CN118320232A - A five-bevel needle tube - Google Patents
A five-bevel needle tube Download PDFInfo
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- CN118320232A CN118320232A CN202410411723.4A CN202410411723A CN118320232A CN 118320232 A CN118320232 A CN 118320232A CN 202410411723 A CN202410411723 A CN 202410411723A CN 118320232 A CN118320232 A CN 118320232A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3286—Needle tip design, e.g. for improved penetration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
- A61B5/150427—Specific tip design, e.g. for improved penetration characteristics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
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Abstract
Description
技术领域Technical Field
本发明属于医用针技术领域,具体涉及一种五斜面针管。这种五斜面针管具有新颖形状的多斜面尖端,与传统的针管相比能够进一步降低穿刺疼痛感。The invention belongs to the technical field of medical needles, and in particular relates to a five-bevel needle tube. The five-bevel needle tube has a multi-bevel tip with a novel shape, and can further reduce the pain of puncture compared with a traditional needle tube.
背景技术Background technique
各种类型的针在医疗领域中用于将可注射的药物通过人或动物的皮肤输送到体内,或将针通过插入人或动物的皮肤以用于采血和其它医学和研究目的。例如,患者通常使用笔针来注射胰岛素,用于治疗糖尿病。Various types of needles are used in the medical field to deliver injectable drugs into the body through the skin of a person or animal, or to insert a needle into the skin of a person or animal for blood sampling and other medical and research purposes. For example, patients often use pen needles to inject insulin for the treatment of diabetes.
笔针针头的一端具有用于穿入患者的皮肤进行注射的针管尖端,而另一端连接注射笔用于输送药物。其中,在注射过程中,不同的针管尖端形状可能需要更大或更小的力来刺穿皮肤,当针尖穿刺力较大时,疼痛感增加,当针尖穿刺力较小时,疼痛感较低。同时,研究表明,在针插入期间患者经受的疼痛由皮肤组织被针尖末端处的斜边缘切割并且随后该组织被针尖牵拉而引起。针尖末端的不同斜面之间的转变越是平缓,针尖的切割和牵拉动作就越是平顺。One end of the pen needle has a needle tip for penetrating the patient's skin for injection, while the other end is connected to the injection pen for drug delivery. During the injection process, different needle tip shapes may require greater or less force to pierce the skin, and when the needle tip piercing force is greater, the pain increases, and when the needle tip piercing force is less, the pain is less. At the same time, studies have shown that the pain experienced by patients during needle insertion is caused by the skin tissue being cut by the beveled edge at the end of the needle tip and then the tissue being pulled by the needle tip. The smoother the transition between the different bevels at the end of the needle tip, the smoother the cutting and pulling action of the needle tip.
中国专利CN107847685A公开了一种用于血液获取装置的五斜面插管,即五斜面针管。该针管的多斜面尖端包括:主斜面、两个中间斜面以及两个末端斜面;主斜面形成的第一倾斜角度在8°和12°之间,中间斜面形成的第二倾斜角度在15°和20°之间,末端斜面形成的第三倾斜角度大于第二倾斜角度,其中,中间斜面形成的第二旋转角度等于末端斜面形成的第三旋转角度,两个末端斜面的长度是多斜面尖端的总长度的15%至30%。该方案能够有效降低穿刺力从而减轻疼痛感,但由于其第三倾斜角度和第二倾斜角度相对于第一倾斜角度较大,两个末端斜面相交形成的棱的倾斜角度也较大,使得针尖部刚刺入皮肤时具有较大的穿刺阻力。又由于末端斜面的长度是多斜面尖端的总长度的15%至30%,在整个多斜面尖端刺入过程中,不能使中间斜面部位的有效外径最小化,因此不足以最小化患者的疼痛。Chinese patent CN107847685A discloses a five-bevel cannula for a blood acquisition device, i.e., a five-bevel needle tube. The multi-bevel tip of the needle tube includes: a main bevel, two intermediate bevels, and two terminal bevels; the first inclination angle formed by the main bevel is between 8° and 12°, the second inclination angle formed by the intermediate bevel is between 15° and 20°, the third inclination angle formed by the terminal bevel is greater than the second inclination angle, wherein the second rotation angle formed by the intermediate bevel is equal to the third rotation angle formed by the terminal bevel, and the length of the two terminal bevels is 15% to 30% of the total length of the multi-bevel tip. This solution can effectively reduce the puncture force and thus alleviate the pain, but because the third inclination angle and the second inclination angle are larger than the first inclination angle, the inclination angle of the ridge formed by the intersection of the two terminal bevels is also larger, so that the needle tip has a larger puncture resistance when it just penetrates the skin. In addition, because the length of the terminal bevel is 15% to 30% of the total length of the multi-bevel tip, the effective outer diameter of the intermediate bevel part cannot be minimized during the entire multi-bevel tip insertion process, and therefore it is not enough to minimize the patient's pain.
为此,如何设计一款五斜面针管,以最大程度化降低疼痛感是本发明需要解决的问题。Therefore, how to design a five-bevel needle tube to minimize the pain is a problem that the present invention needs to solve.
发明内容Summary of the invention
本发明提供一种五斜面针管,其目的是要最大程度化降低多斜面尖端穿刺皮肤时的疼痛感。The present invention provides a five-bevel needle tube, the purpose of which is to minimize the pain when the multi-bevel tip punctures the skin.
为达到上述目的,本发明采用的第一个技术方案是:一种五斜面针管,包括:针管,该针管具有中心轴线,所述针管的一端设置有多斜面尖端,多斜面尖端上设置有用于流体输出或注入的开口,开口周围设置有一个第一斜面、两个第二斜面和两个第三斜面。To achieve the above-mentioned purpose, the first technical solution adopted by the present invention is: a five-bevel needle tube, comprising: a needle tube having a central axis, one end of the needle tube is provided with a multi-bevel tip, the multi-bevel tip is provided with an opening for fluid output or injection, and a first bevel, two second bevels and two third bevels are provided around the opening.
定义多斜面尖端上具有尖部、中部和基部,尖部位于多斜面尖端前端,基部位于多斜面尖端后端,中部位于前端与后端之间。The multi-bevel tip is defined as having a tip portion, a middle portion and a base portion, wherein the tip portion is located at the front end of the multi-bevel tip, the base portion is located at the rear end of the multi-bevel tip, and the middle portion is located between the front end and the rear end.
定义穿过针管的中心轴线并且对称平分针管的平面为第一参考面,定义穿过针管的中心轴线并且垂直于第一参考面的平面为第二参考面。A plane passing through the central axis of the needle tube and symmetrically dividing the needle tube in half is defined as a first reference plane, and a plane passing through the central axis of the needle tube and perpendicular to the first reference plane is defined as a second reference plane.
所述第一斜面位于多斜面尖端的基部,第一斜面以第一参考面为基准对称布置;第一斜面相对于中心轴线具有第一倾斜角,第一斜面以中心轴线为旋转轴线相对于第二参考面具有第一旋转角,且第一旋转角为0°。The first bevel is located at the base of the multi-bevel tip, and the first bevel is symmetrically arranged with the first reference plane as a reference; the first bevel has a first inclination angle relative to the central axis, and the first bevel has a first rotation angle relative to the second reference plane with the central axis as the rotation axis, and the first rotation angle is 0°.
本发明创新在于:The invention is innovative in that:
所述两个第二斜面从多斜面尖端的基部延伸到尖部,两个第二斜面相互间以第一参考面为基准对称布置,两个第二斜面的一端分别与第一斜面相交形成两条第一棱线,两个第二斜面另一端在多斜面尖端的尖部相交形成一条第二棱线,第二棱线前端为针尖。The two second bevels extend from the base of the multi-bevel tip to the tip, and the two second bevels are symmetrically arranged with respect to the first reference plane. One end of the two second bevels intersects with the first bevel to form two first ridges, and the other ends of the two second bevels intersect at the tip of the multi-bevel tip to form a second ridge, and the front end of the second ridge is the needle tip.
所述第二斜面相对于中心轴线具有第二倾斜角,第二斜面以中心轴线为旋转轴线相对于第二参考面具有第二旋转角。The second inclined surface has a second inclination angle relative to the central axis, and the second inclined surface has a second rotation angle relative to the second reference surface with the central axis as the rotation axis.
所述两个第三斜面位于多斜面尖端的中部,两个第三斜面相互间以第一参考面为基准对称布置,每一个第三斜面均与相对应的一个第二斜面相交形成一条第三棱线,相对于第一参考面,第三斜面位于第二斜面的外侧。The two third inclined planes are located in the middle of the multi-bevel tip, and are symmetrically arranged relative to each other with the first reference plane as a reference. Each third inclined plane intersects with a corresponding second inclined plane to form a third edge line. Relative to the first reference plane, the third inclined plane is located on the outside of the second inclined plane.
所述第三斜面相对于中心轴线具有第三倾斜角,第三斜面以中心轴线为旋转轴线相对于第二参考面具有第三旋转角,第三棱线相对于中心轴线具有第四倾斜角。The third inclined surface has a third inclination angle relative to the central axis, the third inclined surface has a third rotation angle relative to the second reference surface with the central axis as the rotation axis, and the third ridge line has a fourth inclination angle relative to the central axis.
所述第一倾斜角为9°±2°,第二倾斜角为12°±2°,第三倾斜角为11°±2°,其中,第二倾斜角>第一倾斜角。The first inclination angle is 9°±2°, the second inclination angle is 12°±2°, and the third inclination angle is 11°±2°, wherein the second inclination angle is greater than the first inclination angle.
所述第二旋转角为45°±5°,第三旋转角为70°±5°。The second rotation angle is 45°±5°, and the third rotation angle is 70°±5°.
上述技术方案中的有关内容解释如下:The relevant contents in the above technical solution are explained as follows:
1.上述方案中,所述“前端”中的“前”是指针尖所指的方向。所述“后端”中的“后”是指“前”的反方向。1. In the above scheme, the "front" in the "front end" refers to the direction pointed by the needle tip. The "rear" in the "rear end" refers to the opposite direction of the "front".
2.上述方案中,“定义穿过针管的中心轴线并且对称平分针管的平面为第一参考面”中的“对称平分针管”的含义是指穿过中心轴线将针管切割成结构为相互对称的两半。即第一参考面是将针管切割成结构为相互对称的两个半管。如果切割后不能保持两个半管的相互对称性则此切割不符合平分针管的含义。2. In the above scheme, the meaning of "the plane passing through the central axis of the needle tube and symmetrically bisecting the needle tube" in "defining the plane passing through the central axis of the needle tube and symmetrically bisecting the needle tube as the first reference plane" is to cut the needle tube through the central axis into two halves with mutually symmetrical structures. That is, the first reference plane is to cut the needle tube into two half tubes with mutually symmetrical structures. If the mutual symmetry of the two half tubes cannot be maintained after cutting, then this cutting does not meet the meaning of bisecting the needle tube.
3.上述方案中,所述两条第一棱线位于第二参考面的一侧,所述一条第二棱线位于第二参考面的另一侧。3. In the above solution, the two first ridges are located on one side of the second reference surface, and the one second ridge is located on the other side of the second reference surface.
4.上述方案中,定义所述针尖到第三斜面后端在中心轴线上的投影距离为第一长度,定义所述针尖到第二斜面后端在中心轴线上的投影距离为第二长度,定义所述针尖到第一斜面后端在中心轴线上的投影距离为第三长度,则:4. In the above scheme, the projection distance from the needle tip to the rear end of the third bevel on the central axis is defined as the first length, the projection distance from the needle tip to the rear end of the second bevel on the central axis is defined as the second length, and the projection distance from the needle tip to the rear end of the first bevel on the central axis is defined as the third length, then:
第一长度<第二长度<第三长度。The first length is less than the second length and less than the third length.
5.上述方案中,所述第二倾斜角>第三倾斜角。5. In the above solution, the second inclination angle is greater than the third inclination angle.
6.上述方案中,所述第二倾斜角为12°±1°。6. In the above solution, the second inclination angle is 12°±1°.
7.上述方案中,所述第三倾斜角为11°±1°。7. In the above solution, the third inclination angle is 11°±1°.
8.上述方案中,所述第三棱线相对于中心轴线具有第四倾斜角,第四倾斜角为13°±3°,第四倾斜角>第二倾斜角。8. In the above solution, the third ridgeline has a fourth inclination angle relative to the central axis, the fourth inclination angle is 13°±3°, and the fourth inclination angle is greater than the second inclination angle.
9.上述方案中,所述第二旋转角为45°±3°,第三旋转角为70°±3°。9. In the above solution, the second rotation angle is 45°±3°, and the third rotation angle is 70°±3°.
为达到上述目的,本发明采用的第二个技术方案是:一种注射器组件,包括:注射器筒以及连接到注射器筒的针管。其中,所述针管与上述第一个技术方案以及对该技术方案的解释完全相同,因此不再重复描述。To achieve the above object, the second technical solution adopted by the present invention is: a syringe assembly, comprising: a syringe barrel and a needle tube connected to the syringe barrel. The needle tube is exactly the same as the first technical solution and the explanation of the technical solution, so it will not be described again.
为达到上述目的,本发明采用的第三个技术方案是:一种血液收集装置,包括:毂部以及连接到毂部的针管。其中,所述针管与上述第一个技术方案以及对该技术方案的解释完全相同,因此不再重复描述。To achieve the above object, the third technical solution adopted by the present invention is: a blood collection device, comprising: a hub and a needle tube connected to the hub. The needle tube is exactly the same as the first technical solution and the explanation of the technical solution, so it will not be described again.
本发明设计原理和技术构思是:为了最大程度化降低多斜面尖端穿刺皮肤时的疼痛感,本发明对现有五斜面针尖进行了改进,其改进点以及有益效果主要体现在以下几个方面:The design principle and technical concept of the present invention are: in order to minimize the pain caused by the multi-bevel tip puncturing the skin, the present invention improves the existing five-bevel needle tip, and its improvements and beneficial effects are mainly reflected in the following aspects:
1.本发明直接以两个第二斜面延伸至尖部形成针尖,让两个第二斜面承担主切割任务,其余斜面作为辅助斜面。而对比专利(背景技术中介绍的最接近现有技术)则是以两个末端斜面形成针尖,而末端斜面从位置以及相互间邻接关系角度来看相当于本发明的第三斜面。本发明中的第二斜面从位置以及相互间邻接关系角度来看相当于对比专利中间斜面。因此,从多斜面尖端设计角度,这是一个突破。它打破了以往多斜面尖端设计采用逐渐过渡的设计构思,为实现本发明目的提供了一种崭新的设计思路。1. The present invention directly extends two second bevels to the tip to form a needle tip, allowing the two second bevels to take on the main cutting task, and the remaining bevels serve as auxiliary bevels. The comparative patent (the closest prior art introduced in the background technology) forms the needle tip with two end bevels, and the end bevels are equivalent to the third bevel of the present invention from the perspective of position and mutual adjacency. The second bevel in the present invention is equivalent to the middle bevel of the comparative patent from the perspective of position and mutual adjacency. Therefore, from the perspective of multi-bevel tip design, this is a breakthrough. It breaks the previous multi-bevel tip design that uses a gradual transition design concept, and provides a new design idea for achieving the purpose of the present invention.
2.本发明与对比专利相比通过降低第二斜面的第二倾斜角度,使两个第二斜面在针部相交形成的第二棱线的第四倾斜角度也变得较小,使得针尖刚刺入皮肤时具有较小的穿刺阻力。2. Compared with the comparative patent, the present invention reduces the second inclination angle of the second bevel, so that the fourth inclination angle of the second ridge formed by the intersection of the two second bevels at the needle portion also becomes smaller, so that the needle tip has a smaller puncture resistance when it just penetrates the skin.
3.本发明与对比专利相比通过延长第二斜面的表面长度(即两个第二斜面从多斜面尖端的尖部延伸到基部),并在第二斜面的外侧边设置第三斜面,使得多斜面尖端的有效外径减小,进一步减小了穿刺阻力。3. Compared with the comparative patent, the present invention reduces the effective outer diameter of the multi-bevel tip by extending the surface length of the second bevel (i.e., the two second bevels extend from the tip to the base of the multi-bevel tip) and arranging the third bevel on the outer side of the second bevel, thereby further reducing the puncture resistance.
4.本发明的两个第三斜面设计能够有效抑制第二斜面在刺入过程中的阻力峰值水平。这种设计使得穿刺过程中,第二斜面到第一斜面穿刺阻力差减小,保证了第二斜面到第一斜面穿刺阻力转变的平缓性,从而使得多斜面尖端的切割和牵拉动作越发平顺,有效降低疼痛感。4. The two third bevel designs of the present invention can effectively suppress the peak resistance level of the second bevel during the puncture process. This design reduces the difference in puncture resistance from the second bevel to the first bevel during the puncture process, ensuring the smooth transition of puncture resistance from the second bevel to the first bevel, thereby making the cutting and pulling actions of the multi-bevel tip smoother and effectively reducing pain.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
附图1为本发明五斜面针管实施例立体图;Figure 1 is a three-dimensional view of a five-bevel needle tube embodiment of the present invention;
附图2为本发明五斜面针管实施例的第一倾斜角示意图;FIG2 is a schematic diagram of a first inclination angle of a five-bevel needle tube embodiment of the present invention;
附图3为图2的左视图;Accompanying drawing 3 is a left side view of Fig. 2;
附图4为本发明五斜面针管实施例的第二倾斜角示意图;FIG4 is a schematic diagram of a second inclination angle of a five-bevel needle tube embodiment of the present invention;
附图5为本发明五斜面针管实施例的第三倾斜角示意图;FIG5 is a schematic diagram of a third inclination angle of a five-bevel needle tube embodiment of the present invention;
附图6为本发明五斜面针管实施例的平面示意图;Figure 6 is a schematic plan view of an embodiment of a five-bevel needle tube of the present invention;
附图7为图6的B-B向剖视图;Accompanying drawing 7 is a cross-sectional view taken along the line B-B of Fig. 6;
附图8为本发明实施例1实验数据显示的五斜面针管穿刺力(针尖所受阻力)随时间变化的曲线图;FIG8 is a graph showing the variation of the puncture force (resistance on the needle tip) of the five-bevel needle tube over time, shown in the experimental data of Example 1 of the present invention;
附图9为本发明对比例实验数据显示的针管穿刺力(针尖所受阻力)随时间变化的曲线图。FIG9 is a graph showing the variation of the needle puncture force (resistance experienced by the needle tip) over time according to comparative experimental data of the present invention.
以上附图中:1.针管;11.多斜面尖端;111.第一斜面;112.第二斜面;113.第三斜面;114.第一棱线;115.第二棱线;116.第三棱线;117.开口;12.中心轴线;a.第一倾斜角;b.第二倾斜角;c.第三倾斜角;d.第四倾斜角;α.第二旋转角;β.第三旋转角;X.第一参考面;Y.第二参考面;L1.第一长度;L2.第二长度;L3.第三长度。In the above figures: 1. needle tube; 11. multi-bevel tip; 111. first bevel; 112. second bevel; 113. third bevel; 114. first edge line; 115. second edge line; 116. third edge line; 117. opening; 12. central axis; a. first inclination angle; b. second inclination angle; c. third inclination angle; d. fourth inclination angle; α. second rotation angle; β. third rotation angle; X. first reference plane; Y. second reference plane; L1. first length; L2. second length; L3. third length.
具体实施方式Detailed ways
下面结合附图及实施例对本发明作进一步描述:The present invention will be further described below in conjunction with the accompanying drawings and embodiments:
实施例1:一种五斜面针管Example 1: A five-bevel needle tube
如图1-7所示,该五斜面针管包括:针管1(见图1),该针管1具有中心轴线12(见图2、图4和图5)。所述针管1的一端设置有多斜面尖端11(见图1),多斜面尖端11上设置有用于流体输出或注入的开口117(见图1和图3),开口117周围设置有一个第一斜面111、两个第二斜面112和两个第三斜面113(见图1)。As shown in Figures 1-7, the five-bevel needle tube includes: a needle tube 1 (see Figure 1), the needle tube 1 having a central axis 12 (see Figures 2, 4 and 5). One end of the needle tube 1 is provided with a multi-bevel tip 11 (see Figure 1), and the multi-bevel tip 11 is provided with an opening 117 for fluid output or injection (see Figures 1 and 3), and a first bevel 111, two second bevels 112 and two third bevels 113 are provided around the opening 117 (see Figure 1).
为了更好地表达各个斜面在多斜面尖端11上的位置和角度关系,定义多斜面尖端11上具有尖部、中部和基部(图中未示出),尖部位于多斜面尖端11前端,基部位于多斜面尖端11后端,中部位于前端与后端之间。其中,“前端”中的“前”是指针尖所指的方向。“后端”中的“后”是指“前”的反方向。同时,定义穿过针管1的中心轴线12并且对称平分针管1的平面为第一参考面X(见图3中的上下方向),定义穿过针管1的中心轴线12并且垂直于第一参考面X的平面为第二参考面Y(见图3中的左右方向)。其中,定义第一参考面X中的“对称平分针管”的含义是指穿过中心轴线12将针管1切割成结构为相互对称的两半。即第一参考面X是将针管1切割成结构为相互对称的两个半管。如果切割后不能保持两个半管的相互对称性则此切割不符合平分针管的含义。In order to better express the position and angle relationship of each bevel on the multi-bevel tip 11, it is defined that the multi-bevel tip 11 has a tip, a middle part and a base (not shown in the figure), the tip is located at the front end of the multi-bevel tip 11, the base is located at the rear end of the multi-bevel tip 11, and the middle part is located between the front end and the rear end. Among them, the "front" in the "front end" refers to the direction pointed by the needle tip. The "rear" in the "rear end" refers to the opposite direction of the "front". At the same time, the plane passing through the central axis 12 of the needle tube 1 and symmetrically bisecting the needle tube 1 is defined as the first reference plane X (see the up and down direction in Figure 3), and the plane passing through the central axis 12 of the needle tube 1 and perpendicular to the first reference plane X is defined as the second reference plane Y (see the left and right direction in Figure 3). Among them, the meaning of "symmetrically bisecting the needle tube" in the definition of the first reference plane X is to cut the needle tube 1 into two halves with mutually symmetrical structures through the central axis 12. That is, the first reference plane X is to cut the needle tube 1 into two half tubes with mutually symmetrical structures. If the mutual symmetry of the two half tubes cannot be maintained after cutting, this cutting does not meet the meaning of bisecting the needle tube.
所述第一斜面111位于多斜面尖端11的基部(见图1),第一斜面111以第一参考面X为基准对称布置(见图3)。第一斜面111相对于中心轴线12具有第一倾斜角a(见图2),第一倾斜角a为9°±2°,较佳为9°±1°。第一斜面111以中心轴线12为旋转轴线相对于第二参考面Y具有第一旋转角,且第一旋转角为0°(见图3、图6和图7)。The first inclined surface 111 is located at the base of the multi-bevel tip 11 (see FIG. 1 ), and the first inclined surface 111 is symmetrically arranged with respect to the first reference plane X (see FIG. 3 ). The first inclined surface 111 has a first inclination angle a relative to the central axis 12 (see FIG. 2 ), and the first inclination angle a is 9°±2°, preferably 9°±1°. The first inclined surface 111 has a first rotation angle relative to the second reference plane Y with the central axis 12 as the rotation axis, and the first rotation angle is 0° (see FIG. 3 , FIG. 6 and FIG. 7 ).
所述两个第二斜面112从多斜面尖端11的基部延伸到尖部(见图1和图6),两个第二斜面112相互间以第一参考面X为基准对称布置(见图3和图6),两个第二斜面112的一端分别与第一斜面111相交形成两条第一棱线114(见图1和图6),两个第二斜面112另一端在多斜面尖端11的尖部相交形成一条第二棱线115,第二棱线115前端为针尖(图1和图6)。所述第二斜面112相对于中心轴线12具有第二倾斜角b(见图4),第二倾斜角b为12°±2°,较佳为12°±1°。第二斜面112以中心轴线12为旋转轴线相对于第二参考面Y具有第二旋转角α(见图7)。第二旋转角α为45°±5°,较佳为45°±3°。The two second inclined surfaces 112 extend from the base to the tip of the multi-bevel tip 11 (see Figures 1 and 6), and the two second inclined surfaces 112 are symmetrically arranged relative to each other with the first reference plane X as the reference (see Figures 3 and 6), and one end of the two second inclined surfaces 112 intersects with the first inclined surface 111 to form two first ridges 114 (see Figures 1 and 6), and the other ends of the two second inclined surfaces 112 intersect at the tip of the multi-bevel tip 11 to form a second ridge 115, and the front end of the second ridge 115 is a needle tip (Figures 1 and 6). The second inclined surface 112 has a second inclination angle b relative to the central axis 12 (see Figure 4), and the second inclination angle b is 12°±2°, preferably 12°±1°. The second inclined surface 112 has a second rotation angle α relative to the second reference plane Y with the central axis 12 as the rotation axis (see Figure 7). The second rotation angle α is 45°±5°, preferably 45°±3°.
所述两个第三斜面113位于多斜面尖端11的中部(见图1和图6),两个第三斜面113相互间以第一参考面X为基准对称布置(见图3和图6),每一个第三斜面113均与相对应的一个第二斜面112相交形成一条第三棱线116(见图1和图6),相对于第一参考面X,第三斜面113位于第二斜面112的外侧(见图3和图6)。所述第三斜面113相对于中心轴线12具有第三倾斜角c(见图5),第三倾斜角c为11°±2°,较佳为11°±1°。第三斜面113以中心轴线12为旋转轴线相对于第二参考面Y具有第三旋转角β(见图7),第三旋转角β为70°±5°,较佳为70°±3°。第三棱线116相对于中心轴线12具有第四倾斜角d(见图2),第四倾斜角d为13°±3°,较佳为13°±1°。The two third inclined surfaces 113 are located in the middle of the multi-bevel tip 11 (see Figures 1 and 6). The two third inclined surfaces 113 are symmetrically arranged relative to the first reference plane X (see Figures 3 and 6). Each third inclined surface 113 intersects with a corresponding second inclined surface 112 to form a third ridgeline 116 (see Figures 1 and 6). Relative to the first reference plane X, the third inclined surface 113 is located outside the second inclined surface 112 (see Figures 3 and 6). The third inclined surface 113 has a third inclination angle c relative to the central axis 12 (see Figure 5), and the third inclination angle c is 11°±2°, preferably 11°±1°. The third inclined surface 113 has a third rotation angle β relative to the second reference plane Y with the central axis 12 as the rotation axis (see Figure 7), and the third rotation angle β is 70°±5°, preferably 70°±3°. The third ridge line 116 has a fourth inclination angle d (see FIG. 2 ) relative to the central axis 12 . The fourth inclination angle d is 13°±3°, preferably 13°±1°.
在本实施例中,第二倾斜角b>第一倾斜角a,第四倾斜角d>第二倾斜角b,第二倾斜角b>第三倾斜角c。In this embodiment, the second inclination angle b>the first inclination angle a, the fourth inclination angle d>the second inclination angle b, and the second inclination angle b>the third inclination angle c.
在本实施例中,所述两条第一棱线114位于第二参考面Y的一侧,所述一条第二棱线115位于第二参考面Y的另一侧(见图1、图3和图6)。In this embodiment, the two first ridges 114 are located on one side of the second reference plane Y, and the one second ridge 115 is located on the other side of the second reference plane Y (see FIGS. 1 , 3 and 6 ).
在本实施例中,如果定义所述针尖到第三斜面113后端在中心轴线12上的投影距离为第一长度L1,定义所述针尖到第二斜面112后端在中心轴线12上的投影距离为第二长度L2,定义所述针尖到第一斜面111后端在中心轴线12上的投影距离为第三长度L3,则:In this embodiment, if the projection distance from the needle tip to the rear end of the third bevel 113 on the central axis 12 is defined as the first length L1, the projection distance from the needle tip to the rear end of the second bevel 112 on the central axis 12 is defined as the second length L2, and the projection distance from the needle tip to the rear end of the first bevel 111 on the central axis 12 is defined as the third length L3, then:
第一长度L1<第二长度L2<第三长度L3(见图6)。The first length L1<the second length L2<the third length L3 (see FIG. 6 ).
本实施例针管1可以由例如医疗级不锈钢的常规材料形成。所述多斜面尖端11上的各个斜面可以通过常规过程(例如通过研磨)而形成在针管1上。The needle tube 1 of this embodiment can be formed of conventional materials such as medical grade stainless steel. Each bevel on the multi-bevel tip 11 can be formed on the needle tube 1 by conventional processes (such as by grinding).
为了减少疼痛感,本实施例针管1可以通过各种常规润滑剂(例如硅油)被润滑以减小针尖与皮肤或组织的摩檫力,进一步降低疼痛感。In order to reduce the pain, the needle tube 1 of this embodiment can be lubricated by various conventional lubricants (such as silicone oil) to reduce the friction between the needle tip and the skin or tissue, thereby further reducing the pain.
实验数据及其说明如下:The experimental data and their descriptions are as follows:
以本实施例针管1选用31G×5mm为测试对象,与同类产品相比,其中对比例为BD31G×5mm五斜面针,根据国家标准《一次性使用无菌注射针》(GB15811-2016)搭建实验平台。采用厚度为0.4mm、邵氏硬度为92.3HA的聚氨酯膜作为被测材料。设计夹具,夹固后暴露区域直径为10mm。采用Instron5900试验机夹持针头并分别以150mm/min的速度匀速垂直穿刺被测材料,记录针头所受的阻力即为刺穿力。本实施例针管1和对比例的针管参数(其中第二倾斜角、第三倾斜角、第二旋转角、第三旋转角均取平均值)如下表:The needle tube 1 of this embodiment uses 31G×5mm as the test object. Compared with similar products, the comparative example is a BD31G×5mm five-bevel needle. The experimental platform is built according to the national standard "Disposable Sterile Injection Needle" (GB15811-2016). A polyurethane film with a thickness of 0.4mm and a Shore hardness of 92.3HA is used as the material to be tested. The fixture is designed, and the diameter of the exposed area after clamping is 10mm. The Instron5900 testing machine is used to clamp the needle and vertically puncture the material to be tested at a uniform speed of 150mm/min. The resistance of the needle is recorded as the puncture force. The needle tube parameters of the needle tube 1 of this embodiment and the comparative example (where the second inclination angle, the third inclination angle, the second rotation angle, and the third rotation angle are all averaged) are as follows:
结合所得出的实验数据,本实施例针管可将进针过程分为四个阶段,如图8所示。第一阶段:聚氨酯膜的表面与针尖接触,在针尖位移的作用下产生形变,针尖并未刺破表面,进针阻力逐渐上升,在数据上对应图8中a1阶段。第二阶段:聚氨酯膜表面所受的局部压力达到其抗拉强度临界值,针尖刺破表面,即第二斜面112刺入薄膜,薄膜应力得到一定程度的释放,进针阻力下降,形成第一个峰值;此过程中由于第二倾斜角度和第四倾斜角角度较小,因此针尖刺破薄膜时其峰值阻力较小,在数据上对应图8中b1阶段。第三阶段:第二斜面112与聚氨酯膜接触面逐渐增大,此过程中由于第二斜面112外侧具有第三斜面113,且第三斜面113具有较大的第三旋转角度,使得多斜面尖端的有效外径减小,进一步减小了穿刺阻力,使进针阻力上升缓慢,在数据上对应图8中c1阶段。第四阶段:多斜面尖端11的第一斜面111从聚氨酯膜穿出,形成第二个峰值,在数据上对应图8中d1阶段。Combined with the experimental data obtained, the needle tube of this embodiment can divide the needle insertion process into four stages, as shown in Figure 8. The first stage: the surface of the polyurethane film contacts the needle tip, and is deformed under the action of the needle tip displacement. The needle tip does not pierce the surface, and the needle insertion resistance gradually increases, which corresponds to the stage a1 in Figure 8 in terms of data. The second stage: the local pressure on the surface of the polyurethane film reaches its critical value of tensile strength, the needle tip pierces the surface, that is, the second inclined surface 112 penetrates the film, the film stress is released to a certain extent, the needle insertion resistance decreases, and the first peak value is formed; in this process, since the second inclination angle and the fourth inclination angle are small, the peak resistance is small when the needle tip pierces the film, which corresponds to the stage b1 in Figure 8 in terms of data. The third stage: the contact surface between the second inclined surface 112 and the polyurethane film gradually increases. In this process, since the third inclined surface 113 is provided on the outside of the second inclined surface 112, and the third inclined surface 113 has a large third rotation angle, the effective outer diameter of the multi-bevel tip is reduced, which further reduces the puncture resistance and makes the needle insertion resistance rise slowly, which corresponds to the stage c1 in Figure 8 in terms of data. Stage 4: the first slope 111 of the multi-slope tip 11 penetrates the polyurethane film to form a second peak, which corresponds to stage d1 in FIG. 8 in terms of data.
对比例针管实验数据如图9所示。第一阶段:聚氨酯膜的表面与针尖接触,在针尖位移的作用下产生形变,针尖并未刺破表面,进针阻力逐渐上升,在数据上对应图9中a2阶段。第二阶段:聚氨酯膜表面所受的局部压力达到其抗拉强度临界值,针尖刺破表面,即末端斜面刺入薄膜,薄膜应力得到一定程度的释放,进针阻力下降,形成第一个峰值;此过程中由于末端斜面的第三倾斜角度和第四倾斜角角度较大,因此针尖刺破薄膜时其峰值阻力相对较大,在数据上对应图9中b2阶段。第三阶段:末端斜面和中间斜面与聚氨酯膜接触面逐渐增大,此过程中由于末端斜面的第二旋转角和中间斜面的第三旋转角几乎相同,使得中间斜面部位的有效外径不能做到最小化,因此进针阻力上升明显,在数据上对应图9中c2阶段。第四阶段:多斜面尖端的主斜面从聚氨酯膜穿出,形成第二个峰值,在数据上对应图9中d2阶段。The experimental data of the comparative needle tube are shown in Figure 9. The first stage: the surface of the polyurethane film contacts the needle tip, and deformation occurs under the action of the needle tip displacement. The needle tip does not pierce the surface, and the needle resistance gradually increases, which corresponds to the a2 stage in Figure 9 in terms of data. The second stage: the local pressure on the surface of the polyurethane film reaches the critical value of its tensile strength, and the needle tip pierces the surface, that is, the end bevel pierces the film, the film stress is released to a certain extent, the needle resistance decreases, and the first peak value is formed; in this process, since the third and fourth inclination angles of the end bevel are large, the peak resistance when the needle tip pierces the film is relatively large, which corresponds to the b2 stage in Figure 9 in terms of data. The third stage: the contact surface between the end bevel and the middle bevel and the polyurethane film gradually increases. In this process, since the second rotation angle of the end bevel and the third rotation angle of the middle bevel are almost the same, the effective outer diameter of the middle bevel cannot be minimized, so the needle resistance increases significantly, which corresponds to the c2 stage in Figure 9 in terms of data. Stage 4: The main slope of the multi-bevel tip penetrates the polyurethane film to form a second peak, which corresponds to stage d2 in Figure 9 in terms of data.
综上所述,结合对比例的穿刺阻力的测量结果,与本实施例相比,对比例在第二阶段和第三阶段的穿刺阻力的峰值水平较大,且第二阶段和第三阶段的穿刺阻力的峰值水平差异明显,而本实施例中第二阶段和第三阶段的穿刺阻力的峰值水平较较小,且差值较小。因此本实施例的五斜面针管具有更小的穿刺阻力且能够有效降低痛感。In summary, combined with the measurement results of the puncture resistance of the comparative example, compared with the present embodiment, the peak levels of the puncture resistance of the comparative example in the second and third stages are larger, and the peak levels of the puncture resistance in the second and third stages are significantly different, while the peak levels of the puncture resistance in the second and third stages of the present embodiment are smaller, and the difference is smaller. Therefore, the five-bevel needle tube of the present embodiment has smaller puncture resistance and can effectively reduce pain.
实施例2:一种注射器组件Embodiment 2: A syringe assembly
该注射器组件包括:注射器筒以及连接到注射器筒的针管1,其中,所述针管1与实施例1的五斜面针管内容完全相同。这里不再重复描述。The syringe assembly comprises: a syringe barrel and a needle tube 1 connected to the syringe barrel, wherein the needle tube 1 is completely the same as the five-bevel needle tube of Example 1. The description will not be repeated here.
实施例3:一种血液收集装置Example 3: A blood collection device
该血液收集装置包括:毂部以及连接到毂部的针管1,其中,所述针管1与实施例1的五斜面针管内容完全相同。这里不再重复描述。The blood collection device comprises: a hub and a needle tube 1 connected to the hub, wherein the needle tube 1 is completely the same as the five-bevel needle tube of Example 1. The description will not be repeated here.
针对上述实施例,本发明可能产生的变化描述如下:With respect to the above-mentioned embodiment, possible changes of the present invention are described as follows:
1.以上实施例1中,针管1由医疗级不锈钢的常规材料形成。但本发明不局限于此,除此而外还可以使用医疗级塑料、复合材料、陶瓷或类似材料可以作为替代材料。这是本领域技术人员能够理解和知晓的。1. In the above embodiment 1, the needle tube 1 is formed of conventional medical grade stainless steel. However, the present invention is not limited thereto, and medical grade plastics, composite materials, ceramics or similar materials may also be used as alternative materials. This is something that those skilled in the art can understand and know.
2.以上实施例1中,针管1选择为31G。但本发明不局限于此,除此而外还可以选择21G(0 .03225英寸外直径,0.02025英寸内直径),23G(0.2525英寸外直径,0.01325英寸内直径),和25G(0 .02025英寸外直径,0.01025英寸内直径)的直径,和0.002-0.005英寸的壁厚度。选择小直径的针,例如31G和32G(0.00925英寸到0.01025英寸外直径),通常用于注射,而选择较大直径的针,例如21G、23G和25G(0 .02025英寸到0 .03225英寸外直径),通常用于抽血液。这是本领域技术人员能够理解和知晓的。2. In the above embodiment 1, the needle tube 1 is selected as 31G. However, the present invention is not limited to this. In addition, the diameters of 21G (0.03225 inch outer diameter, 0.02025 inch inner diameter), 23G (0.2525 inch outer diameter, 0.01325 inch inner diameter), and 25G (0.02025 inch outer diameter, 0.01025 inch inner diameter) and the wall thickness of 0.002-0.005 inch can also be selected. Small diameter needles, such as 31G and 32G (0.00925 inch to 0.01025 inch outer diameter), are usually used for injection, while larger diameter needles, such as 21G, 23G and 25G (0.02025 inch to 0.03225 inch outer diameter), are usually used for drawing blood. This is understandable and known to those skilled in the art.
3.以上实施例1中,所述多斜面尖端11上的各个斜面可以通过常规磨削过程(例如通过研磨)而形成。比如,先磨削第一斜面111和第二斜面112,然后再磨削第三斜面113。再比如,先磨削第二斜面112,然后再磨削第一斜面111和第三斜面113。3. In the above embodiment 1, each bevel on the multi-bevel tip 11 can be formed by a conventional grinding process (e.g., by lapping). For example, the first bevel 111 and the second bevel 112 are ground first, and then the third bevel 113 is ground. For another example, the second bevel 112 is ground first, and then the first bevel 111 and the third bevel 113 are ground.
上述实施例只为说明本发明的技术构思及特点,其目的在于让熟悉此项技术的人士能够了解本发明的内容并据以实施,并不能以此限制本发明的保护范围。凡根据本发明精神实质所作的等效变化或修饰,都应涵盖在本发明的保护范围之内。The above embodiments are only for illustrating the technical concept and features of the present invention, and their purpose is to enable people familiar with the technology to understand the content of the present invention and implement it accordingly, and they cannot be used to limit the protection scope of the present invention. Any equivalent changes or modifications made according to the spirit of the present invention should be included in the protection scope of the present invention.
Claims (10)
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410411723.4A CN118320232A (en) | 2024-04-08 | 2024-04-08 | A five-bevel needle tube |
| PCT/CN2024/106454 WO2025213618A1 (en) | 2024-04-08 | 2024-07-19 | Five-bevel needle tube |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410411723.4A CN118320232A (en) | 2024-04-08 | 2024-04-08 | A five-bevel needle tube |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN118320232A true CN118320232A (en) | 2024-07-12 |
Family
ID=91770199
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202410411723.4A Pending CN118320232A (en) | 2024-04-08 | 2024-04-08 | A five-bevel needle tube |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN118320232A (en) |
| WO (1) | WO2025213618A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2025213618A1 (en) * | 2024-04-08 | 2025-10-16 | 苏州沙力医疗器械有限公司 | Five-bevel needle tube |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3308822A (en) * | 1964-04-02 | 1967-03-14 | Loretta Fontano | Hypodermic needle |
| DE102005027147A1 (en) * | 2005-06-11 | 2006-12-14 | I.I.E. Ingenieurgesellschaft für Industrielle Einwegmedizintechnik m.b.h. | Glide-cut cannula for medical use comprises a standard facet-cut tip that is additionally ground to form two facets on the back of the tip |
| CN106068101B (en) * | 2015-02-19 | 2019-05-28 | 奥林巴斯株式会社 | Biopsy needle |
| CN112998706B (en) * | 2015-09-24 | 2023-12-12 | 贝克顿·迪金森公司 | Five-bevel cannula for blood collection device |
| WO2021033060A1 (en) * | 2019-08-16 | 2021-02-25 | Blazko Anton | Tool with ground edge, mainly cannula or lancet, method of its production and device for its production |
| CN218944061U (en) * | 2022-07-07 | 2023-05-02 | 普昂(杭州)医疗科技股份有限公司 | Five tangent planes injection needle tubing |
| CN117260472A (en) * | 2023-09-06 | 2023-12-22 | 贝普医疗科技股份有限公司 | Five-bevel needle tube for injection and manufacturing method thereof |
| CN118320232A (en) * | 2024-04-08 | 2024-07-12 | 苏州沙力医疗器械有限公司 | A five-bevel needle tube |
-
2024
- 2024-04-08 CN CN202410411723.4A patent/CN118320232A/en active Pending
- 2024-07-19 WO PCT/CN2024/106454 patent/WO2025213618A1/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2025213618A1 (en) * | 2024-04-08 | 2025-10-16 | 苏州沙力医疗器械有限公司 | Five-bevel needle tube |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2025213618A1 (en) | 2025-10-16 |
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