JP2005095521A - Puncture instrument, blood sugar level measuring instrument, and light irradiation device for puncture instrument - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a puncture instrument by which a simple and prompt percutaneous blood collection is enabled, a blood sugar level measuring instrument with the puncture instrument, and a light irradiation device for puncture instrument. <P>SOLUTION: The puncture instrument 1 is equipped with a lancet part 10 having a puncture needle 11 which can be punctured into the skin, and a laser element 20 as a light irradiation part for irradiating a light of wavelength having vasodilation feature at the top edge of the puncture needle 11. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a puncture device for collecting blood from skin, a blood glucose level measuring device including the puncture device, and a light irradiation device for the puncture device.

  A diabetic patient collects blood by himself and measures blood glucose, which is a glucose level in blood. In this case, the patient generally uses a puncture device having a needle, punctures the skin of a fingertip with abundant blood vessels, causes the needle to bleed, and transfers the blood to a blood glucose analyzer to measure the blood glucose level. (For example, refer to Patent Document 1).

  However, because the skin of the fingertip is rich in receptors (pain points) and nerves that sense pain, there is more pain from needle puncture than in other parts. Therefore, it is very painful for patients who are forced to make repeated measurements every day.

  Therefore, for the purpose of reducing puncture pain, a needle is punctured into the skin such as the thigh and the upper arm with few pain points, or 30G (outer diameter 0.30 mm), 33G (outer diameter 0.20 mm), etc. I have come to use needles.

  However, blood collection from skin other than fingers and the use of ultrafine needles have solved the pain problem caused by needle puncture to some extent, but have caused a new problem that it is difficult to produce blood. Furthermore, when blood is collected from the skin of the thigh or the upper arm, even if bleeding occurs, there is a problem that bleeding does not stop easily due to high arterial pressure.

  On the other hand, since the fingertip is located away from the heart, the arterial pressure is low. Furthermore, peripheral blood vessels existing in the skin such as fingertips are easily affected by environmental temperature. That is, the skin temperature tends to decrease and the blood vessels tend to contract. Low arterial pressure and contraction and narrowing of blood vessels mean poor blood circulation. For this reason, even if the skin of the fingertip is injured with a needle, the probability of hitting a blood vessel is low and bleeding is difficult.

  Therefore, if the blood vessels in the skin of the fingertip can be expanded at the time of puncture, there is a possibility that a favorable situation can be created for blood glucose measurement, in which blood can easily bleed even after using a fine needle and blood is likely to stop after bleeding. From this point of view, methods have been used so far, such as warming the puncture site with warm water or massaging from the heart toward the fingertip before puncturing for patients who are difficult to produce blood. However, as in the case of performing massage, when using warm water, the operation is complicated, for example, it is necessary to prepare warm water and to wipe off moisture after warming the puncture site. Furthermore, since the vasodilatory effect by heating is a reflex through the central nerve, a strong vasodilator effect cannot be expected, and it takes time for the effect to appear.

Therefore, the present inventor has focused on light as a means for directly and simply expanding blood vessels in the skin. This is because it is known that light having a wavelength in the ultraviolet region affects vascular smooth muscle. That is, it has been reported that ultraviolet irradiation with a very weak output (wavelength 300 nm to 350 nm) directly and strongly relaxes the isolated blood vessel, and that the effect gradually decreases when the wavelength shifts to the longer wavelength side (for example, non- Patent Document 1). However, since the ultraviolet region having a wavelength of 300 nm to 350 nm has a harmful stimulating action on the skin, this wavelength region cannot be used.
JP 2000-245717 A R. F. RF Furchgott, 2 others, The Journal of General Physiology, (USA), The Rockfeller Institute for Medical research, 1961, 44 , P. 499-519

  The present invention has been made in order to solve the above-described problems, and an object of the present invention is to provide a puncture device and a puncture device that enable simple and quick blood collection from the skin while reducing puncture pain. It is to provide a blood glucose level measuring device and a light irradiation device for a puncture device.

  The object of the present invention is achieved by the following means.

  (1) It has a lancet section provided with a puncture needle that can puncture the skin, and a light irradiation section for irradiating light of a wavelength having a vasodilating action in front of the needle tip of the puncture needle. Puncture device.

  (2) The above (1), further comprising: a chamber provided in front of the needle tip of the puncture needle and substantially sealed by skin; and suction means for sucking air in the chamber. Puncture device.

  (3) The said light irradiation part irradiates the laser beam within the range of wavelength 360nm-600nm, or the light which has an absorption peak within the range of wavelength 360nm-600nm, The said (1) or (2) The puncture device according to 1.

  (4) A casing that houses the lancet unit and the light irradiation unit, an opening that is formed on the upper surface of the casing and that can be almost closed with a fingertip, and a switch that is provided near the opening and that can start and stop the light irradiation The puncture device according to (1) or (2), further comprising:

  (5) The outer diameter of the puncture needle is in the range of 0.1 mm to 0.3 mm, and the length of the portion of the puncture needle that can protrude outward from the opening end surface of the casing in which the lancet portion is housed. Is within the range of 0.5 mm to 3 mm, The puncture device according to any one of (1) to (4) above.

  (6) The puncture device according to any one of (1) to (5), wherein the number of the puncture needles is within a range of 1 to 10.

  (7) A lancet unit provided with a puncture needle that can puncture the skin, a light irradiation unit for irradiating light of a wavelength having a vasodilating action in front of the needle tip of the puncture needle, and puncture by the puncture needle And a blood glucose level measuring apparatus comprising: a puncture device, wherein the blood sugar level is calculated based on blood from the skin.

  (8) A puncture device having a lancet portion provided with a puncture needle that can puncture the skin, a holding body for holding the puncture device, and when the puncture device is mounted on the holding body, A light irradiating device for a puncture device, comprising: a light irradiating unit for irradiating light having a wavelength having a blood vessel expanding action in front of the needle tip of the puncture needle.

  According to the present invention, since the blood vessel of the skin to be punctured by the puncture needle can be easily expanded by irradiating light of a wavelength having a vasodilating action in front of the needle tip of the puncture needle, it is thin as a puncture needle. Even if a needle is used, it is possible to puncture a blood vessel reliably and to quickly collect a sufficient amount of blood from the skin. Therefore, the puncture needle can be made thinner, and puncture pain can be reduced. Moreover, since blood can be easily collected from the skin of the fingertips, hemostasis after blood collection is facilitated.

  Embodiments of the present invention will be described below with reference to the drawings.

  FIG. 1 is a schematic cross-sectional view showing the main part of the puncture device according to the first embodiment of the present invention, and FIG. 2 is a plan view of the puncture device shown in FIG. In FIG. 1, for convenience of explanation, each element inside the puncture device is shown in substantially the same plane.

  As shown in FIG. 1, the puncture device 1 includes a lancet unit 10 provided with a puncture needle 11 that can puncture the skin, and light for irradiating light having a wavelength having a vasodilating action in front of the needle tip of the puncture needle 11. And a laser element 20 as an irradiation unit. Moreover, the puncture device 1 has a casing 30 that constitutes an outer frame.

  The lancet unit 10 has a support 12 with a puncture needle 11 attached to the tip. The support 12 is fitted and inserted into a cylindrical holder 31 erected at the center in the casing 30, and the lancet 10 is movable in the axial direction. A coil spring 40 is provided below the lancet 10 to urge the lancet 10 in the distal direction (upward in the drawing). The casing 30, the support body 12, and the holder 31 are made of, for example, plastic.

  In addition, a groove 13 that can be engaged with the rod 51 of the lancet release mechanism 50 is formed on the side surface of the support 12 of the lancet 10. As the lancet release mechanism 50, for example, an electromagnetic solenoid is used. The rod 51 is engaged with the groove 13 in a state where the coil spring 40 is compressed. The rod 51 can move back and forth in the horizontal direction toward the groove 13 of the support 12. When the rod 51 is retracted and removed from the groove 13, the lancet portion 10 is moved in the distal direction by the elastic force of the coil spring 40. The configuration of the lancet release mechanism unit 50 for controlling the movement of the lancet unit 10 is an example and can be changed as appropriate.

  The puncture needle 11 is generally manufactured using, for example, plastic processing using stainless steel. However, it is also possible to manufacture the puncture needle 11 from other metals such as titanium or materials such as plastic. The puncture needle 11 is fixed to the support 12 by, for example, insert molding or adhesion.

  The outer diameter of puncture needle 11 is preferably in the range of 0.1 mm to 0.3 mm. By providing the upper limit value, the needle can be made thinner to reduce puncture pain. Moreover, a necessary blood collection amount can be ensured by providing a lower limit.

  An opening 32 is formed on the upper surface of the casing 30. The opening 32 is formed in a size that can be almost closed with a fingertip. When the lancet unit 10 moves in the distal direction, the puncture needle 11 can protrude outward from the opening 32. The length of the portion of the puncture needle 11 that can protrude outward from the end face of the opening 32 of the casing 30 is preferably in the range of 0.5 mm to 3 mm. By providing an upper limit, damage to nerves and blood vessels can be minimized. Moreover, a necessary blood collection amount can be ensured by providing a lower limit.

  In addition, a start switch 33 is installed near the opening 32 of the casing 30 to start the operation of the puncture device when pressed by the user. As the start switch 33, a contact type switch is used, but a non-contact type switch may be used.

  The laser elements 20 are arranged substantially evenly around the lancet 10 above the casing 30. The number of installed laser elements 20 is arbitrary. The installation position and direction of the laser element 20 are determined so that the irradiated laser light can pass through the opening 32.

  As the laser element 20, for example, a semiconductor laser can be used. The laser element 20 preferably irradiates laser light within a wavelength range of 360 nm to 600 nm, more preferably within a wavelength range of 400 nm to 500 nm. By providing the lower limit, harmful irritation to the skin can be avoided. Further, by providing the upper limit value, a vasodilatory effect larger than that of the conventional phototherapy device can be exhibited. Instead of a laser element, an element that emits light having an absorption peak in a wavelength range of preferably 360 nm to 600 nm, more preferably in a wavelength range of 400 nm to 500 nm may be used.

  In the casing 30, a control unit 60 that performs various calculations and control of each unit in the instrument is provided. The control unit 60 includes, for example, a CPU, a memory, a dedicated electric circuit, and the like. The casing 30 includes a power source (battery) (not shown) for supplying power.

  FIG. 3 is a schematic block diagram showing a configuration relating to control of the puncture device.

  As shown in FIG. 3, the start switch 33 is connected to the control unit 60. A start signal from the start switch 33 is input to the control unit 60. The laser element 20 and the lancet release mechanism 50 are also connected to the controller 60. The control unit 60 outputs a signal for controlling the operations of the laser element 20 and the lancet release mechanism unit 50.

  Next, a method for using the puncture device 1 will be described.

  As shown in FIG. 2, the user places the finger 100 on the puncture device 1 so that the fingertip substantially closes the opening 32 of the casing 30 and rides on the start switch 33. When the start switch 33 is pushed with the fingertip, the operation of the puncture device 1 is started. When receiving the start signal from the start switch 33, the control unit 60 issues a command to the laser element 20 to irradiate the laser beam and starts a built-in timer for counting the irradiation time. The laser element 20 irradiates laser light toward the opening 32. By irradiating the laser beam, the blood vessels of the skin of the fingertip placed on the opening 32 are expanded.

  When the value of the timer has passed a predetermined time (for example, 1 minute), the control unit 60 issues a release command to the lancet release mechanism unit 50 so as to retract the rod 51. In addition, instead of issuing a release command depending on time, the control unit 60 can also issue a release command depending on, for example, the amount of increase in fingertip temperature. Accordingly, the lancet portion 10 is disengaged by the rod 51 and is moved in the distal direction by the force by which the coil spring 40 extends. Then, the puncture needle 11 of the lancet unit 10 projects a predetermined distance from the end face of the opening 32 and punctures the skin of the fingertip. The puncture needle 11 is pulled back to the proximal end side by a second spring member (not shown) after puncturing the skin, and the needle tip is moved inward from the end face of the opening 32.

  When the user removes the fingertip from the start switch 33, the control unit 60 issues a command to the laser element 20 so as to stop the laser light irradiation. Therefore, it is possible to avoid a situation where the user mistakenly sees the laser beam.

  As described above, according to the present embodiment, the blood vessel of the skin to be punctured with the puncture needle 11 can be easily expanded by irradiating the front of the needle tip of the puncture needle 11 with light having a wavelength having a blood vessel expanding action. Therefore, even if a thin needle is used as the puncture needle 11, it is possible to puncture the blood vessel reliably and to quickly collect a sufficient amount of blood from the skin.

  Therefore, the puncture needle 11 can be made thinner, and puncture pain can be reduced. Moreover, since blood can be easily collected from the skin of the fingertips, hemostasis after blood collection is facilitated.

  Although it is already known that light in the ultraviolet region (wavelength 300 nm to 350 nm) strongly expands blood vessels as described above, the effect of light in the visible region (wavelength 400 nm to 600 nm) and its surrounding wavelengths is It was hardly studied until.

  Therefore, an experiment was conducted to examine the influence of light in the wavelength range of 360 nm to 600 nm used in the above embodiment on the circulating blood flow, which will be described below.

(experimental method)
Experiments were performed using a semiconductor laser device (manufactured by Kochi Toyonaka Giken Co., Ltd.) capable of irradiating 532 nm laser light and a dental semiconductor laser device (manufactured by Unitak Corp.) capable of irradiating 810 nm laser light.

  Rats were used as experimental animals. After anesthetizing the rat with pentobarbital, a probe of a blood flow meter (ALF21; manufactured by Advance Co., Ltd.) was brought into close contact with the inside of the auricle. The irradiation port of the laser irradiation apparatus was installed outside the auricle part so as to be positioned directly above the probe inside the auricle part, and the auricle part was sandwiched. The blood flow in the auricle was recorded with a pen recorder. The blood flow immediately after irradiation with laser light for 1 minute and 5 minutes was shown as an increase rate (average value ± standard deviation (SD)) with respect to the blood flow immediately before irradiation.

  The temperature was measured with the temperature measurement probe in close contact with the inside of the auricle instead of the probe of the blood flow meter. Laser light was radiated in the same manner as during blood flow measurement, and the temperature at 1 minute, 5 minutes and 10 minutes after irradiation was recorded.

(Experimental result)
The results of blood flow measurement are shown in Table 1.

  As can be seen from Table 1, irradiation with laser light of 810 nm and 20 mW hardly affected the blood flow of the auricle. However, irradiation of laser light of 532 nm and 20 mW depended on time and blood in the auricle. Increased flow.

  The results of temperature measurement are shown in Table 2.

  As can be seen from Table 2, there was not much difference between the 532 nm laser light and the 810 nm laser light in the auricle temperature change during laser light irradiation.

  From the above experiment, it is considered that the blood flow increasing effect by the laser light irradiation is an influence by the light irradiation itself. That is, it was found that light having a wavelength of 532 nm sufficiently dilates blood vessels. Therefore, it is possible to puncture the skin with the puncture needle 11 for blood collection, using the puncture device of the present invention, quickly and effectively dilating the blood vessels of the skin without giving harmful stimuli. I understand that

  FIG. 4 is a schematic cross-sectional view showing the main part of the puncture device according to the second embodiment of the present invention, and FIG. 5 is a plan view of the puncture device shown in FIG. In FIG. 4, for convenience of explanation, each element inside the puncture device is shown in substantially the same plane. Hereinafter, a description will be given focusing on differences from the first embodiment. The same code | symbol is used for the member which has a function which is common in 1st Embodiment.

  The puncture device 1a according to the second embodiment further includes a chamber 34 that is provided in front of the needle tip of the puncture needle 11 and can be substantially sealed by skin, and a suction pump 70 for sucking air in the chamber 34. This is different from the first embodiment.

  The lancet unit 10 a has three puncture needles 11. The number of puncture needles 11 can be set arbitrarily, but if there are a plurality of puncture needles 11, the probability that the puncture needle 11 hits the blood vessel can be increased. However, considering the certainty of needle puncture and the viewpoint of manufacturing cost, the number of puncture needles 11 is preferably in the range of 1 to 10.

  An opening 32 a on the upper surface of the casing 30 is formed on the upper surface of the chamber 34. A suction port 35 that opens to the inner surface of the chamber 34 is connected to a suction pump 70 via a passage 36 and a pipe 71. The control unit 60 can output a signal for controlling the operation of the suction pump 70 in addition to the laser element 20 and the lancet release mechanism unit 50.

  In addition, the upper part of the cylindrical holder 31 into which the lancet part 10a is inserted, that is, the part to which the laser light from the laser element 20 hits is formed to be transparent so that the laser light can pass through.

  When using the puncture device 1a configured as described above, as shown in FIG. 5, the user holds the finger 100 so that the fingertip almost covers the opening 32a of the casing 30 and rides on the start switch 33. Place on puncture device 1. When the start switch 33 is pushed with the fingertip, the operation of the puncture device 1 is started. In the following, since the operation until the puncture needle 11 of the lancet unit 10 punctures the skin is the same as that of the first embodiment, the description thereof is omitted.

  In the second embodiment, the control unit 60 issues a command to the suction pump 70 so as to suck the air in the chamber 34 at the same time or after the release command to the lancet release mechanism unit 50. Since the chamber 34 is substantially sealed by the user's finger 100, a negative pressure is generated. Thereby, blood becomes easy to come out from the skin punctured by the puncture needle 11. When the user removes the fingertip from the start switch 33, the light irradiation and suction operations are stopped.

  As described above, the puncture device according to the second embodiment can obtain the same effects as those of the first embodiment, and further has an advantage that blood collection is easier.

  FIG. 6 is a schematic cross-sectional view showing a main part of a light irradiation apparatus for a puncture device according to a third embodiment of the present invention. Hereinafter, a description will be given focusing on differences from the first embodiment. The same code | symbol is used for the member which has a function which is common in 1st Embodiment.

  The puncture device of the above-described embodiment is configured to have both the lancet unit 10 and the laser element 20 as the light irradiation unit. On the other hand, in this embodiment, the puncture device 2 having the lancet unit 10 and the puncture device light irradiation device 3 having the laser element 20 are separately provided separately. That is, the light irradiation device 3 for a puncture device includes a holding body 81 for holding the puncture device 2 and a holding body 81 to which the puncture device 2 having the lancet portion 10 including the puncture needle 11 capable of puncturing the skin can be mounted. When the puncture device 2 is attached to the body 81, the puncture needle 11 has a laser element 20 as a light irradiating unit for irradiating light with a wavelength having a vasodilating action in front of the needle tip.

  The puncture device light irradiation device 3 includes a head portion 4 which is opposed to the surface of the skin 101 of the finger, for example, and a grip portion 5 for a user to grip. Moreover, the light irradiation apparatus 3 for puncture devices has the casing 80 which comprises an outer frame. The casing 80 is composed of, for example, a pair of elements that are divided into two by a plane of symmetry, and is formed of plastic or the like.

  The holding body 81 is formed as a part of the casing 80 above the head portion 4. The holding body 81 can be fixed so as to receive the puncture device 2 and not move. However, the configuration of the holder 81 is not limited to the illustrated one.

  An opening 83 for allowing the laser beam from the laser element 20 to pass through is formed in the tip surface (bottom surface in the figure) of the head unit 4. In addition, an irradiation switch 82 for starting irradiation of light by being pushed by the user is installed in the vicinity of the opening 83 of the casing 80. As the irradiation switch 82, a contact type switch is used, but a non-contact type switch may be used.

  When using the puncture device light irradiation device 3 configured as described above, as shown in FIG. 6, the user attaches the puncture device 2 to the holder 81 of the puncture device light irradiation device 3 in advance and fixes it. To do. When the user holds the grip portion 5 of the puncture device light irradiation device 3 and brings the front end surface of the head portion 4 close to or in contact with the skin 101, the irradiation switch 82 is turned on. When the irradiation switch 82 is turned on, a control unit (not shown) issues a command to the laser element 20 to irradiate laser light. When the blood vessel of skin 101 is sufficiently expanded by the irradiation of laser light (for example, 1 minute has elapsed since the start of irradiation), the user presses release switch 50a of puncture device 2. When a predetermined time (for example, 1 minute) elapses after the laser light irradiation, the user may be notified by sound generation from a speaker or lighting of a lamp.

  When the release switch 50a is pressed, the lancet unit 10 is moved in the distal direction (downward in the figure) by a coil spring (not shown), and the puncture needle 11 of the lancet unit 10 punctures the skin 101. When the puncture device light irradiation device 3 is separated from the skin 101, the light irradiation is stopped.

  Thus, if the light irradiation apparatus 3 for puncture devices of 3rd Embodiment is used, it is possible to acquire the effect similar to above-described embodiment, and also management, such as a maintenance, becomes easy.

  The present invention is not limited to the above-described embodiments, and various modifications can be made within the scope of the claims.

  For example, an analysis unit (not shown) for calculating a blood sugar level based on blood from the skin punctured by the puncture needle 11 is added integrally to the puncture device 1 or 1a of the above embodiment to measure the blood sugar level. It is also possible to configure the device. The analysis unit includes, for example, a sensor unit that can be supplied with blood from the skin punctured by the puncture needle 11 and a calculation unit that quantitatively calculates a blood glucose level from the sensor unit supplied with blood. The supply of blood to the sensor unit is performed by a user, for example. However, blood from the skin may be automatically supplied to the sensor unit.

  According to the blood sugar level measuring apparatus configured as described above, it is possible to obtain the same effect as that of the above-described embodiment, and it is also possible to quickly measure the blood sugar level together with the user. Improved convenience.

It is a schematic sectional drawing which shows the principal part of the puncture device which is 1st Embodiment of this invention. It is a top view of the puncture device shown by FIG. It is a schematic block diagram which shows the structure regarding control of a puncture device. It is a schematic sectional drawing which shows the principal part of the puncture device which is 2nd Embodiment of this invention. It is a top view of the puncture device shown by FIG. It is a schematic sectional drawing which shows the principal part of the light irradiation apparatus for puncture devices which is 3rd Embodiment of this invention.

Explanation of symbols

1, 1a puncture device,
2 Puncture device,
3 Light irradiation device for puncture device,
10, 10a lancet part,
11 puncture needle,
12 support,
13 groove,
20 laser element,
30, 80 casing,
32, 32a, 83 opening,
34 chambers,
60 control unit,
70 suction pump,
81 holder,
100 fingers,
101 Skin.

Claims (8)

A lancet portion having a puncture needle that can puncture the skin;
A light irradiation unit for irradiating light of a wavelength having a vasodilating action in front of the needle tip of the puncture needle;
A puncture device comprising: A chamber provided in front of the needle tip of the puncture needle and substantially sealable by the skin;
Suction means for sucking air in the chamber;
The puncture device according to claim 1, further comprising:   The puncture device according to claim 1 or 2, wherein the light irradiation unit irradiates laser light within a wavelength range of 360 nm to 600 nm or light having an absorption peak within a wavelength range of 360 nm to 600 nm. A casing for housing the lancet part and the light irradiation part;
An opening formed on the upper surface of the casing that can be almost closed with a fingertip;
A switch provided in the vicinity of the opening and capable of starting and stopping the irradiation of the light;
The puncture device according to claim 1, further comprising: The outer diameter of the puncture needle is in the range of 0.1 mm to 0.3 mm,
The length of the part which can protrude outward from the opening end surface of the casing in which the said lancet part is accommodated among the said puncture needles exists in the range of 0.5 mm-3 mm, Any one of Claims 1-4 characterized by the above-mentioned. The puncture device according to any one of the above.   The puncture device according to any one of claims 1 to 5, wherein the number of puncture needles is within a range of 1 to 10. A lancet portion having a puncture needle that can puncture the skin;
A light irradiation unit for irradiating light of a wavelength having a vasodilating action in front of the needle tip of the puncture needle;
An analyzer that calculates a blood glucose level based on blood from the skin punctured by the puncture needle;
A blood glucose level measuring device provided with a puncture device. A holding body for holding the puncture device, to which a puncture device having a lancet portion having a puncture needle capable of puncturing the skin can be mounted;
A light irradiation unit for irradiating light of a wavelength having a vasodilating action in front of the needle tip of the puncture needle when the puncture device is attached to the holding body;
A light irradiation device for a puncture device, comprising:

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