Wearable appliance for preventing thrombus of lower limbs
By combining the design of the calf brace and the foot brace, the system enables pneumatic massage and ankle pump exercises for the calf and foot, solving the problems of excessive restraint and inconvenient observation in existing technologies, and improving patient comfort and nursing convenience.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-25
- Publication Date
- 2026-03-27
AI Technical Summary
Existing intermittent pneumatic compression devices can cause significant constriction of the lower leg when used to prevent lower extremity thrombosis, and make it difficult to observe the condition of the limb at the wrapped location, affecting patient comfort and long-term wear.
Design a wearable device to prevent lower limb thrombosis, which combines a calf brace structure and a foot brace structure. The ankle pump movement is achieved by rotating the foot brace, and massage is provided by inflating and deflating the side massage airbags and bottom airbags, replacing the traditional limb pressure sleeve.
It enables pneumatic massage and ankle pump exercises for the calves and soles, reducing the restriction on the limbs, facilitating observation and adjustment, and improving patient comfort and nursing convenience.
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Figure CN224039585U_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The utility model relates to a wearing appliance for preventing lower limb thrombus. BACKGROUND
[0002] Venous thromboembolism (VTE) includes deep venous thrombosis (DVT) and pulmonary thromboembolism (PTE), is one of common complications of preventable inpatients, has the characteristics of high morbidity and high mortality. At present, the prevention method of VTE includes basic prevention, mechanical prevention and drug prevention, among which intermittent pneumatic compression (IPC) is one of main mechanical prevention methods of VTE. With the attention of hospitals at all levels to the prevention of VTE, how to standardize the use of IPC for scientific prevention of VTE has become a problem to be solved in clinical practice.
[0003] IPC is a method that the main machine of intermittent pneumatic compression device (IPCD) cyclically inflates and deflates its air bag, realizes the intermittent application of pressure on the limb wrapped by the air bag, so as to promote the passive contraction of the muscles of the compressed limb, thereby promoting the return of venous blood. IPC can not only be used for the prevention of VTE, but also be used for the treatment of diseases such as lymphedema and chronic venous insufficiency.
[0004] The IPCD in the prior art adopts the mode of limb compression sleeve to wrap the calf as a whole (similar to the mode of measuring blood pressure), and then realizes the passive massage of the leg by the cyclic inflation and deflation of the air bag by the main machine.
[0005] In actual operation, we found that this operation mode has greater binding to the calf of the patient, is inconvenient for observing the state of the limb at the wrapped position, is not conducive to long-term wearing, and can only play a massage role.
[0006] Based on the above problems, we upgrade the existing IPCD and design a wearing appliance for preventing lower limb thrombus, which can inflate and massage the calf position and also complete ankle pump movement with the main machine. CONTENT OF UTILITY MODEL
[0007] The utility model solves the technical problem of providing a wearing appliance for preventing lower limb thrombus, which can inflate and massage the calf position and also complete ankle pump movement with the main machine.
[0008] To solve the above problems, the utility model adopts the following technical scheme:
[0009] A wearing appliance for preventing lower limb thrombosis, comprising a lower leg brace structure and a foot sole brace structure, the foot sole brace structure is rotatably connected with the lower leg brace structure, and ankle pump movement is formed by reciprocating rotation of the foot sole brace structure along a rotation point; the wearing appliance further comprises a binding assembly which is matched with the lower leg brace structure and the foot sole brace structure.
[0010] Preferably, the lower leg brace structure comprises a lower leg brace, an entering opening is formed on the upper end of the lower leg brace by injection molding, side massage air bags are installed on the inner walls of both sides of the lower leg brace, one common air pipe joint is connected with the side massage air bags on both sides, a first bottom air bag and a second bottom air bag are arranged on the inner bottom of the lower leg brace, a plurality of first bottom air bags are arranged on both sides of the second bottom air bags, one common first air pipe joint is connected with the plurality of first bottom air bags, and one common second air pipe joint is connected with the plurality of second bottom air bags; through grooves are symmetrically arranged on both sides of the lower leg brace close to the top position, the binding assembly passes through the through grooves, and pins are arranged on both sides of the lower leg brace, and the foot sole brace structure rotates along the pins.
[0011] Preferably, massage convex points are arranged on the surfaces of the side massage air bags, the first bottom air bags and the second bottom air bags.
[0012] Preferably, the foot sole brace structure comprises a support body and a foot sole brace, the foot sole brace has a foot sole groove for positioning a foot sole, a foot sole massage air bag is installed on the groove bottom of the foot sole groove, a third air pipe joint connected with the foot sole massage air bag is arranged on the side of the foot sole brace, and pin shaft holes matched with the pins are arranged at both sides of the foot sole brace; the support body has a "7" shaped connecting arm, a damping bolt is matched between the connecting arm and the lower leg brace, an ankle pump air column assembly is installed between the support body and the foot sole brace, and first through grooves matched with the binding assembly are arranged at both sides of the foot sole brace.
[0013] Preferably, the ankle pump air column assembly comprises an air column, one end of the air column is fixed with the support body, the other end of the air column is glued with an end cover, a connecting cover is assembled at the end face of the end cover, a bearing is matched between the connecting cover and the end cover, a threaded hole is arranged on the bottom of the foot sole brace, and the connecting cover is screwed with the threaded hole; the air column is connected with a fourth air pipe joint, and the fourth air pipe joint is fixed with the support body.
[0014] Preferably, shock-absorbing blocks made of elastic rubber material are embedded at four corners of the bottom of the foot sole brace.
[0015] Preferably, a limiting post is formed on both sides of the calf support by injection molding, and the connecting arm is limited by the limiting post when the connecting arm rotates to the limit position along the damping bolt, at which time the end surface B of the support body contacts the floor surface so that the calf is lifted up.
[0016] Preferably, the binding assembly comprises a binding belt, one end of the binding belt is sewn to form a limiting part, the calf support and the sole support are connected through the limiting part, and the other end of the binding belt is fixed by adhesion after passing through the passing groove and the first passing groove, and a magic tape is arranged at the adhesion position.
[0017] Preferably, a soft pad is fixed by adhesion at the position of the binding belt downward.
[0018] Preferably, the soft pad is a silica gel soft pad.
[0019] The IPCD is composed of a host, a connecting pipe and a limb pressurizing sleeve, and is driven by electricity. Most IPCDs work by alternating current, and a few rely on battery driving. The IPCD has two kinds of inflation methods, one is that the host alternately inflates the two limb pressurizing sleeves, and the other is that the host simultaneously inflates the two limb pressurizing sleeves, and there is no obvious difference between the two. According to the different manufacturers of IPCD, the host panel module is also different, mainly including power key and start / stop key, power indicator and fault indicator, etc., and the panel of some devices also includes display screen, power display lamp, timing key, etc. The limb pressurizing sleeve is connected with the host through the connecting pipe, and is divided into two types of reusable for multiple patients and only for single patient according to the different materials.
[0020] In the technical solution, the calf support structure and the sole support structure are combined to replace the limb pressurizing sleeve in the prior art.
[0021] Pressure selection: According to the different IPCD pressurizing modes, the IPC can be divided into two kinds of graded pressurization and equal pressure pressurization. The graded pressurization mode usually applies gradually decreasing pressure at the ankle, calf and thigh, and the equal pressure pressurization mode applies equal pressure to different parts of the leg sleeve. Regardless of which mode is used for pressurization, it is recommended to apply pressure in the range of 35-40mmHg to the thigh and / or calf, and the leg sleeve is inflated for about 10s / time, then relaxed for 1min, and then the cycle is repeated. When using VFP, only the foot is pressurized, and since the foot venous plexus stores less blood, it is recommended to select a pressure of about 130mmHg to promote venous blood return. It is recommended to use a device specially used for thrombus prevention to prevent VTE, and the host panel of the device has no pressure adjustment module, and the default inflation pressure is within the specified range after starting, so as to avoid improper pressure application due to the operator's failure to adjust the pressure in time, and to maximize the safety of the patient.
[0022] Ankle pump exercise is a movement of ankle joint, which plays a role like a pump, promotes blood pressure circulation and lymph circulation of lower limbs. This exercise is very important for functional recovery of patients in various conditions, especially long-term bedridden and postoperative patients.
[0023] Ankle pump exercise promotes blood pressure circulation and lymph circulation of lower limbs mainly through flexion and extension of ankle joint and ankle rotation. This is very important for functional recovery of long-term bedridden and postoperative patients. Braking after surgery can cause slow blood flow, platelets stay and gather around blood vessels, and easily form thrombus, affecting the recovery of postoperative function of lower limbs. Early thrombus can sometimes be active, and if thrombus is unfortunately detached, it can cause embolism in the lungs or brain.
[0024] Ankle pump exercise promotes blood circulation of lower limbs by flexion and extension of ankle joint, so as to prevent deep vein thrombosis of lower limbs.
[0025] The beneficial effects of the utility model are:
[0026] Advantage one, the device can inflate and deflate the calf support structure and the sole support structure to massage the calf and the sole respectively.
[0027] Advantage two, the device can inflate and deflate the sole support structure to realize reciprocating rotation of the sole support structure around the calf support structure, so as to realize passive ankle pump exercise.
[0028] Advantage three, the calf support structure and the sole support structure are both open structures, which are convenient for observing the limb state of the patient, so as to adjust in time, make the patient more comfortable, and are also convenient for daily nursing of the patient's limbs. BRIEF DESCRIPTION OF DRAWINGS
[0029] In order to more clearly illustrate the technical scheme in the embodiments of the utility model or the prior art, the drawings needed to be used in the embodiment or the prior art description will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the utility model, and those skilled in the art can also obtain other drawings according to these drawings without creating creative labor.
[0030] Figure 1 It is a structural schematic view of the utility model;
[0031] Figure 2 It is a perspective view of the calf support structure;
[0032] Figure 3 It is an exploded view of the device structure;
[0033] Figure 4 It is a sectional view of the ankle pump air column assembly;
[0034] Figure 5 The installation diagram of the instep brace structure;
[0035] Figure 6 The enlarged view of A. DETAILED DESCRIPTION
[0036] All features disclosed in this specification, and / or all steps of any methods or processes disclosed in this specification, can be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive.
[0037] Any feature disclosed in this specification, unless stated otherwise, can be replaced by alternative features serving the same, equivalent or similar purpose, to achieve the same, equivalent or similar result.
[0038] In the description of the present application, it is to be understood that the orientation or positional relationship indicated by the terms "one end", "the other end", "outer side", "upper", "inner side", "horizontal", "coaxial", "central", "end", "length", "outer end" and the like is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application.
[0039] In addition, in the description of the present application, "a plurality of" means at least two, for example, two, three, etc., unless otherwise specifically limited.
[0040] In the present application, unless otherwise specifically defined and limited, the terms "provided", "sleeved", "connected", "penetrated", "inserted" and the like should be understood broadly, for example, they can be fixedly connected, or detachably connected, or integrated; they can be mechanically connected, or electrically connected; they can be directly connected, or indirectly connected through an intermediate medium; they can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise specifically limited. For ordinary skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.
[0041] Referring to Figure 1 The wearing device for preventing lower limb thrombosis shown in the figure comprises a calf brace structure 1 and an instep brace structure 2, the instep brace structure 2 is rotationally matched with the calf brace structure 1, and through the reciprocating rotation of the instep brace structure 2 along the rotation point, an ankle pump movement is formed; further comprising a binding assembly 3, the binding assembly 3 is matched with the calf brace structure 1 and the instep brace structure 2.
[0042] In the above technical solution, the patient's lower leg is fixed in the lower leg brace structure 1 by the restraint component 3, and the patient's foot is fixed in the foot brace structure 2. By inflating and deflating the foot brace structure 2, the foot brace structure 2 can reciprocate along the lower leg brace structure 1 to achieve passive ankle pump movement.
[0043] It also includes an outdoor unit, which is used for inflation and deflation.
[0044] See Figure 2 , Figure 3 and Figure 5 As shown, the calf brace structure 1 includes a calf brace 101. An entry opening 102 is injection-molded at the upper end of the calf brace 101. Side massage airbags 103 are installed on the inner walls of both sides of the calf brace 101. The side massage airbags 103 on both sides are connected to a common air pipe connector 1331. A first bottom airbag 104 and a second bottom airbag 105 are provided at the inner bottom of the calf brace 101. Multiple first bottom airbags 104 and second bottom airbags 105 are provided. 04 is disposed on both sides of the second bottom airbag 105. Multiple first bottom airbags 104 are connected to a common first air pipe connector 106, and multiple second bottom airbags 105 are connected to a common second air pipe connector 107. Through slots 108 are symmetrically arranged on both sides of the lower leg brace 101 near the top position, and the restraint assembly 3 passes through the through slots 108. Pins 109 are provided on both sides of the lower leg brace 101, and the foot brace structure 2 rotates along the pins 109.
[0045] In the above technical solution, a first bottom air bladder 104 and a second bottom air bladder 105 are inflated separately. When the first bottom air bladder 104 inflates, the second bottom air bladder 105 deflates. At this time, the first bottom air bladder 104 provides support to the patient's lower leg. Periodically, the second bottom air bladder 105 is inflated while the first bottom air bladder 104 is deflated, and the lower leg is supported by the second bottom air bladder 105. This alternating inflation and deflation changes the position of the lower leg being supported, preventing pressure sores caused by prolonged wearing of the same air bladder in the same position.
[0046] When calf massage is needed, the contralateral massage airbag 103, the first bottom airbag 104, and the second bottom airbag 105 are simultaneously inflated or deflated to achieve a squeezing and massaging effect on the patient's calf.
[0047] See Figure 2 As shown, the surfaces of the side massage airbag 103, the first bottom airbag 104, and the second bottom airbag 105 are evenly distributed with massage bumps 111.
[0048] The massage convex points 111 can increase the massage effect.
[0049] Referring to Figure 3 、 Figure 4 and Figure 5 , the foot sole supporting structure 2 comprises a supporting body 201 and a foot sole supporting device 202, the foot sole supporting device 202 has a foot sole groove 203 for positioning the foot sole, a foot sole massage air bag 204 is installed at the bottom of the foot sole groove 203, a third air pipe joint 205 connected with the foot sole massage air bag 204 is arranged at the side of the foot sole supporting device 202, pin shaft holes 206 matched with the pin shafts 109 are arranged at both sides of the foot sole supporting device 202; the supporting body 201 has a “7” shaped connecting arm 207, a damping bolt 208 is matched between the connecting arm 207 and the calf supporting device 101, an ankle pump air column assembly 209 is installed between the supporting body 201 and the foot sole supporting device 202; first through grooves 210 matched with the binding assembly 3 are arranged at both sides of the foot sole supporting device 202.
[0050] In the above technical solution, the supporting body 201 is reversible, when the patient needs to walk out of the bed, the supporting body 201 is turned back and the damping bolt 208 is locked, at this time, the patient can walk by contacting the foot sole supporting device 202 with the ground.
[0051] After the supporting body 201 is turned back, it can also support the patient's calf on the bed.
[0052] In the above technical solution, the rotation of the foot sole supporting device 202 along the pin shaft 109 is realized by inflating and deflating the ankle pump air column assembly 209, and the passive ankle pump movement is completed.
[0053] Preferably, the ankle pump air column assembly 209 comprises an air column 291, one end of the air column 291 is fixed with the supporting body 201, the other end of the air column 291 is glued and fixed with an end cover 292, a connecting cover 293 is assembled at the end face of the end cover 292, a bearing 294 is matched between the connecting cover 293 and the end cover 292, a threaded hole 295 is arranged at the bottom of the foot sole supporting device 202, the connecting cover 293 is threadedly connected with the threaded hole 295; the air column 291 is connected with a fourth air pipe joint 296, the fourth air pipe joint 296 is fixed with the supporting body 201.
[0054] In the above technical solution, the connecting or disconnecting with the threaded hole 295 is realized by rotating the connecting cover 293, when the ankle pump movement is needed, the connecting cover 293 is connected with the foot sole supporting device 202, at this time, the inflation and deflation of the air column 291 realizes the rotation of the foot sole supporting device 202.
[0055] When walking is needed, the connecting cover 293 is disconnected from the foot sole brace 202, and the support body 201 is flipped backward, so that temporary walking can be performed by contacting the ground with the foot sole brace 202.
[0056] Referring to Figure 3 As shown in the drawings, shock-absorbing blocks 288 made of elastic rubber are embedded at the four corners of the bottom of the foot sole brace 202.
[0057] The shock-absorbing blocks 288 can provide shock-absorbing effect when the patient is walking.
[0058] Referring to Figure 3 As shown in the drawings, limit posts 133 are formed by injection molding on both sides of the lower leg brace 101, and the connecting arm 207 is limited by the limit posts 133 when it is rotated to the limit position along the damping bolt 208. At this time, the end surface B of the support body 201 contacts the bed surface, so that the lower leg is lifted up.
[0059] The limit posts 133 can limit the rotation of the connecting arm 207 to avoid overtravel.
[0060] Referring to Figure 6 As shown in the drawings, the binding assembly 3 includes a binding belt 301, one end of which is sewn to form a limit part 302, and the other end of which is passed through the through slot 108 and the first through slot 210 and then adhesively fixed. A magic tape 303 is arranged at the adhesion position.
[0061] The binding belt 301 can limit the lower leg and foot sole of the patient.
[0062] Referring to Figure 6 As shown in the drawings, a soft pad 304 is adhesively fixed at the downward position of the binding belt 301.
[0063] The function of the soft pad 304 is to softly contact the limb.
[0064] The soft pad 304 is a silica gel soft pad.
[0065] It is to be noted that the terms used herein are only for the purpose of describing specific embodiments, and are not intended to limit the exemplary embodiments according to the present application. As used herein, the singular form is intended to include the plural form, unless the context clearly indicates otherwise, and it should also be understood that, when the terms "comprise" and / or "include" are used in the specification, there is a presence of a feature, step, operation, device, component, and / or combination thereof.
[0066] Unless otherwise specifically stated, the relative arrangement, numerical expressions, and values of the components and steps described in these embodiments do not limit the scope of this invention. It should also be understood that, for ease of description, the dimensions of the various parts shown in the drawings are not drawn to actual scale. Techniques, methods, and devices known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and devices should be considered part of the specification. In all examples shown and discussed herein, any specific values should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters in the following drawings denote similar items; therefore, once an item is defined in one drawing, it need not be further discussed in subsequent drawings.
[0067] For ease of description, spatial relative terms such as "above," "on top of," "on the upper surface of," "above," etc., are used herein to describe the spatial positional relationship of a device or feature as shown in the figures to other devices or features. It should be understood that spatial relative terms are intended to encompass different orientations in use or operation beyond the orientation of the device as described in the figures. For example, if the device in the figures were inverted, a device described as "above" or "on top of" other devices or structures would subsequently be positioned as "below" or "under" other devices or structures. Thus, the exemplary term "above" can include both "above" and "below." The device may also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatial relative descriptions used herein will be interpreted accordingly.
[0068] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to this application. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.
[0069] It should be noted that the terms "first," "second," etc., used in the specification, claims, and accompanying drawings of this application are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of this application described herein can be implemented in sequences other than those illustrated or described herein.
[0070] The above merely describes preferred embodiments of the present application and is not intended to limit the present application. For those skilled in the art, the present application can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.
Claims
1. A prophylactic lower extremity thrombosis wearing device, characterized by: The calf brace structure (1) and the sole brace structure (2) are rotationally connected, and the ankle pump movement is formed by the reciprocating rotation of the sole brace structure (2) along the rotation point.
2. The prevention of lower extremity thrombosis of the wearing appliance according to claim 1, characterized in that: The calf brace structure (1) includes a calf brace (101), an entry opening (102) is formed at the upper end of the calf brace (101), side massage air bags (103) are installed at the inner walls of both sides of the calf brace (101), and one common air pipe joint (1331) is connected to the side massage air bags (103) on both sides; a first bottom air bag (104) and a second bottom air bag (105) are arranged at the inner bottom of the calf brace (101), the first bottom air bag (104) and the second bottom air bag (105) are provided in multiple, the first bottom air bag (104) is arranged on both sides of the second bottom air bag (105), a common first air pipe joint (106) is connected to the multiple first bottom air bags (104), and a common second air pipe joint (107) is connected to the multiple second bottom air bags (105); through grooves (108) are symmetrically arranged at both sides of the calf brace (101) near the top, the binding assembly (3) passes through the through grooves (108), and pin shafts (109) are arranged at both sides of the calf brace (101), and the sole brace structure (2) rotates along the pin shafts (109).
3. The prevention of lower extremity thrombosis of the wearing appliance according to claim 2, characterized in that: The surfaces of the side massage air bags (103), the first bottom air bags (104), and the second bottom air bags (105) are uniformly provided with massage convex points (111).
4. The prevention of lower extremity thrombosis of the wearing appliance according to claim 2, characterized in that: The sole brace structure (2) includes a support body (201) and a sole brace (202), the sole brace (202) has a sole groove (203) for positioning the sole, a sole massage air bag (204) is installed at the groove bottom of the sole groove (203), a third air pipe joint (205) connected to the sole massage air bag (204) is arranged at the side of the sole brace (202), and pin shaft holes (206) matched with the pin shafts (109) are arranged at both sides of the sole brace (202); the support body (201) has a "7" shaped connecting arm (207), a damping bolt (208) is arranged between the connecting arm (207) and the calf brace (101), an ankle pump air column assembly (209) is installed between the support body (201) and the sole brace (202), and first through grooves (210) matched with the binding assembly (3) are arranged at both sides of the sole brace (202).
5. The prevention of lower extremity thrombosis of the wearing appliance according to claim 4, characterized in that: The ankle pump air column assembly (209) comprises an air column (291), one end of the air column (291) is fixed with the support body (201), the other end of the air column (291) is glued with an end cover (292), the end face of the end cover (292) is equipped with a connecting cover (293), a bearing (294) is matched between the connecting cover (293) and the end cover (292), a threaded hole (295) is arranged at the bottom of the instep support (202), the connecting cover (293) is screwed with the threaded hole (295); the air column (291) is connected with a fourth air pipe joint (296), the fourth air pipe joint (296) is fixed with the support body (201).
6. The prevention of lower extremity thrombosis of the wearing appliance according to claim 4, characterized in that: The bottom of the instep support (202) is embedded with shock-absorbing blocks (288) made of elastic rubber material at four corners.
7. The prevention of lower extremity thrombosis of the wearing appliance according to claim 4, characterized in that: The limiting posts (133) are injection molded on both sides of the lower leg support (101), the connecting arm (207) is limited by the limiting posts (133) when rotating to the limit position along the damping bolt (208), at this time, the end face B of the support body (201) contacts the bed surface, so that the lower leg is lifted up.
8. The prevention of lower extremity thrombosis of the wearing appliance according to claim 4, characterized in that: The binding assembly (3) comprises a binding belt (301), one end of the binding belt (301) is sewn to form a limiting part (302), the lower leg support (101) and the instep support (202) are connected through the limiting part (302), the other end of the binding belt (301) passes through the through slot (108) and the first through slot (210) and is adhesively fixed, a magic tape (303) is arranged at the adhesion position.
9. The prevention of lower extremity thrombosis of the wearing appliance according to claim 8, characterized in that: The downward position of the binding belt (301) is adhesively fixed with a soft pad (304).
10. The prevention of lower extremity thrombosis of the wearing appliance according to claim 9, characterized in that: The soft pad (304) is a silica gel soft pad.