Nondestructive punctum flushing needle and preparation method thereof

Abstract

The invention provides a lossless punctum irrigation needle and a preparation method thereof, and relates to a medical instrument for lacrimal passage irrigation, the lossless punctum irrigation needle comprises a medical plastic needle tube, a silica gel layer is sleeved outside the medical plastic needle tube, and the tail end of the silica gel layer is rounded to reduce damage to punctum during insertion; the length of the silica gel layer is LS, the working length of the medical plastic needle tube is Ln, and LS is larger than or equal to Ln + delta L; wherein delta L is the length of the protection end so as to ensure that the silica gel layer covers the tail end of the medical plastic needle tube all the time, and the medical plastic needle tube is prevented from being in direct rigid contact with target tissue. The flushing needle with the protection end can be provided, and has the advantages that the risk of punctum injury caused by improper insertion of the needle head or movement of the head of a patient in the flushing process can be effectively reduced, the protection end is made of soft materials, and the protection end is milder when being inserted into the punctum; and thirdly, whether the liquid temperature is suitable for eye contact or not can be visually displayed through the color change of the thermosensitive color-changing material.

Description

Technical Field

[0001] The invention relates to a lacrimal duct flushing medical device, in particular to a non-destructive lacrimal point flushing needle and a preparation method thereof. Background Art

[0002] When the tear punctum is blocked, tears cannot be discharged normally. In severe cases, it may cause inflammation of the tear punctum channel, stimulate the tear glands to secrete more tears, and cause symptoms such as tearing and conjunctival congestion.

[0003] The current treatment measure is to flush the lacrimal channel through a flushing needle. The flushing needle currently used is usually a slender hollow needle tube with a length of about 17mm and a diameter between 0.4mm and 0.6mm. The needle tube can be straight or curved. During the flushing process, it needs to be inserted into the lacrimal channel about 6mm for flushing.

[0004] However, the existing problem is that the tear point flushing operation poses certain risks to children. Since it is difficult for children to remain still for a long time, they are more likely to twist their heads, especially when they feel uncomfortable or scared, which may cause tear point damage. The existing solution is to stabilize the child's head through a head support fixture, but it is still not enough to avoid the risk. Therefore, further improvements need to be made to the device to reduce the risk of tear point damage caused by children's twisting, so as to better avoid the risk. Summary of the invention

[0005] In view of the deficiencies in the above-mentioned prior art, the technical problem to be solved by the present invention is to provide a non-destructive lacrimal punctum flushing needle and a preparation method thereof, which can reduce the risk of lacrimal duct damage caused by head twisting by providing a protective end.

[0006] In order to solve the above technical problems, the technical solution adopted by the present invention is as follows: the present invention provides a non-destructive lacrimal point flushing needle, comprising a medical plastic needle tube, a silicone layer on the outer cover of the medical plastic needle tube, and the end of the silicone layer is rounded to reduce damage to the lacrimal point during insertion; The length of the silica gel layer is L S , working length of medical plastic needle tube L n ,and L S ≥ L n + ΔL ; in ΔL The length of the protective end is to ensure that the silicone layer always covers the end of the medical plastic needle tube, thereby preventing the medical plastic needle tube from directly and rigidly contacting the target tissue.

[0007] In a preferred embodiment, the length of the silica gel layer is LS Working length with medical plastic needle tube L n difference ΔL 0.5mm to 1mm.

[0008] In the preferred embodiment, a liquid bag is also included; A silicone segment is arranged at the front end of the liquid bag, and the rear end of the medical plastic needle tube passes through the silicone segment and is connected to the inner space of the liquid bag to form a liquid flow path.

[0009] In a preferred embodiment, the liquid bag is used to be filled with physiological saline and artificial tears, so that the liquid is forced to be discharged through a medical plastic needle tube by squeezing, and the plastic needle tube guides the liquid to flow into the lacrimal punctum channel to flush the lacrimal punctum channel; The silicone segment is an annular structure, and a central hole is arranged along the axis of the annular structure for passing a medical plastic needle tube.

[0010] In a preferred embodiment, the invention further comprises a plunger located a distance behind the tail end of the medical plastic needle tube; An expanded diameter opening is provided on the inner wall of the silicone segment near its tail end, and the expanded diameter opening is closely matched with the outer wall of the plunger, and the plunger can be inserted into the expanded diameter opening; The plunger is soft and has a certain resilience, and its shape and size match the expanded diameter port to form a matching sealing structure.

[0011] In a preferred embodiment, the plunger is used to block the communication channel between the medical plastic needle tube and the liquid bag to avoid leakage during transportation; The plunger is connected to one end of the connecting strip, and a buckle a is provided at the other end of the connecting strip. A buckle b corresponding to the position of the buckle a is provided on the inner wall of the liquid bag, which is used to connect the inner wall of the liquid bag to the connecting strip; Distance from buckle b on the inner wall of the liquid bag to the plunger T b Greater than the distance from the buckle a of the connecting strip to the plunger T a , T b and T a The difference between ΔT ,and T b = T a + ΔT , so that the plunger on the connecting strip can be separated from the silicone segment by stretching the inner wall of the liquid bag.

[0012] In a preferred embodiment, a sealing line is further included for sealing the opening of the liquid bag to form an accommodating space, and a protective sleeve is also provided between the front end of the silicone layer and the front end of the medical plastic needle tube; A thermal label is also provided on the outside of the liquid bag to indicate the temperature of the liquid, so as to reach a temperature suitable for the human eye; When working, the thermal label displays green when the liquid temperature is between 20℃ and 30℃, blue when the liquid temperature is below 25℃, and red when it is above 33℃; Among them, the safety threshold temperature is between 25℃ and 33℃ to avoid irritation during flushing.

[0013] In a preferred embodiment, the method comprises the following steps: S1. Heating and extrusion molding of medical plastic needle tubes: Medical plastic needles are made of medical grade plastics, which are heated to a molten state and then extruded through a mold to form a needle-like structure; S2. Mould forming: The extruded needle-like structure is pulled out of the die by combining a pulling device, the pulling speed should match the extrusion speed, and cooled to set the shape; Cutting the cooled and shaped medical plastic needle tube into a preset length; The cut medical plastic needle tube is placed into the mold and accurately fixed by the core mold. One end of the mold cavity is used to form the protective end, and the other end is used to form the expanded silicone segment. Placing the liquid bag in an open state in the mold, placing one end opening of the liquid bag at the position of the silicone segment in the mold cavity, and the opening is connected to the medical plastic needle tube; The room temperature vulcanized silicone is injected into the mold through the injection equipment, and the room temperature vulcanized silicone flows into the gap between the needle tube and the core mold, so that the room temperature vulcanized silicone completely fills the required covering area to form a uniform coating; S3, curing molding: Wait for natural solidification at room temperature, open the mold and take out the finished product, and take out the core mold at the same time; S4, breaking process: Break the medical plastic needle tube with silicone layer from the pre-made crack to ensure that the broken surface is flat; Cut off the silicone layer at a position 0.3-1 mm in front of the end of the medical plastic needle tube where it breaks, and keep a small section of silicone as a protective end, thus obtaining a non-destructive lacrimal point flushing needle with a protective end; S5, buckle processing: A buckle a is provided at one end of the connecting strip, and a buckle b is provided on the inner wall of the liquid bag, which can be connected with and clamped with the buckle a, and the distance from the buckle b to the plunger should be greater than the distance from the buckle a to the plunger; S6. Final processing: Place the plunger in the liquid bag and flush the opened liquid bag. After flushing, place the plunger on the expanded opening in the silicone segment to form a sealing structure through tight fit. Fill the fluid bag with saline or artificial tears and seal the bag by sealing with the sealing line.

[0014] In a preferred embodiment, the medical-grade plastic in step S1 is one of polyetheretherketone and polycarbonate.

[0015] In a preferred embodiment, the method further comprises the following steps: S7. Preparation of heat-sensitive materials: Select transparent PET film as the substrate and cut it into the corresponding size according to the required label size; use spraying or screen printing technology to evenly spray or print the thermochromic material on the substrate and dry the coating; S8. Printing instruction information: Printing instruction information on the surface or the other side of the heat-sensitive coating using printing ink; S9, adhesive coating: Apply high-strength adhesive on the back of the label to ensure that the label can be firmly attached to the liquid bag, and use a roller or other tools to evenly apply the adhesive on the back of the label; S10, film protection: A layer of transparent film material is covered on the surface of the label to protect the label from the external environment and extend its service life. A laminating machine is used to evenly cover the transparent film on the surface of the label.

[0016] The present invention provides a non-destructive lacrimal punctum flushing needle and a preparation method thereof. Through the cooperation between the above structures, a flushing needle with a protective end can be provided, which has the following beneficial effects: first, it can effectively reduce the risk of lacrimal punctum damage caused by improper needle insertion or patient head movement during the flushing process, thereby improving the safety of the flushing process; second, the protective end is made of soft material, such as a silicone layer, which is gentler when inserted into the lacrimal punctum, thereby reducing the patient's discomfort and improving the comfort of the flushing process; third, in order to avoid the irritation reaction that may be caused by the liquid below room temperature taken from the cold storage directly acting on the lacrimal duct, the color change of the thermochromic material can be used to intuitively display whether the liquid temperature is suitable for eye contact, thereby ensuring that the flushing operation is performed only when the ideal temperature range (20°C to 30°C) is reached, thereby minimizing potential discomfort and irritation. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The present invention will be further described below in conjunction with the accompanying drawings and embodiments: Figure 1 It is the overall appearance structure diagram of the present invention; Figure 2 It is a demonstration diagram of the liquid flow path of the present invention; Figure 3 yes Figure 2 A structural diagram of the connection between buckle a and buckle b; Figure 4 It is a structural schematic diagram of the preparation process of the flushing needle of the present invention.

[0018] In the figure: sealing line 1, liquid bag 2, buckle a3, buckle b4, connecting strip 5, plunger 6, enlarged diameter opening 7, silicone segment 8, silicone layer 9, medical plastic needle tube 10, protective cover 11, thermal label 12. DETAILED DESCRIPTION

[0019] In order to better understand the purpose, structure and function of the present invention, the following reference is made to the attached Figure 1-4 The present invention is described in detail with reference to embodiments.

[0020] Example 1 like Figures 1 to 3 As shown, this embodiment provides a non-destructive lacrimal point flushing needle including a liquid bag 2 and a medical plastic needle tube 10; exist Figure 1 In the figure, the medical plastic needle tube 10 is covered with a silicone layer 9 to ensure that the needle tube is firmly fixed when inserted into the lacrimal point and reduce damage to the tissue. A silicone segment 8 is provided at the front end of the liquid bag 2 to guide the flow direction of the liquid in the liquid bag 2. The front end of the medical plastic needle tube 10 passes through the silicone segment 8 and extends to the internal space of the liquid bag 2 to form a liquid flow path and ensure that the flushing liquid can flow smoothly.

[0021] Among them, Figure 1 As shown, the silicone segment 8 is arranged at the front end of the liquid bag 2 and is an annular structure. A central hole is arranged along the axis of the annular structure for passing a medical plastic needle tube 10 therethrough.

[0022] In the preferred embodiment, Figure 1 As shown, in order to ensure that the medical plastic needle tube will not cause damage or other adverse effects due to direct contact with the target tissue during use, a soft silicone layer is added to the medical plastic needle tube 10. This can reduce the direct pressure of the end of the medical plastic needle tube 10 on the tissue and provide better biocompatibility and safety.

[0023] And set the length of the silicone layer 9 L S 10mm longer than medical plastic needle tube L n At least one guard end should be longer ΔL ,Right now: L S ≥ L n + ΔL Specifically in terms of values, the safety margin ΔL The silicone layer 9 needs to extend beyond the end of the medical plastic needle tube 10 by at least 0.5 mm and can extend beyond the end by 1 mm at most. The purpose is to ensure that in any case, the hard end of the medical plastic needle tube 10 will not directly contact the target tissue, but the silicone layer 9 will complete the contact and protect the tissue from damage.

[0024] In addition, the end of the silicone layer 9 should be rounded, and the tip of the silicone layer 9 should be rounded instead of having a sharp edge, which can further reduce the risk of tissue damage during insertion and improve the safety of use.

[0025] In summary, the silicone layer should not only meet the L S ≥ L n + 0.5mm, ideally L S ≈ L n + 1mm, and its tip should be rounded to ensure that no additional trauma is caused to the patient.

[0026] in, ΔL The length of the protective end is ensured to ensure that the silicone layer (9) always covers the end of the medical plastic needle tube (10), thereby preventing the medical plastic needle tube (10) from directly and rigidly contacting the target tissue.

[0027] Preferably, Figure 2 As shown, the liquid bag 2 is pre-filled with an appropriate amount of physiological saline and artificial tears. The liquid can effectively clean the lacrimal point area and reduce irritation and discomfort. When the lacrimal point needs to be flushed, the curved surface formed by the injection pressure can be squeezed to make the liquid in the bag be pressurized and form an outwardly expanding curved surface. The curved surface formed by the injection pressure pushes the liquid along the set flow path, prompting the liquid to be discharged through the medical plastic needle tube 10. The front end of the medical plastic needle tube 10 has been inserted into the lacrimal point position, so the liquid can flow out of the needle tube smoothly. The plastic needle tube 10 is also used to guide the liquid to flow smoothly into the lacrimal point channel, so that the liquid enters the lacrimal point area, and achieves effective lacrimal point flushing; The injection pressure formed by the liquid in the liquid bag 2 under the squeezing action can accurately control the flow rate and flow rate of the flushing liquid. The depth of the flushing needle inserted into the lacrimal punctum channel is generally about 6 mm, ensuring that the flushing process is both gentle and effective, reducing damage to the lacrimal punctum tissue. At the same time, the silicone layer 9 wrapped around the outer layer of the medical plastic needle tube 10 further increases the comfort and safety during insertion, reducing the patient's discomfort.

[0028] Preferably, it also includes a plunger 6 located a distance behind the tail end of the medical plastic needle tube 10, which is used to form a seal between the liquid bag 2 and the medical plastic needle tube 10 to ensure sealing; An enlarged diameter opening 7 is provided on the inner wall of the silicone segment 8 near its tail end, and the enlarged diameter opening 7 is tightly fitted with the outer wall of the plunger 6. The plunger 6 can be completely embedded in the enlarged diameter opening 7 to block the communication channel between the medical plastic needle tube 10 and the liquid bag 2 to avoid liquid seepage during transportation.

[0029] Specifically, the plunger 6 is soft and has a certain resilience, and its shape and size match the expanded diameter opening 7 to form a matching sealing structure.

[0030] During transportation, after the plunger 6 is inserted into the enlarged opening 7, the shaking of the liquid inside the liquid bag 2 caused by vibration or collision can be reduced, thereby further reducing the risk of liquid leakage.

[0031] like Figure 3 As shown, the plunger (6) is connected to one end of the connecting strip (5), the other end of the connecting strip (5) is provided with a buckle a (3), and a buckle b (4) corresponding to the position of the buckle a (3) is provided on the inner wall of the liquid bag (2) for connecting the inner wall of the liquid bag (2) to the connecting strip (5); During implementation, the buckle a3 and the buckle b4 can be aligned and elastically or geometrically locked to each other by applying a directional force, so that the plunger 6 can be removed from the expanded opening 7 by tensioning the connecting strip 5 .

[0032] When the plunger 6 needs to be removed from the enlarged diameter opening 7, the user can pull the connecting strip 5, so that the plunger 6 can be smoothly removed from the enlarged diameter opening 7, which not only ensures a simple disassembly and assembly method when using the liquid bag 2, but also ensures that during transportation and use, the plunger 6 can be firmly embedded in the enlarged diameter opening 7 to prevent liquid leakage.

[0033] In the preferred embodiment, Figure 1 As shown, it includes a sealing line 1 for sealing the opening of the liquid bag 2 to form a accommodating space, ensuring that the flushing liquid inside the liquid bag 2 will not leak. Preferably, the sealing line 1 completely closes the opening of the liquid bag 2 by heat sealing or bonding, thereby ensuring that the flushing liquid inside the liquid bag is in a sealed state to prevent liquid leakage during use or transportation.

[0034] In addition, a protective cover 11 is provided between the front end of the silicone layer 9 and the front end of the medical plastic needle tube 10 to prevent damage to the needle due to accidental collision or improper operation during insertion, thereby ensuring the integrity and flushing effect of the needle and improving the sealing performance during transportation.

[0035] Example 2 Next, further description will be given based on the above-mentioned embodiment 1. Figure 1-4 shown.

[0036] The preparation method of the non-destructive lacrimal point flushing needle according to Example 1 comprises the following steps: S1. Heating extrusion molding: Raw material preparation: The medical plastic needle tube 10 is made of medical grade plastic, such as polyetheretherketone (PEEK) or polycarbonate (PC), to ensure that it has good biocompatibility and mechanical properties; Heating: Feed the plastic granules into the hopper of the extruder, set the temperature of the heating zone of the extruder, for example, the heating range value for polyetheretherketone (PEEK) is 360℃ to 400℃, and the heating range value for polycarbonate (PC) is 260℃ to 300℃. Through the rotation of the screw, the plastic granules are fed into the heating zone to reach a molten state.

[0037] Die extrusion molding: Set the die temperature to ensure that it matches the temperature of the heating zone of the extruder to prevent the material from overheating or overcooling. Extrude the fluid plastic through the die (needle die) to form a needle-like structure. Monitor the pressure and temperature of the die to ensure that the size and wall thickness of the needle tube are uniform.

[0038] S2. Mould forming: Combined with the traction device: connect the traction device to the extruder outlet, ensure that the traction speed is consistent with the extrusion speed, set the appropriate traction speed, ensure that the needle tube is pulled out smoothly, avoid twisting or breaking, and allow it to cool and shape; Cut into preset length: Use a precision cutting machine to set the cutting length, for example 17mm. Make sure the needle tube has completely cooled before cutting to avoid deformation of the needle tube caused by hot cutting. The needle tube should be free of burrs and have a smooth cut surface after cutting.

[0039] Place in the mold and fix: Place the cut medical plastic needle tube into a special mold. The mold design should match the size of the needle tube. One end of the mold cavity is used to form the protective end, and the other end is used to form the expanded silicone segment 8. Use a core mold to fix the needle tube in the mold to ensure that the needle tube does not move during the injection molding process.

[0040] Place the liquid bag 2: Place the liquid bag 2 in the open state in the mold, ensure that one end of the opening of the liquid bag 2 is located at the position of the silicone segment 8 in the mold cavity, and is connected to the medical plastic needle tube 10, and use a clamp to fix the position of the liquid bag 2 to prevent movement during the injection molding process.

[0041] Inject room temperature vulcanized silicone: Inject room temperature vulcanized silicone (RTV Silicone) into the mold through injection equipment to ensure that the silicone is evenly distributed. The injection pressure and speed should be properly adjusted to prevent bubbles from being generated during the silicone injection process. After the injection is completed, ensure that the silicone completely covers the required parts.

[0042] S3, curing molding: Wait for the silicone to cure naturally at room temperature, and maintain a constant indoor temperature, for example 20°C to 25°C, and ensure that the silicone layer 9 is tightly combined with the medical plastic needle tube 10; once the silicone is completely cured, open the mold, take out the finished product, and use special tools to carefully remove the core mold to avoid damaging the silicone layer 9.

[0043] S4, breaking process: Break the medical plastic needle tube 10 with the silicone layer 9 from the pre-made crack to ensure that the broken surface is flat; Cut off the silicone layer 9 at the position 0.3-1 mm from the front end of the end of the medical plastic needle tube 10 where it is broken, leaving a small section of silicone as a protective end to ensure that the needle is safer when inserted into the lacrimal point and reduce damage to the tissue; Through the above steps, a non-destructive punctum flushing needle with a protected end is finally obtained.

[0044] S5, buckle processing: The buckle a3 is fixed to the connecting strip 5 by using adhesive or other fixing means. A buckle b4 is provided on the inner wall of the liquid bag 2, which can be docked and clamped with the buckle a3. The distance from the buckle b4 to the plunger 6 should be greater than the distance from the buckle a3 to the plunger 6 to ensure that the connecting strip 5 can be stretched smoothly.

[0045] S6. Final processing: Place the plunger: place the plunger 6 in the liquid bag 2, and rinse the liquid bag 2 in the open state. After rinsing, place the plunger 6 on the expanded diameter opening in the silicone segment 8 to form a sealing structure through tight fit.

[0046] Inject liquid: inject normal saline or artificial tears into liquid bag 2, ensure sufficient liquid volume, and seal it through sealing line 1 to seal liquid bag 2. Use aseptic technique to inject liquid to avoid contamination.

[0047] Preferably, the above method further comprises the following steps: S7. Preparation of heat-sensitive materials: Select transparent PET film as the substrate and cut it into the corresponding size according to the required label size; use spraying or screen printing technology to evenly spray or print the thermochromic material on the substrate and dry the coating; S8. Printing instruction information: Use printing ink to print instructions on the surface or the other side of the heat-sensitive coating, such as "Safety temperature range: 25℃~33℃", as well as a thermometer icon or other relevant logos, to ensure clear and accurate printing; S9, adhesive coating: Apply a high-strength adhesive on the back of the label to ensure that the label can be firmly attached to the liquid bag 2, and use a roller or other tool to evenly apply the adhesive on the back of the label; S10, film protection: Cover the label surface with a layer of transparent film material to protect the label from the external environment and extend its service life. Use a laminating machine to evenly cover the transparent film on the label surface. In one practicable manner, the medical grade material used in the medical plastic needle tube 10 is polyetheretherketone, which is a high-performance engineering plastic with excellent mechanical strength, chemical corrosion resistance and biocompatibility, and is very suitable for manufacturing medical devices; During the production process, medical-grade PEEK particles that meet medical device standards are selected, and the PEEK particles are heated to a temperature above the melting point (about 343°C) to make them plastic, and then extruded into the required tubular structure through an extruder. The extruded PEEK tube is quickly cooled and shaped in a cooling water tank, and the shaped PEEK tube is cut into predetermined lengths according to design specifications. For the parts that need to have flushing functions, it is necessary to drill or open holes in appropriate locations on the PEEK tube, and assemble the cut and processed PEEK tube to other components of the flushing needle, such as the liquid bag 2, the silicone segment, etc. The assembled lacrimal flushing needle is sterilized to ensure its sterility.

[0048] In another practicable manner, the medical grade material used in the medical plastic needle tube 10 is polycarbonate, which is a transparent thermoplastic with good impact strength and is suitable for medical devices that require a certain degree of transparency and strength; During the preparation process, medical-grade PC particles that meet medical device standards are selected, the PC particles are heated to above the melting point (about 220-300°C), and then injected into a precisely designed mold. The mold cavity is quickly filled with high pressure to form the main structure of the lacrimal punctum flushing needle. The mold is kept in a cooling state for a period of time to ensure that the PC is completely hardened. The cooled PC flushing needle is removed from the mold, and necessary post-processing such as drilling and polishing is performed on the removed PC flushing needle. The processed PC flushing needle is assembled to the corresponding component, and the assembled lacrimal punctum flushing needle is quality inspected and sterilized.

[0049] Further preferably, Figure 1 As shown, the thermochromic material in step S4 is one of microencapsulated thermochromic materials or thermochromic polymers; In one practicable manner, the microencapsulated thermochromic material is composed of a leuco dye, an acidic compound, a developer, and a capsule wall material. The advantage of this material is that it has good stability and durability, but the cost may be higher; The leuco dye may be one of crystal violet leuco salt and Leuco crystal blue.

[0050] The acidic compound may be one of p-cresol sulfate and p-cresol phosphate.

[0051] The color developer may be one of bisphenol A and phenolphthalein.

[0052] The capsule wall material may be one of polyurethane, polyamide, and urea-formaldehyde.

[0053] Furthermore, the leuco dye selects three different colors of leuco dyes, each of which corresponds to a different transition temperature; the developer uses one or more developers and reacts with the leuco dye to produce a color change, and the acidic compound is used to adjust the reaction conditions so that it occurs within a specific temperature range.

[0054] In one practicable manner, the thermochromic polymer achieves a color-changing effect by doping certain heat-sensitive additives. The cost of such materials depends on the polymer itself and the added color-changing components. When such polymers are heated, they undergo a phase change, thereby producing a color change. Among them, polyvinyl pyrrolidone (PVP) can be used: a polymer with thermochromic properties.

[0055] Polystyrene-butadiene copolymer (SBR) can be used: the thermochromic effect can be achieved by doping other ingredients.

[0056] Furthermore, the polymer substrate is selected to have a thermosensitive property, wherein the thermosensitive dye is doped with three thermosensitive dyes with different transition temperatures; After comparing the two feasible methods mentioned above, we can summarize: Although microencapsulated thermochromic materials require complex processes during manufacturing, their cost is relatively moderate compared to liquid crystal materials due to their wide availability and relatively mature production technology.

[0057] Thermochromic polymers: If a base polymer is selected with a simple heat-sensitive additive, the overall cost may be the lowest, especially in large-scale production.

[0058] For applications that need to control costs, such as disposable medical supplies (such as lacrimal punctum flushing needles), microencapsulated thermochromic materials may be a more cost-effective option. Although their initial cost may be higher than some basic polymers, due to their good stability and durability, they can reduce the frequency of replacement and reduce the overall cost in the long run.

[0059] Example 3 Next, further description will be given based on the above-mentioned Example 1, and a detailed introduction will be given in combination with the preparation method of the flushing needle in Example 2. Figure 1 shown.

[0060] A heat-sensitive label (12) is also provided on the outside of the liquid bag (2) for indicating the temperature of the liquid so as to reach a temperature suitable for the human eye; When in operation, the thermal label (12) displays green when the temperature of the liquid is between 20°C and 30°C, and displays red or blue when the temperature of the liquid is below 20°C or above 30°C; Green means the temperature is appropriate and is the most comfortable temperature for eye washing; red or blue means the temperature is too high or too low and is not suitable for eye washing at the moment; Among them, the safety threshold temperature is between 20℃ and 30℃, which not only ensures that the temperature of the flushing fluid is appropriate, but also improves the comfort and safety of patients, reduces potential risks caused by improper temperature, and avoids irritation during flushing.

[0061] In order to enable those skilled in the art to better understand the scheme of the present invention, the above-mentioned embodiments are only preferred implementations of the present invention, and cannot be used to limit the protection scope of the present invention. The protection scope of the present invention shall be the technical scheme recorded in the claims, including the equivalent replacement schemes of the technical features in the technical scheme recorded in the claims. That is, equivalent replacement improvements within this scope are also within the protection scope of the present invention.

[0062] It should also be noted that the terms "first", "second", etc. in the specification and claims of the present invention and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the numbers used in this way can be interchanged where appropriate, so as to describe the embodiments of the present invention described herein.

Claims

1. A non-destructive lacrimal point flushing needle, characterized in that: It comprises a medical plastic needle tube (10), the medical plastic needle tube (10) being covered with a silicone layer (9), the end of the silicone layer (9) being rounded to reduce damage to the lacrimal point during insertion; The length of the silica gel layer (9) is L S , the working length of the medical plastic needle tube (10) L n ,and L S ≥ L n + ΔL ; in ΔL The length of the protective end is ensured to ensure that the silicone layer (9) always covers the end of the medical plastic needle tube (10), thereby preventing the medical plastic needle tube (10) from directly and rigidly contacting the target tissue.

2. The non-destructive lacrimal punctum flushing needle according to claim 1, characterized in that: The length of the silicone layer (9) L S Working length with medical plastic needle tube (10) L n difference ΔL 0.5mm to 1mm.

3. The non-destructive lacrimal punctum flushing needle according to claim 1, characterized in that: Also included is a fluid bag (2); A silicone segment (8) is provided at the front end of the liquid bag (2), and a rear end of the medical plastic needle tube (10) passes through the silicone segment (8) and is connected to the internal space of the liquid bag (2), thereby forming a liquid circulation path.

4. The non-destructive lacrimal punctum flushing needle according to claim 3, characterized in that: The liquid bag (2) is used to be filled with physiological saline and artificial tears, so that the liquid is forced to be discharged through the medical plastic needle tube (10) by squeezing, and the plastic needle tube (10) guides the liquid to flow into the lacrimal punctum channel to flush the lacrimal punctum channel; The silicone segment (8) is an annular structure, and a central hole is provided along the axis of the annular structure for passing a medical plastic needle tube (10).

5. The non-destructive lacrimal punctum flushing needle according to claim 3 or 4, characterized in that: It also includes a plunger (6) located a distance behind the tail end of the medical plastic needle tube (10); An expanded diameter opening (7) is provided on the inner wall of the silica gel segment (8) near its tail end and is closely matched with the outer wall of the plunger (6). The plunger (6) can be inserted into the expanded diameter opening (7); The plunger (6) is soft and has a certain resilience, and its shape and size match the expanded diameter opening (7) to form a matching sealing structure.

6. The non-destructive lacrimal punctum flushing needle according to claim 5, characterized in that: The plunger (6) is used to block the communication passage between the medical plastic needle tube (10) and the liquid bag (2) to prevent liquid leakage during transportation; The plunger (6) is connected to one end of the connecting strip (5); a buckle a (3) is provided at the other end of the connecting strip (5); a buckle b (4) corresponding to the position of the buckle a (3) is provided on the inner wall of the liquid bag (2) for connecting the inner wall of the liquid bag (2) to the connecting strip (5); The distance from the buckle b (4) on the inner wall of the liquid bag (2) to the plunger (6) T b Greater than the distance from the buckle a of the connecting strip (5) to the plunger (6) T a , T b and T a The difference between ΔT ,and T b = T a + ΔT , so that the plunger (6) on the connecting strip (5) can be separated from the silicone segment (8) by stretching the inner wall of the liquid bag (2).

7. The non-destructive punctum flushing needle according to any one of claims 1 to 6, characterized in that: It also includes a sealing line (1) for sealing the opening of the liquid bag (2) to form a containing space, and a protective sleeve (11) is provided between the front end of the silicone layer (9) and the front end of the medical plastic needle tube (10); A heat-sensitive label (12) is also provided on the outside of the liquid bag (2) for indicating the temperature of the liquid so as to reach a temperature suitable for the human eye; When in operation, the thermal label (12) displays green when the liquid temperature is between 20°C and 30°C, displays blue when the liquid temperature is below 25°C, and displays red when the liquid temperature is above 33°C; Among them, the safety threshold temperature is between 25℃ and 33℃ to avoid irritation during flushing.

8. A method for preparing an irrigation needle, applied to the non-destructive lacrimal punctum irrigation needle according to any one of claims 1 to 7, characterized in that: The method comprises the following steps: S1. Heating and extrusion molding of medical plastic needle tubes: The medical plastic needle tube (10) is made of medical grade plastic, which is heated to a molten state and then extruded through a mold to form a needle-shaped structure; S2. Mould forming: The extruded needle-like structure is pulled out of the die by combining a pulling device, the pulling speed should match the extrusion speed, and cooled to set the shape; Cutting the cooled and shaped medical plastic needle tube (10) into a preset length; The cut medical plastic needle tube (10) is placed in a mold and the medical plastic needle tube (10) is accurately fixed by a core mold, wherein one end of the mold cavity is used to form a protective end, and the other end is used to form an expanded silicone segment (8); Placing the liquid bag (2) in an open state in the mold, placing the opening at one end of the liquid bag (2) at the position of the silicone segment (8) in the mold cavity, and connecting the opening to the medical plastic needle tube (10); The room temperature vulcanized silicone is injected into the mold through the injection equipment, and the room temperature vulcanized silicone flows into the gap between the needle tube and the core mold, so that the room temperature vulcanized silicone completely fills the required covering area to form a uniform coating; S3, curing molding: Wait for natural solidification at room temperature, open the mold and take out the finished product, and take out the core mold at the same time; S4, breaking process: Breaking the medical plastic needle tube (10) with the silicone layer (9) from the pre-made crack, ensuring that the broken surface is flat; Cutting off the silicone layer (9) at a position 0.3 to 1 mm from the front end of the end of the medical plastic needle tube (10) at the break position, leaving a small section of silicone as a protective end, thereby obtaining a non-destructive lacrimal punctum flushing needle with a protective end; S5, buckle processing: A buckle a (3) is provided at one end of the connecting strip (5), and a buckle b (4) is provided on the inner wall of the liquid bag (2) so as to be connected with and locked with the buckle a (3), and the distance between the buckle b (4) and the plunger (6) should be greater than the distance between the buckle a (3) and the plunger (6); S6. Final processing: The plunger (6) is placed in the liquid bag (2), and the opened liquid bag (2) is flushed. After flushing, the plunger (6) is placed on the expanded opening in the silicone segment (8) to form a sealing structure through tight fit; Physiological saline or artificial tears are injected into the liquid bag (2), and the bag is sealed with the sealing line (1) to seal the liquid bag (2).

9. The method for preparing a flushing needle according to claim 8, characterized in that: The medical-grade plastic in step S1 is one of polyetheretherketone and polycarbonate.

10. The method for preparing a flushing needle according to claim 8, characterized in that: The method further comprises the following steps: S7. Preparation of heat-sensitive materials: Select transparent PET film as the substrate and cut it into the corresponding size according to the required label size; use spraying or screen printing technology to evenly spray or print the thermochromic material on the substrate and dry the coating; S8. Printing instruction information: Printing instruction information on the surface or the other side of the heat-sensitive coating using printing ink; S9, adhesive coating: Apply a high-strength adhesive to the back of the label to ensure that the label can be firmly attached to the liquid bag (2), and use a roller or other tool to evenly apply the adhesive to the back of the label; S10, film protection: A layer of transparent film material is covered on the surface of the label to protect the label from the external environment and extend its service life. A laminating machine is used to evenly cover the transparent film on the surface of the label.

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