JP4482000B2 - Chemical inspection equipment - Google Patents

Description

  The present invention relates to a chemical test apparatus, and in particular, for elucidation and diagnosis / treatment of diseases of the circulatory system and digestive system, the concentration of nitric oxide in a body cavity or blood vessel of a specific site can be measured. The present invention relates to a chemical test apparatus used for a chemical test deep in the body.

  In recent years, arteriosclerosis has progressed due to inhibition of production or regulation of nitric oxide (hereinafter referred to as “NO”) for many diseases such as hypertension, hyperlipidemia, diabetes and ischemic. It has become clear that serious symptoms such as heart disease and cerebrovascular disorder are reached. The administration of nitroglycerin is well known as a treatment method for angina pectoris, which is a treatment method for adjusting NO concentration in the body.

  Measuring the concentration of NO at a specific site in the body is important for knowing abnormalities in production or regulation of NO and for diagnosing and treating related diseases, particularly cardiovascular diseases.

  Since NO produced in the body is rapidly metabolized, not only its life span is very short, but also the concentration of NO changes from time to time due to hemodynamics and the influence of other physiologically active substances. This measurement is not useful for diagnosis. In other words, in vitro (in vitro) tests are not useful for diseases in which NO concentration is diagnostically important, but in vivo (in vivo) chemical tests deep inside the body, such as in blood vessels and body cavities. is required.

  As a chemical test apparatus for performing the chemical test as described above, a flexible catheter tube and a nitric oxide sensor (hereinafter referred to as “NO sensor”) that is provided on the distal end side of the catheter tube and detects NO in the liquid. )) And a protective body that covers the NO sensor with an opening through which liquid flows (Patent Document 1).

According to the chemical test apparatus of Patent Document 1, a catheter can be inserted into a deep part of a body, such as in a blood vessel or a body cavity, without damaging a blood vessel wall or the NO sensor. Concentration can be measured, and vascular disease related to NO concentration in the body can be diagnosed.
JP 2000-296179 A

  However, when a chemical inspection apparatus is inserted into a body cavity using an endoscope channel in a procedure for inspecting a body cavity such as the mouth, nose, and stomach using an endoscope, this conventional structure uses a protective cylinder. Since the distal end of the body is open, the protection to the NO sensor is weak in the operation inside the channel of the rigid endoscope, and the edge of the opening may become a resistance during insertion.

Specifically, there are various problems as follows.
(1) A NO sensor is attached to the distal end of the catheter tube, and insertion into the endoscope channel is difficult due to the structure of the protective body and the elastic body provided at the distal end of the outer periphery of the NO sensor.
(2) Since the distal end of the protective body is open, the protective body is likely to be deformed during operation in the endoscope channel or body cavity, and the NO sensor may be damaged by being crushed.
(3) Since the NO sensor is covered with a protective body, the flow of liquid and gas into the protective body is small, and the NO concentration detection capability is not sufficient.
(4) In addition, changes in the hydrogen ion concentration (hereinafter referred to as “pH”) are also effective as information emitted from the disease department, and in order to make the clarification of the disease more accurate, pH is measured simultaneously with the measurement of the NO concentration. There is a need for a configuration that measures the change in temperature.

  Accordingly, an object of the present invention is made in view of the problems of the conventional chemical inspection apparatus as described above, and durability and operability when inserted into the endoscope channel while protecting the NO sensor are achieved. In addition, the addition of a hydrogen ion concentration sensor (hereinafter referred to as “pH sensor”) enables simultaneous measurement of NO concentration and pH, enabling further information collection from the lesion. An object of the present invention is to provide a chemical inspection apparatus.

[1] In order to achieve the above object, the present invention is provided with a catheter tube having flexibility and having a lumen, and wiring in the lumen of the tube. A sensor for detecting nitric oxide therein, an opening for allowing the liquid and gas to flow into the lumen of the tube, and a protector for protecting the sensor, and an insertion attached to the tip of the protector Provided is a chemical test apparatus comprising: an elastic body; a cable to which the wiring of the sensor is connected and having a plug connector at an end; and a connection body for connecting the tube and the cable. .
[2] In the chemical inspection apparatus according to [1], the protection body is a cylindrical member having the opening on a predetermined side surface corresponding to the sensor. Also good.
[3] In the chemistry according to the above [1], in the above invention, the protector is a columnar member that is disposed at a position substantially opposed to 180 ° and connects the tube and the insertion elastic body. It may be an inspection device.
[4] In the above invention, the tube has a core inside the tube, and the wiring of the sensor is juxtaposed or wound around the core. It may be the chemical inspection apparatus described in 1.
[5] In the above invention, the connection body may be a chemical test apparatus according to the above [1], wherein the connection body includes a branch connection body having a through hole communicating with the lumen of the tube.
[6] In the above invention, the insertion elastic body may be the chemical testing apparatus according to the above [1], wherein a distal end portion is formed with a convex curved surface.
[7] In the above invention, the insertion elastic body may be a chemical testing apparatus according to the above [1], wherein a pH sensor is provided inside the insertion elastic body.

  According to the present invention, it is possible to improve durability and operability when inserting into an endoscope channel while protecting the NO sensor, and by adding a pH sensor, simultaneous measurement of NO concentration and pH is possible. Therefore, it is possible to provide a chemical test apparatus that enables further information collection from a lesion.

(First embodiment)
FIG. 1 is a partial cross-sectional view of a chemical testing apparatus 1 according to the first embodiment of the present invention. The chemical test apparatus 1 according to the first embodiment of the present invention includes a catheter tube 10, a NO sensor 20 provided in the lumen 10 a of the tube 10, a protector 30 that protects the NO sensor 20, The insertion elastic body 40 attached to the tip of the protection body 30, the cable 50 to which the wiring 120 of the NO sensor 20 is connected, and the connection body 60 that connects the tube 10 and the cable 50 are configured. .

  The tube 10 has a lumen 10a and is formed in a cylindrical shape with a flexible material, and the length, thickness, material, and the like are appropriately adjusted. For example, it is formed of a polyamide elastomer or a polyamide resin having an inner diameter of 1.0 mm, an outer diameter of 1.4 mm, a length of about 1600 mm, and Shore D55 to 74 hardness.

  2 is a partially enlarged view of the front end side of FIG. 1 for explaining the NO sensor 20 and the protective body 30 in detail, (a) is a sectional view, and (b) is a perspective view.

  The NO sensor 20 includes a sheath tube 21 made of a fluororesin that transmits low molecules such as NO, an electrolyte solution 22 filled therein, a carbon electrode 23 immersed in the sheath tube 21, and a sheath tube 21. The reference electrode 24 is provided in close contact with the base side, and an insulator 25 that covers the periphery of the reference electrode 24 so that the reference electrode 24 is not exposed. The NO sensor 20 is supported by an insulator 26 in the lumen 10 a of the tube 10.

  The carbon electrode 23 and the comparison electrode 24 are connected to insulated lead wires 123 and 124, respectively, and the insulator 26 is for a grounding wire that is grounded via the insulated lead wire 126. The insulating lead wires 123, 124, 126 together constitute the wiring 120. The insulator 26 is liquid-tightly bonded to the inner end of the tube 10 with an adhesive 27. The signal based on the NO detection value is not limited to the signal transmitted by an electric signal such as a potential difference, and may be transmitted by an optical signal, for example.

  The protector 30 is provided on the distal end side of the tube 10 and is formed of a cylindrical member having substantially the same diameter as the tube 10. A side hole 30a is provided as an opening on a predetermined side surface of the tube 10 corresponding to the position of the NO sensor 20 so that the liquid flows into the lumen 10a of the tube 10. For example, 2 to 4 side holes 30a having a diameter of 0.5 to 1.0 mm are provided at equal intervals in the length direction, and the side hole rows 31 are adjacent to each other at 90 ° with respect to the circumferential direction. It arrange | positions so that it may become alternate with respect to the side hole row | line | column 32. FIG. The side hole 30a may be circular, oval, rectangular, or oval. In particular, the NO sensor is provided while maintaining the protective effect of the protector 30 by using an oval, rectangle, or oval shape in which the circumferential direction has a major axis. The amount of contact between 20 and NO can be increased.

  The protector 30 is formed of a hard material made of polyamide elastomer or polyamide resin having a Shore D55 to 74 hardness. The protector 30 may be integrally formed as a part of the tube 10, or may be formed separately from the tube 10 and attached to the tube 10.

  The insertion elastic body 40 is attached to the distal end of the protection body 30 and has a shape in which the distal end is processed into a convex curved surface, for example, an R surface, a spherical surface, a hemispherical surface, or a bell shape. The insertion elastic body 40 is formed of a hard material that is the same material as the protection body 30, but may be integrally formed as a part of the protection body 30 or the tube 10, or the protection body 30 or It may be formed separately from the tube 10 and attached to the protector 30.

  The cable 50 is connected to the wiring 120 of the NO sensor 20 and has a plug connector 51 at the end. This plug connector 51 is connected to a signal processing unit (not shown).

  The connection body 60 is configured to connect the tube 10 and the cable 50, to which the insulated lead wires 123, 124, 126 are connected, and to be electrically connected to a signal processing unit (not shown) via the plug connector 51. It has become.

(Effects of the first embodiment)
By providing the insertion elastic body 40 at the distal end of the protection body 30, the insertion into the endoscope channel is performed smoothly, leading to an improvement in operability and improving the shape retention of the protection body 30, and the NO sensor 20 Protective effect on the increase. As a result, the concentration of NO released from the nasal mucosa can be measured, and important information for diagnosis and treatment of respiratory failure, pulmonary hypertension, and sleep apnea can be obtained. Also in the field of digestive system, measurement of NO concentration can contribute to diagnosis and treatment of chronic gastritis, gastric cancer, ulcerative colitis and the like.
(Second Embodiment)

  FIG. 3 is a partial view of the distal end side including the protector 130 of the chemical test apparatus 1 according to the second embodiment of the present invention, where (a) is a cross-sectional view and (b) is a perspective view.

  The protector 130 of the chemical test apparatus 1 according to the second embodiment is formed of a columnar member that is disposed at a position facing substantially 180 ° and connects the tube 10 and the insertion elastic body 40. In order to ensure the protection of the NO sensor 20, a highly rigid resin or metal body with high bending rigidity is preferable. For example, a cylindrical body made of nickel / titanium alloy or stainless steel having a diameter of 1.4 mm and a length of 15 mm is formed by punching with a long side of 10 mm and a short side of 1 mm, and the protective body 130 has two columnar members. It becomes the shape comprised by. In addition, a coating layer is formed on the surface of the protective body 130 by a thermoplastic resin composition such as polyethylene terephthalate resin. Other configurations are the same as those of the first embodiment.

(Effect of the second embodiment)
Since the opening of the protector 130 can be maximized, the protection of the NO sensor 20 can be ensured and the contact amount between the NO sensor 20 and NO can be increased, and the NO concentration with high sensitivity and high accuracy can be obtained. Measurement is possible.

(Third embodiment)
FIG. 4 is a cross-sectional view of the distal end side including the protector 30 of the chemical test apparatus 1 according to the third embodiment of the present invention. FIG. 4A is an example in which the wiring 120 is juxtaposed to the core body 70. ) Is a diagram showing an example in which the wiring 120 is wound around the core body 70.

  The chemical testing apparatus 1 according to the third embodiment has a core body 70 provided in the lumen 10a of the tube 10, and the wiring 120 of the NO sensor 20 is juxtaposed or wound around the core body 70. It has a configuration. The wiring 120 is composed of insulated lead wires 123, 124, and 126.

  The core body 70 is made of stainless steel, for example, and is a metal wire having a diameter of 0.3 to 0.7 mm and elasticity and repulsion. The core body 70 is fixed by the insulator 26 in FIG. 4, but is not limited thereto, and may be configured to be directly fixed to the tube 10, for example. Other configurations are the same as those of the first embodiment.

(Effect of the third embodiment)
The chemical test apparatus 1 according to the third embodiment includes a core body 70 having repulsive properties inside the tube 10, and the configuration in which the wiring 120 of the NO sensor 20 is juxtaposed or wound around the core body 70. Therefore, the bending rigidity and flexibility can be improved, and further, the bending rigidity and flexibility can be further improved by using the tube 10 together with the thickened or hardened structure. it can. Therefore, the number of parts and the price can be suppressed, and the production cost can be reduced.

(Fourth embodiment)
FIG. 5 is a partial cross-sectional view of the chemical testing apparatus 1 according to the fourth embodiment of the present invention. In the chemical testing apparatus 1 according to the fourth embodiment, the connection body 60 of the chemical testing apparatus according to the first embodiment includes a branch connection body 60 a having a through hole 60 b that communicates with the lumen 10 a of the tube 10. Configured. Other configurations are the same as those of the first embodiment.

  The branch connection body 60a is formed by branching from the connection body 60, and a through hole 60b communicating with the lumen 10a of the tube 10 is formed. The through hole 60b extends from the lumen 10 of the tube 10 to the end portion 60c of the branch connection body 60a. It penetrates to.

(Effect of the fourth embodiment)
According to the chemical test apparatus 1 according to the fourth embodiment, the through hole 60b of the branch connection body 60a communicates with the lumen 10a of the tube 10 and the side hole 30a of the protection body 30. As a result, it is possible to inject or suck liquid from the outside according to the environment of the measurement site, and to measure the NO concentration quickly and satisfactorily. It is also possible to treat or treat immediately after injection. In particular, in the measurement of NO concentration, there is an effect that the reliability of the measurement result is improved by manipulating the NO intake.

(Fifth embodiment)
FIG. 6 is a partial cross-sectional view of the chemical testing apparatus 1 according to the fifth embodiment of the present invention. The chemical testing apparatus 1 according to the fifth embodiment is the same as the chemical testing apparatus according to the first embodiment. Instead of the insertion elastic body 40, a hole 41a is formed inside, and a pH sensor 80 is formed in the hole 41a. Is attached to the tip of the protector 30, and the wiring 121 of the pH sensor 80 is connected from the plug connector 53 to a signal processing unit (not shown) via the cable 52. Other configurations are the same as those of the first embodiment.

  For example, the insertion elastic body 41 has a bell shape with a tip having a diameter of 1.4 mm and a height of 5 mm, and is formed of a polyamide elastomer or a polyamide resin having a Shore 70D or more. The insertion elastic body 41 is provided with a hole portion 41a penetrating in a tunnel shape having a bottom of 0.5 mm and a height of 1.0 mm, and inside thereof, a diameter of 0.4 mm, which is a general glass electrode mechanism, is long. A small pH sensor 80 having a thickness of 1.0 mm is mounted.

(Effect of 5th Embodiment)
According to the chemical test apparatus 1 according to the fifth embodiment, it is possible to measure not only the NO concentration due to the generation of NO but also the change in pH as information obtained from the diseased part. By combining them, it becomes possible to grasp the state of a more certain diseased part.

(Usage example of the chemical testing apparatus 1 according to the first to fifth embodiments)
Fig.7 (a) is a figure which shows the condition in case the chemical test apparatus 1 is used for the measurement of NO density | concentration in a body cavity via an endoscope, (b) is the front-end | tip of an endoscope in (a) figure It is a figure which expands and shows a part.

  For example, the endoscope 300 is inserted through the mouth 201 and allowed to reach the stomach 203 through the esophagus 202, and the plug connector 51 or 53 of the chemical test apparatus 1 is connected to a signal processing unit (not shown), The inspection apparatus 1 is inserted into the channel cavity 301 of the endoscope 300, and the distal end portion of the chemical inspection apparatus 1 is exposed from the distal end of the endoscope 300. The endoscope 300 having a channel for inserting forceps or the like preferably has a channel diameter of 2 mm or more, and is generally used.

  Under the above usage conditions, the tip of the chemical test apparatus 1 senses NO generated in the stomach 203, and an oxidation current is generated and converted into NO concentration by a signal processing unit (not shown). Measurement is performed. From the detected NO concentration, the doctor can diagnose the presence or absence or degree of stomach disease.

FIG. 1 is a partial cross-sectional view of a chemical testing apparatus 1 according to the first embodiment of the present invention. 2 is a partially enlarged view of the front end side of FIG. 1 for explaining the NO sensor 20 and the protective body 30 in detail, (a) is a sectional view, and (b) is a perspective view. FIG. 3 is a partial view of the distal end side including the protector 130 of the chemical test apparatus 1 according to the second embodiment of the present invention, where (a) is a cross-sectional view and (b) is a perspective view. FIG. 4 is a cross-sectional view of the distal end side including the protector 30 of the chemical test apparatus 1 according to the third embodiment of the present invention. FIG. 4A is an example in which the wiring 120 is juxtaposed to the core body 70. ) Is a diagram showing an example in which the wiring 120 is wound around the core body 70. FIG. 5 is a partial cross-sectional view of the chemical testing apparatus 1 according to the fourth embodiment of the present invention. FIG. 6 is a partial cross-sectional view of the chemical testing apparatus 1 according to the fifth embodiment of the present invention. Fig.7 (a) is a figure which shows the condition in case the chemical test apparatus 1 is used for the measurement of NO density | concentration in a body cavity via an endoscope, (b) is the front-end | tip of an endoscope in (a) figure It is a figure which expands and shows a part.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Chemical test | inspection apparatus 10 Tube 10a Lumen 20 NO sensor 21 Outer tube 22 Electrolytic solution 23 Carbon electrode 24 Reference electrode 25, 26 Insulator 27 Adhesive material 30, 130 Protective body 30a Side hole
40, 41 Insert elastic body 41a Hole 50, 52 Cable 51, 53 Plug / connector 60 Connector 60a Branch connector 60b Through hole 60c End 70 Core body 80 pH sensor 120, 121 Wiring 123, 124, 126 Insulated lead wire 201 mouth 202 esophagus 203 stomach 300 endoscope 301 channel cavity

Claims (7)

A tube for a catheter having flexibility and a lumen;
A sensor provided with a wiring in the lumen of the tube and detecting nitric oxide in liquid and gas;
A protective body having an opening for allowing the liquid and gas to flow into the lumen of the tube and protecting the sensor;
An insertion elastic body attached to the tip of the protective body;
A cable to which the wiring of the sensor is connected and having a plug connector at an end;
A connecting body for connecting the tube and the cable;
A chemical inspection apparatus characterized by comprising:   The chemical test apparatus according to claim 1, wherein the protective body is a cylindrical member having the opening on a predetermined side surface corresponding to the sensor.   The chemical test apparatus according to claim 1, wherein the protective body is a columnar member that is disposed at a position that is substantially 180 ° opposite to each other and connects the tube and the insertion elastic body.   The chemical test apparatus according to claim 1, wherein the tube has a core body inside the tube, and the wiring of the sensor is juxtaposed or wound around the core body.   The chemical test apparatus according to claim 1, wherein the connection body includes a branch connection body having a through hole that communicates with the lumen of the tube.   The chemical test apparatus according to claim 1, wherein the insertion elastic body is formed with a curved surface having a convex end portion.   The chemical test apparatus according to claim 1, wherein the insertion elastic body includes a pH sensor inside the insertion elastic body.

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