Safety retention needle for dialysis

Abstract

The application discloses a safe indwelling needle for dialysis, which comprises an indwelling component, a puncture component, an anti-backflow device, a flow-stopping clamp and a needle-sticking prevention device; the indwelling component comprises a catheter, a catheter seat, an extension tube and an infusion interface; the puncture component comprises a puncture needle and a needle seat, the rear end of the puncture needle is fixedly connected with the needle seat, and the puncture needle is slidably connected with the inside of the anti-backflow device, the needle-sticking prevention device and the indwelling component; the front end of the anti-backflow device is connected with the infusion interface of the indwelling component, and the rear end is provided with an open end and connected with the needle-sticking prevention device; the needle-sticking prevention device penetrates the puncture needle, the front end is matched with the rear open end of the anti-backflow device, and the rear end is matched with the needle seat; when the puncture is successful and the puncture needle is retreated to the position of the needle-sticking prevention device, the needle head is limited in the needle-sticking prevention device; the flow-stopping clamp is used for temporarily compressing the extension tube after puncture. The application is safe and convenient to use, guarantees the treatment effect of blood dialysis, and reduces the risk of blood-borne diseases of medical staff.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of hemodialysis, in particular to a safety retention needle for dialysis. BACKGROUND

[0002] Hemodialysis is one of the renal replacement therapy methods for patients with acute and chronic renal failure. In traditional hemodialysis treatment, internal fistula needles are commonly used. However, there are obvious shortcomings in using internal fistula needles to establish the vascular access of patients. Because the internal fistula needle is hard, it can easily cause damage to the blood vessel wall, leading to the occurrence of bleeding, loss of the patient's blood, and difficulty in fixing the internal fistula needle due to its hardness, which can easily cause needle slipping and cause bleeding, resulting in interruption of dialysis and affecting the progress of treatment. In addition, during hemodialysis, the patient needs to receive treatment for 4-5 hours, during which the arm needs to be kept stationary and cannot be moved at will. Slight movement can increase the risk of injury and puncture of the inner wall of the blood vessel by the sharp steel needle, causing internal fistula blood vessel swelling and large area subcutaneous hyperemia, increasing the burden on the patient. At the same time, the patient's comfort is poor due to the long time of keeping the same posture.

[0003] With the progress of modern medical technology, retention needles for dialysis are being widely used. After puncture, the needle tube of the retention needle for dialysis can be withdrawn, and the tube-shaped object made of soft high polymer material left in the patient's blood vessel will not cause damage to the blood vessel. However, there are still some problems with the retention needle for dialysis.

[0004] 1. In clinical practice, the retention needle for dialysis is used for vascular puncture and connected with a blood circuit to perform hemodialysis. The product has an exhaust component including an exhaust connector and an exhaust membrane. The component is used for exhaust after vascular puncture to observe blood return and help nurses judge the success of puncture. The special function of the exhaust membrane is to have air permeability and liquid impermeability. After successful puncture, air will be discharged through the exhaust membrane, and blood will not leak through the exhaust membrane. In the prior art, the component is a welded structure, and the exhaust membrane and the exhaust connector are welded by a welding machine to prevent the filter membrane from falling off. However, the above-mentioned product has the following disadvantages: (1) the size of the exhaust connector and the exhaust membrane welding site is small, which is not easy to operate and process; (2) the welding process requires additional purchase of equipment, which is an additional economic burden for small enterprises.

[0005] 2. When medical staff perform puncture, if the catheter is directly held for puncture, the surface of the catheter is smooth, and the medical staff do not have a good force point, which is not convenient to exert force.

[0006] 3. When the needle is withdrawn after puncture, the medical staff have the risk of being pricked by the needle tip, which can cause injury and even infection of the medical staff. At the same time, the direct exposure of the needle tip increases the risk of infection of the treatment personnel by the needle tip when they handle medical waste.

[0007] 4. If there is no suitable anti-backflow device when the puncture and push-out steel needle, blood may overflow. In order to ensure that blood does not overflow when the puncture needle is withdrawn, a blood blocking and isolating device is required.

[0008] 5. After the steel needle is pulled out, an anticoagulant needs to be injected, and then an extracorporeal circulation blood path tube is connected to start dialysis. During this process, the blood path needs to be temporarily blocked. The nurse needs to pinch or clamp the middle section of the hose with an instrument. If the hose section is not pinched tightly, the blood in the blood vessel such as the internal fistula will be ejected, which on the one hand causes the loss and waste of part of the patient's blood, and on the other hand causes blood pollution and increases the risk of hospital infection. In addition, if the clamp of the instrument such as the hemostatic forceps clamps the hose section of the dialysis indwelling needle too tightly, it will cause damage to the hose, also causing blood loss and blood pollution of the bed sheet, clothes and working environment. The product does not design a switch clamp, which causes certain difficulties in daily heparin saline sealing, incomplete sealing, and easy to form thrombus in the dialysis indwelling needle. Some products have a clamp, but the size of the clamp needs to increase the length of the product, which affects the observation of the medical staff during puncture. Moreover, the clamp is only used at the beginning. If the clamp is always carried during dialysis for 4-6 hours, it will cause compression to the patient and affect the comfort.

[0009] 6. When fixing the catheter, the catheter is cylindrical and has a small contact area with the skin, which is easy to slide and not easy to be fixed. In the subsequent treatment process, the patient may move and deviate, causing the patient to be uncomfortable.

[0010] Therefore, a safe indwelling needle for dialysis is provided. SUMMARY

[0011] The purpose of the present application is to provide a safe indwelling needle for dialysis.

[0012] To solve the above technical problems, the present application adopts the following technical solutions:

[0013] A safe indwelling needle for dialysis, comprising an indwelling assembly, a puncture assembly, an anti-backflow device, a flow-stopping clamp and a needle-sticking prevention device;

[0014] The indwelling assembly comprises a catheter, a catheter seat, an extension tube and an infusion interface;

[0015] The puncture assembly comprises a puncture needle and a needle seat, the rear end of the puncture needle is fixedly connected with the needle seat, and the puncture needle penetrates and is slidingly connected to the inside of the anti-backflow device, the needle-sticking prevention device and the indwelling assembly;

[0016] The front end of the anti-backflow device is connected with the infusion interface of the indwelling assembly, the rear end is provided with an open end and is connected with the needle-sticking prevention device; the anti-backflow device has an anti-backflow pad in the middle.

[0017] The anti-needle puncture device runs through the puncture needle, with its front end engaging with the rear end of the anti-backflow device and its rear end engaging with the needle hub. When the puncture is successful, the needle tip is confined within the anti-needle puncture device when the puncture needle retracts to the position of the anti-needle puncture device.

[0018] The flow stop clamp is used to temporarily compress the extension tube after puncture. The flow stop clamp should be removed when not in use.

[0019] Furthermore, the catheter has one or more side holes; the front end of the catheter is beveled; and the catheter is made of a soft polymer material.

[0020] Furthermore, the catheter seat has a protrusion on the upper side and a handle wing on the lower side.

[0021] Furthermore, the front end of the anti-backflow device is a Luer connector, which is connected to the infusion interface of the indwelling component; anti-slip rings are arranged on the outer periphery of the anti-backflow device.

[0022] Furthermore, the anti-backflow pad is a product molded from liquid silicone, with a bowl-shaped arc and cross-shaped cutting edges on both sides of the arc surface. The maximum depth of each cutting edge is 1 / 2 of the wall thickness, and point contact is formed at the intersection to form an openable opening.

[0023] Under normal conditions, the cutting edge is compressed by the plastic parts on both sides of the anti-backflow pad, and is in a sealed state. When a puncture needle passes through the cutting edge, the pressure difference between the inner and outer surfaces and its own contractility at the cutting edge will play a role in sealing the puncture needle.

[0024] Furthermore, the anti-needle puncture device includes an inner cylinder and an outer cylinder. The outer cylinder is installed at the rear end opening of the anti-backflow device, and the rear end of the outer cylinder is set as an opening. The inner cylinder is installed in the outer cylinder through the opening and slides with it in the front-back direction.

[0025] Both the inner and outer cylinders are fixedly provided with front end sealing plates, and the front end sealing plates are provided with front end through holes for the puncture needle to pass through at the center position; the inner cylinder is fixedly provided with rear end sealing plates, and the rear end sealing plates are provided with rear end through holes for the puncture needle to pass through.

[0026] The puncture needle has a limiting part at the front end, the outer diameter of which is larger than the outer diameter of the puncture needle; the inner diameter of the front end through hole is larger than the outer diameter of the limiting part; the inner diameter of the rear end through hole is larger than the outer diameter of the puncture needle and smaller than the outer diameter of the limiting part.

[0027] The inner cylinder is equipped with a one-way blocking component, which is an elastic structure composed of a front plate, an upper bending plate, and a lower bending plate. The front plate is set near the front end of the inner cylinder. The front end of the upper bending plate is connected to the upper side of the front plate, and has a downward protruding upper protrusion in the middle and an upward-curving upper tail at the rear end. The front end of the lower bending plate is connected to the lower side of the front plate, and has an upward protruding lower protrusion in the middle and a downward-curving lower tail at the rear end. The upper and lower protrusions are staggered in the vertical and horizontal directions and the front and back directions.

[0028] Upper slots are provided on the upper sides of both the inner and outer cylinders, corresponding to the upper tail, and lower slots are provided on the lower sides of both the inner and outer cylinders, corresponding to the lower tail.

[0029] Furthermore, the anti-needle puncture device includes a front cylinder and a rear cylinder, with the front cylinder installed at the rear opening of the anti-backflow device; the rear end of the front cylinder and the front end of the rear cylinder are respectively set as openings, and the two are inserted and connected to form a sliding fit in the front-rear direction.

[0030] The front end of the front cylinder is fixedly provided with a front end sealing plate, and a front end through hole for the puncture needle to pass through is provided at the center of the front end sealing plate; the rear end of the rear cylinder is fixedly provided with a rear end sealing plate, and a rear end through hole for the puncture needle to pass through is provided on the rear end sealing plate.

[0031] The puncture needle has a limiting part at the front end, the outer diameter of which is larger than the outer diameter of the puncture needle; the inner diameter of the front end through hole is larger than the outer diameter of the limiting part; the inner diameter of the rear end through hole is larger than the outer diameter of the puncture needle and smaller than the outer diameter of the limiting part.

[0032] A one-way blocking component is provided in the space enclosed by the front and rear cylinders. The one-way blocking component is an elastic structure composed of a lower plate, a middle bending plate, and a vertical plate. The lower plate is installed on the rear cylinder. The middle bending plate has a forward-protruding bending part in the middle. The lower end of the middle bending plate is connected to the lower plate, and the upper end of the middle bending plate is connected to the upper end of the vertical plate. The lower end of the vertical plate extends downward and slides through the lower plate. A clearance groove is provided on the front or rear cylinder at a position corresponding to the vertical plate.

[0033] Furthermore, the anti-needle puncture device includes a limiting cylinder and a guide cylinder. The limiting cylinder is installed at the rear open end of the anti-backflow device, and the rear end of the limiting cylinder is provided with a through hole. The front end of the guide cylinder is provided with an opening and is fixed to the rear through hole of the limiting cylinder.

[0034] The front end of the limiting cylinder is fixedly provided with a front end sealing plate, and a front end through hole for the puncture needle to pass through is provided at the center of the front end sealing plate; the rear end of the guide cylinder is fixedly provided with a rear end sealing plate, and a rear end through hole for the puncture needle to pass through is provided on the rear end sealing plate.

[0035] The puncture needle has a limiting part at the front end, the outer diameter of which is larger than the outer diameter of the puncture needle; the inner diameter of the front end through hole is larger than the outer diameter of the limiting part; the inner diameter of the rear end through hole is larger than the outer diameter of the puncture needle but smaller than the outer diameter of the limiting part; the inner diameter of the rear end through hole of the limiting cylinder and the front end opening of the guide cylinder is larger than the outer diameter of the limiting part.

[0036] The limiting cylinder is provided with a one-way blocking component, which includes a sliding seat that slides with the limiting cylinder in the vertical direction. A stop block pointing towards the puncture needle is fixed on the lower side of the sliding seat, and an elastic mechanism is provided between the upper side of the sliding seat and the limiting cylinder.

[0037] Furthermore, the flow stop clamp includes two clamping bodies arranged opposite each other, and a clamping part is provided on the opposite surface of the two clamping bodies. The clamping part is elongated, and an elongated clamping groove is provided on the side of the clamping part facing the extension tube. The bottom surface of the clamping groove is flat and forms a surface contact fit with the extension tube.

[0038] Furthermore, the needle seat has a convex surface, and an exhaust device is fixedly connected to the rear end of the needle seat. The exhaust device consists of an exhaust connector and a filter plug. The filter plug is air-permeable but liquid-permeable and is interference-fitted into the hollow position of the exhaust connector.

[0039] The beneficial effects of this invention are:

[0040] 1. Compared with ordinary dialysis indwelling needles, the dialysis safety indwelling needle of the present invention is equipped with an anti-needle-puncture device. When the needle tube is retracted to the position of the anti-needle-puncture device after successful puncture, the needle tip is confined within the anti-needle-puncture device and the needle tip is shielded and not exposed to the outside world, preventing the needle tip from pricking medical staff or patients, ensuring the safety of medical staff and patients. At the same time, it can also prevent the needle tip from pricking staff during the subsequent medical waste disposal process, reducing the risk of medical staff being infected with blood-borne diseases.

[0041] 2. This invention enhances the ease of use of the dialysis safety indwelling needle through the design of the flow-stopping clip. During use, the flow-stopping clip can be used to open and close the blood circuit. When injecting anticoagulants and connecting the extracorporeal circulation blood circuit, nurses need to pinch the middle section of the tubing with their hands or clamp it with instruments to prevent blood from spurting out of the blood vessels, such as arteriovenous fistulas, if the tubing is not pinched tightly. This would cause some blood loss and waste for the patient, as well as blood contamination and an increased risk of hospital-acquired infections. In addition, if instruments such as hemostatic forceps clamp the middle section of the dialysis indwelling needle too tightly, it will cause the tubing to break, which will also cause blood loss and blood contamination of bed sheets and the working environment.

[0042] 3. The anti-backflow device designed in this invention mainly addresses the risk of blood leakage during puncture and connection of existing dialysis indwelling needles, ensuring that blood does not leak during puncture and connection.

[0043] 4. This invention uses a soft polymer material for the catheter of the indwelling component, which minimizes irritation to the patient's blood vessel wall and avoids damage to the inner wall of the blood vessel, reducing the incidence of vascular swelling and bleeding. This can extend the lifespan of the patient's arteriovenous fistula. Furthermore, the indwelling catheter material has better biocompatibility than steel needles, resulting in a lower incidence of patient allergies. Patients can also move relatively freely, and the movement of the patient's body during dialysis will not cause sudden changes in blood flow. There is also no need to worry about the needle puncturing the blood vessel, which increases the patient's comfort.

[0044] 5. The design of the catheter seat in this invention allows medical staff to hold the wing handle and protrusion on the catheter seat and insert the metal puncture needle into the patient's blood vessel for puncture. This provides medical staff with a better point of leverage, making the puncture operation easier. At the same time, the wing handle increases the contact area between the indwelling needle and the patient's skin, reducing pressure on the skin and improving comfort. In addition, after the puncture is completed, it is easier for medical staff to fix the indwelling needle, preventing the indwelling needle from breaking due to the patient's movement during subsequent dialysis treatment, which would affect the flow rate during hemodialysis and avoid affecting the treatment effect of hemodialysis.

[0045] 6. In this invention, the exhaust connector and the filter plug are fixed by interference fit, which is easy to operate and process, eliminates the welding process and does not require additional equipment purchase, which can save some expenses for small enterprises and thus reduce production costs. Attached Figure Description

[0046] Figure 1 This is an overall schematic diagram of the present invention;

[0047] Figure 2 This is a schematic diagram of the retention component in this invention;

[0048] Figure 3 This is a cross-sectional view of the indwelling component in this invention;

[0049] Figure 4 This is a schematic diagram of the puncture assembly and the exhaust device in this invention;

[0050] Figure 5 This is a cross-sectional view of the puncture assembly and the exhaust device in this invention;

[0051] Figure 6 This is a schematic diagram of the anti-backflow device in the present invention;

[0052] Figure 7 This is a cross-sectional view of the anti-backflow device in this invention;

[0053] Figure 8 This is a schematic diagram of the flow stop clamp of the present invention;

[0054] Figure 9This is a schematic diagram showing the relationship between the puncture needle and the anti-needle puncture device when the needle is not withdrawn in Example 1;

[0055] Figure 10 for Figure 9 Enlarged view of the part of the needle-punching device in the middle;

[0056] Figure 11 This is a schematic diagram showing the relationship between the puncture needle and the anti-needle-puncture device during needle withdrawal in Example 1;

[0057] Figure 12 for Figure 11 Cross-sectional view;

[0058] Figure 13 This is a schematic diagram of the installation of the puncture needle in Example 1;

[0059] Figure 14 This is a schematic diagram showing the relationship between the puncture needle and the anti-needle puncture device when the needle is not withdrawn in Example 2;

[0060] Figure 15 for Figure 14 Enlarged view of the part of the needle-punching device in the middle;

[0061] Figure 16 This is a schematic diagram showing the relationship between the puncture needle and the anti-needle puncture device during needle withdrawal in Example 2;

[0062] Figure 17 for Figure 15 Cross-sectional view;

[0063] Figure 18 This is a schematic diagram showing the relationship between the puncture needle and the anti-needle puncture device when the needle is not withdrawn in Example 3;

[0064] Figure 19 for Figure 18 Enlarged view of the part of the needle-punching device in the middle;

[0065] Figure 20 This is a schematic diagram showing the relationship between the puncture needle and the anti-needle puncture device during needle withdrawal in Example 3;

[0066] Figure 21 for Figure 20 Cross-sectional view.

[0067] The accompanying drawings are for illustrative purposes only and should not be construed as limiting the scope of this patent. To better illustrate this embodiment, some components in the drawings may be omitted, enlarged, or reduced, and do not represent the actual dimensions of the product. It is understandable to those skilled in the art that some well-known structures and their descriptions may be omitted in the drawings. Detailed Implementation

[0068] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention.

[0069] Example 1:

[0070] like Figures 1 to 13 As shown, this embodiment provides a safe indwelling needle for dialysis, including an indwelling component 1, a puncture component 2, an anti-backflow device 3, a flow stop clamp 4, an anti-needle puncture device 5, and an exhaust device 6.

[0071] The indwelling assembly 1 includes a catheter 11, a catheter base 12, an extension tube 13, and an infusion interface 14. The tip of the catheter 11 is beveled for easy puncture and to reduce damage. The catheter 11 includes one to four side holes to increase blood flow while preventing the catheter from adhering to the vessel wall and affecting dialysis. The catheter 11 is tightly integrated with the extension tube 13 and integrally injection molded with the catheter base 12 to avoid clotting during dialysis due to dead angles in the lumen. The catheter 11 is made of a soft polymer material to avoid damage to the vessel wall, reduce the incidence of vascular swelling and bleeding, and extend the lifespan of the patient's arteriovenous fistula. Furthermore, the indwelling catheter material has better biocompatibility than steel needles, resulting in a lower incidence of patient allergies. Patients can move relatively freely, and movement during dialysis will not cause sudden changes in blood flow, eliminating concerns about needle puncture and increasing patient comfort. Contrast-enhancing materials can also be added to the polymer material, giving the catheter 11 a contrast-enhancing function.

[0072] The catheter hub 12 has a protrusion on the upper side and a handle wing on the lower side, providing support for medical staff during puncture, assisting in vascular puncture, and securing the indwelling needle with the protective sleeve to prevent slippage and puncture of the packaging bag during transportation. Furthermore, the handle wing design increases the contact area with the skin, making it easier to secure and preventing displacement due to patient movement during subsequent treatment, thus avoiding discomfort for the patient.

[0073] The puncture assembly includes a puncture needle 21 and a needle hub 22. The rear end of the puncture needle 21 is fixedly connected to the needle hub 22, and the puncture needle 21 is slidably connected through the anti-puncture device 5, the anti-backflow device 3, and the indwelling assembly 1. The puncture needle 21 is a hollow steel needle, and a limiting part 23 is provided at the front end of the puncture needle 21 to prevent the needle tip from being exposed by cooperating with the anti-puncture device 5.

[0074] The needle hub 22 has an anti-puncture device 5 at its front end and an exhaust device 6 fixedly connected to its rear end. Blood return can be observed at the end of the needle hub 22 near the exhaust device. The convex design of the needle hub 22 provides magnification, facilitating observation of blood return. Furthermore, the increased gap between the needle hub 22 and the puncture needle 21 and the exhaust device 6 also aids in observing blood return.

[0075] The venting device 6 consists of an venting connector 61 and a filter plug 62. The filter plug 62 is entirely air-permeable but liquid-permeable, and is interference-fitted into the hollow position of the venting connector 61, ensuring safety, reliability, and simple manufacturing process. The venting device 6 has a certain taper to mate with the needle seat 22.

[0076] The anti-backflow device 3 ensures that blood does not leak during puncture and connection. One end of the anti-backflow device 3 is connected to the indwelling component 1, and the other end is connected to the anti-needle-puncture device 5. The end of the anti-backflow device 3 connected to the infusion port 14 on the indwelling component 1 is a Luer connector, and the end connected to the anti-needle-puncture device 5 is an open port with a liquid silicone anti-backflow pad 31 in the middle. Anti-slip rings are arranged at intervals along the outer periphery of the anti-backflow device to facilitate separation of the anti-backflow device from the needle hub.

[0077] The anti-backflow pad is a liquid silicone product with a cross-shaped valve. It features a bowl-shaped arc with cross-shaped cutting edges on both sides of the arc. The maximum depth of each cutting edge is half the wall thickness, forming a point contact at the intersection. Under normal conditions, the cutting edges are compressed by the silicone components on both sides, maintaining a sealed state. When an instrument passes through the arc and the cutting edges to transport the instrument or liquid, the pressure difference between the inner and outer surfaces and the cutting edges' own contraction create a seal. This fulfills the functional requirement of the silicone product, continuously maintaining a tight seal.

[0078] The shunt clamp 4 is used to temporarily compress the extension tube after puncture. When in contact with the extension tube, the shunt clamp provides sufficient occlusion to achieve hemostasis without causing excessive pressure that could damage the extension tube. When not in use, the shunt clamp 4 can be removed without compressing the extension tube. It is reusable and convenient to use.

[0079] To achieve a large and uniform contact area between the flow stop clamp and the extension tube 13, the flow stop clamp 4 in this embodiment is configured as follows: The flow stop clamp 4 includes two opposing clamping bodies 41, which are clamped by an outer elastic band 44. A clamping portion 42 is provided on the opposing surfaces of the two clamping bodies 41. The clamping portion is elongated, and an elongated clamping groove 43 is provided on the side of the clamping portion 42 facing the extension tube. The bottom surface of the clamping groove 43 is flat, forming a surface contact fit with the extension tube 13.

[0080] The design of the flow-stopping clip 4 enhances the ease of use of this dialysis safety indwelling needle. During use, the flow-stopping clip can be used to open and close the blood circuit. When injecting anticoagulants and connecting the extracorporeal circulation blood circuit, nurses need to pinch the middle section of the tubing with their hands or clamp it with instruments to prevent blood from spurting out of the blood vessels, such as arteriovenous fistulas, if the tubing is not pinched tightly. This would result in the loss and waste of some blood from the patient, as well as blood contamination and an increased risk of hospital-acquired infections. In addition, if instruments such as hemostatic forceps clamp the middle section of the dialysis indwelling needle too tightly, it will cause the tubing to break, which will also cause blood loss and blood contamination of bed sheets and the work environment.

[0081] The anti-needle-puncture device 5 is inserted through the puncture needle 21, with its front end engaging with the rear end opening of the anti-backflow device 3 and its rear end engaging with the needle hub 22. When the puncture is successful and the puncture needle 21 retracts to the position of the anti-needle-puncture device 5, the needle tip is confined within the anti-needle-puncture device 5, the needle tip is shielded and not exposed to the outside, preventing the needle tip from puncturing medical staff or patients, ensuring the safety of medical staff and patients. At the same time, it can also prevent the needle tip from puncturing staff during subsequent medical waste disposal, reducing the risk of medical staff contracting bloodborne diseases.

[0082] like Figures 9 to 13 As shown, the structure of the anti-needle puncture device 5 in this embodiment is as follows:

[0083] The anti-needle puncture device 5 includes an outer cylinder 51 and an inner cylinder 52. The outer cylinder 51 is fixedly installed at the rear end opening of the anti-backflow device 3, and the rear end of the outer cylinder 51 is set as an opening. The inner cylinder 52 is installed in the outer cylinder 51 through the opening and slides with it in the front-back direction.

[0084] Both the inner cylinder 52 and the outer cylinder 51 are fixedly provided with front end sealing plates, and a front end through hole 53 for the puncture needle to pass through is provided at the center of the front end sealing plate; the inner cylinder 52 is fixedly provided with a rear end sealing plate 54, and a rear end through hole 55 for the puncture needle to pass through is provided on the rear end sealing plate 54.

[0085] The front end of the puncture needle 21 is provided with a limiting part 23, the outer diameter of the limiting part 23 is larger than the outer diameter of the puncture needle 21; the inner diameter of the front end through hole 53 is larger than the outer diameter of the limiting part 53; the inner diameter of the rear end through hole 55 is larger than the outer diameter of the puncture needle 21 and smaller than the outer diameter of the limiting part 23.

[0086] The inner cylinder 22 is equipped with a one-way blocking component, which is an elastic structure integrally composed of a front plate 56, an upper bent plate 57, and a lower bent plate 58. The material can be a thin steel plate with elasticity. The front plate 56 is set as a front end cap near the inner cylinder; the front end of the upper bent plate 57 is connected to the upper side of the front plate, with a downward protruding upper part in the middle and an upward-curving upper tail at the rear end; the front end of the lower bent plate 58 is connected to the lower side of the front plate 56, with an upward protruding lower part in the middle and a downward-curving lower tail at the rear end. The upper and lower protruding parts are staggered in the vertical and horizontal directions and the front-back direction.

[0087] Upper slots are provided on the upper sides of the inner cylinder 52 and the outer cylinder 51 corresponding to the upper tail, and lower slots are provided on the lower sides of the inner cylinder 52 and the outer cylinder 51 corresponding to the lower tail.

[0088] The working principle of the anti-needle-puncture device 5 in this embodiment is as follows:

[0089] During assembly, such as Figure 13 As shown, a portion of the front end of the puncture needle 21 is first flattened using a special tool, forming an elliptical structure. The other parts of the needle tube remain circular. This makes the diameter of the flattened portion larger than the diameter of the other parts, forming a limiting part 23. Then, the puncture needle 21 is inserted backwards from front to back. The rear end of the puncture needle 21 passes through the anti-backflow device 3 and the anti-needle-puncture device 5 before connecting to the needle hub 22.

[0090] When the rear end of the puncture needle 21 passes through the anti-backflow device 3, the rear end of the puncture needle 21 first passes through the front through hole 53, and then enters the one-way blocking member, which opens the upper bending plate 57 and the lower bending plate 58. After the upper bending plate 57 and the lower bending plate 58 are opened, they will clamp onto the puncture needle 21. Then the rear end of the puncture needle will exit through the rear through hole 55. Furthermore, when the upper bending plate 57 and the lower bending plate 58 are opened, the upper tail of the upper bending plate 57 will move and get stuck in the upper slot, and the lower tail of the lower bending plate 58 will move and get stuck in the lower slot, thereby restricting the inner cylinder 52 from moving backward relative to the outer cylinder 51. This completes the assembly.

[0091] After a successful puncture, when the puncture needle 21 retracts to the position of the anti-puncture device 5, it separates from the upper bending plate 57 and the lower bending plate 58, which then return to their original shapes. Because the upper and lower protrusions are misaligned in the vertical and horizontal directions and the front-back direction, the needle cannot pass forward through the one-way blocking member; and because the inner diameter of the rear through-hole 55 is larger than the outer diameter of the puncture needle 21 and smaller than the outer diameter of the limiting part 23, the limiting part 23 cannot pass backward through the rear through-hole 55. Thus, the needle is confined within the anti-puncture device 5.

[0092] Example 2:

[0093] The difference between this embodiment and Embodiment 1 lies in the structure of the anti-needle puncture device 5.

[0094] like Figures 14 to 17 As shown, the structure of the anti-needle puncture device 5 in this embodiment is as follows:

[0095] The anti-needle puncture device 5 includes a front cylinder 71 and a rear cylinder 72. The front cylinder 71 is fixedly installed at the rear opening of the anti-backflow device 3. The rear end of the front cylinder 71 and the front end of the rear cylinder 72 are respectively set as openings, and the two are inserted and connected to form a sliding fit in the front-rear direction.

[0096] The rear cylinder 72 has a connector at its front end, the outer diameter of which is smaller than that of the rear cylinder, forming a step. The outer diameter of the connector also matches the inner diameter of the front cylinder 71. When the connector at the front end of the rear cylinder 72 is inserted into the front cylinder 71, the rear end of the front cylinder 71 abuts against the step, achieving sliding limit in the front-rear direction.

[0097] The front end of the front cylinder 71 is fixedly provided with a front end sealing plate, and a front end through hole 73 for the puncture needle to pass through is provided at the center of the front end sealing plate; the rear end of the rear cylinder 72 is fixedly provided with a rear end sealing plate, and a rear end through hole 74 for the puncture needle to pass through is provided on the rear end sealing plate.

[0098] The puncture needle 21 has a limiting part 22 at its front end, and the inner diameter of the front end through hole 73 is larger than the outer diameter of the limiting part 22; the inner diameter of the rear end through hole 74 is larger than the outer diameter of the puncture needle 21 and smaller than the outer diameter of the limiting part 23.

[0099] A one-way blocking element is provided in the space enclosed by the front cylinder 71 and the rear cylinder 72. The one-way blocking element is an elastic structure integrally composed of a lower plate 75, a middle bent plate 76, and a vertical plate 77. The lower plate 75 is installed on the rear cylinder. The middle bent plate 76 has a forward-protruding bent portion in the middle. The lower end of the middle bent plate 76 is connected to the lower plate 75, and the upper end of the middle bent plate 76 is connected to the upper end of the vertical plate 77. The lower end of the vertical plate 77 extends downward and slides through the lower plate 75 (two vertical plates 77 are provided on the left and right sides). Furthermore, a clearance groove is provided on the front cylinder 71 at a position corresponding to the vertical plate 77.

[0100] The working principle of the anti-needle-puncture device 5 in this embodiment is as follows:

[0101] The assembly method of the puncture needle 21 is the same as that in Example 1.

[0102] When the rear end of the puncture needle 21 passes through the anti-backflow device 3, the rear end of the puncture needle 21 first passes through the front through hole 73, and then enters the one-way blocking member, pressing down the middle bending plate 76. The rebound force of the middle bending plate 76 after being pressed down makes the middle bending plate 76 press tightly upward against the puncture needle 21. Then the rear end of the puncture needle exits through the rear through hole 74. And after the middle bending plate 76 is pressed down, the vertical plate 77 moves down accordingly and passes through the clearance groove on the lower plate 75 and the front cylinder 71, which can restrict the rear cylinder 72 from moving backward relative to the front cylinder 71. The assembly is then complete.

[0103] After successful puncture, when the puncture needle 21 retracts to the position of the anti-puncture device 5, the puncture needle 21 leaves the middle bending plate 76, and the middle bending plate 76 returns to its original shape upwards. At this time, the rear cylinder 72 can also move backwards. Due to the obstruction of the middle bending plate 76, the needle tip cannot pass forward through the one-way blocking member; since the inner diameter of the rear through hole 74 is larger than the outer diameter of the puncture needle 21 and smaller than the outer diameter of the limiting part 23, the limiting part 23 cannot pass backwards out of the rear through hole 74. In this way, the needle tip is confined within the anti-puncture device 5.

[0104] Example 3:

[0105] The difference between this embodiment and Embodiment 1 lies in the structure of the anti-needle puncture device 5.

[0106] like Figures 18 to 21 As shown, the structure of the anti-needle puncture device 5 in this embodiment is as follows:

[0107] The anti-needle puncture device 5 includes a large-diameter limiting cylinder 81 and a small-diameter guide cylinder 82. The limiting cylinder 81 is lockably and movably installed at the rear end opening of the anti-backflow device 3, and the rear end of the limiting cylinder 81 is provided with a through hole. The front end of the guide cylinder 82 is provided with an opening of the same diameter as the through hole, and is fixed to the rear end through hole of the limiting cylinder 81.

[0108] The front end of the limiting cylinder 81 is fixedly provided with a front end sealing plate, and a front end through hole 83 for the puncture needle to pass through is provided at the center of the front end sealing plate; the rear end of the guide cylinder 82 is fixedly provided with a rear end sealing plate, and a rear end through hole 84 for the puncture needle to pass through is provided on the rear end sealing plate.

[0109] The puncture needle 21 has a limiting part 23 at its front end, and the inner diameter of the front end through hole 83 is greater than the outer diameter of the limiting part 23; the inner diameter of the rear end through hole 84 is greater than the outer diameter of the puncture needle 21 and less than the outer diameter of the limiting part 23; the inner diameter of the rear end through hole of the limiting cylinder 81 and the front end opening of the guide cylinder 82 is greater than the outer diameter of the limiting part 23.

[0110] The limiting cylinder 81 is equipped with a one-way blocking component, which includes a sliding seat 85. An upwardly extending sliding rod 86 is fixed to the upper side of the sliding seat 85. The sliding rod 86 slides through the limiting cylinder 81 and the anti-backflow device 3, achieving a sliding engagement between the sliding seat 85 and the limiting cylinder 81 in the vertical direction. A stop block 88 pointing towards the puncture needle 21 is fixed to the lower side of the sliding seat 85. An elastic mechanism is provided between the upper side of the sliding seat 85 and the limiting cylinder 81. The elastic mechanism is an elastic body 87, with its upper and lower ends connected to the sliding seat 85 and the limiting cylinder 81, respectively.

[0111] In other embodiments, the elastic mechanism may also be a spring or the like.

[0112] In this embodiment, the limiting cylinder 81 has a semi-circular structure, and the empty part is used for the downward extension space of the stop 88. At the same time, the limiting cylinder 81 is provided with a through hole at the position corresponding to the stop 88.

[0113] The working principle of the anti-needle-puncture device 5 in this embodiment is as follows:

[0114] The assembly method of the puncture needle 21 is the same as that in Example 1.

[0115] When the rear end of the puncture needle 21 passes through the anti-backflow device 3, the rear end of the puncture needle 21 first passes through the front through hole 83, and then enters the one-way blocking member. The sliding seat 85 and the sliding rod 86 are moved upward by the cooperating tool, which in turn moves the stop block 88 upward, and the rear end of the puncture needle exits through the rear through hole 84. Then the cooperating tool is removed, and the stop block 88, under the action of the elastic body 87, resets and moves downward, pressing firmly against the puncture needle 21. Furthermore, when the sliding rod 86 moves upward through the limiting cylinder 81 and the anti-backflow device 3, it can restrict the backward movement of the limiting cylinder 81. This completes the assembly.

[0116] After a successful puncture, when the puncture needle 21 retracts to the position of the anti-puncture device 5, the puncture needle 21 leaves the stop block 88, and the stop block 88 moves downward under the action of the elastic body 87. The slide rod 86 also moves downward away from the anti-backflow device 3, and the limiting cylinder 81 can move backward. Due to the obstruction of the stop block 88, the needle tip cannot pass forward through the one-way blocking member; because the inner diameter of the rear through hole 84 is larger than the outer diameter of the puncture needle 21 and smaller than the outer diameter of the limiting part 23, the limiting part 23 cannot pass backward through the rear through hole 84. Thus, the needle tip is confined within the anti-puncture device 5.

[0117] The above embodiments are only used to illustrate and not limit the technical solutions of the present invention. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that modifications or equivalent substitutions can still be made to the present invention without departing from the spirit and scope of the present invention. Any modifications or partial substitutions should be covered within the scope of the claims of the present invention.

[0118] If the terms "first" or "second" are used in this document to define components, those skilled in the art should know that the use of "first" or "second" is merely for the convenience of describing the invention and simplifying the description, and unless otherwise stated, the above terms have no special meaning.

[0119] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and are not intended to 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 invention.

[0120] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" 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 invention based on the specific circumstances.

Claims

1. A safe indwelling needle for dialysis, characterized in that: Includes indwelling components, puncture components, anti-backflow devices, flow stop clips, and anti-needle puncture devices; The indwelling assembly includes a catheter, catheter hub, extension tubing, and infusion port; The puncture assembly includes a puncture needle and a needle hub. The rear end of the puncture needle is fixedly connected to the needle hub, and the puncture needle is slidably connected through the anti-puncture device, the anti-backflow device, and the indwelling assembly. The front end of the anti-backflow device is connected to the infusion interface of the indwelling component, and the rear end is open and connected to the anti-needle-puncture device; there is an anti-backflow pad in the middle of the anti-backflow device. The anti-needle puncture device runs through the puncture needle, with its front end engaging with the rear end of the anti-backflow device and its rear end engaging with the needle hub. When the puncture is successful, the needle tip is confined within the anti-needle puncture device as the puncture needle retracts to its position. The flow stop clamp is used to temporarily compress the extension tube after puncture. The flow stop clamp should be removed when not in use. The anti-needle-puncture device includes an inner cylinder and an outer cylinder. The outer cylinder is installed at the rear opening of the anti-backflow device, and the rear end of the outer cylinder is set as an opening. The inner cylinder is installed in the outer cylinder through the opening and slides with it in the front-back direction. Both the inner and outer cylinders are fixedly provided with front end sealing plates, and the front end sealing plates are provided with front end through holes for the puncture needle to pass through at the center position; the inner cylinder is fixedly provided with rear end sealing plates, and the rear end sealing plates are provided with rear end through holes for the puncture needle to pass through. The puncture needle has a limiting part at the front end, the outer diameter of which is larger than the outer diameter of the puncture needle; the inner diameter of the front end through hole is larger than the outer diameter of the limiting part; the inner diameter of the rear end through hole is larger than the outer diameter of the puncture needle and smaller than the outer diameter of the limiting part. The inner cylinder is equipped with a one-way blocking component, which is an elastic structure composed of a front plate, an upper bending plate, and a lower bending plate. The front plate is set near the front end of the inner cylinder. The front end of the upper bending plate is connected to the upper side of the front plate, and has a downward protruding upper protrusion in the middle and an upward-curving upper tail at the rear end. The front end of the lower bending plate is connected to the lower side of the front plate, and has an upward protruding lower protrusion in the middle and a downward-curving lower tail at the rear end. The upper and lower protrusions are staggered in the vertical and horizontal directions and the front and back directions. Upper slots are provided on the upper sides of both the inner and outer cylinders, corresponding to the upper tail, and lower slots are provided on the lower sides of both the inner and outer cylinders, corresponding to the lower tail.

2. The safety indwelling needle for dialysis according to claim 1, characterized in that: The catheter has one or more side holes; the front end of the catheter is beveled; the catheter is made of a soft polymer material.

3. The safety indwelling needle for dialysis according to claim 1, characterized in that: The catheter seat has a protrusion on the upper side and a handle wing on the lower side.

4. The safety indwelling needle for dialysis according to claim 1, characterized in that: The front end of the anti-backflow device is a Luer connector, which is connected to the infusion interface of the indwelling component; anti-slip rings are arranged on the outer periphery of the anti-backflow device.

5. The safety indwelling needle for dialysis according to claim 1, characterized in that: The anti-backflow pad is a product molded from liquid silicone, with a bowl-shaped arc. There are cross-shaped cutting edges on both sides of the arc surface. The maximum depth of each cutting edge is 1 / 2 of the wall thickness. Point contact is formed at the intersection to form an openable opening. Under normal conditions, the cutting edge is compressed by the plastic parts on both sides of the anti-backflow pad, and is in a sealed state. When a puncture needle passes through the cutting edge, the pressure difference between the inner and outer surfaces and its own contractility at the cutting edge will play a role in sealing the puncture needle.

6. The safety indwelling needle for dialysis according to claim 1, characterized in that: The flow stop clamp includes two opposing clamping bodies, which are clamped by an elastic band on the outer sleeve. The opposing surfaces of the two clamping bodies are provided with a clamping part, which is elongated and has an elongated clamping groove on the side of the clamping part facing the extension tube. The bottom surface of the clamping groove is flat and forms a surface contact fit with the extension tube.

7. The safety indwelling needle for dialysis according to claim 1, characterized in that: The needle holder has a convex surface, and an exhaust device is fixedly connected to the rear end of the needle holder. The exhaust device consists of an exhaust connector and a filter plug. The filter plug is air-permeable but liquid-permeable and is interference-fitted into the hollow position of the exhaust connector.

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