A temperature-sensitive double-lumen glue-mixing tube kit for in-situ bio-printing of vocal cords

Abstract

A kind of temperature-sensitive double-lumen mixed glue pipe kit for vocal cord in situ bio-printing, comprising pipe body assembly, microfluidic mixed glue assembly, temperature control sensing assembly and docking base assembly, the pipe body assembly includes outer protective tube and inner isolation partitioned inner partition tube, forming independent first and second infusion cavities, realizing physical isolation delivery of multi-component reactive fluid;The mixed passage of microfluidic mixed glue assembly is provided with staggered arrangement of flow resistance micro-protrusion structure, to realize efficient forced mixing of fluid;The temperature control sensing assembly includes flexible heating film housed in the pipe body annular interlayer and micro temperature sensor embedded in the side wall of the confluence cavity, which is connected with external equipment through the docking base assembly, the patent effectively solves the problems such as easy blockage, uneven mixing and temperature control loss during printing, and significantly improves the quality and stability of in situ bio-printing.

Description

Technical Field

[0001] This invention relates to a temperature-sensitive dual-lumen mixing tubing kit for in-situ vocal cord bioprinting. Background Technology

[0002] With the rapid development of tissue engineering and bioprinting technologies, in-situ bioprinting has shown great potential in the field of tissue repair and reconstruction. Among them, the vocal cords, as an important organ for human voice production, have a precise structure and are located in a narrow natural cavity of the human body, which places extremely high demands on the precision, fluid control capabilities, and dimensional accuracy of in-situ printing equipment.

[0003] In the process of in situ bioprinting of vocal cords, bio-hydrogels with temperature-sensitive properties or multi-component cross-linking properties are often used as "bio-inks". During the transport and extrusion process, the rheological properties (such as viscosity and shear thinning properties) and the survival rate of living cells inside these bio-inks are extremely sensitive to the ambient temperature; at the same time, the timing and uniformity of mixing of various reaction components (such as high-concentration gel matrix and low-concentration cross-linking agent) need to be strictly controlled.

[0004] However, traditional fluid delivery pipelines or injection heads have significant shortcomings when facing complex in-situ printing scenarios: First, the lack of an effective fluid physical isolation mechanism allows multi-component fluids to easily diffuse, backflow, or prematurely contact within slender pipelines, leading to premature cross-linking of bio-inks and severe blockages. Second, traditional static mixers are bulky and have low mixing efficiency for high-viscosity fluids within narrow microchannels, easily resulting in uneven composition of the in-situ deposited bioscaffold, leading to poor mechanical properties and decreased biocompatibility of the repaired vocal cord tissue. Furthermore, existing equipment often lacks real-time monitoring and closed-loop control of the actual temperature of the dispensing area, causing temperature-sensitive bio-inks to lose optimal fluidity due to temperature fluctuations in the microenvironment, and even causing thermal or frost damage to the contained living cells. The background section of this invention aims to describe the current state of the existing technical field. The shortcomings of the prior art are evident, and this section provides necessary background information for understanding the technical contributions and innovations of this invention. The signals disclosed in this background section are merely intended to enhance the understanding of the overall background of this invention and should not be considered as implying any subjective intent. Summary of the Invention

[0005] In view of the above, the purpose of this invention is to provide a temperature-sensitive dual-cavity mixing tubing kit for in-situ vocal cord bioprinting.

[0006] The technical solution adopted to achieve the purpose of this invention is a temperature-sensitive dual-cavity mixed-glue tubing kit for in-situ vocal cord bioprinting. The kit has opposing proximal and distal ends and includes: a tubing assembly comprising an outer protective tube and an inner septum coaxially inserted inside the outer protective tube; an axially extending annular interlayer is formed between the inner wall of the outer protective tube and the outer wall of the inner septum; an axially extending isolation septum is disposed inside the inner septum, and opposite sides of the isolation septum are respectively fixedly connected to the inner wall of the inner septum. The inner cavity of the inner septum is divided into a first infusion chamber and a second infusion chamber that are not interconnected. A microfluidic mixing assembly is fixedly installed at the distal end of the tube assembly. The microfluidic mixing assembly includes a connecting sleeve and a mixing nozzle located at the distal end of the connecting sleeve. A manifold is formed inside the connecting sleeve. The distal end of the inner septum is connected to the proximal end of the connecting sleeve, so that the distal outlets of the first infusion chamber and the second infusion chamber are connected to the manifold. A microfluidic nozzle is formed inside the mixing nozzle and communicates with the manifold. The microfluidic mixing channel has multiple flow-blocking micro-protrusions arranged radially and alternately on its inner wall; a temperature control sensing assembly includes a flexible heating film and a micro temperature sensor. The flexible heating film is rolled up and circumferentially covers the outer wall of the inner septum and is housed in an annular interlayer between the outer protective tube and the inner septum; the micro temperature sensor is embedded in the side wall of the connecting sleeve, with its sensing end located close to the inner wall of the manifold; a docking base assembly is fixedly connected to the proximal end of the tube assembly. The docking base assembly has a first inlet channel and a second inlet channel communicating with the first inlet cavity and the second inlet cavity, respectively. The proximal end face of the docking base assembly has a first inlet interface and a second inlet interface communicating with the first inlet channel and the second inlet channel, respectively; multiple data communication contacts are embedded on the outer surface of the docking base assembly, and the flexible heating film and the micro temperature sensor are electrically connected to the corresponding data communication contacts through wires passing through the annular interlayer.

[0007] In some embodiments, the cross-sectional area of ​​the first infusion chamber is larger than that of the second infusion chamber; the distal end of the isolation septum extends beyond the distal end face of the inner septum and extends into the manifold of the connecting sleeve, and the distal end of the isolation septum has a wedge-shaped structure with a thickness that gradually decreases along the distal direction.

[0008] In some embodiments, the plurality of flow-blocking micro-protrusions are arranged in a spiral staggered pattern along the fluid flow direction of the microfluidic mixing channel, and a meandering flow channel is formed between adjacent flow-blocking micro-protrusions to allow the fluid to undergo laminar folding and eddy current disturbance.

[0009] In some embodiments, the flexible heating film includes a flexible insulating substrate and conductive heating lines attached to the flexible insulating substrate. The conductive heating lines are arranged in a continuous serpentine reciprocating bend along the axial direction of the inner septum to form a planar heating area around the inner septum.

[0010] In some embodiments, the docking base assembly has a sealed mounting cavity inside, and an information identification chip is fixedly embedded in the sealed mounting cavity. The pins of the information identification chip are electrically connected to a portion of the data communication contacts on the outer surface of the docking base assembly.

[0011] In some embodiments, the proximal end face of the docking base assembly is provided with a mechanical locking boss for connection with an external drive device. The mechanical locking boss includes a cylindrical portion extending axially toward the proximal end from the proximal end face, and at least one locking lug protruding radially outward from the outer wall of the cylindrical portion.

[0012] In some embodiments, a blind hole groove is formed inside the side wall of the connecting sleeve, the opening of the blind hole groove faces the outer side wall of the connecting sleeve, and a thermally conductive thin wall is left between the bottom of the blind hole groove and the manifold; the miniature temperature sensor is fixedly embedded in the blind hole groove and abuts against the thermally conductive thin wall.

[0013] In some embodiments, the following steps are included:

[0014] A. Connect the docking base assembly to the external driving device, so that the proximal end face of the docking base assembly is locked with the external driving device, and the electrodes of the external driving device form electrical contact with the data communication contact; the external driving device reads the parameter signal of the internal information identification chip through the data communication contact, and establishes the target control temperature range and the flow rate ratio of the first infusion chamber and the second infusion chamber accordingly;

[0015] B. The external driving device outputs electrical energy to the flexible heating film through the data communication contact, causing the flexible heating film to heat up and conduct heat radially into the inner partition tube; the miniature temperature sensor embedded in the side wall of the connecting sleeve collects the heat conduction temperature around the manifold in real time and feeds back the electrical signal to the external driving device, and adjusts the power supply to maintain the temperature of the inner partition tube and the microfluidic mixing assembly within the target control temperature range;

[0016] C. According to the flow rate ratio, the external drive device pumps the first fluid and the second fluid into the first inlet port and the second inlet port respectively. The first fluid and the second fluid are synchronously propelled to the distal end along the first inlet chamber and the second inlet chamber respectively. During the propulsion process, the isolation partition physically isolates the two fluids, and the outer flexible heating film maintains the constant temperature of the fluid environment.

[0017] D. The first fluid and the second fluid are discharged from the distal outlets of the first infusion chamber and the second infusion chamber, and come into contact and merge in the manifold for the first time. The merged fluid is pushed into the microfluidic mixing channel by the pump pressure. When the fluid flows through the staggered flow-blocking micro-protrusion structure, the flow path is continuously blocked by the protrusion and splits, resulting in laminar folding and entanglement, and the mixing is completed in the channel.

[0018] E. The mixed fluid is extruded from the opening at the distal end of the mixing nozzle and deposited in the target area.

[0019] The beneficial effects of this invention are:

[0020] This application achieves complete physical isolation of the multi-component reactive biofluid before it reaches the remote microfluidic mixing assembly by setting an inner septum with an isolation partition to divide the fluid delivery channel into a first and a second infusion chamber that are not interconnected. This effectively prevents premature cross-linking reactions of the fluid during delivery, fundamentally solving the problem of easy clogging of the printing tubing and ensuring the continuity and high reliability of the in-situ printing process.

[0021] This application innovatively integrates a microfluidic mixing component, with staggered flow-resistant micro-protrusions arranged on the inner wall of its microfluidic mixing channel. When two isolated fluid streams first come into contact in the confluence cavity and enter the channel, the flow-resistant micro-protrusions induce microscopic laminar folding and eddy current disturbances in the fluids. This achieves thorough and uniform forced mixing of high-viscosity biomaterials within an extremely small space, significantly improving the structural uniformity and biomimetic mechanical properties of the printed bioscaffold.

[0022] This application designs a highly integrated temperature control sensing component, utilizing a flexible heating film surrounding the inner septum and a miniature temperature sensor embedded in the sidewall of the manifold, forming a real-time closed-loop temperature control system for the core flow channel and critical junction area. The miniature temperature sensor can monitor the actual fluid temperature in the mixing region with near-zero delay. Combined with the uniform planar heat conduction of the flexible heating film, this ensures that the temperature-sensitive bio-ink is always within the optimal processing temperature range, effectively maintaining the material's rheological properties and maximizing the protection of cell bioactivity.

[0023] The outer protective tube and the inner diaphragm tube of this application form an annular interlayer. This interlayer not only cleverly accommodates the flexible heating film and its wires, maintaining the smoothness and compactness of the tube's exterior (which is beneficial for penetrating narrow anatomical cavities such as the vocal cords), but also acts as a good air insulation layer, reducing heat loss to the external environment and preventing excessively high temperatures on the outer wall of the kit from causing thermal damage to the patient's normal laryngeal mucosa.

[0024] In this application, the distal end of the partition plate has a wedge-shaped structure with a thickness that gradually decreases along the distal direction. This not only guides the two fluids to merge smoothly before entering the microfluidic mixing channel and reduces shear force, but also significantly eliminates the dead water zone at the fluid junction, further reducing the risk of local accumulation of crosslinking products at the end of the partition plate and optimizing the overall hydrodynamic performance. Attached Figure Description

[0025] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0026] Figure 1 This is a schematic diagram of the overall three-dimensional structure of the present invention;

[0027] Figure 2 This is an exploded perspective view of the present invention;

[0028] Figure 3 This is a cross-sectional view of the tube assembly of the present invention;

[0029] Figure 4 This is a longitudinal sectional view of the microfluidic mixing assembly and the distal tube of the present invention;

[0030] Figure 5 This is a longitudinal sectional view of the docking base assembly of the present invention;

[0031] In the diagram, 1-tube assembly, 101-outer protective tube, 102-inner diaphragm tube, 1021-first infusion chamber, 1022-second infusion chamber, 1023-second inlet channel, 103-isolation diaphragm, 104-annular interlayer, 2-microfluidic mixing assembly, 201-connecting sleeve, 202-mixing nozzle, 203-manifold, 204-thermally conductive thin wall, 205-microfluidic mixing channel, 3-dating base assembly, 301-proximal face, 302-data communication contact, 303-sealed mounting cavity, 304-locking lug, 305-information identification chip, 401-flexible heating film, 402-flexible insulating substrate, 403-conductive heating circuit. Detailed Implementation

[0032] The present invention will now be described in this embodiment with reference to the accompanying drawings and some embodiments.

[0033] It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other. The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0034] The following description, in conjunction with the accompanying drawings and embodiments, further illustrates the temperature-sensitive dual-cavity mixing tubing kit for in-situ vocal cord bioprinting of the present invention, aiming to help understand the technical concept and specific implementation of the present invention. However, this description should not be construed as limiting the scope of protection of the present invention.

[0035] like Figures 1 to 5 As shown, a temperature-sensitive dual-lumen mixing tube kit for in-situ vocal cord bioprinting is provided. The kit has an overall tubular structure with opposing proximal and distal ends. The kit mainly includes a tube body assembly, a microfluidic mixing assembly, a temperature control sensing assembly, and a docking base assembly.

[0036] Specifically, the tubular assembly is the main channel for fluid transport. It includes an outer protective tube and an inner baffle tube coaxially inserted inside the outer protective tube. Through the coaxial sleeve design, an axially extending annular interlayer is formed between the inner wall of the outer protective tube and the outer wall of the inner baffle tube. This annular interlayer not only serves as thermal insulation but also provides excellent housing space for subsequent wiring and flexible heating elements. An axially extending partition is installed inside the inner baffle tube. The opposite sides of the partition are fixedly connected to the inner wall of the inner baffle tube, thereby dividing the inner cavity of the inner baffle tube into a first and a second non-communicating fluid delivery chamber. This ensures that the reactive biofluid is strictly physically isolated before reaching the distal end, completely avoiding premature cross-linking reactions during transport.

[0037] In some embodiments, the microfluidic mixing assembly is fixedly installed at the distal end of the tubular assembly. The microfluidic mixing assembly includes a connecting sleeve and a mixing nozzle located at the distal end of the connecting sleeve. A manifold is formed inside the connecting sleeve, and the distal end of the inner septum directly connects to the proximal end of the connecting sleeve, so that the distal outlets of both the first and second infusion chambers are connected to the manifold. At this point, the two isolated fluid streams come into contact for the first time within the manifold. Furthermore, a microfluidic mixing channel communicating with the manifold is formed inside the mixing nozzle. Multiple flow-blocking micro-protrusions, radially protruding towards the center of the channel and arranged in an alternating pattern, are provided on the inner wall of the microfluidic mixing channel. This structure utilizes the principles of microfluidics; when the fluid passes through these alternating flow-blocking micro-protrusions, laminar folding and channel splitting occur at the microscopic level, enabling highly efficient forced mixing.

[0038] In some embodiments, this application provides a temperature control sensing component to address the temperature-sensitive properties of the bio-ink. This component includes a flexible heating film and a miniature temperature sensor. The flexible heating film is rolled up circumferentially and covers the outer wall of the inner septum, and is housed within an annular interlayer between the outer protective tube and the inner septum. The miniature temperature sensor is embedded inside the side wall of the connecting sleeve, with its sensing end positioned close to the inner wall of the manifold. This distribution ensures that the heating area covers the entire flow channel, while the temperature monitoring point is located in the most critical mixing and confluence area (i.e., the manifold), guaranteeing timely and accurate temperature feedback.

[0039] In some embodiments, the docking base assembly is fixedly connected to the proximal end of the tube assembly, serving as an interface with an external drive device or a liquid supply pump station. The docking base assembly has a first inlet channel and a second inlet channel respectively communicating with a first inlet chamber and a second inlet chamber. The proximal end face of the docking base assembly has a first inlet port and a second inlet port (e.g., a standard Luer connector can be used) respectively communicating with the first inlet channel and the second inlet channel. To achieve electromechanical integration, the outer surface of the docking base assembly is embedded with multiple data communication contacts. The flexible heating film and the miniature temperature sensor are electrically connected to the corresponding data communication contacts via wires passing through the annular interlayer.

[0040] In some preferred embodiments, considering that different components in vocal cord bioprinting (e.g., a high concentration of hydrogel matrix and a low concentration of crosslinking agent) often need to be mixed in non-uniform proportions, the cross-sectional area of ​​the first infusion chamber is larger than that of the second infusion chamber. For example, the cross-sectional area ratio can be set to 4:1 or 10:1, which helps to naturally form the desired volume ratio of fluid output during constant velocity pumping.

[0041] In some embodiments, to reduce the risk of shear force and turbulence during fluid convergence, the distal end of the isolation baffle extends beyond the distal end face of the inner baffle and into the confluence cavity of the connecting sleeve. Furthermore, the distal end of the isolation baffle has a wedge-shaped structure with a thickness gradually decreasing along the distal direction. This wedge-shaped structure provides a streamlined flow guiding effect, allowing the two fluid streams to converge more smoothly in a laminar flow state, effectively reducing dead water zones or fluid stagnation at the baffle's tail end and preventing the accumulation and blockage of crosslinking products at this location.

[0042] In some embodiments, for the specific structure of the microfluidic mixing channel, multiple flow-blocking microprotrusions are arranged in a spiral staggered pattern along the fluid flow direction of the microfluidic mixing channel, and a meandering flow channel is formed between adjacent flow-blocking microprotrusions to allow the fluid to undergo laminar folding and eddy current disturbance. The spiral staggered arrangement can induce secondary flow (such as Dean eddies) within the microchannel, greatly increasing the interphase contact area of ​​the two fluids, thereby achieving thorough and uniform mixing in a very short distance and time. This is extremely beneficial for protecting cell activity and the shear-thinning properties of bio-inks.

[0043] In some embodiments, the flexible heating film includes a flexible insulating substrate (such as a polyimide PI film) and conductive heating lines attached to the flexible insulating substrate. The conductive heating lines are arranged in a continuous serpentine pattern along the axial direction of the inner septum to form a planar heating area around the outer periphery of the inner septum. The serpentine arrangement provides uniform heat distribution, avoids localized overheating of the tube wall that could lead to denaturation of the biomaterial or cell death, and also ensures sensitive heating response.

[0044] To enhance the system's intelligence and the security of consumable management, in some embodiments, a sealed mounting cavity is provided inside the docking base assembly. An information identification chip is embedded within this cavity, and its pins are electrically connected to data communication contacts on the outer surface of the docking base assembly. When an external drive device is connected, it can directly read the chip through the communication contacts to obtain parameters such as kit batch, compatible bio-adhesive type, optimal operating temperature range, and theoretical flow rate ratio, achieving "plug-and-play" and automated configuration to prevent misalignment.

[0045] In some embodiments, the proximal end face of the docking base assembly is provided with a mechanical locking boss for connection with an external drive device. The mechanical locking boss includes a cylindrical portion extending axially from the proximal end face towards the proximal end, and at least one locking lug protruding radially outward from the outer wall of the cylindrical portion. This bayonet-like or quick-lock structure, in conjunction with the corresponding external drive device, allows for a secure mechanical lock to be achieved with a slight rotation after insertion, preventing dislodgement during pressure infusion.

[0046] In some embodiments, to ensure accurate temperature measurement without compromising the sealing and sterility of the flow channel, a blind slot is formed inside the side wall of the connecting sleeve. The opening of the blind slot faces the outer side wall of the connecting sleeve, and a thermally conductive thin wall is provided between the bottom of the blind slot and the manifold. The miniature temperature sensor is fixedly embedded in the blind slot and abuts against the thermally conductive thin wall. The thermally conductive thin wall isolates the sensor from the sterile biological fluid inside and minimizes thermal resistance, enabling the sensor to sense the true temperature of the mixed fluid with almost zero delay.

[0047] Based on the temperature-sensitive dual-cavity mixing tube kit of any of the above embodiments of this application, this application also provides a corresponding adhesive control method. This method, through the combination of hardware and control logic, ensures the optimal printing state of the bio-adhesive material. The method includes the following steps:

[0048] A. Docking and Identification: The docking base assembly is docked with the external drive device. Locking lugs and other structures mechanically lock the proximal end face of the docking base assembly to the external drive device. Simultaneously, the electrodes of the external drive device establish reliable electrical contact with the data communication contacts. At this point, the external drive device reads the parameter signals from the information identification chip inside the sealed mounting cavity through the communication contacts, and automatically establishes the target control temperature range required for this printing operation, as well as the flow rate ratio of the first and second infusion chambers.

[0049] B. Closed-loop temperature control: The external drive device outputs electrical energy to the flexible heating film through corresponding data communication contacts, causing the flexible heating film to heat up and conduct heat radially through the inner partition tube wall to the internal fluid. A miniature temperature sensor embedded in the blind slot of the connecting sleeve collects the heat conduction temperature around the manifold in real time and feeds back an electrical signal containing temperature information to the external drive device. The external drive device uses PID algorithms to adjust the power supply, ensuring that the temperature inside the inner partition tube and the microfluidic mixing assembly is stably maintained within the set target control temperature range.

[0050] C. Isolation and Delivery: Based on the flow rate ratio obtained or set in step A, the external drive unit drives its pumping unit to pump the first fluid (e.g., a bio-hydrogel precursor) and the second fluid (e.g., a crosslinking agent) into the first and second inlet ports, respectively. The first and second fluids are synchronously propelled towards the distal end along the first and second delivery chambers, respectively. Throughout the entire propulsion process, an isolation partition physically isolates the two fluids to prevent crosslinking, while a flexible heating film maintains a constant temperature environment for the fluids, ensuring stable fluid viscosity and activity.

[0051] D. Forced Spatial Mixing: The first and second fluids exit from the distal outlets of the first and second infusion chambers, and initially contact and merge within the manifold. Here, initial adhesion is achieved through the guidance of the wedge-shaped baffle ends. The merged fluids are continuously propelled into the microfluidic mixing channel by the subsequent pump pressure. As the fluids flow through the spirally arranged flow-blocking micro-protrusions, the flow path is continuously blocked by the protrusions, causing splitting and laminar folding and entanglement, efficiently and thoroughly completing the preliminary preparation for the mixing and solidification reaction within the channel.

[0052] E. In-situ deposition: The mixed fluid is smoothly extruded from the opening at the distal end of the mixing nozzle and deposited directly onto the vocal cord tissue in situ or the target printing area. Subsequently, thermosensitive or chemical cross-linking occurs within the tissue, completing the construction of the biological scaffold.

[0053] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application 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 this application.

[0054] The specific embodiments of the present invention are merely illustrative and do not limit the scope of protection of the present invention. Various changes and modifications can be made to the specific embodiments of the present invention without departing from the spirit and essence of the invention. All such changes and modifications fall within the scope of the present invention.

[0055] The control components such as "central control unit" and "microcontroller" mentioned in this technical solution embodiment can be common standard controllers on the market, such as single-chip microcomputers (MCUs), programmable logic controllers (PLCs), or processor-based embedded systems.

[0056] In this technical solution, the function of these control components is to achieve coordinated linkage and logical control between the various structural components or functional modules described above. For those skilled in the art, implementing the control logic of the above components through programming or circuit design based on the structural layout and functional relationships disclosed in this patent is a well-known conventional technical means and not the core innovation of this patent.

[0057] Therefore, the scope of protection of this patent is intended to protect the physical structure and its cooperative working relationship, without involving the specific circuit design inside the control unit, the software program code it executes, or the firmware algorithm itself. Any existing or future-developed control method that can achieve the same control function can be applied to the embodiments of this patent, and this patent does not limit it.

[0058] It is worth noting that in the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified. In this invention, unless otherwise explicitly specified and limited, the terms "installed," "connected," "linked," "fixed," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can also refer to a mechanical connection. The circuits described in this invention are all circuits commonly used in the art, and other related components are all commonly used existing components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0059] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of the equivalent elements of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

Claims

1. A temperature-sensitive dual-lumen mixing tubing kit for in-situ vocal cord bioprinting, characterized in that, The kit has opposing proximal and distal ends and includes: The tube assembly (1) includes an outer protective tube (101) and an inner diaphragm tube (102) coaxially inserted inside the outer protective tube (101). An axially extending annular interlayer (104) is formed between the inner wall of the outer protective tube (101) and the outer wall of the inner diaphragm tube (102). An axially extending isolation partition (103) is provided inside the inner diaphragm tube (102). The opposite sides of the isolation partition (103) are fixedly connected to the inner wall of the inner diaphragm tube (102) respectively, dividing the inner cavity of the inner diaphragm tube (102) into a first infusion chamber (1021) and a second infusion chamber (1022) that are not interconnected. A microfluidic mixing assembly (2) is fixedly installed at the distal end of the tube assembly (1). The microfluidic mixing assembly (2) includes a connecting sleeve (201) and a mixing nozzle (202) located at the distal end of the connecting sleeve (201). A manifold (203) is provided inside the connecting sleeve (201). The distal end of the inner septum (102) is connected to the proximal end of the connecting sleeve (201), so that the distal outlets of the first infusion chamber (1021) and the second infusion chamber (1022) are connected to the manifold (203). A microfluidic mixing channel (205) communicating with the manifold (203) is provided inside the mixing nozzle (202). A plurality of flow-blocking micro-protrusions are arranged radially towards the center of the channel and staggered on the inner wall of the microfluidic mixing channel (205). The temperature control sensing component includes a flexible heating film (401) and a miniature temperature sensor. The flexible heating film (401) is rolled up and circumferentially covers the outer wall of the inner partition tube (102) and is housed in an annular interlayer (104) between the outer protective tube (101) and the inner partition tube (102). The miniature temperature sensor is embedded in the side wall of the connecting sleeve (201) and its sensing end is located close to the inner wall of the manifold (203). A docking base assembly (3) is fixedly connected to the proximal end of the tube assembly (1). The docking base assembly (3) has a first inlet channel and a second inlet channel (1023) that are respectively connected to the first inlet chamber (1021) and the second inlet chamber (1022). The proximal end face (301) of the docking base assembly (3) is provided with a first inlet interface and a second inlet interface that are respectively connected to the first inlet channel and the second inlet channel (1023). The outer surface of the docking base assembly (3) is embedded with a plurality of data communication contacts (302). The flexible heating film (401) and the miniature temperature sensor are electrically connected to the corresponding data communication contacts (302) through wires passing through the annular interlayer (104).

2. The temperature-sensitive dual-lumen mixing tubing kit for in-situ vocal cord bioprinting according to claim 1, characterized in that, The cross-sectional area of ​​the first infusion chamber (1021) is larger than that of the second infusion chamber (1022); the distal end of the isolation diaphragm (103) extends beyond the distal end face of the inner diaphragm tube (102) and extends into the manifold (203) of the connecting sleeve (201), and the distal end of the isolation diaphragm (103) has a wedge-shaped structure with a thickness that gradually decreases along the distal direction.

3. The temperature-sensitive dual-lumen mixing tubing kit for in-situ vocal cord bioprinting according to claim 1, characterized in that, Multiple flow-blocking micro-protrusions are arranged in a spiral staggered manner along the fluid flow direction of the microfluidic mixing channel (205), and a meandering flow channel is formed between adjacent flow-blocking micro-protrusions to allow the fluid to undergo laminar flow folding and eddy current disturbance.

4. The temperature-sensitive dual-lumen mixing tubing kit for in-situ vocal cord bioprinting according to claim 1, characterized in that, The flexible heating film (401) includes a flexible insulating substrate (402) and conductive heating lines (403) attached to the flexible insulating substrate (402). The conductive heating lines (403) are arranged in a continuous serpentine reciprocating bend along the axial direction of the inner partition tube (102) to form a planar heating area around the inner partition tube (102).

5. The temperature-sensitive dual-lumen mixing tubing kit for in-situ vocal cord bioprinting according to claim 1, characterized in that, The docking base assembly (3) has a sealed mounting cavity (303) inside, and an information identification chip (305) is fixedly embedded in the sealed mounting cavity (303). The pins of the information identification chip (305) are electrically connected to a portion of the data communication contacts (302) on the outer surface of the docking base assembly (3).

6. The temperature-sensitive dual-lumen mixing tubing kit for in-situ vocal cord bioprinting according to claim 1, characterized in that, The proximal end face (301) of the docking base assembly (3) is provided with a mechanical locking boss for connection with an external drive device. The mechanical locking boss includes a cylindrical portion extending axially from the proximal end face (301) toward the proximal end, and at least one locking lug (304) protruding radially outward from the outer wall of the cylindrical portion.

7. The temperature-sensitive dual-lumen mixing tubing kit for in-situ vocal cord bioprinting according to claim 1, characterized in that, The connecting sleeve (201) has a blind hole groove inside its side wall. The opening of the blind hole groove faces the outer side wall of the connecting sleeve (201). A thermally conductive thin wall (204) is left between the bottom of the blind hole groove and the manifold (203). The miniature temperature sensor is fixedly embedded in the blind hole groove and abuts against the thermally conductive thin wall (204).

8. A method for controlling the adhesive application of a temperature-sensitive dual-cavity mixing tube kit for in-situ vocal cord bioprinting according to any one of claims 1-7, characterized in that, Includes the following steps: A. Connect the docking base assembly (3) to the external driving device, so that the proximal end face (301) of the docking base assembly (3) is locked to the external driving device, and the electrodes of the external driving device form electrical contact with the data communication contact (302); the external driving device reads the parameter signal of the internal information identification chip (305) through the data communication contact (302), and establishes the target control temperature range and the flow rate ratio of the first infusion chamber (1021) and the second infusion chamber (1022) accordingly; B. The external driving device outputs electrical energy to the flexible heating film (401) through the data communication contact (302), causing the flexible heating film (401) to heat up and conduct heat radially to the inner partition tube (102); the micro temperature sensor embedded in the side wall of the connecting sleeve (201) collects the heat conduction temperature around the manifold (203) in real time and feeds back the electrical signal to the external driving device, and adjusts the power supply to maintain the temperature of the inner partition tube (102) and the microfluidic mixing assembly (2) within the target control temperature range; C. According to the flow rate ratio, the external drive device pumps the first fluid and the second fluid into the first inlet port and the second inlet port respectively. The first fluid and the second fluid are synchronously propelled to the far end along the first inlet chamber (1021) and the second inlet chamber (1022) respectively. During the propulsion process, the isolation partition (103) physically isolates the two fluids, and the flexible heating film (401) on the periphery maintains the constant temperature of the fluid environment. D. The first fluid and the second fluid are discharged from the distal outlets of the first infusion chamber (1021) and the second infusion chamber (1022), and come into contact and merge in the manifold (203) for the first time. The merged fluid is pushed into the microfluidic mixing channel (205) by the pump pressure. When the fluid flows through the staggered flow-blocking micro-protrusion structure, the flow path is continuously blocked by the protrusions and splits, resulting in laminar folding and entanglement, and the mixing is completed in the channel. E. The mixed fluid is extruded from the opening at the distal end of the mixing nozzle (202) and deposited in the target area.

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