WO2009109066A1 - 改进型无内创医用针头及其加工方法 - Google Patents
改进型无内创医用针头及其加工方法 Download PDFInfo
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- WO2009109066A1 WO2009109066A1 PCT/CN2008/000445 CN2008000445W WO2009109066A1 WO 2009109066 A1 WO2009109066 A1 WO 2009109066A1 CN 2008000445 W CN2008000445 W CN 2008000445W WO 2009109066 A1 WO2009109066 A1 WO 2009109066A1
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- Prior art keywords
- needle
- arc
- processing
- treatment
- invasive medical
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Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B24—GRINDING; POLISHING
- B24B—MACHINES, DEVICES, OR PROCESSES FOR GRINDING OR POLISHING; DRESSING OR CONDITIONING OF ABRADING SURFACES; FEEDING OF GRINDING, POLISHING, OR LAPPING AGENTS
- B24B19/00—Single-purpose machines or devices for particular grinding operations not covered by any other main group
- B24B19/16—Single-purpose machines or devices for particular grinding operations not covered by any other main group for grinding sharp-pointed workpieces, e.g. needles, pens, fish hooks, tweezers or record player styli
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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
Definitions
- the present invention relates to a medical device, and more particularly to a medical needle, and more particularly to a needle which does not completely remove various tissues of the human body during injection and which has adverse effects on the human body, and a processing method thereof.
- injection needles are widely used in the medical field, and the needles are designed to be directly in contact with the human body, and their design and processing should be perfect, and the harm to the human body should be minimized.
- the conventional injection needle structure is usually made of stainless steel thin tubes, and one of the injection needles has a first inclined surface at the end of the stainless steel thin tube, and then a second inclined surface is formed by secondary cutting at the front end of the first inclined surface. Since the stainless steel thin tube has a certain wall thickness, the inner wall of the stainless steel thin tube of the tip outlet of the needle tip forms an inner needle tip of the needle tip by two cuttings, and the outer wall of the thin tube forms an outer needle tip of the needle tip.
- the second oblique surface of the needle tip and the first inclined surface are used to puncture the human tissue into the blood vessel, and the needle tip is used to break the human tissue, and the liquid medicine flows into the blood vessel from the inner wall of the stainless steel thin tube.
- the second oblique surface is invisible to the human body, and the inner needle tip of the first inclined surface removes the contacted human tissue during the needle insertion process to form an internal wound surface.
- the inventors of the present invention first proposed the first generation of non-invasive needles, which rounded the inner needle in the first bevel of the needle of the existing structure, and retained the outer needle of the original needle to maintain The needle is smooth, and the inner needle that forms the rounded corner does not carry the human tissue, thereby achieving the purpose of no invasiveness.
- the improved non-invasive medical needle comprises a needle thin tube, the second inclined surface and the first inclined surface are arranged at the front end of the needle thin tube, and the first inclined surface has an inner needle front and an outer needle front, wherein the inner needle front forms a strip
- the axially symmetrical arc, the direction of the rear end of the needle is the apex of the arc, and the present invention is characterized in that the inner needle arc of 20 to 60% of the length near the apex end is rounded.
- the length of the inner needle arc that is processed into rounded corners is preferably 30 to 40% of the total length of the inner needle arc.
- the axial depth of the portion removed by the treatment accounts for 5 to 25% of the distance between the inner needle and the outer needle; preferably 10 to 15%.
- Another object of the present invention is to provide a method of processing such an improved non-invasive medical needle.
- the processing method for the part to be processed, is subjected to mechanical refining using a precisely controlled grinding head or heat treatment using a laser to round the treated inner needle
- a CNC refiner When using mechanical refining, a CNC refiner is used to match the fine line of the traditional needle production line. After finishing the first bevel, the CNC refiner rotates at 6000 ⁇ 8000rpm, from the first bevel. The vertices of the line begin to finish grinding at both ends of the arc, and the fine grinding is completed in 3 to 6 seconds, so that the inner needle is processed to form an inner circle.
- the heat treatment time is 0.33.
- the laser heat treatment is performed on the needle tip of the needle. ⁇ 1. 5s, so that the inner needle after the treatment forms an inner circle.
- the invention reduces the range of needle treatment in the second inclined surface of the needle based on the original theoretical analysis and practice verification on the basis of the original non-invasive needle, and the original needle is kept smoothly.
- the non-invasive feature simplifies the processing difficulty of the new non-invasive needle, and the work difficulty and the reduction of the processing volume further increase the economics of the industrial implementation of the invention.
- the invention adopts the advanced mechanical refining or laser heat treatment process, can precisely control the processing process, and is beneficial to industrial implementation.
- Figure 1 is a picture of various tissue debris micrographs taken when the existing structure needle is used
- FIG. 2 is a schematic perspective view showing a conventional intravenous injection needle
- Figure 3 is a cross-sectional structural view of a conventional intravenous needle
- Figure 4 is a cross-sectional enlarged view of the novel non-invasive needle structure of the present invention.
- Fig. 5 is a schematic view showing the processing of a novel non-invasive needle according to the present invention. detailed description
- the present invention is based on the maintenance of the existing needle insertion structure, and the deficiencies thereof are improved, thereby obtaining an invasive medical needle.
- the first slope of the region B and the second slope of the region A form a region where the needle tip is discharged, where the second slope region A is a non-invasive region
- the second inclined surface is used for puncture, and the human tissue that is not in contact is not taken, and in the first inclined surface B region, the inner needle front B1B2 formed by the inner and outer wall surfaces of the needle steel tube and the outer needle front are used to open the contact human body.
- Tissue in which the external needle has no internal creation, and the inner needle B1B2 will pick up the contact tissue during the needle insertion process, creating internal strain on the human tissue.
- the inventor's first generation of non-invasive needles were used to round all of the inner needles B1B2 in the first bevel area B of the needle of the prior art structure.
- the inventors have found that not all of the inner needle B1B2 segments in the first bevel region B are internally invasive to human tissue, and therefore, the processing procedure can be reduced for portions that do not cause invasive injury. To facilitate industrial production.
- the inner needle edge B1B2 in the first slope area B is an arc having an axis X of the needle axis, and the vertex P of the arc is located at the rear end of the needle (the needle insertion direction is defined as the front end)
- the inner needles of the line segments B1B3 and B2B4 at the ends of the arc opening are substantially parallel to the axis X, and the human body tissue is not pulled during the needle insertion process, so that there is no intrinsic segment; and the inner needle is actually generated during the needle insertion process.
- the part is the inner needle of the B3P and B4P segments of the arc, that is, B3 and B4 are the starting points, and the vertex P of the arc is the final point.
- the body tissue With the advancement of the needle, the body tissue is oriented from B3 and B4 to the vertex P.
- the direction indicated by the arrow in Fig. 1 is taken out, so that the internal creation is formed, and the closer to the P point, the worse the internal creation is.
- the inventors realized that the key point in solving the existing needle internal creation is to deal with the inner needle tip near the apex portion of the arc.
- the improvement of the present invention focuses on processing the inner fronts of the arcs B3P and B4P segments to form an inner circular structure.
- the so-called treatment is performed by grinding with a precisely controlled grinding head or heat treatment using a laser, so that the treated portion is removed and the inner needle is rounded.
- the processing range of the present invention is the inner needle of the arc B3B4 segment, and the length thereof is 20 to 60%, preferably 30 to 40%, of the entire segment arc B1B2 of the B region.
- the treatment range is less than 20%, the internal damage can not be well eliminated; when the treatment range reaches 30 ⁇ 40%, the internal damage can be well eliminated, and the treatment range is increased, the elimination of the endogenous effect is not significantly improved, more than 60%. At the time, it is not very economical; if the treatment range reaches 100%, it becomes the first generation of non-invasive medical needles, which is relatively uneconomical.
- the depth of processing can be set as follows:
- the apex of the needle arc in the original needle is P
- the apex of the arc inside the needle is Pl after processing
- the vertex of the needle arc outside the original needle is P2
- P, PI Both P2 and P2 are on the axis X
- the depth to be treated is the length of PP1
- the length is 5 to 25%, preferably 10 to 15%, of the length of PP2.
- the treatment depth is less than 5%, the internal damage caused by the inner needle can not be well eliminated; when the depth is 10 ⁇ 15%, the internal injury can be eliminated very effectively.
- the experiment verifies that the needle of the structure is not involved in the extraction. Any human tissue; no depth will be produced after the depth is greater than 25%, but the degree of processing is deeper and uneconomical.
- the invention adds a "no intrinsic treatment" process in the processing of the original needle.
- the non-invasive treatment can be mechanical fine grinding, that is, after the needle is finely punched to form the first inclined surface and the second inclined surface, it is completed by a precision precise numerical control refining machine matched with the conventional medical needle production line, and the specific grinding is performed. Dimensions are based on the wall type of needles 1 to 17 with RW (normal wall), TW (thin wall) or ETW (ultra-thin wall) different wall thickness, different models, different specifications or different apertures for accurate data calculation input CNC After the refiner is finished, the control device grinds the inner needle of the needle according to the set rotation speed, displacement distance and working time, and grinds the inner needle into rounded corners. After the refining process, the subsequent processes such as the surface treatment of the original needle are continued, thereby processing the invasive medical needle of the invention.
- a traditional medical needle with a single use of No. 12 is used as an example: ⁇
- a data input CNC refiner is matched with the conventional needle production line, and the first bevel is finished, and the CNC refiner is set.
- the rotation speed is 6000 ⁇ 8000rpm, starting from the apex of the needle arc in the first slope to the ends of the arc, and finishing grinding in 3 ⁇ 6 seconds, the processing range is 30 ⁇ 40%, the treatment depth is obtained.
- the non-invasive treatment can also be used for laser heat treatment.
- a CNC laser machine is combined with the traditional needle production equipment.
- the laser head of the CNC laser machine is laser heat treated according to the range and depth of the setting. 5 ⁇
- the heat treatment time is 0. 3 ⁇ 1. 5s, so that the inner needle after the treatment is formed into an inner circle.
- the invention detects the new non-invasive medical needle:
- the rate of detection Take the same type (12 gauge needle) 3 needles, which are respectively installed on the matching syringe, simulate human skin with artificial skin (silicone rubber block), draw distilled water into the syringe according to the conventional injection method, discharge the air, and then The artificial skin was punctured until the needle was directly punctured until the needle tip was unobstructed, and the needle was immediately pulled out.
- the water for injection into the three syringes was poured into a transparent glass cup containing 5 mL of water for injection, and filtered through a 0.54 ⁇ m filter.
- test needle and simulated skin (polyurethane film, thickness 0.35mm ⁇ 0.05mm, hardness: Shore A85 ⁇ 10) at 22 ° C ⁇ 2 ° C for at least 24 h, and test at the same temperature;
- c) Mount the needle to be tested on a transmission unit with a pressure measuring element (pressure sensor measuring range: 0 ⁇ 50N), the axis of which is perpendicular to the surface of the simulated skin, and the tip of the needle points to the circular puncture area (010mm after clamping) center of;
- a pressure measuring element pressure sensor measuring range: 0 ⁇ 50N
- the moving speed is set to 100mm/min, and the needle to be inspected performs a puncture process on the center of the circular puncture area;
- the maximum peak force or the recording force/displacement map of the puncture is measured at the same time.
- Test evaluation The maximum peak value in the obtained force/displacement map is compared with the required specified value (12 needle penetration force 1.15N). When the maximum peak value is less than or equal to the specified value, it is determined as the piercing force of the needle to be tested. Meet the requirements.
- the needles to be inspected are: No. 12 traditional medical needle (code 0); the first model of the same model has no internal needle (code 1); the same model of the second generation of the invention has no internal needle: when the treatment depth is uniform 10%, Processing range 10% (code 2-10), treatment range 20% (code 2-20), treatment range 30% (code 2-30), treatment range 40% (code 2-40), processing range 50% (code 2-50), treatment range 60% (code 2-60), treatment range 80% (code 2-80); processing range is 40%, processing depth 2% (code 3-2), processing depth 4% (code 3-4), treatment depth 5% (code 3-5); processing depth 6% (code 3-6), processing depth 8% (code 3-8), processing depth 10% (code 3-10) , treatment depth 12% (code 3-12), treatment depth 15% (code 3-15), treatment depth 18% (code 3-18), treatment depth 25% (code 3-25), processing depth 30% ( Code 3-30).
- the invention adds a "no intrinsic treatment" process in the existing needle processing process, and performs a depth of 5 to 25% in a range of 20 to 60% of the needle tip in the second inclined surface of the needle by numerical control mechanical fine grinding or laser hot melt processing.
- the shield surface treatment makes the needle after processing smooth and non-invasive, and reduces the difficulty and processing capacity of the processing through accurate calculation. It is industrial and more economical, and is suitable for industrial implementation.
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Description
改进型无内创医用针头及其加工方法 技术领域
本发明涉及医疗器械， 特别涉及一种医用针头， 尤其是一种在注射进针过程中完 全不会摘取人体各种组织进而对人体带来不良影响的针头以及其加工方法。 背景技术
众所周知， 注射针头在医疗领域中大量使用， 并且， 针头作为直接与人体接触的 器件， 其设计、 加工理应尽善尽美， 对人体的危害应该降为最小。
传统的注射针头结构， 通常是以不锈钢细管加工而成， 其中一种注射针头是在不 锈钢细管的端头具有第一斜面， 然后在第一斜面的前端通过二次切削形成第二斜面， 由于不锈钢细管具有一定壁厚， 通过两次切削， 针尖出液口不锈钢细管的内壁会形成 针尖的内针锋， 而细管的外壁则形成针尖的外针锋。 这种结构的针头用于打针输血输液时， 依次以针尖的第二斜面、第一斜面穿刺人 体组织进入血管， 依靠其针尖外针锋破开人体组织， 药液从不锈钢细管内壁流入血管 中。在进针操作中， 第二斜面对人体无内创， 而第一斜面的内针锋在进针过程中会摘 除接触到的人体组织， 形成内创面。 大量的临床研究发现，一次性使用的以上结构的大型号和各种型号的常规针头在 打针输液输血时， 百分之百地会形成注射内创面， 创面下的皮肤组织、肌肉组织、 脂 肪组织、 以及血管管腔组织会在针头内针锋的作用下形成肉粒状或线条状组织碎屑
(参见图 1， 为研究发现的人体各种组织创落的组织碎屑显微镜下观测形态） ， 随药 水一并被推入血管管腔内， 随血液流动并可能停留在某一部位， 流动中如果进入狭窄 的血管中可能形成堵塞诱发血栓，而停留在某一部位的碎屑还可能成长而成为良性或 恶性肿瘤， 由此可见， 针头设计的细微不足都可能对人体带来巨大的潜在危害。
为此， 本发明研究人员首次提出了第一代无内创针头， 将现有结构的针头的第一 斜面中的内针锋打磨为圆角， 既保留了原有针头的外针锋以维持进针顺畅， 又保证形 成圆角的内针锋不牵带人体组织， 从而实现了无内创的目的。
然而， 在对该无内创针头进行加工和产业化推进过程中， 发现第一代无内创针头 可以做到无内创， 对消除内创的效果相当显著； 但对第一斜面内针锋的全面处理并不
经济， 工艺上较为复杂， 并非最佳方案。 因此， 本发明研究人员开发出第二代改进型 无内创针头。
发明内容
本发明的目的在于提供一种设计更为科学并可简化加工工艺的改进型无内创 的医用针头。
本发明提供的改进型无内创医用针头， 包括一针头细管， 针头细管前端设第二斜 面和第一斜面， 第一斜面具有内针锋和外针锋， 其中， 内针锋形成一条轴向对称的弧 线， 针头后端方向为弧线顶点， 本发明的特点是， 靠近顶点端的 20〜60 %长的内针锋 弧线被打磨成圆角。
优化方案中， 被处理成圆角的内针锋弧线长度最好占内针锋弧线总长度的 30〜 40 %。
上述改进型无内创医用针头中，被处理去除掉的部分轴向深度占内针锋和外针锋 之间距离的 5〜25 %； 优选 10〜； 15 %。
本发明的另一目的是提供这种改进型无内创医用针头的加工方法。
该加工方法， 针对需处理的部分， 使用可被精密控制的磨头进行机械精磨或使 用激光进行热处理， 使被处理的内针锋成圆角
使用机械精磨时， 采用一台数控精磨机与传统针头生产线精冲环节匹配， 在第一 斜面精冲完毕， 设定数控精磨机转速为 6000〜8000rpm， 从第一斜面内针锋弧线顶点 开始向弧线两端精磨， 以 3〜6秒来完成精磨， 使被处理后的内针锋形成内圆。
使用激光热处理时， 采用一台数控激光机与传统针头生产设备精冲环节相结合， 数控激光机激光头按设定处理范围和深度， 对针头内针锋进行激光热处理， 热处理时 间在 0. 3〜1. 5s， 使被处理后的内针锋形成内圆。
采用以上技术方案， 本发明在原有无内创针头的基础上， 基于更进一步的理论 分析和实践验证， 减少了针头第二斜面内针锋处理的范围， 既保留了原有针头进针 顺畅、 无内创的特点， 又简化了新型无内创针头的加工难度， 工作难度的减轻和处 理量的减少更增加了本发明工业实施的经济性。本发明采用先进的机械精磨或激光 热处理的工艺， 可以精确控制加工过程， 利于产业化实施。
附图说明
图 1为现有结构针头使用时摘取的各种组织碎屑显微镜下图片；
图 2为现有静脉注射针头的立体结构示意图；
图 3为现有静脉注射针头的剖面结构图；
图 4为本发明新型无内创针头结构剖视放大图；
图 5为本发明新型无内创针头的加工示意图。 具体实施方式
本发明是在保持现有针头进针结构的基础上， 对其不足进行改进， 从而获得一 种无内创的医用针头。
现有结构针头， 参见图 2和图 3所示， 其区域 B的第一斜面和区域 A的第二 斜面形成针尖出液的区域， 这里， 第二斜面区域 A为无内创区， 在进针过程中， 第 二斜面用于穿刺， 不会牵带接触的人体组织， 而第一斜面 B区域中， 针头钢管内外 壁面形成的内针锋 B1B2和外针锋用于划开接触到的人体组织，其中外针锋无内创， 而内针锋 B1B2在进针过程中则会摘取接触的组织， 对人体组织产生内创。
发明人的第一代无内创针头，将现有结构的针头的第一斜面区域 B中的全部内针 锋 B1B2打磨为圆角。 在本发明的进一步研究中， 发明人发现， 并非第一斜面区域 B 中的全部内针锋 B1B2段均对人体组织产生内创， 因此， 对于不会产生内创伤害的 部分可以减少处理程序， 以利于工业化的生产。
继续参见图 3所示， 第一斜面区域 B中的内针锋 B1B2为一段以针头中轴 X为 轴线的弧线， 该弧线的顶点 P位于针头的后端（进针方向定义为前端） ， 该弧线开口 两端线段 B1B3和 B2B4的内针锋， 基本与轴线 X平行， 在进针过程中不会牵带人体 组织， 为无内创段； 而真正在进针过程中产生内创的部分， 为弧线 B3P和 B4P段的 内针锋， 即 B3和 B4为初创点， 弧线顶点 P为终创点， 随着针头的推进， 人体组织 从 B3和 B4向顶点 P的方向依图 1中箭头所指方向被摘取， 因此形成了内创，愈向 P 点靠近， 则内创愈严重。
基于以上研究， 发明人意识到解决现有针头内创的关键点在于要处理靠近弧线 顶点 P部分的内针锋。
因此， 本发明的改进， 集中在将弧线 B3P和 B4P段的内锋口进行处理， 使其形 成内圆结构。参见图 4所示， 在第一斜面 B区域中， 以内针锋弧线的顶点 P为中心
向弧线开口方向进行处理直至 B3和 B4点。 所谓处理， 为采用可被精密控制的磨 头进行精磨或使用激光进行热处理， 使被处理部分被去除而使内针锋呈圆角。 本发 明的处理范围即弧线 B3B4段的内针锋， 其长度为 B区域全段弧线 B1B2的 20〜60%， 优选 30〜40%。 处理范围不足 20%时， 不能很好地消除内创； 处理范围达到 30〜40 %时， 便能很好地消除内创， 处理范围加大后对消除内创效果没有明显提高， 超过 60 %时， 便显得不很经济； 如果处理范围达到 100%， 则成为第一代的无内创医用针头， 比较而言更不经济了。
在被处理的范围内， 处理的深度可以这样设定： 原针头内针锋弧线顶点为 P， 处 理后针头内弧线顶点为 Pl， 原针头外针锋弧线顶点为 P2, P、 PI和 P2均在轴线 X上， 被处理的深度为 PP1的长度， 且该长度为 PP2长度的 5〜25%， 优选在 10〜15%。 处 理深度不足 5 %时， 不能很好地消除内针锋造成的内创； 深度在 10〜15 %时， 便可以 非常有效地消除内创， 实验验证了该结构的针头完全不会牵连摘取任何人体组织； 深 度大于 25%后也不会产生内创， 但加工程度则更深些， 不经济。
为实现上述新型无内创针头， 本发明在原有针头的加工过程中， 增加一道 "无 内创处理"工序。
无内创处理可以为机械精磨， 即在针头经精冲形成第一斜面和第二斜面后， 通 过与常规医用针头生产线相匹配的一台精密精确数控精磨机来完成，精磨的具体尺 寸是根据 1〜17号针头的管壁类型以 R W (正常壁）、 T W (薄壁） 或 E T W (超 薄壁） 不同壁厚、 不同型号、 不同规格或不同孔径进行精确的数据计算输入数控精 磨机来完成， 控制装置按设定的转速、 位移距离、 工作时间对针头的内针锋进行打 磨， 将内针锋磨成圆角。 经过该精磨工序后， 再继续原有针头的表面处理等后续工 序， 从而加工成本发明的无内创医用针头。
以处理一支 12号一次性使用的传统医用针头为例： 釆用一台可数据输入数控精 磨机与传统针头生产线精冲环节匹配， 在第一斜面精冲完毕， 设定数控精磨机转速为 6000〜8000rpm， 从第一斜面内针锋弧线顶点开始向弧线两端精磨， 以 3〜6秒来完成 精磨， 则可得到一支处理范围在 30〜40%， 处理深度为 10〜： 15 %的无内创医用针头。
无内创处理还可以为激光热处理， 采用一台数控激光机与传统针头生产设备精冲 环节相结合， 由数控激光机激光头按设定处理的范围和深度， 对针头内针锋进行激光 热处理， 热处理时间在 0. 3〜1. 5s， 使被处理后的内针锋形成内圆。
本发明新型无内创医用针头的检测：
1、 创率检测：
取同型号（12号针头）被检针头 3只，分别安装在适配的注射器上，采用人造皮肤 (硅 橡胶块)模拟人体皮肤， 按常规注射方式抽取蒸馏水进入注射器中， 排出空气， 然后对 人造皮肤进行穿刺， 直至针头直接穿刺至针尖无阻碍后立即拉出针管， 将三只注射器 中注射用水推入同一透明且装有 5mL注射用水的玻璃杯中， 经 0. 45 μ m滤膜过滤后用 少量生理盐水转移至玻璃载片上在生物显微镜下观察， 考察镜下区域中是否具有颗粒 物及颗粒物数量和尺寸，实验中使用 V D N-200M 数码显微镜。以上操作重复 10次， 取统计数据计算创率， 例如 10次检测中出现 1次粒径大于颗粒物 0. 2mm的颗粒物， 则创率为 10 %。 对 1〜17号针头， 检测中颗粒物大小在 0. 05〜0. 3應范围内变化。
2、 刺穿力检测： 测试方法：
a)将被检针和模拟皮肤 （聚氨酯膜， 厚度 0.35mm±0.05mm， 硬度： 邵氏 A85士 10) 在 22°C ± 2°C下放置至少 24h， 并在相同温度下进行测试；
b)将适当尺寸的模拟皮肤夹在夹具上， 不得有任何明显的拉伸或压缩力施加在模 拟皮肤上；
c)将被检针头装在带有压力测量元件 （压力传感器测量范围： 0〜50N) 的变送单 元上， 其轴线垂直于模拟皮肤的表面， 针尖指向圆形穿刺区域（夹固后 010mm)的中 心；
d)移动变送单元， 移动速度设定为 100mm/min， 被检针头对圆形穿刺区域中心实 施穿刺过程；
e)穿刺过程中， 同时测得穿刺的最大峰值力或记录力 /位移图。
测试评价： 将所得的力 /位移图中的最大峰值与要求规定值 （12号针穿刺力 1. 15N) 比较， 当最大峰值小于等于规定值时， 则判定为该被测针的刺穿力符合要求。
被检针头有： 12号传统医用针头（代号 0) ； 同样型号的第一代无内创针头（代号 1 ) ； 同样型号本发明第二代无内创针头： 处理深度统一为 10%时， 处理范围 10% (代号 2-10) ， 处理范围 20% (代号 2-20) ， 处理范围 30% (代号 2-30) ， 处理范围 40% (代号 2-40) ， 处理范围 50% (代号 2-50) ， 处理范围 60% (代号 2-60) ， 处理范围 80% (代号 2-80) ； 处理范围统一为 40%时， 处理深度 2% (代号 3-2) ， 处理深度 4% (代号 3-4) ， 处理深度 5% (代号 3-5)； 处理深度 6% (代号 3-6)， 处理深度 8% (代号 3-8)， 处理深度 10% (代 号 3-10) ， 处理深度 12% (代号 3-12) ， 处理深度 15% (代号 3-15 ) ， 处理深度 18% (代 号 3-18) ， 处理深度 25% (代号 3-25) ， 处理深度 30% (代号 3-30) 。
检测结果参见表 1所示：
表 1: 针头使用效果检测结果
本发明在现有针头加工工艺中增加一 "无内创处理"工序， 通过数控机械精磨 或激光热熔处理，将针头第二斜面内针锋的 20〜60 %范围进行深度 5〜25 %的盾面 处理， 使加工后的针头既进针顺畅又无内创， 且通过精确计算减少了处理的工作难 度和处理量， 具有工业性并更为经济， 适于产业化实施。
Claims
1、 一种新型无内创医用针头， 包括一针头细管， 针头细管前端设第二斜面和第 一斜面， 第一斜面具有内针锋和外针锋， 其中， 内针锋形成一条轴向对称的弧线， 针 头后端方向为弧线顶点，其特征在于，靠近顶点端的 20〜60 %范围长的弧线内针锋被 处理成圆角。
2、 根据权利要求 1所述的无内创医用针头， 其特征在于， 被处理成圆角的内针 锋弧线长度范围为内针锋弧线总长度的 30〜40 %。
3、 根据权利要求 1或 2所述的无内创医用针头， 其特征在于， 所述被处理采用 精磨或激光热熔方式去除内针锋的一部分， 被处理去除部分轴向深度占内针锋和外针 锋之间距离的 5〜25 %。
4、 根据权利要求 3所述的无内创医用针头， 其特征在于， 被处理去除部分轴向 深度占内针锋和外针锋之间距离的 10〜15 %。
5、权利要求 1至 4任一所述改进型无内创医用针头的加工方法， 其特征在于， 在原有针头的加工过程中， 针对需处理的部分， 使用可被精密控制的磨头进行精磨 或使用激光进行热处理， 使被处理的内针锋成圆角。
6、 根据权利要求 5所述加工方法， 其特征在于， 使用数控机械精磨， 磨头转速 8000〜10000转， 在 3〜6秒完成精磨。
7、 根据权利要求 5所述加工方法， 其特征在于， 使用激光热熔， 激光处理时间 0·3〜1· 5秒。
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