JPS6190644A - Blood sampling aid and method - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

Detailed Description of the Invention ■9 Background of the Invention [Field of the Invention] The present invention is directed to a blood collection device, such as a vacuum blood collection tube, in which a reduced pressure state f1 is maintained so that a required amount of blood sample can be collected, and a blood collection aid. This article concerns the structure of the blood sample and its blood sampling method.

[Prior art and its problems]

A vacuum blood collection tube is used to collect blood for blood tests. As shown in Fig. 1, the vacuum blood collection tube 1 is made of a tube body 2 made of glass or air-impermeable plastic with a stopper 3, which is also air-impermeable, attached to one open end of the tube body 2, and the inside of the tube body 2 is made of glass or air-impermeable plastic. A reduced pressure state is maintained in the space 5 so that the required amount of blood can be collected. The plug body 3 is generally composed of a rubber stopper 4. This rubber stopper 4 reduces the increase in internal pressure of the reduced pressure blood collection tube, but is required to have properties such as sealability and resealability to seal the hole after puncture. Therefore, the rubber stopper 4
Vulcanized butyl rubber is generally used as the constituent material. Vulcanized butyl rubber has excellent sealing properties due to its rubber elasticity, but since it contains sulfur and vulcanization accelerators, there is a risk that it will elute into the collected blood, and there is also the problem of increasing manufacturing costs. Ta. If a polymer composite material with a large compression set is used instead of vulcanized butyl rubber.

Although it is possible to reduce the cost of rubber stoppers, the following problems have been pointed out with the vacuum blood collection tube holder (blood collection aid) used during blood collection, and in reality, polymer-based composite materials are used. The rubber stopper made by the manufacturer could not be used.

The vacuum blood collection tube 1 shown in the first factor is used for blood collection as shown in FIGS. 2 and 3. It is inserted as shown in FIG. The reduced pressure blood collection tube holder 6 has a cylindrical holder main body 9 with an open rear end, and a puncture needle 8 is attached to the tip of the holder by a threaded portion 7 between the hub and the holder main body. The distal end 8a of the puncture needle 8 has a pointed end used for puncturing a human body, etc., and the rear end 8b is covered with a sheath-like elastic body, that is, a rubber tip IO, and has a pointed end capable of puncturing this rubber tip 10. Note that the rubber tip 10 is not limited to the one shown in the drawings; for example, if the puncture needle has an opening only on the side surface, it may be an elastic valve body that exists only on the side surface and exposes the opening by compression.

When collecting blood, the vacuum blood collection tube l is pushed into the holder main body 9 from the state shown in FIG. 2 to the state shown in FIG. At this time, the rear end 8b of the puncture needle 8 is connected to the rubber tip 10, and then to the vacuum blood collection tube l.
Pierce the rubber stopper 4.

Blood is naturally drawn into the internal space 5 of the reduced pressure blood collection tube 1 through the puncture needle 8 due to its reduced pressure state.

At this time, the rubber tip 10 is folded into a bellows shape between the holder main body 9 and the rubber stopper 4 of the vacuum blood collection tube 1. Even if the rubber tip 10 is folded many times due to multiple blood collections, when the blood collection is completed, the rubber tip 10 rebounds to its original state as shown in FIG. 3 to prevent blood from leaking from the rear end 8b of the puncture needle 8 and spilling into the holder. Therefore, it must have strong elasticity.

The rubber stopper 4 of the vacuum blood collection tube 1 must be able to maintain the pushed-in state shown in FIG. 3 against the strong elasticity of the rubber tip.

In the case of the rubber stopper made of vulcanized butyl rubber mentioned above, the compression set is about 27% (70°C, 22 hours), and although there is some kickback, the rubber stopper grips the rear end 8b of the puncture needle. However, when a rubber stopper made of a polymeric composite material is used, the compression set of the material is 40% or more (at 70°C).

22 hours), the frictional force between the rubber stopper and the back end of the puncture needle decreases, and the repulsive force of the rubber tip causes the vacuum blood collection tube to kick back, or move backward, causing the puncture needle to retreat into the rubber stopper, or It may retreat outside the frame, making it impossible to collect blood, or blood may leak into the holder body. In addition,
All of the above measurements of compression set were conducted in accordance with JIS 6301.

In addition, when a rubber stopper made of a polymeric composite material is used, leakage occurs between the rubber stopper and the tube body 2 during low-temperature storage.
It becomes impossible to maintain a reduced pressure state.

■9 Purpose of the Invention The present invention was made in view of the above-mentioned circumstances, and its purpose is to use vulcanized rubber with a large compression set or an inexpensive polymer that does not require vulcanization as a rubber plug material. An object of the present invention is to provide an inexpensive blood sampling aid that uses a system composite material and is configured to ensure reliable blood sampling against the repulsive force of the rubber tip on the vacuum blood sampling tube holder described above during blood sampling, and a blood sampling method thereof. .

10 Specific Structure of the Invention The present invention provides a method for removably inserting a blood sampling device having a conical portion.
'f11 A blood sampling aid having a female part, the blood collecting device comprising a container having an opening in a conical part and a hollow needle protruding into the female part of the blood collecting aid. an elastic plug body of the opening that can be passed through, and the female part has an elastic sheath body that is inserted into the hollow needle to open and close the fluid passage of the hollow needle. A blood collection aid comprising a locking portion that engages with the outer surface of the plug or the outer surface of the blood collection device so that the plug that has been pierced does not retreat due to the repulsive force of the sheath when compressed in the direction of the blood collection device. It provides:

The present invention also provides that the intermediate portion of a hollow needle having pointed ends at both ends is supported by the closed part of the tubular body whose one end is closed, and at least an opening of the needle portion on the side of the tubular body that communicates between the inside of the needle and the outside. The opening of the blood collection container is closed with an elastic stopper at the opening of the other end of the tubular body of the blood collection aid, which is encapsulated in the axial direction of the supporting side of the needle with an elastic sheath, and the space inside the blood collection container is closed. A blood sampling device with a reduced pressure is inserted, and the hollow needle is pierced through the elastic plug body of the blood sampling device against the elastic repulsive force of the elastic sheath body of the blood sampling aid, and the hollow needle penetrates the elastic plug body. When the blood sampling device penetrates into the blood sampling container internal space, the engagement of the locking portion formed on the inner surface of the blood sampling aid with the stopper or the outer surface of the blood sampling container causes the blood sampling device to retain its elasticity. Blood is collected into the blood collection device while preventing it from being moved backward by the elastic repulsive force of the sheath body, and after blood collection, the blood collection device is moved against the engagement force between the locking portion on the outer surface of the blood collection container and the inner surface of the blood collection aid. The present invention provides a blood sampling method characterized in that the blood sampling device is removed from the blood sampling aid.

Preferably, the locking portion is a protrusion provided on the inner surface of the female portion, and the plug body has a compression set of at least 40%.

Hereinafter, a preferred embodiment of the blood collection aid shown in the accompanying drawings will be described in detail.

The rubber stopper used in the present invention is preferably one having gas barrier properties, and is applied to a vacuum blood collection tube to maintain the internal space of the vacuum blood collection tube in the required reduced pressure state even during normal storage or low-temperature storage. In the present invention, vulcanized butyl rubber is not used due to the risk of blood contamination and to reduce manufacturing costs. There is no particular limitation, as long as the compression set has a compression set of 40% or more, but it is preferably made of a polymeric composite material so that it can be manufactured at low cost.

Polymer-based composite materials include thermoplastic resins such as polyethylene to selectively impart fluidity during molding to butyl-based materials such as polyisopropylene and partially cross-linked butyl rubber.
Also, it is possible to use a material containing a filler such as mica (mica) which improves the gas barrier properties.

In order to compensate for the above-mentioned drawbacks of the rubber stopper made of a material with a compression set of 40% or more used in the present invention, the repulsive force of the rubber tip is resisted between the inner circumference of the blood collection aid and the outer circumference of the rubber stopper. It is characterized by having a contact resistor (locking part) that provides contact resistance, and examples of its configuration are shown in FIG. 4 and ft55.

As explained in Figs. 2 and 3, the contact resistor (locking part) provided on the inner periphery of the blood collection aid is a blood collection device that is forcibly folded into a bellows shape with the rubber stopper of the blood collection device during blood collection. Any configuration may be used as long as it generates a frictional force between the rubber stopper and the holder that prevents the rubber stopper from retreating undesirably due to the repulsive restoring force of the rubber tip of the auxiliary tool. There are vertical ribs, lateral force ribs, diagonal ribs, discontinuous protrusions, etc. formed on the inner circumference of the holder. Furthermore, the engaging IF portion can be constructed using various means such as not only frictional locking but also screw engagement.

The repulsive restoring force of the rubber chip mentioned above is approximately 300 to 70.
Since the large static friction force between the hollow needle and the plug body of the blood collection aid is approximately 150 to 400 g, the rubber stopper or tubular body formed in the blood collection aid of the present invention The contact resistor between .

By creating a frictional force with the rubber stopper that is at least greater than the value obtained by subtracting the maximum static frictional force from the repulsive restoring force, it is possible to prevent the elastic stopper from retreating.

An example of the configuration of the blood sampling aid of the present invention that satisfies these conditions will be described below. In these examples, vertical ribs are formed on the inner periphery of the holder, but as described above, the rubber stopper of the present invention is not limited to these. Note that the conical tip end of the tube of the vacuum blood collection tube may have a shape that fits into the female portion of the holder (blood collection aid), and the tubes are not limited to having approximately the same diameter. It may have a conical portion with a small diameter and a rear portion with a larger diameter.

As shown in Fig. 6, the rubber stopper of the vacuum blood collection tube has a recess 21 at the top for storing a rubber tip that is forcibly folded during blood collection, and a puncture needle at the bottom that is inserted into the vacuum blood collection tube. It has a recess 22 for easy exposure to space.

In a blood collection aid into which a vacuum blood collection tube equipped with a rubber plug can be inserted, the example shown in FIG. 4 has four vertical ribs 31 symmetrically formed inside the main body 9.
These ribs 31 come into contact with the rubber stopper of the vacuum blood collection tube and generate a frictional force that resists the repulsive restoring force of the rubber tip.

The example shown in FIG. 5 is an example in which two longitudinal ribs 31 are provided symmetrically. The vertical lip 31 may be provided at any position as long as it is a part of the holder that corresponds to the position of the rubber stopper when the vacuum blood collection tube is completely pushed into the holder.

In addition, as shown in FIG. 11, the outer diameter of the rubber stopper 4 is
If the outer diameter is smaller than the outer diameter of the holder 9, the ribs 31 formed on the holder 9 can be made to engage with the tube body 2.

The rubber stopper material used in the present invention is a material with large compression set, such as a polymer composite material. therefore,
Rubber stoppers made of materials with large compression set, such as polymeric composite materials, may not have sufficient sealing properties for the through holes after being punctured by the puncture needle, and the blood collected through the through holes may not be able to seal properly. There is a risk of leakage and contamination. For this reason,
With this type of rubber stopper, at least part of the area where the puncture needle is expected to penetrate must be resealed with a resealable material to enclose the puncture needle. B32 can be formed.

FIG. 6 shows an example in which the resealing portion 32 is provided from the top recess 21 to the bottom recess 22 of the rubber stopper 30. It is also possible to insert it near the top recess 21+1 of the stopper 30.

The groove 33 shown in Fig. 6 is used to push a tube body such as a glass tube of a vacuum blood collection tube, and the rubber stopper is in close contact with the tube body from the outside, so that the rubber stopper and the tube body are not connected at low temperatures. This is to prevent leaks (increase in pressure inside the pipe) that may occur due to differential thermal contraction. The depth of the groove is 0.2 a
m or more, preferably about 0.7-1.5 m+w.

The slit 34 formed in the bottom recess 22 shown in FIG. 6 is designed to facilitate the attachment and detachment of the rubber stopper to a tube body such as a glass tube, and to effectively prevent detachment during the front frame. belongs to.

Styrene-butadiene block polymer is used as a constituent material for the resealing part formed inside the stopper.

Examples include hydrogenated styrene-butadiene block polymer and mica-containing Lavalon.

FIG. 7 shows a blood collection aid (holder) for attaching and detaching the vacuum blood collection tube of the present invention.

Next, the method for manufacturing the rubber stopper for vacuum blood collection tubes used in J will be briefly explained.

First, 1 part cross-linked butyl rubber 75 weight ratio, polyethylene 2 part
The mixture was kneaded at 150 DEG C. using a Banbury mixer with mica 40 in a weight ratio of 5 and liquid paraffin in a weight ratio of 5, then formed into a sheet, and then pelletized. The pelletized waste material composite material is molded into the shape of a rubber stopper using an injection molding machine, and a resealing portion 32 shown in FIGS. 4 to 6 is further embedded by injection molding.

This series of molding is done using a two-color injection molding machine.
This can be done even more efficiently.

(3) Specific Effects of the Invention Next, the effects of the blood sampling aid and blood sampling method of the present invention will be explained with reference to the circumstances during blood sampling shown in FIGS. 7, 8, and 9.

FIG. 7 is a cross-sectional view of the blood collection aid of the present invention to which a vacuum blood collection tube l equipped with a rubber stopper 30 according to the present invention can be attached and detached. A rib 31 formed on the inner periphery of the holder main body 9 and protruding from the main body surface functions as a contact resistor (locking part) in cooperation with a rubber stopper 30 (or tube body 2) of a vacuum blood collection tube described below. act.

In the blood sampling method of the present invention, a vacuum blood collection tube equipped with a rubber stopper 1
As shown in FIG.
Push in from 1. In the state IL shown in FIG. 8, it is preferable to configure the rib 31 and the rubber stopper 30 so that they do not come into contact with each other. At this time, the rubber stopper is inserted without compressing the air within the holder body. FIG. 9 shows a state in which the vacuum blood collection tube l is completely pushed into the main body 9 of the holder 6. At this time, the rib 31 of the holder body 9 is attached to the rubber stopper 30 at the tip of the vacuum blood collection tube l.
It is pushed in while being in close contact with the outer peripheral wall. In this state, as stated at the beginning of the specification, the rear end 8b of the puncture needle 8 pierces the rubber tip IO, further penetrates the rubber stopper 30 of the vacuum blood collection tube 1, and reaches the internal space 5 of the vacuum blood collection tube 1. , blood under positive pressure is naturally introduced into the internal space 5 under reduced pressure through the puncture needle 8 due to the pressure gradient.

Vacuum blood collection 1f [l tube l is the rubber tip 10 that has been forcibly folded into the recess 21 of the rubber stopper 30 by pushing the vacuum blood collection tube
receives a repulsive force. However, the rib 31 formed on the inner periphery of the holder main body 9 and the outer periphery of the rubber stopper 30 of the vacuum blood collection tube 1 come into close contact, and a large frictional force is generated between the two.

Since this frictional force is set to be larger than the repulsive force of the folded rubber tip lO, the reduced pressure blood collection tube l is completely inserted into the holder 6 and the blood is collected reliably at the position shown in FIG. Maintain the indicated state at all times during blood collection.

When blood is collected from the suspect, the internal space 5 is pressurized and the blood collection is completed. When blood collection is completed, the vacuum blood collection tube l is forcibly pulled out from the holder 6. At this time, the rubber tip 10 is restored to its original state as shown in FIG. 8, thereby preventing blood leakage, contamination of the holder, and contamination of the puncture needle. To prevent. This results in 1
The blood collection method of the present invention enables blood collection in a safe and sanitary manner, in which preparations for blood collection using the next new vacuum blood collection tube are made and blood collection is performed one after another as described above.

Further, in a blood sampling device using a rubber stopper 30 as shown in FIG. 6, the tube body 2 is pushed into the groove 33 of the rubber stopper 30 and is sealed from the inner and outer surfaces of the tube body by the rubber stopper. Even if the tube is kept at low temperatures after blood collection, there will be no leakage due to the difference in thermal shrinkage between the tube and the rubber stopper.

(1) Specific Effects of the Invention As is clear from the above description and the examples below, the blood collection aid and blood collection method of Kihata 1 provides many advantages as described below.

(1) In the blood sampling device of the present invention, since the locking portion is provided on the inner surface of the blood sampling aid, a contact resistance force greater than the repulsive force of the rubber tip folded by the blood sampling tube can be applied to the blood sampling tube body or the rubber stopper. can occur between

(2) In the rubber stopper applied to the blood collection aid of the present invention, it is preferable that vulcanization is performed using a material 1 with large permanent deformation such as a polymeric composite material, rather than using vulcanized butyl rubber as in the past. Therefore, the manufacturing process does not require a vulcanization process, and during use, there is no problem of leaching of sulfur and vulcanized stool enhancers into the blood.Furthermore, in terms of manufacturing cost, the materials are inexpensive and the manufacturing process is small. It is possible to significantly reduce costs. However, even when using vulcanized rubber, it is now possible to use one with large permanent deformation.

(3) According to the blood collection method of the present invention, when the vacuum blood collection tube is pushed into the blood collection aid, a contact resistance force greater than the repulsive force of the folded rubber tip is exerted between the engaging part provided on the inner surface of the blood collection aid and the blood collection aid. Since this occurs between blood vessels, kickback does not occur even if a material with large compressive strain, such as a polymeric composite material, is used for the four plugs, and reliable and hygienic blood collection is guaranteed.

(2) Examples Next, the blood sampling aid of the present invention will be specifically explained with reference to examples.

[Example 1] A blood sampling aid (holder) as shown in Fig. 1θ was produced. The holder is made of polypropylene and has an inner diameter of +7. Ow
rm, and the wall thickness was 0.8 am. The repulsive restoring force of the rubber chip was 350 g. The rubber stopper.

Partially crosslinked butyl rubber 701r! % ratio, low density polyethylene 30iil ratio, mica 40 @ quantity ratio, liquid paraffin 2
Tokeihi was kneaded using a Banbury mixer, pelletized, and produced by injection molding.

The compression set of the rubber stopper is 1 at 75% (70°C, 22 hours).
The outer diameter of the head was 18.8 am.

The tube was made of polyethylene terephthalate by injection molding. The outer diameter of the tube was 15.41 mm. On the other hand, on the holder, two curved plates 40 as shown in FIG. 12 were symmetrically fabricated at the positions shown in FIG. 1θ.

Using the blood sampling aid of the present invention having such a configuration and the blood sampling aid having a similar configuration without ribs, each
When we conducted a blood sampling test on 00 trees, there was no kickback at all with the ribbed version of the present invention.
Anything without ribs was kicked back.

[Example 2] A blood sampling aid (holder) as shown in FIG. 11 was produced. The holder is made of polypropylene and has an inner diameter of 17.0
ml, wall thickness was Q, 8 as. The repulsive restoring force of the rubber chip was 350 g. The rubber stopper is
) Partially crosslinked butyl rubber in a weight ratio of 70, modified low density polyethylene in a weight ratio of 30, mica in a weight ratio of 40, and liquid paraffin in a double clay ratio were kneaded using a Banbury mixer, pelletized, and produced by injection molding.

The compression set of the rubber stopper was 75% (70 inches at 0.22 hours) and the outer diameter of one head was 15.0 m.

The tube was made of polyethylene terephthalate by blow molding. The outer diameter of the tube was 16.81 square meters.

On the other hand, two ribs 40 as shown in FIG. 12 were symmetrically formed on the holder at the positions shown in FIG. 11.

Using the blood sampling aid of the present invention having such a configuration and the blood sampling aid having a similar configuration without ribs, each
When we conducted a blood sampling test on 00 tubes, there was no kickback at all with the ribbed tubes of the present invention.
Anything without ribs was kicked back.

[Brief explanation of the drawing]

FIG. 1 is a cross-sectional view of a conventional vacuum blood collection tube, FIGS. 2V4 and 3 are cross-sectional views showing a state in which blood is collected using the vacuum blood collection tube of FIG. 1, and FIGS. 4 and 5 are blood collection tubes of the present invention. 4a and 5a are plan views, and 4b is an example of the structure of the auxiliary tool.
Fig. 6 and Fig. 5b are sectional views thereof, Fig. 6 is an example of the configuration of a rubber stopper of a vacuum blood collection tube, Fig. 6a is a plan view thereof, Fig. 6b is a sectional view thereof, and Fig. 7 is a blood sampling tube of the present invention. A sectional view of an auxiliary device. FIGS. 8 and 9 are cross-sectional views showing a state in which blood is collected using the blood sampling aid shown in FIG. 7, FIG. FIG. 12 is a sectional view showing details of the ribs of the blood collection aid of FIGS. 10 and 11. FIG. Explanation of symbols 1...Reduced pressure blood collection tube, 2...Tube body, 3...Bung body, 4
... Rubber stopper, 5 ... Internal space, 6 ... Vacuum blood collection tube holder, 7 ... Threaded part, 8 ... Puncture needle, 8a ...
・Tip, 8b... Rear end, 9... Holder main body, 10
...Rubber tip. 21.22... recess, 30... rubber stopper, 31...
Rib, 32... Re-sealing part, 33... Groove, 34...
・Slit, 40...Rib FIG, 1/no. FIG, 4a FIG, 5a
FIG, 4b FIG, 5b FIG, 7 FIG, 8 FIG, 9

Claims (5)

[Claims] (1) A blood sampling aid having a female part into which a blood collecting instrument having a male part can be inserted detachably, the blood collecting instrument comprising a blood collecting container having an opening in the male part, and the blood collecting aid. The female part includes an elastic plug provided in the opening that can be penetrated by a hollow needle protruding into the female part, and a depressurized space in the container. When the elastic sheath, which is pierced by a needle and opens and closes the fluid passage of the hollow needle, is compressed in the axial direction of the hollow needle, the plug body prevents the pierced plug from retreating due to the repulsive force of the sheath body. A blood sampling aid characterized by being provided with a locking portion that engages with an outer surface or an outer surface of a blood sampling device. (2) The blood collection aid according to claim 1, wherein the locking portion is a protrusion provided on the inner surface of the female portion. (3) The blood collection aid according to claim 1, wherein the plug has a compression set of at least 40%. (4) An intermediate portion of a hollow needle having pointed ends at both ends is supported by a closed portion of a tubular body whose one end is closed, and an opening portion of the needle portion on the tubular body side that communicates at least the inside of the needle with the outside is connected to an elastic sheath. The opening of the blood collection container was closed with an elastic stopper at the opening of the other end of the tubular body of the blood collection aid enclosed in the axial direction of the supporting side of the needle, and the internal space of the blood collection container was depressurized. A blood sampling device is inserted, and the hollow needle is pierced through the elastic plug of the blood sampling device against the elastic repulsive force of the elastic sheath of the blood sampling aid, and the hollow needle pushes the elastic plug into the blood sampling device. When the blood sampling aid penetrates into the internal space of the blood collecting container, the blood collecting aid engages with the stopper or the outer surface of the blood collecting container with the locking portion formed on the inner surface of the blood collecting aid. Collect blood into the blood sampling device while preventing it from being pushed back by elastic repulsive force, and after blood collection, move the blood sampling device against the engagement force between the locking portion on the outer surface of the blood sampling container and the inner surface of the blood sampling aid. A method for blood sampling, characterized in that the blood sampling aid is removed from the blood sampling aid. (5) The blood sampling method according to claim 4, wherein the plug has a compression set of at least 40%.