Lower limb brace, control method, and program

Abstract

The present disclosure relates to a lower limb brace, a control method, and a program with which appropriate intervention is made possible. This lower limb brace comprises a sensing unit for acquiring sensing data pertaining to a specific site of a lower limb of a user, and an intervention mechanism configured to be capable of intervening in the specific site. A walking state calculation unit calculates, on the basis of the sensing data, a walking state parameter relating to the walking state of the user. An intervention control unit, by using a comparison between the walking state parameter and a state target value set on the basis of body information pertaining to the user, controls intervention in the specific site by the intervention mechanism. The present disclosure can be applied to, e.g., a shoe-shaped device.

Description

Lower limb orthosis, control method, and program

[0001] The present disclosure relates to a lower limb orthosis, a control method, and a program, and more particularly to a lower limb orthosis, a control method, and a program that enable appropriate intervention to be achieved.

[0002] In recent years, the number of elderly people experiencing musculoskeletal disorders due to aging, knee pain and back pain associated with bone deformation, and even reduced mobility functions such as standing and walking due to falls and fractures, has been increasing rapidly. This condition is called locomotive syndrome (musculoskeletal syndrome), and because it increases the risk of requiring nursing care, efforts to prevent, slow the progression of, and improve this condition are attracting attention. Knee osteoarthritis (knee OA) is known as a typical example of locomotive syndrome.

[0003] One of the treatment methods for knee osteoarthritis is to suppress the incorrect movement of the affected knee joint using corrective devices such as braces, supports, insoles, etc. For example, Patent Documents 1 to 3 disclose insoles with shapes and inclined surfaces that reduce load on the knee joint and allow smooth walking.

[0004] JP 2019-210580 A JP 2015-208398 A JP 2005-304583 A

[0005] Because there are individual differences between patients and changes in condition over time, the insoles disclosed in the above-mentioned patent documents cannot necessarily be said to be orthotics with optimal shapes and inclined surfaces for each individual patient.

[0006] The present disclosure has been made in light of this situation and aims to enable appropriate intervention.

[0007] The lower limb orthosis disclosed herein is a lower limb orthosis that includes a sensing unit that acquires sensing data of a specific part of a user's lower limb, an intervention mechanism that is configured to be able to intervene in the specific part, a walking state calculation unit that calculates walking state parameters related to the walking state of the user based on the sensing data, and an intervention control unit that controls the intervention in the specific part by the intervention mechanism by comparing the walking state parameters with a state target value that is set based on physical information of the user.

[0008] The control method disclosed herein is a control method in which a lower limb orthosis including a sensing unit that acquires sensing data of a specific part of a user's lower limb and an intervention mechanism configured to be able to intervene in the specific part calculates walking state parameters related to the walking state of the user based on the sensing data, and controls the intervention in the specific part by the intervention mechanism by comparing the walking state parameters with a state target value set based on physical information of the user.

[0009] The program disclosed herein is a program for causing a processor mounted on a lower limb orthosis, which includes a sensing unit that acquires sensing data of a specific part of a user's lower limb and an intervention mechanism configured to be able to intervene in the specific part, to execute a process of calculating walking state parameters related to the walking state of the user based on the sensing data, and controlling the intervention of the intervention mechanism in the specific part by the intervention mechanism by comparing the walking state parameters with a state target value set based on physical information of the user.

[0010] In the present disclosure, in a lower limb orthosis including a sensing unit that acquires sensing data of a specific part of a user's lower limb and an intervention mechanism configured to be able to intervene in the specific part, a walking state parameter related to the walking state of the user is calculated based on the sensing data, and intervention in the specific part by the intervention mechanism is controlled by comparing the walking state parameter with a state target value set based on physical information of the user.

[0011] 1 is a block diagram showing an example configuration of a lower limb orthosis according to the present disclosure. FIG. 1 is a diagram showing the overall configuration of an insole orthosis. FIG. 2 is a side view showing the appearance of the insole orthosis. FIG. 3 is a plan view showing the appearance of the insole orthosis. FIG. 4 is a diagram showing an example arrangement of air balloons. FIG. 5 is a diagram showing an example of the trajectory of the center of foot pressure and an example of pressure points. FIG. 6 is a diagram explaining a walking cycle. FIG. 7 is a diagram showing an example configuration of a charging dock. FIG. 8 is a diagram showing an example arrangement of side balloons. FIG. 9 is a block diagram showing an example functional configuration of an insole orthosis. FIG. 10 is a flowchart showing calibration of an insole orthosis. FIG. 11 is a flowchart showing intervention processing by an insole orthosis. FIG. 12 is a diagram showing the principle of a magnetorheological elastomer. FIG. 13 is a diagram showing an example arrangement of coils. FIG. 14 is a diagram showing an example configuration of an insole orthosis using an electrorheological fluid. FIG. 15 is a diagram showing an example configuration of an insole orthosis using a shape memory alloy. FIG. 16 is a diagram showing an example of another device used to calculate walking state parameters. FIG. 17 is a block diagram showing an example functional configuration of a knee orthosis. FIG. 18 is a flowchart showing calibration of a knee orthosis. FIG. 19 is a flowchart showing intervention processing by a knee orthosis. FIG. 19 is a flowchart showing intervention processing by a knee orthosis. FIG. 19 is a diagram showing an example of another device used to calculate walking state parameters. FIG. 19 is a diagram showing an example of intervention by cooperation between lower limb orthosis. FIG. 10 is a diagram illustrating an example of intervention through cooperation between lower limb orthotics.

[0012] Modes for carrying out the present disclosure (hereinafter referred to as embodiments) will be described below in the following order.

[0013] 1. Background 2. Configuration example of lower limb orthosis according to the present disclosure 3. Configuration and operation of insole orthosis 4. Configuration and operation of knee orthosis 5. Cooperation between lower limb orthosis

[0014] <1. Background> Knee osteoarthritis (knee OA) is a walking disorder in which symptoms gradually worsen. Knee OA causes pain, which discourages exercise such as walking, resulting in a decrease in lower limb muscle mass, further worsening the symptoms. As symptoms progress, lower limb alignment is disrupted, increasing mechanical stress on the knee joint, and continuing to walk in this state further worsens the symptoms. Knee OA is a disease that creates this vicious cycle.

[0015] Among conservative treatments for knee OA, bracing therapy is a useful method for breaking the vicious cycle described above, with the aim of alleviating pain and inhibiting the progression of knee OA.

[0016] On the other hand, the lateral wedge-type insoles and leg supports currently used in clinical settings are generally non-electrical devices, which poses the following challenges:

[0017] First, when providing prosthetic devices tailored to a patient, they must be made by a specialized prosthetist, which requires a lot of time and effort, including inspection and adjustment.

[0018] Secondly, diseases of the lower limbs and feet can occur in conjunction with or in combination with other diseases of the lower limbs and feet, and many prefabricated orthoses have shapes and inclinations that are tailored to individual diseases, so they cannot necessarily be said to have the optimal shape or inclination for each individual patient.

[0019] Third, while optimal intervention is required each time based on the symptoms and the patient's condition, if readjustment is necessary, the patient must return to the hospital for further processing.

[0020] In contrast, the technology disclosed herein provides lower limb orthoses such as foot orthoses and knee orthoses with a sensing function and an electrically variable intervention mechanism, enabling the state of the intervention mechanism to be dynamically controlled based on sensing data acquired by the sensing function.

[0021] 2. Configuration Example of Lower Limb Orthosis According to the Present Disclosure FIG. 1 is a block diagram showing a configuration example of a lower limb orthosis according to the present disclosure.

[0022] The lower limb orthosis 1 shown in FIG. 1 is configured as a sole orthosis to be attached to a user's foot, a knee orthosis to be attached to a user's leg including the knee, or the like.

[0023] The lower limb orthosis 1 is configured to include a sensor 11, an IMU (Inertial Measurement Unit) 12, an intervention mechanism 13, and a processor 14. The sensor 11 and the IMU 12 configure a sensing unit that acquires sensing data of a specific part of the user's lower limb.

[0024] That is, the sensor 11 acquires sensing information of a specific part of the user's lower limb and outputs it to the processor 14. When the lower limb orthosis 1 is configured as an insole orthosis, the specific part is the user's foot, and the sensor 11 is configured as a foot pressure sensor that acquires foot pressure information as sensing information. When the lower limb orthosis 1 is configured as a knee orthosis, the specific part is the user's knee, and the sensor 11 is configured as a muscle displacement sensor that acquires muscle displacement information as sensing information.

[0025] The IMU 12 acquires inertial information of a specific part of the user's lower limbs and outputs it to the processor 14 .

[0026] The intervention mechanism 13 is configured to be able to intervene in a specific part of the user's lower limb. When the lower limb orthosis 1 is configured as a foot orthosis, the intervention mechanism 13 is configured as an adjustment mechanism that is able to adjust the height and inclination of the sole. When the lower limb orthosis 1 is configured as a knee orthosis, the intervention mechanism 13 is configured as an electrode pad that applies electrical stimulation to the leg muscles.

[0027] The processor 14 is composed of a CPU (Central Processing Unit), an MPU (Micro Processing Unit), etc. The processor 14 controls intervention by the intervention mechanism 13 on a specific part based on sensing data from the sensing unit, i.e., sensing information from the sensor 11 and inertial information from the IMU 12. Specifically, the processor 14 implements each functional block of the walking state calculation unit 21 and the intervention control unit 22 by executing a program stored in a memory (not shown).

[0028] The walking state calculation unit 21 calculates walking state parameters related to the user's walking state based on sensing data from the sensing unit (at least one of sensing information from the sensor 11 and inertial information from the IMU 12) and supplies them to the intervention control unit 22.

[0029] The intervention control unit 22 controls the intervention by the intervention mechanism 13 on the specific part by comparing the walking state parameters from the walking state calculation unit 21 with state target values ​​set based on the user's physical information.

[0030] Specifically, when the walking state parameter exceeds an error threshold from the state target value, the intervention control unit 22 controls the intervention on the specific part by the intervention mechanism 13. The intervention control unit 22 controls the intervention on the specific part by the intervention mechanism 13 so as to reduce the knee varus moment (KAM). The state target value may be set based on at least one of the user's thigh length, lower leg length, and walking posture, for example.

[0031] The above configuration makes it possible to always provide appropriate intervention in accordance with individual differences in patients and changes in their condition over time.

[0032] That is, when the lower limb orthosis 1 is configured as an insole, gait feedback control becomes possible using a lateral wedge-type insole whose height is variable according to the mechanical stress of the knee joint, based on data such as KAM and foot pressure information. In the insole, the concave and convex shape of the insole may be finely adjusted by the patient (user) themselves or a third party such as a physical therapist or prosthetist.

[0033] Furthermore, when the lower limb orthosis 1 is configured as a knee orthosis, it becomes possible to control inversion / eversion and correct walking posture, such as toe-in walking, which is effective in reducing mechanical stress on the knee joint, based on data such as muscle activity.

[0034] 1 , the lower limb orthosis 1 (foot insole orthosis / knee insole orthosis) can cooperate with other lower limb orthosis 1 (knee orthosis / foot insole orthosis) to perform intervention based on sensing data from the other lower limb orthosis 1. Specifically, the intervention control unit 22 controls intervention by the intervention control unit 22 on a specific part by further using at least one of sensing information and inertial information acquired by the sensor 11 and IMU 12 provided in the other lower limb orthosis 1 attached to another specific part of the user's lower limb.

[0035] This will enable interventions that are more tailored to the patient's (user's) symptoms, based on data that cannot be obtained with a single device.

[0036] The specific configurations and operations of the insole orthosis and knee orthosis, which are embodiments of the lower limb orthosis 1 according to the present disclosure, will be described below.

[0037] 3. Structure and operation of insole orthosis (Outline of insole orthosis) The insole orthosis to which the technology disclosed herein is applied is a shoe structure and a walking feedback system that includes a sensing unit for measuring foot pressure, foot angle, etc., and an intervention mechanism on the sole that is height-adjustable based on the sensing data acquired by the sensing unit.

[0038] In the case of foot orthoses, not only is feedback control based on sensing data acquired by the sensing unit possible, but the sole of the foot can also be adjusted to any height by the patient themselves or a third party such as a physical therapist or prosthetist to suit the patient's symptoms.

[0039] In the insole orthosis, the center of foot pressure (COP) is measured by a foot pressure sensor, and the air pressure of an air balloon serving as an intervention mechanism is adjusted based on the measured COP to reduce KAM, an index of mechanical stress on the knee joint. For example, in the case of a patient with medial knee OA and bow-legged lower limbs, air can be injected into the air balloon on the fibula side (the side of the fibula, on the outside of the leg) to shift the trajectory of COP during the gait cycle outward, thereby reducing mechanical stress on the knee joint.

[0040] (Configuration of insole orthosis) The configuration of an insole orthosis 100 to which the technology according to the present disclosure is applied will be described with reference to Figures 2 to 4. Figure 2 is an overall configuration diagram of the insole orthosis 100. Figure 3 is a side view showing the appearance of the insole orthosis 100, and Figure 4 is a plan view showing the appearance of the insole orthosis 100. Note that Figure 4 shows the configuration of the insole orthosis 100 as seen from the sole. Figures 2 to 4 show the configuration of the insole orthosis 100 worn on the right foot, but the insole orthosis 100 worn on the left foot will have a configuration that is bilaterally symmetrical to the configuration shown in Figures 2 to 4.

[0041] The insole orthosis 100 configured as a shoe-type device comprises, in order from the top surface that contacts the sole of the user's foot, a foot pressure sensor 111, a plate 112 as an upper plate, and an air balloon 113. As shown in Figure 3, a plate 112 as a bottom plate is also provided between the air balloon 113 and the sole of the insole orthosis 100.

[0042] The foot pressure sensor 111 is configured by a pressure sensor capable of measuring the pressure applied to the sole of the user's foot.

[0043] The pressure sensors constituting the foot pressure sensor 111 are arranged at least at three nodes (the ball of the foot, the little toe, and the heel), and preferably at least 100 nodes so that COP can be detected during walking. The pressure sensors constituting the foot pressure sensor 111 are arranged to avoid the metatarsophalangeal joint (MP joint) and the flexing part of the shoe (ball joint) to prevent damage due to the flexion of the ankle joint during walking. Furthermore, the pressure sensors constituting the foot pressure sensor 111 may be made of a flexible and stretchable material that can accommodate repeated flexion.

[0044] A flexible layer (not shown) made of sponge, gel, etc. is laminated on the upper surface of the foot pressure sensor 111. To ensure high durability of the detection section of the foot pressure sensor 111, the flexible layer and the foot pressure sensor 111 are not bonded together or are only partially bonded together so that the interface between the flexible layer and the foot pressure sensor 111 is smooth.

[0045] The plate 112 is made of a material such as hard rubber and is formed to bend at the MP joint. In order to detect the inclination of the foot, the plate 112 provided below the foot pressure sensor 111 is made hard enough to limit bending to a level that does not interfere with sensing, so that minute changes in height / inclination caused by the air balloon 113 are transmitted to the sole of the user's foot while the foot pressure sensor 111 can detect those changes.

[0046] The air balloon 113 is a form of an adjustment mechanism configured to adjust the height and inclination of the sole of the foot, and is composed of one or more air balloons with adjustable air pressure. Specifically, the air balloon 113 is divided into multiple parts and placed on the sole of the foot. The air pressure inside the air balloon 113 is controlled by letting air in and out (injecting and expelling), thereby changing the height and inclination of the sole of the user's foot. The arrangement and number of air balloons 113 will be described in detail below.

[0047] In the foot orthosis 100, an air volume control structure for controlling the amount of air in the air balloon 113 is provided, for example, in a location where the air balloon 113 is not placed (the area corresponding to the arch in the example of Figure 4) or on the surface on the instep side of the foot.

[0048] Specifically, the foot orthosis 100 further includes an air pump 114 for injecting air into the air balloon 113, a drive circuit 115 for driving the air pump 114, an air pressure sensor 116 for measuring the air pressure inside the air balloon 113, a control board 117, and a secondary battery 118.

[0049] Air from the air pump 114 is supplied via tubes 121 to valves 122 provided for each air balloon 113. The valves 122 are connected to the control board 117 by drive wiring 123, and under the control of the control board 117, send air from the air pump 114 to each air balloon 113. The air from the air pump 114 is measured by an air pressure sensor 124 and output to the control board 117. The control board 117 drives the air pump 114 by controlling a drive circuit 115 based on the air pressure measured by the air pressure sensor 124.

[0050] The control board 117 is equipped with a power management integrated circuit (PMIC) 131 , an MPU 132 , and an IMU 133 .

[0051] The PMIC 131 controls the power supply to each component powered by power from the secondary battery 118. The MPU 132 adjusts the air pressure of each air balloon 113 by controlling the drive circuit 115 and each valve 122 based on foot pressure information from the foot pressure sensor 111 and inertia information from the IMU 133. The IMU 133 senses foot movement to obtain inertial information, such as the foot's motion state and posture, including the foot angle. The IMU 133 may be provided in a location corresponding to the foot movement to be sensed. For example, the IMU 133 that senses foot inversion / eversion is provided near the ankle, and the IMU 133 that senses foot angle is provided at least on the heel or toe.

[0052] (Arrangement and Number of Air Balloons) At least one air balloon 113 is provided so that the relative heights of the lateral and medial sides of the sole can be changed to correct lower limb alignment.

[0053] FIG. 5 is a diagram showing an example of the arrangement of the air balloons 113.

[0054] 5A shows an example of the arrangement of four air balloons 113a, 113b, 113c, and 113d. Air balloon 113a is an arch support balloon for maintaining the transverse arch of the foot, and air balloon 113b is an arch support balloon for maintaining the medial longitudinal arch of the foot. Air balloon 113c is a calf-side balloon for adjusting the height of the lateral side of the heel, and air balloon 113d is a tibial-side balloon for adjusting the height of the medial side of the heel (shin-side). This arrangement of air balloons 113 allows for the maintenance of the transverse arch and medial longitudinal arch for other conditions such as foot alignment and hallux valgus while correcting lower limb alignment.

[0055] 5B shows an example of the arrangement of a plurality of air balloons 113e. The air balloons 113e are, for example, 4 cm in size, 2 cm x 2 cm. 2 The air balloons 113 are formed in a size of about 100 mm and arranged in a matrix in an area corresponding to the sole of the foot. By arranging the air balloons 113 in this way, it is possible to address a wider range of foot diseases and conditions.

[0056] The air balloon 113 is positioned to avoid the metatarsophalangeal joints (MP joints) and the flexing parts of the shoe (ball joints) so as not to interfere with the flexing movement of the foot joints when walking.

[0057] (Feedback Control Method) The following three methods are conceivable as feedback control methods based on sensing data acquired by the sensing unit.

[0058] (1) Real-time control within the walking cycle of each step The locus of the center of foot pressure (COP) during walking deviates from the ideal locus due to imbalances in the lower limb alignment and foot alignment. Specifically, as shown on the left side of Figure 6, the locus of the center of foot pressure in flat feet traces a path closer to the inside of the foot (toward the arch) than the ideal locus of the center of foot pressure, and the locus of the center of foot pressure in bow legs traces a path closer to the outside of the foot (toward the calf) than the ideal locus of the center of foot pressure.

[0059] In this case, the intervention control unit realized by the MPU 132 controls the adjustment of the height and inclination of the sole by the adjustment mechanism (air balloon 113) for each step of the user. Specifically, as shown on the right side of Fig. 6, air is injected into the air balloon 113 during the stance phase so that the pressure point PP transitions from the heel to the toe, thereby correcting the foot pressure center trajectory to approach the ideal foot pressure center trajectory.

[0060] (2) Semi-real-time method of determining control parameters for each walking cycle of a few to several tens of steps. In this case, the intervention control unit realized by the MPU 132 controls the adjustment of the height and inclination of the sole of the foot by the adjustment mechanism (air balloons 113) for each of the user's multiple steps. In other words, the state of the air balloons 113 is not changed within each walking cycle of one step, and the optimal air pressure for each air balloon 113 is calculated based on data from the past few to several tens of steps.

[0061] At this time, the IMU 133 or the like detects the swing phase (the period when the foot is not in contact with the ground) in the walking cycle.

[0062] 7 is a diagram illustrating a gait cycle. When focusing on either the left or right foot, the gait cycle can be divided into a stance phase and a swing phase. The stance phase is a period in which any part of the sole of the foot is in contact with the ground, from foot contact to contralateral lower leg lift, heel lift, contralateral lower leg contact, and toe lift. On the other hand, the swing phase is a period in which no part of the sole of the foot is in contact with the ground, from toe lift to both lower legs crossing, lower legs vertical, and foot contact.

[0063] That is, in this method, air is pumped into and released from the air balloon 113 during the swing phase detected by the IMU 133 or the like. In this case, air is pumped into the air balloon 113 little by little over the time period of several to several tens of steps when no weight is being applied, so the air pressure of the air balloon 113 can be adjusted with a lower air pressure and a lower flow rate compared to method (1). That is, a small, quiet, and energy-saving air pump can be used as the air pump 114.

[0064] (3) Charging Dock Method in Which Control Parameters are Determined During Charging Based on Walking Data for One Day FIG. 8 is a diagram showing an example of the configuration of a charging dock (charging station) employed in this method.

[0065] The charging dock CD shown in Figure 8 is configured to be able to place the left and right insole orthoses 100L, 100R on it, and is able to charge the placed insole orthoses 100L, 100R. The charging dock CD can be provided with an air pump and air volume control mechanism (not shown). This eliminates the need to provide an air pump and air volume control mechanism for each of the insole orthoses 100L, 100R, and allows the weight of the insole orthoses to be reduced as a finished product.

[0066] The control unit CU, located in the center of the charging dock CD, is equipped with a display Ds, which can display information such as a daily walking record and air pressure parameters acquired by the foot orthosis 100 to the user.

[0067] In this case, the intervention control unit realized by the MPU 132 determines the amount of adjustment to be made to the sole height and inclination by the adjustment mechanism (air balloon 113) based on the user's walking record over a certain period of time. Both sides of the control unit CU are connected to the inner sides of the insole orthoses 100L, 100R by connectors CnL, CnR equipped with air tubes. By connecting the control unit CU and the insole orthoses 100L, 100R by the connectors CnL, CnR, air can be injected into the air balloons 113 of the insole orthoses 100L, 100R from the charging dock CD based on the amount of adjustment determined by the intervention control unit. Note that a portion of the control board 117 including the MPU 132 may be provided in the control unit CU.

[0068] (Fitting Mechanism) In order to maximize the accuracy of sensing by the foot pressure sensor 111 and the effect of intervention by the adjustment mechanism (air balloon 113), a fitting mechanism for the user's foot may be added as necessary.

[0069] Figure 9 shows an example of the arrangement of a side balloon as an example of a fitting mechanism in a right foot insole orthosis 100R. Figure 9A shows a left side view of the insole orthosis 100R, Figure 9B shows a rear view of the insole orthosis 100R, and Figure 9C shows a right side view of the insole orthosis 100R.

[0070] In the example of Fig. 9, side balloons 113s are arranged in the vicinity of each of the left and right ankles within the foot insole orthosis 100R, as one of the air balloons 113. After the user puts on the foot insole orthosis 100R, air is injected into the side balloons 113s, thereby reducing horizontal misalignment between the foot and the foot insole orthosis 100R when walking.

[0071] (Example of Functional Configuration of Insole Orthosis) FIG. 10 is a block diagram showing an example of the functional configuration of the insole orthosis 100 as a shoe device.

[0072] The foot orthosis 100 shown in Fig. 10 includes the above-mentioned foot pressure sensor 111, air balloon 113, and IMU 133, as well as a control unit 150 and an air balloon control unit 160. In the example of Fig. 10, the air balloon 113 includes arch support balloons 113a and 113b (Fig. 5), lateral / tibial balloons 113c and 113d (Fig. 5), and a side balloon 113s (Fig. 9).

[0073] The control unit 150 and the air balloon control unit 160 can be realized on the control board 117 including the above-mentioned MPU 132 .

[0074] The control unit 150 is configured to include a walking state calculation unit 151, an air pump voltage control unit 152, a storage unit 153, and a communication unit 154. The air balloon control unit 160 is configured to include an air pressure information acquisition unit 161, an air pump control unit 162, and a valve control unit 163.

[0075] The walking state calculation unit 151 corresponds to the walking state calculation unit 21 in Figure 1, and calculates walking state parameters related to the user's walking state based on at least one of the foot pressure information from the foot pressure sensor 111 and the inertia information from the IMU 133, and supplies them to the air pump voltage control unit 152.

[0076] 1 , and controls intervention of the air balloon 113 on the user's foot by comparing the walking state parameters from the walking state calculation unit 151 with state target values ​​set based on the user's physical information. Specifically, the air pump voltage control unit 152 controls the air balloon control unit 160 to indirectly adjust the air pressure of the air balloon 113.

[0077] The storage unit 153 is configured with a volatile memory such as a static random access memory (RAM), etc. The storage unit 153 stores log data, such as the results of intervention control by the air pump voltage control unit 152 and various settings used in the intervention control, as user data.

[0078] The communication unit 154 is a communication module that performs wireless or wired communication with the external terminal 180. The communication unit 154 supplies information received by wireless or wired communication to each unit of the control unit 150, including the storage unit 153, and transmits various types of information, including information stored in the storage unit 153, by wireless or wired communication.

[0079] The external terminal 180 is composed of a smartphone, tablet terminal, PC (Personal Computer), etc. The external terminal 180 is configured to include a communication unit 181 that communicates with the communication unit 154 of the insole orthosis 100, a setting information input unit 182 for inputting various setting information for the insole orthosis 100, and a display unit 183 that displays information received from the insole orthosis 100. The external terminal 180 enables the patient or a third party such as a physical therapist or prosthetist to adjust the sole of the foot to any height according to the patient's symptoms.

[0080] The air pressure information acquisition unit 161 acquires air pressure information indicating the air pressure of each of the arch support balloons 113a, 113b, calf / shin balloons 113c, 113d, and side balloon 113s, which serve as air balloons 113, via the air pressure sensor 116, and supplies the information to the air pump control unit 162.

[0081] The air pump control unit 162 controls the air discharge from the air pump 114 under the control of the air pump voltage control unit 152 based on the air pressure information from the air pressure information acquisition unit 161 .

[0082] The valve control unit 163 controls each valve 122 in accordance with the control of the air pump 114 by the air pump control unit 162 to adjust the air pressure of each air balloon 113 .

[0083] (Calibration of the insole orthosis) First, the calibration of the insole orthosis 100 will be described with reference to the flowchart of Fig. 11. The process of Fig. 11 starts when the insole orthosis 100 is in communication with the external terminal 180, for example.

[0084] In step S111, the air pump voltage control unit 152 reads user data from the storage unit 153. The user data includes log data from the previous walking session, such as various measurement values ​​and settings. The storage unit 153 also stores physical information, such as the user's thigh length, lower leg length, and walking posture, that was input as setting information in the external terminal 180, and reads the information together with the log data from the previous walking session.

[0085] In step S112, the air pump voltage control unit 152 sets a state target value based on the user's physical information. The state target value is set to a walking state parameter value that can realize an ideal walking state.

[0086] In step S113, the external terminal 180 prompts the user to put on the shoes (the sole orthosis 100) and assume a standing position by, for example, displaying a guidance screen on the display unit 183.

[0087] In step S114, the external terminal 180 determines whether or not the insole orthosis 100 fits the user's foot, for example, in response to a user's operation on a confirmation screen displayed on the display unit 183. If it is determined that the insole orthosis 100 does not fit the user's foot, the process proceeds to step S115.

[0088] In step S115, the air pump voltage control unit 152 controls the air balloon control unit 160 to adjust the air pressure of the side balloon 113s, and step S114 is repeated.

[0089] On the other hand, if it is determined in step S114 that the foot orthosis 100 fits the user's foot, the process proceeds to step S116.

[0090] In step S116, the walking state calculation unit 151 estimates the unevenness of the soles of the user's feet based on the foot pressure information from the foot pressure sensor 111.

[0091] In step S117, the air pump voltage control unit 152 controls the air balloon control unit 160 based on the estimation results of the unevenness of the user's soles by the walking state calculation unit 151, thereby adjusting the air pressure of the arch support balloons 113a, 113b.

[0092] In step S118, the external terminal 180 determines whether or not the user feels any discomfort in their feet, for example, in response to the user's operation on the confirmation screen displayed on the display unit 183. At this time, the user checks whether or not there is any discomfort by, for example, stamping their feet. If it is determined that the user feels discomfort in their feet, the process returns to step S114, and the subsequent processes are repeated.

[0093] On the other hand, if it is determined in step S118 that the user's feet are not uncomfortable, the process proceeds to step S119, where the walking state calculation unit 151 performs calibration. At this time, the external terminal 180 prompts the user to lift one foot by, for example, displaying a guidance screen on the display unit 183. Then, the walking state calculation unit 151 regards the pressure distribution detected by the foot pressure sensor 111 in a state where the user is not bearing weight as offset noise, and performs calibration. Here, it is assumed that calibration is performed in a state where the user is not bearing weight, but the offset amount of the sensor output may also be determined by detecting the pressure distribution in a state where the user is bearing weight forward and backward, as necessary.

[0094] When performing calibration, in order to prevent the user from falling, the insole orthosis 100 or the external terminal 180 may provide an automated voice prompt to encourage the user to lift one leg while sitting or holding onto a handrail or the like. Furthermore, the walking state calculation unit 151 may start calibration in response to the IMU 133 detecting that one leg has been lifted.

[0095] Calibration is performed in the manner described above. This calibration may be performed when the foot orthosis 100 is first used, or whenever there is a change in the condition of the foot or body.

[0096] (Intervention process by insole orthosis) Next, the intervention process by the insole orthosis 100 will be described with reference to the flowchart in Fig. 12. The process in Fig. 12 starts when the user starts walking. Note that the description here assumes that intervention is being performed on a user (patient) with symptoms of medial knee OA.

[0097] In step S131 , the walking state calculation unit 151 acquires foot pressure information from the foot pressure sensor 111 and inertia information from the IMU 133 .

[0098] In step S132, the walking state calculation unit 151 calculates walking state parameters based on the acquired foot pressure information and inertia information. For example, the walking state calculation unit 151 calculates the center of foot pressure (COP) and knee joint varus moment (KAM) as the walking state parameters.

[0099] In step S133, the walking state calculation unit 151 determines whether the calculated walking state parameter exceeds the error threshold from the state target value. If it is determined that the walking state parameter exceeds the error threshold from the state target value, intervention is deemed necessary, and the process proceeds to step S134.

[0100] In step S134, the air pump voltage control unit 152 controls the air balloon control unit 160 based on the walking state parameters calculated by the walking state calculation unit 151, thereby adjusting the air pressure of the calf / shin balloons 113c, 113d.

[0101] On the other hand, if it is determined in step S133 that the walking state parameter does not exceed the error threshold from the state target value, intervention is deemed unnecessary and step S134 is skipped.

[0102] Thereafter, in step S135, the walking state calculation unit 151 determines whether or not the user continues walking, for example, based on the inertial information from the IMU 133. If it is determined that the user continues walking, the process returns to step S131, and the subsequent processes are repeated.

[0103] On the other hand, if it is determined in step S135 that the user is not continuing to walk, that is, that the user has finished walking, the process proceeds to step S136.

[0104] In step S136, the air pump voltage control unit 152 stores log data such as the results of the intervention control and various settings used in the intervention control in the storage unit 153 as user data.

[0105] Although the above describes an example in which intervention is performed on a user with symptoms of medial knee OA, intervention tailored to the symptoms may also be performed on patients with other symptoms.

[0106] According to the above processing, the air pressure of the air balloon is adjusted according to the walking state parameters calculated based on the foot pressure information from the foot pressure sensor and the inertial information from the IMU, making it possible to realize appropriate intervention tailored to the user's symptoms and the patient's condition.

[0107] (Other examples of foot orthosis configurations) The above describes a configuration in which one or more air balloons with adjustable air pressure are used as an adjustment mechanism that is configured to adjust the height and inclination of the sole, but other adjustment mechanisms may also be used.

[0108] (1) Magnetorheological Elastomer As an adjustment mechanism configured to be able to adjust the height and inclination of the sole, one or more elastic members made of magnetorheological elastomer whose elastic modulus can be adjusted by a magnetic field may be employed.

[0109] FIG. 13 is a diagram illustrating the principle of the magnetorheological elastomer.

[0110] Magnetorheological elastomers are magnetically responsive functional materials that are made responsive to magnetic fields by incorporating minute magnetic particles into flexible materials such as silicone or rubber. A magnetic field generated by passing an electric current through a coil placed near the magnetorheological elastomer causes the magnetic particles contained in the magnetorheological elastomer to align, thereby increasing the elastic modulus of the magnetorheological elastomer.

[0111] By replacing the air balloon 113 of the above-mentioned foot orthosis 100 with a magnetorheological elastomer, placing a coil for generating a magnetic field directly below it, and controlling the strength of the magnetic field, it is possible to change the elastic modulus of the magnetorheological elastomer.

[0112] FIG. 14 is a diagram showing an example of the arrangement of coils.

[0113] In the foot orthosis 100A shown in Fig. 14, multiple coils 211 are arranged in a matrix in an area corresponding to the sole of the foot. Such an arrangement of the coils 211 makes it possible to control the height and inclination of the sole in accordance with the foot disease or condition.

[0114] In addition, if the magnetic viscoelastic elastomer is crushed by a load while its elastic modulus is increased by the magnetic field, the magnetic particles will stick to each other and remain crushed. Therefore, the magnetic field is controlled to disappear at the timing of the swing phase. A sensor such as an IMU can be used to detect the swing phase.

[0115] (2) Electrorheological Fluid As an adjustment mechanism configured to be able to adjust the height and inclination of the sole, one or more cushion members filled with an electrorheological fluid whose viscosity can be adjusted by an electric field may be employed.

[0116] By replacing the air balloon 113 of the above-mentioned insole orthosis 100 with a cushion material filled with electrorheological fluid and providing electrodes for generating an electric field on both sides of the foot, it is possible to change the viscosity of the electrorheological fluid.

[0117] FIG. 15 is a diagram showing an example of the configuration of a foot orthosis using an electrorheological fluid.

[0118] In the foot orthosis 100B shown in Fig. 15, a cushion member 221a filled with electrorheological fluid is provided from the left side of the sole to the ankle, and a cushion member 221b filled with electrorheological fluid is provided from the right side of the sole to the ankle. The cushion members 221a and 221b are sandwiched between electrodes 222a and 222b near the left and right sides of the foot, respectively. When a high voltage is applied to the electrodes 222a and 222b, the viscosity of the electrorheological fluid sandwiched between the electrodes 222a and 222b increases, increasing the kinetic viscosity. This makes the cushion members 221a and 221b less likely to collapse.

[0119] 15, the voltage applied to electrode 222a is 0 V, and the electrorheological fluid flows through cushion member 221a, making cushion member 221a prone to collapse. On the other hand, the voltage applied to electrode 222b is 400 V, and the electrorheological fluid does not easily flow through cushion member 221b, making cushion member 221b less prone to collapse.

[0120] In the foot orthosis 100B shown in Figure 15, by arranging cushion members filled with electrorheological fluid in the same number as the air balloons 113 of the above-mentioned foot orthosis 100, it is possible to control the height and inclination of the sole according to the foot disease or condition.

[0121] (3) Shape Memory Alloy One or more spring members made of a shape memory alloy whose shape changes depending on the temperature may be used as an adjustment mechanism configured to be able to adjust the height and inclination of the sole.

[0122] By replacing the air balloon 113 of the above-mentioned insole orthosis 100 with a spring member made of a shape memory alloy and providing a heating mechanism nearby to change the shape of the shape memory alloy, it is possible to change the elastic modulus of the spring member.

[0123] FIG. 16 is a diagram showing an example of the configuration of an insole orthosis using a shape memory alloy.

[0124] In the foot orthosis 100C shown in Fig. 16, a spring member 231a made of a shape memory alloy whose shape changes with temperature is provided on the left side of the sole, and a spring member 231b made of a shape memory alloy whose shape changes with temperature is provided on the right side of the sole. Heat insulating materials 232, 233 that are highly heat resistant and can withstand body weight are provided above and below the spring members 231a, 231b, and a further heat insulating material 234 is provided on the ground side of the insulating material 233. Because shape memory alloys change shape with temperature changes, it is necessary to provide such an insulating structure to reduce the effects of heat from the ground.

[0125] Furthermore, in the foot insole orthosis 100C, a heat dissipation layer 235 is provided so as to surround the heat insulating materials 232, 233 sandwiching the spring members 231a, 231b, and so as to surround both side surfaces of the foot. In particular, the heat dissipation layer 235 surrounding both side surfaces of the foot is formed from a material with high thermal conductivity and elasticity. Furthermore, in the foot insole orthosis 100C, mesh parts 236 are provided in areas facing the heat dissipation layer 235 surrounding both side surfaces of the foot to expose the heat dissipation layer 235 to the outside air.

[0126] In the example of Fig. 16, the temperature of spring member 231a is 25°C, which is lower than the activation start temperature, and spring member 231a is in a collapsed state due to the load. On the other hand, the temperature of spring member 231b is 85°C, which is higher than the activation start temperature, and spring member 231b is in an elongated state, trying to return to its original shape.

[0127] In the foot orthosis 100C shown in Figure 16, by arranging spring members made of shape memory alloys whose shape changes depending on temperature in the same number as the air balloons 113 of the above-mentioned foot orthosis 100, it is possible to control the height and inclination of the sole according to the foot disease or condition.

[0128] The shape memory alloy used for the spring member must be an alloy that undergoes a phase change at a temperature of at least 45°C or higher, taking into account body temperature and ambient temperature. For example, a Ti-Ni-Cu alloy may be used.

[0129] (Examples of other devices used to calculate walking state parameters) In addition to the foot pressure sensor 111 and IMU 133 provided in the above-mentioned insole orthosis 100, the degree of intervention may be more appropriately controlled based on sensing data obtained by other devices.

[0130] FIG. 17 is a diagram showing an example of another device used to calculate walking state parameters.

[0131] For example, when it is desired to calculate walking state parameters that represent upper body movements, a device equipped with an IMU and worn on the user's upper limbs can be, for example, an earphone equipped with an IMU.

[0132] Furthermore, when it is desired to calculate walking state parameters that represent estimated behaviors such as walking and sitting, a device equipped with an IMU and worn on the user's arm or upper limb, such as a smart watch, can be used.

[0133] 4. Configuration and Operation of Knee Brace (Overview of Knee Brace) A knee brace to which the technology disclosed herein is applied is a leg support structure and walking feedback system that includes a sensing unit for measuring muscle / tendon / nerve activity, the central position and flexion angle of the knee joint, and an intervention mechanism that uses electrical stimulation to control muscle movement based on the sensing data acquired by the sensing unit.

[0134] In knee braces, in addition to feedback control based on sensing data acquired by the sensing unit, it is possible to present any intervention stimulus tailored to the patient's symptoms under the supervision of a third party such as a physical therapist or prosthetist.

[0135] In the knee brace, the center position of the knee joint is measured by an IMU, and based on the measured center position of the knee joint, electrical stimulation is applied to muscles that affect the inversion / abduction and inversion / eversion of the foot to encourage walking in a way that reduces the KAM, an index of mechanical stress on the knee joint. For example, in the case of a user with medial knee OA who has overpronation in their foot alignment, electrical stimulation is applied to the muscles that affect the inversion of the foot to correct it to neutral pronation, thereby reducing mechanical stress on the knee joint. Furthermore, in order to encourage toe-in walking, which is believed to be effective in reducing the knee joint varus moment (KAM), electrical stimulation is applied to the muscles that affect the inversion of the foot, thereby reducing mechanical stress on the knee joint.

[0136] Furthermore, a knee brace incorporating the technology disclosed herein can be used not only for intervention during walking, but also for EMS (Electro-Massage System) to strengthen muscles at home, or TENS (Tension and Stimulation System) to relieve pain in the knee joint. These can be achieved, for example, by a mode switching function, which can change the parameters of the electrical stimulation pulses depending on the mode, or by being worn in an appropriate position depending on the mode.

[0137] (Configuration of Knee Brace) Although not shown in the drawings, the configuration of a knee brace 300 to which the technology according to the present disclosure is applied will be described.

[0138] The knee brace 300, configured as a leg support device, is composed of an intervention mechanism consisting of electrode pads that electrically stimulate the leg muscles, a control board, an IMU, a muscle displacement sensor that acquires muscle displacement information as sensing information, and a secondary battery. The knee brace 300 acts on the sartorius muscle, the thigh muscles that contribute to the external / internal rotation of the leg, the muscles of the lower limbs related to ankle movement, and the muscles around the knee that contribute to the impact load when landing. Therefore, the knee brace 300 is worn by wrapping around the upper part (thigh), lower part (lower leg), or leg, centered on the knee. This allows intervention through electrical stimulation of the muscles that contribute to the adduction / abduction and inversion / eversion of the foot.

[0139] The knee brace 300 is provided with at least two electrode pads.

[0140] The muscle displacement sensor quantifies muscle movement by detecting the protrusion of the skin surface or body tissue after light is emitted from a light-emitting element and reflected by the skin surface or body tissue with a light-receiving element. A myoelectric potential sensor is generally used to detect muscle movement, but the knee brace 300 uses electrical stimulation from electrode pads, so an optical muscle displacement sensor is used to avoid interference.

[0141] The data acquired by the muscle displacement sensor allows us to understand the movement of the feet or lower limbs while walking. This allows us to estimate the walking cycle and gait (such as the gait specific to patients with knee OA). Furthermore, by feeding back these estimation results during electrical stimulation, it becomes possible to provide electrical stimulation with an appropriate current amount.

[0142] The IMU senses the movements of the lower limbs and feet to acquire the state of foot motion and posture such as foot angle as inertial information. The IMU may be installed in a location that corresponds to the foot movement to be sensed. For example, an IMU that senses the center of the knee joint is installed near the knee joint, and an IMU that senses the foot angle is installed in the lower leg.

[0143] (Materials Used for the Leg Supporter) The leg supporter constituting the knee brace 300 may have electrode pads and may be made of a flexible material or a hard material with low flexibility. For example, the leg supporter may be made of a material such as a rubber band or silicone. If a flexible material is used, the electrode pads may shift from their optimal positions due to deterioration over time or changes in the user's body shape. In this case, the user's skin impedance may be periodically calculated and the wearing position of the leg supporter (knee brace 300) may be calibrated. In response to changes in the positions of the multiple electrode pads, a UI may be presented, such as one that encourages the user to re-wear the knee brace 300 or provides guidance on replacing the electrode pads.

[0144] (Countermeasures against sweating) The electrode pads need to be tightly attached to the skin by the tightening of the leg support. Therefore, there is a possibility that the skin impedance may change due to sweating caused by sweating inside the leg support. To address this, a mechanism may be provided that dynamically changes parameters such as the current intensity and pulse width of the electrical stimulation pulses, or that prompts recalibration or reattachment of the knee brace 300.

[0145] (Functions Other Than Gait Intervention by Muscle Activity Control) The knee brace 300 configured as a leg support device is intended to be used for the gait intervention described above, but it can also simultaneously perform multiple functions by, for example, increasing the number of electrode pad channels. For example, if the primary function is to modify gait, a different function can be simultaneously achieved by outputting electrical stimulation pulses with different waveforms for pain relief using separate electrode pads provided near the knee. Furthermore, multiple functions can be achieved by presenting different electrical stimulations depending on the swing leg / stand leg position during walking detected by sensing.

[0146] (Example of Functional Configuration of Knee Brace) FIG. 18 is a block diagram showing an example of the functional configuration of a knee brace 300 as a leg support type device.

[0147] The knee brace 300 shown in FIG. 18 includes a muscle displacement sensor 311, an IMU 312, a control unit 320, and an electrode pad 330.

[0148] As described above, the muscle displacement sensor 311 receives light reflected from the skin surface or body tissue using a light-receiving element, and senses the protrusion of the skin surface or body tissue to acquire muscle displacement information as sensing information. The acquired muscle displacement information is output to the control unit 320.

[0149] The IMU 312 senses the movements of the lower limbs and feet, and thereby acquires, as inertial information, the state of foot motion and posture such as foot angle. The acquired inertial information is output to the control unit 320.

[0150] The control unit 320 can be realized on a control board including a processor such as an MPU (not shown).

[0151] The control unit 320 is configured to include a walking state calculation unit 321 , an electrical stimulation control unit 322 , a storage unit 323 , and a communication unit 324 .

[0152] The walking state calculation unit 321 calculates walking state parameters related to the user's walking state based on at least one of the muscle displacement information from the muscle displacement sensor 311 and the inertial information from the IMU 312, and supplies them to the electrical stimulation control unit 322.

[0153] The electrical stimulation control unit 322 compares the walking state parameters from the walking state calculation unit 321 with state target values ​​set based on the user's physical information, and controls intervention on the user's knee by the electrode pad 330. Specifically, the electrical stimulation control unit 322 controls the electrode pad 330 to indirectly control the electrical stimulation applied to the user's leg.

[0154] The electrode pad 330 is configured to include an inversion / eversion control electrode 331, an adduction / abduction control electrode 332, and a dorsiflexion / plantarflexion control electrode 333. The inversion / eversion control electrode 331 applies electrical stimulation to muscles that contribute to the inversion / eversion movement of the foot. The adduction / abduction control electrode 332 applies electrical stimulation to muscles that contribute to the adduction / abduction movement of the foot. The dorsiflexion / plantarflexion control electrode 333 applies electrical stimulation to muscles that contribute to the dorsiflexion / plantarflexion movement of the foot. The electrode pad 330 configured in this manner can apply electrical stimulation that is more tailored to the patient's condition.

[0155] The storage unit 323 is configured with a volatile memory such as a RAM, etc. The storage unit 323 stores log data such as the results of intervention control by the electrical stimulation control unit 322 and various settings used in the intervention control as user data.

[0156] The communication unit 324 is a communication module that performs wireless or wired communication with the external terminal 180. The communication unit 324 supplies information received by wireless or wired communication to each unit of the control unit 320, including the storage unit 323, and transmits various types of information, including information stored in the storage unit 323, by wireless or wired communication.

[0157] The external terminal 180 is configured in the same manner as the external terminal 180 described with reference to FIG. 9, and therefore a description thereof will be omitted.

[0158] (Calibration of the knee brace) First, the calibration of the knee brace 300 will be described with reference to the flowchart in Fig. 19. The process in Fig. 19 starts when the knee brace 300 is communicating with the external terminal 180, for example.

[0159] In step S311, electrical stimulation control unit 322 reads user data from storage unit 323. The user data includes log data from the previous walking session, such as various measurement values ​​and settings. Storage unit 323 also stores physical information, such as the user's thigh length, lower leg length, and walking posture, that was input as setting information in external terminal 180, and reads the information together with the log data from the previous walking session.

[0160] In step S312, the electrical stimulation control unit 322 sets a state target value based on the user's physical information. The state target value is set to a value of a walking state parameter that can realize an ideal walking state.

[0161] In step S313, the external terminal 180 prompts the user to wear the leg supporter (knee brace 300) by displaying a guidance screen or the like on the display unit 183, for example.

[0162] In step S314, the walking condition calculation unit 321 performs calibration. Specifically, the electrical stimulation control unit 322 applies a weak current to each electrode constituting the electrode pad 330, and the walking condition calculation unit 321 acquires muscle displacement information at this time from the muscle displacement sensor 311.

[0163] In step S315, the walking condition calculation unit 321 determines whether the wearing position of the knee brace 300 (electrode pad 330) is appropriate or not based on the muscle displacement information acquired from the muscle displacement sensor 311. If it is determined that the wearing position is inappropriate, the process proceeds to step S316.

[0164] In step S316, the external terminal 180 prompts the user to correct the wearing position of the knee brace 300 by, for example, displaying a guidance screen on the display unit 183.

[0165] When correcting the wearing position of the knee brace 300, a specific wearing position may be presented by capturing a still image or a moving image of the wearing site, or the wearing position may be specified by estimating the user's body type from the user's gender, age, height, weight, etc. The wearing position may also be specified based on the results of a previous MRI (Magnetic Resonance Imaging) examination or data on the arrangement of muscles, tendons, and nerves.

[0166] Thereafter, the process returns to step S314, and calibration is performed again with the knee brace 300 in the corrected position.

[0167] On the other hand, if it is determined in step S315 that the mounting position is appropriate, the process (calibration) ends.

[0168] (Intervention Processing by Knee Brace) Next, with reference to the flowcharts of Figures 20 and 21, the intervention processing by the knee brace 300 will be described. The processing of Figures 20 and 21 is started when the user starts walking. Note that in this description, it is assumed that intervention is performed on a user (patient) who has symptoms of overpronation and toe-out walking.

[0169] In step S331 , the walking state calculation unit 321 acquires muscle displacement information from the muscle displacement sensor 311 and inertia information from the IMU 312 .

[0170] In step S332, the walking state calculation unit 321 calculates walking state parameters based on the acquired muscle displacement information and inertia information. For example, the walking state calculation unit 321 calculates the knee joint center position and knee joint varus moment (KAM) as the walking state parameters.

[0171] In step S333, the walking state calculation unit 321 determines whether the calculated walking state parameter exceeds the error threshold from the state target value. If it is determined that the walking state parameter exceeds the error threshold from the state target value, intervention is deemed necessary, and the process proceeds to step S334.

[0172] In step S334, the walking state calculation unit 321 determines whether or not the walking state is toe-out walking based on the walking state parameters. If it is determined that the walking state is toe-out walking, the process proceeds to step S335.

[0173] In step S335, the electrical stimulation control unit 322 controls the electrical stimulation applied by the adduction / abduction control electrode 332 of the electrode pad 330 so as to adduct the foot.

[0174] On the other hand, if it is determined in step S334 that the walking is not toe-out walking, step S335 is skipped.

[0175] In step S336, the walking state calculation unit 321 determines whether or not overpronation is occurring in the early stage of the stance phase of the gait cycle, based on the walking state parameters.

[0176] If it is determined that there is overpronation, the process proceeds to step S337, where the electrical stimulation control unit 322 controls the electrical stimulation applied by the inversion / eversion control electrode 331 of the electrode pad 330 to invert the foot. On the other hand, if it is determined that there is no overpronation, the process proceeds to step S338, where the electrical stimulation control unit 322 controls the electrical stimulation applied by the inversion / eversion control electrode 331 of the electrode pad 330 to evert the foot.

[0177] On the other hand, if it is determined in step S333 that the walking state parameter does not exceed the error threshold from the state target value, intervention is deemed unnecessary, and steps S334 to S338 are skipped.

[0178] Thereafter, the process proceeds to step S339 in FIG. 21, where the electrical stimulation control unit 322 measures the skin impedance based on feedback from the electrode pad 330, for example.

[0179] In step S340, the electrical stimulation control unit 322 determines whether the amount of change in skin impedance exceeds a preset threshold value. If it is determined that the amount of change in skin impedance does not exceed the threshold value, the process proceeds to step S341.

[0180] In step S341, the walking state calculation unit 321 determines whether or not the user is continuing to walk, for example, based on inertia information from the IMU 312. If it is determined that the user is continuing to walk, the process returns to step S331 in Fig. 20, and the subsequent processes are repeated.

[0181] On the other hand, if it is determined in step S341 that the user is not continuing to walk, that is, that the user has finished walking, the process proceeds to step S342.

[0182] In step S342, the electrostimulation control unit 322 stores log data such as the results of the intervention control and various settings used in the intervention control in the storage unit 323 as user data.

[0183] If it is determined in step S340 that the amount of change in skin impedance exceeds the threshold, the process proceeds to step S343.

[0184] In step S343, the external terminal 180 prompts the user to correct the wearing position of the knee brace 300, for example, by displaying a guidance screen on the display unit 183. In other words, even if the user continues walking, the intervention process is temporarily terminated, and calibration is performed in the same manner as in step S314 of FIG.

[0185] Note that, although the above describes an example in which intervention is performed on a user (patient) who has symptoms of overpronation and toe-out walking, intervention tailored to the symptoms of patients with other symptoms is also performed.

[0186] According to the above processing, the electrical stimulation applied from the electrode pads is controlled according to the walking state parameters calculated based on the muscle displacement information from the muscle displacement sensor and the inertial information from the IMU, making it possible to realize appropriate intervention tailored to the user's symptoms and the patient's condition.

[0187] (Examples of other devices used to calculate walking state parameters) In addition to the muscle displacement sensor 311 and IMU 312 provided in the knee brace 300 described above, the degree of intervention may be more appropriately controlled based on sensing data obtained by other devices.

[0188] FIG. 22 is a diagram showing an example of another device used to calculate walking state parameters.

[0189] For example, when it is desired to calculate walking state parameters that represent upper body movements, a device equipped with an IMU and worn on the user's upper limbs can be, for example, an earphone equipped with an IMU.

[0190] Furthermore, when it is desired to calculate walking state parameters that represent estimated behaviors such as walking and sitting, a device equipped with an IMU and worn on the user's arm or upper limb, such as a smart watch, can be used.

[0191] Furthermore, when it is desired to calculate a walking state parameter representing the center of foot pressure (COP), a foot orthosis (shoe-type device) equipped with a pressure sensor can be used as a device to be worn on the user's foot.

[0192] <5. Cooperation between lower limb orthoses> In a lower limb orthosis to which the technology of the present disclosure is applied, in addition to the sensing and intervention using the above-mentioned insole orthosis 100 alone and the sensing and intervention using the knee orthosis 300 alone, intervention that mutually utilizes the sensing data of the insole orthosis 100 and the knee orthosis 300 is also possible.

[0193] FIG. 23 is a diagram showing an example of intervention by the foot orthosis 100 based on sensing data from the knee orthosis 300.

[0194] For example, the insole orthosis 100 can calculate the knee joint center, lever arm, and KAM as walking state parameters by using inertial information from an IMU attached near the knee joint of the user, which is provided in the knee orthosis 300, and sensing information from a pressure sensor attached to the sole of the user, which is provided in the insole orthosis 100. Furthermore, the insole orthosis 100 can calculate the walking cycle and gait as walking state parameters by using sensing information from a muscle displacement sensor or a myoelectricity sensor attached to the user's thigh, lower leg, or both, which are provided in the knee orthosis 300.

[0195] Based on these walking state parameters, the foot orthosis 100 can perform interventional control by adjusting the medial and lateral heights of the shoe sole to correct lower limb alignment to reduce KAM.

[0196] FIG. 24 is a diagram showing an example of intervention by the knee brace 300 based on sensing information from the insole brace 100.

[0197] For example, by using inertial information from the IMUs attached to the heel and toe of the user, which are included in the foot orthosis 100, the knee orthosis 300 can calculate the foot angle as a walking state parameter.

[0198] Based on this walking state parameter, the knee brace 300 can perform intervention control, such as abduction / adduction (toe-in walking), as foot alignment correction during walking using electrical stimulation.

[0199] Furthermore, by using sensing information from a pressure sensor attached to the sole of the user's foot, which is provided in the foot orthosis 100, the knee orthosis 300 can calculate the foot pressure center trajectory and walking cycle as walking state parameters.

[0200] Based on this walking state parameter, the knee brace 300 can perform inversion / eversion (pronation) as an intervention control to correct foot alignment during walking by electrical stimulation.

[0201] The sensing data utilized in the cooperation between the insole orthosis 100 and the knee orthosis 300 is not limited to the above-mentioned examples, and various types of sensing data may be mutually utilized. Furthermore, sensing data from a lower limb orthosis other than the insole orthosis 100 and the knee orthosis 300 may also be utilized.

[0202] The effects described in this specification are merely examples and are not limiting, and other effects may also be present.

[0203] The embodiments of the present disclosure are not limited to the above-described embodiments, and various modifications are possible within the scope of the gist of the present disclosure.

[0204] Furthermore, the technology disclosed herein may have the following configurations: (1) A lower limb orthosis comprising: a sensing unit that acquires sensing data of a specific part of a user's lower limb; an intervention mechanism configured to be able to intervene in the specific part; a walking state calculation unit that calculates a walking state parameter related to the walking state of the user based on the sensing data; and an intervention control unit that controls intervention in the specific part by the intervention mechanism by comparing the walking state parameter with a state target value set based on physical information of the user. (2) The lower limb orthosis described in (1), in which the intervention control unit controls intervention in the specific part when the walking state parameter exceeds an error threshold from the state target value. (3) The lower limb orthosis described in (2), in which the intervention control unit controls intervention in the specific part so as to reduce a knee joint inversion moment. (4) The lower limb orthosis described in (3), in which the state target value is set based on at least one of a thigh length, a lower leg length, and a walking posture of the user. (5) The lower limb orthosis according to (4), configured as an insole orthosis to be worn on the user's foot as the specific part, wherein the sensing unit includes a foot pressure sensor that acquires foot pressure information as sensing information and an IMU (Inertial Measurement Unit) that acquires inertial information of the specific part, and the intervention mechanism includes an adjustment mechanism configured to be able to adjust the height and inclination of the sole. (6) The lower limb orthosis according to (5), wherein the walking state calculation unit calculates at least one of a foot pressure center and a knee joint inversion moment as the walking state parameter. (7) The lower limb orthosis according to (6), wherein the adjustment mechanism is configured by one or more air balloons with adjustable air pressure. (8) The lower limb orthosis according to (6), wherein the adjustment mechanism is configured by one or more elastic members made of a magnetorheological elastomer whose elastic modulus is adjustable by a magnetic field. (9) The lower limb orthosis according to (6), wherein the adjustment mechanism is configured by one or more cushion members filled with an electrorheological fluid whose viscosity is adjustable by an electric field.(10) The lower limb orthosis according to (6), wherein the adjustment mechanism is composed of one or more spring members made of a shape memory alloy whose shape changes depending on temperature. (11) The lower limb orthosis according to any of (6) to (10), wherein the intervention control unit controls the adjustment of the height and inclination of the sole by the adjustment mechanism for each step of the user. (12) The lower limb orthosis according to any of (6) to (10), wherein the intervention control unit controls the adjustment of the height and inclination of the sole by the adjustment mechanism for each of several steps of the user. (13) The lower limb orthosis according to any of (6) to (10), wherein the intervention control unit determines the amount of adjustment of the height and inclination of the sole by the adjustment mechanism based on a walking record of the user for a certain period of time. (14) The lower limb orthosis according to (4), configured as a knee orthosis to be worn on a leg including the knee of the user as the specific part, wherein the sensing unit includes a muscle displacement sensor that acquires muscle displacement information as sensing information and an IMU (Inertial Measurement Unit) that acquires inertial information of the specific part, and the intervention mechanism includes electrode pads that apply electrical stimulation to the leg muscles. (15) The lower limb orthosis according to (14), wherein the walking state calculation unit calculates at least one of a knee joint central position and a knee joint inversion moment as the walking state parameter. (16) The lower limb orthosis according to any of (4) to (15), wherein the intervention control unit controls intervention on the specific part by further using the sensing data acquired by the sensing unit included in another lower limb orthosis worn on another specific part of the user's lower limb. (17) A control method in which a lower limb orthosis including a sensing unit that acquires sensing data of a specific part of a user's lower limb and an intervention mechanism configured to be able to intervene in the specific part calculates walking state parameters related to the walking state of the user based on the sensing data, and controls the intervention in the specific part by the intervention mechanism by comparing the walking state parameters with a state target value set based on physical information of the user.(18) A program for causing a processor mounted on a lower limb orthosis, which includes a sensing unit that acquires sensing data of a specific part of a user's lower limb and an intervention mechanism configured to be able to intervene in the specific part, to execute a process of calculating walking state parameters related to the walking state of the user based on the sensing data, and controlling the intervention in the specific part by the intervention mechanism by comparing the walking state parameters with a state target value set based on physical information of the user.

[0205] REFERENCE SIGNS LIST 1 Lower limb orthosis, 11 Sensor, 12 IMU, 13 Intervention mechanism, 14 Processor, 21 Walking state calculation unit, 22 Intervention control unit, 100 Sole orthosis, 111 Foot pressure sensor, 113 Air balloon, 133 IMU, 150 Control unit, 151 Walking state calculation unit, 152 Air pump voltage control unit, 160 Air balloon control unit, 161 Air pressure information acquisition unit, 162 Air pump control unit, 163 Valve control unit, 300 Knee orthosis, 311 Muscle displacement sensor, 312 IMU, 320 Control unit, 321 Walking state calculation unit, 322 Electrical stimulation control unit, 330 Electrode pad

Claims

1. A lower limb orthosis comprising: a sensing unit that acquires sensing data of a specific part of a user's lower limb; an intervention mechanism configured to be able to intervene in said specific part; a walking state calculation unit that calculates walking state parameters related to the walking state of the user based on said sensing data; and an intervention control unit that controls the intervention in said specific part by said intervention mechanism by comparing said walking state parameters with state target values ​​set based on physical information of the user.

2. The lower limb orthosis according to claim 1, wherein the intervention control unit controls intervention for the specific part when the walking state parameter exceeds an error threshold from the state target value.

3. The lower limb orthosis according to claim 2, wherein the intervention control unit controls the intervention for the specific part so as to reduce the knee joint varus moment.

4. The lower limb orthosis according to claim 3, wherein the target state value is set based on at least one of the user's thigh length, lower leg length, and walking posture.

5. A lower limb orthosis as described in claim 4, configured as an insole orthosis to be worn on the user's foot as the specific part, wherein the sensing unit includes a foot pressure sensor that acquires foot pressure information as sensing information, and an IMU (Inertial Measurement Unit) that acquires inertial information of the specific part, and the intervention mechanism includes an adjustment mechanism configured to be able to adjust the height and inclination of the sole.

6. The lower limb orthosis according to claim 5, wherein the walking condition calculation unit calculates at least one of the center of foot pressure and the knee joint inversion moment as the walking condition parameter.

7. The lower limb orthosis according to claim 6, wherein the adjustment mechanism is composed of one or more air balloons with adjustable air pressure.

8. The lower limb orthosis according to claim 6, wherein the adjustment mechanism is composed of one or more elastic members made of a magnetorheological elastomer whose elastic modulus can be adjusted by a magnetic field.

9. The lower limb orthosis according to claim 6, wherein the adjustment mechanism is composed of one or more cushion members filled with an electrorheological fluid whose viscosity can be adjusted by an electric field.

10. The lower limb orthosis according to claim 6, wherein the adjustment mechanism is composed of one or more spring members made of a shape memory alloy whose shape changes depending on the temperature.

11. The lower limb orthosis according to claim 6, wherein the intervention control unit controls the adjustment of the height and inclination of the sole by the adjustment mechanism for each step of the user.

12. The lower limb orthosis according to claim 6, wherein the intervention control unit controls the adjustment of the height and inclination of the sole by the adjustment mechanism for each of the user's steps.

13. The lower limb orthosis according to claim 6, wherein the intervention control unit determines the amount of adjustment of the height and inclination of the sole by the adjustment mechanism based on the user's walking record for a certain period of time.

14. A lower limb orthosis as described in claim 4, configured as a knee orthosis to be worn on the leg including the knee of the user as the specific part, wherein the sensing unit includes a muscle displacement sensor that acquires muscle displacement information as sensing information and an IMU (Inertial Measurement Unit) that acquires inertial information of the specific part, and the intervention mechanism includes electrode pads that apply electrical stimulation to the leg muscles.

15. The lower limb orthosis according to claim 14, wherein the walking state calculation unit calculates at least one of a knee joint center position and a knee joint varus moment as the walking state parameter.

16. The lower limb orthosis described in claim 4, wherein the intervention control unit further uses the sensing data acquired by the sensing unit provided in another lower limb orthosis attached to another specific part of the user's lower limb to control intervention on the specific part.

17. A control method in which a lower limb orthosis comprising a sensing unit that acquires sensing data of a specific part of a user's lower limb and an intervention mechanism configured to be able to intervene in said specific part, calculates walking state parameters related to the walking state of the user based on said sensing data, and controls intervention in said specific part by said intervention mechanism by comparing said walking state parameters with state target values ​​set based on physical information of the user.

18. A program for causing a processor mounted on a lower limb orthosis, which comprises a sensing unit that acquires sensing data of a specific part of a user's lower limb, and an intervention mechanism configured to be able to intervene in said specific part, to execute a process of calculating walking state parameters relating to the walking state of said user based on said sensing data, and controlling the intervention in said specific part by said intervention mechanism by comparing said walking state parameters with state target values ​​set based on the user's physical information.

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