Systems and methods for peripheral nerve stimulation to treat tremor with removable treatment and monitoring unit

Abstract

The invention provides a system and method for peripheral nerve stimulation to treat tremor with a removable treatment and monitoring unit. Systems and methods for providing treatment to a patient may include a monitoring unit and a treatment unit. The monitoring unit may have a user interface and one or more sensors to measure patient data. The treatment unit may have a stimulator that generates electrical stimulation and a microcontroller that controls the generation of electrical stimulation based on measured patient data.

Description

[0001] This application is a divisional application. The application date of the original application is June 10, 2016, the application number is 2016800461236 (the application number of the divisional application is 2021102041608), and the name of the invention is "System and method for peripheral nerve stimulation to treat tremor using a detachable treatment and monitoring unit".

[0002] Cross-reference to related applications

[0003] This application claims priority to U.S. Provisional Application No. 62 / 173,894, filed June 10, 2016, which is hereby incorporated by reference in its entirety.

[0004] Incorporated by Reference

[0005] US Patent Publication No. 2015 / 0321000 filed July 21, 2015, and International Publication No. WO2015 / 187712 filed June 2, 2015, and are hereby incorporated by reference in their entirety for all purposes.

[0006] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Technical Field

[0007] Embodiments of the present invention generally relate to systems and methods for treating a disease or disorder, and more particularly to systems and methods for treating a disease or disorder, such as tremor, using a monitoring unit and a treatment unit. Background of the Invention

[0009] Essential tremor (ET) is the most common movement disorder, affecting an estimated 10 million patients in the United States, with the number increasing as the population ages. Prevalence increases with age, from 6.3% of the population over 65 years old to more than 20% over 95 years old. ET is characterized by oscillatory movements, e.g., 4-12 Hz, affecting the distal limbs, particularly the hands. Unlike Parkinson's tremor, which is present at rest, essential tremor is postural and kinetic, meaning that the tremor is induced by holding a limb against gravity or during movement, respectively.

[0010] Disability in people with ET is common and ranges from embarrassment to an inability to live independently, as critical tasks such as writing and self-feeding become impossible due to the uncontrolled movements. Despite the high disability and prevalence of ET, treatments are inadequate to address the tremor. Medications used to treat tremor (e.g., propranolol and primidone) have been found to be ineffective in 40% of patients and only reduce tremor by 50%. These drugs also have side effects that can be serious. An alternative treatment is the surgical implantation of a deep brain stimulator, which can effectively reduce tremor amplitude by 90%, but is a highly invasive surgical procedure that carries a high risk and cannot be tolerated by many ET patients. Therefore, alternative treatments for patients with ET are greatly needed.

[0011] Tremor is also a significant problem for patients with orthostatic tremor, multiple sclerosis, and Parkinson's disease. The underlying causes of tremor in these conditions are different from ET, however, treatment options for these conditions are also limited and alternative treatments are needed.

[0012] Many conditions, such as tremors, can be treated with some form of transcutaneous peripheral nerve stimulation. People have great variation in wrist diameter, nerve location, nerve depolarization characteristics, and skin conductance, which leads to challenges in designing devices to comfortably, safely, and reliably stimulate peripheral nerves for a wide range of potential users. For example, in a wrist-worn device for the median, ulnar, and radial nerves at the wrist, the amount of power required for a given stimulation session can vary widely based on skin impedance and usage scenario. SUMMARY OF THE INVENTION

[0014] The present invention generally relates to systems and methods for treating diseases or disorders, and more particularly to systems and methods for treating diseases or disorders using monitoring units and therapeutic units.

[0015] The devices and methods of the present disclosure each have several innovative aspects, no single one of which is solely responsible for the desirable properties disclosed herein. The present application discloses devices and methods for reducing tremors in a subject. In some embodiments, a device is provided. The device may include a housing and one or more effectors, a power source, or a controller. In some embodiments, the device also includes one or more sensors. Further aspects and embodiments of the present invention are set forth herein.

[0016] These and other aspects and embodiments of the invention are described in more detail below with reference to the accompanying drawings.

[0017] In some embodiments, a system for treating tremor in a patient is provided. The system may include a band and a detachable treatment unit. The band may have at least two electrodes, a container, and a first circuit in electrical communication with both the at least two electrodes and the container. The detachable treatment unit may include a second circuit; one or more sensors in electrical communication with the second circuit, the one or more sensors configured to measure data from the patient; a stimulator configured to generate electrical stimulation, the stimulator in electrical communication with the second circuit; at least two electrodes configured to receive electrical stimulation from the stimulator; a controller configured to control the generation of electrical stimulation by the stimulator; and a power source in electrical communication with the second circuit; wherein the detachable treatment unit is configured to reversibly attach to the container of the band so that the at least two electrodes are in electrical communication with the stimulator.

[0018] In some embodiments, the belt further comprises one or more discriminators.

[0019] In some embodiments, one or more discriminators are related to stimulation parameters and / or service life information.

[0020] In some embodiments, the system further comprises a base station configured to charge the power source. In some embodiments, the base station is further configured to receive and transmit data to and from the detachable therapeutic unit, and to and from the cloud computing network.

[0021] In some embodiments, the system further includes an online portal, such as a physician portal, configured to access data stored on the cloud computing network.

[0022] In some embodiments, the system further comprises an online portal, such as a physician portal, configured to provide information and parameter changes back to the removable treatment unit.

[0023] In some embodiments, the system further comprises a portable computing device having a second user interface and a display, wherein the portable computing device is configured to wirelessly communicate with the detachable therapeutic unit and receive data from the cloud computing network.

[0024] In some embodiments, the container includes a fixing member for reversibly attaching the removable treatment unit to the container.

[0025] In some embodiments, the fixing member is selected from the group consisting of a clip, a magnet, a snap mechanism, a twisting mechanism, a screw mechanism, a locking mechanism, a sliding mechanism, a flexible edge, and a hook member.

[0026] In some embodiments, the removable treatment unit further comprises a user interface.

[0027] In some embodiments, the controller is configured to control the generation of electrical stimulation through the stimulator based on data measured by one or more sensors.

[0028] In some embodiments, a system for treating tremor in a patient is provided. The system may include a wearable monitoring unit and a first treatment unit. The wearable monitoring unit may include a circuit; one or more sensors in electrical communication with the circuit, the one or more sensors configured to measure data from the patient; at least two electrodes. The first treatment unit may include a power source; a stimulator powered by the power source, the stimulator configured to generate electrical stimulation, the electrical stimulation being delivered through at least two electrodes of the wearable monitoring unit; and a controller configured to control the generation of electrical stimulation by the stimulator based on data measured by the one or more sensors; wherein the first treatment unit is reversibly attachable to the wearable monitoring unit.

[0029] In some embodiments, the system further includes a second treatment unit. The second treatment unit may include a second power source, wherein the second power source of the second treatment unit has a greater capacity than the power source of the first treatment unit; a second stimulator powered by the second power source, the second stimulator configured to generate electrical stimulation, the electrical stimulation being delivered through at least two electrodes of the wearable monitoring unit; and a second controller configured to control the generation of electrical stimulation by the stimulator based on data measured by one or more sensors; wherein the second treatment unit is reversibly attachable to the wearable monitoring unit.

[0030] In some embodiments, the one or more sensors are configured to measure motion data. In some embodiments, the controller is configured to determine tremor frequency, amplitude, and / or phase from the motion data; and control generation of electrical stimulation by the stimulator based on the determined tremor frequency, amplitude, and / or phase.

[0031] In some embodiments, at least two electrodes are arranged on a band. In some embodiments, at least one of the at least two electrodes is arranged on a band, the band is attached to the housing of the wearable monitoring unit and at least one of the at least two electrodes is arranged on the skin-facing side of the housing of the wearable monitoring unit.

[0032] In some embodiments, a system for treating tremor in a patient is provided. The system may include a wearable monitoring unit and a treatment unit. The wearable monitoring unit may include a user interface; a circuit in electrical communication with the user interface; and one or more sensors in electrical communication with the circuit, the one or more sensors configured to measure data from the patient. The treatment unit may include a stimulator configured to generate electrical stimulation; at least two electrodes configured to receive electrical stimulation from the stimulator; a controller configured to control the generation of electrical stimulation by the stimulator based on data measured by the one or more sensors; and a power source disposed within the wearable monitoring unit or the treatment unit; wherein the treatment unit is reversibly attachable to the wearable monitoring unit.

[0033] In some embodiments, the wearable monitoring unit is a smart watch.

[0034] In some embodiments, the one or more sensors are configured to measure motion data. In some embodiments, the controller is configured to determine tremor frequency, amplitude, and / or phase from the motion data; and control the generation of electrical stimulation based on the determined tremor frequency, amplitude, and / or phase.

[0035] In some embodiments, the controller is configured to provide automatic and / or manual control of electrical stimulation.

[0036] In some embodiments, the wearable monitoring unit further includes a controller configured to determine the tremor frequency, amplitude, and / or phase from the motion data, and the controller of the treatment unit is configured to control the generation of electrical stimulation by the stimulator based on the determined tremor frequency, amplitude, and / or phase.

[0037] In some embodiments, at least two electrodes are arranged on a belt. In some embodiments, at least one of the at least two electrodes is arranged on a belt that is attached to the housing of the treatment unit, and at least one of the at least two electrodes is arranged on the skin-facing side of the housing of the treatment unit.

[0038] In some embodiments, the treatment unit communicates wirelessly with the wearable monitoring unit.

[0039] In some embodiments, both the treatment unit and the wearable monitoring unit have a power supply.

[0040] In some embodiments, at least two electrodes are covered with a porous compressible material infused with a conductive gel, wherein the porous compressible material is configured to release the conductive gel when pressure is applied to the porous compressible material. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] The novel features of the present invention will be described in detail in the following claims. The features and advantages of the present invention will be better understood by referring to the following detailed description of illustrative embodiments in which the principles of the present invention are utilized and the accompanying drawings, wherein the drawings are:

[0043] Figure 1A and 1B Various embodiments of a monitoring unit and a treatment unit forming a two-part treatment system are exemplified.

[0044] Figures 2A-2D An example of an implementation of a two-part system with a single monitoring unit and a plurality of treatment units.

[0045] Figure 3 An example of two-part stimulation implementations, wherein both the monitoring unit and the treatment unit are belts.

[0046] Figure 4A and 4B Examples may be used in an implementation of a touch sensor array that selects electrodes from a corresponding electrode array.

[0047] Figure 5 An example of an implementation of a two-part system formed by a monitoring tablet and a treatment unit.

[0048] Figure 6-8 Various embodiments of the skin interface incorporating conductive gels are exemplified.

[0049] Figures 9A-9I Another embodiment of an example wearable therapy system.

[0050] Fig.10 Examples of an implementation of a wearable treatment system that uses a cloud to receive and transmit data between a treatment system and a physician.

[0051] Fig.11 is an example Fig.10 Block diagram of the treatment unit, belt, and individual components of the base station shown in. DETAILED DESCRIPTION OF THE INVENTION

[0053] Embodiments of the invention include devices and systems and methods to measure and collect movement and biological data (e.g., heart rate, galvanic skin response, temperature, and characteristics of movement disorders such as tremor frequency, amplitude, and phase), analyze the data to interpret how these measurements may affect movement disorders such as tremor or freezing of gait, and provide peripheral nerve stimulation targeted to one or more individual nerves to reduce tremor or initial gait, wherein the applied stimulation may or may not be modified based on the measured data.

[0054] Embodiments of the therapeutic system may include three components: (1) a monitoring unit having sensors, circuitry, and optionally a power source and / or a microcontroller, (2) a therapeutic unit having a stimulator (e.g., a pulse generator), circuitry, a power source, and a microcontroller, and (3) a skin interface having electrodes and electrical connectors for electrically connecting the electrodes to the therapeutic unit. In some embodiments, all three components are separate components that can be reversibly attached to each other to form a wearable therapeutic system. In some embodiments, any two of the components can be combined or integrated together to form a wearable two-part system that can be reversibly attached to each other. It should be noted that some functions can be cross-linked, for example, such as electrodes at the skin interface being used as sensors to measure electrical activity (e.g., EMG and ECG) and impedance. In some embodiments, any of the detachable components can be disposable and / or can be returned to the manufacturer for recycling.

[0055] like Figure 1A One embodiment shown is a two-part system 10 that includes 1) a monitoring unit 12, which may be wearable in some embodiments, and 2) a treatment unit 14. In some embodiments, the treatment unit 14 may be detachable and reversibly attached to the wearable monitoring unit 12. The treatment unit 14 may include an electrical stimulation signal generator 16, a power source 18, and a microprocessor and / or microcontroller 20 to control the stimulation. The treatment unit 14 may be reversibly connected and communicate directly and / or wirelessly to the wearable monitor 12. In some embodiments, the treatment unit 14 may remain separate from the wearable monitoring unit 12 and may communicate wirelessly with the wearable monitoring unit 12. In some embodiments, the treatment unit 14 may have a data / power interface 15, such as a USB interface, that allows a user to charge the power source 18, update software and / or parameters on the microcontroller 20, and / or retrieve data from memory on the wearable monitoring unit 12 and / or the treatment unit 14. In some embodiments, the data / power interface may be located on the wearable monitoring unit 12 or on both the wearable monitoring unit 12 and the therapeutic unit 14. In some embodiments, the wearable monitoring unit 12 and / or the therapeutic unit 14 may communicate wirelessly with an external computing device to update software and / or parameters and / or retrieve data.

[0056] In some embodiments, the wearable monitoring unit 12 can have a housing with a user interface 22, enclosing one or more sensors 24. In some embodiments, the wearable monitor 12 can be used to detect and / or measure tremors. In some embodiments, the wearable monitor 12 can have one or more electrodes 26 located at the base of the housing, which contacts the patient's skin. In addition or alternatively, the wearable monitor 12 can have a belt 28 or other fixed component, wherein one or more electrodes are provided on the skin-facing side of the belt 28. In some embodiments, the wearable monitoring unit 12 has 2 or 3 electrodes, or at least 2 or 3 electrodes. In some embodiments, the wearable monitoring unit 12 lacks a power source and relies on a power source 18 in the treatment unit 14 for power. In other embodiments, both the wearable monitoring unit 12 and the treatment unit 14 have a power source. In some embodiments, only the wearable monitoring unit 12 has a power source and the treatment unit relies on power from the monitoring unit.

[0057] In some embodiments, Figure 1B As shown, the treatment unit 14' can directly contact the wearer's skin and has the ability to provide electrical stimulation to target nerves such as the median nerve and radial nerve or tibial nerve or sacral nerve using electrodes 26. In some embodiments, the treatment unit 14' has 2 or 3 electrodes, or at least 2 or 3 electrodes. These electrodes 26 can be located on the housing of the treatment unit 14' and / or the treatment unit 14' can also have a belt 28 or a fixing component with electrodes 26. In some embodiments, when the treatment unit 14' has electrodes 26, the wearable monitoring unit 12' does not have electrodes. In some embodiments, both the monitoring unit and the treatment unit can have electrodes. As above, the treatment unit 14' can have a stimulator 16, a power supply 18, and a microcontroller 20. The wearable monitoring unit 12' can have a user interface 22 and one or more sensors 24 and, optionally, a power supply 30 and a microcontroller 21. In some embodiments, when the monitoring unit has a power supply 30 and / or a microcontroller 21, the treatment unit does not have a power supply and / or a microcontroller. In some embodiments, the wearable monitoring unit 12' is a smartwatch, such as an Apple Watch or an Android-based smartwatch, with an application that allows the smartwatch to communicate with the treatment unit and perform as a monitoring unit. In some embodiments, the wearable monitoring unit 12' can communicate wirelessly with the treatment unit 14', and one or both of these devices can also communicate wirelessly with an external computing device. In some embodiments, one or both of the wearable monitoring unit 12' and the treatment unit 14' can have a data / power interface 15. In some embodiments, the wearable monitoring unit 12 and the treatment unit 14' can be connected to each other through the data / power interface 15.

[0058] In some embodiments, the sensor may be located in or on the treatment unit instead of the monitoring unit. In some embodiments, the sensor may be located on both the treatment unit and the monitoring unit.

[0059] In some embodiments, the monitoring unit may instead be carried by the user, for example, in the user's hand or pocket, rather than being worn. For example, the monitoring unit carried by the user may be a smart phone, such as an Android smart phone or an iPhone.

[0060] In some embodiments, a two-part system or monitoring unit may instruct a user to perform an action, such as drawing, writing, or holding an object, or holding still or trying to hold still, while the wearable monitoring unit takes measurements using one of the sensors.

[0061] In some embodiments, the user interface may include a display. In some embodiments, the display may be a touch screen display. In some embodiments, the user interface may include one or more buttons and / or a keyboard.

[0062] In some embodiments, for example, the electrodes can be dry contacts (e.g., fabric, metal, silicone, or any other plastic impregnated with conductive fillers, or a combination), use a conductive gel (e.g., a hydrogel), or have a wet electrode surface (e.g., a sponge with water or a conductive liquid or gel), or have fine needles. In some embodiments, the electrodes can have a foam backing as further described below.

[0063] In one embodiment of the system, stimulation is provided by implanted electrodes that stimulate nerves in the wrist, such as the median or radial nerves, or other nerves in a number of other locations, such as nerves in the leg, such as the tibial nerve, or nerves in the back, such as the sacral nerves. The implantable electrodes may be powered by a rechargeable battery housed within the implant and recharged wirelessly from an external power source.

[0064] In another embodiment of the implant electrode that stimulates the nerve, the implant electrode is powered by an external treatment unit, and the stimulation pulse is directly coupled to the electrode and the nerve using capacitive or inductive coupling.

[0065] In some embodiments, the monitoring unit can be a wearable tremor monitor having a housing with a user interface. The housing uses multiple sensors to collect, store, and analyze biometrics about the wearer, including, but not limited to, motion (e.g., accelerometers, gyroscopes, magnetometers, bend sensors), muscle activity (e.g., EMG, using electrodes), cardiovascular measurements (e.g., heart rate, heart rate variability, using electrodes to measure ECG; heart rhythm abnormalities), skin conductance (e.g., skin conductance response, galvanic skin response, using electrodes), breathing rate, skin temperature, and sleep state (e.g., awake, light sleep, deep sleep, REM). In particular, studies have shown that increased stress levels can increase tremors in people with essential tremor, Parkinson's disease, and other tremor-causing diseases. Therefore, using standard statistical analysis techniques, such as logistic regression or Naive Bayes classifiers, these biometrics can be analyzed to assess a person's state, such as stress level - which, in turn, can serve as a predictor of increased tremor levels. In early preliminary studies, patients were asked to perform activities before and after a stressful event. In this case, stress events are performed on a timed mathematical test. In the preliminary study, the patient's flutter amplitude appears to increase by about 20% after the pressure-timed mathematical test.

[0066] In one embodiment of a wearable monitor, the skin interface has an array of microneedles. Microneedles have been shown to measure blood chemistry using electrochemical sensors that can be used to detect specific molecules or pH levels. Thus a monitoring unit could incorporate microneedles with electrochemical sensors to measure specific chemicals in the bloodstream that can affect tremors, such as stress hormones, caffeine, or drugs.

[0067] In one embodiment of the monitor, a saliva sample is collected with a paper strip placed in the mouth, and the saliva chemicals are analyzed by sensors in a wearable monitor or a separate analysis unit for substances that can affect tremors, including stress hormones (e.g., cortisol), caffeine, or medications. The unit can have a light source and a light detector to analyze the chemistry of the strip. The unit can also communicate with an external processing device such as a cell phone. The strip can be visually encoded to record and store information about the measurement (e.g., time, location, etc.).

[0068] The wearable tremor monitor may have a microprocessor to analyze biometrics about the wearer to: determine or predict the onset of increased tremor activity, set parameters of the stimulation waveform applied by the therapy unit, and / or adapt the stimulation waveform applied by the therapy unit in real time. Parameters of the stimulation waveform that may be modified based on the analysis of the biometrics are frequency, amplitude, shape, burst sequence. In some embodiments, the analysis may be performed by a microprocessor on the therapy unit or an external computing device.

[0069] One embodiment of the system may centrally store biometrics from multiple wearers along with other relevant demographic data about each user, including age, weight, height, gender, race, etc., on a server system (e.g., the cloud). Data collected from multiple wearers is analyzed using standard statistical techniques, such as logistic regression or a Naive Bayes classifier (or other classifier) ​​to improve prediction of tremor onset by determining correlations between biometric and other recorded events and onset of increased tremor activity. These correlations are used to set parameters of stimulation waveforms applied by the treatment unit, determine the optimal time to apply stimulation therapy, and / or adapt the stimulation waveforms applied by the treatment unit in real time.

[0070] In one embodiment of the system, a wearable tremor monitor automatically detects and records medication dosage and consumption to (1) track patient compliance; (2) combine with measures of tremor activity to assess efficacy, and (3) determine or predict the onset of an increase or decrease in tremor activity. Medication dosage and consumption can be detected and recorded in a number of ways, including (1) using a visual scanner to record markings on a pill package or bottle each time medication is consumed, (2) a smart pill cap with a force sensor and wireless transmitter to detect each time medication is consumed from a pill bottle, (3) an RFID chip of similar size and shape to a pill that is consumed with each dose of medication activated by digestion and communicates with a monitoring device, (4) an RFID chip embedded in a sugar pill that is consumed with each dose of medication activated by digestion and communicates with a monitoring device, and (5) a pill with a visual code that is scanned and recorded by a camera on a monitoring unit each time medication is consumed.

[0071] In some embodiments, a wearable tremor monitor can have visual, auditory, tactile (e.g., squeeze band), or vibrotactile reminders to notify the wearer of key events based on analysis of biometrics, including, but not limited to, prediction of tremor onset, increase in tremor activity, and / or increase in stress levels. The reminder system can also notify the wearer of other scheduled events or reminders set by the wearer. The reminder system is used to (1) communicate information to the wearer in a more discreet, personalized manner, such as the onset of increased tremor activity or other scheduled events, without attracting the attention of others in a social environment.

[0072] In some embodiments, the wearable monitor and / or treatment unit may be in the form of a wristband or watch, a ring, a glove, a sleeve or armband, earphones / earpieces, a headband, a necklace or neckband, or a compatible patch.

[0073] In one embodiment, the wearable monitor may have a processing unit and memory that collects, stores, processes, and analyzes biometrics, as well as other data input by the wearer.

[0074] In some embodiments, the wearable monitor can obtain user input about events, including dietary history, medication history, caffeine intake, alcohol intake, etc. The monitor can use an accelerometer to measure specific movements, gestures, or tapping patterns to record user input under specific prompts. Other touch sensors, such as resistive strips or pressure-sensitive screens, can be used to measure specific gestures to record user input. These gesture-based measurements that record user input minimize the complexity of the steps required to enter user data into the device. The data can be stored in a memory and processed by a processing unit. In some embodiments, the data can be transmitted from the wearable monitor to an external computing device.

[0075] In one embodiment, the wearable monitor and / or therapeutic unit can be connected with other applications such as calendars and activity logs to synchronize and track events or saved calendars can be saved and stored on the device. In some embodiments, the wearable monitor and / or therapeutic unit can communicate with, for example, various computing devices with these applications, such as smart phones, smart watches, tablets, laptops, or desktop computers.

[0076] In one embodiment, the monitoring unit and / or treatment unit may have a GPS or similar device to track the wearer's location and assess the wearer's activities. GPS measurements can be combined with a mapping or positioning system to determine the environment in which the wearer is active (e.g., gym, office, home) or to determine changes in altitude during specific activities such as running or cycling.

[0077] In such Figures 2A-2DIn some embodiments shown, a single monitoring unit 12 can be used with multiple therapeutic units 14 having different sizes, shapes, colors, markings, and / or performances, including different battery capacities and power outputs. Different wearers and usage scenarios may require different amounts of stimulation duration and power, making smaller or larger therapeutic units more desirable and giving the wearer a choice to meet their needs in different scenarios. In some embodiments, the therapeutic unit 12 may also have different programming, including different stimulation parameters and / or therapies, which may be customized for different types of treatments. For example, one therapeutic unit may be customized for treating essential tremor, while another therapeutic unit may be used to treat Parkinson's disease and another for freezing of gait or overactive bladder. In some embodiments, the therapeutic units may all be customized for providing different treatment intensities, such as one unit for mild treatment of essential tremor and another for severe and aggressive treatment of essential tremor. The different components and performances of the therapeutic units may correspond to different sizes, shapes, colors, and / or markings. The carrying case 32 may be used to accommodate a set of treatment units, such as a set of treatment units that treat idiopathic tremors with different battery capacity and power output or some other components.

[0078] In one embodiment, the treatment unit has a single charging base station that can charge multiple treatment units simultaneously. The charging base station can have a traditional DC connection to the treatment unit or can charge the treatment unit wirelessly in close proximity. Similarly, in some embodiments, the charging base station can charge the monitoring unit in a similar manner.

[0079] In one embodiment, the wearable monitor can track parameters regarding the stimulation provided by the therapy unit, including stimulation time, duration of stimulation phases, and power used by the therapy unit. This data can be stored in a memory in the wearable monitor, processed by the wearable monitor, and / or transmitted to an external computing device.

[0080] In one embodiment, the treatment unit may use switches or electrical sensors to detect the connection of electrodes: (1) to ensure that the appropriate and only electrodes are being installed (i.e., not using different or incorrect types of electrodes); communicate a unique code, such as by RFID, a coded EEPROM chip, a resistance or capacitance based ID, a binary identifier, or a surface pattern; (2) to regulate the number of times each electrode is used to prevent overuse; and (3) to prevent the use of devices without electrodes to prevent minor shocks. In some embodiments, the treatment unit and / or the monitoring unit may have an identifier that can be transmitted and received from each other or transmitted to an external computing device. The identifier can allow one unit to determine the components, performance, and / or configuration of the other device, including the electrode configuration described above, so that the appropriate treatment parameters can be used, as well as the service life or component expiration, which can be based on voltage measurements, time, number of treatment sessions, or other parameters. In some embodiments, instead of using an identifier, the components, performance, and / or configuration of one device can be transmitted directly from one device to the other device, or by entering a user interface, or by an external computing device.

[0081] Other components of the treatment system, including the belt, treatment unit, monitoring unit, skin interface, can have one or more identifiers that perform the functions described above. These identifiers can encode various information as described herein, as well as predetermined dosing regimens, start-up procedures, calibration procedures, or specific parameters. The identifiers can be associated with a lookup table that stores the encoded information.

[0082] In some embodiments, the wearable monitor and / or treatment unit can communicate with an external computer or device (e.g., a tablet, smart phone, smart watch, or a traditional base station) to store data. The communication between the monitor and the external device can be a direct, physical connection, or with a wireless communication connection such as Bluetooth or GSM or cellular.

[0083] In one embodiment of the device, the treatment unit has an electrode array and one or more sensors, such as pressure sensors, between the treatment unit and the wearer's wrist to measure the contact pressure of the skin interface at and / or around the electrodes. This pressure data can be analyzed to determine which electrodes in the array to stimulate to target appropriate nerves or to detect changes in skin contact due to movement or other conditions and shift stimulation of the electrode array to the optimal position. These methods are used to (1) assess poor contact of the electrodes, and (2) adjust the amplitude of the stimulation based on the pressure measurements.

[0084] Increasing the contact pressure between the device and the wearer's skin and / or stimulating with electrodes having sufficient contact pressure or greater than a contact pressure threshold can: (1) increase the contact surface area, which reduces discomfort, (2) activate deep somatic pain (i.e., type C) peripheral nerve fibers, which can reduce discomfort from stimulation that activates superficial pain (i.e., type A delta) fibers, (3) reduce the required stimulation amplitude because it increases stimulation of the target nerve (e.g., by pressing it physically closer to the nerve), or (4) reduce the effects of skin movement.

[0085] In one embodiment, the treatment unit has the form of an inflatable wristband made of a flexible, airtight material. A small pump is driven or activated by the user to fill the bladder with air and increase the pressure to increase the contact surface area, which reduces discomfort. In some embodiments, the pump is integrated into the wristband and can be mechanically driven by the user or electrically activated by a battery. In other embodiments, the pump can be separate from the wristband.

[0086] In one embodiment, the pressure is provided by a compatible material within the band, such as a soft open-cell foam or an array of microsprings (eg, a pogo pin).

[0087] In such Figure 3 In one embodiment of the device shown, the monitoring unit 300 and the treatment unit 302 have a form factor of two distinct wrist bands that can be connected to each other. The monitoring unit 300 is the primary wrist band and secondarily, if desired, the treatment unit 302 is attached to the monitoring unit 300. Optionally, the treatment unit 302 can remain separate from the monitoring unit 300 and can communicate wirelessly with each other.

[0088] In one embodiment as shown in FIG. 4 , the treatment unit 400 has a touch sensor array 402 corresponding to an electrode array 404. When attached to the wearer, the electrode array 404 contacts the wearer's skin and the touch sensor array 402 is on the opposite side of the treatment unit 400. The wearer can use the touch sensor to indicate a preferred location for stimulation of the treatment unit 400 by touching the desired location on the touch sensor. For example, touching one of the touch sensors in the touch sensor array 402 activates the corresponding electrode in the electrode array 404, allowing the user to easily select which electrodes of the electrode array 404 to use for stimulation.

[0089] In such Figure 5In some embodiments shown, the two-part system can include a monitoring unit, which is a wearable monitor sheet 500, and the wearable monitor sheet 500 has at least two electrodes or at least two separated sheets, each of which has electrodes attached to the skin by an adhesive, surface adhesion of a material, or microneedles. The monitor sheet can also include a current spreader at the skin interface to deliver electrical energy to the skin more evenly. Generally, it is desirable to have at least two electrodes or sheets so as to have a ground electrode to sufficiently deliver energy to the nerves transcutaneously. The system can also have a treatment unit 502 that houses a power supply, a signal generator, and a microcontroller for electrical stimulation through the monitor sheet 500 attached thereto via a metal lock, a magnet, or other electrical connector.

[0090] In one of the above embodiments, the treatment unit wirelessly supplies the monitoring sheet.

[0091] In such Figure 6 In some embodiments shown, the skin interface at and / or around the electrodes of the monitoring unit and / or treatment unit is provided by a porous material 600 (such as a foam polymer) infused with a conductive gel 602. In some embodiments, the foam polymer is made of a conductive polymer. In other embodiments, the foam polymer is made of a non-conductive polymer. In some embodiments, the foam material is flexible and compressible and can conform to the patient's skin. The conductive gel is arranged in the holes of the porous material, and when pressure is applied to the porous layer through, for example, the housing and the electrodes, the conductive gel is pushed and squeezed through the holes of the porous material onto the wearer's skin - as the foam material is compressed. Pressure can be applied to the porous material - by the wearer squeezing and / or pushing the housing of the treatment unit against the skin, or by a spiral mechanism, or some other mechanism that tightens the outer shell to compress the gel layer, or by tightening the belt that fastens the treatment unit to the patient.

[0092] In such Figure 7 In some embodiments shown, the skin interface of the housing of the treatment unit and / or monitoring unit and the electrodes may include a thin gel sheet 700 covered by a protective liner with a pull-out tab 702 that slides and / or rests between the device and the wearer's skin. The protective liner can be removed using the pull-out tab 702 to expose the conductive gel. The gel sheet is conductive and creates and / or improves the electrical connection between the skin and the electrodes to deliver electrical energy to the wearer's skin.

[0093] In such Figure 8In some embodiments shown, the housing of the treatment unit and / or monitoring unit and / or structure with electrodes (such as a belt) may include a reservoir 800 filled with a conductive gel 802 and a plurality of holes or channels at the skin interface through which the conductive gel in the reservoir can be dispensed onto the wearer's skin to enhance stimulation of the skin interface. The gel can be dispensed using a screw mechanism 804 or a piston or button or a foldable reservoir or other mechanism that pushes the gel out of the reservoir onto the wearer's skin through small channels or holes.

[0094] In one embodiment, the system helps the wearer relax by using a reminder system to remind the wearer to relax or practice relaxation techniques. The reminder can be auditory, visual, or tactile. Also, the system can provide feedback about the wearer's stress level, which reinforces that the relaxation techniques are working.

[0095] Figures 9A-9I Another embodiment of an exemplary two-part treatment system includes a disposable belt 900 and a treatment unit 902 that can be reversibly attached to the disposable belt 900. The disposable belt 900 can have two or more electrodes 904 (disposed on the skin-facing surface or inner surface of the belt) and a container 906 or a receiving portion for reversibly receiving the treatment unit 902. Within the belt 900 are wires and / or conductive traces that form a flexible circuit 905, which extends from the electrodes 904 to the container 906 for electrically connecting the electrodes 904 to the treatment unit 902 when the treatment unit 902 is disposed in the container 906. In some embodiments, the wires and / or conductive traces of the flexible circuit 905 are arranged in a wavy or wave pattern to enhance its ability to bend. In embodiments such as Fig.9F In some embodiments shown, the container 906 can have one or more electrical contact points, such as one or more needle holes 907, for receiving one or more complementary electrical contacts from the treatment unit 902, such as needles 909. The flexible circuit 905 can extend to the needle holes 907 so that an electrical connection is formed when the needle is inserted into the needle holes. In some embodiments, such as Figure 9G-9I As shown, container 906 may have a clip, a fender, a magnet, a snap device, a twist device, a hook, a latch, a sliding mechanism, or other fixing member for reversibly fixing the treatment unit 902 to the belt 900 . Figure 9G An example may or may not be spring-loaded to form a clip 911 of the snap-up device around the treatment unit 902 . Figure 9H A flexible edge 913 around the opening of the example container, which may be used to maintain the treatment unit 902 after the treatment unit 902 is inserted into the container 906 . Fig.9IExamples of magnets 915 that can be placed in complementary positions in the treatment unit 902 and the container. In some embodiments, the clip, magnet, snap mechanism, twist mechanism, hook, or other fixing member is made of metal or some other conductive material and can be electrically connected to the electrode through wires and / or conductive traces. The electrode 904 can be a dry electrode or can be coated with a conductive gel.

[0096] In some embodiments, the treatment unit 902 may include a battery, which may be rechargeable, and an electronic device to deliver electrical stimulation to the patient's nerves through electrodes. The electronic device may include a stimulator and a microcontroller, and may also include a memory and one or more sensors, such as one or more accelerometers and gyroscopes as described herein. In some embodiments, the device is capable of sensing the impedance of the electrode to assess the integrity of the electrode and the skin interface. In some embodiments, there may be an electrical indication (e.g., a chip read, a sensor push on a connector, etc.) to detect the integrity of the connection between the band and the treatment unit. In some embodiments, the treatment unit 902 may have one or more LEDs, a pocket OLED screen, an LCS, or an indicator 901, which may indicate the status of the treatment unit 902, such as whether the treatment unit 902 is connected to the band 900, the power maintained in the battery of the treatment unit 902, whether the stimulation is delivered, the stimulation level, whether the data is transmitted, whether the sensor measurement is collected, whether the calibration procedure is executed, whether the treatment unit 902 is initialized, whether the treatment unit 902 is paired with another device such as a smart watch and / or a smart phone, whether the battery is charged, etc. In some embodiments, the treatment unit 902 may further include a user interface 903, such as one or more buttons.

[0097] Fig. 9BExamples may be sent to a kit of users. The kit may include a plurality of bands 900 of different sizes, shapes, colors, etc. to accommodate patients with different wrist sizes or other body part sizes (such as ankles, arms, fingers, and legs) and to accommodate different types of connected accessories such as auxiliary displays (e.g., smart watches, iwatches). In some embodiments, the kit has three bands. In addition, the kit may include one or more electronic units 902. If multiple electronic units 902 are provided in the kit, the battery capacities of different electronic units 902 may be different to accommodate different types of use. For example, a relatively low-capacity battery may be used for on-demand stimulation, while a relatively high-capacity battery may be used for automatic and / or responsive stimulation driven by a microcontroller. In some embodiments, only a single electronic unit is provided. In other embodiments, a single band is provided while multiple electronic units are provided. The kit may also include a charger 908 to charge the treatment unit 902. In some embodiments, the charger 908 may charge the treatment unit 902 inductively. In other embodiments, the charger 908 may charge the treatment unit with a charging cable that can be inserted into a power interface in the treatment unit. In some embodiments, the treatment unit 902 may be docked with a charger 908 for charging.

[0098] Fig. 9C An embodiment is exemplified in which a smartwatch 910, such as an Apple Watch, is reversibly or permanently attached to a band 900, which may also have a therapeutic unit 902. In some embodiments, the smartwatch 910 may provide a display and user interface for the therapeutic unit 902. The smartwatch 910 may communicate with the therapeutic unit 902 wirelessly (e.g., via Bluetooth or WiFi), or via a direct connection via a data interface in the smartwatch and a data interface in the therapeutic unit 902. In some embodiments, the electronic unit 902 and / or the smartwatch 910 may communicate with a smartphone 912, as described herein, to transfer data or update software and / or stimulation parameters on the therapeutic unit 902 and / or the smartwatch 910. In some embodiments, the band 900 and the therapeutic unit 902 are permanently fixed or integrated together, while the smartwatch 910 is reversibly attachable to the band 900. The smartphone 912 and / or the smartwatch 910 may include an application that may be downloaded via the cloud or a computer and configured to interface with the therapeutic unit 902.

[0099] Fig.9D and 9EThe example wearable two-part system can be worn and used all day. The therapeutic unit 902 can be recharged with a charger 908 when the power held in the battery of the therapeutic unit is low. Charging can be done at night or whenever the battery is low or when desired. In some embodiments, the therapeutic unit can be removed from the band before charging. In some embodiments, the user can replace a low-charge therapeutic unit with a high-charge therapeutic unit so that the user can always wear the therapeutic unit.

[0100] In some embodiments, Fig. 9B The kit illustrated in the can be used as a diagnostic test kit. The patient can initially wear the treatment system for about 1 to 14 days, or about 1 week, or a predetermined length of time, wherein the treatment is turned off during this time so that electrical stimulation is not provided to the patient. This initial period is used to collect data with sensors in the treatment unit and / or band to characterize tremors or other diseases. The sensor data can be stored in a memory in the treatment unit, and / or can be transmitted to a cloud or server or to another computing device over a network - it can be accessed by the patient's physician.

[0101] After the data collection phase, the patient can turn on the treatment function on the treatment unit and perform patient-directed tasks after and / or while administering one or more therapy treatments, which can be stored on the treatment unit to determine how the patient responded to the various treatments. The patient response data can also be stored on the memory and / or transmitted over a network or to another computing device - which can be accessed by the patient's physician.

[0102] In some embodiments, the patient may return the utensil to the physician or the utensil manufacturer, and the data may be retrieved from the system and transmitted to the patient's physician.

[0103] Using data from the system, the physician can characterize a patient's tremor or other disease, generate a diagnosis, and determine appropriate treatment for the patient, which may include the selection of appropriate treatment systems and stimulation parameters.

[0104] Fig.10Example embodiments of a system for treating tremor or another disease or condition using a wearable therapeutic device. As described above, the therapeutic device may have two parts - a band 900 and a therapeutic unit 902. A base station 1000 - which may replace the charger in the kit described above - may be used to charge the therapeutic device and receive and transmit data to both the therapeutic device and to the cloud 1002. Communication between the base station 1000 and the therapeutic device may be wireless (e.g., via Bluetooth and / or WiFi), and communication between the base station 1000 and the cloud 1002 may be, for example, via a cellular network, using a 3G or 4G connection, or via a wired connection to the Internet, using DSL or cable or Ethernet. A physician or other user may use an online portal or physician portal 1004 to browse and / or retrieve data stored on the cloud 1002. In addition, a physician may use a web portal 1004 to prescribe and / or modify a treatment regimen on the therapeutic unit 902 through the cloud 1002 and the base station 1000.

[0105] In some embodiments, the base station 1000 is used to receive and transmit relatively large amounts of data that may require high bandwidth, such as transmission of raw data from a treatment device, which may be about 10 to 100 Mb / day, or about 10, 20, 30, 40, or 50 Mb / day. In some embodiments, the data may be stored in a memory in the base station 1000 and transmitted at another interval, such as once a week or twice a week, with the transmission bandwidth proportionally increased. The high bandwidth transmission of raw data is performed daily while the treatment device is charging, such as at night during regular charging. In some embodiments, the raw data can be processed into processed data by the cloud and / or a physician and sent back to the treatment device.

[0106] In some embodiments, the system may optionally include a portable computing device 1006, such as a smartphone or tablet, to provide a secondary display and user interface for the patient, and to run applications to more easily control the therapeutic device and view raw and processed data. The portable computing device can be used to allow the patient or physician to adjust the therapeutic device, such as adjusting stimulation parameters and drug administration, and can receive device status data from the therapeutic device, which includes device-related data, such as when the device is used, errors, therapeutic parameters such as amplitude and when they are set and delivered. In some embodiments, the portable computing device 1006 can receive processed data from the cloud 1002, for example, via a cellular network and / or via an Internet connection using WiFi.

[0107] Fig.11Various components are illustrated, which may be included in the treatment unit 1100, the band 1102, and the base station 1104. These components are described in detail above and below as a specific embodiment. For example, the treatment unit 1100 includes one or more indicators 1106, which may be LEDs, and a user interface 1108, which may be a push button, for example. The treatment unit 1100 may also have a stimulator 1110 with a stimulation electronic device and may include the ability to measure current and voltage. The treatment unit 1100 may also have a battery 1112, which may be rechargeable and may be recharged using a charging circuit 1114, which may be inductive. The treatment unit 1110 may further include a processor 1116 and a memory 1118 to store and execute programs and instructions to perform the functions described herein. The treatment unit 1110 may also include a sensor 1120, such as a motion sensor, and a communication module 1122, which may be wireless and may communicate with the base station 1104 and / or an auxiliary display / computing device.

[0108] The tape 1102 may have electrodes 1124 and may also include memory to store identification information or may include some other form of discriminator 1126, as described herein.

[0109] The base station 1104 may include a charging circuit 1128, which may also be inductive and may transfer power to a complementary charging circuit 1114 on the treatment unit 1100. The base station 1104 may also have a processor and memory for storing and executing instructions and programs. The base station 1104 may further include a communication module 1132, which may be cellular, to communicate with the cloud, and another communication module 1134, which may be wireless and used to communicate with the treatment unit.

[0110] When parts or elements are referred to as "on" another part or element in this article, it can be directly on other parts or elements or there can also be parts and / or elements in between.By contrast, when parts or elements are referred to as "directly on" another part or element, then there is no part or element in between to exist.It will also be understood that when parts or elements are referred to as "connecting", "attaching" or "coupling" to another part or element, it can be directly connected, attached or coupled to other parts or elements or there can be parts or elements in between.By contrast, when parts or elements are referred to as "directly connected", "directly attached" or "directly coupled" to another part or element, then there is no part or element in between to exist.Although described or shown about an embodiment, the parts and elements described or shown can be applied to other embodiments.Those skilled in the art will also recognize that the reference to the structure or parts arranged "adjacent" to another part can have the part overlapping with adjacent parts or being located below it.

[0111] The terms used herein are only used to describe specific embodiments and are not intended to limit the present invention. For example, as used herein, the singular forms "one", "a kind of" and "the" are intended to also include plural forms, unless the context clearly indicates otherwise. It should be further understood that when used in this specification, the terms "include" and / or "comprise" specify the presence of the parts, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other parts, steps, operations, elements, components and / or their groups. As used herein, the term "and / or" includes any and all combinations of one or more related listed items and can be abbreviated as " / ".

[0112] For ease of description, spatial relative terms such as "under...", "below...", "lower", "above...", "higher", etc. may be used to describe the relationship between an element or component and another element (one or more) or component (one or more), as shown in the figure. It should be understood that spatial relative terms are intended to include different orientations of the device in use or operation other than the orientation depicted in the drawings. For example, if the device in the figure is inverted, the element described as "under" or "below" other elements or components will be oriented as "above" other elements or components. Therefore, the exemplary term "under..." can cover both "above..." and "under..." orientations. The device can be oriented in other ways (rotated 90 degrees or in other orientations), and the spatial relative descriptors used herein are interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertically", "horizontally", etc. are used herein only for the purpose of explanation unless otherwise specifically noted.

[0113] Although the terms "first" and "second" may be used herein to describe various components / elements (including steps), these components / elements should not be limited by these terms unless the context indicates otherwise. These terms can be used to distinguish one component / element from another component / element. Therefore, without departing from the teachings of the present invention, the first component / element discussed below may be referred to as the second component / element, and similarly, the second component / element discussed below may be referred to as the first component / element.

[0114] Throughout the specification and the claims that follow, unless the context requires otherwise, the word "comprise" and variations such as "include" and "contain" mean that various components can be used together in the methods and articles (e.g., compositions and devices (including apparatus) and methods) herein. For example, the term "comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0115] As used herein in the specification and claims, including as used in the embodiments and unless otherwise expressly provided, all numbers can be read as beginning with the word "about" or "approximately" even if the term is not expressly provided. When describing the amplitude and / or position to indicate that the value and / or position described are within the reasonable expected range of the value and / or position, the phrase "about" or "approximately" can be used. For example, a numerical value can have a value of + / -0.1% of the value (or range of values), + / -1% of the value (or range of values), + / -2% of the value (or range of values), + / -5% of the value (or range of values), + / -10% of the value (or range of values), etc. Unless otherwise indicated by the context, any numerical value given herein should also be understood to include about or approximately the value. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range listed herein is intended to include all sub-ranges contained therein. It is also understood that when a value is disclosed, "less than or equal to" the value, "greater than or equal to" the value, and possible ranges between the values ​​are also disclosed, as appropriately understood by those skilled in the art. For example, if the value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a numerical value) are also disclosed. It is also understood that throughout the application, data is provided in a variety of different formats, and that the data represents endpoints and starting points, as well as ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, equal to 10 and 15, and between 10 and 15 are considered disclosed. It is also understood that every unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0116] Although various illustrative embodiments are described above, any of a variety of changes may be made to the various embodiments without departing from the scope of the invention as claimed. For example, the order in which the various described method steps are performed may generally be changed in optional embodiments, and in other optional embodiments, one or more method steps may be skipped entirely. Optional components of various device and system embodiments may be included in some embodiments but not in other embodiments. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0117] It should be understood that the present disclosure is in many respects merely an illustration of many optional device embodiments of the present invention. Changes may be made in detail, particularly in the shape, size, material and arrangement of the various device components, without exceeding the scope of the various embodiments of the present invention. It will be appreciated by those skilled in the art that the exemplary embodiments and descriptions thereof are merely overall illustrations of the present invention. Although several principles of the present invention are clear in the exemplary embodiments described above, it will be appreciated by those skilled in the art that modifications to structure, arrangement, ratio, elements, materials and methods of use, etc., may be utilized in the practice of the present invention, which are particularly suitable for specific environments and operating requirements without departing from the scope of the present invention. In addition, although certain components and elements have been described in conjunction with specific embodiments, it will be appreciated by those skilled in the art that those components and elements may be combined with other embodiments disclosed herein.

Claims

1. A system for treating tremor in a patient, the system comprising: a strip having at least two electrodes, a container, and a first circuit in electrical communication with both the at least two electrodes and the container; and A detachable treatment unit comprising: Second Circuit; one or more sensors in electrical communication with the second circuit, the one or more sensors configured to measure data from the patient; a stimulator configured to generate electrical stimulation, the stimulator being in electrical communication with the second circuit; at least two electrodes configured to receive electrical stimulation from the stimulator; a controller configured to control generation of said electrical stimulation by said stimulator; and a power source in electrical communication with the second circuit; Wherein the removable therapeutic unit is configured to be reversibly attached to the receptacle of the belt such that the at least two electrodes are in electrical communication with the stimulator.

2. The system of claim 1, wherein the band further comprises one or more identifiers.

3. The system of claim 2, wherein the one or more discriminators are related to stimulation parameters and / or life span information.

4. The system of claim 1, further comprising a base station configured to charge the power source.

5. The system of claim 4, wherein the base station is further configured to receive and transmit data to and from the detachable treatment unit and to and from a cloud computing network.

6. The system of claim 5, further comprising an online portal configured to access data stored on the cloud computing network.

7. The system of any one of claims 1-5, further comprising an online portal configured to provide information and parameter changes back to the detachable treatment unit.

8. The system of claim 5 or 6, further comprising a portable computing device having a second user interface and a display, wherein the portable computing device is configured to wirelessly communicate with the detachable treatment unit and receive data from the cloud computing network.

9. The system of claim 1, wherein the container includes a securing feature for reversibly attaching the removable treatment unit to the container.

10. The system of claim 9, wherein the securing member is selected from the group consisting of a clip, a magnet, a snap mechanism, a twist mechanism, a screw mechanism, a locking mechanism, a sliding mechanism, a flexible edge, and a hook.

Images