JP3178904B2 - Blood collection equipment - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a blood collecting device, and more particularly to a blood collecting device which allows a sample source to communicate with a negative pressure sample storage chamber to enable sample collection.

[0002]

2. Description of the Related Art Conventionally, in the case of collecting blood as a sample, for example, in the case of collecting blood as a sample, a blood collection unit that makes blood collection quick and efficient is frequently used. This unit includes, for example, a single-type blood collection needle provided with cannulas provided at both ends of a hub, a holder outer cylinder to which the blood collection needle is attached at the tip, and a negative pressure inserted beforehand inside the holder outer cylinder. And a blood collection tube.

At the time of blood collection, a holder outer cylinder and a blood collection needle are assembled and integrated in advance, and a venous blood vessel is secured by puncturing an outer cannula into the venous blood vessel. Thereafter, the blood collection tube is pushed into the holder outer tube, and the rubber stopper of the blood collection tube is penetrated by the cannula in the holder outer tube.
Blood collection is started, and the blood collection is completed when the pressure inside the blood collection tube and the venous pressure become equal.

[0004] However, in such a conventional vacuum blood collection system, the determination of whether or not the vein has reliably secured the vein at present depends on the can and experience of the person performing the blood collection. Therefore, sometimes blood can be started due to the negative pressure of the blood collection tube while the vein is outside the vein and remains in the body other than the blood vessel, and the tissue of the punctured part is damaged by the cannula There was a danger.

[0005] In order to solve such a problem, as described in Japanese Patent Publication No. 21809/1990, a blood collection device having a mechanism capable of confirming flashback has already been proposed. However, the proposed blood collection device includes a ventilation device as a communication passage provided inside the hub and an annular compressed sleeve inserted into the communication passage in the device and having a material property of swelling due to moisture. For example, there is a problem that the configuration is extremely complicated and mass production cannot be performed at low cost.

Further, in the above-described configuration, the flashback depends on the difference between the venous pressure and the atmospheric pressure. If the difference is small, blood is not introduced into the mechanism, and even if a blood vessel is secured, the flashback is reduced. There is a problem that there is a case that cannot be confirmed.

[0007]

SUMMARY OF THE INVENTION It is an object of the present invention to provide a blood sampling device which can be manufactured at a very low cost with a simple structure, which can surely confirm flashback for securing a blood vessel.

[0008]

This and other objects are achieved by the inventions (1) to (6) below.

(1) A holder outer cylinder, a hub attached to the tip of the holder outer cylinder, a needle tube having a needle tip extending to both ends of the hub, and a needle tube extending inside the holder outer cylinder. An envelope that is made of an elastic body and hermetically covers the needle tip that has been formed, and a space that extends from the needle tip that extends outside the holder outer cylinder of the needle tube to the inside of the envelope. A blood-collecting device having a confirming portion that faces the blood introduction space to be visually checked for blood inflow, and presses a side surface of the surrounding body held by being inserted into a hole provided in the holder outer cylinder. A pressure regulating means that can change the internal pressure of the blood introduction space by pressing and releasing the pressure on the surrounding body, and actuating the pressure varying means to introduce the blood. Reduce the pressure in the space and The blood collection device is characterized in that blood can be introduced into the blood introduction space and the flashback can be visually confirmed.

(2) The enclosure has a large cross section,
The blood collection device according to (1), wherein the regulating member presses and presses the large cross-section.

(3) The blood sampling device according to the above (1) or (2), wherein the pressure changing means has an urging member for urging the regulating member in a direction in which the pressure of the surrounding body is released. .

(4) The confirmation portion according to (1) to (3), wherein the confirmation portion is a substantially transparent portion formed on the enclosure and / or a substantially transparent portion formed on the hub. The blood collection device according to any one of the above. (5) The blood collection device according to any one of the above (1) to (4), wherein the holder outer cylinder is configured to insert a blood collection tube whose inside has a negative pressure in advance. (6) The blood collection device according to any one of (1) to (5), wherein the surrounding body is installed so as not to be detached.

[0013]

The needle tube extending to the distal end of the hub is punctured into the venous blood vessel to secure the venous blood vessel. Thereafter, the pressure in the blood introduction space is set to a negative pressure by the pressure changing means. If a blood vessel is secured, the difference between the venous pressure in the venous blood vessel and the negative pressure causes flashback in which blood flows into the blood introduction space.

The flashback can be easily confirmed visually through the confirmation section.

As described above, by setting the pressure of the blood introduction space to a negative pressure, the occurrence of flashback can be ensured.

[0016]

[Specific Configuration] A specific configuration example of the present invention will be described below. FIG. 1 is an overall sectional side view of a blood collection device 1 of the present invention. The blood collection device 1 includes a holder 2 and a blood collection needle 3 attached to the holder 2. The holder 2 has a holder outer cylinder 21 into which a blood collection tube whose inside is previously set to a negative pressure can be inserted.
, And a transformer 22. The holder outer cylinder 21
It has a closed-end cylindrical shape with a closed end, and a hole having a helical thread groove formed in the end portion as a mounting portion.

The blood collection needle 3 is mounted on the mounting part 211. The blood collection needle 3 includes a substantially cylindrical hub 31 and the hub 31.
One needle tube 30 penetrating the inside in the axial direction, and both needle tip portions 32 and 33 extend from both ends of the hub 31. An internal passage 34 communicates with the inside of the needle tube 30 in the axial direction, and each needle tip has a sharp tip shape. Such a needle tube 30 is fixed by various adhesives S or the like while being inserted into a communication hole 311 of the hub 31 described later.
The constituent material of the needle tube 30 includes, for example, a metal such as stainless steel.

The hub 31 into which the needle tube 30 is inserted has a communication hole 311 penetrating therethrough in the central axis direction. The communication hole 311 is a hole for inserting and fixing the needle tube 30 described above, and has an inner diameter slightly larger than the outer diameter of the needle tube 30. Normally, the outer diameter of the needle tube 30 is 0
It is formed about 0.3 mm larger.

A helical thread 35 is usually formed on the outer peripheral surface of the hub 31. By screwing the screw thread 35 to the mounting portion 211 of the holder outer cylinder 21,
The blood collection needle 3 is mounted on the holder outer cylinder 21 and the blood collection device 1 is assembled.

A mounting portion 36 for enclosing the surrounding body 4 is provided at the inner end of the holder outer cylinder of the hub 31. The attachment portion 36 has a columnar contact portion 361 to which the opening 41 of the enclosure 4 is fitted and tightly fitted, and a step portion 362 formed in a jaw shape at the tip of the contact portion 361. The surrounding body 4 encapsulated by the step portion 362 is configured not to come off. The mounting portion 36 is not limited to the above-described configuration as long as the configuration is such that the surrounding body 4 cannot be detached airtightly and easily.

The hub 31 is usually formed by injection molding. The constituent materials of the holder outer cylinder 21 and the hub 31 include, for example, polypropylene (PP), polyethylene (PE), polystyrene (PS), polyethylene terephthalate (PET), polymethylpentene (PMP),
Polyvinyl chloride (PVC), polycarbonate (P
C), polyacrylonitrile, and resin materials such as acrylonitrile-butadiene-styrene resin (ABS resin).

The holder outer cylinder 21 is preferably made of a transparent or translucent material. further,
As shown in FIG. 4, the hub 31 has separate needle tubes 30a and 30b inserted from both ends, respectively.
In the case of a structure in which a confirmation part is formed in the gap between a and 30b,
It is preferable to be made of a transparent or translucent material.

The overall length of the holder outer cylinder 21 is not particularly limited, but is about 20 to 100 mm, and the inner diameter is about 10 to 30 mm. The dimensions of the hub 31 are not particularly limited, but may be, for example, about 5 to 30 mm in length and about 2 to 10 mm in outer diameter.

The surrounding body 4 hermetically enclosed by the hub 31 has a cylindrical shape with a bottom. In the encased state, the needle tip 33 is accommodated in a space E formed inside. Then, the opening 41 is rolled inward, and the step portion 36 of the mounting portion 36 is formed.
2 and is configured to abut and engage with the same. The inner diameter of the opening 41 is determined by the contact portion 361 of the mounting portion 36.
It is preferable that the outer diameter of the contact portion 361 be the same as or slightly smaller than the outer diameter of the contact portion 361 so as to be in close contact with the liquid.
The difference may be about 0 to 0.5 mm. The above-mentioned adhesiveness of the surrounding body 4 is achieved by making at least the opening 41 an elastic body.
Further improve.

The surrounding body 4 has a large cross-sectional portion 42 at a position where a regulating member 221 to be described later is pressed, the cross-sectional area of which is larger than the cross-sectional area of other portions. In this configuration example, the shape of the large cross section 42 is spherical, but the shape is not particularly limited as long as the inner volume of the enclosure 4 can be sufficiently ensured. The inner volume of the enclosure 4 may be, for example, about 0.015 to 0.50 ml.

The surrounding body 4 is covered so as to surround the needle tip 33. The internal passage 34 of the needle tube 30 and the space E formed inside the surrounding body 4 form a blood introduction space. Note that the surrounding body 4 in the present embodiment is
Is made of a transparent material, and the entire surrounding body 4 serves as a confirming portion that allows the inside of the surrounding body 4 to be visually recognized.

Further, the material forming the surrounding body 4 may be any material that has resilience to deformation due to external pressure, and examples thereof include an elastic body made of an elastic material or the like. Typical examples are various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, silicone rubber, latex rubber, butyl rubber, ethylene-propylene rubber, olefin-based, styrene-based, urethane-based, PVC-based, and polyester-based materials. And the like, but isoprene rubber, butyl rubber and the like are desirable. In addition, at least the large section 42
Is made of the elastic material, sufficient resilience can be ensured.

On the other hand, a pair of holes 212 is formed in the holder outer cylinder 21 on the opposite surface of the inner wall surface corresponding to the large cross section 42 of the enclosure 4, and the blood introduction Transformation means 22 for adjusting the atmospheric pressure in the space is mounted. The pressure transforming means 22 is connected between a pair of regulating members 221 inserted and held in the holes 212, respectively, and between the pair of regulating members 221 to urge the regulating members 221 outward. And a biasing member 223.

The pair of regulating members 221 are held in a direction in which the regulating members 221 are opposed to each other with the large cross section 42 of the surrounding body 4 interposed therebetween. Pressing surface 2 pressed against the surface
22. On the other hand, as shown in FIG. 2, the urging member 223 is an arc-shaped elastic body, and is urged in a direction in which the arc opens, and both ends of each of the regulating members 221.
Is connected to the connection portion 224 provided at the outer end of the. With this configuration, the biasing member 223
The restricting member 221 is urged toward the outside of the holder outer cylinder 21 by a force that restores the direction in which the arc is opened.

In the above-described mechanism, each regulating member 2
When the connecting portion 224 of the pair 21 is pushed with a finger from the outside, as shown in FIGS. 2 and 3, the pressing contact surfaces 222 of the pair of regulating members 221 are on the opposite sides of the large cross section 42 of the enclosure 4. The surrounding body 4 is crushed by being pressed against the located side surface.
When the finger pushing the regulating member 221 is released, the regulating member 221 moves outward by the action of the urging member 223,
The surrounding body 4 is restored to the original shape. Due to the restoring force of the surrounding body 4, the air pressure in the blood introduction space becomes lower than the outside air pressure, and a fluid flows into the blood introduction space from the needle tip of the needle tip 32.

The operation of the blood collection device 1 configured as described above will be described. The regulating member 221 is pushed in from the outside, and the large cross section 42 of the enclosure 4 is crushed.
While maintaining this state, the outer needle tip 32 is punctured into the venous blood vessel to secure the venous blood vessel. Thereafter, the pressing of the regulating member 221 is released.

At this time, the atmospheric pressure in the blood introduction space becomes negative due to the restoring force of the large cross-section 42. If the venous blood vessels are reliably secured, blood flows from the blood vessels into the blood introduction space due to the venous pressure and the pressure difference between the blood introduction space,
It reaches inside the enclosure 4. Since the surrounding body 4 is transparent or translucent, it can be confirmed visually that the blood has reached the surrounding body 4.

As described above, the pressure in the blood introduction space can be made sufficiently lower than the venous pressure, so that if blood vessels are secured, it is possible to reliably cause flashback.

It is also possible to adopt a method of confirming flashback by restoring the shape of the crushed large cross section 42. Further, a part of the enclosure 4 may be made of a transparent or translucent material so that the inside of the enclosure 4 can be substantially visually recognized. The portion to be transparent is, for example, a position near the tip of the needle tip 33, the bottom 43 of the envelope 4 as shown in the figure, or a portion where the flushed blood accumulates so that flashback can be confirmed early. For example, it is preferable to use a large cross section 42). In this case, the confirmation part is the large section 4 of the enclosure 4.
2 or a transparent part.

The amount of change in the volume of the envelope 4 before and after being crushed by the regulating member 221 is determined by the amount of change in the needle tube 30 so that it is possible to visually recognize that the blood has reached the interior of the envelope 4 via the transparent portion. Desirably, it is larger than the volume of the internal passage 34.

The configuration shown in FIG. 4 shows a blood collection device according to another embodiment. In this configuration, separate needle tubes 30a and 30b are respectively inserted into the communication holes 311 of the hub 31 from both ends, and are fixed with various adhesives S or the like. And, between the needle tubes 30a and 30b,
A gap 37 is provided.

The material of the hub 31 is a transparent or translucent material, as already described, in which the gap 37 is substantially visible.
Is a confirmation unit. That is, flashback is confirmed by visually checking that blood passes through the gap 37.
Providing the confirmation section at such a position has the advantage that the flashback can be confirmed easily and early even if the amount of blood introduced is small.

The confirmation section may be formed by providing a notch on the side surface of the needle tube 30 instead of the gap 37.

[0039]

As described above, the blood collection device of the present invention has a simple structure, can reliably confirm flashback for securing blood vessels, and can be manufactured at extremely low cost.

[Brief description of the drawings]

FIG. 1 is an overall sectional side view of a blood collection device.

FIG. 2 is a sectional view taken along line II-II in FIG.

FIG. 3 is an overall cross-sectional side view of the blood collection device, showing a state where a large cross-section is crushed.

FIG. 4 is an overall cross-sectional side view of a blood collection device showing another configuration example.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Blood sampling apparatus 2 Holder 21 Holder outer cylinder 211 Mounting part 212 Hole 213 Insertion port 22 Transformation means 221 Restriction member 222 Pushing surface 223 Urging member 224 Connection part 3 Blood sampling needle 30 Needle tube 31 Hub 311 Communication hole 32 Needle tip 33 Needle Tip portion 34 Internal passage 35 Screw 36 Mounting portion 361 Close contact portion 362 Step portion 37 Gap 4 Enclosure 41 Opening 42 Large cross section 43 Bottom

Claims (6)

(57) [Claims] 1. A holder outer cylinder, a hub attached to a distal end of the holder outer cylinder, a needle tube having a needle tip extending to both ends of the hub, and an inner side of the holder outer cylinder. An enclosure that is made of an elastic body and hermetically encloses the needle tip, and is formed of a space extending from the needle tip extending outside the holder outer cylinder of the needle tube to the inside of the enclosure. A blood collection space that faces the blood introduction space and has a confirmation unit that can visually confirm blood inflow, and presses a side surface of the enclosure that is inserted and held in a hole provided in the holder outer cylinder. A regulating member, wherein the regulating member presses and releases the pressure on the surrounding body, thereby comprising a transforming means capable of changing the internal pressure of the blood introduction space, and activating the transforming means to cause the blood introduction space to operate. To a reduced pressure state, A blood collection device, wherein blood can be introduced into the blood introduction space so that flashback can be visually confirmed. 2. The blood collection device according to claim 1, wherein the surrounding body has a large cross-section, and the regulating member presses and presses the large cross-section. 3. The blood collection device according to claim 1, wherein the pressure changing unit has an urging member for urging the regulating member in a direction in which the pressure of the surrounding body is released. 4. The device according to claim 1, wherein the confirmation portion is a substantially transparent portion formed on the enclosure and / or a substantially transparent portion formed on the hub. Blood collection equipment. 5. The blood collection device according to claim 1, wherein the holder outer tube is configured to insert a blood collection tube whose inside is previously set to a negative pressure. 6. The blood collection device according to claim 1, wherein the surrounding body is installed so as not to be detached.