Safety type special needle special for infusion port and infusion port assembly

Abstract

The utility model discloses an infusion port special-purpose safety type special needle and infusion port subassembly, wherein the infusion port special-purpose safety type special needle comprises a needle tube and a needle head arranged at the tail end of the needle tube, one side of the needle head is provided with a blade surface, the blade surface comprises a first cutting edge and a second cutting edge, the tail ends of the two sides of the second cutting edge are narrowed to form needle tips, and the needle tips are arranged at the tail ends of the first cutting edge and the second cutting edge. The needle head is gradually bent in an arc shape from the connecting end of the needle head and the needle tube to the tail end, it is ensured that the needle head is located within the tubular range where the peripheral face of the needle tube is located all the time, the first cutting edge and the second cutting edge each comprise an inner cutting edge formed along the inner wall of the needle head and an outer cutting edge formed along the outer wall of the needle head, and the inner cutting edge of the first cutting edge is arranged to be a fillet. And the junction of the inner edge of the first cutting edge and the second cutting edge is in smooth transition. According to the scheme, the special needle cannot form deflection force in the puncture process, the safety performance of subsequent infusion port use is ensured, the puncture resistance is reduced, meanwhile, the puncture area is reduced as much as possible, and the service life and the sealing performance of the injection seat are ensured.

Description

Technical Field

[0001] The utility model relates to the field of infusion ports and special needles for infusion ports, in particular to a special safety needle for an infusion port and an infusion port assembly. Background Art

[0002] The special needle for a disposable implantable drug delivery device, also called a "side hole" needle, is used for infusion and drug delivery, and is used in cooperation with the base of an infusion port (subcutaneous implantable drug delivery device). The liquid medicine is input into the patient's body through the special needle and the infusion port to treat the patient's disease. The basic principle and use process of the special needle are as follows: when the needle tip punctures into the diaphragm / injection seat (highly compressed silicone elastomer) of the implantable drug delivery device, the cutting edge and the liquid outlet of the needle are arranged on the side of the needle, the needle is bent, and the needle tip at the end of the needle is used to block the hollow cutting effect of the needle tube. The bent design of the tip of the special needle makes it not cut the puncture diaphragm of the port body during puncture. During the puncture process, both the inner edge and the outer edge of the cutting edge at the front end of the needle tip need to participate in piercing the punctured object. Therefore, the needle tip edge angle and the needle tube body gradually "squeeze and enter" the surrounding silicone elastic material, which can effectively prevent the puncture diaphragm from being damaged and leaking liquid, and prevent the occurrence of particles cut off from blocking the catheter and blood vessels, thereby avoiding cutting the injection seat and causing puncture debris.

[0003] As Figure 1 shown, on the right is the design of the existing special needle that complies with the national standard YY0881-2013. The needle at the end of the needle tube is bent, and the cutting edge and the needle tip of the needle extend beyond the plane of the outer periphery of the needle tube. However, this directly bent needle design, on the one hand, is prone to form a deflection component force during the downward puncture process (as Figure 1 shown by the arrow), and due to the lack of transition at the bent part, it forms an obstacle, which will greatly increase the resistance of puncture and extraction; on the other hand, due to the large puncture resistance and the difficulty in controlling the puncture force, during puncture, the needle tip is prone to collide with the bottom of the liquid storage cavity due to excessive puncture force, causing the needle tip to curl and form a barb, resulting in the barb scraping the injection seat when the special needle is pulled out of the injection seat, thereby causing usage risks such as debris, chips blocking the needle tube, and wire drawing. As Figure 6 shown, the height of the bent part of the existing special needle is greater than the puncture height formed by the lower surface of the injection seat and the bottom of the liquid storage cavity. Therefore, after penetrating into the infusion port, the bent part of the needle remains in the injection seat, reducing the sealing performance and safety performance.

[0004] In the prior art, in order to solve the problem of low precision in puncture force control caused by direct bending, the bending portion of the special needle is designed to be a relatively smooth arc bend, but the bending portion or the blade surface of the needle still extends beyond the columnar space wrapped by the outer periphery of the needle tube (refer to the bending portion of the needle of the special needle in the Chinese patent with publication number CN117205397A), thereby causing the barb formed by the blade surface or the curled edge of the needle tip that extends beyond the needle tube to scratch the injection seat and increase the puncture and withdrawal resistance.

[0005] The utility model patent with the authorization announcement number CN210992268U provides a puncture needle for an infusion port. The entire needle is in a cylindrical space wrapped by the outer surface of the puncture needle, which solves the problem in the prior art that the blade surface exceeds the wrapped range of the needle tube due to the bending of the needle. At the same time, the bending section of the needle is bent toward the main blade surface of the needle. The main blade surface of the needle is an annular plane, and the main blade surface and the wall of the puncture needle tube form two cutting edges. Its main improvements are:

[0006] 1. The two cutting edges on both sides of the main blade surface form triangular blades at the end of the needle tip, thereby avoiding curling of the needle tip. However, although the triangular blade-shaped needle tip can reduce curling, its blade faces are distributed in different directions. When the needle tip passes through the injection seat, the blade faces and edges in different directions cut the injection seat multiple times in multiple directions, increasing the cutting surface and puncture hole area. On the one hand, it increases the risk of chip drop and leakage, affecting safety performance. On the other hand, the increase in a single puncture area will reduce the number of times the injection seat can be used and shorten its service life.

[0007] 2. The distance between the first blade tip at the end of the needle tip and the second blade tip at the top is less than the wall thickness of the needle tube, and the two are preferably located in the same plane; when the first blade tip is located inside the second blade tip, the first blade tip cannot shield the second blade tip, and secondary cutting will be formed on its main blade surface in sequence by the first blade tip and the second blade tip. Combined with the cutting surfaces formed by the two cutting blades on both sides, the cutting opening will be increased. Even when the first blade tip and the second blade tip are located in the same plane, the deflection force formed by the arc-shaped bending design of the needle and the slight change in the user's puncture angle will cause the cutting points of the two blade tips to not be formed in the same position.

[0008] In addition, the needle tip length of the special needle is actually determined by the length of its main cutting edge. Due to the need for the anti-crimping design of the needle tip, the length of the main cutting edge should not be too long. Therefore, the bending length of the special needle is limited. When the curvature at the bending point is small, the needle tip cannot effectively shield the needle tube, which violates the original intention of the bending design of the special needle; when the bending curvature is large, on the one hand, it is easily guided by the shape of the back bending arc surface, causing the puncture path to deflect into an arc, resulting in the deviation of the puncture point from the penetration point and unable to achieve vertical downward puncture. Multiple punctures of the silicone injection seat will cause an arc cross-cutting effect, and the puncture paths will cross, resulting in chip shedding and liquid leakage, affecting the safety of subsequent use of the infusion port. On the other hand, the deflection of the puncture path will further increase the puncture resistance.

[0009] The utility model patent with the authorization announcement number CN209437790U provides a non-damaging puncture needle for an infusion port. The bending distance L of its needle tip extends from the starting point of the grinding base to the end of the needle tip, and it is ensured that the plane formed after the first grinding of the end of the needle tip is tangent to the plane where the outer diameter wall of the needle tube is located, solving the problem that the first blade tip in the utility model with the authorization announcement number CN210992268U cannot shield the second blade tip. However, its bending position starts from the middle of the needle tip, and the bending distance is extremely short, causing the puncture path to deflect into an arc, affecting the safety performance and increasing the puncture resistance; secondly, the end of the needle tip is tangent to the plane where the outer diameter wall of the needle tube is located. Therefore, when the end of the needle tip contacts the bottom of the liquid storage cavity of the infusion port to form a barb, the barb will extend outwards and scrape the injection seat, forming chip shedding; in addition, Figure 1 as can be seen, the wall thickness at the bending position of the end of the needle tip becomes significantly thicker, which does not conform to the structure and processing principle of the needle tube and cannot be processed normally. At the same time, the increase in wall thickness makes the end of the needle tip blunt, further increasing the puncture resistance and affecting the comfort when passing through the patient's skin. Utility Model Content

[0010] Therefore, to solve the above problems, the present utility model provides a special safety needle for an infusion port and an infusion port assembly.

[0011] The present utility model is realized through the following technical solutions:

[0012] The special safety needle for infusion port includes a needle tube and a needle head arranged at the end of the needle tube. One side of the needle head is provided with a cutting edge. The cutting edge successively forms a first cutting edge and a second cutting edge from the connection end of the needle head and the needle tube to the end. The two ends on both sides of the second cutting edge are narrowed to form a needle tip. The needle head gradually forms an arc-shaped bend from its connection end with the needle tube to the end, and ensures that the needle head is always within the tubular range of the outer peripheral surface of the needle tube. Both the first cutting edge and the second cutting edge include an inner cutting edge formed along the inner wall of the needle head and an outer cutting edge formed along the outer wall of the needle head. The inner cutting edge of the first cutting edge is set as a rounded corner, and the junction between the inner cutting edge of the first cutting edge and the second cutting edge is smoothly transitioned.

[0013] Preferably, the bending radius of the needle head is 5.5 mm - 9.5 mm.

[0014] Preferably, the radial distance L2 between the needle tip and the outer periphery of the needle tube near the cutting edge side is 0.1 mm - 0.27 mm.

[0015] Preferably, the radial distance L2 between the needle tip and the outer periphery of the needle tube near the cutting edge side is less than or equal to the wall thickness of the needle tube.

[0016] Preferably, the ratio of the length L1 of the first cutting edge to the length L3 of the second cutting edge is 2.5:1.

[0017] Preferably, the radius R of the rounded corner is 0.02 mm - 0.04 mm.

[0018] Preferably, the difference between the outer diameter D1 and the inner diameter d2 of the needle tube is 0.15 mm - 0.3 mm.

[0019] Preferably, the other end of the needle tube is connected with an extension tube. A fixed bending tube is arranged between the needle tube and the extension tube. The needle tube, the fixed bending tube and the extension tube are all tube bodies with the same inner and outer diameters. And one end of the extension tube close to the fixed bending tube is provided with a section of adhesive fixing section.

[0020] Preferably, the surface roughness Ra of the adhesive fixing section is 12.5 μm - 25 μm.

[0021] The infusion port assembly includes the special safety needle for infusion port as described above and an infusion port. The infusion port includes a port seat and an injection seat fixed on the top of the port seat. A liquid storage cavity is arranged in the port seat. A puncture height B is formed between the lower surface of the injection seat and the inner cavity bottom of the liquid storage cavity. The puncture height B is greater than the needle head height A of the special safety needle for infusion port.

[0022] The beneficial effects of the technical solution of the present utility model are mainly reflected in:

[0023] 1. The needle gradually forms an arc-shaped bend from its connection end with the syringe tube towards the end, and it is ensured that the needle is always within the tubular range of the outer peripheral surface of the syringe tube. On the one hand, this can ensure that the bending arc of the needle is gentle and the curvature at the bending point is small, ensuring that the puncture path is vertically downward and no deflection force is formed during the puncture process, avoiding the arc cross-cutting effect caused by the silicone injection seat and ensuring the safety performance of subsequent use of the infusion port. On the other hand, the sharp needle tip and the vertical puncture path can minimize the puncture resistance as much as possible and help to accurately control the puncture force.

[0024] 2. The needle is always within the tubular range of the outer peripheral surface of the syringe tube, and the radial distance L2 between the needle tip and the side of the outer periphery of the syringe tube close to the cutting edge is defined. On the one hand, this can ensure that the needle tip blocks the hollow cutting effect of the syringe tube. On the other hand, it can also provide a space for avoiding the barb formed after the needle tip touches the bottom and curls, preventing the barb from scraping the injection seat when the special needle is withdrawn.

[0025] 3. The inner edge of the first cutting edge of the needle is set as a rounded corner, which can ensure that no secondary cutting occurs when the first cutting edge contacts the injection seat. In addition, the junction between the inner edge of the first cutting edge and the second cutting edge has a smooth transition, further reducing the cutting of the injection seat by the cutting surface or edge other than the second cutting edge, minimizing the puncture area as much as possible, thereby improving the service life and use safety of the injection seat.

[0026] 4. The second cutting edge at the end of the needle narrows to form the needle tip. The inner and outer edges of the second cutting edge work together to guide the needle and the syringe tube body to gradually push aside the surrounding silicone elastic material and pass through the injection seat. Only the second cutting edge is not provided with a rounded corner and a smooth transition, and by setting the length ratio of the first cutting edge and the second cutting edge, the puncture opening width of the special needle on the injection seat can be accurately defined. On the one hand, it can reduce the puncture surface, and on the other hand, it can ensure that the injection seat squeezes the outer periphery of the syringe tube, effectively preventing leakage caused by damage to the puncture diaphragm and the situation where the cut particles block the catheter and blood vessels, thus avoiding cutting the injection seat and causing puncture debris.

[0027] 5. In the infusion port assembly, the height A of the needle of the special safety type special needle for the infusion port is less than the puncture height B formed between the lower surface of the injection seat and the inner cavity bottom of the liquid storage cavity, so as to ensure that the needle does not stay in the injection seat after entering the infusion port, further improving the sealing performance and the control of the puncture depth. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 is a schematic diagram of the puncture force direction of the special safety type special needle for the infusion port of the present utility model and the existing special needle;

[0029] Figure 2 is a partial cross-sectional view of the special safety type special needle for the infusion port of the present utility model;

[0030] Figure 3 is a partial schematic view of the cutting edge direction of the special safety needle for the infusion port of the present utility model;

[0031] Figure 4 is a schematic structural view of the special safety needle for the infusion port of the present utility model;

[0032] Figure 5 is a schematic view of the state where the special safety needle for the infusion port of the present utility model and the existing special needle pass through the infusion port assembly of the present utility model at the same time;

[0033] Figure 6 is Figure 5 an enlarged view of part D in Detailed implementation manners

[0034] In order to clearly and detailedly show the purpose, advantages and features of the present utility model, it will be illustrated and explained through the non-restrictive description of the following preferred embodiments. This embodiment is only a typical example of applying the technical solution of the present utility model, and all technical solutions formed by equivalent replacement or equivalent transformation fall within the scope of protection required by the present utility model.

[0035] At the same time, it is stated that in the description of the solution, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "left", "right", "front", "rear", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of description and simplification of the description, rather than indicating or implying 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 utility model.

[0036] In addition, the terms "first" and "second" in this solution are only used for descriptive purposes, and cannot be understood as indicating or implying the ranking of importance, or implicitly indicating the quantity of the technical features shown. Therefore, the features defined with "first" and "second" may explicitly or implicitly include one or more of such features. In the present utility model, the meaning of "a plurality" is two or more, unless otherwise specifically defined.

[0037] The present utility model discloses a special safety needle for an infusion port, such as Figures 1 - 4As shown, it includes a syringe needle 1 and a needle tip 2 provided at the end of the syringe needle 1. One side of the needle tip 2 is provided with a cutting edge surface. The cutting edge surface is successively formed with a first cutting edge 201 and a second cutting edge 202 from the connection end of the needle tip 2 and the syringe needle 1 to the end. The two ends of the second cutting edge 202 are narrowed to form a needle point 203. The needle tip 2 is gradually formed into an arc-shaped bend from its connection end with the syringe needle 1 to the end, and it is ensured that the needle tip 2 is always within the tubular range of the outer peripheral surface of the syringe needle 1. Both the first cutting edge 201 and the second cutting edge 202 include an inner cutting edge 204 formed along the inner wall of the needle tip 2 and an outer cutting edge formed along the outer wall of the needle tip 2. The inner cutting edge 204 of the first cutting edge 201 is set as a rounded corner, and the junction between the inner cutting edge 204 of the first cutting edge 201 and the second cutting edge 202 is smoothly transitioned. Specifically, the second cutting edge 202 with a narrowed end cuts into the injection seat 7. When transitioning to the first cutting edge 201, the outer cutting edge of the first cutting edge 201 participates in the cutting of the injection seat 7, and gradually penetrates the needle tip 2 and the syringe needle 1 into the injection seat 7. After the needle tip 2 and the syringe needle 1 penetrate into the injection seat 7, the injection seat 7 exerts a squeezing effect on the outer periphery of the needle tip 2 and the syringe needle 1, thereby ensuring the sealing performance; on the other hand, by setting the inner cutting edge 204 of the first cutting edge 201 as a rounded corner and smoothly transitioning the junction between the inner cutting edge 204 of the first cutting edge 201 and the second cutting edge 202, the cutting edges that do not participate in cutting on the cutting edge surface do not have a cutting function, and the cutting area can be reduced as much as possible.

[0038] In some embodiments, the bending radius of the needle tip 2 is 5.5 mm - 9.5 mm, which is relatively large compared to the existing bending radius of the needle tip 2 and has a small curvature, making the bending of the needle tip 2 more balanced. As Figure 1 shown by the arrow, it can ensure that the needle tip 2 penetrates vertically downward, thereby avoiding the formation of a deflecting force during the penetration process, avoiding the arc cross-cutting effect caused by the silicone injection seat, and ensuring the safety performance of the subsequent use of the infusion port. On the other hand, the sharp needle point 203 and the vertical penetration path can minimize the penetration resistance as much as possible and help to accurately control the penetration force.

[0039] In one embodiment, the radial distance L2 between the needle point 203 and the outer periphery of the syringe needle 1 near the cutting edge surface is 0.1 mm - 0.27 mm. In a preferred embodiment, the radial distance L2 between the needle point 203 and the outer periphery of the syringe needle 1 near the cutting edge surface is less than or equal to the wall thickness of the syringe needle 1, thereby ensuring that the needle tip 2 effectively shields the syringe needle 1.

[0040] In one embodiment, the ratio of the length L1 of the first cutting edge 201 to the length L3 of the second cutting edge 202 is 2.5:1, and the difference between the outer diameter D1 and the inner diameter d2 of the syringe needle 1 is 0.15 mm - 0.3 mm.

[0041] In one embodiment, the fillet radius R of the fillet is 0.02 mm - 0.04 mm.

[0042] As Figure 4 shown, in one embodiment, the other end of the syringe 1 is connected to an extension tube 4. A fixed bending tube 3 is provided between the syringe 1 and the extension tube 4. The syringe 1, the fixed bending tube 3, and the extension tube 4 are all tube bodies with the same inner and outer diameters. And one end of the extension tube 4 close to the fixed bending tube 3 is provided with an adhesive fixing section 5. In one embodiment, the surface roughness Ra of the adhesive fixing section 5 is 12.5 μm - 25 μm.

[0043] As Figure 5 , Figure 6 shown, an infusion port assembly includes the above-mentioned special safety needle for the infusion port and an infusion port. The infusion port includes a port base 6 and an injection seat 7 fixed on the top of the port base 6. A liquid storage cavity 8 is provided in the port base 6. A puncture height B is formed between the lower surface of the injection seat 7 and the inner cavity bottom of the liquid storage cavity 8. The puncture height B is greater than the height A of the needle 2 of the special safety needle for the infusion port, so as to ensure that the needle 2 will not stay in the injection seat 7 after entering the infusion port, and the sealing performance and the control of the puncture depth can be further improved.

[0044] There are still many implementation manners of the present invention. All technical solutions formed by equivalent transformation or equivalent substitution fall within the protection scope of the present invention.

Claims

1. A special safety needle for an infusion port, characterized by: It includes a needle tube and a needle arranged at the end of the needle tube, a blade surface is arranged on one side of the needle head, and the blade surface is sequentially formed with a first blade edge and a second blade edge from the connection end of the needle head and the needle tube to the end, and the ends of both sides of the second blade edge are narrowed to form a needle tip, and the needle head gradually forms an arc bend from the connection end with the needle tube to the end, and ensures that the needle head is always located within the tubular range where the outer circumferential surface of the needle tube is located, the first blade edge and the second blade edge both include an inner blade edge formed along the inner wall of the needle head and an outer blade edge formed along the outer wall of the needle head, the inner blade edge of the first blade edge is set to be chamfered, and the junction between the inner blade edge of the first blade edge and the second blade edge is smoothly transitioned.

2. The safety-type special needle for infusion port according to claim 1, characterized in that: The bending radius of the needle is 5.5 mm-9.5 mm.

3. The safety-type dedicated needle for an infusion port according to claim 1, characterized in that: The radial distance L2 between the needle tip and the outer periphery of the needle tube close to the blade surface is 0.1 mm-0.27 mm.

4. The safety-type dedicated needle for an infusion port according to claim 1, characterized in that: The radial distance L2 between the needle tip and the outer circumference of the needle tube close to the blade surface is less than or equal to the wall thickness of the needle tube.

5. The safety-type special needle for infusion port according to claim 1, characterized in that: The ratio of the length L1 of the first cutting edge to the length L3 of the second cutting edge is 2.5:

1.

6. The safety-type dedicated needle for an infusion port according to claim 1, characterized in that: The fillet radius R of the fillet is 0.02mm-0.04mm.

7. The safety-type dedicated needle for an infusion port according to claim 1, characterized in that: The difference between the outer diameter D1 and the inner diameter d2 of the needle tube is 0.15 mm-0.3 mm.

8. The safety-type dedicated needle for an infusion port according to claim 1, characterized in that: The other end of the needle tube is connected to an extension tube, and a fixed bending tube is arranged between the needle tube and the extension tube. The needle tube, the fixed bending tube and the extension tube are all tubes with consistent inner and outer diameters, and an adhesive fixing section is arranged at one end of the extension tube close to the fixed bending tube.

9. The safety-type dedicated needle for an infusion port according to claim 8, characterized in that: The surface roughness Ra of the bonding and fixing section is 12.5 μm-25 μm.

10. An infusion port assembly, characterized in that: It comprises a dedicated safety needle for an infusion port as described in any one of claims 1 to 8, and an infusion port, wherein the infusion port comprises a port seat and an injection seat fixed on the top of the port seat, a liquid storage cavity is arranged in the port seat, a puncture height B is formed between the lower surface of the injection seat and the inner cavity bottom of the liquid storage cavity, and the puncture height B is greater than the needle height A of the dedicated safety needle for the infusion port.

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