Segmented airbag staggered timing ankle-foot orthosis and calf compression device and method
Patent Information
- Application Number
- CN202611142370.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-07-30
- Publication Date
- 2026-09-18
AI Technical Summary
[0003]现有技术中对于足畸形矫正与血栓预防往往采用分体式设备,如硬质踝足矫形器配合独立的小腿气压泵,此类分体设计不仅穿戴繁琐,增加了护理工作的负担,而且硬质支具容易造成患者局部皮肤压疮,舒适性较差,此外,传统的小腿加压装置多采用分段独立气囊且同步充气,这种加压方式不符合生理性肌肉泵由远心端向近心端挤压的规律,导致静脉回流促进效果有限,若将矫形与加压功能简单叠加同时充气,又会造成肢体持续受压,影响血液循环,导致肢体肿胀等不适感,现有设备缺乏错峰协同控制机制及一体化的解决方案,难以在保证舒适度的前提下实现高效的综合康复治疗
[0051] I. This invention, by setting an integrated flexible lower limb wearable sleeve and cooperating with a segmented overlapping multi-zone airbag module, uses a double-layer silicone sponge composite cushioning structure to replace the traditional rigid support, effectively avoiding the continuous pressure of rigid splints on the heel and ankle joint bony prominences, reducing the risk of pressure sores in long-term bedridden patients. At the same time, the fully open strap design facilitates quick wearing and adjustment by medical staff, significantly improving the efficiency of daily care and the wearing comfort of patients.
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Figure CN122768031A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology for stroke rehabilitation, specifically a segmented airbag staggered timing ankle and foot orthosis and calf compression device and method. Background Technology
[0002] Patients with hemiplegia due to stroke often face two major complications: ankle and foot flexor muscle spasticity deformity and deep vein thrombosis in the lower extremities. The former manifests as deformities such as foot drop, inversion, or eversion of the foot, while the latter is due to the risk of thrombosis caused by slow blood flow due to prolonged bed rest. Clinically, intervention with specialized medical devices is usually required. Modern rehabilitation medicine widely uses pneumatic compression and orthotic braces to stimulate muscle pump action through changes in air pressure and to maintain normal joint position using external mechanical force. These techniques play an indispensable role in improving limb function and preventing serious complications, and are an important treatment direction in the field of neurorehabilitation.
[0003] Existing technologies for foot deformity correction and thrombosis prevention often employ separate devices, such as rigid ankle-foot orthoses combined with independent calf air pumps. This type of separate design is not only cumbersome to wear and increases the burden of nursing care, but rigid braces are also prone to causing pressure sores on the patient's local skin, resulting in poor comfort. In addition, traditional calf compression devices often use segmented independent air bags that are inflated simultaneously. This compression method does not conform to the physiological muscle pump's compression pattern from the distal end to the proximal end, resulting in limited venous return promotion. If the orthopedic and compression functions are simply superimposed and inflated simultaneously, it will cause continuous pressure on the limb, affecting blood circulation and causing discomfort such as limb swelling. Existing devices lack staggered collaborative control mechanisms and integrated solutions, making it difficult to achieve efficient comprehensive rehabilitation treatment while ensuring comfort. Summary of the Invention
[0004] The purpose of this invention is to solve the technical problems existing in the prior art and to provide a segmented airbag staggered timing ankle and foot orthosis and calf compression device and method.
[0005] To achieve the above objectives, the present invention provides the following technical solution:
[0006] A segmented airbag staggered timing ankle-foot orthosis and calf compression device, comprising:
[0007] The flexible wearable sleeve has a one-piece molded structure, which is divided into a calf wrapping section, an ankle wrapping section, and a full foot wrapping section from top to bottom;
[0008] A multi-zone airbag module is mounted on the flexible wearable sleeve, which includes an ankle-foot orthotic airbag group and a three-segment sequential compression airbag group for the lower leg.
[0009] An independent air supply circuit is provided on the flexible wearable sleeve, including a first air supply branch and a second air supply branch. The first air supply branch is connected to the ankle and foot orthotic airbag group, and the second air supply branch is connected to the lower leg three-segment sequential pressure airbag group.
[0010] An electrically controlled inflation / deflation unit is connected to one end of the independent air supply circuit. It is used to control the first air supply branch and the second air supply branch to alternately inflate and deflate, so that the inflation period of the ankle-foot orthotic airbag group is completely staggered from the inflation period of the lower leg three-segment sequential pressure airbag group.
[0011] Furthermore, the three-segment sequential compression airbag assembly for the lower leg includes:
[0012] The distal ankle airbag is positioned distally along the longitudinal direction of the lower leg.
[0013] The calf mid-section airbag is positioned longitudinally along the middle of the calf.
[0014] The proximal infrakal airbag is positioned proximally along the longitudinal direction of the lower leg.
[0015] The upper edge of the distal ankle airbag extends upward and overlaps with the lower edge of the mid-calf airbag, and the upper edge of the mid-calf airbag extends upward and overlaps with the lower edge of the proximal knee airbag; the distal ankle airbag, the mid-calf airbag, and the proximal knee airbag are all connected to the second air supply branch.
[0016] Furthermore, the ankle-foot orthotic airbag assembly includes:
[0017] The medial foot restraint airbag is designed to fit the inner edge of the foot and is used to restrain the foot inward when inflated to correct abduction and external rotation deformity.
[0018] The dorsiflexion air bladder, which is curved and covers the dorsiflexion area of the foot, is used to pull upwards when inflated to maintain the dorsiflexion function of the ankle joint;
[0019] Both the medial foot limiting airbag and the dorsum foot lifting airbag are connected to the first air supply branch.
[0020] Furthermore, the electronically controlled inflation / deflation unit includes:
[0021] Programmable mainboard, used to pre-store working modes;
[0022] A silent high-pressure air pump is connected to the programmable mainboard.
[0023] A multi-channel two-position three-way electromagnetic reversing valve is installed between the silent high-pressure air pump and the independent air supply circuit for switching air circuits;
[0024] A high-precision pressure sensor is installed on the independent gas supply line to monitor the gas pressure;
[0025] The programmable mainboard is configured to control the first air supply branch and the second air supply branch to alternately inflate and deflate, so that the inflation period of the ankle-foot orthotic airbag group is completely staggered from the inflation period of the lower leg three-segment sequential pressure airbag group.
[0026] Furthermore, the electronically controlled inflation / deflation unit also includes:
[0027] An audible and visual alarm module is connected to the programmable mainboard and is used to trigger an alarm when the air pressure is abnormal.
[0028] The data storage module, connected to the programmable motherboard, is used to store the air pressure and operating mode data for the entire course of a single rehabilitation session, and supports data export.
[0029] Furthermore, the independent gas supply path also includes:
[0030] Quick-connect gas pipe connectors are respectively installed at the ends of the first gas supply branch and the second gas supply branch;
[0031] The quick-plug air tube connector has a one-click separation structure and is used to connect the flexible wearable sleeve to the electronically controlled inflation / deflation host.
[0032] Furthermore, the flexible wearable sleeve also includes:
[0033] Velcro straps are provided on the outside of the flexible wear sleeve for adjusting tightness;
[0034] A removable medical breathable cushioning pad is provided on the inner wall of the flexible wearable sleeve;
[0035] A thickened silicone cushioning layer is installed on the heel, inner and outer ankles, and dorsum of the foot of the removable medical breathable cushioning pad.
[0036] Furthermore, the pre-stored operating modes of the electronically controlled gas charging / discharging main unit include:
[0037] In the ankle-foot dynamic orthopedic mode only, the second air supply branch is shut off, and the first air supply branch is controlled to drive the ankle-foot orthopedic airbag assembly to intermittently circulate inflation and deflation.
[0038] In the calf-only sequential pressurization mode, the first air supply branch is turned off, and the second air supply branch is controlled to drive the three-segment sequential pressurization airbag group of the calf to inflate in the order of distal ankle airbag, mid-calf airbag, and proximal knee airbag.
[0039] The orthopedic pressurization synchronous linkage mode simultaneously activates the first and second gas supply branches, and operates in a staggered and alternating sequence.
[0040] Another technical solution provided by this invention is as follows:
[0041] A segmented airbag staggered timing ankle-foot orthosis and calf compression method includes the following steps:
[0042] S1. Wearing and self-testing steps: Place the hemiplegic lower limb into the flexible wear sleeve, connect the air tube to the electronically controlled inflation and deflation host, and start the whole machine self-test;
[0043] S2. Risk grading and calibration steps: Based on the patient's ankle joint deformity, bed rest duration, lower limb muscle strength and deep vein thrombosis risk score, match the corresponding standardized rehabilitation program and load the initial air pressure and time sequence parameters.
[0044] S3. Execution steps of sub-mode rehabilitation cycle: Select the corresponding working mode and control the electronically controlled inflation / deflation host to execute the inflation / deflation cycle;
[0045] S4. Phased Rehabilitation Progression Steps: Divide each rehabilitation session into an adaptation period, a collaborative intervention period, and a maintenance and consolidation period, and gradually adjust the air pressure.
[0046] S5. Shutdown, disassembly, and disinfection steps: After a single rehabilitation session, the equipment will automatically depressurize and shut down. Disconnect the air tube and remove the flexible wearable sleeve for cleaning and disinfection.
[0047] Furthermore, the standardized rehabilitation program in step S2 includes three sets, respectively adapted to three categories of patients: those with mild foot deformity and low thrombosis risk, those with moderate foot deformity and medium thrombosis risk, and those with severe foot deformity and high thrombosis risk.
[0048] In step S3, for patients with severe foot deformities and high risk of thrombosis, a synchronous linkage mode is adopted, with an inflation pressure of 30-40 kPa, a total duration of single-wheel pressure on the lower leg of 12 seconds, and an ankle-foot correction maintenance duration of 20-30 seconds.
[0049] For patients with mild foot deformities and low risk of thrombosis, a dynamic ankle-foot orthosis mode is used with an inflation pressure of 20–30 kPa.
[0050] Compared with existing technologies, this segmented airbag staggered timing ankle-foot orthosis and calf compression device has the following beneficial effects:
[0051] I. This invention, by setting an integrated flexible lower limb wearable sleeve and cooperating with a segmented overlapping multi-zone airbag module, uses a double-layer silicone sponge composite cushioning structure to replace the traditional rigid support, effectively avoiding the continuous pressure of rigid splints on the heel and ankle joint bony prominences, reducing the risk of pressure sores in long-term bedridden patients. At the same time, the fully open strap design facilitates quick wearing and adjustment by medical staff, significantly improving the efficiency of daily care and the wearing comfort of patients.
[0052] Second, this invention employs an overlapping and overlapping structure between the three sequentially pressurized airbags in the lower leg. During inflation, this structure creates a progressive compression effect from the distal to the proximal end, mimicking the peristaltic mechanism of the human physiological muscle pump. Compared to the segmented and independent pressurization of traditional airbags, this structure helps to more efficiently push venous blood back to the heart in one direction, thereby promoting blood circulation in the lower limb veins and assisting in the prevention of deep vein thrombosis.
[0053] Third, by configuring dual physically isolated independent air supply circuits and a multi-channel staggered timing electronically controlled inflation and deflation host, this invention realizes the alternating staggered operation of the ankle and foot orthotic airbag group and the lower leg sequential pressure airbag group, avoiding the limb from being continuously subjected to high air pressure compression in the same period of time. This design ensures the correction force of foot and ankle deformity while giving the limb an appropriate intermittent pressure release time, which helps to relieve limb swelling and numbness caused by continuous compression. Attached Figure Description
[0054] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0055] Figure 1 This is a three-dimensional structural diagram of the present invention;
[0056] Figure 2 This is a schematic diagram of the planar structure of the present invention;
[0057] Figure 3 This is a top view of the structure of the present invention;
[0058] Figure 4 This is a schematic diagram of the ankle-foot orthotic airbag assembly of the present invention;
[0059] Figure 5 This is a schematic diagram of the three-segment sequential compression airbag assembly for the lower leg according to the present invention;
[0060] Figure 6 This is a schematic diagram of the dual-air-path staggered timing electronic control principle of the present invention.
[0061] In the diagram: 1. Flexible wearable sleeve; 2. Ankle-foot orthotic airbag assembly; 201. Medial foot limiting airbag; 202. Dorsal foot lifting airbag; 3. Lower leg three-segment sequential compression airbag assembly; 301. Distal ankle supra-ankle airbag; 302. Mid-lower leg airbag; 303. Proximal knee supra-knee airbag; 4. First air supply branch; 5. Second air supply branch; 6. Electrically controlled inflation / deflation main unit; 601. Programmable mainboard; 602. Silent high-pressure air pump; 603. Multi-channel two-position three-way electromagnetic reversing valve; 604. High-precision pressure sensor; 605. Audible and visual alarm module; 606. Data storage module; 7. Quick-plug air tube connector; 8. Velcro strap; 9. Removable medical breathable cushioning pad. Detailed Implementation
[0062] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.
[0063] like Figures 1 to 6 As shown, this embodiment provides a segmented airbag staggered timing ankle and foot orthosis and calf compression device. This device is suitable for stroke hemiplegic patients, long-term bedridden patients, and people at risk of ankle and foot deformity and lower limb venous return obstruction. It is used to simultaneously achieve dynamic ankle and foot orthosis and promote lower limb blood circulation during rehabilitation.
[0064] The device in this embodiment adopts a flexible wearable structure. By integrating airbag modules with different functions onto the same flexible wearable sleeve 1, patients can complete ankle and foot posture adjustment and sequential compression therapy of the lower leg without having to wear traditional ankle and foot orthotics and lower limb pneumatic therapy devices separately.
[0065] Specifically, the segmented airbag staggered timing ankle and foot orthosis and calf compression device in this embodiment mainly includes: a flexible wearable sleeve 1, and a multi-zone airbag module disposed on the flexible wearable sleeve 1.
[0066] Independent air supply path connected to the multi-zone airbag module;
[0067] And an electrically controlled inflation and deflation unit 6 for controlling the operation of the independent air supply circuit, wherein the multi-zone airbag module includes an ankle-foot orthotic airbag group 2 and a three-segment sequential pressure airbag group 3 for the lower leg. The ankle-foot orthotic airbag group 2 is used to apply orthotic force to the patient's foot and ankle joint.
[0068] The three-segment sequential compression airbag group 3 for the lower leg is used to progressively compress the lower leg area from distal to proximal.
[0069] The independent air supply circuit includes a first air supply branch 4 and a second air supply branch 5. The first air supply branch 4 is used to supply compressed gas to the ankle-foot orthotic airbag assembly 2, and the second air supply branch 5 is used to supply compressed gas to the lower leg three-segment sequential pressure airbag assembly 3.
[0070] The electronically controlled inflation and deflation unit 6 is connected to the first air supply branch 4 and the second air supply branch 5 respectively, and controls the two air supply branches to work alternately according to the preset control program, so that the ankle and foot orthotic airbag group 2 and the lower leg three-segment sequential pressure airbag group 3 form a staggered operation state.
[0071] In this embodiment, after receiving the pressure relief completion signal (pressure sensor reading <5kPa) from the second gas supply branch 5, the programmable main board 601 of the electronically controlled gas charging and discharging host 6 delays by 0.5~1s before starting the first gas supply branch 4.
[0072] The above structure allows the ankle-foot orthopedic procedure and the calf vein promotion procedure to no longer be performed simultaneously with pressure. Instead, they are performed at different times according to different treatment objectives, thereby avoiding continuous compression caused by the superposition of two pressure effects and improving the comfort and safety of patients during use.
[0073] like Figure 1 and Figure 2 As shown, the flexible wearable sleeve 1 serves as the main support for the entire device, used to cover the patient's lower leg, ankle joint, and foot area.
[0074] In this embodiment, the flexible wearable sleeve 1 is made of flexible material in one piece, and there are no rigid plastic support parts or metal support frames as found in traditional ankle and foot orthotics.
[0075] Along the patient's lower limbs, the flexible sleeve 1 is applied from top to bottom to form a lower leg wrapping section, an ankle wrapping section, and a full foot wrapping section.
[0076] Among them, the lower leg wrapping section is used to cover the patient's lower leg area and to install the lower leg three-segment sequential pressure airbag group 3;
[0077] The ankle wrap section is used to cover the area around the ankle joint and provides a mounting base for the ankle-foot orthotic airbag assembly 2.
[0078] The full-foot wrap is used to cover the patient's foot and works together with the ankle-foot orthotic airbag group 2 to adjust the foot posture.
[0079] Because the flexible wearable sleeve 1 adopts an overall flexible structure, compared with traditional rigid ankle and foot orthotics, it can reduce the local concentrated pressure on bony protrusions such as the heel and inner and outer ankles during long-term wear.
[0080] Furthermore, a Velcro strap 8 is provided on the outer side of the flexible wear sleeve 1. The Velcro strap 8 is arranged around the circumference of the flexible wear sleeve 1 and is used to adjust the degree of fit between the flexible wear sleeve 1 and the patient's limb.
[0081] In actual use, medical staff can adjust the tightness of the Velcro straps 8 according to the patient's leg circumference and the degree of limb swelling to keep the flexible wear sleeve 1 stably covered while avoiding excessive restraint.
[0082] Furthermore, the inner wall of the flexible wearable sleeve 1 is provided with a removable medical breathable cushioning pad 9. The removable medical breathable cushioning pad 9 is designed to fit the patient's skin to improve wearing comfort and reduce discomfort and irritation to the skin during airbag inflation.
[0083] The detachable medical breathable cushioning pad 9 is installed inside the flexible wearable sleeve 1 with a detachable structure, so that it can be removed, cleaned and disinfected after treatment.
[0084] Furthermore, thickened silicone cushioning layers are provided on the removable medical breathable cushioning pad 9 at the positions corresponding to the heel, medial malleolus, lateral malleolus, and dorsum of the foot.
[0085] By adding a thickened silicone cushioning layer, the cushioning thickness of the aforementioned pressure-prone areas can be increased, allowing the pressure generated by the airbag inflation to be transmitted more evenly to the patient's limb surface, thus reducing the risk of localized pressure.
[0086] like Figure 1 , Figure 2 and Figure 4 As shown, the ankle-foot orthotic airbag assembly 2 is positioned on the flexible wear sleeve 1 corresponding to the patient's foot and ankle joint. It is used to dynamically adjust the abnormal foot posture caused by abnormal muscle tone in hemiplegic patients through the flexible restraint force generated by the inflation and deflation of the airbag.
[0087] Specifically, the ankle-foot orthotic airbag group 2 includes a medial foot limiting airbag 201 and a dorsum of the foot lifting airbag 202.
[0088] Among them, the medial foot limiting airbag 201 is set to fit the inner edge area of the patient's foot, extends along the length of the foot, and is fixedly connected to the flexible wearing sleeve 1.
[0089] When the medial foot limiting airbag 201 is in an uninflated state, it can conform to the contour of the patient's foot along with the flexible wearing sleeve 1; when the medial foot limiting airbag 201 is inflated, the internal pressure of the airbag increases, the thickness of the airbag increases, and a flexible supporting force is generated on the medial side of the patient's foot, thereby limiting the tendency of foot abduction and external rotation.
[0090] With the above settings, the medial foot limiting airbag 201 can be used to form a restraining force from the outside to the inside, which can help improve the abnormal abduction and external rotation posture of the foot caused by muscle tone imbalance in stroke hemiplegic patients.
[0091] Furthermore, the dorsum of the foot lifting airbag 202 is placed in the dorsum of the patient's foot area and has an overall arc-shaped structure.
[0092] The dorsolateral lifting airbag 202 extends along the contour of the dorsolateral foot. After inflation, it can apply a uniform support force towards the dorsolateral foot and generate an upward traction effect on the patient's forefoot.
[0093] In actual use, when the foot dorsiflexion airbag 202 is inflated, the airbag expands to form a flexible lifting structure, which gradually adjusts the ankle joint in the dorsiflexion direction to help maintain the ankle joint in a functional position.
[0094] Preferably, the dorsiflexion airbag 202 can keep the ankle joint in a slightly dorsiflexed state near the neutral position, for example, within the range of 5° to 10°, thereby reducing the risk of foot drop deformity in long-term bedridden patients.
[0095] Both the medial foot limiting airbag 201 and the dorsum foot lifting airbag 202 are connected to the first air supply branch 4.
[0096] When the first air supply branch 4 supplies air to the ankle-foot orthotic airbag group 2, the medial foot limiting airbag 201 and the dorsum of the foot lifting airbag 202 inflate simultaneously, so that the two work together to act on different areas of the foot and achieve comprehensive adjustment of foot posture.
[0097] Among them, the medial foot limiting airbag 201 mainly provides lateral posture restraint, and the dorsiflexion airbag 202 mainly provides traction in the dorsiflexion direction of the ankle joint. Through the combination of the two, dynamic flexible orthopedics can be achieved without relying on rigid support structures.
[0098] like Figure 1 , Figure 2 and Figure 5 As shown, the three-segment sequential compression airbag assembly 3 for the lower leg is positioned on the flexible wearable sleeve 1 corresponding to the patient's lower leg area, and is used to promote venous blood return in the lower limbs through periodic pressure changes.
[0099] Specifically, the three-segment sequential compression airbag group 3 for the lower leg is arranged in the following order along the longitudinal direction of the patient's lower leg: distal ankle airbag 301, mid-lower leg airbag 302, and proximal knee airbag 303.
[0100] The distal ankle airbag 301 is positioned near the patient's ankle joint to apply pressure preferentially to the distal area of the lower leg.
[0101] The mid-calf airbag 302 is placed in the middle region of the patient's calf to receive the pressure generated by the distal ankle airbag 301 and further promote venous blood flow proximally.
[0102] The proximal infrakal airbag 303 is positioned near the knee joint to provide final compression to the proximal region of the lower leg.
[0103] Furthermore, in this embodiment, an overlapping covering structure is used between adjacent airbags.
[0104] Specifically: the upper edge of the distal ankle airbag 301 extends upward and covers the lateral side of the lower edge of the mid-calf airbag 302; the upper edge of the mid-calf airbag 302 extends upward and covers the lateral side of the lower edge of the proximal knee airbag 303.
[0105] The overlapping arrangement ensures that there is no obvious pressure gap between adjacent airbags.
[0106] When the distal ankle bladder 301 is inflated, the pressure it generates not only acts on the area it covers, but can also be transmitted to the mid-calf bladder 302 through the overlapping area.
[0107] Subsequently, the mid-calf airbag 302 inflates and continues to transmit pressure towards the proximal infrakal airbag 303;
[0108] This ultimately results in a continuous pressure change process that gradually progresses from the distal end to the proximal end.
[0109] The overlapping airbag layout in this embodiment can reduce the pressure gap between different airbags, making the pressure application process closer to the continuous squeezing process when the human calf muscle pump contracts.
[0110] Preferably, each airbag adopts a double-layer silicone sponge composite cushioning structure. The double-layer silicone sponge composite cushioning structure can provide flexible support during airbag inflation and reduce the possibility of pressure directly acting on the skin surface.
[0111] In this embodiment, the thickness of a single airbag after inflation can be set to 8-12 mm, and the overlap width between adjacent airbags can be set to 15-25 mm to ensure continuous pressure transmission between adjacent areas.
[0112] Furthermore, the distal ankle airbag 301, the mid-calf airbag 302, and the proximal knee airbag 303 are all connected to the second air supply branch 5.
[0113] During the gas supply process of the second gas supply branch 5, the electronically controlled inflation and deflation host 6 controls the three airbags to inflate sequentially according to the preset control program, so that: the distal ankle airbag 301 is inflated; the mid-calf airbag 302 is inflated; and the proximal knee airbag 303 is inflated; and the pressure is released after the overall pressurization is completed.
[0114] By applying pressure in a way that prioritizes distal ends and then gradually increases pressure to proximal ends, the direction of pressure application is aligned with the direction of venous return in the lower limbs.
[0115] like Figure 1 , Figure 2 and Figure 6 As shown, in order to achieve independent control between the ankle-foot orthotic function and the calf compression function, this embodiment is equipped with an independent air supply path.
[0116] An independent air supply circuit is provided on the flexible wearable sleeve 1, including a first air supply branch 4 and a second air supply branch 5.
[0117] Among them: the first air supply branch 4 is connected to the ankle and foot orthotic airbag group 2, and is used to provide compressed air to the medial foot limiting airbag 201 and the dorsum of the foot lifting airbag 202;
[0118] The second air supply branch 5 is connected to the three-segment sequential pressure airbag group 3 of the lower leg, and is used to provide compressed air to the distal ankle airbag 301, the mid-lower leg airbag 302 and the proximal knee airbag 303.
[0119] The first air supply branch 4 and the second air supply branch 5 are physically isolated. The two air supply paths correspond to two different treatment functions: the first air supply branch 4 is responsible for ankle and foot orthotics; the second air supply branch 5 is responsible for sequential compression of the lower leg.
[0120] By using two independent air supply branches, the mutual influence between the two types of airbags due to pressure changes can be avoided, allowing the electronically controlled inflation / deflation unit 6 to adjust the operating status of the two functional modules separately.
[0121] Furthermore, the independent air supply circuit also includes a quick-connect and disconnectable air pipe connector 7, which is respectively located at the end of the first air supply branch 4 and the second air supply branch 5, and is used to realize quick connection and disconnection between the flexible wearable sleeve 1 and the electronically controlled inflation and deflation host 6.
[0122] The quick-connect ventilator connector 7 adopts a one-button separation structure. When the patient needs to be turned over, undergo imaging examinations, or have treatment paused, medical staff do not need to completely disassemble the flexible dressing sleeve 1. They can simply operate the quick-connect ventilator connector 7 to disconnect the airway connection, thereby improving the convenience of nursing operations.
[0123] Meanwhile, even after the electrically controlled inflation / deflation unit 6 is disconnected, the flexible wearable sleeve 1 can still maintain its covering and support function for the patient's foot and ankle joint.
[0124] like Figure 1 , Figure 2 and Figure 6As shown, in order to achieve independent control and staggered operation between the ankle-foot orthotic airbag group 2 and the lower leg three-segment sequential pressure airbag group 3, this embodiment is equipped with an electrically controlled inflation and deflation host 6.
[0125] The electronically controlled gas charging and discharging unit 6 is connected to one end of the independent gas supply circuit. As the control core of the entire device, it is used to generate compressed gas, control the airflow direction, detect the gas pressure status, and execute preset rehabilitation programs.
[0126] Specifically, the electronically controlled inflation / deflation host 6 includes a programmable main board 601, a silent high-pressure air pump 602, a multi-channel two-position three-way solenoid directional valve 603, a high-precision pressure sensor 604, an audible and visual alarm module 605, and a data storage module 606.
[0127] The programmable main board 601 is located inside the electrically controlled gas charging and discharging host 6. It is used to store and execute the device operation control program. The programmable main board 601 is electrically connected to the silent high-pressure air pump 602, the multi-channel two-position three-way solenoid reversing valve 603, the high-precision pressure sensor 604, the audible and visual alarm module 605, and the data storage module 606.
[0128] The programmable motherboard 601 has multiple pre-stored rehabilitation working modes and outputs corresponding control commands according to the working mode selected by the patient.
[0129] Specifically, the programmable mainboard 601 can: control the silent high-pressure air pump 602 to start or stop; control the multi-channel two-position three-way solenoid valve 603 to switch the air path; adjust the air supply status according to the real-time air pressure feedback from the high-precision pressure sensor 604; trigger the audible and visual alarm module 605 in abnormal situations; and record the operating data during the treatment process.
[0130] In particular, the programmable mainboard 601 in this embodiment differs from the traditional pneumatic therapy device which only controls the inflation and deflation of a single airbag. It can simultaneously identify the operating status of the first air supply branch 4 and the second air supply branch 5, and control the two air supply branches to operate alternately according to a preset time logic.
[0131] The silent high-pressure air pump 602 is connected to the programmable main board 601 and is used to provide compressed air to the first air supply branch 4 and the second air supply branch 5.
[0132] When the device is started, the programmable main board 601 controls the silent high-pressure air pump 602 to run, generating an airflow with a certain pressure, which is then selectively delivered to the corresponding air supply branch through the multi-channel two-position three-way solenoid reversing valve 603.
[0133] In this embodiment, the silent high-pressure air pump 602 can output airflow of different pressure levels according to different treatment modes.
[0134] For example: in the ankle-foot dynamic orthosis mode only, the silent high-pressure air pump 602 supplies air to the first air supply branch 4; in the lower leg sequential pressurization mode only, the silent high-pressure air pump 602 supplies air to the second air supply branch 5; in the orthosis pressurization synchronous linkage mode, the silent high-pressure air pump 602 switches between the two air supply branches according to the timing instructions output by the programmable main board 601.
[0135] Furthermore, a multi-channel two-position three-way electromagnetic reversing valve 603 is installed between the silent high-pressure air pump 602 and the independent air supply circuit to control the direction of compressed air flow.
[0136] Specifically, the multi-channel two-position three-way solenoid directional valve 603 is connected to the first air supply branch 4 and the second air supply branch 5 respectively.
[0137] Under the control of the programmable mainboard 601, the multi-channel two-position three-way solenoid directional valve 603 has at least the following operating states:
[0138] First state: Control the airflow into the first air supply branch 4 to make the ankle-foot orthotic airbag assembly 2 work;
[0139] Second state: Control the airflow into the second air supply branch 5 to make the three-segment sequential pressure airbag assembly 3 of the lower leg work;
[0140] Third state: Control the corresponding airway to depressurize, so that the airbag returns to its initial state.
[0141] A high-precision pressure sensor 604 is installed on an independent air supply line to detect pressure changes in the first air supply branch 4 and the second air supply branch 5 in real time.
[0142] During the treatment, the high-precision pressure sensor 604 continuously collects airway pressure data and feeds the detection results back to the programmable motherboard 601.
[0143] When the actual pressure is detected to reach the preset pressure value, the programmable main board 601 controls the silent high-pressure air pump 602 to stop supplying air and controls the multi-channel two-position three-way solenoid reversing valve 603 to maintain the current air circuit state, so that the corresponding airbag maintains the set pressure.
[0144] When an abnormal increase in pressure, continuous overpressure, or abnormal decrease in pressure is detected, the programmable mainboard 601 controls the air circuit to perform pressure relief and activates the audible and visual alarm module 605.
[0145] The audible and visual alarm module 605 is connected to the programmable mainboard 601 and is used to alert the user in the following abnormal situations: the airbag inflation pressure exceeds the set threshold; air leakage occurs in the air circuit, causing an abnormal drop in pressure; the inflation time exceeds the set duration; the equipment operating status is abnormal.
[0146] The aforementioned safety detection structure improves the safety of the device during long-term rehabilitation use.
[0147] The data storage module 606 is connected to the programmable motherboard 601 and is used to record the running data during a single rehabilitation process.
[0148] The specific records include: airbag inflation pressure change data; operating status of different working modes; switching time of the first air supply branch 4 and the second air supply branch 5; number of rehabilitation cycles; and abnormal alarm records.
[0149] After treatment, medical staff can use the data export function to obtain data on the patient's recovery process, and then adjust the subsequent rehabilitation plan according to the patient's recovery status.
[0150] In summary, this application controls the ankle-foot orthotic airbag group 2 and the lower leg three-segment sequential pressure airbag group 3 to operate in a staggered time sequence through the electronically controlled inflation and deflation host 6.
[0151] Specifically, in the orthopedic pressurization synchronous linkage mode, the programmable main board 601 first controls the operation of the second air supply branch 5.
[0152] Phase 1: The second air supply branch 5 supplies air to the three-segment sequential pressurization airbag group 3 of the lower leg.
[0153] The following sequence is followed: the distal ankle airbag 301 is inflated; the mid-calf airbag 302 is inflated; and the proximal knee airbag 303 is inflated.
[0154] During the sequential inflation of the three airbags, the pressure is continuously transmitted from the distal end to the proximal end of the lower leg due to the overlapping and covering structure between adjacent airbags.
[0155] After one sequential pressurization cycle is completed, the second air supply branch 5 is depressurized, allowing the lower leg area to recover.
[0156] Second stage: After the three-segment sequential compression airbag group 3 of the lower leg has finished depressurizing, the programmable main board 601 controls the first air supply branch 4 to start. The first air supply branch 4 supplies air to the ankle and foot orthotic airbag group 2, so that the medial foot limiting airbag 201 and the dorsiflexion airbag 202 are inflated. At this time, the medial foot limiting airbag 201 restricts the lateral posture of the foot, and the dorsiflexion airbag 202 generates dorsiflexion traction on the ankle joint, so that the patient's foot maintains the target functional position.
[0157] When the ankle-foot orthotic airbag assembly 2 reaches the set holding time, the first air supply branch 4 is depressurized, and then the device re-enters the next round of sequential lower leg pressurization cycle.
[0158] It should be noted that, based on the above-mentioned electronically controlled gas filling and discharging host 6 completing gas path control, pressure detection and peak-shifting timing control, this embodiment further uses the programmable mainboard 601 to pre-store multiple rehabilitation working modes to adapt to the treatment needs of different patients at different rehabilitation stages.
[0159] Specifically, the pre-stored working modes of the electronically controlled inflation and deflation unit 6 include: ankle-foot dynamic orthosis mode only; calf-leg sequential compression mode only; and orthosis compression synchronous linkage mode.
[0160] During use, medical staff can select the corresponding working mode by operating the electronically controlled inflation / deflation unit 6, based on the degree of ankle and foot deformity, the risk of lower limb thrombosis, and the stage of rehabilitation.
[0161] Ankle-foot dynamic orthopedic mode only: When patients mainly have ankle-foot postural abnormalities such as foot drop, foot abduction, and foot external rotation, but do not need calf compression therapy, they can choose the ankle-foot dynamic orthopedic mode only.
[0162] In this mode, the programmable mainboard 601 controls the second air supply branch 5 to shut down, so that the three-segment sequential pressure airbag assembly 3 for the lower leg does not participate in the operation.
[0163] At the same time, the programmable main board 601 controls the multi-channel two-position three-way solenoid reversing valve 603 to switch to the first air supply branch 4, so that the compressed air generated by the silent high-pressure air pump 602 enters the ankle and foot orthotic airbag group 2.
[0164] The specific working process is as follows: First, the first air supply branch 4 supplies air to the medial foot limiting airbag 201. As the internal pressure of the medial foot limiting airbag 201 increases, the airbag gradually expands and generates a flexible support force on the medial side of the patient's foot, which restricts the tendency of the foot to deviate outward. Subsequently, the first air supply branch 4 continues to supply air to the dorsum of the foot lifting airbag 202.
[0165] After the dorsiflexion airbag 202 is inflated, its arc-shaped structure fits the dorsiflexion area of the foot and exerts an upward lifting effect on the dorsiflexion, causing the ankle joint to gradually adjust in the dorsiflexion direction.
[0166] When the medial foot limiting airbag 201 and the dorsum foot lifting airbag 202 reach the preset pressure, the programmable main board 601 controls the first air supply branch 4 to maintain for a certain period of time, so that the ankle and foot are kept in the target orthopedic position.
[0167] After the set holding time is reached, the first air supply branch 4 is depressurized to restore some range of motion to the ankle and foot.
[0168] By repeating the above inflation, holding, and depressurization process, dynamic cyclical orthopedic correction of the ankle and foot joints can be achieved.
[0169] This model is suitable for patients with mild foot deformities, patients who need to gradually adapt to orthotic stimulation in the early stages of rehabilitation, and mainly patients with abnormal ankle and foot posture but low risk of deep vein thrombosis.
[0170] Sequential compression mode for calves only: When patients mainly have problems such as prolonged bed rest, reduced lower limb activity, or insufficient deep venous blood return, and the degree of ankle and foot deformity is relatively mild, the sequential compression mode for calves only can be selected.
[0171] In this mode, the programmable mainboard 601 controls the first air supply branch 4 to close, so that the ankle-foot orthotic airbag group 2 stops working. At the same time, it controls the second air supply branch 5 to open, so that the lower leg three-segment sequential pressure airbag group 3 performs cyclic pressure.
[0172] The specific work process is as follows:
[0173] First, the second air supply branch 5 supplies air to the distal ankle airbag 301. Since the distal ankle airbag 301 is located in the distal area of the lower leg, pressure is first applied to the lower leg tissue near the ankle joint. Then, the programmable main board 601 controls the second air supply branch 5 to continue supplying air to the mid-lower leg airbag 302.
[0174] Because there is an overlapping coverage area between the distal ankle airbag 301 and the mid-calf airbag 302, continuous pressure transmission can be formed between the two airbags. After that, the second air supply branch 5 continues to supply air to the proximal knee airbag 303.
[0175] At this time, the three airbags reach the working state in sequence, forming a pressure change process from the far end to the near end. After completing one full pressurization, the programmable main board 601 controls the second air supply branch 5 to depressurize, so that the three airbags are restored in sequence.
[0176] By continuously repeating the above cycle, the calf area undergoes a process similar to the contraction and relaxation of a human muscle pump, thereby promoting the flow of venous blood towards the proximal end.
[0177] This mode is suitable for patients who are bedridden for a long time, patients with decreased venous return in the lower extremities, and patients who need to prevent the risk of deep vein thrombosis.
[0178] Orthopedic compression synchronous linkage mode: When patients have both the risk of ankle and foot deformity and the risk of deep vein thrombosis, the orthopedic compression synchronous linkage mode can be selected.
[0179] In this mode, both the first gas supply branch 4 and the second gas supply branch 5 are in a controllable working state, but they do not continuously fill with gas at the same time. Instead, they alternately operate according to a preset time sequence under the control of the programmable main board 601.
[0180] Specifically, in the first stage, the programmable mainboard 601 controls the operation of the second air supply branch 5, which in turn drives the distal ankle airbag 301, the mid-calf airbag 302, and the proximal knee airbag 303 in sequence.
[0181] After the three airbags complete a sequential pressurization process from distal to proximal, the second air supply branch 5 is depressurized.
[0182] In the second stage, after the three-segment sequential pressure airbag group 3 of the lower leg has finished depressurizing, the programmable main board 601 controls the first air supply branch 4 to start. The first air supply branch 4 drives the medial foot limiting airbag 201 and the dorsum of the foot lifting airbag 202. The two airbags work together to keep the patient's foot in the preset orthopedic position.
[0183] In the third stage, after the ankle-foot orthotic airbag group 2 has been held for a set time, the first air supply branch 4 is depressurized, and then the device re-enters the next round of sequential lower leg pressurization cycle.
[0184] Since the ankle-foot orthotic airbag group 2 and the lower leg three-segment sequential compression airbag group 3 are not in a high-pressure state at the same time, the pressure superposition problem caused by the simultaneous operation of the two treatment functions in traditional technology is avoided.
[0185] During the operation of the above-mentioned orthopedic pressurization synchronous linkage mode, this embodiment further uses the programmable main board 601 to precisely control the operating sequence between the first air supply branch 4 and the second air supply branch 5, so that the ankle-foot orthopedic airbag group 2 and the lower leg three-segment sequential pressurization airbag group 3 form a non-simultaneous high pressure state.
[0186] Specifically, the programmable mainboard 601 has a pre-set peak-shaving control program, which includes air path switching logic, inflation maintenance logic, pressure relief control logic, and cyclic operation logic. When the patient selects the orthopedic pressurization synchronous linkage mode, the programmable mainboard 601 first controls the second air supply branch 5 to open, so that the three-segment sequential pressurization airbag group 3 of the lower leg performs a complete sequential pressurization process.
[0187] During this process, the silent high-pressure air pump 602 generates compressed air and switches to the second air supply branch 5 through the multi-channel two-position three-way solenoid reversing valve 603, so that the compressed air enters the distal ankle airbag 301, the mid-calf airbag 302 and the proximal knee airbag 303 in sequence.
[0188] The distal ankle-surface airbag 301 inflates first, applying circumferential pressure to the distal lower leg region. Subsequently, the mid-lower leg airbag 302 inflates, and in conjunction with the overlapping area of the distal ankle-surface airbag 301, the pressure application area moves proximally. Finally, the proximal knee-surface airbag 303 inflates, creating a pressure fluctuation that progresses from distal to proximal across the entire lower leg region.
[0189] Once all three airbags reach the set pressure, the programmable mainboard 601 controls the second air supply branch 5 to maintain a preset time, keeping the lower leg area under sequential pressure. After the set holding time is reached, the programmable mainboard 601 controls the multi-channel two-position three-way solenoid valve 603 to switch to the depressurization state, allowing the gas in the second air supply branch 5 to be discharged, and the distal ankle airbag 301, the mid-lower leg airbag 302, and the proximal knee airbag 303 sequentially return to their initial states.
[0190] After the second gas supply branch 5 has finished depressurizing, the programmable main board 601 detects and confirms that the second gas supply branch 5 is in a low-pressure state, and only then does it control the first gas supply branch 4 to start.
[0191] After the first air supply branch 4 is activated, compressed air enters the ankle-foot orthotic airbag group 2, causing the medial foot limiting airbag 201 and the dorsum of the foot lifting airbag 202 to inflate synchronously.
[0192] Among them, the medial foot limiting airbag 201 provides flexible restriction to the medial side of the patient's foot after inflation, so as to reduce the tendency of foot abduction and external rotation; the dorsiflexion airbag 202 forms an arc-shaped support along the dorsum of the foot after inflation, and generates an upward traction effect, so that the ankle joint is gradually adjusted to the target dorsiflexion functional position.
[0193] Once the ankle-foot orthotic airbag assembly 2 reaches the set pressure, the programmable mainboard 601 controls the first air supply branch 4 to maintain the orthotic position for a certain period of time, keeping the patient's ankle and foot in the orthotic state. After the set holding time is reached, the first air supply branch 4 depressurizes, allowing some movement space to be restored to the ankle and foot area.
[0194] After completing the above process, the programmable mainboard 601 controls the second air supply branch 5 to start again, entering the next round of calf sequential pressurization cycle.
[0195] Through the above control method, the ankle-foot orthotic airbag group 2 and the lower leg three-segment sequential pressure airbag group 3 operate alternately throughout the treatment process, without the two functional modules being under high pressure at the same time. This avoids the superposition of ankle-foot orthotic pressure and lower leg pressure on the patient's limb, thus improving the comfort during the treatment process.
[0196] Furthermore, to accommodate the differences in the conditions of different patients, the electrically controlled inflation / deflation unit 6 in this embodiment can also be configured with personalized parameters based on patient information.
[0197] Specifically, medical staff can select the corresponding rehabilitation program on the electrically controlled inflation / deflation unit 6 based on the patient's ankle joint range of motion, degree of foot deformity, muscle tone, bed rest time, and deep vein thrombosis risk level.
[0198] For patients with mild foot deformities and a low risk of thrombosis, a dynamic ankle-foot orthosis modality can be used.
[0199] In this mode, the programmable mainboard 601 shuts down the second air supply branch 5 and only controls the first air supply branch 4 to work, so that the ankle-foot orthotic airbag assembly 2 will inflate and depressurize according to the set cycle.
[0200] During treatment, the medial foot limiting airbag 201 and the dorsolateral foot lifting airbag 202 periodically generate flexible orthopedic forces, allowing the patient's ankle and foot to gradually adapt to the target functional position.
[0201] For patients who are bedridden for a long time, have reduced lower limb activity, but have mild ankle and foot deformities, a sequential compression pattern on the lower leg alone can be used.
[0202] In this mode, the programmable mainboard 601 shuts down the first air supply branch 4 and only controls the second air supply branch 5 to work, so that the distal ankle airbag 301, the mid-calf airbag 302, and the proximal knee airbag 303 are inflated sequentially from distal to proximal.
[0203] Because the three airbags use an overlapping covering structure, the problem of obvious pressure intervals between traditional segmented airbags can be avoided, so that a continuous pressure transmission effect is formed in the calf area, which improves the venous return promotion effect.
[0204] For patients with both ankle-foot deformities and deep vein thrombosis risk, a simultaneous orthotic compression and linkage mode is adopted.
[0205] In this mode, the programmable motherboard 601 adjusts the number of sequential compressions on the lower leg, the duration of ankle-foot orthosis, and the inflation pressure according to the patient's risk level.
[0206] For example, for patients with severe foot deformities and a high risk of thrombosis, a higher frequency of sequential compression on the lower leg can be set, and the holding time of the ankle-foot orthotic airbag group 2 can be extended, so that the device can simultaneously meet the needs of promoting venous circulation and adjusting ankle-foot posture.
[0207] Furthermore, the electrically controlled inflation / deflation host 6 in this embodiment also has a safety monitoring function.
[0208] Specifically, during the operation of the device, the high-precision pressure sensor 604 continuously detects the pressure changes in the first air supply branch 4 and the second air supply branch 5, and transmits the collected data to the programmable mainboard 601 in real time.
[0209] When the airbag pressure is detected to reach the preset value, the programmable mainboard 601 controls the silent high-pressure air pump 602 to stop supplying air in order to avoid the air pressure from continuing to rise.
[0210] When the air pressure is detected to exceed the safety threshold, the programmable main board 601 controls the multi-channel two-position three-way solenoid valve 603 to enter the pressure relief state, so that the corresponding airbag can be quickly restored.
[0211] When an abnormal rate of pressure drop is detected, the programmable mainboard 601 determines that there may be a loose air tube or air leakage in the airbag, and activates the audible and visual alarm module 605 to remind medical staff to check.
[0212] In addition, when the quick-connect air pipe connector 7 is accidentally disconnected, the electronically controlled air filling and discharging host 6 can detect sudden changes in air pressure and automatically stop the operation of the silent high-pressure air pump 602 to avoid abnormalities caused by continuous air supply.
[0213] Furthermore, the data storage module 606 in this embodiment can record the operating parameters of each patient's rehabilitation process.
[0214] Specifically, the data storage module 606 can record: treatment start time; treatment end time; the working mode used; the switching time between the first air supply branch 4 and the second air supply branch 5; the maximum pressure value reached by each airbag; the pressure holding time; the number of cycles; and abnormal alarm information.
[0215] Medical staff can analyze the patient's recovery process based on the data stored in the data storage module 606, and adjust the rehabilitation parameters for the next stage according to the patient's recovery status.
[0216] Furthermore, in other embodiments, the number of the three-segment sequential compression airbag group 3 for the lower leg is not limited to three airbags.
[0217] For example, depending on the length of the lower leg and the treatment needs of different patients, the three-segment sequential compression airbag group 3 for the lower leg can be expanded into a four-segment airbag structure or a more segmented airbag structure.
[0218] In this embodiment, each airbag is still arranged sequentially from the distal end to the proximal end along the length of the lower leg, and is controlled by the second air supply branch 5 in a manner that prioritizes the distal end and proceeds to the proximal end, so as to achieve a continuous pressure transmission effect.
[0219] Furthermore, in other embodiments, the number of the medial foot limiting airbag 201 and the dorsum foot lifting airbag 202 in the ankle-foot orthotic airbag group 2 can also be adjusted according to the patient's foot shape.
[0220] For example, lateral foot support airbags or ankle support airbags can be added to further enhance the adaptability to different types of ankle and foot deformities.
[0221] Furthermore, in other embodiments, the flexible wearable sleeve 1 can be made of flexible fabrics, elastic composite materials or medical breathable polymer materials with different elasticities to suit patients of different body types.
[0222] Meanwhile, the removable medical breathable cushioning pad 9 can also be replaced according to the patient's skin sensitivity to improve hygiene and comfort during long-term treatment.
[0223] In summary, the segmented airbag staggered timing ankle and foot orthosis and calf compression device provided in this embodiment integrates the ankle and foot orthosis structure and the calf compression structure through the flexible wearable sleeve 1, achieves independent air supply control for the two functional modules through the first air supply branch 4 and the second air supply branch 5, and achieves precise staggered timing control through the programmable main board 601, the multi-channel two-position three-way electromagnetic reversing valve 603 and the high-precision pressure sensor 604 in the electronically controlled inflation and deflation host 6.
[0224] This device can not only improve postural abnormalities such as foot drop, foot abduction, and foot external rotation in hemiplegic patients by using the ankle-foot orthotic airbag group 2, but also promote venous return in the lower limbs by using the three-segment sequential pressure airbag group 3 of the lower leg. At the same time, it avoids the pressure superposition problem caused by the traditional synchronous pressure method, and achieves coordinated, safe and efficient operation between ankle-foot orthosis and thrombosis prevention functions.
[0225] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.
Claims
1. A segmented airbag staggered timing ankle-foot orthosis and calf compression device, characterized in that, include: The flexible wearable sleeve (1) has an integral molded structure, which is divided into a lower leg wrapping section, an ankle joint wrapping section and a full foot wrapping section from top to bottom; A multi-zone airbag module is mounted on the flexible wearable sleeve (1), which includes an ankle-foot orthotic airbag group (2) and a three-segment sequential pressure airbag group (3) for the lower leg. An independent air supply circuit is provided on the flexible wearable sleeve (1), including a first air supply branch (4) and a second air supply branch (5). The first air supply branch (4) is connected to the ankle and foot orthotic airbag group (2), and the second air supply branch (5) is connected to the lower leg three-segment sequential pressure airbag group (3). An electrically controlled inflation / deflation unit (6) is connected to one end of the independent air supply circuit and is used to control the alternating inflation / deflation of the first air supply branch (4) and the second air supply branch (5) so that the inflation period of the ankle-foot orthotic airbag group (2) is completely staggered from the inflation period of the lower leg three-segment sequential pressure airbag group (3).
2. The segmented airbag staggered timing ankle-foot orthosis and calf compression device according to claim 1, characterized in that, The three-segment sequential compression airbag assembly (3) for the lower leg includes: The distal supra-ankle airbag (301) is positioned distally along the longitudinal direction of the lower leg; The mid-calf airbag (302) is set longitudinally along the mid-calf. The proximal infrakal airbag (303) is positioned proximally along the longitudinal direction of the lower leg. The upper edge of the distal ankle airbag (301) extends upward and overlaps the lower edge of the mid-calf airbag (302), and the upper edge of the mid-calf airbag (302) extends upward and overlaps the lower edge of the proximal knee airbag (303); the distal ankle airbag (301), the mid-calf airbag (302) and the proximal knee airbag (303) are all connected to the second air supply branch (5).
3. The segmented airbag staggered timing ankle-foot orthosis and calf compression device according to claim 1, characterized in that, The ankle-foot orthotic airbag assembly (2) includes: The medial foot limiting airbag (201) is fitted to the inner edge of the foot and is used to restrain the foot inward when inflated to correct abduction and external rotation deformity. The dorsiflexion airbag (202) is an arc-shaped airbag covering the dorsiflexion area of the foot, used to pull upwards when inflated to maintain the dorsiflexion function of the ankle joint; Both the medial foot limiting airbag (201) and the dorsal foot lifting airbag (202) are connected to the first air supply branch (4).
4. The segmented airbag staggered timing ankle-foot orthosis and calf compression device according to claim 1, characterized in that, The electronically controlled inflation / deflation unit (6) includes: The programmable mainboard (601) is used to pre-store the working mode; A silent high-pressure air pump (602) is connected to the programmable mainboard (601); A multi-channel two-position three-way electromagnetic reversing valve (603) is installed between the silent high-pressure air pump (602) and the independent air supply circuit for switching air circuits; A high-precision pressure sensor (604) is installed on the independent gas supply line to monitor the gas pressure; The programmable mainboard (601) is configured to control the first air supply branch (4) and the second air supply branch (5) to alternately inflate and deflate, so that the inflation period of the ankle-foot orthotic airbag group (2) is completely staggered from the inflation period of the lower leg three-segment sequential pressure airbag group (3).
5. The segmented airbag staggered timing ankle-foot orthosis and calf compression device according to claim 4, characterized in that, The electronically controlled inflation / deflation unit (6) also includes: An audible and visual alarm module (605) is connected to the programmable mainboard (601) and is used to trigger an alarm when the air pressure is abnormal. The data storage module (606) is connected to the programmable motherboard (601) and is used to store the air pressure and working mode operation data of a single rehabilitation session, and supports data export.
6. The segmented airbag staggered timing ankle-foot orthosis and calf compression device according to claim 1, characterized in that, The independent gas supply circuit also includes: Quick-connect gas pipe connectors (7) are respectively installed at the ends of the first gas supply branch (4) and the second gas supply branch (5); The quick-plug air tube connector (7) is a one-click separation structure used to connect the flexible wearable sleeve (1) and the electronically controlled inflation / deflation host (6).
7. The segmented airbag staggered timing ankle-foot orthosis and calf compression device according to claim 1, characterized in that, The flexible wearable sleeve (1) also includes: Velcro straps (8) are provided on the outside of the flexible wear sleeve (1) for adjusting tightness; A removable medical breathable cushioning pad (9) is disposed on the inner wall of the flexible wearable sleeve (1); A thickened silicone cushioning layer is placed on the heel, inner and outer ankles and dorsum of the foot of the removable medical breathable cushioning pad (9).
8. The segmented airbag staggered timing ankle-foot orthosis and calf compression device according to claim 1, characterized in that, The pre-stored operating modes of the electronically controlled inflation / deflation unit (6) include: In the ankle-foot dynamic orthopedic mode only, the second air supply branch (5) is closed, and the first air supply branch (4) is controlled to drive the ankle-foot orthopedic airbag group (2) to intermittently circulate inflation and deflation. In the calf-only sequential pressurization mode, the first air supply branch (4) is closed, and the second air supply branch (5) is controlled to drive the calf three-segment sequential pressurization airbag group (3) to inflate in sequence according to the order of distal ankle airbag (301), calf mid-section airbag (302), and proximal knee airbag (303). In the orthopedic pressurization synchronous linkage mode, the first gas supply branch (4) and the second gas supply branch (5) are opened at the same time, and the staggered and alternating timing operation is adopted.
9. A segmented airbag staggered timing ankle-foot orthosis and calf compression method, which refers to the segmented airbag staggered timing ankle-foot orthosis and calf compression device according to any one of claims 1-8, characterized in that, Includes the following steps: S1. Wearing and self-testing steps: Place the hemiplegic lower limb into the flexible wear sleeve (1), connect the air tube to the electronically controlled inflation and deflation host (6), and start the whole machine self-test; S2. Risk grading and calibration steps: Based on the patient's ankle joint deformity, bed rest duration, lower limb muscle strength and deep vein thrombosis risk score, match the corresponding standardized rehabilitation program and load the initial air pressure and time sequence parameters. S3, Sub-mode rehabilitation cycle execution steps: Select the corresponding working mode and control the electronically controlled inflation / deflation host (6) to execute the inflation / deflation cycle; S4. Phased Rehabilitation Progression Steps: Divide each rehabilitation session into an adaptation period, a collaborative intervention period, and a maintenance and consolidation period, and gradually adjust the air pressure. S5. Shutdown, disassembly and disinfection steps: After a single rehabilitation session, the equipment will automatically depressurize and shut down. Disconnect the air duct and remove the flexible wearable sleeve (1) for cleaning and disinfection.
10. The segmented airbag staggered timing ankle-foot orthotics and calf compression method according to claim 9, characterized in that, The standardized rehabilitation program in step S2 includes three sets, which are respectively adapted to three categories of patients: those with mild foot deformity and low thrombosis risk, those with moderate foot deformity and medium thrombosis risk, and those with severe foot deformity and high thrombosis risk. In step S3, for patients with severe foot deformities and high risk of thrombosis, a synchronous linkage mode is adopted, with an inflation pressure of 30-40 kPa, a total duration of single-wheel pressure on the lower leg of 12 seconds, and an ankle-foot correction maintenance duration of 20-30 seconds. For patients with mild foot deformities and low risk of thrombosis, a dynamic ankle-foot orthosis mode is used with an inflation pressure of 20–30 kPa.