JP2002219115A - Blood collecting device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a means for securing the required volume of blood in a short period of time without causing any pain and erroneous blood collection when specified ingredients of both fluids need to be analyzed. SOLUTION: This blood collecting device is equipped with a device body 1 to be attached to a somatic portion other than a finger tip, a puncture tool 2 that enables to puncture the dermal surface of inserting a puncture needle 3 from a portion 4 attached to the device body 1 for inserting the puncture tool 4 and a compression member 6 for compressing the dermal portion surrounding a puncture site 5 from an external side toward an inner side after puncture.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an apparatus (equipment) for analyzing blood components by exuding a body fluid in a living body out of the body, such as a simple blood glucose meter. TECHNICAL FIELD The present invention relates to a technique for securing a required amount of blood to be collected in a short time by a combination of pressure and reduced pressure, and an apparatus (instrument) using the technique.

[0002]

2. Description of the Related Art Recently, self-blood glucose measuring devices and the like have begun to be used at home as devices for analyzing specific components of body fluids such as blood glucose levels, and there has been an opportunity for patients themselves or their reserves to perform puncture and blood collection operations. It has increased. The problem is that one of the blood glucose measurement test strips is wasted due to insufficient blood collection volume and has to be punctured again, which causes "pain" and "puncture spots" due to blood collection. Many people give up self-checks because of these pains.

In order to solve such a problem, fingertip puncturing with a high density of blood vessels has been mainly used. However, the fingertip has a pain point density ten times or more higher than other parts of the body, and the pain at the time of puncture is also large. Further problems such as the hardening phenomenon due to repeated puncture and the infection of fingertips with fungi are also problematic. Therefore, a method has been proposed in which blood is collected using, for example, a forearm as a living body part other than the fingertip. At places other than the fingertips of the living body, the blood vessel density near the epidermis is low, and the blood pressure is also low. Therefore, it is very difficult to secure a sufficient blood collection amount by simply performing puncturing.

Therefore, it is necessary to raise the blood pressure in some way. 5,964,
741 (Title of invention "BODY FLUID SAMP"
LING DEVICE ”), around the puncture point
A method has been proposed in which blood is collected in the direction of the puncture point by applying pressure with a ring cut obliquely.

[0005] However, this blood sampling method is based on pressurization only in the vicinity of the puncture point, and there is a problem in that even if pressure is applied to a place where the blood pressure is low and the blood volume is small, a sufficient blood collection amount cannot be secured.

Another conventional example is disclosed in Japanese Patent Laid-Open No. 10-51.
In Japanese Patent Publication No. 99 (name of the invention, "body fluid analyzer"), blood is exuded by squeezing both sides of the puncture point with a cuff. Although the pressure temporarily increased, the blood flow was often interrupted thereafter, and this method could not secure sufficient blood collection volume.

[0007]

SUMMARY OF THE INVENTION The present invention has been made in view of the above-mentioned problems of the prior art, and has as its object to reduce the amount of blood required for analyzing a specific component of a body fluid. It is an object of the present invention to provide a blood collection apparatus which can secure blood collection in a short time, eliminate blood collection failure, and perform a blood collection operation without pain.

[0008]

In order to solve the above-mentioned problems, according to the first aspect of the present invention, there is provided an apparatus main body 1 mounted on a living body part other than a fingertip, and a puncture device provided on the apparatus main body 1. A puncture device 2 which can puncture the skin surface by inserting the puncture needle 3 from the insertion portion 4, and a pressing member 6 for pressing the skin portion around the puncture point 5 from the outside to the inside after the puncture. With this configuration, pressurization is performed toward the puncture point 5 of the living body portion by the pressurizing operation after the puncture, and the puncture point 5
The blood is concentrated around and the exudation is promoted, so that the blood pressure around the puncture point 5 can be increased without interrupting the blood flow. In addition, because it punctures other than the fingertip, compared to the case where the fingertip is punctured, there is almost no pain,
With a small amount of puncture, it is possible to secure a sufficient amount of blood to be collected, so that it is possible to secure the required amount of blood in a short time when analyzing a specific component of body fluid, eliminating blood collection failures and painlessly collecting blood. Since the operation can be performed, the puncture depth can be reduced, and the puncture needle 3 can be thinned, there is no problem that puncture remains or pain continues for a long time. And reduction of puncture spots ”can be achieved, and the self-check can be performed with confidence. In addition, there is no failure in blood sampling, and there is no need to re-puncture.

The invention according to claim 2 is characterized in that, in claim 1, the puncture device insertion portion 4 is preferably arranged at a substantially central portion of the pressing member 6 in the width direction G. In this case, Pressing force is applied from all sides of the puncture device insertion section 4, whereby blood is easily collected at the puncture point 5 by pressurization from around the puncture point 5.

The invention according to claim 3 is preferably characterized in that, in claim 1 or claim 2, the puncture site is one of the limbs of a living body. Less blood collection operation is easier.

According to a fourth aspect of the present invention, in any one of the eleventh to third aspects, the pressing force setting means 7 for setting the pressing force of the pressing member 6, and controlling the pressing force to be equal to or lower than the systolic blood pressure. It is preferable that a pressure control unit 8 is provided. In this case, the pressure (pressure amount) of the pressure member 6 can be arbitrarily set, and the pressure is controlled to be equal to or lower than the systolic blood pressure. And there is no interruption of blood flow.

According to a fifth aspect of the present invention, in the fourth aspect, it is preferable that the pressing force control unit 8 controls the pressing force by the pressing member 6 to change intermittently. In this case, by intermittently reducing the pressure, the skin moves up and down, producing an squeezing effect, and an effect of returning blood there.

According to a sixth aspect of the present invention, in the first or second aspect, a closed space 9 facing the puncture point 5 is provided in the puncture device insertion portion 4, and the closed space is provided. It is preferable that a decompression means 10 for reducing the pressure of the puncture point 9 is provided. In this case, the closed space 9 after the puncture is brought into a decompressed state (atmospheric pressure or less) to thereby reduce the pressure around the puncture point 5 The blood pressure is further increased to promote blood exudation.

Further, the invention according to claim 7 is preferably characterized in that in claim 6, the pressure reduction control of the closed space 9 is performed intermittently. In this case, the pressure reduction is performed intermittently. As a result, the skin moves up and down, a squeezing effect is created, and the blood pressure around the puncture point 5 can be further increased.

According to an eighth aspect of the present invention, in the sixth or seventh aspect, the pressure reduction and the pressurization are performed by one pump, and the switching between the pressure reduction and the pressure is performed by opening and closing the closed space. It is preferable to perform the operations in conjunction with each other. In this case, switching between depressurization and pressurization can be performed only by opening and closing the space.

According to a ninth aspect of the present invention, in any one of the first to eighth aspects, a cover 11 is provided to cover at least the upper part of the puncture point 5 so as to be openable and closable. Puncture point 5 on skin raised by pressure
Puncture point compression mechanism 12 for further pressing the puncture point 5 from around puncture point 5 toward puncture point 5 by closing cover 11
In this case, it is preferable that the puncture point pressing mechanism 12 automatically closes the skin raised by pressurization by the closing operation of the cover 11 from the periphery of the raised skin to the puncture point at the center of the raised skin. The pressure is further increased toward 5, and the blood on the raised skin portion can be smoothly exuded outside the body.

According to a tenth aspect of the present invention, in the ninth aspect, it is preferable that the puncture point pressing mechanism 12 comprises an uneven member 12a provided on the cover 11, and in this case, Then, the skin (around the puncture point 5) on which the uneven member 12a is raised by the closing operation is further pressurized, and blood can be exuded with a simple structure.

According to an eleventh aspect of the present invention, in the ninth aspect, the puncturing point compression mechanism 12 is disposed around the puncturing point 5 when the cover 11 is closed, so that the puncturing point 5 is moved from the puncturing point 5 periphery.
The movable compression member 12b is preferably characterized in that the movable compression member 12b can compress the surface of the skin while moving toward the surface. In this case, the movable compression member 12b is moved inward (to the puncture point 5 side) by closing the cover 11. , The skin whose blood pressure has been increased by the pressure member 6
Further, the movable pressing member 12b can press from the side.

According to a twelfth aspect of the present invention, in any one of the ninth to eleventh aspects, the elastic body 14 is interposed between the cover 11 and the base 13 disposed below the cover 11, Puncture point compression mechanism 12
It is preferable that the compression operation is performed elastically. In this case, the cover 11 can be moved up and down within a certain range, and the pressure can be arbitrarily repeated with a finger or the like, whereby the skin is moved up and down Exercise, a squeezing effect is created, and a painless pressing operation can be performed.

The invention according to claim 13 is preferably characterized in that in any one of claims 1 to 12, a function of measuring a blood component exuded by a blood sampling operation is provided. In this case, for example, blood that has exuded through a series of blood collection operations is introduced into a test strip for measuring blood components, and a specific blood component can be analyzed by the body fluid analyzer.

According to a fourteenth aspect of the present invention, in any one of the first to thirteenth aspects, the apparatus according to any one of the first to thirteenth aspects further comprises a blood pressure measuring means, and the pressure control unit controls the pressure control unit based on the blood pressure measurement value measured by the blood pressure measuring means. It is preferable to control the pressure so as to be equal to or less than the systolic blood pressure, in this case,
It is possible to apply a tightening pressure suitable for a patient having a variation in blood pressure.

The invention according to claim 15 provides the invention according to claim 14.
, The range of the controlled blood pressure value is the minimum blood pressure value ± 3.
It is preferable that the pressure is 0 mmHg and 30 mmHg or more. In this case, blood collection can be performed more reliably and in a shorter time.

[0023]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below based on embodiments shown in the accompanying drawings.

The blood collecting apparatus of the present embodiment is of a type that collects blood at a living body part other than a fingertip. As shown in FIG. 1, the apparatus main body 1 with a cuff 16 attached to a living body part other than a fingertip, A puncture device 2 that can puncture the skin surface with a puncture needle 3 inserted from a puncture device insertion portion 4 provided in the device main body 1 and a skin portion around a puncture point 5 after puncture is directed from outside to inside. And a pressing member 6 for applying pressure.

The puncture device 2 is called a puncture-type lancet, and is formed separately from the apparatus main body 1 in this embodiment. The puncture device 2 presses the transparent tip cap 21 provided at the tip of the housing 20 against the skin,
When the push plate 23 at the rear end of the plunger 22 is pushed, the puncture needle 3 in the tip cap 21 moves forward to pierce the skin, and when the push plate 23 is stopped from being pushed, a built-in spring (not shown) is used. ), The plunger 22 is automatically retracted and set to the original position. In addition, the structure of the puncture device 2 is not particularly limited.

On the other hand, the apparatus main body 1 has a cuff 16 through which an arm or the like is passed.
And a main body control portion 1a integrally attached to the outside of the cuff 16 and a cover 11 for covering the main body control portion 1a. The pressure member 6 is provided integrally with the cuff 16. In the present embodiment, a plurality of inflatable and contractible inflatable members 6a constituting the pressurizing member 6 are juxtaposed so as to communicate with each other substantially over the entire circumference of the cuff 16, and are provided from a pressurizing pump (not shown). 6
By supplying air into a, the inflating member 6a is inflated to press the skin portion around the puncture point 5 from the outside to the inside in the arrow direction a of FIG. The arrow “a” indicates the direction of expansion of the expansion member 6a, and since the outer side is stretchable, the expansion pressure is applied to the inner side. It should be noted that, as shown in FIG. 3, for example, as shown in FIG. 3, an expansion member 6a is provided around the puncture point 5, and the pressure member 6 is expanded around the puncture point 5. A method of applying pressure by expanding toward the puncture point 5 may be used.
The pressurizing pump may be an electric pump incorporated in the apparatus, or may be manually pressurized with air.

The main body control section 1a includes a base 13 having a puncture device insertion portion 4 at the center. The cover 11 is opened so that the puncture device 2 can be inserted from the puncture device insertion portion 4 to perform puncture. is there.

Thus, a living body part other than the fingertip, for example,
When performing blood collection with the forearm, the cuff 16 of the device body 1 is attached to the forearm of the patient, and the device body 1
And then puncture is performed by puncture tool 2. After the puncture, the plurality of inflatable members 6a constituting the pressurizing member 6 are respectively inflated using the pressurizing pump 10a or the like, and pressurized from the surrounding direction of the puncture point 5 toward the inside (toward the puncture point 5). As a result, the skin bulge 50a is formed, and blood concentrates on the puncture point 5 to promote exudation. Thereafter, as in the related art, the patient himself / herself measures the blood glucose level through the steps of blood introduction to the blood glucose measurement test chip and measurement.

As described above, after the puncture, the skin portion around the puncture point 5 is pressed from the outside to the inside by the pressing member 6 so that the puncture point 5 is moved from the surrounding direction to the puncture point 5. Thus, the blood pressure at the puncture point 5 can be increased without interrupting the blood flow. By the way, in places other than the fingertips of the living body, the blood vessel density near the epidermis is low, and the blood pressure is also low, so it is very difficult to secure a sufficient blood collection volume simply by puncturing, as in the present invention. By applying pressure toward the puncture point 5 after the puncture, the blood is easily exuded. In addition, compared to a case where a fingertip is punctured, it is possible to sufficiently secure a required blood collection amount with little pain and little puncture. As a result, the amount of blood required for analyzing a specific component of the body fluid can be secured in a short time, blood collection failure can be eliminated, and the blood collection operation can be performed without pain.

As a living body part other than a fingertip, for example,
Blood can be collected from the forearm, upper arm, abdomen, thigh, etc. with less pain and easy to operate.
In the case of collecting blood from the thigh, etc., the blood exudation is promoted as described above, so that the puncture depth can be reduced and the puncture needle 3 can be thinned, so that the problem that puncture spots remain and that the pain continues for a long time No problem. As a result, "securing blood collection volume"
And "reduction of pain and puncture spots" can be achieved, and a self-check can be performed with confidence. In particular, since the blood pressure at the puncture point 5 is increased by pressurization from the periphery to the inside after the puncture, there is no failure in blood collection, and thus one blood glucose measurement test strip is wasted,
In addition, it is not necessary to perform puncturing again, and for example, the burden can be reduced for an elderly person or a person with an inconsistent body.

As a puncture site, a portion between the joints of the limbs indicated by oblique lines in FIG. 7 is suitable for a blood sampling portion. In addition, since a thick blood vessel or nerve exists near the epidermis near the joint, it is better to avoid puncturing this part as much as possible.

When a pressure exceeding the range of the systolic blood pressure is applied, the blood flow may be interrupted, and almost no blood may be produced. Therefore, it is desirable that the pressure (pressure amount) of the pressure member 6 can be arbitrarily set, and the pressure is controlled to be equal to or lower than the systolic blood pressure. As an example, as shown in FIG. 21, for example, as shown in FIG. 21, a pressing force setting unit 7 that sets the pressing force of the pressing member 6, a pressing force control unit 8 that controls the pressing force below the systolic blood pressure, and Blood pressure measuring means 15
It is preferable to control the pressurizing pump 10a based on the blood pressure measurement value measured by the blood pressure measuring means 15 so that the pressure control unit 8 becomes equal to or lower than the systolic blood pressure. By setting the tightening pressure by the pressure member 6 to be equal to or lower than the systolic blood pressure, the blood flow is not interrupted, and the amount of blood collected can be secured. In addition, by providing the blood pressure measuring means 15 in the main body control portion 1a so that blood pressure can be measured, the measured blood pressure value is fed back to the pressure value at the time of puncturing, and the pressure is controlled so that the tightening pressure becomes equal to or less than the systolic blood pressure. By doing so, it is possible to apply a tightening pressure suitable for a patient whose blood pressure varies, and blood exudation can be performed smoothly. Further, if the range of the blood pressure value to be controlled is the minimum blood pressure value ± 30 mmHg and 30 mmHg or more, blood collection can be performed more reliably and in a shorter time.

In order to further increase the blood pressure at the puncture point 5, it is desirable to control the pressure of the pressurizing member 6 to change intermittently. One example is shown in FIGS.
Shown in 4A to 4D show intermittent pressurizing patterns and how the pressurized value changes with time. In addition, a time-dependent pattern relating to the pressure reduction is similarly shown. Here, the vertical axis is the suction force, and its unit is represented by (-kPa). FIG. 4A shows the setting value and 0
(Release) is repeated, and FIG. 12B combines continuous and intermittent, thereby obtaining an effect of increasing the blood collection amount. FIG. 10C shows a case where the set value is provided with a certain width and the pressure is intermittently applied, and FIG. 10D shows a case where the intermittent and continuous are combined at a certain width. Has a great effect. Here, the width of the intermittent operation with respect to the set value in the case of (c) or (d) is suitably about the set value ± 30 mmHg. In this way, by making the pressing force (amount of pressurization) work intermittently (or intermittent and continuous repetition) with the passage of time, the effect is more enhanced than simple pressurization is performed continuously. growing. By continuously or intermittently applying pressure to the puncture point 5 from the outside of the puncture point 5, the blood pressure at the puncture point 5 is increased and the blood flow is not interrupted. Therefore, even in a place where the blood pressure is low and the blood volume is small, a sufficient blood collection volume can be secured.

FIG. 5 shows an example in which a puncture point compression mechanism 12 is provided on the cover 11 and the base 13 of the main body control portion 1a. The configuration other than the cover 11 and the base 13 is the same as that of the embodiment of FIG. 1, and only different points will be described.
In this example, a large number of protruding movable compression members 12b are protruded on the cover 11 side, while an elastically deformable ring portion is provided on the base 13 side, and the movable compression member 12b is inserted into this. A hole 17 is drilled. As shown in FIG. 5B, each of the insertion holes 17 has a shape that matches with the movable compression member 12b when the movable compression member 12b is inserted. When inserted into the insertion hole 17 as shown in FIG.
When the inner portion 13a of the swelling expands in the direction of arrow b, the skin is pressurized from the side and a skin bulge 50a is generated, and the puncture point that allows blood to exude from the puncture point 5 more smoothly can be performed. As shown in FIGS. 10 and 11 as another example of the compression mechanism 12, as shown in FIGS. 10 and 11, a cylindrical shape for pressurizing is formed at a location corresponding to the puncturing portion of the cover 11, that is, at a location where the positional relationship between the cover 11 and the puncturing device insertion section 4 is coincident. Irregular member 12
a may be provided. As shown in FIG. 11, the projection of the uneven member 12a has a shape that matches the shape of the puncture device insertion portion 4, and is configured to press around the puncture point 5 when the cover 11 is closed. Have been. By closing the cover 11 in this manner, the uneven member 1
The skin bulge 50a in which the 2a is bulged is further pressed from the side, so that the blood in the skin can be more smoothly oozed out of the body.

FIG. 6 shows an example in which the puncture device insertion section 4 is provided at the center of the pressing member 6 in the width direction G. Other configurations are the same as those of the embodiment of FIG. 1, and only different points will be described. In this example, since the puncture device insertion portion 4 is arranged at the center of the pressing member 6 in the width direction G, pressure is applied from all sides as shown by the arrow c in FIG. Since the blood is easily collected by pressurization from the whole, it is easy to secure the blood collection amount.

FIGS. 8 and 9 show an example in which a closed space 9 is provided in the puncture device insertion section 4 and a pressure reducing means 10 for reducing the pressure in the space 9 is provided. Other configurations are the same as those of the embodiment of FIG. 1, and only different points will be described.
In this example, the packing 18 is attached to the lower surface of the cover 11, and when the cover 11 is closed, the packing 18 is attached to the base 13.
The inner space 9 of the puncture device insertion portion 4 is tightly fitted to the upper surface of the outer peripheral portion of the puncture device insertion portion 4. Further, a pressurizing pump 10 a is built in the base 13, and an intake port 30 thereof communicates with the space 9 and an exhaust port 31 communicates with the inside of the pressurizing member 6. This gives 1
The two pressure pumps 10a have a function of performing decompression and pressurization, and switching between decompression and pressurization can be performed only by a sealing operation of the space 9. That is, by sealing the puncture device insertion portion 4 with the cover 11 and the packing 18 attached to the cover 11, the internal space 9 is sealed, and furthermore, the pressure is reduced (atmospheric pressure) by the suction of the pressurizing pump 10a. The following state). At this time, the pressure pump 1
The expansion member 6a is inflated by the exhaust of 0, and the skin ridge 50a is formed by applying a pressing force from the periphery of the puncture point 5 to the inside, so that the blood pressure around the puncture point 5 is further increased, and blood exudation after puncture is performed. It will be done more smoothly. In addition, decompression and pressurization can be performed simultaneously by one pressurization pump 10a, and switching between decompression and pressurization is performed in conjunction with the operation of opening and closing the closed space 9 (the operation of opening and closing the cover 11). Since the operation is performed, the operability is improved.

Here, it is desirable to control the pressure reduction of the closed space 9 intermittently. In other words, by intermittently repeating the depressurization pattern as shown in FIGS. 4A to 4D, the effect of exuding blood is higher than in the case of continuous suction. The effect of this is that, when simple continuous suction is performed, the area around the puncture device insertion portion 4 and the skin are in close contact with each other, and the blood flow is deteriorated. It is aimed at. In addition, the intermittent pulling causes the skin to move up and down, thereby producing a squeezing effect.

FIGS. 12 and 13 show an example in which a function for measuring the blood component exuded by the blood sampling operation is provided. Other configurations are the same as those of the embodiment of FIG. 1, and only different points will be described. In this example, as shown in FIG. 12, the main body control portion 1a is provided with an insertion portion 33 into which a test strip 32 for measuring a blood component can be inserted. By being introduced into the test strip 32, a specific blood component can be analyzed by a body fluid analyzer (not shown). At this time, as shown in FIG. 13, the analysis values (body fluid measurement values,
Alternatively, it is desirable to provide a display unit 35 for displaying a blood pressure value or the like, or to provide a mechanism for transmitting an analysis value by voice.

FIG. 14 shows the cover 11 of the main body control part 1a.
The elastic member 14 is interposed between the base member 13 and the uneven member 1 forming the puncture point pressing mechanism 12 on the cover 11.
2a, and the uneven member 12a
2 shows a case in which the compression operation by is performed elastically. Other configurations are the same as those of the embodiment of FIG. 1, and only different points will be described. In this example, the cover 11 and the base 13
The cover 11 can be moved up and down within a certain range by the elastic body 14 formed of a coil spring installed between them, and the pressure can be arbitrarily repeated with a finger or the like. As described above, the pressure can be repeatedly applied by the pressing operation of the cover 11, so that the skin moves up and down, and the squeezing effect is produced. In addition, since pressure can be elastically applied, a painless pressing operation can be realized.

FIGS. 15 to 17 show an example in which the puncture device 2 is integrated with the main body control portion 1a. Other configurations are the same as those of the embodiment of FIG. 1, and only different points will be described. In the present example, a hook portion 40 having a twisted shape is protrudingly provided at a central portion of the body of the puncture device 2, and a knob portion 43 having a shape easy to be gripped is integrally formed at an upper portion. As shown in FIG. 16, a locking hole 41 having the same shape as the puncture device 2 and a spring member 42 for locking the hook 40 of the puncture device 2 are provided on the cover 11 side. Puncture device 2
Is inserted into the locking hole 41 and twisted in the direction indicated by the arrow d in FIG. 16 so that, as shown in FIG.
Can be locked so as not to come off from the spring member 42. Then, as shown in FIG. 17 (b), the finger 43 is picked up with the finger and raised to the upper limit, and then released as shown in FIG. 17 (c), the puncture device 2 moves to the lower limit with its momentum,
Puncture is performed, and thereafter, the spring material 42 returns to the original position by the action of the spring material 42. Thereby, puncturing can be easily performed without using a complicated operating device.

The blood collecting apparatus of the present invention can be widely applied not only for collecting blood but also for collecting body fluids.

[0042]

Embodiments of the present invention will be described below.

(Example 1) FIGS. 18 and 19 are graphs showing the blood collection amount in a continuous pressurization for 20 seconds with respect to the blood pressure value of a patient. FIG. 18 shows that the patient's blood pressure is MAX1.
49 mmHg and MIN80 mmHg,
FIG. 19 shows that the blood pressure of another patient is MAX 175 mmHg, M
The case where IN is 100 mmHg is shown. The conditions relating to the puncture and pressurizing jig are as follows: puncture tool insertion section 4 diameter: 13φ, puncture needle 3 diameter: 0.5φ, needle penetration: 2.8 mm, pressure width: 5
0 mm. From these results, it was found that the diastolic blood pressure value was around (about 80 mmHg in the patient of FIG. 18 and 100 mHg in the patient of FIG. 19).
(near mHg), it was confirmed that the best blood collection volume was obtained.

Example 2 FIG. 20 shows a comparison between each pattern of the blood collection amount according to the present invention and the blood collection amount with respect to time according to the conventional method. Conditions for puncture and pressure jig
Same as Example 1. At this time, the examiner's blood pressure value: M
AX was 120 mmHg and MIN was 68 mmHg. A in the figure indicates intermittent pressurization (set value of 70 mmHg ± 3 in FIG. 4C).
0 mmHg) and intermittent decompression (Fig. 4 (b) set value-4)
5 kPa), B is intermittent pressurization (set value of 70 mmHg ± 30 mmHg in FIG. 4C) and partial pressurization repetition as shown in FIG. 14 (using the jig in FIG. 10), and C is intermittent pressurization. (The set value of FIG. 4C is 70 mmHg ± 30 mmH.
g), D is continuous pressurization (set value 140 mmHg), and E is only puncture (no pressurization). From these results, it was confirmed that the amount of blood collected by the method of the present invention increased with time, whereas the amount of blood collected by the conventional method hardly increased.

[0045]

As described above, according to the first aspect of the present invention, there is provided an apparatus main body to be attached to a living body part other than a fingertip, and a puncture needle inserted from a puncture device insertion portion provided in the apparatus main body. Since it has a puncture device capable of puncturing the surface and a pressurizing member for pressing the skin portion around the puncture point from outside to inside after puncturing, the puncture point is applied toward the puncture point of the living body portion. Pressure is generated, blood is concentrated around the puncture point, and exudation is promoted, and blood pressure around the puncture point can be increased without interruption of blood flow. In addition, compared to the case of puncturing the fingertip, the required amount of blood to be collected can be secured with a small amount of puncture with little pain, so that the amount of blood required for analyzing a specific component of bodily fluid can be reduced in a short time. Blood collection operation can be performed without pain, blood collection operation can be performed without pain, and the puncture depth can be reduced and the puncture needle can be made thinner. And self-check can be carried out with confidence. In addition, there is no failure in blood collection and there is no need to re-puncture the blood, so that the burden can be reduced, especially for people who are older or have an irregular body.

According to the second aspect of the present invention, in addition to the effect of the first aspect, the puncture device insertion portion is disposed at substantially the center of the pressing member in the width direction, so that the puncture device insertion portion can be applied from all sides. Pressure is applied, and this makes it easier for blood to collect at the puncture point due to pressurization from the entire area around the puncture point, so that it is easier to secure a blood collection amount.

According to the third aspect of the present invention, in addition to the effect of the first or second aspect, since the puncture site is one of the limbs of the living body, the blood sampling operation is performed with few pain points as a blood sampling site. It will be easy.

According to a fourth aspect of the present invention, in addition to the effect of any one of the eleventh to third aspects, the pressure setting means for setting the pressure of the pressurizing member and a pressure lower than the systolic blood pressure. A pressure control unit for controlling the pressure is provided, so that the pressure (pressurized amount) of the pressure member can be set arbitrarily, and by controlling the pressure to a value less than the systolic blood pressure, the blood flow is not interrupted. Thus, the required blood collection amount can be sufficiently secured.

According to a fifth aspect of the present invention, in addition to the effect of the fourth aspect, since the pressing force control unit controls the pressing force by the pressing member to change intermittently, the blood at the puncture point is controlled. The pressure is increased and the blood flow is not interrupted, so that the required amount of blood to be collected can be sufficiently secured as compared with the case where simple pressurization is performed continuously.

According to a sixth aspect of the present invention, in addition to the effect of the first or second aspect, a sealed space facing the puncture point is provided in the puncture device insertion portion, and the sealed space is provided. Since it has decompression means for decompressing the space,
By setting the closed space after puncturing to a reduced pressure state (atmospheric pressure or lower), the blood pressure around the puncturing point is further increased, and blood exudation after puncturing is performed more smoothly.

According to the seventh aspect of the present invention, in addition to the effect of the sixth aspect, since the pressure reduction control of the closed space is performed intermittently, the effect of exuding blood is improved as compared with continuous suction. Increase. In other words, when a simple continuous suction is performed, the peripheral portion of the space and the skin are in close contact with each other, the blood flow is deteriorated, and the suction power is weakened. Moves up and down, creating an squeezing effect, and the effect of returning blood there.

According to the invention of claim 8, in addition to the effects of claim 6 or claim 7, the pressure reduction and pressurization are performed by one pump, and the switching between pressure reduction and pressurization is performed in the closed state. Since the operation is performed in conjunction with the opening / closing operation of the space, the pressure can be switched between depressurization and pressurization only by opening / closing the space, the number of components can be reduced, and the cost can be reduced.

According to a ninth aspect of the present invention, in addition to the effect of any one of the first to eighth aspects, a cover for covering at least the upper part of the puncture point so as to be freely opened and closed is provided.
The cover is provided with a puncture point compression mechanism for further pressing the puncture point of the skin raised by pressurization by the pressurizing member toward the puncture point from around the puncture point by closing the cover. When the cover is closed, the puncture point compression mechanism automatically presses further from the periphery of the raised skin toward the puncture point at the center of the raised skin, thereby allowing the blood in the raised skin to ooze out of the body smoothly. Will be able to

According to a tenth aspect of the present invention, in addition to the effect of the ninth aspect, since the puncture point pressing mechanism comprises an uneven member provided on the cover, the uneven member formed by closing the cover is raised. The compressed skin (around the puncture point) is further pressurized, and with a simple structure, blood collected on the skin can be exuded more smoothly out of the body.

According to the eleventh aspect of the present invention, in addition to the effect of the ninth aspect, the puncturing point compression mechanism is arranged around the puncturing point when the cover is closed, and moves from the puncturing point to the puncturing point. Since the movable compression member is capable of compressing the skin surface while moving, the movable compression member moves inward (to the puncture point side) by closing the cover, so that the blood pressure is increased by the pressure member. Can be further pressed from the side by the movable pressing member, so that blood exudation from the puncture point can be performed more smoothly.

According to a twelfth aspect of the present invention, in addition to the effects of the ninth to eleventh aspects, an elastic body is interposed between the cover and a base disposed below the cover. The compression operation by the puncture point compression mechanism is performed elastically by pressurizing the cover, so that the cover can be moved up and down within a certain range, and pressurized repeatedly with fingers, etc., thereby moving the skin up and down In addition, a squeezing effect is produced, and a painless pressing operation can be realized.

According to the thirteenth aspect of the present invention, in addition to the effect of any one of the first to twelfth aspects, a function of measuring a blood component exuded by a blood sampling operation is provided. The measurement operation can be easily performed by introducing the blood exuded by a series of blood collection operations into the test strip for measuring the blood components and allowing the body fluid analyzer to analyze a specific blood component.

According to a fourteenth aspect of the present invention, in addition to the effect of any one of the first to thirteenth aspects, a blood pressure measuring means is provided, and the blood pressure is measured based on the blood pressure measurement value measured by the blood pressure measuring means. Since the pressure control unit controls the pressure so as to be equal to or lower than the systolic blood pressure, the tightening pressure by the pressurizing member is controlled so as to be equal to or less than the systolic blood pressure. Pressure can be applied, and blood exudation can be performed smoothly.

The invention according to claim 15 provides the invention according to claim 14.
In addition to the effects described above, since the range of the controlled blood pressure value is the minimum blood pressure value ± 30 mmHg and 30 mmHg or more, it is possible to collect blood more reliably and in a shorter time.

[Brief description of the drawings]

FIG. 1 is a perspective view showing an example of an embodiment of the present invention.

FIG. 2 is a cross-sectional view showing the direction of expansion of the pressing member.

FIG. 3 is a sectional view of another example of the pressing member according to the first embodiment.

FIGS. 4A to 4D are graphs showing intermittent pressurization patterns and how pressure values change with time.

FIG. 5A is a perspective view showing another example of the puncture point compression mechanism,
(B), (c) is explanatory drawing which shows the movement of a movable compression member.

FIG. 6 places a puncture device insertion portion in the center of the pressing member,
It is explanatory drawing which shows the state which pressure is applied from four directions.

FIG. 7 is an explanatory view showing hatched portions of the limb as hatched portions of the cuff, which are indicated by oblique lines.

FIG. 8 is an explanatory diagram of a case where the above-described pressurizable pump is incorporated.

FIG. 9 is an explanatory diagram showing a case where the pressure is reduced in a state where the cover is closed.

FIG. 10 is a perspective view illustrating an uneven member provided on the back side of the cover of the above.

FIG. 11 is an explanatory view showing a state in which the skin portion around the puncture point raised by the uneven member is further pressed.

FIG. 12 is a perspective view showing a state in which a body fluid analyzer is incorporated in the blood collection device.

FIG. 13 is a perspective view when the cover of FIG. 12 is closed.

FIG. 14 is an explanatory view of another example of the above cover.

FIG. 15A is a side sectional view when the puncture device is integrated with the apparatus main body, and FIG. 15B is a bottom view.

FIG. 16 is an exploded perspective view illustrating a case where the puncture device is mounted.

17A is a cross-sectional view showing a state in which the puncture device is set in the apparatus main body, and FIGS. 17B and 17C are states in which the puncture device is moved by picking up the puncture device with a finger and releasing the finger. FIG.

FIG. 18 is a graph showing a relationship between a blood collection amount of a patient and a pressurization value.

FIG. 19 is a graph showing the relationship between the blood collection volume of another patient and the pressure value.

FIG. 20 is a graph comparing the blood collection amount of the present invention with a conventional example.

FIG. 21 is a block diagram of the above.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Device main body 2 Puncture device 3 Puncture needle 4 Puncture device insertion part 5 Puncture point 6 Pressurizing member 7 Pressurizing force setting means 8 Pressurizing force control unit 9 Sealed space 10 Decompression means 11 Cover 12 Puncturing point pressing mechanism 12a 12b movable compression member 13 base 14 elastic body 15 blood pressure measurement means G width direction of pressure member

Continuing on the front page (72) Inventor Takaaki Yoshikawa 1048 Kadoma Kadoma, Osaka Pref.Matsushita Electric Works, Ltd. Reference) 2G045 AA01 CA25 HA06 HA13 HA14 JA07 4C017 AA08 AD01 DE01 FF30 4C038 KK10 KL01 KM00 KX01 KY04 TA02

Claims (15)

[Claims] 1. A puncture device that can puncture the skin surface with a device main body attached to a living body part other than a fingertip, a puncture needle inserted from a puncture device insertion section provided in the device main body, And a pressurizing member for pressurizing the skin portion around the puncture point from outside to inside. 2. The blood collection device according to claim 1, wherein the puncture device insertion portion is disposed substantially at the center of the pressing member in the width direction. 3. The blood collection device according to claim 1, wherein the puncture site is one of the limbs of a living body. 4. A pressurizing force setting means for setting a pressurizing force of a pressurizing member, and a pressurizing force control section for controlling a pressurizing force below a systolic blood pressure.
The blood collection device according to any one of the above. 5. The blood collection apparatus according to claim 4, wherein the pressure control unit controls the pressure by the pressure member to change intermittently. 6. The puncture device insertion section, wherein a closed space facing the puncture point is provided in the puncture device insertion section, and a pressure reducing means for reducing the pressure in the closed space is provided. The blood collection device according to claim 2. 7. The blood collection device according to claim 6, wherein the pressure reduction control of the closed space is performed intermittently. 8. The method according to claim 6, wherein the pressure reduction and the pressure increase are performed by a single pump, and the switching between the pressure reduction and the pressure increase is performed in conjunction with the opening / closing operation of the closed space. 8. The blood collection device according to 7. 9. A cover that covers at least the puncture point so as to be openable and closable, and the cover moves the puncture point of the skin raised by the pressurizing member from the puncture point to the puncture point by closing the cover. The blood collection device according to any one of claims 1 to 8, further comprising a puncture point compression mechanism for further applying pressure. 10. The blood collection device according to claim 9, wherein the puncture point compression mechanism comprises an uneven member provided on the cover. 11. The puncturing point compression mechanism may include a movable compression member that is disposed around the puncturing point when the cover is closed, and that is capable of pressing the skin surface while moving from around the puncturing point toward the puncturing point. The blood collection device according to claim 9, wherein 12. An elastic body is interposed between the cover and a base disposed below the cover, and a pressing operation by the puncture point pressing mechanism is elastically performed by pressing the cover. The blood collection device according to any one of claims 9 to 11. 13. The blood collection apparatus according to claim 1, further comprising a function of measuring a blood component exuded by the blood collection operation. 14. The apparatus according to claim 1, further comprising a blood pressure measuring unit, wherein the pressure control unit controls the pressure so as to be equal to or lower than the systolic blood pressure based on the blood pressure measurement value measured by the blood pressure measuring unit. The blood collection device according to claim 13. 15. The blood collection device according to claim 14, wherein the range of the controlled blood pressure value is a minimum blood pressure value ± 30 mmHg and 30 mmHg or more.