JP4583872B2 - Blood collection instrument - Google Patents

Description

  The present invention relates to a blood collection device used for vacuum blood collection and the like, and more particularly to a blood collection device provided with a backflow prevention valve using a flexible material such as rubber.

  Conventionally, at the time of blood collection such as vacuum blood collection, the tip of a blood collection needle is inserted into a blood vessel of a blood collection subject. The other end of the blood collection needle is connected to the vacuum blood collection tube using a blood collection instrument. In such blood collection, since the inside of the vacuum blood collection tube is depressurized, blood is guided from the blood vessel of the blood sample to the vacuum blood collection tube due to the pressure difference.

  However, when approaching the end of blood collection, the pressure difference becomes small, and in this case, if the position of the vacuum blood collection tube is high or the pressure in the blood sample of the blood sample is lowered, there is a risk of backflow. When the backflow occurs, there is a possibility that the drug may flow to the blood collecting side in addition to the blood anticoagulant or the coagulation accelerator in the vacuum blood collection tube. Therefore, there is a strong demand for preventing such backflow.

  Various structures using a backflow prevention valve made of an elastic material have been proposed as a structure for preventing the backflow.

  For example, the following Patent Document 1 discloses a blood collection needle shown in FIG. The blood collection needle 101 is provided with a first hollow needle 102 that is inserted into the blood vessel of the blood sample and a second hollow needle 103 that is inserted into the vacuum blood collection tube through a plug of the vacuum blood collection tube. Yes. The bases of the first and second hollow needles 102 and 103 opposite to the needle tips are fixed to the hub 104. A space 104a is provided in the hub 104, and the hollow needles 102 and 103 communicate with the space 104a. A check valve 105 made of an elastic material is provided in the space 104a. The check valve 105 has a substantially conical shape that is tapered from the first hollow needle 102 side toward the second hollow needle 103 side. The tip 105a is configured to be opened by blood flow. However, since the tip of the substantially conical check valve 105 is very narrow as an outlet for blood, there is a problem that hemolysis may occur in some cases. Further, when the check valve 105 is constituted by two valve members like a duck's beak shape, the blood outlet at the tip must be widened, and the blood collection needle 101 is enlarged. I had to.

  In addition, it is necessary to form the tip of the check valve 105 so that it always adheres and opens only when blood flows from the first hollow needle 102 to the second hollow needle 103 side. Therefore, when the check valve 105 is formed by a method of forming a cut or the like in a valve member configured by integral molding, cutting waste must be generated. When such cutting waste remains on the upstream side of the check valve 105, there is a problem that cutting waste may enter the blood vessel. Further, even if no cutting waste enters the blood vessel side, if it flows into the blood collection side, it may affect the test value or cause troubles in the analyzer.

On the other hand, Patent Document 2 below discloses an indwelling needle set having the structure shown in FIG. In the indwelling needle set 111, a hollow outer needle 112 is attached to the hub 113 on the proximal end side. Here, a cylindrical valve 114 is disposed in the hub 113. The cylindrical valve 114 has a cylindrical shape, and has a cross-shaped slit 114a at the tip thereof. Here, when the chemical liquid flows from the upper side of the cylindrical valve 114 toward the distal end side, the slit 114a is opened, and the chemical liquid is configured to flow toward the outer needle 112 side. On the contrary, when a back flow occurs from the outer needle 112 side to the hub 113, the slit 114a is closed by the pressure of the back flow, and the back flow of the chemical solution or the like above the cylindrical valve 114 is prevented. That is, backflow is prevented by constituting the cylindrical valve 114 with an elastic body having a slit 114a at the tip.

  However, when such a slit 114a is formed in the cylindrical valve 114 made of an elastic body, it is still necessary to form the slit 114a by cutting or the like in the elastic material. Therefore, as in the case of the blood collection needle 101 described above, there is a possibility that the cutting waste enters the blood vessel or the cutting waste flows into the blood collection tube side.

Although Patent Document 2 discloses a method using a ball valve instead of the cylindrical valve 114, if the specific gravity of the ball valve is too small or too large, backflow is reliably prevented. I couldn't. Further, even if the specific gravity of the ball valve is set to an appropriate size, there is a problem that the ball valve does not act when the backflow momentum is weak.
Japanese Utility Model Publication No. 3-129111 JP 2003-260132 A

  The present invention eliminates the above-mentioned drawbacks of the prior art, and is a blood collection device used during blood collection, which can reliably prevent backflow even when the backflow momentum is weak, and is due to cutting scraps, etc. An object of the present invention is to provide a blood collection device that is hardly contaminated and that is excellent in safety.

  According to the present invention, it is a blood collection device used for blood collection, and has a flow path forming member having a flow path through which blood flows therein, and is disposed in the flow path of the flow path forming member, and has flexibility. A backflow prevention valve made of a material, wherein the backflow prevention valve is open at a first end on one end side in the direction in which the flow path extends, and at an end opposite to the first end. A certain second end is closed, and the outer peripheral surface of the first end is brought into close contact with the inner peripheral surface of the flow path by the elasticity of the material constituting the backflow prevention valve, thereby preventing the backflow of blood. At least a part of the outer peripheral surface of the first end of the backflow prevention valve is within the flow path due to the backflow prevention state and the pressure difference between the blood flow or one side of the flow path sandwiching the backflow prevention valve. It is formed so that it can take a blood flowable state separated from the peripheral surface. , Blood collection equipment is provided.

Blood collector device according to the present invention, the flow path forming and the step portion is formed on the inner peripheral surface extending in the circumferential direction of the member, the diameter of the channel are relatively large at one side of the stepped portion , The diameter of the flow path is relatively small on the other side, the backflow prevention valve is accommodated on the side of the flow path portion having a relatively large diameter, and the first end of the backflow prevention valve is , And is configured to be locked by the stepped portion.

  In another specific aspect of the blood collection device according to the present invention, the flow path forming member is a cylindrical member, and the backflow prevention valve has a dome shape.

  In still another specific aspect of the blood collection device according to the present invention, the blood collection device further includes a blood collection holder having an opening into which the vacuum blood collection tube is inserted at one end and the other end closed, and the blood collection holder is closed. The cylindrical member is connected to the other end side, and a hollow needle extending from the flow path in the cylindrical member into the blood collection holder is connected to the cylindrical member.

In the blood collection device according to the present invention, the backflow prevention valve is disposed in the flow path of the flow path forming member, and the backflow prevention valve is made of a flexible material and has a first end in the direction in which the flow path extends. It has a structure in which the part side is opened and the second end side opposite to the first end is closed. Then, due to the elasticity of the material constituting the backflow prevention valve, the outer peripheral surface of the first end is brought into close contact with the inner peripheral surface of the flow path, thereby preventing the backflow of blood. Then, blood flow in which at least a part of the outer peripheral surface of the first end is separated from the inner peripheral surface of the flow path due to a pressure difference between one side and the opposite side of the flow path sandwiching the blood flow or backflow prevention valve Since it can be made possible, if the pressure difference occurs due to the flow of blood, the blood can surely flow in the correct direction due to the pressure difference. And in the state which should prevent a backflow, the outer peripheral surface of the 1st edge part of this backflow prevention valve comprises a flow path by the backflow force and the elasticity of the material which comprises the backflow prevention valve. Therefore, the backflow can be reliably prevented. In addition, since it is not necessary to form a cut or the like in the backflow prevention valve, blood and blood vessels are hardly contaminated by cutting waste.

  Therefore, according to the present invention, it is possible to reliably prevent backflow even when the backflow momentum is weak, and to provide a highly safe blood collection device that is less likely to be contaminated by cutting waste or the like. it can.

  A step portion extending in the circumferential direction is formed on the inner peripheral surface of the portion constituting the flow channel of the flow channel forming member, and the diameter of the flow channel is relatively increased on one side of the step portion, The other side is relatively small, the backflow prevention valve is accommodated on the relatively large diameter flow path portion side, and the first end is locked by the stepped portion. In this case, the backflow prevention valve can be prevented from moving to the flow path portion side having a relatively small diameter beyond the stepped portion. Therefore, undesired movement of the backflow prevention valve can be suppressed, and the backflow prevention state due to the blood flow and the blood flowable state can be more reliably realized.

  When the flow path forming member is a cylindrical member and the backflow prevention valve has a dome shape, the flow path forming member can be constituted by a general-purpose cylindrical member, and the back flow is made by a dome type elastic material. The prevention valve can be easily formed.

  A blood collection holder that has an opening into which a vacuum blood collection tube is inserted at one end and the other end is closed; and the tubular member is connected to the other end of the blood collection holder that is closed; and When a hollow needle extending from the flow path in the cylindrical member into the blood collection holder is connected to the cylindrical member, the reverse flow can be reliably prevented according to the present invention, and contamination caused by cutting waste is less likely to occur. A blood collection holder having a prevention structure can be provided.

  Hereinafter, the present invention will be clarified by describing specific embodiments of the present invention with reference to the drawings.

  Fig.1 (a) is front sectional drawing which shows the blood collection holder as a blood collection instrument which concerns on one Embodiment of this invention. The blood collection holder 1 has a substantially cylindrical holder body 2. The holder body 2 has an opening 2a at one end, and an end 2b opposite to the opening 2a is closed. And the cylindrical member 3 is provided in the center of the edge part 2b so that it may protrude integrally and outside. The cylindrical member 3 has an outer diameter smaller than the outer diameter of the holder body 2, and a flow path 3a through which blood flows is formed. The flow path 3a is extended from the upper end of the cylindrical member 3 to the lower end. And the hollow needle 4 is attached in the lower end side of the flow path 3a. The tip 4 a of the hollow needle 4 extends below the cylindrical member 3 and reaches the holder body 2. The distal end 4a of the hollow needle 4 is configured to have a sharp cutting edge, and the distal end 4a is configured to be able to pierce a stopper of a blood collection tube (not shown).

A sheath 5 made of an elastic material is attached so as to cover the hollow needle 4. The sheath 5 is provided in order to prevent blood leakage when blood is collected by piercing the stopper of the vacuum blood collection tube with the hollow needle 4.

  By the way, the feature of this embodiment is that the backflow prevention valve 6 is accommodated in the flow path 3a of the cylindrical member 3. As shown in enlarged views in FIGS. 1B and 1C, a step 3b is provided in the middle of the flow path 3a. Here, the diameter of the flow path 3a above the step 3b is larger than the diameter of the flow path portion below the step 3b.

  On the other hand, the backflow prevention valve 6 is made of an elastic material such as rubber or elastomer. And the 1st end part 6a of the backflow prevention valve 6 is opened, and the 2nd end part 6b on the opposite side to the 1st end part 6a is closed. Here, the backflow prevention valve 6 has a dome shape. The first end portion 6a of the backflow prevention valve 6 is an open cylindrical portion, and is always on the inner peripheral surface of the flow path 3a due to the elastic force of the elastic material, as shown in FIG. The outer peripheral surface of one end portion 6a is configured to be in close contact. In order to realize such a state, the material of the elastic material constituting the backflow prevention valve 6, the outer diameter of the first end 6a, and the inner diameter of the flow path 3a are selected.

  On the other hand, at the time of blood collection, as shown by an arrow B in FIG. 1B, blood flows from the outside of the flow path 3a of the cylindrical member 3 into the flow path 3a. In this case, the diameter of the backflow prevention valve 6 is narrowed by the momentum of blood flow, and the close contact state between the outer peripheral surface of the first end 6a and the inner peripheral surface of the flow path 3a is partially released. become. Therefore, a gap C is formed at the step 3b portion, and blood flows toward the hollow needle 4 side.

  As described above, the blood collection holder 1 according to the present embodiment is provided with the backflow prevention structure including the cylindrical member 3 and the backflow prevention valve 6, and therefore, as shown in FIG. The blood can be reliably guided to the hollow needle 4 side and collected in a vacuum blood collection tube. At this time, when the vacuum blood collection tube is used, a pressure difference is generated between the lower side of the backflow prevention valve 6 in FIG. 1B and the upper side of the backflow prevention valve 6, and the backflow is also caused by the pressure difference. The outer peripheral surface of the first end 6a of the prevention valve 6 is partially separated from the inner peripheral surface of the flow path 3a. Therefore, it is possible to promptly guide blood to the vacuum blood collection tube side.

  In addition, as shown in FIG. 1C, when blood flows backward from the hollow needle 4 side as indicated by an arrow A, the elastic force and the force of the backward flow combine to reliably prevent the blood from flowing backward. Is done. That is, when a reverse flow occurs, the first end 6a is deformed by the reverse flow so that the diameter thereof is widened. In the backflow prevention state, the outer peripheral surface of the first end portion 6a becomes the inner peripheral surface of the flow path by both the backflow force and the elastic force on the first end portion 6a side of the backflow prevention valve 6. It will be in close contact. Therefore, even if the backflow momentum is weak, the backflow can be reliably prevented.

  In addition, since it is not necessary to form a cut when manufacturing the check valve 6, it is difficult for blood to be contaminated by cutting waste.

  In the embodiment shown in FIG. 1, the cylindrical member 3 is integrally formed at the tip of the holder body 2 of the blood collection holder 1, but the blood collection instrument of the present invention is not limited to such a blood collection holder. . That is, as shown in FIGS. 2 (a) and 2 (b), a dome-shaped backflow prevention member 12 is inserted into a cylindrical member 11 prepared separately from the blood collection holder, whereby the blood collection device of the present invention is used. It may be configured. Also in this case, the backflow prevention valve 12 has a shape in which the first end portion 12a side is open and the second end portion 12b side is closed, and is made of an elastic material. Accordingly, as in the case of the first embodiment, in the initial state, as shown in FIG. 2B, the outer peripheral surface on the first end portion 12a side is in close contact with the inner peripheral surface of the cylindrical member 11. Has been.

And as shown to Fig.3 (a), when the pressure by the side of the 2nd end part 12b of the backflow prevention valve 12 is higher than the pressure of the flow-path part below the 1st end part 12a, Due to the pressure difference, the diameter on the first end 12a side is reduced. Therefore, the close contact between the outer peripheral surface of the first end 12a and the inner peripheral surface of the cylindrical member 11 is partially released, and the gap X is formed. Therefore, blood flows through the flow path from the second end portion 12b toward the first end portion 11a beyond the backflow prevention valve 12.

  Further, when a backflow occurs, the backflow prevention valve 12 is deformed as shown by an arrow in FIG. 3B due to the elastic force of the backflow prevention valve 12 and the backflow force, and a backflow prevention state is established. In this case, in FIG. 3B, when the pressure in the flow path portion below the backflow prevention valve 12 becomes relatively high, the outer peripheral surface of the first end portion 12a is more strongly cylindrical. 11 is in close contact with the inner peripheral surface, thereby preventing backflow more reliably.

  Further, as shown in a schematic partial cutaway sectional view in FIG. 4, it is preferable to provide a stepped portion 11 a in the cylindrical member 11 as in the case of the first embodiment.

  When guiding blood, the contact state between the outer peripheral surface of the first end portion 12a of the check valve 12 and the inner peripheral surface of the tubular member 11 is at least partially solved. It becomes a state corresponding to the state. Accordingly, the backflow prevention valve 12 is moved in the direction of the arrow in FIG. 4 by the blood flow. However, when the step portion 11b is provided, the movement of the backflow prevention valve 12 can be locked by the step portion 11b. Therefore, it is possible to reliably prevent an undesired displacement of the check valve 12.

  In the present embodiment, in the state where blood flows, the gap is greatly opened when the flow rate of blood is large. When blood flows forcibly through a narrow gap, hemolysis is likely to occur. However, in the present embodiment, as described above, when the blood flow volume is large, the gap becomes large, so that hemolysis can be reliably suppressed. . Further, when the force for vacuuming blood does not work, the backflow prevention state is restored by the elastic return force of the backflow prevention valve 12. Therefore, the flow path is reliably closed. Then, when the pressure on the blood vessel side becomes lower than the pressure on the vacuum blood collection tube side, backflow may occur. In this case, the outer periphery of the first end portion 12a of the backflow prevention valve 12 is caused by the pressure difference. The surface is more closely attached to the inner peripheral surface of the flow path, and the backflow prevention valve can be reliably prevented.

  The said backflow prevention valve 12 is closely_contact | adhered to the flow-path wall surface by the elastic action. Therefore, the position of the check valve 12 is not greatly shifted in the blood flow direction by the blood flow. However, there is a risk of displacement due to impact during transportation or loosening due to aging. Therefore, preferably, the backflow prevention valve 12 may be fixed to the inner surface of the flow path in the blood flow direction by adhesion, welding or fitting so as not to move in the blood flow direction. Further, when the backflow prevention valve 12 is fixed to the inner surface of the flow path, the centers of the outer diameter and the inner diameter of the backflow prevention valve 12 may be shifted to make the thickness of the backflow prevention valve 12 uneven in the circumferential direction. In that case, it is preferable to bond or fix the relatively thick portion to the inner peripheral surface of the cylindrical member, since the deformation in the relatively thin portion can be further facilitated.

  The blood collection device according to the present invention is not limited to the blood collection holder 1 shown in FIG. 1 and can be generally applied to a blood collection device into which the cylindrical member 11 can be incorporated. That is, the cylindrical member 11 may be incorporated in, for example, a winged needle, a hub connected to an injection needle, or the like, and the portion constituting the cylindrical member 11 can be at an arbitrary position of the blood collecting instrument.

  Further, the blood collection instrument of the present invention may be configured by using the injection needle or the winged needle itself as the cylindrical member 11 and housing the backflow prevention valve 12 therein.

(Example)
The dome-shaped backflow prevention valve 6 shown in FIG. 1 made of butyl rubber was produced. The backflow prevention valve 6 has an inner diameter of 1.0 mm, an outer diameter of 2.6 mm, a length of 6.0 mm, and a shape in which the second end portion 6b side is closed in a hemispherical shape. A sample was prepared and set in the blood sampling holder 1 in which the inner diameter of the flow path of the portion of the cylindrical member 3 shown in FIG. 1 where the check valve 6 is set is 2.3 mm. An injection needle 21 is hermetically attached to the outer peripheral surface of the cylindrical member 3, the tip 21 a of the injection needle 21 is immersed in the blood in the beaker, and the vacuum blood collection tube is opened in the holder body 2 of the blood collection holder 1. Inserted from 2a. As a result, blood was able to flow into the vacuum blood collection tube. When the blood flow stopped, the vacuum blood collection tube was removed, the blood in the vacuum blood collection tube was centrifuged, and the serum was observed. Hemolysis was not observed.

  In addition, since the pressure in the vacuum blood collection tube after completion of the suction is almost equal to the atmospheric pressure, the blood flow was stopped in this state. Then, it was confirmed that the backflow prevention valve 6 returned to the initial state due to elasticity and was in close contact with the inner wall of the tubular member 3. Thereafter, as shown in FIG. 5, after blood was collected in the same manner as in the case of the above centrifugation, the sample was turned upside down and the inside of the vacuum blood collection tube 22 was pressurized to +100 mmHg using the pressurizing jig 23. However, blood did not leak from the tip 21a of the injection needle 21.

(A) is front sectional drawing of the blood collecting instrument of one Embodiment of this invention, (b) is a partial notch front sectional drawing which shows the principal part of the blood collecting instrument in the state which can distribute blood, (c) is in a backflow prevention state. The partial notch expansion front view which shows the principal part of a blood collection instrument. (A) And (b) is each partial notch front sectional drawing for demonstrating the modification of the blood collection instrument of this invention. (A) And (b) is each partial notch front sectional drawing which shows a blood circulation state and a backflow prevention state in the blood collection instrument shown in FIG. The partial notch front sectional drawing for demonstrating the movement to the length direction of the flow path of the backflow prevention valve in the case where a blood-collecting instrument is provided with the level | step-difference part, and a blood-collecting instrument. In an Example, the partial notch front sectional drawing for demonstrating the process of performing the blood leakage confirmation test. The longitudinal cross-sectional view which shows an example of the blood collection needle provided with the conventional backflow prevention structure. The partial notch front sectional drawing for demonstrating the indwelling needle provided with the conventional backflow prevention structure.

Explanation of symbols

1 ... Blood collection holder (blood collection device)
DESCRIPTION OF SYMBOLS 2 ... Holder main body 2a ... Opening 2b ... End part 3 ... Cylindrical member 3a ... Flow path 4 ... Hollow needle 5 ... Sheath 6 ... Backflow prevention valve 6a ... First end part 6b ... Second end part 11 ... Cylindrical form Member 11a ... Flow path 12 ... Backflow prevention valve 12a ... First end 12b ... Second end

Claims (3)

A blood collection device used for blood collection,
A flow path forming member having a flow path through which blood flows;
Disposed in the flow path of the flow path forming member, and comprising a backflow prevention valve made of a flexible material,
In the backflow prevention valve, a first end on one end side is opened in a direction in which the flow path extends, and a second end which is an end opposite to the first end is closed. A backflow preventing state in which the outer peripheral surface of the first end is brought into close contact with the inner peripheral surface of the flow path to prevent the backflow of blood due to the elasticity of the material constituting the backflow prevention valve;
At least a part of the outer peripheral surface of the first end portion of the check valve is separated from the inner peripheral surface of the flow path due to a blood pressure or a pressure difference between one side and the other side of the flow path sandwiching the check valve. It is formed so that it can take a blood circulation state ,
A stepped portion extending in the circumferential direction is formed on the inner peripheral surface of the flow path forming member, the diameter of the flow channel is relatively large on one side of the stepped portion, and the diameter of the flow channel is set on the other side. The check valve is relatively small, the check valve is housed on the side of the relatively large diameter channel portion, and the first end of the check valve is locked by the step portion. A blood collection device, characterized by being configured as follows . The blood collecting instrument according to claim 1 , wherein the flow path forming member is a cylindrical member, and the backflow prevention valve has a dome shape. A blood collection holder having an opening into which a vacuum blood collection tube is inserted at one end and the other end closed; the tubular member being connected to the other end of the blood collection holder that is closed; and The blood collecting instrument according to claim 2 , wherein a hollow needle extending from the flow path in the tubular member into the blood collecting holder is connected to the tubular member.

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