Intelligent neck collar based on 4D printing, working method and preparation method

Abstract

The invention is suitable for the technical field of medical rehabilitation instruments, and provides an intelligent neck collar based on 4D printing, a working method and a preparation method. The intelligent neck collar comprises a neck collar body, an inflatable component, an inflation source, a motion sensor and a controller. At least a portion of the collar body includes a shape-adaptive 4D printed material that can change shape under a preset stimulus to conform to a user's contour. The controller obtains and analyzes motion data monitored by the motion sensor, controls the inflation source to inflate the inflatable component to limit neck motion when dangerous motion conditions are recognized, and controls the inflatable component to deflate after danger is removed. The invention further discloses a working method and a preparation method of the neck collar. According to the intelligent neck collar, personalized comfortable fitting and real-time active protection can be taken into consideration, the problems that in the prior art, a neck collar is poor in comfort and only can achieve passive protection are solved, and the wearing safety and comfort are remarkably improved.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of medical rehabilitation equipment, and particularly relates to an intelligent cervical collar based on 4D printing, a working method and a preparation method. BACKGROUND

[0002] A cervical collar is an important external fixation brace for neck injury rehabilitation and daily protection. The existing traditional cervical collars are mostly rigid or semi-rigid structures, and their sizes and shapes are standardized, which cannot perfectly fit the physiological curves of different users. Long-term wearing of the cervical collars can cause pressure points at the mandible, clavicle and other parts, resulting in poor comfort and poor air permeability, and seriously affecting the wearing compliance of the users. In addition, the traditional cervical collars can only provide static and passive physical support, and their protection ability is constant, and they cannot respond to the real-time motion state of the user. When the user encounters sudden and violent dangerous actions, such as falling or whip-lash injury caused by vehicle jolt, the passive support is often insufficient to provide immediate and effective active protection, and the neck still has the risk of secondary injury beyond the safe range.

[0003] To solve the above problems, some intelligent cervical collars integrating sensing and driving devices appear in the prior art. For example, a cervical vertebra rehabilitation training device is disclosed, which includes a cervical collar body, an air bag, a sensing test unit and a control unit. However, the purpose of this scheme is to drive the air bag according to a preset treatment scheme to perform traction, rotation and other rehabilitation training actions, and the control logic is a program-driven treatment mode. This scheme does not solve the technical problem of how to provide active and rapid physical restriction in a sudden dangerous situation, and lacks the ability to provide real-time protection for unpredictable dangerous events. SUMMARY

[0004] The embodiments of the present application provide an intelligent cervical collar based on 4D printing, a working method and a preparation method, aiming to solve the problems of poor comfort of the cervical collar in the prior art, only passive static fixation, and lack of ability to provide real-time protection for unpredictable dangerous events.

[0005] In a first aspect, the embodiments of the present application provide an electric power signal association method, comprising:

[0006] A cervical collar body configured to provide support around the neck of a user;

[0007] At least a portion of the cervical collar body comprises a shape-adaptive 4D printing material configured to change shape when subjected to a predetermined stimulus to fit the body contour of the user;

[0008] An inflatable member (4) provided on the cervical collar body, and an inflation source (7) in fluid communication with the inflatable member (4);

[0009] a motion sensor (5) disposed on the neck support body, configured to monitor the motion data of the user's neck in real time;

[0010] a controller (6) connected with the motion sensor (5) and the inflation source (7); the controller (6) is configured to: acquire and analyze the motion data monitored by the motion sensor (5), control the inflation source (7) to inflate the inflatable member (4) to limit the motion of the user's neck when the motion data is identified to meet the preset dangerous motion condition, and control the inflatable member (4) to deflate to release the limitation on the motion of the user's neck after the dangerous motion condition is removed.

[0011] In a possible implementation manner of the first aspect, the shape-adaptive 4D printing material is a thermally responsive shape memory polymer, and the preset stimulus is human body temperature.

[0012] When the intelligent neck support is worn on the human body, the neck support body changes in shape adaptively under the stimulus of the human body temperature to fit the body contour of the user.

[0013] In a possible implementation manner of the first aspect, the neck support body includes a front support body (1) and a rear support body (2), and the front support body (1) and the rear support body (2) are detachably connected through a buckle connection structure (3); the buckle connection structure (3) is provided with an adjustment gear.

[0014] In a possible implementation manner of the first aspect, the buckle connection structure (3) includes a serpentine bionic hinge (31) disposed at the end of the rear support body (2), which is made of the thermally responsive shape memory polymer; the buckle connection structure (3) is internally integrated with a flexible channel (33) for connecting an air path.

[0015] In a possible implementation manner of the first aspect, the wall structure of the front support body (1) and / or the rear support body (2) is a multi-layer topological structure formed by using 4D printing technology, and at least includes a contact layer (101) in contact with the skin, a structural layer (102), and a functionally integrated layer (103); the inner side surface of the contact layer (101) has a porous lattice structure; the structural layer (102) is internally provided with a reinforcing rib structure for providing mechanical strength; the functionally integrated layer (103) is internally pre-embedded with a cavity for accommodating the inflatable member (4).

[0016] In a possible implementation manner of the first aspect, the controller (6) is configured to determine the flexion, lateral bending, and rotation angles of the neck based on the motion data, and compare the motion data with a preset safe motion mode to identify and determine whether the motion data meets the dangerous motion condition.

[0017] In a possible implementation manner of the first aspect, the controller (6) is configured to learn and adapt to a daily activity mode of a user to distinguish normal motion from dangerous motion.

[0018] In a possible implementation manner of the first aspect, the inflatable member (4) comprises a plurality of independently controlled air bag units; the motion sensor (5) comprises a plurality of sensor units, and the plurality of sensor units are arranged at positions corresponding to the plurality of air bag units.

[0019] The controller (6) is configured to, when a target sensor unit of the plurality of sensor units identifies that the motion data satisfies a preset dangerous motion condition, determine the arrangement position of the target sensor unit, and start the inflation source (7) to inflate an air bag unit corresponding to the arrangement position of the target sensor unit.

[0020] In the second aspect, an embodiment of the present application provides a working method of an intelligent cervical collar, comprising:

[0021] The motion data of the neck of a user is continuously monitored through a motion sensor (5) arranged on the cervical collar body.

[0022] The motion data is analyzed in real time through a controller (6) to determine whether a preset dangerous motion condition is satisfied.

[0023] When it is determined that the dangerous motion condition is satisfied, an inflation source (7) is controlled to inflate an inflatable member (4) arranged on the cervical collar body, so as to limit the motion of the neck of the user through the expansion of the inflatable member (4).

[0024] When the dangerous motion condition is removed, the inflatable member (4) is controlled to deflate, so as to remove the limitation on the motion of the neck of the user.

[0025] In the third aspect, an embodiment of the present application provides a preparation method of an intelligent cervical collar, comprising:

[0026] The cervical collar body is prepared by one-piece molding or assembly after separate printing through 4D printing technology and shape-adaptive 4D printing material, and a cavity for accommodating an inflatable member (4), a controller (6) and an inflation source (7) is formed in the cervical collar body.

[0027] The inflatable member (4), the motion sensor (5), the controller (6) and the inflation source (7) are assembled into the cervical collar body to obtain the intelligent cervical collar.

[0028] Compared with the prior art, the embodiment of the present application has the following beneficial effects:

[0029] The application constructs a closed-loop control logic of perception-decision-execution through a motion sensor, a controller and an inflatable member, can instantaneously trigger the inflation of the inflatable member when detecting dangerous motion, apply physical restriction, change passive fixation to active dynamic protection, greatly improve the safety of the wearer in unexpected situations. In addition, the application uses 4D printed shape adaptive material, under the preset stimulus of human body temperature, etc., makes the cervical collar automatically and accurately fit the individual physiological profile of the user, eliminates the pressure points, significantly improves the comfort and air permeability of wearing. BRIEF DESCRIPTION OF DRAWINGS

[0030] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings needed to be used in the embodiments or prior art description will be briefly introduced. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative labor.

[0031] Figure 1 The system hardware architecture schematic diagram of the intelligent cervical collar provided by the embodiments of the present application is shown in the figure.

[0032] Figure 2 The overall structure schematic diagram of the intelligent cervical collar provided by the embodiments of the present application is shown in the figure.

[0033] Figure 3 The flow chart of the active protection working method provided by the embodiments of the present application is shown in the figure.

[0034] Figure 4 The cross-sectional schematic diagram of the multi-layer topology structure of the cervical collar wall provided by the embodiments of the present application is shown in the figure.

[0035] Figure 5 The precise partition protection layout schematic diagram provided by the embodiments of the present application is shown in the figure.

[0036] Figure 6 The active protection signaling interaction timing diagram provided by the embodiments of the present application is shown in the figure.

[0037] Figure 7 The modular control bin structure schematic diagram provided by the embodiments of the present application is shown in the figure.

[0038] Explanation of reference signs

[0039] Front body 1; rear body 2; snap connection structure 3; inflatable member 4; inflatable member units 4a, 4b, 4c; motion sensor 5; motion sensor units 5a, 5b, 5c; controller 6; inflation source 7; control compartment 9; plug interface 9a; serpentine biomimetic hinge 31; flexible channel 33; perception and execution terminal 100; contact layer 101; porous lattice structure 101a; structure layer 102; reinforcing rib 102a; function integration layer 103; cavity 103a; control terminal 200; cloud platform 300. DETAILED DESCRIPTION

[0040] In the following description, for purposes of explanation and not limitation, specific details are set forth, such as particular system configurations, techniques, etc., in order to provide a thorough understanding of the embodiments of the present application. However, it will be apparent to those skilled in the art that the present application can be practiced in other embodiments that depart from these specific details. In other instances, detailed descriptions of well-known methods, devices, circuits, and

[0041] It will be understood that the term "includes," "including," "has," "having," "comprises," "comprising" or "contains," "containing" when used in this specification and in the following claims, specifies the presence of the stated features, integers, steps, operations, elements, and / or components but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0042] It will be understood that the term "and / or," when used in this specification and in the following claims, can encompass the meaning of "and" and / or the meaning of "or." Similarly, the term "and / or" when used in the context of the following clauses can encompass the meaning of "and" and / or the meaning of "or."

[0043] As used in this specification and claims, the terms "if" and "when" can be interpreted to mean "upon" or "in response to a determination" or "in response to a detection" depending on the context. Similarly, the phrase "if determined" or "if detected [a described condition or event]" can be interpreted to mean "upon determining" or "in response to determining" or "upon detecting [a described condition or event]" or "in response to detecting [a described condition or event]" depending on the context.

[0044] In addition, the terms "first," "second," "third," etc. are used herein only to describe different instances of elements, and are not intended to imply or create an ordinality between elements.

[0045] References to "one embodiment" or "some embodiments" as described in this specification mean that one or more embodiments of this application include a specific feature, structure, or characteristic described in connection with that embodiment. Therefore, the phrases "in one embodiment," "in some embodiments," "in other embodiments," "in still other embodiments," etc., appearing in different parts of this specification do not necessarily refer to the same embodiment, but rather mean "one or more, but not all, embodiments," unless otherwise specifically emphasized. The terms "comprising," "including," "having," and variations thereof mean "including but not limited to," unless otherwise specifically emphasized.

[0046] Example 1

[0047] This application provides a 4D-printed smart neck brace, aiming to solve the technical problems of existing neck braces, such as poor comfort, inability to accurately conform to individual physiological curves, and the inability to provide only passive static fixation without the ability to actively intervene in the event of an accident. The technical solution of this embodiment lies in using 4D-printed shape-adaptive materials to achieve a personalized and comfortable fit for the neck brace, and constructing a closed-loop control system of perception-decision-execution through integrated sensing, control, and execution units, thereby realizing the transformation from passive support to active protection.

[0048] Figure 1 This is a schematic diagram of the system hardware architecture of the smart neck brace provided in an embodiment of this application. Figure 1 As shown, the system can be logically divided into a sensing and execution terminal 100, a control terminal 200, and a cloud platform 300. The three work together to form a complete ecosystem for data acquisition, analysis, execution, and management.

[0049] Among them, the perception and execution terminal 100 is the equipment body of the intelligent cervical collar, which is the core of realizing all physical functions. Its internal highly integrates multiple functional modules, including a sensing module (its core is a motion sensor 5) for collecting neck movement state, a main control module (its core is a controller 6) as a system main control unit, a pneumatic execution module (which includes an inflatable member 4 and an inflation source 7) for executing physical intervention, and a local communication module for communicating with external devices. Specifically, the motion sensor 5 can be a high-precision nine-axis or six-axis inertial measurement unit (IMU) that can simultaneously measure three-axis angular velocity, three-axis acceleration, and optionally contain a three-axis magnetometer for heading calibration, thereby comprehensively capturing the dynamic and static posture of the neck. The controller 6 can be a low-power microcontroller unit (MCU) or system on chip (SoC) with sufficient computing power to run real-time posture solving and danger recognition algorithms. The inflation source 7 can be composed of a micro-pump and a solenoid valve for repeated inflation and deflation; as another optional high-speed implementation, it can also be a one-time or replaceable micro high-pressure gas cylinder (such as a CO2 cylinder) triggered by the controller to provide explosive inflation capacity in a shorter time. The entire perception and execution terminal 100 is powered by an internal rechargeable battery (such as a lithium-ion battery).

[0050] The control terminal 200 can be a portable smart device such as a smartphone, tablet computer, or smartwatch installed with a specific application (App). It serves as the main interface for user interaction with the cervical collar, allowing users to view the real-time status of the cervical collar (such as battery level, connection status), review historical intervention events, adjust the sensitivity threshold of active protection, receive system alerts, and perform firmware upgrades, etc.

[0051] As an optional implementation, the cloud platform 300 can be a remote server cluster connected to the control terminal 200 through the Internet. The cloud platform 300 not only stores users' health data and intervention event records securely and for a long time, but more importantly, it can analyze anonymized data collected from numerous users using big data and cloud computing capabilities to optimize the danger movement recognition algorithm. In addition, it can also provide a remote monitoring portal for authorized doctors or therapists, allowing them to view patients' wearing conditions, activity data, and rehabilitation progress, thereby providing more accurate remote guidance.

[0052] On the communication link, the perception and execution terminal 100 establishes a connection with the control terminal 200 through low-power wireless communication technology (such as Bluetooth Low Energy, BLE) to ensure low energy consumption and stable data transmission. The control terminal 200 then synchronizes data with the cloud platform 300 through a mobile network (such as 4G / 5G) or a wireless local area network (Wi-Fi).

[0053] Figure 2 The overall structure of the intelligent cervical collar provided in the embodiments of the present application is shown in the figure. As shown in the figure, the intelligent cervical collar comprises a cervical collar body composed of a front body 1 and a rear body 2. Specifically, the front body 1 mainly supports the lower jaw and the front neck of the user, and its shape is optimized by ergonomics to avoid improper compression on the trachea and carotid artery. The rear body 2 supports the back of the user's neck and the occiput, providing stable backward support for the cervical vertebrae. In order to facilitate the user to wear and take off, the front body 1 and the rear body 2 are detachably connected through a buckle connection structure 3. As a preferred implementation, the buckle connection structure 3 is provided with a plurality of adjustment gears (not shown in the figure), for example, through a ratchet and pawl structure or a series of clamping grooves and clamping pins, allowing the user to select the most suitable locking position in several preset positions according to the neck circumference of the user, to achieve preliminary and macroscopic size adaptation. Figure 2

[0054] In order to further improve the wearing convenience and structural integration, in one embodiment of the present application, the buckle connection structure 3 is specially designed. Specifically, as shown in the figure, the buckle connection structure 3 comprises a serpentine bionic hinge 31 arranged at the end of the rear body 2. The design inspiration of the serpentine bionic hinge 31 comes from the vertebrae of a snake, and its structure allows a large degree of flexible bending in one plane (i.e. the buckling plane), while maintaining high rigidity in other directions. The hinge is integrally formed with the same thermally responsive shape memory polymer material as the cervical collar body by using 4D printing technology. At room temperature, it has a certain rigidity to ensure the stability of the connection; and during wearing, its unique flexible structure design allows the user to easily bend it to complete the buckling or unfastening action, with smooth operation, simplifying the operation. In addition, the inside of the buckle connection structure 3 is also integrally formed with a flexible channel 33 by 4D printing technology. The flexible channel 33, as part of the internal air path, is used to fluidly connect the inflation source 7 arranged in the rear body 2 with the inflatable member 4 arranged in the front body 1. By seamlessly integrating the air path channel inside the connection structure, the exposure of the external pipeline is completely avoided, not only making the appearance of the cervical collar more simple and beautiful, but also fundamentally reducing the risk of damage or leakage of the external pipeline due to pulling, folding and wear, significantly improving the durability and reliability of the product. Figure 2

[0055] ​​To solve the problem of poor wearing comfort of traditional cervical collar, in the embodiment, at least a part of the cervical collar body (optionally, the whole front body 1 and the back body 2) is made of a shape-adaptive 4D printing material. In the embodiment, the material can be a kind of thermally responsive shape memory polymer (SMP), such as polyurethane-based or epoxy resin-based SMP. The material can memorize a preset permanent shape, which is the ideal fitting contour obtained by computer-aided design after three-dimensional scanning of the neck of a specific user. After the cervical collar is manufactured, it is set to a temporary, easy-to-wear shape through a programming process (i.e., heated to above the glass transition temperature Tg, deformed to a temporary shape, and then cooled to below Tg to lock). In the present application, the preset stimulus is the body temperature of the human body. Specifically, the glass transition temperature Tg of the shape memory polymer can be accurately designed near the body temperature of the human body, for example, in the range of 35-40 degrees Celsius. When the user wears the cervical collar in the room temperature temporary shape (which is usually slightly larger than the target contour, leaving a wearing gap) on the neck, the temperature of the cervical collar material gradually rises due to the heat emitted by the human skin. Once the temperature exceeds Tg, the molecular chains of the material have sufficient activity, and the strain energy stored in the material is released, thereby driving the cervical collar body to change its macro shape. Thus, the inner wall of the cervical collar can slowly, gently and accurately shrink and fit onto the unique physiological curve of the user's mandible, neck and acromioclavicular region within a few minutes, forming a nearly perfect personalized support surface. This adaptive fitting process can eliminate the local high pressure points caused by the shape mismatch of traditional cervical collars, and evenly distribute the support pressure on the entire contact surface, thereby greatly improving the comfort of long-term wearing, and improving the support effect and air permeability due to the perfect fitting.

[0056] To realize the active protection function, a complete sensing-control-execution system is integrated on the cervical collar body. As shown in Figure 2 A inflatable member 4 is provided on the cervical collar body, which can be one or more flat airbags embedded in the inner side of the front body 1 in the embodiment, made of flexible, wear-resistant and airtight materials such as thermoplastic polyurethane (TPU), located between the inner wall of the cervical collar and the user's neck. A source of inflation 7 (e.g., a pneumatic unit composed of a micro-pump and a solenoid valve) is integrated in the back body 2, and is in fluid communication with the inflatable member 4 through the aforementioned flexible channel 33. A motion sensor 5 (in the embodiment, specifically a high-precision inertial measurement unit capable of measuring three-axis angular velocity and three-axis acceleration at the same time) is also provided on the back body 2, and its position is carefully selected (e.g., near the spinous process of the seventh cervical vertebra) to most accurately reflect the overall motion posture of the user's head and neck. A controller 6 (usually a low-power microcontroller unit) is also integrated in the back body 2. The controller 6 is electrically connected to the motion sensor 5 and the source of inflation 7 through internal circuits, forming a control path.

[0057] The following will combine Figure 3 The flowchart of the working method shown is Figure 6 The signaling interaction timing diagram shown below provides a detailed explanation of the active protection working principle of the smart neck brace in this embodiment.

[0058] In step S1 (system initialization and adaptive fit), the user wears the neck brace. As previously described, the neck brace body automatically adapts its shape to fit the user's body contours in response to body temperature, achieving a comfortable daily support state. Upon first wear, the user may be prompted to perform a simple calibration via the control terminal 200 application, such as keeping their head facing forward for several seconds to establish a baseline zero posture.

[0059] Next, the system enters a continuous monitoring cycle, namely step S2 (real-time data acquisition). Motion sensor 5 operates continuously at a preset sampling frequency (e.g., 100 Hz, sufficient to capture the dynamic characteristics of rapid impact events such as whiplash injuries in vehicle collisions), capturing real-time motion data of the user's neck. This includes raw data on angular velocity and linear acceleration along the X, Y, and Z axes, which is continuously transmitted to controller 6 via the internal bus.

[0060] In step S3 (hazard signal recognition), controller 6 analyzes and processes the received motion data in real time. Controller 6 internally runs a preset hazard recognition algorithm. Specifically, controller 6 first uses data fusion algorithms such as Kalman filtering or complementary filtering to fuse angular velocity and acceleration data to calculate the neck's attitude angles (such as flexion-extension angle, lateral bending angle, and rotation angle) in three-dimensional space in real time and accurately. Then, controller 6 compares the calculated real-time attitude angles, angular velocities, angular acceleration, and other key dynamic parameters with a preset, multi-dimensional safe motion pattern. This safe motion pattern defines a safety envelope, which includes a series of thresholds, such as the maximum permissible forward flexion angular velocity, the maximum permissible lateral acceleration, and the time-series characteristics of a specific injury pattern. When controller 6 detects any one or more motion data points changing drastically in a very short time and exceeding this safety envelope (for example, when detecting the characteristic pattern of whiplash injury caused by a simulated rear-end collision: a sharp backward acceleration peak followed by a rapid forward angular velocity peak), controller 6 determines that the current motion data meets the preset hazardous motion conditions.

[0061] After identifying the danger signal (corresponding to) Figure 3 If the branch is in the middle, the system immediately proceeds to step S4 (execute active protection). Figure 6As shown in the timing diagram, after making a decision (the decision delay is typically on the order of microseconds), the controller 6 immediately sends a drive command to the inflation source 7 via the control signal line. In this embodiment, the command triggers the micro-pump in the inflation source 7 to start and open the corresponding valve (or triggers the release valve of the high-pressure gas cylinder). High-pressure gas is injected into the inflatable component 4 through the internal air passage within a very short preset time (e.g., the entire response time from hazard identification to inflation completion is less than 100 milliseconds, which is much faster than the human's autonomous reaction time and is crucial for intervention before injury occurs). The inflatable component 4 expands rapidly, its volume increasing dramatically, thereby filling the reserved gap between the inner wall of the neck brace and the user's neck skin. The expanded inflatable component 4 forms a strong yet flexible physical barrier, providing instantaneous, all-around rigid support for the neck, thereby effectively limiting the excessive range of motion of the neck in the dangerous direction (such as excessive flexion, extension, lateral flexion, or torsion) to prevent secondary damage to ligaments, muscles, and even the spinal cord caused by joint hyperextension or hyperflexion.

[0062] After performing the protective action, the system proceeds to step S5 (risk deactivation judgment). The controller 6 does not immediately deactivate the protection but continues to analyze data from the motion sensor 5 to determine whether the neck's motion state has returned to stability. For example, it determines whether the angular velocity and acceleration values ​​have fallen back below the safe threshold and remained stable for a period of time (e.g., 2-5 seconds) to prevent premature deactivation of protection in scenarios with multiple consecutive impacts. If the dangerous state persists (corresponding to...), the system will proceed to step S5 (risk deactivation judgment). Figure 3 If the branch in the middle is not specified, the controller 6 will maintain the inflatable component 4 in an inflatable state to provide continuous protection.

[0063] When controller 6 determines that the dangerous motion condition has been resolved (corresponding to...) Figure 3 If the branch is in the middle, the system will proceed to step S6 (state recovery and recording). Figure 6As shown, controller 6 sends a new drive command to air source 7, which controls the solenoid valve in air source 7 to open the deflation passage. The gas in inflatable component 4 is quickly expelled, its volume shrinks, and it returns to its initial flat state. In this way, the rigid restriction on neck movement is released, and the neck brace returns to its normal, flexible support state without affecting the user's normal activities. At the same time, controller 6 records the complete intervention event, including key information such as trigger time, type of dangerous movement, peak acceleration / angular velocity, direction of movement, and duration of protection, along with detailed motion data segments before and after the event (e.g., 1 second before and after), in its internal non-volatile memory. This data can be automatically synchronized to control terminal 200 via local communication module and trigger a notification to remind the user. This objective data provides irrefutable evidence for subsequent rehabilitation assessment and accident analysis by the user or doctor. Afterward, the system returns to step S2 to continue a new round of real-time monitoring.

[0064] Through the above technical solutions, the smart neck brace in this embodiment not only provides unprecedented wearing comfort and personalized fit through 4D printed shape-adaptive materials, but also establishes a complete, fast, and reliable active protection mechanism that can provide timely and effective protection in the event of an accident, realizing an intelligent upgrade of neck protection from passive to active.

[0065] Example 2

[0066] This embodiment further optimizes the technical solution of Embodiment 1, aiming to address issues such as the potential restriction of unnecessary degrees of freedom by a single protective action, and the remaining room for improvement in the structural strength, comfort, and functional integration of the neck brace. To this end, this embodiment introduces a refined multi-layered topology design and a zoned, precise protection strategy.

[0067] Figure 4 This is a cross-sectional schematic diagram of the multi-layered topology of the neck support wall in one embodiment of this application. To achieve an optimal balance between lightweight, high strength, and high comfort, in this embodiment, the wall structure of the front support 1 and / or the rear support 2 can be designed using 4D printing technology as a biomimetic multi-layered topology, with a design concept similar to a biological skeleton (dense outer layer, porous inner layer). Figure 4 As shown, the structure comprises at least the following three layers from the inside out (i.e., from the side in contact with the user's skin to the outermost side):

[0068] a) Contact Layer 101: This is the innermost layer that comes into direct contact with the user's skin. To maximize wearing comfort and breathability, the inner surface of the contact layer 101 is designed with an open porous lattice structure 101a. This structure can employ biomimetic structures such as Tri-Period Minimal Surfaces (TPMS) like Gyroid or Schwarz P, and its porosity can be precisely controlled (e.g., between 60% and 80%), or even designed with a gradient of porosity, with larger pores in areas prone to sweating such as the back of the neck and chin. This highly interconnected porous design not only provides ample channels for air and moisture circulation, effectively solving the stuffiness problem of traditional neck braces, but its microscopic flexibility also further enhances the microscopic compliance of the neck brace during the self-adaptive fit process, resulting in a softer contact feel and reducing skin pressure marks.

[0069] b) Structural Layer 102: This layer is located outside the contact layer 101 and serves as the main load-bearing component of the neck brace. To ensure sufficient mechanical strength while minimizing weight, the interior of structural layer 102 is designed using a topology optimization algorithm, and lightweight reinforcing rib structures 102a are manufactured using 4D printing technology. Topology optimization is a computational method that finds the optimal material distribution under given loads and constraints. The distribution and orientation of these reinforcing ribs are repeatedly calculated using finite element analysis (FEA) to provide the highest stiffness in areas requiring the most support (such as the occipital bone support point and the mandibular support point), while reducing material usage in non-critical areas, forming a biomimetic skeletal internal network. This ensures that the neck brace can withstand corresponding loads without structural damage when subjected to external impacts or performing active protection.

[0070] c) Functional Integration Layer 103: This layer can be located outside the structural layer 102 or interwoven with it. Its core function is to provide seamless housing space and wiring channels for various functional components. Through the one-piece molding capability of 4D printing, the interior of the functional integration layer 103 can be directly pre-embedded to form a chamber 103a for accommodating the inflatable component 4, as well as complex three-dimensional channels for laying circuit wires and air pipes connecting the controller 6, motion sensor 5, and inflation source 7. This design encapsulates all functional components within the neck brace structure, effectively protecting them from external moisture, dust, and physical impacts, greatly improving the overall reliability of the product.

[0071] Compared to traditional manufacturing processes such as injection molding and machining, this multi-layer topology can achieve integrated design and manufacturing of structure and function at the microscopic level, which is difficult to achieve with traditional processes. It fully demonstrates the unique advantages of 4D printing technology in manufacturing high-performance, highly integrated, and complex products.

[0072] To achieve more precise and less disruptive protection, this embodiment introduces a partitioned design.Figure 5 This is a schematic diagram of the layout for precise partitioned protection in one embodiment of this application. Figure 5 As shown, in this design, the originally single inflatable component 4 is subdivided into multiple independently controllable airbag units. For example, a front inflatable component unit 4b located directly below the jaw to counteract flexion and extension movements can be provided, along with left and right inflatable component units 4a and 4c located on the left and right sides of the neck to counteract lateral bending and twisting movements, respectively. Accordingly, the inflation source 7 also needs to be equipped with multiple independently controllable valves to supply air to these airbag units separately.

[0073] Accordingly, motion sensor 5 is also designed as an array containing multiple sensor units. For example... Figure 5 As shown, the positions of these motion sensor units 5a, 5b, and 5c correspond to the aforementioned multiple airbag units 4a, 4b, and 4c. Specifically, the left-side motion sensor unit 5a is positioned close to the left-side inflatable component unit 4a; the front motion sensor unit 5b is positioned close to the front inflatable component unit 4b; and the right-side motion sensor unit 5c is positioned close to the right-side inflatable component unit 4c. This distributed sensor layout can more accurately capture local motion characteristics in different areas of the neck.

[0074] Through this partitioned design, controller 6 can execute a more refined vectorized protection strategy. Specifically, controller 6 can integrate data from all sensor units (5a, 5b, 5c), thereby not only determining the occurrence of dangerous movements but also accurately identifying the main direction and location of the dangerous movements. For example, when controller 6 analyzes the data and finds that the left-side motion sensor unit 5a detects a rapid angular velocity to the left exceeding a threshold, it determines that this is a dangerous leftward bending motion. At this time, controller 6 will determine the placement position of the target sensor unit (i.e., 5a) and selectively inflate only the left-side inflatable component unit 4a corresponding to that position. In this way, only the left side of the neck is rigidly restricted to precisely counteract excessive movement in that direction, while the user's neck freedom of movement in other directions (such as flexion and rotation) is almost unaffected. Similarly, if a dangerous forward bending motion of rapid head tilting is detected, it is mainly triggered by data from the front motion sensor unit 5b, and controller 6 controls the expansion of the front inflatable component unit 4b to intervene. For impacts from multiple directions, the controller can even activate multiple airbag units simultaneously in proportion.

[0075] The multi-layer topology and precise partition protection scheme proposed in this embodiment make the structure of the smart neck brace more superior and the wearing more comfortable. Its protective action has also been upgraded from full locking to targeted intervention. While ensuring safety, it maximizes the user's freedom of movement and wearing experience, and reduces unnecessary protective actions that may cause interference and fright to the user.

[0076] Example 3

[0077] This embodiment, based on the aforementioned embodiments, provides a more intelligent control and user management scheme to address issues such as the inability of fixed danger thresholds to adapt to all users or different activity scenarios, and the lack of quantitative tracking methods for rehabilitation progress. To this end, this embodiment introduces adaptive algorithms, wireless data interconnection, and modular hardware design.

[0078] To achieve more intelligent and personalized hazard assessment, the controller 6 in this embodiment can integrate more advanced software algorithms. Unlike the fixed threshold-based assessment method in Embodiment 1, the controller 6 in this embodiment has the ability to learn and adapt to the user's daily activity patterns through machine learning algorithms. Specifically, when the user begins using the neck brace, the system can enter a learning mode. In this mode, the controller 6 continuously records and analyzes the user's motion data characteristics during various daily activities (such as normal walking, bending over, turning, climbing stairs, etc.). By learning from this large amount of normal motion data, the system can build a personalized safe motion model for that specific user. This model is no longer a simple set of static thresholds, but a dynamic model that can describe the distribution of motion parameters within the user's normal activity range, such as a Gaussian Mixture Model (GMM) or a One-Class Support Vector Machine (SVM).

[0079] In daily use, the controller 6 compares the real-time monitored motion data with the personalized safety motion model. Only when the motion data significantly deviates from the model's normal range (i.e., is judged as an anomaly by the algorithm) will it be identified as a potentially dangerous movement. For example, the system can learn to distinguish between a user's rapid but regular head turning motion during basketball and the uncontrolled neck swinging during an accidental fall; the former is normal activity, while the latter will trigger protection. This adaptive hazard recognition logic can significantly reduce the false trigger rate caused by individual differences or specific activity scenarios (such as driving or sports), avoiding unnecessary protection activation, thereby improving user experience and wearing compliance.

[0080] To achieve data-driven management of the rehabilitation process, this embodiment can fully utilize... Figure 1The system architecture is shown. The neck brace itself (i.e., the sensing and actuation terminal 100) establishes a stable wireless connection with the user's control terminal 200 (e.g., a smartphone with a dedicated application installed) through its built-in local communication module (e.g., a Bluetooth Low Energy module), making the neck brace a data-interconnected smart Internet of Things (IoT) device. Users, their therapists, or doctors can access various advanced functions through the mobile application:

[0081] 1. Real-time Status Monitoring and Biofeedback: The application can display various data from the neck brace in real time, such as the current neck posture angle, range of motion, device battery level, and status of inflatable components. It can even provide a posture coach function, reminding the user to correct their posture through vibration or phone notifications when it detects that the user has been in a poor posture for an extended period (such as looking down at a phone).

[0082] 2. Personalized Parameter Settings and Scene Switching: Users or doctors can dynamically adjust the sensitivity of active protection on the application according to the needs of the rehabilitation stage. For example, in the early stages of rehabilitation, the sensitivity can be increased to provide more robust protection; as rehabilitation progresses, the sensitivity can be appropriately decreased to give users greater freedom of movement. Users can also preset different activity modes, such as driving mode, sleep mode, and exercise mode, each corresponding to different algorithm parameters and sensitivity.

[0083] 3. Data Recording, Playback, and Analysis Reports: Every active protection trigger event is recorded in detail. This data is automatically synchronized from the neck brace's storage to the mobile application and can be further uploaded to the cloud platform 300 for backup and in-depth analysis. Users or doctors can view historical records on the application at any time, including the precise time of each dangerous event, the type of movement triggered, the peak intensity of the movement, and the duration of protection. The application can also generate visual weekly or monthly reports, showing the user's neck mobility trends, posture health scores, etc., providing strong data support for objectively assessing rehabilitation progress and adjusting treatment plans.

[0084] In addition, to improve product maintainability, extend service life and facilitate future upgrades, this embodiment may also employ a modular hardware design. Figure 7 This is a schematic diagram of the modular control compartment in one embodiment of this application. Figure 7As shown, the core electronic and pneumatic components, such as the controller 6, the air source 7, and the battery (not shown), can be integrated into a single, pluggable modular control compartment 9. This control compartment 9 connects to the pre-installed circuitry and pneumatic pathways inside the neck brace body via a specially designed plug-in interface 9a, which integrates power contacts (such as spring probes), data signal pins, and a self-sealing pneumatic quick-connect fitting. When the battery is depleted, the user can easily remove the entire control compartment 9 from the neck brace body and replace it with a spare, fully charged control compartment, enabling near-uninterrupted use. Similarly, when a more powerful controller, a more efficient air source, or a larger capacity battery becomes available in the future, the user only needs to replace the upgraded control compartment module to complete the hardware upgrade, without replacing the entire customized neck brace body, greatly reducing the cost and difficulty of maintenance and upgrades. This design also facilitates cleaning, as the neck brace body, without electronic components, can be separated from the control compartment for cleaning.

[0085] Through the intelligent control and data management solution introduced in this embodiment, the intelligent neck brace has evolved from a simple physical protection device into an intelligent rehabilitation management platform that is capable of self-learning, data interconnection, and easy maintenance, thus deeply integrating into the modern digital medical ecosystem.

[0086] Example 4

[0087] This embodiment provides a method for manufacturing the smart neck brace described in the foregoing embodiments. This method leverages the unique advantages of 4D printing technology in manufacturing complex geometries and integrated functional structures to efficiently and precisely produce high-performance smart neck braces.

[0088] A method for manufacturing a smart neck brace may include the following steps:

[0089] Step one: Create a digital model and 4D print it. This step utilizes 4D printing technology to construct the physical basis of the neck brace. First, three-dimensional data of the user's neck is acquired using equipment such as a high-precision 3D scanner, and even dynamic data of the user in different postures can be collected to establish a comprehensive personal digital profile of the neck. Then, based on this personalized data and combined with ergonomic and biomechanical principles, a three-dimensional digital model of the smart neck brace is created in computer-aided design (CAD) software. This model not only defines the external contour of the neck brace but also precisely designs the complex internal structure, such as the multi-layer topology structure described in Example 2 (including the porous lattice structure 101a of the contact layer 101 and the topology-optimized reinforcing ribs 102a of the structural layer 102), as well as the cavities for accommodating functional components (such as the cavity 103a in the functional integration layer 103) and internal wiring channels. After the model design is completed, a suitable shape-adaptive 4D printing material (such as a thermally responsive shape memory polymer) is selected as the printing material. High-precision 4D printing equipment (such as printers based on photopolymerization technologies like SLA / DLP, or fused deposition modeling technologies like FDM) is used to print the three-dimensional digital model layer by layer into a solid object. During the printing process, the neck brace body can be integrally formed, or the front support 1 and rear support 2 can be printed separately and then assembled. 4D printing technology ensures that various complex chambers, channels, and fine microstructures reserved inside the neck brace body are precisely manufactured in one step. For example, the serpentine bionic hinge 31 connecting the front and rear supports and the internally integrated flexible channel 33 can be directly integrally formed during printing without subsequent assembly. After printing, the neck brace body is programmed: it is heated above its glass transition temperature to soften it, then deformed into a temporary shape suitable for wearing, and finally rapidly cooled to lock in this temporary shape.

[0090] Step two, assembling functional components. After the neck brace body is printed and necessary post-processing (such as removing supports, surface smoothing, etc.) is performed, the functional components are assembled. This process is similar to filling components into a pre-fabricated three-dimensional circuit board. Specific operations may include: placing the pre-prepared inflatable component 4 (or multiple inflatable component units 4a, 4b, 4c) into the preset chamber 103a in the functional integration layer 103; fixing the motion sensor 5 (or multiple motion sensor units 5a, 5b, 5c) to the precise reserved position on the rear support body 2 by adhesive or snap-fit; inserting the modular control compartment 9, which integrates the controller 6 and the inflation source 7, into the corresponding slot in the rear support body 2, ensuring good contact between the insertion interface 9a and the corresponding interface on the neck brace body. Subsequently, the internal circuitry and air supply are connected, that is, the pins of the controller 6 are connected to the motion sensor 5, the inflation source 7, and the battery through a preset internal channel (in more advanced manufacturing, these circuits can even be directly integrated into the neck brace structure by printing conductive ink), and the air outlet of the inflation source 7 is airtightly connected to the air inlet of the inflatable component 4 through the internal air supply pipe (including the flexible channel 33).

[0091] Among them, the inflatable component unit 4a: the left independent control airbag unit, corresponding to the left protection area, is used to counteract dangerous left lateral bending / torsion movements;

[0092] Inflatable component unit 4b: Front independent control airbag unit, corresponding to the front protection zone, used to counteract dangerous flexion / reverse leaning movements;

[0093] Inflatable component unit 4c: Right-side independent control airbag unit, corresponding to the right-side protection zone, used to counteract dangerous right-side bending / torsion movements;

[0094] Motion sensor unit 5a: Left-side sensing unit, corresponding to the inflatable component unit 4a, accurately captures left-side neck movement data;

[0095] Motion sensor unit 5b: Front sensing unit, which is arranged in correspondence with inflatable component unit 4b to accurately capture front neck movement data;

[0096] Motion sensor unit 5c: Right-side sensing unit, corresponding to the inflatable component unit 4c, accurately captures right-side neck movement data.

[0097] Among them, the modular control compartment 9 (an independent pluggable module integrating the controller 6, inflation source 7 and power supply unit, which is easy to replace and upgrade); and the plug-in interface 9a (the connection interface between the modular control compartment 9 and the neck brace body, which integrates power contacts, data signal pins and self-sealing pneumatic quick connectors).

[0098] Step 3: System integration, calibration, and testing. After all hardware components are assembled, a comprehensive system integration test is performed on the assembled smart neck brace to verify that the entire system can work together. The test content may include: performing a power-on self-test to confirm that the controller 6 can start normally and recognize all connected hardware; performing sensor calibration and data reading tests, placing the neck brace in a standard posture, calibrating the sensor zero point, and verifying that the controller 6 can accurately and stably receive real-time motion data from the motion sensor 5; performing actuator function tests, checking whether the inflation source 7 can inflate and deflate the inflatable component 4 within a specified time by sending test commands, and performing an airtightness leak test; performing a complete logic link test, using a dedicated test bench to simulate specific dangerous movements (such as simulating the impact curve of a whiplash injury) to verify whether the entire perception-decision-execution closed loop can complete the active protection action within a specified response time; and performing wireless communication tests to verify the connection stability, data synchronization function, and response latency between the neck brace and the control terminal 200.

[0099] After all tests were passed, a fully functional and reliable personalized smart neck brace was completed.

[0100] The preparation method described in this embodiment can efficiently transform complex design ideas into highly integrated physical products, providing a standardized and feasible technical path for the production of personalized, high-performance intelligent medical rehabilitation equipment.

[0101] The above description is merely a preferred embodiment of this application and is not intended to limit the scope of this application. For those skilled in the art, various modifications, alterations, substitutions, and variations can be made within the spirit and principles of this application. For example, the inflatable component can be replaced with other types of fast-response actuators (such as shape memory alloy wires, electrorheological fluids, etc.), and the algorithm in the controller can employ other types of machine learning models, etc. These equivalent substitutions or obvious variations should all fall within the protection scope of this application.

Claims

1. A smart neck brace based on 4D printing, characterized in that, include: A neck brace body configured to provide support around a user's neck; At least a portion of the neck brace body comprises a shape-adaptive 4D printing material configured to change shape upon receiving a preset stimulus in order to conform to the user's body contours. An inflatable component (4) disposed on the neck brace body, and an inflation source (7) in fluid communication with the inflatable component (4); A motion sensor (5) is installed on the neck brace body to monitor the user's neck movement data in real time; A controller (6) is connected to the motion sensor (5) and the inflation source (7); the controller (6) is configured to: acquire and analyze motion data monitored by the motion sensor (5); when the motion data is identified to meet preset dangerous motion conditions, control the inflation source (7) to inflate the inflatable component (4) to restrict the user's neck movement; and after the dangerous motion conditions are lifted, control the inflatable component (4) to deflate to release the restriction on the user's neck movement.

2. The intelligent neck brace according to claim 1, characterized in that, The shape-adaptive 4D printing material is a thermally responsive shape memory polymer, and the preset stimulus is human body temperature; When the smart neck brace is worn on the human body, the main body of the neck brace adapts to change shape under the stimulation of the human body temperature to fit the user's body contour.

3. The intelligent neck brace according to claim 1 or 2, characterized in that, The neck brace body includes a front support (1) and a rear support (2), which are detachably connected by a snap-fit ​​connection structure (3); the snap-fit ​​connection structure (3) is provided with an adjustment position.

4. The intelligent neck brace according to claim 3, characterized in that, The snap-fit ​​connection structure (3) includes a serpentine bionic hinge (31) disposed at the end of the rear support (2), which is made of the thermally responsive shape memory polymer; the snap-fit ​​connection structure (3) has a flexible channel (33) integrated inside for connecting the air passage.

5. The intelligent neck brace according to claim 3, characterized in that, The wall structure of the front support (1) and / or the rear support (2) is a multi-layer topological structure formed by 4D printing technology, including at least a contact layer (101) that contacts the skin, a structural layer (102) and a functional integration layer (103); the inner surface of the contact layer (101) has a porous lattice structure; the structural layer (102) is provided with a reinforcing rib structure to provide mechanical strength; the functional integration layer (103) has a cavity embedded inside to accommodate the inflatable component (4).

6. The intelligent neck brace according to claim 1, characterized in that, The controller (6) is used to determine the flexion, extension, lateral bending and rotation angles of the neck based on the motion data, and to compare the motion data with a preset safe motion mode to identify and determine whether the motion data meets the dangerous motion conditions.

7. The intelligent neck brace according to claim 6, characterized in that, The controller (6) is used to learn and adapt to the user's daily activity patterns in order to distinguish between normal and dangerous activities.

8. The intelligent neck brace according to claim 1, characterized in that, The inflatable component (4) includes multiple independently controlled airbag units; the motion sensor (5) includes multiple sensor units, and the placement of the multiple sensor units corresponds to the placement of the multiple airbag units. The controller (6) is configured to determine the placement position of the target sensor unit when a target sensor unit among the plurality of sensor units detects that the motion data meets preset dangerous motion conditions, and to start the inflation source (7) to inflate the airbag unit corresponding to the placement position of the target sensor unit.

9. A method for operating an intelligent neck brace, characterized in that, include: The motion sensor (5) installed on the neck brace body continuously monitors the user's neck movement data; The controller (6) analyzes the motion data in real time to determine whether the preset dangerous motion conditions are met; When it is determined that the dangerous movement conditions are met, the inflation source (7) is controlled to inflate the inflatable component (4) set on the neck brace body, so as to restrict the user's neck movement by expanding the inflatable component (4); When the dangerous movement conditions are relieved, the inflatable component (4) is deflated to relieve the restriction on the user's neck movement.

10. A method for preparing an intelligent neck brace, characterized in that, include: Using 4D printing technology and shape-adaptive 4D printing materials, the neck brace body is prepared by integral molding or separate printing and assembly, and a cavity is formed inside the neck brace body to accommodate the inflatable component (4), controller (6) and inflation source (7); The inflatable component (4), motion sensor (5), controller (6) and inflation source (7) are assembled into the neck brace body to obtain the smart neck brace.

Images