Needle head and injector for injection treatment of internal hemorrhoid hardening agent

Abstract

The invention discloses a needle head and an injector for injection treatment of an internal hemorrhoid hardening agent, and belongs to the technical field of surgical equipment.The needle head comprises a needle head base and a puncture needle arranged on the needle head base, and a backflow prevention structure is arranged in a channel of the puncture needle and located at the joint of the puncture needle and the needle head base; the backflow prevention structure comprises a fixing ring, and a valve clack is arranged on the fixing ring. By the adoption of the structure, the backflow prevention structure is arranged, the phenomenon of liquid medicine backflow is effectively avoided, it is guaranteed that medicine can be accurately injected into the body, meanwhile, medicine waste is reduced, and the treatment effect is guaranteed.

Description

Technical Field

[0001] The present invention relates to the technical field of surgical devices, and particularly to a needle and a syringe for treating internal hemorrhoids by sclerosing agent injection. Background Art

[0002] At present, the injection therapy for internal hemorrhoids has been proven through more than 100 years of clinical practice to cause no hidden damage to the human body and has become a globally recognized therapy. The drugs used for injection therapy are mainly divided into two categories: sclerosing agents and necrotizing agents. Since there are more complications caused by necrotizing agents, sclerosing agents are mostly advocated at present. However, if too much sclerosing agent is injected, necrosis may also occur. The purpose of injection therapy is to inject the sclerosing agent around the hemorrhoid mass to produce an aseptic inflammatory reaction, achieving the purpose of occluding small blood vessels and fibroplasia and sclerosis atrophy in the hemorrhoid mass. The injection needle for internal hemorrhoids usually uses a No. 5 slender needle and a 5 ml or 10 ml syringe. When performing the injection treatment for internal hemorrhoids, after local anesthesia or simple caudal anesthesia, the patient takes a lateral position, and an anoscope is placed in the anus to observe the number and location of the hemorrhoid nuclei. Then, the doctor will use a 5 ml syringe to draw the original solution of polidocanol injection and perform submucosal injection of the hemorrhoid mucosa with a No. 5 slender needle. At present, in the injection process of the polidocanol foam sclerosing agent clinically used, the sclerosing agent injected into the hemorrhoid tissue during the needle withdrawal process of the injection needle flows back into the syringe along the needle head with the increase of pressure, bringing great inconvenience to the operation. At the same time, this sclerosing agent is expensive. The drug flowing back into the syringe will not only contaminate the syringe but also remain in the syringe, causing waste of the drug and insufficient dosage, having a profound impact on the patient's condition and economy. With the changes in the cross-disciplinary integration of clinical doctors, the combination of medicine and engineering, and the understanding of diseases, the actual application of injection needles has also undergone profound changes. At present, for the treatment of internal hemorrhoids under the new situation, domestic and foreign research has focused on reducing the inconvenience in operation, such as "changing the inner diameter of the injection needle" and "increasing the connection between the injection needle and the tail end of the syringe". However, for the overall integration of the entire perioperative period of the patient and how to more effectively prevent reflux to the greatest extent during the operation, so as to better control the drug reflux of patients undergoing internal hemorrhoid sclerosing agent injection surgery is an urgent problem to be solved. Summary of the Invention

[0003] The purpose of the present invention is to provide a needle and a syringe for treating internal hemorrhoids by sclerosing agent injection. By setting an anti-reflux structure, the phenomenon of liquid medicine reflux is effectively avoided, ensuring that the drug can be accurately injected into the body. At the same time, drug waste is reduced, and the treatment effect is guaranteed.

[0004] To achieve the above purpose, the present invention provides a needle for treating internal hemorrhoids by sclerosing agent injection, including a needle seat and a puncture needle arranged on the needle seat. An anti-reflux structure is arranged in the channel of the puncture needle and is located at the connection between the puncture needle and the needle seat. The anti-reflux structure includes a fixing ring, and a valve flap is arranged on the fixing ring.

[0005] Preferably, the fixing ring is attached to the liquid inlet of the needle seat.

[0006] Preferably, the valve flap includes symmetrically arranged first valve flaps, and symmetrically arranged second valve flaps are provided on the first valve flaps. The symmetrically arranged first valve flaps and the symmetrically arranged second valve flaps both form a frustum-shaped structure.

[0007] Preferably, check rings are arranged on the inner sides of the second valve flaps, and the two check rings are arranged correspondingly.

[0008] Preferably, the anti-reflux structure is made of medical-grade silicone.

[0009] Preferably, the fixing ring is circular.

[0010] Preferably, the surface of the puncture needle channel is smoothed.

[0011] Preferably, the present invention provides a syringe for treating internal hemorrhoids by sclerosing agent injection, including a needle for treating internal hemorrhoids by sclerosing agent injection and an injection tube, and the injection tube is connected to the needle for treating internal hemorrhoids by sclerosing agent injection.

[0012] Therefore, by adopting the above-mentioned needle and syringe for treating internal hemorrhoids by sclerosing agent injection, the present invention has the following beneficial effects:

[0013] (1) An anti-reflux structure made of silicone is provided in the fluid channel inside the needle. When injecting the liquid medicine, it is deformed under pressure to open the channel, and automatically returns to its original state to close the channel after the injection is completed, preventing the liquid medicine from flowing back into the syringe and avoiding the injection tube from being contaminated by the affected part of the patient;

[0014] (2) The fixing ring is attached to the liquid inlet of the needle seat, enabling the anti-reflux structure to be seamlessly connected to the liquid inlet part, ensuring that there is no liquid medicine leakage or waste during the delivery process of the liquid medicine from the syringe to the needle;

[0015] (3) The surface of the puncture needle channel is smoothed, reducing the adhesion of the liquid medicine to the needle and reducing drug waste;

[0016] (4) It is also applicable to injection scenarios of high-viscosity drugs, vaccination, biological agents, and other drugs that require precise delivery.

[0017] The technical solution of the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. Description of the Drawings

[0018] Figure 1 It is a schematic structural diagram of an embodiment of a needle for treating internal hemorrhoids by sclerosing agent injection according to the present invention;

[0019] Figure 2Schematic diagram of the anti-reflux structure of the needle for the treatment of internal hemorrhoids by injection of sclerosing agent according to an embodiment of the present invention;

[0020] Figure 3 Schematic diagram of the flow structure of the syringe for the treatment of internal hemorrhoids by injection of sclerosing agent according to an embodiment of the present invention;

[0021] 1. Needle seat; 2. Puncture needle; 3. Anti-reflux structure; 4. Fixed ring; 5. First valve flap; 6. Second valve flap; 7. Check ring; 8. Injection tube. Detailed implementation manner

[0022] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. Usually, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations. In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of this invention is usually placed during use. It is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to the present invention.

[0023] Embodiment 1

[0024] As Figure 1-2 shown, the present invention provides a needle for the treatment of internal hemorrhoids by injection of sclerosing agent, including a needle seat 1 and a puncture needle 2 provided on the needle seat 1. The material of the puncture needle 2 is medical stainless steel, medical-grade plastic or other anti-corrosion materials, which can ensure the safety and durability of the needle during use. An anti-reflux structure 3 is provided in the channel of the puncture needle 2 and is located at the connection between the puncture needle 2 and the needle seat 1. The anti-reflux structure 3 is an integral structure and is made of medical-grade silicone or other biocompatible elastic materials, has high resilience, and fits with the needle. The anti-reflux structure 3 includes a fixed ring 4. The fixed ring 4 is circular, and valve flaps are provided on the fixed ring 4.

[0025] The fixed ring 4 fits with the liquid inlet of the needle seat 1, so that the anti-reflux structure 3 is seamlessly connected to the liquid inlet part, ensuring that there is no liquid leakage or waste during the delivery of the liquid medicine from the syringe to the needle.

[0026] The valve flaps include symmetrically arranged first valve flaps 5, and second valve flaps 6 are symmetrically arranged on one side of the first valve flaps 5. When not in use, the correspondingly arranged first valve flaps 5 and the correspondingly arranged second valve flaps 6 both form a frustum-shaped structure to prevent the liquid medicine from flowing back.

[0027] On the inner side of the second valve flap 6, a check ring 7 is provided. The two check rings 7 are arranged correspondingly to form a check ring to prevent the backflow of the liquid medicine.

[0028] The surface of the channel of the puncture needle 2 is smoothed by electrolytic polishing technology, which can reduce the adhesion of the liquid medicine to the needle tip and reduce drug waste. This process reduces the surface roughness of the inner surface of the needle tip to below 0.05 μm, reduces the residual drug amount to below 0.5 μL, and at the same time maintains the mechanical strength of the needle tip (bending strength ≥ 1200 MPa). The specific steps include:

[0029] 1. Pretreat the puncture needle 2. First, immerse the puncture needle 2 in an alkaline degreasing solution (pH 12, containing 5% NaOH + 3% Na 3 PO 4 ), and ultrasonically clean it at a temperature of 60°C for 10 minutes to remove machining oil stains. Then, soak it in a mixed solution of 10% HNO 3 and 2% HF at room temperature for 2 minutes for pickling activation to expose the metal lattice.

[0030] 2. Perform electrolytic polishing. Place the puncture needle 2 in a solution containing 65% phosphoric acid, 15% sulfuric acid, 20% glycerol, and 0.5 g / L sodium dodecyl sulfate, and electrolyze it at a temperature of 35 ± 2°C and a current density of 25 A / dm 2 for 90 seconds, with the electrode spacing being 5 mm.

[0031] 3. Fix the needle tip of the puncture needle 2 on a polytetrafluoroethylene fixture with an inner-inserted platinum-iridium alloy microtube electrode (diameter 0.1 mm) to ensure uniform distribution of the electric field.

[0032] 4. Ultrasonically rinse for 5 minutes, then blow-dry with nitrogen, and finally perform vacuum annealing at a temperature of 150°C for 30 minutes to eliminate internal stress.

[0033] Example 2

[0034] The anti-backflow structure 3 can be modularly designed according to requirements to adapt to different models of syringes and injection requirements in different scenarios. The modular structure includes a pretreatment module, an electrolytic polishing module, a post-treatment module, and a quality control and detection module.

[0035] The pretreatment module includes:

[0036] Degreasing and cleaning unit: Ultrasonically clean at a temperature of 60°C using an alkaline degreasing solution (pH 12) to achieve efficient separation of oil stains. A liquid level sensor is built into the module to monitor the consumption of the degreasing solution in real time and trigger automatic replenishment.

[0037] Pickling activation unit: Configure a closed pickling tank containing 10% HNO 3Mix with 2% HF solution and equip with an exhaust gas treatment device to prevent acid mist from escaping. Use a robotic arm to achieve batch loading / unloading of needles, reducing manual contact with corrosive liquids.

[0038] The electrolytic polishing module includes:

[0039] Electrolyte circulation control unit: The electrolyte is circulated by a centrifugal pump with a flow control accuracy of ±0.5 L / min to ensure uniform coverage of the inner cavity with the electrolyte.

[0040] Microelectrode tooling system: Customized platinum-iridium alloy microtube electrodes (diameter 0.1 mm) are used, and precise alignment with the inner cavity of the needle is achieved through a modular fixture, adapting to different needle specifications. A magnetic electrode interface is adopted to support quick replacement and maintenance.

[0041] The post-treatment module includes:

[0042] Multi-stage water washing unit: A three-stage countercurrent rinsing system is set up. The rinsing is carried out through the three-stage countercurrent rinsing system. Among them, the first stage is rinsed with deionized water to remove electrolyte residues, the second stage is ultrasonic oscillation with pure water, and the third stage is high-pressure spraying.

[0043] Vacuum annealing unit: A vacuum chamber is set up, and a nitrogen protection system is arranged in the vacuum chamber. Annealing is carried out at a temperature of 150°C ± 5°C, and nitrogen is used for purging and drying to eliminate the internal stress generated by electrolytic polishing, while maintaining the surface hardness of HV450 - 500.

[0044] The quality control and detection module includes:

[0045] Online surface roughness detection: An integrated laser confocal microscope probe is used to detect the Ra value in real time and synchronize the data to the system.

[0046] Residual amount test unit: A simulated injection test device is used to quantitatively measure the residual amount of the liquid medicine in the inner cavity of the needle with an accuracy of 0.1 μL, and the compliance threshold is set at ≤0.5 μL.

[0047] Through modular design, the processing cycle of a single needle is shortened to 3 minutes (8 minutes for the traditional process), the floor area of the equipment is reduced by 50%, each module can be independently upgraded and maintained, and the failure shutdown rate is reduced by 60%.

[0048] Example 3

[0049] As Figure 3 shown, the present invention provides an injection needle for treating internal hemorrhoids with sclerosing agent, including an injection needle for treating internal hemorrhoids with sclerosing agent and an injection tube 8, and the injection tube 8 is connected to the injection needle for treating internal hemorrhoids with sclerosing agent.

[0050] Working principle: The needle is installed on the injection tube 8. When injecting liquid, the valve flap on the anti-reflux structure 3 is deformed under pressure to open the channel. After the injection is completed, the valve flap returns to its original state to close the channel, preventing the backflow of the liquid medicine. The needle structure can be used once or repeatedly, and corresponding cleaning and disinfection schemes are equipped to meet the requirements of different medical scenarios.

[0051] Therefore, the present invention adopts the above-mentioned needle and syringe for injection treatment of internal hemorrhoid sclerosing agent. By setting the anti-reflux structure made of elastic material, the phenomenon of liquid medicine backflow is effectively avoided, ensuring that the medicine can be accurately injected into the body. At the same time, drug waste is reduced, and the treatment effect is guaranteed.

[0052] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit them. Although the present invention has been described in detail with reference to the preferred embodiments, those of ordinary skill in the art should understand that they can still modify or equivalently replace the technical solutions of the present invention, and these modifications or equivalent replacements cannot make the modified technical solutions deviate from the spirit and scope of the technical solutions of the present invention.

Claims

1. A needle for injection treatment of internal hemorrhoids with a sclerosing agent, characterized in that: It comprises a needle seat and a puncture needle arranged on the needle seat, wherein an anti-backflow structure is arranged in the channel of the puncture needle and located at the connection between the puncture needle and the needle seat, and the anti-backflow structure comprises a fixing ring, and a valve flap is arranged on the fixing ring.

2. A needle for injection treatment of internal hemorrhoids according to claim 1, characterized in that: The fixing ring is fitted with the liquid inlet of the needle seat.

3. A needle for injection treatment of internal hemorrhoids according to claim 1, characterized in that: The valve flap comprises a symmetrically arranged first valve flap, a second valve flap is symmetrically arranged on the first valve flap, and the symmetrically arranged first valve flap and the symmetrically arranged second valve flap both form a truncated cone structure.

4. A needle for injection treatment of internal hemorrhoids with a sclerosing agent according to claim 3, characterized in that: A check ring is arranged inside the second valve disc, and the two check rings are arranged correspondingly.

5. The needle for injection treatment of internal hemorrhoids with a sclerosant according to claim 1, characterized in that: The anti-reflux structure is made of medical-grade silicone.

6. A needle for injection treatment of internal hemorrhoids with a sclerosant according to claim 1, characterized in that: The fixing ring is circular.

7. A needle for injection treatment of internal hemorrhoids with a sclerosing agent according to claim 1, characterized in that: The surface of the puncture needle channel is smoothed.

8. A syringe for injecting a sclerosant for treating internal hemorrhoids, characterized in that: It comprises a needle and an injection tube for injecting a sclerosing agent for internal hemorrhoids as described in any one of claims 1 to 7, wherein the injection tube is connected to the needle for injecting a sclerosing agent for internal hemorrhoids.

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