JP5851247B2 - Inspection instrument - Google Patents

Description

  The present invention relates to an inspection instrument and a method for using the same.

  The present invention also relates to a catheter and a method for operating the catheter.

  2. Description of the Related Art Conventionally, there is known an instrument that collects a wire member or the like provided with an absorber at the tip end by inserting it into a catheter and absorbing the mucus in the body cavity by the absorber (see, for example, Patent Document 1).

  Conventionally, a catheter having two lumens for injecting an X-ray contrast medium and inserting a brush is known (for example, see Non-Patent Document 1). According to such a catheter, it is possible to collect a specimen from the target site using a brush by confirming that the distal end of the catheter is disposed at the target site under fluoroscopy.

JP 2001-137248 A

"RX Cytology Brush", [online], Boston Scientific Corporation, [Search April 27, 2010], Internet <URL: http://www.bostonscientific.jp/templatedata/imports/collateral/Endoscopy /dfu_ME-154_en.pdf>

  However, in order to inspect the mucus collected with the instrument of Patent Document 1, it is necessary to recover the mucus from the absorber by, for example, leaching the mucus by immersing the absorber in the solution. There is an inconvenience. In particular, if the target substance contained in mucus is unstable, the structure may change or deactivate over time after being absorbed by the absorber, and accurate test results can be obtained. There is a problem that it is difficult.

  Further, when the catheter of Non-Patent Document 1 is used, for example, when it is desired to redo sample collection with a brush or when it is desired to collect a sample with a brush from a plurality of parts in the body, the catheter is removed from the body together with the brush, The catheter and brush must be reinserted into the body. Thus, there is a problem that the operation of repeatedly inserting and removing the catheter inside and outside the body is a burden on the operator and the subject. In particular, the procedure for positioning the distal end position of the catheter under fluoroscopy is complicated and burdensome for the operator.

  On the other hand, it is also conceivable that the catheter once inserted into the channel is left as it is, and only the brush is exchanged inside and outside the body through the lumen. However, when the brush is stored in the lumen, the sample attached to the brush adheres to the inner wall of the lumen. Therefore, the next time a new brush is inserted into the lumen, the sample collected earlier will adhere to the new instrument, and the sample collected before the second time will be mixed with the sample collected before that. There is a problem that an accurate test result cannot be obtained from the sample collected in this way.

  The present invention has been made in view of the above-described circumstances, and an object thereof is to provide an inspection instrument capable of improving inspection accuracy by quickly inspecting a collected body fluid while being simple in operation. It is said.

  The present invention further provides a catheter and a catheter capable of collecting or inspecting a target specimen while preventing collection of other specimens each time, while allowing a plurality of specimens to be collected or examined by a simple operation. It aims to provide a method of operation.

In order to achieve the above object, the present invention provides the following means.
A first aspect of the present invention includes a wire member that can be inserted into a body, and a test body that is provided at a distal end portion of the wire member and qualifies or quantifies a target substance contained in the body fluid by absorbing the body fluid. ,
The test body is placed on the tip side, and an absorbent member for absorbing the body fluid, is disposed adjacent to the absorbent strip, the body fluid which the absorbent strip is absorbed and absorbed in the body, contained in the body fluid A test piece for qualitatively or quantitatively determining a target substance to be obtained , the test piece comprising: a developed body bonded to the absorbent piece; and an absorbent pad disposed with the developed body sandwiched between the absorbent piece It is an inspection instrument in which the body fluid absorbed by the absorbent piece is deployed by moving the deployment body in one direction toward the absorption pad .
According to the first aspect of the present invention, the body fluid absorbed by the test body can be simply inspected simply by inserting the wire member to the target site in the body. In addition, since the body fluid is rapidly inspected in the body, the inspection accuracy of the target substance can be improved.

Moreover, by having such a structure, the bodily fluid absorbed by the absorption piece can be easily moved to the test piece and inspected.

Moreover, in the said structure, the said test piece is good also as a structure which is a test piece for affinity chromatography holding the adsorption | suction substance which adsorb | sucks the said target substance specifically.
In the above configuration, the adsorbing substance may be an antibody against the target substance.
With such a configuration, the presence or absence and amount of the target substance can be inspected with high accuracy.
Moreover, in the 1st aspect of the said invention, it is preferable that the said test | inspection instrument has an outer diameter dimension of 1-5 mm.
By doing in this way, while being able to improve the insertion property in a body, the burden on a patient can be reduced.

In the first aspect of the present invention, a configuration may be provided in which a cylindrical sheath is provided that accommodates the test body so as to be able to protrude and retract from the tip inside the body in the insertion direction.
In this way, by inserting the sheath into the body in advance, it is possible to secure the insertion path of the wire member and facilitate the operation of the inspection instrument, and in the process of insertion, the inspection body is not subject to inspection. It is possible to prevent inconvenience that body fluid adheres.

Moreover, in the structure provided with the said cylindrical sheath, the said sheath may be equipped with the sealing member which can be penetrated by the said test body at the front-end | tip.
By adopting such a configuration, it is possible to prevent body fluid and the like from entering the inside from the tip during the process of inserting the sheath into the body, and further improve the inspection accuracy.

Moreover, in the structure provided with the said cylindrical sheath, the said sheath consists of a flexible member, and the front-end | tip part may be brazed in the shape curved in one direction with respect to the insertion direction.
By doing in this way, a sheath can be run in a desired direction according to the tissue shape in the body. In addition, the test object can be made to appear and disappear from the distal end of the sheath in a desired direction.

In the configuration including the cylindrical sheath, an operation wire that is connected to the distal end of the sheath and extends to the proximal end in the insertion direction, and changes the direction of the distal end by the tension from the distal end to the proximal end. You may have.
By doing so, by pulling the operation wire on the proximal end side, the distal end surface of the sheath can be directed in a desired direction while adjusting the angle with respect to the insertion direction.

Moreover, in the structure provided with the said cylindrical sheath, it is preferable that the said sheath has an outer diameter dimension of 1-5 mm.
By doing in this way, the discomfort of the patient when inserted in the body can be reduced.

Moreover, in the structure provided with the said cylindrical sheath, the said sheath may be accommodated in the channel of an endoscope.
In this way, the operation can be facilitated in combination with the endoscope.
Moreover, in the structure provided with the said cylindrical sheath, the said sheath may be comprised separately from the said wire member and the said test body.
By doing in this way, a test body can be arbitrarily moved, such as rotating only a test body with respect to a sheath.

In the first aspect of the invention, the test piece may be covered with a liquid impermeable member that does not allow liquid to permeate.
By doing in this way, it can prevent that a bodily fluid moves to a test piece from the direction which is not intended, and can improve test | inspection precision more.
In the above configuration, the liquid impermeable member may be transparent.
By doing in this way, the test result by a test piece can be visually recognized rapidly, after removing a test | inspection instrument from a body.

Moreover, in the structure provided with the said test piece, it is good also as a plurality of the said test pieces being arrange | positioned in parallel with respect to the insertion direction adjacent to the said absorption piece.
By doing in this way, a bodily fluid moves from an absorption piece to each test piece by one operation. Therefore, when different adsorbed substances are held in each test piece, a plurality of target substances can be inspected at a time. In addition, when the same adsorbed substance is held in each test piece, since one target substance can be inspected a plurality of times, it can be inspected with high accuracy.

In the first aspect of the invention, the test object may be composed of an absorbent piece that absorbs the body fluid and holds an indicator that performs a color reaction with the target substance.
By doing in this way, it can test | inspect the presence or absence and property of a target substance from the coloration of a test body.
In the above configuration, the indicator may be any one of pH, occult blood, sugar, and starch.
By doing in this way, the presence or quantity of the pH value of a bodily fluid, or the occult blood, sugar, or starch contained in a bodily fluid can be test | inspected easily.

Moreover, the reference aspect of the present invention is such that the target substance contained in the body fluid is brought into contact with the body by contacting the body equipped with the above-described inspection device inserted into the body from the side of the body to be tested. This is a method of operating a test instrument that absorbs and qualifies or quantifies the target substance.
According to the reference aspect of the present invention, it is possible to improve the inspection accuracy by quickly inspecting the collected body fluid while being a simple operation only to be inserted into the body.

In the reference aspect of the invention, from the endoscope inserted into the body having a channel formed so as to penetrate along the insertion direction, the inspection instrument appears and disappears through the channel, and the inspection body is It is good also as a structure which absorbs the said target substance.
By doing in this way, it can test | inspect, confirming the position and state of a test body with an endoscopic image.
In the above reference configuration, the result of the reaction by the inspection instrument may be detected in the body by the endoscope.
By doing in this way, a test result can be obtained more rapidly.

  A third aspect of the present invention is a catheter body that can be inserted into the body and has at least two lumens penetrating in the insertion direction, and can be moved in the insertion direction of the catheter body at the distal end portion of the one lumen. And a treatment instrument that collects or inspects the specimen in the body, and a state in which the treatment instrument is accommodated together with the treatment instrument while the treatment instrument is retractable forward in the insertion direction in the one lumen. And the other one of the lumens is a catheter having a suction connection portion connectable to suction means capable of suctioning the inside thereof.

  According to the third aspect of the present invention, the catheter body is inserted into the body, the treatment tool is moved forward in the insertion direction, and the treatment tool is brought into and out of the lumen to bring the catheter into contact with the specimen in the body. The specimen can be collected or examined by moving the treatment tool rearward in the insertion direction while being left in the body and extracting it from the lumen. In addition, a liquid specimen can be collected from the body by suction through the other lumen.

  In this case, the treatment instrument after contact with the specimen passes through the lumen without being in contact with the inner wall of the lumen while being stored in the inner container, and is extracted out of the catheter body. Therefore, when multiple samples are collected or tested, even if a new treatment instrument is inserted into the body through the same lumen as the previous sample collection or testing, the sample collected or tested will be mixed. It is possible to collect or inspect the target specimen while preventing this. Moreover, since the catheter may be left in the body, the operation can be simplified and the burden on the operator and the subject can be reduced.

In the third aspect of the invention, it is preferable that the other lumen has a diameter dimension of 2 mm or more.
In this way, even a relatively viscous specimen can be easily aspirated.

Moreover, in the 3rd aspect of the said invention, the said inner container may have an abutting part by which the base end of the said treatment tool which moved to the said insertion direction back is abutted.
By doing in this way, when the treatment instrument is moved rearward in the insertion direction, the inner end of the treatment instrument moves rearward in the insertion direction together with the treatment instrument when the proximal end of the treatment instrument abuts against the abutting portion of the inner container. Thereby, a treatment tool and an inner container can be simultaneously extracted from the lumen with a simple configuration.

Moreover, in the 3rd aspect of the said invention, the said treatment tool may consist of a porous body.
By doing so, the specimen can be efficiently absorbed by the treatment instrument simply by bringing the treatment instrument into contact with the liquid specimen, and the specimen can be easily collected.
Moreover, in the said invention, the said treatment tool may hold | maintain the indicator substance which carries out a color reaction specifically with the said test substance.
In this way, it is possible to easily inspect whether or not the sample is the target sample based on whether or not the treatment tool is colored.

In the third aspect of the invention, the treatment tool may be a brush.
By doing so, the specimen on the tissue surface can be easily collected by bringing the brush into contact with the tissue surface in the body.

In the third aspect of the invention, the treatment instrument is connected to a wire member that extends through the one lumen to the outside of the catheter body, and the inner container has the wire member on a proximal end surface thereof. A through-hole into which the through-hole is movably inserted is formed, provided at a midway position between the pretreatment tool of the wire member and the base end surface, and may include a lid that can close the through-hole.
By doing so, when the wire member is pulled and the treatment tool is pulled out of the lumen, the through hole is closed by the lid, so that the specimen attached to the treatment tool leaks out of the inner container through the through hole. Can be prevented.

  A fourth aspect of the present invention is a catheter body that can be inserted into the body and has a lumen that penetrates in the insertion direction, and a distal end portion in the lumen is arranged to be movable in the insertion direction of the catheter body. A catheter operating method comprising: a treatment tool that is brought into contact with a specimen in the body to collect or test the specimen; and an inner container that accommodates the treatment tool in the lumen so as to be retractable forward in the insertion direction. Thus, when the treatment instrument moves backward in the insertion direction, the inner container moves backward in the insertion direction in a state in which the treatment instrument is housed together with the treatment instrument.

  According to the present invention, while the operation is simple, there is an effect that the inspection accuracy can be improved by quickly inspecting the collected body fluid.

  Alternatively, according to the present invention, while it is possible to collect a plurality of samples by a simple operation, there is an effect that a target sample can be collected while preventing other samples from being mixed each time.

1 is an overall configuration diagram of an inspection instrument according to a first embodiment of the present invention. It is a figure which shows the detailed structure of a test body. It is a figure which shows the example of a sealing member. It is a figure which shows another example of a sealing member. It is a flowchart explaining the usage method of the test | inspection instrument of FIG. It is a modification of a test body, and is a figure which shows a structure in case a test body consists of an absorption piece holding an indicator. It is another modification of a test body, and is a figure showing an example at the time of a plurality of test pieces being provided. It is a figure which shows the modification of a sheath, (a) The state which is not operating the operation wire, (b) The state which pulled the operation wire and curved the front-end | tip part is shown. It is another modification of a test | inspection instrument, and is a figure which shows an example of a structure in case the test body is provided in the wire so that rocking | fluctuation is possible. It is a flowchart explaining the usage method of the test | inspection instrument which concerns on the 2nd Embodiment of this invention. 1 is an overall configuration diagram of a catheter according to a reference embodiment of the present invention. It is a figure explaining operation | movement of the test | inspection tool of the catheter of FIG. 11, and has shown the state by which the test | inspection tool was made to swell forward. It is a figure explaining operation | movement of the test | inspection tool of the catheter of FIG. 11, and has shown the state accommodated in the inner container. It is a figure explaining the operation | movement of the test | inspection tool and inner container of the catheter of FIG. 11, and has shown the state by which the inner container is pulled back with the test tool. It is a figure which shows arrangement | positioning when test | inspecting using the catheter and endoscope of FIG. It is a modification of the catheter of FIG. 11, and has shown the structure provided with the brush.

The inspection instrument 1 according to the first embodiment of the present invention will be described below with reference to FIGS.
An inspection instrument 1 according to this embodiment is used for a digestive system or respiratory system inspection using an endoscope, and as shown in FIG. 1, a wire (wire member) 2 that can be inserted into a body cavity, The test body 3 provided at the tip of the wire 2 and the sheath 4 for housing the wire 2 and the test body 3 are provided.

  The wire 2 is flexible so that it can be bent along the shape of the body cavity, and has an appropriate rigidity so that the movement when the operator pushes and pulls the proximal end side in the front-rear direction is transmitted to the distal end. ing. The tip of the wire 2 may be brazed so as to bend in one direction. As a result, when the distal end portion of the wire 2 appears and disappears from the sheath 4, the wire 2 is bent in one direction with respect to the sheath 4, and can be easily brought into contact with a cavity wall or the like disposed laterally with respect to the insertion direction.

The inspection body 3 includes an absorbent piece 5 disposed on the distal end side and a test piece 6 disposed adjacent to the absorbent piece 5.
The absorbent piece 5 may be made of a material having high biocompatibility, and may absorb the liquid by capillary action when in contact with the liquid. For example, a porous body molded from fibers or polymers is used. In order to efficiently absorb the liquid, the absorbent piece 5 may be formed so that the surface area becomes large with respect to its volume, for example, a groove (not shown) is provided on the surface.

  The absorbent piece 5 has a hemispherical tip surface and is coated with a lubricant such as polyethylene glycol or silicone oil so that the discomfort given to the patient when contacted with the cavity wall is reduced. Yes. Although the dimension of the radial direction of the absorption piece 5 is based also on the collection | collection site | part of a bodily fluid, 1-5 mm is preferable and 1.5-3 mm is more preferable. If the size of the absorbent piece 5 in the radial direction is less than 1 mm, a sufficient amount of body fluid may not be absorbed, and if it exceeds 5 mm, the operability in the body may be reduced.

  The test piece 6 is a test piece for immunochromatography. As shown in FIG. 2, the test piece 6 a has a developed body 6 a bonded to the absorbent piece 5, and an absorbent pad 6 b disposed between the absorbent piece 5 and the developed body 6 a. . The liquid absorbed by the absorbent piece 5 moves along the developing body 6a in one direction toward the absorption pad 6b and is developed.

  A test in which a conjugate pad 6c that holds a dye-labeled primary antibody against a target substance to be examined and an antibody specific to the antigen of the primary antibody are immobilized on the developing body 6a in order from the absorption piece 5 side. A line 6d is provided at an interval. When the target substance is contained in the liquid moving through the developing body 6a, the target substance is labeled with a dye on the conjugate pad 6c and adsorbed on the test line 6d. Thereby, a detection line of the color of the pigment appears on the test line 6d so that the inspection result can be confirmed visually. When the target substance is not contained in the liquid, since the dye-labeled primary antibody-target substance complex is not formed, the dye-labeled primary antibody passes through the test line 6d without being adsorbed, and no detection line appears.

  For the dye labeling of the primary antibody, for example, colloidal gold, colored latex, or nanoparticles made of a semiconductor are used. Here, when colored latex or nanoparticles are used, a plurality of types of primary antibodies recognizing different antigens are labeled with colored latexes having different colors or nanoparticles having different emission wavelengths for each type to form conjugate pads 6c. Hold. In this case, a test line 6d is provided for each primary antibody. Thereby, a plurality of types of target substances can be inspected with a single operation.

  Further, a control line 6e may be provided between the test line 6d and the absorption pad 6b in the development body 6a. The control line 6e is for confirming whether or not the reaction has been performed correctly regardless of the presence or absence of the target substance. The control line 6e holds an antibody specific to the dye-labeled primary antibody, and when the antibody catches the dye-labeled primary antibody flowing through the test line 6d, the dye is accumulated and appears as a line. ing. If the liquid cannot be sufficiently absorbed by the absorbing piece 5 or cannot be absorbed at all, the development of the liquid does not proceed to the control line 6e, so that no detection line appears on the control line 6e. For this reason, the control line 6e is useful for confirming whether or not the liquid has been correctly absorbed by the absorbent strip 5. In particular, it is effective in preventing erroneous diagnosis when no detection line appears on the test line 6d.

  The entire outer surface of the test piece 6 is covered with a cover 7 made of a liquid-impermeable material such as a vinyl or rubber thin film. The cover 7 may be entirely transparent so that the test line 6d can be visually recognized from the outside, and the position of the test line 6d and the control line 6e are provided as in the example shown in FIG. In some cases, a transparent window 6f may be provided at the position of the control line 6e.

The outer diameter size of the inspection instrument 1 is appropriately selected depending on the inspection site of the body fluid. When the inspection site is the upper digestive system (stomach, duodenum, small intestine, etc.), the lower digestive system (large intestine, In the case of the small intestine, it is preferably 2.8 to 3.7 mm, and in the case of the respiratory system, it is preferably 1.2 to 3.2 mm.
The longitudinal dimension of the wire 2 and the test body 3 is 1.2 to 1.65 m when the examination site is the upper digestive system, and 1.8 to 2. 7 m is preferable.

  The sheath 4 has a cylindrical shape in which a through-hole 4a is formed along the insertion direction, and has a flexibility that can be bent along the shape in the body cavity. The sheath 4 is configured separately from the test body and the wire, and the test body 3 and the wire 2 inserted into the through hole 4 a are rotatable in the circumferential direction with respect to the sheath 4. Thereby, for example, even if the sheath 4 is inserted and twisted while meandering along the tissue shape in the body, it is possible to prevent the test body 3 and the wire 2 in the through hole 4a from being twisted. The through-hole 4a has a diameter dimension that forms a gap between the absorption piece 5 so that the wire 2 and the test body 3 can move smoothly even when the absorption piece 5 absorbs liquid and swells. It is preferable.

  The sheath 4 has an outer diameter dimension that can be inserted into a channel formed so as to penetrate in the insertion direction of the endoscope, and preferably has an outer diameter dimension of 1 to 5 mm. The distal end of the sheath 4 is formed in a rounded shape with chamfered corners so as to reduce discomfort felt by the patient when contacting the cavity wall.

  The distal end portion of the sheath 4 is brazed so as to bend in one direction, and is corrected in accordance with the shape of the channel in the channel, and is bent in a predetermined direction when it moves in and out of the channel. The distal end surface of the sheath 4 is closed by a sealing member 4 b that can be penetrated by the test body 3. As shown in FIG. 3, the sealing member 4b is made of a thin film of vinyl material containing perforations 4c, or an elastic material provided with cuts 4d radially from a substantially central position as shown in FIG. A thin film is used. Thereby, when the operator pushes the wire 2 forward, the inspection body 3 easily penetrates the sealing member 4 b and protrudes from the tip of the sheath 4. Further, the operator may push the wire 2 forward so that the wire 2 can be projected and retracted from the distal end portion of the sheath 4.

  As the material of the sheath 4, polyolefin, polyester, polyamide, or vinyl chloride resin is preferable. As the polyolefin, for example, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, or a mixture of polypropylene and preethylene or polybutene is preferable. As the polyester, for example, polyethylene terephthalate or polybutylene terephthalate is preferable. As the vinyl chloride resin, for example, polyvinyl chloride, vinyl chloride-vinyl acetate copolymer, and vinyl chloride-vinylidene chloride copolymer are preferable.

The use method and operation of the thus configured inspection instrument 1 will be described below with reference to the flowchart of FIG. 5, taking the duodenal occult blood test as an example. In this case, the target substance is hemoglobin contained in blood (body fluid), and an anti-hemoglobin antibody is used as the primary antibody.
In order to examine the presence or absence of occult blood in the duodenum using the inspection instrument 1 according to the present embodiment, first, an endoscope is inserted into the duodenum while imaging the inside of the body (step S1), and the physiology through the channel. The cavity wall is washed by letting saline flow into the duodenum. Thereby, when there is occult blood on the cavity wall, the blood is contained in the cleaning liquid.

  Next, when the sheath 4 is inserted into the channel (step S2), the tip of the sheath 4 appears and disappears from the channel and appears in the endoscopic image. Subsequently, the sheath 4 is rotated in the circumferential direction while observing the endoscopic image, so that the distal end of the curved sheath 4 is directed toward the cleaning liquid stored in the duodenum. In this state, by pushing the wire 2 forward, the test body 3 is penetrated through the sealing member 4b (step S3) and protruded toward and away from the cleaning liquid, and the absorbent piece 5 is left in the cleaning liquid for a predetermined time, for example, 1 minute. Immerse (step S4). Thereafter, the wire 2 is pulled to house the test body 3 in the sheath 4 (step S5), and the sheath 4 is pulled out from the channel together with the test body 3 (step S6). Then, by confirming the presence or absence of the detection line of the test line 6d outside the body (step S7), the presence or absence of occult blood can be examined.

  Thus, according to the present embodiment, the inspection is started when the cleaning liquid is absorbed in the body. Thereby, there exists an advantage that it can test | inspect by simple operation. The body fluid present in the duodenum includes pancreatic juice and bile in addition to duodenal mucus, and hemoglobin is decomposed over time by a large number of proteolytic enzymes present in these secretions. However, there is an advantage that the examination accuracy of occult blood can be improved by starting the examination quickly before the hemoglobin decomposition proceeds.

  In addition, when the cleaning liquid is sucked with a catheter or the like, or absorbed by a cotton swab or the like and squeezed outside the body and then collected for inspection, the cleaning liquid is lost. Therefore, the cleaning liquid is actually applied to the test piece 6. It is necessary to collect more cleaning solution than the amount. However, according to the inspection instrument 1 according to the present embodiment, the cleaning liquid absorbed by the absorbent piece 5 moves to the deployment body 6a as it is without being lost on the way.

  As a result, it is possible to reduce the burden on the patient by suppressing the amount of the cleaning liquid flowing into the duodenum to a small amount. In addition, by suppressing the amount of the cleaning solution to a small amount, it is possible to prevent blood from being diluted and the hemoglobin concentration in the cleaning solution to decrease, and even if the amount of occult blood is small, it can be reliably detected. There are advantages. In the above-described example, the cavity wall is washed with the washing liquid and the hemoglobin in the washing liquid is inspected. However, the duodenal mucus secreted from a specific site without using the washing liquid is absorbed by the absorption piece 5 and inspected. By doing so, occult blood at a specific site can be examined.

In the above embodiment, the presence or absence of occult blood in the duodenum is inspected. Alternatively, digestive juices of digestive organs such as pancreas, liver, and gallbladder may be inspected.
When examining the digestive tract using an endoscope, the patient is in a state where the amount of digestive juice secretion has decreased due to fasting and consultation. As a general method, the secretion of digestive juice can be reduced by taking an excretory agent. The test is done after prompting. However, according to the test instrument 1 according to the present embodiment, even a small amount of digestive juice secreted in a fasted state is sufficient for the test, so it is not necessary to promote the secretion of digestive juice by the excretion agent, which is necessary for the test. The time can be shortened, and the burden on the patient due to taking the effluent can be reduced.

  Moreover, in the said embodiment, the test body 3 is good also as holding | maintaining a proteolytic enzyme inhibitor. The proteolytic enzyme inhibitor is held, for example, in the absorption piece 5 or the development body 6a. By doing so, it is possible to prevent the hemoglobin from being decomposed while the cleaning liquid moves from the absorbent piece 5 to the test piece 6, and to further improve the inspection accuracy.

Moreover, in the said embodiment, although the absorption piece 5 and the test piece 6 for immunochromatography were used as the test | inspection body 3, instead of this, as shown in FIG. It is good also as using the absorption piece 5 holding the indicator which shows reaction.
An indicator that color-reacts with components in the blood is soaked into the absorbent strip 5 and then dried. And the presence or absence of occult blood is test | inspected from the coloring of the absorption piece 5 by making the absorption piece 5 contact the washing | cleaning liquid stored in the duodenum. Even in this way, it is possible to quickly inspect with a simple operation, and since only a small amount of cleaning liquid is required for the inspection, the presence or absence of occult blood can be inspected with high accuracy even if the amount of occult blood is very small. .

  As the indicator, for example, a pH indicator or a sugar or starch indicator may be used. By doing in this way, the pH of a bodily fluid or the presence or absence of the saccharide | sugar and starch in a bodily fluid can be test | inspected.

  In the above embodiment, as shown in FIG. 7, a plurality of test pieces 6 may be arranged in parallel and bonded to the absorbent piece 5. Each test piece 6 is preferably isolated from each other by a liquid-impermeable material so that body fluid does not move to the adjacent test piece 6. By doing in this way, when combining the test piece 6 which test | inspects a different target substance, it can test | inspect about several target substance by one operation. Moreover, when combining the test piece 6 which test | inspects the same target substance, test | inspection precision can be improved by inspecting several times. The test piece 6 is not limited to the one for immunochromatography, but other specific bonds between biomolecules, such as biomolecules and their receptors, enzymes and their substrates, nucleic acids having mutually complementary sequences, etc. Those for affinity chromatography using can also be used.

  In the above embodiment, the position of the inspection body 3 is confirmed by the endoscopic image. Instead, at least a part of the inspection instrument 1 is formed of a radiopaque material, and the X It is good also as confirming the position of the test body 3 with a fluoroscopic image. For example, by using a wire 2 made of metal such as stainless steel, or by forming at least a part of the cover 7 with an X-ray impermeable material, the position of the inspection body 3 can be easily determined with an X-ray fluoroscopic image. Can be confirmed.

  Moreover, in the said embodiment, although the front-end | tip part of the sheath 4 was decided to bend by a bending hook, instead of this, as shown to Fig.8 (a), it connects to the front-end | tip of the sheath 4, and the sheath 4 As shown in FIG. 8 (b), the direction of the distal end of the sheath 4 is changed by pulling the operation wire 4e. Also good. By doing so, by adjusting the pulling force of the operation wire 4e, the specimen 3 can be easily guided in the desired direction with the distal end surface of the sheath 4 directed in the desired angle direction.

  In the above embodiment, as shown in FIG. 9, the inspection body 3 is provided so as to be able to swing in the radial direction with respect to the wire 2, and the inspection body 3 is swung by the tension of the operation wire 3a. Also good. In the example shown in FIG. 9, the inspection body 3 is swingably connected to the wire 2 via a link 3b. The inspection body 3 and the link 3b are connected by an elastic wire 3c having elasticity, and the inspection body 3 faces the front with respect to the wire 2 in a state where a part of the elastic wire 3c is pulled by the operation wire 3a. . Then, by intensifying or weakening the pulling force of the operation wire 3a, the inspection body 3 swings and the direction of the distal end surface is changed. By doing in this way, the test body 3 can be easily brought into contact with the body fluid in the direction of the body fluid.

Moreover, in the said embodiment, although the case where a digestive organ or a respiratory organ was test | inspected using an endoscope was mentioned as an example, it can be used also for the test | inspection of another site | part.
For example, the test body 3 is inserted into the oral cavity or trachea to inspect saliva, light or bronchial exudate, inserted into the nasal cavity to examine nasal discharge, or inserted into the uterine cavity or fallopian tube cavity. Intrauterine fluid, vaginal solution, and cervical mucus can be examined. Even in such a case, since a small amount of body fluid is necessary for the examination, it is possible to reduce the burden on the patient for securing the amount of the body fluid, and it is possible to examine the body fluid quickly and easily.

  In this case, the outer diameter of the inspection instrument 1 is preferably about 5 mm for the pharynx, about 3 mm for the nasal cavity, and about 1 to 4 mm for the gynecological system. The length from the distal end of the test body 3 to the proximal end of the wire 2 is preferably about 15 cm for pharynx and nasal cavity, and about 20 to 40 cm for gynecological system for uterine cavity. It is preferably about 35 to 55 cm for an oviduct and about 10 to 20 cm for a cervix. Moreover, when the test body 3 can be easily guided to the test site, the sheath 4 may be omitted.

In the above embodiment, the sheath 4 or the wire 2 may have a memory indicating the length from the tip.
In this way, particularly when the operator blindly inserts the inspection instrument 1 into the body cavity without confirming the position of the inspection body 3 with an endoscopic image, an X-ray transmission image, or the like, It is possible to easily grasp the insertion position of the inspection body 3 and inspect the body fluid at an appropriate position in the body cavity.

  In the above embodiment, all steps from collection of body fluid to inspection are completed in the body, but instead, after the target substance is absorbed by the test piece 6, it is further removed from the body. It is good also as processing.

For example, when the presence or absence of a virus in a body fluid is examined using EIA (enzyme immunoassay), an unlabeled antibody against the virus is immobilized on the test piece 6. In this case, the conjugate pad 6c is unnecessary. By absorbing the body fluid from the absorbing piece 5 to the test piece 6 in the body, the virus is adsorbed on the test piece 6 to perform the primary reaction. Next, the inspection instrument 1 is taken out of the body, a secondary antibody solution labeled with an enzyme is dropped on the test piece 6 to perform a secondary reaction, and then a substrate solution showing a color reaction with the enzyme is added. Thus, the presence or absence of a virus is inspected based on the presence or absence of coloration.
In this way, even in an examination that requires processing outside the body, the examination is started in the body as the body fluid is collected, so that labor and time required for the examination can be saved.

Next, a second embodiment of the present invention will be described below with reference to FIG. This embodiment differs from the first embodiment in the method of using the inspection instrument 1. About the structure of the test | inspection instrument 1, since it is common in 1st Embodiment, description is abbreviate | omitted.
Below, the usage method of the test | inspection instrument which concerns on this embodiment is demonstrated with reference to the flowchart of FIG. In the flowchart to be referred to, steps S1 to S5 are the same as those in the first embodiment, and thus description thereof is omitted.

  In the method of using the inspection instrument according to this embodiment, after performing steps S1 to S5, the sheath 4 is housed in the channel together with the inspection body 3 (step S8), and further endoscopic inspection of other organs or the like is performed (step). S9). Then, after the inspection waiting time (about 10 to 15 minutes) by the inspection body 3 has elapsed, the tip of the sheath 4 is caused to appear and disappear from the channel and appear in the endoscopic image. Subsequently, the test body 3 is passed through the sealing member 4b by pushing the wire 2 forward (step S10), and the sheath 4 is rotated in the circumferential direction while observing the endoscopic image, whereby the test line 6d. The presence or absence of the detection line is confirmed (step S11). Next, the wire 2 is pulled to house the test body 3 in the sheath 4 (step S12), and the sheath 4 is pulled out from the channel together with the test body 3 (step S13).

  As described above, according to the present embodiment, when the inspection by the inspection body 3 is completed during the endoscopic inspection, the inspection result can be confirmed in the body under the endoscope. In particular, in the case of a test in which a test result can be obtained in a very short time, such as a pH indicator, a sugar or starch indicator, or a occult blood reaction indicator, the test result can be obtained more rapidly. Furthermore, if a transparent material is used for the sheath 4, the inspection result can be obtained only by moving the distal end of the sheath 4 out of the channel without causing the inspection body 3 to protrude from the sealing member 4 b, thereby making the operation easier. can do.

Hereinafter, a catheter 11 according to a reference embodiment of the present invention will be described with reference to the drawings. In this reference embodiment, the catheter 11 will be described by taking as an example the one used when collecting pancreatic juice from the duodenum in combination with an endoscope.
The catheter 11 according to this reference embodiment, as shown in FIG. 11, an elongated catheter body 12 having two lumens 12a, 12b, and inner vessel 13 disposed at the tip of the one lumen 12b, the contents And an inspection tool (treatment tool) 14 housed in the instrument 13.

The catheter body 11 has an outer dimension that can be inserted into a channel formed in the longitudinal direction of the insertion portion of the endoscope. The diameter of the channel of the digestive endoscope used in this reference embodiment is generally 2.8 to 2.9 mm. Therefore, the outer dimension of the catheter body 11 is preferably 2.6 to 2.7 mm.

  The lumens 12 a and 12 b are a suction lumen 12 a for sucking a body fluid, and an inspection tool lumen 12 b into which the inspection tool 14 is inserted, and both lumens 12 a and 12 b are open on the distal end surface of the catheter body 12. The suction lumen 12a opens at a suction connection portion 12c provided on the side surface of the proximal end side of the catheter body 12. A suction means (not shown) such as a tube or a syringe connected to a suction pump is connected to the suction connection portion 12c, and the suction lumen 12a is suctioned to a negative pressure by the suction means, whereby the distal end surface of the suction lumen 12a Body fluid can be sucked from the opening. The suction lumen 12a preferably has a diameter of 2 mm or more so that even relatively viscous pancreatic juice can be sucked easily. The inspection tool lumen 12 b is open to the proximal end surface of the catheter body 12.

  The inner container 13 has a cylindrical shape, a distal end surface is opened, and a through hole 13b into which a wire 15 described later is inserted so as to be movable in the longitudinal direction is formed on the proximal end surface 13a. For example, the inner container 13 is formed of a material that does not easily generate friction with the inner surface of the inspection tool lumen 12b, so that the inner container 13 can move smoothly in the longitudinal direction in the inspection tool lumen 12b. Further, the inner container 13 is locked from moving forward in the insertion direction by the stopper 12d protruding inward in the radial direction provided at the tip of the inspection instrument lumen 12b, so that the inner container 13 can be moved out of the inspection instrument lumen 12b. It does not appear in front of the insertion direction.

  The inspection tool 14 is connected to a wire (wire member) 15 extending to the outside of the catheter body 12. In addition, the outer diameter of the inspection tool 14 is designed so that a sufficiently large gap is formed between the inner surface of the inner container 13. As a result, the operator pushes and pulls the wire 15 on the proximal end side of the catheter body 12, so that the test tool 14 can be stored even when the test tool 14 absorbs body fluid and expands as will be described later. It can be moved smoothly in the vessel 13.

  Here, when the operator pushes the wire 15, as shown in FIG. 12, the inspection tool 14 protrudes forward from the inside of the inner container 13 and the inside of the inspection tool lumen 12 b. Then, when the operator pulls the wire 15 from the state of FIG. 12, the inspection tool 14 is stored in the inner container 13 as shown in FIG. 13, and when the operator pulls the wire 15, the operator pulls the wire 15 as shown in FIG. As described above, when the proximal end of the inspection tool 14 abuts against the proximal end surface (abutting portion) 13 a of the inner container 13 through the lid body 16, the inner container 13 also moves to the proximal end side together with the inspection tool 14. It has become.

  The inspection tool 14 is made of a porous body and holds an indicator substance that specifically reacts with color with pancreatic juice, which is a specimen to be collected. As a result, when the inspection tool 14 is brought into contact with the body fluid, the body fluid is efficiently absorbed by the inspection tool 14, and the color of the inspection tool 14 changes when the body fluid contains pancreatic fluid. It has become. As the indicator, p-amylase or bicarbonate indicator specifically contained in pancreatic juice, or a pH indicator that develops color around pH 8.0, which is the pH of pancreatic juice, can be used.

  Specifically, amylose in which 5 to 7 glucose is linearly polymerized and a chromogenic substrate is bonded to the terminal can be used as an indicator of p-amylase. The chromogenic substrate is colorless in a state where it is bound to amylose, and develops color when the bond with amylose is cleaved and released by p-amylase in the pancreatic juice. Alternatively, a mixture of amylose and iodine solution can be used as an indicator for p-amylase. For example, the inspection tool 14 holding a mixture of amylose and iodine solution in which a sufficient number of glucose is polymerized exhibits a blue color due to the coloration of iodine. And when the test | inspection tool 14 contacts pancreatic juice, amylose will be decomposed | disassembled by p-amylase in this pancreatic juice, and the blue coloration of iodine will turn into purple or red, or it will lose | disappear.

As an indicator of bicarbonate, a mixture of potassium phosphoenolpyruvate, 3-acetylpyridine adenine dinucleotide (aNADH), phosphoenolpyruvate carboxylase, malate dehydrogenase, magnesium chloride, sodium oxamate can be used. . Bicarbonate reacts with potassium phosphoenolpyruvate in the presence of morphoenolpyruvate carboxylase and magnesium ions to form oxaloacetate and inorganic phosphate. Oxaloacetic acid is reduced to malate by malate dehydrogenase, and at the same time oxidizes aNADH to produce aNAD ⁺ . At this time, the absorbance of aNADH at wavelengths of 405 nm and 700 nm decreases in proportion to the bicarbonate concentration, thereby changing the color of the indicator.

Here, it is preferable that the color exhibited by the indicating substance is a color having a wavelength in the visible region so that the color can be visually recognized more reliably in the endoscopic image. Further, the color exhibited by the indicator substance is more preferably a color different from the environmental color of the site where the specimen is collected. In this reference embodiment, since the duodenum is an environment in which yellow body fluids such as gastric juice and broth are mixed, it is preferable that the indicator substance exhibits blue, green or red.

  The wire 15 is provided with a lid body 16 having a diameter larger than that of the through-hole 13 b and not allowing liquid to permeate on the proximal end side of the inspection tool 14. As a result, when the inspection tool 14 is pulled out of the lumen 12b for the inspection tool, the through hole 13b is blocked by the lid 16, and the body fluid absorbed by the inspection tool 14 may leak out of the inner container 13 from the through hole 13b. It is to be prevented.

  FIG. 11 shows a state in which the inner container 13 and the inspection tool 14 are arranged in the inspection tool lumen 12b. However, the operator places the inner container 13 in a state in which the inspection tool 14 is stored into the inspection tool. These can be installed as shown in FIG. 11 by inserting them from the opening on the proximal end side of the lumen 12b. At this time, a wire or the like (not shown) may be connected to the inner container 13 so that the inner container 13 can be easily inserted into the inspection instrument lumen 12b.

The usage method and operation of the catheter 11 configured as described above will be described below.
To collect pancreatic juice from the duodenum using a catheter 11 according to this reference embodiment, the endoscope 17 is inserted into the duodenum while observing the endoscopic image, duodenal papilla in endoscopic images The endoscope 15 is placed at a position to be reflected. Next, when the catheter body 12 is inserted from the distal end side along the channel 17a of the endoscope 17, the distal end portion of the catheter body 12 appears and disappears from the opening of the channel 17a.

  The operator operates the catheter body 12 while observing the endoscope image, and places the distal end of the catheter body 12 in the vicinity of the duodenal papilla. Then, by pushing the wire 15 extending from the proximal end of the catheter body 12 outside the body, the inspection tool 14 is made to appear and disappear from the lumen 12b for the inspection tool, and as shown in FIG. The inspection tool 14 is arranged. Reference numeral 17b denotes an observation window of the endoscope 15. Then, the inspection tool 14 is brought into contact with the body fluid that has exuded in the duodenal papilla, and the color of the inspection tool 14 is confirmed by an endoscopic image. When the operator can confirm the change in the color of the test tool 14, the operator pulls the wire 15 to store the test tool 14 in the test tool lumen 12b, and places the distal end surface of the catheter body 12 on the duodenal papilla. In this state, the body fluid is sampled by the suction means through the suction lumen 12a.

  On the other hand, when the operator cannot confirm the change in the color of the inspection tool 14, the operator pulls out the inspection tool 14 and the inner container 13 from the inspection tool lumen 12b, and removes the new inspection tool 14 and the inner container 13 from the inspection tool lumen. Installed at the tip in 12b. And the front-end | tip position of the catheter main body 12 is shifted, and a bodily fluid is test | inspected using the test | inspection tool 14 again. Thereafter, the movement of the collection position and the inspection by the inspection tool 14 are repeated in the same manner until the color of the inspection tool 14 can be confirmed, and the body fluid is collected when the color of the inspection tool 14 is confirmed.

In this case, according to this reference embodiment, the inspection device 14 when withdrawn from the inspection-instrument lumen 12b of the inspection instrument 14 within the inspection instrument lumens 12b while being protected is housed in inner vessel 13 Therefore, the bodily fluid absorbed by the test tool 14 is prevented from adhering to the inner wall of the test tool lumen 12b. Therefore, even if a new test tool 14 is next inserted into the same test tool lumen 12b, body fluids that have been tested before that are prevented from adhering to the new test tool 14. Accordingly, there is an advantage that a correct inspection result can be obtained by using the new inspection tool 14 in a clean state for the inspection.

  Moreover, since it is not necessary to insert and remove the catheter body 12 inside and outside the body of the subject every time the inspection tool 14 is replaced, there is an advantage that the procedure can be simplified and the burden on the operator and the subject can be reduced. Furthermore, since the test tool 14 is taken out from the test tool lumen 12b while being stored in the inner container 13, the specimen attached to the test tool 14 can be prevented from coming into contact with the operator. There is an advantage that the inspection tool 14 can be easily handled after being taken out.

In the reference embodiment, the body fluid is sucked after confirming whether or not the body fluid is the target body fluid using the inspection tool 14, but instead, the inspection tool 14 is sucked while sucking the body fluid. You may perform an inspection.

In the above-described reference embodiment, the inspection tool 14 is used. However, instead of this, a sampling tool for collecting specimens such as cells and mucous membranes from tissues in the body may be used. As the collection tool, for example, a brush (treatment tool) 18 can be used as shown in FIG. In this case, the suction lumen 12a may not be provided, and an X-ray contrast medium or the like may be injected into the body from the suction connection portion 12c through the suction lumen 12a.

  Even in such a case, even after the specimen is collected by wiping the tissue surface in the body with the brush 18, the brush 18 is still protected by the inner container 13 even if the brush 18 is housed in the lumen 12b for the inspection tool. It is allowed to pass through the inspection tool lumen 12b. Therefore, for example, even when sample collection is repeated while exchanging the brushes 18 from a plurality of collection positions, the sample collected by the other brushes 18 adheres to each brush 18 via the inner surface of the lumen for inspection tool 12b. Can be prevented.

Next, examples of the catheter according to the reference embodiment described above will be described.
[Example 1]
A catheter according to Example 1 was prepared according to the following procedure.

  An endoscopic contrast tube (PR-130, manufactured by Olympus) and a catheter having an outer diameter of 0.5 mm are arranged in parallel and bonded to form a catheter body according to this embodiment having two lumens. did. As the inner container, a transparent tube having a length of 1 cm and an outer diameter of 0.4 mm was used. A filter paper (length 0.3 cm, outer diameter 0.3 cm) that was impregnated with an indicator for amylase and dried was used as an inspection tool. As the indicator, a solution in which amylose and iodine were mixed was used. The filter paper was arranged at the approximate center in the tube. An endoscope guide wire was connected to the filter paper as a wire. In addition, the filter paper was prevented from appearing and falling from the base end side of the tube by heating and deforming the base end of the tube to be thin.

Using the catheter according to this example prepared as described above, body fluid was examined and collected in the following procedure.
First, 5 ml of pancreatic juice or duodenal juice collected from a human was dropped at different positions on a stomach / duodenal three-dimensional model for practice of operation of an endoscope. The pancreatic juice and duodenal juice were used after confirming that the pancreatic juice contained 10 times more amylase than the duodenal juice, as determined in advance.

  Insert the endoscope from the stomach side of the three-dimensional model and place it in front of the position where the pancreatic juice is stored, insert the catheter according to this embodiment into the channel of the placed endoscope, and emerge from the opening of the channel The tip of the catheter body was placed in the vicinity of the position where the pancreatic juice was stored. Next, the test tool was made to appear and disappear from the catheter body by pushing the guide wire. Next, pancreatic juice was sucked into the contrast tube by connecting a syringe to the proximal end of the endoscope contrast tube constituting the catheter body and pulling the plunger. At this time, it was confirmed by endoscopic video that the aspirated pancreatic fluid touched the test tool and the blue color of the test tool disappeared.

  Next, when the guide wire was pulled, the test tool was accommodated in the tube, and passed through the catheter together with the tube, and could be taken out of the catheter. Next, a new examination tool according to this example was inserted into the catheter. The inserted test tool remained blue. Next, when duodenal juice was aspirated in the same manner as before, it was confirmed by an endoscopic image that the examination tool had turned pale blue-purple. That is, it was confirmed that the color of the test tool according to the amount of amylase originally contained in the duodenum.

  From the above experiment, according to the catheter according to the present embodiment, even when the test tool was repeatedly inserted into the same lumen, the sample collected before was not adhered to the new test tool, and the test tool was kept clean. It was confirmed that it can be used for inspection in the state.

[Comparative Example]
In order to compare with the catheter according to the present example, the following control catheter was prepared and a control experiment was performed.
The control catheter is different from the catheter according to Example 1 in that it does not include a tube for containing the filter paper.

Using the control catheter configured as described above, body fluid was examined and collected in the same procedure as in Example 1. At that time, after aspiration of pancreatic juice and removal of the filter paper, when a new filter paper was inserted into the lumen, a change in the color of the filter paper was confirmed by an endoscopic image.
From the above two experiments, the configuration of the catheter according to the present invention shows that the test tool or the sample collected by the test tool can be used with another test tool when the test and collection of the sample are repeated a plurality of times through the same lumen. It was confirmed that it was effective in preventing the collected specimen from adhering or mixing, and that it was effective in obtaining an accurate test result from the specimen.

1 Inspection instrument 2 Wire (wire member)
DESCRIPTION OF SYMBOLS 3 Test body 3a Operation wire 3b Link 3c Elastic wire 4 Sheath 4a Through-hole 4b Sealing member 4c Perforation 4d Cut 4e Operation wire 5 Absorption piece 6 Test piece 6a Deployment body 6b Absorption pad 6c Conjugate pad 6d Test line 6e Control line 6f Window 7 Cover 11 Catheter 12 Catheter body 12a Lumen for suction 12b Lumen for inspection tool 12c Suction connection part 12d Stopper 13 Inner container 13a Base end face (butting part)
13b Through-hole 14 Inspection tool (treatment tool)
15 Wire (Wire member)
16 Lid 17 Endoscope 17a Channel 17b Observation window 18 Brush (treatment tool)

Claims (16)

A wire member insertable into the body;
An inspection body provided at the tip of the wire member,
The specimen is
An absorbing piece that is disposed on the tip side of the test body and absorbs body fluid;
Is disposed adjacent to the absorbent strip, the body fluid which the absorbent strip is absorbed and absorbed in the body, and a qualitative or quantitative test piece a target substance contained in the body fluid,
The test piece has a developed body bonded to the absorbent piece, and an absorbent pad disposed with the developed body sandwiched between the absorbent piece,
An inspection instrument in which the body fluid absorbed by the absorbent piece is deployed by moving the deployment body in one direction toward the absorption pad .   The test instrument according to claim 1, wherein the test piece is an affinity chromatography test piece that holds an adsorbent substance that specifically adsorbs the target substance. The test instrument according to claim 2 , wherein the adsorbed substance is an antibody against the target substance. The inspection instrument according to any one of claims 1 to 3 , which has an outer diameter of 1 to 5 mm. The inspection instrument in any one of Claims 1-4 provided with the cylindrical sheath which accommodates the said test body so that it can protrude from the front-end | tip inside a body with respect to an insertion direction. The inspection instrument according to claim 5 , wherein the sheath includes a sealing member that can be penetrated by the inspection body at a distal end thereof. The inspection instrument according to claim 5 or 6 , wherein the sheath is made of a flexible member, and a distal end portion thereof is brazed in a shape curved in one direction with respect to the insertion direction. Extends to the proximal end is connected along the insertion direction to the tip of the sheath, according to claim 7 by the tension to the proximal end from the distal end of claim 5, an operation wire for changing the direction of the tip Inspection equipment. The inspection instrument according to any one of claims 5 to 8 , wherein the sheath has an outer diameter of 1 to 5 mm. The inspection instrument according to any one of claims 5 to 9 , wherein the sheath can be accommodated in a channel of an endoscope. The inspection instrument according to any one of claims 5 to 10 , wherein the sheath is configured separately from the wire member and the inspection body. Inspection device as claimed in any of the test piece, claims 1 to 11 which is coated with a liquid impervious member which does not transmit liquid. The inspection instrument according to claim 12 , wherein the liquid impermeable member is transparent. The test piece is adjacent to the absorbent strip, the inspection device according to any of claims 13 claim 1 arranged in plural and in parallel to the insertion direction.   The inspection instrument according to claim 1, wherein the inspection body includes an absorption piece that holds an indicator that absorbs the body fluid and performs a color reaction with the target substance. The test instrument according to claim 15 , wherein the indicator is any one of pH, occult blood, sugar and starch.

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