Guide needle and manufacturing method thereof

Abstract

The invention relates to the technical field of medical instruments, in particular to a guiding needle and a manufacturing method thereof.The guiding needle comprises a needle body and a connecting body integrated with the needle body through in-mold injection molding, the needle body comprises a needle part and a head part, and the connecting body is in sealed connection with the needle body at the head part; the head portion comprises a groove-shaped front section, a groove-shaped rear section and a connecting section connected between the front section and the rear section, symmetrically-distributed disconnecting grooves are formed in the top face and the bottom face of the center of the connecting section, and a first bending groove and a second bending groove are formed in the bottom face, connected with the front section and the rear section, of the connecting section. The connecting body is provided with a glue inlet point arranged over the disconnecting groove so that the connecting section can be disconnected when the connecting section is subjected to glue filling pressure. Sealing connection is achieved by injection molding of the connector on the head of the needle body, and during injection molding, the disconnection groove of the connection section is disconnected after being subjected to glue filling pressure and then is filled with plastic, so that the channel of the guide needle is blocked by the connector, the problem of poor air tightness is solved, the situation of air leakage is completely eradicated, and the production quality is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a guide needle and a manufacturing method thereof. BACKGROUND

[0002] With the development of technology, continuous glucose monitoring (CGM) is a device that can continuously monitor the glucose concentration of interstitial fluid in the subcutaneous tissue. It measures blood glucose levels through a small sensor, usually placed on the abdomen or upper arm, and transmits data wirelessly to a receiver or smartphone application. When the sensor is implanted in the abdomen or upper arm, an implant device is needed, which involves the use of a guide needle.

[0003] As a Class III medical product, CGM has high requirements for the air tightness of the guide needle in the implant device. During production, the problem of poor air tightness often occurs. The conventional improvement method is to open multiple holes and notches on the needle tube to hinder the passage of gas. For example, a guide needle (application number: 202421153957.5) of the Chinese utility model patent, although the structure that hinders the flow of gas in the above structure increases, the passage of the needle tube still exists, therefore, there is still a risk of gas leakage. SUMMARY

[0004] Therefore, one of the purposes of the present application is to provide a guide needle to solve the problem of poor air tightness and the risk of gas leakage during the production process of the existing guide needle.

[0005] To achieve the above-mentioned purpose, the technical solution adopted by the present application is: a guide needle, comprising a needle body and a connecting body integrated with the needle body by in-mold injection, the needle body comprising a needle part and a head part, the connecting body being sealingly connected with the needle body at the head part, the head part comprising a front segment and a rear segment in the form of a groove, and a connecting segment connected between the front segment and the rear segment, the top surface and the bottom surface of the connecting segment at the center being provided with symmetrically distributed disconnection grooves, the bottom surface of the connecting segment at the connecting part with the front segment and the rear segment being provided with a first bending groove and a second bending groove, the connecting body being provided with a glue inlet point placed directly above the disconnection groove, so that the connecting segment is disconnected when subjected to glue pressure.

[0006] Further, the width of the front segment and the rear segment is greater than the width of the connecting segment.

[0007] Further, the connecting body is provided with a pressure groove corresponding to the front segment and the rear segment.

[0008] Further, the front segment is provided with a boss between the pressure groove and the connecting segment, and a connecting hole is provided below the boss, so that the connecting body penetrates through the connecting hole.

[0009] Further, the disconnection groove, the first bending groove and the second bending groove are one of a V-shaped groove, an arc-shaped groove or a trapezoidal groove.

[0010] The beneficial effects of the technical scheme of the present application compared with the prior art are: the present application realizes sealed connection by injection molding the connecting body at the head of the needle body, and sets symmetrically distributed disconnection grooves at the top surface and the bottom surface of the center of the connecting body, the bottom surfaces at the connecting positions of the connecting section and the front section and the rear section are respectively provided with first and second bending grooves, the connecting body is provided with a glue inlet point located directly above the disconnection groove, and when injection molding, the disconnection groove of the connecting section is disconnected after being subjected to glue filling pressure, and then is filled with plastic, so that the channel of the guide needle is blocked by the connecting body, thereby fundamentally solving the problem of poor air tightness, without the need to add blocking structures, and eliminating the situation of air leakage, improving the quality and efficiency of guide needle production.

[0011] The second purpose of the present application is to provide a manufacturing method applied to the above-mentioned guide needle, comprising the following steps: Step one: select a metal plate, stamp the metal plate into a needle body with a needle part and a head part through a stamping die, and the head part has a positioning tape; Step two: the front end of the needle part has a needle tip, and the needle tip is ground by a grinding machine; Step three: the connecting body is injection molded by an injection molding die and wrapped on the surface of the head part, the disconnection groove of the connecting section is disconnected when the connecting section is subjected to glue filling pressure, the needle part and the head part form a separation structure in the connecting body, the plastic of the connecting body is filled in the disconnected position, and then the positioning tape is broken along the connecting body.

[0012] Through the above steps, the positioning tape can be used to assist the positioning and limiting of the guide needle during injection molding, and the disconnection of the connecting section utilizes the pressure of the glue filling, which is simple and convenient. BRIEF DESCRIPTION OF DRAWINGS

[0013] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiments or prior art description. Obviously, the drawings in the following description are only part of the present application, and other drawings can be obtained by those skilled in the art without creating laborious work.

[0014] Figure 1 is the overall structure perspective view of the present application; Figure 2 is the overall structure sectional view of the present application; Figure 3 is the structure schematic view of the needle body in the present application; Figure 4 is Figure 3 is the enlarged view of A in Figure 5 is another structure schematic view of the connecting section in the present application; Figure 6 is another structural schematic diagram of the connecting segment in the application; Figure 7 is a flow chart of the process of forming the guide needle in the application; Figure 8 is a flow chart of the method of manufacturing the guide needle in the application.

[0015] Explanation of reference numerals: 1-needle body; 2-needle part, 21-needle tip; 3-head part, 31-fore segment, 311-boss, 312-connecting hole, 32-aft segment, 33-connecting segment, 331-disconnection groove, 34-first bending groove, 35-second bending groove; 4-positioning tape; 5-connecting body, 51-gel feeding point, 52-pressing groove. DETAILED DESCRIPTION

[0016] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, not all the embodiments.

[0017] In the entire specification, the terms “comprise”, “have”, etc. are used herein to specify the presence of the stated features, numbers, steps, operations, elements, components, or combinations thereof, but do not exclude the presence or addition of one or more other features, numbers, steps, operations, elements, components, or combinations thereof. The technical terms “first”, “second”, etc. are only used to distinguish different objects, and cannot be understood as indicating or implying relative importance or implicitly indicating the number, specific order or primary and secondary relationship of the indicated technical features. Embodiment 1

[0018] As shown in Figures 1 to 4 , a guide needle comprises a needle body 1 and a connecting body 5 integrally formed with the needle body 1 by in-mold injection, the needle body 1 comprises a needle part 2 and a head part 3, the connecting body 5 is sealingly connected with the needle body 1 at the head part 3, the head part 3 comprises a fore segment 31 and an aft segment 32 in the form of a groove, and a connecting segment 33 connected between the fore segment 31 and the aft segment 32, the top surface and the bottom surface of the center of the connecting segment 33 are provided with symmetrically distributed disconnection grooves 331, the bottom surfaces of the connecting segment 33 at the connecting positions with the fore segment 31 and the aft segment 32 are respectively provided with a first bending groove 34 and a second bending groove 35, and the connecting body 5 is provided with a gel feeding point 51 placed directly above the disconnection grooves 331, so that the connecting segment 33 is disconnected when subjected to the gel filling pressure.

[0019] Through the above scheme, the connecting body 5 is integrally formed at the head 3 of the needle body 1 by injection molding, realizing the sealed connection of the needle body 1 and the connecting body 5, and the symmetrically distributed disconnection grooves 331 are arranged at the top surface and the bottom surface of the center of the connecting section 33 of the head 3, the first bending groove 34 and the second bending groove 35 are arranged at the bottom surfaces of the connecting sections 33 respectively at the connecting positions of the connecting section 33 and the front section 31 and the rear section 32, and the connecting body 5 is provided with the glue inlet point 51 arranged above the disconnection groove 331. When injection molding, the disconnection groove 331 of the connecting section 33 is disconnected after being subjected to the glue filling pressure, and then is filled with plastic, so that the channel of the guide needle is blocked by the connecting body 5, thereby fundamentally solving the problem of poor air tightness, without the need to add blocking structures, eliminating the air leakage situation, and improving the quality and efficiency of the guide needle production.

[0020] In the embodiment, the needle body 1 is a metal product made of stainless steel, and the connecting body 5 is a plastic product. The connecting body 5 is subjected to three-stage pressure injection molding. The glue filling pressure parameter during each stage of injection molding is 70-90 Mpa. The connecting section 33 is arranged below the glue inlet point 51 of the plastic. The center of the glue inlet point 51 corresponds to the disconnection groove 331. At this time, the connecting section 33 is a relatively narrow connecting position, which can ensure the efficiency of injection molding and ensure that the connecting section 33 is disconnected by the glue filling pressure. Of course, in actual production, the glue filling pressure parameter can be adjusted according to the actual situation by the person skilled in the art according to different hardware materials and injection molding machines.

[0021] As shown in Figure 3 , as an improved specific embodiment, the widths of the front section 31 and the rear section 32 are greater than the width of the connecting section 33.

[0022] Specifically, the width of the connecting section 33 is 0.1-0.4 mm, the widths of the front section 31 and the rear section 32 are 0.5-0.7 mm, the length of the connecting section 33 is 0.6-1.5 mm, and the thicknesses of the front section 31, the rear section 32 and the connecting section 33 are the same. Such arrangement can ensure the structural strength of the needle body 1 and the uniformity of production, reduce the weight of the guide needle after stamping, make the guide needle more portable and easy to transport, ensure that the connecting section 33 can be disconnected under the glue filling pressure, and avoid breaking during transportation after stamping.

[0023] As shown in Figure 1 and Figure 2 , as an improved specific embodiment, the connecting body 5 is provided with the pressing groove 52 corresponding to the front section 31 and the rear section 32.

[0024] Specifically, based on the fact that the needle part 2 and the head part 3 are both groove-shaped structures, the groove-shaped structure of the needle part 2 can be used to accommodate the biological probe, and the extension groove is arranged at the needle part 2 corresponding to the front section 31. Therefore, the material pressing grooves 52 are arranged on the other symmetrical wall surface of the front section 31 corresponding to the extension groove and the upper and lower wall surfaces of the rear section 32, and are symmetrically distributed. In actual production, a material pressing column matched with the material pressing grooves 52 is arranged in the injection mold. The front section 31 and the rear section 32 are clamped from top to bottom by the material pressing column, so as to press the head part 3 and prevent the needle body 1 from running or deviating during the filling of the glue, thereby ensuring the processing quality of the guide needle.

[0025] As shown in Figure 1 and Figure 3 , as an improved specific embodiment, the front section 31 is provided with a boss 311 arranged between the material pressing groove 52 and the connecting section 33, and a connecting hole 312 is arranged below the boss 311 to allow the connecting body 5 to penetrate through the connecting hole 312.

[0026] Specifically, based on the fact that the needle body 1 is stamped and formed, the needle part 2 and the head part 3 are integrated, and the head part 3 of the needle body 1 is tightly connected with the connecting body 5. The boss 311 can prevent the needle body 1 from longitudinally slipping, thereby improving the stability of the structure. The arrangement of the boss 311 increases the contact area with the connecting body 5, and the connecting hole 312 below the boss 311 penetrates through the front section 31, so that the connecting hole 312 and the groove of the front section 31 are communicated. During injection molding, the glue is injected into the groove of the front section 31, so as to connect the upper and lower connecting bodies 5 together. The boss 311 can prevent the needle body 1 from transversely slipping, and clamps the needle body 1 and the connecting body 5, thereby further improving the stability and structural strength of the connection. After the connecting section 33 is disconnected, the passage of the gas in the head part 3 is closed, and the gas cannot flow in the direction from the front section 31 to the rear section 32. At this time, the design of the boss 311 and the connecting hole 312 can improve the stability and firmness of the connection between the front section 31 and the connecting body 5, and avoid the loosening or falling off of the needle part 2.

[0027] As shown in Figure 3 and Figure 4 , as an improved specific embodiment, the disconnection groove 331, the first bending groove 34 and the second bending groove 35 are all V-shaped grooves.

[0028] Specifically, the top surface and the bottom surface at the center of the connecting section 33 are provided with symmetrically distributed disconnection grooves 331, forming a double-V design. The glue feeding point 51 is directly opposite the V-shaped groove on the top surface of the connecting section 33, so that the connecting section 33 is easy to disconnect when subjected to glue pressure. The bottom surface of the connecting section 33 at the connection with the front section 31 and the rear section 32 is provided with a first bending groove 34 and a second bending groove 35, forming a single-V design, which is easy to bend and deform downward under stress and avoids the ends of the connecting section 33 from disconnecting, which can assist the disconnection at the disconnection groove 331 and improve production efficiency. The depths of the disconnection groove 331, the first bending groove 34, and the second bending groove 35 are set to 1 / 3 to 2 / 3 of the thickness of the connecting section 33, and the forming angle is 60 to 150 degrees. The shortest distance between the two disconnection grooves 331 is 1 / 4 to 2 / 4 of the thickness of the connecting section 33. Of course, in some embodiments, when the disconnection groove 331 is a V-shaped groove, the first bending groove 34 and the second bending groove 35 are both arc-shaped grooves or trapezoidal grooves. Those skilled in the art can choose the same or different combination of the first bending groove 34 and the second bending groove 35 according to the actual situation. In actual production, the first bending groove 34 and the second bending groove 35 are preferably of the same structure. On the one hand, this can ensure the uniformity of processing and facilitate production. On the other hand, it can ensure the precise design of the pressure for disconnecting the connecting section 33 and the uniform stress, avoiding the phenomenon of high and low left and right sections after the connecting section 33 is disconnected, reducing the influence of other factors on the disconnection of the connecting section 33. It is worth noting that the structure design of the disconnection groove 331 is different, and the parameter design of the glue pressure is also different. Those skilled in the art can adjust it according to the actual situation to avoid excessive or insufficient glue pressure affecting the disconnection of the connecting section 33. Example 2

[0029] As Figure 5 shown, unlike Example 1, the disconnection groove 331, the first bending groove 34, and the second bending groove 35 are all arc-shaped grooves.

[0030] Specifically, the top surface and the bottom surface at the center of the connecting section 33 are provided with symmetrically distributed disconnection grooves 331, forming a double R-shaped design, the glue inlet point 51 is opposite to the arc-shaped groove on the top surface of the connecting section 33, further increasing the stress area of the disconnection groove 331, so that the connecting section 33 is easy to disconnect when subjected to the glue filling pressure, and the bottom surfaces of the connecting section 33 at the connection positions with the front section 31 and the rear section 32 are respectively provided with the first bending groove 34 and the second bending groove 35, forming a single R-shaped design, which is easy to bend and deform downward under stress, further avoiding the disconnection of the two ends of the connecting section 33, assisting the disconnection of the disconnection groove 331, and improving the production efficiency; of course, in some embodiments, when the disconnection groove 331 is an arc-shaped groove, the first bending groove 34 and the second bending groove 35 are V-shaped grooves or trapezoidal grooves, and those skilled in the art can select the same or different combination of the first bending groove 34 and the second bending groove 35 according to the actual situation, while in actual production, the first bending groove 34 and the second bending groove 35 are preferably of the same structure, which on the one hand can ensure the uniformity of processing and facilitate production, and on the other hand can ensure the precise design of the pressure for disconnecting the connecting section 33 and the uniform stress, avoiding the phenomenon that the left and right sections are high and low after the connecting section 33 is disconnected, and reducing the influence of other factors on the disconnection of the connecting section 33.

[0031] The other structures are the same as those of Embodiment 1, which will not be described in detail here. Embodiment 3

[0032] As shown in Figure 6 , different from Embodiment 1 is that the disconnection groove 331, the first bending groove 34 and the second bending groove 35 are all trapezoidal grooves.

[0033] Specifically, the top surface and the bottom surface at the center of the connecting section 33 are provided with symmetrically distributed disconnection grooves 331, forming a double trapezoidal design, the glue inlet point 51 is opposite to the trapezoidal groove on the top surface of the connecting section 33, further increasing the stress area of the disconnection groove 331, so that the connecting section 33 is easy to disconnect when subjected to the glue filling pressure, and the bottom surfaces of the connecting section 33 at the connection positions with the front section 31 and the rear section 32 are respectively provided with the first bending groove 34 and the second bending groove 35, forming a single trapezoidal design, which is easy to bend and deform downward under stress, further avoiding the disconnection of the two ends of the connecting section 33, assisting the disconnection of the disconnection groove 331, and improving the production efficiency; of course, in some embodiments, when the disconnection groove 331 is a trapezoidal groove, the first bending groove 34 and the second bending groove 35 are V-shaped grooves or arc-shaped grooves, and those skilled in the art can select the same or different combination of the first bending groove 34 and the second bending groove 35 according to the actual situation, while in actual production, the first bending groove 34 and the second bending groove 35 are preferably of the same structure, which on the one hand can ensure the uniformity of processing and facilitate production, and on the other hand can ensure the precise design of the pressure for disconnecting the connecting section 33 and the uniform stress, avoiding the phenomenon that the left and right sections are high and low after the connecting section 33 is disconnected, and reducing the influence of other factors on the disconnection of the connecting section 33.

[0034] Other structures and embodiments 1 are the same, not here in detail. Embodiment 4

[0035] As Figures 7 to 8 The application is applied to the manufacturing method of the guide needle, which comprises the following steps: Step one: first, select a metal plate, for example, a rectangular plate of stainless steel material, and then stamp the metal plate into a needle body 1 with a needle part 2 and a head part 3 through a stamping die, and the head part 3 has a positioning tape 4, so as to form a stamped semi-finished product; Step two: then, the needle tip 21 of the needle part 2 is ground by a grinding machine to enhance the puncture ability of the needle body 1, so as to ensure that the guide needle can smoothly pierce the skin and enter the human body by means of the needle tip 21, and facilitate the completion of the puncture action of the guide needle; Step three: the connecting body 5 is injection molded and coated on the surface of the head part 3 by an injection mold. When injection molding, the needle body 1 is inserted into the injection mold by the insertion mode, so that the head part 3 is placed in the injection mold. At this time, the positioning tape 4 can realize the positioning and limiting of the needle body 1, and under the auxiliary setting of the pressing groove 52, the head part 3 is fixed, avoiding the offset or movement of the needle body 1 during injection molding. At this time, the connecting section 33 is disconnected at the disconnection groove 331 when subjected to the glue pressure, and the plastic of the connecting body 5 fills the disconnection position. The connecting section 33 forms a separated structure in the connecting body 5, so that the front section 31 and the rear section 32 become two independent parts with part of the connecting section 33. After injection molding, the positioning tape 4 is broken along the outer side surface of the connecting body 5, or the positioning tape 4 is reserved according to the user's demand and broken during assembly.

[0036] Through the above manufacturing method, the design of the positioning tape 4 and the pressing groove 52 can assist the positioning and limiting of the guide needle during injection molding, and can also ensure that the connecting section 33 is more stable when subjected to the glue pressure. Before the connecting body 5 is injection molded, the connecting section 33 plays the role of a bridge between the front section 31 and the rear section 32, preventing the needle body 1 from being broken during processing and transportation. When the connecting section 33 is disconnected, only the pressure of the glue is used, which is a necessary process for the forming of the connecting body 5, and no additional machining is needed. The processing is simple and convenient, and the guide needle has good air tightness and stability.

[0037] Finally, it should be noted that the above description is only an embodiment of the present application, and does not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation using the content of the present application specification and drawings, or direct or indirect application in other related technical fields, is also included in the patent protection scope of the present application.

Claims

1. A guide needle, comprising a needle body (1) and a connector (5) integrally formed with the needle body (1) by in-mold injection molding, wherein the needle body (1) comprises a needle portion (2) and a head (3), and the connector (5) is sealed to the needle body (1) at the head (3), characterized in that, The head (3) includes a groove-shaped front section (31) and a rear section (32), and a connecting section (33) connecting the front section (31) and the rear section (32). The top and bottom surfaces of the connecting section (33) are provided with symmetrically distributed break grooves (331). The bottom surfaces of the connecting section (33) at the connection points with the front section (31) and the rear section (32) are provided with a first bending groove (34) and a second bending groove (35). The connector (5) is provided with a glue inlet (51) located directly above the break groove (331) so that the connecting section (33) breaks when subjected to glue filling pressure.

2. A guide needle according to claim 1, characterized in that, The widths of the front segment (31) and the rear segment (32) are both greater than the width of the connecting segment (33).

3. A guide needle according to claim 1, characterized in that, The connector (5) is provided with a pressing groove (52) at both the front section (31) and the rear section (32).

4. A guide needle according to claim 3, characterized in that, The front section (31) is provided with a boss (311) placed between the pressing groove (52) and the connecting section (33), and a connecting hole (312) is provided below the boss (311) so that the connecting body (5) passes through the connecting hole (312).

5. A guide pin according to claim 1, characterized in that, The disconnect groove (331), the first bending groove (34) and the second bending groove (35) are all one of V-shaped grooves, arc-shaped grooves or trapezoidal grooves.

6. A method for manufacturing a guide pin applicable to any one of claims 1-5, characterized in that, Includes the following steps: Step 1: Select a metal sheet and stamp it into a needle body (1) with a needle part (2) and a head (3) using a stamping die. The head (3) has a positioning strip (4). Step 2: The front end of the needle (2) has a needle tip (21), and the needle tip (21) is sharpened by a grinding machine; Step 3: The connector (5) is injection molded and covered on the surface of the head (3). When the connector (33) is subjected to the filling pressure, it breaks at the disconnect groove (331). The needle (2) and the head (3) form a separation structure in the connector (5). The plastic of the connector (5) fills the disconnection point. Then the positioning strip (4) is broken along the connector (5).

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