Endoscope system, balloon device, and method for diagnosing gastroesophageal reflux disease

Abstract

An endoscope system 1 comprises: an endoscope 2 having an insertion portion 21 in which an imaging element is disposed at a distal end; a first gas supply device 6 that supplies a gas, via a gas supply channel provided in the insertion portion 21, to the inside of a space in which the distal end of the insertion portion 21 is positioned; an atmospheric pressure detection sensor 7 that detects the atmospheric pressure inside the space in which the distal end of the insertion portion 21 is positioned; a balloon 91 mounted on an outer peripheral surface of the insertion portion 21 and inflated by injection of the gas; a second gas supply device 92 that injects the gas into the balloon 91; and a balloon pressure sensor 93 that detects the pressure applied to the balloon 91. A processor 44 generates diagnosis support information for supporting diagnosis of gastroesophageal reflux disease on the basis of a captured image captured by the imaging element, first pressure information relating to the atmospheric pressure detected by the atmospheric pressure detection sensor 7, and second pressure information relating to the pressure detected by the balloon pressure sensor 93.

Description

Endoscope system, balloon device, and method for diagnosing gastroesophageal reflux disease

[0001] The present invention relates to an endoscope system, a balloon device, and a method for diagnosing gastroesophageal reflux disease.

[0002] Gastroesophageal reflux disease (GERD) is a pathological condition caused by the reflux of gastric contents rich in gastric acid into the esophagus. Conventionally, an endoscope system using an endoscope has been proposed as a system for diagnosing gastroesophageal reflux disease (see, for example, Patent Document 1). In the endoscope system described in Patent Document 1, the insertion portion of the endoscope is inserted into the stomach, the gastroesophageal junction is set to be imaged using the endoscope, and air is introduced into the stomach. Then, in the endoscope system, based on the pressure change in the stomach detected during the introduction of air into the stomach and the state of the gastroesophageal junction observed from the captured image captured using the endoscope, the function of the lower esophageal sphincter is evaluated.

[0003] International Publication No. 2021 / 166127

[0004] However, in the diagnosis of gastroesophageal reflux disease, it is necessary to evaluate not only the function of the lower esophageal sphincter but also the motility function of the esophagus. For this reason, in addition to the examination using the endoscope system described in Patent Document 1, it is necessary to additionally evaluate the motility function of the esophagus by, for example, high-resolution manometry (HRM). This high-resolution manometry cannot be performed with the endoscope system described in Patent Document 1. Therefore, in addition to the examination using the endoscope system described in Patent Document 1, it is necessary to perform this high-resolution manometry with another examination device, which imposes a burden on the examinee. Therefore, there is a demand for a technique that can diagnose gastroesophageal reflux disease while reducing the burden on the examinee.

[0005] The present invention has been made in view of the above, and an object thereof is to provide an endoscope system, a balloon device, and a method for diagnosing gastroesophageal reflux disease that can reduce the burden on the examinee.

[0006] To solve the above-mentioned problems and achieve the objective, the endoscope system according to the present invention comprises an endoscope having an insertion section with an image sensor positioned at its tip, a first air supply device that supplies gas to the space where the tip of the insertion section is located via an air supply conduit provided in the insertion section, a pressure detection sensor that detects the air pressure inside the space where the tip of the insertion section is located, a balloon attached to the outer surface of the insertion section that inflates when gas is injected, a second air supply device that injects gas into the balloon, a balloon pressure sensor that detects the pressure applied to the balloon, and a processor. The processor generates diagnostic support information to assist in the diagnosis of gastroesophageal reflux disease based on the image captured by the image sensor, first pressure information relating to the air pressure detected by the pressure detection sensor, and second pressure information relating to the pressure detected by the balloon pressure sensor.

[0007] The balloon device according to the present invention comprises a balloon attached to the outer surface of the insertion section of an endoscope that inflates when gas is injected into it, an air supply device that injects gas into the balloon, and a pressure sensor that detects the pressure applied to the balloon.

[0008] The method for diagnosing gastroesophageal reflux disease according to the present invention involves inserting the insertion part of an endoscope into the stomach, enabling imaging of the gastric cardia using the endoscope, setting a balloon attached to the outer surface of the insertion part to be located inside the esophagus, inflating the balloon by injecting gas into the balloon and infusing air into the stomach, and diagnosing gastroesophageal reflux disease based on the image captured using the endoscope during air insufflation into the stomach, first pressure information regarding the atmospheric pressure inside the stomach detected by a pressure detection sensor, and second pressure information regarding the pressure applied to the balloon detected by a balloon pressure sensor.

[0009] The endoscopic system, balloon device, and diagnostic method for gastroesophageal reflux disease according to the present invention can reduce the burden on the person being examined.

[0010] Figure 1 is a diagram illustrating the configuration of an endoscope system according to an embodiment. Figure 2 is a diagram illustrating the configuration of an endoscope system according to an embodiment. Figure 3 is a diagram illustrating the configuration of a balloon device. Figure 4 is a diagram illustrating a diagnostic method for gastroesophageal reflux disease according to an embodiment. Figure 5 is a diagram illustrating a diagnostic method for gastroesophageal reflux disease according to an embodiment. Figure 6 is a diagram illustrating a diagnostic method for gastroesophageal reflux disease according to an embodiment. Figure 7 is a diagram illustrating a diagnostic method for gastroesophageal reflux disease according to an embodiment. Figure 8 is a diagram illustrating a diagnostic method for gastroesophageal reflux disease according to an embodiment. Figure 9 is a diagram illustrating an example of the display of diagnostic support information. Figure 10 is a diagram illustrating an example of the display of diagnostic support information. Figure 11 is a diagram illustrating an example of the display of diagnostic support information. Figure 12 is a diagram illustrating modification 1 of the embodiment. Figure 13 is a diagram illustrating modification 2 of the embodiment.

[0011] The embodiments for carrying out the present invention (hereinafter referred to as "embodiments") will be described below with reference to the drawings. However, the present invention is not limited to the embodiments described below. Furthermore, in the drawings, the same parts are denoted by the same reference numerals.

[0012] [Configuration of the Endoscope System] Figures 1 and 2 show the configuration of the endoscope system 1 according to an embodiment. The endoscope system 1 is used in the medical field and is a system for diagnosing gastroesophageal reflux disease in a patient using an endoscope 2. As shown in Figures 1 and 2, the endoscope system 1 comprises an endoscope 2, a light source device 3, a processing device 4, a display device 5, a first air insufflation device 6, a gastric pressure measuring device 7, a microphone 8, and a balloon device 9.

[0013] In this embodiment, the endoscope 2 is a so-called flexible endoscope. Part of this endoscope 2 is inserted into the living body, images are captured within the living body, and an image signal generated by the imaging is output. As shown in Figure 1, the endoscope 2 comprises an insertion section 21, an operating section 22, and a universal cord 23.

[0014] The insertion portion 21 is a part that is inserted into the living body and is at least partially flexible. As shown in Figures 1 and 2, the insertion portion 21 comprises a tip portion 24, a flexible curved portion 25 (Figure 1) composed of multiple curved pieces, and a long, flexible flexible tube portion 26 (Figure 1) connected to the base end of the curved portion 25. An image sensor 244 (Figure 2) is built into the tip portion 24. The insertion portion 21 is inserted into the body cavity of the subject and uses the image sensor 244 to image subjects such as living tissue located in a position where external light cannot reach.

[0015] Here, multiple balloons 91 constituting the balloon device 9 are attached to the outer surface of the insertion portion 21 at predetermined intervals along the longitudinal direction of the insertion portion 21. The detailed configuration and arrangement of the balloons 91 will be explained later in the section "Configuration of the balloon device".

[0016] The operating unit 22 is connected to the proximal end portion of the insertion unit 21. The operating unit 22 receives various operations on the endoscope 2. As shown in Figure 1, the operating unit 22 includes a bending knob 221 that bends the bending unit 25 in the vertical and horizontal directions, a treatment instrument insertion unit 222 that extends from the operating unit 22 to the tip of the insertion unit 21 and inserts treatment instruments such as biopsy forceps, electrosurgical units and examination probes into the body cavity of the subject, an air supply line 223 (Figure 2) that extends from the operating unit 22 to the tip of the insertion unit 21 and supplies air into the body cavity of the subject, and a plurality of switches 224 for operating peripheral equipment such as the first air supply device 6 and a water supply device (not shown).

[0017] The universal cord 23 incorporates at least a light guide 241 (Figure 2) and a bundled cable 245 (Figure 2) that bundles one or more signal lines. The light guide 241 is made of glass fiber or the like and forms a light guide path for the light emitted by the light source device 3. As shown in Figure 1, the universal cord 23 branches at the end opposite to the end connected to the operation unit 22. At the branched end of the universal cord 23, a connector 231 that can be attached to the light source device 3 and a connector 232 that can be attached to the processing unit 4 are provided. A part of the light guide 241 extends from the end of the connector 231. The universal cord 23 propagates the illumination light emitted from the light source device 3 to the tip 24 via the connector 231 (light guide 241), the operation unit 22, and the flexible tube section 26. The universal cord 23 also transmits the image signal captured by the image sensor 244 provided at the tip 24 to the processing unit 4 via the connector 232. The bundled cable 245 includes signal lines for transmitting image signals, signal lines for transmitting drive signals for driving the image sensor 244, and signal lines for sending and receiving information including unique information about the endoscope 2 (image sensor 244). In this embodiment, it is described as transmitting electrical signals using signal lines, but optical signals may be transmitted, or signals may be transmitted between the endoscope 2 and the processing unit 4 by wireless communication.

[0018] The exit end of the light guide 241 is inserted into the tip portion 24. As shown in Figure 2, this tip portion 24 includes an illumination lens 242, a light-gathering optical system 243, and an image sensor 244 provided at the imaging position of the optical system 243, which receives the light gathered by the optical system 243, converts it into an electrical signal via photoelectricity, and performs predetermined signal processing.

[0019] The optical system 243 is composed of one or more lenses and forms an observation image on the light-receiving surface of the image sensor 244. The optical system 243 may also have an optical zoom function to change the angle of view and a focus function to change the focal point.

[0020] The image sensor 244 converts light from the optical system 243 into electrical signals (image signals). This image sensor 244 is made up of multiple pixels arranged in a matrix, each having a photodiode that stores charge according to the amount of light, and a capacitor that converts the charge transferred from the photodiode into a voltage level. The image sensor 244 generates electrical signals by converting the light incident on it through the optical system 243 into electrical signals, and sequentially reads out the electrical signals generated by pixels arbitrarily set as readout targets from among the multiple pixels, and outputs them as image signals. This image sensor 244 can be realized using, for example, a CCD (Charge Coupled Device) image sensor or a CMOS (Complementary Metal Oxide Semiconductor) image sensor.

[0021] For the sake of clarity, in the following explanation, the image signal generated by the image sensor 244 will be referred to as the captured image.

[0022] Here, the endoscope 2 has a memory (not shown) that stores data including execution programs and control programs for the image sensor 244 to perform various operations, as well as identification information for the endoscope 2. This identification information includes the endoscope 2's unique information (ID), year of manufacture, specifications, and transmission method. The memory may also temporarily store images generated by the image sensor 244.

[0023] As shown in Figure 2, the light source device 3 comprises a light source unit 31, an illumination control unit 32, and a light source driver 33.

[0024] The light source unit 31 emits light under the control of the illumination control unit 32. This light source unit 31 emits light having a visible light wavelength range (white light (illumination light)). This light source unit 31 can be implemented using an LED (Light Emitting Diode) light source, as well as a laser light source, xenon lamp, halogen lamp, or any other light source. The light source unit 31 may also have one or more lenses. The light generated by the light source unit 31 is then emitted from the tip of the tip unit 24 toward the subject via the light guide 241 and illumination lens 242.

[0025] Furthermore, the light emitted from the light source unit 31 is not limited to white light; it may also be narrowband light having a specific wavelength range, or excitation light that excites substances contained in the object being observed.

[0026] The lighting control unit 32 controls the operation of the light source driver 33 under the control of the processing unit 4.

[0027] The light source driver 33, under the control of the lighting control unit 32, supplies current to the light source unit 31, thereby causing the light source unit 31 to emit light.

[0028] The processing unit 4 corresponds to the processor according to the present invention. As shown in Figure 2, the processing unit 4 comprises an image processing unit 41, a synchronization signal generation unit 42, an input unit 43, a control unit 44, and a storage unit 45.

[0029] The image processing unit 41, under the control of the control unit 44, performs predetermined image processing on the captured image received from the endoscope 2 to generate an endoscopic image.

[0030] Examples of image processing performed by the image processing unit 41 include optical black subtraction (clamping), white balance adjustment, demosaicing, color correction matrix processing, gamma correction, YC processing to convert RGB signals into luminance chromatic difference signals (Y, Cb / Cr signals), digital gain adjustment to multiply digital gain, noise reduction, and filtering to enhance structure.

[0031] Furthermore, the image processing unit 41 generates first support information based on the pressure signal (hereinafter referred to as intragastric pressure information) detected by the intragastric pressure measuring device 7, under the control of the control unit 44. This intragastric pressure information corresponds to the first pressure information according to the present invention.

[0032] Furthermore, the image processing unit 41 generates second support information based on a pressure signal (hereinafter referred to as esophageal pressure information) detected by the balloon pressure sensor 93 constituting the balloon device 9, under the control of the control unit 44. This esophageal pressure information corresponds to the second pressure information according to the present invention.

[0033] Furthermore, the image processing unit 41 generates third support information based on signals related to the muffled sound collected by the microphone 8 (hereinafter referred to as muffled sound information) under the control of the control unit 44.

[0034] The image processing unit 41 then generates diagnostic support information for diagnosing gastroesophageal reflux disease based on the endoscopic image and the first to third support information. This diagnostic support information is output to the display device 5 and displayed on the display device 5.

[0035] Further details regarding the first to third support information and diagnostic support information will be explained in "Examples of Displaying Diagnostic Support Information" below.

[0036] The image processing unit 41 described above is configured using a general-purpose processor such as a CPU (Central Processing Unit) or a dedicated processor such as an ASIC (Application Specific Integrated Circuit) or various arithmetic circuits that perform specific functions.

[0037] The synchronization signal generation unit 42 generates a clock signal (synchronization signal) that serves as the reference for the operation of the processing unit 4, and outputs the generated synchronization signal to the light source device 3, image processing unit 41, control unit 44, and endoscope 2. Here, the synchronization signal generated by the synchronization signal generation unit 42 includes a horizontal synchronization signal and a vertical synchronization signal. As a result, the light source device 3, image processing unit 41, control unit 44, and endoscope 2 operate in synchronization with each other based on the generated synchronization signal.

[0038] The input unit 43 is implemented using a keyboard, mouse, switches, or touch panel, and accepts various operations to instruct the operation of the endoscope system 1. The input unit 43 may also include switches provided on the operation unit 22 or portable terminals such as external tablet computers.

[0039] The control unit 44 corresponds to the processor according to the present invention. This control unit 44 is configured using a general-purpose processor such as a CPU or a dedicated processor such as an ASIC that performs various arithmetic circuits that execute specific functions.

[0040] The storage unit 45 stores data including various programs executed by the control unit 44 and various parameters and the like necessary for the processing of the control unit 44. These various programs can also be recorded on a computer-readable recording medium such as a hard disk, a flash memory, a CD-ROM, a DVD-ROM, a flexible disk, etc. and widely distributed. Note that these various programs can also be acquired by downloading via a communication network. The communication network mentioned here is realized by, for example, an existing public line network, a LAN (Local Area Network), a WAN (Wide Area Network), etc., and can be either wired or wireless.

[0041] The storage unit 45 having the above configuration is realized by using a ROM (Read Only Memory) in which various programs and the like are pre-installed, a RAM (Random Access Memory) that stores arithmetic parameters and data for each process, a hard disk, and the like.

[0042] In the present embodiment, the light source device 3 and the processing device 4 are provided in separate housings, but it is not limited to this, and they may be integrally provided in the same housing.

[0043] The display device 5 displays the display image received from the processing device 4 (image processing unit 41) via a video cable. This display device 5 is configured by using a monitor such as a liquid crystal or an organic EL (Electro Luminescence).

[0044] The first air supply device 6 regulates the pressure of the gas supplied from a gas supply source (not shown, for example, a carbon dioxide gas cylinder) to a predetermined pressure and discharges it into the space where the tip of the insertion unit 21 is located from the tip of the insertion unit 21 via the air supply pipeline 223. As shown in FIG. 1, this first air supply device 6 includes an air supply unit 61, a flow rate measurement unit 62, and a control unit 63.

[0045] Although not shown in detail, the air supply unit 61 includes a primary pressure reducer, a secondary pressure reducer, and a flow control valve. These primary pressure reducer, secondary pressure reducer, and flow control valve are connected in this order by an air supply pipeline formed of silicon, fluororesin, or the like. The gas supplied from a gas supply source not shown passes through the air supply pipeline in the order of the primary pressure reducer, secondary pressure reducer, and flow control valve, is adjusted to a predetermined pressure and flow rate, and then is discharged from the gastric insufflation tube TU1 (FIG. 1) via the flow measurement unit 62.

[0046] The flow measurement unit 62 measures the flow rate of the gas discharged from the air supply unit 61 and flowing through the gastric insufflation tube TU1.

[0047] The control unit 63 controls the flow control valve provided in the air supply unit 61 based on the flow rate measured by the flow measurement unit 62, and adjusts the flow rate of the gas supplied to the endoscope 2 to a predetermined value. The flow control valve is, for example, a type of electromagnetic drive valve, and is constituted by a regulating valve using an electromagnetic coil in the drive unit. By controlling the position of the plunger according to the magnitude of the current flowing through the electromagnetic coil, the opening degree of the valve part is controlled, and the flow rate of the gas flowing through the air supply pipeline is adjusted to a predetermined value.

[0048] The intragastric pressure measuring device 7 corresponds to the pressure detection sensor according to the present invention. This intragastric pressure measuring device 7 detects the air pressure inside the space where the tip is located via the pressure measurement probe 71 inserted to the tip of the insertion unit 21 through the treatment tool insertion unit 222. Then, a signal regarding the air pressure detected by the intragastric pressure measuring device 7 (hereinafter referred to as intragastric air pressure) (hereinafter referred to as intragastric air pressure information) is output to the processing device 4.

[0049] The microphone 8 is disposed on the throat or the like of the subject and collects the eructation sound (gup sound) emitted from the esophagus of the subject. Then, a signal regarding the eructation sound collected by the microphone 8 (hereinafter referred to as eructation sound information) is output to the processing device 4.

[0050] [About the balloon device configuration] Figure 3 is a diagram illustrating the configuration of the balloon device 9. As shown in Figure 3, the balloon device 9 comprises a balloon 91, a second air supply device 92, and a balloon pressure sensor 93.

[0051] In this embodiment, multiple balloons 91 are provided. These multiple balloons 91 have the same configuration and are arranged in different positions. Specifically, the balloons 91 are made of a flexible resin material such as silicone rubber or polyester. The balloons 91 have an annular shape that extends over the entire circumference in the rotational direction around a central axis along the axial direction of the insertion portion 21, and are attached to the outer circumferential surface of the insertion portion 21 and inflate when gas is injected.

[0052] The balloons 91 are arranged on the outer circumferential surface of the insertion portion 21 at intervals along the axial direction of the insertion portion 21, as shown in Figure 3. The intervals are not particularly limited, but may be 3 centimeters or less, for example 2 centimeters or less, for example 1 centimeter, or even less than 1 centimeter. In the example shown in Figure 3, only three balloons 91 are shown, but any other number may be provided. In the example shown in Figure 3, three balloons 91 are provided: a first balloon 911, a second balloon 912, and a third balloon 913.

[0053] The first balloon 911 is positioned so that when the insertion portion 21 is inserted into the stomach, pressure is applied from the inner wall of the esophagus due to the contraction and relaxation of the upper esophageal sphincter.

[0054] The second balloon 912 is positioned so that when the insertion portion 21 is inserted into the stomach, pressure is applied from the inner wall of the esophagus due to the contraction and relaxation of the esophagus from the upper esophageal sphincter to the lower esophageal sphincter.

[0055] The third balloon 913 is positioned so that when the insertion portion 21 is inserted into the stomach, pressure is applied from the inner wall of the esophagus due to the contraction and relaxation of the lower esophageal sphincter.

[0056] The second air supply device 92 has the same configuration as the first air supply device 6, and adjusts the gas supplied from the gas supply source (not shown) to a predetermined pressure and injects it into each of the balloons 91 via the balloon insufflation tube TU2 (Figure 3). The balloon insufflation tube TU2 corresponds to the tube according to the present invention. Here, there are as many balloon insufflation tubes TU2 as there are balloons 91. In the example shown in Figure 3, only three balloons 91 are shown, so only three balloon insufflation tubes TU2 are also shown. Hereinafter, the balloon inflation tube TU2 connecting the first balloon 911 and the second inflation device 92 will be referred to as the first balloon inflation tube TU21, the balloon inflation tube TU2 connecting the second balloon 912 and the second inflation device 92 will be referred to as the second balloon inflation tube TU22, and the balloon inflation tube TU2 connecting the third balloon 913 and the second inflation device 92 will be referred to as the third balloon inflation tube TU23.

[0057] The balloon pressure sensor 93 detects the pressure applied to the balloon 91 by detecting the air pressure inside the balloon 91 via the balloon inflation tube TU2. Here, there is one balloon pressure sensor 93 for each balloon 91. In the example shown in Figure 3, only three balloons 91 are shown, so only three balloon pressure sensors 93 are also shown. Hereafter, the balloon pressure sensor 93 that detects the air pressure inside the first balloon 911 via the first balloon inflation tube TU21 will be referred to as the first balloon pressure sensor 931, the balloon pressure sensor 93 that detects the air pressure inside the second balloon 912 via the second balloon inflation tube TU22 will be referred to as the second balloon pressure sensor 932, and the balloon pressure sensor 93 that detects the air pressure inside the third balloon 913 via the third balloon inflation tube TU23 will be referred to as the third balloon pressure sensor 933. The pressure signal (esophageal pressure information) detected by the balloon pressure sensor 93 is then output to the processing unit 4.

[0058] [Method for Diagnosing Gastroesophageal Reflux Disease] Next, a method for diagnosing gastroesophageal reflux disease will be described. Figures 4 to 8 are diagrams illustrating a method for diagnosing gastroesophageal reflux disease according to an embodiment. Specifically, Figure 4 is a flowchart illustrating the method for diagnosing gastroesophageal reflux disease. Figure 5 is a cross-sectional view showing the area around the gastric cardia, illustrating steps S1 to S4. Note that in Figure 5, for the sake of explanation, the balloon 91 provided on the outer surface of the insertion part 21 is not shown. Figures 6 and 7 are diagrams showing the structure of the stomach and esophagus. Figure 6 is a cross-sectional view showing the structure of the stomach and esophagus. Figure 7 is a view of the stomach and esophagus from the outside. Figure 8 is a diagram showing images taken in Phase 1 to Phase 3, which correspond to the dynamic changes that occur when air is insufflated into the stomach (during pneumoperitoneum).

[0059] First, the user, such as a physician, inserts the insertion part 21 into the person being examined through a natural opening, such as the mouth or nose, and introduces the insertion part 21 into the stomach via the esophagus, as shown in Figure 5 (Step S1).

[0060] After step S1, the user, such as a physician, operates the bending knob 221 (bending operation) to set the gastric cardia as the field of view (step S2). In step S2, in response to the operation of the bending knob 221, the insertion part 21 is set into a J-shape with its tip pointing towards the gastric cardia, as shown in Figure 5. In this state, the balloons 91 are positioned inside the esophagus from the upper esophageal sphincter to the lower esophageal sphincter. Specifically, the first balloon 911 is positioned where pressure is applied from the inner wall of the esophagus due to the contraction and relaxation of the upper esophageal sphincter. The second balloon 912 is positioned where pressure is applied from the inner wall of the esophagus due to the contraction and relaxation of the esophagus from the upper esophageal sphincter to the lower esophageal sphincter. The third balloon 913 is positioned where pressure is applied from the inner wall of the esophagus due to the contraction and relaxation of the lower esophageal sphincter.

[0061] After step S2, the user, such as a physician, operates the second air supply device 92 and injects gas into the balloon 91 from the second air supply device 92 via the balloon insufflation tube TU2 (step S3). Specifically, in step S3, gas is injected until the air pressure inside all balloons 91 (air pressure detected by the balloon pressure sensor 93) reaches a predetermined pressure. In this state, all balloons 91 expand due to the injection of gas so as to contact the inner wall of the esophagus.

[0062] After step S3, the user, such as a physician, operates switch 224 to start infusing air into the stomach through the air supply tube 223 from the first air supply device 6 (step S4). In Figure 5, the state in which the gastric air pressure increases due to air supply is represented by a white arrow.

[0063] During insufflation of air into the stomach (pneumoperitoneum), if the subject is healthy, the following three dynamic changes occur: Phase 1 to Phase 3. Before explaining Phases 1 to 3, the structure of the stomach and esophagus will be described with reference to Figures 6 and 7.

[0064] The Intramural Anti-Reflux Barrie Complex (IM-ARB complex), which is part of the anti-reflux mechanism at the gastroesophageal junction, is composed of three main components: Collar Sling Muscle fibers (Figure 7), Clasp Muscle fibers (Figure 7), and the lower esophageal sphincter (Figures 6 and 7).

[0065] Collar sling muscle fibers are obliquely running muscles located along the greater curvature of the stomach (Figure 6), forming a sling-like structure that surrounds the upper part of the stomach (Figure 7). These collar sling muscle fibers function to prevent stomach contents from refluxing into the esophagus by constricting the gastric cardia. From inside the stomach, the collar sling muscle fibers can be identified as a gastroesophageal flap valve (Figure 6). This gastroesophageal flap valve (GEFV) is a projection within the gastroesophageal junction, created by the acute angle between the esophagus and the gastric cardia, and is a type of mucosal flap valve (MFV). An MFV located at the gastroesophageal junction is called a gastroesophageal flap valve. An MFV is a part where the mucosa is formed in a flap shape. The morphology of the gastroesophageal flap valve changes with the contraction and relaxation of muscles such as collar sling muscle fibers and clasp muscle fibers.

[0066] Clasp muscle fibers are located on the lesser curvature side of the stomach (Figure 6) and consist of a circular layer of muscle. These clasp muscle fibers function to prevent stomach contents from refluxing into the esophagus by constricting the gastric cardia.

[0067] The lower esophageal sphincter (LES) is a ring of muscle located at the junction of the esophagus and stomach. It normally contracts to close the esophagus and prevent the reflux of stomach contents.

[0068] Phase 1 begins with zero air insufflation into the stomach. In Phase 1, as shown in Figures 8(a) and 8(b), the gastroesophageal flap valve and the longitudinal folds of the lesser curvature are observed. These longitudinal folds of the lesser curvature are mucosal folds that extend longitudinally along the inner wall of the stomach. Their morphology changes with the contraction and relaxation of muscles such as clasp muscle fibers, and they gradually stretch and flatten as the gastric pressure increases. In Phase 1, the esophageal mucosa is not observed. Then, in Phase 1, as the air insufflation into the stomach increases, as shown in Figure 8(b), the longitudinal folds of the lesser curvature are stretched, the gastroesophageal flap valve gradually flattens, and its legs spread, but the esophageal mucosa is not observed.

[0069] In other words, Phase 1 makes it possible to evaluate the valve function (reflux prevention mechanism) of the gastric structure formed by the gastroesophageal flap valve and the longitudinal folds of the lesser curvature.

[0070] Phase 2 is the phase that occurs after Phase 1. In Phase 2, as shown in Figure 8(c), the esophageal mucosa is observed beyond the squamous columnar junction (Figure 6, Squamocolumnar Junction (SCJ)). This SCJ is the point where the squamous epithelium of the esophagus and the columnar epithelium of the stomach intersect, located at the gastroesophageal junction (GEJ), and marks the boundary between different epithelial cells of the digestive tract. The GEJ is located near the boundary between the esophagus and the stomach and is composed of various anatomical components that form a barrier to prevent reflux of gastric contents. Collar sling muscle fibers, clasp muscle fibers, lower esophageal sphincter, gastroesophageal flap valve, and the SCJ are all included in the GEJ. If the subject is healthy, the Scope Holding Sign (SHS) is observed. This SHS refers to the phenomenon in which the insertion portion 21 is held in place by the contraction of the lower esophageal sphincter when the gastric pressure rises. The state shown in Figure 8(c) is SHS.

[0071] In other words, Phase 2 makes it possible to evaluate the valve function (reflux prevention mechanism) of the lower esophageal sphincter.

[0072] Phase 3 is the phase that occurs after Phase 2. In Phase 3, the gastric pressure exceeds the contractile force of the lower esophageal sphincter, causing relaxation of the sphincter. In Figure 8(d), the arrows indicate that gas leaks into the esophagus (causing a babbling sound) due to the relaxation of the lower esophageal sphincter. If the subject is healthy, peristaltic waves will then descend from the upper esophagus, and SHS will be observed again.

[0073] In other words, Phase 3 makes it possible to evaluate the acid clearance function mediated by esophageal peristalsis.

[0074] After step S4, the user, such as a physician, determines whether the condition corresponds to Phase 1 described above based on the diagnostic support information displayed on the display device 5, and evaluates the valve function (condition of the gastric cardia) due to the gastric structure (step S5).

[0075] After step S5, the user, such as a physician, determines whether the state corresponds to Phase 2 described above based on the diagnostic support information displayed on the display device 5, and evaluates the valve function of the lower esophageal sphincter (state of the lower esophageal sphincter) (step S6).

[0076] After step S6, the user, such as a physician, determines whether the patient is in a state corresponding to Phase 3 described above, based on the diagnostic support information displayed on the display device 5, and evaluates the acid clearance function by esophageal peristalsis (the state of peristaltic movement in the esophagus) (step S7).

[0077] Further details regarding the diagnostic support information will be explained in the section "Examples of Displaying Diagnostic Support Information" below.

[0078] After step S7, the user, such as a physician, diagnoses gastroesophageal reflux disease based on the evaluation results from steps S5 to S7 (step S8).

[0079] [Examples of Display of Diagnostic Support Information] Next, we will explain the diagnostic support information. Figures 9 to 11 are diagrams illustrating examples of the display of diagnostic support information I0. Specifically, Figure 9 is a diagram showing an example of diagnostic support information I0 displayed on the display device 5 when the person being examined is healthy. Figure 10 is a diagram showing an example of diagnostic support information I0 displayed on the display device 5 when the person being examined is suspected of having gastroesophageal reflux disease. Figures 11(a) to 11(c) are diagrams showing examples of the first to third support information I2 to I4 that constitute diagnostic support information I0 when the person being examined is healthy. Figures 11(d) to 11(f) are diagrams showing examples of the first to third support information I2 to I4 that constitute diagnostic support information I0 when the person being examined is suspected of having gastroesophageal reflux disease.

[0080] As shown in Figures 9 to 11, the processing unit 4 generates an endoscopic image I1 by performing predetermined image processing on the image received from the endoscope 2 when air is insufflated into the stomach by the first air insufflation device 6. The processing unit 4 also generates first support information I2 based on the gastric pressure information detected by the gastric pressure measuring device 7 during the air insufflation. Furthermore, the processing unit 4 generates second support information I3 based on the esophageal pressure information detected by the balloon pressure sensor 93 during the air insufflation. Furthermore, the processing unit 4 generates third support information I4 based on the aerated sound information collected by the microphone 8 during the air insufflation. Finally, the processing unit 4 generates diagnostic support information I0 for diagnosing gastroesophageal reflux disease based on the endoscopic image I1, the first to third support information I2 to I4, and time information I5 related to the air insufflation time into the stomach by the first air insufflation device 6 (hereinafter referred to as pneumoperitoneum time).

[0081] Here, the processing unit 4 processes the captured image, gastric pressure information, esophageal pressure information, and aerated sound information in a time-synchronized manner based on the synchronization signal generated by the synchronization signal generation unit 42. The processing unit 4 also processes the esophageal pressure information detected by each of the multiple balloon pressure sensors 93 in a time-synchronized manner based on the synchronization signal.

[0082] The first support information I2 includes a pressure waveform I21 showing the change in pressure (intragastric pressure) based on the increase in intragastric pressure due to air delivery into the stomach by the first air delivery device 6, as shown in Figures 9 to 11. The first support information I2 also includes the current intragastric pressure (Current IGP) I22, the maximum intragastric pressure (Maximum IGP) I23 when the intragastric pressure increases, and the basal intragastric pressure (Basal IGP) I24 before the increase in intragastric pressure, as shown in Figures 9 and 10. The first support information I2 is not limited to the pressure waveform I21, the current intragastric pressure I22, the maximum intragastric pressure I23, and the basal intragastric pressure I24, but may also include the pressure difference between the maximum intragastric pressure I23 and the basal intragastric pressure I24, or the pressure gradient obtained by dividing the pressure difference by the insufflation time.

[0083] Furthermore, the current intragastric pressure I22, the maximum intragastric pressure I23 when intragastric pressure rises, and the baseline intragastric pressure I24 before the rise in intragastric pressure may be represented using any appropriate representation, such as bar graphs, line graphs, contour graphs, other representations, or any appropriate combination thereof.

[0084] The second support information I3 includes a pressure waveform I31 showing the pressure changes detected by a plurality of balloon pressure sensors 93, as shown in Figures 9 to 11. In this embodiment, the pressure waveform I31 is constructed using a pressure topography, as shown in Figures 11(c) and 11(f). Specifically, the pressure topography (pressure waveform I31) is a diagram in which time is used as the horizontal axis, and the pressure changes detected by the balloon pressure sensors 93, which detect the air pressure inside the balloons 91 positioned from the upper esophageal sphincter side to the lower esophageal sphincter side, are represented as a color pattern from the top to the bottom of the vertical axis.

[0085] Here, the color patterns shown in Figure 11(c) and Figure 11(f) can, for example, use blue to represent the low-pressure range and red to represent the high-pressure range. The temporal representation shown on the horizontal axis can move horizontally along the time dimension to show the passage of time within the time interval in which the displayed pressure value was measured. For example, the far right of the temporal representation can correspond to the most recent time within the time interval displayed in the temporal representation, and the far left can represent the earliest time. To show the passage of time within the time interval, the temporal representation moves continuously to the left on the screen, allowing the user to observe the representation of pressure measured in the esophagus over time. This continuous movement to the left allows the user to confirm the temporal changes in pressure at the displayed position (if any) and to confirm the occurrence of events that caused the pressure change (e.g., relaxation of the lower esophageal sphincter or peristalsis in the esophagus).

[0086] Furthermore, information indicating the location of multiple balloons 91 within the esophageal tube may be added to the pressure topography (pressure waveform I31). For example, markers indicating the location of the upper and lower esophageal sphincters may be added to the vertical axis.

[0087] Furthermore, even if the pressure data detected by the number of balloons 91 placed may be detected at discrete locations, the pressure data can be made quasi-continuous in the spatial dimension. The pressure data can be made quasi-continuous by including interpolated pressure values ​​in the pressure data. Based on quasi-continuous pressure data, a quasi-continuous visual representation (e.g., having a smooth change) can be provided. Any suitable visual representation described below may be quasi-continuous.

[0088] Furthermore, the second support information I3 includes the basal LES pressure I32 detected by a balloon pressure sensor 93 (third balloon pressure sensor 933) that detects the air pressure inside the balloon 91 (third balloon 913) located on the lower esophageal sphincter side before the rise in gastric pressure, as shown in Figures 9 and 10. Note that the second support information I3 is not limited to the pressure waveform I31 and the basal pressure I32, but may also include the maximum and minimum pressure values ​​detected by each of the multiple balloon pressure sensors 93.

[0089] The third support information I4 includes a waveform I41 of the muffled sound based on the muffled sound information detected by the microphone 8, as shown in Figures 9 to 11. The third support information I4 also includes the maximum sound pressure of the muffled sound detected by the microphone 8, as shown in Figures 9 and 10.

[0090] Then, the user, such as a doctor, checks the diagnostic support information I0 displayed on the display device 5 and diagnoses the patient with gastroesophageal reflux disease.

[0091] In step S5, the user, such as a physician, checks the diagnostic support information I0 displayed on the display device 5, determines whether the state corresponds to Phase 1, and evaluates the valve function due to the structure of the stomach. For example, if the person being examined is healthy, the pressure waveform I21 will be a sloped pressure waveform as shown in Figure 11(a). On the other hand, if the person being examined is suspected of having an abnormality, the pressure waveform I21 will be a flat pressure waveform as shown in Figure 11(d). Therefore, the user, such as a physician, checks, for example, the endoscopic image I1 and the first support information I2 that constitute the diagnostic support information I0, and evaluates the valve function due to the structure of the stomach.

[0092] In step S6, the user, such as a physician, checks the diagnostic support information I0 displayed on the display device 5, determines whether the state corresponds to Phase 2, and evaluates the valve function of the lower esophageal sphincter. For example, if the person being examined is healthy, SHS will be observed, and the contraction pressure of the lower esophageal sphincter will also be observed. Therefore, the user, such as a physician, checks, for example, the endoscopic image I1, and the first and second support information I2 and I3 that constitute the diagnostic support information I0, and evaluates the valve function of the lower esophageal sphincter.

[0093] In step S7, the user, such as a physician, checks the diagnostic support information I0 displayed on the display device 5 and determines whether the state corresponds to Phase 3, and evaluates the acid clearance function by esophageal peristalsis. For example, if the person being examined is healthy, the gastric pressure will be around 19 mmHg, a babbling sound will occur, and the lower esophageal sphincter will relax (Figures 11(a) to 11(c)). On the other hand, if the person being examined is suspected of having an abnormality, the gastric pressure will be around 14 mmHg and the lower esophageal sphincter will relax. Also, if the person being examined is healthy, peristaltic movement in the esophagus will be observed (Figure 11(c)), and SHS will be observed again. For example, on pressure topography (pressure waveform I31), as peristalsis progresses over time (to the right on the time axis, but the representation itself moves to the left), the contractile pressure in each part of the esophagus can be seen progressing from the top to the bottom (from the upper esophageal sphincter to the lower esophageal sphincter).

[0094] On the other hand, if an abnormality is suspected in the subject being examined, peristaltic movement in the esophagus will not be observed (Figure 11(f)). Therefore, users such as physicians can, for example, check the endoscopic image I1 and the first to third support information I2 to I4 that constitute the diagnostic support information I0 to evaluate the acid clearance function due to esophageal peristalsis.

[0095] Then, in step S8, if the user, such as a physician, suspects an abnormality in any of the valve function due to the gastric structure, the valve function due to the lower esophageal sphincter, or the acid clearance function due to esophageal peristalsis, which were evaluated in steps S5 to S7, the user diagnoses suspected gastroesophageal reflux disease.

[0096] Furthermore, the diagnostic support information I0 shown in Figures 9 and 10 includes diagnostic result information I6. The diagnostic result information I6 is information regarding the diagnostic result that the processing device 4 automatically diagnoses whether or not the person being examined has gastroesophageal reflux disease (or whether or not there is a suspicion of gastroesophageal reflux disease) based on the captured images, gastric pressure information, esophageal pressure information, and aerated sound information. This diagnostic result information I6 includes an evaluation result I61 that evaluates which phase the current phase is in, an evaluation result I62 that evaluates whether or not the person is in a state corresponding to each of Phases 1 to 3, and a diagnostic result I63 that evaluates whether or not the person has gastroesophageal reflux disease (or whether or not there is a suspicion of gastroesophageal reflux disease) based on the evaluation result I62.

[0097] The processing unit 4 stores the captured image, gastric pressure information, esophageal pressure information, and aerated sound information in memory, which are processed in a time-synchronized manner based on the synchronization signal. In other words, the captured image and various support information can be referenced in a time-synchronized state. Therefore, for example, a user such as a doctor can view the endoscopic image at a time specified by the user, along with the various support information for that timing.

[0098] The embodiment described above provides the following advantages. According to this embodiment, it is possible to evaluate the valve function due to the gastric structure, the valve function due to the lower esophageal sphincter, and the acid clearance function due to esophageal peristalsis using only the endoscope system 1, without using other examination equipment, and to diagnose whether or not the person being examined has gastroesophageal reflux disease. Therefore, according to this embodiment, the burden on the person being examined when being tested for gastroesophageal reflux disease can be reduced.

[0099] Incidentally, the diameter of the esophagus is said to be approximately 2 to 3 centimeters, but there are individual differences. Furthermore, the examination equipment used in high-resolution manometry is not necessarily designed to accommodate these individual differences. For this reason, there is a risk that the measurement may be affected in high-resolution manometry. In contrast, in this embodiment, the balloon 91 inflates so as to come into contact with the inner wall of the esophagus. Therefore, in the diagnosis of gastroesophageal reflux disease, the influence of individual differences in esophageal structure on the measurement can be suppressed.

[0100] (Other Embodiments) While embodiments for carrying out the present invention have been described so far, the present invention should not be limited to the embodiments described above. In the embodiments described above, the invention was described as a technique that can diagnose gastroesophageal reflux disease, but this is not the only example. For example, it can also be used to evaluate relaxation failure of the lower esophageal sphincter, and thus can be useful in diagnosing esophageal achalasia. Furthermore, it can be used to evaluate the function of major sphincters present in the human digestive tract. Specifically, it can be used to evaluate the external anal sphincter, that is, physiological anorectal function associated with aging.

[0101] In the above-described embodiment, the configurations of the following modified examples 1 and 2 may also be adopted.

[0102] (Modification 1) Figure 12 is a diagram illustrating modification 1 of the embodiment. Specifically, Figure 12 corresponds to Figure 3 and is a diagram illustrating the configuration of the balloon device 9 according to this modification 1. In the embodiment described above, the balloon pressure sensor 93 detected the air pressure inside the balloon 91 via the balloon internal air supply tube TU2 for injecting gas into the balloon 91 from the second air supply device 92, but is not limited to this.

[0103] In this modified example 1, the balloon pressure sensor 93 detects the air pressure inside the balloon 91 via a detection tube TU3 (Figure 12) that is different from the balloon air supply tube TU2. The balloon air supply tube TU2 corresponds to the air supply tube according to the present invention. In the example shown in Figure 12, only three balloons 91 are shown, so only three detection tubes TU3 are also shown. Hereafter, the detection tube TU3 connecting the first balloon 911 and the first balloon pressure sensor 931 will be referred to as the first detection tube TU31, the detection tube TU3 connecting the second balloon 912 and the second balloon pressure sensor 932 will be referred to as the second detection tube TU32, and the detection tube TU3 connecting the third balloon 913 and the third balloon pressure sensor 933 will be referred to as the third detection tube TU33.

[0104] Even when adopting the configuration of the modified example 1 described above, the same effects as those of the embodiment described above are achieved.

[0105] (Modification 2) Figure 13 is a diagram illustrating modification 2 of the embodiment. Specifically, Figure 13 corresponds to Figure 3 and is a diagram illustrating the configuration of the balloon device 9 according to this modification 2. As shown in Figure 13, the balloon device 9 according to this modification 2 has an initial pressure detection sensor 94 added to the balloon device 9 described in the above-described embodiment. This initial pressure detection sensor 94 corresponds to the pressure sensor according to the present invention.

[0106] The initial pressure detection sensor 94 detects the air pressure inside the balloon 91 via the balloon inflation tube TU2. This initial pressure detection sensor 94 is used in step S3. That is, in step S3, gas is injected until the air pressure inside all balloons 91 (the air pressure detected by the initial pressure detection sensor 94) reaches a predetermined pressure.

[0107] Even when adopting the configuration of the modified example 2 described above, the same effects as those of the embodiment described above are achieved.

[0108] 1 Endoscope system 2 Endoscope 3 Light source device 4 Processing device 5 Display device 6 First air insufflation device 7 Intragastric pressure measuring device 8 Microphone 9 Balloon device 21 Insertion section 22 Operation section 23 Universal cord 24 Tip section 25 Bending section 26 Flexible tube section 31 Light source section 32 Illumination control section 33 Light source driver 41 Image processing section 42 Synchronization signal generation section 43 Input section 44 Control section 45 Storage section 61 Air insufflation section 62 Flow rate measurement section 63 Control section 71 Pressure measuring probe 91 Balloon 92 Second air insufflation device 93 Balloon pressure sensor 94 Initial pressure detection sensor 221 Bending knob 222 Instrument insertion section 223 Air insufflation line 224 Switch 231, 232 Connector 241 Light guide 242 Illumination lens 243 Optical system 244 Image sensor 245 Cable 911 First balloon 912 Second balloon 913 Third balloon 931 Pressure sensor for first balloon 932 Pressure sensor for second balloon 933 Pressure sensor for third balloon I0 Diagnostic support information I1 Endoscopic image I2 First support information I21 Pressure waveform I22 Current gastric pressure I23 Maximum gastric pressure I24 Basal gastric pressure I3 Second support information I31 Pressure waveform I32 Basal pressure I4 Third support information I41 Waveform I5 Time information I6 Diagnostic result information I61, I62 Evaluation result I63 Diagnostic result TU1 Tube for gastric insufflation TU2 Tube for balloon insufflation TU21 Tube for first balloon insufflation TU22 Second balloon inflation tube TU23 Third balloon inflation tube TU3 Detection tube TU31 First detection tube TU32 Second detection tube TU33 Third detection tube

Claims

1. An endoscope system comprising: an endoscope having an insertion section with an image sensor positioned at its tip; a first air supply device that supplies gas to the space inside where the tip of the insertion section is located via an air supply line provided in the insertion section; a pressure detection sensor that detects the air pressure inside the space inside where the tip of the insertion section is located; a balloon attached to the outer surface of the insertion section that inflates when gas is injected into it; a second air supply device that injects gas into the balloon; a balloon pressure sensor that detects the pressure applied to the balloon; and a processor, wherein the processor generates diagnostic support information to assist in the diagnosis of gastroesophageal reflux disease based on an image captured by the image sensor, first pressure information relating to the air pressure detected by the pressure detection sensor, and second pressure information relating to the pressure detected by the balloon pressure sensor.

2. The endoscope system according to claim 1, wherein the balloon is made of resin.

3. The endoscopic system according to claim 1, wherein a plurality of balloons are provided.

4. The endoscopic system according to claim 3, wherein the balloon comprises at least a first balloon, a second balloon, and a third balloon.

5. The endoscope system according to claim 4, wherein the first balloon is positioned such that pressure is applied from the inner wall of the esophagus by the contraction and relaxation of the upper esophageal sphincter when the insertion portion is inserted into the stomach and the gastric cardia is made image-capable by the image sensor by bending the endoscope.

6. The endoscope system according to claim 4, wherein the second balloon is positioned such that pressure is applied from the inner wall of the esophagus by contraction and relaxation of the esophagus from the upper esophageal sphincter to the lower esophageal sphincter, when the insertion portion is inserted into the stomach and the gastric cardia can be imaged by the image sensor by bending the endoscope.

7. The endoscope system according to claim 4, wherein the third balloon is positioned such that pressure is applied from the inner wall of the esophagus by the contraction and relaxation of the lower esophageal sphincter when the insertion portion is inserted into the stomach and the gastric cardia is made image-capable by the image sensor due to the bending operation of the endoscope.

8. The endoscope system according to claim 1, wherein the balloon is inflated by the injection of gas so as to come into contact with the inner wall of the esophagus when the insertion portion is inserted into the stomach and the gastric cardia is made imageable by the image sensor by bending the endoscope.

9. The endoscope system according to claim 1, wherein the balloon expands at least radially in the insertion portion when gas is injected.

10. The endoscope system according to claim 1, wherein the second air supply device injects gas into the balloon via a tube, and the balloon pressure sensor detects the pressure applied to the balloon by detecting the air pressure inside the balloon via the tube.

11. The endoscope system according to claim 1, wherein the second air supply device injects gas into the balloon via an air supply tube, and the balloon pressure sensor detects the pressure applied to the balloon by detecting the air pressure inside the balloon via a detection tube.

12. The endoscope system according to claim 1, further comprising a pressure sensor for detecting the air pressure inside the balloon, separate from the balloon pressure sensor.

13. A balloon device comprising a balloon attached to the outer surface of the insertion section of an endoscope and which inflates when gas is injected into it; an air supply device for injecting gas into the balloon; and a pressure sensor for detecting the pressure applied to the balloon.

14. A method for diagnosing gastroesophageal reflux disease, comprising: inserting the insertion part of an endoscope into the stomach, enabling imaging of the gastric cardia using the endoscope, setting a balloon attached to the outer surface of the insertion part to be located inside the esophagus, inflating the balloon by injecting gas into the balloon, insufflating air into the stomach, and diagnosing gastroesophageal reflux disease based on the image captured using the endoscope during air insufflation into the stomach, first pressure information relating to the atmospheric pressure inside the stomach detected by a pressure detection sensor, and second pressure information relating to the pressure applied to the balloon detected by a balloon pressure sensor.

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