a flat edge 120 of the loop 106 to lock the band 104 in place. To remove the band 104, the user 42 can push the band 104 in the opposite direction and deform the wedges 110 when the wedges 110 are pulled through the opening 116 of the loop 106. Alternatively, something like the hook and loop 20 of the wearable tremor control system 10 of FIG. 1 may be used. The band 104 may be provided in several different models or sizes to optimize placement on patients of a particular size (e.g., small, medium, large, or pediatric, adult). The wearable tremor control system 100 also includes a user interface 101 supported on a visible surface 103 of the housing 102.
[0010]
[0039] The wearable tremor control system 100 includes an outer cuff 122 that extends circumferentially within the band 104 between the second end 124 and the first portion 108 of the band 104. The outer cuff 122 is fixed to the band 104 along a first edge 126 and a second edge 128, each extending circumferentially around the inner circumference 129 of the band 104. The outer cuff 122 may be fixed to the band 104 at the first and second edges 126, 128 by an adhesive, epoxy, or hot melt, or may be sewn, molded, stapled, or fixed by other fixing means. The outer cuff 122, as the name implies, represents the outer layer, but is the inner part of the circle when attached. As shown in FIG. 9, the outer cuff 122 is configured to have an internal space 130 in which other dynamic components of the wearable tremor control system 100 can move.
[0011]
[0040] The outer cuff 122 supports a pair of detection elements 132, 134 (e.g., sensors or transducers) and a pair of vibration elements 136, 138. In some embodiments, the detection elements 132, 134 may comprise piezoelectric crystals and may be configured to vibrate at about 40 Hz to about 500 Hz, or 50 Hz to about 450 Hz, or about 60 Hz to about 400 Hz, or about 100 Hz to about 350 Hz. The detection elements 132, 134 are configured to detect physiological signals from the user's limb related to muscle contraction, including movement detected as displacement. Physiological signals indicative of tremors tend to include repetitive waveforms that can be measured by the motion sensors (detection elements 132, 134). The vibration elements 136, 138 can include piezoelectric crystals and can be configured to vibrate at about 1 Hz to about 30 Hz, or about 2 Hz to about 15 Hz, or about 3 Hz to about 10 Hz. Frequencies in the range of about 1 Hz to about 30 Hz are very effective in suppressing the swaying of a patient's limb (such as the arm or wrist), and thus, the vibration elements 136, 138 can be configured to reduce or completely stop the vibrations caused by one or more forms of tremors if they are composed of a suitable material and have a suitable thickness to vibrate at one or more frequencies in the range of 1 - 30 Hz. The piezoelectric crystal may include quartz, synthetic quartz, or PZT (lead zirconate titanate) ceramic. In other cases, the vibration elements 136, 138 may include piezo crystals and may be configured to vibrate at ultrasonic frequencies of about 15 kHz to about 1 MHz, or about 20 kHz to about 700 kHz, or about 20 kHz to 500 kHz, or about 25 kHz to about 500 kHz, or about 30 kHz to about 500 kHz, or about 30 kHz to about 200 kHz, or about 20 kHz to about 200 kHz, or about 100 kHz to about 300 kHz. Frequencies in the range of about 20 kHz to about 700 kHz are very effective for stimulating nerves such as the median nerve in the arm. Thus, the vibration elements 136, 138 can be configured to stimulate the median nerve via vibration if they are composed of a suitable material and have a suitable thickness to vibrate at one or more frequencies in the range of 15 kHz to 1 MHz, more specifically in the range of 20 - 700 kHz.Vibrations applied to the median nerve are detected in the user's brain and, as part of a physiological feedback loop, cause the limb vibrations to change accordingly. Thus, the brain is "tricked" into playing a role in more complex interventions. In some cases, the applied vibrations may reduce the activity of the thalamus, particularly in its contribution to the control and regulation of muscle movement. In some embodiments, one of the vibration elements 136 may be configured to vibrate at one of the lower frequency ranges (e.g., 1 - 30 Hz, 2 - 15 Hz, 3 - 10 Hz), and the other vibration element 138 may be configured to vibrate at one of the higher (ultrasonic) frequency ranges (e.g., 20 - 700 kHz, 25 - 500 kHz, 30 - 200 kHz) to induce the effects of both types. In other embodiments, two or more of the vibration elements 136, 138 may be configured to vibrate at one of the lower frequency ranges (e.g., 1 - 30 Hz, 2 - 15 Hz, 3 - 10 Hz), and two or more additional vibration elements 136, 138 (not shown) may be configured to vibrate at one of the higher (ultrasonic) frequency ranges (e.g., 20 - 700 kHz, 25 - 500 kHz, 30 - 200 kHz). In some embodiments, one or more of the vibration elements 136, 138 may be configured to vibrate at multiple frequencies, such as the fundamental frequency (or first harmonic) and the second harmonic. For example, in a particular embodiment, the first harmonic may be 10 Hz and the second harmonic may be 20 Hz. In another embodiment, the first harmonic may be 150 kHz and the second harmonic may be 300 kHz. In other embodiments, a third harmonic, or even a fourth, fifth, or higher harmonic may be used, as described by a harmonic series. One particular treatment protocol can include a first activation period of the vibration elements 136, 138 that begins immediately after the detection elements 132, 134 detect tremors, and more specifically, after a signal is received from one or more of the detection elements 132, 134 that are within a range indicating active tremors. As will be described in more detail, after this first activation period, pressurization of the inflatable inner cuff 146 within the outer cuff 122 may continue.With respect to FIGS. 1-7, in a further embodiment of the wearable tremor control system 10, additional vibration elements 136, 138 may be added. A specific treatment protocol associated with this alternative embodiment of the wearable tremor control system 10 may include a first activation period of the additional vibration elements 136, 138 that begins immediately after the sensor 28 detects a tremor or a detection signal related thereto. After this first activation period, an increase in the pressurization of the inflatable cuff 22 may follow.
[0012]
[0041] In some embodiments, the detection elements 132, 134 and the vibration elements 136, 138 can be replaced with multi-purpose elements configured to perform both the detection function of the detection elements 132, 134 and the energy application function of the vibration elements 136, 138. In some embodiments, one or more of the detection elements 132, 134 and / or the vibration elements 136, 138 may include a mechanical displacement amplifier for improving the energy transfer to / from the wearer / patient.
[0013]
[0042] One or more of the detection elements 132, 134 or the vibration elements 136, 138 may be supported on the outer surface 140 of the outer cuff 122, or on the inner surface 142 (FIG. 9) of the outer cuff 122, or a combination thereof. The outer cuff 122 is configured to maintain the detection elements 132, 134 and the vibration elements 136, 138 near the wrist 38 of the user 42 (or other part of the limb to which the band 104 is attached). It may be desirable to cover the wrist 38 with an acoustic coupling gel or other acoustic coupling medium for optimal acoustic coupling between the skin of the user 42 and the detection elements 132, 134 or the vibration elements 136, 138. The detection elements 132, 134 and the vibration elements 136, 138 can be fixed to the outer surface 140 and / or the inner surface 142 of the outer cuff 122 by an epoxy or adhesive 144 having appropriate transitional acoustic impedance characteristics.
[0014]
[0043] Within the internal space 130 of the outer cuff 122, the inflatable inner cuff 146 (FIG. 9) is secured to the band 104 within the outer cuff 122 along a first edge 148 and a second edge 150, each running circumferentially around the inner perimeter of the band 104. The inner cuff 146 may be secured to the band 104 at the first and second edges 148, 150 by an adhesive, epoxy, or hot melt, or may be sewn, stapled, or secured by other securing means. The inner cuff 146 includes a surface 152 to which four compression springs 154, 156, 158, 160 are secured. The first ends 162, 164, 166, 168 of the compression springs 154, 156, 158, 160 may be secured to the surface 152 with epoxy or an adhesive. In an alternative embodiment, the inner cuff 146 comprises a composite structure including a woven layer providing the surface 152, and the compression springs 154, 156, 158, 160 are woven, knotted, or otherwise combined with the woven layer. The second ends 170, 172, 174, 176 of the compression springs 154, 156, 158, 160 are configured to abut the inner surface 142 of the outer cuff 122.
[0015]
[0044] In FIG. 9, the inner cuff 146 is in a first, substantially unexpanded state, and the second ends 170, 172, 174, 176 of the compression springs 154, 156, 158, 160 apply little or no radially directed vertical force N0 against the outer cuff 122 (e.g., at the inner surface 142). Thus, the compression springs 154, 156, 158, 160 are substantially uncompressed or not compressed at all, and thus maintain a length L0 at which they are not subject to their stress. In some embodiments, each compression spring 154, 156, 158, 160 can have a different length or orientation, or even a different material, than the other compression springs 154, 156, 158, 160, and thus their lengths and / or the resulting vertical forces can be different from each other. In FIG. 10, the inner cuff 146 is in a second semi-expanded or partially expanded state. Due to the effect of this expansion, the surface 152 of the inner cuff 146 expands inwardly and the diameter decreases, pushing the second ends 170, 172, 174, 176 of the compression springs 154, 156, 158, 160 against the inner surface 142 of the outer cuff 122 with an increased vertical force N1. The inner cuff 146 has an internal space 147 (FIGS. 12-15) whose volume increases as the inner cuff 146 expands (e.g., as the internal pressure increases). The compression springs 154, 156, 158, 160 are compressed by this vertical force N1 to a length L1. Thus, the length L1 and the vertical force N1 shown in FIG. 10 represent the equilibrium values when the surface 152 compresses the compression springs 154, 156, 158, 160 against the inner surface 142 of the outer cuff 122. In FIG. 11, the inner cuff 146 is in a third substantially expanded state. Due to the effect of this expansion, the surface 152 of the inner cuff 146 expands further inwardly to a further decreased diameter. The second ends 170, 172, 174, 176 of the compression springs 154, 156, 158, 160 are further pushed against the inner surface 142 of the outer cuff 122 with a further increased vertical force N2. The compression springs 154, 156, 158, 160 are further compressed by this vertical force N2 to a length L2. Thus, N2 is greater than N1, and N1 is greater than N0. Further, L2 is less than L1, and L1 is less than L0.Since the band 104 of the wearable tremor control system 100 is fixed around the user's wrist 38, the vertical forces N0, N1, N2 are applied to the wrist 38 respectively and are applied at different positions, for example, at four equally spaced, or equally distributed quadrants. For example, in some embodiments, the equal distribution may be different from the equal spacing because the non-circular cross-section of the human wrist may indicate different intervals (such as the four vertices of a rectangle) to disperse the force on the wrist. The compression springs 154, 156, 158, 160 usually have a specific spring constant k, whereby the vertical force N. i is given by the formula N i = -k × L i is proportional to the compression length L i The outer cuff 122 is between the second ends 170, 172, 174, 176 of the compression springs 154, 156, 158, 160 and the wrist 38, and functions as a buffer layer to protect the wrist 38 from lacerations, abrasions or contusions while enabling the vertical forces N0, N1, N2 to be applied to the wrist 38. An increase in the inflation of the inner cuff 146 causes an increase in the vertical force applied to the wrist 38 (N0 increases to N1 or N2). In some embodiments, washers or disks can be added to the second ends 170, 172, 174, 176 of the compression springs 154, 156, 158, 160 to create an annular or circular compression surface. The washer or disk may include a hard material such as stainless steel or other metal, or a relatively rigid polymeric material such as nylon (polyamide), polyimide, or PEEK. However, as shown in FIG. 11, the compression springs 154, 156, 158, 160 in a substantially compressed state can apply the effect of a substantially annular compression surface to the wrist 38, which can be homogenized by the effect of the intermediate outer cuff 122.
[0016]
[0045] FIG. 12 shows a wearable tremor control system 100 in use on a wrist 38 of a user 42 in a first state where the inner cuff 146 is not substantially inflated. A cross-section is taken through a portion of the wearable tremor control system 100 proximal to the carpal bones, so the bones of the radius 178 and ulna 180 are shown in the cross-section of the wrist 38. The muscles 35 surrounding the radius 178 and ulna 180 are also shown. FIG. 13 shows the wearable tremor control system 100 in use on a wrist 38 of a user 42 in a second semi-inflated or partially inflated state of the inner cuff 146. FIG. 14 shows the wearable tremor control system 100 in use on a wrist 38 of a user 42 in a third state where the inner cuff 146 is substantially inflated. An increase in the volume of the internal space 147 of the inner cuff 146 is seen as progressing from FIG. 12 to FIG. 13 and from FIG. 13 to FIG. 14. An increase in the compression of the resulting compression springs 154, 156, 158, 160 is also seen.
[0017]
[0046] Referring to FIG. 15, the wearable tremor control system 100 is shown in more detail, but the wrist 38 is not visible. The housing 102 of the wearable tremor control system 100 includes a wall 182 and an internal cavity 184. The battery 186 is held within the internal cavity 184 and is covered by a removable battery cover 188. The battery 186 is configured to supply power to the circuit board 190 of the wearable tremor control system 100. The circuit board 190 includes a controller 192 configured to control the pneumatic pump 194. The pneumatic pump 194 is configured to pump air entering the internal cavity 184 through the inlet / outlet hole 196 and push the air entering the internal cavity 184 from the wall 182 through the inner cuff 146 into the inflation tube 198. The valve 199 is configured to be closable to maintain a constant pressure within the internal space 147 of the inner cuff 146 when inflated. The valve 199 may be an electromagnetically actuated valve (e.g., a microsolenoid) or a mechanical valve (e.g., a pinch valve). The circuit board 190 further includes a memory unit 197 configured to store data such as patient data, calibration data, treatment programs, treatment data (e.g., reduction or increase in tremor amplitude, intensity, and / or prevalence), and measurement algorithms. The circuit board 190 also includes a transceiver 195 configured to communicate with an external device 193 such as a smartphone, a tablet, a personal computer, or other communicable device. The external device 193 can include an application (App) 189 that allows a user to control and modify the operation of the wearable tremor control system 100. The application can include a computer program embodied in a non-transitory computer-readable medium that, when executed by one or more computers (e.g., the external device 193), provides one or more operation instructions to the wearable tremor control system 100. The housing 102 further includes a connection port 191 for transferring data or transferring energy (e.g., to enable charging). The connection port 191 can include a USB port, USB Type 3, Thunderbolt, Thunderbolt 3, etc.Connection to Application 189 can be achieved using one of several wireless technologies such as Bluetooth® or WiFi.
[0018]
[0047] Figure 16 shows a user interface 101 that includes a power switch 109 configured to turn the wearable tremor control system 100 on or off. The user interface 101 may comprise a touch screen and may utilize capacitive or resistive touch sensitivity. Alternatively, mechanical or membrane buttons / switches may be utilized. A first control unit 111 having a first button 113 and a second button 115 is configured to manually adjust the vibration mode. In other words, the vibration elements 136, 138 can be manually set (e.g., to low vibration, medium vibration, or high vibration) using the first and / or second buttons 113, 115. Alternatively, the controller 192 and / or the application 189 can receive one or more signals from the detection elements 132, 134 (via software or firmware) and be configured to automatically adjust the vibration mode by turning the vibration mode on or off or adjusting between low vibration, medium vibration, and high vibration. The vibration mode in some embodiments may be automatically adjustable via servo control or other means, and the vibration elements 136, 138 are operated in a manner that is somehow proportional or consistent with a decrease or increase in the amplitude, intensity, and / or morbidity of the tremor. For example, the vibration elements 136, 138 may be configured to operate as a derived function of the dominant tremor frequency measured or calculated by the detection elements 132, 134.
[0019]
[0048] The second control unit 117 having the first button 119 and the second button 121 is configured to manually adjust the compression mode. The inflation of the internal space 147 of the inner cuff 146 can be manually set (e.g., to low inflation, medium inflation, or high inflation) using the first and / or second buttons 119, 121. Alternatively, the controller 192 and / or the application 189 can receive one or more signals from the detection elements 132, 134 (via software or firmware), turn the compression mode on or off, or adjust the compression / spring vertical force between low, medium, and high to automatically adjust the compression mode.
[0020]
[0049] FIG. 17 shows a user 200 having restless legs syndrome (RLS) wearing the wearable tremor control system 100 in a fixed position around the ankle 202. The wearable tremor control system 100 may be worn by the user 200 during sleep or rest to control involuntary leg movements that affect RLS patients. All of the functions of the wearable tremor control system 100 described with respect to use at the wrist 38 of the user 42 can also be incorporated into a user 200 wearing the wearable tremor control system 100 on the ankle 202 or other parts of one or both legs where RLS is present.
[0021]
[0050] FIG. 18 is similar to the wearable tremor control system 100 of FIG. 15, but shows a wearable tremor control system 210 that includes additional weights 212, 214, 216, 218 coupled to respective ends 170, 172, 174, 176 of compression springs 154, 156, 158, 160. Each weight 212, 214, 216, 218 can increase the force applied to the wrist (limb, etc.) during compression due to inflation of the inner cuff 146, and the vertical force applied by the compression springs 154, 156, 158, 160. Similar to the case of the compression springs 154, 156, 158, 160, a force is applied to the "footprint" of each weight 212, 214, 216, 218, and thus to the focusing region. Additionally, the combined weights (loads) of the four weights 212, 214, 216, 218 function as a certain static load that can further minimize the likelihood of tremors while being supported by the band wearable tremor control system 210. The inertia of each weight 212, 214, 216, 218, alone and in combination with each other, serves to counteract limb movements initiated by involuntary muscle contractions. The applied force is also detected within the user's brain and, as part of the physiological feedback loop, changes the limb sway accordingly. Thus, the brain is "tricked" into playing a more complex intervention role. The weights 212, 214, 216, 218 are made of a high-density material such as lead, allowing for a lower profile and better fit within the closed band 104. Each weight may have a mass of from about 0.5 g to about 2 kg, or from about 10 g to about 500 g, or from about 50 g to about 500 g, or from about 10 g to about 250 g, or from about 50 g to about 250 g. In some embodiments, wave springs may be used instead of the compression springs 154, 156, 158, 160 to reduce the overall profile of the wearable tremor control systems 100, 210 on the wearer's wrist or ankle. In other embodiments, the compression springs 154, 156, 158, 160 may be attached to a rigid or semi-rigid backing having a footprint or region configured to amplify the compression force by a desired amount.
[0022]
[0051] In one embodiment of the present disclosure, a system for treating involuntary muscle contractions includes a wearable interface configured to at least partially surround a first portion of a subject's limb, a sensing module supported by the wearable interface and configured to output signals related to contractions of the limb muscles, and an energy application module supported by the wearable interface and configured to apply one or more forms of mechanical energy to the limb. The energy application module can change the characteristics of one or more forms of mechanical energy in response to changes in the signals output from the sensing module. In some embodiments, the system for treating involuntary muscle contractions further includes a controller configured to receive the signals output from the sensing module and control a change in at least one characteristic of one or more forms of mechanical energy applied by the energy application module. In some embodiments, the controller is a microcontroller. The microcontroller may be, in some embodiments, an LFQP-100 microcontroller and may include an ARM (Advanced RISC Machine) architecture. In some embodiments, the controller is supported by the wearable interface, electrically coupled to the sensing module (a sensor or an array of two or more sensors), and / or electrically coupled to the energy application module (an energy delivery element or an array of two or more energy supply elements). In some embodiments, the wearable interface is in the form of a band, or a watch, or a bracelet. In some embodiments, the wearable interface is configured to completely surround the subject's limb (arm, leg) at a location such as the wrist or ankle. In some embodiments, the wearable interface includes a closure device such as a snap, a lock, a hook, a Velcro® closure, a button closure, a snap closure, an adhesive closure, or a magnetic closure.In some embodiments, the sensory module comprises one or more piezoelectric elements, or one or more inflatable cuffs, or one or more non-inflatable cuffs, or one or more electrodes, or one or more displacement sensors, or one or more accelerometers, or one or more gyroscopes, or one or more electromyogram (EMG) sensors. The one or more displacement sensors may comprise one or more piezoelectric crystals. In some embodiments, the piezoelectric crystal is configured to vibrate at at least a first frequency and a second frequency. In some embodiments, the first frequency is lower than the second frequency. In some embodiments, the vibration at the first frequency is configured to at least partially attenuate the vibration of the limb of the subject, and the vibration at the second frequency is configured to stimulate the nerve of the limb of the subject. In some embodiments, the second frequency is a harmonic of the first frequency. In some embodiments, the piezoelectric crystal is configured to vibrate at a frequency of about 40 Hz to about 500 Hz, or about 50 Hz to about 450 Hz, or about 60 Hz to about 400 Hz, or about 100 Hz to about 350 Hz. In some embodiments, the energy application module comprises one or more inflatable cuffs, or two or more inflatable cuffs. In some embodiments, each of the one or more or two or more inflatable cuffs is arranged along the longitudinal axis of the limb of the subject when the wearable interface is in a fixed position on the first part of the limb of the subject. In some embodiments, each of the one or more inflatable cuffs or two or more inflatable cuffs is arranged along the outer periphery of the limb of the subject when the wearable interface is arranged in a fixed position on the first part of the limb of the subject. In some embodiments, the energy application module comprises one or more weights. The one or more weights may be configured to apply a force to the limb of the subject. The one or more weights may be adjustable such that the force applied to the limb of the subject is variable. In some embodiments, one or more biasing members are coupled to one or more of the one or more weights.In some embodiments, one or more biasing members comprise one or more helical elements or one or more compression springs. In some embodiments, one or more compression springs are configured to be adjustable such that a variable force is applied to the limb by one or more weights. In some embodiments, one or more compression springs are configured to be adjustable by expansion or contraction of at least a portion of an energy application module. In some embodiments, at least a portion of the energy application module comprises an inflatable cuff coupled to at least one of the one or more compression springs. In some embodiments, at least one of the one or more compression springs includes an inflatable helix. In some embodiments, each of the one or more weights has a mass of from about 0.5 grams to about 2,000 grams, or from about 10 grams to about 500 grams, or from about 10 grams to about 250 grams, or from about 50 grams to about 500 grams, or from about 50 grams to about 250 grams. In some embodiments, the energy application module comprises one or more ultrasonic transducers. In some embodiments, one or more ultrasonic transducers are coupled to the inflatable cuff. In some embodiments, each of the one or more ultrasonic transducers of the energy application module is configured to vibrate at a frequency of from about 1 Hz to about 30 Hz, or from about 2 Hz to about 15 Hz, or from about 3 Hz to about 10 Hz. In some embodiments, each of the one or more ultrasonic transducers is configured to vibrate at a frequency of from about 15 kHz to about 1 MHz, or from about 20 kHz to about 700 kHz, or from about 25 kHz to about 500 kHz, or from about 30 kHz to about 500 kHz, or from about 20 kHz to about 500 kHz, or from about 20 kHz to about 200 kHz, or from about 30 kHz to about 200 kHz, or from about 100 kHz to about 300 kHz.
[0023]
[0052] In some embodiments, the characteristics of one or more forms of mechanical energy include the amplitude of the applied energy. In some embodiments, the characteristics of one or more forms of mechanical energy include the orientation of the geometric shape of one or more forms of mechanical energy. In some embodiments, the characteristics of one or more forms of mechanical energy include the ratio of the amount of energy applied by each of two or more of one or more forms of mechanical energy. In some embodiments, the characteristics of one or more forms of mechanical energy include the duration of the application of one or more forms of mechanical energy. In some embodiments, the characteristics of one or more forms of mechanical energy include the duration of the pause between two or more applications of one or more forms of mechanical energy. In some embodiments, the characteristics of one or more forms of mechanical energy include the number of applications of one or more forms of mechanical energy. In some embodiments, the energy application module is configured to increase the amplitude of the energy applied to the limb in response to an increase in the amplitude of the signal output from the sensory module. In some embodiments, the energy application module is configured to decrease the amplitude of the energy applied to the limb in response to a decrease in the amplitude of the signal output from the sensory module. In some embodiments, the energy application module is configured to increase the frequency characteristics of the energy applied to the limb in response to an increase in the amplitude of the signal output from the sensory module. In some embodiments, the energy application module is configured to decrease the frequency characteristics of the energy applied to the limb in response to an increase in the amplitude of the signal output from the sensory module. The frequency characteristics may include the average frequency of the waves of a particular type of energy.
[0024]
[0053] In some embodiments, the sensory module is configured to output signals related to essential tremors of the subject. In some embodiments, the sensory module is configured to output signals related to restless legs syndrome of the subject. In some embodiments, the sensory module is configured to output signals related to Parkinson's syndrome of the subject. In some embodiments, the sensory module is configured to output signals related to cerebellar tremors of the subject. In some embodiments, the sensory module is configured to output signals related to dystonic tremors of the subject. In some embodiments, the sensory module is configured to output signals related to action tremors of the subject. In some embodiments, the sensory module is configured to output signals related to resting tremors of the subject. In some embodiments, the sensory module is configured to output signals related to one or more mental disorders of the subject. In some embodiments, the sensory module is configured to be manually adjusted by the user. In some embodiments, the energy application module is configured to be manually adjusted by the user. In some embodiments, the controller is configured to be manually adjusted by the user. In some embodiments, the system for treating involuntary muscle contractions further comprises a battery supported by a wearable interface and configured to supply power to at least one of the sensory module or the energy application module. In some embodiments, the system for treating involuntary muscle contractions further comprises a communication module supported by the wearable interface and configured for wireless communication. In some embodiments, the communication module is configured to communicate with a mobile phone. In some embodiments, the system for treating involuntary muscle contractions further comprises a smartphone configured to execute communication software capable of controlling communication with the communication module. In some embodiments, the communication software is firmware supported by the smartphone. In some embodiments, the communication software is a downloadable application.In some embodiments, at least one of the smartphone or the communication software provides a user interface for controlling the operation of at least one element of the system for the treatment of involuntary muscle contractions. In some embodiments, the communication module is configured to output data to the smartphone via the communication software. In some embodiments, the communication between the communication module and the smartphone includes at least one security element. In some embodiments, the at least one security element includes encryption. In some embodiments, the at least one security element is controlled by a password.
[0025]
[0054] In another embodiment of the present disclosure, a system for treating involuntary muscle contractions includes a wearable interface configured to at least partially surround a first portion of a subject's limb, a sensory module supported by the wearable interface and configured to output signals related to contractions of the limb muscles, and an energy application module including at least one compression element and at least one vibration element. In some embodiments, the system for treating involuntary muscle contractions further includes a controller configured to receive signals output from the sensory module and control changes in the characteristics of at least one or more forms of mechanical energy applied by the energy application module. In some embodiments, the controller is a microcontroller. The microcontroller may be, in some embodiments, an LFQP-100 microcontroller and may include an ARM (Advanced RISC Machine) architecture. In some embodiments, the controller is supported by the wearable interface, electrically coupled to the sensory module (a sensor or an array of two or more sensors), and / or electrically coupled to the energy application module (an energy delivery element or an array of two or more energy supply elements). In some embodiments, at least one vibration element includes at least one ultrasonic transducer. In some embodiments, the wearable interface is in the form of a band, or a watch, or a bracelet. In some embodiments, the wearable interface is configured to completely surround a subject's limb (arm, leg) at a location such as the wrist or ankle. In some embodiments, the wearable interface includes a closure device such as a snap, a lock, a hook, a Velcro® closure, a button closure, a snap closure, an adhesive closure, or a magnetic closure.In some embodiments, the sensory module comprises one or more piezoelectric elements, or one or more inflatable cuffs, or one or more non-inflatable cuffs, or one or more electrodes, or one or more displacement sensors, or one or more accelerometers, or one or more gyroscopes, or one or more electromyogram (EMG) sensors. The one or more displacement sensors may comprise one or more piezoelectric crystals. In some embodiments, the piezoelectric crystals are configured to vibrate at at least a first frequency and a second frequency. In some embodiments, the energy application module comprises one or more inflatable cuffs, or two or more inflatable cuffs. In some embodiments, each of the one or more or two or more inflatable cuffs is arranged along the longitudinal axis of the subject's limb when the wearable interface is in a fixed position on the first portion of the subject's limb. In some embodiments, each of the one or more inflatable cuffs or two or more inflatable cuffs is arranged along the outer periphery of the subject's limb when the wearable interface is disposed in a fixed position on the first portion of the subject's limb. In some embodiments, the energy application module comprises one or more weights. The one or more weights may be configured to apply a force to the subject's limb. The one or more weights may be adjustable such that the force applied to the subject's limb is variable. In some embodiments, one or more biasing members are coupled to one or more of the one or more weights. In some embodiments, the one or more biasing members comprise one or more helical elements, or one or more compression springs. In some embodiments, the one or more compression springs are adjustably configured such that a variable force is applied to the limb by the one or more weights. In some embodiments, the one or more compression springs are adjustably configured by at least partial inflation or contraction of the energy application module. In some embodiments, at least a portion of the energy application module comprises an inflatable cuff coupled to at least one of the one or more compression springs.In some embodiments, at least one of the one or more compression springs includes an expandable helix. In some embodiments, each of the one or more weights has a mass of from about 0.5 grams to about 2,000 grams, or from about 10 grams to about 500 grams, or from about 10 grams to about 250 grams, or from about 50 grams to about 500 grams, or from about 50 grams to about 250 grams. In some embodiments, the energy application module comprises one or more ultrasonic transducers. In some embodiments, one or more of the ultrasonic transducers are coupled to an inflatable cuff. In some embodiments, each of the one or more ultrasonic transducers of the energy application module is configured to vibrate at a frequency of from about 1 Hz to about 30 Hz, or from about 2 Hz to about 15 Hz, or from about 3 Hz to about 10 Hz. In some embodiments, each of the one or more ultrasonic transducers of the energy application module is configured to vibrate at a frequency of from about 1 Hz to about 30 Hz, or from about 2 Hz to about 15 Hz, or from about 3 Hz to about 10 Hz. In some embodiments, each of the one or more ultrasonic transducers is configured to vibrate at a frequency of from about 15 kHz to about 1 MHz, or from about 20 kHz to about 700 kHz, or from about 25 kHz to about 500 kHz, or from about 30 kHz to about 500 kHz, or from about 20 kHz to about 500 kHz, or from about 20 kHz to about 200 kHz, or from about 30 kHz to about 200 kHz, or from about 100 kHz to about 300 kHz.
[0026]
[0055] In some embodiments, the characteristics of one or more forms of mechanical energy include the amplitude of the applied energy. In some embodiments, the characteristics of one or more forms of mechanical energy include the orientation of the geometric shape of one or more forms of mechanical energy. In some embodiments, the characteristics of one or more forms of mechanical energy include the ratio of the amount of energy applied by each of two or more of one or more forms of mechanical energy. In some embodiments, the characteristics of one or more forms of mechanical energy include the duration of the application of one or more forms of mechanical energy. In some embodiments, the characteristics of one or more forms of mechanical energy include the duration of the rest between two or more applications of one or more forms of mechanical energy. In some embodiments, the characteristics of one or more forms of mechanical energy include the number of applications of one or more forms of mechanical energy. In some embodiments, the energy application module is configured to increase the amplitude of the energy applied to the limb in response to an increase in the amplitude of the signal output from the sensory module. In some embodiments, the energy application module is configured to decrease the amplitude of the energy applied to the limb in response to a decrease in the amplitude of the signal output from the sensory module. In some embodiments, the energy application module is configured to increase the frequency characteristics of the energy applied to the limb in response to an increase in the amplitude of the signal output from the sensory module. In some embodiments, the energy application module is configured to decrease the frequency characteristics of the energy applied to the limb in response to an increase in the amplitude of the signal output from the sensory module. The frequency characteristics may include the average frequency of the waves of a particular type of energy.
[0027]
[0056] In some embodiments, the sensory module is configured to output signals related to the essential tremors of the subject. In some embodiments, the sensory module is configured to output signals related to the restless legs syndrome of the subject. In some embodiments, the sensory module is configured to output signals related to the Parkinson's syndrome of the subject. In some embodiments, the sensory module is configured to output signals related to the cerebellar tremors of the subject. In some embodiments, the sensory module is configured to output signals related to the dystonic tremors of the subject. In some embodiments, the sensory module is configured to output signals related to the action tremors of the subject. In some embodiments, the sensory module is configured to output signals related to the resting tremors of the subject. In some embodiments, the sensory module is configured to output signals related to one or more mental disorders of the subject. In some embodiments, the sensory module is configured to be manually adjusted by the user. In some embodiments, the energy application module is configured to be manually adjusted by the user. In some embodiments, the controller is configured to be manually adjusted by the user. In some embodiments, the system for treating involuntary muscle contractions further comprises a battery supported by a wearable interface and configured to supply power to at least one of the sensory module or the energy application module. In some embodiments, the system for treating involuntary muscle contractions further comprises a communication module supported by a wearable interface and configured for wireless communication. In some embodiments, the communication module is configured to communicate with a mobile phone. In some embodiments, the system for treating involuntary muscle contractions further comprises a smartphone configured to execute communication software capable of controlling communication with the communication module. In some embodiments, the communication software is firmware supported by the smartphone. In some embodiments, the communication software is a downloadable application.In some embodiments, at least one of the smartphone or the communication software provides a user interface for controlling the operation of at least one element of the system for the treatment of involuntary muscle contractions. In some embodiments, the communication module is configured to output data to the smartphone via the communication software. In some embodiments, the communication between the communication module and the smartphone includes at least one security element. In some embodiments, the at least one security element includes encryption. In some embodiments, the at least one security element is controlled by a password.
[0028]
[0057] In another embodiment of the present disclosure, a system for treating involuntary muscle contractions includes a wearable interface configured to at least partially surround a first portion of a subject's limb, and an energy application module including at least one compression element and at least one ultrasonic transducer. In some embodiments, the compression element includes at least one weight. In some embodiments, the compression element includes at least one inflatable cuff. In some embodiments, the involuntary muscle contraction treatment system further includes a controller configured to control at least one characteristic change of one or more forms of mechanical energy applied by the energy application module. In some embodiments, the controller is a microcontroller. The microcontroller may be, in some embodiments, an LFQP-100 microcontroller and may include an ARM (Advanced RISC Machine) architecture. In some embodiments, the controller is supported by the wearable interface, electrically coupled to a sensing module (a sensor or an array of two or more sensors), and / or electrically coupled to the energy application module (an energy delivery element or an array of two or more energy supply elements). In some embodiments, at least one vibration element includes at least one ultrasonic transducer. In some embodiments, the wearable interface is in the form of a band, or a watch, or a bracelet. In some embodiments, the wearable interface is configured to completely surround a subject's limb (arm, leg) at a location such as the wrist or ankle. In some embodiments, the wearable interface includes a closure device such as a snap, a lock, a hook, a Velcro® closure, a button closure, a snap closure, an adhesive closure, or a magnetic closure. In some embodiments, the system for treating involuntary muscle contractions further includes a communication module supported by the wearable interface and configured for wireless communication. In some embodiments, the communication module is configured to communicate with a mobile phone.In some embodiments, the system for treating involuntary muscle contractions further comprises a smartphone configured to execute communication software capable of controlling communication with a communication module. In some embodiments, the communication software is firmware supported by the smartphone. In some embodiments, the communication software is a downloadable application. In some embodiments, at least one of the smartphone or the communication software provides a user interface for controlling the operation of at least one element of the system for treating involuntary muscle contractions. In some embodiments, the communication module is configured to output data to the smartphone via the communication software. In some embodiments, the communication between the communication module and the smartphone includes at least one security element. In some embodiments, the at least one security element includes encryption. In some embodiments, the at least one security element is controlled by a password.
[0029]
[0058] In another embodiment of the present disclosure, a system for treating involuntary muscle contractions includes a wearable interface configured to at least partially surround a first portion of a subject's limb, and an energy application module including at least one compression element having one or more adjustable weights. In some embodiments, the system for treating involuntary muscle contractions further includes at least one vibration element. In some embodiments, the involuntary muscle contraction treatment system further includes a controller configured to control a change in at least one characteristic of one or more forms of mechanical energy applied by the energy application module. In some embodiments, the controller is a microcontroller. The microcontroller may be, in some embodiments, an LFQP-100 microcontroller and may include an ARM (Advanced RISC Machine) architecture. In some embodiments, the controller is supported by the wearable interface and may be electrically coupled to the energy application module. In some embodiments, the at least one vibration element includes at least one ultrasonic transducer. In some embodiments, the wearable interface is in the form of a band, or a watch, or a bracelet. In some embodiments, the wearable interface is configured to completely surround a subject's limb (arm, leg) at a location such as the wrist or ankle. In some embodiments, the wearable interface includes a closure device such as a snap, a lock, a hook, a Velcro® closure, a button closure, a snap closure, an adhesive closure, or a magnetic closure. In some embodiments, the system for treating involuntary muscle contractions further includes a communication module supported by the wearable interface and configured for wireless communication. In some embodiments, the communication module is configured to communicate with a mobile phone. In some embodiments, the system for treating involuntary muscle contractions further includes a smartphone configured to execute communication software capable of controlling communication with the communication module.In some embodiments, the communication software is firmware supported by a smartphone. In some embodiments, the communication software is a downloadable application. In some embodiments, at least one of the smartphone or the communication software provides a user interface for controlling the operation of at least one element of the system for the treatment of involuntary muscle contractions. In some embodiments, the communication module is configured to output data to the smartphone via the communication software. In some embodiments, the communication between the communication module and the smartphone includes at least one security element. In some embodiments, the at least one security element includes encryption. In some embodiments, the at least one security element is controlled by a password.
[0030]
[0059] FIG. 19 shows a wearable tremor control system 250 similar to the wearable tremor control system 100 of FIG. 8, but further includes stimulation electrodes 252, 254, 256 supported on the outer surface 140 of the outer cuff 122. The user interface 101 and / or the application 189 may be configured to adjust or program the controller 192 such that a current flows through wires or traces 258, 260, 262 electrically coupled to the electrodes 252, 254, 256 by a signal received from one or more signals from the detection elements 132, 134, and to apply one or more potentials (voltages) to two or more of the electrodes. In some embodiments, voltage control may be used to apply current. In some embodiments, current control may also be used to apply current. The applied current can activate nerves, for example, to provide additional input to the brain. The user interface 101 (FIG. 16) can include a third mode that is an electrical stimulation mode, which can also be adjusted manually (e.g., with two buttons) or with feedback from the detection elements 132, 134. Any combination of two or three (or more) modes is possible, or in some embodiments, only a single mode may be possible. The electrodes 252, 254, 256 may be configured such that one or more applied potentials are directed at the median nerve, thereby controlling the brain to change or induce brain control or modification of tremors. In an alternative embodiment, the electrodes 252, 254, 256 may be configured to detect physiological signals related to tremors. The controller 192 may be configured, or configured to be programmable, via hardware, firmware, or software, such that any one or more of the inflation of the inner cuff 146, the activation of the electrodes 252, 254, 256, or the activation of the vibration elements 136, 138 are applied within a specific range of set parameters or a range of set parameters to function as a programmable pulse generator. For example, in certain embodiments, the voltage, current, frequency, or pulse width of the activation of the electrodes 252, 254, 256 can be controlled within the following ranges. Current: 0.1 mA to 200 mA, or 0.1 mA to 50 mA.Frequency / rate of the application: 0.1 mA to 200 mA, or 1 Hz to 5,000 Hz, or 1 Hz to 1,000 Hz, or 1 Hz to 200 Hz. Pulse width: 0.01 microseconds (μs) to 1000 microseconds (μs), or 1 microsecond (μs) to 1000 microseconds (μs), or 0.01 microseconds (μs) to 5 microseconds (μs). The controller 192 can activate the electrodes in continuous mode or in random mode including one or more bursts. The one-time of the burst and the off-time of the burst can be controlled independently. The on-time and off-time can be changed using a specific program or algorithm. In an alternative embodiment, the controller 192 is configured, or programmed to be configured, via hardware, firmware, or software, such that any one or more of the inflation of the inner cuff 146, the operation of the electrodes 252, 254, 256, or the operation of the vibration elements 136, 138 is applied at least partially randomly or pseudo-randomly. The human body is adaptable and, like many physiological systems, tends to adapt to therapeutic treatments, sometimes being useful to the body when actually counteracting the purpose and effect of the treatment. The nervous system can constantly change through processes such as synaptic adaptation. These changes can actually gradually reduce the effect of the initial effective treatment. Therefore, by adding random changes to the way the therapeutic elements (inner cuff 146 / compression springs 154, 156, 158, 160 / weights 212, 214, 216, 218, vibration elements 136, 138, electrodes 252, 254, 256) are applied, it may prove to anticipate or "trick" the body's adaptation scheme, which would otherwise actually be adversarial to efforts to minimize the effects of tremors, or can serve as a "tricking" method.Parameters that can be adjusted randomly or non - randomly by the controller 192 include the application time of energy (mechanical, electrical, etc.), the length of the time interval between energy applications, the number of repetitions of energy application, the specific operating frequency of the non - static mode of energy (for example, applying ultrasonic waves at various pulse rates), the amplitude of the applied energy, and the timing of a specific combination of a specific type of energy or multiple elements of two or more different types of energy. Any of these parameters can be increased or decreased. The controller 192 may be configured so that the user / patient can control some or all of these parameter adjustments, for example, via the user interface 101 and / or the application 189. Further, in some embodiments, there may be a security level for controlling how much, or whether, a user can control, such as a first level for the user and a second level for the prescribing physician. In some embodiments, the presence of controls that are not available to the user but are available to the physician can ensure a certain amount of randomness in the treatment. This may be necessary in some cases, for example, for certain patients who do not want to be surprised by, for example, compression, electrode activation, or vibration events. The security level may include encryption and / or password control. Due to the "smart" nature of the wearable tremor control system 250 or other systems described in the embodiments of this specification, it becomes possible to be managed by a primary care physician without the need for a specialist doctor.
[0031]
[0060] Figure 20 shows a wearable tremor control system 300 having a multimode energy delivery therapy that includes both vibration and electrical stimulation. The wearable tremor control system 300 is similar to the wearable tremor control system 100 of FIG. 8, but does not include compression and includes stimulation electrodes 302, 304, 306 supported on a surface 308 facing the limb of the band 310. The band 310 has a first end 330 and a second end 332 and is removably attached to a removable / exchangeable housing 336. A loop 334 is fixed to the band 310 and has an opening width W1. The insertion portion 340 of the band 310 has a thickness W2 that is smaller than the opening width W1. The normal wall 338 of the band 310 has a thickness W3 that is slightly larger than the opening width W1, thus creating a friction fit and thereby eliminating the need for the wedge 110 or the hook / loop 20a / 20b. In use, the user places the band 310 around the target limb, inserts the insertion portion 340 into the loop 334, and pulls the band 310 from the first end 330 until it is adjusted to the tolerance of the user / wearer's limb. The friction between the normal wall 338 and the loop 334 holds the band 310 securely. The loop 334 can include an elastomeric material such as rubber or elastomer, or a thermoplastic elastomer, and allows the loop to stretch when the normal wall 338 portion of the band 310 is placed through the loop. The user interface 312 and / or the application 189 (FIG. 15 or FIG. 18) may be configured to adjust or program the controller 314 such that a current flows through wires or traces 320, 322, 324 electrically coupled to the electrodes 302, 304, 306 in response to signals received from one or more signals from the detection elements 316, 318 and to apply one or more potentials (voltages) to two or more of the electrodes. Current can be applied using voltage control. Current can also be applied using current control. The applied current can activate nerves, for example, to provide additional input to the brain.The user interface 312 includes a vibration mode (for actuating the vibration elements 326, 328) and a stimulation mode (via the electrodes 302, 304, 306), which can be adjusted manually or by feedback from the detection elements 316, 318 respectively. Any combination of the two modes is possible so as to generate a mixed signal. The mixed signal may include a cycle having a first period of only one of vibration or stimulation and a second period of the other of vibration or stimulation. The mixed signal may include at least one cycle of simultaneous vibration and stimulation. The mixed signal may include a first period including both vibration and stimulation and a second period including both vibration and stimulation, and the ratio of the amounts of vibration and stimulation (such as energy or amplitude) may be different between the first period and the second period. The electrodes 302, 304, 306 may be configured such that one or more applied potentials are directed towards the median nerve, thereby controlling the brain to change or induce the control or modification of tremors in the brain. In an alternative embodiment, the electrodes 302, 304, 306 may be configured to detect physiological signals related to tremors. The controller 314 is configured, or configurable via hardware, firmware, or software, such that the operation of one or more of the electrodes 302, 304, 306 or the operation of the vibration elements 326, 328 is applied with a specific range of set parameters or set parameter ranges to function as a programmable pulse generator. For example, in a particular embodiment, the voltage, current, frequency, or pulse width of the operation of the electrodes 302, 304, 306 may be controlled within the following ranges. Current: 0.1 mA to 200 mA, or 0.1 mA to 50 mA. Application frequency / rate: 0.01 Hz to 50 kHz, or 1 Hz to 5,000 Hz, or 1 Hz to 1,000 Hz, or 1 Hz to 200 Hz. Pulse width: 1 microsecond (μs) to 1000 milliseconds (ms), or 1 microsecond (μs) to 1000 microseconds (μs), or 0.01 millisecond (ms) to 5 milliseconds (ms). The controller 314 can activate the electrodes in continuous mode or in random mode including one or more bursts.The operating periods of electrodes 302, 304, and 306 may include one or more of the following patterns: biphasic sine wave, polyphasic wave, monophasic sine wave, biphasic pulsatile sine wave, biphasic rectangular wave, monophasic square wave, monophasic pulsatile rectangular wave, biphasic spike wave, monophasic spike wave, and monophasic pulsatile spike wave. The on-time and off-time of the burst can be controlled independently. A specific program or algorithm can be used to vary the on-time and off-time. In an alternative embodiment, controller 314, via hardware, firmware, or software, is configured or programmed to be configured such that the operation of one or more of electrodes 302, 304, 306 or the operation of vibration elements 326, 328 is applied at least partially randomly or pseudo-randomly as described with respect to the embodiment of FIG. 19. Any one of electrodes 302, 304, 306 can function as a patient return electrode, thus eliminating the need for an additional skin-mounted return electrode patch. Thus, by simply attaching the limb band 310 of the wearer / user, the wearer / user can immediately start using the wearable tremor control system 300.
[0032]
[0061] Multiple touch points are provided by electrodes 302, 304, 306 and vibration elements 326, 328, which are arranged at different clock positions around surface 308 facing the limbs of band 310, and the optimal anatomical position for effective treatment is identified and is likely to be treated, enabling a high success rate. Electrodes 302, 304, 306 and vibration elements 326, 328 can be controlled by controller 314 to operate synchronously to provide optimal results. Controller 314 may be configured such that the user / patient can control some or all of these parameter adjustments, for example, via user interface 312 and / or application 189. Further, in some embodiments, there may be security levels that control how much the user can control, i.e., a first level for the user and a second level for the prescribing physician. In some embodiments, the presence of controls that are not available to the user but are available to the physician can ensure a certain amount of randomness in the treatment. This may be necessary in some cases, for example, for certain patients who do not want to be surprised by, for example, electrode activation or vibration events. The security level may include encryption and / or password control. Many of the components described in wearable tremor control system 300 are suitable for a rechargeable battery system because the required power is relatively low. Connection port 191 may be used to attach a wireless antenna, if necessary, regardless of whether there is an internal wireless function within wearable tremor control system 300.
[0033]
[0062] The wearable tremor control system 300 may include an adaptive capability. For example, the controller 314 may be programmable or pre-programmed to provide a specific treatment plan such as morning application of energy, daytime application of energy, and evening application of energy. However, by analyzing the physiological activities measured by the detection elements 316, 318, the controller 314 may be configured to change the treatment plan to optimize the patient's response. For example, the changes may include a greater amplitude and / or longer duration of the application of vibrational energy, and a smaller amplitude and / or shorter duration of the application of electrical stimulation energy. Or, in other cases, the changes may include a greater amplitude and / or longer duration of the application of electrical stimulation energy, and a smaller amplitude and / or shorter duration of the application of vibrational energy. An energy modulation algorithm can be applied to enable the wearable tremor control system 300 to learn and better provide each wearer with a custom neuromodulation management that corresponds to the specific tremor symptoms of each patient. Thus, an individual treatment plan can be constructed or tailored to each patient / user.
[0034]
[0063] In FIG. 21, the housing 336 is removed from the band 310. The housing 336 is removable from the band 310 for a plurality of reasons and is reattachable to the band 310. The housing 336 may include one or more rechargeable batteries that can be recharged by attaching a power cable to the connection port 191 (FIG. 20) or another port connected to a battery. The battery may be rechargeable by a wired or wireless method including inductive coupling charging. The one or more batteries may be similar to the battery 186 of FIGS. 12-15. In an alternative embodiment, the one or more batteries may be primary batteries configured to be used and discarded (or recycled). The housing 336 is fixed to the band 310 via two magnets 346, 348 configured to attract the magnets 350, 352 supported by the band 310. In the embodiment of FIG. 21, the magnet 348 has a positive pole facing the outside configured to magnetically engage the magnet 350 having a negative pole facing the outside. The magnet 346 has a negative pole facing the outside configured to magnetically engage the magnet 352 having a positive pole facing the outside. The magnets may include rare earth magnets such as neodymium iron boron or samarium cobalt. The neodymium iron boron magnet may be selected from grades of N30 or higher, or N33 or higher, or N35 or higher, or N38 or higher, or N40 or higher, or N42 or higher, or N45 or higher, or N48 or higher, or N50 or higher. In some embodiments, the neodymium iron boron magnet may have a grade of N30-N52, or N33-N50, or N35-N48.
[0035]
[0064] The electrical connection may be achieved by a conductive protrusion 354 configured to be conductively engaged with a conductive recess 356 supported on the bottom surface 342 of the housing 336 and supported on the band 310. The conductive recess 356 may be electrically connected to various components of the housing 336 that can include the user interface 312, the controller 314, and the connection port 191, or any of the electrical components described in the previous embodiments. The conductive protrusion 354 is electrically connected to the traces 320, 322, 324 and the stimulation electrodes 302, 304, 306, the vibration elements 326, 328, and the detection elements 316, 318 (FIG. 20). Thus, when the housing 336 is attached to the band 310 via the attraction of the magnets 346, 348, 350, 352, the conductive protrusion 354 is electrically coupled to the conductive recess 356. They may comprise a terminal connection featuring a pin and a hole. Thereby, the user interface 312, the controller 314, the connection port 191, and other electrical components are electrically coupled to the traces 320, 322, 324 and the stimulation electrodes 302, 304, 306, the vibration elements 326, 328, and the detection elements 316, 318. The user may choose to remove the housing 336 from the band 310 for reasons other than recharging. For example, if the first housing 336 is damaged or non-functional, the first housing 336 can be replaced with a second housing 336. The housing 336 may be removed for presentation to a medical facility, which may upload or download a revised version of information or software, or provide it for maintenance or repair. The conductive protrusion 354 and the conductive recess 356 are shown in FIG. 21 and are located between the magnets 350, 352 or the magnets 346, 348, respectively. However, in other embodiments, the conductive protrusion 354 may be electrically coupled to the conductive recess 356 and be laterally positioned from the magnets 350, 352 or the magnets 346, 348. In some embodiments, the conductive protrusion 354 and the conductive recess 356 may be replaced, respectively, with a series of conductive terminals each having both a protrusion and a recess, or a series of terminals having a substantially planar arrangement of conductive terminals (neither a protrusion nor a recess).
[0036]
[0065] In an alternative embodiment, the magnets 350, 352 may be replaced with iron metal strips that are also attracted to the iron 346, 348. Alternatively, the magnets 346, 348 may be replaced with iron metal strips instead of the magnets 350, 352. In other alternative embodiments, the magnets 346, 348, 350, 352 may be replaced with other connections such as snaps, hook and loop (Velcro®), slide engagement, or adhesive strips.
[0037]
[0066] In one embodiment of the present disclosure, a system for treating involuntary muscle contractions includes a wearable interface having an internal contact surface configured to at least partially surround a first portion of a subject's limb, one or more weights supported by the wearable interface, and one or more electrodes supported by the internal contact surface and configured to contact the skin within the first portion of the subject's limb. In some embodiments, the system for treating involuntary muscle contractions further includes a controller configured to power the one or more electrodes. In some embodiments, the one or more electrodes are configured to apply one or more impulses to stimulate the median nerve of the subject's upper limb. In some embodiments, the controller is configured to apply the impulses by the electrodes in a random pattern. In some embodiments, the random pattern includes a period that randomly varies between successive series of impulses. In some embodiments, the random pattern includes randomly varying the operating frequency between one series of impulses and another series of impulses.
[0038]
[0067] In another embodiment of the present disclosure, a system for the treatment of involuntary muscle contractions includes a wearable interface having an internal contact surface configured to at least partially surround a first portion of a subject's limb, one or more electrodes supported on the internal contact surface and configured to contact the skin within the first portion of the subject's limb, and a control unit configured to control the operation of the one or more electrodes. In some embodiments, the control unit is programmable. In some embodiments, the control unit includes a microcontroller. The microcontroller may be, in some embodiments, an LFQP-100 microcontroller and may include an ARM (Advanced RISC Machine) architecture. In some embodiments, the control unit is configured to at least partially define a pulse of the operation of the electrodes. In some embodiments, the control unit is configured to be programmed to operate one or more electrodes to apply a current of about 0.1 mA to about 50 mA. In some embodiments, the control unit is configured to be programmed to pulse one or more electrodes at a rate of about 1 Hz to about 5,000 Hz, or about 1 Hz to about 1,000 Hz, or about 1 Hz to about 200 Hz. In some embodiments, the control unit is configured to be programmed to operate one or more electrodes with a pulse having a pulse width of about 1 to about 1,000 μs. In some embodiments, the control unit is configured to be able to control at least one of the on-time and off-time of the pulse. In some embodiments, the control unit is configured to operate one or more electrodes randomly or pseudo-randomly. In some embodiments, the control unit is configured to operate one or more electrodes to stimulate the median nerve of the subject's upper limb.
[0039]
[0068] In another embodiment of the present disclosure, a system for treating involuntary muscle contractions includes a wearable interface having an internal contact surface configured to at least partially surround a first portion of a subject's limb, one or more electrodes supported by the internal contact surface and configured to contact the skin within the first portion of the subject's limb, an energy application module including at least one vibration element, and a control unit configured to control the operation of the one or more electrodes. In some embodiments, the system for treating involuntary muscle contractions further includes a sensory module supported by the wearable interface and configured to output signals related to muscle contractions within the limb. In some embodiments, the control unit is programmable. In some embodiments, the control unit is further configured to control the operation of at least one vibration unit. In some embodiments, the control unit includes a microcontroller. The microcontroller may be, in some embodiments, an LFQP-100 microcontroller and may include an ARM (Advanced RISC Machine) architecture. In some embodiments, the control unit is configured to operate one or more electrodes and at least one vibration element to generate a mixed signal together. In some embodiments, the control unit is configured to generate an operating cycle including a first period of operating at least one vibration element without operating one or more electrodes and a second period of operating one or more electrodes. In some embodiments, the second operating period includes the operation of at least one vibration element. In some embodiments, the second operating period of the one or more electrodes includes continuous activation. In some embodiments, the second operating period of the one or more electrodes includes pulsed activation. In some embodiments, the second operating period of the one or more electrodes includes a sine wave. In some embodiments, the second operating period of the one or more electrodes includes a square wave.In some embodiments, the second operating period of one or more electrodes includes at least one of the patterns in the list consisting of a biphasic sine wave, a polyphasic wave, a monophasic sine wave, a biphasic pulsatile sine wave, a biphasic rectangular wave, a monophasic square wave, a monophasic pulsatile rectangular wave, a biphasic spike wave, a monophasic spike wave, and a monophasic pulsatile spike wave. In some embodiments, the control unit is configured to repeat the operating cycle one or more times. In some embodiments, the control unit is configured to at least partially define the pulses of the operation of the electrodes. In some embodiments, the control unit is configured to be programmed to operate one or more electrodes to apply a current of about 0.1 mA to about 200 mA. In some embodiments, the control unit is configured to be programmed to pulse one or more electrodes at a rate of about 0.01 Hz to about 5,000 Hz, or about 0.01 Hz to about 1,000 Hz, or about 0.01 Hz to about 5 Hz. In some embodiments, the control unit is configured to be programmed to operate one or more electrodes with pulses having a pulse width of about 0.01 milliseconds to about 5 milliseconds. In some embodiments, the control unit is configured to control at least one of the on-time and off-time of the pulses. In some embodiments, the control unit is configured to operate one or more electrodes randomly or pseudo-randomly. In some embodiments, the control unit is configured to operate one or more electrodes to stimulate the median nerve of the upper limb of the subject.
[0040]
[0069] In some embodiments, the sensory module comprises at least one piezoelectric crystal. In some embodiments, the at least one piezoelectric crystal is configured to vibrate at a frequency of about 40 Hz to about 500 Hz, or about 50 Hz to about 450 Hz, or about 60 Hz to about 400 Hz, or about 100 Hz to about 350 Hz. In some embodiments, the control unit is supported by a wearable interface. In some embodiments, the wearable interface is in the form of a band, or a watch, or a bracelet. In some embodiments, the wearable interface is configured to completely surround a limb (arm, leg) of the subject at a part such as the wrist or ankle. In some embodiments, the wearable interface includes a closure device such as a snap, a lock, a hook, a Velcro® closure, a button closure, a snap closure, an adhesive closure, or a magnetic closure. In some embodiments, the control unit is configured to control the operation of at least one vibrating element at a first frequency and a second frequency. In some embodiments, the first frequency is lower than the second frequency. In some embodiments, the vibration at the first frequency is configured to at least partially attenuate the vibration of the subject's limb, and the vibration at the second frequency is configured to stimulate the nerves of the subject's limb. In some embodiments, the second frequency is a harmonic of the first frequency. In some embodiments, a system for the treatment of involuntary muscle contractions is further provided with a communication module supported by a wearable interface and configured for wireless communication. In some embodiments, the communication module is configured to communicate with a mobile phone. In some embodiments, a system for the treatment of involuntary muscle contractions further comprises a smartphone configured to execute communication software capable of controlling communication with the communication module. In some embodiments, the communication software is firmware supported by the smartphone. In some embodiments, the communication software is a downloadable application.In some embodiments, at least one of the smartphone or the communication software provides a user interface for controlling the operation of at least one element of the system for the treatment of involuntary muscle contractions. In some embodiments, the communication module is configured to output data to the smartphone via the communication software. In some embodiments, the communication between the communication module and the smartphone includes at least one security element. In some embodiments, the at least one security element includes encryption. In some embodiments, the at least one security element is controlled by a password.
[0041]
[0070] In some embodiments, the sensory module is configured to output a signal related to the essential tremor of the subject. In some embodiments, the sensory module is configured to output a signal related to the restless legs syndrome of the subject. In some embodiments, the sensory module is configured to output a signal related to the Parkinson's syndrome of the subject. In some embodiments, the sensory module is configured to output a signal related to the cerebellar tremor of the subject. In some embodiments, the sensory module is configured to output a signal related to the dystonic tremor of the subject. In some embodiments, the sensory module is configured to output a signal related to the action tremor of the subject. In some embodiments, the sensory module is configured to output a signal related to the resting tremor of the subject. In some embodiments, the sensory module is configured to output a signal related to one or more mental disorders of the subject.
[0042]
[0071] In some embodiments, the control unit is supported by a housing configured to be removably fixed to at least one of a band, a watch, or a bracelet. In some embodiments, the housing includes a first coupling member, at least one of the band, the watch, or the bracelet includes a second coupling member, and the first coupling member and the second coupling member are detachable from each other. In some embodiments, at least one of the first coupling member or the second coupling member includes a magnet. In some embodiments, one of the first coupling member or the second coupling member includes a magnet and the other of the first coupling member or the second coupling member includes a ferrous metal. In some embodiments, the first coupling member includes a first magnet and the second coupling member includes a second magnet. In some embodiments, the N pole of one of the first magnet or the second magnet is configured to magnetically couple with the S pole of the other of the first coupling member or the second coupling member. In some embodiments, the housing includes a third coupling member, at least one of the band, the watch, or the bracelet includes a fourth coupling member, and the third coupling member and the fourth coupling member are detachable from each other. In some embodiments, at least one of the third coupling member or the fourth coupling member includes a magnet. In some embodiments, one of the third coupling member or the fourth coupling member includes a magnet and the other of the third coupling member or the fourth coupling member includes a ferrous metal. In some embodiments, the third coupling member includes a third magnet and the fourth coupling member includes a fourth magnet. In some embodiments, the N pole of one of the third magnet or the fourth magnet is configured to magnetically couple with the S pole of the other of the third coupling member or the fourth coupling member. In some embodiments, the first coupling member and the second coupling member include a snap. In some embodiments, the first coupling member and the second coupling member include a hook and loop system. In some embodiments, one of the first coupling member and the second coupling member includes a channel and the other of the first coupling member and the second coupling member includes a protrusion configured to lock within the channel.In some embodiments, at least one of the housing or band, watch, or bracelet comprises a proximity sensor configured to output a signal when the housing is secured to at least one of the band, watch, or bracelet. In some embodiments, the proximity sensor comprises a Hall effect device.
[0043]
[0072] In some embodiments, at least one vibrating element comprises one or more ultrasonic transducers configured to vibrate at a frequency of from about 15 kHz to about 1 MHz, or from about 20 kHz to about 700 kHz, or from about 25 kHz to about 500 kHz, or from about 30 kHz to about 500 kHz, or from about 20 kHz to about 500 kHz, or from about 20 kHz to about 200 kHz, or from about 30 kHz to about 200 kHz, or from about 100 kHz to about 300 kHz.
[0044]
[0073] An alternative embodiment of the wearable tremor control system 100 of FIG. 8 is shown in FIGS. 22-27. In FIG. 22, the wearable tremor control system 410 in use is shown at a fixed position on the wrist 38 of the arm 40 of the user 42. The band 414 of the wearable tremor control system 410 may be fixed very close to the hand 44 of the user 42, or may be attached around the wrist 38 (or other part of the arm 40) at a distance d from the hand 44, for example, 0.5 cm, 1 cm, 2 cm, 5 cm, 10 cm, or 15 cm, or at a distance of 0 cm to 15 cm. The wearable tremor control system 410 includes a housing 412, and the band 414 is coupled to the lower side 416 of the housing 412 by epoxy or an adhesive. In other embodiments, the band 414 may be fixed to the housing 412 by a fixture, sewing, fusion, or may slide through a slit or elongated space in the housing 412. The band 414 is configured to wrap around the wrist 38 of the user / patient 42 and secure itself using a hook and loop (Velcro® type) system 420 or an alternative closure system. In some embodiments, the band 414 may be configured to be worn like a watch or bracelet and may be configured to partially or completely surround a limb (arm, leg) at a part (wrist, ankle, etc.). The hook and loop system 420 can be replaced with a button closure, snap closure, adhesive closure, or magnetic closure in alternative embodiments. The controller 432 in the housing 412 is configured to receive signals from the sensor 428. The sensor 428 includes a ring 417 configured to surround a finger of the user 42. In FIG. 22, the ring 417 is at a fixed position on the thumb 45 of the hand 44. The ring 417 includes a band 419 for surrounding the thumb 45 and a magnet 421 attached to the band 419. The magnet 421 is disposed on the band 419 such that its N pole 423 and S pole 425 can be oriented as shown. In this orientation of the change, a baseline magnetic field is generated near the wrist 38 as indicated by the magnetic field lines 427. The sensor 428 also includes a magnetometer 429 and is shown disposed within the housing 412.The magnetometer 429 is configured to detect changes to the magnetic field 427 that may be caused by disturbances from the tremors of the arm 40, wrist 38, or hand 44 of the patient 42. The magnetometer 429 may be coupled to the controller 432 and include a digital 3-axis magnetometer such as the LIS3MDL supplied by Pololu Corporation of Las Vegas, Nevada. The LIS3MDL provides magnetic field strength measurements in a configurable range from ±4 gauss to ±16 gauss, which can be read via a digital PC or SPI interface. The magnet 421 can include a rare earth magnet such as a neodymium iron boron magnet or a samarium cobalt magnet, and can have a grade of N45 or higher, or N48 or higher, or N52 or higher. The magnitude (magnetic flux density) of the baseline of the magnetic field supplied by the magnet 421 may be measured at or near the wrist 38 and be about 1.0 to 3.0 gauss. For comparison, the magnetic flux density of the Earth's magnetic field is between about 0.2 gauss and 0.7 gauss, and thus the magnetic field of the magnet 421 is distinct. The magnet 421 is shown as a cylindrical magnet in FIG. 22, but other configurations including semi-cylindrical or disk may be used. The magnetometer 429 is also configured to enable a dynamic evaluation of the vibration / frequency characteristics of changes to the magnetic field 427. The controller 432 may be configured to recognize dynamic activity within the measured magnetic field 427 that is within the typical tremor frequency range. The sensor 428 may be an independent detector of tremors, or an initial detection system that can be further corroborated by other sensors such as the aforementioned sensors (sensor 28 or detection elements 132, 134). Vibration elements 437, 438 (FIGS. 23-25) may optionally be included and configured to be operated by the controller 432.
[0045]
[0074] The controller 432 may comprise a microcontroller including those described herein. The controller 432 may be coupled to a transceiver 434 configured to wirelessly communicate with a mobile phone, smartphone, or other personal communication device including a chip embedded in the user's body or supported by a part of the user's body or clothing. The transceiver 434 may comprise a WiFi antenna. An actuator 436 (such as an automatic pump, jack, etc.) coupled to the controller 432 is configured to receive a signal from the controller 432 and expand the inflatable inner cuff 446 (Figs. 23 - 25) within the inner space 430 of the outer cuff 422.
[0046]
[0075] FIG. 23 shows a wearable tremor control system 410 in use on the wrist 38 of a user 42 in a first state where the inner cuff 446 is substantially unexpanded. A cross-section is taken through a portion of the wearable tremor control system 410 proximal to the carpal bones, showing the bones of the radius 178 and ulna 180 in the cross-section of the wrist 38. The muscle 35 surrounding the radius 178 and ulna 180 is also shown. FIG. 24 shows the wearable tremor control system 410 in use on the wrist 38 of a user 42 in a second semi-expanded or partially inflated state of the inner cuff 446. FIG. 25 shows the wearable tremor control system 410 in use on the wrist 38 of a user 42 in a third state where the inner cuff 446 is substantially inflated. An increase in the volume of the inner space 447 of the inner cuff 446 is seen as progressing from FIG. 23 to FIG. 24 and from FIG. 24 to FIG. 25. An increase in the compression of the resulting compression springs 454, 456, 458, 460 is also seen.
[0047]
[0076] The housing 412 of the wearable tremor control system 410 includes a wall 482 and an internal cavity 484. The battery 486 is held within the internal cavity 484 and covered by a removable battery cover 488. The battery 486 is configured to supply power to the circuit board 490 of the wearable tremor control system 410. The circuit board 490 includes a controller 432 configured to control the actuator 436 (FIG. 22). The circuit board 490 also includes a transceiver 434 configured to communicate with an external device 193 (FIGS. 15 and 18) such as a smartphone, a tablet, a personal computer, or another communicable device. The external device 193 can include an application (App) 189 that enables a user to control and modify the operation of the wearable tremor control system 410. The housing 412 further includes a connection port 491 for transferring data or transferring energy (e.g., for enabling charging). The connection port 491 can include a USB port, USB Type 3, Thunderbolt, Thunderbolt 3, and the like. The connection to the application 189 can be achieved using one of several wireless technologies such as Bluetooth or WiFi.
[0048]
[0077] Referring to FIGS. 26 and 27, the wearable tremor control system 410 is different from the wearable tremor control system 100 of FIG. 8 in that the actuator 436 and the band 414 each include several new features. The actuator 436 includes a rolling micropump 494 configured to pump air from an inlet 431 and deliver it to a conduit 435 via an outlet 433. The rolling micropump 494 can be configured to achieve a no-load flow rate of 0.02 liters / min to 0.15 liters / min, or 0.07 liters / min to 0.12 liters / min, or about 0.08 liters / min to about 0.10 liters / min. In some embodiments, the rolling micropump 494 may comprise an Oken RSP08D01R. Alternatively, a piezo pump such as a piezo pump commonly used in a non-invasive blood pressure monitor (NIBP) can also be used. In some embodiments, the SDMP320 / 330W pump of Takasago Fluidic Systems having a typical flow rate of 0.02 liters / min to 0.03 liters / min can be utilized. Piezo pumps such as the SDMP320 / 330W have a relatively flat profile and can fit into a small space (e.g., within the internal cavity 484 (FIG. 25)). The solenoid valve 499 is controlled by a controller 432 (FIG. 23) to open and close the conduit 435, close (arrow) to maintain the pressure achieved by the pumping of the rolling micropump 494, and open (shown position) to allow pressure relief. The pressure sensor 411 is configured to transmit a signal (e.g., to the controller 432) based on the pressure measured within the conduit 435. By continuously or intermittently detecting the pressure with the pressure sensor 411, the internal space 447 of the inner cuff 446 can be accurately pressurized. When the pressure approaches a predetermined or pre-calculated set point, the controller 432 can switch the operation of the rolling micropump 494 and / or the solenoid valve 499 to maintain the set point pressure. The pressure sensor 411 may include an analog or digital output.An exemplary sensor is the Panasonic ADP5240 which has an appropriate detection range of 0 kPa to 100 kPa. Returning to FIG. 23, the circuit board 490 further includes a memory unit 497 configured to store data such as patient data, calibration data, treatment programs, treatment data (e.g., reduction or increase in amplitude, intensity and / or morbidity of tremors), and measurement algorithms.
[0049]
[0078] The time to pressurize the internal space 447 of the inner cuff 446 can be minimized for efficiency by increasing the flow rate capacity of the pump being used. Alternatively, the internal space 447 can be minimized and thus optimized by reducing the width or profile area 439 between the compression springs 454, 456, 458, 460 and the wide area 441 that directly surrounds the compression springs 454, 456, 458, 460. Thus, the portion of the conduit 435 that extends through the band 414 and forms the internal space 447 has a volume that is not larger than necessary. The non-expandable portion 413 of the band 414 surrounds the narrow area 439. Thus, the inner cuff 446 expands preferentially only where it needs to expand, under the compression springs 454, 456, 458, 460. To further strengthen the compression springs 454, 456, 458, 460, a rigid base 415 is connected to the inner cuff 446 on the side adjacent to the outer cuff 422, where the compression springs 454, 456, 458, 460 can be connected. This is shown in detail in FIG. 27. In some embodiments, the rigid base 415 may include a polyimide (e.g., Kapton®) sheet. Further, the major component of the force applied by the compression springs 454, 456, 458, 460 is proportional to the area of the rigid base 415 that couples the compression springs 454, 456, 458, 460 to the inner cuff 446. Thus, the coupling to the wrist 38 (or other anatomical feature) of the patient 42 is increased. The same type of focused coupling using the rigid base 415 may be used with the vibration elements 437, 438 (FIG. 23). The vibration elements 437, 438 that are pressed against the wrist 38 of the patient 42 with increased pressure can be more effective, similar to the compression springs 454, 456, 458, 460. In some embodiments, the rigid base 415 can also function as an acoustic coupling of the vibration elements 437, 438 to the outer cuff 422, for example having a matched acoustic impedance. The coupling can be made to the outer wall surface (as in FIGS. 23 - 25) or alternatively to the inner wall surface of the outer cuff 422.An alternative method of increasing the pressure to which the vibration elements 437, 438 are applied is to preferentially place it under a portion of the outer cuff 422 that is itself disposed directly under the housing 412 which tends to be more rigid, and thus to allow the vibration elements 437, 438 to be pushed into or preloaded more against the wrist 38. Thus, the described embodiments provide the possibility of a drug-free tremor management option for the patient. The discreet nature of the device appears similar to that of a conventional watch or smartwatch, so that the user can minimize attention and social embarrassment.
[0050]
[0079] Figures 28-30 show a wearable tremor control system 500 having a housing 502 and a band 504. The housing 502 comprises a housing top 506 and a housing bottom 508 configured to be attached to each other as shown in Figure 28. The band 504 comprises a first band portion 510 and a second band portion 512. The housing bottom 508 is coupled to a base 514 having a first bracket 516 and a second bracket 518, the brackets having holes 520. Screws 522 connect the first bracket 516 to the first band portion 510 at a first end 524 and connect the second bracket 518 to the second band portion 512 at a first end 526. A second end 528 of the first band portion 510 and a second end 530 of the second band portion 512 overlap each other. In some embodiments, there may be a hook and loop (e.g., Velcro®) connection between the first band portion 510 and the second band portion 512. In other embodiments, the first band portion 510 and the second band portion 512 may each be made of a material such as a high durometer elastomer having sufficient thickness to be bent out of the way while the user places the wrist or other limb portion in the central opening 532, but having sufficient rigidity to maintain the band 504 in a fixed position on the wrist or other limb portion.
[0051]
[0080] The on / off button 534 is disposed in the housing 502 for easy access by the user, and an LED 536 or other indicator indicates whether the wearable tremor control system 500 is operating, stopped, or in standby mode. Multiple-color LEDs may be used to indicate the status (e.g., green for on, orange or yellow for standby, red for operating error). Although not shown in FIG. 28, a display or touch screen may be supported on the upper surface 538 of the upper part 506 of the housing as described in connection with the previous embodiments. Any combination of sensors (piezoelectric crystals, accelerometers, gyroscopes, EMC sensors), stimulation electrodes, or vibration elements (e.g., piezoelectric crystals) may be supported on the band 504, the lower side 540 of the base 514, or the housing 502.
[0052]
[0081] Referring to FIG. 29, a wirelessly chargeable battery 542 is within the housing 502, which can be wirelessly charged via a wireless power charging coil 544 comprising a flat coil 546, a ferrite sheet 548, and a dielectric sheet 550 and an EMI shield. The wireless power charging coil 544 receives current from a wireless charging unit via inductive coupling and charges the battery 542. The thin wireless power charging coil 544 can be obtained from Wurth Electronik eiSos GmbH&Co of Waldbronn, Germany. The microcontroller 552 and the transceiver 554 are supported on a circuit board 556 and function as described in connection with the microcontroller and transceiver of the previous embodiments. FIG. 30 shows other parts of the circuit board, such as an AC / DC converter 558 that may include a rectifier, and a transient voltage suppression unit 560 that may include a voltage-dependent resistor (varistor).
[0053]
[0082] Piezo tactile actuators 562, 564 are held within the housing 502 and are configured to operate (displace) when a voltage is applied. The base 514 includes openings 566, 568, and the bottom 508 of the housing includes openings 571, 573 in which membranes 570, 572 are respectively disposed. The openings 566, 571 are aligned with the membrane 570, and the openings 568, 573 are aligned with the membrane 572. The displacement of the piezo tactile actuators 562, 564 displaces the membranes 570, 572 respectively, so that when the wearable tremor control system 500 is in a fixed position on the user's wrist, the movement and force directly applied to the user's skin by the membranes 570, 572 provide tactile feedback. The tactile feedback may be initiated to alert the user of events such as device power on, device power off, device error, start of treatment, end of treatment, start of measurement, end of measurement, data generation, change in treatment plan, request or suggestion to contact a physician or medical institution, or other commands. In addition to, or instead of, this, treatment may be provided to the patient by applying pressure directly to the portion of the user's wrist where the membranes 570, 572, and thus the actuators 562, 564, are located, using the tactile feedback. The pressure applied is somewhat similar to the compression applied by the inflatable or expandable cuff described in previous embodiments. In some embodiments, the piezo tactile actuator may comprise PowerHap™ 7G supplied by EPCOS AG of Munich, Germany.
[0054]
[0083] By applying an energy modulation algorithm, any of the wearable tremor control systems 10, 100, 210, 250, 300, 410, 500 can learn to better provide each wearer with custom neuromodulation management corresponding to the specific tremor symptoms of each patient. Thus, individual treatment plans can be constructed or tailored to each patient / user. For example, a control unit (such as a controller, microcontroller, etc.) can be configured, or configurable, to reduce the power output by an energy applicator (electrode, vibration element, compression element, or others) when a signal output from a sensor (any of the sensors described herein) changes by a specific amount or to a specific value. For example, after energy is applied by the energy applicator, the signal output by the sensor can decrease. Thus, the control unit can determine that the treatment is effective to a level that guarantees a reduction in the applied energy of the treatment, a reduction in the duration of the treatment cycle, or a complete cessation of the treatment (at least temporarily). For example, in some embodiments, if the signal output by the sensor after the application of energy by the energy applicator is less than about 80% of the signal output by the sensor before the application of energy by the energy applicator, the control unit can be configured, or configurable, to reduce the level of power output by the energy applicator. When two types of energy are being used (such as electrical stimulation and vibration), the power reduction can be a reduction of only one of the two types of energy or a reduction of both types of energy. In some embodiments, if the signal output by the sensor after the application of energy by the energy applicator is less than about 50% of the signal output by the sensor before the application of energy by the energy applicator, the control unit can be configured, or configurable, to reduce the level of power output by the energy applicator.In some embodiments, if the signal output by the sensor after the application of energy by the energy applicator is less than about 20% of the signal output by the sensor before the application of energy by the energy applicator, the control unit may be configured or configurable to reduce the level of power output by the energy applicator. In some embodiments, if the signal output by the sensor after the application of energy by the energy applicator is less than about 10% of the signal output by the sensor before the application of energy by the energy applicator, the control unit may be configured or configurable to reduce the level of power output by the energy applicator.
[0055]
[0084] In some embodiments, the control unit can be configured, or can be configurable, to change the output parameters of the electrical stimulation and the output of the vibration independently of each other. The output parameters of the electrical stimulation to be changed include voltage, current, power, frequency, duration, or amplitude. The output parameters of the vibration to be changed include power, frequency, harmonic mode number, duration, or amplitude. In some embodiments, the control unit can be configured to control the operation of the energy applicator based at least on patient activity characteristics. Examples of patient activity characteristics that can be used are eating, drinking, walking, running, sleeping, resting while awake, sitting, talking, meditating, typing, or writing. The memory units of the wearable tremor control systems 10, 100, 210, 250, 300, 410, 500 can be used, for example, to store one or more of the patient activity characteristics for later use. In some embodiments, the multimodal energy applicator may also be used as a multimodal sensor. For example, a combination of one or more electrodes for electrical stimulation and one or more piezoelectric elements for therapeutic vibration can also have the ability to detect the stimulation and activity of muscles during active tremors. The control unit may also be able to switch between a "detection" mode in which signals from the electrodes and piezoelectric elements are received and processed, and a "supply" mode in which the electrodes and piezoelectric elements are intentionally excited for the purpose of supplying energy. The control unit can also provide a feedback loop, and the amount of activity in the "supply" mode depends on the signal measured in the "detection" mode. In any of the described embodiments, the data may be shared wirelessly with others, including medical personnel. The specific algorithm of the feedback loop can be adjusted manually by the user or other users using the user interface, or manually wirelessly by medical personnel or other users. Alternatively, the specific algorithm of the feedback loop may be automatically adjusted in response to changes in specific parameters.
[0056]
[0085] Any of the above embodiments may be configured for use on an arm, hand, leg, or foot such that one or more of the electrodes 252, 254, 256 or 302, 304, 306 can treat one or more nerves of the arm, hand, leg, or foot that communicate with the central nervous system. In particular, the nerves are nerves that cause tremors or involuntary movements. The nerves include, but are not limited to, the median nerve. Other nerves that are the target of treatment by the devices of the embodiments presented herein include the radial nerve and the ulnar nerve.
[0057]
[0086] In some embodiments, including variations of the embodiments disclosed above, the user interfaces 101, 312 may be configured to communicate remotely with the electronics of the housings 12, 102, 336, 412, 502 via, for example, Bluetooth, WiFi, or other wireless networks. The user interfaces 101, 312 may be configured to be attachable to a part of the user's body, such as the wrist, arm, ankle, leg, head, waist, or neck, by having, for example, a belt, an elastic band, or a band that can be tied. In still other embodiments, there may be a wired connection, such as an extendable wire, between the user interfaces 101, 312 and the housings 12, 102, 336, 412, 502.
[0058]
[0087] In some embodiments, one or more of the piezoelectric crystals described herein may be attached to the bands 14, 104, 310, 414, 504 via a rigid or semi-rigid backing material such as polyimide (Kapton). Further, the piezoelectric crystal may include a mechanical displacement amplifier to improve energy transfer to the wearer / patient. The mechanical displacement amplifier may include a resonator or an oscillator.
[0059]
[0088] In one embodiment of the present disclosure, a system for treating involuntary muscle contractions includes a wearable interface having an inner contact surface and configured to at least partially surround a first portion of a limb of a subject, a sensing module including a magnetic element and a magnetic sensor configured to be worn proximate to the first portion of the limb of the subject, and an energy application module supported by the wearable interface and configured to apply one or more forms of mechanical energy to the limb, wherein the energy application module is capable of changing the characteristics of one or more forms of mechanical energy. In some embodiments, the energy application module is configured to change the characteristics of one or more forms of mechanical energy in response to a change in a signal output from the sensing module. In some embodiments, the magnetic element comprises a magnet. In some embodiments, the magnet includes a rare earth magnet such as neodymium iron boron or samarium cobalt. In some embodiments, the magnetic sensor comprises a magnetometer. In some embodiments, the energy application module comprises one or more compression springs. In some embodiments, the energy application module comprises one or more piezoelectric elements. In some embodiments, the energy application module is coupled to a cuff via one or more rigid sheets. In some embodiments, the cuff is an inflatable cuff.
[0060]
[0089] While the foregoing is directed to embodiments of the present invention, further embodiments of the present invention may be devised without departing from the basic scope thereof. Embodiment 1 A system for treating involuntary muscle contractions, comprising: a wearable interface having an inner contact surface and configured to at least partially surround a first portion of a limb of a subject; and an energy applicator supported by the wearable interface and configured to apply two or more types of energy to the limb of the subject. A system comprising the above. Embodiment 2 The system according to Embodiment 1, wherein the two or more types of energy include vibration energy. Embodiment 3 The system according to Embodiment 1, wherein the two or more types of energy include electrical stimulation energy. Embodiment 4 The system according to Embodiment 3, wherein the two or more types of energy further include vibration energy. Embodiment 5 The system according to Embodiment 2, wherein the vibration energy is provided by one or more piezoelectric elements supported by the wearable interface. Embodiment 6 The system according to Embodiment 5, wherein at least one of the one or more piezoelectric elements is configured to vibrate at a frequency of about 20 kHz to about 1 MHz. Embodiment 7 The system according to Embodiment 5, wherein the one or more piezoelectric elements include a first piezoelectric element configured to vibrate at a first frequency and a second piezoelectric element configured to vibrate at a second frequency different from the first frequency. Embodiment 8 The system according to Embodiment 7, wherein the first frequency is about 1 Hz to about 30 Hz and the second frequency is about 20 kHz to about 1 MHz. Embodiment 9 The system according to Embodiment 3, wherein the electrical stimulation energy is provided by one or more electrodes supported by the wearable interface. Embodiment 10 The system according to Embodiment 1, further comprising a sensor supported by the wearable interface and configured to output a signal related to muscle contraction within the limb. Embodiment 11 The system according to Embodiment 10, wherein the sensor includes one or more piezoelectric elements. Embodiment 12 The system according to embodiment 11, wherein at least one of the one or more piezoelectric elements is configured to vibrate at a frequency of about 40 Hz to about 500 Hz. Embodiment 13 The system according to embodiment 10, wherein the sensor includes an ultrasonic transducer. Embodiment 14 The system according to embodiment 1, further comprising a computer program embodied in a non-transitory computer-readable medium, the computer program providing instructions for operating the energy applicator when executed by one or more computers. Embodiment 15 The system according to embodiment 1, further comprising a control unit configured to control the operation of the energy applicator. Embodiment 16 The system according to embodiment 15, wherein the control unit is supported by the wearable interface. Embodiment 17 The system according to embodiment 15, wherein the control unit is programmable. Embodiment 18 The system according to embodiment 15, wherein the control unit is configured to modify the operation of the energy applicator over time. Embodiment 19 The system according to embodiment 18, wherein the modification of the operation of the energy applicator over time includes changing the amount of vibrational energy applied. Embodiment 20 The system according to embodiment 18, wherein the modification of the operation of the energy applicator over time includes changing the amount of electrical stimulation energy applied. Embodiment 21 The system according to embodiment 18, further comprising a sensor supported by the wearable user interface and configured to output signals related to muscle contractions within the limb, wherein the modification of the operation of the energy applicator over time is based on at least some measured changes in tremors in the subject. Embodiment 22 The system according to embodiment 15, further comprising a sensor supported by the wearable user interface and configured to output signals related to muscle contractions within the limb. Embodiment 23 The system according to embodiment 22, wherein the control unit is configured to modify the operation of the energy applicator based at least in part on measured changes in the signals output by the sensor. Embodiment 24 The system according to embodiment 23, wherein the two or more types of energy include vibrational energy. Embodiment 25 The system according to embodiment 23, wherein the two or more types of energy include electrical stimulation energy. Embodiment 26 The system according to embodiment 25, wherein the two or more types of energy further include vibrational energy. Embodiment 27 The system according to any one of embodiments 23 to 26, wherein when the signal output by the sensor after the application of the two or more types of energy is less than about 80% of the signal output by the sensor before the application of the two or more types of energy, the control unit is configured or configurable to reduce the power output by the energy applicator. Embodiment 28 The system according to embodiment 27, wherein the sensor comprises an accelerometer and the signal output by the sensor corresponds to the acceleration of the limb. Embodiment 29 The system according to embodiment 27, wherein the sensor comprises a gyroscope and the signal output by the sensor corresponds to the angular velocity of the limb. Embodiment 30 The system according to embodiment 27, wherein the sensor includes an electromyogram (EMG) sensor, and the signal output by the sensor corresponds to the electromyogram signals of one or more muscles. Embodiment 31 The system according to any one of embodiments 23 to 26, wherein when the signal output by the sensor after the application of the two or more types of energy is less than about 50% of the signal output by the sensor before the application of the two or more types of energy, the control unit is configured or configurable to reduce the power output by the energy applicator. Embodiment 32 The system according to embodiment 31, wherein the sensor includes an accelerometer, and the signal output by the sensor corresponds to the acceleration of a limb. Embodiment 33 The system according to embodiment 31, wherein the sensor includes a gyroscope, and the signal output by the sensor corresponds to the angular velocity of a limb. Embodiment 34 The system according to embodiment 31, wherein the sensor includes an electromyogram (EMG) sensor, and the signal output by the sensor corresponds to the electromyogram signals of one or more muscles. Embodiment 35 The system according to any one of embodiments 23 to 26, wherein when the signal output by the sensor after the application of the two or more types of energy is less than about 20% of the signal output by the sensor before the application of the two or more types of energy, the control unit is configured or configurable to reduce the power output by the energy applicator. Embodiment 36 The system according to embodiment 35, wherein the sensor includes an accelerometer, and the signal output by the sensor corresponds to the acceleration of a limb. Embodiment 37 The system according to embodiment 35, wherein the sensor includes a gyroscope, and the signal output by the sensor corresponds to the angular velocity of a limb. Embodiment 38 The system according to embodiment 35, wherein the sensor includes an electromyogram (EMG) sensor, and the signal output by the sensor corresponds to an electromyogram signal of one or more muscles. Embodiment 39 The system according to any one of embodiments 23 to 26, wherein when the signal output by the sensor after the application of the two or more types of energy is less than about 10% of the signal output by the sensor before the application of the two or more types of energy, the control unit is configured or configurable to reduce the power output by the energy applicator. Embodiment 40 The system according to embodiment 39, wherein the sensor includes an accelerometer, and the signal output by the sensor corresponds to the acceleration of a limb. Embodiment 41 The system according to embodiment 39, wherein the sensor includes a gyroscope, and the signal output by the sensor corresponds to the angular velocity of a limb. Embodiment 42 The system according to embodiment 39, wherein the sensor includes an electromyogram (EMG) sensor, and the signal output by the sensor corresponds to an electromyogram signal of one or more muscles. Embodiment 43 The system according to embodiment 15, wherein the two or more types of energy include vibration energy. Embodiment 44 The system according to embodiment 15, wherein the two or more types of energy include electrical stimulation energy. Embodiment 45 The system according to embodiment 44, wherein the two or more types of energy further include vibration energy. Embodiment 46 The system according to any one of embodiments 15 and 43 to 45, wherein the control unit is configured or configurable to change the power level output by the energy applicator. Embodiment 47 The system according to any one of Embodiments 15 and 43 to 45, wherein the control unit is configured or configurable to change the frequency of the signal output by the energy applicator. Embodiment 48 The system according to any one of Embodiments 15 and 43 to 45, wherein the control unit is configured or configurable to change the duration of the application of the energy output by the energy applicator. Embodiment 49 The system according to any one of Embodiments 15 and 43 to 45, wherein the control unit is configured or configurable to change the amplitude of the signal output by the energy applicator. Embodiment 50 The system according to Embodiment 45, wherein the control unit is configured or configurable to change the output parameters of the electrical stimulation and the output parameters of the vibration independently of each other. Embodiment 51 The system according to Embodiment 50, wherein the output parameters of the electrical stimulation are selected from the list consisting of voltage, current, power, frequency, duration, and amplitude. Embodiment 52 The system according to Embodiment 50, wherein the output parameters of the vibration are selected from the list consisting of power, frequency, harmonic mode number, duration, and amplitude. Embodiment 53 The system according to any one of Embodiments 15 and 43 to 45, further comprising a sensor supported by the wearable user interface and configured to output a signal related to muscle contraction in the limb. Embodiment 54 The system according to Embodiment 53, wherein the sensor includes an accelerometer, and the signal output by the sensor corresponds to the acceleration of the limb. Embodiment 55 The system according to Embodiment 53, wherein the sensor includes a gyroscope, and the signal output by the sensor corresponds to the angular velocity of the limb. Embodiment 56 The system according to embodiment 53, wherein the sensor includes an electromyogram (EMG) sensor, and the signal output by the sensor corresponds to an electromyogram signal of one or more muscles. Embodiment 57 The system according to embodiment 53, wherein the control unit is configured to control the operation of the energy applicator based at least on patient activity characteristics. Embodiment 58 The system according to embodiment 57, further comprising a memory unit configured to store at least one patient activity characteristic. Embodiment 59 The system according to embodiment 53, wherein the patient activity characteristic is related to at least one of eating, drinking, walking, running, sleeping, resting while awake, sitting, talking, meditating, typing, and writing. Embodiment 60 The system according to embodiment 1, further comprising a compression member configured to increase the contact pressure of the inner contact surface of the wearable interface on the limb of the subject. Embodiment 61 The system according to embodiment 60, wherein the compression member includes an inflatable cuff. Embodiment 62 The system according to embodiment 60, wherein the compression member includes a tactile actuator. Embodiment 63 The system according to embodiment 1, wherein the energy applicator is configured to apply the two or more types of energy to the limb of the subject simultaneously. Embodiment 64 The system according to embodiment 1, further comprising a transmitter supported by the wearable interface and configured for wireless communication. Embodiment 65 The system according to embodiment 64, wherein the transmitter includes a transceiver. Embodiment 66 The system according to embodiment 1, wherein the energy applicator comprises at least one electrode supported on the inward-facing surface of the wearable interface. Embodiment 67 The system according to embodiment 1, wherein the energy applicator includes at least one piezoelectric crystal.
[0061]
[0090] The ranges disclosed herein also include all overlaps, subranges, and combinations thereof. Terms such as "at most", "at least", "greater than", "less than", "between", etc. include the recited numbers. Terms such as "about", "approximately", and "substantially" that precede a number herein include the recited number (e.g., about 10% = 10%) and also indicate an amount close to the recited amount that performs the desired function or achieves the desired result. For example, the terms "about", "approximately", and "substantially" may refer to an amount that is less than 10%, less than 5%, less than 1%, less than 0.1%, less than 0.01% of the recited amount.
Claims
1. A system for treating involuntary muscle contractions, comprising: a wearable interface having an inner contact surface and configured to at least partially surround a first portion of a limb of a subject; a first piezoelectric element supported by the wearable interface so as to be disposed outside the limb of the subject, and configured to apply vibration energy having a frequency of 15 kHz to 1 MHz toward one or more nerves of the limb of the subject through the skin of the subject; an electrode supported by the wearable interface so as to be disposed outside the limb of the subject, and configured to apply electrical stimulation energy toward the one or more nerves of the subject through the skin of the subject, wherein the system does not include a mechanical displacement amplifier.
2. The system according to claim 1, further comprising a controller configured to control the application of the vibration energy by the first piezoelectric element and configured to control the application of the electrical stimulation energy by the electrode.
3. The system according to claim 2, wherein the controller is configured to apply the vibration energy and the electrical stimulation energy simultaneously.
4. The system according to claim 2, wherein the controller is configured to apply both the vibration energy and the electrical stimulation energy during a first period, and to apply only one of the vibration energy or the electrical stimulation energy during a second period.
5. The system according to claim 2, wherein the controller is configured to apply only the vibration energy during a first period and to apply only the electrical stimulation energy during a second period.
6. The system according to claim 2, wherein the controller is configured to apply both the vibration energy and the electrical stimulation energy during a first period at a first ratio between an amount of the vibration energy during the first period and an amount of the electrical stimulation energy during the first period, and to apply both the vibration energy and the electrical stimulation energy during a second period at a second ratio between an amount of the vibration energy during the second period and an amount of the electrical stimulation energy during the second period, and wherein the second ratio is different from the first ratio.
7. The system according to claim 2, wherein the controller is configured to apply the vibration energy and / or the electrical stimulation energy at least partially randomly.
8. The system according to any one of claims 2 to 7, wherein the controller is configured to vary the amount of vibration energy applied over time.
9. The system according to any one of claims 2 to 7, wherein the controller is configured to vary the amount of electrical stimulation energy applied over time.
10. The system according to any one of claims 2 to 7, further comprising a second piezoelectric element supported by the wearable interface so as to be disposed outside the limb of the subject and configured to apply vibration energy through the skin of the subject toward the one or more nerves of the limb of the subject, wherein the controller is configured to control the operation of the first piezoelectric element at a first frequency and the operation of the second piezoelectric element at a second frequency, and the second frequency is different from the first frequency.
11. The system according to any one of claims 2 to 7, wherein the wearable interface is configured to at least partially surround the wrist of the subject.
12. The system according to any one of claims 2 to 7, wherein the wearable interface is configured to at least partially surround the ankle of the subject.
13. The system according to any one of claims 2 to 7, further comprising a transmitter supported by the wearable interface and configured for wireless communication.
14. The system according to claim 1, further comprising a sensor supported by the wearable interface so as to be disposed outside the limb of the subject.
15. The system according to claim 14, wherein the sensor is a sensor type selected from the list consisting of an accelerometer, a gyroscope, an electrical angle meter, a force gauge, a strain gauge, and an electromyogram sensor.
16. The system according to claim 14, wherein the sensor is a piezoelectric sensor.
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