Orthotic systems and rehabilitation of impaired body parts

Abstract

Systems and methods for rehabilitating an impaired body part (e.g., of a stroke patient), including using an orthotic system configured to be attached to the impaired body part and to move or assist movement of the impaired body part. A control system is configured to operate the orthotic system in a mode in which the orthotic system first allows the subject to consciously move or attempt to consciously move the impaired body part in a predetermined motion, and then operates to move or assist the predetermined motion of the impaired body part. Other modes of operation include: a brain-machine interface mode of operation; and a mode in which the orthotic system operates in a continuous passive mode of operation, including multiple repetitions of an exercise to move the impaired body part. Additional orthotic features include a hand interface assembly, a flexible intermediate member, and a force sensing module.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application Serial No. 62 / 914,162, filed October 11, 2019, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] This manual relates to orthopedic systems and rehabilitation of damaged limbs, such as upper limb rehabilitation due to hemispheric stroke events. Background Technology

[0004] Orthotic devices exist that operate to move or assist in the movement of body parts (e.g., the upper or lower limbs of a person). Some orthotic devices are designed to aid in the rehabilitation of damaged body parts (such as injuries caused by a stroke).

[0005] Brain-computer interface (BCI) technology involves the acquisition and interpretation of brain signals to determine the intention of the person generating the brain signals, and involves using the determined intention to perform a pre-defined task. BCI technology has been explored in conjunction with the rehabilitation of damaged body parts, such as the rehabilitation of upper limb body parts, including arms and hands that have lost function due to a stroke.

[0006] Examples of BCI-based systems for injured body parts include the description in U.S. Patent No. 9,730,816 to Leuthardt et al. ('816 Patent), the contents of which are incorporated herein by reference with the permission of the assignee of this patent application. '816 Patent describes the use of BCI technology to assist a hemiplegic subject, or in other words, a subject who has suffered a unilateral stroke and is therefore injured in or primarily in one hemisphere of the brain. For this patient, the other hemisphere of the brain may be normal. '816 Patent describes the idea of ​​ipsilateral control, wherein brain signals from one side of the brain are adapted to control bodily functions on the same side of the body during BCI training. Additional examples of BCI-based systems for injured body parts include the description in U.S. Patent No. 9,539,118 to Leuthardt et al. ('118 Patent), which is jointly assigned with this patent application and the contents of which are incorporated herein by reference. '118 Patent describes a wearable orthotic device design that operates to move or assist the movement of an injured body part (e.g., injured due to a stroke event), and other situations described in '118 Patent. For example, '118 patent describes a rehabilitation method for damaged fingers (including other body parts such as the upper and lower limbs) using a wearable orthotic device that is operated to move or assist in the movement of the damaged body part and is controlled using a brain-computer interface (BCI). '118 patent further elaborates on a BCI-based rehabilitation technique that utilizes brain plasticity to "rewire" the brain to achieve motor control of the damaged body part.

[0007] Orthotics employs various mechanisms to accomplish and / or assist the movement of injured body parts. One such mechanism involves physically attaching or securing a movable portion of an orthopedic device to the body part to be moved or assisted in moving. The movable portion of the orthopedic device, secured to the body part, can then be activated to move via a motor or some other form of actuation, thus accomplishing or assisting the movement of the injured body part secured to the movable portion. Another such mechanism for accomplishing or assisting body part movement is through a technique called functional electrical stimulation (“FES”), which involves applying gentle electrical stimulation to muscles to aid or improve muscle movement.

[0008] Rehabilitation of damaged body parts can also involve applying continuous passive movement (“CPM”) to the damaged body part, where the body part is moved without the subject’s conscious will. In many cases, therapists can manually apply CPM to the patient, essentially “working” the body part to promote its recovery. Furthermore, various machines exist designed to apply CPM to body parts to achieve their rehabilitation.

[0009] Despite the existence of various orthopedic devices and rehabilitation systems and techniques that utilize them, there is still much room for improvement to achieve better rehabilitation outcomes. Summary of the Invention

[0010] This manual describes systems, devices, and methods for the movement and / or rehabilitation of body parts, such as the rehabilitation of an upper limb damaged due to a hemispheric stroke event.

[0011] In one aspect, a system is provided for the rehabilitation of a subject's damaged body part. The rehabilitation system includes: a brain signal acquisition system configured to collect brain signals from the subject; an orthotic system configured to attach to the damaged body part and to move or assist in the movement of the damaged body part; and a control system configured to operate the orthotic system in: (a) a first mode, wherein the orthotic system operates to move or assist in the movement of the damaged body part based on the subject's intention determined by analysis of the brain signals; and (b) a second mode, wherein the orthotic system operates to move the damaged body part.

[0012] In various embodiments, the rehabilitation system may include one or more of the following. When operating in the second mode, the orthotic system can be operated to move the injured body during repeated exercises. The second mode may be a continuous passive operating mode.

[0013] The control system can be further configured to operate the orthotic system in (c) a third mode, wherein the orthotic system first allows the subject to move or attempt to move the damaged body part with a predetermined movement, and then operates to move or assist the predetermined movement of the damaged body part. When the orthotic system operates in the third mode, it can operate to move or assist the predetermined movement of the damaged body part in response to the control system detecting that the damaged body part has not yet completed the predetermined movement. In this case, the control system can be configured to detect that the damaged body part has not yet completed the predetermined movement by determining whether the predetermined movement has occurred within a predetermined time period, and / or the control system can be configured to detect that the damaged body part has not yet completed the predetermined movement by determining whether the predetermined movement has occurred to a predetermined extent. The predetermined extent may correspond to a predetermined extension amount of the damaged body part. For the third mode of operation, the control system can be configured to send a prompt to instruct the subject to begin moving or attempt to move the damaged body part with the predetermined movement. In addition, the control system can be configured to detect that the damaged body part has not yet completed the predetermined movement by determining whether the predetermined movement has begun within a predetermined time period.

[0014] Rehabilitation systems can be used for cases where the affected body part is damaged due to a stroke experienced by the subject. Orthopedic devices can be configured to be worn on the subject's hand and operated to move or assist in hand movement. Orthopedic devices can be configured to use motor-actuated actuation to move or assist in the movement of the affected body part. Orthopedic devices can be configured to use functional electrical stimulation to move or assist in the movement of the affected body part.

[0015] In a second aspect, a rehabilitation system for a subject with an injured body part is provided, comprising: an orthotic system configured to attach to the injured body part and to move or assist in the movement of the injured body part; and a control system configured to operate the orthotic system in an autonomous movement mode, wherein the orthotic system first allows the subject to intentionally move or attempt to intentionally move the injured body part with a predetermined movement, and then operates to move or assist in the predetermined movement of the injured body part.

[0016] In various embodiments, the rehabilitation system of the second aspect may include one or more of the following: The orthotic system may operate to move or assist the injured body part in a predetermined movement in response to the control system detecting that the injured body part has not yet completed a predetermined movement. The control system may be configured to detect that the injured body part has not yet completed a predetermined movement by determining whether the predetermined movement has occurred within a predetermined time period. The control system may be configured to detect that the injured body part has not yet completed a predetermined movement by determining whether the predetermined movement has occurred to a predetermined extent, which may correspond to a predetermined extension amount of the injured body part. The control system may be configured to send a prompt to instruct the subject to begin moving or attempt to move the injured body part in a predetermined movement. The control system may be configured to detect that the injured body part has not yet completed a predetermined movement by determining whether the predetermined movement has begun within a predetermined time period. Furthermore, the rehabilitation system may further include a brain signal acquisition system configured to collect brain signals from the subject, and in this case, the control system may be further configured to operate in a mode in which the orthotic system operates to move or assist the movement of the injured body part based on the subject's intention determined according to the analysis of the brain signals.

[0017] Rehabilitation systems can be used for cases where the affected body part has been damaged due to a stroke experienced by the subject. Orthopedic devices can be configured to be worn on the subject's hand and operated to move or assist in hand movement. Orthopedic devices can be configured to use motor-actuated actuation to move or assist in the movement of the affected body part. Orthopedic devices can be configured to use functional electrical stimulation to move or assist in the movement of the affected body part.

[0018] In a third aspect, a rehabilitation system is provided for the rehabilitation of a subject's damaged body part. In this case, the rehabilitation system includes: a brain signal acquisition system configured to collect brain signals from the subject; an orthotic system configured to attach to the damaged body part and to move or assist in the movement of the damaged body part; and a control system configured to operate the orthotic system in the following ways: (a) a first mode, wherein the orthotic system operates to move or assist in the movement of the damaged body part based on the subject's intention determined according to analysis of the brain signals; (b) a second mode, wherein the orthotic system operates in a continuous passive operation mode, including multiple repetitive movements to move the damaged body part; and (c) a third mode, wherein the orthotic system first allows the subject to move or attempt to move the damaged body part with a predetermined movement, and then operates to move or assist in the predetermined movement of the damaged body part.

[0019] In various embodiments, the rehabilitation system of the third aspect may include one or more of the following: The damaged body part may be damaged due to a stroke event experienced by the subject. An orthotic device may be configured to be worn on the subject's hand and operated to move or assist in hand movement. Furthermore, the orthotic device may be configured to be operated using motor-actuated actuation to move or assist in the movement of the damaged body part. The additional features and details of the first and second aspects of the combined rehabilitation system may also be provided in conjunction with this third aspect of the rehabilitation system.

[0020] In the fourth aspect, an orthotic device is provided for the subject. The orthotic device includes: a main housing assembly configured to be worn on the upper limb of the subject and including a motor mechanism configured to actuate movement of a body part of the upper limb, the body part interface assembly being configured to be fixed to a portion of the upper limb and causing bending and extension movements of the fixed body part upon actuation of the motor mechanism; and a flexible intermediate member inserted between the main housing assembly and the body part interface assembly, wherein the flexible intermediate member is configured to bend or extend in response to actuation of the motor mechanism, so that the body part interface assembly bends or extends the fixed body part.

[0021] In various embodiments, the orthopedic device of the fourth aspect may include one or more of the following: A main housing assembly may be configured to be worn on the forearm of a subject's upper limb, the body part may be at least one finger of the subject's upper limb, and the body part interface assembly may be a finger and / or thumb interface assembly configured to be fixed to at least one finger and / or thumb of the subject's upper limb in a manner that allows the fixed at least one finger and / or thumb to extend and flex about a joint associated with the finger and / or thumb. Alternatively, the main housing assembly may be configured to be worn entirely or partially on the hand of a subject's upper limb, in which case the body part may be at least one finger (digit) (at least one finger and / or thumb) of the subject's upper limb, and the body part interface assembly may be a finger and / or thumb interface assembly configured to be fixed to at least one finger and / or thumb of the subject's upper limb in a manner that allows the fixed at least one finger and / or thumb to extend and flex about a joint associated with the finger and / or thumb. In addition, the main housing assembly can be configured to be worn on the forearm of the upper limb of the subject, the body part can be the hand of the upper limb of the subject, and the body part interface assembly can be configured to be fixed to the hand of the upper limb of the subject in a manner that allows the hand to extend and bend around the wrist and relative to the forearm.

[0022] Furthermore, the orthotic device can be configured such that, when worn, the flexible intermediate member crosses the knuckles of the subject. In this case, the orthotic device is further configured such that, when worn, the flexible intermediate member maintains a spaced relationship above the knuckles of the subject during flexion and extension of the flexible intermediate member. The flexible intermediate member may include a plurality of baffle members, wherein each baffle member is oriented substantially perpendicular to an axis along the length of the subject's forearm when the orthotic device is worn by the subject. The orthotic device may also include a push-pull line extending longitudinally through each baffle member and connecting the motor mechanism of the main housing assembly to the body part interface assembly. Each baffle member may have an opening through which the push-pull line extends, wherein each opening is aligned with the openings of other baffle members. The motor mechanism can be configured to push or pull the push-pull line to extend or compress the baffle members relative to each other, causing the body part interface assembly to rotate downward or upward. The motor mechanism includes a linear actuator.

[0023] Furthermore, the orthotic device can be configured such that a motor mechanism pushing a push-pull line causes the upper portions of the baffle members of the flexible intermediate member to extend away from each other and the body part interface assembly to rotate downward. The orthotic device can also be configured such that a motor mechanism pulling a push-pull line causes the upper portions of the baffle members of the flexible intermediate member to compress towards each other and the body part interface assembly to rotate upward. The flexible intermediate member may include a flat bottom structure attached to the bottom surface of each baffle member, such that the opposing top surfaces of each baffle member can freely compress or expand relative to each other. In this case, even if the upper portions of the baffle members are extended and compressed due to the operation of the push-pull line, the flat bottom structure can maintain the spacing between each of the multiple baffle members at the bottom of the baffle members.

[0024] Fifthly, a rehabilitation system for a subject is provided, comprising: a brain signal acquisition device configured to collect brain signals from the subject; and an orthopedic device. The orthopedic device includes: a main housing assembly configured to be worn on the upper limb of the subject and including a motor mechanism configured to actuate movement of a body part of the upper limb in response to brain signals; a body part interface assembly configured to be fixed to a portion of the upper limb and, upon actuation of the motor mechanism, cause flexing and extension movements of the fixed body part; and a flexible intermediate member inserted between the main housing assembly and the body part interface assembly, wherein the flexible intermediate member is configured to bend or extend in response to actuation of the motor mechanism, causing the body part interface assembly to bend or extend the fixed body part.

[0025] In various embodiments, the rehabilitation system of the fifth aspect may include one or more of the following. With regard to the orthopedic system of the rehabilitation system, the main housing assembly may be configured to be worn on the forearm of the subject's upper limb, the body part may be at least one finger of the subject's upper limb, and the body part interface assembly may be a finger and / or thumb interface assembly configured to be fixed to at least one finger and / or thumb of the subject's upper limb in a manner that allows the fixed at least one finger and / or thumb to extend and flex about a joint associated with the finger and / or thumb. Alternatively, the main housing assembly may be configured to be worn entirely or partially on the hand of the subject's upper limb, in which case the body part may be at least one finger (digit) (at least one finger and / or thumb) of the subject's upper limb, and the body part interface assembly may be a finger and / or thumb interface assembly configured to be fixed to at least one finger and / or thumb of the subject's upper limb in a manner that allows the fixed at least one finger and / or thumb to extend and flex about a joint associated with the finger and / or thumb. In addition, the main housing assembly can be configured to be worn on the forearm of the upper limb of the subject, the body part can be the hand of the upper limb of the subject, and the body part interface assembly can be configured to be fixed to the hand of the upper limb of the subject in a manner that allows the hand to extend and bend around the wrist and relative to the forearm.

[0026] Furthermore, the orthotic device of the rehabilitation system can be configured such that, when worn, the flexible intermediate member crosses the finger joints of the subject. In this case, the orthotic device is further configured such that, when worn, the flexible intermediate member maintains a spaced relationship above the finger joints of the subject during flexion and extension of the flexible intermediate member. The flexible intermediate member may include multiple baffle members, wherein each baffle member is oriented substantially perpendicular to an axis along the length of the subject's forearm when the orthotic device is worn by the subject. The orthotic device may also include a push-pull line extending longitudinally through each baffle member and connecting the motor mechanism of the main housing assembly to the body part interface assembly. Each baffle member may have an opening through which the push-pull line extends, wherein each opening is aligned with the openings of other baffle members. The motor mechanism can be configured to push or pull the push-pull line to extend or compress the baffle members relative to each other, causing the body part interface assembly to rotate downward or upward. The motor mechanism includes a linear actuator.

[0027] Furthermore, the orthotic device of the rehabilitation system can be configured such that a motor mechanism pushing a push-pull line causes the upper portions of the baffle members of the flexible intermediate member to extend away from each other and the body part interface assembly to rotate downward. The orthotic device can be configured such that a motor mechanism pulling a push-pull line causes the upper portions of the baffle members of the flexible intermediate member to compress towards each other and the body part interface assembly to rotate upward. The flexible intermediate member may include a flat bottom structure attached to the bottom surface of each baffle member, such that the opposing top surfaces of each baffle member can freely compress or expand relative to each other. In this case, even if the upper portions of the baffle members are extended and compressed due to the operation of the push-pull line, the flat bottom structure can maintain the spacing between each of the multiple baffle members at the bottom of the baffle members.

[0028] In a sixth aspect, an orthotic device for a subject is provided, comprising a main housing assembly configured to be worn on the upper limb of the subject and including a motor mechanism configured to actuate at least one finger of the subject, and a finger interface assembly connected to the main housing assembly and configured to be secured to at least one finger of the subject and configured to cause flexion and extension movements of the at least one secured finger when actuated by the motor mechanism. The orthotic device also allows at least one finger to be unsecured to the orthotic device, meaning that at least one finger is not secured to at least one finger of a finger strut assembly.

[0029] In various embodiments, the orthopedic device of the sixth aspect may include one or more of the following: The orthopedic device may include a thumb interface assembly configured to hold the thumb of the subject in an extended position. A finger interface assembly may be configured to secure two fingers of the subject (e.g., index and middle fingers). The finger interface assembly may be configured to allow free movement of two unsecured fingers of the subject while securing the two fingers of the subject. The finger interface assembly may be configured to slide longitudinally relative to the remainder of the orthopedic device along an axis extending along the length of the at least one secured finger in response to flexion and extension movements of at least one secured finger. In this case, the finger interface assembly may include a sleeve bearing at its upper surface, configured to engage with a corresponding sleeve bracket of a separate portion of the orthopedic device, such that the sleeve bearing slides along the sleeve bracket. The sleeve bearing may include a generally flat rectangular base plate and a plurality of guide rails extending upward from the base plate, the guide rails being configured to engage with the sleeve bracket. The finger interface assembly may include a finger support foam pad configured to contact at least one secured finger of the subject. The finger interface component may have at least one opening configured to receive at least one strap for securing the finger interface component to at least one fixed finger.

[0030] A seventh aspect provides a rehabilitation system for a subject, comprising: a brain signal acquisition device configured to collect brain signals from the subject; and an orthotic device. The orthotic device of the rehabilitation system includes a main housing assembly configured to be worn on the upper limb of the subject and including a motor mechanism configured to actuate movement of the subject's hand; and a finger interface assembly connected to the main housing assembly and configured to be fixed to at least one finger of the subject and configured to cause flexion and extension movements of the at least one fixed finger when actuated by the motor mechanism. The orthotic device is configured such that at least one finger is not fixed to the orthotic device, and the at least one finger is not fixed to at least one finger of a finger strut assembly.

[0031] In various embodiments, the rehabilitation system of the seventh aspect may include one or more of the following. With regard to the orthotic system of the rehabilitation system, the orthotic device may include a thumb interface assembly configured to hold the thumb of the subject in an extended position. A finger interface assembly may be configured to secure two fingers of the subject (e.g., index and middle fingers). The finger interface assembly may be configured to allow free movement of two unsecured fingers of the subject while securing the two fingers of the subject. The finger interface assembly may be configured to slide longitudinally relative to the remainder of the orthotic device along an axis along the length of the at least one secured finger in response to flexion and extension movements of at least one secured finger. In this case, the finger interface assembly may include a sleeve bearing at its upper surface, the sleeve bearing being configured to engage with a corresponding sleeve bracket of a separate portion of the orthotic device, such that the sleeve bearing slides along the sleeve bracket. The sleeve bearing may include a generally flat rectangular base plate and a plurality of guide rails extending upward from the base plate, these guide rails being configured to engage with the sleeve bracket. The finger interface assembly may include a finger support foam pad configured to contact at least one secured finger of the subject. The finger interface component may have at least one opening configured to receive at least one strap for securing the finger interface component to at least one fixed finger.

[0032] In an eighth aspect, a system is provided for moving or assisting the movement of a body part of a subject. The system includes a body part interface configured to be fixed to the body part; a motor actuation component connected to the body part interface to move the body part interface to cause bending or extending movement of the body part; and a force sensing module configured to measure the force applied between the body part interface and the motor actuation component to determine at least one of conscious bending and conscious extending movement of the body part of the subject.

[0033] In various embodiments, the system of the eighth aspect may include one or more of the following: The force sensing module may include a plurality of force sensors, at least one force sensing resistor, and / or at least one load unit force sensor.

[0034] The motor actuation assembly and the body part interface are pivotally connected such that they are configured to pivot relative to each other, and the body part interface is configured to rotate in a first direction and a second direction opposite to the first direction. In the case of multiple force sensors, this may include a first force sensor and a second force sensor, and the motor actuation assembly may be configured to apply a force to the first force sensor when the motor actuation assembly rotates the body part interface in the first direction, and to apply a force to the second force sensor when the motor actuation assembly rotates the body part interface in the second direction. One of the motor actuation assembly or the body part interface assembly may include an extension member having an upper surface and a lower surface opposite to the upper surface.

[0035] A first force sensor may be located on the upper surface, while a second force sensor may be located on the lower surface of the extension member. The first force sensor on the upper surface may be aligned with a downward-facing structure on one of the upper surfaces of the motor actuation assembly or body part interface assembly that does not have an extension member, wherein the first force sensor can be applied against the downward-facing structure when the motor actuation assembly and the body part interface pivot relative to each other in a first direction. The second force sensor on the lower surface may be aligned with an upward-facing structure on one of the upper surfaces of the motor actuation assembly or body part interface assembly that does not have an extension member, wherein the second force sensor can be applied against the upward-facing structure when the motor actuation assembly and the body part interface pivot relative to each other in a second direction.

[0036] The system of the eighth aspect can be configured such that a first force sensor is used to detect when the motor-actuated assembly operates to induce an extension movement of a fixed body part, and when the subject makes little or no contribution to the extension movement, and / or to detect when the subject consciously induces a flexion movement of the fixed body part, and when the motor-actuated assembly does not operate to move or assist in the flexion movement. Furthermore, the system can be configured such that the first force sensor is used to detect when the motor-actuated assembly operates to induce an extension movement of a fixed body part, and when the subject makes little or no contribution to the flexion movement, and / or to detect when the subject consciously induces an extension movement of the fixed body part, and when the motor-actuated assembly does not operate to move or assist in the extension movement.

[0037] In addition, the system can be an orthotic device configured to be worn on the upper limb of the subject, and the body parts can be associated with the subject's hand (e.g., the fingers, thumb, hand / wrist, elbow or shoulder of the upper limb or body parts of the lower limb).

[0038] In a ninth aspect, a rehabilitation system is provided, comprising a brain signal acquisition device configured to collect brain signals from a subject; and an orthopedic system for moving or assisting in the movement of a body part of the subject in response to the brain signals. The orthopedic system includes a body part interface configured to be fixed to the body part; a motor drive assembly connected to the body part interface to move the body part interface to cause flexion or extension movement of the body part; and a force sensing module configured to measure the force applied between the body part interface and the motor drive assembly to determine the voluntary flexion and extension movement of the subject's body part.

[0039] In various embodiments, the rehabilitation system of the ninth aspect may include one or more of the following. With regard to the orthopedic system of the rehabilitation system, the force sensing module may include a plurality of force sensors, at least one force-sensing resistor, and / or at least one load unit force sensor. The motor actuation assembly and the body part interface may be pivotally connected such that the motor actuation assembly and the body part interface are configured to pivot relative to each other, such that the body part interface is configured to rotate in a first direction and a second direction opposite to the first direction. In the case of multiple force sensors, this may include a first force sensor and a second force sensor, and the motor actuation assembly may be configured to apply a force to the first force sensor when the motor actuation assembly rotates the body part interface in the first direction, and to apply a force to the second force sensor when the motor actuation assembly rotates the body part interface in the second direction. One of the motor actuation assembly or the body part interface assembly may include an extension member having an upper surface and a lower surface opposite to the upper surface.

[0040] A first force sensor may be located on the upper surface, while a second force sensor may be located on the lower surface of the extension member. The first force sensor on the upper surface may be aligned with a downward-facing structure on one of the upper surfaces of the motor actuation assembly or body part interface assembly that does not have an extension member, wherein the first force sensor can be applied against the downward-facing structure when the motor actuation assembly and the body part interface pivot relative to each other in a first direction. The second force sensor on the lower surface may be aligned with an upward-facing structure on one of the upper surfaces of the motor actuation assembly or body part interface assembly that does not have an extension member, wherein the second force sensor can be applied against the upward-facing structure when the motor actuation assembly and the body part interface pivot relative to each other in a second direction.

[0041] The rehabilitation system of the ninth aspect can be configured such that a first force sensor is used to detect when the motor-actuated component operates to induce an extension movement of a fixed body part, and when the subject makes little or no contribution to the extension movement, and / or to detect when the subject consciously induces a flexion movement of the fixed body part, and when the motor-actuated component does not operate to move or assist in the flexion movement. Furthermore, the system can be configured such that the first force sensor is used to detect when the motor-actuated component operates to induce an extension movement of a fixed body part, and when the subject makes little or no contribution to the flexion movement, and / or to detect when the subject consciously induces an extension movement of the fixed body part, and when the motor-actuated component does not operate to move or assist in the extension movement.

[0042] In addition, the rehabilitation system may include orthotic devices configured to be worn on the subject's upper limbs, and body parts may be associated with the subject's hands (e.g., fingers, thumbs, hands / wrists, elbows, or shoulders of the upper limbs or body parts of the lower limbs).

[0043] The following drawings and description illustrate details of one or more embodiments of the present invention. Other features, objects, and advantages of this disclosure will become apparent from the specification, drawings, and claims. Attached Figure Description

[0044] Figure 1A This is a diagram of a rehabilitation system used to rehabilitate damaged body parts (in this example, the hand).

[0045] Figure 1B Is Figure 1A The diagram shows a brain signal acquisition system used in the system and in the form of an electroencephalogram (EEG) headset, worn on the head of the subject.

[0046] Figure 1C Is Figure 1A The diagram shows the local and mobile computing systems in the form of tablet computers used in the system.

[0047] Figure 1D Is Figure 1A The diagram shows the wearable orthotic device used in the system, worn on the left forearm and hand of the subject.

[0048] Figure 2A Is with Figure 1D The image shows a similar orthotic device, but adapted to be worn on the right forearm and hand of the subject rather than the left. The orthotic device is shown in an extended position, with the index and middle fingers of the right hand of the subject attached to the orthotic device in an extended position.

[0049] Figure 2B Is with Figure 1DThe image shows a similar orthotic device, but adapted to be worn on the right forearm and hand of the subject rather than the left. The orthotic device is shown in an extended position, with the index and middle fingers of the right hand of the subject attached to the orthotic device in an extended position.

[0050] Figure 3A It is shown Figure 1A A general diagram showing the relationships between the components of a rehabilitation system.

[0051] Figure 3B Is using Figure 1A The flowchart of the rehabilitation system process.

[0052] Figure 3C For example, in Figure 3B The flowchart of the process of performing a treatment session within the procedure.

[0053] Figures 4A-4G It shows that it can be shown Figure 1A Figures showing details of an embodiment of an orthotic device used in a rehabilitation system.

[0054] Figure 5A -Figure 5F is also like this. Figure 4A-4G The diagram shows an orthopedic device, but for clarity, the finger support components are not shown.

[0055] Figures 6A-6H It is shown that it includes Figures 4A-4G and Figure 5A - A diagram showing further details of the structure and operation of the connection / force sensing module assembly in the orthopedic device shown in Figure 5F.

[0056] Figures 7A-7B It is shown that it includes Figures 4A-4G and Figure 5A - A diagram showing further details of the structure of the finger support component in the orthopedic device shown in Figure 5F.

[0057] Figure 7C It is shown that it includes Figures 4A-4G and Figure 5A - A further detail of the external structure of the thumb strut component in the orthopedic device shown in Figure 5F.

[0058] Figures 8A-8C This is a system and flowchart illustrating an embodiment of the architecture and operation of a rehabilitation system.

[0059] Figure 9 This is a diagram of another embodiment of the orthopedic device, shown incompletely to illustrate the use of load cell force sensing.

[0060] Figure 10 Example computing devices and mobile computing devices that can be used in the methods and apparatus described in this specification are shown.

[0061] The same reference numerals and names in the various figures indicate the same elements. Detailed Implementation

[0062] This manual describes systems, devices, and methods for improving rehabilitation of injured limbs, such as for improving rehabilitation of the upper limbs injured due to a hemispheric stroke event. Although stroke rehabilitation will be described in detail in this manual, the techniques described herein have a wider range of applications than stroke rehabilitation.

[0063] like Figure 1A One example implementation shown is a rehabilitation system 100 suitable for use by a patient 102 who has experienced brain injury (e.g., stroke, trauma, infection, hemorrhage, neonatal malformation, cerebral palsy, neurodegeneration) to rehabilitate the patient's impaired motor control hand. Typically, the rehabilitation system 100 includes: (i) a brain signal acquisition system 104, in this example a headset with multiple surface electrodes that acquire electroencephalogram (EEG) brain signals from multiple different and distributed surface locations on the patient's skin adjacent to the brain, thereby enabling a brain-computer interface (“BCI”) operating mode with the rehabilitation device 100; (ii) an orthotic device 106 designed and configured to be fully wearable on the patient's forearm and hand 108 (in this example, the left forearm and hand 108), and designed and configured to be fixed to the injured body part (in this case, the hand) and induce or assist in inducing movement of the injured hand; (iii) a local clock. The system 110 includes one or more associated applications and user display devices 112 to provide instructions, guidance, prompts and information for setting up, performing rehabilitation sessions and monitoring progress; (iv) a local network router device 114 that provides network connectivity to remote or external systems via local devices and information; and (v) a network-accessible central rehabilitation management computing system 116 that can be used for the setup, continuous operation and monitoring of the local aspects of the rehabilitation system 100 and can be located at a location remote from the patient performing rehabilitation activities (e.g., in a healthcare facility (e.g., a hospital, clinic, etc.) or certain other types of institutions (such as a rehabilitation service provider)).

[0064] like Figure 1A As shown and Figure 1BThe brain signal acquisition system 104, shown in more detail in this example, may be a commercially available dry electrode EEG headset, model DSI 7, commercially available and sold by Wearable Sensing LLC, San Diego, California. The brain signal acquisition system 104 acquires brain signals, performs low-level signal processing, and (e.g., wirelessly) transmits the EEG brain signals to be received directly by orthopedic device 108 or via local computing system 112 for further processing by a computer system embedded within orthopedic device 108. Alternatively, the acquired EEG brain signals may be transmitted to and further processed by local computing system 112, which may then send control signals to orthopedic device 118 for action.

[0065] EEG brain signals can be acquired by acquisition system 104 (as in this example, using a plurality of arranged surface electrodes 118 as part of acquisition system 104). Each of the surface electrodes 118 is located at the end of a corresponding arm that extends from the housing of acquisition system 104 to a distal position, such that when acquisition system 104 is worn by a patient, electrode 118 can be positioned to rest on the skin near the patient's brain. Although Figure 1A and Figure 1B The brain signal acquisition system in the example is a dry EEG electrode system, but alternatively a wet EEG electrode system can be used. In the case of a wet EEG electrode system, the electrode 118 can be moistened by applying a liquid or gel to the electrode 118 before being applied to the patient's skin. This can increase the conductivity of the patient's skin and allow for more accurate detection and recording of brain signals in some cases.

[0066] Although Figure 1 shows the brain signal acquisition system 104 from only one side of the patient 102, it may include electrodes 118 designed to be positioned on both sides of the patient's head to acquire brain signals from both sides of the brain. That is, in some applications where a patient has suffered a unilateral stroke, where one hemisphere of the brain is negatively affected or damaged, but the other hemisphere remains effective and / or healthy, useful brain signal activity may be generated solely from the unaffected hemisphere of the patient's brain, which may be located on the same side of the body as, or ipsilateral to, the limb whose motor control has been adversely affected by the stroke. In such cases, the ipsilateral brain signal associated with the patient's motor control intention for movement of a body part on the same side of the body as the acquired brain signal may (in terms of brain signal frequency, location, amplitude) differ from the contralateral brain signal associated with the patient's motor control intention for movement of a body part on the opposite side of the body as the acquired brain signal, as described in U.S. Patent No. 9,730,816 ('816 Patent) to Leuthardt et al., which is incorporated herein by reference. In some cases, it is only possible, or in some cases sufficient, to acquire “ipsilateral” brain signals from the unaffected hemisphere of a patient’s brain located on the same side of the body as the injured body part. In such cases, the brain signal acquisition system 104 can be designed and adapted to acquire brain signals from only one side of the patient’s brain. In other cases, contralateral brain signals (on the opposite side of the body from the affected body part) may also be sufficiently present and detectable, and therefore can be acquired and utilized during rehabilitation to leverage the concept of brain plasticity or reconnection to establish new connections for improved motor control following a stroke event.

[0067] Despite Figure 1A The example illustrates an EEG-based brain signal acquisition system 104 with skin surface electrodes; other brain signal acquisition systems can alternatively be used in conjunction with the BCI devices, systems, and methods described herein. For example, an acquisition system with implantable electrodes can be used. For instance, electrocorticography (ECOG) electrodes can be used and implanted under the patient's skull and positioned such that the electrodes rest on the brain surface but do not penetrate into the brain tissue. Another example electrode system that can be used alternatively is a "point" electrode system, which is also implanted under the patient's skull, but this type of electrode system has electrode tips that penetrate into the brain tissue. Typically, such "point" implantable electrode systems include a plurality of forks designed such that each fork penetrates into the brain tissue at a different location.

[0068] Implantable electrodes may be more needed than surface EEG electrodes because the brain signals acquired can contain more information about the patient's intentions. For example, with implantable electrodes, it is possible to distinguish the intentions associated with the movement of each of the patient's fingers, which is impossible, or at least much more difficult, with brain signals acquired using surface EEG electrodes. That is, because the skull can block or inhibit some brain signals, especially higher-frequency brain signals. Thus, it will be recognized that implantable electrodes have the potential disadvantage of requiring medical procedures for electrode implantation. Furthermore, advancements in processing and analyzing brain signals captured via EEG electrodes (including those described herein) make EEG-based systems more useful in BCI-based rehabilitation.

[0069] As mentioned above, Figure 1A Wearable orthopedic devices 106 (also in) Figure 1D (Seen in more detail below) can receive (e.g., wirelessly) transmitted signals containing information about brain signals acquired by acquisition system 104. Orthopedic device 106 can then process those received signals using embedded processing equipment to determine the patient's intention, and based on some detected patient intention, induce or assist movement of the patient's hand and / or fingers via robotic or motor-driven actions of orthopedic device 106. As previously described, orthopedic device 106 can receive brain signal information directly from brain signal acquisition system 104 for processing, or alternatively via local computing system 110 (in the latter example, local computing system 110 can receive brain signal information from brain signal acquisition system 104, store the brain signal information locally in local computing system 112 for recording, and wirelessly and in real time retransmit the brain signal information to orthopedic device 106 for further processing to activate orthopedic control functions).

[0070] Wearable orthotic device 106 (specifically in Figure 1A and Figure 1D In the example, it was designed and adapted to assist the patient's finger movement, specifically the index finger 120 (in Figure 1D (middle mark) and adjacent middle finger (in) Figure 1A and 1D (Not shown in the image), both fingers are securely attached to the orthotic device 106 via finger support components 122. Specifically, by... Figure 1A and Figure 1D The specific movement achieved by the orthopedic device 106 is the extension (opening) and bending (closing) of the finger strut component 122, which causes the attached index finger 120 and the adjacent middle finger to extend (open) and bend (close).

[0071] The wearable orthotic device 106 also includes a thumb piece 134, which is attached proximally to one side of the main housing structure 124 on the thumb side of the main body, depending on whether the device 106 is worn on the right arm and right hand or on the left arm and left hand. Figure 1A and Figure 1D In this case, the device 106 is worn on the left forearm and left hand, and the thumb piece 134 extends correspondingly from one side of the main body housing structure 124 where the left thumb of the main body is located. Figure 1A and Figure 1D In the example, the thumb member 134 extends to the thumb contact portion 138, which contacts the inner surface of the thumb 136 during use in order to hold the thumb 136 as... Figure 1D The approximate extension position is shown. In this embodiment, the thumb member 134 can be manually adjusted to, for example... Figure 1D The device is positioned as shown, and once manually adjusted to that position, it remains in that position; or in other words, in this embodiment, it is not actuated by an actuator such as a motor, but remains in the same position during use of the orthopedic device 106 in a rehabilitation session.

[0072] The extension and bending of the finger support device 122, and thus the extension and bending of the index and middle fingers fixed thereto, are achieved by a linear motor device ( Figure 1D (Not shown in the diagram, but will be shown and described below in this specification) The linear motor device is located inside the main housing structure 124 of the orthotic device 106. (As shown in the diagram) Figure 1D The main housing structure 124 shown is designed and configured to be worn on top of and abut against the upper surface (i.e., the dorsal side) of the patient's forearm and hand. The main housing structure 124 is designed such that it extends parallel to the forearm from proximal to distal, with the proximal end approximately located at the midpoint of the forearm (between the wrist and elbow) when worn, and the distal end approximately just proximal to the patient's finger joints when worn. Figure 1D As best shown. The linear motor device within the main housing structure 124 has a longitudinally advancing and retracting push-pull line 126 that extends distally from the distal end of the main housing structure 124 and, as will be described below, extends longitudinally through the flexible intermediate structure 128 and connects to a connection point on the force sensing module (“FSM”) assembly 130.

[0073] A flexible intermediate component 128 with a flexible baffle structure is attached to the distal end of the main housing component 124. For example... Figure 1D As shown, the flexible intermediate member 128 is configured such that, when properly worn, it extends from a proximal end located approximately slightly proximal and above the knuckle to a distal end located approximately above the knuckle of the index and middle fingers, as... Figure 1DAs best shown. A push-pull line 126, extending distally from the main housing structure 124, extends through the entire length of the flexible intermediate structure 128 and beyond its distal end. Specifically, the push-pull line 126 extends longitudinally through a series of aligned openings formed in the various baffle elements constituting the flexible intermediate structure 128. Figure 1A and 1D In the example, there are seven such baffle elements in the flexible intermediate structure 128, through which push-pull lines 126 extend. The push-pull lines 126 extend longitudinally from the distal end of the flexible intermediate component 128 to connect to a connection point on the FSM assembly 130.

[0074] A connection and force sensing module (“FSM”) assembly 130 is attached to the distal end of the flexible intermediate member 128 and configured such that it extends generally longitudinally. The FSM assembly is also referred to as the “connector” and the FSM assembly because it connects the flexible intermediate structure 128 to the finger support member 122 fixed to the finger (in a slidable manner, as described below). Figure 1D As shown, the connection / FSM assembly 130 is configured such that, when worn, it extends longitudinally over the hand (or on the back of the hand) from its proximal end, generally above the joints of the index and middle fingers, to a point generally beyond the distal end of the fingers, but only slightly beyond the distal end. A finger strut member 122 is attached longitudinally slidably to the underside of the connection / FSM assembly 130, such that bending and extending movements of the connection / FSM assembly 130 translate into bending and extending movements of the finger strut member 122 (and thus the fingers are secured therein), while the finger strut member 122 slides freely longitudinally relative to the connection / FSM assembly 130. This connection mechanism avoids unwanted friction of the orthopedic device on the fingers.

[0075] The connection / force sensing module 130 is also used for force sensing purposes and includes a force sensor for this purpose. Figure 1D (Not shown in the image), the force sensor is capable of measuring the force resulting from the motor-activated movement of the finger flexion and extension relative to the orthotic device 106 caused by the patient. The force sensing function of the connection / force sensing module 130 can be used for various purposes, including, for example, determining the extent of the flexion and extension capacity that the patient has without the assistance of the orthotic device 106, determining the extent of motor-activated assistance required or desired to induce finger flexion and extension during rehabilitation exercises, and other purposes that will be readily understood by those skilled in the art.

[0076] The push-pull cable 126 (attached at its proximal end to a linear motor within the main housing structure 124, as previously described) is attached at its distal end to the connection / FSM assembly 130. Therefore, when the linear motor pulls the cable proximal, the attachment assembly 130 is pulled proximal, causing the flexible intermediate structure 128 to bend, thus pointing its distal end more upward, thereby inducing or assisting in the extensional movement of the fixed index finger and adjacent middle finger. This upward bending of the flexible intermediate structure 128, causing its distal end to point further upward (and back), is achieved by the baffle structure of the flexible intermediate structure 128. Specifically, a generally flat bottom structure 132 is disposed on the flexible intermediate structure 128, wherein the bottom structure 132 is configured to attach to the bottom or hand side of each individual baffle member, while the opposite or top side of each individual baffle member is not so constrained, and is therefore freely compressed closer or further separated by operating the push-pull line 126 to expand and / or reduce the top side distance between the distal end of the main housing structure 124 and the proximal end of the connection / FSM module 130.

[0077] Therefore, the linear motor pulling the push-pull line 126 proximally causes the upper or outer part of the baffle structure to be longitudinally compressed, while the lower or underside of the baffle structure remains in a constant longitudinally compressed state. Thus, pulling the line 126 proximally causes the flexible intermediate member 128 to bend, making its distal end more upward-oriented, thereby causing or assisting the index and middle fingers to extend or, in other words, open. Conversely, pushing the push-pull line 126 distally causes the upper or outer part of the baffle structure to become longitudinally uncompressed or extended, while the lower or underside of the baffle structure remains in the same longitudinally compressed state, and thus, pushing the line 126 distally causes the flexible intermediate member 128 to bend back to its distal end, becoming more downward-oriented, thereby causing or assisting the index and middle fingers to bend or, in other words, close.

[0078] The main housing component 124 accommodates three straps 140 to detachably secure the main housing component 124 and thus other attachment components of the device 106 to the top of the forearm and hand, such as Figure 1A and Figure 1D As shown in the example. The three straps 140 can be, as in this example, hooks or loops. Type of straps. Each strap 140 is attached to the bottom of one lateral side of the main housing member 124 and extends around the arm to the bottom of the opposite side of the main housing member 124. In this example, the first strap 140a is positioned relative to the main housing member 124 such that the strap 140a can be wrapped around the forearm of the subject approximately at the midpoint between the elbow and wrist; the second strap 140b is positioned relative to the main housing member 124 such that the strap 140b can be wrapped around the forearm of the subject just proximal to the wrist; and the third strap 140c is positioned relative to the main housing member 124 such that the strap 140c can be wrapped around the hand of the subject and between the thumb 136 and the index finger 120.

[0079] exist Figure 1A and Figure 1D In the example, the finger support component 122 has an upper surface slidably connected to the lower surface of the connection / FSM assembly 130, such that, as previously described, bending and extending movements of the connection / FSM assembly 130 translate into bending and extending movements of the finger support component 122 (and thus the fingers fixed therein), but the finger support component 122 slides freely longitudinally relative to the connection / FSM assembly 130. As shown, the finger support component 122 is provided with an upper plate resting above the two fixed fingers and a generally horizontal lower plate resting below the two fingers. Two adjustable straps 123a, 123b are provided with the two plates to secure the plates in place, with the index and middle fingers fixed as a unit between the two plates. Further details of the finger support component 122 are provided in... Figures 7A-7B It is provided in [the document], which will be described below.

[0080] Now for reference Figure 2A and 2B This demonstrates a design intended to be worn on the right arm and right hand, rather than as... Figure 1A and Figure 1D The orthotic device 206 in Figure 2 is worn on the left arm and left hand as in the orthotic device 106. The orthotic device 206 in Figure 2 is otherwise identical to the device 106 on the left side of Figure 1. The orthotic device 206 is... Figure 2A It is displayed as being in the extended or open position, while Figure 2B The image shows the object in a bent or closed position.

[0081] refer to Figures 2A-2B It will be understood that the flexible intermediate component 128 is configured to maintain a gap between its structure and the patient's finger joint throughout the entire range of finger flexion and extension movements. Furthermore, the design of the flexible intermediate component 128 and the manner in which the orthotic device 106 is attached to the finger (i.e., utilizing a finger strut component 122 with an upper surface that is longitudinally slidably attached to the connection / FSM assembly 130, which is generally positioned above the finger) provide comfortable finger flexion and extension, particularly by avoiding or minimizing any stretching and / or friction between the finger strut component 122 and its straps 123a, 123b and the fixed index and middle fingers. Otherwise, flexion and extension movements could be more difficult and / or uncomfortable.

[0082] In various embodiments, the orthopedic device according to the design principles of this disclosure can induce or assist various other motor activities in the hand and arm beyond finger movements, such as Figure 1A and Figure 1DFor example, orthotic devices within the scope of this disclosure can be designed to supplement or replace finger movement, eliciting or assisting movement of the patient's wrist, thumb, elbow, and / or shoulder. In other embodiments, orthotic devices within the scope of this disclosure can facilitate movement of other limbs, such as the foot, ankle, knee, or hip.

[0083] Figure 1A The rehabilitation system 100 includes a BCI component for processing brain signals to determine the patient's intention and, in response, initiate a predetermined or calculated motor or other mechanical response of the orthotic device. In some embodiments, the wearable orthotic device 106 may include an embedded processing device (…). Figure 1A and 1D (Not shown in the image), the embedded processing device includes a BCI component and thus performs BCI functions. In other embodiments, the BCI component and processing functions may be provided separately from the orthopedic device, for example, by a system residing locally (such as...). Figure 1A The service is provided on a local computing system 110 (e.g., a desktop computer) and by an application executed thereon, or alternatively by a computer system residing in a remote location and network (such as...). Figure 1A The central rehabilitation management computing system (116) is provided by the application that executes it.

[0084] Figure 1AThe system 100 shown also enables remote monitoring of a patient's rehabilitation work and progress. For example, the tablet computer 110 and / or orthopedic device 106 can periodically send reports to the central rehabilitation management system 116 via a local router 114 and network. Reports may indicate, for example, compliance information, i.e., whether the patient has completed a requested or recommended rehabilitation session. Furthermore, reports provided to the central system 116 can be reviewed by healthcare providers or other rehabilitation specialists to see if any progress has been made in the rehabilitation work and to provide guidance to the patient, where appropriate, on future treatment sessions, feedback, and possible encouragement. In some implementations, information included in reports from multiple patients can be anonymized and aggregated to identify factors and trends that typically lead to improved patient rehabilitation outcomes. By analyzing overall device usage statistics (e.g., usage time, number of repetitions, etc.) and patient characteristics (e.g., injury type, age, etc.), the central rehabilitation management system 116 can, for example, identify patient groups that typically benefit from specific types of treatment. For example, system 116 can determine, based on the progress of similar patients (e.g., other stroke patients of similar age) who have undergone similar treatment sessions, that a patient (e.g., a stroke patient of a specific age) may benefit from a specific type of treatment session (e.g., including a specific number of repeated sessions at a specific time of day). Feedback from the healthcare provider and instructions for the treatment session can be provided to the patient, for example, on the display device 112 of tablet computer 110 at the start of the patient's next rehabilitation session.

[0085] Now for reference Figure 3A The diagram shows a general block diagram of the rehabilitation system 300. Figure 3A The block diagram not only shows Figures 1A-1D and Figures 2A-2B The example rehabilitation system 100 also illustrates other embodiments of rehabilitation systems, such as systems for controlling other body movements (e.g., arms, shoulders, elbows, wrists, hands, legs, knees, ankles, feet, etc.), and systems using other than those described above. Figure 1A Systems for acquiring different types of brain signals other than EEG brain signals as shown in the embodiments (e.g., systems that alternatively use implantable electrodes).

[0086] like Figure 3AAs shown, the rehabilitation system 300 includes: (i) one or more system control and data management components 305; (ii) a brain signal acquisition system 310; (iii) a brain-computer interface (BCI) component 315; and (iv) an orthotic device 320. The orthotic device 320 may be worn on the body and therefore may be a portable, body part movement control, and / or movement assistance system. The system control and data management system 305 may include not only local control and data management of the system 300, i.e., co-located with the subject performing rehabilitation (and may be integrated with the BCI component 315 and / or the orthotic device 320), but also integrated in the form of a tablet computer into a local computing device (such as local computing system 110), as... Figure 1A (As shown in the example), and may also include a remote, network-accessible central rehabilitation management computing system, such as Figure 1A Example system 112. A central rehabilitation management computing system can be used for, for example, system setup and continuous operation, and can be located in a location remote from the patient, such as at a healthcare facility or a facility of another type of service provider.

[0087] Typically, the brain signal acquisition system 310 acquires brain signals, performs low-level signal processing, and transmits the brain signals, which are then received by the BCI component 315 under the control of the system control and data management system 305. Brain signals can be acquired by the acquisition system 310 using several arranged electrodes that are part of the acquisition system. As previously mentioned, these electrodes can be EEG surface electrodes or implantable electrodes (e.g., ECOG electrodes or "point" electrodes). For example, the acquired neural signals may also include magnetoencephalography (MEG) signals, mu rhythm signals, beta rhythm signals, low-gamma rhythm signals, high-gamma rhythm signals, action potential discharges, etc. The brain signal acquisition system 310 may also include: a processing circuitry system for performing low-level processing and formatting of the brain signal information for use by the BCI component 315; and a connection interface for implementing the transmission. The connection between the brain signal acquisition system 310 and the BCI component can be wireless or hardwired, and can be direct or indirect through intermediate components. Therefore, the connection interface in the brain signal computing system 310 and the components communicating with the system 310 will be adapted accordingly to enable wireless or hardwired transmission. For example, the connection interface may include a USB interface device, Communication equipment, Wi-Fi communication equipment, or some other wireless or hardwired transmission protocol interface mechanisms and circuit systems.

[0088] In some embodiments, the body-worn device of system 300 may include movable and actuable devices that move or assist in the movement of body parts, as well as a BCI component 315. The BCI component 315 in this example typically includes components adapted to be worn on a user (e.g., in…). Figure 1AThe BCI processing capability (in the example, on the user's forearm or another body part in other embodiments). In such embodiments, the body movement assistive component can be operatively connected to the BCI component 315 and can also be adapted for use by a user (e.g., in…) Figure 1A (In the example, the user wears it on their hand or in other embodiments, on certain other body parts that are to be moved.)

[0089] BCI component 315 includes processing and control circuitry for operating BCI functions in training mode, operational mode (e.g., rehabilitation session), calibration mode, and communication mode. Therefore, BCI component 315 includes one or more processing units, such as a central processing unit (CPU) component, volatile memory such as random access memory (RAM) and non-volatile memory such as read-only memory (ROM) and / or various forms of programmable read-only memory (PROM), for storing periodically updatable software or firmware programs and operating parameters. BCI component 315 may also include one or more of the following additional hardware components: (i) one or more batteries for making the BCI component portable (the batteries can provide power to various components of the wearable device and can be recharged via an adapter or charging device (not shown here), (ii) a visual output display device, including a visual display and associated display drivers and circuitry, (iii) a user input device, such as an on / off switch and other buttons or a touchscreen display, for enabling manual user input, (iv) an audio output device for providing audio commands, information and prompts to the user, (v) an audio input device, such as a microphone, for receiving audio input from the user, and (vi) a connectivity interface for enabling communication between BCI component 315 and brain signal acquisition system 310, for example, to receive neural signals transmitted wirelessly or hardwired, and also for enabling communication between BCI component 315 and system control and data management system 305.

[0090] System 300 may include various components for providing information to and receiving input from a user. For example, a visual output display may be a conventional or touchscreen display for providing visual cues (e.g., graphics, instructions, etc.) or other types of information to the user and / or for receiving user input. For example, an input device may include one or more buttons for controlling (e.g., pausing, powering on / off, sending data, receiving data, changing modes, etc.) a wearable device. For example, input devices such as buttons may be used as soft keys adjacent to the display and / or may be placed away from the display. For example, an audio output device (e.g., a speaker) may be used to provide auditory cues (e.g., live or recorded voice instructions, tones indicating success or error, etc.). For example, an audio input device (e.g., a microphone) may be used to receive voice input from a user (e.g., voice control) and / or may be used in conjunction with the audio output device for real-time communication sessions with remote technicians.

[0091] In terms of software and / or firmware, the system control and data management system 305 and the BCI component 315 may include various programs stored in non-volatile memory, including executable program instructions executed by the CPU to perform various processing functions. This may include one or more of the following program modules: (i) a neural signal interpreter for interpreting neural signals received from the brain signal acquisition system 310 and specifically determining whether those received signals indicate a user intention to perform certain predefined body movements that will be induced or assisted by the orthotic device 320; (ii) a device control module for providing control signals to the orthotic device to actuate movement; (iii) a training mode module for performing a training process; (iv) an operation mode module for performing operation of the system 300 in routine operation (e.g., in a rehabilitation session); (v) a calibration mode module for performing an operation calibration process; and (vi) a communication module for performing a communication process between the brain signal acquisition system 310, the BCI component 315, the orthotic device 320, and the central network-accessible rehabilitation management system.

[0092] The non-volatile memory may also include an information storage area for operating parameter settings or other input information used during operation of the BCI component 315. These settings and other input information may be input by the user or transferred to the BCI component 315 from the system control and data management system 305 (e.g., from a remote, network-accessible system). The information storage area may include one or more of the following: (i) device parameter setting storage for storing (e.g., settings that may be selected by the user or selected and provided by a central rehabilitation management system) various operating parameter settings; (ii) user intent information storage for storing one or more sets of previously determined brain signals, each set indicating the user's intent to perform different body movements, particularly movement-assisted movements (this intent information is used, for example, by a neural signal interpreter program); and (iii) calibration data storage for collected calibration data, including brain signal information collected during calibration sessions, and this calibration data may be stored by the BCI component. 315. Retrieve and send to a remote, network-accessible central system for evaluation; (iv) Body range of motion parameter settings (which can be used by the equipment controlling the movement of the orthotic device 320), including parameter settings indicating the range of motion of the orthotic device 320 (e.g., the degree of finger flexion and extension); and (v) Usage information storage, wherein information about the user's use of the wearable BCI / assistive device can be stored, such as how many times the device was used, how long it was used, when it was used, and what the result of each use session was (which usage information can be retrieved by the local equipment and sent to a remote, network-accessible central system).

[0093] Orthopedic device 320 can operate under the control of BCI components and may include various components that induce or assist body movement (e.g., external robotic assistive devices, prosthetic devices, functional electrical stimulation (FES) devices, etc.). For this purpose, orthopedic device 320 may include one or more sensors, tactile devices, motors, electrical stimulators, and movable components that can be coupled to a body part. For example, sensors can be used to detect the magnitude of forces applied to the body part to assist its movement, to detect the position of movable components, and / or to detect forces being generated by the patient or the subject inducing the desired movement. Such force detectors can provide information about whether the patient is effectively moving the body part independently, how much assistance is needed to achieve the movement, and whether the patient's motor control allows the patient to unintentionally prevent movement. For example, a position detector can be used to inform system 300 that a finger is now fully bent, fully extended, or in an intermediate position. The information collected by the sensors can be provided to a device control module, a training mode module, a calibration mode module, and an operating mode module.

[0094] For example, a haptic feedback device can provide haptic feedback to a user in association with a cue and / or with an identified user intent (e.g., vibrational haptic feedback). In some embodiments, to cue a user to move a body part (e.g., a hand), the haptic device can operate alone or in combination with other types of cueing mechanisms (e.g., visual and / or auditory) (e.g., vibration). Similarly, to indicate to a user that an intent to move a body part has been identified, in some embodiments, the haptic device can operate alone or in combination with other feedback mechanisms (e.g., visual and / or auditory) (e.g., vibration).

[0095] For example, the motor may include a rotary motor, servo motor, and / or linear motor for driving gears, pistons, etc. For example, a device control module executed by the processing unit may provide signals for controlling the motor. For example, a movable part may be coupled to and moved by the motor, and may include one or more mechanisms for guiding or assisting the movement of a corresponding body part.

[0096] For example, an electrical stimulator can use an electric current to activate muscles or nerves in a body part of the user that is affected. For instance, when an intention to move a body part (e.g., a hand) is detected, the electrical stimulator can deliver an electric current to the body part to facilitate movement. In some embodiments, electrical stimulation of the body part can be provided alone or in combination with mechanical mechanisms for guiding or assisting the body part.

[0097] For example, a remote, network-accessible central rehabilitation management system (such as...) Figure 1A System 116 may include one or more computing devices configured to receive information from local components of the brain signal acquisition system 310, BCI component 315, orthopedic device 320, and / or system control and data management system 305 to execute one or more applications for processing, analyzing, and tracking rehabilitation and other data, and to provide operational and configuration data to system 300. For example, a remote, network-accessible central system may execute computer application code associated with a device usage analyzer and rehabilitation management module. For example, a technician may use the device usage analyzer to analyze information received from a remote device and determine the operational instructions and parameters to be used by the remote device. For example, the rehabilitation management module may be used by a technician or healthcare professional to track the device user's progress over time and to configure local components of system 300.

[0098] Figure 3BEach component may include a connection interface for receiving and providing data to other devices via wired and / or wireless connections. For example, the connection interface may include a USB driver, Bluetooth driver, WiFi driver, and / or mobile data connection driver (such as a 3G driver, 4G LTE driver, and 4G WiMAX driver). For instance, the connection interface of BCI component 315 may be configured to receive neural signal data directly from the corresponding connection interface of brain signal acquisition system 310. The connection interface may be configured to send and receive data between local components of system 300 and a remote, network-accessible central system via a network.

[0099] System 300 may additionally include local user computing devices, such as laptops, desktop computers, smartphones, and tablet computing devices (in... Figure 1A In some implementations, the user computing device may include a BCI component 315, or alternatively, may communicate with a BCI component not present thereon. For example, the local user computing device may obtain rehabilitation data (e.g., logs of rehabilitation sessions, summaries of repetitions performed, usage periods, and progress along the rehabilitation plan) from the system 300 during a rehabilitation session. The user computing device may also present rehabilitation data through a user interface that is easier to use and more interactive than a user interface provided through a display on the wearable device. Furthermore, the user computing device may communicate with a central management computing system via a network to view remotely stored rehabilitation data. For example, the user computing device may include one or more applications (e.g., a web browser) that can authenticate the user associated with the user computing device (e.g., log in) and provide access to rehabilitation data already provided by the local device to the central rehabilitation management computer system.

[0100] refer to Figure 3B We are now turning to how to use rehabilitation systems (such as...) Figure 1A The general procedure 350 of the rehabilitation system 100 shown is as follows. For illustrative and exemplary purposes only, the introductory description used below pertains to unilateral stroke patients undergoing rehabilitation for motor impairments or paralyzed hands. That is to say, the devices and methods described in this specification are not limited to stroke rehabilitation applications.

[0101] For stroke patients with impaired hand motor control, the first thing that may occur is that the patient may undergo a test (355) to determine whether the patient is a suitable candidate for treatment using a BCI-based system. The timing of the rehabilitation / recovery schedule for such stroke patients may vary. For example, stroke patients may undergo the test (355) after acute or subacute rehabilitation or after outpatient rehabilitation. One objective of such a suitability test is to determine whether finger movement intentions can be determined from brain signals generated by the patient and acquired by the brain signal acquisition system 104. As an example, this suitability test can be performed using the brain signal acquisition system 104 (appropriately selected and sized for the patient and properly positioned on the patient's head) and the central rehabilitation management system 116 (which is capable of receiving wireless transmissions directly from the brain signal acquisition system 104). In other words, suitability testing can be performed without the need for the wearable orthotic device 106 and the associated tablet computer 110, which is appropriate given that the patient has not yet been deemed suitable for treatment using such devices 106 and 110. For example, suitability testing can be conducted at a rehabilitation clinic where the central rehabilitation management system 116 is located, under the supervision of qualified BCI and / or rehabilitation therapy specialists. Alternatively, suitability testing can be conducted on patients located far from the central rehabilitation system 116 and clinics, where remotely captured brain signals are transmitted via a network to the central rehabilitation management system 116 for processing and analysis.

[0102] In some implementations, prior to performing the suitability tests described in the preceding paragraph using the brain signal acquisition system 104, the patient may participate in a first round of suitability testing as part of a patient suitability test (355) using a research-grade EEG headset and BCI device (e.g., BCI2000). Such research-grade equipment can be used to determine whether the patient exhibits any ipsilateral or motor-derived signals for BCI. The research-grade equipment may be more sensitive to brain signals than the brain signal acquisition system 104 and therefore can be used as part of an initial screening process prior to the screening performed by the brain signal acquisition system 104, the wearable orthotic device 106, and the associated tablet computer 110. Screening using the research-grade equipment may involve procedures similar to those described with respect to the brain signal acquisition system 104 and the wearable orthotic device 106. Alternatively, the research-grade equipment may also use anatomical or functional magnetic resonance imaging or magnetoencephalography (MEG) to further enhance the patient's suitability for the BCI system.

[0103] If a patient passes one or more screening tests using research-grade equipment, which may be inaccessible and located in a clinic / research facility, the patient can be screened using the brain signal acquisition system 104, the wearable orthotic device 106, and the associated tablet computer 110. The screening process using the brain signal acquisition system 106, the wearable orthotic device 106, and the associated tablet computer 110 may involve: displaying real-time (near real-time) results on a monitor; comparing the results with those from the research-grade screening to determine consistency regarding various detected control features of the patient (e.g., brain signals identified as indicating and corresponding to user intentions to move body parts along the same side of the brain as the detected signal—ipsilateral brain signals); and using the various detected control features to perform cueing controls (e.g., device-guided actions) to complete one or more tasks (e.g., moving a graphic bar displayed on the tablet computer 110 beyond a threshold level). If the patient successfully performs one or more tasks, the patient can be identified as a candidate for rehabilitation using the brain signal acquisition system 104, the orthotic device 106, and the associated tablet computer 110. In addition, the brain signal acquisition system 104 can detect specific physiological characteristics (e.g., specific frequency bands, amplitude modulation, or phase or time series correlation phenomena) that can predict a patient's response to a rehabilitation program.

[0104] Assuming the patient is a suitable candidate for rehabilitation, the patient can be fitted with a wearable orthotic device 106 of appropriate size (360°). The rehabilitation clinic may have several sizes of wearable orthotic devices 106 on hand. Alternatively, the orthotic device 106 can be manufactured on-site (e.g., using 3D printing or other on-site custom manufacturing techniques) and specifically sized for the patient. For example, a 3D scan of the patient can be performed, and a custom model of the orthotic device 106 can be manufactured for the patient based on the measurements from the scan.

[0105] Next, the patient can undergo initial training exercises (365), which can be conducted, for example, in a rehabilitation facility and under the supervision of a qualified BCI and / or rehabilitation specialist. The purpose of the initial training exercises is to determine which specific brain signals (which may include, for example, changes in baseline signal levels detected at one or more electrodes) the brain signal acquisition system senses as the patient plans and performs certain anticipated movements, thereby indicating a particular brain activity, and the amplitude and frequency of the sensed brain activity.

[0106] To conduct these initial training exercises, the patient can be prompted to attempt various finger movements, and the brain signals generated during the patient's preparation for and attempt to perform these tasks can be acquired and ultimately stored in the memory of the orthopedic device 106 and / or tablet computer 110. Finger movement cues can be provided by the tablet computer 110, for example, using a visual display provided on a desktop computer display device 112 and / or using other sensory cues generated by the orthopedic device 106 or tablet computer 110 (e.g., audio signal cues, tactile vibration cues, etc.). As these cues are provided to the patient, the brain signal acquisition system 104 continuously captures brain signal samples (amplitudes at various frequency levels) sensed at each of the multiple electrodes.

[0107] Initial training exercises may include several different calibration exercises during which specific brain signals are tested and various levels of feedback are provided to the patient. For example, in the first calibration exercise, the patient may be prompted / awakened to alternate between rest and generating ipsilateral brain signals (e.g., considering moving the right hand). This first calibration exercise may be configured to assess whether the patient is able to produce sufficient physiological changes in relation to previously identified control features(s). Such an assessment can be made by comparing the ipsilateral movement performed by the user with the rest time. No feedback may be provided to the patient during this first calibration exercise. In the second calibration exercise, the patient may be prompted / awakened to generate ipsilateral signals (e.g., considering moving the right hand) to control an object presented on the display 112 of the tablet computer 110, such as a stick that moves based on the intensity of the ipsilateral signals generated by the patient. In the third calibration exercise, the patient may be prompted / awakened to generate ipsilateral signals that will control the movement (e.g., turning on and off) of the wearable orthotic device 106. The prompts may be displayed on the display 112 of the tablet computer 110 and may be provided in the form of movement of the orthopedic device 106 as well as through sensory feedback (e.g., playing sounds, engaging vibrating tactile devices, delivering electrical stimulation) and / or other visual feedback (e.g., presenting information on the display 110). The sampling rate of the brain signal acquisition system 104 may be, for example, 256 Hz and / or 512 Hz.

[0108] The signal, containing a representation of the captured brain signals and other relevant information, can be wirelessly transmitted by the acquisition system 104 for direct reception by the wearable orthotic device 106 or received by the orthotic device 106 via the tablet computer 110. The brain signal data received by the acquisition system 104 can be any of a variety of suitable forms, such as amplitude, power modulation, phase changes, changes in event-related potentials, and / or changes in the raw time series of the signal.

[0109] Brain signal information received in the wearable orthotic device 106 and / or tablet computer 110 can be time-stamped in some way (e.g., by timestamps) and stored in the memory of the wearable orthotic device 106 and / or in the tablet computer 110. For example, this allows the timing of the acquired brain signals to be correlated with the timing of various cues given to the patient. After a series of training cues are completed (and the brain signals and timing information are stored in memory as described), the acquired data can be transmitted from the orthotic device 106 or the tablet computer 110 to the central rehabilitation management system 116 for evaluation and processing.

[0110] Typically, the central rehabilitation management system 116 can perform computer processing (370) on the data to determine specific characteristics (e.g., which specific electrodes and the amplitude and frequency of the signal) of the brain signals generated by the patient when the patient plans and attempts to perform various finger movements prompted by the patient. The central system 116 can then determine (370) appropriate parameter settings and / or control characteristics to be used by the orthopedic device 106 and the associated tablet computer 110 based on the determined brain signals, which may include variations in electrode specifications, frequency bands, and / or signal power or amplitude. The central computer 116 can perform this analysis and feature selection using at least part of the input from a technician.

[0111] The central system 116 can then transmit these parameter settings to the tablet computer and / or wearable orthotic device 106, enabling their use during the patient's rehabilitation exercises. In some embodiments, the information transmitted to the orthotic device 106 and / or its associated tablet computer 110 may include instructions such as a series of recommended rehabilitation sessions for the patient (e.g., optimal type and manner) and other configurable settings such as time limits between sessions.

[0112] Using the brain signal acquisition system 104, the wearable orthotic device 106, and the tablet computer 110, patients are now able to perform rehabilitation exercises. Due to the portable nature of the wearable orthotic device 106 and the tablet computer 110, patients can perform rehabilitation exercises outside of a rehabilitation clinic. For example, patients can exercise at home. It is believed that such home-based rehabilitation contributes to rehabilitation effectiveness. For example, the portability and wearability of system 110 can increase the number of opportunities to use system 100, which can increase the number of repetitions performed by the patient using system 100. It is believed that such an increase in the number of repetitions is positively correlated with improved functional outcomes for the patient. Furthermore, the portability and wearability of system 100 allow for its use and integration into the patient's daily life, which can allow the patient to perform environment-dependent rehabilitation tasks (e.g., folding clothes, opening doors, picking up and tidying up items) rather than mechanical processes (e.g., repeatedly opening and closing hands without a specific purpose). Such environment-dependent rehabilitation tasks are also believed to have a positive impact on the patient's functional outcomes. Combined, the ability to use System 100 more frequently and in the context of a patient's daily life to perform physical tasks may enhance brain plasticity and rehabilitation benefits beyond the classic inpatient setting with a predetermined treatment cycle.

[0113] In order to establish Figure 3B The rehabilitation session generally illustrated in the diagram (385, or alternatively 380 and 385) involves the patient first wearing a brain signal acquisition system 104 (e.g., an EEG headset) and having electrodes 118 (see [link to diagram]). Figure 1B Position and secure the electrodes in a suitable location close to the skin near the brain. Ideally, the electrode placement will be similar to that during rehabilitation, as in training exercises, but this may not be possible in some cases. Additionally, since previous treatment sessions (385) and / or training sessions (in... Figure 3B Since the events of 365, 370, and 375, the subject may have experienced changes in brain signals. For these reasons, a calibration process (380) can be utilized, as will be discussed in more detail below. The patient then places the wearable orthotic device 106 on his or her forearm and hand as previously described, i.e., by securing the main housing structure 124 to the forearm and hand and positioning the thumb and securing the index and middle fingers, as... Figure 1D As shown. The patient can then activate (turn on) the brain signal acquisition system 104, the wearable orthosis 106, and the tablet computer 110 to begin a rehabilitation session.

[0114] The rehabilitation session (385) can be conducted in several ways. In one scenario, the patient can perform any desired finger movement of the type involved in the training session, for example, in a BCI operating mode. For instance, the patient might initially wish to perform ten repetitions of bending and extending the index / middle finger pair. In this example, the patient first attempts to bend the finger pair and generates certain brain signals corresponding to the planning and execution of that finger pair movement while doing so. Throughout the rehabilitation session (385) when operating in BCI mode, the brain signal acquisition system 104 acquires periodic samples of brain signals and wirelessly transmits these samples to the tablet computer 110 and / or wearable orthosis 106 for evaluation (e.g., 256 or 512 samples per second). Each sample may include a set of information including parameters (e.g., amplitude, frequency) of the signal sensed at each of the multiple electrodes. The BCI component (provided in the wearable orthosis 106 or tablet computer 110) processes those brain signal samples to determine the patient's intention. If and when the BCI component detects that the patient has generated a brain signal instructing the patient to flex the index and middle finger pairs, the BCI component will generate a control signal that activates the orthopedic device 106 to assist or induce movement of the patient's index and middle finger pairs.

[0115] During a rehabilitation session (385), continuous feedback can be provided to the patient via tablet computer 110 and / or wearable orthotic device 106. Feedback can take several forms and enhance the overall effectiveness of the rehabilitation session. Typically, feedback provided to the patient in BCI operating mode can take the form of visual, auditory, tactile (e.g., vibratory tactile), and / or electrical stimulation that supplements the control response. One example of feedback in BCI operating mode is providing the patient with an indication that a specific intention has been detected. One example way this can be done is by tablet computer 110 generating a visual display (on display device 112) that, for example, shows that a specific intention has been detected by a BCI component (e.g., performing a flexing movement of the index / middle finger pair). The patient can easily see that system 100 has detected this specific intention on a display device that is conveniently positioned, for example. Another example way feedback can be presented in BCI operating mode is by orthotic device 106 and / or tablet computer 110 generating sound (e.g., using a speaker included in tablet computer 110 or implemented in orthotic device 106). For example, tonal or recorded verbal feedback may be generated (such as a recorded voice saying "open your hand"). Another example of how feedback can be presented in BCI operating mode is by using tactile feedback and / or electrical stimulation with wearable orthotic device 106. For example, upon recognizing the user's intention to open his / her hand, wearable orthotic device 106 may provide the user with tactile (e.g., vibratory tactile) feedback and / or provide electrical current to the user's hand. In some implementations, multiple forms of feedback in BCI operating mode may be provided to the user simultaneously. For example, the simultaneous presentation of visual, auditory, tactile, and / or electrical feedback can simultaneously stimulate multiple areas of the patient's brain and may promote neuroplasticity.

[0116] In some implementations, the rehabilitation session (385) may include prompts / reminders instructing the patient to perform specific actions using system 100. Typically, prompts / reminders may include one or more visual, auditory, and / or tactile elements. For example, display device 112 may display prompts for the patient to move his / her right hand (e.g., open his / her right hand, close his / her right hand), move his / her left hand, and / or rest. Tablet computer 110 may generate prompts to be displayed on display 112 (and / or output to the user via one or more other output mechanisms, such as speakers and / or tactile devices as part of wearable orthosis 106) based on various factors, such as a predetermined treatment plan generated by central rehabilitation management system 116, the user's current progress (e.g., number of repetitions performed, progress along the treatment plan), and / or information obtained by sensors of wearable orthosis 106 (e.g., the level of force detected by pressure sensors in wearable orthosis 106 indicating the extent to which the patient drives movement of wearable orthosis 106 and / or the appearance or recurrence of brain signals or features detected by brain signal acquisition system 104).

[0117] In some implementations, system 100 may also be configured to operate in a free-assist mode, during which the patient can use the wearable orthotic device 106 to perform tasks in the patient's daily living environment. During free-assist mode, the wearable orthotic device 106 may be configured to operate in a non-cue BCI operating mode, wherein brain signals detected by the brain signal acquisition system 104 are continuously interpreted to determine what action the user wishes the wearable orthotic device 106 to perform (if any), such as opening and / or closing the hand on which the wearable orthotic device 106 is mounted. System 100 may provide a user interface (e.g., on an easily locatable display) that provides feedback to the patient regarding the type of action the BCI component has determined the user's intention to perform based on brain signals detected by the brain signal acquisition system 104. The wearable orthotic device 106 may be configured to perform actions (e.g., closing or opening fingers) that the wearable orthotic device 106 determines the patient intends to perform, enabling the patient to interact more fully with his / her environment using the body part (e.g., hand) on which the wearable orthotic device 106 is mounted. For example, during the free-assist mode, the patient can generate brain signals that cause the wearable orthotic device 106 to close and open the patient's left hand when needed, in order to open and close doors, pick up objects around the patient's home, fold laundry, and perform other daily tasks. As described above, the use of the wearable orthotic device 106 in such environments in the patient's daily life can enhance the patient's rehabilitation.

[0118] With this type of feedback, for example, if a patient anticipates a specific movement and the BCI-based rehabilitation system 100 does not respond by assisting the patient in performing that movement, the patient will immediately know that the problem lies in the system 100 not detecting the patient's intention, rather than some other problem. One reason for not detecting the intention might be the electrodes 118 of the headset 104 (…). Figure 1B The brain signals may not be in their correct positions, and repositioning can resolve the issue. Another reason for undetected intent may be that the patient's brain signals evolve over time during recovery through a process called brain plasticity, in which neural pathways are reorganized. In many cases, this can be a positive development for the patient, as additional or different brain activity is occurring to compensate for brain regions damaged by the stroke. For example, specific characteristics can be associated with these plastic changes, such as amplitude variations in specific frequency bands or changes in phase interactions between two cortical sites. Therefore, performing a calibration process (e.g., Figure 3B (380) is appropriate for updating system 100 regarding the brain signals generated by the patient in response to a specific finger movement intention.

[0119] To perform the calibration procedure (380), the patient can perform a new training procedure similar to, or a simplified version of, the procedure performed during setup. This calibration procedure can be guided by the wearable orthotic device 106 and its associated tablet computer 110 (e.g., using an appropriate display on display device 112). For example, system 100 can guide the patient through several finger exercises, during which brain signal information is acquired and stored in memory, for example, on the wearable orthotic device 106 and / or on the tablet computer 110. At the end of the calibration procedure, the patient can initiate a process in which the data acquired during the calibration procedure is transmitted via network from the tablet computer 110 and / or the orthotic device 106 to a central rehabilitation management system 116. The central system 116 can evaluate this data as previously described in conjunction with the initial training procedure, and once the evaluation is complete, an update, including updated operating parameters, is transmitted to the tablet computer 110 and / or the wearable orthotic device 106 for use in the next rehabilitation session. Therefore, the calibration procedure can be performed remotely at any rehabilitation clinic where the central system 116 is located or operates.

[0120] Another example of feedback that system 100 can provide to the patient relates to the state of a specific rehabilitation session, and even more generally, to the state of achieving certain goals of the overall rehabilitation effort. Typically, information can be provided in association with measurement characteristics and phenomena from wearable orthotic device 106 and brain signal acquisition system 104. For example, feedback provided to the patient may include information associated with repetitions during one or more rehabilitation sessions, as well as the time of day and duration of use, which can be derived from wearable orthotic device 106. Furthermore, information associated with changes that may occur in the patient's brain physiology can be measured, recorded, and presented (e.g., in the form of a graphical representation showing an increase or decrease in signals associated with task performance or signals unrelated to the task but associated with rehabilitation outcomes). For example, for a specific rehabilitation session, system 100 may record the number of repetitions of a specific finger movement that the patient has completed and display that number to the patient on display device 112. System 100 may also identify and display suggested exercises for the patient. Additionally, system 100 may sense and display the magnitude of the force that must be applied to the finger to assist the desired movement. For example, if less and less force is needed to assist the desired movement, this may indicate to the patient that the rehabilitation work is making progress. System 100 can also display, for example, a summary report of all exercises performed during the rehabilitation session at the end of the session, as well as an overall assessment of the patient's progress toward a specific goal in the rehabilitation work.

[0121] Now for reference Figure 3C It provides a treatment session with multiple operating modes (385, Figure 3BExample implementation of the following. In this example, the three operating modes are (1) Continuous Passive Motion (“CPM”) therapy operating mode; (2) Willpower operating mode; and (3) BCI operating mode.

[0122] Figure 3C The treatment session (385) shown begins at 386, where an operating mode is selected. The operating mode can be selected automatically, as programmed in the rehabilitation system, for example, where the rehabilitation system can be programmed to cycle through various operating modes during the treatment session. Alternatively or additionally, the operating mode can be selected by the user, for example, by the patient or clinician using a computer user interface to input the selection of the operating mode to be performed.

[0123] If the CPM operating mode is selected at (386), the procedure proceeds to 387, where treatment is performed in CPM mode. In CPM mode, for example, the orthotic device 106 can be operated to perform multiple repetitive exercises in multiple sets without requiring voluntary movement of the patient (e.g., Figure 1A The example shows hand exercises, which are used as part of a rehabilitation program to "work" on body parts.

[0124] If the will-operation mode is selected at (386), the process proceeds to 388, where treatment is performed in what may be called the will-operation mode. For example, in the will-operation mode, the patient may be prompted by visual instructions, such as moving the affected body part. The system may monitor the subject's response, for example, whether the prompted action has begun and continues to be completed, and if the system detects that the subject cannot begin or complete the exercise, the orthotic device 106 may take over and assist the subject in completing the exercise. For example, if the system detects that the subject has not begun the exercise within three (3) seconds of the prompt to perform the exercise, the system may be triggered to prompt the orthotic device 106 to assist in performing the exercise. Furthermore, if the patient does begin the exercise but cannot perform it to the desired extent (e.g., in a hand extension exercise, the subject is unable to extend his or her fingers by the programmed amount), the system may then allow the orthotic device 106 to assist in performing the exercise to the desired extent after allowing the subject sufficient time to reach the desired goal on their own.

[0125] If the BCI operating mode is selected at (386), the procedure proceeds to 389, where treatment is performed in the BCI operating mode. In this case, the system can operate in the BCI operating mode as previously described, wherein the subject's intent is determined and the orthopedic device 106 operates accordingly.

[0126] After a treatment session is completed in one operating mode, it is determined at 390 whether the treatment session is complete. If complete, the treatment session ends. If not complete, the treatment session process can then return to the selection of the next operating mode at 386, where the process can continue in the same or a different operating mode.

[0127] Figures 4-8 show Figures 2A-2B More details of the orthopedic device (right-hand type) 206 shown. Specifically, Figures 4A-4G This is a schematic diagram of the entire orthopedic device 206, in which... Figure 4A It's a 3D image. Figure 4B It is a side view. Figure 4C This is the remote end view. Figure 4D It's a top view. Figure 4E (and Figure 4G This is an exploded view showing the various parts and components of the orthopedic device 206, and Figure 4F This is a perspective view of the upper shell 445 of the main housing structure 124 of the orthopedic device. Figure 5A Figure 5F is a diagram of orthopedic devices 106 and 206 without thumb strut assemblies 134 and 234, in which... Figure 5A It is a side view. Figure 5B This is the remote end view. Figure 5C It is a top view. Figure 5D Figure 5(and Figure 5F) is an exploded view showing the various parts and components, while Figure 5E is a perspective view of the flexible intermediate structure 128. Figures 6A-6H This is a schematic diagram of the connection and FSM component 130, in which Figure 6A It's a 3D image. Figure 6B It is an exploded view showing its individual components. Figure 6C This is a perspective view of component 130 without its upper shell 460, and for clarity, its parts are shown as transparent. Figure 6D This is another perspective view of component 130 without its upper shell 460, and Figure 6E-6H This is a diagram illustrating the operation of component 130 and similar components. Figures 7A-7B This is a schematic diagram of the finger support component 122, in which... Figure 7A It is its perspective view, and Figure 7B This is an exploded view of its various components. Figure 8 is a schematic diagram of a portion of the right thumb strut assembly 234, showing only the exposed part when connected to the rest of the orthopedic device.

[0128] Typically, the orthopedic device 206 can be made of durable, lightweight materials (e.g., plastic for rigid components and rubber or similar materials for flexible components) and can be manufactured using technologies such as factory-based machining or injection molding, factory-based or on-site 3D printing, and / or other suitable manufacturing techniques.

[0129] First look Figure 4A The diagram illustrates an orthotic device 206, which includes a main housing structure 124, a flexible intermediate structure 128, a connection / FSM assembly 130, a finger strut assembly 122, and a right thumb strut assembly 234, the orthotic device 206 being combined as previously described. Figure 1A , Figure 1D and Figures 2A-2B Configured and designed as described above. Also, Figure 4A As shown, a push-button power switch 442 is located near the end / top of the main housing structure 124. This switch 442 is operated to activate the power supply in the orthopedic device 206 to operate its electronic and motor components. Furthermore, in this exemplary embodiment, a battery charging port 444 is also located near the end of the main housing structure 124, close to and directly below the power switch 442.

[0130] like Figure 4B As shown and Figure 4E As shown in the exploded view, the main housing structure 124 includes an upper housing 445 and a lower housing 446, in which a linear actuator 474 (such as...) is formed. Figure 4E The chamber (shown). The upper shell 445 and lower shell 446 may be provided with a snap-fit ​​function around their respective outer peripheries, so that the two parts 445, 446 can be fixed or assembled together. As a unit, the upper shell and lower shell 446 are designed and configured to be worn on the upper or back side of the forearm of the main body, such as Figures 2A-2B As shown in the image.

[0131] The main housing structure 124 also includes a forearm support 447 and an internal foam layer 448 applied thereto (see...). Figure 4A , Figure 4E and Figure 4G This device is designed and configured to be worn on the underside or ventral side of the forearm. In this example, the width of the forearm support 447 and the associated foam layer 448 is approximately the width of the forearm, and the length is approximately the same as or slightly shorter than the length of the upper shell 445 and the lower shell 446, such that the forearm support 447 and the associated foam layer 448 extend from a proximal end located approximately midway between the elbow and wrist when worn to a distal end when worn in the palm of the hand. The forearm support 447 may be located at position 441 (see...). Figure 4B A slight bend is provided at the position 441, which is located approximately on the ventral side of the wrist when worn, and thus the forearm support 447 and the associated foam layer 448 serve to maintain the wrist in a slightly extended orientation.

[0132] Adjustable straps 140 (specifically, three straps 140a, 140b, and 140c in this example) are provided to connect the upper shell 445 and the lower shell 446 to the forearm support 447 and the associated foam layer 448, and to secure the forearm and part of the body hand between them. Straps 140a, 140b, and 140c are connected to the upper shell 445 on one side of the orthopedic device 206. They extend downward from the upper shell and enter the openings of three corresponding lateral strap channels 450a, 450b, and 450c in the forearm support 447 located on the same side of the orthopedic device 206. They extend laterally through the forearm support 447 to the opposite side of the orthopedic device 206 and extend out of the lateral strap channels 450a, 450b, and 450c of the forearm support 447. Finally, they extend upward on the opposite side of the orthopedic device 206 to the opposite side of the upper shell 445, where the straps are connected to the upper shell 445.

[0133] In this example, straps 450a, 450b, and 450c are connected to the upper housing 445 by means of six strap retainers 449a-449f disposed on the outside of the upper housing 445 (see Figure 4B-4E Three strap retainers 449a-449c are located on one side of the upper housing 445, while three strap retainers 449d-449f are located on the opposite sides of the upper housing 445, as shown below. Figure 4D As best shown in the example. In this example, the strap retainer may include pins 492a-492f and pin retainers 493a1-493a2-493f1-493f3, as... Figure 4F The best illustration shows only the pins 492a, 492b, 492c and pin retainers 493a1-493a2, 493b1-493b2, 493c1-493c2 located on one side of the upper housing 445. In this example, one end of the straps 140a, 140b, 140c can extend through and around the three corresponding pins 492a, 492b, 492c and be permanently secured to a portion of the straps (therefore the straps on the side of the orthopedic device 206 are not adjustable), while the other end of the straps 140a, 140b, 140c can extend through and around the three corresponding pins 492d, 492e, 492f and be detachably secured to a portion of the straps on that side (therefore the straps on the side of the orthopedic device 206 are adjustable). The straps 140a, 140b, and 140c can be hook-and-loop type, thus having an adjustable overlap on one side of the strap (e.g., the overlap 451a of strap 140a, such as...). Figure 4C and Figure 4E (as shown in the image).

[0134] like Figure 4BAs shown, the thumb strut assembly 234 includes: a proximal segment 452, the proximal end of which is rotatably connected to one side of the upper housing 445, and an intermediate joint 454 movably connected to the distal end of the proximal segment 452; a distal segment 453, the proximal end of which is movably connected to the intermediate joint 454; and a thumb interface component 455 rotatably connected to the distal end of the distal segment 453. Figure 4G As shown, the proximal segment 452 of the thumb strut assembly 234 is rotatably connected at its proximal end to an elongated connector portion 483 via a rotatable joint 484, which connects the thumb strut assembly 234 to the lower housing 445 of the main housing assembly. Specifically, the connector portion 483 of the thumb strut assembly fits into a recess formed by a laterally extending notch structure 479 formed in the bottom portion of the lower housing 446, as shown. Figure 4G As best shown (and received by a corresponding recess 469 provided on the lower side of the upper shell 445, as...) Figures 4E-4F (As best shown in the diagram), and the connector portion 483 has a fastening plate 485 including a screw hole located in the fastening plate 485, which extends from the connector portion 483 to secure the connector portion 483 to the lower housing 446, thus the connector portion 483 is secured within and to the recessed structure 479 of the lower housing 446. Due to the rotatable joint 484, the proximal segment 452 is rotatable relative to the connector portion 484 secured to the lower housing 446. The intermediate joint 454 is configured such that the distal segment 453 is adjustable with two degrees of freedom relative to the proximal segment 452. Furthermore, the thumb interface component 455 is configured to be rotatable relative to the distal segment 453. Therefore, the thumb strut assembly 234 can be sufficiently adjusted during rehabilitation sessions to accommodate different anatomical structures and position the thumb of the subject in the desired position, typically in the extended position. Furthermore, the groove or notch structure 479 of the thumb strut assembly and the connector portion 483 are designed such that, for different applications, the right thumb strut assembly 234 can be used with orthopedic devices or alternatively, the left thumb strut assembly 134 can be used (and a corresponding notch similar to notch 441 is also provided in the opposite lower side of the upper housing 445 to accommodate, for example, on the other side...). Figure 1A and Figure 1D The left thumb strut assembly (similar to assembly 134) is included. Apart from the thumb strut assembly 134 / 234, the remaining components of the orthotic device 106 / 206 are identical in both right-hand and left-hand applications.

[0135] As mentioned above and as Figure 4BAs shown, the orthopedic device 206 has a flexible intermediate member 128 with a baffle structure comprising a plurality of baffle members 456, seven in this example, each oriented substantially perpendicular to the longitudinal axis of the upper limb. Push-pull lines 126 extend longitudinally through the baffle members 456 to compress and extend one side (i.e., the upper side) of the baffle members 456 to bend and extend the upper side of the flexible intermediate member 128, and thus the upper part of the baffle structure is compressed (for upward orientation, e.g.) Figure 2A (as shown) or extend (for downward orientation, such as) Figure 2B (As shown), this allows the distal end of the flexible intermediate structure 128 to be oriented further upwards or downwards. The push-pull line 126 is connected at its proximal end to the linear actuator 474 (see...). Figure 4E The linear actuator 474 operates to push and pull a line to achieve bending and extension of the flexible intermediate member 128, thereby achieving bending and extension of (a plurality of) fixed fingers. The push-pull line 126 is connected at its distal end to a finger interface assembly. The finger interface assembly in this example includes two components: a connection / FSM assembly 130 connected at the distal end of the flexible intermediate member 128, and a finger strut component 122 having a longitudinally slidable connection and fixed to at least one finger of the body at the underside of the connection / FSM assembly 130.

[0136] As described above, the baffle structure of the flexible intermediate structure 128 also has a generally flat bottom structure 132, which is configured to attach to the bottom or hand side of each individual baffle member 456, while the opposite or top side of each individual baffle member is not so constrained, and thus can be freely compressed closer or further separated by operating the push-pull line 126 to expand and / or reduce the top side distance between the distal end of the main housing structure 124 and the proximal end of the connection / FSM module 130. Also as in Figure 4B As shown, the force-sensing resistor connector cable assembly 457 extends through each baffle member 456, and through an opening formed in the end plate 495 and through an opening 518 formed in the distal end wall 480 (see Figure 1). Figure 4G (and Figure 5F) to connect the force-sensing resistor provided in the connection / FSM assembly 130 (described below) to the electronic equipment provided in the main housing structure 124, namely, PCBA 471 (see Figure 5F). Figure 4G The flexible intermediate structure 128 also includes, for example, Figure 4B The distal connection portion 458 shown is fixedly connected to the proximal end of the connection / FSM assembly 130.

[0137] Still referencing Figure 4BThe connection / FSM assembly 130 includes a central support 459 fixedly attached to the distal end of the distal connection portion 458 of the flexible intermediate structure 128, and two fixedly connected shells (upper shell 460 and lower shell 461) pivotally connected to the central support 459, as will be discussed later. Figures 6B-6H The connection / FSM assembly 130 has a bottom surface configured to engage with the finger strut component 122 in a longitudinally slidable configuration, as discussed. Figures 6B-6H and Figure 7B As mentioned above, this will be described below. Figure 4B As shown, a finger support component 122 is provided, wherein an upper elongated plate-shaped finger engaging assembly 462 is positioned above two fixed fingers during use, while a lower elongated plate-shaped finger engaging assembly 463 is positioned below the two fixed fingers during use. As previously described, two adjustable straps 123a, 123b are provided with two finger engaging assemblies 462, 463 to secure assemblies 123a, 123b to the index and middle fingers, wherein in use, assemblies 123a, 123b are fixed as a unit between the two assemblies 462, 463. Further details of the finger support component 122 are provided in... Figures 7A-7B It is provided in [the document], which will be described below.

[0138] Figure 4C An end view of the orthopedic device 206 is provided from a distal vantage point, thus showing further details of the connection / FSM assembly 130 and the finger strut component 122, especially from a distal angle. Figure 4C Also shown is a portion of a thin sleeve 464 disposed on the upper part of the finger strut component 122, for longitudinally slidable connection with a guide rail structure ( Figure 4C (Not shown in the image) Joining. Figure 4C The diagram further illustrates the thumb strut assembly 234 and how it extends from the side of the main housing structure 124, particularly the curved configuration of the thumb interface component 455, which is designed to provide a comfortable thumb contact portion 238 on the thumb interface component 455 to hold the thumb in a fixed and extended position during rehabilitation sessions, as shown in the illustration. Figures 2A-2B As shown in the image.

[0139] Figure 4D A top view of the orthopedic device 206, taken from an advantageous position above it, is provided. Among other things, the view shows further details of the positioning of all six strap retainers 449a-449f, with three strap retainers 449a-449c located on one side of the upper shell 445 of the main housing structure 124, and the other three strap retainers 449d-449f located on the opposite side of the upper shell 445 of the main housing structure 124.

[0140] Figure 4EThis is an exploded view of the orthopedic device 206, showing details of the device components, while Figure 4G It is shown Figure 4E A second exploded view showing further details of the portion shown. (Reference) Figure 4E A power switch washer 465 can be provided for the push-button switch 442 to power the device 206. The push-button switch 442 and the associated washer 465 are assembled into and connected to the opening 468 in the upper housing 445 (see also...). Figure 4F (Details of the upper shell 445 are shown). Still refer to Figure 4E It provides connector jack 466 and charging port 444 (see...) Figure 4B The cylindrical plug washer 467, and the connector socket 466 and the cylindrical plug washer 467 are assembled into and connected to the second opening 443 in the upper housing 445, which is located near the end of the housing 445, directly below the power switch 442. Figure 4B and Figure 5A As shown in the image. Figure 4E Also shown is a power cable harness 486 and a force-sensing resistor (“FSR”) connecting cable 487. As is known in the art, polyolefin heat shrink tubing 488, 489, 490 can be provided to protect various cables.

[0141] like Figure 4E As further shown, the linear actuator 474 is assembled on top of the lower main housing 446, and thus, when the upper housing 445 is connected to the lower housing 446, a closure is formed between the lower housing 446 and the upper main housing 445. In particular, now referring to... Figure 4G The lower main housing 446 includes an electronic housing portion 470 with an enclosed chamber accessible from the underside of the lower housing 446. Further details of the lower main housing 446 and the linear actuator 474 are provided in FIG. 5F. As shown in FIG. 5F, the electronic housing portion 470 is formed by two generally flat sidewalls 526a, 526b and two generally flat endwalls 526c, 526d, which extend upward from the lower plate 478 of the lower main housing 446, which is configured in a rectangular box shape. A top wall 502 is disposed on and connected to the top edge of the corresponding sidewalls 526a, 526b and endwalls 526c, 526d, thereby forming a seal for the electronic devices within the walls 526a-526d and below the top wall 502.

[0142] Referring to Figure 5F, a bracket 501 is disposed on the top surface of a top wall 502. The bracket is provided for mounting a linear actuator 474 therein. Specifically, the bracket is formed by a vertically extending wall positioned approximately corresponding to the periphery of the stationary linear motor portion 476 of the linear actuator 464. The linear actuator 474 includes the aforementioned linear motor portion 476, which remains stationary within the bracket 501, and a linear actuator arm 477 extending from a distal opening in the motor portion 476 of the actuator 474 and, under the control of the stationary motor portion 476 of the linear actuator 474, moving linearly in a piston-like manner away from (distal direction) and towards (proximal direction) the linear motor portion 474. In this example configuration, the motor portion 476 of the linear actuator 474 is provided with a tab-shaped alignment guide 504 having a through vertical hole. The vertical hole in the tab-shaped alignment guide 504 engages with a mounting alignment post extending upward from the top wall 502 of the electronic housing portion 470 to position the linear actuator 474 and secure it in place at the top of the electronic housing portion 470 of the lower housing 446.

[0143] Now for reference Figure 4E , Figure 4G and Figure 5D Connector 475 is located at the distal end of linear actuator arm 477 (this connector 475 is screwed into the distal internal thread opening 505 in arm 477). The purpose of connector 475 is to connect arm 477 to push-pull cable 126, as previously described, which extends through flexible intermediate structure 128 and is attached to connection / FSM assembly 130. Figure 5D As shown, the connector 475 is secured to the push-pull cable 126 by inserting the proximal end of the cable 126 into the corresponding distal opening in the connector 475 and pressing the cable 126 into the distal opening of the connector 475 using a positioning screw 506 inserted into a side hole 507 in the connector 475. At its distal end, the push-pull cable 126 is fixedly connected to a spool collar 508, which in turn is fixedly connected to the central support 459 of the connection / FSM assembly 130. The connection between the cable 126 and the spool collar 508 can be achieved by inserting a positioning screw 516 into a side hole in the spool collar 508 to press the cable 126 into and secure it therein.

[0144] A sandwich-configured printed circuit board assembly (“PCBA”) 471 and battery pack 494 are provided within the cavity of the electronic housing portion 470. Specifically, the PCBA 471 and battery pack 494 have a generally similar shape configuration (typically a flat rectangular box), with their peripheries generally corresponding to the rectangular shape of the cavity disposed in the electronic housing portion 470 of the lower housing 446. This configuration is important in providing the orthopedic device 206 with a shape factor that allows the device to be worn comfortably and easily on the forearm of the body in a fully portable manner.

[0145] PCBA 471 can be connected via screws such as 496 (see...). Figure 4G Any suitable fastening device, such as a screw 496, is fixed to the inner surface of the top wall 502, the screw 496 extending through the corresponding screw hole 440 in the PCBA 471 and the screw hole in the top wall 502 of the electronic housing portion 470. Figure 4E and Figure 4G And also as Figure 5D As shown, a battery retainer clip 473 with a generally rectangular configuration (its dimensions roughly correspond to the dimensions of the cavity of the electronic housing portion 470) is provided within the cavity of the electronic housing portion 470 sandwiched between the PCBA 471 and the battery pack 494, and thus abuts against the lower surface of the PCBA 471 and the top surface of the battery pack 494. The retainer clip may have an opening formed therein as shown, thereby enabling an electrical connection between the PCBA 471 and the battery pack 494 via an electronic wiring harness 498. Finally, a battery cover / retainer 472, also with a generally rectangular configuration (its dimensions roughly correspond to the dimensions of the cavity of the electronic housing portion 470), is removably secured to the bottom of the electronic housing portion 470. The battery cover / retainer 472 can be secured to the underside of the lower main housing 446 by any suitable fastening device such as a screw 523, which can be secured to a corresponding threaded insert 524 (see Figures 5G and 5F).

[0146] refer to Figure 4G As shown in Figure 5F, the distal wall 480 is integrally formed with the lower main housing 446 and provides a distal connection structure for fixing the main housing structure 124 to the flexible intermediate structure 128. In this case, the distal wall 480 is a generally vertically configured wall structure located at a position spaced apart from (and away from) the electronic housing portion 470 of the lower housing 446. Integral with the lower main housing 446 is a centrally vertically and longitudinally extending support wall 481, which extends from the proximal surface of the distal wall 480 and the distal outer surface of the electronic housing portion 470 (specifically, the distal surface of the end wall 526c of the electronic housing portion 470). Referring specifically to Figure 5F, the distal wall 480 has a small circular opening formed at its upper portion to accommodate a push-pull wire 126 extending therethrough (see Figure 5F). Figure 4G Additionally, the tubular wire guide 482 can be longitudinally fixed to the proximal surface of the distal wall 480 and its cavity aligned with the wire opening 510 in the distal wall 480. Low-friction tubular wire guide 509 (see...) Figure 5D It can be placed inside the cavity of the tubular wire guide 482 to reduce or eliminate any friction that may be encountered when pushing or pulling with the push-pull wire 126.

[0147] Still referencing Figure 4G The diagram shows a flexible intermediate structure 128 having a proximal vertical end plate 495, sized and configured such that its proximal surface mates with the distal surface of the distal end wall 480 of the lower main housing 446. (Reference) Figure 5D As shown in Figure 5F, the proximal surface of the end plate 495 has two prongs 514 extending proximally from the end plate. These prongs are received in corresponding openings 513 provided in the distal end wall 480 of the lower main housing 446 to securely fasten the end plate 495 to the distal end wall 480 and thus securely fasten the flexible intermediate structure 128 to the main housing structure 124. Each of the two prongs 514 has a transverse screw hole 522 formed therein (see Figure 5E), as does the central support wall 481 at a corresponding location (not shown), so that screws 519 and threads 525 can be used to fasten the end plate 495 to the distal end wall 480.

[0148] To provide a comfortable fit on the back of the forearm, the forearm padding layer 491 (see...) Figure 4G The forearm padding layer 491 is disposed on the lower surface of the lower main housing 446. The dimensions of the padding layer can be designed such that its periphery roughly corresponds to the periphery of the lower plate 478 of the lower housing 446, wherein a gap is provided at the location of the notch structure 479. The forearm padding layer 491 can be secured to the underside of the lower plate 478 of the lower main housing 446 using a fastening mechanism 497 (such as screws and corresponding nuts).

[0149] Figure 5E shows details of a flexible intermediate structure 128 having seven horizontally spaced baffle members 456. These baffle members 456 have a flat and flexible bottom structure 132 integrally formed and connected to each of the baffle members 456, the proximal vertical end plate 495 (configured to connect to the distal end of the main housing structure 124), and the distal connecting portion 458 (configured to connect to the proximal end of the connection / FSM assembly 130). As can be seen in Figure 5E, each of the vertical end plate 495, baffle members 456, and distal connecting portion 458 has aligned and longitudinally extending holes or cavities 511, 512 extending through them to accommodate a longitudinally extending push-pull line 126. As shown, low-friction tubular members can be provided in the holes or cavities 511, 512. Furthermore, each of the baffle member 456, the proximal plate 495, and the distal connection portion 458 has a second set of aligned and longitudinally extending holes or cavities 499, 515 extending therethrough to accommodate the force-sensing resistor connector cable assembly 457 (assembly 457, for example, in...). Figure 4G and Figure 5D (as shown in the image).

[0150] As previously described, the central support 459 of the connection / FSM assembly 130 is fixedly connected at its proximal end to the distal connection portion 458 of the flexible intermediate structure 128 (see...). Figure 5D -Figure 5E). The mechanism for securing the central support 459 to the distal connecting portion 458 can be referenced. Figure 5D Understood. Figure 5D As shown in Figure 5E, the central support member 459 has two proximal prongs 517 configured to insert into and engage with two corresponding openings 520 formed in the distal end of the distal connecting portion 458. Each of the two prongs 517 has a vertical opening 521 formed therethrough, which is received by a retaining screw 525. The retaining screw 525 can be placed into the opening 521 of each of the two prongs 517, and then the prongs 517 can be inserted into the openings 520 of the distal connecting portion 458. Once the prongs 517 are thus inserted into the openings 520, a screw 519 can be inserted through a screw hole (not shown) formed through the underside of the distal connecting portion 458 and aligned with the opening 520. Screw 519 can therefore be screwed into retaining screw 525 located in opening 521 of pin 517, thereby securing pin 517 to opening 520 and thus securing central support 459 of connection / FSM assembly 130 to distal connection portion 458.

[0151] Now for reference Figures 6A-6H This provides details of the structure and operational diagrams of the connection / FSM component 130. First refer to... Figures 6A-6BThe diagram shows that component 130 includes a housing assembly comprising two fixedly connected shells (upper shell 460 and lower shell 461) and a central support 459. The housing assemblies of shells 460 and 461 are typically in the form of elongated, nose-like structures, generally tapering from their proximal to their distal ends. Upper shell 450 serves as a top cover for the housing assembly. This is achieved through a connecting structure (e.g., a ridge) 623 disposed on the distal inner surface of upper shell 460. Figure 6B (Not shown in the image) mates with a corresponding connecting ridge 622, which is formed on the top distal surface of the lower housing 461, and then fasteners (such as two screws 624a, 624b and corresponding two threaded inserts 631a, 631b) are used. Figure 6B Only 631b is shown in the diagram. The upper shell 460 can be aligned to connect with the lower shell 461. After the two shells 460, 461 are positioned relative to each other, two screws 624a, 624b can be pushed through the screw holes 630a, 630b in the upper shell 460 and further through the holes 625a, 625b in the lower shell 461, and the screws 624a, 624b are screwed together with the corresponding threaded inserts 631a, 631b (only 631b is shown) located on the underside of the screw holes 625a, 625b in the lower shell 461, thereby securing the upper shell 460 and the lower shell 461 together. (Except for...) Figure 6B , and see Figures 6C-6D ).

[0152] Still referencing Figure 6B And now we are also referring to Figures 6C-6D The central support 459 of component 130 is shown as including a vertically oriented proximal end plate 602 and an elongated extension 604 extending distally from the distally facing side surface 603 of the end plate 602. The elongated extension 604 serves as a carrier for two force-sensing resistors 615, 616 in a manner described below. The extension 604 includes two vertical sidewalls 609a, 609b, which are generally parallel to each other and extend distally from and substantially perpendicular to the distally facing surface 603 of the proximal end plate 602. The vertical sidewalls 609a, 609b may be integrally formed with the proximal end plate 602. At the distal portions of the two distally extending sidewalls 609a, 609b, the walls 609a, 609b are bent inward toward each other to form a curved vertical end wall 610 of the extension 604. The extension member 604 may be reinforced by two side support structures 611, each side support structure 611 being formed between the distal surface 603 of the proximal end plate 602 and a corresponding one of the sidewalls 609a, 609b, as shown below. Figures 6B-6D As shown.

[0153] like Figure 6BAs best shown, a horizontally oriented partition wall 612 extends between and is integrally formed with the two vertical sidewalls 609. This partition wall 612 separates the structures of the two force-sensing resistors (“FSRs”) 615, 616 from each other; or in other words, it separates a first FSR 615 (hereinafter referred to as the “top” FSR 615) that can be assembled above the partition wall 612 from a second FSR 616 (hereinafter referred to as the “bottom” FSR 616) that can be assembled below the partition wall 612. The horizontally oriented partition wall 612 extends proximally from the distal end wall 610 of the extension member and extends proximally therefrom until reaching a downwardly curved portion 614 of the partition wall 612, the downwardly curved portion 614 of which begins at approximately two-thirds to three-quarters of the distance from the vertical end wall 610 to the proximal end plate 602.

[0154] like Figure 6B As shown in the optimal configuration, the top FSR 615 can be assembled to rest on top of the FSR support surface 619 of the horizontal partition wall 612, which can be located on the distal portion of the horizontal partition wall 612. Specifically, the top FSR 615 rests on top of the support surface 619, abutting against the distal end wall 610 of the extension member and the distal portions of the side walls 609a, 609b of the extension member. Two leads 617a, 617b (in...) Figure 6C The lead wire (referred to as lead wire 617) serves the top FSR 615 and extends proximally from the top FSR 615 on the top of the horizontal partition wall 612, and eventually extends downward through the opening 613 provided between the partition wall 612 and the end plate 602.

[0155] Refer again Figure 6B The bottom FSR 616 can be assembled in the lower chamber 620 below the FSR support surface 619 and below the horizontal partition wall 612. The bottom FSR 616 can abut against the distal wall 610 of the extension member and the distal portions of the side walls 609a, 609b of the extension member. Two leads 618a, 618b (in Figure 6C The leads 617a and 617b (together referred to as leads 618) serve the bottom FSR 616 and extend proximally below the horizontal partition wall 612, and ultimately extend to connect with the leads 617a and 617b of the top FSR (i.e., after such leads 617a and 617b have extended downward through the opening 613) after such leads 617a and 617b have extended downward through the opening 613. Figure 6C (617) will meet, such as Figure 6B and Figure 6C As shown in the diagram. Two sets of leads 617a-b and 618a-b form a connector cable assembly 457, which extends proximally through an opening 629 formed in the proximal end plate 602 of the central support 459 (see Figure 1). Figure 6B ), and from there (now see) Figure 5D (Figure 5F) Cable assembly 457 extends proximally through openings 515 and 499 in the flexible intermediate structure 128 and further through opening 518 in the distal wall 480 of the lower housing. From there, connector cable assembly 457 continues proximally and extends within the electronic housing 470 of the lower main housing, within which connector cable assembly 457 connects to PCBA 471 (see Figure 5F). Figure 4E This provides the signal PCBA 471 sensed by the FSR 615, 616 for processing and control of the orthopedic device 206.

[0156] As previously described, the fixed upper shell 460 and lower shell 461 assembly has a pivotal connection to the central support 459, so that the two components—i.e., (1) the shells 460 and 461 fixed together, and (2) the central support 459—are able to swing forward distally and backward proximally relative to each other. Now refer to Figures 6B-6D In this configuration, the pivotable connection providing such oscillation is achieved via a lower housing 461, on which a pin 606 is provided. The pin 606 is supported by two pin retainers 607a and 607b, located proximal to the sides of the upper surface of the lower housing 461. Thus, during assembly, the pin 606 and the pin retainers 607a and 607b are located within the cavity formed by the upper housing 460 and the lower housing 461. Next, the central support 459 has two holes 605a and 605b formed by two vertically oriented sidewalls 609a and 609b passing through the extension 604 of the central support (see...). Figure 6B Only one hole 605a is shown. The pin 606 is assembled to extend through holes 605a and 605b, such that the upper shell 460 and lower shell 461, which are fixed together, can pivot up and down as a unit relative to the central support 459 (and specifically around the pivot point of the pin 606).

[0157] refer to Figures 6B-6D After the central support 459 is assembled with the upper shell 460 and the lower shell 461, the proximal end surface 627 of the lower shell 461 (particularly the bottom plate 621 of the lower shell 461) becomes located at the bottom 628 of the distal side surface 603 of the proximal end plate 602 of the central support, and spaced apart from it, such that when the central support 459 swings or pivots relative to the fixed upper shell 460 and lower shell 461, the lower shell 461 (including its proximal end surface 627) can move up and down relative to the end plate 602 of the central support 459. Additionally, from Figure 6BIt can be best seen and understood that the proximal edge 639 of the upper shell 460 is similarly located around the upper periphery and side periphery of the distal side surface 603, facing the distal side surface 603 of the proximal end plate 502 of the central support, and when the central support 459 swings or pivots relative to the upper shell 460 and lower shell 461 fixed together, the proximal edge 639 is spaced apart from the side surface 603, so that the upper shell 460 (including its proximal edge 639) can move up and down relative to the end wall 602.

[0158] like Figure 6B As can be seen from the image, cutout 626 can be formed in the proximal edge of the lower housing 461, including in the proximal end surface 627, to accommodate leads 617a-b, 618a-b (i.e., ...) when the central support 459 is assembled with the upper housing 460 and the lower housing 461. Figure 6C The connector cable assembly 457, marked with leads 617 and 618, extends through an opening 629 in the proximal plate 602 of the central support member. Figure 6B (marked in the middle).

[0159] Regarding the force sensing capability of the connection / FSM component 130, two force-sensing resistors (“FSR”) are used as buffers, buttons, or plungers 637a and 637b, such as Figures 6B-6D As shown. The first FSR buffer 637a is fixedly positioned on the lower surface of the upper shell 460, aligned with the top FSR 615, such that when the distal end of the central support 459 swings or pivots upward relative to the fixed upper shell 460 and lower shell 461, the upward-facing surface of the top FSR (i.e., its force-sensing surface) is... Figure 6E , Figure 6G and Figure 6H The second FSR 637b (marked 642) contacts and presses against the first FSR 637a. The second FSR 637b is fixedly positioned above and within the opening or recess 640 on the top surface of the lower housing 461, aligned with the bottom FSR 616, such that when the proximal end of the central support 459 swings or pivots downward relative to the fixed upper and lower housings 460 and 461, the downward-facing surface of the bottom FSR (i.e., its force-sensing surface) contacts and presses against the first FSR 637a. Figure 6E , Figure 6G and Figure 6H The part marked 641) contacts and presses against the second FSR buffer 637b.

[0160] When the distal end of the central support 459 swings or pivots downward relative to the upper shell 460 and the lower shell 461 (e.g. Figure 6GAs shown), the force sensing surface 642 of the first FSR 615 may no longer be in contact with the first buffer 637a; and when the distal end of the central support 459 swings or pivots upward relative to the upper shell 460 and the lower shell 461 (as shown), Figure 6H As shown), the force-sensing surface 641 of the second FSR 616 may no longer be in contact with the second buffer 637b. The swinging or pivoting of the central support 459 may be limited by the constraints imposed by the gaps between the two buffers 637a, 637b and their corresponding FSRs 615, 616. In some embodiments (such as...) Figure 6B In the embodiment depicted, such gaps are minimized to minimize the allowable amount of sway or pivoting, but the force sensing function of both FSRs remains effective.

[0161] like Figure 6B As shown, by using any suitable fastening mechanism (such as screws 635a, 635b), the thin sleeve bearing housing 601 can be securely attached to the lower surface of the lower housing 461. These fastening mechanisms extend through screw holes 636a, 636b in the lower housing 462 and into internally threaded screw receivers 634a, 634b in the corresponding sleeve bearing bracket 601, wherein the screws 635a, 635b threadedly engage with the screw receivers 634a, 634b to firmly secure the sleeve bearing brackets 601, 602 to the lower side of the lower housing 461. Figure 6B As shown, the sleeve bearing bracket 601 includes a longitudinally extending central portion 632 having a rectangular plate-like configuration and two longitudinally extending side rails 633a, 633b disposed on each lateral side of the central portion 632. As previously described, the side rails 633a, 633b provide the sleeve bearing bracket 601 (and thus the connection / FSR assembly 130 to which the sleeve bearing bracket 601 is fixedly engaged) with the finger support member 122 (see, for example...). Figure 4A The longitudinal slidable engagement between the two sides. This slidable engagement is in... Figure 6F The middle part is indicated by arrow B.

[0162] Therefore, the lower shell 461 of the connecting / FSM assembly 130 is connected to the finger support member 122 attached thereto in such a way that the angular orientation of the assembly 130 and the finger support member 122 remains fixed, while allowing the finger support member 122 to move or slide freely longitudinally relative to the lower shell. As previously described, the upper shell 460 is fixedly attached to the lower shell 461, and thus the movement of the upper shell relative to the finger support member 122 is the same as the movement of the lower shell 461 relative to the finger support member 122. In other words, the upper shell 460 and the lower shell 461 can move in space in a fixed angular relationship with the finger support member 122 while maintaining the upper shell 460 and the lower shell 461 fixed together. In other words, if the subject extends his or her finger upward, for example, causing the distal end of the finger to pivot upward, the distal ends of the upper shell and the lower shell 460, 461 fixed together will similarly pivot upward. In other words, while such upward pivoting may occur (maintaining a fixed angular orientation between the fixed shells 460, 461 and the finger support component 122), the fixed upper shell 460 and lower shell 461 may also move longitudinally (i.e., slide) relative to the finger support component 122, as previously described, which provides the subject with a comfortable wearing and use of rehabilitation systems and orthotic devices.

[0163] Furthermore, as previously stated, the central support 459 and the lower shell 461 are configured to "swing" relative to each other due to their pivotable connection. Therefore, the central support 459 is configured to "swing" relative to both the lower shell 461 and the upper shell 460. The direction of the "swing" of the upper shell 460 and the lower shell 461 relative to the central support 459 is longitudinal with respect to the arm of the body. As previously stated, the central support 459 is also fixedly connected at its proximal end to the distal end of the flexible intermediate member 128 (see...). Figure 4A This causes the central support 459 to move in a fixed relationship with the flexible intermediate member 128. Therefore, when the flexible intermediate member 128 is bent to extend its distal end upward, the central support 459 similarly extends upward in a manner in which the central support 459 is essentially a fixed extension of the distal end of the flexible intermediate member 128.

[0164] As discussed, the central support 459 carries two FSRs, namely, a top FSR 615 and a bottom FSR 616. The sensing surface 642 of the top FSR 615 faces upward toward a top buffer, button, or plunger structure 637a, which is fixed to the downward-facing inner surface of the upper housing 460. The sensing surface 641 of the bottom FSR 616 faces downward toward a bottom buffer, button, or plunger structure 637b, which is fixed to the upward-facing inner surface of the lower housing 461. In the illustrated embodiment, the two buffers 637a and 637b are separate from and fixed to the corresponding surfaces of the upper and lower housings 460 and 461, respectively. Specifically, the top buffer 637a is fixed to the upper housing 460, and more specifically, to the inner surface of the upper housing 460, such that the "dome" portion of the top buffer faces downward toward the upward-facing sensing surface 642 of the top FSR 615. The bottom buffer 637b is fixed to the lower housing 461, and specifically, fixed in or therein in a circular groove / opening 640 provided in the lower housing 461, such that the "dome" portion of the bottom buffer 637b faces upward toward the downward-facing sensing surface 641 of the bottom FSR 616.

[0165] Now let's turn to a discussion on how to utilize these force-sensing capabilities in orthopedic devices, see [reference needed]. Figures 6G-6H As Figure 6G The first example shown assumes that the orthotic device is not actuated but rather the patient opens / extends his or her fingers under his or her own force, such as Figure 6G As indicated by arrow C. Furthermore, assuming the orthotic device can be "forced" open by the patient's own finger-opening force (i.e., forced into the "extended" position), in some cases this may involve activating a motor associated with the orthotic device's ability to "follow" the subject's willful actions. In other words, while such movement in the orthotic device is caused by the patient's own finger-operating force, the linear actuator can "open" to allow the fingers to open under the patient's own force (without assistance). Figure 6G In the scenario shown, the patient's own finger-spreading force causes a portion of the lower housing 461 located distal to the pivot point / pin 606 (including the bottom buffer 637b fixed thereto) to move upward relative to the portion of the central support also located distal to the pivot point / pin 606, such that the dome surface of the bottom buffer 637b contacts and applies force to the downward-facing sensing surface 641 of the bottom FSR 616. Therefore, in Figure 6G In the scenario shown, the bottom FSR 616 captures measurements from which the patient's finger opening force can be determined.

[0166] Even in Figure 6CIn the scenario shown, the orthotic device can also assist in opening the patient's hand depending on the magnitude of the force sensed by the patient's own volitional movement. For example, if the patient extends his or her fingers as far as he or she can in his or her volition and cannot move further, causing the force on sensing surface 641 to decrease or cease entirely, the orthotic device can be programmed to take over from there the remaining way of opening the fingers to achieve a full range of motion.

[0167] The following is for reference. Figure 6H The diagram illustrates a second scenario where it can be assumed that the patient closes / bends his or her finger at his or her own will, and the orthotic device is again not actuated but is able to "follow" the subject's willful action, such that the orthotic device can be "forced" into a bent or closed position by the patient's own finger closing force. In this second scenario, the patient's own finger closing force causes a portion of the upper shell 460 located distal to the pivot point / pin 606 (and thus the top buffer 637a fixed thereto) to be "pulled" downward, as indicated by arrow D in 6H, such that the dome surface of the top buffer 637a contacts and applies force to the upward-facing sensing surface 642 of the top FSR 615. Therefore, the top FSR 615 is able to measure the patient's "finger closing force".

[0168] The following will still refer to Figure 6H This illustrates another use case where it can be assumed that the orthopedic device is actuated to open / extend the finger strut assembly 122 and thus open / extend the patient's fingers fixed thereto, but the patient cannot provide any finger opening / extending force. In this case, the flexible intermediate member 128 can be actuated such that its distal end is oriented more upward to move the central support 459 of the connection / FSM assembly upward and in a clockwise direction, as shown. Figure 6H As indicated by arrow E in the diagram. Since it is assumed that the patient will not provide assistance in opening the fingers in this situation, the distal portions of the upper shell 460 and lower shell 461 will "swing" downwards counterclockwise relative to the central support 459, causing the upward-facing sensing surface 642 of the top FSR 615 to contact and abut against the top buffer 637a fixed to the inner surface of the upper shell 460. In this case, the downward-facing sensing surface 641 of the bottom FSR 616 will no longer contact the bottom buffer 637b fixed to the lower shell 461. The presence of force at the top FSR 615 and the absence of force at the bottom FSR 616 in this situation informs the orthotic device that the patient provides little or no assistance in the finger opening / extension movement actuated by the orthotic device.

[0169] Next, let's return to the reference. Figure 6GThis can illustrate another use case where, assuming the orthotic device is actuated again, this time by closing or bending the finger support component 122 and thus closing or bending the patient's finger. In this case, the patient cannot provide any closing or bending force on the finger, but instead moves it to a bent position through the operation of the orthotic device. In this case, the flexible intermediate component 128 is actuated, causing its distal end to become more downwardly oriented, as... Figure 6G As indicated by arrow F, this causes the central support 459 of the connection / FSM assembly to move downwards in a counter-clockwise direction, as shown in the reference. Figure 6G Because the patient does not provide assistance in closing the fingers in this situation, the upper shell 460 and lower shell 461, which are fixed together (again oriented at a fixed angle relative to the finger support member 122 and therefore relative to the patient's fingers), will then "swing" clockwise relative to the central support 459 until the downward-facing sensing surface 641 of the bottom FSR 616 contacts and abuts against the bottom buffer 637b fixed to the lower shell 461. Furthermore, the upward-facing sensing surface 642 of the top FSR 615 will not contact the top buffer 637a fixed to the upper shell 460. In this situation, the presence of force at the bottom FSR 616 and the absence of force at the top FSR 615 informs the orthotic device that the patient is not providing any assistance in the finger closing / bending movement actuated by the orthotic device.

[0170] To illustrate yet another scenario and continue referencing Figure 6G It can be assumed that in this scenario, the orthotic device is actuated to open / extend the finger strut component 122 as indicated by arrow G, but the patient provides a full finger opening force exceeding the opening / extending force provided by the orthotic device 206, as indicated by arrow C. In this case, although the flexible intermediate component 128 is providing a force that will reference... Figure 6G The force applied by moving the central support 459 upward in a clockwise direction causes the patient to provide a greater opening / extension force on the finger strut component 122 and thus on the upper shell 460 and lower shell 461, which are angled to it. Consequently, the patient intentionally moves the upper shell 460 and lower shell 461 at a faster rate than the actuated central support 459 is actuated by the orthopedic device. Therefore, in this case, the bottom buffer 637b, fixed to the lower shell 461, can contact and press against the downward-facing sensing surface 641 of the bottom FSR, while the top buffer 637a, fixed to the upper shell 460, can be unforced and therefore does not provide force to the upward-facing sensing surface 642 of the top FSR. Thus, in this case, the presence of force sensed at the bottom FSR 616 and the absence of force sensed at the top FSR 615 inform the orthopedic device that the patient is providing all the necessary finger opening force to achieve the desired finger opening / bending.

[0171] In other embodiments, the load unit force sensor can be used in conjunction with the push-pull wire 126 to provide the aforementioned force sensing function. Figure 9 In one embodiment shown, the load unit force sensor 950, in the form of a cylindrical drum structure, can be connected in series with the aforementioned push-pull wire 126, for example, wherein one side of the drum structure faces proximal and the other side faces distal. In this embodiment, the push-pull wire 126 may include two portions of a wire, a proximal portion 126a and a distal portion 126b. The proximal portion of the push-pull wire 126a may have its proximal end attached as previously discussed (i.e., attached to the distal end of the linear motor 974 within the main housing structure 124) and its distal end fixedly attached to the proximal side of the load unit drum structure 950. The distal portion of the push-pull wire 126b may have its proximal end fixedly attached to the distal side of the load unit drum structure 950 and its distal end fixedly attached to the force sensing module assembly 924. Figure 9 In this document, the load unit force sensor 950 is positioned as associated with or contained within the force sensing module assembly 927, but it should be understood that the load unit force sensor 950 may be positioned closer (e.g., within the main assembly 124). A load unit force sensor design capable of sensing tension (e.g., applied to the load unit force sensor by extending the push-pull line 126 distally against it) and compressive force (e.g., applied to the load unit force sensor by pulling the push-pull line proximally to effectively “pull” the load unit force sensor) can be selected. Therefore, such implementations of the force sensing module can provide functionality in conjunction with, for example, the previously described will mode of operation, as well as other functions including those that aid in monitoring rehabilitation progress. In addition to the will mode, the orthopedic device described herein can also operate in other modes of operation.

[0172] Now for reference Figures 7A-7B An embodiment of a finger strut component 122 for use in orthopedic devices (such as the previously described devices 106, 206) is shown. The finger strut component 122 is designed to secure two adjacent fingers (e.g., the index finger and the adjacent middle finger). The finger strut component 122 is designed for use with both the right and left hands. The finger strut component 122 includes an upper elongated plate-shaped finger engagement assembly 462 located above the two secured fingers during use and a lower elongated plate-shaped finger engagement assembly 463 located below the two secured fingers during use. Two adjustable straps 123a, 123b are provided with the two finger engagement assemblies 462, 463 to secure the assemblies 123a, 123b to the fingers, wherein the assemblies 123a, 123b are secured as a unit between the two assemblies 462, 463 during use.

[0173] exist Figures 7A-7BIn the illustrated embodiment, the lower finger engagement assembly 463 includes a rigid housing 700 (also referred to as the lower shell) and a corresponding lower finger support pad 702, which is fitted within the lower rigid housing 700 and abuts against the bottom surface of the two fixed fingers of the body during use. The lower rigid housing 700 can be sized such that its length (parallel to the fingers when worn) is selected such that the lower housing 700 extends from a proximal position where it will reside between the knuckle and the first set of joints of the body during use to a distal position where it will reside at or slightly beyond the distal tip of the finger during use, for example... Figure 1D and Figures 2A-2B As shown, and the dimensions can be further designed such that its width (perpendicular to the fingers when worn) is chosen such that the lower shell 700 extends approximately the width of two fingers to which it will be secured. The lower shell 700 may have a shape that generally conforms to the two fingers to be secured and may include a longitudinal ridge extending along the center of the shell 700 as shown, which will conform to the shape of the two fingers, wherein the ridge positions the adjacent meeting point of the two fingers. The lower shell 720 may also include two spaced-apart cavities 722a, 723b that extend laterally through them to receive two straps 123a, 123b that will be screwed into them. The lower finger support pad 702 may have approximately the same length, width, and shape as the lower rigid shell 700, wherein the shape generally conforms to the fingers to be secured and includes a longitudinal ridge extending along the center of the pad 702. The lower finger support pad 702 may include foam or foam-like material that is comfortable against the skin of the wearer when worn.

[0174] refer to Figure 7B The upper finger engagement assembly 462 includes a rigid shell 701 (also referred to as the upper shell) and a corresponding upper finger support pad 703, which is fitted within the upper rigid shell 701 and abuts against the top surface of the two fixed fingers of the body during use. The upper rigid shell 701 can be sized similarly to the lower rigid shell 700, i.e., its length (parallel to the fingers when worn) is selected such that the upper shell 701 extends from a proximal position where it will reside between the knuckle and the first set of joints of the body during use to a distal position where it will reside at or slightly beyond the distal tip of the finger during use, for example, in… Figure 1D and Figures 2A-2BAs shown, and the dimensions can be further designed such that its width (perpendicular to the fingers when worn) is chosen such that the upper shell 701 extends approximately the width of two fingers, to which the shell 701 will be secured. The upper shell 701, again similar to the lower shell 700, may have a shape that generally conforms to the shape of the two fingers to be secured, and may include a longitudinal ridge extending along the center of the shell 701 as shown, which will conform to the shape of the two fingers, wherein the ridge positions the adjacent meeting point of the two fingers. The upper finger support pad 703 may have approximately the same length, width, and shape as the upper rigid shell 701, wherein the shape generally conforms to the fingers to be secured and includes a longitudinal ridge extending along the center of the pad 703. The upper finger support pad 703 may include foam or foam-like material that is comfortable against the skin of the wearer when worn.

[0175] like Figure 7B As shown, the upper finger engagement assembly 462 further includes a thin sleeve bearing bracket 601 configured to engage with the connection / FSM assembly (see Figure 1). Figure 6B A thin sleeve bearing 704 is used to provide a longitudinally slidable engagement between the previously described connection / FSM 130 and the finger support component 122. In this embodiment, the sleeve bearing 704 is configured to be attached to the outside of the upper rigid housing 701 (i.e., on the side of housing 701 opposite to the lower pad 702).

[0176] like Figure 7B As further shown, in order to accommodate the sleeve bearing 704 thereon, the upper rigid housing 701 has a rectangular open chamber structure 713 formed on its outer surface, within which the rectangular sleeve bearing 704 is located. The open chamber structure 713 includes four rectangularly arranged walls 714a, 714b, 715a, 715b, the dimensions of which are designed to correspond to the dimensions of the sleeve bearing 704, such that the sleeve bearing 704 is located within the open chamber structure 713, its sides adjacent to the four side walls 714a, 714b, 715a, 715b. These four walls specifically include a distal side wall 714a and a proximal side wall 714b, and two transverse side walls 715a, 715b. The outer surface of the upper rigid shell 701 includes a flat surface region 716 located within the four walls 714a, 714b, 715a, 715b. This surface region 716 serves as the bottom surface of the open chamber structure 713, on which the bottom surface of the sleeve bearing 704 abuts.

[0177] Still referencing Figure 7BThe dimensions of the sleeve bearing 704 are as shown in the figure. Its length is slightly less than the length of the upper housing 701 on which it rests, while its width is approximately one-third to one-half the width of the upper rigid housing 701. The sleeve bearing 704 may have a transverse cross-section that is identical along its entire longitudinal range, the cross-section being generally upward-facing "C" shaped. The sleeve bearing 704 includes a generally flat rectangular base plate 707 and two arms 718a, 718b. These arms first extend upward from each transverse side of the base plate 707 and then inward toward each other, thus forming two longitudinally extending grooves that connect to the corresponding side rails 633a, 633b of the sleeve bearing bracket 702 of the / FSM assembly (see Figure 633a, 633b). Figure 6B It is located within the groove in a longitudinally slidable manner.

[0178] like Figure 7B As shown, the sleeve bearing 704 can be secured within its open chamber 713 using any suitable fastening mechanism (such as socket head screws 707a, 707b and corresponding threaded inserts 706a, 706b). Figure 7B Only 706a) is shown, which is fixedly attached to the upper rigid housing 701. Specifically, screws 707a and 707b can be inserted into two screw holes 708a and 708b extending through the sleeve bearing 704 and located at opposite longitudinal ends of the sleeve bearing 704, and further through two corresponding screw holes 708a and 708b extending through the upper housing 701 and engaging with the internal threads of threaded inserts 706a and 706b located below the threaded holes 708a and 708b. Figure 7B Only 708a is shown in the text.

[0179] The upper finger engagement assembly 462 may also include two resilient clips 705a, 705b, such as Figure 7B As shown, the resilient clips 705a and 705b can be partially used to secure the straps 123a and 123b to the upper finger engagement assembly 462. Specifically, the resilient clips 705a and 705b can be elongated in the overall configuration and have a cross-section that is generally “L”-shaped along their entire longitudinal length, as shown. Each of the two resilient clips 705a and 705b can have a length as shown, approximately the same as the length of the sleeve bearing 704, and each of the resilient clips 705a and 705b can be designed and configured to be secured to the outer surface of the upper rigid housing 701 adjacent to the sleeve bearing 704. Specifically, the first resilient clip 705a can be disposed on one lateral side of the sleeve bearing 704, while the second resilient clip 705b can be disposed on the opposite lateral side of the sleeve bearing 704, as shown. Figure 7B As shown in the image.

[0180] Each of the resilient clips 705a and 705b includes part of a leg with an "L"-shaped cross-section, configured to abut the outward-facing surface of the rigid shell 701 along the entire longitudinal extent of the clips 705a and 705b. This abutting portion of the clips 705a and 705b includes two spaced-apart grooves 719a and 719b forming two gaps between the clips 705a and 705b and the outer surface of the rigid shell 701, intended to accommodate corresponding ends of the straps 123a and 123b below them. Therefore, corresponding first ends 720a and 720b of the straps 123a and 123b can be disposed within and below the grooves 719a and 719b of the first clip 705a, and corresponding second ends of the straps 123a and 123b can be disposed below similar grooves in the second clip 705b (these grooves in the second clip 705b are located within...). Figure 7B Not shown, but may be similar in form to the grooves 720a, 720b in the first clamp 705a. The dimensions of the grooves 720a, 720b may be designed such that when the clamps 705a, 705b are clamped downwards onto the outer surface of the rigid shell 701, the clamps 705a, 705b secure the ends of the two straps 123a, 123b within their grooves 705a, 705b.

[0181] Clips 705a and 705b can be secured to the upper rigid housing 701 using any suitable fastener mechanism, such as six screws 711a-711f and corresponding threaded inserts 712a-712f. Specifically, the screws 711a-711f can be hexagonal driven flathead screws as shown, which can be inserted through six screw holes 709a-709f extending through the two resilient clips 705a and 705b (three screws 709a-709c in one clip 705a and three screws 709d-709f in the other clip 705b) and further through six corresponding screw holes 710a-710f extending through the upper housing 701, and engage with the internal threads of the threaded inserts 712a-712f located below the screw holes 710a-710f.

[0182] One of the straps (particularly the proximal strap 123a) can be configured to be adjustable, in which case one end 720a of the strap 123a may not be fixed below the clip 705a, but instead may be adjustablely fixed to a device including pin retainers 721a1, 721a2 and corresponding pins. Figure 7B Not shown in the diagram, but similar in configuration. Figure 4FThe upper main housing 445 shown is provided below and fixed to the strap connection structure with pins 492a-492c. With this configuration, the distal strap 123b can be fixed and non-adjustable, while the proximal strap 123a can be adjustable. Therefore, when wearing the orthotic device, the subject can slide two of his or her fingers between the two finger support pads 702, 703 from the proximal ends of the finger support pads 702, 703. The distal strap 123b can be configured such that the distal ends of the two fingers can slide relatively close between the pads 702, 703, and then, when the fingers are fully extended longitudinally between the two pads 702, 703, the proximal strap 123a can be tightened into place to ensure patient comfort by connecting the end 720a of the proximal strap 123a to the pin-type adjustable strap connection structure. Alternatively, straps 123a and 123b can be configured to be non-adjustable, in which case, for example, end 720a of proximal strap 123a can be fixed below the corresponding groove 719a of elastic clip 705a.

[0183] Turn now Figure 7C Further details of the outer portion of the left thumb member 234 are shown. As previously described, the thumb member 234 is attached proximally to one side of the main housing structure 124 where the thumb of the body resides. Figure 7C In the example, the thumb piece 234 extends to the thumb contact portion 138, which contacts the inner surface of the thumb during use to hold the thumb in place as follows: Figure 1D and Figures 2A-2B The approximate extension position is shown. In this embodiment, the thumb member 234 can be manually adjusted to, for example... Figure 1D and Figures 2A-2B The position shown is maintained, and once manually adjusted to that position, it remains in that position; or in other words, in this embodiment, it is not actuated by an actuator such as a motor, but remains in the same position during use of the orthopedic device in a rehabilitation session.

[0184] like Figure 7C As shown, the thumb strut assembly 234 includes a proximal segment 452, the proximal end of which is rotatably connected to the upper housing 445 (see Figure 1). Figure 4E On one side, a middle joint 454 is movably connected to the distal end of a proximal segment 452; a distal segment 453, the proximal end of which is movably connected to the middle joint 454, and a thumb interface component 455 is rotatably connected to the distal end of the distal segment 453. The above combination... Figure 4G-4F The description provides Figure 7C Additional description of these and further aspects of the thumb strut assembly shown. Figure 7CThe thumb interface component 455 is further shown, which includes a shoulder pivot interface configured to allow the proximal segment 452 to be positioned relative to the connector portion 483 of the thumb strut assembly (see [link]). Figure 4G It is pivotally adjustable; and has an adjustment setting / release mechanism, wherein the proximal section 452 can be rotatably released from the connector portion 483 to adjust the angular relationship between them, and locks into the setting position when adjusted to the appropriate angular relationship for the body.

[0185] In other embodiments that will be understood by those skilled in the art, a wearable orthotic device may be provided that enables movement of additional and / or alternative body parts besides the fingers of the damaged upper limb as illustrated above and described above. For example, various aspects of the systems and components described above may be configured to provide rehabilitative movement of other body parts associated with the upper and lower limbs. For example, upper limb movement may be provided in conjunction with the thumb (e.g., extension and flexion, and lateral movement of the thumb relative to the hand), the wrist (e.g., extension and flexion, and lateral movement of the hand relative to the forearm), the elbow (e.g., extension and flexion of the forearm relative to the upper arm), and the shoulder. For example, in the case of wrist movement, a main housing structure 124 configured to be worn on the forearm as described above may be provided, and a body part attachment structure including a force-sensing component may be provided to secure the hand. Furthermore, in other embodiments that provide rehabilitative movement of the fingers and / or thumb, a main housing structure 124 may be provided that is configured to be worn partially or solely on the hand and provides finger and / or thumb attachment structures.

[0186] Turn now Figure 8A This provides an example system architecture for rehabilitation systems such as System 100 shown in Figure 1. Regarding communication between the components of System 100, in this embodiment, the application provided on the tablet computing device 110 can communicate via applications such as... It communicates with the EEG headset 104 via wireless communication protocols such as Wi-Fi Direct, and with the orthopedic device 106 via wireless communication protocols such as WiFi, and with the router 114 via wireless communication protocols such as WiFi.

[0187] With EEG headphones 104 The connection can be paired only once via the communication (COM) port on the tablet computer 110, and the communication number can be saved in the application on the tablet computer 110. The tablet computer can also connect via the COM port whenever the user opens the application on the tablet computer 110. It automatically connects wirelessly to the EEG headset 104.

[0188] The connection between the application on the tablet computer 110 and the orthopedic device 106 can be established based on the serial number of the orthopedic device, which can be entered into the application only once. Whenever the user opens the application, the application can automatically search for the serial number and then connect to the orthopedic device.

[0189] Figure 8B The illustration shows that in some embodiments of the treatment system 100, three operating modes can exist during a treatment session: a setup mode, a calibration mode, and a prompting mode. Each mode can handle different tasks.

[0190] In setup mode, the application can use a setup mode code sequence to check the contact of the sensors in the EEG headset at the start of a treatment session and after the user puts on the headset. In setup mode, all EEG data received from the EEG headset can be sent to an orthopedic device, which can then determine the contact quality of each sensor and the entire EEG headset.

[0191] In calibration mode, the application can store EEG data and send it to the orthopedic device. The orthopedic device can then compare the data from the "Rest / Relax" prompt with the data from the "Imagine Moving Your Finger" prompt. These two sets of data can then be compared and stored for later use in prompt mode, and the results can be sent from the orthopedic device back to the application on the tablet for permanent storage.

[0192] In prompt mode, the application can store EEG data and send it to the orthopedic device. The orthopedic device can then determine the patient's intention to continue moving and can send the results back to the application, which can display the results graphically on the screen and store them in permanent storage.

[0193] Figure 8C In one implementation, the application may have a "viewer-model" structure. The "viewer" can display treatment session information on the screen and receive input from the user. The "model" can receive EEG data and results from the orthopedic device, such as... Figure 8C As shown in the image.

[0194] In some implementations, a screenshot may be displayed during the process of using the rehabilitation system 100 of FIG1. ​​For example, the screenshot may be displayed on the display screen 112 of the tablet computing device 110 and may be generated by an application being executed by the tablet computer 110.

[0195] For example, a display could be provided where a tablet computer automatically connects to the monitor of an EEG headset and orthopedic device, and once the connection to the orthopedic device is successful, the application can display "Connected" on the display device. Once the connection with the EEG headset is successful and the received data is considered good, the application can display "EEG: Good" on the display device.

[0196] Additional displays related to the initial setup can be provided on the display device, and in some cases, these can be displayed only once per user. Initially, regarding the setup of the EEG headset, a contact check can be provided between the EEG headset sensors and the user's head. The application can record brain signal data from EEG signals captured during certain specific cues to the subject, and can send the recorded brain signal data to an orthopedic device that can compare the data to determine the quality of sensor contact and provide a quality outcome assessment.

[0197] In addition, screen displays related to the initial screening can be provided. For example, before starting a treatment session, the application can allow screening of the subject's EEG data. This data can be used to determine the optimal EEG frequency for a particular subject.

[0198] Furthermore, a screen display can be provided on a display device associated with the patient setup and can be displayed once per user. Specifically, a display can be provided to guide input from healthcare professionals to enter patient data, such as for a treatment session. The application can use a tablet computer and its associated display to transmit this information to the orthopedic device, and the orthopedic device can store this information in its memory.

[0199] Furthermore, various screen displays can be provided to guide daily treatment using orthopedic devices. For example, after initial setup and patient setup, the application can then facilitate daily treatment sessions. This could begin with setting up the EEG headset. Thus, at the start of each treatment session, the application can confirm the sensor contact quality of the EEG headset. Next, the application can facilitate system calibration as part of the treatment session, such as during… Figure 3B As shown in Reference 380. The application can calibrate the EEG headset to the user's brain signals of the day in two steps: 1) reading brain signals while the user performs a specified action; and 2) reading brain signals while the user imagines performing the specified action. The comparison of these two sets of signals can be used for the remainder of the therapy session.

[0200] Next, a screen display can be provided to facilitate the first daily exercise session to be performed. For example, the application can begin by providing a "start" screen and then collect two datasets with the goal of: 1) recording the user's brain signals while performing a specified action chosen as the basis for the EEG; and 2) recording the user's brain signals while performing or imagining performing a specified signal corresponding to a defined motor function. The application can then send the incoming brain signal data to an orthotic device, which can determine based on the signals whether the patient intends to perform a specific action corresponding to the defined motor function. If so, the orthotic device can operate to assist the user in performing the defined motor function. The orthotic device can report this data back to the application, which can graphically display the success of performing the defined motor function and can also store the data. There can be a specified number of daily treatment sessions, for example, five sessions. When a session is completed, the application can operate to display the results of that session to the user. Furthermore, an overall results display can be provided after all treatment sessions for the day are completed.

[0201] Figure 10 This is a block diagram of computing devices 1000, 1050 that can be used to implement the systems and methods described in this document as clients, servers, or multiple servers. Computing device 1000 is intended to represent various forms of digital computers, such as laptops, desktops, workstations, personal digital assistants, servers, blade servers, mainframes, and other suitable computers. Computing device 1050 is intended to represent various forms of mobile devices, such as personal digital assistants, cellular phones, smartphones, and other similar computing devices. Furthermore, computing devices 1000 or 1050 may include a Universal Serial Bus (USB) flash drive. The USB flash drive can store an operating system and other applications. The USB flash drive may include input / output components, such as a wireless transmitter or USB connector that can be plugged into a USB port of another computing device. The components shown herein, their connections and relationships, and their functions are merely exemplary and are not intended to limit the implementations described and / or claimed in this document.

[0202] Computing device 1000 includes a processor 1002, a memory 1004, a storage device 1006, a high-speed interface 1008 connected to the memory 1004 and a high-speed expansion port 1010, and a low-speed interface 1012 connected to a low-speed bus 1014 and the storage device 1006. Each of components 1002, 1004, 1006, 1008, 1010, and 1012 is interconnected using various buses and may be suitably mounted on a common motherboard or otherwise mounted. The processor 1002 can process instructions for execution within computing device 1000, including instructions stored in memory 1004 or storage device 1006, for displaying graphical information of a GUI on an external input / output device, such as a display 1016 coupled to the high-speed interface 1008. In other embodiments, multiple processors and / or multiple buses, as well as multiple memories and memory types, may be used as appropriate. In addition, multiple computing devices 1000 can be connected, each of which provides a portion of the necessary operation (e.g., as a server group, blade server cluster, or multiprocessor system).

[0203] Memory 1004 stores information within computing device 1000. In one embodiment, memory 1004 is one or more volatile memory cells. In another embodiment, memory 1004 is one or more non-volatile memory cells. Memory 1004 may also be another form of computer-readable medium, such as a magnetic disk or optical disk.

[0204] Storage device 1006 provides large-capacity storage for computing device 1000. In one embodiment, storage device 1006 may be or contain computer-readable media, such as floppy disk devices, hard disk devices, optical disk devices, magnetic tape devices, flash memory or other similar solid-state storage devices, or arrays of devices (including devices in storage area networks or other configurations). A computer program product may be tangibly embodied in an information carrier. A computer program product may also contain instructions that, when executed, perform one or more methods, such as those described above. The information carrier is a computer or machine-readable medium, such as memory 1004, storage device 1006, or memory on processor 1002.

[0205] High-speed controller 1008 manages bandwidth-intensive operations of computing device 1000, while low-speed controller 1012 manages less bandwidth-intensive operations. This functional allocation is merely exemplary. In one embodiment, high-speed controller 1008 is coupled to memory 1004, display 1016 (e.g., via a graphics processor or accelerator), and high-speed expansion port 1010, which can accept various expansion cards (not shown). In another embodiment, low-speed controller 1012 is coupled to storage device 1006 and low-speed expansion port 1014. The low-speed expansion port may include various communication ports (e.g., USB, Bluetooth, Ethernet, Wireless Ethernet) that can be coupled (e.g., via a network adapter) to one or more input / output devices, such as keyboards, pointing devices, scanners, or network devices (such as switches or routers).

[0206] The computing device 1000 can be implemented in a variety of different forms, as shown in the figure. For example, it can be implemented as a standard server 1020, or multiple times in a group of such servers. It can also be implemented as part of a rack server system 1024. Furthermore, it can be implemented in a personal computer such as a laptop computer 1022. Alternatively, components from the computing device 1000 can be combined with other components (not shown) in a mobile device (such as device 1050). Each of such devices can contain one or more of the computing devices 1000, 1050, and the entire system can consist of multiple computing devices 1000, 1050 communicating with each other.

[0207] Computing device 1050 includes a processor 1052, memory 1064, input / output devices (such as a display 1054), a communication interface 1066, and a transceiver 1068, as well as other components. Device 1050 may also be equipped with storage devices (such as microdrives or other devices) to provide additional storage. Each of components 1050, 1052, 1064, 1054, 1066, and 1068 is interconnected using various buses, and several components may be mounted on a common motherboard or otherwise suitably mounted.

[0208] Processor 1052 is capable of executing instructions within computing device 1050, including instructions stored in memory 1064. The processor can be implemented as a chipset comprising individual and multiple analog and digital processors. Furthermore, the processor can be implemented using any of a variety of architectures. For example, processor 1052 can be a CISC (Complex Instruction Set Computer) processor, a RISC (Reduced Instruction Set Computer) processor, or a MISC (Minimum Instruction Set Computer) processor. For example, the processor can provide coordination for other components of device 1050, such as control of the user interface, applications running on device 1050, and wireless communication of device 1050.

[0209] Processor 1052 can communicate with the user via control interface 1058 and display interface 1056 coupled to display 1054. For example, display 1054 may be a TFT (Thin Film Transistor Liquid Crystal Display) or OLED (Organic Light Emitting Diode) display, or other suitable display technology. Display interface 1056 may include suitable circuitry for driving display 1054 to present graphics and other information to the user. Control interface 1058 can receive commands from the user and translate them for submission to processor 1052. Additionally, an external interface 1062 may be provided to communicate with processor 1052 to enable near-field communication between device 1050 and other devices. For example, external interface 1062 may provide wired communication in some embodiments or wireless communication in others, and multiple interfaces may be used.

[0210] Memory 1064 stores information within computing device 1050. Memory 1064 may be implemented as one or more computer-readable media, one or more volatile memory cells, or one or more non-volatile memory cells. Extended memory 1074 may also be provided and connected to device 1050 via an extended interface 1072, which may include, for example, a SIMM (Single In-line Memory Module) card interface. Such extended memory 1074 may provide additional storage space for device 1050, or it may store applications or other information for device 1050. Specifically, extended memory 1074 may include instructions for performing or supplementing the above processes, and may also include security information. Thus, for example, extended memory 1074 may be provided as a security module of device 1050 and may be programmed with instructions that allow secure use of device 1050. Furthermore, secure applications and additional information, such as placing identification information on the SIMM card in an unbreakable manner, may be provided via a SIMM card.

[0211] The memory may include, for example, flash memory and / or NVRAM memory, as discussed below. In one embodiment, the computer program product is tangibly embodied in an information carrier. The computer program product contains instructions that, when executed, perform one or more methods, such as those described above. The information carrier is a computer-readable or machine-readable medium, such as memory 1064, extended memory 1074, or memory on processor 1052, which may be received, for example, via transceiver 1068 or external interface 1062.

[0212] Device 1050 can communicate wirelessly via communication interface 1066, which may include a digital signal processing circuitry system (if necessary). Communication interface 1066 can provide communication under various modes or protocols, including GSM voice calls, SMS, EMS or MMS messages, CDMA, TDMA, PDC, WCDMA, CDMA2000, or GPRS, etc. For example, such communication can be performed via radio frequency transceiver 1068. Additionally, short-range communication can occur, such as using Bluetooth, WiFi, or other such transceivers (not shown). Furthermore, GPS (Global Positioning System) receiver module 1070 can provide additional navigation and location-related wireless data to device 1050, which can be appropriately used by applications running on device 1050.

[0213] Device 1050 can also communicate audibly using audio codec 1060, which can receive verbal information from a user and convert it into usable digital information. Audio codec 1060 can also generate audible sounds for the user (e.g., through a speaker, for example, in a handheld device of device 1050). Such sounds may include sounds from voice telephone calls, recorded sounds (e.g., voice messages, music files, etc.), and sounds generated by applications operating on device 1050.

[0214] The computing device 1050 can be implemented in a variety of different forms, as shown in the figure. For example, it can be implemented as a cellular phone 1080. It can also be implemented as part of a smartphone 1082, a personal digital assistant, or other similar mobile devices.

[0215] Various implementations of the systems and techniques described herein can be implemented in digital electronic circuit systems, integrated circuit systems, specially designed ASICs (Application-Specific Integrated Circuits), computer hardware, firmware, software, and / or combinations thereof. These various implementations may include implementations in one or more computer programs that are executable and / or interpretable on a programmable system, the programmable system including at least one programmable processor (which may be dedicated or general-purpose), coupled to receive and transmit data and instructions from and to a data storage system, at least one input device, and at least one output device.

[0216] These computer programs (also referred to as programs, software, firmware applications, or code) include machine instructions for a programmable processor and may be implemented in high-level procedural and / or object-oriented programming languages ​​and / or in assembly / machine language. As used herein, the terms "machine-readable medium" and "computer-readable medium" refer to any computer program product, apparatus, and / or device (e.g., disk, optical disk, memory, programmable logic device (PLD)) used to provide machine instructions and / or data to a programmable processor, including machine-readable media that receive machine instructions as machine-readable signals. The term "machine-readable signal" refers to any signal used to provide machine instructions and / or data to a programmable processor.

[0217] To provide interaction with the user, the systems and techniques described herein can be implemented on a computer having a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) for displaying data to the user and a keyboard and positioning device (e.g., a mouse or trackball) through which the user can provide input to the computer. Other types of devices can also be used to provide interaction with the user; for example, the feedback provided to the user can be any form of sensory feedback, such as visual feedback, auditory feedback, or tactile feedback; and input from the user can be received in any form, including voice input, speech input, or tactile input.

[0218] The systems and technologies described herein can be implemented in computer systems that include back-end components (e.g., as data servers), middleware components (e.g., application servers), or front-end components (e.g., client computers with graphical user interfaces or web browsers through which users can interact with the implementation of the systems and technologies described herein), or any combination of such back-end, middleware, or front-end components. The components of the system can be interconnected by digital data communications (e.g., communication networks) of any form or medium. Example communication networks include: local area networks (“LANs”), wide area networks (“WANs”), peer-to-peer networks (with self-organizing or static members), grid computing infrastructure, and the Internet.

[0219] A computing system may include clients and servers. Clients and servers are typically geographically separated and usually interact via a communication network. The client-server relationship is determined by computer programs running on the respective computers that have a client-server relationship with each other.

[0220] Several embodiments have been described. However, it should be understood that various modifications can be made without departing from the spirit and scope of the invention. Furthermore, the logical flow depicted in the drawings does not require the specific order or sequence shown to achieve the desired results. Additionally, other steps may be provided, or steps may be eliminated from the described flow, and other components may be added to or removed from the described system. Therefore, other embodiments are included within the scope of the appended claims.

Claims

1. A rehabilitation system for rehabilitating a damaged body part of a subject, comprising: a brain signal acquisition system configured to collect brain signals from the subject; an orthotic system configured to be attached to a forearm and at least one finger of the subject and to move or assist in flexion movement and / or extension movement of the at least one finger, wherein the orthotic system comprises: a force sensing module configured to measure a voluntary flexion movement force of the at least one finger and / or a voluntary extension movement force of the at least one finger; and a control system configured to operate the orthotic system in: (a) a first mode in which the orthotic system operates to move or assist in the flexion movement and / or the extension movement of the at least one finger based on an intention of the subject determined from an analysis of brain signals, (b) a second mode in which the orthotic system first prompts the subject by a visual instruction, then allows the subject to move or attempt to move the at least one finger in a predetermined movement according to the visual instruction, then operates to move or assist in a predetermined movement of the at least one finger in response to the control system detecting that the subject is unable to move the at least one finger in the predetermined movement to a desired extent, and (c) a third mode in which the orthotic system operates to move the at least one finger in the flexion movement and / or the extension movement without requiring voluntary movement of the subject. When operating in the third mode, the orthotic system operates to move the at least one finger in a plurality of repetitions of the exercise.

2. The rehabilitation system of claim 1, wherein, 3. The rehabilitation system of any one of the preceding claims, wherein the third mode is a continuous passive operation mode. When operating in the second mode, the orthotic system operates to move or assist in the flexion movement and / or the extension movement of the at least one finger in response to the control system detecting that the at least one finger has not completed the predetermined movement, wherein the predetermined movement comprises a predetermined flexion movement and / or a predetermined extension movement.

4. The rehabilitation system of claim 1, wherein, The control system is configured to detect that the at least one finger has not completed the predetermined flexion movement and / or the predetermined extension movement by determining whether the predetermined flexion movement and / or the predetermined extension movement has occurred within a predetermined time period.

5. The rehabilitation system of claim 4, wherein, The control system is configured to detect that the at least one finger has not completed the predetermined flexion movement and / or the predetermined extension movement by determining whether the predetermined flexion movement and / or the predetermined extension movement has occurred to a predetermined extent.

6. The rehabilitation system of any one of claims 4-5, wherein, The predetermined extent corresponds to a predetermined extension movement amount of the at least one finger.

7. The rehabilitation system of claim 6, wherein, The control system is configured to send a prompt to indicate to the subject to start moving or attempt to move the at least one finger in the predetermined flexion movement and / or the predetermined extension movement.

8. The rehabilitation system of any one of claims 4-7, wherein, ​ 9. The rehabilitation system of any one of claims 4-8, wherein, The control system is configured to detect that the at least one finger has not completed the predetermined bending movement and / or the predetermined extension movement by determining whether the predetermined bending movement and / or the predetermined extension movement has started within a predetermined time period.

10. The rehabilitation system of any of the preceding claims, wherein, The at least one finger is impaired due to a stroke event experienced by the subject.

11. The rehabilitation system of any of the preceding claims, wherein, The orthotic system is configured to operate using motor-driven actuation to move or assist the bending movement and / or the extension movement of the at least one finger.

12. The rehabilitation system of any of the preceding claims, wherein, The orthotic system is configured to operate using functional electrical stimulation to move or assist the bending movement and / or the extension movement of the at least one finger.

13. A rehabilitation system for rehabilitating an impaired body part of a subject, comprising: a brain signal acquisition system configured to collect brain signals from the subject; an orthotic system configured to be attached to a forearm and at least one finger of the subject, and to move or assist a bending movement and / or an extension movement of the at least one finger; and a control system configured to operate the orthotic system in (a) a first mode in which the orthotic system operates to move or assist the bending movement and / or the extension movement of the at least one finger based on an intention of the subject determined from an analysis of brain signals, and (b) a second mode in which the orthotic system first prompts the subject by a visual instruction, then allows the subject to consciously move or attempt to consciously move the at least one finger according to the visual instruction, then operates to move or assist the predetermined movement of the at least one finger in response to the control system detecting that the at least one finger does not perform the predetermined movement to a desired extent, wherein the predetermined movement comprises a predetermined bending movement and / or a predetermined extension movement.

14. The rehabilitation system of claim 13, wherein, The control system is configured to detect that the at least one finger has not completed the predetermined movement by determining whether the predetermined movement has occurred within a predetermined time period.

15. The rehabilitation system of claim 13, wherein, The control system is configured to detect that the at least one finger has not completed the predetermined movement by determining whether the predetermined movement has occurred to a predetermined extent.

16. The rehabilitation system of claim 15, wherein, The predetermined extent corresponds to a predetermined extension amount of the at least one finger.

17. The rehabilitation system of any one of claims 13-16, wherein, The control system is configured to send a prompt to indicate to the subject to move or attempt to move the at least one finger with the predetermined movement.

18. The rehabilitation system of any one of claims 13-17, wherein, The control system is configured to detect that the at least one finger has not completed the predetermined movement by determining whether the predetermined movement has started within a predetermined time period.

19. The rehabilitation system of any one of claims 13-18, comprising: a force sensing module configured to measure a voluntary bending movement force of the at least one finger and / or a voluntary extension movement force of the at least one finger.

20. The rehabilitation system of any one of claims 13-19, wherein, The control system is configured to operate the orthotic system to move the at least one finger in the flexion movement and / or the extension movement without requiring voluntary movement of the subject.

21. The rehabilitation system of any one of claims 13-20, wherein, The orthotic system is configured to operate using motor-driven actuation to move or assist the flexion movement and / or the extension movement of the at least one finger.

22. The rehabilitation system of any one of claims 13-21, wherein, The orthotic system is configured to operate using functional electrical stimulation to move or assist the flexion movement and / or the extension movement of the at least one finger.

23. A rehabilitation system for rehabilitating an impaired body part of a subject, comprising: a brain signal acquisition system configured to collect brain signals from the subject; an orthotic system configured to be attached to the impaired body part and to move or assist flexion and extension movements of the impaired body part, wherein the orthotic system comprises a force sensing module configured to measure voluntary flexion movement forces of the impaired body part and voluntary extension movement forces of the impaired body part; and a control system configured to operate the orthotic system in: (a) a first mode in which the orthotic system operates to move or assist the flexion and extension movements of the impaired body part based on an intention of the subject determined from an analysis of brain signals; (b) a second mode in which the orthotic system first prompts the subject by visual instructions, then allows the subject to move or attempt to move the impaired body part according to the visual instructions, then operates to move or assist a predetermined movement of the impaired body part in response to the control system detecting that the subject is unable to move the impaired body part to the desired extent according to the predetermined movement, wherein the predetermined movement comprises a predetermined flexion movement and a predetermined extension movement; and (c) a third mode in which the orthotic system operates in a continuous passive operation mode comprising a plurality of repetitions of exercises to move the impaired body part.

24. The rehabilitation system of claim 23, wherein, The impaired body part is impaired as a result of a stroke event experienced by the subject.

25. The rehabilitation system of any one of claims 23-24, wherein, The orthotic system is configured to be worn on a hand of the subject and to operate to move or assist the flexion and extension movements of the hand.

26. The rehabilitation system of any one of claims 23-25, wherein, The orthotic system is configured to operate using motor-driven actuation to move or assist the flexion and extension movements of the impaired body part. The orthotic system is configured to operate using functional electrical stimulation to move or assist the flexion and extension movements of the impaired body part.

Images