Preparation process of CGM guide needle

Abstract

The invention relates to the technical field of medical instruments, in particular to a preparation process of a CGM guide needle, and the preparation process comprises the steps of primary stamping, deburring, secondary stamping and grinding edging, so that production and manufacturing of the guide needle are completed, specifically, selected raw materials are subjected to primary stamping to form a T-shaped plate, fillets are generated on the periphery of the T-shaped plate after deburring, and the T-shaped plate is subjected to secondary stamping and grinding edging; the T-shaped plate is subjected to secondary stamping to form a needle tube with a needle tip, and finally the needle tip is ground and edged, so that the needle tip is hidden when the T-shaped plate is subjected to deburring, a fillet is prevented from being generated at the needle tip, the sharpness of the needle tip can be guaranteed, edge faces are formed at the two side ends of the needle tip, the sharpness of the needle tip is further improved, and meanwhile, burrs of the needle tube can be removed.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a preparation process of a CGM guiding needle. Background Art

[0002] CGM (Continuous Glucose Monitoring System) is a monitoring technology that monitors the glucose concentration in interstitial fluid of subcutaneous tissue through a glucose sensor, thereby indirectly reflecting the blood glucose level. The CGM guiding needle is a medical device designed specifically for CGM equipment, mainly used to assist the CGM sensor to accurately and safely implant into human tissue for continuous blood glucose monitoring.

[0003] Currently, a stamping guiding needle and a medical detection device (Application No.: 202321665959.8) are disclosed in the prior patent technology. The stamping guiding needle has a receiving structure and a tip portion. The receiving structure is used to receive a biological probe. The tip portion is made of stainless steel with a hardness of 420 HV or more, and the surface of the tip portion is coated with a biocompatible coating. Among them, the stamping guiding needle 100 is formed by punching a blanking sheet 101. The sharp corner portion 1011 can be punched and formed together with the blanking sheet 101 without additional machining, and the edge-opening operation of the stamping guiding needle 100 is omitted.

[0004] However, since there is always a burr surface during the punching process of the stamping process, and the CGM guiding needle is a class III medical structural part with very strict requirements for burrs. On the one hand, the biocompatible coating is mainly used to improve lubricity, corrosion resistance or drug-carrying function (such as a procoagulant coating to reduce bleeding), but its essence is surface modification rather than physically removing metal processing residues. Therefore, if the burrs are not removed and directly coated, the biocompatible coating may be locally peeled off due to the uneven substrate, which may instead exacerbate tissue damage. On the other hand, after the above-mentioned tip portion and the receiving structure are integrally punched and formed and then the existing conventional polishing process is used for overall deburring, a fillet will appear at the tip portion, thus affecting the sharpness of the tip. Summary of the Invention

[0005] In view of this, the purpose of this application is to provide a preparation process of a CGM guiding needle to solve the technical problem that burrs are generated after the tip portion and the receiving structure of the existing medical guiding needle are integrally stamped and formed, and directly deburring through a conventional process will generate a fillet at the tip portion, affecting the sharpness of the tip.

[0006] To achieve the above purpose, the technical solution adopted by the present invention is: a preparation process of a CGM guiding needle, including the following steps: Step 1: Select raw materials and perform a first stamping through a stamping die to form a T-shaped plate; Step 2: Polish the four peripheral edges of the T-shaped plate to remove burrs and create a first rounded corner on the four peripheral edges of the T-shaped plate; Step 3: Use a stamping die to perform secondary stamping on the polished T-shaped plate to form a syringe needle with a tip at the front end; Step 4: Use grinding equipment to grind and sharpen the two side surfaces at the front end of the tip to form two symmetric cutting edges.

[0007] Further, the raw material selected in Step 1 is a stainless steel plate. Among them, the T-shaped plate formed by one-time stamping according to requirements includes a rectangular section, a trapezoidal section connected to the rectangular section on the same straight line, and a hidden tip section perpendicularly connected to the trapezoidal section. The tip is accommodated in the hidden tip section.

[0008] Further, the tip is exposed through the blanking process of the secondary stamping in Step 3 so that the tip is connected to the trapezoidal section, and the rectangular section and the trapezoidal section form a syringe needle through the bending process of the secondary stamping in Step 3.

[0009] Further, at the connection between the tip and the trapezoidal section in Step 3, the width of the tip is greater than the width of the trapezoidal section.

[0010] Further, the bottom surface of the tip is ground to form a cutting edge, and the tip has an isosceles triangle structure.

[0011] Further, the inclination angle of the cutting edge is 40 - 60 degrees.

[0012] Further, the syringe needle includes a main body plate and a first bend and a second bend symmetrically arranged on the top surface of the main body plate. The first bend and the second bend are parallel to each other and both perpendicular to the main body plate, so that the main body plate, the first bend, and the second bend enclose a receiving groove.

[0013] Further, slopes are provided at one ends of the first bend and the second bend facing the tip.

[0014] Further, chamfers are formed at both side ends of the main body plate to create a second rounded corner. The main body plate is connected to the tip so that the cutting edge is connected to the second rounded corner.

[0015] Further, the polishing process in Step 2 is electro-polishing by a polishing machine.

[0016] The beneficial effects of the technical solution of this application compared with the prior art are as follows: In this application, the preparation process of the guiding needle is designed as: primary stamping, deburring, secondary stamping, and grinding to form a cutting edge, thereby completing the production and manufacturing of the guiding needle. Among them, after primary stamping, a T-shaped plate is formed, and after deburring, rounded corners are generated around the T-shaped plate. After secondary stamping, a needle tube with a needle tip is formed. Finally, by grinding and forming a cutting edge on the needle tip, the needle tip is hidden when the T-shaped plate is deburred, avoiding the generation of rounded corners at the needle tip. Thus, it is possible to ensure the sharpness of the needle tip, form cutting edges on both sides of the needle tip, further improve the sharpness of the needle tip, remove the burrs of the needle tube at the same time, and avoid peeling or scratching when applying a biocompatible coating to the needle tip. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the embodiments of this application, the following will briefly introduce the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only part of this application. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0018] Figure 1 is a flowchart of the present invention; Figure 2 is a structural schematic diagram of the T-shaped plate in Step 1 of the present invention; Figure 3 is a structural schematic diagram of the T-shaped plate in Step 2 of the present invention; Figure 4 is a structural schematic diagram of the exposed needle tip in Step 3 of the present invention; Figure 5 is a structural schematic diagram of the needle tube with a needle tip in Step 3 of the present invention; Figure 6 is a structural schematic diagram of the cooperation between the needle tip with a cutting edge and the needle tube of the present invention; Figure 7 is a cross-sectional schematic diagram of the needle tip with a cutting edge of the present invention.

[0019] Explanation of the reference numerals in the drawings: 1 - T-shaped plate, 11 - rectangular section, 12 - trapezoidal section, 13 - hidden edge section, 14 - first rounded corner; 2 - needle tip, 21 - cutting edge; 3 - needle tube, 31 - main body plate, 32 - first bend, 33 - second bend, 34 - accommodation groove, 35 - slope, 36 - second rounded corner. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0020] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments.

[0021] Throughout the specification, terms such as "including" and "having" are used herein to specify the presence of the described 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. Technical terms such as "first" and "second" are only used to distinguish different objects, and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity, specific order, or primary-secondary relationship of the indicated technical features.

[0022] As Figures 1 to 6 shown, a preparation process of a CGM guiding needle includes the following steps: Step 1: Select a stainless steel plate as the raw material and perform a first stamping through an existing stamping die to form a T-shaped plate 1; among them, the raw material can be selected with appropriate size specifications according to requirements, such as thickness, length, and width, etc., which are not specifically limited herein; see Figure 2 , at this time, the T-shaped plate 1 after blanking includes a rectangular section 11, a trapezoidal section 12 connected to the rectangular section 11 on the same straight line, and a hidden edge section 13 vertically connected to the trapezoidal section 12. The rectangular section 11, the trapezoidal section 12, and the hidden edge section 13 are of an integral structure, and the upper base (shorter) and the lower base (longer) of the trapezoidal section 12 are respectively connected to the hidden edge section 13 and the rectangular section 11, so that the width of the rectangular section 11 is the same as the length of the lower base.

[0023] Step 2: See Figure 3 , polish the four edges of the T-shaped plate 1 to remove burrs and generate a first rounded corner 14 on the four edges of the T-shaped plate 1; among them, the above polishing process can be carried out by an electrolytic polishing machine, a magnetic polishing machine, etc. on the market for electro-polishing to remove burrs, and the first rounded corner 14 is an arc section, which can remove the burrs of the T-shaped plate 1 after the first stamping; but it should be noted that: at this time, the hidden edge section 13 is used to hide the needle tip 2 (exposed after subsequent secondary stamping), so when removing burrs, the hidden edge section 13 can be not targeted, and only the rectangular section 11 and the trapezoidal section 12 need to be deburred, that is, the burrs are removed at the needle tube 3, which can improve the preparation efficiency.

[0024] Step 3: See Figure 4 and Figure 5, a stamping die is used to perform secondary stamping on the polished T-shaped plate 1 to form a needle tube 3 with a needle tip 2 at the front end; among them, the secondary stamping can include processes such as blanking and bending. Based on the fact that the needle tip 2 is accommodated in the tip-concealing section 13 in Step 1 and Step 2, only the tip-concealing section 13 is processed and part of it is removed during the blanking process, so as to form and expose the needle tip 2 with an isosceles triangle structure, making the needle tip 2 connected to the trapezoidal section 12; then through the bending process, only the trapezoidal section 12 and the rectangular section 11 are bent and processed, and the needle tube 3 composed of the rectangular section 11 and the trapezoidal section 12 can be formed, and the needle tip 2 is connected to the needle tube 3.

[0025] See Figure 5 , the formed needle tube 3 includes a main body plate 31 and a first bend 32 and a second bend 33 which are symmetrically distributed on the top surface of the main body plate 31. The first bend 32 and the second bend 33 are parallel to each other and both perpendicular to the main body plate 31, so that the main body plate 31, the first bend 32 and the second bend 33 enclose to form a receiving groove 34; specifically, the width of the main body plate 31 is the same as the length of the two isosceles sides of the needle tip 2. At one end of the first bend 32 and the second bend 33 facing the needle tip 2, a slope 35 is provided. The cross-sectional area of the slope 35 gradually increases along the length direction of the needle tube 3 away from the needle tip 2. The first bend 32 and the second bend 33 are bent from both sides of the rectangular section 11 and the trapezoidal section 12 with the two connection end points of the needle tip 2 and the trapezoidal section 12 as the positioning points, which can improve the comfort of the guiding needle and reduce the resistance; and at the connection of the needle tip 2 and the trapezoidal section 12, the width of the needle tip 2 is greater than the width of the trapezoidal section 12. On the one hand, it can facilitate providing a positioning point for bending, and on the other hand, it can provide enough width for subsequent grinding and edge-opening of the needle tip 2, ensure removing the burrs at the needle tip 2, and also meet the required dimensions and specifications; the receiving groove 34 is a U-shaped structure and is used to accommodate the biological probe. When the needle tip 2 of the guiding needle pierces the human skin, the biological probe in the receiving groove 34 can enter the human body together with the guiding needle to detect human health data such as blood sugar. According to different specifications of biological probes, the width and depth of the receiving groove 34 can be adjusted according to the width of the rectangular section 11 and the trapezoidal section 12; it should be noted that: the width and length of the main body plate 31, the height and thickness of the first bend 32 and the second bend 33, the angle and length of the needle tip 2, etc. have been described in detail in the prior art and will not be elaborated and defined here.

[0026] See Figure 5, Further, chamfering is performed on both side ends of the main body plate 31 to form a second rounded corner 36. The main body plate 31 is connected to the needle tip 2 so that the cutting edge surface 21 is connected to the second rounded corner 36. Specifically, the second rounded corner 36 can be formed simultaneously when the first bending 32 and the second bending 33 are formed by bending the trapezoidal section 12 and the rectangular section 11. And the second rounded corner 36 is an arc section, which can enhance the structural strength. The second rounded corner 36 is connected to the cutting edge surface 21 to further reduce the resistance. At this time, the formation of the first rounded corner 14 can safely remove the burrs of the needle tube 3, and the formation of the second rounded corner 36 can avoid the generation of burrs.

[0027] Step Four: Refer to Figure 6 and Figure 7 , Use grinding equipment to grind and sharpen the two side surfaces at the front end of the needle tip 2 to form two symmetrical cutting edge surfaces 21. Among them, the grinding equipment can be a fully automatic precision tip grinding machine or a special grinding machine for medical puncture needles on the market, which is suitable for large-scale production and can ensure the sharpness and symmetry of the needle tip 2. The two symmetrical edges at the bottom surface of the needle tip 2 are ground to form the cutting edge surfaces 21, that is, the cutting edge surfaces 21 are formed on the surface of the needle tip 2 facing away from the first bending 32 and the second bending 33. After grinding the needle tip 2, the second rounded corner 36 is connected to the cutting edge surfaces 21. Compared with the prior art where the guiding needle lacks the edge-opening operation, it can further improve the sharpness of the needle tip 2, and the inclination angle B of the cutting edge surface 21 is 40-60 degrees. Among them, B is preferably 45 degrees in this embodiment, which can not only ensure the sharpness of the needle tip 2 but also avoid the needle tip 2 corresponding to the cutting edge surface 21 being too thin and resulting in insufficient structural strength.

[0028] Compared with the prior art where the needle tip part and the accommodating structure of the guiding needle are formed by integral blanking and bending, the first bending part and the second bending part form a rectangular structure, and the edge-opening operation of the needle tip part is omitted. Through the above preparation process of the present application, the tip can be hidden first (hide the needle tip 2), then the burrs can be removed, and then the needle tip 2 can be exposed and then edge-opened, that is, one-time stamping (preliminary forming), deburring, secondary stamping (exposing the needle tip 2 and forming the needle tube 3), and grinding and edge-opening are sequentially adopted. The hidden tip design of the present application combined with the additional secondary stamping can ensure the sharpness of the needle tip 2 of the guiding needle, and at the same time solve the problem of removing the burrs of the needle tube 3, thus meeting the requirements of the medical guiding needle. It should be noted that: when the needle tip 2 of the present application is coated with the biocompatible coating in the prior art, it can also avoid falling off during use. The smooth needle tip 2 can improve the coating adhesion and extend the service life.

[0029] Finally, it should be noted that: the above are only the embodiments of the present application, and do not limit the patent scope of the present application. Any equivalent structure or equivalent process transformation made by using the content of the specification and drawings of the present application, or directly or indirectly applied in other related technical fields, shall be included in the patent protection scope of the present application by the same token.

Claims

1. A process for preparing a CGM guide needle, characterized in that: The following steps are involved: Step 1: Select the raw materials and punch them through the stamping die to form a T-shaped plate; Step 2: Polishing the edges of the T-shaped plate to remove burrs and to form first rounded corners on the edges of the T-shaped plate; Step 3: using a stamping die to perform secondary stamping on the polished T-shaped plate to form a needle tube with a needle tip at the front end; Step 4: Grind and sharpen the two side surfaces of the front end of the needle tip using a grinding device to form two symmetrical blade surfaces.

2. The preparation process of a CGM guide needle according to claim 1, characterized in that: The raw material selected in the step one is a stainless steel plate, wherein the T-shaped plate formed by one-time stamping according to demand comprises a rectangular section, a trapezoidal section connected to the rectangular section on the same straight line, and a hidden tip section vertically connected to the trapezoidal section, and the needle tip is accommodated in the hidden tip section.

3. The preparation process of a CGM guide needle according to claim 2, characterized in that: The needle tip is exposed by the cutting process of the secondary stamping in step three, so that the needle tip is connected to the trapezoidal section. The rectangular section and the trapezoidal section form the needle tube by the bending process of the secondary stamping in step three.

4. The preparation process of a CGM guide needle according to claim 3, characterized in that: In the step three, at the connection between the needle tip and the trapezoidal segment, the width of the needle tip is greater than the width of the trapezoidal segment.

5. The preparation process of a CGM guide needle according to claim 4, characterized in that: The bottom surface of the needle tip is ground to form the blade surface, and the needle tip is an isosceles triangle structure.

6. The process for preparing a CGM guide needle according to claim 5, characterized in that: The inclination angle of the blade surface is 40-60 degrees.

7. The process for preparing a CGM guide needle according to claim 3, characterized in that: The needle tube includes a main body plate and a first bend and a second bend which are symmetrically distributed and arranged on the top surface of the main body plate. The first bend and the second bend are parallel to and perpendicular to the main body plate, so that the main body plate, the first bend and the second bend are combined to form a receiving groove.

8. The process for preparing a CGM guide needle according to claim 7, characterized in that: The first bend and the second bend are both provided with a slope at one end facing the needle tip.

9. The process for preparing a CGM guide needle according to claim 7, characterized in that: The two side ends of the main body plate are chamfered to form a second rounded corner, and the main body plate is connected to the needle tip so that the blade surface is connected to the second rounded corner.

10. The preparation process of a CGM guide needle according to claim 1, characterized in that: The polishing process in step 2 is performed by electropolishing using a polishing machine.

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