CN101351153A - Biosensors and Component Concentration Measuring Devices - Google Patents

Abstract

Translated fromChinese

本发明提供一种通过激光束穿刺进行血液收集的成分浓度测量装置，该装置可以防止激光穿刺过程中产生的异味的泄漏，并改善使用者的方便性。本发明的成分浓度测量装置包括主体(2)。该主体(2)设置有激光装置、聚光透镜、与分析物试剂通过酶反应分析体液的成分的分析装置、激光操作按钮(5)、显示器(3)、显示开光按钮(4)、可充电电池、以及电路，该电路设置有存储器，该存储器储存激光装置的操作、分析装置输出的成分浓度的分析和分析结果。具有设置在激光束的光轴上的膜的滑片(6)和其内部为中空的插入保持器(7)被插入主体(2)。包含设置在激光束光轴上的膜的生物传感器(8)设置为使得插入保持器(7)的突起嵌合到生物传感器(8)的开口。

The present invention provides a component concentration measuring device for blood collection by laser beam puncture, which can prevent leakage of odor generated during laser puncture and improve user convenience. The component concentration measuring device of the present invention includes a main body (2). The main body (2) is provided with a laser device, a condenser lens, an analysis device for analyzing the composition of body fluids with an analyte reagent through an enzyme reaction, a laser operation button (5), a display (3), a display button (4), a rechargeable A battery, and an electric circuit provided with a memory storing the operation of the laser device, analysis of the concentration of components output by the analyzing device, and analysis results. A slide (6) having a film disposed on the optical axis of the laser beam and an insertion holder (7) whose interior is hollow are inserted into the main body (2). A biosensor (8) including a film disposed on the optical axis of the laser beam is arranged such that the protrusion of the insertion holder (7) fits into the opening of the biosensor (8).

Description

Translated fromChinese

生物传感器和成分浓度测量装置Biosensors and Component Concentration Measuring Devices

技术领域technical field

本发明涉及一种成分浓度测量装置，其可用激光束刺穿人体的皮肤，且快速和容易地确定被采样的生物样本中的微量的各种特定成分的数量，并涉及用于该成分浓度测量装置的生物传感器。The present invention relates to a component concentration measuring device which can pierce the skin of a human body with a laser beam and quickly and easily determine the amount of trace amounts of various specific components in a sampled biological sample, and relates to a device for measuring the component concentration. Device biosensors.

背景技术Background technique

传统的生物传感器将通过概念图予以描述。A conventional biosensor will be described through a conceptual diagram.

图58显示了传统的激光装置，且在其一方面中，指尖腹被使用传统的激光装置的激光束照射。参考标记101表示内部固态激光振荡器，标记102表示主体，固态激光振荡器101设置在其中，且电源和控制装置设置在控制器103中作为单独的单元。透镜罩104设置在主体102中的激光束的输出侧，聚光透镜105设置在透镜罩104的内部，且来自固态激光振荡器101的激光束输出被聚光透镜105聚集。Fig. 58 shows a conventional laser device, and in one aspect thereof, the belly of the fingertip is irradiated with a laser beam using the conventional laser device. Reference numeral 101 denotes an internal solid-state laser oscillator,numeral 102 denotes a main body in which the solid-state laser oscillator 101 is provided, and power supply and control means are provided in acontroller 103 as a separate unit. Alens cover 104 is provided on the output side of the laser beam in themain body 102 , acondensing lens 105 is provided inside thelens cover 104 , and the laser beam output from the solid-state laser oscillator 101 is condensed by thecondensing lens 105 .

为了从指尖采样血液，其血液要被采样的人的部分手指腹放置在平台106上，朝向聚光透镜105。手指托108在其内侧弯曲，使得人指尖可稍微进入，且固定到平台106的上表面，使得激光束可聚集在该托的上边缘的外侧附近。To sample blood from a fingertip, the part of the finger pulp of the person whose blood is to be sampled is placed on theplatform 106 , facing thecondenser lens 105 .Finger rest 108 is curved on its inside so that a person's fingertips can enter slightly, and is secured to the upper surface ofplatform 106 so that the laser beam can be focused near the outside of the rest's upper edge.

当其血液要被采样的人的手指107被用激光束照射，在照射点产生微创口，且血液渗出。接着，其血液要被采样的人的血液由单独设置的生物传感器采样，且血液中的微量的特定成分被量化(例如，参考专利文献1)。When thefinger 107 of the person whose blood is to be sampled is irradiated with a laser beam, a micro-incision is made at the irradiated point, and blood oozes out. Next, the blood of the person whose blood is to be sampled is sampled by a separately provided biosensor, and minute amounts of specific components in the blood are quantified (for example, refer to Patent Document 1).

此外，图59是作为传统的生物传感器的一个实施例的葡萄糖传感器的分解透视图。在绝缘基板120上，包括树脂粘合剂的银膏和导电碳膏被印刷，且形成有包括导线112和113、测量电极114和反电极115的电极系统。而且，绝缘层116通过印刷绝缘膏而形成。In addition, FIG. 59 is an exploded perspective view of a glucose sensor as an example of a conventional biosensor. On theinsulating substrate 120, a silver paste including a resin binder and a conductive carbon paste are printed, and an electrode system including lead wires 112 and 113, a measuring electrode 114, and acounter electrode 115 is formed. Also, theinsulating layer 116 is formed by printing insulating paste.

对于电极114和115的系统，在抛光露出的部分后，羧甲基纤维素(后文称为CMC，其为亲水性的聚合物)的水溶液涂覆在电极上，由此形成CMC层，且其中作为酶的葡萄糖氧化酶(GOD)溶解在磷酸缓冲溶液中的物质被涂覆，以覆盖CMC层，由此形成包括CMC-GOD层的反应层。For the system ofelectrodes 114 and 115, after polishing the exposed part, an aqueous solution of carboxymethyl cellulose (hereinafter referred to as CMC, which is a hydrophilic polymer) is coated on the electrodes, thereby forming a CMC layer, And a substance in which glucose oxidase (GOD) as an enzyme was dissolved in a phosphate buffer solution was coated to cover the CMC layer, thereby forming a reaction layer including the CMC-GOD layer.

如图59所示，基板120、由树脂板制成的隔板117、以及盖板119这三个构件结合并整合，使得各个构件可具有虚线所示的位置关系。当整合时，切开部分的一端变为样本溶液的导入口110，且中间部分形成空间部118。此外，盖板119具有孔，当整合时，其变为排出口111。As shown in FIG. 59, three members of thebase plate 120, thespacer 117 made of a resin plate, and thecover plate 119 are combined and integrated so that the respective members can have a positional relationship shown by a dotted line. When integrated, one end of the cut portion becomes theinlet port 110 for the sample solution, and the middle portion forms the space portion 118 . Furthermore, thecover plate 119 has a hole which becomes the discharge port 111 when integrated.

当样本溶液即血液接触导入口110时，该血液从导入口110导入内部。此时，空间部118内的空气被快速地从排出口111排出。同样，血液在电极表面快速扩散，且充满该空间部。血液溶解CMC且变为粘胶液，且血液内的葡萄糖通过承载在电极上的葡萄糖氧化酶的作用而发生氧化反应，由此产生过氧化氢。通过施加电压到电极之间，通过酶反应产生的过氧化氢氧化该测量电极，且伴随的氧化电流值对应葡萄糖物质的浓度(例如，参考专利文献2)。When blood, which is a sample solution, contacts theinlet 110 , the blood is introduced from theinlet 110 into the inside. At this time, the air in the space portion 118 is quickly discharged from the discharge port 111 . Likewise, the blood rapidly spreads on the surface of the electrode and fills the space. The blood dissolves the CMC and turns into viscose, and the glucose in the blood undergoes an oxidation reaction by the action of glucose oxidase carried on the electrode, thereby generating hydrogen peroxide. By applying a voltage between the electrodes, hydrogen peroxide generated by an enzymatic reaction oxidizes the measurement electrode, and the accompanying oxidation current value corresponds to the concentration of glucose species (for example, refer to Patent Document 2).

在另一方面，当激光束刺穿皮肤(激光穿刺)时，照例研究减轻使用者的疼痛的技术。图60是显示传统的激光穿刺装置的操作的流程图。在传统的激光穿刺装置中，如果该装置的开始按钮被按下，开关是否被半按下在步骤S1中确定。如果需要产生声音(是)，该开关被半按下，且程序前进到步骤S2，在该步骤，例如音乐的声音从扬声器产生。接着，通过在步骤S3中按压穿刺开关，程序前进到进行穿刺的步骤S4。接着，在经过固定时段的时间后，程序前进到步骤S5，在该步骤，来自扬声器的声音被停止。On the other hand, when a laser beam pierces the skin (laser perforation), techniques for alleviating the user's pain are routinely studied. Fig. 60 is a flowchart showing the operation of a conventional laser perforating device. In the conventional laser perforating device, if the start button of the device is pressed, whether the switch is half-pressed is determined in step S1. If it is desired to generate sound (Yes), the switch is pressed halfway, and the program proceeds to step S2 where sound such as music is generated from the speaker. Next, by pressing the puncturing switch in step S3, the program proceeds to step S4 where puncturing is performed. Then, after a fixed period of time has elapsed, the procedure proceeds to step S5 where the sound from the speaker is stopped.

此外，如果在步骤S1中开关被半按下，程序前进到步骤S6，在该步骤，穿刺开关被按下。相应地，在步骤S7，来自扬声器的声音没有传出，但进行了穿刺(例如，参考专利文献3)。同样，在传统的激光穿刺装置中，扬声器设置在该激光穿刺装置中，以产生音乐或声音，其抵消穿刺过程中的操作声音。这减轻了穿刺过程中的疼痛。Also, if the switch is half-pressed in step S1, the process proceeds to step S6 where the piercing switch is pressed. Accordingly, in step S7, the sound from the speaker is not emitted, but the puncture is performed (for example, refer to Patent Document 3). Also, in a conventional laser puncturing device, a speaker is provided in the laser puncturing device to generate music or sound which cancels operation sound during puncturing. This reduces pain during piercing.

专利文献1：JP-A-04-314428Patent Document 1: JP-A-04-314428

专利文献2：JP-A-01-291153Patent Document 2: JP-A-01-291153

专利文献3：JP-A-2005-131088Patent Document 3: JP-A-2005-131088

发明内容Contents of the invention

本发明要解决的问题The problem to be solved by the present invention

然而，传统的激光穿刺装置和生物传感器结合的成分浓度测量装置中存在下面的问题。However, there are the following problems in the component concentration measuring device in which a conventional laser perforation device and a biosensor are combined.

首先是在激光穿刺皮肤的过程中，使用者闻到产生的烟流异味，且感到相当不舒服，且烟流沾到光学元件上造成污染。激光穿刺皮肤是通过吸收激光束能量到皮肤组织的主要成分水分中，通过加热或蒸发水分对皮肤组织进行热处理。此时，在空间产生烟流蒸发物。First of all, during the process of laser puncturing the skin, the user smells the peculiar smell of the generated smoke and feels quite uncomfortable, and the smoke sticks to the optical components to cause pollution. Laser perforation of the skin is to absorb laser beam energy into the main component of skin tissue, water, and heat the skin tissue by heating or evaporating water. At this time, smoke vapor is generated in the space.

皮肤从外侧依次包括表皮、真皮和皮下组织。为了采样血液，必须刺穿皮肤到真皮的第一层表皮的侧面上的皮肤乳突中的毛细管，且大部分穿刺发生在表皮上。在手掌皮肤中，特别是例如手指肉，皮肤的表皮较厚，具有厚度1至1.5mm，且大部分皮肤是角质层，其主要成分为角蛋白质。作为角蛋白质的成分的氨基酸产生的挥发性的物质被分解流动在烟流中。角质层由角蛋白质的纤维组织组成，且纤维由胱氨酸键结合，该键是包含的相对较多的氨基酸胱氨酸的硫部分的键。The skin consists of the epidermis, dermis, and subcutaneous tissue in order from the outside. To sample blood, the skin must be pierced into capillaries in the skin papillae on the side of the first epidermis of the dermis, and most piercings occur on the epidermis. In the skin of the palm, especially such as the flesh of fingers, the epidermis of the skin is thick, having a thickness of 1 to 1.5 mm, and most of the skin is the stratum corneum, the main component of which is keratin. The volatile matter produced by the amino acid which is a component of the keratin protein is decomposed and flows in the smoke. The stratum corneum is composed of a fibrous tissue of keratin, and the fibers are bound by cystine bonds, which are bonds of the sulfur moieties of the relatively abundant amino acid cystine.

由于这些氨基酸在蒸发过程中分解，产生了挥发性的硫化合物或氮化合物，特别地，人感觉它们是一种异味。此外，当这些蒸发物附着到激光束的光学元件上时，由于附着物对激光束的吸收，光学元件的透光度降低，且附着物的烧着情形发生。As these amino acids are decomposed during evaporation, volatile sulfur compounds or nitrogen compounds are produced, which are perceived as an off-flavor in particular. In addition, when these evaporating substances are attached to the optical elements of the laser beam, the light transmittance of the optical elements is lowered due to the absorption of the laser beam by the attached substances, and burning of the attached substances occurs.

第二个问题是，当血液被激光装置采样时的传染问题。为了聚集激光束以在1平方毫米以下的区域内穿刺皮肤，聚光透镜和皮肤之间的距离应以至少1cm以下的精度保持恒定。因此，事实上，皮肤被压靠在特定的固定结构上，且用激光束照射。由于这个结构被同一使用者多次使用，或者被两个以上用户使用，担心经由这个结构传染。此外，如也在前文所述，当使用激光装置进行穿刺时产生烟流。由于该烟流粘附，也存在传染的担心。The second problem is that of contamination when the blood is sampled by the laser device. In order to focus the laser beam to puncture the skin in an area below 1 mm2, the distance between the condenser lens and the skin should be kept constant with an accuracy of at least 1 cm. Thus, in fact, the skin is pressed against a specific fixed structure and irradiated with a laser beam. Since this structure is used multiple times by the same user, or is used by more than two users, there is concern about infection via this structure. Furthermore, as also mentioned above, a plume of smoke is generated when the laser device is used for piercing. There is also a concern of infection due to the adherence of the plume.

第三个问题是使用过程中的并发症。在用装置采样血液后，使用者应把血液放进单独设置传感器中，把该传感器与显示器连接，且量化血液中的微量的各种特定成分。而且，当存在大量的替换零件来解决迄今为止的问题时，使用者的方便性可能降低。The third problem is the complication during use. After sampling blood with the device, the user should place the blood into a separate sensor, connect the sensor to a display, and quantify trace amounts of various specific components in the blood. Also, user convenience may be reduced when there are a large number of replacement parts to solve the hitherto problems.

此外，在传统的激光装置的激光照射情况中，激光束的聚光直径为0.5mm以上，且疤痕可保持一周以上。尽管皮肤含水量和厚度存在个体差异，为了利用一次发射的激光束脉冲可靠地进行穿刺以稳定地进行采血，因此放射出过量的激光束能量。为此，在一些情况中，由于皮肤的穿刺深度太深，疼痛变得强烈。In addition, in the case of laser irradiation of a conventional laser device, the laser beam has a focusing diameter of 0.5 mm or more, and the scar can be maintained for more than a week. Although there are individual differences in skin moisture content and thickness, excessive laser beam energy is emitted in order to stably perform blood sampling by stably performing puncture with a laser beam pulse emitted at one time. For this reason, in some cases, the pain becomes severe due to the puncture depth of the skin being too deep.

由于发明人的研究，产生了一种不留疤痕的激光束的聚光直径，该聚光直径为0.15mm以下，且优选地为0.1mm以下。此外，本发明人已发现如果聚光直径是0.5mm(传统的)，则血液采样所需的激光束能量的个体差异是大约两倍，且如果聚光直径被0.15mm以下，则变为约百分之几十。而且，本发明人已发现，如果聚光直径为0.15mm以下，血液采样所需的激光束能量还可以是约几十mJ的相当小的能量。As a result of the inventor's research, a scar-free laser beam has been produced with a focal diameter of 0.15 mm or less, and preferably 0.1 mm or less. In addition, the present inventors have found that if the spot diameter is 0.5 mm (conventional), individual differences in laser beam energy required for blood sampling are about twice, and if the spot diameter is made 0.15 mm or less, it becomes about Dozens of percent. Furthermore, the present inventors have found that if the focused diameter is 0.15 mm or less, the energy of the laser beam required for blood sampling can also be a relatively small energy of about several tens of mJ.

由于详细研究使用激光穿刺从皮肤进行血液采样，本发明人已发现以下事实。图61是皮肤的示意图。皮肤从外依次包括表皮和真皮，为了采样血液，必须破坏真皮中的皮肤乳突好的毛细管。然而，检测疼痛的自由神经末梢也存在于皮肤乳突的附近。表皮包括五种层，包括最外表面上的角质层。As a result of detailed studies of blood sampling from skin using laser perforation, the present inventors have found the following facts. Figure 61 is a schematic illustration of a skin. The skin consists of the epidermis and dermis in order from the outside, and in order to sample blood, it is necessary to destroy the fine capillaries of the skin papillae in the dermis. However, free nerve endings that detect pain also exist in the vicinity of the cutaneous papillae. The epidermis consists of five layers, including the stratum corneum on the outermost surface.

通常，血液采样是在指尖或手掌的皮肤上进行。这是因为指尖或手掌的毛细管中的血液葡萄糖水平可被无时间滞后地测量，例如当测量糖尿病人的血液葡萄糖水平时。据称最普遍的血液采样点的指尖具有厚度为1到1.5mm的表皮，特别是角质层。此外，该角质层是死亡组织，且具有不同于活的组织的外观，例如具有毛细管的真皮的皮肤乳突。Typically, blood sampling is done on the skin of a fingertip or palm. This is because blood glucose levels in capillaries of fingertips or palms can be measured without time lag, for example when measuring blood glucose levels of diabetics. The fingertip, which is said to be the most common blood sampling site, has a thickness of 1 to 1.5 mm of the epidermis, especially the stratum corneum. Furthermore, the stratum corneum is dead tissue and has an appearance different from that of living tissue, such as the dermal papillae of the dermis with capillaries.

本发明人在激光穿刺过程中沿其深度方向观察皮肤的形状时发现，例如当皮肤的表面被使用激光聚集图案照射时，主要由角质层组成的表皮具有大致圆柱形的截面形状，且真皮具有圆锥形的截面形状。When the present inventors observed the shape of the skin in its depth direction during laser perforation, for example, when the surface of the skin was irradiated with a laser focus pattern, the epidermis mainly composed of the stratum corneum had a substantially cylindrical cross-sectional shape, and the dermis had a Conical cross-sectional shape.

为了实现微痛激光照射方法，重要的是控制圆锥形的激光穿刺的孔的截面形状的深度到必需的最小深度。如果深度过度，则刺激自由神经末梢、使得使用者感到疼痛且出血可超过需要的可能性变高。此外，如果真皮被深深地刺穿，由于激光束能量的光学吸收使得真皮组织的蒸发和加热反应，可产生沿与蒸发相反的方向的冲击波(压缩波)，这也可变为一种疼痛。In order to realize the micropain laser irradiation method, it is important to control the depth of the cross-sectional shape of the conical laser perforated hole to a necessary minimum depth. If the depth is excessive, there is a high chance that free nerve endings will be stimulated, causing pain to the user and bleeding may be more than necessary. In addition, if the dermis is pierced deeply, the vaporization and heating reaction of the dermal tissue due to the optical absorption of the energy of the laser beam can generate a shock wave (compression wave) in the opposite direction to the vaporization, which can also become a pain .

在另一方面，如上所述，在传统的激光穿刺装置中，通过在激光穿刺装置中设置扬声器减轻穿刺过程中的疼痛，以及通过产生音乐或声响抵消穿刺过程中的操作声音。然而，如果使用者总是听相同的音乐等，他/她可能习惯于该音乐等。结果，使用者的意识无法集中到该音乐等，且穿刺过程中的疼痛不会减轻。On the other hand, as mentioned above, in the conventional laser puncturing device, the pain during puncturing is alleviated by providing a speaker in the laser puncturing device, and the operation sound during puncturing is counteracted by producing music or sound. However, if the user always listens to the same music or the like, he/she may get used to the music or the like. As a result, the user's consciousness cannot be concentrated on the music or the like, and the pain during puncturing is not relieved.

此外，由于激光穿刺的时机总是发生在穿刺开关被按下后的同一时间，使用者可无意识地到留意激光穿刺的时机，因此穿刺过程中的疼痛不会减轻。In addition, since the timing of the laser puncture always occurs at the same time after the puncture switch is pressed, the user can unconsciously pay attention to the timing of the laser puncture, so the pain during the puncture will not be alleviated.

此外，在传统的激光穿刺装置中，激光脉冲束的聚光直径或时间宽度可均匀地设计。然而，由于可靠的血液采样的最佳条件对于每个使用者是不同的，激光脉冲束能量的可变宽度被设置，且使用者个别地设置激光脉冲束能量。为此，为了供使用者检查采样血液的激光束能量，首先，他/她应进行实验激光穿刺，因此不能使用单次激光穿刺进行血液采样。此外，由于检查的条件一天一天地改变，该条件应每次检查。Furthermore, in conventional laser puncture devices, the focusing diameter or temporal width of the laser pulse beam can be uniformly designed. However, since the optimal conditions for reliable blood sampling are different for each user, the variable width of the laser pulse beam energy is set, and the laser pulse beam energy is individually set by the user. For this reason, in order for the user to check the laser beam energy for sampling blood, first, he/she should perform experimental laser puncture, so blood sampling cannot be performed using a single laser puncture. Also, since the condition to be checked changes day by day, the condition should be checked every time.

本发明的做出是为了解决这些传统的问题。因此，本发明的一个目的是提供一种生物传感器和成分浓度测量装置，其能使使用者避免在使用激光束穿刺过程中感觉到异味，并进行简单而容易的测量而不担心使用造成传染。The present invention has been made to solve these conventional problems. Accordingly, an object of the present invention is to provide a biosensor and component concentration measuring device which enables a user to avoid feeling an odor during puncture with a laser beam and perform simple and easy measurement without fear of infection from use.

此外，本发明的目的是提供一种激光穿刺装置的激光照射方法，其能进行稳定的血液采样而不留下疤痕，且在穿刺过程中疼痛很小。Furthermore, an object of the present invention is to provide a laser irradiation method of a laser puncturing device that can perform stable blood sampling without scarring and with little pain during puncturing.

此外，本发明的目的是要提供一种激光穿刺装置和激光穿刺方法，其中使用者不会意识到激光穿刺的时机，使用者的疼痛检测水平较低，且穿刺过程中的疼痛很小。Furthermore, an object of the present invention is to provide a laser puncture device and a laser puncture method in which a user is not aware of the timing of laser puncture, the user's pain detection level is low, and pain during puncture is small.

此外，本发明的目的是提供一种激光穿刺装置和激光穿刺方法，其可以供使用者可靠地采样血液而不需要实验穿刺。Furthermore, an object of the present invention is to provide a laser puncturing device and a laser puncturing method, which allow a user to reliably sample blood without requiring experimental puncturing.

而且，本发明的目的是提供激光穿刺装置的操作状态，具体地，监测闪光灯的劣化程度，其为该装置的主要退化因素。此外，另一目的是要监测激光穿刺装置的使用次数。Furthermore, it is an object of the present invention to provide the operating status of the laser perforating device, in particular, monitor the degree of deterioration of the flash lamp, which is the main degradation factor of the device. Furthermore, another object is to monitor the number of times the laser perforating device is used.

解决问题的手段means of solving problems

本发明的成分浓度测量装置包括：主体，其至少具有发射激光束的激光装置、该激光束的聚光装置、体液的成分的分析装置、以及显示由该分析装置计算的结果的显示装置；片；具有不遮蔽该激光束的开口的插入体；和试纸。这里，主体沿激光束的光轴方向设置开口。开口安装有插入体，且该插入体的一端安装有试纸。片提供位于聚光装置和插入体之间的膜，且该膜不被激光束穿刺。The component concentration measuring device of the present invention includes: a main body having at least a laser device for emitting a laser beam, a condensing device for the laser beam, an analysis device for a component of body fluid, and a display device for displaying a result calculated by the analysis device; ; an insert having an opening that does not shield the laser beam; and a test paper. Here, the main body is provided with openings along the optical axis direction of the laser beam. An insertion body is installed in the opening, and a test paper is installed at one end of the insertion body. The sheet provides a membrane between the light concentrating means and the insert and which is not pierced by the laser beam.

通过该配置，由于使用者不会闻到激光穿刺过程中产生的烟流中的异味，且每次穿刺更换接触使用者的采样点的试纸，不必担心感染，且由于使用者可利用一个机构进行采样和分析，可实现简单而容易的使用。With this configuration, since the user will not smell the peculiar smell in the smoke generated during the laser puncture process, and the test paper that contacts the sampling point of the user is replaced every time the puncture is performed, there is no need to worry about infection, and since the user can use one mechanism to carry out Sampling and analysis for simple and easy use.

此外，在本发明的成分浓度测量装置中，试纸设置有成分测量用电极，插入体设置有电极，且试纸的成分测量用电极和插入体的电极通过与试纸嵌合而电连接。Furthermore, in the component concentration measuring device of the present invention, the test paper is provided with the component measuring electrodes, the insert is provided with the electrodes, and the component measuring electrodes of the test paper and the electrodes of the insert are electrically connected by fitting with the test paper.

通过该配置，在通过激光穿刺的体液采样的成分分析中，使用者可进行成分分析而不去除试纸和重新安装其再次用于成分分析，且由此简单和容易的使用变得可能。With this configuration, in component analysis of body fluid sampling by laser perforation, the user can perform component analysis without removing the test paper and reinstalling it for component analysis again, and thus simple and easy use becomes possible.

此外，在本发明的成分浓度测量装置中，分析装置通过样本试剂的酶反应分析该体液的成分。Furthermore, in the component concentration measuring device of the present invention, the analyzing means analyzes the component of the body fluid by enzymatic reaction of the sample reagent.

通过该配置，由于使用者不会闻到激光穿刺过程中产生的烟流中的异味，且每次穿刺更换接触使用者的采样点的试纸，不必担心感染，且由于使用者可利用一个机构进行采样和分析，可实现简单而容易的使用。With this configuration, since the user will not smell the peculiar smell in the smoke generated during the laser puncture process, and the test paper that contacts the sampling point of the user is replaced every time the puncture is performed, there is no need to worry about infection, and since the user can use one mechanism to carry out Sampling and analysis for simple and easy use.

而且，在本发明的成分浓度测量装置中，分析装置是通过样本试剂的显色反应分析该体液的成分的光学装置。Furthermore, in the component concentration measuring device of the present invention, the analysis device is an optical device for analyzing components of the body fluid by a color reaction of the sample reagent.

通过该配置，由于使用者可在用一个机构中进行采样和分析，可获得简单而容易的使用。With this configuration, since the user can perform sampling and analysis in one mechanism, simple and easy use can be obtained.

此外，在本发明的成分浓度测量装置中，试纸提供位于激光束的光轴上被激光束穿刺的膜。Furthermore, in the component concentration measuring device of the present invention, the test paper provides a film on the optical axis of the laser beam pierced by the laser beam.

通过该配置，激光穿刺过程中产生的烟流穿过穿刺的孔从使用者的皮肤排出。因此，该烟流不会泄漏到使用者，因此使用者可被防止闻到激光穿刺过程中产生的烟流中的异味。With this configuration, the smoke generated during laser perforation is discharged from the user's skin through the perforated hole. Therefore, the plume does not leak to the user, so the user can be prevented from smelling the peculiar smell in the plume generated during laser perforation.

此外，在本发明的成分浓度测量装置中，试纸还提供位于激光束的光轴上没有被激光束穿刺的膜。Furthermore, in the component concentration measuring device of the present invention, the test paper also provides a film that is not pierced by the laser beam on the optical axis of the laser beam.

通过该配置，激光穿刺过程中产生的烟流穿过穿刺的孔从使用者的皮肤排出，且限制在试纸中。因此，烟流不会泄漏到使用者，因此使用者可被防止闻到激光穿刺过程中产生的烟流中的异味。With this arrangement, the plume of smoke generated during laser puncture is exhausted from the user's skin through the punctured hole, and is confined in the test strip. Therefore, the smoke does not leak to the user, so the user can be prevented from smelling the peculiar smell in the smoke generated during laser perforation.

此外，在本发明的成分浓度测量装置中，试纸还具有如同片的功能。Furthermore, in the component concentration measuring device of the present invention, the test paper also functions as a sheet.

通过该配置，使用者不必拥有和管理结构不同的两种片和生物传感器，且使用者的方便性可被改善。With this configuration, the user does not have to own and manage two kinds of sheets and biosensors having different structures, and the user's convenience can be improved.

此外，在本发明的成分浓度测量装置中，试纸还提供位于激光束的光轴上用作片的膜，当用作片时，该膜不被激光束穿刺。Furthermore, in the component concentration measuring device of the present invention, the test paper also provides a film on the optical axis of the laser beam serving as a sheet, and when used as a sheet, the film is not pierced by the laser beam.

通过该配置，由于使用者不必拥有和管理结构不同的两种片和生物传感器，且不必每次使用时更换该片，使用者的方便性可被改善。With this configuration, since the user does not have to own and manage two kinds of sheets and biosensors having different structures, and does not have to replace the sheet every time it is used, user's convenience can be improved.

而且，在本发明的成分浓度测量装置中，在插入体嵌合到主体内的侧部上设置有非对称结构。Also, in the component concentration measuring device of the present invention, an asymmetric structure is provided on the side portion where the insert fits into the main body.

通过该配置，使用者不会弄错插入方向，且因此简单和容易的使用变得可能。With this configuration, the user does not mistake the direction of insertion, and thus simple and easy use becomes possible.

而且，本发明的成分浓度测量装置提供一结构，其中试纸和插入体之间的嵌合是通过非对称结构进行的。Also, the component concentration measuring device of the present invention provides a structure in which fitting between the test paper and the insert is performed by an asymmetric structure.

通过该配置，使用者不会弄错配合方向，且因此简单而容易的使用变得可能。With this configuration, the user does not mistake the fitting direction, and thus simple and easy use becomes possible.

而且，本发明的成分浓度测量装置提供一结构，其中试纸和插入体之间的嵌合是通过试纸的开口和插入体的突起之间的嵌合进行的。Furthermore, the component concentration measuring device of the present invention provides a structure in which fitting between the test paper and the insert is performed by fitting between the opening of the test paper and the protrusion of the insert.

通过该配置，使用者不会弄错配合方向，其不会发生滑出。因此，简单而容易的使用变得可能。With this configuration, the user does not mistake the fitting direction, and it does not slip out. Therefore, simple and easy use becomes possible.

而且，在本发明的成分浓度测量装置中，片的膜、插入体、以及试纸的膜的至少一部分或全部设置有除臭功能。Furthermore, in the component concentration measuring device of the present invention, at least a part or all of the film of the sheet, the insert, and the film of the test paper are provided with a deodorizing function.

通过该配置，激光穿刺过程中产生的烟流中的异味可被消除。With this configuration, odors in the smoke generated during laser perforation can be eliminated.

而且，在本发明的成分浓度测量装置中，试纸、插入体、以及试纸的膜的至少一部分或全部设置有抗菌功能。Furthermore, in the component concentration measuring device of the present invention, at least a part or all of the test paper, the insert, and the film of the test paper are provided with an antibacterial function.

通过该配置，可防止使用者使用时的感染。With this arrangement, infection at the time of use by the user can be prevented.

本发明的生物传感器是用于分析利用激光束穿刺来收集的样本标本中的成分的生物传感器。这里，该传感器形成样本供应通道，所供应的样本标本通过该样本供应通道被吸到该第一和第二基板之间；通过贴合在该第一和第二基板之间，过滤器和与该样本标本中的成分反应的试剂设置在该样本供应通道内；且从该样本供应通道通到外部的空气孔设置在该第二基板内。试剂具有酶和色原体，其特定地与该成分反应，部分或全部共用的开口设置在第一和第二基板中的样本供应通道的外部，且第一和第二基板的至少任意一个开口设置有膜。The biosensor of the present invention is a biosensor for analyzing components in a sample specimen collected by puncturing with a laser beam. Here, the sensor forms a sample supply channel through which the supplied sample specimen is sucked between the first and second substrates; by being attached between the first and second substrates, the filter and Reagents for reacting components in the sample sample are arranged in the sample supply channel; and air holes leading from the sample supply channel to the outside are arranged in the second substrate. The reagent has an enzyme and a chromogen specifically reacting with the component, a part or all of the common opening is provided outside the sample supply channel in the first and second substrates, and at least any one of the openings of the first and second substrates Set with membrane.

通过该配置，在穿刺过程中由激光束产生的包括异味的烟流被限制在传感器板中，可抑制烟流泄漏到外部。With this configuration, the smoke including odor generated by the laser beam during puncturing is confined in the sensor plate, and the leakage of the smoke to the outside can be suppressed.

此外，在本发明的生物传感器中，膜具有除臭功能。Furthermore, in the biosensor of the present invention, the membrane has a deodorizing function.

通过该配置，穿刺过程中由激光束产生的烟流中的恶臭成分可被消除。With this configuration, malodorous components in the smoke generated by the laser beam during piercing can be eliminated.

而且，在本发明的生物传感器中，第一和第二基板还设置有该开口之外的部分或全部共用的开口。Moreover, in the biosensor of the present invention, the first and second substrates are further provided with a part or all of common openings other than the opening.

通过该配置，可以可靠地建立与包括激光振荡器的激光穿刺装置的连接。由此，激光振荡器和传感器之间的相对距离可被确定，且激光穿刺孔的形状可变得稳定。With this configuration, connection with a laser perforating device including a laser oscillator can be reliably established. Thereby, the relative distance between the laser oscillator and the sensor can be determined, and the shape of the laser perforated hole can become stable.

本发明的激光穿刺用生物传感器是用于分析利用激光束穿刺来收集的样本标本中的成分的生物传感器。该传感器形成样本供应通道，所供应的样本标本通过该样本供应通道被吸到该第一和第二基板之间；至少通过贴合在该第一和第二基板之间，与该样本标本中的成分反应的试剂设置在该样本供应通道内；且从该样本供应通道通到外部的空气孔设置在该第二基板内。传感器具有电极系统，该电极系统至少包括测量电极和电极电偶，且反应被电极系统检测。部分或全部共用的开口设置在第一和第二基板中的样本供应通道的外部，且第一和第二基板的至少任意一个开口设置有膜。The biosensor for laser perforation of the present invention is a biosensor for analyzing components in a sample specimen collected by perforation with a laser beam. The sensor forms a sample supply channel through which the supplied sample specimen is sucked between the first and second substrates; at least by being attached between the first and second substrates, with the sample specimen The reagents reacted with the components are arranged in the sample supply channel; and the air holes leading from the sample supply channel to the outside are arranged in the second substrate. The sensor has an electrode system comprising at least a measuring electrode and an electrode couple, and the reaction is detected by the electrode system. Part or all of the common opening is provided outside the sample supply channel in the first and second substrates, and at least any one of the openings of the first and second substrates is provided with a membrane.

通过该配置，穿刺过程中激光束产生的包括异味的烟流被限制在传感器板中，且可抑制烟流泄漏到外部。With this configuration, the smoke including odor generated by the laser beam during puncturing is confined in the sensor plate, and the leakage of the smoke to the outside can be suppressed.

此外，在本发明的生物传感器中，膜具有除臭功能。Furthermore, in the biosensor of the present invention, the membrane has a deodorizing function.

通过该配置，穿刺过程中由激光束产生的烟流中的恶臭成分可被消除。With this configuration, malodorous components in the smoke generated by the laser beam during piercing can be eliminated.

而且，在本发明的生物传感器中，第一和第二基板还设置有该开口之外的部分或全部共用的开口。Moreover, in the biosensor of the present invention, the first and second substrates are further provided with a part or all of common openings other than the opening.

通过该配置，可以可靠地建立与包括激光振荡器的激光穿刺装置的连接。由此，激光振荡器和传感器之间的相对距离可被确定，且激光穿刺孔的形状可变得稳定。With this configuration, connection with a laser perforating device including a laser oscillator can be reliably established. Thereby, the relative distance between the laser oscillator and the sensor can be determined, and the shape of the laser perforated hole can become stable.

而且，在本发明的激光穿刺用生物传感器中，第一和第二基板还设置有该开口之外的分享部分或全部的至少两个开口，使得电极系统可露出。Moreover, in the biosensor for laser perforation of the present invention, the first and second substrates are further provided with at least two openings that share part or all of the openings, so that the electrode system can be exposed.

通过该配置，可以可靠地建立与包括激光振荡器和分析装置的设备的连接。由此，激光振荡器和传感器之间的相对距离可被确定，且激光穿刺孔的形状可变得稳定。而且，可以电连接传感器和装置，由此监测连接状态。With this configuration, it is possible to reliably establish a connection with a device including a laser oscillator and an analysis device. Thereby, the relative distance between the laser oscillator and the sensor can be determined, and the shape of the laser perforated hole can become stable. Also, the sensor and the device can be electrically connected, thereby monitoring the state of the connection.

此外，本发明的成分浓度测量装置包括：主体，其至少具有发射激光束的激光装置、该激光束的聚光装置、体液的成分的分析装置、以及显示由该分析装置计算的结果的显示装置；片；具有激光束穿过的开口的插入体；和试纸。主体沿激光束的光轴方向设置开口。开口安装有插入体，且该插入体的一端安装有试纸。片位于聚光装置和插入体之间，且该片具有试纸的功能。In addition, the component concentration measuring device of the present invention includes: a main body having at least a laser device emitting a laser beam, a condensing device for the laser beam, an analyzing device for a component of body fluid, and a display device for displaying a result calculated by the analyzing device ; a sheet; an insert having an opening through which a laser beam passes; and a test paper. The main body is provided with an opening along the optical axis direction of the laser beam. An insertion body is installed in the opening, and a test paper is installed at one end of the insertion body. A sheet is located between the light collecting means and the insert, and this sheet has the function of a test strip.

通过该配置，由于使用者不会闻到激光穿刺过程中产生的烟流中的异味，且没有由烟流造成的作为聚光装置的光学元件的污染，可以实现简单而容易的使用，使用者可使用一种消耗品来管理片和传感器。With this configuration, since the user will not smell the peculiar smell in the smoke generated during the laser puncture process, and there is no pollution caused by the smoke to the optical elements as the concentrating device, simple and easy use can be achieved, and the user One consumable is available to manage the chips and sensors.

此外，该片提供位于该激光束的光轴上的膜，该膜在用作该片时不被该激光束穿刺，且当用作该试纸时被该激光束穿刺。Furthermore, the sheet provides a film on the optical axis of the laser beam which is not pierced by the laser beam when used as the sheet and which is pierced by the laser beam when used as the test paper.

通过该配置，由于使用者不会闻到激光穿刺过程中产生的烟流中的异味，且没有由烟流造成的作为聚光装置的光学元件的污染，可以实现简单而容易的使用，使用者可使用一种消耗品来管理片和传感器。With this configuration, since the user will not smell the peculiar smell in the smoke generated during the laser puncture process, and there is no pollution caused by the smoke to the optical elements as the concentrating device, simple and easy use can be achieved, and the user One consumable is available to manage the chips and sensors.

而且，片提供位于该激光束的光轴上的被用作该试纸时被该激光束穿刺的膜，且提供位于该激光束的光轴上的被用作该片时被该激光束穿刺的膜。Furthermore, the sheet provides a film on the optical axis of the laser beam that is pierced by the laser beam when used as a test paper, and provides a membrane that is on the optical axis of the laser beam and that is pierced by the laser beam when used as the sheet. membrane.

通过该配置，由于使用者不会闻到激光穿刺过程中产生的烟流中的异味，且没有由烟流造成的作为聚光装置的光学元件的污染，可以实现简单而容易的使用，使用者可使用一种消耗品来管理片和传感器。With this configuration, since the user will not smell the peculiar smell in the smoke generated during the laser puncture process, and there is no pollution caused by the smoke to the optical elements as the concentrating device, simple and easy use can be achieved, and the user One consumable is available to manage the chips and sensors.

而且，还提供检测片插入到主体的功能。Moreover, a function of detecting the insertion of the sheet into the main body is also provided.

而且，可防止使用者忘记片的插入，且相应地，可以可靠地防止由烟流造成的作为聚光装置的光学元件的污染。Also, the user can be prevented from forgetting the insertion of the sheet, and accordingly, the contamination of the optical element as the light collecting means by the smoke flow can be reliably prevented.

而且，检测片插入到主体的功能是通过片的插入的机械接触操作来进行。Also, the function of detecting the insertion of the sheet into the main body is performed by a mechanical contact operation of the insertion of the sheet.

通过该配置，可防止使用者忘记片的插入，且相应地，可以可靠地防止由烟流造成的作为聚光装置的光学元件的污染。With this configuration, it is possible to prevent the user from forgetting the insertion of the sheet, and accordingly, it is possible to reliably prevent the contamination of the optical element as the light concentrating means by the smoke flow.

而且，检测片插入到主体的功能是通过设置在片中的电极的电连接来进行。Also, the function of detecting the insertion of the sheet into the main body is performed through the electrical connection of the electrodes provided in the sheet.

通过该配置，可防止使用者忘记片的插入，且相应地，可以可靠地防止由烟流造成的作为聚光装置的光学元件的污染。With this configuration, it is possible to prevent the user from forgetting the insertion of the sheet, and accordingly, it is possible to reliably prevent the contamination of the optical element as the light concentrating means by the smoke flow.

而且，片的膜和插入体中的至少一个或两个设置有除臭功能。Furthermore, at least one or both of the membrane of the sheet and the insert are provided with a deodorizing function.

通过该配置，激光穿刺过程中产生的烟流中的异味可别消除。With this arrangement, the odor in the plume generated during laser perforation can be eliminated.

而且，插入保持器和片中的至少一个或两个设置有抗菌功能。Furthermore, at least one or both of the insertion holder and the sheet are provided with an antimicrobial function.

通过该配置，可防止使用者使用时的任何感染。With this configuration, any infection at the time of use by the user can be prevented.

根据本发明的穿刺适配器是安装在利用激光束照射皮肤的激光穿刺装置上由此进行穿刺的穿刺适配器。该适配器包括：在两个端部具有开口的中空体；和设置用来封闭该两个端部的开口的第一膜和第二膜。第一膜吸收激光束且被穿刺，第二膜透射激光束而不吸收激光束。The puncturing adapter according to the present invention is a puncturing adapter that is mounted on a laser puncturing device that irradiates skin with a laser beam to thereby perform puncturing. The adapter includes: a hollow body having openings at both ends; and first and second membranes provided to close the openings at the two ends. The first film absorbs the laser beam and is pierced, and the second film transmits the laser beam without absorbing the laser beam.

根据上述配置，由第一膜、中空体和第二膜形成封闭空间。由此，当利用压在皮肤上的第一膜进行激光穿刺时，产生的烟流可被限制在封闭的空间内。因此，使用者可进行激光穿刺而不会闻到异味和感到不舒服。此外，通过每次使用时更换穿刺适配器，不用担心使用过程中的感染，且穿刺可被简单而容易地进行。According to the above configuration, the closed space is formed by the first membrane, the hollow body, and the second membrane. Thereby, when laser perforation is performed with the first membrane pressed against the skin, the generated smoke flow can be confined in the closed space. Therefore, the user can perform laser puncture without smelling and feeling uncomfortable. Furthermore, by replacing the puncture adapter every time of use, there is no fear of infection during use, and puncture can be performed simply and easily.

此外，在根据本发明的穿刺适配器中，中空体具有形成在第一膜周围的突起。Furthermore, in the puncture adapter according to the present invention, the hollow body has a protrusion formed around the first membrane.

根据上述配置，由于突起将按压预定的激光穿刺点的周围，可以减轻在激光穿刺过程中使用者感觉到的刺激。而且，当通过穿刺血液被采样时，可以稳定地采样血液。According to the above configuration, since the protrusion will press the periphery of the predetermined laser puncture point, it is possible to reduce the irritation felt by the user during laser puncture. Also, when blood is sampled by puncturing, blood can be sampled stably.

此外，在根据本发明的穿刺适配器中，第一膜、中空体和第二膜中的至少一个设置有除臭功能。Furthermore, in the piercing adapter according to the present invention, at least one of the first membrane, the hollow body and the second membrane is provided with a deodorizing function.

根据上述配置，激光穿刺过程中产生的烟流中的异味可被消除。According to the above configuration, the odor in the smoke generated during laser perforation can be eliminated.

此外，在根据本发明的穿刺适配器中，第一膜设置有抗菌功能。Furthermore, in the piercing adapter according to the invention, the first membrane is provided with an antimicrobial function.

根据上述配置，可防止经由穿刺适配器的感染。According to the above configuration, infection via the puncture adapter can be prevented.

而且，根据本发明的激光穿刺装置包括可分离的根据本发明的穿刺适配器，该中空体的中心轴和激光光轴设置为彼此重合。Furthermore, the laser puncturing device according to the present invention includes a detachable puncturing adapter according to the present invention, the central axis of the hollow body and the laser optical axis are arranged to coincide with each other.

根据上述配置，由第一膜、中空体和第二膜形成封闭空间。由此，当利用压在皮肤上的第一膜进行激光穿刺时，产生的烟流可被限制在封闭的空间内。因此，使用者可进行激光穿刺而不会闻到异味和感到不舒服。此外，根据上述配置，由于要接触使用者的皮肤的穿刺适配器在每次使用时被更换，不必担心感染，且穿刺可被简单而容易地进行。According to the above configuration, the closed space is formed by the first membrane, the hollow body, and the second membrane. Thereby, when laser perforation is performed with the first membrane pressed against the skin, the generated smoke flow can be confined in the closed space. Therefore, the user can perform laser puncture without smelling and feeling uncomfortable. Furthermore, according to the above configuration, since the puncture adapter to be in contact with the user's skin is replaced every time it is used, there is no need to worry about infection, and puncture can be performed simply and easily.

通过设置彼此不同的用于激光穿刺真皮的激光照射条件和用于激光穿刺表皮的激光照射条件，和利用不同类型的激光脉冲束能量进行多次照射，本发明实现了稳定的血液采样和几乎无痛的激光穿刺。By setting the laser irradiation conditions for laser puncture of the dermis and the laser irradiation conditions for laser puncture of the epidermis different from each other, and performing multiple irradiations with different types of laser pulse beam energies, the present invention achieves stable blood sampling and almost no Painful laser puncture.

特别地，穿刺表皮的第一激光脉冲束的时间宽度被设置等于或长于穿刺真皮的第二激光脉冲束，且激光束能量被设置大于第二激光脉冲束。这里，把穿刺表皮的激光脉冲束分成多个激光脉冲束对于稳定的血液采样是有效的。在该例中，当穿刺表皮的激光脉冲束和穿刺真皮的激光脉冲束的照射条件被比作单个激光脉冲束时，它们可以相同，或穿刺装配的激光脉冲束的即使宽度长于且激光束能量大于穿刺表皮的每个激光脉冲束。In particular, the time width of the first laser pulse beam piercing the epidermis is set to be equal to or longer than that of the second laser pulse beam piercing the dermis, and the energy of the laser beam is set greater than that of the second laser pulse beam. Here, dividing the laser pulse beam that punctures the epidermis into a plurality of laser pulse beams is effective for stable blood sampling. In this example, when the irradiation conditions of the laser pulse beam that pierces the epidermis and the laser pulse beam that pierces the dermis are compared to a single laser pulse beam, they may be the same, or the laser pulse beam that pierces the assembly even if the width is longer and the laser beam energy Larger than each laser pulse beam that punctures the epidermis.

此外，根据本发明的激光照射方法是一种利用激光脉冲束照射包括表皮和真皮的皮肤由此进行激光穿刺的激光照射方法。该方法包括步骤：放射用于穿刺该表皮的激光脉冲束；和放射用于穿刺该表皮的穿刺点中的真皮的激光脉冲束。Furthermore, the laser irradiation method according to the present invention is a laser irradiation method of irradiating the skin including the epidermis and dermis with a laser pulse beam, thereby performing laser perforation. The method includes the steps of: radiating a laser pulse beam for puncturing the epidermis; and irradiating a laser pulse beam for puncturing the dermis in a puncture point of the epidermis.

根据上述配置，用于穿刺真皮的激光脉冲束照射到与用于穿刺表皮的激光脉冲束相同的位置，且臼形穿刺孔形成在真皮中。因此，真皮没有被深深地穿刺，不会留下疤痕，且穿刺过程中几乎没有疼痛，且可进行稳定的血液采样。According to the above configuration, the laser pulse beam for puncturing the dermis is irradiated to the same position as the laser pulse beam for puncturing the epidermis, and a socket-shaped puncture hole is formed in the dermis. Therefore, the dermis is not punctured deeply, no scars are left, there is little pain during the puncture, and stable blood sampling can be performed.

此外，在根据本发明的激光照射方法中，用于穿刺该表皮的激光脉冲束的时间宽度等于或长于用于穿刺真皮的激光脉冲束，且用于穿刺该表皮的激光脉冲束的能量大于用于穿刺真皮的激光脉冲束。Furthermore, in the laser irradiation method according to the present invention, the time width of the laser pulse beam used to puncture the epidermis is equal to or longer than that of the laser pulse beam used to puncture the dermis, and the energy of the laser pulse beam used to puncture the epidermis is greater than that of the laser pulse beam used to puncture the epidermis. A pulsed laser beam used to puncture the dermis.

根据上述配置，真皮中的激光穿刺孔的截面形状的深度可被控制到必要的最小值，且不会留下任何疤痕，且穿刺过程中几乎没有疼痛，且可进行稳定的血液采样。According to the above configuration, the depth of the cross-sectional shape of the laser puncture hole in the dermis can be controlled to the necessary minimum without leaving any scars, there is little pain during the puncture, and stable blood sampling can be performed.

此外，在根据本发明的激光照射条件中，用于穿刺表皮的激光脉冲束的时间宽度为100至400μs，用于穿刺真皮的激光脉冲束的时间宽度为50至300μs。Furthermore, in the laser irradiation conditions according to the present invention, the time width of the laser pulse beam for puncturing the epidermis is 100 to 400 μs, and the time width of the laser pulse beam for puncturing the dermis is 50 to 300 μs.

根据上述配置，由于真皮没有被深深地穿刺，不会留下疤痕，且穿刺过程中几乎没有疼痛，且可进行稳定的血液采样。According to the above configuration, since the dermis is not deeply punctured, no scar is left, there is little pain during the puncture, and stable blood sampling can be performed.

此外，在根据本发明的激光照射方法中，用于穿刺表皮的激光脉冲束的时间宽度和用于穿刺真皮的激光脉冲束的时间宽度之间的差别为50至200μs。Furthermore, in the laser irradiation method according to the present invention, the difference between the time width of the laser pulse beam for piercing the epidermis and the time width of the laser pulse beam for piercing the dermis is 50 to 200 μs.

根据上述配置，由于其血液被采样的人觉察到一个穿刺，穿刺过程中几乎没有疼痛，且可进行稳定的血液采样。According to the above configuration, since the person whose blood is sampled feels a puncture, there is little pain during the puncture, and stable blood sampling can be performed.

此外，在根据本发明的激光照射方法中，用于穿刺表皮的激光脉冲束和用于穿刺真皮的激光脉冲束之间的照射间隔为500ms以下。Furthermore, in the laser irradiation method according to the present invention, the irradiation interval between the laser pulse beam for piercing the epidermis and the laser pulse beam for piercing the dermis is 500 ms or less.

根据上述配置，由于其血液被采样的人觉察到一个穿刺，穿刺过程中几乎没有疼痛，且可进行稳定的血液采样。According to the above configuration, since the person whose blood is sampled feels a puncture, there is little pain during the puncture, and stable blood sampling can be performed.

此外，在根据本发明的激光照射方法中，用于穿刺表皮的激光脉冲束和用于穿刺真皮的激光脉冲束的能量总和为每平方厘米100至300J。Furthermore, in the laser irradiation method according to the present invention, the sum of the energy of the laser pulse beam for piercing the epidermis and the laser pulse beam for piercing the dermis is 100 to 300 J per square centimeter.

根据上述配置，用于血液采样的激光脉冲束的能量可被最小化，不会留下疤痕，且穿刺过程中几乎没有疼痛，且可进行稳定的血液采样。According to the above configuration, the energy of the laser pulse beam used for blood sampling can be minimized, no scar is left, there is little pain during puncturing, and stable blood sampling can be performed.

此外，在根据本发明的激光照射方法中，用于穿刺真皮的激光脉冲束的能量是用于穿刺表皮和用于穿刺真皮的激光脉冲束的能量总和的10至40％。Furthermore, in the laser irradiation method according to the present invention, the energy of the laser pulse beam for piercing the dermis is 10 to 40% of the sum of the energy of the laser pulse beams for piercing the epidermis and the laser pulse beam for piercing the dermis.

根据上述配置，真皮中的锥形激光穿刺孔的截面形状的深度可被控制到必要的最小值，且不会留下任何疤痕，且穿刺过程中几乎没有疼痛，且可进行稳定的血液采样。According to the above configuration, the depth of the cross-sectional shape of the tapered laser perforation hole in the dermis can be controlled to the necessary minimum without leaving any scars, there is little pain during the puncture, and stable blood sampling can be performed.

此外，在根据本发明的激光照射方法中，激光脉冲束的聚光直径为0.15mm以下。Furthermore, in the laser irradiation method according to the present invention, the focusing diameter of the laser pulse beam is 0.15 mm or less.

根据上述配置，血液采样所需的激光脉冲束的能量中的个体差异可被设置得较小，不会留下任何疤痕，且穿刺过程中几乎没有疼痛，且可进行稳定的血液采样。According to the above configuration, individual differences in the energy of the laser pulse beam required for blood sampling can be set small, without leaving any scars, with little pain during puncturing, and stable blood sampling can be performed.

此外，在根据本发明的激光照射方法中，用于穿刺表皮的激光脉冲束包括多个激光脉冲束。Furthermore, in the laser irradiation method according to the present invention, the laser pulse beam used to puncture the epidermis includes a plurality of laser pulse beams.

根据上述配置，由于用于穿刺表皮的激光脉冲束可根据皮肤厚度、含水量等的个体差异而被细微地控制，不会留下任何疤痕，且穿刺过程中几乎没有疼痛，且可进行稳定的血液采样。According to the above configuration, since the laser pulse beam used to puncture the epidermis can be finely controlled according to individual differences in skin thickness, water content, etc., no scars are left, there is little pain during the puncture, and stable puncturing is possible. blood sampling.

此外，在根据本发明的激光照射方法中，用于穿刺表皮的多个激光脉冲束中的每个的时间宽度为100至400μs。Furthermore, in the laser irradiation method according to the present invention, the time width of each of the plurality of laser pulse beams for puncturing the epidermis is 100 to 400 μs.

根据上述配置，由于其血液被采样的人觉察到一个穿刺，穿刺过程中几乎没有疼痛，且可进行稳定的血液采样。According to the above configuration, since the person whose blood is sampled feels a puncture, there is little pain during the puncture, and stable blood sampling can be performed.

此外，在根据本发明的激光照射方法中，用于穿刺表皮的多个激光脉冲束的照射间隔为500ms以下。Furthermore, in the laser irradiation method according to the present invention, the irradiation interval of the plurality of laser pulse beams for puncturing the epidermis is 500 ms or less.

根据上述配置，由于其血液被采样的人觉察到一个穿刺，穿刺过程中几乎没有疼痛，且可进行稳定的血液采样。According to the above configuration, since the person whose blood is sampled feels a puncture, there is little pain during the puncture, and stable blood sampling can be performed.

此外，在根据本发明的激光照射方法中，用于穿刺表皮的多个激光脉冲束和用于穿刺真皮的激光脉冲束的能量总和为每平方厘米5至100J。Furthermore, in the laser irradiation method according to the present invention, the sum of the energy of the plurality of laser pulse beams for piercing the epidermis and the laser pulse beams for piercing the dermis is 5 to 100 J per square centimeter.

根据上述配置，用于血液采样的激光脉冲束的能量可被最小化，不会留下疤痕，且穿刺过程中几乎没有疼痛，且可进行稳定的血液采样。According to the above configuration, the energy of the laser pulse beam used for blood sampling can be minimized, no scar is left, there is little pain during puncturing, and stable blood sampling can be performed.

根据本发明的激光穿刺装置是一种利用激光束照射皮肤由此进行穿刺的激光穿刺装置，其包括产生周期性声音的周期性声音产生装置。穿刺是在产生该周期性声音的期间进行。A laser perforation device according to the present invention is a laser perforation device that irradiates skin with a laser beam to thereby perform perforation, and includes a periodic sound generating device that generates a periodic sound. Piercing is performed while the periodic sound is generated.

根据上述配置，通过产生周期性声音，使用者的意识被转移，其使得使用者不意识到穿刺的时刻。由此，使用者感觉到疼痛的阈值水平降低。由于激光穿刺在该状态下进行，可减小穿刺过程中的疼痛。According to the above configuration, by generating the periodic sound, the user's consciousness is diverted, which makes the user unaware of the timing of the puncturing. Thereby, the threshold level at which the user perceives pain is lowered. Since the laser puncture is performed in this state, the pain during the puncture can be reduced.

此外，在根据本发明的激光穿刺装置中，周期性声音是其中心频率以20至100Hz单调重复的声音。Furthermore, in the laser perforating device according to the present invention, the periodic sound is a sound whose center frequency monotonously repeats at 20 to 100 Hz.

根据上述配置，由于穿刺在使用者的意识被引向单调重复的声音的状态下进行，且使用者关于疼痛的检测水平被变低，穿刺过程中的疼痛可减轻。According to the above configuration, since puncturing is performed in a state where the user's consciousness is directed to monotonously repeated sounds, and the user's detection level regarding pain is made lower, pain during puncturing can be reduced.

此外，在根据本发明的激光穿刺装置中，单调重复的声音包括泵的操作声和发动机声。Furthermore, in the laser perforating device according to the present invention, the monotonously repeated sound includes the operation sound of the pump and the sound of the engine.

根据上述配置，由于使用者的意识被引向单调重复的声音，例如泵的操作声和发动机声，使用者关于疼痛的检测水平被变低，穿刺过程中的疼痛可减轻。According to the above configuration, since the user's consciousness is directed to monotonously repeated sounds such as the operation sound of the pump and the sound of the engine, the user's detection level of pain is lowered, and the pain during puncturing can be reduced.

此外，在根据本发明的激光穿刺装置中，周期性声音是具有每分钟击打60至208的重复节拍的声音。Furthermore, in the laser perforating device according to the present invention, the periodic sound is a sound having a repetitive beat of 60 to 208 beats per minute.

根据上述配置，由于穿刺是在使用者的意识被引向单调重复的声音的状态下进行，且使用者关于疼痛的检测水平被变低，穿刺过程中的疼痛可减轻。According to the above configuration, since puncturing is performed in a state where the user's consciousness is directed to the monotonously repeated sound, and the user's detection level regarding pain is lowered, pain during puncturing can be reduced.

此外，在根据本发明的激光穿刺装置中，具有重复节拍的声音包括节拍器的声音、机械开关的ON/OFF的声音和敲击键盘的声音，且使用者关于疼痛的检测水平被变低，穿刺过程中的疼痛可减轻。Furthermore, in the laser perforating device according to the present invention, the sound with repeated beats includes the sound of a metronome, the sound of ON/OFF of a mechanical switch, and the sound of tapping a keyboard, and the user's detection level regarding pain is lowered, Pain during piercing can be reduced.

根据上述配置，由于穿刺在使用者的意识被引向具有重复节拍的声音、节拍器的声音、机械开关的ON/OFF的声音和敲击键盘的声音的状态下进行，且使用者关于疼痛的检测水平被变低，穿刺过程中的疼痛可减轻。According to the above-mentioned configuration, since the puncturing is performed in a state where the user's consciousness is directed to the sound of repeating beats, the sound of a metronome, the sound of ON/OFF of a mechanical switch, and the sound of typing on a keyboard, and the user's perception of pain The detection level is lowered, and the pain during puncture can be reduced.

此外，在根据本发明的激光穿刺装置中，该周期性声音发生装置产生音质或周期不同的多种类型的周期性声音，且随机地改变每次穿刺时产生的周期性声音的类型。Furthermore, in the laser puncturing device according to the present invention, the periodic sound generating means generates various types of periodic sounds different in sound quality or period, and randomly changes the type of periodic sound generated every time of puncturing.

根据上述配置，由于音质或周期不同的多个类型的周期性声音随机改变，使用者不会习惯于环境声音，且使用者的意识被从穿刺转移。因此，即使在激光穿刺装置被使用的情况下，减轻穿刺过程中的疼痛的效果可被保持。According to the above-described configuration, since a plurality of types of periodic sounds different in sound quality or cycle randomly change, the user does not get used to the ambient sound, and the user's consciousness is diverted from the puncture. Therefore, even in the case where the laser puncturing device is used, the effect of alleviating pain during puncturing can be maintained.

此外，在根据本发明的激光穿刺装置中，从周期性声音的产生到穿刺的时间在每次穿刺时随机地改变。Furthermore, in the laser puncturing device according to the present invention, the time from the generation of the periodic sound to the puncturing is randomly changed every puncturing.

此外，由于从周期性声音的产生到穿刺的时间在每次穿刺时随机地改变，使用者不会预测到激光穿刺的时机，且穿刺期间的疼痛可被减轻。In addition, since the time from the generation of the periodic sound to the puncturing is randomly changed every puncturing, the user cannot predict the timing of the laser puncturing, and the pain during the puncturing can be reduced.

此外，根据本发明的激光穿刺方法是一种利用激光束照射皮肤由此进行穿刺的激光穿刺方法，由此进行穿刺。该方法包括步骤：从音质或周期不同的多种类型的周期性声音中选择和产生预定的周期性声音，以及在从预定的周期性声音的产生经过随机的时间之后进行穿刺。In addition, the laser perforation method according to the present invention is a laser perforation method in which skin is irradiated with a laser beam to thereby perforate, thereby perforating. The method includes the steps of selecting and generating a predetermined periodic sound from a plurality of types of periodic sounds different in sound quality or period, and performing puncturing after a random time elapses from generation of the predetermined periodic sound.

根据上述配置，由于音质或周期不同的多种类型的周期性声音随机地改变，使用者不会预测激光穿刺的时机，且穿刺过程中的疼痛可被减轻。According to the above-described configuration, since various types of periodic sounds different in sound quality or cycle randomly change, the user cannot predict the timing of laser puncture, and pain during puncture can be reduced.

根据本发明的激光穿刺装置是一种利用激光束照射皮肤由此进行穿刺的激光穿刺装置。该激光穿刺装置包括调节装置，其根据通过测量皮肤含水量的含水量测量传感器测量的皮肤含水量来调节该激光脉冲束的能量。A laser perforating device according to the present invention is a laser perforating device that irradiates skin with a laser beam to thereby perform perforation. The laser perforating device includes adjusting means for adjusting the energy of the laser pulse beam according to the water content of the skin measured by the water content measuring sensor for measuring the water content of the skin.

根据上述配置，根据皮肤含水量的合适的激光脉冲束的能量可被设定。因此，不进行实验穿刺，或使用者自己不进行激光脉冲束的设定，且几乎没有疼痛的可靠的血液采样可根据个体差异、日常波动和时间波动进行。According to the above configuration, the energy of the laser pulse beam appropriate according to the water content of the skin can be set. Therefore, reliable blood sampling with little pain can be performed according to individual differences, daily fluctuations, and time fluctuations without performing experimental puncture, or setting of the laser pulse beam by the user himself.

此外，根据本发明的激光穿刺装置包括含水量测量传感器。此外，在根据本发明的激光穿刺装置中，含水量测量传感器包括传感器电极，其设置在激光穿刺装置的主体的表面上，以测量皮肤含水量。Furthermore, the laser perforating device according to the present invention includes a water content measuring sensor. Furthermore, in the laser perforating device according to the present invention, the moisture content measuring sensor includes sensor electrodes provided on the surface of the main body of the laser perforating device to measure the skin moisture content.

根据上述配置，由于用于测量皮肤含水量的传感器电极设置在激光穿刺装置的主体的表面上，皮肤含水量可容易地测量。According to the above configuration, since the sensor electrodes for measuring the skin moisture content are provided on the surface of the main body of the laser perforating device, the skin moisture content can be easily measured.

此外，根据本发明的激光穿刺装置包括保持装置，其可分离地保持具有含水量测量传感器的穿刺帽。该穿刺帽包括在两个端部具有开口的中空体，和设置为封闭该两个端部的开口的第一膜和第二膜。该第一膜透射激光束并吸收激光束且被穿刺，且该第二膜透射激光束而不吸收激光束。含水量测量传感器包括设置在第一膜的相同平面上的传感器电极，以测量皮肤含水量。Furthermore, the laser perforation device according to the invention comprises a holding device which detachably holds the perforation cap with the water content measurement sensor. The piercing cap includes a hollow body having openings at both ends, and first and second membranes arranged to close the openings at the two ends. The first film transmits and absorbs the laser beam and is pierced, and the second film transmits the laser beam without absorbing the laser beam. The water content measurement sensor includes sensor electrodes disposed on the same plane of the first membrane to measure skin water content.

根据上述配置，由于穿刺帽包括测量皮肤含水量的传感器电极，可进行简单、容易、可靠的血液采样，通过在每次使用时更换穿刺帽，而不担心使用期间的感染。According to the above configuration, since the piercing cap includes the sensor electrode for measuring the moisture content of the skin, simple, easy, and reliable blood sampling can be performed without worrying about infection during use by replacing the piercing cap every time it is used.

此外，根据本发明的激光穿刺装置包括输入使用者的属性的设定按钮。调节装置根据从设定按钮输入的属性来调节激光脉冲束的能量。Furthermore, the laser perforating device according to the present invention includes a setting button for inputting attributes of a user. The adjusting means adjusts the energy of the laser pulse beam according to the attribute input from the setting button.

根据上述特征，根据从设定按钮输入的使用者的属性，例如年龄、性别、人种或肤质，调节激光脉冲束的能量。因此，可以根据皮肤的条件设定理想的激光脉冲束能量，且可以进行几乎没有疼痛的可靠的血液采样。According to the above features, the energy of the laser pulse beam is adjusted according to the user's attributes such as age, sex, race or skin type input from the setting button. Therefore, ideal laser pulse beam energy can be set according to the condition of the skin, and reliable blood sampling with little pain can be performed.

此外，根据本发明的激光穿刺装置包括测量环境空气的湿度的湿度传感器。调节装置根据湿度传感器测量的环境空气的湿度来调节激光脉冲束的能量。Furthermore, the laser perforating device according to the present invention includes a humidity sensor that measures the humidity of the ambient air. The adjusting device adjusts the energy of the laser pulse beam according to the humidity of the ambient air measured by the humidity sensor.

根据上述配置，由于激光脉冲束根据与皮肤含水量非常紧密相关的环境空气的湿度而被调节，可以准确地设定适于血液采样的最小激光脉冲束能量。According to the above configuration, since the laser pulse beam is adjusted according to the humidity of the ambient air which is closely related to the moisture content of the skin, the minimum laser pulse beam energy suitable for blood sampling can be accurately set.

此外，根据本发明的激光穿刺方法是一种利用激光束照射皮肤由此进行穿刺的激光穿刺方。该方法包括测量皮肤含水量；以及根据测量的皮肤含水量来调节该激光脉冲束的能量。In addition, the laser perforation method according to the present invention is a laser perforation method in which skin is irradiated with a laser beam to thereby perform perforation. The method includes measuring skin moisture content; and adjusting energy of the laser pulse beam based on the measured skin moisture content.

根据上述配置，根据皮肤含水量的合适的激光脉冲束能量可被设定。因此，不进行实验穿刺，或使用者自己不进行激光脉冲束的设定，且几乎没有疼痛的可靠的血液采样可根据个体差异、日常波动和时间波动进行。According to the above configuration, an appropriate laser pulse beam energy according to the water content of the skin can be set. Therefore, reliable blood sampling with little pain can be performed according to individual differences, daily fluctuations, and time fluctuations without performing experimental puncture, or setting of the laser pulse beam by the user himself.

此外，本发明的插入保持器是一种安装在利用激光束照射皮肤由此进行穿刺的激光穿刺装置上的插入保持器。该插入保持器包括：在两个端部具有开口的中空体；设置为封闭该开口的一个端部，且透射激光束而不吸收激光束的膜；设置为封闭该开口的另一端部的生物传感器；以及设置在该中空体的外周面或内周面以电连接该激光穿刺装置和该生物传感器的电极。In addition, the insertion holder of the present invention is an insertion holder mounted on a laser perforating device that irradiates the skin with a laser beam to thereby perform perforation. The insertion holder includes: a hollow body having openings at both ends; a film provided to close one end of the opening and transmits a laser beam without absorbing the laser beam; a biological film provided to close the other end of the opening. a sensor; and an electrode arranged on the outer peripheral surface or inner peripheral surface of the hollow body to electrically connect the laser perforating device and the biosensor.

根据上述配置，插入保持器通过生物传感器、插入保持器和滑片三个元件构成，但是现在有一个插入保持器构成。因此，具有一优点，当使用者使用该装置时，要更换的零件可以是仅一个。According to the configuration described above, the insertion holder is constituted by the three elements of the biosensor, the insertion holder, and the slider, but now it is constituted by one insertion holder. Therefore, there is an advantage that when the user uses the device, the part to be replaced can be only one.

此外，在本发明的插入保持器中，手指托膜形成在该生物传感器的部分表面内，且样本试剂供应通道开口形成在该生物传感器的侧面中。Furthermore, in the insertion holder of the present invention, the finger rest is formed in part of the surface of the biosensor, and the sample reagent supply channel opening is formed in the side surface of the biosensor.

此外，在本发明的插入保持器中，生物传感器具有形成在试剂层中的测量电极和电极电偶。Furthermore, in the insertion holder of the present invention, the biosensor has a measurement electrode and an electrode couple formed in the reagent layer.

此外，本发明的插入保持器是一种安装在利用激光束照射皮肤由此进行穿刺的激光穿刺装置上的插入保持器。该插入保持器包括：通过弯曲生物传感器和连接生物传感器的端部形成的中空体；设置为封闭该中空体的一个端部，且透射激光束而不吸收激光束的膜；设置为封闭该中空体的另一端部，且吸收激光束并被穿刺的膜；以及设置在该中空体的外周面或内周面以电连接该激光穿刺装置和该生物传感器的电极。In addition, the insertion holder of the present invention is an insertion holder mounted on a laser perforating device that irradiates the skin with a laser beam to thereby perform perforation. The insertion holder includes: a hollow body formed by bending a biosensor and connecting ends of the biosensor; a film provided to close one end of the hollow body and transmits a laser beam without absorbing the laser beam; a film provided to close the hollow the other end of the body, and a film that absorbs the laser beam and is punctured; and an electrode provided on the outer peripheral surface or the inner peripheral surface of the hollow body to electrically connect the laser puncturing device and the biosensor.

此外，本发明的激光照射方法是一种利用激光脉冲束经由膜照射皮肤由此进行激光穿刺的激光照射方法。该方法包括步骤：放射用于穿刺该膜的第一激光脉冲束；以及放射用于在该膜的穿刺点穿刺皮肤的第二激光脉冲束。Furthermore, the laser irradiation method of the present invention is a laser irradiation method in which skin is irradiated with a laser pulse beam through a membrane to thereby perform laser perforation. The method includes the steps of: radiating a first laser pulse beam for puncturing the membrane; and irradiating a second laser pulse beam for puncturing skin at a puncture point of the membrane.

此外，在本发明的激光照射方法中，第一激光脉冲束的强度弱于第二激光脉冲束的强度。Furthermore, in the laser irradiation method of the present invention, the intensity of the first laser pulse beam is weaker than that of the second laser pulse beam.

根据上述配置，由第一激光脉冲束在膜中形成通孔，且当皮肤的激光穿刺条件中存在个体差异时，通过调节第二激光脉冲束可允许稳定的血液采样。According to the above configuration, the through hole is formed in the film by the first laser pulse beam, and when there is an individual difference in the laser puncture condition of the skin, stable blood sampling can be allowed by adjusting the second laser pulse beam.

此外，本发明的生物传感器是一种安装在利用激光束照射皮肤由此进行穿刺的激光穿刺装置上的生物传感器。该生物传感器包括：第一基板，具有贴附在其上的试剂层且具有激光束穿过的第一开口；第二基板，设置为以预定间隔面对该第一基板，具有对应该第一开口的第二开口，且具有位于比该试剂层更远离该第二开口的位置的空气孔；以及样本试剂供应通道，从该第一开口到该试剂层形成于该第一基板和该第二基板之间。In addition, the biosensor of the present invention is a biosensor mounted on a laser perforation device that irradiates the skin with a laser beam, thereby performing puncture. The biosensor includes: a first substrate having a reagent layer attached thereon and having a first opening through which a laser beam passes; a second substrate arranged to face the first substrate at a predetermined interval and having a corresponding first opening. a second opening that is open and has an air hole located at a position farther from the second opening than the reagent layer; and a sample reagent supply channel formed in the first substrate and the second substrate from the first opening to the reagent layer between substrates.

根据上述配置，使用者可供应作为要测量的目标的血液到生物传感器，即使他/她在激光穿刺后不把他/她的手指进入样本试剂供应通道的开口。According to the above configuration, the user can supply blood, which is a target to be measured, to the biosensor even if he/she does not enter his/her finger into the opening of the sample reagent supply channel after laser puncture.

此外，在本发明的生物传感器中，该激光束的光轴设置为平行于该第一开口的中心线，且位于比该第一开口的中心线更靠近该样本试剂供应通道的位置。In addition, in the biosensor of the present invention, the optical axis of the laser beam is set parallel to the centerline of the first opening and located closer to the sample reagent supply channel than the centerline of the first opening.

根据上述配置，由于渗出的血液更靠近样本试剂供应通道而非更靠近传感器开口中心，可以通过毛细现象更有效地到达试剂层。According to the above-described configuration, since the seeped blood is closer to the sample reagent supply channel than to the center of the sensor opening, it can reach the reagent layer more efficiently by capillary phenomenon.

此外，本发明的激光穿刺装置是一种利用闪光灯激励的激光束照射皮肤由此进行穿刺的激光穿刺装置。该激光穿刺装置包括光学传感器，其检测闪光灯的光发射以监测闪光灯的劣化程度。Furthermore, the laser puncturing device of the present invention is a laser puncturing device that irradiates the skin with a laser beam excited by a strobe lamp, thereby performing puncture. The laser perforating device includes an optical sensor that detects light emission of the flashlight to monitor the degree of deterioration of the flashlight.

根据上述配置，可以提示使用者激光穿刺装置的保养时间，且可以增加穿刺装置的可靠性。According to the above configuration, the user can be reminded of the maintenance time of the laser puncturing device, and the reliability of the puncturing device can be increased.

此外，本发明的激光穿刺装置包括告知装置，其基于光电传感器检测的装置的使用次数，告知使用者该装置要求保养的消息。In addition, the laser perforation device of the present invention includes notification means for notifying the user that the device requires maintenance based on the number of times the device is used detected by the photoelectric sensor.

根据上述配置，可以根据使用次数提示使用者保养时间，且可以根据在一定周期内的使用次数，让承担医疗费用的人，例如糖尿病人，承担医疗费用等。According to the above configuration, the user can be reminded of the maintenance time according to the number of times of use, and the person who bears the medical expenses, such as a diabetic, can be asked to bear the medical expenses according to the number of times of use within a certain period.

本发明的效果Effect of the present invention

本发明提供一种成分浓度测量装置，其利用激光束穿刺皮肤以采样少量体液且通过利用样本试剂的显色反应测量体液的成分。在该成分浓度测量装置中，主体至少设置有激光装置、激光束的聚光装置、分析显色反应的光学装置、成分的分析装置以及分析结果的显示装置。主体具有沿激光束的光轴的开口。设置有没有被激光束穿刺的膜的片，以及具有不遮蔽激光束的开口的插入体可分离地插入开口内。而且，分析体液的成分的试纸被设置嵌合在插入体内。由此，可以提供具有下面效果的成分浓度测量装置。即，由于使用者不会闻到激光穿刺过程中产生的烟流中的异味，且每次采样更换接触使用者的采样点的试纸，不必担心感染，且由于使用者可利用一个机构进行采样和分析，可实现简单而容易的使用。The present invention provides a component concentration measuring device that punctures skin with a laser beam to sample a small amount of body fluid and measures components of the body fluid by utilizing a color reaction of a sample reagent. In the component concentration measuring device, the main body is provided with at least a laser device, a laser beam condensing device, an optical device for analyzing a color reaction, a component analyzing device, and an analysis result display device. The body has an opening along the optical axis of the laser beam. A sheet provided with a film that is not pierced by the laser beam, and an insertion body having an opening that does not shield the laser beam are detachably inserted into the opening. Furthermore, a test paper for analyzing the components of the body fluid is set and fitted in the insertion body. Thus, a component concentration measuring device having the following effects can be provided. That is, because the user will not smell the peculiar smell in the smoke stream produced in the laser puncture process, and the test paper that contacts the sampling point of the user is replaced every time sampling, there is no need to worry about infection, and since the user can use one mechanism for sampling and analysis for simple and easy use.

此外，本发明提供一种成分浓度测量装置，其利用激光束穿刺皮肤以采样少量体液并测量体液的成分。在该成分浓度测量装置中，主体至少设置有激光装置、激光束的聚光装置、成分的分析装置以及分析结果的显示装置。主体具有沿激光束的光轴的开口。设置有没有被激光束穿刺的膜的片，以及具有不遮蔽激光束的开口的插入体可分离地插入开口内。而且，体液的试纸被设置嵌合在插入体内。由此，可以提供具有下面效果的成分浓度测量装置。即，由于使用者不会闻到激光穿刺过程中产生的烟流中的异味，且每次采样更换接触使用者的采样点的试纸，不必担心感染，且由于使用者可利用一个机构进行采样和分析，可实现简单而容易的使用。Furthermore, the present invention provides a component concentration measuring device that punctures the skin with a laser beam to sample a small amount of body fluid and measures the components of the body fluid. In the component concentration measuring device, the main body is provided with at least a laser device, a laser beam condensing device, a component analysis device, and an analysis result display device. The body has an opening along the optical axis of the laser beam. A sheet provided with a film that is not pierced by the laser beam, and an insertion body having an opening that does not shield the laser beam are detachably inserted into the opening. Furthermore, the test paper of the body fluid is installed and fitted in the insertion body. Thus, a component concentration measuring device having the following effects can be provided. That is, because the user will not smell the peculiar smell in the smoke stream produced in the laser puncture process, and the test paper that contacts the sampling point of the user is replaced every time sampling, there is no need to worry about infection, and since the user can use one mechanism for sampling and analysis for simple and easy use.

此外，根据本发明，设置有穿过传感器的基板的开口，且膜设置为覆盖该开口。由此，激光穿刺用生物传感器可具有一效果，即，激光穿刺过程中产生的包括异味的烟流可被防止泄漏到外部。Furthermore, according to the invention, an opening is provided through the substrate of the sensor, and the membrane is arranged to cover this opening. Thereby, the biosensor for laser perforation can have an effect that the smoke including odor generated during laser perforation can be prevented from leaking to the outside.

此外，本发明提供一种成分浓度测量装置，其利用激光束穿刺皮肤以采样少量体液且测量体液的成分。成分浓度测量装置包括主体，该主体至少设置有发射激光束的激光装置、激光束的聚光装置、体液的成分的分析装置、以及显示由分析装置计算的结果的显示装置；片；具有不遮蔽激光束的开口的插入体；和试纸。该主体沿激光束的光轴方向设置开口。开口安装有插入体，且该插入体的一端安装有试纸。片位于聚光装置和插入体之间，且片具有试纸的功能。由此，可以提供一种具有下面效果的成分浓度测量装置。即，由于使用者不会闻到激光穿刺过程中产生的烟流中的异味，还可防止作为聚光装置的光学元件被烟流污染，且每次采样更换接触使用者的采样点的试纸，不必担心感染，且由于使用者可以用一种消耗品管理至少片和试纸，且使用者可利用一个机构进行采样和分析，可实现简单而容易的使用。Furthermore, the present invention provides a component concentration measuring device that punctures the skin with a laser beam to sample a small amount of body fluid and measures components of the body fluid. The component concentration measuring device includes a main body provided with at least a laser device for emitting a laser beam, a focusing device for the laser beam, an analyzing device for a component of a body fluid, and a display device for displaying a result calculated by the analyzing device; a sheet; having a non-shielding an insert for the opening of the laser beam; and a test paper. The main body is provided with an opening along the optical axis direction of the laser beam. An insertion body is installed in the opening, and a test paper is installed at one end of the insertion body. A sheet is located between the light collecting means and the insert, and the sheet has the function of a test strip. Thus, a component concentration measuring device having the following effects can be provided. That is, since the user will not smell the peculiar smell in the smoke stream generated during the laser puncture process, it can also prevent the optical element as the concentrating device from being polluted by the smoke stream, and replace the test paper at the sampling point that contacts the user every time the sample is taken. There is no need to worry about infection, and since the user can manage at least the sheet and the test paper with one consumable, and the user can perform sampling and analysis with one mechanism, simple and easy use can be realized.

此外，根据本发明，由第一膜、中空体和第二膜可形成封闭的空间。由此，当用压在皮肤上的第一膜进行激光穿刺时，所产生的烟流可被限制在封闭的空间内。因此，使用者可进行激光穿刺而不会闻到异味和感到不舒服。Furthermore, according to the present invention, a closed space can be formed by the first membrane, the hollow body, and the second membrane. Thereby, when laser perforation is performed with the first membrane pressed against the skin, the generated plume can be confined within a closed space. Therefore, the user can perform laser puncture without smelling and feeling uncomfortable.

根据本发明，用于穿刺真皮的激光脉冲束发射到与用于穿刺表皮的激光脉冲束相同的位置，且臼形穿刺孔形成在真皮中。因此，真皮不被深深地穿刺，不会留下疤痕，且穿刺过程中的疼痛很小，且可进行稳定的血液采样。According to the present invention, the laser pulse beam for puncturing the dermis is emitted to the same position as the laser pulse beam for puncturing the epidermis, and a socket-shaped puncture hole is formed in the dermis. Therefore, the dermis is not punctured deeply, no scar is left, pain is minimal during puncture, and stable blood sampling can be performed.

根据本发明，通过产生周期性声音，使用者的意识被转移，且使用者被使得不注意穿刺的时机。由此，使用者感觉疼痛的阈值水平变低。由于激光穿刺是在这种状态下进行，穿刺过程中的疼痛被减少。According to the present invention, by generating a periodic sound, the user's consciousness is diverted, and the user is made not to pay attention to the timing of the puncture. As a result, the threshold level at which the user feels pain becomes lower. Since the laser puncture is performed in this state, the pain during the puncture is reduced.

此外，根据本发明，根据皮肤含水量可设定合适的激光脉冲束能量。因此，不进行实验穿刺，或使用者自己不进行激光脉冲束的设定，且可根据个体差异、日常波动和时间波动进行疼痛很小的可靠的血液采样。Furthermore, according to the present invention, an appropriate laser pulse beam energy can be set according to the water content of the skin. Therefore, experimental puncture is not performed, or setting of the laser pulse beam is not performed by the user himself, and reliable blood sampling with little pain can be performed according to individual differences, daily fluctuations, and temporal fluctuations.

而且，根据本发明，可以提示使用者激光穿刺装置的保养时间，且可以增加穿刺装置的可靠性。另外，可以根据使用次数提示使用者保养时间，且可以根据在一定周期内的使用次数，让承担医疗费用的人，例如糖尿病人，承担医疗费用等。Moreover, according to the present invention, the maintenance time of the laser puncturing device can be reminded to the user, and the reliability of the puncturing device can be increased. In addition, the user can be reminded of the maintenance time according to the number of times of use, and people who bear medical expenses, such as diabetics, can be asked to bear medical expenses according to the number of times of use within a certain period.

附图说明Description of drawings

图1是本发明的第一实施例中的成分浓度测量装置的顶视图；Fig. 1 is a top view of a component concentration measuring device in a first embodiment of the present invention;

图2是从侧面观察的本发明的第一实施例的成分浓度测量装置的内部结构示意图；2 is a schematic view of the internal structure of the component concentration measuring device of the first embodiment of the present invention viewed from the side;

图3是从顶部观察的本发明的第一实施例的成分浓度测量装置的下部内部结构示意图；3 is a schematic view of the lower internal structure of the component concentration measuring device of the first embodiment of the present invention viewed from the top;

图4是本发明的第一实施例中的插入保持器；Fig. 4 is the insertion holder in the first embodiment of the present invention;

图5是本发明的第一实施例中的滑片的平面图和断面图；5 is a plan view and a sectional view of a slide in a first embodiment of the present invention;

图6是本发明的第一实施例中的生物传感器的平面图和断面图；6 is a plan view and a sectional view of a biosensor in a first embodiment of the present invention;

图7是在穿刺过程中的激光穿刺点的放大视图；Figure 7 is an enlarged view of the laser puncture point during puncture;

图8是在穿刺过程中的激光穿刺点的放大视图；Figure 8 is an enlarged view of the laser puncture point during puncture;

图9是本发明的第二实施例中的生物传感器的平面图和断面图；9 is a plan view and a sectional view of a biosensor in a second embodiment of the present invention;

图10是本发明的第三实施例中的生物传感器的平面图和断面图；10 is a plan view and a sectional view of a biosensor in a third embodiment of the present invention;

图11是本发明的第四实施例中的生物传感器的平面图和断面图；11 is a plan view and a sectional view of a biosensor in a fourth embodiment of the present invention;

图12是本发明的第一实施例中的生物传感器的分析单元的结构示意图；Fig. 12 is a schematic structural diagram of the analysis unit of the biosensor in the first embodiment of the present invention;

图13是本发明的第五实施例中的插入保持器的透视图；13 is a perspective view of an insertion holder in a fifth embodiment of the present invention;

图14是本发明的第五实施例中的生物传感器的平面图和断面图；14 is a plan view and a sectional view of a biosensor in a fifth embodiment of the present invention;

图15是本发明的第六实施例中的激光穿刺用生物传感器的分解透视图；15 is an exploded perspective view of a biosensor for laser perforation in a sixth embodiment of the present invention;

图16是本发明的第六实施例中的激光穿刺用生物传感器的总视图；16 is a general view of a biosensor for laser perforation in a sixth embodiment of the present invention;

图17是当本发明的第六实施例中的激光穿刺用生物传感器在中心部分沿图16的纵向方向剖切时的断面图；17 is a cross-sectional view when the biosensor for laser perforation in the sixth embodiment of the present invention is cut along the longitudinal direction of FIG. 16 at the central portion;

图18是示出当使用本发明的第六实施例中的激光穿刺用生物传感器时，传感器、手指和激光束之间的关系的视图；18 is a view showing the relationship between the sensor, finger and laser beam when using the biosensor for laser perforation in the sixth embodiment of the present invention;

图19是当使用本发明的第六实施例中的激光穿刺用生物传感器时，详细显示激光穿刺过程中的情形的视图；19 is a view showing in detail the situation during laser perforation when the biosensor for laser perforation in the sixth embodiment of the present invention is used;

图20是本发明的第七实施例中的激光穿刺用生物传感器的平面图和断面图；20 is a plan view and a cross-sectional view of a biosensor for laser perforation in a seventh embodiment of the present invention;

图21是本发明的第七实施例中的激光穿刺用生物传感器的平面图和断面图；21 is a plan view and a cross-sectional view of a biosensor for laser perforation in a seventh embodiment of the present invention;

图22是说明如何使用本发明的第六实施例中的激光穿刺用生物传感器的视图；FIG. 22 is a view illustrating how to use the biosensor for laser perforation in the sixth embodiment of the present invention;

图23是本发明的第九实施例中的生物传感器的平面图和断面图；23 is a plan view and a sectional view of a biosensor in a ninth embodiment of the present invention;

图24是本发明的第十实施例中的另一生物传感器的平面图和断面图；24 is a plan view and a cross-sectional view of another biosensor in the tenth embodiment of the present invention;

图25是说明如何辨认本发明的第九实施例中的另一滑片的视图；FIG. 25 is a view illustrating how to identify another slider in the ninth embodiment of the present invention;

图26是本发明的第十一实施例中的另一生物传感器的平面图和断面图；26 is a plan view and a cross-sectional view of another biosensor in the eleventh embodiment of the present invention;

图27是本发明的第十二实施例的激光穿刺装置1的透视图；FIG. 27 is a perspective view of alaser perforation device 1 according to a twelfth embodiment of the present invention;

图28是本发明的第十二实施例的激光穿刺装置1的穿刺适配器507的示意图；FIG. 28 is a schematic diagram of the puncturingadapter 507 of thelaser puncturing device 1 according to the twelfth embodiment of the present invention;

图29是本发明的第十二实施例的激光穿刺装置1的穿刺适配器514的示意图；FIG. 29 is a schematic diagram of the puncturingadapter 514 of thelaser puncturing device 1 according to the twelfth embodiment of the present invention;

图30是本发明的第十三实施例的激光穿刺装置的激光照射条件的示意图；30 is a schematic diagram of the laser irradiation conditions of the laser perforation device according to the thirteenth embodiment of the present invention;

图31是本发明的第十三实施例的激光穿刺装置的激光照射条件中的皮肤的穿刺的孔的放大视图；31 is an enlarged view of the punctured hole of the skin in the laser irradiation condition of the laser puncturing device according to the thirteenth embodiment of the present invention;

图32是本发明的第十三实施例的激光穿刺装置的其它激光照射条件的示意图；Fig. 32 is a schematic diagram of other laser irradiation conditions of the laser perforation device according to the thirteenth embodiment of the present invention;

图33是本发明的第十三实施例的搭载在激光穿刺装置上的激光振荡器620的示意图；FIG. 33 is a schematic diagram of alaser oscillator 620 mounted on a laser perforation device according to a thirteenth embodiment of the present invention;

图34是本发明的第十三实施例的激光穿刺装置1的透视图(1)；Fig. 34 is a perspective view (1) of alaser perforating device 1 according to a thirteenth embodiment of the present invention;

图35是本发明的第十四实施例的激光穿刺装置1的透视图；FIG. 35 is a perspective view of alaser perforating device 1 according to a fourteenth embodiment of the present invention;

图36是本发明的第十四实施例的激光穿刺装置1的操作的流程图；FIG. 36 is a flowchart of the operation of thelaser perforation device 1 of the fourteenth embodiment of the present invention;

图37是显示本发明的第十四实施例的激光穿刺装置1使用的周期声音的示例的视图；FIG. 37 is a view showing an example of periodic sounds used by thelaser perforating device 1 of the fourteenth embodiment of the present invention;

图38是本发明的第十四实施例的激光穿刺装置1的框图；FIG. 38 is a block diagram of alaser perforation device 1 according to a fourteenth embodiment of the present invention;

图39是本发明的第十五实施例的激光穿刺装置1中的穿刺帽507的示意图，其中含水量测量传感器被设定在穿刺帽507内；Fig. 39 is a schematic diagram of the piercingcap 507 in thelaser piercing device 1 according to the fifteenth embodiment of the present invention, wherein the water content measuring sensor is set in the piercingcap 507;

图40是本发明的第十五实施例的穿刺帽7用于皮肤的情形的断面图；Fig. 40 is a sectional view of the case where thepuncture cap 7 of the fifteenth embodiment of the present invention is applied to the skin;

图41是本发明的第十五实施例的穿刺帽507的附近的断面图；Fig. 41 is a cross-sectional view of the vicinity of the piercingcap 507 of the fifteenth embodiment of the present invention;

图42是本发明的第十五实施例的激光穿刺装置1的使用流程的视图；FIG. 42 is a view showing the flow of use of thelaser perforating device 1 according to the fifteenth embodiment of the present invention;

图43是本发明的实施例中的激光脉冲束能量基于皮肤含水量测量结果而被校正的情况的示意图；Figure 43 is a schematic diagram of the situation where the energy of the laser pulse beam is corrected based on the skin moisture content measurement results in an embodiment of the present invention;

图44是含水量测量用传感器电极821，以及设置在本发明的实施例中的激光穿刺装置1的表面上的湿度传感器822的例子的视图；44 is a view of an example of a sensor electrode 821 for water content measurement, and a humidity sensor 822 provided on the surface of thelaser perforating device 1 in an embodiment of the present invention;

图45是本发明的实施例中的在激光穿刺过程中的激光穿刺点的放大视图；Fig. 45 is an enlarged view of laser puncture points during laser puncture in an embodiment of the present invention;

图46是本发明的第十六实施例中的插入保持器的示意图；FIG. 46 is a schematic diagram of an insertion holder in a sixteenth embodiment of the present invention;

图47是本发明的第十六实施例中的插入保持器的示意图；47 is a schematic diagram of an insertion holder in a sixteenth embodiment of the present invention;

图48是本发明的第十六实施例中的生物传感器的示意图；48 is a schematic diagram of a biosensor in a sixteenth embodiment of the present invention;

图49是本发明的地十六实施例中的插入保持器的示意图；Fig. 49 is a schematic diagram of the insertion holder in the sixteenth embodiment of the present invention;

图50是本发明的第十七实施例中的激光脉冲束的振荡状态的视图；Fig. 50 is a view of an oscillation state of a laser pulse beam in a seventeenth embodiment of the present invention;

图51是本发明的第十七实施例中的第一激光脉冲束的照射后的激光穿刺点的放大视图，以及第二激光脉冲束照射后的激光穿刺点的放大视图(b)；51 is an enlarged view of the laser puncture point after irradiation of the first laser pulse beam and an enlarged view (b) of the laser puncture point after irradiation of the second laser pulse beam in the seventeenth embodiment of the present invention;

图52是本发明的第十八实施例中的生物传感器的平面图和断面图；52 is a plan view and a sectional view of a biosensor in an eighteenth embodiment of the present invention;

图53是本发明的第十八实施例中的激光穿刺过程中的激光穿刺点的放大视图(a)，以及激光穿刺后的激光穿刺点的放大视图(b)；53 is an enlarged view (a) of a laser puncture point during laser puncture and an enlarged view (b) of a laser puncture point after laser puncture in the eighteenth embodiment of the present invention;

图54是本发明的第十九实施例的激光穿刺过程中的激光穿刺点的放大视图；Fig. 54 is an enlarged view of the laser puncture point during the laser puncture process according to the nineteenth embodiment of the present invention;

图55是本发明的第二十实施例中的激光穿刺装置的示意图；Fig. 55 is a schematic diagram of the laser perforation device in the twentieth embodiment of the present invention;

图56是本发明的第二十实施例中的激光穿刺装置的操作的流程图；Fig. 56 is a flowchart of the operation of the laser perforating device in the twentieth embodiment of the present invention;

图57是本发明的第二十实施例中的光波形的示意图；Fig. 57 is a schematic diagram of an optical waveform in a twentieth embodiment of the present invention;

图58是传统的激光装置的总视图；Figure 58 is a general view of a conventional laser device;

图59是传统的生物传感器的分解透视图；Figure 59 is an exploded perspective view of a conventional biosensor;

图60是传统激光穿刺装置的操作的流程图；Figure 60 is a flowchart of the operation of a conventional laser perforating device;

图61是用于解释激光穿刺的皮肤的示意图。Fig. 61 is a schematic diagram for explaining laser perforation of skin.

参考标记reference mark

1：成分浓度测量装置1: Component concentration measuring device

2，102：主体2, 102: Subject

3：显示器3: Display

4：显示开关按钮4: Display switch button

5：激光操作按钮5: Laser operation button

6：滑片6: slide

7，207：插入保持器7, 207: insert retainer

8：生物传感器8: Biosensor

9：激光装置9: Laser device

10：电池10: battery

11：电路11: circuit

12，105：聚光透镜12, 105: condenser lens

13：分析光学装置13: Analytical Optics

14，213：圆柱体14, 213: Cylinder

15，214：切口15, 214: Incision

16：突起16: Protrusion

17，313：激光束17, 313: Laser beam

18，107，314：手指18, 107, 314: fingers

19：通孔19: Through hole

20：激光穿刺20: Laser piercing

21：烟流21: Smoke Stream

22，32：开口22, 32: opening

31，51，100，251，301，451：基板31, 51, 100, 251, 301, 451: substrate

33，54，63，65，254，304，325，454：膜33, 54, 63, 65, 254, 304, 325, 454: film

52：过滤器52: filter

53，255，305，455：样本试剂53, 255, 305, 455: sample reagents

55，117，256，306，456：隔板55, 117, 256, 306, 456: bulkhead

56，257，307，457：样本试剂供应通道56, 257, 307, 457: sample reagent supply channels

57，119，258，308，458：盖板57, 119, 258, 308, 458: cover plate

58，259，459：空气孔58, 259, 459: air holes

59：基板开口59: Substrate opening

60：隔板开口60: Partition opening

61：盖板开口61: Cover opening

62：第二开口62: Second opening

64：第三开口64: Third opening

66：光发射元件66: Light emitting element

67：光接收元件67: Light receiving element

101：固态激光振荡器101: Solid State Laser Oscillator

103：控制器103: Controller

104：透镜罩104: Lens cover

106：平台106: Platform

108：手指托108: finger rest

110：导入口110: Import port

111：排出口111: discharge port

112，113：导线112, 113: Wire

114：测量电极114: Measuring electrode

115：反电极115: counter electrode

116：绝缘层116: insulation layer

118：空间部118: Department of Space

218：第一电极218: first electrode

215：第一突起215: First protrusion

216：第二突起216: second protrusion

217：第三突起217: The third protrusion

425：开关425: switch

本发明的最佳实施方式BEST MODE FOR CARRYING OUT THE INVENTION

第一实施例first embodiment

在下文中，本发明的第一实施例中的生物传感器和成分浓度测量装置将参考附图予以描述。图1是本发明的第一实施例中的成分浓度测量装置的顶视图，图2是当图1从侧面观察时成分浓度测量装置的内部结构示意图，且图3是当图1从上面观察时成分浓度测量装置的下部内部结构示意图。Hereinafter, the biosensor and component concentration measuring device in the first embodiment of the present invention will be described with reference to the drawings. 1 is a top view of the component concentration measuring device in the first embodiment of the present invention, FIG. 2 is a schematic diagram of the internal structure of the component concentration measuring device when FIG. 1 is viewed from the side, and FIG. 3 is when FIG. 1 is viewed from above Schematic diagram of the lower internal structure of the component concentration measuring device.

在图1中，成分浓度测量装置1包括显示器1、显示器3的显示开关按钮3、以及激光操作按钮5，其被设置在主体2中；且另外包括，相对于主体2可替换的滑片6、嵌合在主体2中的插入保持器7、以及生物传感器8。尽管图1显示了插入保持器7和生物传感器8是分离的，当在操作过程中插入保持器7和生物传感器8通过嵌合而整合在一起。In FIG. 1, the componentconcentration measuring device 1 includes adisplay 1, adisplay switch button 3 of thedisplay 3, and alaser operation button 5, which are arranged in themain body 2; , aninsertion holder 7 fitted in themain body 2, and abiosensor 8. Although FIG. 1 shows that theinsertion holder 7 and thebiosensor 8 are separated, theinsertion holder 7 and thebiosensor 8 are integrated by fitting during operation.

在图2中，其为当图1从侧面观察时的内部结构的分解视图，与图1相同的参考标记表示与图1相同的元件。激光装置9、可充电电池10、电路11和聚光透镜12设置在主体2内部。在图3中，其为当图1从上面观察时的内部结构的分解视图，与图1和2相同的参考标记表示与图1和2相同的元件。生物传感器8的分析用分析光学装置13、激光操作按钮5、显示器3、显示开关按钮3、电池4和激光装置9通过未示出的配线与电路11相连接。类似地，激光装置9通过未示出的配线与电池10连接。In FIG. 2 , which is an exploded view of the internal structure when FIG. 1 is viewed from the side, the same reference numerals as in FIG. 1 denote the same elements as in FIG. 1 . Alaser device 9 , arechargeable battery 10 , anelectric circuit 11 and acondenser lens 12 are provided inside themain body 2 . In FIG. 3 , which is an exploded view of the internal structure of FIG. 1 viewed from above, the same reference numerals as in FIGS. 1 and 2 denote the same elements as in FIGS. 1 and 2 . Analyticaloptical device 13 for analysis ofbiosensor 8 ,laser operation button 5 ,display 3 ,display switch button 3 ,battery 4 andlaser device 9 are connected tocircuit 11 through unshown wiring. Similarly, thelaser device 9 is connected to thebattery 10 through unshown wiring.

(插入保持器)(insert retainer)

图4是插入保持器7的详细透视图。在插入保持器7中，切口15设置在圆柱体14的一端，且突起16沿三个方向设置在圆柱体的另一端。FIG. 4 is a detailed perspective view of theinsertion holder 7 . In theinsertion holder 7, acutout 15 is provided at one end of acylinder 14, andprotrusions 16 are provided at the other end of the cylinder in three directions.

对于圆柱体14，可使用各种塑料材料，如聚乙烯、聚氯乙烯、聚丙烯、聚苯乙烯、多乙酸乙烯酯、ABS树脂、AS树脂、丙烯酸树脂、聚缩醛、聚酰亚胺树脂、聚碳酸酯、改性聚亚苯醚(PPE)、聚丁烯对苯二酸酯(PPB)、多芳基化合物、聚砜、聚亚苯硫化物、聚醚醚酮、氟树脂等。在该实施例中，使用AS树脂。在塑料表面上具有低电动电位(zeta potential)的材料是优选的。For thecylinder 14, various plastic materials such as polyethylene, polyvinyl chloride, polypropylene, polystyrene, polyvinyl acetate, ABS resin, AS resin, acrylic resin, polyacetal, polyimide resin can be used , polycarbonate, modified polyphenylene ether (PPE), polybutylene terephthalate (PPB), polyarylate, polysulfone, polyphenylene sulfide, polyether ether ketone, fluororesin, etc. In this example, AS resin was used. Materials with low zeta potential on plastic surfaces are preferred.

插入保持器7的外直径在这样的范围内，即生物传感器8可被插入，且优选地为3到25mm。此外，圆柱体14的壁厚为0.2至3mm，且其长度为5至30mm。在该实施例中，插入保持器形成为圆柱形。然而，也可使用多面管体或类似的。The outer diameter of theinsertion holder 7 is within a range in which thebiosensor 8 can be inserted, and is preferably 3 to 25 mm. Furthermore, the wall thickness of thecylinder 14 is 0.2 to 3 mm, and its length is 5 to 30 mm. In this embodiment, the insertion holder is formed in a cylindrical shape. However, it is also possible to use polyhedral tubes or the like.

(滑片)(slide)

图5是滑片6的详细视图。图5(a)是平面图，图5(b)是当沿纵向在中心部分剖开时的断面图。FIG. 5 is a detailed view of theslider 6 . Fig. 5(a) is a plan view, and Fig. 5(b) is a cross-sectional view when cut at a central portion in the longitudinal direction.

基板31由聚乙烯对苯二甲酸酯、聚酯、聚烯烃、聚酰胺、聚醚、聚酰胺酰亚胺、聚苯乙烯、聚碳酸酯、聚乙烯-ρ-苯基硫、聚氯乙烯等制成。在该实施例中，使用聚乙烯对苯二甲基酸酯。基板31具有开口32，且开口32用膜33覆盖。对于膜33，可使用聚酰胺、聚酯、聚酰亚胺、氟系、氯乙烯、聚乙烯、聚烯烃、聚乙烯醇、聚丙烯等。滑片6总厚度为0.1至1mm，短边的长度为5至30mm，长轴的长度为30至60mm。Substrate 31 is made of polyethylene terephthalate, polyester, polyolefin, polyamide, polyether, polyamideimide, polystyrene, polycarbonate, polyethylene-rho-phenylsulfide, polyvinyl chloride and so on. In this example, polyethylene terephthalate was used. Thesubstrate 31 has anopening 32 , and theopening 32 is covered with afilm 33 . For thefilm 33, polyamide, polyester, polyimide, fluorine-based, vinyl chloride, polyethylene, polyolefin, polyvinyl alcohol, polypropylene, or the like can be used. The total thickness of the slidingsheet 6 is 0.1 to 1 mm, the length of the short side is 5 to 30 mm, and the length of the long axis is 30 to 60 mm.

(生物传感器)(biological sensor)

图6是生物传感器8的详细视图。图6(a)是平面图，图6(b)是当中心部分沿纵向剖切时的断面图，图6(c)是当中心部分沿横向剖切时的断面图。FIG. 6 is a detailed view of thebiosensor 8 . 6( a ) is a plan view, FIG. 6( b ) is a sectional view when the central portion is cut longitudinally, and FIG. 6( c ) is a sectional view when the central portion is cut transversely.

基板51是由绝缘材料制造，包括聚乙烯对苯二甲基酸酯等，盖板57是由绝缘材料制造，空气孔58大致为圆形。盖板57的材料优选为塑料膜，且包括聚酯、聚烯烃、聚酰胺、聚醚、聚酰胺酰亚胺、聚苯乙烯、聚碳酸酯、聚乙烯-ρ-苯基硫、聚氯乙烯等。此外，盖板具有对于可见光至近红外光几乎是透明的厚度。在该实施例中，使用聚碳酸酯。此外，共聚物、混合材料以及桥接材料可用于盖板57，且可使用厚度0.01mm至0.5mm的盖板。Thebase plate 51 is made of insulating material, including polyethylene terephthalate, etc. Thecover plate 57 is made of insulating material, and theair hole 58 is roughly circular. The material of thecover plate 57 is preferably a plastic film, and includes polyester, polyolefin, polyamide, polyether, polyamideimide, polystyrene, polycarbonate, polyethylene-rho-phenylsulfide, polyvinyl chloride wait. In addition, the cover plate has a thickness that is almost transparent to visible light to near-infrared light. In this example, polycarbonate was used. In addition, copolymers, hybrid materials, and bridging materials can be used for thecover plate 57, and a cover plate with a thickness of 0.01 mm to 0.5 mm can be used.

而且，具有切口部以形成供应样本试剂的样本试剂供应通道56的隔板55、用于分离微粒成分的过滤器52、以及浸渍有试剂的试剂层53，夹在盖板57和基板51之间，且该盖板与基板51整合设置。试剂层53通过涂覆包含酶、电子受体、氨基酸、糖醇、水溶聚合物等的试剂而形成。Also, apartition 55 having a cutout portion to form a samplereagent supply channel 56 for supplying the sample reagent, afilter 52 for separating particulate components, and areagent layer 53 impregnated with reagents are sandwiched between thecover plate 57 and thebase plate 51 , and the cover plate is integrated with thebase plate 51 . Thereagent layer 53 is formed by coating reagents including enzymes, electron acceptors, amino acids, sugar alcohols, water-soluble polymers, and the like.

分别穿透基板51、隔板55和盖板57的开口分别为基板开口59、隔板开口60和盖板开口61。膜54粘附到基板51的与隔板55相对的面上，以覆盖基板开口59。此外，设置有三个第二开口62。第二开口62设置得分别穿透基板51、隔板55和盖板57，且它们中的一些或所有设置为彼此对齐。The openings penetrating through thesubstrate 51 , thepartition 55 and thecover 57 are respectively thesubstrate opening 59 , thepartition opening 60 and thecover opening 61 . Afilm 54 is adhered to the face of thesubstrate 51 opposite to thespacer 55 to cover thesubstrate opening 59 . Furthermore, threesecond openings 62 are provided. Thesecond openings 62 are provided through thebase plate 51, thespacer 55 and thecover 57, respectively, and some or all of them are provided in alignment with each other.

生物传感器8的总厚度为0.1至1mm，短边的长度为5至30mm，且长轴的长度为30至60mm。The total thickness of thebiosensor 8 is 0.1 to 1 mm, the length of the short side is 5 to 30 mm, and the length of the long axis is 30 to 60 mm.

接着，将对操作进行详细描述。Next, the operation will be described in detail.

(准备)(Prepare)

首先，使用者将滑片6插入到主体2中。接着，类似地，插入保持器7通过嵌合插入体2内。插入保持器7设置有切口15，且切口15设置使得使用者不会弄错插入方向。尽管在此使用了切口，造成插入保持器7不对称的其它形状，如突起或多个切口或突起也可使用。First, the user inserts theslider 6 into themain body 2 . Next, similarly, theinsertion holder 7 is inserted into thebody 2 by fitting. Theinsertion holder 7 is provided with acutout 15, and thecutout 15 is provided so that the user does not mistake the insertion direction. Although a cutout is used here, other shapes that cause theinsertion holder 7 to be asymmetrical, such as a protrusion or a plurality of cutouts or protrusions may also be used.

接着，使用者通过嵌合把生物传感器8插入到插入保持器7内。生物传感器8的第二开口62设置得它们可嵌合在插入保持器7的突起16上。由于第二开口62不对称地设置在生物传感器8内，使用者可插入该生物传感器而不会弄错插入方向。参考图6，设置有三个第二开口62。然而，本发明不仅限于此，满足上述目的的各种设置可被使用。开口的截面形状也可以是各种形状，例如除了双圆的部分切口，还有圆形、长方形、正方形、多边形和椭圆形。在改变生物传感器8的第二开口62的形状和结构的情况中，无需说，插入保持器7的突起16的形状、布置和数量也相应地改变。Next, the user inserts thebiosensor 8 into theinsertion holder 7 by fitting. Thesecond openings 62 of thebiosensor 8 are arranged so that they can fit on theprotrusion 16 of theinsertion holder 7 . Since thesecond opening 62 is asymmetrically disposed in thebiosensor 8, the user can insert the biosensor without mistakenly inserting the direction. Referring to FIG. 6, threesecond openings 62 are provided. However, the present invention is not limited thereto, and various arrangements satisfying the above-mentioned objects may be used. The cross-sectional shape of the opening may also be various shapes such as circular, rectangular, square, polygonal, and elliptical in addition to the partial cutout of a double circle. In the case of changing the shape and structure of thesecond opening 62 of thebiosensor 8, it goes without saying that the shape, arrangement and number of theprotrusions 16 inserted into theholder 7 are also changed accordingly.

随后，使用者把皮肤贴到生物传感器8的膜54上，使得预定的激光穿刺点可以到达基板开口59。同时，插入保持器7的突起16从生物传感器8凸出约1至3mm，且该突起挤压皮肤。这将刺激预定的激光穿刺点的周围。为此，这可减轻使用者在激光穿刺期间感觉到的刺激。Subsequently, the user sticks the skin on themembrane 54 of thebiosensor 8 so that the predetermined laser puncture point can reach thesubstrate opening 59 . At the same time, theprotrusion 16 of theinsertion holder 7 protrudes from thebiosensor 8 by about 1 to 3 mm, and the protrusion presses the skin. This will stimulate around the intended laser puncture point. For this reason, this reduces the irritation felt by the user during laser perforation.

(激光穿刺)(Laser piercing)

在使用者把皮肤贴到生物传感器8后，由此完成激光穿刺的准备，使用者按下激光操作按钮5，以进行激光穿刺。激光装置9利用激光操作按钮5从电路11产生的信号和电池10的电能振荡激光束。振荡的激光束被聚光透镜12聚焦，且穿刺使用者的皮肤。After the user attaches the skin to thebiosensor 8 to complete the preparation for laser puncture, the user presses thelaser operation button 5 to perform laser puncture. Thelaser device 9 oscillates a laser beam using the signal generated from thecircuit 11 by thelaser operation button 5 and the electric energy of thebattery 10 . The oscillating laser beam is focused by thecondenser lens 12, and punctures the user's skin.

对于激光束的波长，具有高的皮肤吸收系数的波长是优选的，且3μm波段(光激励激光或掺铒介质的中红外半导体激光)，或9至10μm波段(放电激励激光或二氧化碳气体介质的中红外半导体激光)是可以使用的。For the wavelength of the laser beam, the wavelength with high skin absorption coefficient is preferred, and the 3 μm band (light-excited laser or mid-infrared semiconductor laser of erbium-doped medium), or the 9 to 10 μm band (discharge-excited laser or carbon dioxide gas medium) mid-infrared semiconductor laser) is available.

此外，皮肤上的激光束的聚光直径优选地为φ0.5mm以下，更优选地为φ0.15mm以下。尽管该聚光形状优选地为圆形，还可使用长轴设定为0.5mm以下的椭圆形。激光束优选地以脉冲方式振荡，且脉冲的波形的时间宽度优选地为1μs以上和400μs以下。激光束的照射可以是单脉冲束照射或多脉冲束照射。In addition, the focusing diameter of the laser beam on the skin is preferably φ0.5 mm or less, more preferably φ0.15 mm or less. Although the light-concentrating shape is preferably a circle, an ellipse whose major axis is set to 0.5 mm or less may also be used. The laser beam is preferably oscillated in a pulsed manner, and the time width of the waveform of the pulse is preferably 1 μs or more and 400 μs or less. The irradiation of the laser beam may be single pulse beam irradiation or multi-pulse beam irradiation.

对于聚光透镜12，通过在氟化钙(CaF₂)、钇铝石榴石(YAG)、锗(Ge)、硒化锌(ZnSe)、无水人造水晶和氟化物模制材料制造的基板上进行非反射涂覆(介质多层膜)而得到聚光透镜，且其焦距优选地为5至30mm。在该实施例中，使用氟化钙基板。此外，聚光透镜12大致为圆形，且其外部尺寸为6至30mm。For the condensinglens 12, on a substrate made of calcium fluoride (CaF₂ ), yttrium aluminum garnet (YAG), germanium (Ge), zinc selenide (ZnSe), anhydrous artificial crystal, and fluoride molding material Concentrating lenses are obtained by non-reflective coating (dielectric multilayer film), and their focal length is preferably 5 to 30 mm. In this example, a calcium fluoride substrate was used. In addition, the condensinglens 12 is substantially circular, and its outer dimension is 6 to 30 mm.

图7是激光穿刺过程中的激光穿刺点的放大视图。激光束被聚光透镜12聚焦在进行激光穿刺的使用者的手指18上，且其地点是激光束的地点17。使用者的手指18接触生物传感器8的膜54，且来自主体的激光束17传播，同时其光束直径逐渐地收缩，如图7。激光束17被设置，以传播穿过滑片6的膜33、开口32、插入保持器7的内部、生物传感器8的开口22和膜54，以聚焦在使用者的手指18上。Fig. 7 is an enlarged view of a laser puncture point during laser puncture. The laser beam is focused by the condensinglens 12 on thefinger 18 of the user performing laser puncture, and its location is thelocation 17 of the laser beam. The user'sfinger 18 touches thefilm 54 of thebiosensor 8, and thelaser beam 17 from the subject propagates while its beam diameter gradually shrinks, as shown in FIG. 7 . Thelaser beam 17 is arranged to propagate through themembrane 33 of theslide 6 , theopening 32 , the interior of theinsertion holder 7 , theopening 22 of thebiosensor 8 and themembrane 54 to focus on the user'sfinger 18 .

构成滑片6的开口32的开口59、60和61的开口直径、插入保持器7和生物传感器8的开口22的内直径可以是这样的直径，该直径使得激光束17基本上不被遮蔽，且所有直径不必相同。此外，开口的最小直径为1mm。而且，参考图6，该开口为圆形。然而，可能是各种形状，例如矩形、正方形、多边形和椭圆形。The opening diameters of theopenings 59, 60 and 61 constituting theopening 32 of theslide 6, the inner diameter of theopening 22 of theinsertion holder 7 and thebiosensor 8 may be such a diameter that thelaser beam 17 is substantially not shielded, And all diameters do not have to be the same. In addition, the minimum diameter of the opening is 1mm. Also, referring to FIG. 6, the opening is circular. However, various shapes such as rectangle, square, polygon and ellipse are possible.

激光束被膜33部分地吸收，但是通孔没有形成在膜中，而激光束17几乎聚集在膜54上且其能量密度高。因此，激光束被膜吸收，以加热和蒸发该膜，由此形成通孔。随后，激光束被使用者的手指18的皮肤吸收，以加热和蒸发皮肤，由此最终破坏真皮的毛细管，以允许血液采样。The laser beam is partially absorbed by thefilm 33, but no through hole is formed in the film, whereas thelaser beam 17 is almost concentrated on thefilm 54 and its energy density is high. Accordingly, the laser beam is absorbed by the film to heat and evaporate the film, thereby forming via holes. The laser beam is then absorbed by the skin of the user'sfinger 18 to heat and vaporize the skin, thereby eventually breaking the capillaries of the dermis to allow blood sampling.

图8是在紧接着激光穿刺后的激光穿刺点的放大视图。由于激光穿刺在膜54中形成通孔19，且在使用者的手指18的皮肤中形成激光穿刺孔20，由于皮肤组织的蒸发产生烟流21Fig. 8 is an enlarged view of a laser perforation point immediately after laser perforation. Since the laser perforation forms a throughhole 19 in thefilm 54 and alaser perforation hole 20 is formed in the skin of the user'sfinger 18, asmoke stream 21 is generated due to evaporation of the skin tissue.

类似于图8，当皮肤的组织蒸发时产生的烟流21，经由激光束照射膜54形成的通孔19，穿过生物传感器8的开口22、插入保持器7的内部、以及膜33形成处的开口。由于膜54的通孔19非常小，类似于皮肤的激光穿刺孔20，即使在使用者从生物传感器8抬起他/她的手指18，流回的烟流的量非常小，因此，使用者可避免闻到烟流21的异味。Similar to FIG. 8 , thesmoke stream 21 generated when the tissue of the skin evaporates passes through theopening 22 of thebiosensor 8, the inside of theinsertion holder 7, and the place where thefilm 33 is formed via the throughhole 19 formed by the laserbeam irradiation film 54. opening. Since the throughhole 19 of themembrane 54 is very small, similar to thelaser perforation hole 20 of the skin, even when the user lifts his/herfinger 18 from thebiosensor 8, the amount of smoke flowing back is very small, therefore, the user Can avoid smelling the peculiar smell ofsmoke flow 21.

这个实施例的成分浓度测量装置在手套箱中使用以进行激光穿刺，其中，与外部可靠气密的手套箱的内部填充有氮气。当激光穿刺后，手套箱内部的气体被抽风机抽到评估箱且被检测硫化物成分的气体检测管检查时，检测到的数量的水平即使与没有进行激光穿刺的情况相比较也是相等的。The component concentration measuring device of this embodiment is used in a glove box whose interior is reliably airtight from the outside is filled with nitrogen gas for laser perforation. When the gas inside the glove box was sucked into the evaluation box by the exhaust fan after the laser perforation and checked by the gas detection tube for detecting the sulfide composition, the level of the detected quantity was equal even compared with the case where the laser perforation was not performed.

对于膜54的基材，可以使用聚酰胺、聚酯、聚酰亚胺、氟系、氯乙烯、聚乙烯、聚烯烃、聚乙烯醇、聚丙烯等。更优选地膜54具有对激光束17的波长较高的吸收系数。在该实施例中使用聚碳酸酯。由于不仅基材的吸收系数而且其厚度以及添加剂的吸收系数对该吸收系数起作用，优选地调整厚度和添加剂，以适当地调整该吸收系数。As the base material of thefilm 54, polyamide, polyester, polyimide, fluorine-based, vinyl chloride, polyethylene, polyolefin, polyvinyl alcohol, polypropylene, or the like can be used. More preferably thefilm 54 has a higher absorption coefficient for the wavelength of thelaser beam 17 . Polycarbonate is used in this example. Since not only the absorption coefficient of the substrate but also its thickness and the absorption coefficients of the additives contribute to the absorption coefficient, it is preferable to adjust the thickness and the additives to properly adjust the absorption coefficient.

对于膜33的基材，可以使用聚酰胺、聚酯、聚酰亚胺、氟系、氯乙烯、聚乙烯、聚烯烃、聚乙烯醇、聚丙烯等。在该实施例中使用环烯聚合物。更优选地膜33具有对于激光束17的波长较低的吸收系数。由于不仅基材的吸收系数而且其厚度以及添加剂的吸收系数对该吸收系数起作用，优选地调整厚度和添加剂，以适当地调整该吸收系数。As the base material of thefilm 33, polyamide, polyester, polyimide, fluorine-based, vinyl chloride, polyethylene, polyolefin, polyvinyl alcohol, polypropylene, or the like can be used. In this example a cycloolefin polymer was used. More preferably thefilm 33 has a lower absorption coefficient for the wavelength of thelaser beam 17 . Since not only the absorption coefficient of the substrate but also its thickness and the absorption coefficients of the additives contribute to the absorption coefficient, it is preferable to adjust the thickness and the additives to properly adjust the absorption coefficient.

膜54、膜33以及插入保持器7的内部也具有对于烟流21的异味成分的除臭功能。由构成皮肤组织的蛋白质成分的氨基酸产生的挥发性物质被分解在烟流21中流动。激光穿刺过程中的主要目标角质层由角蛋白质的纤维组织组成，且纤维是由胱氨酸键结合，该键是包含相对较多的氨基酸胱氨酸的硫部分的键。这些氨基酸在蒸发过程中分解，产生挥发性硫化合物或氮化合物，人感觉到作为异味的硫化合物。Themembrane 54 , themembrane 33 , and the inside of theinsertion holder 7 also have a deodorizing function for odor components of thesmoke 21 . Volatile substances generated from amino acids constituting protein components of skin tissue are decomposed and flow in thesmoke stream 21 . The stratum corneum, which is the main target during laser perforation, is composed of fibrous tissue of keratin, and the fibers are bonded by cystine bonds, which are bonds containing relatively many sulfur moieties of the amino acid cystine. These amino acids break down during evaporation to produce volatile sulfur compounds, or nitrogen compounds, which are perceived as off-flavors.

硫化氢或甲基硫醇作为主要的硫化合物被提及。硫化氢可通过化学吸附剂除臭，且可使用锰、铜和钴的复合氧合物。另外，类似地，通过使用包括锰、铜、锌和钴任意其一的氧化物、氢氧化物、复合氧合物、或其混合物，可获得对于硫化氢的有效的化学吸收作用的吸附剂。Hydrogen sulfide or methyl mercaptan are mentioned as main sulfur compounds. Hydrogen sulfide can be deodorized by a chemical adsorbent, and complex oxygen compounds of manganese, copper, and cobalt can be used. In addition, similarly, by using an oxide, a hydroxide, a composite oxygen compound, or a mixture thereof including any one of manganese, copper, zinc, and cobalt, an adsorbent effective in chemical absorption for hydrogen sulfide can be obtained.

化学吸附剂化学地吸收硫化氢，最终是以硫酸盐或简单的硫物质的形式。此外，化学吸附剂还具有媒介作用，其将同样的硫基异味的甲基硫醇转换为具有较高阈值的二甲基二硫醚。由于该作用，人可感觉到相当于除臭的效果。化学吸附剂具有约0.1至1μm的尺寸，且该化学吸附剂的形状没有特别限制。Chemisorbents chemically absorb hydrogen sulfide, ultimately in the form of sulfate or simple sulfur species. In addition, the chemisorbent also acts as an intermediary, converting the same sulfur-based off-flavor methyl mercaptan to dimethyl disulfide with a higher threshold. Due to this action, humans can perceive an effect corresponding to deodorization. The chemical adsorbent has a size of about 0.1 to 1 μm, and the shape of the chemical adsorbent is not particularly limited.

而且，由于二甲基二硫醚可通过搭载的物理吸附剂的物理吸附剂作用而被去除，其大体上可去除硫化合物。具有较大部分硅的疏水沸石可被用作物理吸附剂。另外，即使使用沸石、海泡石、硅石、氧化铝等，也可得到相同的效果。Also, since dimethyl disulfide can be removed by the physisorbent action of the carried physisorbent, it can substantially remove sulfur compounds. Hydrophobic zeolites with a larger fraction of silicon can be used as physical adsorbents. In addition, even if zeolite, sepiolite, silica, alumina, etc. are used, the same effect can be obtained.

这些化学吸附剂和物理吸附剂可通过添加到膜33和54或插入保持器7基材，或通过涂覆在膜33和54上或插入保持器7的内部而实现。此外，还优选地添加或涂覆这些吸附剂到/在基板51、隔板55或盖板57。These chemisorbents and physisorbents can be achieved by being added to themembranes 33 and 54 or inserted into theholder 7 substrate, or by coating on themembranes 33 and 54 or inserted inside theholder 7 . Furthermore, it is also preferable to add or coat these adsorbents to/on thesubstrate 51 , thespacer 55 or thecover 57 .

此外，由于膜54接触使用者的手指18，优选地给予膜抗菌特性。各种抗菌剂可被使用，且可通过涂覆或混炼到基材之上/之内而实现。抗菌剂包括Ag、Cu、Zn、Ni、Co或其合金、TiO₂、ZnO、WO₃等。Furthermore, since thefilm 54 contacts the user'sfinger 18, antimicrobial properties are preferably imparted to the film. Various antimicrobial agents can be used and can be achieved by coating or compounding onto/into the substrate. Antibacterial agents include Ag, Cu, Zn, Ni, Co or alloys thereof, TiO₂ , ZnO, WO₃ and the like.

另外，抗菌特性通过不仅植入在生物传感器8的膜54上而且在生物传感器8、插入保持器7和滑片6的外表面上而有效。In addition, antibacterial properties are effective by being implanted not only on themembrane 54 of thebiosensor 8 but also on the outer surfaces of thebiosensor 8 , theinsertion holder 7 and theslide 6 .

在该实施例中，其中银携带在磷酸锆中的抗菌剂被以0.5wt％添加到涂层材料，然后涂覆在基板上。而且，在基板的外表面上，0.5wt％的上述抗菌剂被添加到构成基板的树脂中。另外，在这两个处理方法中，0.5wt％至1.0wt％的抗菌剂具有抗菌作用，且是经济的。In this example, an antimicrobial agent in which silver is carried in zirconium phosphate was added to the coating material at 0.5 wt%, and then coated on the substrate. Also, on the outer surface of the substrate, 0.5wt% of the above antibacterial agent was added to the resin constituting the substrate. In addition, in these two treatment methods, 0.5wt% to 1.0wt% of antibacterial agent has antibacterial effect and is economical.

使用者从生物传感器8移离皮肤且推挤穿刺点的周围，以挤出0.5至几微升血液作为试样标本。随后，通过使血液采样点接触生物传感器8一侧的样本试剂供应通道56，空气孔58动作，由此血液通过毛细现象收集在生物传感器8中。对于血液，血液中的血球成分在途中被过滤器52俘获，且仅血浆成分到达样本试剂53。The user moves away from the skin from thebiosensor 8 and pushes around the puncture point to squeeze out 0.5 to several microliters of blood as a sample specimen. Subsequently, by bringing the blood sampling point into contact with the samplereagent supply channel 56 on the side of thebiosensor 8, theair hole 58 operates, whereby blood is collected in thebiosensor 8 by capillary phenomenon. Regarding blood, blood cell components in the blood are captured by thefilter 52 on the way, and only the plasma components reach thesample reagent 53 .

过滤器52是由纤维性材料制成，例如玻璃纤维或无纺布，且设置成网状。依赖于纤维之间的间隔，可以捕获尺寸大于该间隔的待分析液体中的成分。被捕获的成分是妨碍样本试剂53中的分析物和试剂之间的反应的成分，以及具有除了分析物之外的颜色的成分。纤维之间的间隔约为几微米到几十微米，其优选为1至5μm。沿样本试剂供应通道56的方向的长度约为几毫米，且优选为1至5mm。Thefilter 52 is made of fibrous material, such as glass fiber or non-woven fabric, and is arranged in a net shape. Depending on the spacing between the fibers, components in the liquid to be analyzed having a size larger than the spacing can be captured. The captured components are components that interfere with the reaction between the analyte in thesample reagent 53 and the reagent, and components that have a color other than the analyte. The interval between fibers is about several micrometers to several tens of micrometers, which is preferably 1 to 5 μm. The length in the direction of the samplereagent supply channel 56 is about several millimeters, and preferably 1 to 5 mm.

本领域技术人员已知的酶比色法的色原体和酶设置在样本试剂53中，该样本试剂53处于涂覆、粘附或印刷在基板51上，或它们通过涂覆、印刷、注入或捏炼而与滤纸、膜或其它载体整合的状态。样本试剂53的尺寸优选地一边为3mm以上的正方形或矩形。The chromogens and enzymes of the enzyme colorimetric method known to those skilled in the art are set in thesample reagent 53, which is coated, adhered or printed on thesubstrate 51, or they are coated, printed, injected Or the state of kneading and integrating with filter paper, membrane or other carriers. The size of thesample reagent 53 is preferably a square or a rectangle with a side of 3 mm or more.

对于到达样本试剂53的待分析液体是血液，如果分析物是葡萄糖，则葡萄糖+氧+水-(葡萄糖氧化酶)→葡萄糖酸+过氧化氢的反应发生在葡萄糖和样本试剂53中的酶之间，且过氧化氢+色原体-(过氧化酶)→过氧化氢+苯醌基色素的另外反应发生在反应产物和色原体之间。通过一系列反应，样本试剂53显示与分析物葡萄糖的浓度相对应的颜色。For the liquid to be analyzed that reaches thesample reagent 53 is blood, if the analyte is glucose, then the reaction of glucose+oxygen+water-(glucose oxidase)→gluconic acid+hydrogen peroxide occurs between glucose and the enzyme in thesample reagent 53 Between, and another reaction of hydrogen peroxide+chromogen-(peroxidase)→hydrogen peroxide+benzoquinone-based pigment occurs between the reaction product and the chromogen. Through a series of reactions, thesample reagent 53 displays a color corresponding to the concentration of the analyte glucose.

吡喃糖氧化酶也可被使用代替葡萄糖氧化酶。除了过氧化酶，还可使用血红蛋白、硫氰酸铁、氰亚铁酸铁、碘化钾、钼酸铵等。Pyranose oxidase can also be used instead of glucose oxidase. In addition to peroxidase, hemoglobin, ferric thiocyanate, ferric ferrocyanide, potassium iodide, ammonium molybdate, and the like can be used.

对于发色(color development)情形，色原体可具有可视范围内的吸收性。可使用基于o-茴香胺、对二氨基联苯、o-联甲苯胺、四甲基联苯胺和白色的色原体；可使用通过结合4-氨基安替比林和苯酚获得的trinder基试剂、或其衍生物和苯胺衍生物等。In the case of color development, chromogens may have absorbance in the visible range. Chromogens based on o-anisidine, p-diaminobenzidine, o-toluidine, tetramethylbenzidine and white can be used; trinder-based reagents obtained by combining 4-aminoantipyrine and phenol can be used , or its derivatives and aniline derivatives, etc.

图12用于测量样本试剂53显色状态的分析光学装置13的结构示意图。与电路11电连接的光发射元件66的光穿透设置在主体2中的开口，且经由基本上对于生物传感器8的光发射元件66的光是透明的盖板57进入样本试剂53，类似地，反射光被与电路11电连接的光接收元件67检测。FIG. 12 is a schematic structural diagram of the analyticaloptical device 13 for measuring the color development state of thesample reagent 53 . The light of the light emitting element 66 electrically connected to thecircuit 11 penetrates the opening provided in themain body 2, and enters thesample reagent 53 through thecover plate 57 which is substantially transparent to the light of the light emitting element 66 of thebiosensor 8, similarly , the reflected light is detected by thelight receiving element 67 electrically connected to thecircuit 11 .

用于防止来自外部的灰尘或类似物进入的、对于光发射元件66发射的光的波长是透明的窗口材料还可设置在主体2的分析光学装置13的开口。作为窗口材料，可以使用聚碳酸酯、有机玻璃、MS树脂、聚丙烯、ABS树脂、聚苯乙烯、环氧树脂、polyarete、聚砜、聚-4-甲基戊烯-1、苯氧基树脂、聚酰亚胺树脂、烯/马来酰亚胺共聚物、苯酚树脂、非溴基耐火PC、环烯共聚物、甲基丙酸烯树脂、三乙酰纤维素和各种玻璃材料，例如二氧化硅(SiO₂)和BK7。A window material transparent to the wavelength of light emitted from the light emitting element 66 for preventing entry of dust or the like from the outside may also be provided at the opening of theanalytical optics 13 of themain body 2 . As the window material, polycarbonate, plexiglass, MS resin, polypropylene, ABS resin, polystyrene, epoxy resin, polyarete, polysulfone, poly-4-methylpentene-1, phenoxy resin can be used , polyimide resin, vinyl/maleimide copolymer, phenol resin, non-brominated fire-resistant PC, cycloolefin copolymer, methacrylic resin, triacetyl cellulose and various glass materials, such as di Silicon oxide (SiO₂ ) and BK7.

依赖于可见光或近红外光的单色的反射率，或多束这样的光的强度比，显色的程度被转换成浓度。作为光源，可使用灯和频谱过滤器的组合、发光二极管(LED)和激光二极管(LD)。在该实施例中，使用葡萄糖氧化酶、过氧化物酶、以及醌色素，利用波长为610nm的发光二极管的反射光进行分析。Depending on the reflectance of a single color of visible light or near-infrared light, or the intensity ratio of multiple such lights, the degree of color development is converted into density. As light sources, combinations of lamps and spectral filters, light emitting diodes (LEDs) and laser diodes (LDs) can be used. In this example, glucose oxidase, peroxidase, and quinone dye were used for analysis using reflected light from a light emitting diode with a wavelength of 610 nm.

通过分析获得的血液中待测量的物质的浓度显示在显示器3上，且被使用者识别。电路11还包括未示出的存储单元，且分析结果连同测量数据和时间或使用者代码被记录。使用显示开关按钮4，使用者后来可再次识别过去的测量结果。The concentration of the substance to be measured in the blood obtained by the analysis is displayed on thedisplay 3 and recognized by the user. Thecircuit 11 also includes a memory unit, not shown, and the results of the analysis are recorded together with the measurement data and the time or user code. Using thedisplay switch button 4, the user can later identify past measurement results again.

如上所述，根据本发明的第一实施例的成分浓度测量装置被这样设置，其主体设置有激光装置、聚光透镜、用于确定生物传感器的显色反应的光学装置、电路、能显示分析结果的显示器以及可充电电池，且滑片和插入保持器沿激光束的光轴插入到主体内，且生物传感器嵌合到插入保持器内。因此，由于使用者没有闻到激光穿刺过程中产生的烟流中的异味，且接触使用者的采样点的试纸每次采样时替换，因此不担心传染，且由于使用者可在一个机构中进行采样和分析，可实现简单而容易的使用。As described above, the component concentration measuring device according to the first embodiment of the present invention is configured such that its main body is provided with a laser device, a condensing lens, an optical device for determining a color reaction of a biosensor, a circuit, a display capable of analyzing The display of the result and the rechargeable battery, and the slide and the insertion holder are inserted into the main body along the optical axis of the laser beam, and the biosensor is fitted into the insertion holder. Therefore, since the user does not smell the peculiar smell in the smoke generated during laser puncture, and the test paper at the sampling point that touches the user is replaced every time sampling, there is no fear of infection, and since the user can carry out the test in one institution Sampling and analysis for simple and easy use.

此外，要被激光束光轴上的激光束穿透的膜设置在生物传感器中，该生物传感器通过样本试剂的显色反应进行成分分析。因此，在激光穿刺过程中产生的烟流从使用者的皮肤穿过穿透的孔排出，且在激光穿刺过程中产生的烟流通过穿透从使用者的皮肤排出。因此，烟流没有泄漏到使用者，因此使用者可被防止闻到在激光穿刺过程中产生的烟流中的异味。In addition, a film to be penetrated by the laser beam on the optical axis of the laser beam is provided in a biosensor that performs component analysis by a color reaction of a sample reagent. Accordingly, the smoke generated during the laser perforation is discharged from the user's skin through the pierced hole, and the smoke generated during the laser perforation is discharged from the user's skin through the penetration. Therefore, the plume does not leak to the user, so the user can be prevented from smelling the peculiar smell in the plume generated during laser perforation.

而且，激光束光轴上的滑片的膜上设置有除臭功能，类似地在激光束光轴上的插入保持器的至少内表面上、以及类似地设置在激光束光轴上的生物传感器的膜上设置有除臭功能。因此，可消除激光穿刺过程中产生的烟流中的异味。Also, a deodorizing function is provided on the film of the slide on the optical axis of the laser beam, similarly on at least the inner surface of the insertion holder on the optical axis of the laser beam, and a biosensor similarly provided on the optical axis of the laser beam The membrane is equipped with a deodorizing function. Therefore, it is possible to eliminate odors in the plume generated during laser perforation.

第二实施例second embodiment

在下文中，根据本发明的第二实施例的生物传感器将予以详细描述。另外，仅与第一实施例不同点予以描述。Hereinafter, a biosensor according to a second embodiment of the present invention will be described in detail. In addition, only points different from the first embodiment will be described.

在第一实施例中，使用者使用图5的滑片6和图6的生物传感器8在结构上不同。在该实施例中，图6的生物传感器8用作滑片8。图6的生物传感器8的膜54和开口59、60和61设置在激光束的光轴上，以对应图5的滑片6的膜33和开口32。In the first embodiment, the user uses theslider 6 of FIG. 5 and thebiosensor 8 of FIG. 6 are different in structure. In this embodiment, thebiosensor 8 of FIG. 6 is used as theslide 8 . Themembrane 54 and theopenings 59, 60 and 61 of thebiosensor 8 of FIG. 6 are arranged on the optical axis of the laser beam to correspond to themembrane 33 and theopening 32 of theslide 6 of FIG. 5 .

在激光穿刺期间，由于用作滑片6的生物传感器8的膜54位于聚光透镜的侧面，而不在该聚光透镜的焦点上，因此膜上的激光束能量密度较低，且由于激光束没有形成通孔，用作滑片之后的生物传感器可再被用作生物传感器。相应地，由于使用者可减少要管理的消耗品的类型的数目，方便性得以提高。During laser perforation, since themembrane 54 of thebiosensor 8 used as theslide 6 is located on the side of the condenser lens, not on the focus of the condenser lens, the energy density of the laser beam on the membrane is low, and because the laser beam No through hole is formed, and the biosensor after being used as a slide can be used again as a biosensor. Accordingly, since the user can reduce the number of types of consumables to be managed, convenience is improved.

第三实施例third embodiment

在下文中，将详细描述本发明中的第三实施例的生物传感器。另外，仅描述不同于前述实施例的点。生物传感器在图10中示出。图10(a)为平面图，图10(b)是当沿纵向在中心部分剖切时的横断面图，图10(c)是当沿横向在中心部分剖切时的横断面图。当生物传感器用作滑片时，还设置有第三开口64和膜65。当生物传感器用作滑片时，第三开口64和膜65设置在激光束的光轴上，且膜65设置为使得即使激光束多次照射在该膜上也不会在该膜上形成通孔。Hereinafter, a biosensor of a third embodiment in the present invention will be described in detail. In addition, only points different from the foregoing embodiments are described. The biosensor is shown in FIG. 10 . 10( a ) is a plan view, FIG. 10( b ) is a cross-sectional view when the central portion is cut in the longitudinal direction, and FIG. 10( c ) is a cross-sectional view when the central portion is cut in the transverse direction. When the biosensor is used as a slide, athird opening 64 and a membrane 65 are also provided. When the biosensor is used as a slide, thethird opening 64 and the film 65 are arranged on the optical axis of the laser beam, and the film 65 is arranged so that no passage is formed on the film even if the laser beam is irradiated on the film many times. hole.

对于膜65，可以使用各种塑料或树脂，例如聚酰胺、聚酯、聚酰亚胺、氟系、氯乙烯、聚乙烯、聚烯烃、聚乙烯醇、聚丙烯等。此外，还可使用通过在氟化钙(CaF₂)、钇铝石榴石(YAG)、锗(Ge)、硒化锌(ZnSe)、无水人造水晶和氟化物模制材料上进行非反射涂覆(介质多层膜)而得到的膜。在该实施例中使用环烯聚合物。For the film 65, various plastics or resins such as polyamide, polyester, polyimide, fluorine-based, vinyl chloride, polyethylene, polyolefin, polyvinyl alcohol, polypropylene, etc. can be used. In addition, non-reflective coatings on calcium fluoride (CaF₂ ), yttrium aluminum garnet (YAG), germanium (Ge), zinc selenide (ZnSe), anhydrous artificial crystal, and fluoride molding materials can also be used. The film obtained by coating (dielectric multilayer film). In this example a cycloolefin polymer was used.

更优选地，膜65具有对于激光束的波长较低的吸收系数。由于不仅基材的吸收系数而且其厚度以及添加剂的吸收系数对该吸收系数起作用，优选地调整厚度和添加剂，以适当地调整该吸收系数。此外，类似于第一实施例，优选地给予膜65以除臭功能和抗菌特性。More preferably, the film 65 has a lower absorption coefficient for the wavelength of the laser beam. Since not only the absorption coefficient of the substrate but also its thickness and the absorption coefficients of the additives contribute to the absorption coefficient, it is preferable to adjust the thickness and the additives to properly adjust the absorption coefficient. Furthermore, similarly to the first embodiment, it is preferable to impart a deodorizing function and antibacterial properties to the film 65 .

相应地，通常购买25到50枚生物传感器作为一个单位的使用者可使用仅其中之一作为滑片。因此，防止了由于暴露生物传感器与空气较长时间而导致的样本试剂的分析性能的下降，且不需要每次进行滑片的替换。因此，可提高使用者的方便性。Accordingly, a user who typically purchases 25 to 50 biosensors as a unit can use only one of them as a slide. Therefore, the degradation of the analytical performance of the sample reagent due to exposure of the biosensor to the air for a long time is prevented, and replacement of the slide does not need to be performed every time. Therefore, user's convenience can be improved.

第四实施例Fourth embodiment

在下文中，图9和11示出了本发明第四实施例中的生物传感器。图9示出通过改变图6的第一实施例中生物传感器得到的生物传感器。图9(a)是平面图，图9(b)是当沿纵向在中心部分剖切时的横断面图，图9(c)是当沿横向在中心部分剖切时的横断面图。此外，图11显示了通过改变图10的第三实施例中生物传感器获得的生物传感器。图11(a)是平面图，图11(b)是当沿纵向在中心部分剖切时的横断面图，图11(c)是当沿横向在中心部分剖切时的横断面图。在下文中，仅描述不同于前述实施例的点。Hereinafter, FIGS. 9 and 11 show a biosensor in a fourth embodiment of the present invention. FIG. 9 shows a biosensor obtained by modifying the biosensor in the first embodiment of FIG. 6 . 9( a ) is a plan view, FIG. 9( b ) is a cross-sectional view when cut at the central portion in the longitudinal direction, and FIG. 9( c ) is a cross-sectional view when cut at the central portion in the transverse direction. Furthermore, FIG. 11 shows a biosensor obtained by changing the biosensor in the third embodiment of FIG. 10 . 11( a ) is a plan view, FIG. 11( b ) is a cross-sectional view when the central portion is cut in the longitudinal direction, and FIG. 11( c ) is a cross-sectional view when the central portion is cut in the transverse direction. Hereinafter, only points different from the foregoing embodiments are described.

在图9和11的生物传感器中，除了膜54设置在开口59、60和61的一侧，膜63还设置在这些开口的另一侧。对于膜63，可使用各种塑料或树脂，例如聚酰胺、聚酯、聚酰亚胺、氟系、氯乙烯、聚乙烯、聚烯烃、聚乙烯醇、聚丙烯等。此外，还可使用通过在氟化钙(CaF₂)、钇铝石榴石(YAG)、锗(Ge)、硒化锌(ZnSe)、无水人造水晶和氟化物模制材料上进行非反射涂覆(介质多层膜)而得到的膜。在该实施例中使用环烯聚合物。更优选地，膜63具有对于激光束的波长较低的吸收系数。由于不仅基材的吸收系数而且其厚度以及添加剂的吸收系数对该吸收系数起作用，优选地调整厚度和添加剂，以适当地调整该吸收系数。此外，类似于第一实施例，优选地给予膜63以除臭功能和抗菌特性。In the biosensors of FIGS. 9 and 11, in addition to themembrane 54 being arranged on one side of theopenings 59, 60 and 61, themembrane 63 is also arranged on the other side of these openings. For thefilm 63, various plastics or resins such as polyamide, polyester, polyimide, fluorine-based, vinyl chloride, polyethylene, polyolefin, polyvinyl alcohol, polypropylene, etc. can be used. In addition, non-reflective coatings on calcium fluoride (CaF₂ ), yttrium aluminum garnet (YAG), germanium (Ge), zinc selenide (ZnSe), anhydrous artificial crystal, and fluoride molding materials can also be used. The film obtained by coating (dielectric multilayer film). In this example a cycloolefin polymer was used. More preferably, thefilm 63 has a lower absorption coefficient for the wavelength of the laser beam. Since not only the absorption coefficient of the substrate but also its thickness and the absorption coefficients of the additives contribute to the absorption coefficient, it is preferable to adjust the thickness and the additives to properly adjust the absorption coefficient. Furthermore, similarly to the first embodiment, it is preferable to impart a deodorizing function and antibacterial properties to thefilm 63 .

在第一实施例中，在激光穿刺过程中产生的包含异味成分的烟流，经由在激光穿刺过程中形成在人体侧的膜54中的通孔，流进由生物传感器8的开口59、60和61、插入保持器7的内部、以及滑片6形成的空间。通过这些除臭功能，防止使用者闻到烟流的异味。In the first embodiment, the smoke containing odorous components generated during the laser perforation flows into theopenings 59, 60 of thebiosensor 8 through the through holes formed in thefilm 54 on the human body side during the laser perforation. and 61 are inserted into the inside of theretainer 7 and the space formed by the slidingpiece 6 . These deodorizing functions prevent the user from smelling the smoke.

在该实施例中，在激光穿刺过程中产生的包含异味成分的烟流，经由在激光穿刺过程中形成在生物传感器8的膜54中的通孔，流进由生物传感器8的开口59、60和61，以及在激光穿刺过程中在其中不形成通孔的膜63形成的空间。异味成分被膜54和膜63的除臭成分消除，由此防止使用者闻到烟流的异味，因此方便性得以提高。In this embodiment, the smoke containing odorous components generated during the laser perforation flows into theopenings 59, 60 of thebiosensor 8 through the through holes formed in themembrane 54 of thebiosensor 8 during the laser perforation. and 61, and a space formed by thefilm 63 in which no through hole is formed during laser perforation. The odor components are removed by the deodorizing components of thefilm 54 and thefilm 63, thereby preventing the user from smelling the smoke, and thus the convenience is improved.

另外，对于经由皮肤采样的样本标本，可使用例如血液或组织间隙液，且对于分析物，可使用血液葡萄糖水平(葡萄糖浓度)、或各种血清或生化项目。In addition, for sample specimens sampled through the skin, for example, blood or interstitial fluid can be used, and for analytes, blood glucose level (glucose concentration), or various serum or biochemical items can be used.

第五实施例fifth embodiment

在下文中，将详细描述本发明的第五实施例。图13是插入保持器207的详细透视图。在图13中，参考标记213表示圆柱体，参考标记214表示圆柱体213的一端的切口、参考标记215表示圆柱体213的一端的第一突起，参考标记216表示圆柱体213的一端的第二突起，参考标记217表示圆柱体213的一端的第三突起，参考标记218表示在圆柱体213的外壁上朝向第一突起215延伸的第一电极。此外，尽管未示出，在圆柱体213的外壁上设置有朝向第二突起216延伸的第二电极。Hereinafter, a fifth embodiment of the present invention will be described in detail. FIG. 13 is a detailed perspective view of theinsertion holder 207 . In Fig. 13,reference numeral 213 represents a cylinder,reference numeral 214 represents a notch at one end of thecylinder 213,reference numeral 215 represents a first protrusion at one end of thecylinder 213, andreference numeral 216 represents a second protrusion at one end of thecylinder 213. protrusions,reference numeral 217 denotes a third protrusion at one end of thecylinder 213 , andreference numeral 218 denotes a first electrode extending toward thefirst protrusion 215 on the outer wall of thecylinder 213 . In addition, although not shown, a second electrode extending toward thesecond protrusion 216 is provided on the outer wall of thecylinder 213 .

对于圆柱体213，可使用各种塑料，它们是聚乙烯、聚氯乙烯、聚丙烯、聚苯乙烯、多乙酸乙烯酯、ABS树脂、AS树脂、丙烯酸树脂、聚缩醛、聚酰亚胺树脂、聚碳酸酯、改性聚亚苯醚(PPE)、聚丁烯对苯二酸酯(PPB)、多芳基化合物、聚砜、聚亚苯硫化物、聚醚醚酮、氟树脂等。在该实施例中使用AS树脂。在塑料表面上具有低电动电位的材料是优选的。第一电极218和第二电极可由具有导电性的材料制成。在该实施例中使用铜。优选地，可使用金属性材料，例如铜和铝，以及其中金属性材料经过金属电镀和防锈处理的材料。For thecylinder 213, various plastics can be used, which are polyethylene, polyvinyl chloride, polypropylene, polystyrene, polyvinyl acetate, ABS resin, AS resin, acrylic resin, polyacetal, polyimide resin , polycarbonate, modified polyphenylene ether (PPE), polybutylene terephthalate (PPB), polyarylate, polysulfone, polyphenylene sulfide, polyether ether ketone, fluororesin, etc. AS resin was used in this example. Materials with low zeta potential on plastic surfaces are preferred. Thefirst electrode 218 and the second electrode may be made of a material having conductivity. Copper is used in this example. Preferably, metallic materials such as copper and aluminum, and materials in which metallic materials are subjected to metal plating and antirust treatment may be used.

插入保持器207的外直径在这样的范围内，即生物传感器8可被插入，且优选为3到25mm。此外，圆柱体213的壁厚为0.2至3mm，且其长度为5至30mm。在该实施例中，插入保持器形成为圆柱形。然而，也可使用多面管体或类似的。The outer diameter of theinsertion holder 207 is within a range in which thebiosensor 8 can be inserted, and is preferably 3 to 25 mm. In addition, the wall thickness of thecylinder 213 is 0.2 to 3 mm, and its length is 5 to 30 mm. In this embodiment, the insertion holder is formed in a cylindrical shape. However, it is also possible to use polyhedral tubes or the like.

(生物传感器)(biological sensor)

图14是根据该实施例的生物传感器8的详细视图。图14(a)是平面图，图14(b)是当沿纵向在中心部分剖切时的横断面图，图14(c)是当沿横向在中心部分剖切时的横断面图。Fig. 14 is a detailed view ofbiosensor 8 according to this embodiment. 14( a ) is a plan view, FIG. 14( b ) is a cross-sectional view when cut at the central portion in the longitudinal direction, and FIG. 14( c ) is a cross-sectional view when cut at the central portion in the transverse direction.

参考标记251表示由聚乙烯对苯二甲酸酯等制造的绝缘基板。在基板251的表面上，电极电偶253和测量电极252通过丝网印刷法或溅射气相沉积法由例如金和钯的贵金属，或例如碳的导电材料形成。Reference numeral 251 denotes an insulating substrate made of polyethylene terephthalate or the like. On the surface of thesubstrate 251, theelectrode couple 253 and themeasurement electrode 252 are formed of noble metals such as gold and palladium, or conductive materials such as carbon by a screen printing method or a sputtering vapor deposition method.

标记258表示绝缘盖板，参考标记259表示大致圆形的空气孔。盖板258的材料优选地为塑料膜，且包括聚酯、聚烯烃、聚酰胺、聚醚、聚酰胺酰亚胺、聚苯乙烯、聚碳酸酯、聚乙烯-ρ-苯基硫、聚氯乙烯等。在该实施例中使用聚碳酸酯。此外，共聚物、混合材料以及它们的桥接材料可用于盖板258，且可使用厚度0.01mm至0.5mm的盖板。Reference numeral 258 denotes an insulating cover plate, andreference numeral 259 denotes a substantially circular air hole. The material of thecover plate 258 is preferably a plastic film and includes polyester, polyolefin, polyamide, polyether, polyamideimide, polystyrene, polycarbonate, polyethylene-p-phenylsulfide, polychloride vinyl etc. Polycarbonate is used in this example. In addition, copolymers, hybrid materials, and their bridging materials can be used for thecover plate 258, and a cover plate with a thickness of 0.01 mm to 0.5 mm can be used.

而且，隔板256具有切口部分以形成供应样本试剂的样本试剂供应通道257，试剂层255浸渍有试剂，该隔板256和试剂层255夹在盖板258和基板251之间，且该盖板与基板251整合设置。Also, thepartition 256 has a cutout portion to form a samplereagent supply channel 257 for supplying the sample reagent, thereagent layer 255 is impregnated with the reagent, thepartition 256 and thereagent layer 255 are sandwiched between thecover plate 258 and thebase plate 251, and the cover plate It is integrated with thesubstrate 251 .

隔板256设置为覆盖基板251上的电极电偶253和测量电极252；样本供应通道257通过设置在隔板256的前边缘的中间的长方形切口部分来形成；且试剂层255通过在隔板256切口部分露出的电极电偶253和测量电极252上涂覆包含酶、电子受体、氨基酸、糖醇、水溶聚合物等的试剂而形成。Theseparator 256 is arranged to cover the electrodegalvanic couple 253 and the measuringelectrode 252 on thesubstrate 251; thesample supply channel 257 is formed by a rectangular cutout portion provided in the middle of the front edge of theseparator 256; and thereagent layer 255 passes through theseparator 256 The electrodegalvanic couple 253 exposed by the cutout and the measuringelectrode 252 are coated with reagents including enzymes, electron acceptors, amino acids, sugar alcohols, water-soluble polymers and the like.

而且，基板开口260、隔板开口261和盖板开口262为分别穿透基板251、隔板256和盖板258的开口。而且，膜254粘附到基板251与隔板256相对的表面，以覆盖基板开口260。生物传感器的总厚度为0.1至1mm，其短边的长度为5至30mm，其长轴的长度为30至60mm。Also, thesubstrate opening 260 , thepartition opening 261 and thecover opening 262 are openings penetrating through thesubstrate 251 , thepartition 256 and thecover 258 , respectively. Also, afilm 254 is adhered to the surface of thesubstrate 251 opposite to thespacer 256 to cover thesubstrate opening 260 . The total thickness of the biosensor is 0.1 to 1 mm, the length of its short side is 5 to 30 mm, and the length of its long axis is 30 to 60 mm.

此外，设置有第二开口263和第三开口264，且测量电极252和电极电偶253暴露于开口264中的部分。第二开口263和第三开口264设置为分别穿过基板251、隔板256和盖板258，且这些开口的部分或全部设置为彼此对齐。In addition, asecond opening 263 and athird opening 264 are provided, and the portion of themeasurement electrode 252 and theelectrode couple 253 exposed in theopening 264 is provided. Thesecond opening 263 and thethird opening 264 are disposed through thebase plate 251 , thespacer 256 and thecover plate 258 , respectively, and some or all of these openings are disposed in alignment with each other.

接着，将对操作进行详细描述。Next, the operation will be described in detail.

(准备)(Prepare)

首先，使用者把滑片6插入到主体2内，接着，类似地，插入保持器207通过嵌合插入体2内。插入保持器207设置有切口214，且该切口214设置使得使用者不会弄错插入方向。尽管在此使用了切口，不过也可使用造成插入保持器207不对称的其它形状，如突起或多个切口或突起。First, the user inserts theslider 6 into themain body 2, and then, similarly, theinsertion holder 207 is inserted into thebody 2 by fitting. Theinsertion holder 207 is provided with acutout 214, and thecutout 214 is provided so that the user does not mistake the insertion direction. Although a cutout is used here, other shapes that cause theinsertion retainer 207 to be asymmetrical may be used, such as a protrusion or multiple cutouts or protrusions.

接着，使用者通过嵌合把生物传感器8插入到插入保持器207内。生物传感器8的第二开口263和第三开口264设置成使得它们可嵌合在插入保持器207的第一突起215、第二突起216和第三突起217上。由于第二开口263是不对称地设置在生物传感器8内，使用者可插入该生物传感器而不会弄错插入方向。参考图14，设置有一个第二开口263。然而，本发明不仅限于此，满足上述目的的各种设置可被使用。第三开口264和第二开口263的截面形状还可以是各种形状，例如除了双圆的部分切块，还有圆形、长方形、正方形、多边形和椭圆形。在改变生物传感器8的第二开口263和第三开口264的形状和结构的情况中，无需说，插入保持器207的包括第一突起215、第二突起216和第三突起217的突起的形状、结构和数量也相应地改变。Next, the user inserts thebiosensor 8 into theinsertion holder 207 by fitting. Thesecond opening 263 and thethird opening 264 of thebiosensor 8 are provided so that they can be fitted on thefirst protrusion 215 , thesecond protrusion 216 and thethird protrusion 217 of theinsertion holder 207 . Since thesecond opening 263 is asymmetrically disposed in thebiosensor 8, the user can insert the biosensor without mistakenly inserting the direction. Referring to FIG. 14, asecond opening 263 is provided. However, the present invention is not limited thereto, and various arrangements satisfying the above-mentioned objects may be used. The cross-sectional shapes of thethird opening 264 and thesecond opening 263 can also be various shapes, for example, in addition to partial cuts of double circles, there are also circles, rectangles, squares, polygons and ellipses. In the case of changing the shape and structure of thesecond opening 263 and thethird opening 264 of thebiosensor 8, needless to say, the shape of the protrusions including thefirst protrusion 215, thesecond protrusion 216, and thethird protrusion 217 of theinsertion holder 207 , structure and quantity are changed accordingly.

当生物传感器通过嵌合插入到插入保持器207内时，生物传感器8的第三开口262中的电极电偶253和测量电极252与插入保持器207的圆柱体213的外周的第二电极(未示出)和第一电极218分别电连接。而且，尽管在图1至3中未示出，用于第一电极218和第二电极的端子设置在主体2侧的侧部上，使得插入保持器207的通过嵌合插入到主体2的第一电极218和第二电极与主体2中的电路11电连接。如果生物传感器8和主体2置于相互电连接的状态，成分浓度测量装置1将处于来自电路11的激光穿刺和成分浓度测量的预备状态，且该装置已达到此状态的事实显示在显示器3上，由此使用户能认识到该事实。When the biosensor is inserted into theinsertion holder 207 by fitting, the electrodegalvanic couple 253 and themeasurement electrode 252 in thethird opening 262 of thebiosensor 8 are connected to the second electrode (not shown) on the outer periphery of thecylinder 213 of theinsertion holder 207. shown) and thefirst electrode 218 are respectively electrically connected. Moreover, although not shown in FIGS. 1 to 3 , terminals for thefirst electrode 218 and the second electrode are provided on the side portion of themain body 2 side so that the second electrode of theinsertion holder 207 is inserted into themain body 2 by fitting. Thefirst electrode 218 and the second electrode are electrically connected to thecircuit 11 in themain body 2 . If thebiosensor 8 and themain body 2 are placed in a state of being electrically connected to each other, the componentconcentration measuring device 1 will be in a ready state for laser perforation and component concentration measurement from thecircuit 11, and the fact that the device has reached this state is displayed on thedisplay 3 , thereby making the user aware of this fact.

随后，使用者把皮肤贴到生物传感器8的膜54上，使得预定的激光穿刺点可以到达基板开口260。此时，插入保持器207的突起，即，第一突起215、第二突起216和第三突起217，从生物传感器8凸出约1至3mm，且该突起挤压皮肤。这将刺激预定的激光穿刺点的周围。为此，这可减轻使用者在激光穿刺期间感觉到的刺激。Subsequently, the user sticks the skin on themembrane 54 of thebiosensor 8 so that the predetermined laser puncture point can reach thesubstrate opening 260 . At this time, the protrusions of theinsertion holder 207 , that is, thefirst protrusion 215 , thesecond protrusion 216 and thethird protrusion 217 protrude from thebiosensor 8 by about 1 to 3 mm, and the protrusions press the skin. This will stimulate around the intended laser puncture point. For this reason, this reduces the irritation felt by the user during laser perforation.

(激光穿刺)(Laser piercing)

在使用者把皮肤贴到生物传感器8后，由此完成激光穿刺的准备，使用者按下激光操作按钮5以进行激光穿刺。激光装置9利用激光操作按钮5来自电路11的信号和电池10的电能振荡激光束。振荡的激光束被聚光透镜12聚焦，且穿刺使用者的皮肤。After the user attaches the skin to thebiosensor 8, thus completing the preparation for laser puncture, the user presses thelaser operation button 5 to perform laser puncture. Thelaser device 9 oscillates the laser beam using the signal from thecircuit 11 of thelaser operation button 5 and the electric energy of thebattery 10 . The oscillating laser beam is focused by thecondenser lens 12, and punctures the user's skin.

对于激光束的波长，具有高的皮肤吸收系数的波长是优选的，且3μm波段(光激励激光或掺铒介质的中红外半导体激光)，或9至10μm波段(放电激励激光或二氧化碳气体介质的中红外半导体激光)是可以使用的。此外，皮肤上的激光束的聚光直径优选地为φ0.5mm以下，且更优选地为φ0.15mm以下。尽管该聚光形状优选地为圆形，还可使用其长轴设定为0.5mm以下的椭圆形。激光束优选地以脉冲的方式振荡，且脉冲的波形的时间宽度优选地为1μs以上和400μs以下。激光束的照射可以是单脉冲束的照射或多脉冲束的照射。For the wavelength of the laser beam, the wavelength with high skin absorption coefficient is preferred, and the 3 μm band (light-excited laser or mid-infrared semiconductor laser of erbium-doped medium), or the 9 to 10 μm band (discharge-excited laser or carbon dioxide gas medium) mid-infrared semiconductor laser) is available. In addition, the focusing diameter of the laser beam on the skin is preferably φ0.5 mm or less, and more preferably φ0.15 mm or less. Although the concentrating shape is preferably a circle, an ellipse whose major axis is set to 0.5 mm or less may also be used. The laser beam is preferably oscillated in a pulsed manner, and the time width of the waveform of the pulse is preferably 1 μs or more and 400 μs or less. The irradiation of the laser beam may be irradiation of a single pulse beam or irradiation of a multi-pulse beam.

对于聚光透镜12，通过在氟化钙(CaF₂)、钇铝石榴石(YAG)、锗(Ge)、硒化锌(ZnSe)、无水人造水晶和氟化物模制材料制成的基板上进行非反射涂覆(介质多层膜)而得到聚光透镜是可以使用的，且其焦距优选地为5至30mm。在该实施例中使用氟化钙基板。此外，聚光透镜12大致为圆形，且其外直径为6至30mm。For thecondenser lens 12, a substrate made of calcium fluoride (CaF₂ ), yttrium aluminum garnet (YAG), germanium (Ge), zinc selenide (ZnSe), anhydrous artificial crystal, and fluoride molding material is used. Concentrating lenses obtained by non-reflective coating (dielectric multilayer film) on them are available, and their focal lengths are preferably 5 to 30 mm. A calcium fluoride substrate was used in this example. In addition, the condensinglens 12 is substantially circular and has an outer diameter of 6 to 30 mm.

在激光穿刺后，使用者从生物传感器8移离皮肤且推挤穿刺点的周围，以挤出0.5至几微升血液作为试样标本。因此，通过使血液采样点接触生物传感器8的一侧的样本试剂供应通道56，空气孔259动作，由此血液通过毛细现象收集在生物传感器8中。对于采样的血液，试剂和采样的血液中的待测量物质在试剂层255中彼此反应。对于反应中产生的电荷，由电路11通过测量电极252、电极电偶253和插入保持器207的电极来分析电荷量。通过分析获得的血液中的待测量的物质的浓度显示在显示器3上，且被使用者识别。电路11还包括未示出的存储单元，且分析结果连同测量数据和时间或使用者代码被记录。使用显示开关按钮4，使用者后来可再次识别过去的测量结果。After laser puncture, the user moves away from thebiosensor 8 from the skin and pushes around the puncture point to squeeze out 0.5 to several microliters of blood as a sample specimen. Therefore, by bringing the blood sampling point into contact with the samplereagent supply channel 56 on one side of thebiosensor 8, theair hole 259 operates, whereby blood is collected in thebiosensor 8 by capillary phenomenon. For the sampled blood, the reagent and the substance to be measured in the sampled blood react with each other in thereagent layer 255 . As for the charge generated in the reaction, the amount of charge is analyzed by thecircuit 11 through the measuringelectrode 252 , theelectrode couple 253 , and the electrode inserted into theholder 207 . The concentration of the substance to be measured in the blood obtained by the analysis is displayed on thedisplay 3 and recognized by the user. Thecircuit 11 also includes a memory unit, not shown, and the results of the analysis are recorded together with the measurement data and the time or user code. Using thedisplay switch button 4, the user can later identify past measurement results again.

根据本发明的该实施例的成分浓度测量装置，主体设置有激光装置、聚光透镜、能分析成分的电路、能显示分析结果的显示器、和可充电电池，且滑片和插入保持器插入到沿激光束的光轴的主体内，且生物传感器嵌合在插入保持器内。因此，由于使用者没有闻到激光穿刺过程中产生的烟流中的异味，且接触使用者的采样点的试纸每次采样时替换，因此不担心传染，且由于使用者可在一个机构中进行采样和分析，可实现简单而容易的使用。According to the component concentration measuring device of this embodiment of the present invention, the main body is provided with a laser device, a condensing lens, a circuit capable of analyzing components, a display capable of displaying analysis results, and a rechargeable battery, and the slide and the insertion holder are inserted into In the main body along the optical axis of the laser beam, and the biosensor is fitted in the insertion holder. Therefore, since the user does not smell the peculiar smell in the smoke generated during laser puncture, and the test paper at the sampling point that touches the user is replaced every time sampling, there is no fear of infection, and since the user can carry out the test in one institution Sampling and analysis for simple and easy use.

此外，激光束光轴上的要被激光束穿透的膜设置在生物传感器中。因此，在激光穿刺过程中产生的烟流从使用者的皮肤穿过穿刺孔排出，且在激光穿刺过程中产生的烟流通过该穿刺从使用者的皮肤排出。因此，烟流没有泄漏到使用者，因此使用者可被防止闻到在激光穿刺过程中产生的烟流中的异味。Furthermore, a membrane to be penetrated by the laser beam on the optical axis of the laser beam is provided in the biosensor. Therefore, the smoke generated during the laser perforation is discharged from the user's skin through the puncture hole, and the smoke generated during the laser perforation is discharged from the user's skin through the puncture. Therefore, the plume does not leak to the user, so the user can be prevented from smelling the peculiar smell in the plume generated during laser perforation.

而且，通过在插入到主体内的插入保持器的侧部上设置不对称结构，使用者不会弄错插入方向，且因此可实现简单而容易的使用。Also, by providing an asymmetrical structure on the side of the insertion holder inserted into the main body, the user does not mistake the insertion direction, and thus simple and easy use can be achieved.

而且，通过设置一结构，其中生物传感器和插入保持器之间的嵌合是通过生物传感器的开口和插入保持器的突起之间的嵌合实现的，使用者不会弄错配合方向，且因此可实现简单而容易的使用。Also, by providing a structure in which the fitting between the biosensor and the insertion holder is achieved by fitting between the opening of the biosensor and the protrusion of the insertion holder, the user does not mistake the fitting direction, and therefore Simple and easy use is possible.

而且，通过设置一结构，其中生物传感器和插入保持器之间的嵌合是通过生物传感器的开口和插入保持器的突起之间的嵌合实现的，使用者不会弄错配合方向，且几乎不会发生滑出。因此可实现简单而容易的使用。Moreover, by providing a structure in which the fitting between the biosensor and the insertion holder is achieved by fitting between the opening of the biosensor and the protrusion of the insertion holder, the user does not mistake the fitting direction, and almost No slip-out will occur. Simple and easy use can thus be achieved.

而且，通过设置一结构，其中生物传感器的测量电极和电极电偶通过生物传感器和插入保持器之间的嵌合而与设置在插入保持器的表面上的各个电极电连接。由此，在通过激光穿刺采样的体液的成分分析过程中，使用者可进行成分分析，而不用去除试纸和重新安装其以供再次成分分析，且由此可实现简单而容易的使用。Also, by providing a structure in which the measurement electrode and the electrode couple of the biosensor are electrically connected to the respective electrodes provided on the surface of the insertion holder by fitting between the biosensor and the insertion holder. Thus, during component analysis of body fluid sampled by laser perforation, the user can perform component analysis without removing and reinstalling the test paper for component analysis again, and thus simple and easy use can be achieved.

而且，除臭功能设置在激光束的光轴上的滑片的膜上、至少在类似地在激光束的光轴上的插入保持器的内表面上、和类似地在激光束的光轴上的生物传感器的膜上。因此，可消除激光穿刺过程中产生的烟流中的异味。Also, the deodorizing function is provided on the film of the slide on the optical axis of the laser beam, at least on the inner surface of the insertion holder similarly on the optical axis of the laser beam, and similarly on the optical axis of the laser beam on the membrane of the biosensor. Therefore, it is possible to eliminate odors in the plume generated during laser perforation.

而且，通过在生物传感器、插入保持器和滑片上设置抗菌功能，可防止使用者在使用时被感染。Also, by providing an antibacterial function on the biosensor, the insertion holder, and the slide, it is possible to prevent the user from being infected while using it.

另外，对于样本标本，可使用这些经由皮肤的采样的例如血液和组织间隙液，且对于分析物，可使用血液葡萄糖水平(葡萄糖浓度)，或各种血清或生化项目。In addition, for sample specimens, such percutaneous sampling such as blood and interstitial fluid can be used, and for analytes, blood glucose level (glucose concentration), or various serum or biochemical items can be used.

此外，在血液葡萄糖水平(葡萄糖浓度)用作分析物的情况中，作为能够用作试剂的例子，酶在一些情况中辅酶、和介质(mediator)的组合包括：葡萄糖氧化酶+氰铁酸钾或ferricynium；和葡萄糖氧化酶+pyrroloquinolinequinine或nicotinamide adenine+phenanthroline quinine、osmium comple、或potassium ferricyanide。Furthermore, in the case where blood glucose level (glucose concentration) is used as an analyte, as an example that can be used as a reagent, a combination of an enzyme in some cases a coenzyme, and a mediator includes: glucose oxidase + potassium ferricyanide or ferricynium; and glucose oxidase + pyrroloquinolinequinine or nicotinamide adenine + phenanthroline quinine, osmium comple, or potassium ferricyanide.

第六实施例Sixth embodiment

本发明的第六实施例的激光穿刺用生物传感器显示在图15至17中。图15是生物传感器的分解透视图，图16是生物传感器的总的视图，图17是当图16的传感器沿纵向在中心部分剖切时的横断面图。A biosensor for laser perforation of a sixth embodiment of the present invention is shown in FIGS. 15 to 17 . 15 is an exploded perspective view of the biosensor, FIG. 16 is a general view of the biosensor, and FIG. 17 is a cross-sectional view when the sensor of FIG. 16 is cut at a central portion in a longitudinal direction.

基板301是由包括聚乙烯对苯二甲酸酯等的绝缘材料制造。在基板301的表面上，由例如金或钯的贵金属或例如碳的导电材料制造的电极电偶303和测量电极302通过丝网印刷或溅射气相沉积法形成。Thesubstrate 301 is made of an insulating material including polyethylene terephthalate or the like. On the surface of thesubstrate 301, anelectrode couple 303 made of a noble metal such as gold or palladium or a conductive material such as carbon and ameasurement electrode 302 are formed by screen printing or sputtering vapor deposition.

盖板308是由绝缘材料制造，空气孔309是大致圆形。盖板308的材料优选地为塑料膜，且包括聚酯、聚烯烃、聚酰胺、聚醚、聚酰胺酰亚胺、聚苯乙烯、聚碳酸酯、聚乙烯-ρ-苯基硫、聚氯乙烯等。Thecover plate 308 is made of insulating material, and theair hole 309 is substantially circular. The material of thecover plate 308 is preferably a plastic film and includes polyester, polyolefin, polyamide, polyether, polyamideimide, polystyrene, polycarbonate, polyethylene-p-phenylsulfide, polychloride vinyl etc.

在该实施例中使用聚碳酸酯。Polycarbonate is used in this example.

此外，共聚物、混合材料以及桥接材料可用于盖板308，且可使用厚度0.01mm至0.5mm的盖板。In addition, copolymers, hybrid materials, and bridging materials can be used for thecover plate 308, and a cover plate with a thickness of 0.01 mm to 0.5 mm can be used.

而且，具有切口以形成供应样本试剂的样本试剂供应通道307的隔板306，以及浸渍有试剂的试剂层305，夹在盖板308和基板301之间，且该盖板与基板301整合设置。Also, apartition 306 having cutouts to form samplereagent supply channels 307 for supplying sample reagents, and areagent layer 305 impregnated with reagents are sandwiched between acover plate 308 and abase plate 301 , and the cover plate is integrally provided with thebase plate 301 .

隔板306设置为覆盖基板301上的电极电偶303和测量电极302，样本供应通道307通过设置在隔板306的前边缘的中间的长方形切口部分来形成，且试剂层305通过在隔板306切口部分露出的电极电偶303和测量电极302上涂覆包含酶、电子受体、氨基酸、糖醇、水溶聚合物等的试剂而形成。Theseparator 306 is arranged to cover the electrodegalvanic couple 303 and the measuringelectrode 302 on thesubstrate 301, thesample supply channel 307 is formed by a rectangular cutout portion provided in the middle of the front edge of theseparator 306, and thereagent layer 305 passes through theseparator 306. The electrodegalvanic couple 303 exposed by the cutout and the measuringelectrode 302 are coated with reagents including enzymes, electron acceptors, amino acids, sugar alcohols, water-soluble polymers and the like.

而且，基板开口310、隔板开口311和盖板开口312是分别穿透基板301、隔板306和盖板308的开口。而且，膜304粘附到基板301与隔板306相对的表面上，以覆盖基板开口310。此外，膜325粘附到盖板308的与隔板306相对的表面上，以覆盖盖板开口312。生物传感器的总厚度为0.1至1mm，其短边的长度为5至30mm，其长轴的长度为30至60mm。Also, thesubstrate opening 310 , thespacer opening 311 and thecover opening 312 are openings penetrating through thesubstrate 301 , thespacer 306 and thecover 308 , respectively. Also, afilm 304 is adhered to the surface of thesubstrate 301 opposite to thespacer 306 to cover thesubstrate opening 310 . In addition, afilm 325 is adhered to the surface of thecover plate 308 opposite to thepartition 306 to cover thecover plate opening 312 . The total thickness of the biosensor is 0.1 to 1 mm, the length of its short side is 5 to 30 mm, and the length of its long axis is 30 to 60 mm.

接着，将对操作进行详细描述。Next, the operation will be described in detail.

图22是解释如何使用的视图。在图22中，参考标记319表示主体，参考标记321表示主体319上的显示装置，参考标记322表示主体319上的操作装置，且参考标记320表示激光穿刺用生物传感器(下文有时称为传感器)。在主体319内部，设置有未示出的激光振荡器、类似地未示出的聚集来自激光振荡器的激光束的聚光装置、类似地未示出的用于操作和控制激光振荡器的电路板。Fig. 22 is a view explaining how to use it. In FIG. 22 ,reference numeral 319 denotes a main body,reference numeral 321 denotes a display device on themain body 319,reference numeral 322 denotes an operating device on themain body 319, andreference numeral 320 denotes a biosensor for laser perforation (hereinafter sometimes referred to as a sensor) . Inside themain body 319, an unshown laser oscillator, a similarly unshown light-condensing device that condenses a laser beam from the laser oscillator, and a similarly unshown circuit for operating and controlling the laser oscillator are provided. plate.

对于激光束的波长，具有高的皮肤吸收系数的波长是优选的，且3μm波段或9至10μm波段是可以使用的。此外，皮肤上的激光束的聚光直径优选地为φ0.5mm以下，且更优选地为φ0.15mm以下。尽管该聚光形状优选地为圆形，还可使用其长轴设定为0.5mm以下的椭圆形。激光束优选地以脉冲的方式振荡，且脉冲的波形的时间宽度优选地为1μs以上和400μs以下。激光束的照射可以是单脉冲束的照射或多脉冲束的照射。As for the wavelength of the laser beam, a wavelength having a high skin absorption coefficient is preferable, and a 3 μm band or a 9 to 10 μm band is usable. In addition, the focusing diameter of the laser beam on the skin is preferably φ0.5 mm or less, and more preferably φ0.15 mm or less. Although the concentrating shape is preferably a circle, an ellipse whose major axis is set to 0.5 mm or less may also be used. The laser beam is preferably oscillated in a pulsed manner, and the time width of the waveform of the pulse is preferably 1 μs or more and 400 μs or less. The irradiation of the laser beam may be irradiation of a single pulse beam or irradiation of a multi-pulse beam.

而且，尽管未示出，主体319保持激光穿刺用生物传感器。在主体内设置有：施加恒定电压到激光穿刺用生物传感器的转换电路，其此时将与样本标本中分析物的浓度相对应的电流转换为电压；A-D转换器，将所转换的电压转换为数字数值；存储器，其记录测量的数值；以及电路板，用于操作和控制这些元件。此外，尽管未示出，设置有给上述元件供电的电源。Also, although not shown, themain body 319 holds a biosensor for laser perforation. The main body is provided with: a conversion circuit that applies a constant voltage to the biosensor for laser puncture, which converts the current corresponding to the concentration of the analyte in the sample specimen into a voltage; an A-D converter converts the converted voltage into digital values; memory, which records measured values; and circuit boards, which operate and control these components. In addition, although not shown, a power supply for supplying power to the above-mentioned elements is provided.

测量数值、存储在存储器内的数值、装置的状态、日期和时间等显示在显示装置321上。操作装置322是例如按钮，且进行激光束的振荡操作、测量的启动操作、显示显示装置321的开关操作等。Measured values, values stored in memory, status of the device, date and time, etc. are displayed on thedisplay device 321 . Theoperation device 322 is, for example, a button, and performs an oscillation operation of a laser beam, an operation to start measurement, an operation to switch thedisplay device 321 on and off, and the like.

使用者设置传感器320，使得传感器可接触主体319的整个表面。使用者把他/她的手指放在传感器320上，因此预定的穿刺点可到达传感器320的膜304的几乎中心。通过操作操作装置322以从激光振荡器振荡激光，在手指的皮肤上进行用于血液采样的穿刺。在穿刺后，使用者首先把他/她的手指从传感器320分离，且挤压穿刺点的附近，以挤出作为样本标本的0.5至几微升血液。随后，通过使血液采样点接触传感器320的一侧的样本试剂供应通道307，血液被收集在传感器320中。分析结果显示在显示装置321上，且被使用者识别。The user positions thesensor 320 such that the sensor can contact the entire surface of thebody 319 . The user places his/her finger on thesensor 320 so that the predetermined puncture point reaches almost the center of themembrane 304 of thesensor 320 . By operating theoperating device 322 to oscillate laser light from a laser oscillator, puncture for blood sampling is performed on the skin of the finger. After puncturing, the user first separates his/her finger from thesensor 320, and squeezes the vicinity of the puncturing point to squeeze out 0.5 to several microliters of blood as a sample specimen. Then, blood is collected in thesensor 320 by bringing the blood sampling point into contact with the samplereagent supply channel 307 on one side of thesensor 320 . The analysis result is displayed on thedisplay device 321 and recognized by the user.

图18是显示使用时的传感器、手指和激光束之间的关系的视图。在图18中，进行激光穿刺的使用者的手指314，和被聚光装置聚焦的激光束313的地点被示出。使用者的手指314接触传感器320的膜304，且激光束313从主体传播同时其光束直径逐渐地收缩，如同图18。激光束313被设置，以传播穿过传感器320的盖板开口312、隔板开口311和基板开口310，且聚焦在使用者的手指314上。Fig. 18 is a view showing the relationship among the sensor, finger and laser beam in use. In FIG. 18, the user'sfinger 314 performing laser puncture, and the location of thelaser beam 313 focused by the light-collecting means are shown. The user'sfinger 314 touches thefilm 304 of thesensor 320, and thelaser beam 313 propagates from the body while its beam diameter gradually shrinks, as in FIG. 18 . Thelaser beam 313 is arranged to propagate through thecover opening 312 , thebulkhead opening 311 and the base plate opening 310 of thesensor 320 and to focus on the user'sfinger 314 .

开口310、311和312的开口直径可以是这样的直径，即激光束313基本上没有被遮蔽，且所有直径不必相同。此外，开口的最小直径为1mm。而且，参考图15至17，这些开口为圆形。然而，可以是例如矩形、正方形、多边形和椭圆形的各种形状。The opening diameters of theopenings 310, 311, and 312 may be such that thelaser beam 313 is substantially unshielded, and all diameters need not be the same. In addition, the minimum diameter of the opening is 1 mm. Also, referring to Figures 15 to 17, these openings are circular. However, various shapes such as rectangle, square, polygon and ellipse are possible.

激光束313被膜325部分地吸收，但是通孔没有形成在膜中，同时激光束聚焦在膜304上，以加热和蒸发该膜，由此形成通孔。随后，激光束被使用者的手指314的皮肤吸收，以加热和蒸发皮肤，由此最终破坏真皮的毛细管，以允许血液采样。Thelaser beam 313 is partially absorbed by thefilm 325, but a through hole is not formed in the film, while the laser beam is focused on thefilm 304 to heat and evaporate the film, thereby forming a through hole. The laser beam is then absorbed by the skin of the user'sfinger 314 to heat and vaporize the skin, thereby eventually breaking the capillaries of the dermis to allow blood sampling.

图19是详细显示激光穿刺过程中的状况的视图。在图19中，激光束在膜304中形成通孔315。类似地，激光穿刺的孔316形成在使用者的手指314的皮肤上。在激光穿刺过程中，当皮肤组织蒸发时，产生烟流317。Fig. 19 is a view showing in detail the conditions during laser perforation. In FIG. 19 , a laser beam forms viaholes 315 infilm 304 . Similarly, laser-puncturedholes 316 are formed in the skin of the user'sfingers 314 . During laser perforation, a plume ofsmoke 317 is generated when the skin tissue evaporates.

如同图19，皮肤组织蒸发时产生的烟流317，经由通过激光束照射膜304形成的通孔315，流向基板开口310、隔板开口311、盖板开口313，和膜325形成处的开口。由于膜304的通孔315类似于皮肤的激光穿刺的孔315且非常小，即使使用者从传感器举起他/她的手指314后，流回的烟流的量也非常小，因此使用者可避免闻到烟流317的异味。As shown in FIG. 19 , thesmoke 317 generated when the skin tissue is evaporated flows to thesubstrate opening 310 , thepartition opening 311 , thecover opening 313 , and the opening where thefilm 325 is formed through the throughhole 315 formed by irradiating thefilm 304 with the laser beam. Since the through-hole 315 of themembrane 304 is similar to the laser-puncturedhole 315 of the skin and is very small, even after the user lifts his/herfinger 314 from the sensor, the amount of backflow of smoke is very small, so the user can Avoid smelling theplume 317.

对于膜304的基材，可以使用尼龙、聚酯、聚酰亚胺、氟系、氯乙烯、聚苯乙烯、聚乙烯、聚烯烃、聚乙烯醇、聚丙烯等。在该实施例中使用聚乙烯。As the base material of thefilm 304, nylon, polyester, polyimide, fluorine-based, vinyl chloride, polystyrene, polyethylene, polyolefin, polyvinyl alcohol, polypropylene, or the like can be used. Polyethylene was used in this example.

更优选地膜304具有对激光束313的波长较高的吸收系数。由于不仅基材的吸收系数而且其厚度以及添加剂的吸收系数对该吸收系数起作用，优选地调整厚度和添加剂，以适当地调整该吸收系数。More preferably thefilm 304 has a higher absorption coefficient for the wavelength of thelaser beam 313 . Since not only the absorption coefficient of the substrate but also its thickness and the absorption coefficients of the additives contribute to the absorption coefficient, it is preferable to adjust the thickness and the additives to properly adjust the absorption coefficient.

对于膜325的基材，可以使用尼龙、聚酯、聚酰亚胺、氟系、氯乙烯、聚苯乙烯、聚乙烯、聚烯烃、聚乙烯醇、聚丙烯等。在该实施例中使用聚苯乙烯。As the base material of thefilm 325, nylon, polyester, polyimide, fluorine-based, vinyl chloride, polystyrene, polyethylene, polyolefin, polyvinyl alcohol, polypropylene, or the like can be used. Polystyrene was used in this example.

更优选地膜325具有对于激光束313的波长较低的吸收系数。由于不仅基材的吸收系数而且其厚度以及添加剂的吸收系数对该吸收系数起作用，优选地调整厚度和添加剂，以适当地调整该吸收系数。More preferably thefilm 325 has a lower absorption coefficient for the wavelength of thelaser beam 313 . Since not only the absorption coefficient of the substrate but also its thickness and the absorption coefficients of the additives contribute to the absorption coefficient, it is preferable to adjust the thickness and the additives to properly adjust the absorption coefficient.

膜304和膜325还具有对于烟流317的异味成分的除臭功能。由构成皮肤组织的蛋白质的成分氨基酸产生的挥发性物质被分解流到烟流317中。激光穿刺过程中的主要目标角质层由角蛋白质的纤维组织组成，且纤维是由胱氨酸键结合，该键是氨基酸胱氨酸的硫部分的键，其包含的相对较多。由于这些氨基酸在蒸发过程中分解，产生挥发性硫化合物或氮成分，特别地，人感觉到作为异味的硫化合物。Themembrane 304 and themembrane 325 also have a deodorizing function for odor components of thesmoke 317 . Volatile substances generated from amino acids which are components of protein constituting the skin tissue are decomposed and flow into thesmoke stream 317 . The main target stratum corneum during laser perforation is composed of fibrous tissue of keratin, and the fibers are bound by cystine bonds, which are bonds of the sulfur moiety of the amino acid cystine, which contain relatively many. As these amino acids are decomposed during evaporation, volatile sulfur compounds or nitrogen components are produced, and in particular, sulfur compounds are perceived by humans as off-flavors.

硫化氢或甲基硫醇作为主要的硫化合物被提及。硫化氢可通过化学吸附剂除臭，且可使用锰、铜和钴的复合氧合物。另外，类似地，通过使用包括锰、铜、锌和钴任意一种的氧化物、氢氧化物、复合氧合物、或其混合物，可获得对于硫化氢的有效的化学吸收作用的吸附剂。Hydrogen sulfide or methyl mercaptan are mentioned as main sulfur compounds. Hydrogen sulfide can be deodorized by a chemical adsorbent, and complex oxygen compounds of manganese, copper, and cobalt can be used. In addition, similarly, by using an oxide, a hydroxide, a composite oxygen compound, or a mixture thereof including any one of manganese, copper, zinc, and cobalt, an adsorbent effective in chemical absorption for hydrogen sulfide can be obtained.

化学吸附剂化学地吸收硫化氢，最终是以硫酸盐或简单的硫物质的形式。此外，化学吸附剂还具有媒介作用，其转换同样的硫基异味的甲基硫醇为具有较高阈值的二甲基二硫醚。由于该作用，人可感觉到相当于除臭的效果。化学吸附剂具有约0.1至1μm的尺寸，且该化学吸附剂的形状没有特别限制。Chemisorbents chemically absorb hydrogen sulfide, ultimately in the form of sulfate or simple sulfur species. In addition, the chemisorbent also acts as an intermediary, which converts the same sulfur-based off-flavor methyl mercaptan to dimethyl disulfide with a higher threshold. Due to this action, humans can perceive an effect corresponding to deodorization. The chemical adsorbent has a size of about 0.1 to 1 μm, and the shape of the chemical adsorbent is not particularly limited.

而且，由于二甲基二硫醚可通过使用装载的物理吸附剂的物理吸附剂作用而被去除，其大体上可去除硫化合物。具有较大部分硅的疏水沸石可被用作物理吸附剂。另外，即使使用沸石、海泡石、硅石、氧化铝等，也可得到相同的效果。Also, since dimethyl disulfide can be removed by physisorbent action using a loaded physisorbent, it can substantially remove sulfur compounds. Hydrophobic zeolites with a larger fraction of silicon can be used as physical adsorbents. In addition, even if zeolite, sepiolite, silica, alumina, etc. are used, the same effect can be obtained.

这些化学吸附剂和物理吸附剂可通过添加到膜的基材中，或通过涂覆在膜上而实现。此外，还优选地添加或涂覆这些吸附剂到基板或其上。These chemisorbents and physisorbents can be added to the substrate of the membrane, or by coating on the membrane. Furthermore, it is also preferred to add or coat these adsorbents to or onto the substrate.

此外，由于膜304接触使用者的手指314，优选地给予该膜抗菌特性。各种抗菌剂可被使用，且可通过涂覆或混炼到基材之上/之内而实现。这些抗菌剂包括Ag、Cu、Zn、Ni、Co或其合金、TiO₂、ZnO、WO₃等。在该实施例中，其中银携带在磷酸锆中的抗菌剂被以0.5wt％添加到膜304中。Furthermore, since thefilm 304 contacts the user'sfinger 314, antimicrobial properties are preferably imparted to the film. Various antimicrobial agents can be used and can be achieved by coating or compounding onto/into the substrate. These antibacterial agents include Ag, Cu, Zn, Ni, Co or alloys thereof, TiO₂ , ZnO, WO₃ and the like. In this example, an antimicrobial agent with silver carried in zirconium phosphate was added tofilm 304 at 0.5 wt%.

根据本发明的第六实施例的激光穿刺用生物传感器，且膜设置在传感器中，且在其一侧，且给予这些膜除臭功能。因此，包括激光穿刺过程中产生的异味的烟流可被防止泄漏到外部，且可消除异味成分。According to the biosensor for laser perforation according to the sixth embodiment of the present invention, films are provided in the sensor on one side thereof, and a deodorizing function is given to these films. Therefore, a plume of smoke including an odor generated during laser perforation can be prevented from leaking to the outside, and odor components can be eliminated.

第七实施例Seventh embodiment

接下来，图20显示了本发明的第七实施例的激光穿刺用生物传感器。图20(a)是平面图，图20(b)是当沿图20(a)的纵向在中心部分剖切时的横断面图。第七实施例不同于第六实施例之处仅在于新设置了三个第二开口323。第二开口323设置为分别穿过基板301、隔板306和盖板308，且这些开口中的一些或全部被设置为彼此对齐。Next, FIG. 20 shows a biosensor for laser perforation of a seventh embodiment of the present invention. Fig. 20(a) is a plan view, and Fig. 20(b) is a cross-sectional view when cut at the central portion in the longitudinal direction of Fig. 20(a). The seventh embodiment is different from the sixth embodiment only in that threesecond openings 323 are newly provided.Second openings 323 are provided through thebase plate 301 ,spacer 306 andcover plate 308 respectively, and some or all of these openings are provided in alignment with each other.

第二开口323的操作如下。在第六实施例中，传感器和主体通过接触连接在一起。然而，在第七实施例中，突起设置在主体中以与第二开口323对齐。使用者可把传感器插入突起，由此把其与主体连接。为此，激光振荡器和传感器之间的相对距离可被确定，且激光穿刺的孔的形状可稳定地获得。The operation of thesecond opening 323 is as follows. In a sixth embodiment, the sensor and the body are connected together by contact. However, in the seventh embodiment, a protrusion is provided in the body to be aligned with thesecond opening 323 . A user may insert the sensor into the protrusion, thereby connecting it to the main body. For this reason, the relative distance between the laser oscillator and the sensor can be determined, and the shape of the laser-punctured hole can be stably obtained.

此外，第二开口323沿传感器的短边设置在非对称位置。因此，使用者可插入生物传感器而不弄错插入方向。而且，当使用者把他/她的手指贴到传感器时，主体的从第二开口323凸起的突起将刺激预定的激光穿刺点的附近。因此，可减轻使用者在激光穿刺期间感觉到刺激。Furthermore, thesecond opening 323 is provided at an asymmetrical position along the short side of the sensor. Therefore, the user can insert the biosensor without mistakenly inserting the direction. Also, when the user sticks his/her finger to the sensor, the protrusion of the body protruding from thesecond opening 323 will stimulate the vicinity of the predetermined laser puncture point. Therefore, it is possible to reduce the user's feeling of irritation during laser perforation.

另外，参考图20，设置有三个第二开口323。然而，本发明不限于此，可以使用满足上述目的的各种设置。第二开口323的截面形状也可以是各种形状，例如圆形、长方形、正方形、多边形和椭圆形，除了双圆形的部分切块。In addition, referring to FIG. 20 , threesecond openings 323 are provided. However, the present invention is not limited thereto, and various arrangements satisfying the above-mentioned purpose may be used. The cross-sectional shape of thesecond opening 323 can also be various shapes, such as circle, rectangle, square, polygon and ellipse, except for partial cutouts of double circles.

如上所述，根据本发明的第七实施例的激光穿刺用生物传感器，新的开口设置得离开被过滤器覆盖的开口。由此，激光振荡器和传感器之间的相对距离可被确定，且激光穿刺的孔的形状可稳定地获得。而且，传感器和主体之间的连接方向可被准确设置，且可减轻激光穿刺期间的刺激，这依赖于从开口凸起的突起导致的刺激。As described above, according to the biosensor for laser perforation of the seventh embodiment of the present invention, the new opening is provided away from the opening covered by the filter. Thereby, the relative distance between the laser oscillator and the sensor can be determined, and the shape of the hole punctured by the laser can be stably obtained. Also, the connection direction between the sensor and the main body can be accurately set, and stimulation during laser perforation, which depends on the stimulation caused by the protrusion protruding from the opening, can be alleviated.

第八实施例Eighth embodiment

接着，本发明的第八实施例的激光穿刺用生物传感器示出在图21中。图21(a)是平面图，图21(b)是当沿图21(a)的纵向在中心部分剖切时的横断面图，图21(c)是当沿图21(a)的横向在中心部分剖切时的横断面图。Next, a biosensor for laser perforation according to an eighth embodiment of the present invention is shown in FIG. 21 . Fig. 21 (a) is a plan view, Fig. 21 (b) is a cross-sectional view when the central part is cut along the longitudinal direction of Fig. Cross-sectional view of the central section.

第八实施例不同于第六实施例之处在于新设置了第二开口323和第三开口324，且暴露于表面的测量电极302和电极电偶303被移到开口324内，不同于第七实施例之处在于第二开口323的两个变为第三开口324，暴露于表面的测量电极302和电极电偶303设置为使得分别暴露到第三开口324内。第二开口323和第三开口324被设置为分别穿过基板301、隔板306和盖板308，且这些开口中的一些或全部被设置为彼此对齐。The eighth embodiment is different from the sixth embodiment in that thesecond opening 323 and thethird opening 324 are newly provided, and the measuringelectrode 302 and theelectrode couple 303 exposed on the surface are moved into theopening 324, which is different from the seventh The difference of the embodiment is that two of thesecond openings 323 become thethird openings 324 , and themeasurement electrodes 302 and the electrode couples 303 exposed on the surface are arranged so as to be respectively exposed into thethird openings 324 . Thesecond opening 323 and thethird opening 324 are provided through thebase plate 301 , thespacer 306 and thecover plate 308 respectively, and some or all of these openings are provided in alignment with each other.

第二开口323和第三开口324的操作如下。在第六实施例中，传感器和主体通过接触连接在一起。然而，在第八实施例中，突起设置在主体中，以与第二开口323和第三开口324对齐。在它们的与第三开口324对齐的突起中，用于电分析样本标本中的分析物浓度的电极在主体内延伸。因此，使用者可把传感器插入突起，由此把其与主体电连接和机械连接。由此，激光振荡器和传感器之间的相对距离可被确定，且激光穿刺的孔的形状可稳定地获得。而且，插入可被电检测，使用者能识别插入错误。因此，使用者的方便性得以改善。The operation of thesecond opening 323 and thethird opening 324 is as follows. In a sixth embodiment, the sensor and the body are connected together by contact. However, in the eighth embodiment, protrusions are provided in the main body to be aligned with thesecond opening 323 and thethird opening 324 . In their protrusions aligned with thethird opening 324, electrodes for the electroanalysis of the analyte concentration in the sample specimen extend within the body. Thus, a user can insert the sensor into the protrusion, thereby electrically and mechanically connecting it to the body. Thereby, the relative distance between the laser oscillator and the sensor can be determined, and the shape of the hole punctured by the laser can be stably obtained. Furthermore, the insertion can be detected electrically, allowing the user to recognize an insertion error. Therefore, user's convenience is improved.

此外，第二开口323和第三开口324沿传感器的短边方向设置在非对称位置中。因此，使用者可插入生物传感器而不弄错插入方向。而且，当使用者把他/她的手指贴到传感器时，主体的从第二开口323和第三开口324凸起的突起将刺激预定的激光穿刺点的附近。因此，可减轻使用者在激光穿刺期间感觉到刺激。In addition, thesecond opening 323 and thethird opening 324 are provided in asymmetrical positions along the short-side direction of the sensor. Therefore, the user can insert the biosensor without mistakenly inserting the direction. Also, when the user sticks his/her finger to the sensor, the protrusions of the main body protruding from thesecond opening 323 and thethird opening 324 will stimulate the vicinity of a predetermined laser puncture point. Therefore, it is possible to reduce the user's feeling of irritation during laser perforation.

另外，参考图21，在总共三个点中设置第二开口323和第三开口324。然而，本发明不限于此，可以使用满足上述目的的各种设置。第二开口323和第三开口324的截面形状也可以是各种形状，例如圆形、长方形、方形、多边形和椭圆形，除了双圆形的部分切块。In addition, referring to FIG. 21 , thesecond opening 323 and thethird opening 324 are provided in a total of three points. However, the present invention is not limited thereto, and various arrangements satisfying the above-mentioned purpose may be used. The cross-sectional shapes of thesecond opening 323 and thethird opening 324 can also be various shapes, such as circular, rectangular, square, polygonal and elliptical, except for partial cutouts of double circular shapes.

如上所述，根据本发明的第八实施例的激光穿刺用生物传感器，新的开口设置得离开被过滤器覆盖的开口，且方向电极暴露到这些开口中。由此，激光振荡器和传感器之间的相对距离可被确定，且激光穿刺的孔的形状可稳定地获得。而且，由于插入的状态可被电检测和确认，使用者能够识别插入错误。而且，传感器和主体之间的连接方向可被准确设置，且可减轻激光穿刺期间的刺激，这依赖于从开口凸起的突起导致的刺激。As described above, according to the biosensor for laser perforation of the eighth embodiment of the present invention, new openings are provided away from the openings covered with filters, and the direction electrodes are exposed into these openings. Thereby, the relative distance between the laser oscillator and the sensor can be determined, and the shape of the hole punctured by the laser can be stably obtained. Also, since the state of insertion can be detected and confirmed electrically, the user can recognize an insertion error. Also, the connection direction between the sensor and the main body can be accurately set, and stimulation during laser perforation, which depends on the stimulation caused by the protrusion protruding from the opening, can be alleviated.

另外，对于样本标本，可使用这些经由皮肤的采样的例如血液和组织间隙液，且对于分析物，可使用血液葡萄糖水平(葡萄糖浓度)，或各种血清或生化项目。In addition, for sample specimens, such percutaneous sampling such as blood and interstitial fluid can be used, and for analytes, blood glucose level (glucose concentration), or various serum or biochemical items can be used.

此外，在血液葡萄糖水平(葡萄糖浓度)用作分析物的情况中，作为能够用作试剂的例子，酶在一些情况中辅酶、和介质的组合包括：葡萄糖氧化酶+氰铁酸钾或ferricynium；和葡萄糖氧化酶+pyrroloquinoline quinine或nicotinamide adenine+phenanthroline quinine、osmium comple、或potassiumferricyanide。Furthermore, in the case of blood glucose level (glucose concentration) being used as an analyte, as an example of what can be used as a reagent, an enzyme, in some cases a coenzyme, and a combination of a mediator include: glucose oxidase + potassium ferricyanide or ferricynium; And glucose oxidase + pyrroloquinoline quinine or nicotinamide adenine + phenanthroline quinine, osmium comple, or potassiumferricyanide.

第九实施例Ninth embodiment

图23是根据该实施例的生物传感器8的详细视图。图23(a)是平面图，图23(b)是当沿纵向在中心部分剖切时的横断面图，图23(c)是当沿横向在中心部分剖切时的横断面图。FIG. 23 is a detailed view of thebiosensor 8 according to this embodiment. FIG. 23( a ) is a plan view, FIG. 23( b ) is a cross-sectional view when cut at the central portion in the longitudinal direction, and FIG. 23( c ) is a cross-sectional view when cut at the central portion in the transverse direction.

在基板451的表面上，其中使用了聚乙烯对苯二甲酸酯、聚酯、聚烯烃、聚酰胺、聚醚、聚酰胺酰亚胺、聚苯乙烯、聚碳酸酯、聚乙烯-ρ-苯基硫、聚氯乙烯等，在该实施例中使用聚乙烯对苯二甲基酸酯，由例如金或钯的贵金属或例如碳的导电材料制造的电极电偶453和测量电极452通过丝网印刷或溅射气相沉积法形成。On the surface of thesubstrate 451, polyethylene terephthalate, polyester, polyolefin, polyamide, polyether, polyamideimide, polystyrene, polycarbonate, polyethylene-p- Phenylsulfide, polyvinyl chloride, etc., polyethylene terephthalate is used in this embodiment, theelectrode couple 453 and the measuringelectrode 452 made of a noble metal such as gold or palladium or a conductive material such as carbon are passed through a wire Formed by screen printing or sputtering vapor deposition.

绝缘盖板458具有大致圆形的空气孔459。盖板458的材料优选地为塑料膜，包括聚酯、聚烯烃、聚酰胺、聚醚、聚酰胺酰亚胺、聚苯乙烯、聚碳酸酯、聚乙烯-ρ-苯基硫、聚氯乙烯等。在该实施例中使用聚乙烯对苯二甲酸酯。此外，共聚物、混合材料以及它们的桥接材料可用于盖板458，且可使用厚度0.01mm至0.5mm的盖板。The insulatingcover 458 has a substantiallycircular air hole 459 . The material of thecover plate 458 is preferably a plastic film including polyester, polyolefin, polyamide, polyether, polyamideimide, polystyrene, polycarbonate, polyethylene-p-phenylsulfide, polyvinyl chloride wait. Polyethylene terephthalate was used in this example. In addition, copolymers, hybrid materials, and their bridging materials can be used for thecover plate 458, and a cover plate with a thickness of 0.01 mm to 0.5 mm can be used.

而且，具有切口部分以形成供应样本试剂的样本试剂供应通道457的隔板456，和浸渍有试剂的试剂层455，夹在盖板458和基板451之间，且盖板与基板451整合设置。Also, apartition 456 having a cutout portion to form a samplereagent supply channel 457 for supplying a sample reagent, and areagent layer 455 impregnated with a reagent are sandwiched between acover plate 458 and abase plate 451, and the cover plate is integrally provided with thebase plate 451.

隔板456设置为覆盖基板451上的电极电偶453和测量电极452，样本供应通道457通过设置在隔板456的前边缘的中间的长方形切口部分来形成，且试剂层455通过在隔板456的切口部分露出的电极电偶453和测量电极452上涂覆包含酶、电子受体、氨基酸、糖醇、水溶聚合物等的试剂而形成。Theseparator 456 is arranged to cover the electrodegalvanic couple 453 and the measuringelectrode 452 on thesubstrate 451, thesample supply channel 457 is formed by a rectangular cutout portion provided in the middle of the front edge of theseparator 456, and thereagent layer 455 passes through theseparator 456. The electrodegalvanic couple 453 and the measuringelectrode 452 exposed by the cutout are formed by coating reagents including enzymes, electron acceptors, amino acids, sugar alcohols, and water-soluble polymers.

而且，基板开口460、隔板开口461和盖板开口462为分别穿透基板451、隔板456和盖板458的开口。而且，膜454粘附到基板451与隔板456相对的表面上，以覆盖基板开口460。生物传感器的总厚度为0.1至1mm，其短边的长度为5至30mm，其长轴的长度为30至60mm。Also, thesubstrate opening 460 , thepartition opening 461 and thecover opening 462 are openings penetrating through thesubstrate 451 , thepartition 456 and thecover 458 , respectively. Also, afilm 454 is adhered to the surface of thesubstrate 451 opposite to thespacer 456 to cover thesubstrate opening 460 . The total thickness of the biosensor is 0.1 to 1 mm, the length of its short side is 5 to 30 mm, and the length of its long axis is 30 to 60 mm.

此外，设置有第二开口463和第三开口464，测量电极452和电极电偶453暴露于开口464中的部分。第二开口463和第三开口464设置为分别穿过基板451、隔板456和盖板458，且这些开口中的一些或全部设置为彼此对齐。In addition, asecond opening 463 and athird opening 464 are provided, and portions of theelectrode 452 and theelectrode couple 453 exposed in theopening 464 are measured. Thesecond opening 463 and thethird opening 464 are disposed through thebase plate 451 , thespacer 456 and thecover plate 458 respectively, and some or all of these openings are disposed in alignment with each other.

接着，将对操作进行详细描述。Next, the operation will be described in detail.

(滑片的安装)(Installation of the slider)

首先，使用者把滑片6插入到主体2内。在本发明中，生物传感器8可被用作滑片6。通过图23的生物传感器23的膜454和开口460、461和462，展现了防止由于激光穿刺过程中的蒸发物导致的聚光透镜12的污染(模糊)的功能，这是滑片6的目的。因此，由于使用者不需要与对于成分分析必不可少的生物传感器8分开地准备滑片6，使用者的方便性得以改善。First, the user inserts theslider 6 into themain body 2 . In the present invention, thebiosensor 8 can be used as theslider 6 . Through thefilm 454 and theopenings 460, 461 and 462 of the biosensor 23 of FIG. 23, the function of preventing the contamination (blur) of thecondenser lens 12 due to the evaporation during the laser perforation process is exhibited, which is the purpose of theslide plate 6. . Therefore, since the user does not need to prepare theslide 6 separately from thebiosensor 8 essential for component analysis, user convenience is improved.

图25是用于允许主体2识别滑片6的安装的示意性的结构图。设置有与主体2内的电路11电连接的开关425，且当滑片6没有插入时开关425打开(图25(a))。当滑片6被插入到主体2内时，开关425进入关闭状态，且随后，电路11可识别滑片6的插入(图25(b))。FIG. 25 is a schematic configuration diagram for allowing themain body 2 to recognize the installation of theslider 6 . Aswitch 425 electrically connected to thecircuit 11 in themain body 2 is provided, and theswitch 425 is turned on when theslider 6 is not inserted ( FIG. 25( a )). When theslider 6 is inserted into themain body 2, theswitch 425 enters an off state, and then, thecircuit 11 can recognize the insertion of the slider 6 (FIG. 25(b)).

第十实施例Tenth embodiment

现在，识别滑片6的安装的方法是使用滑片6上的电极的方法。图24显示了通过修改与图23的生物传感器相同的滑片6获得的生物传感器。图24(a)是平面图，图24(b)是当沿纵向在中心部分剖切时的横断面图，图24(c)是当沿横向在中心部分剖切时的横断面图。该生物传感器不同于图23的传感器之处在于，盖板458和隔板456配置成测量电极452和电极电偶453可在生物传感器的端部露出。尽管未示出，通过滑片6的插入来建立主体2内部的电路11与测量电极452和电极电偶453之间的电连接。因此，滑片6的插入可被检测到。尽管图24显示了一配置，其中使用了测量电极452和电极电偶453，独立于测量电极452和电极电偶453的电极可被设置用来检测插入。Now, a method of identifying the installation of theslider 6 is a method of using electrodes on theslider 6 . FIG. 24 shows a biosensor obtained by modifying thesame slide 6 as the biosensor of FIG. 23 . FIG. 24( a ) is a plan view, FIG. 24( b ) is a cross-sectional view when cut at the central portion in the longitudinal direction, and FIG. 24( c ) is a cross-sectional view when cut at the central portion in the transverse direction. This biosensor is different from the sensor of FIG. 23 in that thecover plate 458 and theseparator 456 are configured so that themeasurement electrodes 452 and the electrode couples 453 can be exposed at the ends of the biosensor. Although not shown, the electrical connection between theelectrical circuit 11 inside themain body 2 and themeasurement electrode 452 and theelectrode couple 453 is established by the insertion of theslider 6 . Therefore, the insertion of theslider 6 can be detected. Although FIG. 24 shows a configuration in which themeasurement electrode 452 and theelectrode couple 453 are used, electrodes separate from themeasurement electrode 452 and theelectrode couple 453 may be provided for detection of insertion.

(插入保持器的安装)(installation of insert holder)

接着，类似地，插入保持器207(参见图13)通过嵌合而被插入体2。插入保持器207设置有切口214，该切口214设置为使得使用者不会弄错插入方向。尽管在此使用了切口，也可使用例如突起或多个切口或突起的其它形状，其给予插入保持器非对称性。Next, similarly, the insertion holder 207 (see FIG. 13 ) is inserted into thebody 2 by fitting. Theinsertion holder 207 is provided with acutout 214 provided so that the user does not mistake the insertion direction. Although a cutout is used here, other shapes such as a protrusion or multiple cutouts or protrusions, which impart asymmetry to the insertion retainer, may also be used.

(生物传感器的安装)(Installation of biosensors)

接着，使用者通过嵌合把生物传感器8插入到插入保持器207中。生物传感器8的第二开口463和第三开口464设置为使得它们可嵌合在插入保持器207的第一突起215、第二突起216和第三突起217上。由于第二开口463非对称地设置在生物传感器8中，使用者可插入生物传感器而不弄错插入方向。参考图23，设置有一个第二开口463。然而，本发明不仅限于此，也可使用满足上述目的的各种配置。第三开口464和第二开口463的截面形状还可以是各种形状，例如除了双圆的部分切块，还有圆形、长方形、正方形、多边形和椭圆形。在改变生物传感器8的第二开口463和第三开口464的形状和结构的情况中，无需说，插入保持器207的包括第一突起215、第二突起216和第三突起217的突起的形状、结构和数量也相应地改变。Next, the user inserts thebiosensor 8 into theinsertion holder 207 by fitting. Thesecond opening 463 and thethird opening 464 of thebiosensor 8 are provided so that they can be fitted on thefirst protrusion 215 , thesecond protrusion 216 and thethird protrusion 217 of theinsertion holder 207 . Since thesecond opening 463 is asymmetrically disposed in thebiosensor 8, the user can insert the biosensor without mistakenly inserting the direction. Referring to FIG. 23, asecond opening 463 is provided. However, the present invention is not limited thereto, and various configurations satisfying the above objects are also available. The cross-sectional shapes of thethird opening 464 and thesecond opening 463 can also be various shapes, for example, in addition to a partial cut of a double circle, there are also circles, rectangles, squares, polygons and ellipses. In the case of changing the shape and structure of thesecond opening 463 and thethird opening 464 of thebiosensor 8, needless to say, the shape of the protrusions including thefirst protrusion 215, thesecond protrusion 216, and thethird protrusion 217 of theinsertion holder 207 , structure and quantity are changed accordingly.

当生物传感器通过嵌合插入所述插入保持器207中时，生物传感器8的第三开口464中的电极电偶453和测量电极452与插入保持器207的圆柱体213的外周的第二电极(未示出)和第一电极218分别电连接。而且，尽管在图1至3中未示出，用于第一电极218和第二电极的端子设置在主体2侧的侧部上，使得插入保持器207的通过嵌合插入到主体2的第一电极218和第二电极与主体2中的电路11电连接。如果生物传感器8和主体2进入相互电连接状态，成分浓度测量装置1将处于激光穿刺和来自电路11的成分浓度测量的预备状态，且该装置已达到此状态的事实显示在显示器3上，由此使用户能认识到该事实。When the biosensor is inserted into theinsertion holder 207 by fitting, the electrodegalvanic couple 453 and themeasurement electrode 452 in thethird opening 464 of thebiosensor 8 and the second electrode ( not shown) and thefirst electrode 218 are respectively electrically connected. Moreover, although not shown in FIGS. 1 to 3 , terminals for thefirst electrode 218 and the second electrode are provided on the side portion of themain body 2 side so that the second electrode of theinsertion holder 207 is inserted into themain body 2 by fitting. Thefirst electrode 218 and the second electrode are electrically connected to thecircuit 11 in themain body 2 . If thebiosensor 8 and themain body 2 enter into a mutual electrical connection state, the componentconcentration measuring device 1 will be in a ready state for laser perforation and component concentration measurement from thecircuit 11, and the fact that the device has reached this state is displayed on thedisplay 3 by This enables the user to recognize this fact.

随后，使用者把皮肤贴到生物传感器8的膜454上，使得预定的激光穿刺点可以到达基板开口460。同时，插入保持器207的突起，第一突起215、第二突起216和第三突起217从生物传感器8凸出约1至3mm，且这些突起挤压皮肤。这将刺激预定的激光穿刺点的周围。因此，这可减轻使用者在激光穿刺期间感觉到的刺激。Subsequently, the user sticks the skin on thefilm 454 of thebiosensor 8 so that the predetermined laser puncture point can reach thesubstrate opening 460 . Meanwhile, the protrusions of theholder 207 are inserted, thefirst protrusion 215 , thesecond protrusion 216 and thethird protrusion 217 protrude from thebiosensor 8 by about 1 to 3 mm, and these protrusions press the skin. This will stimulate around the intended laser puncture point. Therefore, this can reduce the irritation felt by the user during laser perforation.

(激光穿刺)(Laser piercing)

在使用者把皮肤贴到生物传感器8后，由此完成激光穿刺的准备，使用者按下激光操作按钮5，以进行激光穿刺。激光装置9利用激光操作按钮5从电路11产生的信号和电池10的电能振荡激光束。振荡的激光束被聚光透镜12聚焦，且穿刺使用者的皮肤。After the user attaches the skin to thebiosensor 8 to complete the preparation for laser puncture, the user presses thelaser operation button 5 to perform laser puncture. Thelaser device 9 oscillates a laser beam using the signal generated from thecircuit 11 by thelaser operation button 5 and the electric energy of thebattery 10 . The oscillating laser beam is focused by thecondenser lens 12, and punctures the user's skin.

对于激光束的波长，具有高的皮肤吸收系数的波长是优选的，且3μm波段(光激励激光或掺铒介质的中红外半导体激光)，或9至10μm波段(放电激励激光或二氧化碳气体介质的中红外半导体激光)是可以使用的。此外，皮肤上的激光束的聚光直径优选地为φ0.5mm以下，其更优选地为φ0.15mm以下。尽管该聚光形状优选地为圆形，还可使用其长轴设定为0.5mm以下的椭圆形。激光束优选地以脉冲的方式振荡，且脉冲的波形的时间宽度优选地为1μs以上和400μs以下。激光束的照射可以是单脉冲束的照射或多脉冲束的照射。For the wavelength of the laser beam, the wavelength with high skin absorption coefficient is preferred, and the 3 μm band (light-excited laser or mid-infrared semiconductor laser of erbium-doped medium), or the 9 to 10 μm band (discharge-excited laser or carbon dioxide gas medium) mid-infrared semiconductor laser) is available. In addition, the focusing diameter of the laser beam on the skin is preferably φ0.5 mm or less, more preferably φ0.15 mm or less. Although the concentrating shape is preferably a circle, an ellipse whose major axis is set to 0.5 mm or less may also be used. The laser beam is preferably oscillated in a pulsed manner, and the time width of the waveform of the pulse is preferably 1 μs or more and 400 μs or less. The irradiation of the laser beam may be irradiation of a single pulse beam or irradiation of a multi-pulse beam.

对于聚光透镜12，通过在氟化钙(CaF₂)、钇铝石榴石(YAG)、锗(Ge)、硒化锌(ZnSe)、无水人造水晶和氟化物模制材料制造的基板上进行非反射涂覆(介质多层膜)而得到聚光透镜，且其焦距优选地为5至30mm。在该实施例中使用氟化钙基板。此外，聚光透镜12大致为圆形，且其外直径为6至30mm。For the condensinglens 12, on a substrate made of calcium fluoride (CaF₂ ), yttrium aluminum garnet (YAG), germanium (Ge), zinc selenide (ZnSe), anhydrous artificial crystal, and fluoride molding material Concentrating lenses are obtained by non-reflective coating (dielectric multilayer film), and their focal length is preferably 5 to 30 mm. A calcium fluoride substrate was used in this example. In addition, the condensinglens 12 is substantially circular and has an outer diameter of 6 to 30 mm.

(成分浓度的测量)(measurement of component concentration)

在激光穿刺后，使用者从生物传感器8移离皮肤且推挤穿刺点的周围，以挤出0.5至几微升血液作为试样标本。因此，通过使血液采样点接触生物传感器8的一侧的样本试剂供应通道457，空气孔459动作，由此血液通过毛细现象收集在生物传感器8中。对于采样的血液，试剂和采样的血液中的待测量物质在试剂层455中彼此反应。对于反应中产生的电荷，电路11经由测量电极452、电极电偶453和插入保持器207的电极分析电荷量。通过分析获得的血液中的待测量的物质的浓度显示在显示器3上，且被使用者识别。电路11还包括未示出的存储单元，且分析结果连同测量数据和时间或使用者代码被记录。使用显示开关按钮4，使用者后来可再次识别过去的测量结果。After laser puncture, the user moves away from thebiosensor 8 from the skin and pushes around the puncture point to squeeze out 0.5 to several microliters of blood as a sample specimen. Therefore, by bringing the blood sampling point into contact with the samplereagent supply channel 457 on one side of thebiosensor 8, theair hole 459 operates, whereby blood is collected in thebiosensor 8 by capillary phenomenon. For the sampled blood, the reagent and the substance to be measured in the sampled blood react with each other in thereagent layer 455 . For the charges generated in the reaction, thecircuit 11 analyzes the charge amount via the measuringelectrode 452 , theelectrode couple 453 , and the electrodes inserted into theholder 207 . The concentration of the substance to be measured in the blood obtained by the analysis is displayed on thedisplay 3 and recognized by the user. Thecircuit 11 also includes a memory unit, not shown, and the results of the analysis are recorded together with the measurement data and the time or user code. Using thedisplay switch button 4, the user can later identify past measurement results again.

在该实施例中，在生物传感器被首先用作滑片6后，在前述测量中被用作滑片6的生物传感器在接下来的成分测量中被用作生物传感器8。此外，由于使用者在每次成分测量时替换生物传感器，和一天进行多次测量，使用者准备数十片单元的生物传感器8。因此，其还有助于仅使用数十个生物传感器的一个用于滑片。In this embodiment, after the biosensor is used as theslide 6 first, the biosensor used as theslide 6 in the foregoing measurement is used as thebiosensor 8 in the next component measurement. In addition, since the user replaces the biosensor every time a component is measured, and performs multiple measurements a day, the user preparesbiosensors 8 of tens of sheet units. Therefore, it also helps to use only one of dozens of biosensors for the slide.

第十一实施例Eleventh embodiment

而且，还可以为生物传感器提供用于如同图26的滑片的分离的开口和膜。图26(a)是平面图，图26(b)是当沿纵向在中心部分剖切时的横断面图，26(c)是当沿横向在中心部分剖切时的横断面图。该生物传感器不同于图23和24的生物传感器之处在于，其中设置有穿过基板451、隔板456、盖板458和膜466的开口465。开口465可具有一激光束基本上没有被遮蔽的直径，且其最小直径为1mm。而且，参考图26，这些开口为圆形。然而，可以是例如矩形、正方形、多边形和椭圆形的各种形状。尽管基板451、隔板456和盖板458中的开口465的形状是相同的，但它们可以是激光束基本上没有被遮蔽的不同的形状。Furthermore, the biosensor can also be provided with separate openings and membranes for the slide like FIG. 26 . 26( a ) is a plan view, FIG. 26( b ) is a cross-sectional view when cut at the central portion in the longitudinal direction, and 26( c) is a cross-sectional view when cut at the central portion in the transverse direction. This biosensor differs from the biosensor of FIGS. 23 and 24 in that an opening 465 is provided therein through thesubstrate 451 ,spacer 456 ,cover 458 and membrane 466 . The opening 465 may have a diameter where the laser beam is substantially unshielded, and has a minimum diameter of 1 mm. Also, referring to Figure 26, these openings are circular. However, various shapes such as rectangle, square, polygon and ellipse are possible. Although the shapes of the openings 465 in thebase plate 451,spacer 456, andcover plate 458 are the same, they may be of different shapes in which the laser beam is not substantially shielded.

从与膜454相同的基材组中选择膜466。在该实施例中使用环烯聚合物。希望增加膜466对于激光束的透射性，使得即使膜被使用激光束多次照射时，也不会在其中形成通孔。而且，类似于前述膜454，无需说，赋予膜466除臭功能和抗菌特性是有用的。Film 466 is selected from the same substrate group asfilm 454 . In this example a cycloolefin polymer was used. It is desirable to increase the transmittance of the film 466 with respect to the laser beam so that through holes are not formed therein even when the film is irradiated with the laser beam multiple times. Also, similarly to theaforementioned film 454, needless to say, it is useful to impart a deodorizing function and antibacterial properties to the film 466.

根据本发明的该实施例的成分浓度测量装置，主体设置有激光装置、聚光透镜、能分析成分的电路、能显示分析结果的显示器和可充电电池，滑片和插入保持器被插入到激光束光轴上的主体内，生物传感器嵌合在插入保持器内，且滑片也能被用作生物传感器。因此，由于使用者没有闻到激光穿刺过程中产生的烟流中的异味，且也没有作为聚光装置的光学元件被烟流污染，可以实现简单和容易的使用，即，使用者可利用一种消耗物品来管理片和试纸。According to the component concentration measuring device of this embodiment of the present invention, the main body is provided with a laser device, a condensing lens, a circuit capable of analyzing components, a display capable of displaying analysis results, and a rechargeable battery, and the slide and the insertion holder are inserted into the laser In the main body on the optical axis of the beam, the biosensor is fitted in the insertion holder, and the slide can also be used as the biosensor. Therefore, since the user does not smell the peculiar smell in the smoke generated during the laser puncture process, and the optical element as the light-collecting device is not polluted by the smoke, simple and easy use can be realized, that is, the user can use a A consumable item to manage tablets and test strips.

此外，在也具有生物传感器功能的滑片内设置有膜，该膜设置在激光束的光轴上，当用作滑片时没有被激光束刺穿且当用作生物传感器时被激光束刺穿。由此，由于使用者没有闻到激光穿刺过程中产生的烟流中的异味，且也没有作为聚光装置的光学元件被烟流污染，可以实现简单和容易的使用，即，使用者可利用一种消耗物品来管理片和试纸。Furthermore, a membrane is arranged inside the slide which also functions as a biosensor, which is arranged on the optical axis of the laser beam, which is not pierced by the laser beam when used as a slide and which is pierced by the laser beam when used as a biosensor. wear. Thus, since the user does not smell the peculiar smell in the smoke generated in the laser puncture process, and the optical element as the light-collecting device is not polluted by the smoke, simple and easy use can be realized, that is, the user can use A consumable item to manage tablets and test strips.

而且，在也具有生物传感器功能的滑片内设置有在激光束的光轴上当用作生物传感器时没有被激光束刺穿的膜和在激光束的光轴上当用作滑片时没有被激光束刺穿的膜。由此，由于使用者没有闻到激光穿刺过程中产生的烟流中的异味，且也没有作为聚光装置的光学元件被烟流污染，可以实现简单和容易的使用，即，使用者可利用一种消耗物品来管理片和试纸。Furthermore, a film that is not pierced by the laser beam on the optical axis of the laser beam when used as a biosensor and that is not pierced by the laser beam when used as a slide on the optical axis of the laser beam is provided in the slide that also functions as a biosensor. The bundle pierces the membrane. Thus, since the user does not smell the peculiar smell in the smoke generated in the laser puncture process, and the optical element as the light-collecting device is not polluted by the smoke, simple and easy use can be realized, that is, the user can use A consumable item to manage tablets and test strips.

而且，通过提供检测滑片插入到主体的功能，可防止使用者忘记滑片的插入，且相应地，可以可靠地防止聚光透镜被烟流污染。Also, by providing the function of detecting the insertion of the slider into the main body, it is possible to prevent the user from forgetting the insertion of the slider, and accordingly, it is possible to reliably prevent the condensing lens from being contaminated by smoke.

而且，通过滑片的插入操作开口以执行滑片插入到主体的检测功能，可防止使用者忘记滑片的插入，且相应地，可以可靠地防止聚光透镜被烟流污染。Also, by performing the detection function of inserting the slide into the main body by operating the opening through the insertion of the slide, the user can be prevented from forgetting the insertion of the slide, and accordingly, the concentrating lens can be reliably prevented from being polluted by smoke.

而且，通过与设置在滑片中的电极的连接可执行滑片插入到主体的检测功能，可防止使用者忘记滑片的插入，且相应地，可以可靠地防止聚光透镜被烟流污染。Also, the detection function of the insertion of the slider into the main body can be performed by the connection with the electrodes provided in the slider, the user can be prevented from forgetting the insertion of the slider, and accordingly, the condensing lens can be reliably prevented from being polluted by smoke.

而且，除臭功能设置在激光束的光轴上具有生物传感器功能的滑片的膜上，类似地在激光束的光轴上至少插入保持器的内表面，和类似地在激光束的光轴上的生物传感器的膜。由此，可消除激光穿刺过程中产生的烟流中的异味。Also, the deodorizing function is provided on the film of the slide having the biosensor function on the optical axis of the laser beam, similarly inserted into at least the inner surface of the holder on the optical axis of the laser beam, and similarly on the optical axis of the laser beam on the membrane of the biosensor. As a result, odors in the smoke generated during laser perforation can be eliminated.

而且，通过在具有生物传感器功能的滑片和插入保持器中提供抗菌功能，可防止当被使用者使用时的感染。Also, by providing an antibacterial function in the slider and the insertion holder having a biosensor function, infection when used by a user can be prevented.

另外，对于样本标本，另外，对于样本标本，可使用这些经由皮肤的采样的例如血液和组织间隙液，且对于分析物，可使用血液葡萄糖水平(葡萄糖浓度)，或各种血清或生化项目。In addition, for sample specimens, these percutaneous samples such as blood and interstitial fluid can be used, and for analytes, blood glucose level (glucose concentration), or various serum or biochemical items can be used.

此外，在血液葡萄糖水平(葡萄糖浓度)用作分析物的情况中，作为能够用作试剂的例子，酶在一些情况中辅酶、和介质的组合包括：葡萄糖氧化酶+氰铁酸钾或ferricynium；和葡萄糖氧化酶+pyrroloquinoline quinine或nicotinamide adenine+phenanthroline quinine、osmium comple、或potassiumferricyanide。Furthermore, in the case of blood glucose level (glucose concentration) being used as an analyte, as an example of what can be used as a reagent, an enzyme, in some cases a coenzyme, and a combination of a mediator include: glucose oxidase + potassium ferricyanide or ferricynium; And glucose oxidase + pyrroloquinoline quinine or nicotinamide adenine + phenanthroline quinine, osmium comple, or potassiumferricyanide.

第十二实施例Twelfth embodiment

下文中，将要描述激光穿刺装置的例子，其中可安装地设置有本发明的第十二实施例的穿刺适配器。Hereinafter, an example of a laser perforating device in which the perforating adapter of the twelfth embodiment of the present invention is mountably provided will be described.

根据本发明的激光穿刺装置包括激光振荡器、用来显示电源、电池和操作状态的显示器、设定操作模式的设定按钮和其中设置有启动穿刺操作的操作操作开关的主体、以及可替换的穿刺适配器。对于穿刺适配器，在具有平行于激光光轴的轴线的中空体中，聚光透镜保护膜设置在聚光透镜的侧部上的中空体的开口中，且穿刺膜设置在激光穿刺过程中穿刺点的皮肤被按压的位置处的侧部上，在中空体的相对开口中。The laser puncture device according to the present invention includes a laser oscillator, a display for displaying power supply, battery and operation status, a setting button for setting an operation mode, and a main body in which an operation switch for starting a puncture operation is arranged, and a replaceable piercing adapter. For the piercing adapter, in a hollow body with an axis parallel to the laser optical axis, the condenser lens protection film is placed in the opening of the hollow body on the side of the condenser lens, and the piercing film is placed at the piercing point during laser piercing On the side where the skin is pressed, in the opposite opening of the hollow body.

通过采用这样的配置，穿刺膜、中空体和聚光透镜保护膜形成封闭的空间。通过在穿刺膜中用激光束形成孔，穿过该孔激光穿刺皮肤，产生的烟流可被限制在该封闭的空间内，且异味可被设置在穿刺膜、中空体和聚光透镜保护膜中的除臭功能去除。此外，由于还设置有抗菌功能，不必担心感染。而且，由于该适配器可被替换，可通过每次使用时替换适配器来防止感染。By employing such a configuration, the piercing membrane, the hollow body, and the condenser lens protective film form a closed space. By forming a hole with a laser beam in the puncture membrane through which the laser punctures the skin, the generated smoke can be confined in the closed space, and the odor can be set in the puncture membrane, the hollow body, and the condenser lens protective film The deodorizing function in the removal. In addition, since an antibacterial function is also provided, there is no need to worry about infection. Also, since the adapter is replaceable, infection can be prevented by replacing the adapter each time it is used.

图27(a)是根据本发明的该实施例的激光穿刺装置1的顶视图，图27(b)是显示激光穿刺装置的内部结构的示意截面图。激光穿刺装置1包括主体2、包括操作电源的激光振荡器9、聚光透镜12、穿刺适配器507、控制板11、电池10、操作开关5、设定按钮4和显示器3。电池10、控制板11和激光振荡器9、控制板11和激光振荡器9、设定按钮4、显示器3和操作开关5电学和信号连接。Fig. 27(a) is a top view of thelaser perforating device 1 according to the embodiment of the present invention, and Fig. 27(b) is a schematic sectional view showing the internal structure of the laser perforating device. Thelaser puncturing device 1 includes amain body 2 , alaser oscillator 9 including an operating power source, acondenser lens 12 , a puncturingadapter 507 , acontrol panel 11 , abattery 10 , anoperating switch 5 , asetting button 4 and adisplay 3 . Thebattery 10, thecontrol board 11 and thelaser oscillator 9, thecontrol board 11 and thelaser oscillator 9, thesetting button 4, thedisplay 3 and theoperation switch 5 are electrically and signally connected.

图28是本发明的该实施例的激光穿刺装置1中的穿刺适配器507的示意图。该穿刺适配器507具有基于圆柱体513的形状。对于适配器的材料，可使用各种塑料材料，它们是聚乙烯、聚氯乙烯、聚丙烯、聚苯乙烯、多乙酸乙烯酯、ABS树脂、AS树脂、丙烯酸树脂、聚缩醛、聚酰亚胺树脂、聚碳酸酯、改性聚亚苯醚(PPE)、聚丁烯对苯二酸酯(PPB)、多芳基化合物、聚砜、聚亚苯硫化物、聚醚醚酮、氟树脂等。在塑料表面上具有低电动电位的材料是优选的。FIG. 28 is a schematic diagram of the puncturingadapter 507 in thelaser puncturing device 1 of the embodiment of the present invention. The piercingadapter 507 has a shape based on a cylinder 513 . For the material of the adapter, various plastic materials can be used, which are polyethylene, polyvinyl chloride, polypropylene, polystyrene, polyvinyl acetate, ABS resin, AS resin, acrylic resin, polyacetal, polyimide Resin, polycarbonate, modified polyphenylene ether (PPE), polybutylene terephthalate (PPB), polyarylate, polysulfone, polyphenylene sulfide, polyether ether ketone, fluororesin, etc. . Materials with low zeta potential on plastic surfaces are preferred.

穿刺膜508(第一膜)设置在人的皮肤(手指等)接触部分的开口中。穿刺膜508吸收激光束且被穿刺。对于膜508的基材，可使用尼龙、聚酯、聚酰亚胺、氟系、氯乙烯、聚苯乙烯、聚乙烯、聚烯烃、聚乙烯醇、聚丙烯等。A puncture film 508 (first film) is provided in the opening of the human skin (finger, etc.) contact portion. The puncture film 508 absorbs the laser beam and is punctured. As the base material of the film 508, nylon, polyester, polyimide, fluorine-based, vinyl chloride, polystyrene, polyethylene, polyolefin, polyvinyl alcohol, polypropylene, or the like can be used.

主体的侧部上的开口安装有聚光透镜保护膜506(第二膜)。聚光透镜保护膜506不吸收激光束，而是传输该激光束。由于该膜没有被激光束的吸收穿刺，不像穿刺膜508(第一膜)，其具有防止激光穿刺过程中从皮肤蒸发的组织碎片粘附到聚光透镜12且污染聚光透镜12的功能。对于聚光透镜保护膜506的基材，可使用尼龙、聚酯、聚酰亚胺、氟系、氯乙烯、聚苯乙烯、聚乙烯、聚烯烃、聚乙烯醇、聚丙烯等。The opening on the side of the main body is fitted with a condenser lens protective film 506 (second film). The condenser lens protective film 506 does not absorb the laser beam but transmits the laser beam. Since the film is not punctured by the absorption of the laser beam, unlike the puncture film 508 (first film), it has the function of preventing tissue fragments evaporated from the skin during laser puncture from adhering to thecondenser lens 12 and contaminating thecondenser lens 12 . As the base material of the condenser lens protective film 506, nylon, polyester, polyimide, fluorine-based, vinyl chloride, polystyrene, polyethylene, polyolefin, polyvinyl alcohol, polypropylene, or the like can be used.

接着，将描述操作。首先，当使用者按压操作开关5时，激光穿刺装置1开始启动。接着，使用者利用设定按钮4输入激光穿刺装置1的操作条件。在输入后，使用者把穿刺适配器507插入到主体2内，且把他/她的手指即激光穿刺点压在穿刺适配器507上。Next, the operation will be described. First, when the user presses theoperation switch 5, thelaser perforating device 1 starts to start. Next, the user inputs the operating conditions of thelaser perforating device 1 using thesetting button 4 . After the input, the user inserts thepuncture adapter 507 into themain body 2 and presses his/her finger, which is the laser puncture point, on thepuncture adapter 507 .

在完成准备后，当“待命”显示在显示器3上，且使用者再次按压操作开关5时，激光振荡器9振荡激光脉冲束，振荡的激光束被聚光透镜12聚焦，且聚焦在使用者的手指的皮肤上，同时其束直径设置的较小而位于中空穿刺适配器507中。然后，激光束被皮肤吸收，且皮肤被渐热和蒸发，由此被穿刺。通过穿刺，皮肤的表皮和其真皮的最上表面蒸发，例如真皮的皮肤乳突中的毛细管被创伤，且血液渗出。然后，血液穿过穿刺的孔渗出皮肤表面。After the preparation is completed, when "standby" is displayed on thedisplay 3, and the user presses theoperation switch 5 again, thelaser oscillator 9 oscillates the laser pulse beam, and the oscillating laser beam is focused by thecondenser lens 12, and focused on the user On the skin of the finger, its beam diameter is set smaller and is located in the hollow piercingadapter 507 at the same time. Then, the laser beam is absorbed by the skin, and the skin is gradually heated and evaporated, thereby being punctured. By puncturing, the epidermis of the skin and the uppermost surface of its dermis are evaporated, for example the capillaries in the dermal papillae of the dermis are traumatized and blood oozes out. The blood then oozes out of the skin's surface through the pierced hole.

此时，没有孔形成在聚光透镜保护膜506中，同时激光束在皮肤接触处的穿刺膜508被吸收，由此形成孔。穿过该孔，进行前述激光穿刺。在激光穿刺过程中通过皮肤的蒸发产生的烟流通过穿刺膜508的孔散播到中空体513中。At this time, no hole is formed in the condensing lens protective film 506, while the laser beam is absorbed at the piercing film 508 where the skin contacts, thereby forming a hole. Through this hole, the aforementioned laser perforation is performed. The smoke generated by the vaporization of the skin during laser perforation spreads into the hollow body 513 through the holes of the perforation membrane 508 .

由构成皮肤组织的蛋白质的成分氨基酸产生的挥发性物质被分解流动在烟流中。激光穿刺过程中的主要目标角质层由角蛋白质的纤维组织组成，且纤维是由胱氨酸键结合，该键是氨基酸胱氨酸的硫部分的键，其包含的相对较多。由于这些氨基酸在蒸发过程中分解，产生挥发性硫化合物或氮成分，特别地，人感觉到作为异味的硫化合物。Volatile substances generated from amino acids, which are components of proteins that make up skin tissue, are decomposed and flow in the smoke. The main target stratum corneum during laser perforation is composed of fibrous tissue of keratin, and the fibers are bound by cystine bonds, which are bonds of the sulfur moiety of the amino acid cystine, which contain relatively many. As these amino acids are decomposed during evaporation, volatile sulfur compounds or nitrogen components are produced, and in particular, sulfur compounds are perceived by humans as off-flavors.

因此，对于烟流中的异味成分的除臭功能被设置到穿刺适配器507的内侧。硫化氢或甲基硫醇作为主要的硫化合物被提及。硫化氢可通过化学吸附剂除臭，且可使用锰、铜和钴的复合氧合物。另外，类似地，通过使用包括锰、铜、锌和钴任意一种的氧化物、氢氧化物、复合氧合物、或其混合物，可获得对于硫化氢的有效的化学吸收作用的吸附剂。Therefore, a deodorizing function for odor components in smoke is provided inside the piercingadapter 507 . Hydrogen sulfide or methyl mercaptan are mentioned as main sulfur compounds. Hydrogen sulfide can be deodorized by a chemical adsorbent, and complex oxygen compounds of manganese, copper, and cobalt can be used. In addition, similarly, by using an oxide, a hydroxide, a composite oxygen compound, or a mixture thereof including any one of manganese, copper, zinc, and cobalt, an adsorbent effective in chemical absorption for hydrogen sulfide can be obtained.

化学吸附剂化学地吸收硫化氢，最终是以硫酸盐或简单的硫物质的形式。此外，化学吸附剂还具有媒介作用，其转换同样的硫基异味的甲基硫醇为具有较高阈值的二甲基二硫醚。由于该作用，人可感觉到相当于除臭的效果。Chemisorbents chemically absorb hydrogen sulfide, ultimately in the form of sulfate or simple sulfur species. In addition, the chemisorbent also acts as an intermediary, which converts the same sulfur-based off-flavor methyl mercaptan to dimethyl disulfide with a higher threshold. Due to this action, humans can perceive an effect corresponding to deodorization.

而且，由于二甲基二硫醚可通过使用装载的物理吸附剂的物理吸附剂作用而被去除，其大体上可去除硫化合物。具有较大部分硅的疏水沸石可被用作物理吸附剂。另外，即使使用沸石、海泡石、硅石、氧化铝等，也可得到相同的效果。Also, since dimethyl disulfide can be removed by physisorbent action using a loaded physisorbent, it can substantially remove sulfur compounds. Hydrophobic zeolites with a larger fraction of silicon can be used as physical adsorbents. In addition, even if zeolite, sepiolite, silica, alumina, etc. are used, the same effect can be obtained.

这些化学吸附剂和物理吸附剂添加到聚光透镜膜506、穿刺膜508或穿刺适配器507的基材。或者，吸收剂可涂覆在聚光透镜膜506、穿刺膜508或穿刺适配器507的内部上。These chemisorbents and physisorbents are added to the substrate of condenser lens film 506 , puncture film 508 orpuncture adapter 507 . Alternatively, an absorber may be coated on the interior of condenser lens film 506 , piercing film 508 or piercingadapter 507 .

此外，由于穿刺膜508接触使用者的手指，优选地给予膜抗菌特性。抗菌特性可通过涂覆或混炼到基材之上或之内而实现。这些抗菌剂包括Ag、Cu、Zn、Ni、Co或它们的合金、TiO₂、ZnO、WO₃等。另外，抗菌特性通过不仅浸渍在穿刺膜508上而且在穿刺适配器507的中空体513的外表面上而有效。Furthermore, since the piercing membrane 508 is in contact with the user's finger, it preferably imparts antimicrobial properties to the membrane. Antimicrobial properties can be achieved by coating or compounding onto or into the substrate. These antibacterial agents include Ag, Cu, Zn, Ni, Co or their alloys, TiO₂ , ZnO, WO₃ and the like. In addition, the antimicrobial properties are effective by being impregnated not only on the puncture membrane 508 but also on the outer surface of the hollow body 513 of thepuncture adapter 507 .

图29(a)是本发明的实施例的激光穿刺装置1中的另一穿刺适配器514的示意图。对于穿刺适配器514，皮肤压靠的开口的直径通过绕穿刺膜508形成的突起515控制。由于实现理想的对皮肤的按压的直径依赖于突起515的形状设置，可获得可靠的血液采样。Fig. 29(a) is a schematic diagram of another puncturingadapter 514 in thelaser puncturing device 1 according to the embodiment of the present invention. For the piercingadapter 514 , the diameter of the opening against which the skin is pressed is controlled by a protrusion 515 formed around the piercing membrane 508 . Since the diameter to achieve a desired pressure against the skin is set depending on the shape of the protrusion 515, reliable blood sampling can be obtained.

图29(b)是激光穿刺期间激光穿刺点的放大视图。使用者把穿刺适配器514安装到皮肤516的预定激光穿刺点。此时，突起515从穿刺膜508凸起约1至3mm，该突起515将推挤皮肤516。这将刺激预定的激光穿刺点的周围。因此，可减轻使用者在激光穿刺过程中感觉到的刺激。Fig. 29(b) is an enlarged view of a laser puncture point during laser puncture. The user attaches the piercingadapter 514 to the predetermined laser piercing point of the skin 516 . At this time, the protrusion 515 protrudes about 1 to 3 mm from the puncture membrane 508 , and the protrusion 515 will push the skin 516 . This will stimulate around the intended laser puncture point. Therefore, the irritation felt by the user during laser perforation can be reduced.

如上所述，根据该实施例的激光穿刺装置1，穿刺膜508、中空体513和聚光透镜保护膜506可形成封闭的空间。然后，通过在穿刺膜508中用激光束形成孔，穿过该孔激光穿刺皮肤，产生的烟流可被限制在该封闭的空间内。As described above, according to thelaser perforating device 1 of this embodiment, the perforating film 508, the hollow body 513, and the condenser lens protective film 506 can form a closed space. Then, by forming a hole with a laser beam in the puncture membrane 508 through which the laser punctures the skin, the generated plume can be confined within the enclosed space.

此外，异味可被设置在穿刺膜508、中空体513和聚光透镜保护膜506中的除臭功能去除。此外，由于还设置有抗菌功能，不必担心感染。而且，由于穿刺适配器507或514可被替换，可通过每次使用时替换适配器来防止感染。In addition, odors can be removed by a deodorizing function provided in the puncture film 508 , the hollow body 513 and the condenser lens protective film 506 . In addition, since an antibacterial function is also provided, there is no need to worry about infection. Also, since the piercingadapter 507 or 514 can be replaced, infection can be prevented by replacing the adapter each time it is used.

第十三实施例Thirteenth embodiment

在下文中，将描述作为本发明的第十三实施例的用激光束穿刺(激光穿刺)人体皮肤的激光照射方法。在首先描述激光照射方法后，将描述激光穿刺装置。Hereinafter, a laser irradiation method of puncturing (laser perforating) human skin with a laser beam as a thirteenth embodiment of the present invention will be described. After first describing the laser irradiation method, the laser perforating device will be described.

图30是根据本发明的第十三实施例的激光穿刺装置的激光照射条件的示意图。在该视图中，横坐标表示时间，纵坐标表示激光束强度。左激光脉冲束L1是用于穿刺表皮的激光脉冲束，右激光脉冲束L2是用于穿刺真皮的激光脉冲束。Fig. 30 is a schematic diagram of laser irradiation conditions of a laser perforating device according to a thirteenth embodiment of the present invention. In this view, the abscissa represents time and the ordinate represents laser beam intensity. The left laser pulse beam L1 is a laser pulse beam for puncturing the epidermis, and the right laser pulse beam L2 is a laser pulse beam for puncturing the dermis.

用于穿刺表皮的激光脉冲束L1的总时间宽度T1为100至400μs。用于穿刺真皮的激光脉冲束L2的总时间宽度T3为50至300μs。激光脉冲束L1和L2的总时间宽度T1和T3之间的差(T1-T3)优选地为50至200μs。另外，激光脉冲束L1和激光脉冲束L2之间的间隔越短越好。该间隔优选地为500ms以下，且更优选地为1ms以下。The total time width T1 of the laser pulse beam L1 used to puncture the epidermis is 100 to 400 μs. The total time width T3 of the laser pulse beam L2 for puncturing the dermis is 50 to 300 μs. The difference (T1-T3) between the total time widths T1 and T3 of the laser pulse beams L1 and L2 is preferably 50 to 200 μs. In addition, the shorter the interval between the laser pulse beam L1 and the laser pulse beam L2, the better. The interval is preferably 500 ms or less, and more preferably 1 ms or less.

对于激光脉冲束的能量，当使用两个激光脉冲束L1和L2照射单位面积(1cm²)时获得的能量总和优选地为100至300J。例如，如果照射面积的直径为0.1mm(＝0.01cm)，面积为7.85×10^-5cm²(＝0.005×0.005×π)。通过把面积乘以每照射单位的能量强度100至300J/cm²得到的7.85×10^-5cm²×100至300J/cm²＝7.85至23.6mJ变为激光脉冲束L1和L2的能量总和。As for the energy of the laser pulse beams, the sum of the energy obtained when a unit area (1 cm² ) is irradiated with two laser pulse beams L1 and L2 is preferably 100 to 300 J. For example, if the diameter of the irradiated area is 0.1 mm (=0.01 cm), the area is 7.85×10^-5 cm² (=0.005×0.005×π). 7.85 x 10^-5 cm² x 100 to 300 J/cm² = 7.85 to 23.6 mJ obtained by multiplying the area by theenergy intensity 100 to 300 J/cm² per irradiation unit becomes the energy sum of the laser pulse beams L1 and L2.

此外，用于穿刺真皮的激光脉冲束的能量优选地为用于穿刺表皮的激光脉冲束的能量和用于穿刺真皮的激光脉冲束的能量的能量总和的10％至40％。即，如果激光脉冲束L1和L2的能量总和为20mJ，则用于穿刺真皮的激光脉冲束的能量优选地为该能量总和的10％至40％(2至8mJ)。In addition, the energy of the laser pulse beam for piercing the dermis is preferably 10% to 40% of the sum of the energy of the laser pulse beam for piercing the epidermis and the energy of the laser pulse beam for piercing the dermis. That is, if the sum of the energies of the laser pulse beams L1 and L2 is 20 mJ, the energy of the laser pulse beam for puncturing the dermis is preferably 10% to 40% of the sum (2 to 8 mJ).

而且，激光脉冲束的聚光直径为0.15mm以下，优选地为0.1mm以下。此外，激光脉冲束L1和L2之间的时间间隔T2越短越好。该间隔为500ms以下，且优选地为1ms以下。Furthermore, the focusing diameter of the laser pulse beam is 0.15 mm or less, preferably 0.1 mm or less. In addition, the shorter the time interval T2 between the laser pulse beams L1 and L2, the better. The interval is 500 ms or less, and preferably 1 ms or less.

图31是根据本发明的实施例的激光穿刺装置的激光照射条件中的皮肤的穿刺孔的放大视图。当皮肤被用于穿刺表皮的第一激光脉冲束L1照射时，柱形穿刺孔形成在表皮中，如同图31(a)。31 is an enlarged view of a puncture hole of the skin in laser irradiation conditions of the laser puncture device according to the embodiment of the present invention. When the skin is irradiated with the first laser pulse beam L1 for puncturing the epidermis, columnar puncture holes are formed in the epidermis as in FIG. 31( a ).

接着，当与第一激光脉冲束L1相同的位置被用于穿刺真皮的第二激光脉冲束L2照射时，臼形穿刺孔形成在真皮中，如同图31(b)。同时，真皮中的毛细管被创伤，血液渗出。渗出的血液经由表皮的激光穿刺孔渗出。激光穿刺孔到真皮的深度是0.05至0.3mm，且优选地0.05至0.25mm。Next, when the same position as the first laser pulse beam L1 is irradiated with the second laser pulse beam L2 for puncturing the dermis, a socket-shaped puncture hole is formed in the dermis as shown in FIG. 31(b). At the same time, the capillaries in the dermis are traumatized and blood seeps out. Exuded blood seeps through laser-punctured holes in the epidermis. The depth of the laser perforation hole to the dermis is 0.05 to 0.3 mm, and preferably 0.05 to 0.25 mm.

图32显示了根据本发明的第十三实施例的其它激光照射条件。图30所示的用于穿刺表皮的第一激光脉冲束L1进一步分成多个激光脉冲束L3、L4和L5。用于穿刺表皮的激光束L3、L4和L5的时间宽度T4、T6和T8分别为100至400μs。Fig. 32 shows other laser irradiation conditions according to the thirteenth embodiment of the present invention. The first laser pulse beam L1 for puncturing the epidermis shown in FIG. 30 is further divided into a plurality of laser pulse beams L3, L4, and L5. The time widths T4, T6, and T8 of the laser beams L3, L4, and L5 for puncturing the epidermis are 100 to 400 μs, respectively.

此外，激光脉冲束L3、L4、L5和L6照射单位面积(1cm²)获得的能量总和优选地为5至100J(每照射单位面积的能量强度为5至100J/cm²)。激光脉冲束L3、L4、L5和L6的时间间隔越短越好。该间隔为500ms以下，且优选地为1ms以下。In addition, the sum of the energy obtained per unit area (1 cm² ) irradiated by laser pulse beams L3 , L4 , L5 and L6 is preferably 5 to 100 J (energy intensity per irradiated unit area is 5 to 100 J/cm² ). The shorter the time interval of the laser pulse beams L3, L4, L5 and L6, the better. The interval is 500 ms or less, and preferably 1 ms or less.

图33是装在根据本发明的实施例的激光穿刺装置上的激光振荡器620的示意图。激光振荡器620包括：激光棒625，用于激光束谐振器的镜膜623和624形成在其端部；用于激发激光束的闪光灯621；用于有效地把闪光灯621的光线引导到激光棒625的灯罩622。另外，还有用于操作闪光灯621的电源(未示出)。另外，激光棒625和两个镜膜623和624组成激光束谐振器。FIG. 33 is a schematic diagram of alaser oscillator 620 mounted on a laser perforating device according to an embodiment of the present invention. Thelaser oscillator 620 includes: a laser bar 625 on which mirror films 623 and 624 for the laser beam resonator are formed; a flash lamp 621 for exciting the laser beam; 625 shades 622. In addition, there is a power source (not shown) for operating the flash 621 . In addition, the laser bar 625 and the two mirror films 623 and 624 constitute a laser beam resonator.

从闪光灯621发出的白光被直接反射或在灯罩722内部，且激光棒625的吸收的波长被激光棒625吸收。然后，激光棒625内的活性介质被激励，且反转分布形成。自发发射光在激光棒625内部传播，且被在激光棒625的两个端面处的镜膜623和624反射，在光谐振器内以特征解的模式往复运动，且被感应发射放大，且被从反射系数稍低的一个镜膜623引出作为激光束。The white light emitted from the flash lamp 621 is directly reflected or inside thelamp housing 722 , and the absorbed wavelength of the laser rod 625 is absorbed by the laser rod 625 . Then, the active medium within the laser rod 625 is energized, and an inversion profile is formed. The spontaneous emission light propagates inside the laser rod 625, and is reflected by the mirror films 623 and 624 at both end faces of the laser rod 625, reciprocates in the mode of the characteristic solution in the optical resonator, and is amplified by the induced emission, and is A mirror film 623 having a slightly lower reflection coefficient is extracted as a laser beam.

由触发电极预先离子化，通过充在电容器内的高压电荷，玻璃管内的氙气放电时，闪光灯621发出白光。为了振荡多个激光脉冲束，闪光灯621应多次发光。这是可以实现的，例如通过被半导体门开关(IGBT)一次充电的门控制高压电荷，且在充电时进行门控制，使得多次发光的方法。通过检查门控制模式，可以控制每个激光脉冲束的脉冲的数目、总时间宽度、光能量和脉冲间隔。The flash lamp 621 emits white light when the xenon gas in the glass tube is discharged through the pre-ionization of the trigger electrode and the high-voltage charge charged in the capacitor. In order to oscillate a plurality of laser pulse beams, the flash lamp 621 should emit light a plurality of times. This can be achieved, for example, by gate-controlling high-voltage charges once charged by a semiconductor gate switch (IGBT), and performing gate control during charging so as to emit light multiple times. By checking the gate control mode, the number of pulses, total time width, light energy and pulse interval of each laser pulse beam can be controlled.

图34是根据本发明的实施例的激光穿刺装置1的示意图。主体的内部设置有结构振荡器620、未示出的电源、以及激光振荡器620的激光光轴632上的聚光透镜12。开口633设置在主体的激光光轴632上的聚光透镜12的焦点中。通过将手指贴到开口和进行激光穿刺，可从手指进行血液采样。Fig. 34 is a schematic diagram of thelaser perforating device 1 according to the embodiment of the present invention. The inside of the main body is provided with astructural oscillator 620 , a power source not shown, and acondenser lens 12 on the laser optical axis 632 of thelaser oscillator 620 . The opening 633 is provided in the focal point of thecondenser lens 12 on the laser optical axis 632 of the main body. Blood is sampled from the finger by taping it to the opening and performing laser puncture.

如上所述，根据该实施例的激光穿刺方法，用于穿刺真皮的激光脉冲束照射到与用于穿刺表皮的激光脉冲束相同的位置，且臼形穿刺孔形成在真皮中。因此，真皮没有被穿刺的较深，其不会留下伤疤，穿刺过程中的疼痛较小，且可进行稳定的血液采样。As described above, according to the laser puncture method of this embodiment, the laser pulse beam for puncturing the dermis is irradiated to the same position as the laser pulse beam for puncturing the epidermis, and a socket-shaped puncture hole is formed in the dermis. Therefore, the dermis is not punctured deeply, it does not leave a scar, the puncture is less painful, and stable blood sampling can be performed.

此外，用于穿刺表皮的激光脉冲束的时间宽度等于或大于用于穿刺真皮的激光脉冲束的时间宽度，且用于穿刺表皮的激光脉冲束的能量大于用于穿刺真皮的激光脉冲束的能量。因此，真皮中的锥形激光穿刺孔的截面形状的深度可被控制到必须的最小值，且不会留下疤痕，穿刺过程中的疼痛较小，且可进行稳定的血液采样。In addition, the time width of the laser pulse beam used to puncture the epidermis is equal to or greater than that of the laser pulse beam used to puncture the dermis, and the energy of the laser pulse beam used to puncture the epidermis is greater than the energy of the laser pulse beam used to puncture the dermis . Therefore, the depth of the cross-sectional shape of the tapered laser puncture hole in the dermis can be controlled to the necessary minimum without leaving a scar, the pain during the puncture is small, and stable blood sampling can be performed.

第十四实施例Fourteenth embodiment

首先，将描述本发明已经发明的研究内容。本发明已发现作为研究血液采样过程中疼痛的结果的以下事实。即，用于血液采样的人的皮肤的穿刺由针直接进行，和由激光束间接地进行。如果发生与人体的相互作用，可给予人体对于作用的反应。此外，疼痛的检测机构是通过对于表皮的侧部上的真皮的自由神经末梢的刺激的神经反应，其检测疼痛。当神经反应量高于疼痛检测阈值时，疼痛被检测。First, the research content that the present invention has invented will be described. The present inventors have discovered the following facts as a result of studying pain during blood sampling. That is, puncturing of human skin for blood sampling is performed directly by a needle, and indirectly by a laser beam. If an interaction with the human body occurs, the human body's response to the effect can be given. Furthermore, the detection mechanism of pain is through the neural response to the stimulation of free nerve endings of the dermis on the side of the epidermis, which detects pain. Pain is detected when the amount of neural response is above the pain detection threshold.

即，为了实现无痛穿刺，使得神经反应量低于疼痛检测阈值，或者考虑使得疼痛检测阈值充分高的装置。为了使得神经反应量较小，希望在没有自由神经末梢的位置进行穿刺，以不刺激其它自由神经末梢。然而，作为通常的血液采样点，手指尖具有较高密度的自由神经末梢，且不容易避开。That is, in order to achieve painless puncture, the amount of nerve response is lower than the pain detection threshold, or a device that makes the pain detection threshold sufficiently high is considered. In order to keep the amount of nerve response small, it is desirable to puncture at a location without free nerve endings so as not to stimulate other free nerve endings. However, fingertips, as usual blood sampling sites, have a higher density of free nerve endings and are not easily avoided.

同时，还被证实的是，疼痛检测阈值可从外部控制到某些程度。即，已发现，降低疼痛检测阈值的作用随着人对于刺激的意识而改变。该意识可通过把人的意识集中到穿刺时机以外而被降低。At the same time, it was also demonstrated that the pain detection threshold can be externally controlled to some extent. That is, it has been found that the effect of lowering the pain detection threshold varies with the person's awareness of the stimulus. This awareness can be reduced by focusing the person's awareness away from the timing of the piercing.

特别地，已发现，当激光穿刺装置使用时，同时给予使用者周期性声音，例如泵的运转声音或发动机声，使用者的意识被集中到该周期性声音，而非穿刺的时机，且激光穿刺期间由刺激导致的疼痛的感觉被降低。In particular, it has been found that when the laser puncturing device is used, while giving the user a periodic sound, such as the sound of a pump running or an engine, the user's consciousness is focused on the periodic sound, rather than the timing of the puncture, and the laser The sensation of pain caused by stimulation during puncture is reduced.

另外，可准备任意类型的周期性声音，且可以每次随机改变。此外，从周期性声音的产生到激光穿刺的时间可以每次随机改变。这是因为，如果使用者总听到相同的周期性声音，则不能把使用者的意识集中到该周期性声音上，且如果到激光穿刺的时间总是相同，则使用者可无意地意识到激光穿刺的时机。In addition, any type of periodic sound can be prepared, and can be changed randomly every time. In addition, the time from the generation of the periodic sound to the laser perforation can be randomly changed each time. This is because if the user always hears the same periodic sound, the user's consciousness cannot be focused on the periodic sound, and if the time until the laser perforation is always the same, the user may unintentionally realize Timing of laser perforation.

图35是根据本发明的实施例的激光穿刺装置1的示意图。该激光穿刺装置1包括主体2、包括操作电源的激光振荡器9、聚光透镜12、穿刺帽507、控制板11、电池10、操作开关5、设定按钮4、显示器3和扬声器517。电池10、控制板11和激光振荡器9、控制板11和激光振荡器9、设定按钮4、显示器3、操作开关5和扬声器517电和信号连接。扬声器517基于内部产生的控制信号产生周期性声音，如下文所述。Fig. 35 is a schematic diagram of thelaser perforating device 1 according to the embodiment of the present invention. Thelaser puncture device 1 includes amain body 2 , alaser oscillator 9 including an operating power source, acondenser lens 12 , apuncture cap 507 , acontrol panel 11 , abattery 10 , anoperation switch 5 , asetting button 4 , adisplay 3 and aspeaker 517 . Thebattery 10, thecontrol board 11 and thelaser oscillator 9, thecontrol board 11 and thelaser oscillator 9, thesetting button 4, thedisplay 3, theoperation switch 5 and thespeaker 517 are electrically and signally connected.Speaker 517 produces periodic sounds based on internally generated control signals, as described below.

图36是根据本发明的实施例的激光穿刺装置1的操作的流程图。该操作将根据该流程图予以描述。首先，使用者按下操作开关5(步骤S11)时，激光穿刺装置1开始启动。接着，使用者通过设定按钮4输入条件，例如激光穿刺条件(步骤S12)。Fig. 36 is a flowchart of the operation of thelaser perforating device 1 according to the embodiment of the present invention. The operation will be described based on this flowchart. First, when the user presses the operation switch 5 (step S11), thelaser puncturing device 1 starts to start. Next, the user inputs conditions, such as laser puncture conditions, through the setting button 4 (step S12).

在设定后，使用者把作为穿刺点的他/她的手指压在穿刺帽507上。同时，穿刺帽507可被替换(步骤S13)。接着，当使用者再次按下操作开关5时(步骤S14)，周期性声音开始从扬声器517中发出(步骤S17)，且激光振荡器9的操作电源进入待命状态(步骤S15)。After setting, the user presses his/her finger as the piercing point on the piercingcap 507 . Meanwhile, the piercingcap 507 can be replaced (step S13). Then, when the user presses theoperation switch 5 again (step S14), the periodic sound starts to be emitted from the speaker 517 (step S17), and the operation power of thelaser oscillator 9 enters a standby state (step S15).

接着，激光振荡器9振荡具有特定时序的激光脉冲束，振荡的激光脉冲束被聚光透镜12聚焦且聚焦在使用者的手指的皮肤上，同时其束直径设置得较小，位于中空穿刺帽507中。然后，激光束被皮肤吸收，且皮肤被加热和蒸发，其由此被穿刺(步骤S16)。Next, thelaser oscillator 9 oscillates a laser pulse beam with a specific time sequence, the oscillating laser pulse beam is focused by thecondenser lens 12 and focused on the skin of the user's finger, while its beam diameter is set to be smaller, located in thehollow puncture cap 507 in. Then, the laser beam is absorbed by the skin, and the skin is heated and evaporated, thereby being punctured (step S16).

通过穿刺，皮肤的表皮和其真皮的最外表面蒸发，例如真皮的皮肤乳突中的毛细管被创伤，血液渗出。然后，血液通过穿刺的孔渗出皮肤的表面。周期性声音在激光穿刺后的特定固定周期后消失(步骤S18)。By puncturing, the epidermis of the skin and the outermost surface of its dermis evaporate, for example the capillaries in the dermal papillae of the dermis are traumatized and blood oozes out. The blood then seeps to the surface of the skin through the pierced hole. The periodic sound disappears after a certain fixed period after the laser puncture (step S18).

根据该实施例的激光穿刺装置1，使用者的意识被集中在周期性声音上。因此，使用者不会等待激光穿刺的时机，且可在疼痛的感觉的阈值较低的状态下进行激光穿刺。因此，可减轻疼痛。According to thelaser perforating device 1 of this embodiment, the user's consciousness is focused on the periodic sound. Therefore, the user does not wait for the timing of laser puncture, and can perform laser puncture in a state where the pain threshold is low. Therefore, pain can be reduced.

此外，存在几种周期性声音，且从周期性声音的产生(步骤S17)到激光穿刺(步骤S16)的时间可每次随机改变。因此，使用者不会习惯于该周期性声音或时间，而可以把他/她的意识集中在激光穿刺以外的事情上。In addition, there are several kinds of periodic sounds, and the time from the generation of the periodic sounds (step S17) to the laser perforation (step S16) can be randomly changed each time. Therefore, the user does not get used to the periodic sound or time, and can concentrate his/her consciousness on things other than laser perforation.

图37是显示被根据本发明的实施例的激光穿刺装置1使用的周期性声音的例子的视图。这里，周期性声音是指单调重复的声音，例如泵或发动机的声音，或重复节拍内的特定范围内的声音，例如节拍器的声音。FIG. 37 is a view showing an example of periodic sounds used by thelaser perforating device 1 according to the embodiment of the present invention. Here, the periodic sound refers to a monotonously repeated sound, such as the sound of a pump or a motor, or a sound within a specific range within a repeating beat, such as the sound of a metronome.

图37(a)是例如泵或发动机的声音的单调重复的声音的强度的视图。单调重复的声音是低频声音，其中心频率为20至100Hz，且更优选地为40至70Hz。因此，使用者可将他的意识指向该声音，而不感觉分散。FIG. 37( a ) is a view of the intensity of a monotonously repetitive sound such as the sound of a pump or an engine. The monotonously repetitive sound is a low-frequency sound with a center frequency of 20 to 100 Hz, and more preferably 40 to 70 Hz. Therefore, the user can direct his consciousness to the sound without feeling distracted.

图37(b)是例如节拍器的声音的具有重复节拍的特定范围的声音的强度的视图。对于具有重复节拍的其它声音，有机械开关的ON/OFF声音、敲击键盘的声音等。如果以节拍器的标准(每分钟击打多少次)表示的话重复的节拍是在60至208的范围之内，且更优选地为120至180。因此，使用者可把他的意识指向拍子而不感觉刺激。FIG. 37( b ) is a view of the intensity of a certain range of sounds having repeating beats, such as the sound of a metronome. For other sounds with repeating beats, there are ON/OFF sounds of mechanical switches, keyboard tapping sounds, and the like. The repeated beats are in the range of 60 to 208, and more preferably 120 to 180, if expressed in terms of a metronome (beats per minute). Therefore, the user can direct his consciousness to the beat without feeling stimulation.

图38是显示该实施例的激光穿刺装置1的内部结构的框图。如该图所示，激光穿刺装置1设置有作为穿刺装置的激光振荡器9、显示器3、操作开关5、设定按钮4、CPU 721，用来存储使CPU 721进行周围环境声音处理的程序719和周期性声音信息720的存储器718、用于产生周期性声音的周期性声音处理单元722、以及作为声源的扬声器517。FIG. 38 is a block diagram showing the internal structure of thelaser perforating device 1 of this embodiment. As shown in the figure, thelaser puncturing device 1 is provided with alaser oscillator 9 as a puncturing device, adisplay 3, anoperation switch 5, asetting button 4, and aCPU 721 for storing aprogram 719 for causing theCPU 721 to process ambient sound. and amemory 718 for periodicsound information 720, a periodicsound processing unit 722 for generating periodic sound, and aspeaker 517 as a sound source.

在存储器718中，多个周期性声音被存储为周期性声音信息720，这些声音例如为单调重复的声音，如泵或发动机的声音，和重复节拍的特定范围的声音，如节拍器的声音。当激光穿刺的条件等被从设定按钮4设定后操作开关5被按下时，根据储存在存储器718中的程序719，CPU 721从存储器718中读取预定项目的周期性声音信息720，其与根据随机函数产生的随机数值对应，且传送其到周期性声音处理单元722，以从扬声器517产生预定的周期性声音。In thememory 718, a plurality of periodic sounds are stored asperiodic sound information 720, such as monotonically repeated sounds such as the sound of a pump or a motor, and sounds of a specific range repeating beats such as the sound of a metronome. When theoperation switch 5 is pressed after the condition of laser perforation etc. is set from thesetting button 4, according to theprogram 719 stored in thememory 718, theCPU 721 reads theperiodic sound information 720 of the predetermined item from thememory 718, It corresponds to a random value generated according to a random function, and is transmitted to the periodicsound processing unit 722 to generate a predetermined periodic sound from thespeaker 517 .

此后，在经过根据随机函数产生的随机时间后，CPU 721使得皮肤被来自激光振荡器9的激光脉冲束照射，由此进行穿刺。同样，在该实施例的激光穿刺装置1中，在穿刺过程中产生随机的周期性声音，且从周期性声音的产生到激光尺寸的时间随机地变化。因此，使用者的意识可被从穿刺分散。此外，使使用者难于等待激光穿刺的时机。由此，穿刺过程中的疼痛可别减轻。Thereafter, after a random time generated according to a random function, theCPU 721 causes the skin to be irradiated with a laser pulse beam from thelaser oscillator 9, thereby performing puncture. Also, in thelaser puncturing device 1 of this embodiment, random periodic sounds are generated during puncturing, and the time from the generation of the periodic sounds to the size of the laser light varies randomly. Therefore, the user's consciousness can be distracted from the puncture. In addition, it is difficult for the user to wait for the timing of laser puncture. As a result, the pain during the puncture can be reduced.

如上所述，根据该实施例的激光穿刺装置1，产生周期性的仿真声音，使用者的意识被转移到该声音，且使得使用者不意识到穿刺时机。因此，可在使用者感觉疼痛的阈值水平的状态下进行激光穿刺。As described above, according to thelaser puncturing device 1 of this embodiment, a periodic simulated sound is generated to which the user's consciousness is shifted and the user is made unaware of the puncturing timing. Therefore, laser perforation can be performed at a threshold level at which the user feels pain.

此外，在穿刺过程中产生随机周期性声音，且从周期性声音的产生到激光穿刺的时间随机地改变。因此，使用者的意识可被从穿刺转移。此外，使用者难于等待激光穿刺的时机。因此，穿刺过程中的疼痛可被减轻。In addition, a random periodic sound is generated during puncturing, and the time from generation of the periodic sound to laser puncturing is randomly changed. Therefore, the user's consciousness can be diverted from the puncture. In addition, it is difficult for the user to wait for the opportunity of laser puncture. Therefore, pain during puncturing can be reduced.

第十五实施例Fifteenth embodiment

在描述本发明的实施例之前，首先，将描述本发明已达成的进步。通过激光脉冲束进行的激光穿刺是通过穿刺被瞄准的表皮、破坏真皮内的皮肤乳突中的毛细管，使得血液从毛细管渗出，且使得血液穿过表皮中的孔渗出皮肤。此外，激光脉冲束对皮肤的激光穿刺的实现是由于皮肤被皮肤内吸收的激光脉冲束能量加热和蒸发。Before describing the embodiments of the present invention, first, the progress achieved by the present invention will be described. Laser perforation with a pulsed laser beam works by puncturing the targeted epidermis, disrupting the capillaries in the skin papillae within the dermis, causing blood to seep from the capillaries, and allowing the blood to seep out of the skin through pores in the epidermis. In addition, the laser puncture of the skin by the laser pulse beam is achieved because the skin is heated and evaporated by the energy of the laser pulse beam absorbed in the skin.

皮肤的主要成分是水，且选择具有高的水吸收系数的激光脉冲束的波长。例如，使用Er:YAG固态激光介质的2.94μm的波长被最有效地吸收到水，且可允许使用最低激光脉冲束能量进行穿刺。The main component of the skin is water, and the wavelength of the laser pulse beam is selected to have a high water absorption coefficient. For example, the wavelength of 2.94 μm using Er:YAG solid-state laser media is most efficiently absorbed into water and may allow perforation with the lowest laser pulse beam energy.

因此，激光穿刺要求的激光脉冲束能量中的个体之间的形式的形成因素包括皮肤的表皮的厚度和表皮的含水量。通常，真皮的厚度随年龄变大，男人的真皮比女人厚，且肤色和皮肤的厚度的关系是黑皮肤最厚，黄皮肤第二厚，且白皮肤最薄。此外，皮肤的厚度还跟人的手指尖的使用频率有关，且使用其手指尖的音乐家和运动员具有比一般人厚的皮肤。Thus, inter-individual form factors in the laser pulse beam energy required for laser perforation include the thickness of the epidermis of the skin and the moisture content of the epidermis. Generally, the thickness of the dermis increases with age, and the dermis of men is thicker than that of women, and the relationship between skin color and skin thickness is that black skin is the thickest, yellow skin is the second thickest, and white skin is the thinnest. In addition, the thickness of the skin is also related to the frequency of use of a person's fingertips, and musicians and athletes who use their fingertips have thicker skin than the average person.

而且，尽管表皮的含水量与表皮的厚度也具有负关联，其具有比表皮的厚度更随机的个体差别。此外，由于表皮的最上表面的含水量与周围环境的湿度平衡，天与天之间以及一天之内存在波动。Also, although the moisture content of the epidermis also has a negative correlation with the thickness of the epidermis, it has more random individual differences than the thickness of the epidermis. Furthermore, there are fluctuations from day to day and within a day as the moisture content of the uppermost surface of the epidermis is in balance with the humidity of the surrounding environment.

此外，由于本发明的研究结果，证明了，如果利用与传统的激光穿刺装置比较非常小的聚光直径(＜φ0.15mm)，由于个体差异，该含水量比表皮的厚度对于激光穿刺有更大的作用。已证明，在例如φ0.5mm的聚光直径处，激光穿刺要求的激光脉冲束能量有大约两倍的差异，而在φ0.15mm的聚光直径处，几乎看不到差异。已发现，尽管表皮的厚度不大，也存在较大的差异。然而，在表皮的含水量中没有差异。In addition, due to the research results of the present invention, it has been proved that the water content is more effective for laser puncture than the thickness of the epidermis due to individual differences if a very small light-concentrating diameter (<φ0.15 mm) is used compared with conventional laser puncture devices. big effect. It has been proved that at a focal diameter of eg φ0.5 mm, the laser pulse beam energy required for laser perforation differs by about two times, while at a focal diameter of φ0.15 mm, almost no difference is visible. It was found that, despite the small thickness of the epidermis, there were large differences. However, there was no difference in the moisture content of the epidermis.

由于以上研究，根据本发明的实施例的激光穿刺装置被配置，使得含水量传感器可设置在接触使用者的皮肤的穿刺帽内。因此，穿刺点的含水量可在穿刺前被测量此外，使用者的属性，如年龄、性别、人种和肤质(厚、硬、薄和软)被预先输入。Due to the above studies, the laser perforation device according to the embodiment of the present invention is configured such that the water content sensor can be provided in the perforation cap contacting the user's skin. Therefore, the water content of the puncture point can be measured before the puncture. In addition, the attributes of the user such as age, sex, race, and skin type (thick, hard, thin, and soft) are input in advance.

此外，从年龄，性别、人种和肤质的数据，与储存在激光穿刺装置内的存储器内的激光脉冲束能量设定参数比较，设定值被给出，由此允许可靠的血液采样。In addition, from the data of age, sex, race and skin quality, compared with the laser pulse beam energy setting parameters stored in the memory in the laser perforating device, set values are given, thereby allowing reliable blood sampling.

而且，还可以在激光穿刺装置内部或其表面上设置湿度传感器，以测量环境空气的湿度，以确定设定值。另外，测量含水量的传感器可设置在激光穿刺装置的表面上而被穿刺头上。Moreover, a humidity sensor can also be arranged inside or on the surface of the laser perforating device to measure the humidity of the ambient air to determine the set value. Additionally, a sensor for measuring water content may be provided on the surface of the laser perforating device and on the perforating head.

根据本发明的实施例的激光穿刺装置1与图35所示的几乎相同。该实施例的激光穿刺装置1包括主体2、包括操作电源的激光振荡器9、聚光透镜12、穿刺帽507、控制板11、电池10、操作开关5、设定按钮4和显示器3。电池10、控制板11和激光振荡器9、控制板11和激光振荡器9、设定按钮4、显示器3和操作开关5电和信号连接。然而，在该实施例中，含水量测量传感器设置在穿刺帽507中，且通过穿刺帽507与控制板11连接。Thelaser perforating device 1 according to the embodiment of the present invention is almost the same as that shown in FIG. 35 . Thelaser perforation device 1 of this embodiment includes amain body 2 , alaser oscillator 9 including an operating power source, acondenser lens 12 , apuncture cap 507 , acontrol panel 11 , abattery 10 , anoperation switch 5 , asetting button 4 and adisplay 3 . Thebattery 10, thecontrol board 11 and thelaser oscillator 9, thecontrol board 11 and thelaser oscillator 9, thesetting button 4, thedisplay 3 and theoperation switch 5 are electrically and signally connected. However, in this embodiment, the water content measurement sensor is disposed in the piercingcap 507 and connected to thecontrol board 11 through the piercingcap 507 .

图39是本发明的实施例的激光穿刺装置1中，设置有含水量测量传感器的穿刺帽507的示意图。穿刺帽507具有基于圆柱体513的形状，主体的侧部上的帽的开口安装有聚光透镜保护膜506。聚光透镜保护膜506不吸收激光束，而是传播激光束。该膜具有激光穿刺期间从皮肤蒸发的组织碎片粘附到聚光透镜12上并污染该透镜12。Fig. 39 is a schematic diagram of the piercingcap 507 provided with the water content measurement sensor in thelaser piercing device 1 according to the embodiment of the present invention. The piercingcap 507 has a shape based on a cylinder 513 , and the opening of the cap on the side of the main body is fitted with a condenser lens protective film 506 . The condensing lens protective film 506 does not absorb the laser beam, but propagates the laser beam. The film has tissue fragments evaporated from the skin during laser perforation adhering to and contaminating thecondenser lens 12 .

对于该聚光透镜保护膜506的基材，可使用尼龙、聚酯、聚酰亚胺、氟系、氯乙烯、聚苯乙烯、聚乙烯、聚烯烃、聚乙烯醇、聚丙烯等。Nylon, polyester, polyimide, fluorine-based, vinyl chloride, polystyrene, polyethylene, polyolefin, polyvinyl alcohol, polypropylene, etc. can be used as the base material of the condenser lens protective film 506 .

开口设置在接触人手指的用于穿刺部分，且该开口安装有穿刺膜508。穿刺膜508传播激光束，且吸收激光束而被穿刺。而且，用于测量含水量的传感器电极821被设置环绕穿刺膜的周围。在穿刺帽507中，传感器电极821被固定到中空体513，且传感器电极的表面涂覆有绝缘材料玻璃。另外，连接部分814电连接传感器电极821和装置主体2。另外，连接部分814可设置在中空体513的外周面或内周面。An opening is provided at a portion for puncturing that contacts a human finger, and a puncturing membrane 508 is installed on the opening. The puncture film 508 propagates the laser beam and absorbs the laser beam to be punctured. Also, a sensor electrode 821 for measuring the water content is provided around the circumference of the punctured membrane. In the piercingcap 507, the sensor electrode 821 is fixed to the hollow body 513, and the surface of the sensor electrode is coated with insulating material glass. In addition, the connection portion 814 electrically connects the sensor electrode 821 and the devicemain body 2 . In addition, the connecting portion 814 may be provided on the outer peripheral surface or the inner peripheral surface of the hollow body 513 .

当该穿刺帽507被贴到皮肤上时，电容形成，其中表皮的角质层具体地用作介质体。尽管该电容的静电容量由作为介质体的皮肤的介质常数决定，但该介质常数严重依赖于皮肤含水量。这是因为水的比介质常数约为80，与形成角质层的其它物质的介质常数例如蛋白质的介质常数约1.5相比较大。因此，该静电容量显著地反映了皮肤含水量，且如果皮肤含水量改变，静电容量的数值也大幅改变。When the piercingcap 507 is applied to the skin, a capacitor is formed, wherein the stratum corneum of the epidermis is used in particular as a medium. Although the electrostatic capacity of this capacitor is determined by the dielectric constant of the skin as a medium body, the dielectric constant is heavily dependent on the water content of the skin. This is because the specific dielectric constant of water is about 80, which is large compared with the dielectric constant of other substances forming the stratum corneum, such as protein, which is about 1.5. Therefore, the electrostatic capacity significantly reflects the water content of the skin, and if the water content of the skin changes, the value of the electrostatic capacity also greatly changes.

图40(a)是穿刺帽507贴到皮肤的状态的横断面图。在穿刺帽507的末端，传感器电极821固定到基板，传感器的表面涂覆有绝缘材料玻璃。当该穿刺帽507被贴到皮肤时，如该图所示，传感器电极821不直接接触皮肤，但经由绝缘材料玻璃接触皮肤。Fig. 40(a) is a cross-sectional view of the state where thepuncture cap 507 is attached to the skin. At the end of the piercingcap 507, sensor electrodes 821 are fixed to the substrate, the surface of the sensor is coated with insulating material glass. When the piercingcap 507 is attached to the skin, as shown in the figure, the sensor electrodes 821 do not directly contact the skin, but contact the skin via the insulating material glass.

另一方面，待检测的人的皮肤从表面依次由皮脂层826、角质层827和表皮828组成。当传感器电极821贴到皮肤时，其中角质层827被用作介质体的电容器形成，如图中所示的C。尽管该电容器的静电容量C由介质体皮肤的介质常数决定，该介质常数严重依赖于皮肤含水量。On the other hand, the skin of a person to be tested is composed of a sebum layer 826 , a stratum corneum 827 , and an epidermis 828 in order from the surface. When the sensor electrode 821 is attached to the skin, a capacitor in which the stratum corneum 827 is used as a dielectric body is formed, as shown in C in the figure. Although the electrostatic capacity C of the capacitor is determined by the dielectric constant of the skin as a medium, the dielectric constant is heavily dependent on the water content of the skin.

静电容量检测装置能产生具有由静电容量和电阻值决定的频率的矩形波，且转化该振动频率为皮肤含水量。图40(b)是解释用于获取静电容量C的改变的静电容量检测装置的示意框图。The electrostatic capacity detection device can generate a rectangular wave with a frequency determined by the electrostatic capacity and resistance value, and convert the vibration frequency into skin water content. FIG. 40(b) is a schematic block diagram explaining an electrostatic capacity detection device for acquiring a change in the electrostatic capacity C. FIG.

在该图中，特别地，用于检测静电容量的部分示出电路配置的具体例子。由于该附中的C是传感器电极821之间的静电容量，且随皮肤含水量而改变，其被描述为可变电容。电路为公知的C-MOS的NOR门组成的多频振荡器。In this figure, in particular, a portion for detecting an electrostatic capacity shows a specific example of a circuit configuration. Since C in this appendix is the electrostatic capacitance between the sensor electrodes 821 and changes with the moisture content of the skin, it is described as a variable capacitance. The circuit is a multi-frequency oscillator composed of known C-MOS NOR gates.

该电路可产生具有由C和R决定的频率的矩形波。该电路配置为使得静电容量C的改变可作为振荡频率的改变而被获得。该矩形波输入到作为皮肤含水量计算装置的微型计算机819中，微型计算机819转换该频率为皮肤含水量，且把它储存在存储器820中。而且，微型计算机819根据含水量调节激光脉冲束能量。This circuit generates a rectangular wave with a frequency determined by C and R. The circuit is configured such that a change in the electrostatic capacity C can be obtained as a change in the oscillation frequency. This rectangular wave is input into the microcomputer 819 as the skin water content calculation means, and the microcomputer 819 converts the frequency into the skin water content and stores it in the memory 820. Also, the microcomputer 819 adjusts the laser pulse beam energy according to the water content.

此外，穿刺帽507设置于状态，该穿刺帽被弹簧推出用来准确测量含水量，且被设计为使得可以通过推入而测量含水量。该机构利用激光穿刺装置1的互锁来连接，且调适为聚光透镜12和手指皮肤的之间的距离可被高重复性地精确实现。另外，穿刺帽507由穿刺装置1主体的帽保持器831可分离地支撑。In addition, a piercingcap 507 is provided in a state, which is pushed out by a spring for accurate measurement of water content, and is designed so that the water content can be measured by pushing in. The mechanism is connected by means of the interlocking of thelaser perforating device 1 and is adapted so that the distance between thecondenser lens 12 and the finger skin can be precisely achieved with high repeatability. In addition, thepuncture cap 507 is detachably supported by the cap holder 831 of the main body of thepuncture device 1 .

图41是穿刺帽507的附近的横断面图。穿刺帽507连接到帽保持器831，且帽保持器831通过作为弹性体的弹簧832被组成外壳的壳833保持。通过这样的配置，帽保持器831被配置，以在穿刺帽507的部分被压靠在皮肤上时，通过弹簧832的弹性而朝壳833的内部滑动。FIG. 41 is a cross-sectional view of the piercingcap 507 and its vicinity. The piercingcap 507 is connected to a cap holder 831, and the cap holder 831 is held by a case 833 constituting the housing through a spring 832 which is an elastic body. With this configuration, the cap holder 831 is configured to slide toward the inside of the housing 833 by the elasticity of the spring 832 when part of the piercingcap 507 is pressed against the skin.

即，尽管穿刺帽507通常被弹簧832向外推，但是由于凸缘835接触壳833，穿刺帽507处于不跳跃的状态。当穿刺帽507压在皮肤上时，穿刺帽507凹进壳内部，且通过弹簧压力保持恒定。如果弹簧压力调整地合适，传感器电极821通过固定的压力接触皮肤，且因此改善了测量的稳定性。That is, although the piercingcap 507 is normally pushed outward by the spring 832, since the flange 835 contacts the housing 833, the piercingcap 507 is in a non-jumping state. When the piercingcap 507 is pressed against the skin, the piercingcap 507 is recessed inside the housing and is held constant by spring pressure. If the spring pressure is properly adjusted, the sensor electrode 821 contacts the skin with a constant pressure and thus improves the stability of the measurement.

接着，将描述操作。图42显示了根据本发明的实施例的激光穿刺装置1的使用流程。首先，使用者按压操作开关5(步骤S21)，激光穿刺装置1开始启动。然后，如果使用者首次使用激光穿刺装置1(没有步骤S22)，使用者使用设定按钮4输入例如年龄、性别、人种和肤质(厚、硬、薄和软)的特征(步骤S23)。在输入后，使用者把他/她的手指用力地完全按在帽上(步骤S24)。然后，开始皮肤含水量的测量(步骤S25)。Next, the operation will be described. Fig. 42 shows the flow of use of thelaser perforation device 1 according to the embodiment of the present invention. First, the user presses the operation switch 5 (step S21), and thelaser puncturing device 1 starts to start. Then, if the user uses thelaser perforating device 1 for the first time (without step S22), the user uses thesetting button 4 to input characteristics such as age, gender, race and skin quality (thick, hard, thin and soft) (step S23) . After the input, the user fully presses his/her finger firmly on the cap (step S24). Then, the measurement of the water content of the skin is started (step S25).

在皮肤含水量的测量之后，作为激光穿刺条件的激光脉冲束能量根据前面输入的信息和皮肤含水量的测量结果而被设定(步骤S26)。关于设定的方法示于图43中。首先，由于大致的激光脉冲束能量的比例函数根据输入条件而被准备，激光脉冲束能量相应地被设置。After the measurement of the water content of the skin, the energy of the laser pulse beam as the laser puncture condition is set based on the previously input information and the measurement result of the water content of the skin (step S26). The method for setting is shown in FIG. 43 . First, since an approximate proportional function of the laser pulse beam energy is prepared according to the input conditions, the laser pulse beam energy is set accordingly.

图43(a)是显示如何依据输入条件来设定激光脉冲束能量。如图所示，预先根据年龄高或低、性别是男或女(二元)、人种是否白种人或黄种人或黑人(肤色)、或肤质是薄或厚、或软或硬，准备激光脉冲束能量。对于该关系，可以是比例、幂和指数关系。Fig. 43(a) shows how to set the energy of the laser pulse beam according to the input conditions. As shown in the figure, according to whether the age is high or low, gender is male or female (binary), race is white or yellow or black (skin color), or skin is thin or thick, soft or hard, Prepare the laser pulse beam energy. For this relationship, proportional, power and exponential relationships are possible.

图43(b)是本发明实施例中激光脉冲束能量基于皮肤含水量的测量结果而被校正的情况的解释视图。根据上面输入条件设定的数值基于皮肤含水量的测量结果被沿该视图中的垂直方向校正，且要放射的激光脉冲束能量被确定。此时，如果含水量较多，该数值被向下校正，且校正为使得激光脉冲束能量可变低。Fig. 43(b) is an explanatory view of the case where the energy of the laser pulse beam is corrected based on the measurement result of the skin water content in the embodiment of the present invention. The values set according to the above input conditions are corrected in the vertical direction in this view based on the measurement of skin water content, and the energy of the laser pulse beam to be emitted is determined. At this time, if the water content is high, the value is corrected downward, and corrected so that the energy of the laser pulse beam can be lowered.

在校正完成后，当“待命”显示在显示器3上，且使用者再次按下操作开关5(步骤S27)时，激光振荡器振荡激光脉冲束，振荡的激光束被聚光透镜12聚焦，且聚焦在使用者的手指的皮肤上，同时其束直径设置得较小，位于中空穿刺帽507内。然后，激光束被皮肤吸收，且皮肤被加热和蒸发，由此被穿刺(步骤S28)。After the calibration is completed, when "standby" is displayed on thedisplay 3, and the user presses theoperation switch 5 again (step S27), the laser oscillator oscillates the laser pulse beam, the oscillating laser beam is focused by thecondenser lens 12, and Focused on the skin of the user's finger, while its beam diameter is set small, inside the hollow piercingcap 507 . Then, the laser beam is absorbed by the skin, and the skin is heated and vaporized, thereby being punctured (step S28).

通过穿刺，皮肤的表皮和其真皮的最上表面蒸发，例如真皮的皮肤乳突中的毛细管被创伤，且血液渗出。然后，渗出的血液穿过穿刺孔渗出皮肤表面。另外，如果相同的使用者以后再次使用生物传感器，由于以前的输入条件被储存，且第二次使用后的处理(步骤S22的“是”)从皮肤含水量的测量开始。By puncturing, the epidermis of the skin and the uppermost surface of its dermis are evaporated, for example the capillaries in the dermal papillae of the dermis are traumatized and blood oozes out. The seeped blood then oozes out of the skin surface through the puncture hole. Also, if the same user uses the biosensor again later, since the previous input conditions are stored, and the processing after the second use ("YES" in step S22) starts from the measurement of the skin water content.

因此，使用者可简单而容易地实现可靠地血液采样而不被激光脉冲束能量中的个体差异、天天的波动和一天中波动影响，且不预先进行没有采样血液的激光穿刺。Therefore, the user can simply and easily achieve reliable blood sampling without being affected by individual differences in laser pulse beam energy, day-to-day fluctuations, and day-to-day fluctuations without performing laser perforation without sampling blood in advance.

图44(a)示出示例，其中，在根据本发明的实施例的激光穿刺装置1中，测量含水量的传感器电极821设置在除了穿刺帽507以外的激光穿刺装置1的表面上。在这种情况下，在进行穿刺前，手指尖被贴到用于测量含水量的传感器电极821，且含水量随后被测量。根据该实施例的激光穿刺装置，由于测量含水量的传感器电极821设置在激光穿刺装置1的表面上，皮肤含水量可简单而容易地测量。44( a ) shows an example in which, in thelaser perforating device 1 according to the embodiment of the present invention, the sensor electrode 821 for measuring the water content is provided on the surface of thelaser perforating device 1 other than the perforatingcap 507 . In this case, before puncturing, the fingertip is attached to the sensor electrode 821 for measuring the water content, and the water content is then measured. According to the laser perforating device of this embodiment, since the sensor electrode 821 for measuring the water content is provided on the surface of thelaser perforating device 1, the water content of the skin can be measured simply and easily.

而且，还可以在激光穿刺装置内部或其表面上设置湿度传感器，以测量环境空气的湿度，以确定设定值。图44(b)示出示例，其中，在根据本发明的实施例的激光穿刺装置1中，测量环境空气的湿度的传感器822设置在激光穿刺装置1的表面上。由于环境空气的湿度与皮肤含水量密切相关，如果激光脉冲束的能量根据环境空气的湿度来校正，则可以准确地设置适于血液采样的最小激光脉冲束能量。Moreover, a humidity sensor can also be arranged inside or on the surface of the laser perforating device to measure the humidity of the ambient air to determine the set value. FIG. 44( b ) shows an example in which, in thelaser perforating device 1 according to the embodiment of the present invention, a sensor 822 that measures the humidity of ambient air is provided on the surface of thelaser perforating device 1 . Since the humidity of the ambient air is closely related to the moisture content of the skin, if the energy of the laser pulse beam is corrected according to the humidity of the ambient air, the minimum laser pulse beam energy suitable for blood sampling can be accurately set.

图45是激光穿刺期间的激光穿刺点的放大视图。首先，当使用者按下操作开关5时，激光穿刺装置1开始启动。然后，使用者使用设定按钮4输入激光穿刺装置1的操作条件。在输入后，使用者把穿刺帽507插入主体2，其把作为穿刺点的他/她的手指压在穿刺帽507上。然后，皮肤含水量被测量，且作为激光穿刺条件的激光脉冲束能量根据前面输入信息和皮肤含水量的测量结果而被设定。Fig. 45 is an enlarged view of a laser perforation point during laser perforation. First, when the user presses theoperation switch 5, thelaser perforating device 1 starts to start. Then, the user inputs the operating conditions of thelaser perforating device 1 using thesetting button 4 . After the input, the user inserts the piercingcap 507 into themain body 2 , who presses his/her finger as a piercing point on the piercingcap 507 . Then, the water content of the skin is measured, and the energy of the laser pulse beam as the laser puncture condition is set based on the previously input information and the measurement result of the water content of the skin.

在准备完成后，当“待命”显示在显示器3且使用者再次按下操作开关5时，激光振荡器9振荡激光脉冲束，振荡的激光束被聚光透镜12聚焦，且聚焦在使用者的手指的皮肤上，同时其束直径设置得较小，以位于中空穿刺帽507内。然后，激光束被皮肤吸收，且皮肤被加热和蒸发，由此被穿刺。通过穿刺，皮肤的表皮和其真皮的最上表面蒸发，例如真皮的皮肤乳突中的毛细管被创伤，且血液渗出。然后，渗出的血液穿过穿刺孔渗出皮肤表面。After the preparation is completed, when "standby" is displayed on thedisplay 3 and the user presses theoperation switch 5 again, thelaser oscillator 9 oscillates the laser pulse beam, and the oscillating laser beam is focused by thecondenser lens 12 and focused on the user's on the skin of the finger while its bundle diameter is set smaller to be located within the hollow piercingcap 507. Then, the laser beam is absorbed by the skin, and the skin is heated and vaporized, thereby being punctured. By puncturing, the epidermis of the skin and the uppermost surface of its dermis are evaporated, for example the capillaries in the dermal papillae of the dermis are traumatized and blood oozes out. The seeped blood then oozes out of the skin surface through the puncture hole.

此时，没有孔形成在聚光透镜保护膜506中，而激光束被皮肤接触处的穿刺膜508吸收，由此形成孔。穿过该孔，在前的激光穿刺被执行。在激光穿刺期间由于皮肤蒸发产生的烟流穿过穿刺膜508的孔扩散到中空体513中。At this time, no hole is formed in the condensing lens protective film 506, but the laser beam is absorbed by the puncture film 508 where the skin contacts, thereby forming a hole. Through this hole, the preceding laser perforation is performed. The plume generated by skin evaporation during laser perforation diffuses through the pores of the perforation membrane 508 into the hollow body 513 .

由构成皮肤组织的蛋白质的成分氨基酸产生的挥发性物质被分解流动在烟流中。激光穿刺过程中的主要目标角质层由角蛋白质的纤维组织组成，且纤维是由胱氨酸键结合，该键是氨基酸胱氨酸的硫部分的键，其包含的相对较多。由于这些氨基酸在蒸发过程中分解，产生挥发性硫化合物或氮成分，人感觉到作为异味的硫化合物。Volatile substances generated from amino acids, which are components of proteins that make up skin tissue, are decomposed and flow in the smoke. The main target stratum corneum during laser perforation is composed of fibrous tissue of keratin, and the fibers are bound by cystine bonds, which are bonds of the sulfur moiety of the amino acid cystine, which contain relatively many. Humans perceive the sulfur compounds as off-flavors as these amino acids decompose during the evaporation process, producing volatile sulfur compounds or nitrogen components.

因此，对于烟流中的异味成分的除臭功能被设置到穿刺适配器507的内部。硫化氢或甲基硫醇作为主要的硫化合物被提及。硫化氢可通过化学吸附剂除臭，且可使用锰、铜和钴的复合氧合物。另外，类似地，通过使用包括锰、铜、锌和钴任意一种的氧化物、氢氧化物、复合氧合物、或其混合物，可获得对于硫化氢的有效的化学吸收作用的吸附剂。Therefore, a deodorizing function for odor components in smoke is provided inside the piercingadapter 507 . Hydrogen sulfide or methyl mercaptan are mentioned as main sulfur compounds. Hydrogen sulfide can be deodorized by a chemical adsorbent, and complex oxygen compounds of manganese, copper, and cobalt can be used. In addition, similarly, by using an oxide, a hydroxide, a composite oxygen compound, or a mixture thereof including any one of manganese, copper, zinc, and cobalt, an adsorbent effective in chemical absorption for hydrogen sulfide can be obtained.

化学吸附剂化学地吸收硫化氢，最终是以硫酸盐或简单的硫物质的形式。此外，化学吸附剂还具有媒介作用，其转换同样的硫基异味的甲基硫醇为具有较高阈值的二甲基二硫醚。由于该作用，人可感觉到相当于除臭的效果。Chemisorbents chemically absorb hydrogen sulfide, ultimately in the form of sulfate or simple sulfur species. In addition, the chemisorbent also acts as an intermediary, which converts the same sulfur-based off-flavor methyl mercaptan to dimethyl disulfide with a higher threshold. Due to this action, humans can perceive an effect corresponding to deodorization.

而且，由于二甲基二硫醚可通过使用装载的物理吸附剂的物理吸附剂作用而被去除，其大体上可去除硫化合物。具有较大部分硅的疏水沸石可被用作物理吸附剂。另外，即使使用沸石、海泡石、硅石、氧化铝等，也可得到相同的效果。Also, since dimethyl disulfide can be removed by physisorbent action using a loaded physisorbent, it can substantially remove sulfur compounds. Hydrophobic zeolites with a larger fraction of silicon can be used as physical adsorbents. In addition, even if zeolite, sepiolite, silica, alumina, etc. are used, the same effect can be obtained.

这些化学吸附剂和物理吸附剂可通过添加到聚光透镜膜506、穿刺膜508或穿刺帽507。或吸收剂可涂覆在聚光透镜膜506、穿刺膜508或穿刺帽507的内部上。These chemisorbents and physisorbents can be added to the condenser lens film 506 , the puncture film 508 or thepuncture cap 507 . Or the absorber can be coated on the inside of the condenser lens film 506 , piercing film 508 or piercingcap 507 .

此外，由于穿刺膜508接触使用者的手指，优选地给予膜抗菌特性。抗菌特性可通过涂覆或混炼到基材之上或之内而实现。这些抗菌剂包括Ag、Cu、Zn、Ni、Co或它们的合金、TiO₂、ZnO、WO₃等。另外，抗菌特性通过不仅植入在穿刺膜508上而且在穿刺帽507的中空体513的外表面上而有效。Furthermore, since the piercing membrane 508 is in contact with the user's finger, it preferably imparts antimicrobial properties to the membrane. Antimicrobial properties can be achieved by coating or compounding onto or into the substrate. These antibacterial agents include Ag, Cu, Zn, Ni, Co or their alloys, TiO₂ , ZnO, WO₃ and the like. In addition, the antimicrobial properties are effective by being embedded not only on the puncture membrane 508 but also on the outer surface of the hollow body 513 of thepuncture cap 507 .

如上所述，根据该实施例的激光穿刺装置1和激光穿刺方法，激光脉冲束能量根据通过测量皮肤含水量的传感器821测量得到的皮肤含水量而被调节。因此，可以根据皮肤含水量的波动设定理想的激光脉冲束能量，且可以进行可靠的血液采样而不进行穿刺测试，且几乎没有疼痛。As described above, according to thelaser perforating device 1 and the laser perforating method of this embodiment, the laser pulse beam energy is adjusted according to the water content of the skin measured by the sensor 821 for measuring the water content of the skin. Therefore, ideal laser pulse beam energy can be set according to fluctuations in skin moisture content, and reliable blood sampling can be performed without puncture testing with little pain.

此外，设置有设定按钮，其输入使用者的属性，如年龄、性别、人种或肤质，且激光脉冲束能量根据从设定按钮输入的年龄、性别、人种或肤质而被调节。因此，可以皮肤条件设定理想的激光脉冲束能量，且可以进行几乎没有疼痛的可靠的血液采样。In addition, a setting button is provided, which inputs user's attributes such as age, sex, race or skin type, and the laser pulse beam energy is adjusted according to the age, sex, race or skin type input from the setting button . Therefore, ideal laser pulse beam energy can be set for skin conditions, and reliable blood sampling with little pain can be performed.

第十六实施例Sixteenth embodiment

本发明的第十六实施例设计一种新形插入体，其中片、插入体和试纸是一体的。当不具有成分浓度测量功能的激光穿刺装置被考虑时，膜插入体的整体配置和膜也是允许的。The sixteenth embodiment of the present invention designs a new type of insert, wherein the sheet, insert and test paper are integrated. The overall configuration of the membrane insert and the membrane is also permissible when a laser perforation device without component concentration measurement is considered.

图46是本发明的第十六实施例中的修改的插入保持器907的详细透视图。在该图中，参考标记913表示中空体，标记906表示膜，标记908表示生物传感器，标记914表示第一电极，标记915表示第二电极。FIG. 46 is a detailed perspective view of a modifiedinsertion holder 907 in the sixteenth embodiment of the present invention. In this figure,reference numeral 913 denotes a hollow body, numeral 906 denotes a membrane, numeral 908 denotes a biosensor, numeral 914 denotes a first electrode, and numeral 915 denotes a second electrode.

插入保持器907与例如根据第五实施例(图13)的插入保持器207相同，且主体上的插入保持器907的开口安装有膜906。膜906与滑片6的膜33相同。Theinsertion holder 907 is the same as, for example, theinsertion holder 207 according to the fifth embodiment ( FIG. 13 ), and the opening of theinsertion holder 907 on the main body is fitted with afilm 906 . Themembrane 906 is identical to themembrane 33 of theslider 6 .

生物传感器908被插入到插入保持器907的与其在主体侧部上的开口相对的开口中。生物传感器908与生物传感器8相同。尽管在图46中未示出，生物传感器8的样本试剂供应通道56配置为位于插入保持器907的外周部分。此外，生物传感器8的测量电极252和电极电偶253设置为使得它们可分别连接到第一电极914和第二电极915。Thebiosensor 908 is inserted into the opening of theinsertion holder 907 opposite to its opening on the main body side.Biosensor 908 is the same asbiosensor 8 . Although not shown in FIG. 46 , the samplereagent supply channel 56 of thebiosensor 8 is configured to be located at the outer peripheral portion of theinsertion holder 907 . Furthermore, themeasurement electrode 252 and theelectrode couple 253 of thebiosensor 8 are arranged such that they can be connected to thefirst electrode 914 and thesecond electrode 915, respectively.

插入保持器907曾由生物传感器8、插入保持器207和滑片6三个元件构成，但是现在由一个插入保持器907构成。因此，有这样的优点：当使用者使用该装置是要替换的零件的数目可以是仅一个。Theinsertion holder 907 was composed of three elements of thebiosensor 8, theinsertion holder 207, and theslider 6, but is now composed of oneinsertion holder 907. Therefore, there is an advantage that the number of parts to be replaced when the user uses the device can be only one.

图47是根据该实施例的生物传感器补片型插入保持器。在该图中，标记913表示中空体，标记906表示聚光透镜保护膜，标记908表示生物传感器，标记914表示第一电极，标记916表示手指托膜，标记917表示样本试剂供应通道开口。与主体的分析单元电连接的一组电极形成在中空体913的外周从而电化学地使用生物传感器，且由第一电极914和未示出的第二电极构成。Fig. 47 is a biosensor patch type insertion holder according to this embodiment. In this figure,reference numeral 913 denotes a hollow body,reference numeral 906 denotes a condenser lens protective film,reference numeral 908 denotes a biosensor,reference numeral 914 denotes a first electrode,reference numeral 916 denotes a finger support film, andreference numeral 917 denotes an opening of a sample reagent supply channel. A set of electrodes electrically connected to the analysis unit of the main body is formed on the outer periphery of thehollow body 913 to electrochemically use the biosensor, and is composed of afirst electrode 914 and a second electrode not shown.

聚光透镜保护膜906形成在插入保持器907的主体侧部上和激光束的光轴上，以包括激光束。生物传感器908贴在插入保持器907的与主体相对的侧部上激光束的光轴上，以包括激光束。A condenser lensprotective film 906 is formed on the main body side of theinsertion holder 907 and on the optical axis of the laser beam so as to contain the laser beam. Thebiosensor 908 is attached on the optical axis of the laser beam on the side of theinsertion holder 907 opposite to the main body so as to include the laser beam.

在包括生物传感器908的光轴和激光束的部分，手指托膜916形成在要被照射的皮肤压靠的位置。此外，用来供应激光穿刺后从皮肤渗出的血液等到生物传感器908的样本试剂供应通道形成在生物传感器908的侧面。手指托膜916是吸收激光束且被穿刺的膜。通过把手指压在手指托膜916上，被照射的部分可被固定且可被稳定地穿刺。At a portion including the optical axis of thebiosensor 908 and the laser beam, afinger rest 916 is formed at a position where the skin to be irradiated is pressed against. In addition, a sample reagent supply channel for supplying blood or the like exuded from the skin after laser perforation to thebiosensor 908 is formed on the side of thebiosensor 908 . Thefinger rest membrane 916 is a membrane that absorbs the laser beam and is punctured. By pressing the finger against thefinger pad 916, the irradiated portion can be fixed and stably punctured.

图48是图47的生物传感器908的详细视图和中心断面图(另外，该配置的各个部分与第五实施例的图14的相同)。为了把生物传感器908和图47中空体913外周的第一电极914和第二电极(未示出)电连接，生物传感器908的侧部上的各个电极暴露在生物传感器908的侧部上外周上，且在贴附期间这些电极彼此接触。Fig. 48 is a detailed view and a central sectional view of thebiosensor 908 of Fig. 47 (in addition, the respective parts of the configuration are the same as those of Fig. 14 of the fifth embodiment). In order to electrically connect thebiosensor 908 with thefirst electrode 914 and the second electrode (not shown) on the periphery of thehollow body 913 in FIG. , and these electrodes are in contact with each other during attachment.

图49是中空生物传感器型插入保持器907的示意图，其中生物传感器弯曲成中空体且它们的端部被连接，且聚光透镜保护膜和手指托膜设置在中空体的两个端部。在该图中，参考标记913、908表示中空体和生物传感器，参考标记906表示聚光透镜保护膜，参考标记914表示第一电极，参考标记916表示手指托膜，参考标记917表示样本试剂供应通道开口，参考标记918表示第二电极，且参考标记919表示空气孔。49 is a schematic diagram of a hollow biosensortype insertion holder 907 in which biosensors are bent into hollow bodies and their ends are connected, and condenser lens protective films and finger rest films are provided at both ends of the hollow body. In this figure,reference numerals 913, 908 denote hollow bodies and biosensors,reference numeral 906 denotes a condenser lens protective film,reference numeral 914 denotes a first electrode,reference numeral 916 denotes a finger rest membrane, andreference numeral 917 denotes a sample reagent supply. A channel opening,reference numeral 918 denotes a second electrode, andreference numeral 919 denotes an air hole.

该保持器的获得是通过使传统的生物传感器(例如图59)的隔板和盖板的尺寸与绝缘层相同，使第一电极914和第二电极918暴露于隔板和盖板，且设置切口以在中空体弯曲成中空体并制成为插入保持器时能嵌合到主体的插入保持器容纳部分。电极暴露于未示出的主体的侧部上的插入保持器容纳部分的插入保持器侧，且当插入保持器907被配合时，允许与生物传感器的各个电极的电连接。The holder is obtained by making the spacer and cover of a conventional biosensor (eg, FIG. 59 ) the same size as the insulating layer, exposing thefirst electrode 914 and thesecond electrode 918 to the spacer and cover, and setting A cutout is made to fit to the insertion holder accommodating portion of the main body when the hollow body is bent into a hollow body and made into the insertion holder. The electrodes are exposed on the insertion holder side of the insertion holder accommodating portion on the side of the main body not shown, and allow electrical connection with respective electrodes of the biosensor when theinsertion holder 907 is fitted.

聚光透镜保护膜906被贴在制成中空体内的生物传感器的主体侧部上，且手指托膜916被贴在与主体侧部相对的表面上。此外，样本试剂供应通道开口917设置在手指托膜916的侧部上，且空气孔919设置在插入保持器907的外周，使得采样的血液可通过毛细现象流动穿过样本试剂流道。A condenser lensprotective film 906 is attached to the main body side of the biosensor made in the hollow body, and afinger rest film 916 is attached to the surface opposite to the main body side. Furthermore, a sample reagentsupply channel opening 917 is provided on the side of thefinger holder 916, and anair hole 919 is provided on the outer periphery of theinsertion holder 907 so that sampled blood can flow through the sample reagent flow channel by capillary phenomenon.

第十七实施例Seventeenth embodiment

本发明的第十七实施例涉及一种双脉冲激光脉冲束，尤其涉及利用第一弱发射的穿刺试纸膜和利用第二强发射穿刺皮肤的穿刺方法。The seventeenth embodiment of the present invention relates to a double-pulse laser pulse beam, in particular to a puncturing method for puncturing a test paper membrane by using the first weak emission and by using the second strong emission to puncture the skin.

图50是显示本发明的第十七实施例中的激光脉冲束的振荡状态的视图。如图50所示，激光穿刺是通过第一激光脉冲束和第二激光脉冲束进行的。这里，第一激光脉冲束的光能量和峰值光强度设置为弱于第二激光脉冲束的光能量和峰值光强度。Fig. 50 is a view showing an oscillation state of a laser pulse beam in a seventeenth embodiment of the present invention. As shown in FIG. 50, laser perforation is performed by a first laser pulse beam and a second laser pulse beam. Here, the light energy and peak light intensity of the first laser pulse beam are set to be weaker than the light energy and peak light intensity of the second laser pulse beam.

图51(a)是本发明的第十七实施例中的第一激光脉冲束照射后的激光穿刺点的放大视图，图51(b)是第二激光脉冲束照射后的激光穿刺点的放大视图。激光束被聚光透镜12聚焦在进行激光穿刺的使用者的手指18上且其地点是激光束的地点17。Fig. 51(a) is an enlarged view of the laser puncture point after irradiation of the first laser pulse beam in the seventeenth embodiment of the present invention, and Fig. 51(b) is an enlarged view of the laser puncture point after irradiation of the second laser pulse beam view. The laser beam is focused by the condensinglens 12 on thefinger 18 of the user performing the laser puncture at thelocation 17 of the laser beam.

使用者的手指18接触生物传感器8的膜54，且激光束17从主体传播同时其束直径逐渐地收缩，如同图51(a)。激光束17设置为以传播穿过滑片6的膜33、开口32、插入保持器907的内部、生物传感器8的开口24、以及膜54传播，从而聚焦在使用者的手指18上。The user'sfinger 18 touches thefilm 54 of thebiosensor 8, and thelaser beam 17 propagates from the main body while its beam diameter gradually shrinks, as in FIG. 51(a). Thelaser beam 17 is arranged to propagate through themembrane 33 of theslide 6 , theopening 32 , the inside of theinsertion holder 907 , the opening 24 of thebiosensor 8 , and themembrane 54 so as to be focused on the user'sfinger 18 .

组成滑片6的开口32的开口59、60和61的开口直径、插入保持器907的内径和生物传感器8的开口22可以具有这样的直径，即激光束17基本上没有被遮蔽，且所有直径不必相同。此外，开口的最小直径为1mm。The opening diameters of theopenings 59, 60, and 61 constituting theopening 32 of theslide 6, the inner diameter of theinsertion holder 907, and theopening 22 of thebiosensor 8 may have such diameters that thelaser beam 17 is substantially not shielded, and all diameters It doesn't have to be the same. In addition, the minimum diameter of the opening is 1 mm.

第一激光脉冲束被膜33部分地吸收，但膜中没有形成通孔，同时激光束17几乎聚集在膜54上，且其能量密度较高。因此，激光束被膜吸收以加热和蒸发该膜，由此形成通孔(图51(a))。随后，第二激光脉冲束被使用者的手指18的皮肤吸收，以加热和蒸发皮肤，由此最终破坏真皮的毛细管，以允许血液采样(图51(b))。The first laser pulse beam is partially absorbed by thefilm 33, but no through hole is formed in the film, while thelaser beam 17 is almost focused on thefilm 54, and its energy density is high. Accordingly, the laser beam is absorbed by the film to heat and evaporate the film, thereby forming via holes (FIG. 51(a)). Subsequently, a second laser pulse beam is absorbed by the skin of the user'sfinger 18 to heat and vaporize the skin, thereby eventually breaking the capillaries of the dermis to allow blood sampling (Fig. 51(b)).

因此，由第一激光脉冲束在膜54中形成通孔，且当皮肤的激光穿刺条件中存在个体差异时，通过调节第二激光脉冲束可允许稳定的血液采样。Therefore, a through hole is formed in thefilm 54 by the first laser pulse beam, and when there is an individual difference in the laser puncture condition of the skin, stable blood sampling can be allowed by adjusting the second laser pulse beam.

第十八实施例Eighteenth embodiment

图52显示了根据本发明的第十八实施例的激光穿刺用生物传感器。该实施例的生物传感器是生物传感器，其中样本试剂供应通道设置在膜的侧部上。图52(a)是平面图，图52(b)是当图52(a)的传感器沿纵向在中心部分剖切时的横断面图。在图52中，存在一特征，样本试剂供应通道307不与生物传感器的外侧连接，而是与盖板开口311连接。此外，由于空气孔309设置为面对横跨试剂层305的样本试剂供应通道307，其位置改变。Fig. 52 shows a biosensor for laser perforation according to an eighteenth embodiment of the present invention. The biosensor of this embodiment is a biosensor in which the sample reagent supply channel is provided on the side of the membrane. Fig. 52(a) is a plan view, and Fig. 52(b) is a cross-sectional view when the sensor of Fig. 52(a) is cut at the central portion in the longitudinal direction. In FIG. 52 , there is a feature that the samplereagent supply channel 307 is not connected to the outside of the biosensor, but is connected to thecover plate opening 311 . In addition, since theair hole 309 is provided to face the samplereagent supply channel 307 across thereagent layer 305, its position is changed.

接着，将利用图53描述操作。图53(a)是显示传感器、手指和激光束在使用时的关系的视图。激光束13被膜325部分地吸收，但在该膜中没有形成通孔，同时激光束被聚集在膜304上，以加热和蒸发该膜，由此形成通孔。随后，激光束被使用者的手指314的皮肤吸收，以加热和蒸发皮肤，由此最终破坏真皮的毛细管。Next, the operation will be described using FIG. 53 . Fig. 53(a) is a view showing the relationship of the sensor, finger and laser beam in use. Thelaser beam 13 is partially absorbed by thefilm 325, but no through hole is formed in the film, while the laser beam is focused on thefilm 304 to heat and evaporate the film, thereby forming a through hole. Subsequently, the laser beam is absorbed by the skin of the user'sfinger 314 to heat and vaporize the skin, thereby eventually destroying the capillaries of the dermis.

图53(b)是详细显示激光穿刺后的状态的视图。在图53(b)中，利用激光束在膜304中形成通孔。类似地，激光穿刺的孔316形成在使用者的手指314的皮肤中。Fig. 53(b) is a view showing in detail the state after laser perforation. In FIG. 53(b), a via hole is formed in thefilm 304 using a laser beam. Similarly, a laser-puncturedhole 316 is formed in the skin of the user'sfinger 314 .

从创伤的毛细管渗出的血液穿过激光穿刺的孔316渗出到手指314的外部。利用空气孔309，渗出的血液穿过样本试剂供应通道307通过毛细现象供应到试剂层305，因此血液中的成分浓度可被测量。Blood seeping from the capillaries of the wound seeps to the outside of thefinger 314 through the laser-puncturedholes 316 . With theair hole 309, the seeped blood is supplied to thereagent layer 305 through the samplereagent supply channel 307 by capillary phenomenon, so that the concentration of components in the blood can be measured.

根据该配置，使用者可供应作为测量目标的血液到生物传感器，即使他/她没有把他/她的手指在激光穿刺后带到样本试剂供应通道。According to this configuration, the user can supply blood as a measurement target to the biosensor even if he/she does not bring his/her finger to the sample reagent supply channel after laser puncture.

第十九实施例Nineteenth embodiment

图54显示了本发明的第十九实施例中的激光穿刺后的激光穿刺点的放大视图。在该实施例中，激光穿刺是利用从人体的侧部上的膜开口的中心偏向样本供应通道的激光光轴进行的。在该图中，d-1是表示传感器的开口310、311和312以及传感器的312的大致中心的中心线，且d-2是表示激光束313的中心的激光光轴。Fig. 54 shows an enlarged view of a laser puncture point after laser puncture in the nineteenth embodiment of the present invention. In this embodiment, laser perforation is performed with the optical axis of the laser offset from the center of the membrane opening on the side of the human body toward the sample supply channel. In this figure, d−1 is a centerline representing the approximate center of theopenings 310 , 311 , and 312 of the sensor and 312 of the sensor, and d−2 is a laser optical axis representing the center of thelaser beam 313 .

在该实施例中，传感器的开口的中心轴d1和激光光轴d-2在不同的位置，尽管它们平行。特别地，激光光轴d-2被设置到偏向样本试剂供应通道307的位置。激光穿刺在激光光轴d-2与使用者的手指314相交的地方进行，且从皮肤的真皮的被激光穿刺创伤的毛细管渗出的血液渗出手指314的外部。由于渗出的血液比传感器开口中心d-1更靠近样本试剂供应通道307，可以更有效地通过毛细现象接触试剂层305。In this embodiment, the central axis d1 of the opening of the sensor and the laser optical axis d-2 are at different positions although they are parallel. In particular, the laser optical axis d-2 is set to a position deviated from the samplereagent supply channel 307 . The laser puncture is performed at the place where the laser optical axis d- 2 intersects the user'sfinger 314 , and blood seeps out of thefinger 314 from the capillary of the dermis of the skin wounded by the laser puncture. Since the oozing blood is closer to the samplereagent supply channel 307 than the sensor opening center d-1, it can more effectively contact thereagent layer 305 through capillary phenomenon.

第二十实施例Twentieth embodiment

在该实施例的激光穿刺装置中，激光振荡器620与第十三实施例的图33的相同。该激光振荡器620包括：激光棒625，用于激光束谐振器的镜膜623和624形成在其端部；用于激发激光束的闪光灯621；用于把闪光灯621的光线有效引导到激光棒625的灯罩622。另外，还有用于操作闪光灯621的电源(未示出)。In the laser perforating device of this embodiment, thelaser oscillator 620 is the same as that of FIG. 33 of the thirteenth embodiment. Thislaser oscillator 620 includes: a laser bar 625, mirror films 623 and 624 for the laser beam resonator are formed at its ends; a flash lamp 621 for exciting the laser beam; a light beam for effectively guiding the flash lamp 621 to the laser bar 625 shades 622. In addition, there is a power source (not shown) for operating the flash 621 .

从闪光灯621发出的白光被直接反射或在灯罩722内部，且激光棒625的吸收的波长被激光棒625吸收。然后，激光棒625内的活性介质被激励，且反转分布形成。自发发射光在激光棒625内部传播，且被在激光棒625的两个端面处的镜膜623和624反射，在光谐振器内以特征解的模式往复运动，且被感应发射放大，且被从反射系数稍低的一个镜膜引出作为激光束。The white light emitted from the flash lamp 621 is directly reflected or inside thelamp housing 722 , and the absorbed wavelength of the laser rod 625 is absorbed by the laser rod 625 . Then, the active medium within the laser rod 625 is energized, and an inversion profile is formed. The spontaneous emission light propagates inside the laser rod 625, and is reflected by the mirror films 623 and 624 at both end faces of the laser rod 625, reciprocates in the mode of the characteristic solution in the optical resonator, and is amplified by the induced emission, and is A mirror film with a slightly lower reflectance is drawn as a laser beam.

由触发电极预先离子化，通过充在电容器内的高压电荷，玻璃管内的氙气放电时，闪光灯621发出白光。同样，如果设置有真空管且存在高压电荷放电，通过放电的电极溅射现象，溅射的粒子漂流在氙气中，且白光的发射强度由于粒子光学吸收而下降。The flash lamp 621 emits white light when the xenon gas in the glass tube is discharged through the pre-ionization of the trigger electrode and the high-voltage charge charged in the capacitor. Also, if a vacuum tube is provided and there is a high-voltage charge discharge, the sputtered particles drift in the xenon gas through the electrode sputtering phenomenon of the discharge, and the emission intensity of white light decreases due to the optical absorption of the particles.

此外，由于电极的形状通过溅射而改变，特别是来自负(-)电极的空间电子供应状态改变，放电的空间同质性下降，类似地，白光的发射强度下降。而且，只要提供真空管，泄漏不会消除，即使当氙气的浓度改变时，白光的发射强度下降。这样，激励源的闪光灯621的发射强度的改变减少激光振荡器620的输出，且即使在相同的设定条件下，激光穿刺变得不可能。Furthermore, since the shape of the electrode is changed by sputtering, especially the state of the supply of space electrons from the negative (−) electrode, the spatial homogeneity of the discharge decreases, and similarly, the emission intensity of white light decreases. Also, as long as the vacuum tube is provided, the leak will not be eliminated, even if the emission intensity of white light decreases when the concentration of xenon gas is changed. In this way, a change in the emission intensity of the strobe lamp 621 of the excitation source reduces the output of thelaser oscillator 620, and laser perforation becomes impossible even under the same setting conditions.

在该实施例的激光穿刺装置中，设置有测量闪光灯621发射的白光的传感器。通过监测传感器的峰值输出，把峰值输出与设定条件中获得的进行比较。如果差别超出恒定数值(例如20％)，告知使用者状态和使使用者进行保养的消息发出。更优选地，还可以通过监测不是发射但是作为输入的闪光灯621的直接输出，来进行上述告知。In the laser perforating device of this embodiment, a sensor for measuring the white light emitted by the flash lamp 621 is provided. By monitoring the peak output of the sensor, compare the peak output with that obtained in the set conditions. If the difference exceeds a constant value (for example 20%), a message is issued to inform the user of the status and to make maintenance by the user. More preferably, the above-mentioned notification can also be performed by monitoring the direct output of the flashlight 621 which is not an emission but an input.

此外，使用上述传感器监测白光发射的频率。如果超过特定设定触发水平的设置被输入到传感器，这被存储器计数。该计数可在激光穿刺装置的显示器上显示合计和固定周期内的计数值(在一次重启后)。In addition, the frequency of white light emission was monitored using the sensor described above. If settings exceeding a certain set trigger level are input to the sensor, this is counted by the memory. The count can be displayed on the display of the laser puncturing device as a total and a count value within a fixed period (after a restart).

相应地，如果该计数接近合计的次数的固定数字，使用者被提示要求保养，且如果该计数超过合计的次数的固定数字，可能禁止使用，且要求使用者保养。Correspondingly, if the count is close to a fixed number of total times, the user is prompted to require maintenance, and if the count exceeds the fixed number of total times, use may be prohibited and the user is required to maintain.

此外，例如，如果糖尿病患者使用该装置作为用于在家测量他/她自己血液葡萄糖水平的血液采样装置，和用来控制他/她的血液葡萄糖水平，例如胰岛素给药和口服给药，由于现有穿刺装置的针型穿刺装置简单且其元件较少，其非常便宜。由于与针型穿刺装置相比，该激光穿刺装置具有压倒性的许多组成零件，其难于以与针型穿刺装置相同的价格提供。In addition, for example, if a diabetic patient uses the device as a blood sampling device for measuring his/her own blood glucose level at home, and for controlling his/her blood glucose level, such as insulin administration and oral administration, due to the present Needle piercing devices with piercing devices are simple and have fewer components, which are very cheap. Since the laser puncturing device has an overwhelming number of constituent parts compared with the needle-type puncturing device, it is difficult to provide at the same price as the needle-type puncturing device.

然而，如果使用针型穿刺装置，每次使用要购买新针且替换。因此，如果即使在激光穿刺装置中也允许根据使用次数计算费率，可能使得最初成本便宜。However, if a needle-type lancing device is used, a new needle must be purchased and replaced for each use. Therefore, if it is allowed to calculate the rate according to the number of usages even in the laser perforating device, it is possible to make the initial cost cheap.

对于费率，使用保险系统接收治疗的病人携带此激光穿刺装置，例如，当他/她每个月有规律地去医院一次，保健专家可确定使用的次数，且增加和收取医疗费用。此外，如果在医疗机构使用该穿刺针在，对于制造商或销售商可以周期性地走访，以确定使用次数，收取费用。而且，还可以给该激光穿刺装置的外部设置有线或无线通讯功能，以利用该功能从外部确定使用次数，且向使用者收取费用。For the rate, the patient receiving treatment with the insurance system carries this laser perforating device, for example, when he/she goes to the hospital regularly once a month, the health care professional can determine the number of times of use, and increase and charge the medical fee. In addition, if the puncture needle is used in a medical institution, the manufacturer or seller can periodically visit to determine the number of times of use and charge a fee. Moreover, a wired or wireless communication function may be provided on the outside of the laser puncturing device, so as to use this function to determine the number of times of use from the outside and charge the user.

图55是根据该实施例的激光穿刺装置的示意图。该激光穿刺装置包括：主体2、组成激光振荡器的激光头952和激光电源951、聚光透镜12、穿刺帽507、控制板11、电池10、操作开关5、设定按钮4、显示器3和光电传感器950。电池10和控制板11、激光电源951和光电传感器950、控制板11、激光电源951、设定按钮4、显示器3、操作开关5、以及光电传感器950电和信号连接。Fig. 55 is a schematic diagram of the laser perforating device according to this embodiment. This laser puncture device comprises:main body 2,laser head 952 andlaser power supply 951 that form laser oscillator,condenser lens 12,puncture cap 507,control panel 11,battery 10,operation switch 5,setting button 4,display 3 andPhotoelectric sensor 950.Battery 10 andcontrol board 11,laser power supply 951 andphotoelectric sensor 950,control board 11,laser power supply 951, settingbutton 4,display 3,operation switch 5, andphotoelectric sensor 950 are electrically and signally connected.

图56显示了本实施例的激光穿刺装置的使用流程。接着，将描述操作。首先，当使用者按压操作开关5时，激光穿刺装置1开始启动(步骤S31)。接着，使用者利用设定按钮4输入例如激光穿刺条件的条件(步骤S32)。同时，固定周期内的使用次数的计数可被复位(步骤S41)。这里，当没有前进到前面流程中的固定周期时，激光穿刺装置将自动处于结束状态。Fig. 56 shows the flow of using the laser puncture device of this embodiment. Next, the operation will be described. First, when the user presses theoperation switch 5, thelaser perforating device 1 starts to start (step S31). Next, the user inputs conditions such as laser puncture conditions using the setting button 4 (step S32). At the same time, the count of the number of times of use within a fixed period may be reset (step S41). Here, the laser perforating device will automatically be in the end state when the fixed period in the previous flow is not advanced.

在输入后，当使用者把他/他的作为穿刺点的手指压在穿刺帽507上时(步骤S33)，当“待命”显示在显示器3上，且当使用者再次按下操作开关5时(步骤S34)时，激光振荡器34振荡激光脉冲束，振荡的激光束被聚光透镜12聚焦，且聚焦在使用者的手指的皮肤上，同时其束直径设置得较小，以位于中空穿刺帽507中。然后，激光束被皮肤吸收，且皮肤被渐热和蒸发，由此被穿刺(步骤S35)。通过穿刺，皮肤的表皮和其真皮的最上表面蒸发，例如真皮的皮肤乳突中的毛细管被创伤，且血液渗出。然后，血液穿过穿刺的孔渗出皮肤表面。After the input, when the user presses his/his finger as the puncture point on the puncture cap 507 (step S33), when "standby" is displayed on thedisplay 3, and when the user presses theoperation switch 5 again (Step S34), the laser oscillator 34 oscillates the laser pulse beam, the oscillating laser beam is focused by thecondenser lens 12, and focused on the skin of the user's finger, and its beam diameter is set smaller at the same time, so as to be located in thehollow puncture Cap 507. Then, the laser beam is absorbed by the skin, and the skin is gradually heated and evaporated, thereby being punctured (step S35). By puncturing, the epidermis of the skin and the uppermost surface of its dermis are evaporated, for example the capillaries in the dermal papillae of the dermis are traumatized and blood oozes out. The blood then oozes out of the skin's surface through the pierced hole.

同时，激光穿刺装置内的光电传感器950测量发射白光以操作激光振荡器的闪光灯621的光发射的波形(步骤S42)。另外，被聚光透镜12反射的激光脉冲束的传播波形被观测。对于光电传感器950，具有从Si或InGaAs的可见光到不包括激光脉冲束的近红外光的灵敏性的传感器可用于白光。Simultaneously, thephotosensor 950 inside the laser perforating device measures the waveform of the light emission of the flash lamp 621 emitting white light to operate the laser oscillator (step S42). In addition, the propagation waveform of the laser pulse beam reflected by the condensinglens 12 is observed. For thephotosensor 950, a sensor having sensitivity from visible light of Si or InGaAs to near-infrared light excluding laser pulse beams may be used for white light.

此外，由于目标皮肤的主要成分是水，所以选择具有高的水吸收系数的激光脉冲束的波长。例如，使用Er:YAG固态激光介质的2.94μm的波长能最有效地吸收到水里，且允许利用最低激光脉冲束能量进行穿刺，因此，作为激光脉冲束的传感器，选择对于红外光具有灵敏性且优选地在室温下操作的传感器，例如HgCdTe(MCT)。In addition, since the main component of the target skin is water, the wavelength of the laser pulse beam having a high water absorption coefficient is selected. For example, the wavelength of 2.94 μm using Er:YAG solid-state laser medium can absorb into the water most effectively and allow the puncture with the lowest laser pulse beam energy. Therefore, as a sensor for the laser pulse beam, it is selected to have sensitivity to infrared light And preferably a sensor operating at room temperature, such as HgCdTe(MCT).

光电传感器950测量的光波形被如下分析。图57(a)是用来解释分析光波形的方法的视图。在该附图中，横坐标轴表示时间，纵坐标轴表示检测的光强度。此外，图57(b)示出光电传感器950检测从自激光头952发射的光的方面。The light waveform measured by thephotosensor 950 is analyzed as follows. Fig. 57(a) is a view for explaining a method of analyzing an optical waveform. In this drawing, the axis of abscissas represents time, and the axis of ordinates represents detected light intensity. In addition, FIG. 57( b ) shows an aspect in which thephotosensor 950 detects light emitted from thelaser head 952 .

首先，如果输入超过预设触发水平，则进行波形记录。在普通环境下，在设置在主体中的光电传感器950中，触发水平被设定到触发不会由于外部白光或红外光而有效的水平。如果输入超过该触发，控制板11中的存储器的计数的数字增加1(步骤S43)。First, waveform recording is performed if the input exceeds a preset trigger level. Under normal circumstances, in thephotosensor 950 provided in the main body, the trigger level is set to a level at which the trigger is not effective due to external white light or infrared light. If the input exceeds the trigger, the counted number of the memory in thecontrol board 11 is incremented by 1 (step S43).

接着，类似地，波状峰值数值被记录在控制板11中的存储器中(步骤S45)。然后，与基于通过条件设定而设置的激光穿刺条件而预先储存在存储器中的估计峰值数值进行比较。然后，测量的峰值数值与估计的峰值数值比较(步骤S46)。然后，如果测量的峰值数值低于估计的峰值数值一允许的下限水平，显示器3的要求保养的显示被执行。Next, similarly, the waveform peak value is recorded in the memory in the control board 11 (step S45). Then, it is compared with an estimated peak value stored in memory in advance based on the laser perforation conditions set by the condition setting. Then, the measured peak value is compared with the estimated peak value (step S46). Then, if the measured peak value is lower than the estimated peak value by an allowable lower limit level, the display of thedisplay 3 requiring maintenance is performed.

此外，如果从开始使用的综合次数的数字接近类似地预先储存在控制板11内的存储器中的上限次数的数字，保养临近的消息显示在显示器3上，且如果达到上限综合次数的数字，显示器3的要求保养的显示被执行。如果显示要求保养，还可以执行禁止接着使用和锁定该装置的显示。In addition, if the number of integration times from the beginning of use is close to the number of the upper limit number of times similarly pre-stored in the memory in thecontrol board 11, a message that maintenance is imminent is displayed on thedisplay 3, and if the number of the upper limit integration times is reached, thedisplay 3. The display of the required maintenance is carried out. Inhibition of further use and locking of the device can also be performed if maintenance is required.

为了显示合计和固定周期内的综合次数的数字，可以在条件输入屏幕上操作设定按钮4，由此使得它们被显示。此外，可以设定密码，由此使得仅主管人员复位固定周期内的综合次数的数字。而且，尽管未示出，可通过在外部设置通讯功能，例如有线通讯(电话线或LAN电路)或无线通讯(移动通讯、红外通讯或无线LAN)，从外部读取固定周期内的综合次数的数字。In order to display the numbers of the total and the integrated times within a fixed period, thesetting button 4 can be operated on the condition input screen, thereby causing them to be displayed. In addition, a password may be set, thereby allowing only a person in charge to reset the number of integrated times within a fixed period. And, although not shown, can be by externally setting communication function, such as wired communication (telephone line or LAN circuit) or wireless communication (mobile communication, infrared communication or wireless LAN), can read from the outside the integrated number of times in fixed period. number.

尽管本发明以参考特定实施例予以详细描述，对于本领域技术人员清楚的是，可进行各种替换和修改而不离开本发明的精神和范围。本申请要求2006年3月22日提交的日本专利申请No.2006-078430、2006年3月24日提交的日本专利申请No.2006-082303、2006年4月13日提交的日本专利申请2006-110673、以及2006年4月14日提交的日本专利申请2006-111805的利益，其引用结合于此。Although the present invention has been described in detail with reference to specific embodiments, it will be apparent to those skilled in the art that various alternatives and modifications can be made without departing from the spirit and scope of the invention. This application claims Japanese Patent Application No. 2006-078430 filed on March 22, 2006, Japanese Patent Application No. 2006-082303 filed on March 24, 2006, Japanese Patent Application No. 2006-082303 filed on April 13, 2006 110673, and for the benefit of Japanese Patent Application 2006-111805 filed Apr. 14, 2006, which are incorporated herein by reference.

工业实用性Industrial Applicability

如上所述，根据本发明的成分浓度测量装置具有防止激光束穿刺过程中产生的包含异味的烟流泄漏到外部、处理作为异味成分的烟流的作用，且被用作生物传感器和可利用激光束穿刺人体的皮肤的成分浓度测量装置，且快速和容易地确定采样的生物样本中的很小量的各种特定成分的数量。As described above, the component concentration measuring device according to the present invention has the functions of preventing the leakage of the mist-containing mist generated during laser beam puncture to the outside, processing the mist as the mist component, and is used as a biosensor and can utilize laser light. A component concentration measuring device whose beam penetrates the skin of a human body, and quickly and easily determines the amount of various specific components in a very small amount in a sampled biological sample.

Claims (70)

Translated fromChinese

1.一种成分浓度测量装置，包括：1. An ingredient concentration measuring device comprising:主体，其至少具有发射激光束的激光装置、所述激光束的聚光装置、体液的成分的分析装置、以及显示由所述分析装置计算的结果的显示装置；a main body having at least laser means for emitting a laser beam, light-condensing means for said laser beam, analysis means for components of body fluid, and display means for displaying results calculated by said analysis means;片；piece;具有不遮蔽所述激光束的开口的插入体；和an insert having an opening that does not shield said laser beam; and试纸，test strips,其中所述主体沿所述激光束的光轴方向设置开口，Wherein the main body is provided with an opening along the optical axis direction of the laser beam,其中所述开口安装有所述插入体，且所述插入体的一端安装有所述试纸，以及wherein the opening is fitted with the insert, and one end of the insert is fitted with the test paper, and其中所述片提供位于所述聚光装置和所述插入体之间的膜，且所述膜不被所述激光束穿刺。Wherein said sheet provides a membrane between said light concentrating means and said insert, and said membrane is not pierced by said laser beam.2.如权利要求1所述的成分浓度测量装置，其中所述试纸设置有成分测量用电极，所述插入体设置有电极，且所述试纸的成分测量用电极和所述插入体的电极通过与所述试纸嵌合而电连接。2. The component concentration measuring device according to claim 1, wherein the test paper is provided with an electrode for component measurement, the insert is provided with an electrode, and the component measurement electrode of the test paper and the electrode of the insert pass through Fitted with the test paper to be electrically connected.3.如权利要求1所述的成分浓度测量装置，其中所述分析装置通过样本试剂的酶反应分析所述体液的成分。3. The component concentration measuring device according to claim 1, wherein said analysis device analyzes components of said body fluid by an enzymatic reaction of a sample reagent.4.如权利要求3所述的成分浓度测量装置，其中所述分析装置是通过样本试剂的显色反应分析所述体液的成分的光学装置。4. The component concentration measuring device according to claim 3, wherein the analysis device is an optical device that analyzes components of the body fluid by a color reaction of a sample reagent.5.如权利要求1所述的成分浓度测量装置，其中所述试纸提供位于所述激光束的光轴上被激光束穿刺的膜。5. The component concentration measuring device according to claim 1, wherein said test paper provides a film on an optical axis of said laser beam pierced by a laser beam.6.如权利要求5所述的成分浓度测量装置，其中所述试纸还提供位于所述激光束的光轴上没有被激光束穿刺的膜。6. The component concentration measuring device according to claim 5, wherein said test paper is further provided with a film on the optical axis of said laser beam which is not pierced by the laser beam.7.如权利要求1所述的成分浓度测量装置，其中所述试纸还具有如同所述片的功能。7. The component concentration measuring device according to claim 1, wherein said test paper also functions as said sheet.8.如权利要求7所述的成分浓度测量装置，其中所述试纸还提供位于所述激光束的光轴上用作所述片的膜，当用作所述片时，所述膜不被激光束穿刺。8. The component concentration measuring device according to claim 7, wherein said test paper is further provided with a film on the optical axis of said laser beam serving as said sheet, and when used as said sheet, said film is not Laser beam puncture.9.如权利要求1所述的成分浓度测量装置，其中在所述插入体的主体和开口之间的嵌合的侧部上设置有非对称结构。9. The component concentration measuring device according to claim 1, wherein an asymmetric structure is provided on a side portion of the fitting between the main body of the insert and the opening.10.如权利要求1所述的成分浓度测量装置，其中所述试纸和所述插入体之间的嵌合是通过非对称结构进行的。10. The component concentration measuring device according to claim 1, wherein the fitting between the test paper and the insert is performed by an asymmetric structure.11.如权利要求10所述的成分浓度测量装置，其中所述试纸和所述插入体之间的嵌合是通过所述试纸的开口和所述插入体的突起之间的嵌合进行的。11. The component concentration measuring device according to claim 10, wherein the fitting between the test paper and the insert is performed by fitting between the opening of the test paper and the protrusion of the insert.12.如权利要求1所述的成分浓度测量装置，其中所述片的膜、所述插入体、以及所述试纸的膜的至少一部分或全部设置有除臭功能。12. The component concentration measuring device according to claim 1, wherein at least a part or all of the film of the sheet, the insert, and the film of the test paper are provided with a deodorizing function.13.如权利要求1所述的成分浓度测量装置，其中所述试纸、所述插入体、以及所述试纸的膜的至少一部分或全部设置有抗菌功能。13. The component concentration measuring device according to claim 1, wherein at least a part or all of the test paper, the insert, and the film of the test paper are provided with an antibacterial function.14.一种用于分析利用激光束穿刺来收集的样本标本中的成分的生物传感器，14. A biosensor for analyzing components in a sample specimen collected by laser beam puncture,其中所述传感器形成样本供应通道，所供应的样本标本通过所述样本供应通道被吸到所述第一和第二基板之间；通过贴合在所述第一和第二基板之间，过滤器和与所述样本标本中的成分反应的试剂设置在所述样本供应通道内；且从所述样本供应通道通到外部的空气孔设置在所述第二基板内，以及Wherein the sensor forms a sample supply channel, and the supplied sample specimen is sucked between the first and second substrates through the sample supply channel; by being attached between the first and second substrates, the filter a reagent and a reagent reacting with components in the sample specimen are disposed in the sample supply channel; and an air hole leading from the sample supply channel to the outside is disposed in the second substrate, and其中所述试剂具有酶和色原体，其特定地与所述成分反应，部分或全部共用的开口设置在所述第一和第二基板中的样本供应通道的外部，且所述第一和第二基板的至少任意一个开口设置有膜。wherein the reagents have enzymes and chromogens that specifically react with the components, partially or fully common openings are provided outside the sample supply channels in the first and second substrates, and the first and At least any one opening of the second substrate is provided with a film.15.如权利要求14所述的生物传感器，其中所述膜具有除臭功能。15. The biosensor according to claim 14, wherein the film has a deodorizing function.16.如权利要求14或15所述的生物传感器，其中所述第一和第二基板还设置有所述开口之外的部分或全部共用的开口。16. The biosensor according to claim 14 or 15, wherein the first and second substrates are further provided with some or all common openings other than the openings.17.一种用于分析利用激光束穿刺来收集的样本标本中的成分的生物传感器，17. A biosensor for analyzing components in a sample specimen collected by laser beam puncture,其中所述传感器形成样本供应通道，所供应的样本标本通过所述样本供应通道被吸到所述第一和第二基板之间；至少通过贴合在所述第一和第二基板之间，与所述样本标本中的成分反应的试剂设置在所述样本供应通道内；且从所述样本供应通道通到外部的空气孔设置在所述第二基板内，wherein the sensor forms a sample supply channel through which the supplied sample specimen is sucked between the first and second substrates; at least by being attached between the first and second substrates, a reagent reacting with a component in the sample specimen is provided in the sample supply channel; and an air hole leading from the sample supply channel to the outside is provided in the second substrate,其中所述传感器具有电极系统，所述电极系统至少包括测量电极和电极电偶，且反应被所述电极系统检测，以及wherein the sensor has an electrode system comprising at least a measuring electrode and a galvanic electrode, and a reaction is detected by the electrode system, and部分或全部共用的开口设置在所述第一和第二基板中的所述样本供应通道的外部，且所述第一和第二基板的至少任意一个开口设置有膜。A partially or fully common opening is provided outside the sample supply channel in the first and second substrates, and at least any one of the openings of the first and second substrates is provided with a membrane.18.如权利要求17所述的激光穿刺用生物传感器，其中所述膜具有除臭功能。18. The biosensor for laser perforation according to claim 17, wherein the film has a deodorizing function.19.如权利要求17或18所述的激光穿刺用生物传感器，其中所述第一和第二基板还设置有所述开口之外的部分或全部共用的开口。19. The biosensor for laser perforation according to claim 17 or 18, wherein the first and second substrates are further provided with some or all common openings other than the openings.20.如权利要求17或18所述的激光穿刺用生物传感器，其中所述第一和第二基板还设置有所述开口之外的分享部分或全部的至少两个开口，使得所述电极系统可露出。20. The biosensor for laser perforation as claimed in claim 17 or 18, wherein the first and second substrates are also provided with at least two openings other than the openings that share part or all of them, so that the electrode system can be exposed.21.一种成分浓度测量装置，包括：21. An ingredient concentration measuring device comprising:主体，其至少具有发射激光束的激光装置、所述激光束的聚光装置、体液的成分的分析装置、以及显示由所述分析装置计算的结果的显示装置；a main body having at least laser means for emitting a laser beam, light-condensing means for said laser beam, analysis means for components of body fluid, and display means for displaying results calculated by said analysis means;片；piece;具有激光束穿过的开口的插入体；和an insert having an opening through which the laser beam passes; and试纸，test strips,其中所述主体沿所述激光束的光轴方向设置开口，Wherein the main body is provided with an opening along the optical axis direction of the laser beam,其中所述开口安装有所述插入体，且所述插入体的一端安装有所述试纸，以及wherein the opening is fitted with the insert, and one end of the insert is fitted with the test paper, and其中所述片位于所述聚光装置和所述插入体之间，且所述片具有所述试纸的功能。Wherein the sheet is located between the light concentrating device and the insertion body, and the sheet has the function of the test paper.22.如权利要求21所述的成分浓度测量装置，其中所述片提供位于所述激光束的光轴上的膜，所述膜在用作所述片时不被所述激光束穿刺，且当用作所述试纸时被所述激光束穿刺。22. The component concentration measuring device according to claim 21, wherein said sheet provides a film positioned on the optical axis of said laser beam, said film not being pierced by said laser beam when used as said sheet, and Perforated by the laser beam when used as the test paper.23.如权利要求21所述的成分浓度测量装置，其中所述片提供位于所述激光束的光轴上的被用作所述试纸时被所述激光束穿刺的膜，且提供位于所述激光束的光轴上的被用作所述片时被所述激光束穿刺的膜。23. The component concentration measuring device according to claim 21 , wherein said sheet provides a film that is pierced by said laser beam when being used as said test paper on the optical axis of said laser beam, and provides a film located on said laser beam. The film on the optical axis of the laser beam is used as the sheet is pierced by the laser beam.24.如权利要求21所述的成分浓度测量装置，其中还提供检测所述片插入到所述主体的功能。24. The component concentration measuring device according to claim 21, wherein a function of detecting insertion of the sheet into the main body is further provided.25.如权利要求24所述的成分浓度测量装置，其中检测所述片插入到所述主体的功能是通过所述片的插入的机械接触操作来进行。25. The component concentration measuring device according to claim 24, wherein the function of detecting the insertion of the sheet into the main body is performed by a mechanical contact operation of insertion of the sheet.26.如权利要求24所述的成分浓度测量装置，其中检测所述片插入到所述主体的功能是通过设置在所述片中的电极的电连接来进行。26. The component concentration measuring device according to claim 24, wherein the function of detecting insertion of the sheet into the main body is performed by electrical connection of electrodes provided in the sheet.27.如权利要求21至26任一项所述的成分浓度测量装置，其中所述片的膜和所述插入体中的至少一个或两个设置有除臭功能。27. The component concentration measuring device according to any one of claims 21 to 26, wherein at least one or both of the film of the sheet and the insert are provided with a deodorizing function.28.如权利要求21至27任一项所述的成分浓度测量装置，其中所述插入体和所述片中的至少一个或两个设置有抗菌功能。28. The component concentration measuring device according to any one of claims 21 to 27, wherein at least one or both of the insert and the sheet are provided with an antibacterial function.29.一种安装在利用激光束照射皮肤的激光穿刺装置上由此进行穿刺的穿刺适配器，所述适配器包括：29. A puncturing adapter mounted on a laser puncturing device for irradiating skin with a laser beam to thereby puncture, the adapter comprising:在两个端部具有开口的中空体；和a hollow body having openings at both ends; and设置用来封闭所述两个端部的所述开口的第一膜和第二膜，a first membrane and a second membrane provided to close said openings of said two ends,其中所述第一膜吸收激光束且被穿刺，所述第二膜透射激光束而不吸收激光束。Wherein the first film absorbs the laser beam and is pierced, the second film transmits the laser beam without absorbing the laser beam.30.如权利要求29所述的穿刺适配器，其中所述中空体具有形成在所述第一膜周围的突起。30. The piercing adapter of claim 29, wherein the hollow body has a protrusion formed around the first membrane.31.如权利要求30或31所述的穿刺适配器，其中所述第一膜、所述中空体和所述第二膜中的至少一个设置有除臭功能。31. Piercing adapter according to claim 30 or 31, wherein at least one of said first membrane, said hollow body and said second membrane is provided with a deodorizing function.32.如权利要求30或31所述的穿刺适配器，其中所述第一膜设置有抗菌功能。32. A piercing adapter as claimed in claim 30 or 31, wherein the first membrane is provided with an antimicrobial function.33.一种包括可分离的如权利要求29至32任一项所述的穿刺适配器的激光穿刺装置，所述中空体的中心轴和激光光轴设置为彼此重合。33. A laser puncture device comprising a detachable puncture adapter according to any one of claims 29 to 32, wherein the central axis of the hollow body and the laser optical axis are arranged to coincide with each other.34.一种利用激光脉冲束照射包括表皮和真皮的皮肤由此进行激光穿刺的激光照射方法，所述方法包括步骤：34. A laser irradiation method for irradiating skin including epidermis and dermis with a laser pulse beam, thereby performing laser perforation, said method comprising the steps of:放射用于穿刺所述表皮的激光脉冲束；和emitting a laser pulse beam for piercing said epidermis; and放射用于穿刺所述表皮的穿刺点中的真皮的激光脉冲束。A laser pulse beam for puncturing the dermis in the puncture point of the epidermis is irradiated.35.如权利要求34所述的激光照射方法，其中用于穿刺所述表皮的激光脉冲束的时间宽度等于或长于用于穿刺真皮的激光脉冲束，且用于穿刺所述表皮的激光脉冲束的能量大于用于穿刺真皮的激光脉冲束。35. The laser irradiation method as claimed in claim 34, wherein the time width of the laser pulse beam used to puncture the epidermis is equal to or longer than that of the laser pulse beam used to puncture the dermis, and the laser pulse beam used to puncture the epidermis The energy is greater than the laser pulse beam used to penetrate the dermis.36.如权利要求34所述的激光照射方法，其中用于穿刺表皮的激光脉冲束的时间宽度为100至400μs，且用于穿刺真皮的激光脉冲束的时间宽度为50至300μs。36. The laser irradiation method according to claim 34, wherein the time width of the laser pulse beam for puncturing the epidermis is 100 to 400 μs, and the time width of the laser pulse beam for puncturing the dermis is 50 to 300 μs.37.如权利要求34所述的激光照射方法，其中用于穿刺表皮的激光脉冲束的时间宽度和用于穿刺真皮的激光脉冲束的时间宽度之间的差别为50至200μs。37. The laser irradiation method according to claim 34, wherein a difference between the time width of the laser pulse beam for piercing the epidermis and the time width of the laser pulse beam for piercing the dermis is 50 to 200 [mu]s.38.如权利要求34所述的激光照射方法，其中用于穿刺表皮的激光脉冲束和用于穿刺真皮的激光脉冲束之间的照射间隔为500ms以下。38. The laser irradiation method according to claim 34, wherein the irradiation interval between the laser pulse beam for piercing the epidermis and the laser pulse beam for piercing the dermis is 500 ms or less.39.如权利要求34所述的激光照射方法，其中用于穿刺表皮的激光脉冲束和用于穿刺真皮的激光脉冲束照射时的能量总和为每平方厘米100至300J。39. The laser irradiation method as claimed in claim 34, wherein the sum of energy at the time of irradiation of the laser pulse beam for piercing the epidermis and the laser pulse beam for piercing the dermis is 100 to 300 J per square centimeter.40.如权利要求34所述的激光照射方法，其中用于穿刺真皮的激光脉冲束的能量是用于穿刺表皮和用于穿刺真皮的激光脉冲束的能量总和的10至40％。40. The laser irradiation method as claimed in claim 34, wherein the energy of the laser pulse beam for piercing the dermis is 10 to 40% of the sum of the energy of the laser pulse beams for piercing the epidermis and the laser pulse beam for piercing the dermis.41.如权利要求34所述的激光照射方法，其中所述激光脉冲束的聚光直径为0.15mm以下。41. The laser irradiation method according to claim 34, wherein the focused diameter of the laser pulse beam is 0.15 mm or less.42.如权利要求34所述的激光照射方法，其中用于穿刺表皮的激光脉冲束包括多个激光脉冲束。42. The laser irradiation method according to claim 34, wherein the laser pulse beam for puncturing the epidermis includes a plurality of laser pulse beams.43.如权利要求42所述的激光照射方法，其中用于穿刺表皮的多个激光脉冲束中的每个的时间宽度为100至400μs。43. The laser irradiation method according to claim 42, wherein each of the plurality of laser pulse beams for puncturing the epidermis has a time width of 100 to 400 [mu]s.44.如权利要求42所述的激光照射方法，其中用于穿刺表皮的多个激光脉冲束的照射间隔为500ms以下。44. The laser irradiation method according to claim 42, wherein the irradiation interval of the plurality of laser pulse beams for puncturing the epidermis is 500 ms or less.45.如权利要求42所述的激光照射方法，其中用于穿刺表皮的多个激光脉冲束和用于穿刺真皮的激光脉冲束照射时的能量总和为每平方厘米5至100J。45. The laser irradiation method as claimed in claim 42, wherein the sum of energy when irradiated by the plurality of laser pulse beams for piercing the epidermis and the laser pulse beam for piercing the dermis is 5 to 100 J per square centimeter.46.一种利用激光束照射皮肤由此进行穿刺的激光穿刺装置，包括：46. A laser puncture device for puncturing skin by irradiating a laser beam, comprising:产生周期性声音的周期性声音产生装置，Periodic sound generating devices for generating periodic sounds,其中穿刺是在产生所述周期性声音的期间进行。Wherein the puncturing is performed during the generation of the periodic sound.47.如权利要求46所述的激光穿刺装置，其中所述周期性声音是其中心频率以20至100Hz单调重复的声音。47. The laser perforating apparatus according to claim 46, wherein the periodic sound is a sound whose center frequency is monotonously repeated at 20 to 100 Hz.48.如权利要求47所述的激光穿刺装置，其中所述单调重复的声音包括泵的操作声和发动机声。48. The laser perforating device according to claim 47, wherein the monotonously repeated sound includes a pump operation sound and an engine sound.49.如权利要求46所述的激光穿刺装置，其中所述周期性声音是具有每分钟击打60至208的重复节拍的声音。49. The laser perforation device of claim 46, wherein the periodic sound is a sound having a repeating beat of 60 to 208 beats per minute.50.如权利要求49所述的激光穿刺装置，其中所述具有重复节拍的声音包括节拍器的声音、机械开关的ON/OFF的声音和敲击键盘的声音。50. The laser perforating device according to claim 49, wherein the sound with a repeating beat includes a sound of a metronome, a sound of ON/OFF of a mechanical switch, and a sound of tapping a keyboard.51.如权利要求46所述的激光穿刺装置，其中所述周期性声音发生装置产生音质或周期不同的多种类型的周期性声音，且随机地改变每次穿刺时产生的周期性声音的类型。51. The laser puncturing device as claimed in claim 46, wherein the periodic sound generating device produces multiple types of periodic sounds with different sound quality or periods, and randomly changes the type of periodic sound produced every time puncturing .52.如权利要求46所述的激光穿刺装置，其中从周期性声音的产生到穿刺的时间在每次穿刺时随机地改变。52. The laser puncturing device according to claim 46, wherein a time from generation of the periodic sound to puncturing is randomly changed every puncturing.53.一种利用激光束照射皮肤由此进行穿刺的激光穿刺方法，所述方法包括步骤：53. A laser perforation method for puncturing skin by irradiating a laser beam, said method comprising the steps of:从音质或周期不同的多种类型的周期性声音中随机选择和产生预定的周期性声音；以及Randomly select and generate a predetermined periodic sound from a plurality of types of periodic sounds different in tone quality or period; and在从所述预定的周期性声音的产生经过随机的时间之后进行穿刺。Piercing is performed after a random time elapses from the generation of the predetermined periodic sound.54.一种利用激光束照射皮肤由此进行穿刺的激光穿刺装置，所述装置包括步骤：54. A laser puncture device for puncturing skin by irradiating a laser beam, said device comprising the steps of:调节装置，其根据通过测量皮肤含水量的含水量测量传感器测量的皮肤含水量来调节所述激光脉冲束的能量。adjusting means for adjusting the energy of the laser pulse beam according to the water content of the skin measured by the water content measuring sensor for measuring the water content of the skin.55.如权利要求54所述的激光穿刺装置，包括所述含水量测量传感器。55. The laser perforation device of claim 54, comprising the water content measurement sensor.56.如权利要求55所述的激光穿刺装置，其中所述含水量测量传感器包括传感器电极，所述传感器电极设置在所述激光穿刺装置的主体的表面上以测量皮肤含水量。56. The laser perforation device according to claim 55, wherein the water content measurement sensor includes a sensor electrode provided on a surface of the main body of the laser perforation device to measure skin moisture content.57.如权利要求54所述的激光穿刺装置，包括保持装置，所述保持装置可分离地保持具有所述含水量测量传感器的穿刺帽，57. The laser perforating device as claimed in claim 54, comprising a holding device which detachably holds the piercing cap with the water content measuring sensor,其中所述穿刺帽包括在两个端部具有开口的中空体，和设置为封闭所述两个端部的开口的第一膜和第二膜，wherein the piercing cap comprises a hollow body having openings at both ends, and a first membrane and a second membrane arranged to close the openings of the two ends,其中所述第一膜透射激光束并吸收激光束且被穿刺，且所述第二膜透射激光束而不吸收激光束，以及wherein the first film transmits and absorbs laser beams and is punctured, and the second film transmits and does not absorb laser beams, and其中所述含水量测量传感器包括设置在所述第一膜的相同平面上的传感器电极，以测量皮肤含水量。Wherein the water content measuring sensor includes sensor electrodes arranged on the same plane of the first membrane to measure skin water content.58.如权利要求54所述的激光穿刺装置，包括输入使用者的属性的设定按钮，其中所述调节装置根据从所述设定按钮输入的属性来调节所述激光脉冲束的能量。58. The laser perforating apparatus according to claim 54, comprising a setting button for inputting a user's attribute, wherein said adjusting means adjusts the energy of said laser pulse beam according to the attribute input from said setting button.59.如权利要求54所述的激光穿刺装置，包括测量环境空气的湿度的湿度传感器，其中所述调节装置根据所述湿度传感器测量的环境空气的湿度来调节所述激光脉冲束的能量。59. The laser perforating device as claimed in claim 54, comprising a humidity sensor measuring humidity of ambient air, wherein said adjusting means adjusts the energy of said laser pulse beam according to the humidity of ambient air measured by said humidity sensor.60.一种利用激光束照射皮肤由此进行穿刺的激光穿刺方法，所述方法包括步骤：60. A laser perforation method for puncturing skin by irradiating a laser beam, said method comprising the steps of:测量皮肤含水量；以及measure skin moisture; and根据测量的皮肤含水量来调节所述激光脉冲束的能量。The energy of the laser pulse beam is adjusted according to the measured skin moisture content.61.一种安装在利用激光束照射皮肤由此进行穿刺的激光穿刺装置上的插入保持器，所述插入保持器包括：61. An insertion holder mounted on a laser perforation device for irradiating skin with a laser beam to thereby perform puncture, the insertion holder comprising:在两个端部具有开口的中空体；a hollow body having openings at both ends;设置为封闭所述开口的一个端部，且透射激光束而不吸收激光束的膜；a film provided to close one end of the opening and transmit the laser beam without absorbing the laser beam;设置为封闭所述开口的另一端部的生物传感器；以及a biosensor configured to close the other end of the opening; and设置在所述中空体的外周面或内周面以电连接所述激光穿刺装置和所述生物传感器的电极。It is arranged on the outer peripheral surface or the inner peripheral surface of the hollow body to electrically connect the laser perforating device and the electrodes of the biosensor.62.如权利要求67所述的插入保持器，其中手指托膜形成在所述生物传感器的部分表面内，且样本试剂供应通道开口形成在所述生物传感器的侧面中。62. The insertion holder as claimed in claim 67, wherein a finger rest film is formed in part of a surface of the biosensor, and a sample reagent supply channel opening is formed in a side surface of the biosensor.63.如权利要求61所述的插入保持器，其中所述生物传感器具有形成在试剂层中的测量电极和电极电偶。63. The insertion holder of claim 61, wherein the biosensor has a measurement electrode and an electrode couple formed in a reagent layer.64.一种安装在利用激光束照射皮肤由此进行穿刺的激光穿刺装置上的插入保持器，所述插入保持器包括：64. An insertion holder mounted on a laser puncturing device for irradiating skin with a laser beam to thereby perform puncture, the insertion holder comprising:通过弯曲生物传感器和连接生物传感器的端部形成的中空体；a hollow body formed by bending the biosensor and connecting the ends of the biosensor;设置为封闭所述中空体的一个端部，且透射激光束而不吸收激光束的膜；a film arranged to close one end of the hollow body and transmit the laser beam without absorbing the laser beam;设置为封闭所述中空体的另一端部，且吸收激光束并被穿刺的膜；以及a membrane arranged to close the other end of the hollow body, absorbing the laser beam and being pierced; and设置在所述中空体的外周面或内周面以电连接所述激光穿刺装置和所述生物传感器的电极。It is arranged on the outer peripheral surface or inner peripheral surface of the hollow body to electrically connect the laser perforating device and the electrodes of the biosensor.65.一种利用激光脉冲束经由膜照射皮肤由此进行激光穿刺的激光照射方法，所述方法包括步骤：65. A laser irradiation method of irradiating skin with a laser pulse beam through a membrane thereby performing laser perforation, said method comprising the steps of:放射用于穿刺所述膜的第一激光脉冲束；以及emitting a first laser pulse beam for piercing the membrane; and放射用于在所述膜的穿刺点穿刺皮肤的第二激光脉冲束。A second laser pulse beam for piercing the skin at the piercing point of the membrane is emitted.66.如权利要求65所述的激光照射方法，其中所述第一激光脉冲束的强度弱于所述第二激光脉冲束的强度。66. The laser irradiation method according to claim 65, wherein the intensity of the first laser pulse beam is weaker than the intensity of the second laser pulse beam.67.一种安装在利用激光束照射皮肤由此进行穿刺的激光穿刺装置上的生物传感器，所述生物传感器包括：67. A biosensor mounted on a laser puncturing device that irradiates skin with a laser beam to thereby puncture, the biosensor comprising:第一基板，具有贴附在其上的试剂层且具有激光束穿过的第一开口；a first substrate having a reagent layer attached thereto and having a first opening through which a laser beam passes;第二基板，设置为以预定间隔面对所述第一基板，具有对应所述第一开口的第二开口，且具有位于比所述试剂层更远离所述第二开口的位置的空气孔；以及a second substrate disposed to face the first substrate at a predetermined interval, has a second opening corresponding to the first opening, and has an air hole located farther from the second opening than the reagent layer; as well as样本试剂供应通道，从所述第一开口到所述试剂层形成于所述第一基板和所述第二基板之间。A sample reagent supply channel is formed between the first substrate and the second substrate from the first opening to the reagent layer.68.如权利要求67所述的生物传感器，其中所述激光束的光轴设置为平行于所述第一开口的中心线，且位于比所述第一开口的中心线更靠近所述样本试剂供应通道的位置。68. The biosensor of claim 67, wherein the optical axis of the laser beam is disposed parallel to the centerline of the first opening and located closer to the sample reagent than the centerline of the first opening The location of the supply channel.69.一种利用闪光灯激励的激光束照射皮肤由此进行穿刺的激光穿刺装置，包括：光学传感器，所述光学传感器检测所述闪光灯的光发射以监测所述闪光灯的劣化程度。69. A laser perforating device for irradiating skin with a laser beam excited by a strobe lamp to thereby puncture, comprising: an optical sensor that detects light emission of the strobe lamp to monitor a degree of deterioration of the strobe lamp.70.如权利要求69所述的激光穿刺装置，包括告知装置，所述告知装置基于由光电传感器检测的装置的使用次数，告知使用者所述装置要求保养的消息。70. The laser perforating device according to claim 69, comprising notifying means for notifying a user that the device requires maintenance based on the number of times of use of the device detected by the photoelectric sensor.

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