JP2000245717A - Puncture tool - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a puncture tool capable of safely and surely performing a puncture with a simple operation. SOLUTION: This puncture tool 1 is formed of a puncture needle cartridge 2, and a puncture tool body 10 having a tip to which the puncture needle cartridge 2 is attachably and detachably installed. The puncture tool body 10 comprises a lengthy housing 3, a plunger 5, a regulation part 6, a puncture operation part 7, a set operation part 8, a coil spring 91 for energizing the plunger 5 to the tip direction, and a coil spring 92 for energizing the plunger 5 to the base end direction. The housing 3 is formed of a housing body 30 and a cap-like member 4 provided on the base end part of the housing body 30. The ratio k1/k2 of the spring constant k1 of the coil spring 91 to the spring constant k2 of the coil spring 92 is preferably set to 1 or more.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for puncturing a living body surface such as a fingertip with a puncture needle to obtain a required amount of body fluid (blood) when examining a body fluid such as blood or interstitial fluid. Puncture device.

[0002]

2. Description of the Related Art In recent years, with the increase in the number of diabetic patients, autologous blood glucose measurement in which patients monitor daily fluctuations in blood glucose levels has been recommended.

In order to measure the blood sugar level, a test paper which develops a color according to the amount of glucose in the blood is mounted, blood is supplied to the test paper, the color is developed and developed, and the degree of the color development is measured optically. The measurement is performed using a blood glucose measuring device that measures (colorimeters) and quantifies the blood glucose level.

Prior to this measurement, a patient may take his or her own blood by puncturing the skin of the fingertip with a puncture device equipped with a puncture needle or a scalpel, and pressing around the puncture site with a finger or the like. The blood is squeezed out.

[0005] However, the fingertips are concentrated in capillaries and are suitable for collecting blood. On the other hand, since nerves are concentrated and painful, the pain and burden on the patient are great. Because it involves fear,
Many patients are unable to continue their own blood glucose measurements.

[0006]

SUMMARY OF THE INVENTION The inventor of the present application has disclosed a cartridge type cartridge in which a puncture needle cartridge having a casing and a puncture needle movably housed in the casing is detachably mounted on a distal end portion of the housing. A puncture device, which is a puncture device that performs puncture automatically, has been invented (not known).

This puncture device has a single coil spring for urging the puncture needle of the puncture needle cartridge in the housing, and the elastic force of the coil spring pushes out the puncture needle. The puncture needle is stored in the casing by returning to the natural length.

However, since the puncture needle cartridge is configured so that the puncture needle can move only a relatively short distance (for example, about 3 mm) in the casing, the puncture needle can be pushed and pushed by a single coil spring. If both operations of storing (pulling) are performed, one of these operations may be insufficient.

For example, if the coil spring is configured to be able to push out the puncture needle with a relatively strong force (a force capable of puncturing), the puncture needle will not return, and conversely,
If the puncture needle is configured to be securely returned, the puncture needle cannot be pushed out with a puncturing force.

An object of the present invention is to provide a puncture device that can perform puncture safely and securely with a simple operation.

[0011]

This and other objects are achieved by the present invention which is defined below as (1) to (11).

(1) A puncture needle cartridge having a casing having an opening at the tip, a puncture needle movably housed in the casing, and a length in which the puncture needle cartridge is detachably mounted at the tip. A long housing, the puncture needle of the puncture needle cartridge is detachable, and a plunger that can move in the housing in the longitudinal direction; and a first urging unit that urges the plunger at least in a distal direction of the housing. Means, a second urging means for urging the plunger at least in the proximal direction of the housing, and an operating means for performing puncturing with the puncture needle, the operation of the operating means, the plunger, The plunger is urged in the distal direction by the first urging means and moves in the distal direction to perform puncturing. At this time, the plunger is moved by the second urging means. A puncture device configured to be urged in a proximal direction and moved in a proximal direction.

(2) The puncture device according to (1), wherein the maximum moving distance of the puncture needle with respect to the casing is 5 mm or less.

(3) The puncture device according to (1) or (2), wherein the puncture needle cartridge has a function of regulating a maximum protruding length of the puncture needle from the opening.

(4) The plunger has a locking portion that locks to the housing in a state where the plunger is biased in the distal direction by the first biasing means, and the locking portion is operated by operating the operating means. (1) wherein the plunger is moved in the distal direction by releasing the locking of
The puncture device according to any one of (3) to (3).

(5) The puncture device according to the above (4), further comprising an operation portion for performing an operation of locking the locking portion to the housing.

(6) The above-mentioned (5), wherein a position restricting means is provided at a base end of the housing to prevent the operation part from moving in the base end direction when the operation part is operated. Puncture tool.

(7) The puncture device according to any one of the above (1) to (6), further comprising an adjustment mechanism for adjusting a puncture depth by the puncture needle.

(8) The adjusting mechanism is a first protrusion provided on the plunger and an adjusting portion provided to be rotatable in a circumferential direction with respect to the housing. And an adjusting portion having a second protrusion that abuts the first protrusion at the time of puncturing.
The puncture device according to the above (7), wherein the protrusion has a plurality of portions having different longitudinal positions of the housing on contact surfaces that contact the first protrusion.

(9) The first urging means and the second urging means
The puncture device according to any one of the above (1) to (8), wherein the urging means is formed of a spring.

(10) The spring constant k1 of the first biasing means
And the ratio between the spring constant k2 of the second urging means and k1 / k
2 is the puncture device according to (9), which is 1 or more.

(11) The second urging means is located closer to the base end than the first urging means.
The puncture device according to any one of 0).

[0023]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A puncture device according to the present invention will be described below in detail with reference to a preferred embodiment shown in the accompanying drawings.

FIG. 1 is a sectional view showing an embodiment of the puncture device of the present invention, FIGS. 2, 3 and 4 are sectional views showing a puncture needle cartridge of the puncture device shown in FIG. 1, respectively, and FIG. FIG.
FIG. 6 is a sectional view showing a plunger of the puncture device shown in FIG.
FIG. 7 is a diagram showing a configuration (side surface and both end surfaces) of the adjusting portion of the puncture device shown in FIG.
FIG. 9 is a sectional view taken along line AA in FIG. 6, and FIG.
10 is a sectional view taken along line CC in FIG. 6, FIG. 11 is a sectional view taken along line DD in FIG. 6, FIG.
FIGS. 13, 14, 15, 16, and 17 are cross-sectional views each showing a use state of the puncture device shown in FIG.

In this specification, the side views of FIGS. 1 to 5 and 6 and the left and right directions (longitudinal direction of the housing 3) of FIGS. "Tip" on the left
It will be described as.

As shown in these figures, the puncture device 1 includes a puncture needle cartridge 2 and a puncture needle cartridge 2 at the distal end.
And a puncture device body 10 which is detachably mounted. The puncture device main body 10 includes a long housing 3, a plunger 5, an adjustment unit 6, and a puncture operation unit (operation means) 7.
, A setting operation unit (operation unit) 8, a coil spring (first urging unit) 91 for urging the plunger 5 in the distal direction, and a coil spring (second urging unit) for urging the plunger 5 in the proximal direction. 92. Hereinafter, each of these components will be described.

As shown in FIG. 2, the puncture needle cartridge 2
Is attached to and detached from a tubular casing (puncture needle holder) 21, a lancet (puncture needle hub) 22 which is accommodated in the casing 21 so as to be movable in the axial direction and has a puncture needle 23, and a distal end portion of the casing 21. And a cap 24 that can be freely mounted.

The distal end of the casing 21 is a portion that comes into contact with the surface of a living body, such as a fingertip, upper arm, abdomen, thigh, or earlobe, and has an opening 211 formed therein. An opening 214 is formed at the base end of the casing 21.

The inner diameter of the casing 21 is constant in section a, but gradually decreases toward the tip in section b.

In the section a, the inner diameter of the casing 21 is the maximum outer diameter of the lancet 22 (the outer diameter of the large diameter portion 224).
At a position c slightly larger than the boundary between the section a and the section b and slightly on the tip side, the maximum outer diameter of the lancet 22 is the same.

Therefore, when the corner 225 of the large diameter portion 224 of the lancet 22 is located at the position c, the lancet 22
The tip does not move unless a force greater than a predetermined value is applied.

On the outer peripheral surface of the casing 21, a ring-shaped rib 215 is formed which comes into contact with the distal end 35 of the housing 3 (housing main body 30) when the puncture needle cartridge 2 is mounted on the puncturing device main body 10. .

The inner peripheral surface of the casing 21 has a pair of projections 21 that can lock the large diameter portion 224 of the lancet 22.
3, 213 are formed (only one protrusion 213 is shown in FIG. 2). As shown in FIG. 4, the large diameter portion 224 of the lancet 22 is locked to the projection 213, so that the lancet 22 can be prevented from coming off from the base end side of the casing 21.

Further, as shown in FIG.
Of the puncture needle 23 through the opening 211 of the casing 2 by the end surface 222 of the
The maximum protrusion length (maximum protrusion amount) is regulated.

The lancet 22 extends axially in the casing 21 between a position shown in FIG. 3 where the end face 222 contacts the surface 212 and a position shown in FIG. 4 where the end face 223 contacts the projection 213. You can move.

The maximum moving distance L1 of the lancet 22 with respect to the casing 21 is preferably 5 mm or less.

When the maximum moving distance L1 exceeds 3 mm,
The movement stroke of the lancet 22 is too large, and the puncture needle cartridge 2 becomes unnecessarily long (increases in size).

A cylindrical pressing member 241 is formed inside the cap 24. The axial length of the pressing member 241 is such that the cap 24 is attached to the casing 21 and the corner 225 of the large diameter portion 224 of the lancet 22 is at the position c.
When the pressing member 241 is located at
2 is set to such an extent that it comes into contact with the second end face 221.

As shown in FIG. 1, the housing 3 includes a housing body 30 and a cap-shaped member 4 provided at a base end of the housing body 30. The housing 3 also has a function as a grip when the puncture device 1 is used.

The housing 3 has a hollow portion 3 opened at the tip.
The hollow portion 31 has a plunger 5
And a coil spring 91 for urging the plunger 5 in the distal direction.
And a coil spring 92 for urging the plunger 5 in the proximal direction.
And a puncture mechanism having the following.

A casing 21 of the puncture needle cartridge 2 is detachably attached to the tip of the housing 3. That is, the puncture needle cartridge 2 is
When mounted on the base, the base end of the casing 21 is fitted into the front end of the housing body 30.

Further, an elastically deformable plate-shaped puncturing operation section 7 and an index 33 are provided on the upper side of the housing body 30 in FIG. Note that the index 33 is disposed on the proximal end side of the puncture operation unit 7.

An operation button 71 having a projection 711 projecting downward in FIG. 1 is formed at the tip of the puncture operation section 7. The protrusion 7 of the housing body 30
At a position corresponding to 11, larger than the protrusion 711,
An opening 32 smaller than the operation button 71 is formed.

On the base end side of the index 33 of the housing body 30, a pair of long holes 34, 34 are formed along the circumferential direction. One long hole 34 is arranged on the upper side in FIG. 1, and the other long hole 34 is arranged on the lower side in FIG.

The plunger 5 is housed in the housing 3.
It is installed so that it can move in the axial direction.

The plunger 5 has a cylindrical mounting portion 51 at the distal end to which the lancet 22 of the puncture needle cartridge 2 is removably mounted. That is, when the puncture needle cartridge 2 is mounted on the puncture device main body 10, the base end of the lancet 22 is fitted into the distal end of the mounting portion 51.

As shown in FIG. 5, a pair of notches 511 and 511 opened at the tip are formed at the tip of the mounting portion 51 (only one notch 511 is shown in FIG. 5). Has been).

On the inner peripheral surface of the tip of the mounting portion 51,
A tapered surface 512 shown in FIG. 5 is formed. That is, the inner diameter of the distal end portion of the mounting portion 51 gradually increases toward the distal end. Thereby, when the puncture needle cartridge 2 is mounted on the puncture device main body 10, the lancet 22 of the puncture needle cartridge 2 is smoothly and securely attached to the mounting portion 51 of the plunger 5.
Can be fitted (mounted).

The plunger 5 has, at its base end, a first protruding portion 56 erected downward in FIG.

The plunger 5 has a pair of rod-shaped projections 52, 52 erected on the base end thereof toward the base end.
At the base end of each projection 52,
A projection 521 is formed. One protruding portion 52 is arranged on the upper side in FIG. 5, and the other protruding portion 52 is arranged on the lower side in FIG.

An elastically deformable rod-shaped lock member 53 is provided above the plunger 5 in FIG.
Note that the lock member 53 is disposed on the base end side of the mounting portion 51.

A locking portion 531 having a protrusion 532 projecting upward in FIG.

When the preparation (set) for puncturing, which will be described later, is completed, the plunger 5 is urged toward the distal end with respect to the housing 3 by the coil spring 91, and the projection 532 of the locking portion 531 is moved to the housing body 30. Opening 3
2, whereby the locking portion 53 is locked to the housing 3 (see FIG. 14).

Ring-shaped flanges 54 and 55 are formed on the outer peripheral surface of the plunger 5. The flange 55 is arranged on the base end side of the flange 54.

When the plunger 5 moves, each of the flanges 54 and 55 slides on the inner peripheral surface of the housing main body 30, whereby the posture of the flange 55 is maintained.

The base end portion of the flange 55 functions as a spring seat (first urging means contact portion) with which the tip end of the coil spring 91 contacts. At the base end of the housing main body 30 and at the distal end side of the cap-shaped member 4, a tubular adjusting section (adjustment dial) 6 is installed so as to be rotatable in the circumferential direction of the housing main body 30.

As shown in FIGS. 6 to 11, a pair of support portions 610, 610 are formed on the inner peripheral surface of the adjustment portion 6. A ring-shaped puncture depth control plate (second protrusion) 61 that comes into contact with the protrusion 56 of the plunger 5 during puncturing is formed on these support portions 610. The pair of support portions 610 and 610 are respectively inserted into the pair of long holes 34 and 34 of the housing main body 30 described above, and the puncture depth control plate 61 is located inside the housing main body 30.

The support portions 610 are arranged to face each other with the center of the puncture depth control plate 61 interposed therebetween. The puncture depth control plate 61 is disposed concentrically with the housing main body 30 substantially at the center of the adjusting section 6 in the axial direction.

The puncture depth control plate 61 has four portions having different axial positions of the contact surfaces that contact the projections 56 of the plunger 5. Puncture depth (= opening 211 of puncture needle 23)
(The maximum amount of protrusion) can be adjusted in four stages.

That is, three convex portions (spacers) 611, 612 and 613 having different heights (lengths in the axial direction) are provided on the base end surface of the puncture depth control plate 61 along the circumferential direction. Is formed. These protrusions 611, 612, and 613 are arranged in the order of the protrusions 611, 612, and 613 at an interval of 30 ° and in a counterclockwise direction in the drawing on the right side of FIG.

The height of the projections 611 to 613 is
Is the highest, the protrusion 612 is the next highest, and the protrusion 613 is the lowest. That is, the projection 56 of the plunger 5 is
The position of the contact surface of the puncture depth control plate 61 in contact with the axial direction is such that the position of the contact surface in the convex portion 611 is the most proximal side, and the position of the contact surface in the convex portion 613 is the most distal side. Part 61
The position of the contact surface in FIG.
And between.

Accordingly, when the projection 611 faces the projection 56 of the plunger 5, the puncture depth of the puncture needle 23 into the living body surface becomes the smallest (minimum), and hereinafter, the projection 612, the projection The puncture depth by the puncture needle 23 becomes deeper (larger) in the order of 613 and a portion where no convex portion is formed (a portion without a protruding portion) 614.

The adjusting section 6 and the projection 56 of the plunger 5 constitute an adjusting mechanism. With this adjusting mechanism, the puncture needle 23 is adjusted according to the individual difference of the blood-collecting person (examinee) and the puncture site.
, That is, the puncture depth into the living body surface can be adjusted.

The distal end portion of the puncture depth control plate 61 functions as a spring seat (first urging means contact portion) with which the proximal end of the coil spring 91 contacts.

That is, the coil spring 91 is inserted between the puncture depth control plate 61 and the flange 55 in a substantially unloaded state (natural length).

In this case, it is preferable that at least one of the distal end and the proximal end of the coil spring 91 is configured to be separated from the flange 55 and the puncturing depth control plate 61. That is, it is preferably one of the following.

The tip of the coil spring 91 is connected to the flange 55
The base end is fixed to the puncture depth control plate 61.

The tip of the coil spring 91 is the flange 55
, And the base end can be separated from the puncture depth control plate 61.

The distal end and the proximal end of the coil spring 91
Each can be separated from the flange 55 and the puncture depth control plate 61.

In the above cases, the coil spring 91 urges the plunger 5 substantially only in the distal direction at the time of puncturing, so that puncturing (projection and storage of the puncture needle 23 from the casing 21) can be performed more reliably. Can be done.

On the outer peripheral surface of the adjusting portion 6, four ribs 621, 622, 623 and 624 having different lengths are provided.
Each is formed.

The ribs 621, 622, 623 and 624 are arranged at intervals of 30 ° (projections 611, 612, 613).
And the ribs 621, 622, 623, 624 are arranged in this order in the counterclockwise direction on the right side of FIG.

Specifically, the rib 621 is arranged at a position shifted by 180 ° in the circumferential direction from the projection 611. That is, the rib 621 is arranged so as to be located at the position of the index 33 when the protrusion 611 faces the protrusion 56 of the plunger 5.

Similarly, ribs 622, 623 and 624
Are arranged at positions 180 ° circumferentially shifted from the convex portions 612 and 613 and the portion 614 where no convex portion is formed. That is, the ribs 622, 623, and 624 have the protrusions 612, 613, and the portion 614 where the protrusion is not formed, respectively.
It is arranged so as to be located at the position of the index 33 when facing the 6.

The length of the ribs 621 to 624 is
Is the longest, the rib 623 is the second longest, the rib 622 is the third longest, and the rib 621 is the shortest. The length of the rib indicates the level of the puncture depth by the puncture needle 23. That is, the longer the rib is, the deeper the puncture needle 23 punctures the living body surface.

The ribs 621 and 6 on the outer peripheral surface of the adjusting portion 6
Numerals “1”, “2”, “3”, and “4” indicating the level of the puncture depth of the puncture needle 23 into the living body surface are respectively attached to the distal ends of 22, 623, and 624.

Further, a plurality of grooves 6 are formed on the outer peripheral surface of the adjusting portion 6.
3 are arranged side by side along the circumferential direction. These grooves 63
The ribs 621 to 624 each function as a non-slip when the adjusting unit 6 is rotated.

As shown in FIG. 1, a set operation section 8 is provided in the cap-shaped member 4 so as to be movable in the axial direction.

A ring-shaped rib 41 is formed at the tip of the cap-shaped member 4 to be in contact with the tip of the set operating section 8.

At the base end of the cap-shaped member 4, a head (position regulating means) 42 is formed. At the time of operating the set operation unit 8, the base end of the set operation unit 8 abuts on the head 42, and the movement of the set operation unit 8 in the base direction is prevented.

A long hole 43 is formed on each of the upper and lower sides of the cap-shaped member 4 in FIG.

The set operation section 8 has a cylindrical set operation section main body 80 in which a coil spring 92 is housed.

A ring-shaped rib 81 is formed at the tip of the setting operation section main body 80. A base end portion of the rib 81 functions as a spring seat (a second urging means contact portion) with which the distal end side of the coil spring 92 contacts.

On the upper side and the lower side in FIG. 1 of the base end of the setting operation section main body 80, grips 82 inserted into the corresponding long holes 43 of the cap-shaped member 4 are formed. . The upper handle portion 82 in FIG. 1 projects upward (outward) in FIG. 1 from the long hole 43, and the lower handle portion 82 in FIG.
Project from the long hole 43 to the lower side (outside) in FIG.

Further, a ring-shaped spring receiving member 93 having a spring seat (a second urging means abutting portion) on the distal end side is installed in the set operating portion 8 so as to be movable in the axial direction. .

A coil spring 92 is inserted between the spring receiving member 93 and the rib 81 in a substantially unloaded state (natural length). The coil spring 92 is located closer to the base end than the coil spring 91 is. The spring constant of the coil spring 92 is smaller than the spring constant of the coil spring 91.

The spring receiving member 93 is locked by the pair of projections 521, 521 with the pair of projections 52, 52 of the plunger 5 inserted.

In this case, at least one of the distal end and the proximal end of the coil spring 92 is connected to the rib 81 or the spring receiving member 93.
It is preferable to be configured so as to be able to be separated from. That is, it is preferably one of the following.

The distal end of the coil spring 92 can be separated from the rib 81, and the proximal end is fixed to the spring receiving member 93.

The distal end of the coil spring 91 is fixed to the rib 81, and the proximal end can be separated from the spring receiving member 93.

The distal end and the proximal end of the coil spring 91
Each can be separated from the rib 81 and the spring receiving member 93.

In the above cases, the coil spring 92 urges the plunger 5 substantially only in the proximal direction at the time of puncturing, so that puncturing (projection and storage of the puncture needle 23 from the casing 21) can be further improved. It can be done reliably.

Various conditions such as the spring constants and axial lengths of the coil springs 91 and 92 are set so that the puncture can be performed reliably, that is, at the time of the puncture, the puncture needle 23 can be securely connected to the casing 21. Projecting from the opening 211 of the casing 2, and thereafter, the puncture needle 23 is securely inserted into the casing 2.
1.

Here, the spring constant of the coil spring 91 is k
1. When the spring constant of the coil spring 92 is k2, the ratio, k1 / k2, is preferably 1 or more.
The degree is more preferred.

If k1 / k2 is larger than the upper limit, the puncture needle 23 may not be stored in the casing 21 after puncturing.

Conversely, if k1 / k2 is smaller than the lower limit, the puncture needle 23 will be
In some cases, the puncture cannot be performed because the puncture does not protrude from the puncture 1.

The components (components) of the puncture device 1 other than the puncture needle 23 and the coil springs 91 and 92 described above are, for example, acrylic resin, styrene resin, various thermoplastic elastomers, polypropylene, polyethylene, and polyethylene, respectively. Terephthalate, acrylic-butyl-
It is molded with an injection moldable resin such as a styrene copolymer (ABS resin).

Next, the operation of the puncture device 1, that is, the operation procedure when puncturing is performed using the puncture device 1 and the operation of each unit will be described.

[1] As shown in FIG.
The puncture needle cartridge 2 is mounted on the tip of the cartridge. That is, the rib 2 of the casing 21 is
The base end of the casing 21 is fitted into the distal end of the housing 3 and the base end of the lancet 22 is fitted into the distal end of the mounting portion 51 of the plunger 5 until 15 comes into contact.

At this time, as described above, the lancet 22
When the corner portion 225 of the large diameter portion 224 is located at the position c, the lancet 22 does not move unless a force greater than a predetermined value is applied to the tip thereof, and the flange 55 of the plunger 5 does not move.
Is in contact with the distal end of the coil spring 91, so that the proximal end of the lancet 22 can be fitted into the mounting portion 51 of the plunger 5.

In the state shown in FIG.
The lock member 53 is displaced (elastically deformed) downward in FIG. 1 by the protrusion 532 of the locking portion 531 abutting on the inner peripheral surface of the housing 3. That is, the locking portion 531
Are biased upward in FIG. 1 by the elastic force of the lock member 53.

The puncture needle cartridge 2 may be mounted after removing the cap 24 from the puncture needle cartridge 2, but it is preferable that the puncture needle cartridge 2 is mounted while the cap 24 is mounted. It is more preferable to perform it while performing.

By mounting the puncture needle cartridge 2 with the cap 24 mounted, the safety at the time of mounting is improved. Then, by pressing the cap 24 to the proximal end side, as shown in FIG. 2, the state in which the pressing member 241 is in contact with the end surface 221 of the lancet 22 can be reliably held, and as a result, the lancet 22 can be reliably prevented from moving toward the distal end.

When the puncture needle cartridge 2 is mounted with the cap 24 mounted, the cap 24 is removed from the puncture needle cartridge 2 after the puncture needle cartridge 2 is mounted, preferably immediately before puncturing. .

[2] The puncture depth of the puncture needle 23 into the living body surface is adjusted as required. That is, the puncture needle 23
Is set to a puncture depth according to the individual difference of the blood sampler and the puncture site.

As a criterion for setting the puncture depth, for example, the puncture depth at which the minimum blood volume necessary for blood glucose measurement can be obtained can be used. Thereby, the pain associated with the puncture can be minimized.

When setting the puncturing depth, the adjusting portion 6 is gripped with a finger, and the adjusting portion 6 is rotated in the circumferential direction with respect to the housing 3 so that a predetermined one of the ribs 621 to 624 is set. It is located at the position of the index 33.

The puncturing depth is set once,
Since there is no need to reset the settings each time blood is collected, the operation is not troublesome.

FIGS. 1 and 12 to 15 show a state in which the puncture depth of the puncture needle 23 into the living body surface is the smallest.

[3] As shown in FIGS. 12 and 13, the grip 82 of the set operation unit 8 is gripped by a finger, and the set operation unit 8 is pressed against the housing 3 against the elastic force of the coil springs 91 and 92. And move it in the proximal direction. Then, when the base end of the setting operation section 8 comes into contact with the head section 42 of the housing 3, the finger is released from the grip section 82 that has been gripped.

In this case, first, as shown in FIG. 12, a coil spring 92 having a small spring constant is compressed, and then, as shown in FIG. 13, a coil spring 91 having a large spring constant is compressed. The plunger 5 moves in the proximal direction by an amount corresponding to the compression of 91.

As shown in FIG. 13, the set operation section 8
When the base end moves until it comes into contact with the head 42 of the housing 3, the projection 532 of the locking portion 531 of the locking member 53 of the plunger 5 is positioned at the position of the opening 32 of the housing 3, and the elastically deformed locking member The projection 53 returns to its original shape due to its elastic force, the projection 532 is inserted into the opening 32 of the housing 3, and the projection 532 contacts (or faces) the projection 711 of the operation button 71.

Then, when the finger is released from the grip portion 82 which has been gripped, as shown in FIG.
2 abuts against the edge on the front end side facing the opening 32 of the housing 3, the locking portion 531 is locked (locked) to the housing 3, whereby the compressed state of the coil spring 91, that is, the coil spring 91 By plunger 5
Is kept urged toward the distal end with respect to the housing 3.

On the other hand, when the finger is released from the grip portion 82 that has been gripped, as shown in FIG. 14, the compressed (compressed) coil spring 92 expands due to its elastic force, and the set operation portion 8 The rib 81 moves to the distal end side until it contacts the rib 41 of the housing 3. Also, the coil spring 92
Returns to its natural length and does not bias the plunger 5 in either the distal or proximal direction.

In this state, preparation (set) for puncturing the living body surface is completed. As described above, the puncture device 1 can easily, quickly, and reliably prepare for puncturing the living body surface.

[4] After crimping the tip of the casing 21 of the puncture needle cartridge 2 to a predetermined site, for example, the surface of a living body such as a fingertip, press the operation button 71 of the puncture operation unit 7 (push downward in FIG. 14). ).

When the operation button 71 is pressed, the projection 711 pushes the projection 532 of the locking portion 531 as shown in FIG. 15, whereby the locking member 53 is elastically deformed and the locking portion 531 is moved as shown in FIG. It is displaced to the middle and lower sides, and the locking of the edge of the locking portion 531 facing the opening 32 of the projection 532 is released (released).

On the other hand, the puncturing operation section 7 is elastically deformed, and when the finger is released from the operation button 71, the elastically deformed puncturing operation section 7 returns to its original shape by its elastic force.

When the locking of the locking portion 531 is released,
As shown in FIG. 15, the compressed coil spring 91 expands due to its elastic force, the plunger 5 moves in the distal direction, the puncture needle 23 projects from the opening 211 of the casing 21, and punctures the surface of the living body.

At this time, since the protrusion of the plunger comes into contact with the protrusion 611 of the puncture depth control plate 61, the movement of the plunger 5 in the distal direction is restricted.
The puncture depth to the living body surface by 3 is adjusted to a constant (minimum value).

When the plunger 5 moves in the distal direction, the coil spring 91 and the flange 55 are separated from each other, and the coil spring 92 is compressed, and the plunger 5 is moved by the coil spring 92 into the housing 3.
Is biased in the proximal direction.

In this case, as described above, the coil spring 9
Since the spring constant k1 of 1 is larger than the spring constant k2 of the coil spring 92, the plunger 5 moves to the distal end side against the elastic force of the coil spring 92, and can puncture the living body surface with the puncture needle 23.

Further, after being separated from the flange 55, the coil spring 91 returns to its natural length, and does not bias the plunger 5 in any of the distal end and the proximal end.

After the puncture needle 23 punctures the surface of the living body, as shown in FIG. 1, the compressed coil spring 92 expands due to its elastic force, the plunger 5 moves in the proximal direction, and punctures from the surface of the living body. The needle 23 comes off and the puncture needle 23
Is stored (stored) in the casing 21. That is, the state returns to the state shown in FIG.

As described above, the puncture needle 23 does not protrude from the opening 211 of the casing 21 except at the time of puncture, so that the puncture needle 23 does not accidentally injure the skin or the like and can prevent infection. High safety.

As described above, the lancet 22
Is the maximum, the end face 222 is the face 21 of the casing 21
2 can be moved in the distal direction only up to the position shown in FIG. For example, at the time of puncturing, even if the lancet 22 comes off the mounting portion 51 of the plunger 5, the lancet 22 is locked by its end face 222 abutting on the face 212 of the casing 21. It is possible to prevent the casing 21 from projecting more than a predetermined amount from the opening 211.

[5] After the puncture, the puncture device 1 is separated from the surface of the living body, and blood on the puncture site is collected. The blood can be collected, for example, by directly supplying the blood on the test paper, or by sucking the blood through a thin tube and supplying the blood to the test paper.

The operation when the puncture depth of the puncture needle 23 into the living body surface is set to the minimum value has been described above. Next, the operation when the puncture depth is set to the maximum value will be briefly described. I do.

[6] As shown in FIG. 16, by rotating the adjusting portion 6 in the circumferential direction with respect to the housing 3,
At the position of the index 33. Thereby, the portion 614 of the puncture depth control plate 61 where the protrusion is not formed faces the protrusion 56 of the plunger 5. That is, the puncture needle 23
Is set to the maximum value.

Then, as described above, after the preparation for puncturing the living body surface is completed, the casing 2 of the puncture needle cartridge 2 is
After the front end of the puncture device 1 is pressed against a predetermined portion, for example, a living body surface such as a fingertip, the operation button 71 of the puncture operation section 7 is pressed.

As shown in FIG. 17, the locking portion 5
31 is released, and the compressed coil spring 91 is released.
Is extended by the elastic force, the plunger 5 moves in the distal direction, the puncture needle 23 projects from the opening 211 of the casing 21, and punctures the living body surface.

At this time, the projection 56 of the plunger comes into contact with the portion 614 of the puncture depth control plate 61 where the projection is not formed, whereby the movement of the plunger 5 in the distal direction is restricted. Is adjusted to a constant (maximum value).

After the puncture needle 23 punctures the surface of the living body, as shown in FIG. 16, the compressed coil spring 92 expands due to its elastic force, the plunger 5 moves in the proximal direction, and punctures from the surface of the living body. The needle 23 comes off and the puncture needle 23
Is stored (stored) in the casing 21. That is, the state returns to the state shown in FIG.

As described above, the puncture device 1 is a cartridge-type puncture device in which the puncture needle cartridge 2 is detachably mounted on the distal end portion of the puncture device main body 10, so that the puncture needle can be safely, easily and easily replaced. Can be done quickly.

The puncture needle cartridge 2 has a function of regulating the maximum projection length (maximum projection amount) of the puncture needle 23 from the opening 211 of the casing 21, and the lancet 22 has a maximum end face. 3 can move in the distal direction only up to the position shown in FIG. 3 in which the 222 abuts on the surface 212 of the casing 21, so that the safety at the time of puncturing is high.

Since the puncture device 1 has the coil spring 91 for urging the plunger 5 in the distal direction and the coil spring 92 for urging the plunger 5 in the proximal direction, the puncture needle is surely inserted at the time of puncturing. The puncture needle 23 can protrude from the opening 211 of the casing 21 by a predetermined amount, and then the puncture needle 23 can be reliably stored in the casing 21. Thereby, it is possible to puncture the surface of the living body safely and reliably.

In the puncture device 1, the puncture depth of the puncture needle 23 into the living body surface can be arbitrarily adjusted by the adjusting mechanism, and a constant puncture depth can be realized each time blood is collected. Can be.

In particular, since the adjusting mechanism has the rotary adjusting portion 6, the puncturing depth can be quickly and reliably adjusted by a simple operation.

Since the puncture device 1 has the coil springs 91 and 92, the puncture device (the puncture needle 23) can be surely inserted at all puncture depths that can be set by the adjustment mechanism.
From the casing 21 and storage).

In the puncture device 1, the coil spring 91 can be compressed and the locking portion 531 can be locked to the housing 3 by a simple operation of moving the setting operation portion 8 in the proximal direction. That is, it is possible to easily and quickly prepare for puncturing the living body surface. For this reason, it is advantageous also when used regularly or when used repeatedly.

In the puncture device 1, the direction in which the operation button 71 is pressed, that is, the direction in which the plunger 5 is operated to perform puncture, and the direction in which the plunger 5 moves (the puncture direction) are different (substantially orthogonal). Direction). For this reason, the fear of puncture is reduced and at the time of puncture,
The contact pressure of the distal end of the casing 21 on the living body surface does not change due to the pressing force of the operation button 71, and thus the puncturing depth as set is realized.

In the puncture device 1, the head 42 is located at the most proximal side of the puncture device 1 (the plunger 5 and the like are not exposed at the proximal side), and the entire length (axial (Length in the direction) is the same (the total length is constant) between when the preparation for puncturing the living body surface is completed and after the puncturing, so that the puncturing device 1 can be easily operated.

As described above, the puncture device 1 is suitable for use when a patient himself / herself measures a blood sugar level or the like. The puncture device 1 has a simple configuration and is suitable for mass production.

Although the puncture device of the present invention has been described based on the illustrated embodiment, the present invention is not limited to this, and each component may have any configuration having the same function. Can be replaced by

For example, in the above embodiment, the adjusting mechanism is configured to adjust the puncturing depth by the puncture needle in a stepwise manner. It may be configured to be able to adjust continuously.

In the above, the embodiment in the case of collecting blood has been described. However, the puncture device of the present invention may be for collecting body fluids other than blood, such as interstitial fluid. Is not particularly limited.

[0147]

As described above, according to the puncture device of the present invention, the puncture needle cartridge is removably mounted on the tip of the housing, so that the puncture needle can be replaced safely, easily and quickly. Can be.

Particularly, the puncture needle cartridge has a maximum protrusion length (maximum protrusion amount) of the puncture needle from the opening of the casing.
When the puncture has the function of regulating puncture, the safety at the time of puncturing is high.

The puncture device of the present invention has the first urging means for urging the plunger in the distal direction and the second urging means for urging the plunger in the proximal direction. The puncture needle can be reliably protruded from the opening of the casing by a predetermined amount, and thereafter, the puncture needle can be securely stored in the casing. Thereby, it is possible to puncture the surface of the living body safely and reliably.

In particular, the first urging means and the second urging means are each constituted by a spring, and the spring constant k of the first urging means is
1 and the spring constant k2 of the second biasing means, k1 / k2
Is set to the above-mentioned suitable value (preferably 1 or more, more preferably about 10 to 20),
Puncture (projection and storage of the puncture needle from the casing) can be performed.

In the puncture device of the present invention, the puncture can be performed by a simple operation using the operating means.

[Brief description of the drawings]

FIG. 1 is a sectional view showing an embodiment of a puncture device of the present invention.

FIG. 2 is a sectional view showing a puncture needle cartridge of the puncture device shown in FIG.

FIG. 3 is a sectional view showing a puncture needle cartridge of the puncture device shown in FIG. 1;

4 is a sectional view showing a puncture needle cartridge of the puncture device shown in FIG.

5 is a sectional view showing a plunger of the puncture device shown in FIG.

FIG. 6 is a diagram showing a configuration (side surface and both end surfaces) of an adjusting unit of the puncture device shown in FIG. 1;

FIG. 7 is a sectional view taken along line EE in FIG. 6;

FIG. 8 is a cross-sectional view taken along line AA in FIG.

FIG. 9 is a sectional view taken along line BB in FIG. 6;

FIG. 10 is a sectional view taken along line CC in FIG. 6;

11 is a cross-sectional view taken along line DD in FIG.

FIG. 12 is a sectional view showing a use state of the puncture device shown in FIG. 1;

FIG. 13 is a sectional view showing a use state of the puncture device shown in FIG. 1;

FIG. 14 is a sectional view showing a use state of the puncture device shown in FIG. 1;

FIG. 15 is a sectional view showing a use state of the puncture device shown in FIG. 1;

FIG. 16 is a sectional view showing a use state of the puncture device shown in FIG. 1;

FIG. 17 is a sectional view showing a use state of the puncture device shown in FIG. 1;

[Explanation of symbols]

 Reference Signs List 1 puncture device 10 puncture device main body 2 puncture needle cartridge 21 casing 211 opening 212 surface 213 projection 214 opening 215 rib 22 lancet 221-223 end surface 224 large diameter portion 225 corner portion 23 puncturing needle 24 cap 241 pressing member 3 housing 30 housing body 31 Hollow part 32 Opening 33 Indicator 34 Slot 35 Tip 4 Cap-shaped member 41 Rib 42 Head 43 Slot 5 Plunger 51 Mounting part 511 Notch 512 Tapered surface 513 Tip 52 Projection 521 Projection 53 Lock member 531 Locking portion 532 Projection 54, 55 Flange 56 First protrusion 6 Adjustment part 61 Puncture depth control plate 610 Support part 611-613 Convex part 614 Part where no convex part is formed 621-624 Rib 63 Groove 7 Puncture operation part 71 Operation button 711 Protrusion Setting operation section 80 sets the operation portion main body 81 rib 82 grip portions 91 and 92 the coil spring 93 spring receiving member

Claims (7)

[Claims] 1. A puncture needle cartridge including a casing having an opening at a distal end, and a puncture needle movably housed in the casing, and a long length to which the puncture needle cartridge is detachably mounted at a distal end portion. -Shaped housing, a plunger in which the puncture needle of the puncture needle cartridge is detachable, and which can move in the housing in the longitudinal direction; and a first urging means for urging the plunger at least in a distal direction of the housing. A second urging means for urging the plunger at least in the proximal direction of the housing; and an operating means for performing puncturing by the puncture needle, wherein the operation of the operating means causes the plunger to The plunger is urged in the distal direction by the first urging means, moves in the distal direction, and performs puncturing.
A puncture device characterized in that the puncture device is configured to be urged in the proximal direction by the urging means and moved in the proximal direction. 2. The plunger has a locking portion that locks to the housing in a state where the plunger is urged in a distal direction by the first urging means, and the plunger is locked by operating the operating means. The puncture device according to claim 1, wherein the plunger is configured to move in a distal direction by releasing the lock. 3. The puncture device according to claim 1, further comprising an adjustment mechanism for adjusting a puncture depth by the puncture needle. 4. The adjustment mechanism is a first projection provided on the plunger, and an adjustment portion provided on the housing so as to be rotatable in a circumferential direction thereof, and is provided along the circumferential direction. And an adjusting portion having a second projection that comes into contact with the first projection at the time of puncturing, wherein the second projection has a contact surface that comes into contact with the first projection. The puncture device according to claim 3, wherein the puncture device has a plurality of portions having different longitudinal positions of the housing. 5. The puncture device according to claim 1, wherein each of the first urging unit and the second urging unit is formed of a spring. 6. A ratio k1 / k2 between a spring constant k1 of the first urging means and a spring constant k2 of the second urging means is:
The puncture device according to claim 5, wherein the number is one or more. 7. The puncture device according to claim 1, wherein the second urging means is located closer to the proximal end than the first urging means.