WO2014019204A1 - 整体式真空采血装置 - Google Patents

整体式真空采血装置 Download PDF

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Publication number
WO2014019204A1
WO2014019204A1 PCT/CN2012/079601 CN2012079601W WO2014019204A1 WO 2014019204 A1 WO2014019204 A1 WO 2014019204A1 CN 2012079601 W CN2012079601 W CN 2012079601W WO 2014019204 A1 WO2014019204 A1 WO 2014019204A1
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WO
WIPO (PCT)
Prior art keywords
blood
tube
cylindrical cavity
plug
blood sample
Prior art date
Application number
PCT/CN2012/079601
Other languages
English (en)
French (fr)
Inventor
张建铭
Original Assignee
Zhang Jianming
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Zhang Jianming filed Critical Zhang Jianming
Priority to CN201280074564.9A priority Critical patent/CN104470436B/zh
Priority to PCT/CN2012/079601 priority patent/WO2014019204A1/zh
Publication of WO2014019204A1 publication Critical patent/WO2014019204A1/zh

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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
    • A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • A61B5/1405—Devices for taking blood samples
    • A61B5/1438—Devices for taking blood samples using pre-evacuated means
    • 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
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • 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
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150259—Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
    • 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
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150267—Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
    • 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
    • A61B5/150351—Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • 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
    • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • 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
    • A61B5/150473—Double-ended needles, e.g. used with pre-evacuated sampling tubes
    • 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
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150572—Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
    • 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
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694—Procedure for removing protection means at the time of piercing
    • A61B5/150725—Procedure for removing protection means at the time of piercing removal procedure linked to further actions, e.g. cocking of the piercing device, which indicate that the piercing device is used or tempered
    • 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
    • A61B5/150732—Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
    • 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
    • A61B5/15074—Needle sets comprising wings, e.g. butterfly type, for ease of handling
    • 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
    • A61B5/150992—Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves
    • 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
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154—Devices using pre-evacuated means
    • 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
    • A61B5/155—Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals

Definitions

  • the invention relates to a human external vacuum blood collection device for clinical medical treatment, in particular to an integral vacuum blood collection device.
  • FIG. 1 and FIG. 2 A vacuum blood collection device in the prior art is shown in FIG. 1 and FIG. 2, and includes a blood collection needle 1 and a blood sample collection tube 2, and a blood collection needle 1 One end is a vascular puncture needle 11 and the other end is provided with a rubber sleeve blood collection needle 12, which is connected by a PVC catheter 13 in the middle.
  • the device When the device is used for collecting blood, first remove the protective sleeve on the two needles and puncture the needle into the needle 11 Pierce the patient's arm vein, wait for the blood to enter the blood collection tube, and the medical staff immediately press the needle handle of the blood vessel needle 11 with the little finger to prevent the needle tube from falling off; because the blood sample collection tube 2
  • the sealing rubber plug is very thick, and the blood collecting needle 12 has a large angle of the bevel, the needle tip is blunt, and the blood collecting needle 12 is tight when the sealing tube is subjected to axial compression, so the hands need to be used to take the blood collecting needle 12 Piercing into the blood sample collection tube is quite inconvenient to operate.
  • the inside is negative pressure and the blood flows into the collection tube at a faster rate.
  • the blood collection needle 12 can be pulled out from the collection tube 2 by both hands.
  • the blood collection tube 12 The outer soft rubber sleeve is restored, and the blood collection needle tube is wrapped to prevent the blood in the catheter from flowing out to pollute the environment, and then the previous intubation operation is repeated; if it is not necessary to draw blood, the human needle on the human body must be pulled out first. Then, put on the needle tip sheath, and then remove the blood collection needle 12 on the collection tube 2 .
  • the vacuum blood collection device has a separate structure of the blood collection needle 1 and the collection tube 2, and the blood collection process needs to take care of the catheter at the same time.
  • the two needles lead to complicated and cumbersome operation, multiple operation steps even require hands and a certain and just enough force to complete the extraction and insertion of the needle tube, and at this time, it is impossible to care for the needle tube at the other end, and thus It involves the coordinated operation of more than one medical staff.
  • This complicated and cumbersome operation and the presence of two needles Invisibly increases the workload and psychological burden of medical staff, and it is prone to misuse in the case of patients with unconsciousness, incitement, uncooperative patients, and infants and children with large physical activity.
  • the object of the present invention is to overcome the deficiencies in the prior art and to provide an integrated vacuum blood collection device which is simplified in structure and simple in operation.
  • the object of the present invention is achieved by the following route.
  • the integrated vacuum blood collecting device comprises a puncture needle tube with an operating handle, a soft connecting tube, a blood collecting needle tube and a blood sample collecting tube, and the main point of the composition is that the blood collecting needle seat has a cylindrical cavity.
  • the end of the cylindrical cavity is open, the blood collection needle tube is fixed on the front end wall thereof and extends backward into the cylindrical cavity, and the blood sample collection tube tube is inserted in the cylindrical cavity in a pluggable manner.
  • the length of the cylindrical cavity is smaller than the length of the blood sample collection tube, and the tail of the blood sample collection tube inserted in the cylindrical cavity is exposed outside the cylindrical cavity, and the front end surface of the blood sample collection tube and the cylindrical cavity There is a gap between the front end walls A.
  • the back wall of the blood sample collection tube plug has a sealing layer pierceable by the rear end of the blood collection tube, and the thickness of the sealing layer is smaller than the gap A.
  • the thickness of the cylindrical cavity has a connection structure adapted to the blood sample collection tube plug, which is coupled with the blood sample collection tube plug to form a tight connection relationship, and the blood sample collection tube is loaded through the structure. And removing the cylindrical cavity, the vascular puncture needle tube core, the soft connecting tube die, the blood sampling needle tube core, and the blood sample collection tube lumen after being pierced by the sealing layer constitute a blood channel.
  • the blood collection needle holder is added and the blood sample collection tube is connected to the blood collection needle holder and the blood collection needle tube in advance, so that the entire blood collection device is integrated.
  • the above-mentioned matching structure of the cylindrical cavity and the plug not only facilitates the loading and unloading of the blood sample collecting tube, but also forms a tight connection relationship with the blood sample collecting tube plug, so that it is convenient to be inserted in the cylindrical space.
  • the blood sample collection tube in the cavity is not easily detached when standing upright, and the degree of insertion of the blood sample collection tube installed in the cylindrical cavity is given from the touch, thereby facilitating installation.
  • the human end puncture needle is withdrawn first, and then the blood collection tube is withdrawn. Since the blood collection needle holder is longer than the blood collection needle tube, it can ensure that the needle tip of the blood collection needle does not injure the person, and blood is collected during the repeated replacement of the blood collection tube.
  • the needle seat also plays the role of insertion and guiding. The blood collection needle tip does not puncture the person, so it plays a safety protection role. At the same time, the blood collection sealing sleeve is rebounded and sealed, and the blood collection needle head is sealed to avoid blood pollution.
  • the object of the present invention can also be achieved by the following means.
  • the adapted connection configuration has a variety of options, such as the size of the inner diameter of the barrel and the transition fit. The following is an optimized choice:
  • the configuration in the cylindrical cavity that fits the plug is a plurality of configurations that are circumferentially distributed or symmetrically distributed along the inner wall of the cylindrical cavity.
  • the elastic snap configuration can be a short arc cam or the blood sample collection tube plug is made of a resilient material.
  • the elastic snap-in configuration can cause an elastic tight connection between the inner wall of the cylindrical cavity and the plug, but the blood sample collection tube can still be pushed forward or backward relative to the cylindrical cavity when an axial force is applied.
  • Such short arc convex card points are bumps protruding from the inner wall of the cylindrical cavity, the thickness is low and the front and rear sides have curved transitions to facilitate the crawling of the pipe plug.
  • the configuration in the cylindrical cavity that fits the plug is a plurality of elastic snap contacts that are circumferentially distributed or symmetrically distributed along the inner wall of the cylindrical cavity, and another suitable configuration is made in the tube.
  • L on the outer circumference of the plug a groove and a projecting point formed on the inner wall of the cylindrical cavity, the protruding point entering from the end of the vertical section of the L-shaped groove at the front end face of the pipe plug
  • the groove can slide therein, and when the inner wall of the cylindrical cavity is elastically caught by the pipe plug, the protruding point has entered L In the vertical section of the shaped groove but not yet reaching the bottom end of the vertical section, the rear end of the blood collection needle tube is just before the sealing layer to be pierced, and after the current blood sample collection tube to the blood collection needle tube pierces the sealing layer, The protruding point just reaches the bottom end of the vertical section, at this time, the blood sample collection tube is rotated, and the protruding point enters A cross-section in an
  • the blood sample collection tube can also be connected to the cylindrical cavity in this way:
  • the blood sample collection tube is threaded into the cylindrical cavity and the adapted configuration is a threaded connection configuration.
  • the blood sample collection tube plug is composed of a sealing rubber plug and a protective cover, the sealing rubber plug is plugged in the collecting tube lumen, and the protective cover is plugged on the collecting tube nozzle and the sealing rubber plug.
  • the configuration adapted to the cylindrical cavity is generally provided on the protective cover.
  • the blood collection needle tube is covered with a blood collection sealing sleeve, and the blood sample collection tube tube plug center is provided with a core hole extending axially to the sealing layer, and the inner diameter of the core hole is slightly larger than the outer diameter of the blood collection sealing sleeve.
  • the blood sample collection tube plug sealing layer has a thickness of 3-0.5 MM, preferably 1.5-0.5 MM.
  • the blood collection needle holder is disposed at a position corresponding to the inner portion of the blood sample collection tube in the cylindrical cavity, and a long groove is arranged along the axial direction of the blood collection needle seat as an operation window.
  • the operation window has two, relative distribution On both sides of the cylindrical cavity.
  • the blood can be observed through the operation window, the state of the blood volume in the blood sample collection tube can be observed, the insertion state and the insertion degree of the blood sample collection tube can also be observed, and the blood sample collection tube can be first passed through the operation window.
  • the pinch plug is forced back out of the blood sample collection tube to prevent detachment of the collection tube body from the tube plug when exiting the blood sample collection tube.
  • the present invention has the following advantages over the prior art: adding a blood collection needle holder and previously connecting the blood sample collection tube with the blood collection needle holder and the blood collection needle tube, so that the entire blood collection device becomes an integral structure, and the tubular shape is empty
  • the configuration of the cavity and the plug is adapted to the structure of the elastic snap, which is convenient for the blood sample collection tube inserted in the cylindrical cavity to not fall off when standing upright, and is also installed in the cylindrical cavity from the tactile sensation.
  • the blood sample collection tube is inserted to facilitate the installation.
  • the entire device structure is simplified and the operation is simple and easy.
  • FIG. 1 is a schematic view showing the insertion state of a blood sample collection tube of a vacuum blood collection tube apparatus in the prior art.
  • Fig. 2 is a schematic view showing the state in which the blood sample collection tube of the vacuum blood collection tube device is withdrawn in the prior art.
  • Figure 3 is a front elevational view showing the appearance of the integrated vacuum blood collection device of the present invention.
  • Figure 4 is a schematic left side view showing the structure of the integrated vacuum blood collection device of the present invention.
  • Fig. 5 is a schematic view showing the state in which the blood collection needle of the integral vacuum blood collection device of the present invention is inserted.
  • Figure 6 is a schematic view showing the state of withdrawal of the blood collection needle of the integral vacuum blood collection device of the present invention.
  • Fig. 7 is a schematic front view showing the structure of a blood collection needle holder in the first embodiment of the present invention.
  • Fig. 8 is a schematic plan view showing the structure of a blood collection needle holder in the first embodiment of the present invention.
  • Figure 9 is a schematic view showing the structure of a blood sample collection tube in the first embodiment of the present invention.
  • Figure 10 is a schematic view showing the structure of a blood sample collection tube protective cover in the second embodiment of the present invention.
  • Figure 11 is a schematic perspective view showing the structure of a blood sample collection tube protective cover in the second embodiment of the present invention.
  • Figure 12 is a schematic perspective view showing the structure of a blood sample collection tube protective cover in a preferred embodiment of the present invention.
  • Embodiment 1 is a diagrammatic representation of Embodiment 1:
  • the integrated vacuum blood collection device includes a puncture needle 11 with an operating handle and the like, and a soft connecting tube 13 , blood collection needle 12, blood sample collection tube 2 and a blood collection needle holder 3, the blood collection needle holder 3 has a cylindrical cavity 31, the end of the cylindrical cavity is open, the blood collection needle 12 It is fixed to the front end wall thereof and extends rearward into the cylindrical cavity 31, and the blood sample collection tube 2 is inserted into the cylindrical cavity 31 in a pluggable manner, and the cylindrical cavity 31 is inserted.
  • the length of the blood sample collection tube 2 is smaller than the length of the blood sample collection tube 2, and the tail portion of the blood sample collection tube 2 inserted in the cylindrical cavity is exposed outside the cylindrical cavity 31, and the blood sample collection tube 2 has a front end surface and a cylindrical cavity 31. There is a gap A between the front end walls, and the blood sample collection tube 2 has a sealing layer 21 pierceable by the rear end of the blood collection needle tube 12.
  • the thickness of the sealing layer 21 is smaller than the thickness of the gap A, and the cylindrical cavity 31 has a configuration adapted to the blood sample collection tube 2 tube plug, a vascular puncture needle 11 die, a soft connecting tube 13 die, a blood collection needle 12 die, and a pierced sealing layer 21 After the blood sample collection tube 2 lumens form a blood channel.
  • the blood sample collection tube 2 tube plug is composed of a sealing rubber plug 23 and a protective cover 22, and the sealing rubber plug 23
  • the sleeve is plugged into the collection tube lumen, and the protective cover 22 is capped on the collection tube nozzle and the sealing plug 23.
  • the front end surface of the blood sample collection tube 2 is the front end surface of the protective cover.
  • the aforementioned blood sample collection tube 2 The sealing layer 21 of the rear end wall of the pipe plug is located on the sealant plug.
  • the sealing layer 21 has a thickness of 1.0 MM.
  • the inner fit to the plug is a configuration of two resilient snaps that are circumferentially symmetrically distributed along the inner wall of the cylindrical cavity.
  • the elastic snap construction is a short arc convex click point 33, which is a short arc convex click point 33 Made of elastic material.
  • the blood collection needle holder 3 is placed along the blood collection needle holder 3 at a position corresponding to the inside of the cylindrical cavity 31 in the blood sample collection tube 2 A long groove is provided in the axial direction as the operation window 32.
  • the operation window 32 has two opposite sides, and is relatively distributed on both sides of the cylindrical cavity 31. This operation window 32 is misaligned with the short arc convex card point 33 described above. Degree distribution.
  • the blood collection needle tube 12 is covered with a blood collection sealing sleeve 14
  • the blood sample collection tube plug center is provided with a core hole 24 extending axially to the sealing layer 21, and the inner diameter of the core hole 24 is slightly larger than the outer diameter of the blood collection sealing sleeve 14.
  • the blood collection needle 12 is brought with the blood collection sealing sleeve 14
  • the blood collection sealing sleeve 14 is subjected to axial compression and compression, and is radially twisted and expanded, just like the core hole 24
  • the inner hole wall is pressed and rubbed, and the blood collection needle tube is not allowed to come out of the sealing rubber plug.
  • the puncture needle 11 is first inserted into the blood vessel of the human body, and the blood is filled with the soft extension tube, and the small finger is gently pressed to fix the puncture needle 11
  • the remaining four fingers pinch the blood collection needle holder 3. Since the tube sealing layer 21 is relatively thin, the other hand gently pushes the blood sample collection tube 2 from the bottom to allow the blood collection needle 12 tip to pass through the sealing layer 21 Entering the collection tube until the collection tube touches the front end wall of the cylindrical cavity 31 and cannot move forward; the blood quickly flows into the blood collection tube due to the negative pressure inside the collection tube 2
  • the human end puncture needle 11 is withdrawn first, and then the blood collection tube 2 is withdrawn. Since the blood collection needle holder 3 is longer than the blood collection needle 12, the blood collection needle can be ensured. 12 The needle tip will not injure people, and during the repeated replacement of the blood collection tube, the blood collection needle holder 3 also plays an insertion guide, and the blood collection needle tip does not puncture the person, so it plays a safety protection role, and at the same time, the blood collection sealing sleeve 14 The rebound was sealed and 12 blood collection tubes were sealed to avoid blood contamination.
  • Embodiment 2 is a diagrammatic representation of Embodiment 1:
  • the configuration of the cylindrical cavity 31 that fits the pipe plug is defined by a short arc cam. And a threaded connection configuration in which male and female threads in the threaded connection are formed on the inner peripheral wall of the protective cover 22 and the cylindrical cavity 31, respectively.
  • the configuration in the cylindrical cavity that fits the pipe plug is a plurality of elastic snap contacts distributed circumferentially or symmetrically along the inner wall of the cylindrical cavity, the elastic snap contact structure being a short arc convex
  • the card point, the short arc convex card point and the blood sample collection tube plug are made of an elastic material.
  • plug protection cover 22 an L-shaped groove on the outer peripheral surface and a projecting point formed on the inner wall of the cylindrical cavity, the protruding point entering from the end of the vertical section 25 of the L-shaped groove at the front end face of the pipe plug
  • the slot can slide therein, and when the inner wall of the cylindrical cavity is elastically engaged with the plug protection cover, the protruding point has entered the vertical section 25 in the L-shaped slot but has not yet reached the bottom of the vertical section 25.
  • the blood collection tube 12 Immediately before the sealing layer 21 to be pierced, the front blood sample collection tube 2 to the blood collection needle 12 pierce the sealing layer 21, the protruding point just reaches the vertical section 25 At the bottom end, the blood sample collection tube 2 is rotated at this time, and the projecting point enters the cross-fold section 26 in the L-shaped groove.
  • the cooperation of the cross-section 26 in the L-shaped groove with the protruding point can lock the blood sample collection tube 2
  • the degree of freedom in the axial direction makes it impossible to push forward or backward relative to the blood collection needle holder 3.

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  • Engineering & Computer Science (AREA)
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  • Molecular Biology (AREA)
  • Pathology (AREA)
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  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

一种整体式真空采血装置，包括有一采血针座（3），采血针座（3）具有筒形空腔（31），筒形空腔（31）尾端开放，采血针管（12）固定在其前端壁上并向后延伸到筒形空腔（31）中，血液样本收集管（2）管塞在前以可拔插的方式插置在该筒形空腔（31）中。所述装置通过增加采血针座（3）并预先将血液样本收集管（2）与采血针座（3）以及采血针管（12）连接在一起，使整个采血装置成为一体构造，而筒形空腔（31）内与管塞相适配的构造既方便插在筒形空腔（31）中的血液样本收集管（2）直立时不会脱落出来，又从触感上指示安装在筒形空腔（31）中的血液样本收集管（2）的插入程度，从而方便安装。整个装置结构简化而且操作简单容易。

Description

整体式真空采血装置 技术领域
本发明涉及 临床医疗上 一种人体外真空采血器械，特别是一种整体式真空采血装置。
背景技术
现有技术中的 一种真空采血装置如图 1 、图 2 所示，包括采血针 1 和血液样本收集管 2 ，采血针 1 一端是血管穿刺针管 11 ，另一端是带有胶套采血针管 12 ，中间通过 PVC 导管 13 连接。该装置在采血时，先拔除两头针管上保护套，将血管穿刺针管 11 刺入病患手臂静脉中，等血液进入采血导管中，医务人员立即用小拇指压住该血管穿刺针管 11 的针柄，以防穿刺针管脱落；由于血液样本收集管 2 密封胶塞很厚，采血针管 12 针尖斜面角度大，针尖钝，加上采血针管 12 密封胶管在受到轴向挤压时弹力很大，故需要双手才能将采血针管 12 刺入血液样本收集管中，操作相当不便。由于血液样本收集管 2 内是负压，血液流入该收集管中的速度较快。待采集到所需样量，若需采集多管血液样本，还得双手操作才能将采血针管 12 从收集管 2 中拔出。此时采血针管 12 外软胶套复原，包住采血针管，防止导管中血液流出污染环境，然后再重复之前的插管操作；若是不需要再抽血，就得先拔出人体上穿刺针管 11 ，再套上针尖护套，再拔除收集管 2 上采血针管 12 。由此可见这种真空采血装置由于采血针 1 和收集管 2 分体构造，采血过程需同时关顾导管 13 的两头针管，导致操作复杂繁琐，多个操作步骤甚至需要双手且还需施以一定且恰到好处的力道才能完成针管的拔出和插入，而此时就无法关顾到另一头的针管，这样又牵涉到需要一个以上的医护人员的协同操作。这种复杂繁琐的操作步骤以及两头针管的存在， 无形中增加了医护人员工作量和心理负担，在遭遇到意识不清、躁动、不合作的病人以及婴幼儿病人而肢体活动幅度大的情景下，容易产生误操作。
发明内容
本发明的目的在于克服现有技术中的不足之处，而提供一种结构简化、操作简单容易的整体式真空采血装置。
本发明的目的是通过以下途径来实现的。
整体式真空采血装置，包括附带有操作手柄等的穿刺针管、软连接管、采血针管和血液样本收集管，其组成要点在于，还包括有一种采血针座，采血针座具有筒形空腔，筒形空腔尾端开放，采血针管固定在其前端壁上并向后延伸到筒形空腔中，血液样本收集管管塞在前以可拔插的的方式插置在该筒形空腔中，筒形空腔的长度小于血液样本收集管的长度，插置在筒形空腔中的血液样本收集管的尾部裸露在筒形空腔外，血液样本收集管前端面与筒形空腔前端壁之间具有间隙 A ，血液样本收集管管塞后端壁具有一可被采血针管后端刺穿的密封层 , 此密封层厚度小于间隙 A 的厚度，筒形空腔内具有与血液样本收集管管塞相适配的连接构造，其与血液样本收集管管塞配合连接形成较紧实的连接关系，血液样本收集管经由此构造装入和取出筒形空腔，血管穿刺针管管芯、软连接管管芯、采血针管管芯以及被刺穿密封层后的血液样本收集管管腔组成一种血液通道。
这样，增加采血针座并预先将血液样本收集管与采血针座以及采血针管连接在一起，使整个采血装置成为一体构造。上述筒形空腔与管塞的适配构造不但方便血液样本收集管的装入和取出，同时又与血液样本收集管管塞配合连接形成较紧实的连接关系，这样方便插在筒形空腔中的血液样本收集管直立时不易脱落出来，又从触感上给出了安装在筒形空腔中的血液样本收集管的插入程度，从而方便安装。
实际使用时，首先将穿刺针管刺入人体血管中，等血液充满软延长管，一只手小拇指轻压固定穿刺针管，其余四指捏住采血针座，由于管塞密封层比较薄，另一只手从底部轻推血液样本收集管，让采血针管针尖穿过密封胶，进入收集管中，直至收集管与筒形空腔前端壁碰触无法再往前动；由于收集管内负压作用，血液快速流入血液收集管中至要求的样量后，若需采集多管血液样本，可捏住采血针座，轻松退出血液样本收集管，再插入新收集管采血。采血结束后，先撤出人体端穿刺针管，再退出血液收集管，由于采血针座比采血针管长，故能保证采血针管针尖不会伤到人，而且在反复更换血液收集管过程中，采血针座还起到插入导向作用，采血针尖不会刺到人，故起到安全防护作用，同时采血密封套回弹密闭，封住采血针管头，避免了血液污染。
由此可见，本发明变现有技术中的两体分立而为一体构造，结构简化而且操作简单容易。
本发明的目的还可以通过以下途径来实现。
当筒形空腔与管塞二者处于适配连接状态时，采血针管后端恰处于待刺穿的密封层前。
这样便于在插入的触感上把握采血针管的预插入程度。
该适配的连接构造具有多种选择，比如筒腔内径内缩后过渡配合的尺寸方式，下述一种是一种优化选择：
筒形空腔内与管塞相适配的构造是一种复数个沿筒形空腔的内壁周向分布或对称分布的弹性卡触的构造。
此弹性卡触构造可以是一种短弧凸卡点，或者此短弧凸卡点或者血液样本收集管管塞由弹性材料制成。
这种弹性卡触构造可以造成筒形空腔内壁与管塞的弹性紧迫连接状态，但在施加轴向力时，血液样本收集管依然会相对筒形空腔做自如的前推或后退。
这种短弧凸卡点顾名思义就是一种突凸在筒形空腔内壁上的凸点，厚度低浅而且前后侧均有弧形过渡，以便于管塞的爬行穿越。
还可以在这种弹性卡触构造的基础上另行增加其他的适配连接构造进行配合使用以达到更好的使用效果，以下是其中一种优化的配合使用：
筒形空腔内与管塞相适配的构造是一种复数个沿筒形空腔的内壁周向分布或对称分布的弹性卡触的构造，另一种相适配的构造是制作在管塞外周面上的 L 形槽以及制作在筒形空腔内壁上的突凸点，该突凸点从位于管塞前端面的 L 形槽竖直段的端头进入 L 形槽并可在其中滑动，当筒形空腔内壁与管塞弹性卡触时，该突凸点已进入 L 形槽中的竖直段中但尚未到达该竖直段的底端，此时采血针管后端恰处于待刺穿的密封层前，当前顶血液样本收集管至采血针管刺穿密封层后，该突凸点恰到达该竖直段的底端，此时旋转血液样本收集管，该突凸点进入 L 形槽中的横折段。
这样， L 形槽中的横折段可以锁死血液样本收集管在轴向上的自由度，使其相对针筒既不能前推也不能后退。
血液样本收集管还可以以这种方式与筒形空腔连接：
血液样本收集管螺纹连接在筒形空腔中，相适配的构造是一种螺纹连接构造。
血液样本收集管管塞由密封胶塞和保护盖组成，密封胶塞套塞在收集管管腔中，保护盖盖塞在收集管管口及密封胶塞上。
与筒形空腔相适配的构造一般设置在保护盖上。
采血针管外包覆有采血密封套，血液样本收集管管塞中心设置有轴向延伸至密封层的芯孔，此芯孔内径比采血密封套外径稍大。
这样，采血针管带同采血密封套沿此芯孔穿入管塞时，采血密封套受到轴向挤压压缩径向扭曲扩张变形，正好与此芯孔内孔壁挤压摩擦，更不致让采血针管脱出密封胶塞。
血液样本收集管管塞密封层厚度为 3-0.5MM, 最好是 1.5-0.5MM 。
这样采血针管可轻松穿破密封层。
采血针座在与血液样本收集管管塞内含在筒形空腔内相适配的位置上沿采血针座轴向设置有一种长条槽作为操作窗，此操作窗共有两个，相对分布在筒形空腔的两侧。
这样可通过此操作窗观察回血，观察血液样本收集管内血量的状态，也可观察血液样本收集管的插入状态和插入程度，还可在拔出血液样本收集管时，先透过此操作窗捏持管塞向后用力退出血液样本收集管，从而防止退出血液样本收集管时收集管本体与管塞的脱离。
综上所述，本发明相比现有技术具有如下优点：增加采血针座并预先将血液样本收集管与采血针座以及采血针管连接在一起，使整个采血装置成为一体构造，而筒形空腔内与管塞相适配的构造乃至弹性卡触的构造既方便插在筒形空腔中的血液样本收集管直立时不会脱落出来，又从触感上给出了安装在筒形空腔中的血液样本收集管的插入程度，从而方便安装。整个装置结构简化而且操作简单容易。
附图说明
图1是现有技术中一种 真空采血管装置血液样本收集管插入状态示意图。
图2是现有技术中一种 真空采血管装置血液样本收集管撤出状态示意图。
图 3 是本发明所述整体式真空采血装置的外观示意主视图。
图 4 是本发明所述整体式真空采血装置的结构示意左视图。
图 5 是本发明所述整体式真空采血装置采血针管插入状态示意图。
图 6 是本发明所述整体式真空采血装置采血针管撤出状态示意图。
图 7 是本发明实施例一中采血针座的结构示意主视图。
图 8 是本发明实施例一中采血针座的结构示意俯视图。
图 9 是本发明实施例一中血液样本收集管的结构示意图。
图 10 是本发明实施例二中血液样本收集管保护盖的结构示意图。
图 11 是本发明实施例二中血液样本收集管保护盖的结构示意立体图。
图 12 是本发明最佳实施例中血液样本收集管保护盖的结构示意立体图。
标号说明：
11 穿刺针管 12 采血针管 13 软连接管 14 采血密封套 2 血液样本收集管 21 密封层 22 保护盖 23 密封胶塞 24 芯孔 25 L 形槽竖直段 26 L 形槽横折段 3 采血针座 31 筒形空腔 32 操作窗 33 短弧凸卡点。
下面结合附图对本发明进行更详尽的描述。
具体实施方式
实施例一：
参照图 3 、图 4 ，整体式真空采血装置，包括附带有操作手柄等的穿刺针管 11 、软连接管 13 、采血针管 12 、血液样本收集管 2 以及一种采血针座 3 ，采血针座 3 具有筒形空腔 31 ，筒形空腔尾端开放，采血针管 12 固定在其前端壁上并向后延伸到筒形空腔 31 中，血液样本收集管 2 管塞在前以可拔插的的方式插置在该筒形空腔 31 中，筒形空腔 31 的长度小于血液样本收集管 2 的长度，插置在筒形空腔中的血液样本收集管 2 的尾部裸露在筒形空腔 31 外，血液样本收集管 2 前端面与筒形空腔 31 前端壁之间具有间隙 A ，血液样本收集管 2 管塞后端壁具有一可被采血针管 12 后端刺穿的密封层 21 ，此密封层 21 厚度小于间隙 A 的厚度，筒形空腔 31 内具有与血液样本收集管 2 管塞相适配的构造，血管穿刺针管 11 管芯、软连接管 13 管芯、采血针管 12 管芯以及被刺穿密封层 21 后的血液样本收集管 2 管腔组成一种血液通道。
参照图 9 ，血液样本收集管 2 管塞由密封胶塞 23 和保护盖 22 组成，密封胶塞 23 套塞在收集管管腔中，保护盖 22 盖塞在收集管管口及密封胶塞 23 上。前述血液样本收集管 2 前端面即为保护盖前端面。前述血液样本收集管 2 管塞后端壁的密封层 21 位于密封胶塞上。密封层 21 厚度为 1.0MM 。
参照图 7 、图 8 ，筒形空腔 31 内与管塞相适配的构造是一种两个沿筒形空腔的内壁周向对称分布的弹性卡触的构造。此弹性卡触构造是一种短弧凸卡点 33 ，此短弧凸卡点 33 由弹性材料制成。当血液样本收集管 2 的保护套 22 与此短弧凸卡点 33 卡触时，采血针管 12 后端恰处于待刺穿的密封层 21 前。
采血针座 3 在与血液样本收集管 2 管塞内含在筒形空腔 31 内相适配的位置上沿采血针座 3 轴向设置有一种长条槽作为操作窗 32 ，此操作窗 32 共有两个，相对分布在筒形空腔 31 的两侧。此操作窗 32 与上述短弧凸卡点 33 错位 90 度分布。
参照图 5 、图 6 ，采血针管 12 外包覆有采血密封套 14 ，血液样本收集管管塞中心设置有轴向延伸至密封层 21 的芯孔 24 ，此芯孔 24 内径比采血密封套 14 外径稍大。这样，采血针管 12 带同采血密封套 14 沿此芯孔 24 穿入管塞时，采血密封套 14 受到轴向挤压压缩径向扭曲扩张变形，正好与此芯孔 24 内孔壁挤压摩擦，更不致让采血针管脱出密封胶塞。
实际使用时，首先将穿刺针管 11 刺入人体血管中，等血液充满软延长管，一只手小拇指轻压固定穿刺针管 11 ，其余四指捏住采血针座 3 ，由于管塞密封层 21 比较薄，另一只手从底部轻推血液样本收集管 2 ，让采血针管 12 针尖穿过密封层 21 进入收集管中，直至收集管与筒形空腔 31 前端壁碰触无法再往前动；由于收集管内负压作用，血液快速流入血液收集管 2 中至要求的样量后，若需采集多管血液样本，可捏住采血针座 3 ，并透过操作窗 32 捏住血液样本收集管 2 将其轻松退出，再插入新收集管采血。采血结束后，先撤出人体端穿刺针管 11 ，再退出血液收集管 2 ，由于采血针座 3 比采血针管 12 长，故能保证采血针管 12 针尖不会伤到人，而且在反复更换血液收集管过程中，采血针座 3 还起到插入导向作用，采血针尖不会刺到人，故起到安全防护作用，同时采血密封套 14 回弹密闭，封住采血针管 12 头，避免了血液污染。
本实施例未述部分与现有技术相同。
实施例二：
参照图 10 、图 11 ，筒形空腔 31 内与管塞相适配的构造由短弧凸卡点 33 和一种螺纹连接构造组成，该螺纹连接构造中的公母螺纹分别制作在保护盖 22 和筒形空腔 31 内周壁上。先将血液样本收集管 2 螺旋入筒形空腔 31 中，待与短弧凸卡点 33 卡触时停止旋入，此时采血针管 12 后端恰处于待刺穿的密封层 21 前。采血时，再次螺旋即可将采血针管顶穿密封层 21 。
本实施例未述部分与实施例一相同。
最佳实施例：
参照图 12 ，筒形空腔内与管塞相适配的构造是一种复数个沿筒形空腔的内壁周向分布或对称分布的弹性卡触的构造，此弹性卡触构造是一种短弧凸卡点，此短弧凸卡点以及血液样本收集管管塞由弹性材料制成。另一种相适配的构造是制作在管塞保护盖 22 外周面上的 L 形槽以及制作在筒形空腔内壁上的突凸点，该突凸点从位于管塞前端面的 L 形槽竖直段 25 的端头进入 L 形槽并可在其中滑动，当筒形空腔内壁与管塞保护盖弹性卡触时，该突凸点已进入 L 形槽中的竖直段 25 中但尚未到达该竖直段 25 的底端，此时采血针管 12 后端恰处于待刺穿的密封层 21 前，当前顶血液样本收集管 2 至采血针管 12 刺穿密封层 21 后，该突凸点恰到达该竖直段 25 的底端，此时旋转血液样本收集管 2 ，该突凸点进入 L 形槽中的横折段 26 。这样， L 形槽中的横折段 26 与该突凸点的配合可以锁死血液样本收集管 2 在轴向上的自由度，使其相对采血针座 3 既不能前推也不能后退。
本实施例未述部分与实施例一相同。

Claims (14)

  1. 整体式真空采血装置，包括附带有操作手柄等的穿刺针管、软连接管、采血针管和血液样本收集管，其特征在于，还包括有一种采血针座，采血针座具有筒形空腔，筒形空腔尾端开放，采血针管固定在其前端壁上并向后延伸到筒形空腔中，血液样本收集管管塞在前以可拔插的的方式插置在该筒形空腔中，筒形空腔的长度小于血液样本收集管的长度，插置在筒形空腔中的血液样本收集管的尾部裸露在筒形空腔外，血液样本收集管前端面与筒形空腔前端壁之间具有间隙 A，血液样本收集管管塞后端壁具有一可被采血针管后端刺穿的密封层 , 此密封层厚度小于间隙 A 的厚度，筒形空腔内具有与血液样本收集管管塞相适配的连接构造，其与血液样本收集管管塞配合连接形成较紧实的连接关系，血液样本收集管经由此构造装入和取出筒形空腔，血管穿刺针管管芯、软连接管管芯、采血针管管芯以及被刺穿密封层后的血液样本收集管管腔组成一种血液通道。
  2. 根据权利要求 1 所述的整体式真空采血装置，其特征在于，当筒形空腔与管塞二者处于适配连接状态时，采血针管后端恰处于待刺穿的密封层前。
  3. 根据权利要求 1 或 2 所述的整体式真空采血装置，其特征在于，该适配的连接构造是一种筒腔内径内缩后过渡配合的尺寸方式。
  4. 根据权利要求 1 或 2 所述的整体式真空采血装置，其特征在于，筒形空腔内与管塞相适配的构造是一种复数个沿筒形空腔的内壁周向分布或对称分布的弹性卡触的构造，经由此弹性卡触构造筒形空腔内壁与管塞形成弹性紧迫连接状态，但此弹性阻滞力小于手动施加的轴向力。
  5. 根据权利要求 4 所述的整体式真空采血装置，其特征在于，此弹性卡触构造可以是一种短弧凸卡点，或者此短弧凸卡点或者血液样本收集管管塞由弹性材料制成。
  6. 根据权利要求 5 所述的整体式真空采血装置，其特征在于，这种短弧凸卡点是一种突凸在筒形空腔内壁上的凸点，厚度低浅而且前后侧均有便于管塞爬行穿越的弧形过渡。
  7. 根据权利要求 1 或 2 所述的整体式真空采血装置，其特征在于，筒形空腔内与管塞相适配的构造是一种复数个沿筒形空腔的内壁周向分布或对称分布的弹性卡触的构造，另一种相适配的构造是制作在管塞外周面上的 L 形槽以及制作在筒形空腔内壁上的突凸点，该突凸点从位于管塞前端面的 L 形槽竖直段的端头进入 L 形槽并可在其中滑动，当筒形空腔内壁与管塞弹性卡触时，该突凸点已进入 L 形槽中的竖直段中但尚未到达该竖直段的底端，此时采血针管后端恰处于待刺穿的密封层前，当前顶血液样本收集管至采血针管刺穿密封层后，该突凸点恰到达该竖直段的底端，此时旋转血液样本收集管，该突凸点进入 L 形槽中的横折段。
  8. 根据权利要求 1 或 2 所述的整体式真空采血装置，其特征在于，血液样本收集管螺纹连接在筒形空腔中，相适配的构造是一种螺纹连接构造。
  9. 根据权利要求 1 所述的整体式真空采血装置，其特征在于，血液样本收集管管塞由密封胶塞和保护盖组成，密封胶塞套塞在收集管管腔中，保护盖盖塞在收集管管口及密封胶塞上。
  10. 根据权利要求 1 所述的整体式真空采血装置，其特征在于，血液样本收集管管塞由密封胶塞和保护盖组成，密封胶塞套塞在收集管管腔中，保护盖盖塞在收集管管口及密封胶塞上，与筒形空腔相适配的构造设置在保护盖上。
  11. 根据权利要求 1 所述的整体式真空采血装置，其特征在于，采血针管外包覆有采血密封套，血液样本收集管管塞中心设置有轴向延伸至密封层的芯孔，此芯孔内径比采血密封套外径稍大，采血针管带同采血密封套沿此芯孔穿入管塞时，采血密封套受到轴向挤压压缩径向扭曲扩张变形，与此芯孔内孔壁挤压摩擦。
  12. 根据权利要求 1 所述的整体式真空采血装置，其特征在于，血液样本收集管管塞密封层厚度为 3-0.5MM 。
  13. 根据权利要求 12 所述的整体式真空采血装置，其特征在于，血液样本收集管管塞密封层厚度为 1.5-0.5MM 。
  14. 根据权利要求 1 所述的整体式真空采血装置，其特征在于，采血针座在与血液样本收集管管塞内含在筒形空腔内相适配的位置上沿采血针座轴向设置有一种长条槽作为操作窗，此操作窗共有两个，相对分布在筒形空腔的两侧。
PCT/CN2012/079601 2012-08-02 2012-08-02 整体式真空采血装置 WO2014019204A1 (zh)

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WO2021224751A1 (de) * 2020-05-05 2021-11-11 Medizinische Universität Wien Vorrichtung zum verbinden einer kanüle mit einem behältnis

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