An impermeable adjustable clinical infusion device

Abstract

This invention relates to the field of medical technology, specifically to a leak-proof adjustable clinical infusion device. It includes a catheter with a roller clamp on its outer wall. The roller clamp includes a housing and rollers rotatably connected inside the housing. The catheter end has a tube tip, and the puncture needle end has a needle tip. The tube tip and needle tip are movably engaged. The needle tip includes a tube seat with multiple locking assemblies on its inner wall. The tube tip includes a branch tube with an annular groove on its outer wall. When the tube tip is inserted into the needle tip, the branch tube compresses and drives the locking assemblies to engage with the annular groove on the outer wall of the branch tube, achieving axial locking. The tube tip can rotate circumferentially relative to the needle tip around the multiple locking assemblies. A lever is engaged on the outer wall of the housing. When the lever is removed from the housing, it is movably engaged inside the rollers. If the rollers rotate, the lever moves synchronously with the rollers and abuts against the surface of the housing to limit the rotation angle of the rollers.

Description

Technical Field

[0001] This invention relates to the field of medical technology, and more specifically, to a leak-proof adjustable clinical infusion device. Background Technology

[0002] Clinical infusion devices are the core medical consumables for medical institutions to carry out intravenous fluid replacement, drug infusion, nutritional support and precision drug delivery. They are widely used in various diagnosis and treatment scenarios such as general wards, pediatrics, geriatrics, and intensive care units. They mainly rely on the puncture connection structure and tubing flow structure to achieve continuous drug infusion. They are the basic instruments to ensure the safety of clinical drug delivery and the stable conduct of diagnosis and treatment.

[0003] Currently, most routinely used infusion devices in clinical practice are integrated disposable infusion kits. Their structure mainly includes a puncture needle, catheter, drip chamber, flow regulator (such as a roller clamp), and connectors. The puncture needle is secured to the patient's puncture site with medical tape. The flow regulator controls the fluid flow rate by linearly moving the roller along a groove, changing the inner diameter of the catheter. After setting the initial flow rate according to the doctor's orders at the start of the infusion, the patient or their family can manually adjust the drip rate at any time during the subsequent infusion by manually adjusting the roller. This simple design, characterized by low cost and intuitive operation, has been widely used in clinical practice.

[0004] However, in actual clinical applications, existing integrated infusion kits are prone to loosening when the patient becomes agitated, turns over, moves their limbs, or moves slightly out of bed, as the needle and tubing are rigidly fixed without a stress relief structure. The torque or tension generated by the tubing is directly transmitted to the needle, which can easily cause the needle to shift, loosen, or even come out, leading to subcutaneous extravasation of the medication and exacerbating local tissue damage.

[0005] Furthermore, in scenarios where strict control of low-speed infusion is required, such as in children, elderly cardiovascular patients, or when receiving special drug treatment, the traditional roller clamp has a stepless coarse adjustment mode. When patients are unattended or without family assistance, they may accidentally turn the roller themselves, which could lead to an unexpected increase in the flow rate and safety risks such as excessively rapid infusion and excessive cardiac load.

[0006] Therefore, there is an urgent need for a leak-proof, adjustable clinical infusion device to solve the above problems. Summary of the Invention

[0007] This invention provides a leak-proof, adjustable clinical infusion device. By configuring the catheter tip and the needle tip of the puncture needle as a rotatable locking structure, axial locking and circumferential rotation are achieved. This allows the torque or tension generated by the tubing to be released at the connection point and not directly transmitted to the puncture needle. Simultaneously, by providing a detachable lever on the outside of the housing, the maximum rotation angle of the roller component is limited within a preset range by the lever's contact and limiting action with the housing as the roller component rotates. This solves the problems mentioned in the background art, namely:

[0008] In existing infusion devices, the needle is rigidly connected to the tubing. When the patient moves, the needle may easily dislodge and fall out, causing extravasation of the medication. In addition, traditional roller clamps cannot limit the maximum flow rate. If the patient or family members accidentally increase the flow rate, it may cause the infusion to be too fast and lead to safety risks.

[0009] To achieve the above objectives, the leak-proof adjustable clinical infusion device includes a catheter and a puncture needle. The outer wall of the catheter is provided with a roller clamp, which includes a housing and a roller component rotatably connected inside the housing. The end of the catheter is provided with a tube head component, and the end of the puncture needle is provided with a needle head component. The tube head component and the needle head component are movably engaged.

[0010] The needle assembly includes a tube seat, and the inner wall of the tube seat is provided with multiple retaining shaft assemblies, which can extend and retract inside the tube seat.

[0011] The tube head includes a branch tube, and the outer wall of the branch tube is provided with an annular groove. When the tube head is inserted into the needle head, the branch tube squeezes and drives the locking shaft assembly to engage in the annular groove on the outer wall of the branch tube, thereby achieving axial locking between the tube head and the needle head. The tube head can rotate circumferentially relative to the needle head around multiple locking shaft assemblies.

[0012] The outer wall of the housing is fitted with a lever. When the lever is removed from the housing, it can be movably engaged inside the roller component. If the roller component rotates, the lever moves synchronously with the roller component and abuts against the surface of the housing to limit the rotation angle of the roller component.

[0013] In the above technical solution, the tube head and the needle head are connected by a retractable locking shaft assembly and an annular groove to form a rotatable locking structure. This allows the tube head to be locked firmly in the annular groove by the locking shaft assembly, ensuring the connection sealing and conduction stability during drug delivery, while also allowing the tube head to rotate freely in the circumferential direction relative to the needle head.

[0014] When the patient turns over or becomes agitated, causing torque or tension on the catheter, this rotating structure can automatically release the external force at the connection point, preventing the torque or tension from being directly transmitted to the puncture needle, thus preventing needle displacement, needle dislodgement, and local tissue damage caused by extravasation of medication.

[0015] Meanwhile, the roller assembly is equipped with a detachable and retractable paddle limiting structure. The paddle is normally stored on the outer wall of the housing and does not affect the regular speed adjustment operation. After the medical staff sets the upper limit of the safe infusion flow rate, they can lock the paddle into the roller assembly. When the roller assembly rotates, the paddle will abut against the housing to form a physical stop, limiting the maximum rotational opening of the roller assembly. This prevents patients or their families from increasing the infusion flow rate on their own, reducing and avoiding the medical safety risks of excessively fast infusion and increased cardiac load due to misoperation in low-speed infusion scenarios such as children and elderly cardiovascular patients.

[0016] Based on this, the pipe fitting also includes a tapered connector, one end of which is fixedly connected to the branch pipe and the other end of which is fixedly connected to the conduit.

[0017] The needle assembly also includes a needle connector and a sealing gasket. One end of the needle connector is fixedly connected to the tube seat, and the other end of the needle connector is fixedly connected to the puncture needle. The sealing gasket is fixedly connected to the inner wall connection between the tube seat and the needle connector.

[0018] Preferably, the retaining assembly includes a circular block, a first elastic element, and a ball. The circular block is slidably connected inside the tube seat, the first elastic element is disposed between the circular block and the tube seat, and the ball is movably engaged with the end of the circular block.

[0019] Furthermore, the end corners of the branch pipe are arc-shaped, the surface of the bead is arc-shaped, and the end corners of the block are arc-shaped.

[0020] When the branch pipe is inserted into the pipe seat, the arc-shaped end corner of the branch pipe presses against the arc-shaped surface of the ball and the block, causing the block to compress the first elastic element. When the annular groove on the outer wall of the branch pipe moves to the position corresponding to the ball, the first elastic element resets and pushes the block and the ball into the annular groove.

[0021] In another technical solution, the roller component includes a gear, a rotating shaft, and two toothed rings. The rotating shaft passes through the gear and is rotatably connected inside the housing. The two toothed rings are respectively fixedly connected to the outer walls on both sides of the gear.

[0022] Preferably, both the gear and the gear ring are provided with a plurality of circumferentially distributed teeth, and the teeth of the gear and the gear ring are distributed opposite to each other; a notch is formed between two adjacent teeth of the gear ring, and a locking component is provided at the notch.

[0023] In this technical solution, the locking assembly includes a blocking block and a second elastic element. The two blocking blocks are symmetrically slidably connected to one of the recesses of the toothed ring. The second elastic element is disposed between the blocking block and the teeth of the toothed ring. Under the action of the second elastic element, the blocking block can be extended and retracted inside the teeth of the toothed ring.

[0024] Since the paddle has an overall T-shaped structure, two square holes are provided at the bottom of the T-shape;

[0025] When the paddle is removed from the housing, the T-shaped bottom of the paddle can be inserted into one of the notches of the toothed ring, so that the block can be extended and engaged inside the square hole.

[0026] Based on this, the blocking block has a trapezoidal structure, with the trapezoidal inclined surface of the blocking block facing the outside of the notch of the toothed ring and the trapezoidal plane of the blocking block facing the inside of the notch of the toothed ring.

[0027] When the paddle is inserted into the notch of the toothed ring, the paddle slides down the trapezoidal inclined surface of the two blocks, causing the two blocks to retract towards each other. When the square hole of the paddle moves to the position corresponding to the block, the block extends out and is locked into the square hole under the action of the second elastic element.

[0028] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0029] 1. By setting the tube tip and needle tip of the catheter end as a rotatable snap-fit ​​structure, when the branch tube is inserted into the tube seat, the arc-shaped end corner of the branch tube squeezes the arc-shaped surface of the ball and the block, causing the block to compress the first elastic element. When the annular groove on the outer wall of the branch tube moves to the position corresponding to the ball, the first elastic element resets and pushes the block and the ball into the annular groove, thus achieving axial locking of the tube tip and the needle tip. The tube tip can rotate circumferentially relative to the needle tip around multiple snap-fit ​​components.

[0030] When the patient turns over or moves their limbs, causing torque or tension on the catheter, the rotating structure automatically releases the external force at the connection point, preventing the external force from being directly transmitted to the puncture needle. This prevents needle displacement, loosening, and subcutaneous extravasation of medication, reducing the risk of local tissue damage.

[0031] 2. By detachably snapping the paddle onto the outer wall of the housing, after medical staff set the upper limit of the safe infusion flow rate according to the doctor's order, the paddle is removed from the housing and inserted into one of the notches of the toothed ring. The paddle slides down the trapezoidal slope of the two blocks, causing the blocks to retract towards each other. When the square hole of the paddle moves to the position corresponding to the block, the block extends out under the action of the second elastic element and is snapped into the square hole, thus realizing the fixed connection between the paddle and the roller.

[0032] If the roller rotates at this time, the paddle moves synchronously with the roller and abuts against the surface of the housing to form a physical stop, thereby limiting the maximum rotation angle of the roller and avoiding medical safety risks caused by accidental increase in flow rate in low-speed infusion scenarios such as children and elderly cardiovascular patients. Attached Figure Description

[0033] Figure 1 This is a schematic diagram of the overall structure of the present invention;

[0034] Figure 2 This is a schematic diagram of the internal structure of the housing of the present invention;

[0035] Figure 3 This is a schematic diagram of the tube head and needle head structure of the present invention;

[0036] Figure 4 This is a schematic diagram of the connection steps between the branch pipe and the pipe seat according to the present invention;

[0037] Figure 5 This is a schematic diagram of the shaft assembly structure of the present invention;

[0038] Figure 6 This is a schematic diagram of the branch pipe rotation structure of the present invention;

[0039] Figure 7 This is a schematic diagram of the disassembly structure of the paddle of the present invention;

[0040] Figure 8 This is a schematic diagram of the roller component structure of the present invention;

[0041] Figure 9 This is a schematic diagram of the tooth distribution structure of the gear and gear ring of the present invention;

[0042] Figure 10 This is a schematic diagram of the paddle insertion structure of the present invention;

[0043] Figure 11 This is a schematic diagram of the paddle blocking structure of the present invention;

[0044] Figure 12 This is a schematic diagram of the locking component structure of the present invention.

[0045] The meanings of the labels in the diagram are as follows:

[0046] 1. Catheter;

[0047] 2. Pipe end fittings; 21. Branch pipes; 22. Tapered joints;

[0048] 3. Needle tip; 31. Tube socket; 32. Needle connector; 33. Sealing gasket;

[0049] 34. Pin assembly; 340. Round block; 341. Elastic element No. 1; 342. Round ball;

[0050] 4. Puncture needle;

[0051] 5. Housing; 51. Paddle;

[0052] 6. Roller components; 61. Gears; 62. Shafts; 63. Gear rings;

[0053] 64. Locking assembly; 640. Block; 641. Second elastic element. Detailed Implementation

[0054] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0055] Currently, existing infusion devices suffer from problems such as rigidly fixed needles and tubing, which can easily lead to needle displacement and dislodgement due to patient movement, as well as extravasation of medication causing local damage. Furthermore, traditional stepless roller adjustment lacks flow rate limits, making it easy for non-medical personnel to accidentally adjust the flow rate too high during low-speed infusions. This invention provides a leak-proof, adjustable clinical infusion device. (See [link to relevant documentation]). Figure 1 and Figure 2 As shown, it includes a catheter 1 and a puncture needle 4. The outer wall of the catheter 1 is provided with a roller clamp. The roller clamp includes a housing 5 and a roller 6 rotatably connected inside the housing 5. The end of the catheter 1 is provided with a tube head 2, and the end of the puncture needle 4 is provided with a needle head 3. The tube head 2 and the needle head 3 are movably engaged.

[0056] It should be noted that in the basic structural layout of the present invention, the overall design is based on the mature base architecture of existing clinical infusion devices and optimized. The catheter 1 and the puncture needle 4 included therein are conventional core components of disposable infusion consumables in the prior art. The catheter 1 is used to realize the closed-loop delivery of the drug solution, and the puncture needle 4 is used to puncture the patient's blood vessels to establish the drug solution infusion pathway. The two together constitute the basic connection structure for drug solution transmission.

[0057] and, Figure 2 In this device, the roller clamp mounted on the outer wall of the catheter 1, as well as the housing 5 contained in the roller clamp and the roller component 6 rotatably installed inside the housing 5, also adopt the configuration of the infusion flow rate regulating component commonly used in the prior art. This type of roller clamp is the standard speed regulation structure of the current clinical routine infusion device. By rotating and squeezing the outer wall of the catheter 1, the flow orifice inside the catheter 1 is deformed, thereby realizing the basic regulation of the drug infusion flow rate and meeting the infusion speed regulation needs in routine scenarios.

[0058] For details, see Figure 3 As shown, the needle tip 3 serves as the docking and transfer component between the puncture needle 4 and the catheter tip 2, and is used to realize the detachable and movable connection between the puncture needle 4 and the catheter 1. It mainly consists of a tube seat 31, a needle connector 32, a sealing gasket 33, and multiple retaining shaft assemblies 34. Among them, the tube seat 31 is the main support structure of the needle tip 3, and has a hollow tubular shape, providing installation support space for the retaining shaft assemblies 34. By evenly arranging multiple retaining shaft assemblies 34 along the circumference of the inner wall of the tube seat 31, the retaining shaft assemblies 34 can extend and retract inside the tube seat 31 along the radial direction of the tube seat 31.

[0059] Furthermore, one end of the needle connector 32 is fixedly connected to the tail of the puncture needle 4, and a sealed assembly structure is adopted to make the drug channel inside the puncture needle 4 and the needle connector 32 interconnected, so as to realize the complete flow path of drug from the tube seat 31 through the needle connector 32 to the puncture needle 4, and then injected into the patient's blood vessel through the puncture needle 4.

[0060] Furthermore, by fixing the sealing gasket 33 to the inner wall connection between the tube seat 31 and the needle connector 32, it fills the tiny gap at the connection between the inner walls of the tube seat 31 and the needle connector 32, preventing leakage of the medicine at this connection point, avoiding waste of medicine and the risk of local tissue irritation or infection caused by leakage of medicine; and, since the tube head 2 and the needle head 3 are a movable snap-fit ​​structure, the tube head 2 can rotate circumferentially relative to the needle head 3, and the sealing gasket 33 can continuously fit the connection point during rotation, maintaining the sealing performance, ensuring that the medicine can still be delivered in a closed manner under the rotation state, and avoiding the failure of the seal due to relative rotation;

[0061] It should be noted that the sealing gasket 33 is made of medical-grade flexible sealing material, which can be adapted to the connection contour of the tube seat 31 and the needle connector 32, while reducing drug residue at the connection point, reducing the risk of cross-contamination, and ensuring the safety of clinical infusion.

[0062] Figure 3 In this system, the tube head 2 serves as a connecting and transitional component between the catheter 1 and the needle head 3. It is used to achieve the movable snap-fit ​​assembly of the catheter 1 and the needle head 3, while ensuring smooth flow and sealed delivery of the medication. Specifically, the tube head 2 is mainly composed of two parts: a branch tube 21 and a conical connector 22. The two are fixedly connected and are integrally molded to ensure a firm connection and no leakage of medication, forming a continuous medication flow channel that meets the airtight requirements of clinical infusion.

[0063] The branch tube 21 has a hollow tubular structure, and its internal channel is interconnected with the internal channel of the tapered connector 22, forming a delivery path for the liquid to flow from the conduit 1 to the needle 3. The outer wall of the branch tube 21 has an annular groove along the circumference. The size of the annular groove is adapted to the retaining shaft assembly 34 arranged on the inner wall of the needle 3, ensuring that the retaining shaft assembly 34 can be inserted into the groove to achieve axial positioning of the two.

[0064] In working condition, see Figure 4 As shown, when it is necessary to assemble the tube head 2 and the needle head 3, the medical staff manually inserts the branch tube 21 end of the tube head 2 into the tube seat 31 of the needle head 3. During the insertion process, the end of the branch tube 21 will come into contact with the retaining shaft assembly 34 on the inner wall of the tube seat 31 and generate a squeezing force. Since the retaining shaft assembly 34 can extend and retract radially along the tube seat 31, under the drive of this squeezing force, the retaining shaft assembly 34 will retract into the tube seat 31, thereby providing space for the insertion of the branch tube 21.

[0065] As the branch tube 21 is continuously inserted, when the annular groove on the outer wall of the branch tube 21 moves to the position corresponding to the locking assembly 34, the locking assembly 34 loses the squeezing force of the branch tube 21, returns to its initial extension and retraction state, and is locked into the annular groove on the outer wall of the branch tube 21, thus completing the axial locking of the tube head 2 and the needle head 3, preventing the tube head 2 and the needle head 3 from axially separating, and ensuring the connection stability during the infusion process.

[0066] See Figure 5 As shown, the retaining shaft assembly 34 is assembled inside the tube seat 31 of the needle part 3, and is mainly composed of three parts: a round block 340, an elastic element 341, and a ball 342.

[0067] Among them, the circular block 340 is the main sliding base of the clamping shaft assembly 34. The circular block 340 is slidably assembled inside the preset installation cavity of the tube seat 31 along the radial direction of the tube seat 31, and can make stable telescopic displacement within the cavity. The first elastic element 341 is arranged between the circular block 340 and the cavity wall of the tube seat 31, and provides a continuous pushing and resetting force by its own elastic deformation, providing power support for the contraction and rebound of the circular block 340. The circular ball 342 is movably embedded and clamped at the end of the circular block 340 facing the center of the tube seat 31, and can maintain flexible rotation at the end of the circular block 340, reducing contact friction resistance.

[0068] In this solution, by setting the insertion end of the branch pipe 21 to an arc-shaped structure, and processing the outer surface of the ball 342 and the end of the block 340 that mates with the ball 342 into an arc transition structure, the jamming and squeezing resistance caused by the hard right-angle butt joint can be eliminated, and a flexible guiding transition can be achieved in the insertion process.

[0069] During actual assembly, as the branch pipe 21 of the pipe head 2 is gradually inserted into the pipe seat 31, the arc-shaped end corner of the front end of the branch pipe 21 will first contact and squeeze the arc surface of the ball 342. The squeezing force is transmitted to the round block 340 through the ball 342, which in turn pushes the round block 340 to slide outward along the cavity of the pipe seat 31, and simultaneously compresses the first elastic element 341 to deform, so that the entire clamping shaft assembly 34 shrinks and makes room, reserving passage space for the continued deep insertion of the branch pipe 21.

[0070] As the branch pipe 21 is inserted into place, the annular groove on the outer wall of the branch pipe 21 moves to the position corresponding to the ball 342. At this time, the external squeezing pressure on the ball 342 is released, and the first elastic element 341 returns to its original shape by its own elasticity, pushing the round block 340 in the opposite direction to reset synchronously with the ball 342, so that the ball 342 is embedded and locked inside the annular groove on the outer wall of the branch pipe 21.

[0071] like Figure 6As shown, when the patient turns over or moves his / her limbs, causing the catheter 1 to generate torque or tension, the force will first be transmitted to the tube head 2 and the branch tube 21 connected to the end of the catheter 1; since the ball 342 is flexibly embedded in the end of the round block 340 and can roll freely, and at the same time the ball 342 is stably engaged in the annular groove on the outer wall of the branch tube 21, the branch tube 21 can form an annular rolling fit structure with multiple sets of balls 342 based on the annular groove;

[0072] At this time, the torsional stress generated by the catheter 1 will cause the branch tube 21 to rotate circumferentially along the surface of the ball 342. The rolling friction of the ball 342 will greatly reduce the rotational resistance, allowing the branch tube 21 and the tube head 2 to achieve autonomous rotation and stress relief relative to the needle head 3. Through this rotation process, the torsional and tensile forces on the catheter 1 are dissolved at the docking position of the tube head 2 and the needle head 3, reducing the external force transmitted to the needle head 3, needle connector 32 and puncture needle 4 on the inner side.

[0073] In another technical solution, see Figure 7 As shown, a lever 51 is attached to the outer wall of the housing 5. When the lever 51 is removed from the housing 5, it can be movably attached to the inside of the roller component 6. At this time, if the roller component 6 rotates, the lever 51 moves synchronously with the roller component 6 and abuts against the surface of the housing 5 to limit the rotation angle of the roller component 6.

[0074] For details, see Figure 8 As shown, the roller component 6 is composed of three parts: a gear, a rotating shaft, and two gear rings 63. The gear is the main force-bearing component of the roller component 6. It has a circular gear structure and its outer circumference abuts against the outer wall of the conduit 1. By rotating itself, it squeezes the outer wall of the conduit 1, changes the size of the internal flow orifice of the conduit 1, and thus adjusts the flow rate of the drug infusion.

[0075] In this technical solution, the rotating shaft passes through the gear along the central axis of the gear and is fixedly connected to ensure that the gear can rotate synchronously with the rotating shaft. At the same time, both ends of the rotating shaft are rotatably connected to the preset mounting holes inside the housing 5, so that the roller 6 can rotate around the rotating shaft inside the housing 5. Furthermore, by symmetrically arranging two toothed rings 63 on the outer walls of both sides of the gear and fixing them to the gear, it is ensured that the toothed rings 63 and the gear can rotate synchronously.

[0076] like Figure 9 As shown, both the gear and the gear ring 63 are provided with multiple circumferentially distributed teeth. The teeth of the gear and the gear ring 63 are arranged in a relatively distributed manner, that is, each tooth on the outer periphery of the gear is aligned with the corresponding teeth on the outer periphery of the gear rings on both sides in the same radial plane, forming a symmetrical and synchronous tooth distribution structure.

[0077] Specifically, since the subsequent paddle 51 needs to be simultaneously engaged in the recesses of the toothed rings 63 on both sides to achieve the limiting, the relative distribution of the teeth can make the recesses of the toothed rings 63 on both sides align synchronously, ensuring that the paddle 51 can form a stable engagement with the toothed rings 63 on both sides after insertion, avoiding the loosening of the limiting caused by unilateral engagement.

[0078] Furthermore, an inwardly recessed notch is naturally formed between two adjacent teeth of the toothed ring 63. The notch has an arc-shaped structure, and a set of locking components 64 is provided at each notch. The locking components 64 are embedded in the inner side of the notch of the toothed ring 63 and cooperate with the teeth and the notch to achieve positioning and locking after the paddle 51 is engaged, preventing the paddle 51 from loosening or falling off during the limiting process.

[0079] During operation, the gear, gear ring 63, and locking assembly 64 work together with the housing 5 of the roller clamp and the lever 51 to achieve flow rate regulation in two working stages: normal flow rate adjustment and flow rate limit locking.

[0080] In the normal flow rate adjustment state, there is no limit switch 51, which is suitable for routine infusion scenarios. Medical staff can manually rotate the gear of the roller component 6 according to the patient's treatment needs. Since the gear is fixedly connected to the shaft and the two toothed rings 63 are synchronously fixed with the gear and the teeth are relatively distributed, the rotation of the gear will drive the shaft to rotate synchronously. The toothed rings 63 on both sides will also rotate around the shaft together with the gear. At the same time, the outer circumferential surface of the gear abuts against the outer wall of the catheter 1. As the gear rotates, the degree of compression of the catheter 1 by the gear changes, thereby changing the flow orifice inside the catheter 1 and realizing the routine adjustment of the drug infusion flow rate.

[0081] During this process, the notches of the toothed rings 63 on both sides rotate synchronously with the gears, and the locking component 64 is in a naturally extended state, embedded in the inside of the notch, without affecting the normal rotation of the gears and toothed rings 63, ensuring smooth flow rate adjustment operation and conforming to the conventional operating habits of existing roller clamps.

[0082] When the flow rate is locked, after medical staff have determined the safe maximum infusion flow rate according to the treatment needs of special groups such as children and elderly cardiovascular patients, the rotation angle of the roller component 6 must be limited to prevent patients or their families from increasing the flow rate on their own.

[0083] The paddle 51, which is attached to the outer wall of the roller clamp housing 5, is manually removed by medical staff. The paddle 51 has a T-shaped structure. The core purpose of this T-shaped design is to facilitate the engagement of its T-shaped tail with the notch of the toothed ring 63, while extending the distance of the top strip to avoid directly locking the roller 6 due to the use of a single plate structure. This ensures that the flow rate adjustment range is limited, rather than completely locking the rotation of the roller 6.

[0084] See Figure 10As shown, due to the relative distribution of the teeth of the gear and the toothed ring 63, the notches of the two toothed rings 63 always remain synchronously aligned. Without additional adjustment, it can be ensured that the paddle 51 can be aligned with the same set of notches of the two toothed rings 63 at the same time. During the insertion process, the T-shaped bottom end of the paddle 51 will contact the locking component 64 inside the notch and generate a squeezing force, which will drive the locking component 64 to retract into the teeth to make room for the insertion of the paddle 51.

[0085] When the paddle 51 is inserted into place, the T-shaped bottom of the paddle 51 is fully embedded in the recess of the toothed rings 63 on both sides. The two square holes at its bottom correspond to the locking component 64. At this time, the squeezing force of the paddle 51 on the locking component 64 is released. The locking component 64 returns to its original position by its own elasticity, extends out from inside the teeth and engages with the square hole inside the paddle 51, thereby achieving the positioning and locking of the paddle 51 in the recess.

[0086] After the latch 51 is engaged and locked, if someone attempts to turn the gear to increase the infusion flow rate, such as Figure 11 As shown, the gear will drive the toothed rings 63 on both sides to rotate synchronously. At this time, the top of the rotating paddle 51 will abut against the surface of the housing 5. Through the abutment and blocking effect of the paddle 51 and the housing 5, the maximum rotation angle of the gear and toothed ring 63 is limited, so that the roller part 6 cannot continue to rotate in the direction of increasing the flow rate, thereby locking the upper limit of the infusion flow rate and preventing unauthorized personnel from arbitrarily increasing the flow rate.

[0087] In this embodiment, see Figure 12 As shown, the locking assembly 64 is mainly composed of a blocking block 640 and a second elastic element 641, and is integrally fitted into the notch formed by two adjacent teeth of the toothed ring 63, adapting to the structural contour of the notch.

[0088] Among them, the two blocking blocks 640 are symmetrically distributed and are slidably connected in the inner side wall of the toothed ring 63 recess, and can slide in opposite directions or in opposite directions along the recess; the second elastic element 641 is limited and installed between the blocking block 640 and the inside of the recess, and relies on its own elastic deformation to provide a continuous elastic pushing force for the blocking block 640, so that the two blocking blocks 640 are normally extended into the recess.

[0089] In addition, the stop block 640 has a trapezoidal structure, with the trapezoidal inclined surface of the stop block 640 facing the outside of the notch of the toothed ring 63 and the trapezoidal plane facing the inside of the notch of the toothed ring 63. When the paddle 51 is inserted, the inclined surface can decompose the axial insertion force of the paddle 51 into a component force that drives the stop block 640 to retract, avoiding jamming when the paddle 51 is inserted and ensuring convenient and efficient operation for medical staff. The trapezoidal plane of the stop block 640 facing the inside of the notch serves to prevent the paddle 51 from coming out after it is engaged.

[0090] When someone attempts to pull out the lever 51 without authorization, the inner wall of the square hole of the lever 51 will abut against the trapezoidal plane of the block 640. The trapezoidal plane cannot provide a guiding force, but instead forms a rigid block, causing the block 640 to be jammed in the square hole under the pushing force of the second elastic element 641, thus jamming the lever 51 and making it impossible to pull it out easily.

[0091] In the above technical solution, it should be noted that this infusion device is a single-use instrument and there is no need to consider the repeated disassembly and reuse of the lever 51. Therefore, the locking design does not need to take into account the subsequent disassembly requirements. It only needs to focus on ensuring the reliability of the limit lock, preventing unauthorized personnel from pulling out the lever 51 and adjusting the flow rate, thereby improving the safety of clinical infusion.

[0092] When medical staff insert the paddle 51 into the notch of the toothed ring 63, the T-shaped bottom end of the paddle 51 will first contact the trapezoidal inclined surface of the two blocks 640. As the paddle 51 continues to be inserted into the notch, the paddle 51 generates a squeezing force along the inclined surface. This squeezing force is decomposed into a component force that drives the two blocks 640 to move towards each other, causing the two blocks 640 to retract towards each other along the groove, and simultaneously squeezing the second elastic element 641 to undergo elastic deformation. At this time, the two blocks 640 contract into the teeth of the toothed ring 63, making way for the continued insertion of the paddle 51, ensuring that the paddle 51 can be smoothly inserted into the notch.

[0093] When the two square holes at the bottom of the lever 51T move to the positions corresponding to the two blocks 640, the squeezing force of the lever 51 on the blocks 640 is released. The second elastic element 641 returns to its original state by its own elasticity, releases the stored elastic potential energy, and pushes the two blocks 640 outward until the ends of the two blocks 640 are inserted into the corresponding square holes of the lever 51, thus realizing the engagement between the blocks 640 and the lever 51.

[0094] Working principle:

[0095] When medical staff perform routine infusion procedures and there is no need for flow rate limiting, the device is in the routine infusion working state. At this time, according to the patient's treatment needs, the medical staff manually rotates the gear of the roller component 6, and changes the flow orifice diameter of the catheter 1 by rotating the gear to achieve routine adjustment of the drug infusion flow rate. At the same time, the tube head component 2 and the needle head component 3 remain in a movable locking state. The torque generated when the patient moves is automatically dissipated by the rotatable structure. The ball 342 in the locking shaft assembly 34 cooperates with the branch tube 21, so that the tube head component 2 can rotate flexibly relative to the needle head component 3, avoiding the transmission of external force to the puncture needle 4 and ensuring stable drug infusion.

[0096] When patients are special populations such as children or elderly cardiovascular patients, and strict control of the infusion flow rate is required to avoid misoperation, the device switches to the flow rate limiting working state. At this time, medical staff remove the lever 51 from the housing 5. Due to the relative distribution of the teeth of the gear and the toothed ring 63, and the synchronous alignment of the notches on both sides of the toothed ring 63, the lever 51 can be smoothly inserted into the notches on both sides of the toothed ring 63. Relying on the structural adaptation of the gear and the toothed ring 63, the upper limit of the flow rate is locked. At the same time, the synchronous rotation characteristics of the gear and the toothed ring 63 ensure that the lever 51 can be stably limited after insertion, preventing the roller 6 from rotating arbitrarily and eliminating the possibility of unauthorized personnel adjusting the flow rate.

[0097] When the patient becomes agitated, turns over, or gets out of bed, the device enters the anti-leakage protection state. The torsional and pulling forces in the tubing generated by the patient's movements are dissipated through the movable connection structure between the tube head 2 and the needle head 3. The tube head 2 can rotate freely around the needle head 3 to prevent the needle from shifting.

[0098] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely preferred examples and are not intended to limit the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of the present invention is defined by the appended claims and their equivalents.

Claims

1. A leak-proof adjustable clinical infusion device, comprising a catheter (1) and a puncture needle (4), wherein the outer wall of the catheter (1) is provided with a roller clamp, the roller clamp comprising a housing (5) and a roller component (6) rotatably connected inside the housing (5), characterized in that: The catheter (1) is provided with a tube head (2) at its end, and the puncture needle (4) is provided with a needle head (3) at its end. The tube head (2) and the needle head (3) are movably engaged. The needle tip (3) includes a tube seat (31), and the inner wall of the tube seat (31) is provided with a plurality of retaining shaft assemblies (34), which can extend and retract inside the tube seat (31); The tube head (2) includes a branch tube (21). The outer wall of the branch tube (21) is provided with an annular groove. When the tube head (2) is inserted into the needle head (3), the branch tube (21) squeezes and drives the locking shaft assembly (34) to engage in the annular groove on the outer wall of the branch tube (21), thereby achieving axial locking between the tube head (2) and the needle head (3). The tube head (2) can rotate circumferentially relative to the needle head (3) around multiple locking shaft assemblies (34). The outer wall of the housing (5) is fitted with a paddle (51). When the paddle (51) is removed from the housing (5), it can be movably fitted inside the roller (6). If the roller (6) rotates, the paddle (51) moves synchronously with the roller (6) and abuts against the surface of the housing (5) to limit the rotation angle of the roller (6).

2. The leak-proof adjustable clinical infusion device according to claim 1, characterized in that: The pipe head (2) also includes a tapered connector (22), one end of which is fixedly connected to the branch pipe (21), and the other end of which is fixedly connected to the conduit (1).

3. The leak-proof adjustable clinical infusion device according to claim 1, characterized in that: The needle tip component (3) also includes a needle connector (32) and a sealing gasket (33). One end of the needle connector (32) is fixedly connected to the tube seat (31), and the other end of the needle connector (32) is fixedly connected to the puncture needle (4). The sealing gasket (33) is fixedly connected to the inner wall connection between the tube seat (31) and the needle connector (32).

4. The leak-proof adjustable clinical infusion device according to claim 1, characterized in that: The locking assembly (34) includes a round block (340), a first elastic element (341), and a ball (342). The round block (340) is slidably connected inside the tube seat (31). The first elastic element (341) is disposed between the round block (340) and the tube seat (31). The ball (342) is movably locked to the end of the round block (340).

5. The leak-proof adjustable clinical infusion device according to claim 4, characterized in that: The end corners of the branch pipe (21) are arc-shaped, the surface of the bead (342) is arc-shaped, and the end corners of the block (340) are arc-shaped. When the branch pipe (21) is inserted into the pipe seat (31), the arc-shaped end corner of the branch pipe (21) presses the arc-shaped surface of the ball (342) and the round block (340), causing the round block (340) to compress the first elastic element (341). When the annular groove on the outer wall of the branch pipe (21) moves to the position corresponding to the ball (342), the first elastic element (341) resets and pushes the round block (340) and the ball (342) into the annular groove.

6. The leak-proof adjustable clinical infusion device according to claim 1, characterized in that: The roller component (6) includes a gear (61), a rotating shaft (62) and two toothed rings (63). The rotating shaft (62) passes through the gear (61) and is rotatably connected inside the housing (5). The two toothed rings (63) are respectively fixedly connected to the outer walls on both sides of the gear (61).

7. The leak-proof adjustable clinical infusion device according to claim 6, characterized in that: Both the gear (61) and the toothed ring (63) are provided with a plurality of circumferentially distributed teeth, and the teeth of the gear (61) and the toothed ring (63) are distributed relative to each other; a notch is formed between two adjacent teeth of the toothed ring (63), and a locking component (64) is provided at the notch.

8. The leak-proof adjustable clinical infusion device according to claim 7, characterized in that: The locking assembly (64) includes a blocking block (640) and a second elastic element (641). The two blocking blocks (640) are symmetrically slidably connected to one of the recesses of the toothed ring (63). The second elastic element (641) is disposed between the blocking block (640) and the toothed ring (63). Under the action of the second elastic element (641), the blocking block (640) is retractably disposed inside the toothed ring (63).

9. The leak-proof adjustable clinical infusion device according to claim 8, characterized in that: The paddle (51) has a T-shaped structure, and two square holes are provided at the bottom of the T-shape of the paddle (51); When the paddle (51) is removed from the housing (5), the T-shaped bottom of the paddle (51) can be inserted into one of the notches of the toothed ring (63), so that the block (640) can be telescopically engaged in the square hole.

10. The leak-proof adjustable clinical infusion device according to claim 9, characterized in that: The block (640) has a trapezoidal structure, with the trapezoidal inclined surface of the block (640) facing the outside of the notch of the toothed ring (63) and the trapezoidal plane of the block (640) facing the inside of the notch of the toothed ring (63). When the paddle (51) is inserted into the notch of the toothed ring (63), the paddle (51) slides down along the trapezoidal slope of the two blocks (640), causing the two blocks (640) to retract towards each other. When the square hole of the paddle (51) moves to the position corresponding to the block (640), the block (640) extends out and is inserted into the square hole under the action of the second elastic element (641).

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