WO2012036220A1

WO2012036220A1 - Catheter

Info

Publication number: WO2012036220A1
Application number: PCT/JP2011/071041
Authority: WO
Inventors: 博美佐貫; 武山　哲英
Original assignee: オリンパス株式会社; オリンパスメディカルシステムズ株式会社
Priority date: 2010-09-16
Filing date: 2011-09-14
Publication date: 2012-03-22

Abstract

To sample a target body fluid reliably, the present invention provides a catheter (1) including: a tubular catheter body (2) having a suction opening (2a) at the leading end thereof; and a detection means (3) that is provided inside the catheter body (2) close to the base-end side of the suction opening (2a) and that detects the target body fluid. According to the present invention, if the body fluid that has been sucked contains the target body fluid, the detection means (3) will detect the target body fluid promptly after the start of suction, and the target body fluid that has been detected will pass through the catheter body (2) as-is and be sampled.

Description

catheter

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

Conventionally, when collecting a secretion from a body cavity, a catheter is inserted into an endoscope channel previously inserted into the body cavity, and the secretion is confirmed while confirming the position of the suction port of the catheter and the body cavity by an endoscopic image. A method of collecting a liquid by sucking it into a catheter is used (see, for example, Non-Patent Document 1 and Non-Patent Document 2).

Also, an inspection instrument that is connected to the proximal end of a catheter and inspects body fluid sucked from the body by the catheter is known (for example, see Patent Document 1). Such an inspection instrument is used, for example, to confirm whether or not the distal end of the catheter is disposed at a desired position in the body, and extends outside the body while the catheter once inserted into the body is left in the body. The test can be performed a plurality of times by changing the test instrument on the proximal end side of the catheter.

JP 2009-115609 A

However, even if the collection position of the secretory fluid can be roughly selected on the endoscopic image, whether or not it is surely sucked into the catheter, especially when the target secretion fluid is transparent, I do n’t know. Therefore, for example, in the duodenum, duodenal juice and pancreatic juice and bile discharged from the papilla into the duodenum are mixed, but even if the secretion is collected from the duodenum, the target secretion is contained therein. There is a problem that may not be included sufficiently.

In addition, in the case of the inspection instrument of Patent Document 1, for example, when the desired result cannot be obtained in the first inspection result, when the inspection instrument is newly replaced and the body fluid is again aspirated with the catheter, the first aspiration is performed. Since the body fluid thus adhered remains in the catheter, the body fluid sucked in the first time is mixed with the body fluid sucked in the second time. Therefore, there is a problem that there is a possibility that an accurate inspection result may not be obtained in the second and subsequent inspections.

The present invention has been made in view of the above-described circumstances, and an object thereof is to provide a catheter that can reliably collect a target body fluid.

It is another object of the present invention to provide a catheter and a catheter operating method capable of obtaining accurate test results every time even when body fluid is repeatedly aspirated and tested.

In order to achieve the above object, the present invention provides the following means.
A first aspect of the present invention includes a cylindrical catheter body having a suction port at a distal end thereof, and a detection unit that is provided in the catheter body in the vicinity of the proximal end side of the suction port and detects a target body fluid. It is a catheter provided with.
According to the first aspect of the present invention, body fluid can be sucked and collected from the suction port by sucking the inside of the catheter body from the proximal end side while the catheter body is inserted into the body cavity from the distal end. .

In this case, if the target body fluid is contained in the aspirated body fluid, the target body fluid is quickly detected by the detecting means from the start of the suction, and the detected target body fluid is collected as it is through the catheter body. The Therefore, the operator can reliably collect the target body fluid by sucking the body fluid while confirming that the target body fluid is detected by the detection means.

In the first aspect of the invention, the catheter body can be inserted into a channel of an endoscope insertion portion, and at least a portion near the proximal end side of the suction port is made of a transparent member, and the detection means However, a configuration may be adopted in which a reaction unit is provided that holds an indicator that specifically reacts with the target body fluid.
In this way, the distal end portion of the catheter body is projected and retracted from the channel, and the reaction portion in the distal end portion is sucked in while observing the endoscopic image through the transparent member, thereby presenting the reaction portion. The presence or absence of the target body fluid can be easily confirmed from the color.

Further, in the above configuration, it is preferable that the reaction portion is disposed at a position 0.1 to 5 cm away from the suction port.
By doing in this way, when the front-end | tip part of a catheter main body is made to appear and disappear from a channel, a reaction part can be easily arrange | positioned in the visual field of an endoscope.

In the configuration including the reaction section, the reaction section may be formed of a porous body having pores having a pore diameter of 0.05 to 10 μm.
By doing so, it is possible to secure a sufficiently wide reaction field between the body fluid and the indicator substance and improve the detection accuracy of the target body fluid.

Moreover, in the structure provided with the said reaction part, the said reaction part communicates in the longitudinal direction of the said catheter main body, and the structure which has a communicating hole with a hole diameter of 10 micrometers or more is preferable.
By doing in this way, a bodily fluid can be smoothly attracted | sucked through a communicating hole, even if the porous body is filled in the middle position in the catheter main body.

Moreover, in the structure provided with the said reaction part, the said indicator substance is good also as exhibiting blue, green, or red.
In this way, even in an environment where yellow body fluids such as gastric juice and bile are present, the color of these body fluids and the coloration of the indicator substance can be easily distinguished.

Moreover, in the structure provided with the said reaction part, the said indicator may be hold | maintained with the density which colors when it contacts the said target body fluid of the density | concentration higher than a predetermined threshold value.
In this way, the target body fluid can be reliably collected at a sufficiently high concentration.
In the first aspect of the invention, the catheter body may be transparent or translucent.
By doing in this way, even if the front-end | tip part of a catheter main body is imaged from what angle, the coloring of the reaction part can be easily confirmed with an endoscopic image.

According to a second aspect of the present invention, a cylindrical catheter body having a suction port for sucking a body fluid opened on the distal end side, and a position close to the proximal end side of the suction port in the catheter body along the longitudinal direction. A cylindrical inner container disposed, and an inspection that is detachably provided in the catheter body and that inspects the body fluid while allowing the body fluid housed in the inner container and sucked from the suction port to pass therethrough And the inner container is a catheter that is detachably provided in the catheter body together with the test body in a state in which the test body is housed.

According to the second aspect of the present invention, by inserting the catheter body into the body and sucking the body fluid from the suction port, the body fluid that has passed through the position of the inner container and the test body is examined while the body fluid is inspected by the test body. Can be collected. In addition, by extracting the inspected test body from the inside of the catheter body and inserting a new test body into the catheter body, it is possible to repeat the inspection of the body fluid while using the common catheter body.

In this case, the inspected test body and the inner container housing the test body are also extracted from the catheter body, and the new test body is a bodily fluid adhering to the inner surface of the catheter body while being housed in the new inner container. It is installed near the suction port in the catheter body while being protected from the above. This prevents the previously aspirated body fluid from adhering to a new specimen, and prevents the previously aspirated body fluid from being mixed into the inspected body fluid. Even in the case of an error, an accurate test result can be obtained every time.

In the second aspect of the present invention, the catheter body can be inserted into a channel formed through the endoscope insertion portion in the longitudinal direction, and at least a portion close to the proximal end side of the suction port May be made of an optically transparent member, and the test body may hold an indicator substance that specifically reacts with the target body fluid.
In this way, the catheter body is inserted into the body through the channel and the body fluid is sucked, and the color of the test object at that time is observed with an endoscopic image, thereby easily checking the test result. can do.

In the second aspect of the invention, the catheter body has a locking member for locking the movement of the inner container toward the distal end side at a position close to the proximal end side of the suction port. May be.
In this way, when the test body and the inner container are inserted into the catheter body, they are prevented from being placed beyond the position of the suction port, and the inner container and the test body can be easily positioned at appropriate positions. Can be arranged.

The third aspect of the present invention includes a cylindrical catheter body having a suction port for sucking body fluid opened on the distal end side, and a position close to the proximal end side of the suction port in the longitudinal direction in the catheter body. And a test body that is provided so as to be insertable / removable in the catheter body, and that inspects the body fluid while allowing the body fluid housed in the inner container and sucked from the suction port to pass therethrough. The inner container is disposed inside and outside the catheter body in a state in which the test body is housed together with the test body when the test body is inserted into and removed from the catheter body. It is the operating method of the moving catheter.

According to the present invention, there is an effect that the target body fluid can be reliably collected.

Alternatively, according to the present invention, there is an effect that an accurate test result can be obtained every time even when the suction and the test of body fluid are repeatedly performed.

1 is an overall configuration diagram of a catheter according to a first embodiment of the present invention. It is a figure which shows the state which inserted the catheter of FIG. 1 in the channel of the endoscope. It is a figure which shows the modification of the reaction part of the catheter of FIG. It is a figure which shows another modification of the reaction part of the catheter of FIG. It is a figure explaining the usage method of the catheter of FIG. It is a figure which shows the modification of the reaction part of the catheter of FIG. It is a whole block diagram of the catheter which concerns on the 2nd Embodiment of this invention. It is a whole block diagram of the catheter which concerns on the 2nd Embodiment of this invention. It is a figure explaining the usage method of the catheter which concerns on the 2nd Embodiment of this invention. It is a figure which shows the modification of an inner container. It is a figure which shows another modification of an inner container.

Below, the catheter 1 which concerns on the 1st Embodiment of this invention is demonstrated with reference to FIGS. 1-4.
A catheter 1 according to the present embodiment is used for collecting pancreatic juice from the body of a subject. As shown in FIG. 1, a catheter body 2 having a suction port 2a opened at the tip, and the catheter body 2 is provided in the vicinity of the proximal end side of the suction port 2a, and a reaction part (detection means) 3 that specifically reacts with the pancreatic fluid.

The catheter body 2 is made of a transparent or translucent material having flexibility that can be bent in accordance with the shape of the body cavity, such as polytetrafluoroethylene, and the inside can be visually recognized from the outside. The outer diameter of the catheter body 2 may be inserted into a channel formed through the insertion portion of the endoscope in the longitudinal direction, and is preferably 2.6 to 2.7 mm. The position of the suction port 2a can be appropriately changed depending on the body fluid collection site, and may be opened at the distal end surface of the catheter body 2 as illustrated, or may be opened at the side surface. The catheter body 2 may be bent at the distal end portion by pulling a wire (not shown) connected to the distal end and extending to the proximal end side.

The reaction part 3 is formed by filling a part of the catheter body 2 with the porous body 4. The reaction unit 3 has a distal end surface disposed at a position 0.1 to 5 cm away from the suction port 2 a toward the proximal end, and has a dimension of about 0.5 to 2 cm in the longitudinal direction of the catheter body 2. Thereby, as shown in FIG. 2, when the distal end portion of the catheter body 2 is projected and retracted from the channel 5 a of the endoscope 5, the reaction portion 3 is surely arranged in the field of view of the endoscope 5 to be The reaction part 3 can be observed by the endoscopic image. Reference numeral 5b denotes an objective lens.

The porous body 4 is made of a material having high biocompatibility and capable of stably holding an indicator substance described later, such as natural fibers such as cellulose, synthetic fibers, glass fibers, and porous ceramics, and has a thickness of 0.05 to 10 μm. It has innumerable pores with a pore diameter of. Further, the porous body 4 has communication holes 4a communicating from the distal end side to the proximal end side of the catheter body 2 by communicating voids that are larger in size than the pores and irregularly present therein. Has been. The hole diameter of the communication hole 4a is preferably 10 μm or more, more preferably 30 μm or more, and further preferably 100 μm or more.

In addition, the structure of the reaction part 3 and the communication hole 4a shown by FIG. 1 is an example, Comprising: It is not limited to this. For example, as shown in FIG. 3A, the reaction portion 3 is formed by filling the catheter body 2 with the beads of the porous body 4, and the communication holes 4a are formed by the gaps between the beads communicating with each other. May be. In this case, the shape of the reaction part 3 is kept constant, for example, by storing the beads in a mesh bag. Further, as shown in FIG. 3B, the reaction portion 3 may be formed from a cylindrical porous body 4, and a communication hole 4 a penetrating in the longitudinal direction may be provided therein. In this case, one communication hole 4a having a relatively large hole diameter may be formed, or a plurality of communication holes 4a having a relatively small hole diameter may be formed substantially in parallel.

The porous body 4 holds an indicator that specifically reacts with the pancreatic juice. Thereby, when pancreatic fluid is contained in the bodily fluid sucked from the suction port 2a toward the proximal end, the reaction part 3 is discolored by causing a color reaction with the pancreatic fluid of the indicator substance.

As the indicator substance, amylose in which 5 to 7 glucoses are linearly polymerized and a chromogenic substrate is bonded to the terminal is used. The chromogenic substrate is colorless when bound to amylose, and develops color when cleaved from the amylose by p-amylase in the pancreatic juice and released. The color exhibited by the chromogenic substrate at this time is preferably blue, green, or red so that it can be easily distinguished from the color of these body fluids even in an environment where yellow body fluids such as gastric juice and broth are mixed. The indicator substance is held in the porous body 4 by, for example, infiltrating the porous body 4 in a state dissolved in the buffer solution and then sufficiently drying the buffer solution.

The indicator substance does not react with amylose when the concentration of amylose in the contacted body fluid is lower than the predetermined threshold, and when the concentration of amylose in the contacted body fluid is higher than the predetermined threshold, The porous body 4 is held at an appropriately adjusted density so that the reaction proceeds rapidly. As a result, even if pancreatic fluid is contained in the body fluid sucked into the catheter main body 2, the color of the reaction part 3 does not change when the concentration of the pancreatic fluid is lower than a predetermined threshold value.

The usage method and operation of the catheter 1 configured as described above will be described below.
In order to collect pancreatic juice from the body of the subject using the catheter 1 according to the present embodiment, the endoscope 5 is inserted into the duodenum A while observing the endoscopic image, and the nipple B is displayed in the endoscopic image. The endoscope 5 is placed at a position to be reflected. Next, when the catheter body 2 is inserted from the distal end side along the channel 5a of the endoscope 5, the distal end portion of the catheter body 2 appears and disappears from the opening of the channel 5a and appears in the endoscope image.

As shown in FIG. 4, the operator operates the catheter body 2 while observing an endoscopic image to place the suction port 2a in the vicinity of the nipple B, and from the proximal end of the catheter body 2 extending outside the body. The inside of the catheter body 2 is sucked with a pump (not shown). Thereby, the bodily fluid secreted in the vicinity of the nipple B into the catheter body 2 from the suction port 2a is sucked. In the illustrated example, a direct endoscope having a channel 5a opened on the distal end surface is used as the endoscope 5, but a side endoscope having a channel 5a opened on the side surface may be used.

The operator observes the reaction unit 3 with an endoscopic image when the body fluid suction is started. Then, when the operator can confirm the change in the color of the reaction unit 3, the operator continues the suction until the amount of body fluid collected reaches a desired amount. On the other hand, when the color change of the reaction unit 3 cannot be confirmed, the operator temporarily stops the suction, shifts the position of the suction port 2a, and sucks again to find the position where the color of the reaction unit 3 changes. The body fluid is then aspirated until the desired volume is reached.

Thus, according to the present embodiment, when body fluid starts to be sucked, whether or not pancreatic fluid is contained in the sucked body fluid is quickly detected from the color change of the reaction unit 3, and the pancreatic fluid is detected. The detected body fluid is collected as it is. Therefore, when the body fluid does not contain pancreatic fluid, the body fluid collection is continued without being aware of this, or the collected body fluid is used for the examination as it is, and the correct test result is obtained. There is an advantage that it is possible to avoid the failure of the pancreas and to reliably collect a sufficiently high concentration of pancreatic juice.

Further, by holding the indicator substance in the porous body 4 having pores, there is an advantage that the reaction field between the body fluid and the indicator substance can be secured sufficiently wide and the reaction between the body fluid and the indicator substance can be stabilized. is there. Further, since the color-developing substrate released from amylose does not immediately flow away in accordance with the suction and remains in the porous body 4, the coloration of the reaction unit 3 is maintained for at least a certain period to facilitate the visual recognition of the coloration by the operator. There is an advantage that can be. Even if the porous body 4 is filled in the middle of the catheter body 2 in this way, pancreatic fluid having a relatively high viscosity can be smoothly blocked without clogging in the middle of the porous body 4 through the communication hole 4a. There is an advantage that it can be sucked.

In the above embodiment, amylose to which a chromogenic substrate is bound is used as an indicator for detecting pancreatic juice. However, the indicator is a substance that reacts with color depending on the specific properties of pancreatic juice, or is specific to pancreatic juice. Any material may be used as long as it reacts with the substance contained therein.
For example, it is known that the pH of pancreatic juice is about 8.0, which is higher than that of secretory fluids such as duodenal juice and bile secreted from surrounding tissues of the pancreas. Accordingly, a pH indicator such as litmus, thymol blue, or naphthanolphthalein that turns blue at pH 8.0 can be used as the indicator.

Also, a mixture of amylose and iodine solution may be used as the indicator substance. For example, when the porous body 4 is infiltrated with a mixed solution of amylose and iodine solution in which a sufficient number of glucose is polymerized and then dried, the reaction part 3 exhibits blue due to the coloration of iodine. When the reaction unit 3 comes into contact with the pancreatic juice, amylose is decomposed by p-amylase in the pancreatic juice, and the blue color of iodine changes to purple or red, or disappears.

In addition, bicarbonate and potassium phosphoenolpyruvate, phosphoenolpyruvate carboxylase (PEPC), 3-acetylpyridine adenine dinucleotide, malate dehydrogenase, magnesium chloride or sodium oxamate may be used as the indicator substance.
Bicarbonate anion reacts with phosphoenolpyruvate in the presence of PEPC and Mg ions to produce oxaloacetate and inorganic phosphorus, which is reduced to malate by malate dehydrogenase and simultaneously cofactor NADH The reduced form of the analog 3-acetylpyridine adenine dinucleotide (aNADH) is oxidized. At this time, the absorbance of aNADH at 405 nm and 700 nm decreases in proportion to the total carbon dioxide concentration in the sample, and can be observed as a color change.
As described above, even when other indicator substances are used, it is possible to easily detect whether or not pancreatic fluid is contained in the body fluid by observing the coloration of the reaction unit 3 with an endoscopic image.

Moreover, in the said embodiment, although the porous body 4 holding the indicator substance was used as the reaction part 3, it may replace with this and may provide the test piece 6 for immunochromatography.
For example, as shown in FIG. 5, the immunochromatographic test strip 6 is formed in a cylindrical shape, and a surface other than the tip surface is covered with a cover (not shown) so as not to come into contact with a body fluid. The test piece 6 has a deployment body 6a and an absorption pad 6b in order from the distal end surface side, and the body fluid absorbed from the distal end surface of the deployment body 6a moves the deployment body 6b in one direction toward the absorption pad 6b. To be deployed.

In the developing body 6a, a conjugate pad 6c holding a dye-labeled primary antibody against a target substance to be detected, for example, p-amylase, and an antibody specific to the antigen of the primary antibody are fixed in order from the distal end surface side. A phased test line 6d is provided at an interval. For the dye labeling of the primary antibody, for example, colloidal gold, colored latex, or nanoparticles made of a semiconductor are used.

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. As a result, the position of the test line 6d is colored in the color of the pigment and a detection line appears, so that the inspection result can be confirmed visually. When the target substance is not contained in the liquid, the dye-labeled primary antibody-target substance complex is not formed, and therefore the dye-labeled primary antibody passes through the test line 6d without being adsorbed, and no detection line appears. Even in this way, it is possible to detect with high sensitivity whether or not pancreatic fluid is contained in the aspirated body fluid.

In the above embodiment, the pancreatic fluid in the body fluid is detected by observing the color of the reaction part 3 in the endoscopic image, but instead of this, an electrode ( Detection means) may be provided, and pancreatic fluid may be detected by monitoring the potential change due to the reaction of the electrode with the body fluid.

For example, a detection electrode disposed in the vicinity of the suction port 2a in the catheter body 2 and a comparison electrode immersed in a solution having a constant pH are provided, and the potential between the detection electrode and the comparison electrode is measured. Thus, the pH of the body fluid in contact with the detection electrode is measured. Even in this way, it is possible to detect whether or not pancreatic fluid is contained in the body fluid sucked from the suction port 2a.

Next, a catheter 11 according to a second embodiment of the present invention will be described with reference to FIGS. In this embodiment, the catheter 11 will be described by taking as an example a catheter 11 that is used when collecting pancreatic juice from the duodenum in combination with an endoscope.
As shown in FIG. 6A, the catheter according to this embodiment is accommodated in a tubular catheter body 12, a tubular inner container 13 disposed in the catheter body 12, and the inner container 13. And an inspection body 14.

The catheter body 12 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 embodiment is generally 2.8 to 2.9 mm. Therefore, the outer dimension of the catheter body 12 is preferably 2.6 to 2.7 mm. The catheter body 12 is made of an optically transparent or translucent material at least at the distal end portion. The material constituting the catheter body 12 is preferably, for example, PTFE (polytetrafluoroethylene) from the viewpoints of flexibility, biocompatibility, and optical transparency.

The catheter body 12 has a suction port 12a opened at the distal end surface, and the opening at the proximal end surface can be sealed by attaching a lid 12b. The lid 12b may be detachable from the proximal end of the catheter main body 12 with a screw, for example, or may be a rubber plug packed in the catheter main body 12. A suction port 2c that can be connected to suction means such as a tube or a syringe connected to a suction pump is provided on the proximal end side of the catheter body 12, and the suction means is operated with the lid 12b attached. Body fluid can be sucked from the suction port 12a toward the suction port 12c. Although FIG. 6A shows an example in which the suction port 12c is provided on the side surface of the catheter body 12, the suction port 12c may be provided on the lid 12b.

Both ends of the inner container 13 are open and are disposed in the catheter body 12 along the longitudinal direction. Thereby, the bodily fluid sucked from the suction port 12a passes through the inner container 13. Further, the inner container 13 can be smoothly moved along the insertion direction in the catheter main body 12 because the outer surface is made of a material that hardly generates friction with the inner surface of the catheter main body 12. At this time, the movement of the inner container 13 forward in the insertion direction is locked by a main body side stopper (locking member) 12d protruding inward in the radial direction provided on the distal end surface of the catheter main body 12, and the suction port 12a It is supposed to be prevented from appearing and disappearing from.

The inner container 13 is made of an optically transparent or translucent material, and the inspection body 14 disposed in the inner container 13 can be observed through the catheter body 12 and the side wall of the inner container 13 by an endoscope. ing. Further, on the inner surface of the inner container 13, there are inner container side stoppers 13 a projecting inward in the radial direction in the vicinity of both ends of the inspection body 14 with the inspection body 14 disposed substantially at the center in the inner container 13. Is provided. Thereby, the movement of the test body 14 toward the distal end side and the base end side with respect to the inner container 13 is locked by the inner container side stopper 13a so that the position of the test body 14 in the inner container 13 is held substantially at the center. It has become.

At this time, the length of the inner container 13 in the longitudinal direction of the test body 14 is set so that the test body 14 is disposed in the inner container 13 at positions sufficiently away from the openings at both ends of the inner container 13. It is sufficiently longer than the dimension, and preferably designed to be twice or more the longitudinal dimension of the inspection object 14. Thereby, the test body 14 is more reliably prevented from coming into contact with body fluid outside the inner container 13.

The operation rod 15 extending to the outside of the catheter body 12 is connected to the test body 14. The operation rod 15 is not particularly limited as long as it has flexibility capable of bending according to deformation of the catheter body 12 and has rigidity capable of transmitting the operation on the proximal end side to the distal end. Or a plastic wire is used.

Here, when the operator pulls the operating rod 15, as shown in FIG. 6B, the inner container 13 also moves to the proximal end side together with the inspection body 14, and the inspection body 14 is stored in the inner container 13. In the state, it is extracted out of the catheter body 12. Further, when the operator pushes the operating rod 15 and inserts the test body 14 into the catheter main body 12, the test body 14 is passed through the catheter main body 12 while being stored in the inner container 13. Then, when the operator pushes the operation rod 15 to a position limited by the main body side stopper 12d, the inspection body 14 and the inner container 13 are installed in the state shown in FIG. 6A.

The inspection body 14 is made of a porous body, and the body fluid sucked from the suction port 12a passes through the inspection body 14 along the suction direction. The test body 14 may be made of, for example, synthetic fiber or glass fiber, or may be made of porous ceramic. Moreover, the test | inspection body 14 may be comprised by filling bead bodies, such as a synthetic polymer, glass, and ceramics, into the bag body which has liquid permeability, such as a mesh. Moreover, it is preferable that the test body 14 has a relatively large communication hole (not shown). As a result, solid components such as relatively viscous pancreatic juice and tissue pieces peeled from the tissue can be easily passed through the test body 14 and smoothly sucked. Further, the dimension in the longitudinal direction of the inspection body 14 is preferably 0.5 to 2 cm so that the whole is displayed in the endoscopic image.

The test body 14 holds an indicator substance that specifically reacts with the pancreatic fluid, which is a body fluid to be collected. Thereby, when the bodily fluid sucked from the suction port 12a passes through the test body 14, the color of the test body 14 changes when pancreatic fluid is contained in the bodily fluid. As the indicator, a p-amylase or bicarbonate indicator specifically contained in pancreatic juice, or a pH indicator that develops a color in the vicinity of pH 8.0, which is the pH of pancreatic juice, can be used.

Specifically, amylose in which 5 to 7 glucose are 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 when bound to amylose, and develops color when cleaved from the amylose by p-amylase in the pancreatic juice and released. Alternatively, a mixture of amylose and iodine solution can be used as an indicator for p-amylase. For example, the test body 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. When the test body 14 comes into contact with the pancreatic juice, amylose is decomposed by p-amylase in the pancreatic juice, and the blue color of iodine changes to purple or red, or disappears.

As a bicarbonate indicator, 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 indicator substance is a color having a wavelength in the visible region so that it can be more reliably visually recognized 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 the present 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.

In the present embodiment, a porous body holding an indicator substance is used as the test body 14. However, instead of this, a test piece for immunochromatography may be provided.
For example, as shown in FIG. 5, the immunochromatographic test strip 6 is formed in a cylindrical shape, and a surface other than the tip surface is covered with a cover (not shown) so as not to come into contact with a body fluid. The test piece 6 has a deployment body 6a and an absorption pad 6b in order from the distal end surface side, and the body fluid absorbed from the distal end surface of the deployment body 6a moves the deployment body 6b in one direction toward the absorption pad 6b. To be deployed.

The usage method and operation of the catheter 11 configured as described above will be described below.
In order to collect pancreatic juice from the body of a subject using the catheter 11 according to the present embodiment, the endoscope 16 is inserted into the duodenum while observing the endoscope image, and the position where the nipple is reflected in the endoscope image An endoscope is placed in Next, when the catheter main body 12 is inserted from the distal end side along the channel 16a of the endoscope 16, the distal end portion of the catheter main body 12 protrudes and disappears from the opening of the channel 16a as shown in FIG. Appearing in the endoscopic image, the inspection body 14 in the catheter body 12 can be observed in the endoscopic image. Reference numeral 16b denotes an observation window of the endoscope.

The operator operates the catheter body 12 while observing the endoscopic image to place the suction port 12a near the nipple, and sucks the inside of the catheter body 12 from the proximal end of the catheter body 12 extending outside the body by suction means. To do. Thereby, the bodily fluid that has oozed into the vicinity of the nipple in the catheter body 12 from the suction port 12a is sucked.

The operator observes the inspection body 14 with an endoscopic image when the suction of the body fluid is started. When the operator can confirm the change in the color of the test object 14, the operator continues the suction until the amount of the collected body fluid reaches a desired amount. On the other hand, when the operator cannot confirm the change in the color of the test body 14, the operator temporarily stops the suction, pulls the operating rod 5, pulls out the test body 14 and the inner container 13 from the catheter body 12, and creates a new test body. 14 and the inner container 13 are inserted into the distal end portion of the catheter body 12 and installed. Then, the position of the suction port 12a is shifted and sucked again to find a position where the color of the test body 14 changes, and then the body fluid is sucked until a desired collection amount is reached.

In this case, according to the present embodiment, the new test body 14 is stored in the inner container 13 while being protected from the previously sucked body fluid adhering to the inner surface of the catheter body 12. Passed through. Further, since the new test body 14 is installed close to the suction port 12a, the next sucked body fluid reaches the test body 14 without contacting the inner surface of the catheter main body 12, and the inner surface of the catheter main body 12 is reached. It is prevented that the body fluid sucked before adhering to the body fluid is mixed into the body fluid to be inspected by the inspection body 14.

This has the advantage that a correct test result can be obtained every time even if the same catheter body 12 is used for repeated tests. In addition, since it is not necessary to insert / remove the catheter body 12 into / from the channel 16a with the replacement of the test body 14, the procedure is simplified, the burden on the operator is reduced, and the time required for the test is shortened. The burden can be reduced.

In the present embodiment, the presence or absence of the body fluid to be collected is examined by observing the color reaction with the body fluid to be collected by an endoscopic image. However, the inspection method using the specimen 14 is limited to this. Is not to be done. For example, the pancreatic fluid may be detected by providing an electrode as the test body 14 at the distal end of the catheter body 12 and monitoring the potential change of the electrode due to the pH of the body fluid.

Further, in the present embodiment, the inner container side stopper 13a is provided in the middle of the inner surface of the inner container 13 with the inspection body 14 disposed substantially at the center in the inner container 13, but the inner container side stopper 13a should just be provided in the position which can latch the movement to the back of the test | inspection body 14 in the inner container 13 at least at the insertion direction.

For example, the inner container side stopper 13a may be provided only on the base end side of the inspection body 14 as shown in FIG. 8A, and is provided at both ends of the inner container 13 as shown in FIG. 8B. May be. When the inner container side stopper 13a is provided only on the proximal end side of the test body 14 as shown in FIG. 8A, when the test body 14 is inserted into the catheter body 12, it can be inserted while being accommodated in the inner container 13. The inner container 13 is also provided with an operation rod (not shown). Further, instead of providing the inner container side stopper 13a, the inspection body 14 may be fixed to the inner container 13 by press-fitting the inspection body 14 into the inner container 13 or by adhering it to the inner surface of the inner container 13. Good.

Next, examples of the catheter according to the first embodiment will be described.
[Example 1]
A catheter according to this example was manufactured according to the following procedure.
As the catheter body, a commercially available contrast catheter having a suction port opened at the distal end surface and having an outer diameter of 2.6 mm was used. The reaction part was produced by the following procedure.

First, a porous ceramic bead (manufactured by Nippon Sheet Glass Co., Ltd.) having a diameter of 0.1 mm and a pore diameter of 0.1 μm is soaked with an indicator solution in which about 100 glucose is polymerized and iodine solution, and dried. Thus, porous ceramic beads exhibiting a blue color holding amylose and iodine were prepared. Next, the produced porous ceramic beads were sealed in a mesh-like bag so as to have a volume equivalent to that of a cylinder having the same inner diameter as the contrast catheter and having a height of 5 mm, thereby creating a reaction part. . The prepared reaction part was installed in the contrast catheter so that the distal end face was arranged at a position 5 mm away from the distal end face of the contrast catheter toward the proximal end.

By using the catheter according to the present example manufactured as described above, body fluid was aspirated according to the following procedure, thereby evaluating pancreatic fluid detection sensitivity and body fluid aspiration ability by the reaction part.
5 ml each of pancreatic juice or duodenal juice collected from a person was dropped at different positions on the three-dimensional model of the stomach and duodenum for practice of endoscope operation. 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 duodenal juice is stored, insert the catheter according to this embodiment into the channel of the placed endoscope, and open the channel from the opening of the channel. The opening at the tip of the catheter that appeared was placed in contact with the duodenal juice. Next, duodenal juice was sucked into the catheter from the suction port by connecting a syringe to the proximal end of the catheter and pulling the plunger. At this time, in the endoscopic image, it was confirmed that the color of the reaction part changed to a light blue-purple color.

Next, the endoscope was moved to a position just before the position where the pancreatic juice was sprayed in a state where the catheter was housed in the channel, and the pancreatic juice was sucked from the suction port in the same procedure as before. At this time, it was confirmed that the color of the reaction part disappeared in the endoscopic image.
From the above experiments, it was confirmed that the catheter according to this example can detect pancreatic juice with sufficient sensitivity.

[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.
Amylose and iodine solution were held in the same manner as in Example 1 on a porous ceramic flat plate having a pore diameter of 0.1 μm. Next, a reaction part was created by cutting a flat plate into a circle having a diameter of 2.5 mm and laminating a plurality of plates until the thickness of the plate became 5 mm without any gap in the plate pressure direction. The prepared reaction part was installed in the same contrast catheter as in Example 1 so that the distal end face was placed at a position 5 mm away from the distal end face to the proximal end side, and a control catheter was created.

Using the prepared control catheter, duodenal juice and pancreatic juice were aspirated in the same procedure as in Example 1. As a result, the same color change in the reaction part as in Example 1 was confirmed. However, even when both duodenal juice and pancreatic juice are aspirated, the reaction part becomes clogged immediately after the suction starts, making it difficult to aspirate. Even if the suction force is increased, the dispersed duodenal fluid and pancreatic juice are sufficiently aspirated. I couldn't.

From the control experiment described above, in the catheter of Example 1, the communication hole formed by the gap between the porous ceramic beads contributes to smooth suction of body fluid, and the catheter of Example 1 is suitable for suction of body fluid. Was confirmed.

Next, examples of the catheter according to the second embodiment described above will be described.
[Example 2]
A catheter according to Example 2 was prepared according to the following procedure.

As the inner container, a transparent tube having a length of 2 cm and an outer diameter of 2.3 mm was used. As the test object, a filter paper which was impregnated with an indicator substance mixed with amylose and iodine and dried and formed into a substantially cylindrical shape having a length of 5 mm in the longitudinal direction was used. The filter paper was press-fitted into the tube and arranged at a substantially central position of the tube. In addition, a guide wire for an endoscope was connected to the filter paper as an operation rod.

As the catheter body, a commercially available endoscope contrast tube provided with a lid on which the guide wire can be attached and detached on the proximal end side and a suction port was used. The contrast tube was made transparent about 2 cm at the tip. The prepared inner container and test object were inserted into the distal end portion of the contrast tube, and a guide wire was connected to the lid.

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 Then, the tip of the contrast tube was placed at a position where pancreatic juice was stored. Next, the pancreatic juice was sucked into the contrast tube by connecting a syringe to the proximal end of the contrast tube and pulling the plunger. At this time, it was confirmed by an endoscopic image that the sucked pancreatic fluid soaked into the filter paper and the blue color of the filter paper disappeared.

Next, the inspected filter paper was pulled out of the contrast tube together with the inner container by pulling the guide wire, and a new specimen and inner container were inserted into the distal end portion of the contrast tube. At this time, the inserted filter paper remained blue. Next, when duodenal juice was aspirated in the same manner as before, it was confirmed by endoscopic video that the filter paper had turned pale blue-purple. That is, coloration of the filter paper according to the amount of amylase originally contained in the duodenum was confirmed.

[Comparative Example]
In order to compare with the catheter according to Example 2, a control catheter as shown below was prepared and a control experiment was performed.
The control catheter was prepared in the same manner as the catheter according to Example 2 except that it did 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 2. At that time, after the pancreatic juice was aspirated to remove the tested filter paper from the contrast tube, the color change of the filter paper was confirmed when a new filter paper was inserted into the catheter body.

From the above control experiment, the configuration of the catheter of Example 2 shows that the previously aspirated body fluid adheres to a new specimen when the examination and collection of the specimen are repeated a plurality of times through the same catheter body. It was confirmed that it was effective to prevent this, and that it was effective to obtain accurate test results every time.

DESCRIPTION OF SYMBOLS 1 Catheter 2 Catheter main body 2a Suction port 3 Reaction part (detection means)
4 Porous body 4a Communication hole 5 Endoscope 5a Channel 5b Objective lens 6 Test piece

6a Deployment body

6b Absorption pad 6c Conjugate pad 6d Test line A Duodenum B Papilla 11 Catheter 12 Catheter body

12a Suction port 12b Lid

12c Suction port 12d Main body side stopper (locking member)
13 Inner container 13a Inner container side stopper 14 Inspection object 15 Operation rod 16 Endoscope 16a Channel 16b Observation window

Claims

A cylindrical catheter body having a suction port at the tip;
A catheter provided in the catheter body in the vicinity of the proximal end of the suction port and detecting means for detecting a target body fluid.
The catheter body can be inserted into the channel of the endoscope insertion portion, and at least a portion near the proximal end side of the suction port is made of a transparent member,
The catheter according to claim 1, wherein the detection unit includes a reaction unit that holds an indicator that specifically reacts with the target body fluid.
The catheter according to claim 2, wherein the reaction part is disposed at a position 0.1 to 5 cm away from the suction port.
The catheter according to claim 2 or 3, wherein the reaction part is formed of a porous body having pores having a pore diameter of 0.05 to 10 µm.
The catheter according to claim 4, wherein the reaction part communicates in the longitudinal direction of the catheter body and has a communication hole having a hole diameter of 10 µm or more.
The catheter according to any one of claims 2 to 5, wherein the indicator substance exhibits blue, green, or red.
The catheter according to any one of claims 2 to 6, wherein the indicator substance is held at a density that develops color when the target substance comes into contact with the target body fluid having a concentration higher than a predetermined threshold value.
The catheter according to any one of claims 1 to 7, wherein the catheter body is transparent or translucent.
A cylindrical catheter body having a suction port for sucking body fluid opened on the distal end side;
A cylindrical inner container disposed along the longitudinal direction at a position close to the proximal end side of the suction port in the catheter body;
The test body is provided so as to be insertable / removable in the catheter body, and includes a test body that inspects the body fluid while allowing the body fluid housed in the inner container and sucked from the suction port to pass therethrough,
A catheter in which the inner container is detachably inserted into the catheter body together with the test body in a state in which the test body is stored.
The catheter body can be inserted into a channel formed through the endoscope insertion portion in the longitudinal direction, and at least a portion close to the proximal end side of the suction port is made of an optically transparent member,
The catheter according to claim 9, wherein the test body holds an indicator that specifically color-reacts with a target body fluid.
The catheter according to claim 9 or 10, wherein the catheter body has a locking member that locks the movement of the inner container toward the distal end side at a position close to the proximal end side of the suction port.
A cylindrical catheter body having a suction port for sucking body fluid opened on the distal end side, an inner container disposed along the longitudinal direction at a position close to the proximal end side of the suction port in the catheter body, and the catheter A method of operating a catheter comprising a test body that is provided in a body so as to be insertable / removable, and that inspects the body fluid while passing through the body fluid housed in the inner container and sucked from the suction port,
The method of operating a catheter, wherein the inner container moves in and out of the catheter body while the test body is housed together with the test body when the test body is inserted into and removed from the catheter body.
A method for testing body fluids,
An endoscopic channel comprising a catheter comprising: a cylindrical catheter body having a suction port at the distal end; and a detection means provided in the catheter body adjacent to the proximal end side of the suction port and detecting a target body fluid. Passing through and inserting into the body cavity,
Sucking the desired body fluid into the catheter;
Inspection of body fluid, including determining the presence of a specific component in the aspirated body fluid by observing with a endoscope camera a color reaction that occurs specifically by reacting the aspirated body fluid with the reaction part Method.
The method according to claim 13, wherein the body fluid is any of pancreatic juice, bile, and duodenal fluid.