WO2015000368A1 - 一种出针孔带缓冲装置的采血装置 - Google Patents

一种出针孔带缓冲装置的采血装置 Download PDF

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Publication number
WO2015000368A1
WO2015000368A1 PCT/CN2014/080522 CN2014080522W WO2015000368A1 WO 2015000368 A1 WO2015000368 A1 WO 2015000368A1 CN 2014080522 W CN2014080522 W CN 2014080522W WO 2015000368 A1 WO2015000368 A1 WO 2015000368A1
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Prior art keywords
blood collection
housing
component
collection device
launching
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PCT/CN2014/080522
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English (en)
French (fr)
Inventor
施国平
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苏州施莱医疗器械有限公司
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Publication of WO2015000368A1 publication Critical patent/WO2015000368A1/zh

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150412Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150053Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150106Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
    • A61B5/150152Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced by an adequate mechanical impact on the puncturing location
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150503Single-ended needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15103Piercing procedure
    • A61B5/15107Piercing being assisted by a triggering mechanism
    • A61B5/15113Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15115Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15117Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188Constructional features of reusable driving devices
    • A61B5/1519Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit

Definitions

  • the invention relates to the field of medical instruments, in particular to a blood collection device with a pinhole buffering device.
  • the pain at the time of blood collection is divided into: spontaneous pain (pain that is immediately felt when blood is collected) and remaining pain (continuous pain after a few minutes or hours after blood collection).
  • the conventional mechanical blood collection operation device uses a linear motion drive, and the drive mechanism is often composed of a pair of springs.
  • the drive mechanism is often composed of a pair of springs.
  • the user compresses the spring, and then presses the button release mechanism, and the first time the hair lance is pulled into the skin.
  • the second time the lancet is recovered into the protective "shell" in the device the direction of advancement of the lancet and the vertical direction of the main motion vector are not accurately controlled, which leads to a series of problems:
  • the tremor path leads to a rough wound passage, which is an important cause of residual pain
  • the sudden stop of the lancet in the deepest part of the skin is an inherent problem of this design before it begins to eject the movement back to the starting position.
  • the maximum force acts on the skin.
  • the simple bounce of the mechanism into the device is like a ball bounce off the ground.
  • the lancet sends a shock wave to the skin, activates the pain receptor near the lance, which will greatly expand. Spontaneous pain.
  • the cam-driven device avoids the hard stop of the lancet to some extent, the cam mechanism is usually spring-driven and A better guiding drive on the body, the needle of the lancet is controlled by a needle on the cam to control the trajectory of the lancet, and the cam drive mechanism allows a predetermined speed and a gentle rotation. This will greatly avoid spontaneous pain.
  • the cam-driven blood collection device has a complicated structure, is very troublesome to manufacture, and is costly, which is not conducive to popularization.
  • the technical problem to be solved by the present invention is to provide a blood collection device capable of effectively reducing the pain of a patient.
  • a blood collection device with a pinhole buffering device comprising a housing, a transmitting component, a triggering device between the housing and the emitting component, the housing is provided with a pinhole, the shell The body is provided with an elastic component, and the elastic component provides ejection power.
  • the elastic component When the elastic component is compressed, the two ends respectively abut the housing and the emitting component, and the head of the emitting component can be installed with the blood collecting needle or integrated with the blood collecting needle, and the buffering device is arranged inside the needle hole.
  • the elastic member is a spring.
  • the spring sleeve is on the emitting member.
  • the triggering device comprises a button and a lever
  • the button is disposed on the housing
  • the lever is disposed under the button
  • the launching member is provided with a hook capable of catching the lever.
  • the triggering device comprises a button and a resilient arm
  • the button is disposed on the housing
  • the resilient arm is disposed on the transmitting member
  • the resilient arm is locked with the housing when the elastic member is compressed.
  • the inner casing of the casing is a card slot.
  • the launching member stop is a radial projection.
  • the buffer device is a damper.
  • the damper is made of TPA, or TPE, or neoprene, or hytrel.
  • the damper is annular or square.
  • the speed of the blood collection needle is from high speed to zero due to the impact caused by the spring-driven emergency stop.
  • the rapid drop of the rapid speed requires slow control.
  • the present invention uses the damping material to reduce the impact of the emergency stop.
  • the invention adopts the correct application of the damping material to decelerate the blood collection device to a moment before the set depth, and reduces and absorbs the diffusion vibration around the head of the blood collection needle located in the human skin layer due to the rapid linear motion of the spring. Achieve the effect of approximate cam mechanism, thereby reducing impromptu pain.
  • the invention has a simple structure and is convenient for popularization.
  • Embodiment 1 is a schematic structural view of Embodiment 1 of the present invention.
  • FIG. 2 is a schematic structural view of Embodiment 2 of the present invention
  • Figure 3 is a schematic view of the needle shaking when the blood collection device is launched to the furthest distance.
  • a blood collection device with a pinhole buffering device includes a housing 1, an emitting part 2, a triggering device between the housing 1 and the emitting part 2, and the emitting part 2 is sleeved with a spring 6 One end of the spring 6 is connected to the housing 1, and the other end is connected to the emitting part 2.
  • the housing 1 is provided with a pinhole 9.
  • the emitting part head 2-1 can be equipped with a blood collecting needle 7, and a buffering device is arranged inside the needle opening 9. 5.
  • the front part of the needle handle of the blood collection needle 7 is blocked by the buffer device 5, so as to reduce the blood collection needle located in the human skin layer when the blood collection needle 7 is suddenly stopped.
  • the surrounding part of the department spreads and vibrates.
  • the triggering device comprises a button 3 and a lever 4, the button 3 is disposed on the housing 1, the lever 4 is disposed under the button 3, and the transmitting member 2 is provided with a hook capable of catching the lever 4.
  • the buffer device 5 is a damper, and the damper is made of neoprene, has a circular shape, has a hardness of 30HA, and has a thickness of 6 mm.
  • the needle 8 is oscillated in the XY direction when the blood collection device is emitted to the farthest position. After the comparison test, it is found that the sway generated by the needle 8 is ⁇ 0.3 mm without the damper. In the case of adding a damper, the sway is ⁇ 0.1 mm, and it can be seen that the sway of the needle 8 is effectively controlled.
  • Embodiment 2 differs from Embodiment 1 in that the lancet and the head of the transmitting member are 2-1, and the triggering device includes a button 3 and a resilient arm 10, and the button 3 is disposed on the housing 1.
  • the elastic arm 10 is disposed on the transmitting member 2, and the elastic arm 10 is locked with the housing 1 when the spring 6 is compressed.
  • the damper may also be made of a material such as TPA, TPE or hytrd.
  • the invention has a simple structure and is convenient for popularization.
  • the description of the terms “one embodiment”, “some embodiments”, “example”, “specific example”, or “some examples” and the like means a specific feature described in connection with the embodiment or example.
  • a structure, material or feature is included in at least one embodiment or example of the invention.
  • the schematic representation of the above terms does not necessarily mean the same embodiment or example.
  • the particular features, structures, materials, or characteristics described may be combined in a suitable manner in any one or more embodiments or examples.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

一种出针孔带缓冲装置的采血装置,包括壳体(1)、发射部件(2)、壳体(1)与发射部件(2)之间的触发装置(3,4,10),壳体(1)上设有出针孔(9),壳体(1)内设有弹性部件(6),弹性部件(6)提供弹射动力,弹性部件(6)压缩时其两端分别抵住壳体(1)和发射部件(2),发射部件(2)头部可以安装采血针(7)或者与采血针(7)一体,出针孔(9)内侧设有缓冲装置(5)。通过阻尼材料减少急停时位于人体皮肤层的采血针(7)头部的四周扩散震动,减少疼痛。

Description

一种出针孔带缓冲装置的采血装置
技术领域
本发明涉及医疗器械领域, 尤其涉及一种出针孔带缓冲装置的采血装置。
背景技术
使用采血针穿剌皮肤, 来获取血液样本的行为仍然是可预见的将来的标准方法, 因为 采取血液样本的其他方法尚未证明其优越性(例如使用激光技术)。 避免完全切口的其他方 法也尚未获得市场的认可 (例如微创动态血糖监测), 或者尚未展现其技术可行性 (例如无 创血糖监测)。
但是, 在使用采血装置对患者进行采血时, 患者身体产生的疼痛会导致患者不愿意进 行采血, 不利于采血技术的推广。
采血时的疼痛分为: 自发性疼痛 (采血时立即感觉到的疼痛) 和余后疼痛 (采血后几 分钟或几个小时后的持续性疼痛)。
下面几个因素决定采血操作的疼痛: 穿剌深度, 穿剌速度, 整体剌入轨迹, 采血针尺 寸, 皮肤表面, 皮肤固定, 以及指尖采血位置定位; 大多数的生产商已经在采血针的生产 质量上取得相当大的进展例如握持规格的更高精度、 针尖质量、 有效抛光以及顺利滑入皮 肤的表层设计, 但在对于整体剌入轨迹的控制上目前市场上还未出现有效的采血产品。
传统的机械采血操作设备使用的是直线运动驱动, 驱动机构经常由一对弹簧构成, 当 竖起时, 使用者压缩弹簧, 然后按住按钮释放机构, 第一次弹动使采血针剌入皮肤; 第二 次回收采血针到装置里的起保护作用的 "壳子里", 采血针的前进方向和主运动矢量的垂直 方向并不是准确地受到控制的, 这会导致一系列问题:
运动终止点的不准确性;
穿剌最深度 (回转点) 的硬停, 这是造成自发性疼痛的一个重要原因;
颤动路径, 导致粗糙的伤口通道, 这是造成残余疼痛的一个重要原因;
不受控制的退出速度, 导致缓慢的伤口缝合以及后出血);
整体运动的 "摆动"(残余疼痛, 持久创伤, 以及伤疤);
机构的回弹, 导致非计划的再次采血操作。
在它开始弹出运动回到开始位置之前, 采血针在皮肤里最深处的突然停止是这种设计的 一个内在问题, 当针尖停留在剌入的最深点时, 最大的力度作用于皮肤了, 驱入机构简单的 弹跳脱离装置终端就像一个球弹跳脱离地面, 在它驱入运动末端的突然一停, 采血针向皮肤 发出一冲击波, 激活采血针附近的疼痛受体, 这将会极大地扩大自发性疼痛。
有凸轮驱动的装置某种程度上避免了采血针的硬停, 凸轮机构通常是弹簧驱动, 并在整 体上更好的引导驱动, 通过凸轮上的一针栓来控制采血针把手路径进而控制采血针的轨迹, 凸轮驱动机构允许预定速度, 较柔和的回转。 这将会极大地避免自发性疼痛, 但是, 凸轮驱 动的采血装置结构复杂, 生产制造非常麻烦, 成本很高, 不利于推广使用。
发明内容
本发明要解决的技术问题是提供一种能够有效减缓患者疼痛感的采血装置。
本发明采用的技术方案是: 一种出针孔带缓冲装置的采血装置, 包括壳体、 发射部件、 壳体与发射部件之间的触发装置, 壳体上设有出针孔, 所述壳体内设有弹性部件, 弹性部 件提供弹射动力, 弹性部件压缩时其两端分别抵住壳体和发射部件, 发射部件头部可以安 装采血针或者与采血针一体, 出针孔内侧设有缓冲装置。
作为优选, 所述的弹性部件为弹簧。
作为优选, 所述的弹簧套在发射部件上。
作为优选, 所述的触发装置包括按钮和杠杆, 所述的按钮设置在壳体上, 杠杆设置在 按钮下方, 发射部件上设有能够卡住杠杆的挂钩。
作为优选, 所述的触发装置包括按钮和弹性臂, 按钮设置在壳体上, 所述的弹性臂设 置在发射部件上, 弹性臂在弹性部件被压缩时与壳体锁定。
作为优选, 所述的壳体内侧挡块为卡槽。
作为优选, 发射部件挡块为径向凸起。
作为优选, 所述的缓冲装置为阻尼器。
作为优选, 所述的阻尼器的材质采用 TPA, 或 TPE, 或氯丁橡胶, 或 hytrel。
作为优选, 所述的阻尼器为环形或方形。
直线运动驱动的采血装置在采血时, 由于弹簧驱动急停导致的撞击, 采血针的速度从高 速至零, 该迅猛的速度急降需要缓慢的控制, 本发明使用阻尼材料来减少急停的冲击效果, 本发明通过阻尼材料的正确应用来使采血装置发射到设定深度之前的一瞬间进行减速, 减少 并吸收由于弹簧快速直线运动急停时位于人体皮肤层的采血针头部的四周扩散震动, 达到近 似凸轮机构才能的效果, 从而减少即兴疼痛。
本发明的有益效果-
1、 通过阻尼材料减少急停时位于人体皮肤层的采血针头部的四周扩散震动, 减少疼痛。
2、 本发明结构简单, 便于推广。
附图说明
图 1为本发明实施例 1的结构示意图;
图 2为本发明实施例 2的结构示意图; 图 3为采血装置发射到最远距离时针头晃动的示意图。
图中: 1、 壳体; 2、 发射部件; 2-1、 发射部件头部; 3、 按钮; 4、 杠杆; 5、 缓冲装 置; 6、 弹簧; 7、 采血针; 8、 针头; 9、 出针孔; 10、 弹性臂。
具体实施方式
下面详细描述本发明的实施例, 所述实施例的示例在附图中示出, 其中自始至终相同 或类似的标号表示相同或类似的元件或具有相同或类似功能的元件。 下面通过参考附图描 述的实施例是示例性的, 仅用于解释本发明, 而不能理解为对本发明的限制。
实施例 1
参阅图 1所示, 一种出针孔带缓冲装置的采血装置, 包括壳体 1、 发射部件 2、 壳体 1 与发射部件 2之间的触发装置, 所述发射部件 2上套有弹簧 6, 弹簧 6的一端连接壳体 1, 另一端连接发射部件 2, 壳体 1上设有出针孔 9, 发射部件头部 2-1可以安装采血针 7, 出 针孔 9内侧设有缓冲装置 5, 当采血针 7随发射部件 2向出针孔 9方向运动时, 采血针 7的 针柄前部将被缓冲装置 5阻挡, 以减少采血针 7急停时, 位于人体皮肤层的采血针头部的 四周扩散震动。
所述的触发装置包括按钮 3和杠杆 4, 所述的按钮 3设置在壳体 1上, 杠杆 4设置在按 钮 3下方, 发射部件 2上设有能够卡住杠杆 4的挂钩。
所述的缓冲装置 5为阻尼器, 阻尼器的材质采用氯丁橡胶, 为圆环形, 硬度为 30HA, 厚度为 6mm
参照图 3所示, 本实施例中采血装置发射到最远位置时针头 8产生 X-Y向的晃动, 经 过对比试验后发现, 在不加阻尼器的情况下, 针头 8产生的晃动为 ± 0.3mm, 在加阻尼器的 情况下, 晃动为 ± 0.1mm, 可以看出针头 8的晃动得到了有效的控制。
实施例 2
参阅图 2所示, 实施例 2与实施例 1的不同之处在于, 采血针与发射部件头部 2-1— 体, 触发装置包括按钮 3和弹性臂 10, 按钮 3设置在壳体 1上, 所述的弹性臂 10设置在发 射部件 2上, 弹性臂 10在弹簧 6被压缩时与壳体 1锁定。
经过对比试验后发现, 在不加阻尼器的情况下, 采血装置发射到最远位置时针头 8产 生的晃动为 ± 0.28mm, 在加阻尼器的情况下, 晃动为 ± 0.11mm, 可以看出针头 8的晃动得 到了有效的控制。
在上述实施例中, 阻尼器还可以采用 TPA、 TPE或 hytrd等材料。
本发明的有益效果-
1、 通过阻尼材料减少急停时位于人体皮肤层的采血针头部的四周扩散震动, 减少疼痛。 2、 本发明结构简单, 便于推广。
在本说明书的描述中, 参考术语 "一个实施例"、 "一些实施例"、 "示例"、 "具体示 例"、 或 "一些示例"等的描述意指结合该实施例或示例描述的具体特征、 结构、 材料或者 特点包含于本发明的至少一个实施例或示例中。 在本说明书中, 对上述术语的示意性表述 不一定指的是相同的实施例或示例。 而且, 描述的具体特征、 结构、 材料或者特点可以在 任何的一个或多个实施例或示例中以合适的方式结合。
尽管已经示出和描述了本发明的实施例, 本领域的普通技术人员可以理解: 在不脱离 本发明的原理和宗旨的情况下可以对这些实施例进行多种变化、 修改、 替换和变型, 本发 明的范围由权利要求及其等同物限定。

Claims

权 利 要 求 书
1、 一种出针孔带缓冲装置的采血装置, 包括壳体、 发射部件、 壳体与发射部件之间的触 发装置, 壳体上设有出针孔, 所述壳体内设有弹性部件, 弹性部件提供弹射动力, 弹性部 件压缩时其两端分别抵住壳体和发射部件,发射部件头部可以安装采血针或者与采血针一 体, 其特征在于, 出针孔内侧设有缓冲装置。
2、 根据权利要求 1所述的采血装置, 其特征在于, 所述的弹性部件为弹簧。
3、 根据权利要求 2所述的采血装置, 其特征在于, 所述的弹簧套在发射部件上。
4、 根据权利要求 1所述的采血装置, 其特征在于, 所述的触发装置包括按钮和杠杆, 所 述的按钮设置在壳体上, 杠杆设置在按钮下方, 发射部件上设有能够卡住杠杆的挂钩。
5、 根据权利要求 1所述的采血装置, 其特征在于, 所述的触发装置包括按钮和弹性臂, 按钮设置在壳体上,所述的弹性臂设置在发射部件上,弹性臂在弹性部件被压缩时与壳体 锁定。
6、 根据权利要求 1所述的采血装置, 其特征在于, 所述的壳体内侧挡块为卡槽。
7、 根据权利要求 1所述的采血装置, 其特征在于, 发射部件挡块为径向凸起。
8、 根据权利要求 1所述的采血装置, 其特征在于, 所述的缓冲装置为阻尼器。
9、 根据权利要求 8所述的采血装置,其特征在于,所述的阻尼器的材质采用 TPA,或 TPE, 或氯丁橡胶, 或 hytrel。
10、 根据权利要求 8所述的采血装置, 其特征在于, 所述的阻尼器为环形或方形。
PCT/CN2014/080522 2013-07-02 2014-06-23 一种出针孔带缓冲装置的采血装置 WO2015000368A1 (zh)

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