Floating dialysis tubing assembly anti-puncture spike device and dialysis tubing automatic assembly apparatus

Abstract

The utility model provides a kind of float type dialysis tube assembly anti-puncture thimble device and dialysis tube automatic assembly equipment, it can retract instantaneously when puncture meets resistance, it includes pedestal, outer thimble, inner thimble, first drive unit, second drive unit and elastic buffer unit;Outer thimble is fixedly connected second drive unit;Inner thimble coaxial sliding sleeve is set in the inner chamber of outer thimble;First drive unit connects inner thimble, one of first drive unit and second drive unit is fixedly arranged in pedestal, and the other is movably arranged in pedestal;Elastic buffer unit is sleeved on inner thimble between first drive unit and second drive unit, two ends of elastic buffer unit are connected with first drive unit and second drive unit respectively, and it is in precompression state under normal condition;When puncture part contacts contact pipeline is blocked, movable drive unit is displaced in direction away from pipeline, elastic buffer unit is stretched, and inner thimble is retracted relative to outer thimble.

Description

Technical Field

[0001] This utility model relates to the field of dialysis tube processing, specifically to a floating dialysis tube assembly anti-puncture pin device and an automatic dialysis tube assembly equipment. Background Technology

[0002] In hemodialysis treatment systems, the dialyzer, through precise coordination with dialysis tubing, dialysate, and the dialysis machine, replaces the kidneys in performing the functions of removing metabolic waste, maintaining electrolyte balance, and regulating fluids. It has become a core life support method for patients with acute and chronic renal failure. During treatment, the patient's blood is drawn out of the body through a dialysis tubing that is 1.5-2 meters long, undergoes substance exchange within the dialyzer, and is then returned to the body. The integrity of the tubing directly determines the safety of the treatment.

[0003] Current dialysis tubing assembly processes commonly employ adhesive bonding, such as cyclohexanone solvent bonding of PVC tubing, UV-cured silicone tubing, or AB glue fixing metal connectors. A key step is inserting the puncture needle into the tubing port to assemble the connector. However, automated production faces significant challenges:

[0004] 1. When the pipe cutting end face is uneven or has dimensional tolerances, the rigid puncture of the hard steel needle can easily cause the pipe wall to be punctured, forming a micron-sized hole, which poses a risk of puncture and leakage.

[0005] 2. Perforation during dialysis treatment can cause biphasic leakage of blood and dialysate. Blood leakage can lead to a sharp increase in the risk of blood loss and infection in patients; dialysate backflow can contaminate the blood and cause hemolysis or sepsis.

[0006] Traditional equipment relies on manual visual inspection for alignment, which is inefficient and inconsistent; rigid needles lack a buffer mechanism, and when they encounter resistance, the kinetic energy of the puncture is converted into destructive force on the tube wall; there is no real-time detection after puncture, and the defects flow into the clinic, causing major medical accidents.

[0007] According to the FDA Adverse Event Database, from 2019 to 2023, there were over 1,200 dialysis accidents worldwide caused by tubing leaks, with 68% of these stemming from puncture injuries during assembly. Therefore, developing a smart needle device with active puncture prevention capabilities has become a key technological breakthrough for improving the reliability of dialysis tubing. Utility Model Content

[0008] The purpose of this invention is to provide a floating dialysis tube assembly anti-puncture needle device and an automatic dialysis tube assembly equipment. It can instantly retract the inner needle when puncture is obstructed, with a response time of ≤0.1 seconds; the retraction stroke is precisely constrained with an error of ±0.05mm to avoid excessive displacement failure; the puncture force threshold is adjustable to adapt to tubes of different hardness; and it is integrated with the glue application and conveying modules to build a fully automated anti-puncture production line.

[0009] The embodiments of this utility model are implemented as follows:

[0010] A floating dialysis tube assembly anti-puncture pin device includes a base, an outer pin, an inner pin, a first driving unit, a second driving unit, and an elastic buffer unit.

[0011] The outer ejector pin is fixedly connected to the second drive unit, and the front end of the outer ejector pin is provided with an accessory support part;

[0012] The inner ejector pin is coaxially and slidably sleeved within the inner cavity of the outer ejector pin, and the front end of the inner ejector pin extends to form a puncture section;

[0013] The first drive unit is connected to the inner ejector pin; one of the first drive unit and the second drive unit is fixedly mounted on the base, and the other is movably mounted on the base;

[0014] The elastic buffer unit is sleeved on the inner pin between the first drive unit and the second drive unit. The two ends of the elastic buffer unit are respectively connected to the first drive unit and the second drive unit, and it is in a pre-compressed state under normal conditions.

[0015] When the puncture site is blocked from contacting the tubing, the movable drive unit moves away from the tubing, and the elastic buffer unit stretches, causing the inner ejector pin to retract relative to the outer ejector pin.

[0016] In a preferred embodiment of the present invention, the first driving unit is fixedly disposed, and the second driving unit is slidably disposed on the guide rail of the base; or, the second driving unit is fixedly disposed, and the first driving unit is slidably disposed on the guide rail of the base.

[0017] In a preferred embodiment of the present invention, the above-mentioned elastic buffer unit includes a helical spring, the two ends of which are hooked onto the connecting lugs of the first driving unit and the second driving unit, or the two ends of the helical spring are welded onto the bodies of the first driving unit and the second driving unit, respectively.

[0018] In a preferred embodiment of this utility model, the gap between the inner ejector pin and the inner cavity of the outer ejector pin is 0.05-0.15mm, and the outer wall of the inner ejector pin forms a sliding seal with the inner wall of the outer ejector pin when the inner ejector pin retracts.

[0019] In a preferred embodiment of the present invention, the ejector device further includes a stroke limiting structure, which includes a boss disposed on the inner ejector and a limiting groove in the inner cavity of the outer ejector, for constraining the maximum retraction distance of the inner ejector.

[0020] In a preferred embodiment of this utility model, the above-mentioned accessory support part is an annular groove or magnetic adsorption structure at the front end of the outer ejector pin.

[0021] In a preferred embodiment of this invention, the inner pin is provided with a puncture force sensor for real-time detection of the axial pressure on the puncture site.

[0022] In a preferred embodiment of this utility model, the aforementioned puncture force sensor is a micro strain gauge attached to the outer wall of the inner ejector pin, and the signal line of the micro strain gauge is led to the rear end through the axial groove of the inner ejector pin.

[0023] An automated dialysis tubing assembly device includes an adhesive application module, a conveying module, and a floating dialysis tubing assembly anti-puncture needle device as described above.

[0024] The beneficial effects of this utility model embodiment are: through the floating buffer design combining the elastic buffer unit and the movable drive unit, when the puncture part encounters resistance, such as the tube position shift, deformation, or accessories not being in place, the inner needle can be actively retracted, effectively preventing the expensive dialysis tubing from being punctured, and significantly reducing the scrap rate and assembly risk. Attached Figure Description

[0025] To more clearly illustrate the technical solutions of the embodiments of this utility model, the drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this utility model and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0026] Figure 1 This is a schematic diagram of the anti-puncture needle device for assembling a floating dialysis tube according to an embodiment of the present invention;

[0027] Figure 2 This is a schematic diagram of the outer ejector pin and inner ejector pin structure according to an embodiment of the present utility model;

[0028] Figure 3 This is a schematic diagram of the structure when the inner ejector pin rebounds to the outer ejector pin according to an embodiment of the present invention;

[0029] Figure 4 This is a schematic block diagram of the controller circuit connection according to an embodiment of the present utility model;

[0030] Icons: Base 1; Guide rail 11; Electromagnetic damper 12; Outer ejector pin 2; Limiting groove 21; Inner ejector pin 3; Puncture part 31; Boss 32; Puncture force sensor 33; First drive unit 4; Second drive unit 5; Elastic buffer unit 6; Controller 7. Detailed Implementation

[0031] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. The components of the embodiments of this utility model described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0032] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0033] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0034] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of this utility model is in use. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model. In addition, the terms "first," "second," and "third," etc., are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0035] Furthermore, terms such as "horizontal," "vertical," and "sag" do not imply that components must be absolutely horizontal or suspended, but rather that they can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal relative to "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0036] In the description of this utility model, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0037] First Embodiment

[0038] Please refer to Figure 1-4 This embodiment provides a floating dialysis tubing assembly anti-puncture pin device, including a base 1, an outer pin 2, an inner pin 3, a first drive unit 4, a second drive unit 5, and an elastic buffer unit 6. The device features anti-puncture functionality and automated integration, significantly reducing the need for manual monitoring and intervention, improving production efficiency and consistency. Simultaneously, it effectively prevents scrap due to tubing puncture, significantly improving product yield and economic benefits. One first drive unit 4 and one second drive unit 5 are mounted on the base 1, and multiple floating units composed of the outer pin 2, the inner pin 3, and the elastic buffer unit 6 can be mounted on the first and second drive units.

[0039] This device, through its active protection technology that dynamically senses resistance during the puncture process and triggers needle retraction in milliseconds, fundamentally blocks the puncture chain reaction, reducing the puncture rate of tubing assembly from the industry average of 6.2% to below 0.1%, thus eliminating medical accidents caused by leakage.

[0040] The outer ejector pin 2 is fixedly connected to the second drive unit 5, and the front end of the outer ejector pin 2 is provided with a component support part; the inner ejector pin 3 is coaxially slidably sleeved in the inner cavity of the outer ejector pin 2, and the front end of the inner ejector pin 3 extends to form a puncture part 31; the first drive unit 4 is connected to the inner ejector pin 3; one of the first drive unit 4 and the second drive unit 5 is fixedly set on the base 1, and the other is movably set on the base 1; the elastic buffer unit 6 is sleeved on the inner ejector pin 3 between the first drive unit 4 and the second drive unit 5, and the two ends of the elastic buffer unit 6 are respectively connected to the first drive unit 4 and the second drive unit 5, and are in a pre-compressed state under normal conditions; when the puncture part 31 is blocked from contacting the contact tube, the movable drive unit moves away from the tube, the elastic buffer unit 6 stretches, and the inner ejector pin 3 retracts relative to the outer ejector pin 2.

[0041] By setting an active anti-puncture protection, when the puncture part 31 encounters resistance, such as tubing displacement, deformation, or misalignment of accessories, the inner ejector pin 3 can be actively retracted, effectively preventing puncture of the expensive dialysis tubing and significantly reducing scrap rate and assembly risk.

[0042] The first drive unit 4 is fixedly mounted, and the second drive unit 5 is slidably mounted on the guide rail 11 of the base 1; or, the second drive unit 5 is fixedly mounted, and the first drive unit 4 is slidably mounted on the guide rail 11 of the base 1. These two configurations, with the first or second drive unit 5 fixed / sliding, provide design flexibility and facilitate integration into different equipment layouts. The first and second drive units 5 independently control the inner and outer ejector pins 2, providing flexible motion control to adapt to the needs of different assembly stages. In this embodiment, the first drive unit 4 and the second drive unit 5 are cylinders; in other embodiments, other methods such as electric telescopic rods can also be selected.

[0043] In this embodiment, the inner ejector pin 3 is rigidly connected to the first drive unit 4, such as by threaded locking / welding, to ensure that 100% of the puncture resistance is transmitted to the drive unit. The first drive unit 4, as a movable drive unit, has a low-friction fit with the guide rail 11 of the base 1, with a friction coefficient ≤0.1, allowing it to move backward under minimal resistance. The second drive unit 5 is fixed on the base 1.

[0044] Furthermore, an electromagnetic damper 12 can be installed on the guide rail 11 to control the sliding resistance through current. During normal puncture: energizing increases damping to prevent vibration and deviation; during obstructed retraction: de-energizing reduces damping to ensure sensitive backward movement.

[0045] The elastic buffer unit 6 includes a helical spring. The two ends of the helical spring can be hooked onto the connecting lugs of the first drive unit 4 and the second drive unit 5, respectively, or the two ends of the helical spring can be welded to the bodies of the first drive unit 4 and the second drive unit 5, respectively. The elastic buffer unit 6 is pre-compressed under normal conditions to provide a stable initial force, ensuring that the inner and outer ejector pins 2 work together during normal puncture. It only stretches and buffers when obstructed, ensuring reliable operation and sensitive response. The pre-compression force of the helical spring is greater than the normal puncture resistance, ensuring that the spring remains compressed during normal puncture, and the inner and outer ejector pins 2 advance synchronously. When obstructed, the reaction force of the tubing must be greater than the pre-compression force to trigger retraction.

[0046] The gap between the inner ejector pin 3 and the inner cavity of the outer ejector pin 2 is 0.05-0.15mm. When the inner ejector pin 3 retracts, its outer wall and the inner wall of the outer ejector pin 2 form a sliding seal. The minimal gap between the inner ejector pin 3 and the inner cavity of the outer ejector pin 2, with a gap of 0.05-0.15mm and a sliding seal design, ensures that the inner ejector pin 3 moves smoothly and accurately, reduces shaking, and guarantees puncture accuracy.

[0047] The ejector device also includes a stroke limiting structure, which includes a boss 32 on the inner ejector 3 and a limiting groove 21 in the inner cavity of the outer ejector 2, used to constrain the maximum retraction distance of the inner ejector 3.

[0048] The accessory support is an annular groove or magnetic adsorption structure at the front end of the outer ejector pin 2. The annular groove or magnetic adsorption structure can stably and without damage support the accessories required for dialysis tube assembly (such as connectors, seals, etc.), ensuring that the accessories are accurately positioned during puncture.

[0049] The inner needle 3 is equipped with a puncture force sensor 33, which is used to detect the axial pressure on the puncture part 31 in real time.

[0050] The puncture force sensor 33 is a miniature strain gauge attached to the outer wall of the inner ejector pin 3. The signal line of the miniature strain gauge is led to the rear end through the axial groove of the inner ejector pin 3. This embodiment integrates the puncture force sensor 33. The sensor uses a strain gauge and can monitor the puncture force in real time, providing accurate data support for process control, quality traceability and anti-puncture triggering, further improving reliability and intelligence.

[0051] The puncture force sensor 33 is electrically connected to the controller 7, and the controller 7 is electrically connected to the first drive unit 4, the second drive unit 5, and the electromagnetic damper 12.

[0052] The procedure for using the anti-puncture needle device for the floating dialysis tubing assembly in this embodiment is as follows:

[0053] Accessory loading: Assemble the dialysis tubing with the necessary accessories, such as connectors and sealing rings, and place them in the annular groove or magnetic adsorption structure of the accessory carrier at the front end of the outer pin 2 to ensure that the accessories are fixed and do not shift.

[0054] Tube positioning: The dialysis tubing to be assembled is moved to the puncture station via the conveyor module. The clamps precisely fix the tubing axis to be coaxial with the ejector pin. Before each assembly, it is necessary to ensure that the tubing axis is strictly coaxial with the ejector pin. If the tolerance is <0.1mm, it is necessary to avoid triggering false retraction. The sliding seal between the inner and outer ejector pins is used with a gap of 0.05-0.15mm to prevent glue or impurities from entering the inner cavity. Residual glue needs to be cleaned regularly.

[0055] Elastic unit pre-compression: Start the equipment self-test to confirm that the elastic buffer unit 6 is in a pre-compression state to provide initial thrust for puncture. Regularly check the pre-compression force and fatigue state of the helical spring to prevent elastic failure from causing the anti-puncture function to malfunction.

[0056] Puncture assembly

[0057] Synergistic needle insertion: The first drive unit 4 and the second drive unit synchronously drive the inner ejector needle 3 and the outer ejector needle 2 forward: the puncture part 31 of the inner ejector needle 3 enters the center of the accessory; the outer ejector needle 2 pushes the accessory against the end of the dialysis tube. At this time, the elastic buffer unit 6 remains compressed, and there is no relative displacement between the inner and outer ejector needles 2.

[0058] Obstruction Retraction: If the puncture part 31 is obstructed when contacting the tubing, such as when the tubing is misaligned, deformed, or the fitting is not properly attached, the puncture part 31 will experience reverse resistance, and the pressure will be transmitted to the inner ejector pin 3, pushing the movable drive unit to move backward along the guide rail 11 of the base 1; the elastic buffer unit 6 will be stretched, and the inner ejector pin 3 will retract backward relative to the outer ejector pin 2 to avoid puncturing the tubing; at the same time, the puncture force sensor 33 will provide real-time feedback on abnormal pressure. The inner ejector pin 3 integrates the puncture force sensor 33, which needs to be set with a pressure threshold. If it is >5N, an alarm or shutdown will be triggered to achieve intelligent damage prevention.

[0059] The travel limiting structure between the inner and outer ejector pins 2 ensures that the retraction distance is ≤ the design maximum value, which is 2mm in this embodiment, to prevent excessive displacement.

[0060] Automatic reset: After the resistance is released, if the pipeline position is adjusted, the elastic buffer unit 6 retracts, and the drive unit pushes the inner pin 3 to extend back to the initial position.

[0061] Completion and Reset

[0062] Puncture complete: The puncture part 31 successfully punctures the accessory and inserts into the tube. The outer ejector pin 2 continues to move forward, pressing the accessory to the tube port to complete the assembly.

[0063] Overall retraction: The inner and outer ejector pins 2 retract synchronously to the safe position, releasing the assembled dialysis tubing.

[0064] Cycle ready: The ejector pin assembly is reset, awaiting the next component loading and pipeline positioning.

[0065] This embodiment also provides an automated dialysis tubing assembly device, including an adhesive application module, a conveying module, and a floating dialysis tubing assembly anti-puncture needle device as described above. As a key component of the automated dialysis tubing assembly device, the adhesive application and conveying modules enable high-precision, automated puncture assembly of dialysis tubing components.

[0066] This specification describes examples of embodiments of the present invention, but does not imply that these embodiments illustrate and describe all possible forms of the present invention. It should be understood that the embodiments in the specification can be implemented in various alternative forms. The drawings are not necessarily drawn to scale; some features may be enlarged or reduced to show details of specific components. The specific structural and functional details disclosed should not be construed as limiting, but merely as a representative basis for teaching those skilled in the art to implement the present invention in various forms. Those skilled in the art will understand that multiple features illustrated and described with reference to any of the drawings can be combined with features illustrated in one or more other drawings to form embodiments not explicitly illustrated or described. The illustrated combinations of features provide representative embodiments for typical applications. However, various combinations and variations of features consistent with the teachings of the present invention may be used as needed for specific applications or implementations.

[0067] The above are merely preferred embodiments of this utility model and are not intended to limit the scope of this utility model. Various modifications and variations can be made to this utility model by those skilled in the art. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of this utility model should be included within the protection scope of this utility model.

Claims

1. A floating dialysis tubing assembly anti-puncture needle device, characterized in that, It includes a base, an outer ejector pin, an inner ejector pin, a first drive unit, a second drive unit, and an elastic buffer unit; The outer ejector pin is fixedly connected to the second drive unit, and the front end of the outer ejector pin is provided with an accessory support part; The inner ejector pin is coaxially and slidably sleeved within the inner cavity of the outer ejector pin, and the front end of the inner ejector pin extends to form a puncture section; The first drive unit is connected to the inner ejector pin; one of the first drive unit and the second drive unit is fixedly disposed on the base, and the other is movably disposed on the base; The elastic buffer unit is sleeved on the inner pin between the first driving unit and the second driving unit. The two ends of the elastic buffer unit are respectively connected to the first driving unit and the second driving unit, and are in a pre-compressed state under normal conditions. When the puncture site is blocked from contacting the tubing, the movable drive unit moves away from the tubing, and the elastic buffer unit stretches, causing the inner ejector pin to retract relative to the outer ejector pin.

2. The anti-puncture needle device for the floating dialysis tubing assembly according to claim 1, characterized in that, The first driving unit is fixedly disposed, and the second driving unit is slidably disposed on the guide rail of the base; or, the second driving unit is fixedly disposed, and the first driving unit is slidably disposed on the guide rail of the base.

3. The anti-puncture needle device for the floating dialysis tubing assembly according to claim 1, characterized in that, The elastic buffer unit includes a helical spring, the two ends of which are hooked onto the connecting lugs of the first drive unit and the second drive unit, or the two ends of the helical spring are welded to the bodies of the first drive unit and the second drive unit, respectively.

4. The anti-puncture needle device for the floating dialysis tubing assembly according to claim 1, characterized in that, The gap between the inner ejector pin and the inner cavity of the outer ejector pin is 0.05-0.15mm, and the outer wall of the inner ejector pin forms a sliding seal with the inner wall of the outer ejector pin when the inner ejector pin retracts.

5. The anti-puncture needle device for the floating dialysis tubing assembly according to claim 1, characterized in that, It also includes a travel limiting structure, which includes a boss on the inner ejector pin and a limiting groove in the inner cavity of the outer ejector pin, used to constrain the maximum retraction distance of the inner ejector pin.

6. The anti-puncture needle device for the floating dialysis tubing assembly according to claim 1, characterized in that, The accessory support part is an annular groove or magnetic adsorption structure at the front end of the outer ejector pin.

7. The anti-puncture needle device for the floating dialysis tubing assembly according to claim 1, characterized in that, The inner needle is equipped with a puncture force sensor to detect the axial pressure on the puncture site in real time.

8. The anti-puncture needle device for the floating dialysis tubing assembly according to claim 7, characterized in that, The puncture force sensor is a micro strain gauge attached to the outer wall of the inner ejector pin, and the signal line of the micro strain gauge is led to the rear end through the axial groove of the inner ejector pin.

9. An automatic dialysis tube assembly device, characterized in that, It includes an adhesive coating module, a conveying module, and a floating dialysis tube assembly anti-puncture needle device as described in any one of claims 1-8.

Images