TW201924639A - Ankle foot orthosis and method of manufacturing the same - Google Patents

Abstract

An ankle foot orthosis includes a foot plate, a foot plate side strut, a calf fastening unit and a supporting unit. The foot plate is configured to place the patient's foot. The foot plate side strut is disposed corresponding to the patient's Medial Malleolus and Lateral Malleolus, and is connected to the foot plate. The calf fastening unit is configured to secure the patient's calf. The calf fastening unit and the foot plate side strut are connected in a rotatable manner. The supporting unit is disposed between the foot plate and the calf fastening unit, and includes a damping device and an elastic device.

Description

Foot and ankle aid and manufacturing method thereof

The present disclosure relates to an ankle assist device and a manufacturing method thereof, and more particularly to an ankle assist device that can make a wearer's gait close to a normal person's gait and a manufacturing method thereof.

In the natural walking process of human beings, the human ankle joints will have different angles in different Gait cycles. However, for patients with walking disorders, such as patients with central nervous system disability, peripheral nervous system sensation and motor dysfunction, lack of motor unit or structural damage, because of leg muscles during walking The weakness or other factors cause the ankle and foot to be unable to rise normally and cause a foot-foot condition, which in turn causes the patient to change his or her body posture in order to maintain balance. It is not only easy to fall but also consumes more power than the average person walking, which seriously affects the patient's quality of life.

One of the objects of the present disclosure is to provide an ankle assist device and a method of fabricating the same to solve the above problems. One embodiment of the present disclosure provides an ankle assist device including a foot bottom plate, a foot bottom side bracket, a lower leg fixing unit, and a supporting unit. The sole of the foot is used to place the foot of the patient. The foot sole side bracket includes an inner foot bottom side bracket and an outer foot bottom side bracket, respectively corresponding to the inner and lateral side of the patient and connected to the sole. The calf fixing unit is for fixing the calf of the patient, and the calf fixing unit and the sole side bracket are connected in a rotatable manner. The supporting unit is disposed between the calf fixing unit and the sole plate, wherein the supporting unit comprises a damping element for providing a footboard damping effect when the patient wears the ankle aid to extend the falling time of the foot, and an elastic component It is used to provide the elastic support of the sole of the foot when the patient wears the ankle aid to avoid the foot. Another embodiment of the present disclosure provides a method of making an ankle aid, comprising the following steps. Positioning markers are attached to a plurality of feature points of the ankle of the patient. The ankle of the patient is scanned to form a contour of the ankle. According to the outline of the ankle and foot, a one-foot image model is produced.

The disclosure provides several different implementations or embodiments that can be used to implement different features of the invention. For simplicity of explanation, the present disclosure also describes examples of specific components and arrangements. Please note that these specific examples are provided for demonstration purposes only and are not intended to be limiting. For example, in the following description of how the first feature is on or above the second feature, certain embodiments may be included, where the first feature is in direct contact with the second feature, and the description may include other differences Embodiments wherein there are other features in between the first feature and the second feature such that the first feature is not in direct contact with the second feature. In addition, various examples in the disclosure may use repeated reference numerals and/or text annotations to make the document more simplistic and clear, and such repeated reference numerals and annotations do not represent an association between different embodiments and configurations. In addition, the present disclosure uses spatially related narrative vocabulary, such as "under", "low", "lower", "above", "upper", "above", and the like, For ease of description, the usage is to describe the relative relationship of one element or feature to another element or feature. In addition to the angular orientations shown in the figures, these spatial relative terms are also used to describe the possible angles and directions of the device in use and during operation. The angular orientation of the device may vary (rotating 90 degrees or other orientations), and the spatially related descriptions used in this disclosure may be interpreted in the same manner. The terms "first", "second", "third", and "fourth" as used herein are used to describe various elements, components, regions, layers, and/or sections, such elements, components, regions, Layers and/or sections should not be limited to these terms. The words may be used in a single element, component, region, layer, or section and another element, component, region, layer, or section. The terms "first," "second," "third," and "fourth" are used herein to mean a sequence or order unless the context clearly dictates otherwise. Please refer to Figure 1 first. Figure 1 depicts a schematic diagram of the gait cycle of human walking. As shown in Figure 1, the gait cycle can be roughly divided into several stages, namely the initial contact, the loading response, the midstance, the terminal stance, Preswing, initial & mid-swing, and terminal swing. During different periods of the gait cycle, the muscles of the buttocks, legs and feet of the human body will have different force output modes, and control the different bending degrees of the hip joint, the knee joint and the ankle joint so that the human body is in the gait cycle. Different periods can shift the center of gravity to reach balance and walk naturally. Please refer to Figure 2 to Figure 9. 2 to FIG. 9 are schematic diagrams of an ankle assist device according to one or more embodiments of the present disclosure, wherein FIG. 2 is a schematic diagram of the appearance of an ankle assist device, and FIG. 3 is a front view of the ankle assist device, FIG. 4 FIG. 5 is a left side view of the ankle assist device, FIG. 6 is a right side view of the ankle assist device, FIG. 7 is a top view of the ankle assist device, and FIG. 8 is a foot view. FIG. A bottom view of the shackle, and Figure 9 is a schematic view of an ankle aid equipped with a drawstring. As shown in FIG. 2 to FIG. 9, the ankle assist device 1 of the present embodiment includes a foot bottom plate 10, a foot bottom side bracket 20, and a lower leg fixing unit 30. The sole plate 20 is used to place the foot of the patient. The sole plate side bracket 20 includes an inner foot bottom side bracket 22 and an outer foot bottom side bracket 24, respectively corresponding to the inner and side jaws of the patient and connected to the sole board 10. In some embodiments, the material of the sole plate 10 and the sole plate side bracket 20 may be plastic or other suitable material. In some embodiments, the sole plate 10 and the sole plate side bracket 20 can be an integrally formed structure that can be fabricated using 3D printing or other suitable methods. The lower leg fixing unit 30 is for fixing the calf of the patient, and the calf fixing unit 30 and the sole bottom side bracket 20 are rotatably connected. In some embodiments, the sole plate side bracket 20 and the lower leg fixing unit 30 have a rotation axis S, and when the patient wears the ankle assist device 1, the rotation axis S can substantially overlap with the rotation axis of the patient's ankle joint. Therefore, when the patient wears the ankle assist device 1 to walk, the rotation mechanism can be similar to the rotation mechanism of the ankle joint and is more in line with the dynamics (Biodynamics). For example, the sole floor side bracket 20 and the lower leg fixing unit 30 may have corresponding holes, and the bolts are passed through the holes so that the calf fixing unit 30 can rotate with the rotation axis S as an axis with respect to the foot sole side bracket 20. To allow the patient's ankle joint to rotate in the direction of back curvature or distortion. In some embodiments, the material of the sole plate 10, the sole plate side bracket 20, and the lower leg securing unit 30 may be selected from a non-rigid material that allows for some degree of deformation, thereby increasing wear comfort. In addition, during walking, the deformation of the sole plate 10, the sole plate side bracket 20 and the calf fixing unit 30 under the force of the leg and ankle of the patient can also provide a moderate pulling force to provide supporting force and slow down. Downright condition. In some embodiments, the lower leg fixing unit 30 can include two lower leg fixing members 32, 34 respectively corresponding to the left and right opposite sides of the patient's lower leg, and the lower leg fixing members 32, 34 can be respectively associated with the inner leg bottom side bracket 22 and The outer leg bottom side bracket 24 is rotatably connected. In some embodiments, the ankle assist device 1 can further include a coupling unit 40 coupled between the two lower leg mounts 32, 34 of the calf fixation unit 30 and corresponding to the posterior side of the patient's lower leg. In some embodiments, the attachment unit 40 can include a width adjustable attachment unit for adjusting the tightness of the calf fixation unit 30 to accommodate the patient's calf size. In some embodiments, the connecting unit 40 may include two connecting structures 42, 44, one end of which is respectively fixed to the two leg fixing members 32, 34 of the lower leg fixing unit 30, and the lower leg fixing members are respectively provided by the two connecting structures 42, 44 The direction of the 34 and the calf fasteners 32 adjusts the width between the calf fasteners 32, 34. In some embodiments, the attachment structures 42, 44 can be elongated connectors. In other embodiments, the attachment structures 42, 44 may be curved connection structures that may have curved curvatures corresponding to the back side of the lower leg to increase wear comfort. When the width between the lower leg fixing members 32, 34 is set, the relative position of the two connecting structures 42, 44 can be fixed by a fastening member (not shown) to adjust the tightness of the lower leg fixing unit 30. For example, a plurality of through holes may be respectively disposed on the two connecting structures 42, 44, and the width between the lower leg fixing members 32, 34 may be adjusted and fixed by using a fastening member such as a screw or a card through different holes. . In some embodiments, since the material of the calf fixing unit 30 is non-rigid, adjusting the tightness of the calf fixing unit 30 can also adjust the overall flexibility of the sole plate 10, the sole plate side bracket 20 and the calf fixing unit 30 to adjust The effect of the overall support force of the ankle aid 1 . In some embodiments, the ankle assist device 1 may further include a support unit 50 disposed between the lower leg fixing unit 30 and the sole plate 10. The support unit 50 can provide dynamic support ability when the patient is in an asynchronous state in which the ankle assist device 1 is worn, and provides different support forces in conjunction with the asynchronous state. In some embodiments, the support unit 50 can include a damping element 52 and a resilient element 54. The damping element 52 can be used to provide a damping effect of the sole plate 10 when the patient wears the ankle assist device 1. Precisely, the damping effect provided by the damping element 52 can provide an upward pulling force when the patient has problems such as insufficient muscle strength or abnormal leg tension causing the foot to fall. The characteristic of the damping element 52 is that the greater the downward force of the foot, the greater the reverse pulling force it provides, thus effectively extending the fall time of the foot. On the other hand, the elastic member 54 can be used to provide the elastic support effect of the sole plate 10 when the patient wears the ankle assist device to avoid the foot. Precisely, the characteristic of the resilient member 54 is that the reverse pulling force it provides is proportional to its shape, and the greater the extent to which the patient's foot falls, the greater the reverse pulling force provided by the resilient member 54. Avoid hanging feet. In some embodiments, the resilient element 54 can include a spring or other resilient element. In some embodiments, the support unit 50 is secured to the lower leg fixation unit 30 and coupled to the sole plate 10 via a pull cord 60. In some embodiments, the support unit 50 can be disposed on the two lower leg fixing members 32, 34 of the lower leg fixing unit 30, and the two ends of the pull cord 60 are respectively connected to the two lower leg fixing members 32, 34 located in the lower leg fixing unit 30. On the support unit 50. In addition, the bottom of the sole plate 10 can have a recess 12 for receiving a portion of the drawstring 60 so that the drawstring 60 can be nested within the recess 12. In some embodiments, the ankle assist device 1 can further include a securing member 62 for securing the drawstring 60 within the recess 12. For example, the fixation element 62 can include a screw or other fixation element that can pass through the drawstring 60 and be secured within the threaded bore 14 of the footplate 10, thereby securing the drawstring 60 to the soleplate 10. Since the two ends of the drawstring 60 are connected to the support unit 50 on the two lower leg fixing members 32, 34 of the lower leg fixing unit 30, the support unit 50 can pull the sole plate 10 through the drawstring 60 to achieve dynamic limiting distortion. . For example, when the gait cycle is from the end of the support phase to the pre-swing period, the patient's footsteps will cause the drawstring 60 to be relaxed due to the increased double-action of the center of gravity and the forward movement of the torso. Therefore, the elastic member 54 is retracted to the original length without the pulling force of the cord 60. At this time, when the patient lifts the foot into the early and middle phases of the swing phase and the end of the swing phase, the drawstring 60 will begin to be in a tensioned state so that the tension provided by the elastic member 54 can be transmitted to the sole plate 10 to provide a distortion limit. ability. In some embodiments, the position of the recess 12 corresponds to the joint of the toe of the patient's foot to achieve a better lifting effect. For example, if the groove 12 is placed near the fingertip of the toe, the joint of the toe will bend when the drawstring 60 lifts the sole plate 10 to offset the pulling force. In addition, if the groove 12 is placed close to the arch, the pulling force will be weakened due to the short force of the pulling arm, and the patient's foot will be subjected to excessive tension. Therefore, the position of the groove 12 corresponding to the joint of the toe of the patient's foot can prevent the drawstring 60 from being pulled off due to the bending of the joint of the toe when pulling the sole 10 of the foot. And get a larger arm without excessive strain on the patient's arch. As shown in FIG. 9, in some embodiments, the ankle assist device 1 can further include a securing strap (not shown) that can tighten the calf mounts 32, 34 to further secure the patient's lower leg to the lower leg. Inside the fixed unit 30. Please refer to Figure 10 again. FIG. 10 is a schematic diagram showing the minimum step angle and the maximum step angle of the ankle assist device. The minimum step angle and the maximum step angle are an evaluation index for estimating the change of the ankle angle when the patient wears the ankle assist device by using the angle between the sole of the foot and the ground and the ground. As shown in FIG. 10, when the toe is facing downward, the angle between the sole plate and the ground can be defined as the minimum foot angle A1; and when the toe is upward, the angle between the sole plate and the ground can be defined as the maximum step angle. (max foot angle) A2. The minimum step angle A1 can be used as an index to evaluate the flexural limitation ability of the ankle assist device, and the maximum step angle A2 can represent the back curve angle, which can be used as an evaluation of the ability of the ankle assist device to restrain the foot, for example, at the first touch. The ground period should have an appropriate back bend angle, and when the back bend angle is too small, the foot will be generated. In addition, in the present disclosure, the load-bearing reaction period as a proportion of the gait cycle and the loading response score are used to measure the function of the ankle assist device. In the normal gait cycle, the time occupied by each stage has a certain proportion, wherein the load-bearing reaction period accounts for about 10% of the gait cycle. When the patient wears the ankle-supporting device, the load-bearing reaction period accounts for the gait cycle. The closer the ratio is to 10%, the closer to the gait cycle of a normal person. The load-bearing response score is the ratio of the weight-bearing reaction period to the gait cycle when the patient wears the ankle-supporting device and the proportion of the gait cycle and other conditions with the patient, such as age, height, sex, etc. The model data is compared to the calculated score, wherein the closer the weight-bearing reaction score is to 1.00, the closer to the normal person's gait cycle. Please refer to FIG. 11 to FIG. 14. Figure 11 to Figure 14 show the statistical data of the patients who did not wear the ankle aids and the different ankle aids. Figure 11 shows the statistics of the minimum step angle, and Figure 12 shows the statistics of the maximum step angle. Data, Figure 13 is the statistical data of the weight-bearing reaction period as a proportion of the gait cycle, and Figure 14 is the statistical data of the weight-bearing reaction score. In the above statistics, sample 1 is the measurement result of the patient wearing the athlete's foot aid, and sample 2 is the measurement result of the patient wearing the ankle aid with the angle of the foot fixed at 90 degrees, and the sample 3 is for the patient to wear. The measurement result of the amphibious attachment of the shank fixing unit and the sole plate side bracket rotatably connected, the sample 4 is rotatably connected and set by the shank fixing unit and the foot sole side bracket of the embodiment of the present invention. The measurement results of the ankle aid with the support unit. As shown in Fig. 11 to Fig. 14, the results of sample 2, sample 3 and sample 4 are superior to those of sample 1, that is, the minimum step angle and the maximum step angle in the case where the patient wears the ankle assist device. The measurement results of the load-bearing reaction period and the load-bearing reaction score are better than those of the patients who do not wear the ankle-supporting device. In addition, the measurement results of the sample 3 and the sample 4 are more prominent than those of the sample 2 in which the ankle angle of the sample 2 is fixed at 90 degrees. That is to say, the minimum step angle, the maximum step angle, the proportion of the load-bearing reaction period, the proportion of the gait cycle and the load-bearing reaction score of the ankle-supporting device of the sample leg 3 and the foot-base side bracket are rotatably connected. Both of them are superior to the condition of the ankle aid of the sample 2 with an ankle angle fixed at 90 degrees. In addition, the minimum step angle, the maximum step angle, the proportion of the load-bearing period, and the weight-bearing reaction fraction of the ankle aid of the sample leg of the sample 4 and the foot-base side bracket are rotatably connected and the support unit is additionally provided. The test result is better than the condition of the ankle aid of the sample 3. It can be seen from the above that the ankle assist device of the present disclosure has a supporting unit which is rotatably connected with the calf fixing unit and the sole plate side bracket and provides a damping effect and an elastic supporting effect, and can significantly increase the minimum step angle and the maximum step angle. The load-bearing reaction period accounts for the proportion of the gait cycle and the load-bearing reaction score. When wearing the ankle-supporting device disclosed in the present disclosure, the minimum step angle of the patient will be reduced, indicating that the ankle-foot assisting device of the present disclosure can guide the patient to shift with a normal center of gravity, so that the patient can try to shift his or her center of gravity to On the feet with obstacles. In this way, a large ankle back angle can be tolerated during the early swing period, which helps to walk. Furthermore, when the ankle-ankle aid of the present disclosure is worn, the dynamic support force provided by the support unit can slow down the back angle of the ankle in the first touchdown period to avoid the foot-foot condition. Please refer to Figure 15. 15 is a flow chart of a method of making an ankle assist device in accordance with one or more embodiments of the present disclosure. As shown in FIG. 15, the method 100 for manufacturing an ankle assist device of the present embodiment includes the following steps: Step 110: attaching a positioning mark to a plurality of feature points of the ankle of the patient; Step 120: The foot of the patient The ankle is scanned to form an ankle contour data; and step 130: a full ankle image model is created based on the ankle contour data. The method 100 of making an ankle aid is merely an example, and the disclosure is not limited to what is explicitly stated in the scope of the patent application. Additional steps may be provided before, during, and after the method 100 of making an ankle aid, and some of the steps described may be replaced, eliminated, or moved for additional embodiments of the method. Please refer to Figure 16 to Figure 25. 16 through 25 are schematic diagrams of a method of making an ankle assist device in accordance with one or more embodiments of the present disclosure. Figure 16 is a schematic view of the ankle bone of the human body. As shown in Figure 16, in some embodiments, the ankle of the patient includes the following feature points, wherein the first feature point P1 is located at the joint of the second metatarsal of the patient's foot; the second feature Point P2 is located at the joint of the third metatarsal of the patient's foot; the third feature point P3 is located at the joint of the fourth metatarsal of the patient's foot; the fourth feature point P4 is located at the joint The outermost point of the affected foot; the fifth feature point P5 is located at the innermost point of the patient's foot; the sixth feature point P6 is located in the patient's medial malleolus; and the seventh feature point P7 is located in the patient Lateral malleolus. The patient's ankle is scanned and the positioning marks are attached to the above-mentioned feature points of the patient's ankle (as indicated by the black dots in the figure). The feature points of the ankle and foot are the main feature points of the ankle and foot, which have a critical influence on the shape of the ankle assisted device, and the external contour is caused by the skin of the ankle and the foot covering the feature point. Scanning cannot accurately confirm the correct position. Therefore, it is ensured that the feature points are confirmed by palpation before the scan and the positioning marks are used by the professional to ensure that the ankle assisted device can fully conform to the patient's ankle. The shape and size of the part. Then, the scanner is matched with the computer and the image processing software to scan the ankle of the patient to form a contour data of the foot and the outline of the foot and the contour is stored in a storage device such as a memory or a hard disk, as shown in the figure. 17 is shown. In some embodiments, after the foot contour data labeled with the feature points are scanned, the display device, such as a display, can be displayed and the auxiliary feature points can be further marked on the ankle contour data. For example, the ankle of the patient may include the following auxiliary feature points, wherein the first auxiliary feature point Q1 is located at the joint of the first metatarsal of the patient's foot; the second auxiliary feature point Q2 is located in the disease The joint of the fifth metatarsal of the affected foot; the third auxiliary feature point 3 is located at the fingertip of the second toe of the patient's foot; the fourth auxiliary feature point Q4 is located at the foot of the patient The bottom of the calcaneus (Calcaneus); and the fifth auxiliary feature point Q5 is located at the heel of the calcaneus of the patient's foot. Compared with the main feature points, the position of the auxiliary feature points can be recognized by the outline data of the ankle and the foot, so that the position of the auxiliary point data can be marked after scanning to obtain the complete feature point position. The above main feature points and auxiliary feature points are merely examples, and the feature points of the ankle and foot used in the method for manufacturing an ankle aid are not limited thereto. Next, an ankle image model is created based on the outline of the ankle. In some embodiments, the production of the ankle image model can generally include establishing a footplate model of the ankle image model and a footplate side stent model for establishing the ankle image model, as illustrated below. First, the foot plate model of establishing the ankle image model according to the outline data of the ankle can include the following steps. As shown in FIG. 17, a first plane S1 is defined by the third feature point P3, the first auxiliary feature point Q1, and the fourth auxiliary feature point Q4 as a reference plane of the foot bottom. As shown in FIG. 18, a second plane S2 parallel to the first plane S1 is established according to the first plane S1. In some embodiments, the second plane S2 is located above the first plane S1, for example the second plane S2 is substantially intersecting the fifth auxiliary feature point Q5. As shown in FIG. 19, a first block B1 covering the range of the foot contour data on the second plane S2 is established, and the first block B1 is projected onto the first plane S1. For example, the range of the first block B1 may be a rectangular block whose length and width are both slightly larger than the length of the foot and the width of the foot on the second plane S2. For example, the length of the first block B1 may be the length of the foot + 10mm, and the width can be the foot width +10mm, but not limited to this. Next, the foot contour of the ankle contour data on the first plane S1 is drawn on the first block B1 to form a sketch D1 of the foot floor model of the ankle image model. The thickness of the foot sole model can be defined by itself, for example, not less than 4 mm. As shown in Fig. 20, the contour of the toe portion of the sole plate is then adjusted. In some embodiments, a second block B2 is drawn at a center of a position projected onto the first plane S1 by the sixth feature point P6, wherein the radius of the second block B2 is customizable, for example, it may be substantially equal to the sixth The distance from the feature point P6 to the third auxiliary feature point Q3. In addition, a third block B3 is drawn with a line connecting the fourth feature point P4 and the fifth feature point P5 as a side length. Next, the intersection range X of the second block B2 and the third block B3 is selected, and the outline of the sketch D1 of the foot plate model is adjusted according to the intersection range X to conform to the toe portion of the patient's foot, and the foot plate model is created. . Next, the footplate side bracket model of establishing the ankle image model according to the outline data of the ankle can include the following steps. As shown in FIG. 21, a third plane S3 perpendicular to the first surface S1 is defined by the first feature point P1 and the fourth auxiliary feature point Q4. As shown in FIG. 22, the sixth feature point P6 is projected to the third plane S3 to establish a fourth plane S4 perpendicular to the third plane S3. As shown in Fig. 23, a sketch D2 of the foot bottom side bracket model is drawn with the fourth plane S4 as a reference plane. For example, the distance between the seventh feature point P7 and the third plane S3 plus an adjustment value defines the contour of the outer foot bottom side bracket of one of the bottom side brackets, with the sixth feature point P6 and the third plane S3. The distance between the distance and the adjustment value defines the contour of the foot side bracket of one of the side brackets of the foot plate, and the distance from the seventh feature point P7 projected to the first plane S1 plus an adjustment value defines the foot side bracket. height. In some embodiments, the adjustment value of the contour of the outer sole side bracket and the adjustment value of the contour of the inner sole side bracket may be outwardly expanded or retracted according to the contour of the ankle. The adjustment value of the height of the foot side bracket can be adjusted according to the height of the jaw. In some embodiments, the outer sole side bracket and the inner sole bottom bracket may respectively have a bent structure, for example, the outer sole bottom bracket and the inner sole bottom bracket may respectively have an inclined portion, one end of which is respectively connected to the sole plate. The opposite edges are placed in an outwardly inclined manner to evade the patient's foot. For example, the inclination angle of the inclined portion of the outer sole side bracket may be about 30 degrees, and the inclination angle of the inclined portion of the inner sole side bracket may be about 15 degrees, but not limited thereto. The outer leg bottom side bracket and the inner foot bottom side side bracket may respectively have a vertical portion which is respectively connected to the other end of the inclined portion and extends upward. The thickness of the foot side bracket can be defined by itself, for example, not less than 4 mm. As shown in Fig. 24, in some embodiments, a hole may be formed in the vertical portion of the outer sole side bracket and the inner sole bottom bracket for connection with the lower leg fixing unit. In some embodiments, the connecting portion of the foot sole side bracket to the sole plate may be provided with a rounded corner to reduce the risk of breakage of the connecting portion. In some embodiments, the footplate model for establishing the ankle image model based on the ankle contour data may further include a connection with the fourth feature point P4 (see FIG. 17) and the fifth feature point P5 (see FIG. 17). Translating as a center line to both sides to form a fourth block B4, and reducing the thickness of the bottom plate corresponding to the fourth block B4 to form a retracted groove for accommodating the drawstring, as shown in FIG. Show. In some embodiments, the footplate may define a threaded bore corresponding to the location of the recess to secure the drawstring to the soleplate with a screw. Through the above steps, the ankle image model of the present disclosure can be produced. As shown in FIGS. 2 to 9, the ankle image model can be output as the foot bottom 10 and the foot bottom side bracket 20 of the ankle aid 1 . In some embodiments, the ankle image model can be output in 3D using a 3D printing machine or using other suitable methods to make the ankle aid 1 . In addition, in some embodiments, the method of the present disclosure may further include connecting the lower leg fixing unit 30 with the sole floor side bracket 20, and providing the supporting unit 50 between the lower leg fixing unit 30 and the foot bottom plate 10. In some embodiments, the supporting unit 50 may include the damping element 52 and the elastic element 54. The acting and setting positions of the damping element 52 and the elastic element 54 are as described in the foregoing embodiments, and are not described herein again. In summary, the ankle assist device of the present disclosure can significantly increase the minimum step angle by using a rotatably connected calf fixing unit and a foot sole side bracket, and a supporting unit for providing a damping effect and an elastic supporting effect. The maximum step angle, the load-bearing reaction period accounted for the proportion of the gait cycle and the load-bearing reaction score, which in turn enhanced the auxiliary effect of the ankle-supporting aid. In addition, the method for manufacturing an ankle assist device attaches a positioning mark to a characteristic point of the ankle of the patient before scanning the ankle and the foot, so as to avoid the error and accurately mark the position of the feature point of the ankle and the foot. Therefore, the size of the ankle and ankle of the patient with an ankle assist device can be ensured to improve the functionality and comfort of the ankle assist device. While the invention has been described and illustrated with reference to the specific embodiments of the invention It will be apparent to those skilled in the art that various changes can be made and the equivalents of the present invention as defined by the appended claims. The description may not necessarily be drawn to scale. Due to the variables in the manufacturing process and the like, there may be a difference between the artistic reproduction in the present invention and the actual device. There may be other embodiments of the invention that are not specifically described. The description and drawings are to be regarded as illustrative and not limiting. Modifications may be made to adapt a particular situation, material, material composition, method or procedure to the objects, spirit and scope of the invention. All such modifications are intended to be within the scope of the appended claims. Although the methods disclosed herein have been described with reference to specific operations performed in a particular order, it is understood that the operations can be combined, sub-sequenced, or re-sequenced to form an equivalent method without departing from the teachings of the present invention. . Therefore, the order of operations and groupings are not limiting of the invention unless specifically indicated herein.

1‧‧‧foot assistive equipment

10‧‧‧foot floor

12‧‧‧ Groove

14‧‧‧ screw holes

20‧‧‧foot floor side bracket

22‧‧‧Inner foot floor side bracket

24‧‧‧foot foot side bracket

30‧‧‧Leg fixed unit

32‧‧‧Leg fixation

34‧‧‧Leg fixation

40‧‧‧ Connection unit

42‧‧‧ Connection structure

44‧‧‧Connection structure

50‧‧‧Support unit

52‧‧‧damage element

54‧‧‧Flexible components

60‧‧‧Drawstring

62‧‧‧Fixed components

A1‧‧‧Minimum step angle

A2‧‧‧Maximum step angle

B1‧‧‧ first block

B2‧‧‧Second block

B3‧‧‧ third block

B4‧‧‧Four Block

D1‧‧‧ Sketch of the footboard model

Sketch of the D2‧‧‧ foot floor side bracket model

P1‧‧‧ first feature point

P2‧‧‧ second feature point

P3‧‧‧ third feature point

P4‧‧‧ fourth feature point

P5‧‧‧ fifth feature point

P6‧‧‧ sixth feature point

P7‧‧‧ seventh feature point

Q1‧‧‧First auxiliary feature point

Q2‧‧‧Second auxiliary feature points

Q3‧‧‧ Third auxiliary feature point

Q4‧‧‧4th auxiliary feature point

Q5‧‧‧ fifth auxiliary feature point

S‧‧‧Rotary axis

S1‧‧‧ first plane

S2‧‧‧ second plane

S3‧‧‧ third plane

S4‧‧‧fourth plane

X‧‧‧ intersection range

In order to assist the reader to achieve the best understanding, it is recommended to refer to the attached figure and its detailed text description when reading this disclosure. Please note that in order to comply with industry standards, the drawings in this patent specification are not necessarily drawn to the correct scale. In some drawings, the dimensions may be deliberately enlarged or reduced to assist the reader in understanding the discussion. 1 is a schematic view showing the gait cycle of human walking; FIG. 2 is a schematic view of the appearance of an ankle assist device; FIG. 3 is a front view of the ankle assist device; FIG. 4 is a rear view of the ankle assist device; 5 is a left side view of the ankle assist device; Fig. 6 is a right side view of the ankle assist device; Fig. 7 is a top view of the ankle assist device; Fig. 8 is a bottom view of the ankle assist device; FIG. 10 is a schematic view showing the minimum step angle and the maximum step angle of the ankle assist device; FIG. 11 is a statistical diagram of the minimum step angle; FIG. 12 is the maximum step angle. Figure 13 is a statistical data of the ratio of the load-bearing reaction period to the gait cycle; Figure 14 is the statistical data of the load-bearing reaction score; Figure 15 is a flow chart of the method for manufacturing the ankle-supporting aid according to one or more embodiments of the present disclosure Figure 16 and Figure 25 are schematic illustrations of a method of making an ankle aid in accordance with one or more embodiments of the present disclosure.

Claims (20)

An ankle assist device comprises: a sole plate for placing a foot of a patient; a foot side bracket comprising an inner sole side bracket and an outer sole bottom bracket respectively corresponding to the inner and lateral sides of the patient And a calf fixing unit for fixing the calf of the patient, wherein the calf fixing unit and the sole side bracket are rotatably connected; and a supporting unit disposed on the calf Between the unit and the sole plate, wherein the supporting unit comprises: a damping element for providing a damping effect of the foot sole when the patient wears the ankle assisting device to extend the falling time of the foot; and an elastic element, It is used to provide the elastic support effect of the sole of the foot when the patient wears the ankle assist device to avoid the foot. The foot support device of claim 1, wherein the calf fixing unit and the sole plate side bracket have a rotation axis, and when the patient wears the ankle assist device, the rotation shaft system rotates with the ankle joint of the patient The axes substantially overlap. The ankle assist device of claim 1, wherein the support unit is fixed to the calf fixing unit and connected to the sole plate via a drawstring. The ankle assist device of claim 3, wherein the calf fixing unit comprises two lower leg fixing members respectively corresponding to the left and right opposite sides of the calf of the patient. The foot support device of claim 4, wherein the support unit is disposed on the two lower leg fixing members of the lower leg fixing unit, and the two ends of the pull rope are respectively connected to the two lower leg fixing portions of the lower leg fixing unit On the supporting unit on the piece. The footrest of claim 5, wherein the bottom of the sole has a recess for receiving a portion of the drawstring so that the drawstring is nested within the recess. The ankle aid of claim 6, wherein the groove corresponds to the joint of the toe of the patient's foot. The ankle assist device of claim 4, wherein the ankle assist device further comprises a connecting unit connected between the two lower leg fixing members of the calf fixing unit and corresponding to the back side of the patient's lower leg. The footrest accessory of claim 8, wherein the connecting unit comprises a width adjustable connecting unit for adjusting the tightness of the lower leg fixing unit. The ankle aid of claim 1, wherein the sole plate and the sole plate side bracket are integrally formed. A method for making an ankle assist device, comprising: attaching a positioning mark to a plurality of feature points of a foot and an ankle of the patient; scanning the ankle of the patient to form a contour of the ankle; and according to the ankle The contour data is used to create a full-length image of the ankle. The method of claim 11 , wherein the method of creating the ankle image according to the outline data of the ankle portion comprises: establishing a foot plate model of the image of the ankle portion according to the contour data of the ankle portion; According to the outline data of the ankle and the foot, one of the image models of the ankle and the foot is supported. The method of claim 12, wherein the feature points comprise: a first feature point located at a joint of a second metatarsal of a patient's foot; a second feature point, Located at the joint of the third metatarsal at the foot of the patient; a third feature point at the joint of the fourth metatarsal of the patient's foot; a fourth characteristic point located in the disease The outermost point of the affected foot; a fifth feature point located at the innermost point of the patient's foot; a sixth feature point located within the patient's medial malleolus; and a seventh feature point located at Lateral malleolus of the patient. The method of claim 13, wherein the foot contour data is marked with a plurality of auxiliary feature points, wherein the auxiliary feature points include: a first auxiliary feature point located at the foot of the patient The joint of the first metatarsal; a second auxiliary feature point at the joint of the fifth metatarsal of the patient's foot; a third auxiliary feature point at the foot of the patient a fingertip of the second toe; a fourth auxiliary feature point at the bottom of the calcaneus of the patient's foot; and a fifth auxiliary feature point located at the calcaneus of the patient's foot Follow the department. The method of claim 14 , wherein the foot plate model of the foot image model is established according to the foot contour data includes: using the third feature point, the first auxiliary feature point, and the The fourth auxiliary feature point defines a first plane; establishing a second plane parallel to the first plane according to the first plane, wherein the second plane is substantially intersecting the fifth auxiliary feature point; establishing covers the foot a first block of the range of the crotch contour data on the second plane, and projecting the first block onto the first plane; the foot of the foot contour profile on the first plane Drawing a contour on the first block to form a sketch of the foot plate model of the ankle image model; drawing a second block at a center of the sixth feature point projected onto the first plane Draw a third block by using a line connecting the fourth feature point and the fifth feature point as a side length; and selecting an intersection range of the second block and the third block, and according to the intersection range Adjusting the sketch of the footboard model Profile, in order to comply with the toe portion of the patient's foot. The method of claim 15 , wherein the foot plate model of the foot and ankle image model is further included according to the outline data of the ankle portion: further comprising: the fourth feature point and the fifth feature point The line translates as a centerline to both sides to form a fourth block and reduces the thickness of the foot plate corresponding to the fourth block to form a retracted groove. The method of claim 15 , wherein the foot floor side bracket model of the foot and ankle image model is configured to: use the first feature point and the fourth auxiliary feature point Defining a third plane perpendicular to the first surface; projecting the sixth feature point to the third plane to establish a fourth plane perpendicular to the third plane; using the fourth plane as a reference plane, Drawing a sketch of the foot side bracket model, comprising: defining a size of the outer sole side bracket of the foot sole side bracket by adding a distance between the seventh feature point and the third plane And determining, by using a distance between the sixth feature point and the third plane, an adjustment value to define a size of the inner sole side bracket of the one of the sole side brackets; and projecting the first feature point to the first The distance of the plane plus an adjustment value defines the height of the side bracket of the sole. The method for producing an ankle aid according to claim 11, further comprising outputting the ankle image model as one foot and one foot and one foot side bracket. The method of claim 18, wherein the method further comprises: connecting a calf fixing unit to the sole side bracket; and providing a supporting unit between the calf fixing unit and the sole substrate. The method of claim 19, wherein the supporting unit comprises: a damping element for providing a damping effect of the sole of the foot when the patient wears the ankle assisting device to extend the foot of the patient The time of the fall; and an elastic element for providing the elastic support of the sole when the patient wears the ankle assist device to avoid excessive falling of the foot of the patient.