Medical biological material crosslinking device

Abstract

The invention provides a medical biological material cross-linking device. The medical biological material cross-linking device comprises a box body, an electrical control unit, a cross-linking liquid circulating structure and a cross-linked material bearing platform swinging structure, the box body is divided into a reaction cavity and an electric control cavity; the circulating structure consists of a circulating pump and a filter which are connected in series with the liquid pipeline; one-way circulation of the cross-linking liquid scours the surface of the biological material, and cross-linking can be accelerated; the swing structure comprises horizontal displacement and vertical inclination which act together to enable the biological material bearing platform to swing up and down, left and right and front and back, so that the cross-linking of the biological material is more uniform, stable and thorough. By setting related parameters, the temperature of the cross-linking liquid, the cross-linking time, the swing frequency, the swing amplitude and the swing displacement range can be regulated and controlled; monitoring the crosslinking state of the biological material through a camera; under the combined action of the structures, the quality and quality requirements of the crosslinking process are guaranteed through acquisition, recording, storage and transmission of crosslinking parameters and images.

Description

Technical Field

[0001] The present invention relates to a manufacturing device for a biomaterial medical device, in particular to a medical biomaterial cross-linking device. Background Art

[0002] Currently, biomaterial-based medical devices have a wide range of applications, primarily in clinical tissue repair and replacement procedures, such as biologically constructed artificial skin, biocompatible heart valves, periosteum, hernia patches, meningeal patches, and pericardial patches. Different application scenarios require corresponding forms; most biomaterials, whether derived from homologous or heterologous animal tissue, require specific processing steps and processes, such as decellularization, modification, cross-linking, and sterilization, to become medical devices.

[0003] Cross-linking refers to the use of cross-linking agents to couple intramolecular and intermolecular (carboxyl, hydroxyl, and amino) groups within biomaterials, collagen fibers, and proteins to form a multidimensional network polymer. This can increase the material's molecular weight, enhance its strength, hardness, toughness, and density, reduce porosity, improve its resistance to degradation, enhance its structural stability, and reduce immunogenicity. This is a critical process in the preparation of medical biomaterials.

[0004] During the cross-linking process, the degree of cross-linking varies depending on several factors, such as the concentration and temperature of the cross-linking solution, and the flow and flushing of the cross-linking agent solution, all of which affect the performance of the cross-linked product. Maintaining a consistent cross-linking degree while maintaining the biomaterial's shape is the greatest challenge in large-scale, industrialized production.

[0005] This requires that the cross-linking device must ensure the purity of the cross-linking process and prevent the intrusion of impurities and pyrogens; it must also ensure that cross-linking reaches the entire layer of the material and completes cross-linking evenly; in addition, the cross-linking process must be tested for performance: monitoring and recording of the entire cross-linking process parameters will facilitate traceability and improvement of product quality.

[0006] Current cross-linking devices often rely on manual experience (a practice often seen in practice as a truncated attempt to find a sword in a boat). This involves relying on a validated process (parameters) to guide subsequent production processes, neglecting to monitor and control the cross-linking process. Consequently, when quality issues arise, they often fail to address them promptly and effectively. Common medical biomaterial cross-linking equipment involves installing a circulation line for the cross-linking solution within a container or stirring the material to be cross-linked without properly testing and monitoring the temperature, time, concentration of the cross-linking solution, degree of cross-linking, and homogenization of the cross-linking process. This makes it difficult to guarantee the quality of the biomaterial cross-linking. Therefore, it is necessary to develop a new device for the cross-linking process of medical biomaterials that can meet the requirements of large-scale production. Summary of the Invention

[0007] The purpose of the present invention is to address the above-mentioned problems in the existing technology and to propose a medical biomaterial cross-linking device.

[0008] The objectives of the present invention can be achieved through the following technical solutions: a medical biomaterial cross-linking device, including a housing, an electrical control unit, a cross-linking liquid circulation structure, and a cross-linking material carrying platform swinging structure; the characteristics are: the housing is divided into a reaction chamber and an electrical control chamber; the circulation structure is composed of a circulation pump and a filter connected in series with the liquid pipeline; the unidirectional circulation of the cross-linking liquid can flush the surface of the biomaterial and accelerate cross-linking; the swinging structure includes horizontal displacement and vertical tilt, the two of which work together to cause the biomaterial carrying platform to swing up and down, left and right, and back and forth, making the cross-linking of the biomaterial more uniform, stable and thorough; by setting relevant parameters, the cross-linking liquid temperature, cross-linking time, swing frequency, amplitude and displacement range can be regulated and the cross-linking state of the biomaterial can be monitored; the above structures work together to collect, record, store and transmit cross-linking parameters and images to ensure the quality and quality requirements of the cross-linking process.

[0009] The swing structure includes horizontal displacement and vertical tilt. The horizontal displacement structure includes a motor and a worm, and the shaft at the far end of the worm is inserted into the center hole of the loading platform; the vertical tilt structure includes a motor, a worm and a connecting rod; the connecting rod is suspended at a corner of the platform; the simultaneous rotation of the two motors and their combined effect can cause the loading platform to swing up and down, left and right, and forward and backward; the platform is supported on the bottom plate in the reaction chamber by four spring columns; a horizontal displacement motor is installed in the center of the bottom plate, and a sealing cover is used to prevent the motor from contacting the cross-linking liquid.

[0010] The parameter setting and control of the cross-linking process are achieved through the buttons and display screen of the electrical control unit; the temperature, cross-linking time, swing speed, amplitude and range of the cross-linking liquid can be set and controlled separately; the cross-linked appearance characteristics of the biomaterial can be photographed through the camera; the collection, recording, storage and transmission of the above parameters are all controlled by the control unit.

[0011] The baffles located on the front and rear side walls of the reaction chamber of the box body are displaced forward and backward by foldable and retractable brackets, and can be displaced to the center line of the reaction chamber at most. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Attachment Figure 1 This is a schematic diagram of the box structure of a medical biomaterial cross-linking device of the present invention; Attachment Figure 2 This is a schematic diagram of an electrical control block diagram of a medical biomaterial cross-linking device of the present invention; Attachment Figure 3 This is a schematic diagram of a cross-linking liquid circulation pathway of a medical biomaterial cross-linking device of the present invention; Attachment Figure 4 This is a schematic diagram of the swing structure of the reaction chamber loading platform of a medical biomaterial cross-linking device of the present invention; Attachment Figure 5 The present invention is a schematic diagram of a cross-linking rack baffle in a reaction chamber of a medical biomaterial cross-linking device.

[0013] In the picture: 1. Box body; 11. Cross-linking chamber; 12. Control chamber; 13. Box cover; 14. Keyboard; 15. Display screen; 16. Drain valve; 2. Electrical control unit; 21. Control panel; 22. Power module; 23. Temperature sensor; 24. Electric heating tube; 25. Camera; 26. Memory; 27. Wireless transmission module (Bluetooth); 28. Data interface; 2A. Cycle control relay; 2B. Swing control relay; 3. Circulation pipeline: 311, liquid outlet; 312, liquid inlet; 32, circulation pump; 33, filter; 4. Swinging device; 40. Flat plate (reaction pool loading platform); 41. Support springs (one at each corner); 42. Vertical tilt motor; 421. Vertical worm; 422. Connecting rod; 43. Horizontal displacement motor; 431. Horizontal worm. Specific embodiments

[0014] The present invention is a medical biomaterial cross-linking device composed of a box 1, an electrical control unit 2, a cross-linking liquid circulation path 3, and a swing device 4. Figure 1 As can be seen, the box body 1 is made of stainless steel and is divided into two chambers. The larger chamber 11 on the left is the cross-linking reaction chamber; the smaller chamber on the right is the electrical control panel placement area. The box cover 13 can seal the box body. A liquid drain valve 16 is located at the bottom of one side of the box body. A keyboard 14 and a digital display screen 15 are installed on the side wall in front of the chamber. A camera 25 is installed on the inner side of the upper cover 13. Figure 2 This is a schematic diagram of the electrical control block of a medical biomaterial cross-linking device of the present invention. As can be seen from the figure, the electrical control unit includes: a power supply module 22, which supplies power to the controller 21, sensor 23, keyboard 14, display 15, camera 25, memory 26, wireless transmission 27, and data interface 28 through step-down rectification and voltage stabilization; and supplies power to the electric heater 24, swing motor 43, horizontal displacement motor 42, and circulation pump 32 (see attached) through control relays. Figure 3 , Attachment Figure 4The operating principle is as follows: the temperature is set using the keyboard and display; the controller's control panel controls the power supply through a relay to connect the heating element; when the temperature rises to the set value, the sensor's electrical signal is transmitted to the control panel, which outputs a signal, activates the relay, and the heating element loses power and ceases heating. This maintains the cross-linking solution in the reaction chamber at a constant temperature (±0.5°C). The speed and amplitude of the rocking device are set by the keyboard and display screen. The horizontal worm 431 is rotated by the shaft of the horizontal displacement motor 43, and the latter is inserted into the middle hole of the reaction plate 40. As the motor rotates, the worm rotates and drives the platform 40 to perform four-dimensional displacement movement.

[0015] Similarly, the vertical tilt motor 42 and the matching vertical worm gear make the plate 40 move up and down through the connecting rod 422.

[0016] The data collection time set by the controller can control the camera 25 to take pictures of the reactants (biomaterials) in cooperation with the lighting, record them in the memory 26, and collect them through wireless transmission or data interface.

[0017] Attachment Figure 3 This is a schematic diagram of the cross-linking liquid circulation pipeline structure of a medical biomaterial cross-linking device according to the present invention. As shown, the circulation path consists of a conduit 31, a circulation pump 32, and a filter 33. The pipeline's inlet 311 is located at the bottom of one side of the reaction chamber (box). As it extends to the bottom of the control chamber, it passes through the bottom plate, bends upward, and connects in series with the filter 33 and the circulation pump 32 (mounted on the side wall of the reaction chamber). The cross-linking liquid flows through the outlet 311, through the conduit 31 at the bottom of the box, through the filter 33, and, driven by the circulation pump 32, re-enters the reaction chamber through the inlet 312. This creates a unidirectional, top-down, left-to-right circulation of the cross-linking liquid, which flushes the surface of the biomaterial, accelerating and homogenizing cross-linking. The filter 33 intercepts and removes cilia, impurities, and particles shed from the biomaterial, preventing them from becoming fixed to the biomaterial during the cross-linking process and forming protrusions that could affect the quality and appearance of the reactants. One end of the pipeline 31 is connected to the drain valve 16 through a three-way pipe. After the cross-linking work is completed, the valve can be opened to drain the cross-linking liquid and clean the reaction chamber.

[0018] Attachment Figure 4This is a schematic diagram of the swinging structure of the reaction chamber loading platform of a medical biomaterial cross-linking device of the present invention; in the figure, the cross-linking material loading platform 40 is supported in the reaction chamber 11 of the box body by four column springs 41, and an electric heating tube 24 and a temperature sensor 23 are arranged below it. A horizontal displacement motor 43 is installed in the sealed cavity on the bottom surface of the box body 1, and its rotation speed is between 1.5 and 8.0 r / min; a horizontal worm 431 is inserted into the center hole of the platform (plate). As the horizontal motor 43 rotates, the turbine end shaft head drives the platform 40 to make four-quadrant displacements in the front, back, left and right directions, and the displacement range is between 20 and 100 mm. A vertical tilt motor 42 is installed on the upper side wall of the electrical control chamber 12 on the right side of the box body 1. Its rotation speed is 1.5~8.0r / min. It also pulls (suspends) one side of the platform 40 through the vertical worm 421 and the connecting rod 422, slowly lifting / lowering it, causing one side of the platform to tilt and swing up and down; in coordination with the horizontal displacement motor 43, the platform 40 swings up and down, left and right, and front and back, making the cross-linking process more sufficient, uniform and thorough.

[0019] Figure 5 This is a schematic diagram of the crosslinking rack baffles of the reaction chamber of a medical biomaterial crosslinking device according to the present invention. In the figure, a baffle 5 is mounted on each of the front and rear inner walls of the reaction chamber 11 of the housing 1. Foldable sliding brackets 51 allow the baffles 5 to move forward and backward, with a maximum displacement of up to the centerline of the reaction chamber (i.e., 1 / 2 the width of the reaction chamber). These brackets act together to restrain the biomaterial-fixing baffles, preventing them from tipping over and preventing biomaterials from adhering to each other, which could affect crosslinking quality.

[0020] The present invention provides a medical biomaterial cross-linking device. By adopting digital control technology, the cross-linking process is carried out in a timed, constant temperature, rocking, and cross-linking solution circulation process. The parameters of the cross-linking process and the state of the biomaterial can be measured, recorded, and data transmitted. This ensures the authenticity of the cross-linking process and the control of the cross-linking parameters.

[0021] Due to the interaction of horizontal and vertical displacement motors, the biomaterial can move up and down, left and right, and forward and backward on the platform (driven by it), so that the biomaterial is in full contact with the cross-linking solution, making the cross-linking process more stable, uniform and thorough.

[0022] Due to the adoption of a cross-linking solution circulation filtration structure, the fluff, fibers, and particles on the surface of the biological substrate during the cross-linking process can be filtered out after falling off, preventing them from being cross-linked and fixed with the surface of the biological material, forming adhesion to the surface and affecting the quality.

[0023] Due to the adoption of the above-mentioned new structure and technology, the cross-linked material prepared by the present invention is more uniform, has a smoother and flatter surface, and has more stable performance. The cross-linking process can be automated and digitized.

Claims

1. A medical biomaterial cross-linking device, comprising a housing (1), an electrical control unit (2), a cross-linking liquid circulation structure (3), a swinging structure (4), and a baffle (5); characterized in that: The housing (1) is divided into a reaction chamber (11) and an electrical control chamber (12); the circulation structure (3) is composed of a liquid outlet (311) located on the bottom plate of the reaction chamber, a liquid flowing through a liquid pipeline (31) and a serially connected circulation pump (32), a filter (33), and then a liquid outlet (312) located at the upper end of the side wall on the other side of the reaction chamber; the one-way circulation of the cross-linking liquid flushes the surface of the biomaterial, thereby accelerating cross-linking.

2. A medical biomaterial cross-linking device according to claim 1, characterized in that: The swing structure (4) includes two parts: a horizontal displacement and a vertical tilt. The horizontal displacement structure includes a horizontal motor (43) and a horizontal worm (431), and the shaft at the distal end of the worm is inserted into the center hole of the loading platform (40); the vertical tilt structure includes a vertical motor (42), a vertical worm (421) and a connecting rod (422); the connecting rod (422) is suspended at a corner of the platform; the vertical motor (42) and the horizontal motor (43) rotate simultaneously, and their combined action can cause the loading platform (40) to swing up and down, left and right, and forward and backward; the platform (40) is supported on the bottom plate of the reaction chamber by four spring columns (41); a horizontal displacement motor (43) is installed in the center of the bottom plate, and a sealing cover is used to prevent the motor from contacting the cross-linking liquid.

3. The medical biomaterial cross-linking device according to claim 1, characterized in that: The parameter setting and operation control of the cross-linking process are achieved by selecting the menu in the electrical control unit (2) and inputting the program controller through the buttons (14) and the display screen (15); the cross-linked appearance of the biomaterial can be photographed through the camera; the collection, recording, storage and transmission of the above parameters are all controlled by the control unit.

4. The medical biomaterial cross-linking device according to claim 1, characterized in that: The baffles (5) located on the front and rear inner side walls of the reaction chamber (11) of the housing (1) are displaced forward and backward by a foldable and retractable bracket (51), and can be displaced to the center line of the reaction chamber (11) at most.

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