JP2000225110A - Stabbing tool - Google Patents

Abstract

PROBLEM TO BE SOLVED: To sample blood in a short time after stabbing by a simple operation by continuously or simultaneously performing stabbing by a stabbing needle and reducing pressure in the housing by operation of suction plunger, and causing operation of a stabbing plunger by movement of the suction plunger. SOLUTION: When a pressing force is applied to an operating member 40, a seal member 41 deforms to open a vent 42, and an air release valve 7 opens so that inside and outside of a second space 21 communicate with each other. A gasket 34 is pressed in to the tip direction of the second space 21 to release a first coil spring 4, and a plunger 3 for stabbing moves to the tip direction to stab. When the pressing pressures on a suction plunger 5 and the operating member 40 are released while the tip is pressed on skin, the gasket 34 moves to the base end direction by the action of a second coil spring 6, a first space 22 in a stabbing housing 10 and the second space 21 in the suction housing 11 decrease the pressure to suck out body fluid. When only the operating member 40 is pressed, an air release means 7 opens to release the reduced pressure state.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a puncture device for collecting a required amount of bodily fluid by inserting a puncture needle into a fingertip or the like as a bodily fluid collecting method for performing a clinical examination or the like of a bodily fluid.

[0002]

2. Description of the Related Art With the increase in the number of diabetic patients in recent years, autologous blood glucose measurement for monitoring daily fluctuations in blood glucose level has been recommended. The measurement of the blood glucose level is performed by mounting a test paper that develops a color according to the amount of glucose in the blood, supplying the blood to the test paper, developing the color, and optically measuring the degree of the coloration ( The measurement is performed using a blood glucose measurement device that quantifies the blood glucose level by performing colorimetry. As a method of collecting blood for measuring the blood glucose level, after puncturing the skin of the fingertip using a puncture needle or a puncture tool equipped with a lancet-like lancet, pressing around the puncture portion with a finger or the like. Squeezing blood is performed.

[0003] However, the fingertips are concentrated in capillaries and are suitable for collecting blood. On the other hand, the nerves are also concentrated and painful, so that the pain and burden on the patient is great.
In addition, there are many patients who cannot continue self-blood glucose measurement due to fear of puncturing. For this reason, a method of performing a salvage from the upper arm and abdomen, which is said to have relatively little pain, and a method of relieving pain caused by pressure on the affected part when squeezing blood by sucking around the puncture part and sucking blood are performed. .

A conventional puncture device is disclosed in Japanese Patent No.
JP-A-63-197197 and JP-A-8-598. These puncture tools consist of a lancet holder for mounting a lancet having a puncture needle in a housing, and a plunger having a gasket that slides along the inner wall of the housing. Release the plunger pressure,
Blood is drawn from the puncture site on the skin by utilizing the fact that the inside of the housing is sucked and negative pressure is generated as the plunger retracts in the proximal direction.

However, since such a conventional puncture device does not have a mechanism for returning the inside of the housing to the atmospheric pressure after sucking blood by negative pressure, the distal end surface of the housing that is attracted to the fingertip is moved from the fingertip. At the time of peeling, there is a problem that the air suddenly flows in from the tip portion, that is, the portion where the sucked blood droplet exists, and the blood may be scattered by the impact.

It is conceivable that the plunger is pressed again to return the inside of the housing to the atmospheric pressure. However, the puncture needle also moves forward in the distal direction, and if the plunger is pushed too much, the fingertip may be pushed. Lack of safety due to re-puncture. In order to prevent such a double puncture, the amount of pushing of the plunger must be finely adjusted, and the operability is extremely poor.

[0007]

SUMMARY OF THE INVENTION It is an object of the present invention to provide a puncture device which can collect blood in a short time after puncture with a simple operation, does not cause blood to scatter, and is highly safe. And

[0008]

The above objects are achieved by the present invention described below. (1) The present invention relates to a puncture device for collecting a bodily fluid by puncturing a body surface with a puncture needle, wherein the puncture device has a housing having an opening at a distal end, and a puncture needle attached to the distal end. A puncturing plunger movable in the housing, first urging means for urging the puncturing plunger in a distal direction, and a sealing member having airtightness, wherein the housing is moved in a proximal direction. A suction plunger for depressurizing the inside, a second urging means for urging the suction plunger to move, and when the inside of the housing is in a depressurized state, the inside of the housing is opened to the atmospheric pressure. And an operation for performing at least the puncture by the puncture needle and the depressurization in the housing by the operation of the suction plunger in this order continuously or simultaneously. Has a step, operation of the puncture plunger is puncture device, characterized in that due by the movement of the suction plunger.

(2) The present invention has a first locking portion for locking the puncture plunger to the housing while being urged by the first urging means, wherein the first locking portion is provided. Is released by the movement of the suction plunger against the urging of the second urging means or the movement by the urging of the second urging means, and the puncturing plunger moves in the distal direction to puncture. The puncture device according to the above (1), wherein

(3) The present invention has a second locking portion for locking the suction plunger to the housing while being urged by the second urging means. Is released, the suction plunger is moved, and the movement releases the lock of the first locking portion, and the inside of the housing is depressurized. The puncture device according to 2).

(4) In the present invention, a first space in which the puncturing plunger moves and a second space in which the suction plunger moves are provided in parallel in the housing via a side hole. The puncture device according to any one of (1) to (3) above. (5) The present invention is the puncture device according to any one of (1) to (4), wherein the first locking portion is locked in the side hole to lock the puncture plunger in the housing. is there.

(6) According to the present invention, the air release means may move while the suction plunger is released until the suction plunger releases the locking of the first locking portion, and / or the suction plunger may be moved to the second position. The puncture device according to any one of (1) to (5), wherein the housing is opened to the atmosphere after being moved by the urging means. (7) In the present invention, the suction plunger has a ventilation path communicating between the inside and the outside of the housing, and the atmosphere opening means is provided in the ventilation path.
A puncture device according to any one of (1) to (6).

(8) In the present invention, the housing has a communication hole communicating between the inside and outside of the second space, and the atmosphere opening means is provided in the ventilation hole.
A puncture device according to any one of (1) to (6). (9) The present invention is the puncture device according to any one of (1) to (8), wherein the atmosphere opening unit is configured by a one-way valve.

(10) The present invention is the puncture device according to any one of (1) to (9), further including an adjusting mechanism for adjusting a depth at which the puncture needle punctures the body surface. (11) The present invention is the puncture device according to any one of (1) to (10), wherein the adjustment mechanism controls movement of the puncture plunger in a distal direction. (12) The present invention is the puncture device according to any one of (1) to (10), wherein the adjusting mechanism controls an axial length of the housing.

(13) The invention according to (1) to (12), wherein the direction of movement of the suction plunger for causing the operation of the puncture plunger is different from the direction of the one-way valve. It is the puncture device described. (14) The present invention has an operating means for moving the suction plunger to cause the operation of the puncturing plunger, and the operating direction of the operating means and the direction of the one-way valve are different. A puncture device according to any one of (1) to (13) above.

(15) In the present invention, the puncture needle is accommodated in a cap connectable to an opening at a tip of the housing so as to be movable in a longitudinal axis direction, and the cap is inserted into an opening at a tip of the housing. The puncture device according to any one of (1) to (14), wherein when connected, the puncture device is connected to the plunger while being housed in the cap. In addition,
In any of the puncture devices of the present invention, the direction in which the suction plunger is urged and moved by the second urging means may be the distal direction or the proximal direction.
The body fluid particularly refers to blood.

[0017]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Two embodiments of the present invention will be described below with reference to the drawings. Note that in all drawings, the upper side is described as a “base end” and the lower side is described as a “distal end”.

[1] The first embodiment of the present invention will be described in detail. FIG. 1 is a sectional view showing a puncture device 1A which is an example of the puncture device of the present invention, and FIGS. 1 to 5 are sectional views showing a series of operating states thereof. As shown in FIG. 1, the puncture device 1A includes a housing 2, a puncture plunger 3, a first coil spring 4 as first urging means for urging the puncture plunger 3 in a distal direction, and a suction device. Plunger 5
A second coil spring 6 as second urging means for urging the suction plunger 5 in the proximal direction;
And an adjusting mechanism 9 for adjusting the puncturing depth.

The puncture housing 10 has a first space 22 in which the puncture plunger 3 moves,
And a suction housing 11 having a second space 21 in which the suction plunger 5 moves. Puncture housing 1
0 and the suction housing 11 are provided in parallel, and the first space 22 and the second space 21 are configured to communicate with each other through the side holes 12. Puncture housing 10
Has an opening at its tip, and a cap 13 is detachably attached to the tip. Note that the housing 2 and the cap 13 are made of a material that does not substantially transmit air. Further, a sealing 14 made of an elastic material is interposed between the tip of the puncture housing 10 and the cap 13,
The cap 13 is hermetically attached to the housing 2.

The cap 13 is a portion that comes into contact with the surface of a living body, such as a fingertip, upper arm, abdomen, thigh, and earlobe, and has a cylindrical tip 15 formed at the tip. The opening diameter (opening area) of the distal end portion 15 is adjusted so that suction blood collection can be performed well regardless of individual differences such as gender and age, and the puncture site. Specifically, the opening diameter of the distal end opening 15 is preferably about 4 to 10 mm, and particularly preferably about 4 to 6 mm when the puncture site is a finger or an earlobe.

Further, the distal end portion 15 relieves pain at the time of puncturing by stimulating the vicinity of the puncturing portion when pressed against the surface of the living body (skin), and furthermore, the cap 13 when the inside of the housing 2 is decompressed. It is suitable for preventing air from flowing into the housing 2 from between the body and the living body surface. It is preferable that the cap 13 and the distal end portion 15 are made of a transparent or colored transparent material in order to secure the visibility of the inside, and particularly to visually confirm the bleeding state after the puncture.

A lancet 16 having a puncture needle 8 is attached (fitted) to the puncture plunger 3 via a cup-shaped needle holder 17 provided at the tip thereof. This needle holder 17
, The lancet 16 is detachably mounted. Also,
The puncture plunger 3 is fixed near its base end,
An elastically deformable elastic piece 19 extending in the distal direction is provided. Further, the elastic piece 19 is provided with a protruding first locking portion 18 at its tip.

The first locking portion 18 is urged by the elastic force of the elastic piece 19 to contact the wall portion 20 (shown in FIG. 1).
When the puncture plunger 3 is moved against the biasing direction of the first coil spring 4 and reaches the position of the side hole 12 formed in the wall portion 20, the puncture plunger 3 is inserted into the side hole 12 and the second Part thereof projects into the space 21 (shown in FIG. 2). Thereby, the movement of the puncture plunger 3 in the distal direction is restricted. At this time, the first coil spring 4 is in a compressed state, and is fixed in a state of urging the puncture plunger 3 in the distal direction.

The first coil spring 4 has its distal end fixed to the proximal end of the puncturing plunger 3 and its proximal end fixed to the puncturing housing 10 via the inner cylinder 29, and the shaft 25 is inserted through the inside thereof. Is provided. The coil spring 4
Release the regulation and extend the puncture plunger 3
It is desirable to set the elastic coefficient so that the puncture needle 8 does not puncture the living body surface again during the damping movement after the puncture needle 8 punctures the living body surface by moving the needle in the distal direction.

Further, protrusions 23 are formed near the distal end and the proximal end of the side portion of the puncture plunger 3, respectively. Both projections 23 are inserted into guide grooves 24 formed on the inner surface of puncture housing 10. Thereby, the puncture plunger 3 moves in the axial direction along the guide groove 24, that is, in a stable state without swinging in the axial rotation direction in the puncture housing 10.

The suction plunger 5 is provided with a gasket 34 at the tip thereof, and slides in the second space 21 of the suction housing 11 in an airtight manner. The gasket 34 may be formed integrally with the suction plunger 5, or may be provided and fixed as a separate member. Further, it is desirable to provide a second O-ring 35 made of an elastic material in the circumferential direction of the outer periphery of the gasket 34. The suction plunger 5 is provided with a ventilation path 39 inside and a vent opening means 7 at the base end.

The suction housing 11 is provided with a flange-shaped first flange 36 at the center. The suction plunger 5 is inserted through the center opening of the first flange 36. The first flange 36 has a function of restricting the movement of the gasket 34 in the proximal direction, and the second coil spring 6
It also has a function as a spring seat. The suction housing 11 is provided with a shielding member 38 at the tip, and
Shield. The first flange 36 and the shielding member 38
May be formed integrally with the suction housing 11, or may be provided and fixed as a separate member.

The second coil spring 6 has the distal end fixed to the first flange 36 and the proximal end fixed to the second flange 37 at the proximal end of the suction plunger 5, so that the suction plunger 5 can pass through the inside thereof. It is provided in. Second coil spring 6
Urges the suction plunger 5 in the proximal direction by its elasticity.

The open-to-atmosphere means 7 has a U-shaped operating member 40 in plan view (FIG. 6), as shown in FIG.
Seal member 41 fixed in the distal direction of operation member 40
And a seal member ventilation path 41 a provided near the center of the seal member 41, a pipe 43 having a vent 42, and a casing 48 for protecting these. FIG. 7 shows a state in which the atmosphere opening means 7 is closed.

The seal member 41 is made of a deformable and elastic material, and has a fitting portion 44 formed therein.
The fitting portion 44 is fixed to a part of the operation member 40. The proximal ends of the sealing member 41 and the suction plunger 5 are
It is desirable that the fixing member 41 is fixed by a fixing surface 41d located on the opposite side of the fitting portion 44 with respect to the sealing member ventilation path 41a. The pipe body 43 is inserted into and fixed to the ventilation path 39 in the distal direction, and the large-diameter section 45 in which the ventilation path 39 and the ventilation port 42 communicate with each other, the small-diameter section 46 closed in the proximal direction, and an intermediate portion between them. Is provided. The tapered portion 47 is formed with a vent 42 that communicates the inside and outside of the tube 43. The small-diameter portion 46 and the tapered portion 47 of the tube body 43 are sandwiched and in close contact with the seal member ventilation path 41a of the seal member 41 over the entire circumference thereof.

Next, the operation of the atmosphere opening means 7 will be described. When no pressing force is applied to the operation member 40, the ventilation port 42 of the tube 43 is shielded by the seal member 41 (the cross section is shown in FIGS. 7 and 8). When a pressing force acts on the operation member 40 in the direction of A in FIG. 9 (partial sectional view), the direction of the force is changed to the direction of B by the fixing base 49, and the seal member 41 is moved by the fitting portion 44 of the operation member 40. B is deformed by being pulled in the direction of B,
Is expanded, the vent 42 is opened, and the atmosphere release valve 7 is opened.

As shown in FIG. 10, when the atmosphere release valve 7 is open, the ventilation path 39, the ventilation port 42, and the sealing member ventilation path 41a communicate with each other, and the air inside and outside the second space 21 flows. It becomes possible. At this time, even if the operation member 40 is pressed with a finger, the operation member 40 has a U-shape in plan view (FIG. 6), and the seal member ventilation path 41a is formed through the U-shape opening 40a. The air escaping from is released. If that is not enough, the sealing member 4
1 may be provided with a seal member side hole 41b and the casing 48 may be provided with a casing side hole 48a. Seal member side hole 41
“b” is closed at a portion of the tube 43 where the vent 42 is not provided when the atmosphere release valve 7 is closed. Thereafter, when the pressing force acting on the operation member 40 is released, the seal member 4 is released.
1 returns to its original state due to its restoring force, and the atmosphere release valve 7 is closed. Further, depending on the material constituting the seal member 41, the seal member 41 extends in the direction B, so that a small gap may be formed in the seal member base end surface 41c, and the seal member 41 flows out from the base end of the seal member ventilation path 41a. The air is also released from there.

The adjusting mechanism 9 includes a shaft 25, a movable member 2
6 and an inner cylinder 29. FIG. 12 shows a partially enlarged cross-sectional view thereof. The inner cylinder 29 is provided inside the puncture housing 10 and has a shape in which a cylindrical portion 29b is connected to a base 29a extending toward the center of the puncture housing 10 in a rear end direction. The base 29a and the cylindrical portion 29b are provided by being integrally molded or fixed with the puncture housing 10. The cylindrical member 29b is provided with a movable member axis movement adjusting protrusion 29c and a movable member rotation adjusting protrusion 29d.

The shaft 25 is fixed to the base end of the puncture plunger 3 through the inner cylinder 29, and moves in the puncture housing 10 in the axial direction together with the puncture plunger 3 in a stable state. Note that the shaft 25 is provided with a locking portion 31 for stopping movement. The movable member 26 is inserted into the puncture housing 10 except for an uninserted portion,
Is fitted. It should be noted that a shaft 25 is inserted through the inside thereof, and a first stopper 32 is provided.
9, the movable member shaft movement adjusting protrusion 29c
Groove 30a spirally formed in the circumferential direction in which
And a plurality of grooves 30b intermittently provided in the circumferential direction to be fitted with the movable member rotation adjusting protrusion 29d.

The adjusting mechanism 9 is arranged such that the stop portion 31 for stopping movement provided on the shaft 25 and the first stopper 32 provided on the movable member 26 come into contact with each other, so that the puncture plunger 3 to which the shaft 25 is connected can be moved in the distal direction. To control the movement to. That is, by controlling the movement of the puncture plunger 3 in the distal direction, the puncture housing 1 is controlled.
The puncture depth of the puncture needle 8 protruding from the opening at the tip of the zero can be adjusted. The adjustment of the moving distance of the puncture plunger 3 is achieved by rotating the uninserted portion of the movable member 26 around an axis.
By relatively moving the spirally formed groove 30a and the movable member axis movement adjusting protrusion 29c, the movable member 2
6 moves in the axial direction, and accordingly, the movement stopping locking portion 31
This is performed by moving a position where the first stopper 32 and the first stopper 32 come into contact with each other. The movable member rotation adjusting projection 29d
By means of the groove 30b, the axial rotation of the uninserted portion of the movable member 26 can be performed stepwise, that is, the movement of the puncture plunger 3 in the distal direction can be performed stepwise.

A spacer 2 is provided between the shaft 25 and the inner cylinder 29 to smoothly and surely slide the shaft 25.
8 are desirably provided. The fixing between the base end of the first coil spring 4 and the inner cylinder 29 is performed by the first coil spring 4.
The fixing may be performed by fixing the spacer 28 and the spacer 28.

A first O-ring 33 is fitted in the outer circumferential surface of the movable member 26 in the circumferential direction. Thereby, the airtightness of the first space 22 is maintained regardless of the position of the movable member 26 in the axial direction, and the space 22 can be maintained in a reduced pressure state.

In the present embodiment, the cap 13
As another form, there is a form such as a cap 13b of which a cross section of a tip portion is shown in FIG. That is,
The cap 13b accommodates a lancet 16b that can slide inside the cap and connects the puncture needle 8b to one end. The lancet 1 is connected to the puncture housing 10 by connecting the cap 13b to the puncture housing 10.
Needle holder 17 of puncturing plunger 3b at the other end of 6b
b. Thereafter, it can be used in the same manner as the method of use of the present embodiment described later.

In the present embodiment, the sealing 14, the first O-ring 33, the second O-ring 35, and the sealing member 4
Numerals 1 are each made of an elastic body. Examples of such an elastic body include natural rubber, isoprene rubber, butadiene rubber, styrene butadiene rubber, nitrile rubber, chloroprene rubber, butyl rubber, acrylic rubber, ethylene-propylene rubber, hydrin rubber, urethane rubber, silicone rubber, and fluoro rubber. Such as various rubber materials and styrene, polyolefin, polyvinyl chloride,
Various thermoplastic elastomers such as polyurethane, polyester, polyamide, polybutadiene, and fluoro rubber are exemplified. For each of the other components, a hard plastic, metal, or the like can be appropriately used.

Next, a method of using the puncture device 1A will be described. After removing the cap 13 from the puncture housing 10 and attaching the lancet 16 to the needle holder 17, the needle holder 17 is pushed into the puncture housing 10 until the first locking portion 18 engages with the side hole 12, and the cap 13 is attached. . The state at this time is shown in FIG. At this time, the first coil spring 4 is held in a compressed state. By adjusting the rotation direction and the amount of rotation of the movable member 26 with respect to the puncture housing 10, the length of the puncture needle 8 protruding from the distal end portion 15 of the cap 13, that is, the puncture depth of the puncture needle 8 into the skin 27 is preset. You.

As shown in FIG. 3, when the distal end portion 15 of the cap 13 is pressed against the puncture site of the skin 27 of the subject, the operating member 40 of the air release means 7 is pushed in, and when the plunger 5 for suction is further pushed in, the gasket 34 is sucked. It is pushed in toward the tip of the housing 11. The gasket 34 moves hermetically in the suction housing 11 by the second O-ring 35. Since the operating member 40 is located at the base end of the second flange 37 and the casing 48, the operating member 40 is necessarily pushed when the suction plunger 5 is pushed.

When a pressing force acts on the operating member 40, the fitting portion 44 is pulled in the direction B to deform the seal member 41, as shown in FIG. 9, the seal member air passage 41a is expanded, and the air vent 42 is opened. Then, the atmosphere release valve 7 is opened, and the inside and outside of the second space 21 communicate with each other through the ventilation path 39, the ventilation port 42, and the sealing member ventilation path 41a as shown in FIG. Therefore, when the suction plunger 5 is pushed, the second space 21 does not become positive pressure, and the suction plunger 5 can be pushed without resistance.

Then, the gasket 34 is
The gasket 34 or the second O-ring 35 pushes out a part of the first locking portion 18 protruding from the side hole 12 into the second space 21 so that the first engagement portion 18 By releasing the engagement of the stopper 18, the compressed first coil spring 4 is released, and the puncture plunger 3 is released.
Is moved toward the tip. Thereby, as shown in FIG. 3, the puncture needle 8 protrudes from the distal end portion 15 of the cap 13 and punctures the skin 27.

At this time, the movement of the puncture plunger 3 in the distal direction is restricted by the contact between the movement stopping locking portion 31 provided on the shaft 25 and the stopper 32 provided on the movable member 26. The puncture depth of the puncture needle 8 into the skin is kept constant. After the puncture needle 8 punctures the skin 27, the first coil spring 4 returns to its natural length through a damping motion, whereby the puncture needle 8 comes off from the surface of the skin 27,
It is stored inside the tip 15 of the cap 13. As described above, the puncture needle 8 does not protrude from the distal end portion 15 except at the moment of puncturing, so that the puncture needle 8 does not injure the skin or the like accidentally and can prevent infection. can get.

When the pressing of the suction plunger 5 and the operating member 40 is released while the distal end portion 15 of the cap 13 is pressed against the skin 27, the gasket 34 is formed via the suction plunger 5 by the action of the second coil spring 6. Move toward the end. Accordingly, as shown in FIG. 4, the first space 22 in the puncture housing 10 and the suction housing 1
The pressure in the second space 21 in 1 is reduced, and the body fluid is sucked out from the puncture site of the skin 27. In addition, the minimum pressure in the first space 22 and the second space 21 when the pressure is reduced is -300 mm.
Hg or less is preferable. Thus, a required amount of bodily fluid can be discharged in a short time.

During the above-mentioned use, if the inside of the first space 22 and the inside of the second space 21 are not sufficiently decompressed due to, for example, the distal end portion 15 of the cap 13 separating from the skin 27, etc. Can perform the suction operation again. That is, the operating member 40 is pushed again, and the suction plunger 5 is pushed again, and the interlocking gasket 34 is pushed again to the distal end direction. Then, the pressing force is released and the gasket 34 is moved in the proximal direction by the second coil spring 6. To the second space 21 and the second space 21 again.
The inside can be in a reduced pressure state, and the bodily fluid can flow out from the puncture site of the skin 27. At this time, since the engagement of the first locking portion 18 is released, the puncture is not performed again. Further, the re-suction by this process can be repeated any number of times.

Finally, after confirming the outflow of bodily fluid, only the operating member 40 is pressed with a pressing force that does not push the suction plunger 5 while the tip portion 15 of the cap 13 is in contact with the skin 27. Thereby, as shown in FIG. 5, the air release means 7 is opened according to the above-described operation principle, and outside air flows into the first space 22 in the puncture housing 10,
The reduced pressure state is released. At this time, the position of the atmosphere opening means 7 into which the outside air flows and the position of the distal end portion 15 of the cap 13 are considerably separated, and the ventilation path 39 and the like are separated from the first space 22.
And since it is narrower than the second space 21 and the inflow of the outside air is not performed rapidly, the body fluid flowing out to the skin 27 does not scatter.

When it is confirmed that the suction feeling of the skin 27 has disappeared and the inside of the first space 22 and the inside of the second space 21 have returned to the atmospheric pressure, the puncture device 1A is separated from the skin 27 and the body fluid on the skin 27 is collected. . The collection of the bodily fluid is performed, for example, by directly supplying the bodily fluid onto the test paper, or by sucking it through a thin tube and supplying it to the test paper.

[2] A second embodiment of the present invention will be described. FIG. 13 shows a puncture device 1B which is an example of the puncture device of the present invention.
13 to 18 are cross-sectional views showing a series of operating states. Hereinafter, puncture device 1B will be described focusing on the differences from puncture device 1A described above, and description of the same items will be omitted. As shown in FIG. 13, the puncture device 1B includes a housing 2, a puncture plunger 3, a first coil spring 4 as first urging means for urging the puncture plunger 3 in a distal direction, and a suction device. The plunger 5 includes a second coil spring 6 as second urging means for urging the suction plunger 5 in the proximal direction, an atmosphere opening means 66, and an adjusting mechanism 9 for adjusting the puncture depth. . The puncture device 1B performs a preliminary operation of the suction means in advance to perform puncture and suction at the same time.

A pressing member 50 is fixed to the base end of the suction plunger 5. At the side end of the pressing member 50,
A second locking portion 51 for restricting the movement of the suction plunger 5 in the proximal direction is formed. The pressing member 50
Has also a function as a spring seat of the second coil spring 6.

The second coil spring 6 is a plunger 5 for suction.
Of the first flange 36 and the pressing member 5 at the base end of the suction plunger 5, respectively.
The suction plunger 5 is urged in the proximal direction by its elasticity.

The distal end of the second space 21 is shielded by a shielding member 52. The shielding member 52 is provided with a shielding member vent 53, and a cap-shaped one-way valve 54 is installed so as to close the shielding member vent 53. The one-way valve 54
Although it is possible to discharge the air in the second space 21 to the outside through the shielding member vent 53, on the contrary, the second space 2
1 has a function of preventing the introduction of air through the shielding member vent 53, and is desirably made of a deformable elastic material.

The suction means in this embodiment is operated by the operation means 55. The operating means 55 includes a second stopper 57 installed rotatably about a first fulcrum 56 with respect to the housing 2, and a second stopper control spring 58 for urging the second stopper 57 counterclockwise (in the drawing). A fixing portion 62 that determines the maximum rotation position of the second stopper in the counterclockwise direction; a first lever 59 that rotates about the second fulcrum 60 with respect to the housing 2; a second stopper 57 and a first lever 59 Are connected to each other. The second stopper 57 is provided with a claw 63 for locking the second locking portion 51. In a state where the first lever 59 is not touched with the hand, the pawl 63 projects from the opening 65 formed in the wall portion 64 by the urging force of the second stopper control spring 58 and is engaged with the second locking portion 51. (Shown in FIG. 14) or in a lockable state.

This operating means may not have the connecting member 61, and in that case, a lever portion may be provided on the shaft of the second stopper 57 on the side where the claw 63 is not provided (the side connected to the connecting member 61). . At this time, to release the second locking portion 51, the lever is rotated so as to be tilted in the proximal direction. Thus, the puncture direction of the puncture needle 8 and the direction of the operation for puncturing are different, so that the force of the operation is not related to the skin 27 to be punctured, so that a stable puncture can be performed and the puncture depth as set can be achieved. As well as being realized, the fear of puncturing is reduced.

The operating means 55 operates the pressure reducing means, and in conjunction therewith, can operate the puncturing means almost simultaneously. That is, as shown in FIG. 15, when the first lever 59 is rotated so as to be tilted in the distal direction, the connecting member 61 moves in the proximal direction, and accordingly, the second stopper 57 rotates clockwise (in the figure). As a result, the engagement between the claw 63 and the second locking portion 51 is released, and when the suction plunger 5 moves in the proximal direction, immediately after that, it is locked in the side hole 12 and protrudes into the second space 21. The first locking portion 18 is pressed by the gasket 34 and pushed back to the first space 22 side, and the engagement between the first locking portion 18 and the side hole 12 is released. As a result, the puncture plunger 3 moves in the distal direction, the puncture needle 8 punctures the skin 27, and the inside of the second space 21 and the inside of the first space 22 are brought into a reduced pressure state.

The reduced pressure state in the second space 21 and the first space 22 caused by the pressure reducing means can be released by the atmosphere opening means 66. The atmosphere releasing means 66 includes a second lever 68 rotatably mounted on the housing 2 about a third fulcrum 67 and an atmosphere releasing means for urging the second lever 68 in a counterclockwise direction (in the drawing). It comprises a control spring 69 and a pull wire 70. A button 71 projecting out of the housing 2 is formed at one end of the second lever 68, and a hook 72 is formed at the other end of the second lever 68. One end of the pull wire 70 is hooked on the hook 72, and the other end is fixed to the edge of the one-way valve 54.

When the button 71 is not touched,
As shown in FIG. 13, almost no tension acts on the pulling wire 70 due to the urging force of the air release control spring 69, and the one-way valve 54 has the above-described function. As shown in FIG. 18, inside the second space 21 and the first space 22
When the button 71 is pressed with a finger or the like in a decompressed state, the second lever 68 rotates clockwise against the urging force of the atmosphere release means control spring 69, and tension acts on the pulling wire 70,
The edge of the one-way valve 54 is pulled and deformed in the distal direction. As a result, the outside air flows into the second space 21 and the first space 22 through the shielding member vent 53, and reaches the atmospheric pressure.

In this embodiment, the cap 13
As another form, there is a form such as a cap 13b of which a cross section of a tip portion is shown in FIG. That is,
The cap 13b accommodates a lancet 16b that can slide inside the cap and connects the puncture needle 8b to one end. The lancet 1 is connected to the puncture housing 10 by connecting the cap 13b to the puncture housing 10.
Needle holder 17 of puncturing plunger 3b at the other end of 6b
b. Thereafter, it can be used in the same manner as the method of use of the present embodiment described later.

In the present embodiment, the sealing 14, the sealing 14b, the first O-ring 33, the second O-ring 3
5 and the one-way valve 54 are each formed of an elastic body. Examples of such an elastic body include natural rubber, isoprene rubber, butadiene rubber, styrene butadiene rubber, nitrile rubber, chloroprene rubber, butyl rubber,
Various rubber materials such as acrylic rubber, ethylene-propylene rubber, hydrin rubber, urethane rubber, silicone rubber, fluorine rubber, and styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, and fluorine rubber And various kinds of thermoplastic elastomers. For each of the other components, a hard plastic, metal, or the like can be appropriately used.

Next, a method of using the puncture device 1B will be described. By adjusting the direction and amount of rotation of the movable member 26 with respect to the puncture housing 10, the length of the puncture needle 8 protruding from the distal end portion 15, that is, the skin 2 by the puncture needle 8.
The puncturing depth to 7 is set in advance. The pressing member 50 is pressed, and the gasket 34 is pushed in through the suction plunger 5 in the distal direction. At this time, the gasket 34 moves hermetically in the suction housing 11 by the second O-ring 35. Further, with the movement of the suction plunger 5 in the distal direction, the air in the second space 21 is discharged to the outside through the side hole 12, the first space 22, and the distal end portion 15, and the gasket 34 is After passing through, the shielding member vent 53
Is discharged through.

After that, the gasket 34 is moved to the shielding member 52.
The second locking portion 5 of the pressing member 50
1 is locked when it is located beyond the claw 63 while pushing the claw 63 against the bias of the second stopper control spring 58, and the second coil spring 6 is held in a compressed state. At this time, it is desirable that the gasket 34 does not come into contact with the shielding member 52 but stays at a position closest to about 0.5 to 2 mm. Thus, the preparation for the operation of the pressure reducing means is completed.

After removing the cap 13 from the puncture housing 10 and attaching the lancet 16 to the needle holder 17, the needle holder 17 is punctured until the first locking portion 18 engages with the side hole 12, as shown in FIG. Push into housing 10. At this time, the first coil spring 4 is held in a compressed state. In this state, preparation for puncturing is completed.

When a force in the distal direction is applied to the first lever 59, as shown in FIG. 15, the connecting member 61 is pushed in the proximal direction, and the second stopper 57 receives the urging force of the second stopper control spring 58. Rotate clockwise (in the figure) in opposition,
The pawl 63 retreats from the opening 65 and is disengaged from the second locking portion 51, and the suction plunger 5 is urged by the second coil spring 6 to start moving in the proximal direction. At this time, the second space 2
1 and the first space 22 communicating therewith are the sealing 1
4. First O-ring 33, second O-ring 35, and skin 2
7, and the inflow of outside air from the shielding member vent 53 is prevented by the action of the one-way valve 54, so that the suction plunger 5 moves in the proximal direction. The pressure inside the second space 21 and the second space 22 is reduced, and the second space 21 and the second space 22 are reduced in pressure.

When the suction plunger 5 starts moving in the proximal direction, immediately after that, the gasket 34
When the gasket 34 passes through the gasket 2, the gasket 34 comes into contact with the first locking portion 18 engaged with the side hole 12, and is pushed back to the first space 22 side as shown in FIG. Thereby, the first locking portion 18
Is released, and the puncture plunger 3 moves in the distal direction by the elastic force of the compressed first coil spring 4,
The puncture needle 8 protrudes from the tip portion 15 of the cap 13 and
As shown in FIG. 7, the surface of the skin 27 is punctured.

At this time, the movement of the puncture plunger 3 in the distal direction is restricted by the contact between the movement stopping locking portion 31 provided on the shaft 25 and the stopper 32 provided on the movable member 26. The puncture depth of the puncture needle 8 into the skin is kept constant. After the puncture needle 8 punctures the skin 27, the first coil spring 4 returns to its natural length through a damping motion, whereby the puncture needle 8 comes off from the surface of the skin 27,
It is stored inside the tip 15 of the cap 13. As described above, the puncture needle 8 does not protrude from the distal end portion 15 except at the moment of puncturing, so that the puncture needle 8 does not injure the skin or the like accidentally and can prevent infection. can get.

As described above, since the second space 21 and the second space 22 are in a decompressed state, the puncture site of the skin 27 located inside the distal end portion 15 of the cap 13 by the puncture needle 8 is sucked, and Blood is congested, and bodily fluid is sucked out from the puncture site. That is, the outflow of the body fluid is promoted as compared with the case where such suction is not performed. The minimum pressure in the first space 22 and the second space 21 when the pressure is reduced is preferably -300 mmHg or less. Thus, a required amount of bodily fluid can be discharged in a short time.

During the above-mentioned use, if the inside of the first space 22 and the inside of the second space 21 are not sufficiently decompressed due to, for example, the distal end portion 15 of the cap 13 separating from the skin 27, etc. Can perform the suction operation again. That is, the gasket 34 interlocked with the suction plunger 5 is pushed again to the distal end direction by pushing the pressing member 50 again, and then the second locking portion 51 is brought into the claw 6.
3 is engaged. Thereafter, when the first lever 59 is rotated to be tilted in the proximal direction, as described above, the engagement between the second locking portion 51 and the claw 63 is released, and the pressure can be reduced again.
At this time, since the engagement of the first locking portion 18 is released, the puncture is not performed again. Further, the re-suction by this process can be repeated any number of times.

Finally, when the outflow of bodily fluid is confirmed, the button 71 is pressed while the tip 15 of the cap 13 is in contact with the skin 27. As a result, as shown in FIG. 18, the second lever 68 rotates clockwise (in the figure) against the urging force of the atmosphere release means control spring 69, and the pulling wire 70
Then, the edge of the one-way valve 54 is pulled and deformed in the distal direction, and the outside air flows into the first space 22 in the puncture housing 10 through the shielding member vent 53, and the depressurized state is released. At this time, the outside air is supplied to the first lever 59 of the housing 2.
And the gap from which the second lever 68 is inserted, but the position and the position of the distal end portion 15 of the cap 13 are considerably separated from each other, and the gap is narrow, so that the inflow of outside air does not occur rapidly, The body fluid that has flowed to the skin 27 does not scatter.

When it is confirmed that the suction feeling of the skin 27 has disappeared and the inside of the first space 22 and the inside of the second space 21 have returned to the atmospheric pressure, the puncture device 1B is separated from the skin 27, and the body fluid on the skin 27 is collected. . The collection of the bodily fluid is performed, for example, by directly supplying the bodily fluid onto the test paper, or by sucking it through a thin tube and supplying it to the test paper.

[0070]

According to the puncture device of the present invention, after puncturing the skin,
In order to promote the outflow of bodily fluids, especially blood, a mechanism is provided for aspirating the area around the puncture part of the skin by reducing the pressure inside the housing of the puncture device. An air opening means is provided for releasing the reduced pressure state in the housing of the puncture device so as not to scatter the body fluid.

That is, the puncture device of the present invention can secure a sufficient amount of blood for measurement by puncturing the skin at a necessary and sufficient depth, and puncture the body without scattering body fluids and the like after puncturing. A series of operations from to the measurement can be performed. This makes it possible to reduce the pain at the time of puncturing and to perform the operation safely.

[Brief description of the drawings]

FIG. 1 is a cross-sectional view of a puncture device 1A according to the present invention.

FIG. 2 is a cross-sectional view showing an operating state of puncture device 1A.

FIG. 3 is a cross-sectional view showing an operating state of the puncture device 1A.

FIG. 4 is a sectional view showing an operating state of the puncture device 1A.

FIG. 5 is a sectional view showing an operating state of the puncture device 1A.

FIG. 6 is a plan view of the atmosphere opening means 7 of the puncture device 1A.

FIG. 7 is a vertical cross-sectional view of the atmosphere opening means 7 of the puncture device 1A.

FIG. 8 is a cross-sectional view of the atmosphere opening means 7 of the puncture device 1A.

FIG. 9 is a partial vertical cross-sectional view of an atmosphere opening means 7 of the puncture device 1A.

FIG. 10 is a vertical cross-sectional view showing an operation state of the atmosphere opening means 7 of the puncture device 1A.

FIG. 11 is a transverse cross-sectional view showing an operation state of the atmosphere opening means 7 of the puncture device 1A.

FIG. 12 is a partial vertical sectional view of an adjusting mechanism 9 for adjusting the puncturing depth of the puncture device 1A.

FIG. 13 is a sectional view of a puncture device 1B according to the present invention.

FIG. 14 is a sectional view showing an operating state of the puncture device 1B.

FIG. 15 is a sectional view showing an operating state of the puncture device 1B.

FIG. 16 is a sectional view showing an operating state of the puncture device 1B.

FIG. 17 is a sectional view showing an operating state of the puncture device 1B.

FIG. 18 is a sectional view showing an operating state of the puncture device 1B.

FIG. 19 is a cross-sectional view showing a cap 13b as another embodiment of the cap 13.

[Explanation of symbols]

1A / 1B puncture device, 2 housing,
Reference Signs List 3 puncture plunger, 4 first coil spring, 5 suction plunger, 6 second coil spring, 7 atmosphere opening means, 8 puncture needle, 9 adjustment mechanism, 10 puncture housing, 11 suction housing, 12 side hole, 13 cap, 14 sealing, 15 tip, 16 lancet, 17 needle holder, 18 first locking part, 19 elastic piece, 20
Puncture housing wall, 21 second space,
22 first space, 23 protrusion,
24 guide grooves, 25 shafts,
26 movable members, 27 skin,
28 spacer, 29 inner cylinder,
29a base, 29b cylindrical part,
29c Movable member shaft movement adjusting protrusion, 29d Movable member rotation adjusting protrusion, 30a Spirally formed groove, 30b
A plurality of grooves provided intermittently in the circumferential direction, 31 locking portions for stopping movement, 32 first stoppers, 33
1st O-ring, 34 gasket, 3
5 second O-ring, 36 first flange, 37 second flange, 38 puncturing housing shielding member, 39 air passage,
40 operation members, 40a U-shaped opening,
41 seal member, 41a seal member ventilation path,
41b seal member side hole, 41c seal member base end surface, 41d fixing surface, 42 vent,
43 pipe, 44 fitting part,
45 large diameter part, 46 small diameter part,
47 taper part, 48 casing,
49 fixing base, 50 pressing member,
51 second locking portion, 52 suction housing shielding member, 53 shielding member vent, 54 one-way valve,
55 operation means, 56 first fulcrum,
57 second stopper, 58 second stopper control spring, 59 first lever, 60 second fulcrum, 61 connecting member, 62 fixing portion, 63 claw, 64 wall portion,
65 opening, 66 atmosphere opening means,
67 Third fulcrum, 68 Second lever,
69 air release control spring, 70 traction wire, 71 button, 72 hook, 13b cap, 3b puncture plunger, 8b puncture needle, 14b sealing, 16b lancet,

Claims (9)

[Claims] 1. A puncture device for collecting a bodily fluid by puncturing a body surface with a puncture needle, wherein the housing has an opening at a distal end, and the puncture needle is mounted in the housing with the puncture needle mounted toward the distal end. A puncturing plunger that can move the puncturing plunger, a first urging unit that urges the puncturing plunger in a distal direction, and a sealing member having airtightness. A suction plunger for reducing the pressure, a second biasing means for biasing the suction plunger to move, and an atmosphere for releasing the inside of the housing to atmospheric pressure when the inside of the housing is in a reduced pressure state. Opening means; at least an operation of continuously or simultaneously performing puncturing by the puncture needle and depressurization in the housing by operation of the suction plunger in this order. A puncture device comprising means, wherein the operation of the puncture plunger is caused by movement of the suction plunger. A first locking portion for locking the puncturing plunger to the housing in a state where the puncturing plunger is urged by the first urging means; 2. The puncture plunger is released by the movement of the suction plunger against the urging of the second urging means or the movement by the urging of the second urging means, and the puncturing plunger moves toward the distal end to perform puncturing. The puncture device according to 1. 3. A second locking portion for locking the suction plunger to the housing while being urged by the second urging means, wherein the locking of the second locking portion is released. The puncture according to claim 1, wherein the suction plunger is moved by the movement, and the movement releases the lock of the first locking portion, and the interior of the housing is depressurized. 4. Utensils. 4. The air release means is moved until the suction plunger releases the locking of the first locking portion, and / or the suction plunger is moved by the second urging means. The puncture device according to claim 1, wherein the inside of the housing is opened to the atmosphere after performing. 5. The puncture device according to claim 1, wherein said atmosphere opening means is constituted by a one-way valve. 6. The puncture device according to claim 1, further comprising an adjusting mechanism for adjusting a depth at which the puncture needle punctures the body surface. 7. The puncture device according to claim 1, wherein the adjustment mechanism controls movement of the puncture plunger in a distal direction. 8. The puncture device according to claim 1, wherein the direction of the operating means for performing the puncturing operation is different from the direction of the operating means for performing the opening to the atmosphere. 9. The puncture needle is accommodated in a cap connectable to an opening at a distal end of the housing so as to be movable in a longitudinal axis direction, and when the cap is connected to an opening at a distal end of the housing, the cap is closed. The puncture device according to any one of claims 1 to 8, wherein the puncture device is connected to the plunger while being housed therein.