A safe drug-dissolving needle and a processing method thereof

Abstract

The present invention relates to the technical field of medical devices, and in particular to a safe drug-dissolving needle and a processing method thereof, comprising a needle seat and a needle tube, wherein the rear end of the needle tube is mounted on the needle seat, and the front end of the needle tube is provided with a ground needle tip, wherein the needle tip comprises a blade tip for puncturing, a pair of cutting blades for cutting, a pair of recessed blades without cutting capability, a pair of recessed surfaces and a recessed axis formed by the intersection of the two recessed surfaces. The present invention adopts a "V"-shaped groove design, so that at the same recessed depth, the occupied needle tube space is smaller and the drug circulation is smoother. At the same time, the corresponding "V"-shaped mold used for processing is easier to fix the force point during the pressing process, thereby reducing the accidental rotation of the needle tube, increasing the yield rate, reducing the production cost, and being more suitable for production and processing. At the same time, the angled puncture blade that has undergone secondary processing makes the puncture smoother and more convenient to use.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a safe drug-dissolving needle and a processing method thereof. Background Art

[0002] Before intravenous infusion, the powdered medicine must first be dissolved, diluted and mixed to prepare the infusion liquid. The above operations are generally performed using a syringe with a needle. We also know that the sealing stoppers of medicine bottles used to hold medicines are mostly rubber products, and the syringe needle that extracts liquid medicines or dissolves powdered medicines from the bottles must puncture the sealed rubber stopper. Currently, the needle tips of disposable drug-dissolving needles on the market are mostly beveled needle tips with sharp inner edges, and the inclination angle of the beveled needle tip is 12°-15°. When it passes through the sealing rubber stopper, the sharp inner edge will cut off tiny rubber crumbs, which are mixed into the drug solution during the syringe suction process, causing serious health hazards to the patient's intravenous infusion, or remain in the needle tube and cause blockage.

[0003] There are also disposable side-hole drug-dissolving needles on the market. For example, ZL2006200197956 discloses a liquid dispensing needle, the front end of which is a solid conical needle tip. The hole originally located at the needle tip is changed to the side of the tube near the tail of the same cone. The middle part is a thin round tube, and the tail is a needle cover. In this way, the needle tip has no hole, which can avoid cutting the rubber plug during drug-dissolving puncture. However, since the needle tip of the side-hole drug-dissolving needle is processed by cold extrusion, the side hole is processed by punching. After the side hole is formed, there will be a certain space in the front end of the side hole inside the needle tube and the conical needle tip. After the side-hole drug-dissolving needle is processed, the cleaning process will cause dirt to be retained inside the needle tip, which is difficult to clean. In this way, this space may become "a space for hiding dirt and filth". Therefore, the existing side-hole drug-dissolving needle has a great safety hazard and may cause serious health hazards to the patient's intravenous infusion.

[0004] Chinese patent ZL201620190548.3 discloses a solution for the inner blade of the needle to be recessed downward. By recessing the inner blade into the needle tube, the inner blade no longer has the ability to cut the rubber, thereby preventing the rubber scraps from being cut and falling into the medicine. However, the arc-shaped recess takes up a lot of space in the needle tube. When extracting medicine, the aperture of the needle tube becomes smaller, and there is resistance to extraction. It is even difficult to extract some medicines with high viscosity. At the same time, when the arc-shaped recess is processed, the arc mold used to press the recess has no fixed force point when contacting the cylindrical needle tube due to the cylindrical shape of the needle tube itself, which can easily cause the needle tube to rotate unexpectedly, so that the pressed recess is offset, resulting in defective products, low production yield, and affecting production costs. Summary of the invention

[0005] In order to overcome the above problems, the present invention provides a safe drug-dissolving needle, which adopts a "V"-shaped groove design, so that at the same recess depth, the occupied needle tube space is smaller and the drug flow is smoother. At the same time, the corresponding "V"-shaped mold used in the processing is easier to fix the force point during the pressing process, which reduces the accidental rotation of the needle tube, increases the yield, reduces the production cost, and is more suitable for production and processing. At the same time, the angled puncture blade that has undergone secondary processing makes the puncture smoother and more convenient to use.

[0006] The present invention is achieved through the following technical solutions:

[0007] A safe drug-dissolving needle, comprising a needle seat and a needle tube, wherein the rear end of the needle tube is mounted on the needle seat, and the front end of the needle tube is provided with a ground needle tip, wherein the needle tip comprises a blade tip for puncturing, a pair of cutting blades for cutting, a pair of concave blades without cutting ability, a pair of concave surfaces and a concave axis formed by the intersection of the two concave surfaces, wherein the blade tip is arranged at the front end of the needle tip, and the cutting blades are symmetrically arranged on both sides of the blade tip, one end of the two cutting blades intersects at the blade tip, and the other end extends to the tube wall of the needle tube and is respectively connected to the end points of the two symmetrical concave blades, the two symmetrical concave blades intersect at one end of the concave axis, and the other end of the concave axis extends to the surface of the tube wall of the needle tube, and the plane with the concave blade as the bottom edge, the concave axis as the height, and the line connecting the intersection point of the concave axis and the tube wall of the needle tube and the connection point of the concave blade and the cutting blade as the hypotenuse is the concave surface;

[0008] The plane where the concave axis and the blade tip are located is the axial section of the needle tube, and the distance between the intersection of the concave axis and the two symmetrical concave blades and the axis of the needle tube is less than the distance between the line connecting the two connection points of the cutting blade and the concave blade and the axis of the needle tube;

[0009] Wherein, the angle between the two concave surfaces is 120°-130°;

[0010] The maximum distance between the connecting point of the two cutting edges and the concave edge and the needle tube wall is 3 / 4 of the inner diameter of the needle tube. The longer the processed cutting edge is, the smaller the corresponding concave edge is. However, since the length of the concave edge will directly affect the shape of the concave edge, a too small concave edge cannot completely lose the cutting ability of the concave edge. After repeated tests and verifications, processing the cutting edge to 3 / 4 of the auxiliary surface can achieve the best cutting effect while the concave edge completely loses its cutting ability.

[0011] Wherein, the distance between the intersection of the concave axis and the concave blade and the axis of the needle tube does not exceed 2 / 3 of the radius of the needle tube;

[0012] Wherein, the angle between the planes where the two cutting edges are located is 150°-170°;

[0013] A method for processing the safe drug-dissolving needle, characterized in that the safe drug-dissolving needle is formed by grinding a grinding blade, comprising the following steps:

[0014] S1: Fix the needle tube and use the grinding blade to grind the needle tube along the inclination angle α to obtain an elliptical reference surface, and the distal end of the reference surface is used as the blade tip;

[0015] S2: Take the point on the long axis of the reference plane that is 3 / 4 of the long axis length from the blade tip as the midpoint, make a chord on the reference plane that is perpendicular to the long axis, the point where the chord compares with the reference plane is the end point of the cutting edge, take the blade tip as the other end point of the cutting edge, tilt the grinding edge to an angle of 5°-15° with the horizontal direction, use the grinding edge to grind the needle tube along the two end points, and grind the other side symmetrically to obtain two symmetrical cutting edges;

[0016] S3: Use a "V"-shaped mold, the bottom edge of the "V"-shaped mold corresponds to the concave axis, and the two symmetrical side surfaces correspond to the concave surface. Align the bottom edge of the "V"-shaped mold with the proximal end of the reference surface, press the needle tube wall down along the needle tube axis until the lowest point of the bottom edge of the "V"-shaped mold is a specified distance from the needle tube axis, and remove the "V"-shaped mold to obtain the corresponding concave axis and concave surface. The pressed portion of the reference surface serves as a symmetrical concave blade;

[0017] Wherein, the inclination angle α is 28°-40°.

[0018] The beneficial effects of the present invention are: (1) the "V"-shaped concave structure occupies less space in the needle tube, and the drug flow is smoother; (2) the processing is convenient. During the pressing process of the "V"-shaped mold, the force point is easier to fix, which reduces the accidental rotation of the needle tube, increases the yield rate, and reduces the production cost; (3) the inclination angle of the concave surface is larger, and the puncture is smoother; (4) the puncture blade has an angle, which makes the puncture smoother. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is the overall structure diagram of this application.

[0020] Figure 2 This is a partial enlarged view of the needle tip.

[0021] Figure 3 It is a top view of the needle tip.

[0022] Figure 4 It is a cross-sectional view of the needle tip along the depression axis.

[0023] Figure 5 It is a radial view of the needle tip along the axis of the needle tube.

[0024] Figure 6 This is a schematic diagram of the first step of processing.

[0025] Figure 7This is a schematic diagram of the second step of processing.

[0026] In the figure, 1, needle seat, 2, needle tube, 3, recessed surface, 4, cutting blade, 5, blade tip, 6, recessed blade, 7, recessed axis, 8, reference surface. DETAILED DESCRIPTION

[0027] The present invention is further described below with reference to the accompanying drawings and embodiments.

[0028] As shown in the figure, the drug dissolving needle usually includes a needle seat 1 and a needle tube 2 fixedly connected to the needle seat 1. The needle tube 2 is a tubular structure with an internal through hole. One end of the needle tube 2 is fixed to the needle seat 1 for connecting to the syringe barrel, and the other end is a needle tip. In the prior art, the needle tip is processed by a one-step bevel cutting process, and the cut surface of the needle tip is a complete cutting surface. The outer circle of the cutting surface is the outer blade, and the inner circle is the inner blade. In this way, when puncturing the rubber stopper, the outer blade of the needle tip punctures the rubber, and the needle continues to move until the inner blade contacts the rubber stopper. Since the inner blade is also cut and is as sharp as the outer blade, the inner blade that contacts the rubber stopper will also cut the rubber stopper, resulting in the rubber fragments cut by the outer blade being cut by the inner blade on the side connected to the rubber stopper, and the rubber fragments fall off and fall into the bottle with the needle, contaminating the medicine.

[0029] The disposable safe drug-dissolving needle provided by the present invention has a needle tip that is processed in three steps. First, like a normal needle tip, a grinding blade is used to grind the needle tube 2 along an inclination angle α for bevel cutting to form a normal bevel needle tip. The formed elliptical bevel needle tip serves as a reference plane 8 for the following processing, and the distal end of the reference plane 8 serves as the blade tip 5. Normally, the inclination angle α is selected to be 30°. Too large an inclination angle will increase the resistance during puncture, while too small an inclination angle will lengthen the reference plane, affecting processing and use, and will also affect the subsequent pressing process and make it impossible to completely press the inner blade into the needle tube.

[0030] In the second step, take the point on the long axis of the reference plane 8 that is 3 / 4 of the long axis length from the blade tip 5 as the midpoint, make a chord on the reference plane 8 that is perpendicular to the long axis, the point where the chord intersects the reference plane 8 is the endpoint of the cutting edge 4, take the blade tip 5 as the other endpoint of the cutting edge 4, tilt the grinding edge to an angle of 5°-15° with the horizontal direction (that is, the angle between the planes where the two cutting edges 4 are cut is 150°-170°), use the grinding edge to grind the needle tube 2 along the two endpoints, and grind the other side symmetrically to obtain two symmetrical cutting edges 4, and the remaining unground reference plane 8 is the subsequent recessed edge 6. It can be obviously seen that the longer the processed cutting edge 4 is, the shorter the remaining reference plane 8 will be. However, if the remaining reference plane 8 is too short, when the recess is pressed in the next step, the remaining The remaining reference surface 8 is pressed into a recessed blade 6. The angle and depth at which the recessed blade 6 is pressed cannot make the inner blade part of the recessed blade 6 completely pressed into the needle tube 2, resulting in the recessed blade 6 not completely losing its cutting ability and still having the risk of cutting the rubber. After multiple tests and verifications, the cutting blade 4 is processed to 3 / 4 of the auxiliary surface (that is, the distance a is 3 / 4 of the distance b). While obtaining the best cutting effect, the recessed blade 6 also completely loses its cutting ability. Moreover, after grinding, there is a certain angle between the two symmetrical cutting blades 4, which makes the puncture ability of the blade tip 5 stronger, the resistance during puncture is smaller, and it is easier to pierce the rubber. The ground cutting blade 4 is sharper and the cutting is smoother. The third step is to use a "V"-shaped mold to press the recessed blade 6. The bottom edge of the "V"-shaped mold used corresponds to the recessed axis 7, and the two symmetrical side faces correspond to the recessed surface 3. When pressing, align the bottom edge of the "V"-shaped mold with the midpoint of the unprocessed reference surface 8 (i.e., the intersection of the recessed blade 6), adjust the angle of the mold, and press down radially along the needle tube 2. When the recessed blade 6 is completely pressed down (i.e., the end point of the recessed blade 6 is pressed down to the end point of the cutting blade 4), the pressing stops. At this time, the pressing is completed. The trace of the bottom edge of the "V"-shaped mold being pressed down is the recessed axis 7, and the plane pressed by the two symmetrical side faces is the recessed surface 3. The inner blade part of the recessed blade 6 is completely pressed into the interior of the needle tube 2, and the recessed blade 6 forms a plane in the radial direction of the needle tube, losing the ability to cut rubber.Compared with the arc-shaped mold used in the prior art, when pressing a cylindrical needle tube, due to the lack of fixed force points between the arcs, it is not easy to fix, and the needle tube is easy to rotate, which causes the pressed groove to deviate easily, resulting in defective products and the yield rate cannot be guaranteed. The "V"-shaped groove provided by the present invention uses a corresponding "V"-shaped mold when performing the pressing process. The bottom edge of the "V"-shaped mold is the recessed axis 7 of the corresponding groove. When performing the pressing process, the mold is pressed down with the recessed axis 7. The bottom edge of the mold first contacts the recessed axis 7 to form a force point. When continuing to press down, the bottom edge of the mold can be pressed down along the recessed axis 7, reducing the problem of needle tube rotation caused by the lack of force points in the prior art, improving the yield rate, and reducing production costs. At the same time, at the same recess depth, the "V"-shaped groove of the present invention occupies relatively less needle tube space, so that the circulation space of the drug is larger and smoother. Among them, the depth of the pressed depression and the angle of the "V"-shaped mold used (i.e., the angle of the recessed surface) determine the length of the recessed axis. The shorter the recessed axis 7, that is, the shorter the length of the recessed surface 3, the larger the angle formed by the recessed axis 7 and the wall of the needle tube 2, and the greater the friction generated with the rubber during puncture. In theory, as the recessed axis 7 increases, the smaller the inclination angle of the recessed axis 7, the smaller the resistance with the rubber during puncture, and the more convenient the puncture. However, an excessively long recessed axis 7 will also cause the rubber to contact the recessed surface 3 for too long, which will also affect the smoothness of the puncture. At the same time, an excessively long recessed surface 3 will also affect the practicality and aesthetics of the needle. After many tests and verifications, it was found that better results can be achieved when the "V"-shaped mold angle (i.e., the angle of the recessed surface 3) is selected to be 120°-130° and the pressed distance is not more than 2 / 3 from the axis.

[0031] The working principle of the disposable safe drug-dissolving needle of the present invention is as follows: when puncturing the rubber stopper, the blade tip 5 first contacts the rubber and punctures the rubber, and the needle is continued to be moved, and the cutting blades 4 polished on both sides cut and puncture the rubber, and an arc-shaped opening is cut out of the rubber stopper, and the cut rubber fragments are still connected to the rubber stopper; the needle is continued to be moved until the recessed blade 6 contacts the rubber stopper, and the recessed blade 6 is pressed into the needle tube to form a "V"-shaped groove, and the inner blade part of the recessed blade 6 is pressed into the inner part of the needle tube 2. The recessed blade loses its cutting effect and will not cut the rubber. The rubber fragments cut by the cutting blade 4 are pressed into the inner side of the rubber stopper due to the pressure of the recessed blade 6, and will not be cut and dropped by the recessed blade 6; the needle is continued to be moved, and the needle tube continues to penetrate into the medicine bottle. Due to the inclination angle of the recessed surface 3, the resistance of the rubber stopper to the needle tube is smaller, and puncture is easier, until the needle tube is completely punctured into the medicine bottle, and the medicine is taken out. Since the needle tube space occupied by the "V"-shaped groove is smaller, the medicine circulates more quickly, and the medicine is taken out more conveniently and quickly, and the drug-dissolving needle puncture is completed. During the whole process, since the flat half-blade produced by the "V"-shaped groove has no cutting effect, rubber debris will not be cut and fall into the medicine bottle to contaminate the medicine. At the same time, compared with the existing technology, the drug circulation is smoother, the puncture resistance is smaller, the processing is more convenient, the yield rate is higher, and the production cost is lower.

Claims

1. A method for processing a safe drug-dissolving needle, the safe drug-dissolving needle comprising a needle seat (1) and a needle tube (2), wherein the rear end of the needle tube (2) is mounted on the needle seat (1), and the front end of the needle tube (2) is provided with a ground needle tip, characterized in that: The needle tip comprises a blade tip (5) for puncturing, a pair of cutting blades (4) for cutting, a pair of recessed blades (6) without cutting ability, a pair of recessed surfaces (3), and a recessed axis (7) formed by the intersection of the two recessed surfaces (3); the blade tip (5) is arranged at the front end of the needle tip, the two cutting blades (4) are symmetrically arranged on both sides of the blade tip (5), one end of the two cutting blades (4) intersects at the blade tip (5), and the other end extends to the wall of the needle tube (2) and is respectively connected to the end points of the two symmetrical recessed blades (6); the two symmetrical recessed blades (6) intersect at one end of the recessed axis (7), and the other end of the recessed axis (7) extends to the surface of the wall of the needle tube (2); the plane with the recessed blade (6) as the bottom edge, the recessed axis (7) as the height, and the line connecting the intersection point of the recessed axis (7) and the wall of the needle tube (2) and the connection point of the recessed blade (6) and the cutting blade (4) as the hypotenuse is the recessed surface (3); The plane where the concave axis (7) and the blade tip (5) are located is the axial section of the needle tube (2), and the distance between the intersection point of the concave axis (7) and the two symmetrical concave blades (6) and the axis of the needle tube (2) is less than the distance between the line connecting the two connection points of the corresponding cutting blade (4) and the concave blade (6) and the axis of the needle tube (2); The safe drug-dissolving needle is made by grinding a grinding blade, and comprises the following steps: S1: fix the needle tube, use the grinding blade to grind the needle tube along the inclination angle α, and obtain an elliptical reference surface (8), and the distal end of the reference surface (8) is used as the blade tip (5); S2: With the point on the long axis of the reference plane (8) that is 3 / 4 of the long axis length from the blade tip as the midpoint, a chord perpendicular to the long axis is made on the reference plane (8), the point where the chord is compared with the reference plane (8) is the end point of each of the two cutting edges (4), with the blade tip (5) as the other common end point of the two cutting edges (4), the grinding edge is tilted to an angle of 5°-15° with the horizontal direction, and the needle tube (2) is ground along the two end points using the grinding edge, and the other side is ground symmetrically to obtain two symmetrical cutting edges (4); S3: Use a "V"-shaped mold, the bottom edge of which corresponds to the recessed axis (7), and the two symmetrical side faces correspond to the recessed surface (3). Align the bottom edge of the "V"-shaped mold with the proximal end point of the reference surface (8), press the needle tube wall down along the needle tube axis until the lowest point of the bottom edge of the "V"-shaped mold is at a specified distance from the axis of the needle tube (2), and remove the "V"-shaped mold to obtain the corresponding recessed axis (7) and recessed surface (3). The pressed portion of the reference surface (8) serves as a symmetrical recessed blade (6).

2. A method for processing a safe drug-dissolving needle according to claim 1, characterized in that: The angle between the two concave surfaces (3) is 120°-130°.

3. The method for processing a safe drug-dissolving needle according to claim 1, characterized in that: The maximum distance between the line connecting the connection points of the two cutting edges (4) and the corresponding recessed edges (6) and the inner wall of the needle tube (2) is 3 / 4 of the inner diameter of the needle tube (2).

4. The method for processing a safe drug-dissolving needle according to claim 1, characterized in that: The distance between the intersection of the concave axis (7) and the concave blade (6) and the axis of the needle tube (2) does not exceed 2 / 3 of the radius of the needle tube (2).

5. The method for processing a safe drug-dissolving needle according to claim 1, characterized in that: The angle between the planes on which the two cutting edges (4) are respectively located is 150°-170°.

6. The method for processing a safe drug-dissolving needle according to claim 1, characterized in that: The inclination angle α in S1 is 28°-40°.

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