Medical system and control method of a medical system

Abstract

A medical system and a control method of a medical system are provided. The medical system includes an endoscope and a control device. An endoscope action of the endoscope is electrically driven, and the endoscope captures an endoscope image. The endoscope action is at least one of advancement and retreat of an insertion section, adjustment of a bending angle of a bending section of the insertion section, and roll rotation of the insertion section. The control device controls the endoscope action based on the electrical driving. The control device performs a first positioning in which the insertion section is positioned with respect to a papillary portion of a duodenum, and then performs a second positioning in which the endoscope action based on the electrical driving is controlled based on the endoscope image, thereby positioning a distal end portion of the insertion section with respect to the papillary portion.

Description

Technical Field

[0001] This invention relates to medical systems and methods for controlling medical systems. Background Technology

[0002] Known procedures include ERCP (Endoscopic Retrograde Cholangiopancreatography), in which a cannula is inserted into the bile duct through the instrument channel of an endoscope, contrast agent is injected into the cannula, and X-ray or CT images of the bile duct are obtained. U.S. Patent Application Publication No. 2017 / 0086929 discloses examples of using a robotic catheter system for remotely manipulating the catheter system in ERCP.

[0003] During ERCP, the only information obtained is an endoscopic image of the papilla. Due to individual differences in the morphology of the papilla and ductal tissue, it is difficult to determine the insertion position and direction of the catheter based solely on the endoscopic image. To more accurately estimate the location of the opening and the direction of bile duct travel, alignment is desired so that the papilla is captured at a specified position in the image. However, adjusting the position of the endoscope tip is difficult because operations performed at the base of the insertion site are difficult to transmit to the tip, or the tip of the endoscope may vibrate relative to the papilla. Furthermore, although U.S. Patent Application Publication No. 2017 / 0086929 discloses an example of applying a robotic catheter system to ERCP, it does not disclose or suggest solutions to the aforementioned problems. Summary of the Invention

[0004] One aspect of this disclosure relates to a medical system comprising: an endoscope whose endoscopic movement is electrically driven, the endoscope capturing endoscopic images, the endoscopic movement being at least one of forward and backward movement of an insertion portion, adjustment of the bending angle of a bending portion of the insertion portion, and rolling rotation of the insertion portion; and a control device that controls the electrically driven endoscopic movement, wherein after a first positioning of the insertion portion relative to the duodenal papilla, the control device performs a second positioning by controlling the electrically driven endoscopic movement based on the endoscopic images, thereby positioning the anterior end of the endoscope relative to the papilla.

[0005] Another aspect of this disclosure relates to a control method for a medical system using an endoscope whose endoscopic movement is electrically driven, the endoscope capturing endoscopic images, and the endoscopic movement being at least one of forward / reverse movement of an insertion portion, adjustment of the bending angle of a curved portion of the insertion portion, and rolling rotation of the insertion portion. The control method of the medical system includes the following steps: the medical system inserts the insertion portion of the endoscope into the body; the medical system performs a first positioning of the insertion portion relative to the duodenal papilla; after performing the first positioning step, the medical system performs a second positioning: controlling the electrically driven endoscopic movement based on the endoscopic images, thereby positioning the anterior end of the endoscope relative to the opening of the luminal tissue; and after performing the second positioning step, the medical system performs cannulation from the duodenal papilla into the bile duct. Attached Figure Description

[0006] Figure 1 This is a diagram showing the organs and tissues involved in ERCP surgery.

[0007] Figure 2 This is the ERCP procedure.

[0008] Figure 3 It is a diagram that schematically shows the shape of the nipple when viewed directly from the nipple, and shows morphological examples showing individual differences.

[0009] Figure 4 It is a cross-sectional view showing the morphology of the luminal tissue and its opening.

[0010] Figure 5 This is an example of the basic structure of the medical system in this embodiment.

[0011] Figure 6 This is the first step of the surgery in this embodiment.

[0012] Figure 7 This is a diagram comparing the case without a sleeve and the case with a sleeve.

[0013] Figure 8 This is a diagram showing the area near the tip of an endoscope positioned via a cannula and balloon.

[0014] Figure 9 This is a detailed structural example of a medical system.

[0015] Figure 10 This is a detailed structural example of a drive control device.

[0016] Figure 11 This is a schematic diagram of an endoscope including a curved section and its drive mechanism.

[0017] Figure 12 This is a detailed structural example of an advance / reverse drive device.

[0018] Figure 13 It is a perspective view including the connecting part of the rolling drive device.

[0019] Figure 14 This is a detailed structural example of the front end of an endoscope that includes a lifting platform for handling instruments.

[0020] Figure 15 This is a detailed structural example of the treatment device.

[0021] Figure 16 This is a structural example of a bushing drive system.

[0022] Figure 17 This is a structural example of a balloon drive system.

[0023] Figure 18 This is the first variation of the retaining component.

[0024] Figure 19 This is the second variation of the retaining component.

[0025] Figure 20 This is a diagram showing the organ structure of a patient who underwent gastric bypass surgery based on the Roux-en-Y method.

[0026] Figure 21 This is a variation of an operating device for manually operating an electric endoscope. Detailed Implementation

[0027] In the following disclosure, various embodiments and implementations of different features of the presented subject matter are provided. These are merely examples and are not intended to limit the invention. Furthermore, in this disclosure, there are instances of repeated reference numerals and / or words in various examples. Such repetition is for clarity and does not necessarily imply a relationship to the various embodiments and / or the described structures. Additionally, when described as "connected" or "linked" to the first and second elements, such description includes embodiments where the first and second elements are directly connected or linked to each other, and also embodiments where the first and second elements are indirectly connected or linked to each other by having one or more other elements disposed between them.

[0028] 1. About ERCP

[0029] This embodiment relates to the automated control of ERCP performed using an electrically powered medical system. ERCP is short for Endoscopic Retrograde Cholangiopancreatography. First, the procedures involved in ERCP will be explained before describing this embodiment.

[0030] Figure 1 The images show the organs and tissues involved in ERCP surgery. Furthermore, organs are composed of various tissues, forming unique structures with specific functions. Figure 1 In traditional Chinese medicine, the liver, gallbladder, pancreas, esophagus, stomach, and duodenum correspond to organs. Tissues, such as blood vessels, muscles, and skin, are composed of interconnected cells. Figure 1 In this context, the bile duct and pancreatic duct are equivalent to tissues.

[0031] ERCP involves the bile duct. The bile duct is the passageway through which bile produced by the liver flows into the duodenum. When accessing the bile duct using an endoscope, with the endoscope positioned in the duodenum, a treatment instrument inserted through the endoscope's channel is inserted into the bile duct from the duodenal papilla. Hereinafter, the duodenal papilla will be simply referred to as the papilla. The papilla is the region including the opening of the luminal tissue relative to the duodenal opening, encompassing the opening and surrounding structures. The opening of the luminal tissue is the portion of the common tube where the bile duct and pancreatic duct merge relative to the duodenal opening. However, as described later, there are various individual differences in the papilla, for example, in cases where the bile duct and pancreatic duct do not merge and the bile duct opens directly into the duodenum. In such cases, the opening of the luminal tissue is the opening of the bile duct.

[0032] Figure 2 This illustrates the ERCP procedure. In ERCP, a side-viewing endoscope with a camera, illumination lens, and an opening for accessing instruments is used on the side of the endoscope's tip. The camera is also referred to as a video recording device.

[0033] In the endoscopic insertion step, the insertion section of the endoscope is inserted through the mouth, esophagus, and stomach into the duodenum. At this point, the insertion section is positioned so that the nipple is roughly visible in the endoscopic field of view. Next, in the alignment step, the endoscope is aligned relative to the nipple. Specifically, the position of the tip of the endoscope is adjusted so that the nipple is within the camera's field of view. Alternatively, the position of the tip of the endoscope is adjusted so that the camera is directly facing the nipple and captures the nipple in the center of the field of view.

[0034] Next, in the cannulation procedure, a cannula is inserted into the bile duct from the nipple. Specifically, the cannula is inserted into the endoscope's instrument channel, causing it to protrude from the opening at the endoscope's tip. The tip of the cannula is then inserted into the opening of a common tube, and further inserted into the common tube, from the confluence of the bile duct and pancreatic duct towards the bile duct. Cannulation refers to the insertion of a cannula into the body. A cannula is a medical tube inserted into the body for medical use.

[0035] Next, during the contrast and imaging steps, contrast agent is injected into the cannula, allowing it to flow into the bile duct from the tip. X-ray or CT scans are then performed in this state to obtain images of the bile duct, gallbladder, and pancreatic duct. This completes the ERCP procedure, after which various treatments are performed based on the diagnostic results from the X-ray or CT images. An example is described below.

[0036] In the guidewire insertion step, the guidewire is inserted into the cannula until it protrudes from the tip, and then inserted into the bile duct. In the cannula removal step, the cannula is removed while the guidewire remains in the bile duct. This leaves only the guidewire protruding from the tip of the endoscope and remaining in the bile duct. Next, in the instrument insertion step, the instrument is inserted into the bile duct along the guidewire. One example of an instrument is a basket or stent. The basket is used together with the catheter. While passing the guidewire through the catheter, the catheter is inserted into the bile duct along the guidewire. The basket, composed of multiple metal wires, is inserted into the bile duct from the tip of the catheter. The object to be removed, such as gallstones, is placed and held in the basket. In this state, the basket and catheter are removed from the bile duct, thereby removing the object from the bile duct. A stent is also used together with the catheter and inserted into the bile duct from the tip of the catheter. The narrowed portion of the bile duct is widened by inserting a stent into it, and the narrowed portion is maintained in a widened state by leaving the stent in place.

[0037] ERCP can be performed using the methods described above, but the localization step can be challenging due to individual differences in the nipple or ductal tissues. The following section will address this point. Figure 3 and Figure 4 Please provide an explanation.

[0038] Figure 3 This diagram schematically illustrates the morphology of the nipple when viewed directly from the nipple, and shows examples of individual differences in morphology. As shown in the diagram, the main nipple, which serves as the opening of the luminal tissue, has nipple-specific structures around it. Specifically, around the main nipple are structures called frenulum, surrounding folds, and lateral ridges.

[0039] However, while the diagrams show typical nipple morphology, as illustrated in examples a-d, nipple morphology varies from patient to patient due to individual differences. For example, the main nipple, frenulum, surrounding folds, or lateral ridges may be indistinct, or the morphology may differ significantly from the typical form. Furthermore, the openings of luminal tissues are often closed, making it difficult to accurately determine their location visually.

[0040] Figure 4 This is a cross-sectional view showing the morphology of the luminal tissue and its opening. Among the morphologies of the luminal tissue and its opening, there are Type I, known as the Y-shape; Type II, known as the V-shape; and Type III, known as the U-shape or separated type. In Type I, the bile duct and pancreatic duct merge into a common duct at the confluence, which opens at the papilla. In Type II, the bile duct and pancreatic duct open at the papilla at the confluence, and there is no common duct. In Type III, the bile duct and pancreatic duct are separate and open at the papilla, without a confluence or common duct. Although Type I is the most common, Type II or Type III patients also exist.

[0041] During the bile duct cannulation procedure, the procedure was basically performed based on the images captured on film. Figure 3 Examples a through d show endoscopic images of the nipple. Figure 3 and Figure 4 As explained, the morphology of the nipple and lumen tissues is diverse, making it difficult to determine the insertion position and direction of the cannula based on endoscopic images.

[0042] In response, the surgeon observes the endoscopic images while inferring the location of the bile duct opening and its direction of travel based on past cases or experience. Following this estimation, the surgeon attempts to insert a cannula into the bile duct through the opening. At this point, to more accurately estimate the location of the opening and the direction of travel of the bile duct, it is desirable that the position of the papillae in the image and the field of view are easily comparable to past cases or situations commonly encountered by surgeons.

[0043] like Figure 1 The endoscope is positioned by reaching the tip of the endoscope insertion section from outside the duodenum. However, because the insertion section and the organs it passes through are flexible, operations performed at the base of the insertion section are difficult to transmit to the tip. Furthermore, the tip of the endoscope is suspended in the air relative to the duodenum, making it unstable relative to the papilla and difficult to determine its positional relationship. For these reasons, it is difficult to adjust the position of the tip of the endoscope so that the endoscope's field of view is directly facing the papilla or that the papilla is captured centrally within the field of view.

[0044] 2. Surgical procedure and medical system of this embodiment

[0045] Therefore, in this embodiment, the aforementioned alignment is automated by an electrically powered medical system to assist ERCP surgery. Furthermore, by adding a structure that holds the endoscope insertion portion in the duodenum, the electric drive can be easily transmitted to the tip of the endoscope, allowing free control of its position. Details are described below.

[0046] Figure 5 This diagram illustrates a basic structural example of the medical system 10 according to this embodiment. The medical system 10 includes an endoscope 100, a cannula 710, a balloon 720, a treatment device 400, and a control device 600. The medical system 10 is also referred to as an endoscope system or a motorized endoscope system.

[0047] The cannula 710 is a variable-rigidity tube that covers the insertion portion 110 of the endoscope 100. A balloon 720 is positioned near the front end of the cannula 710 on its outer side. With the endoscope 100 and cannula 710 inserted into the body, at least the curved portion of the insertion portion 110 protrudes from the front end of the cannula 710. The curved portion is a portion near the front end of the insertion portion 110 that is bent at an angle corresponding to the bending operation. Furthermore, the base end of the cannula 710 is outside the body, and the base end side of the insertion portion 110 protrudes from the base end of the cannula 710.

[0048] An insertion port 190 for a treatment instrument is provided at the base end of the insertion portion 110, and a treatment instrument channel is provided inside the insertion portion 110. This treatment instrument channel allows the treatment instrument 400 to pass through the insertion port 190 to the opening of the front end portion 130. The insertion port 190 for the treatment instrument is also referred to as a tweezers port, but the treatment instrument used is not limited to tweezers.

[0049] Endoscope 100 is detachably connected to control device 600 via connectors 201 and 202. Control device 600 includes a drive control device 200 connected to connector 201 and an image control device 500 connected to connector 202. Drive control device 200 controls the electric drive of endoscope 100 via connector 201. Although in Figure 5 Although not shown, an operating device for manually operating the electric drive can also be connected to the drive control device 200. The image control device 500 performs the following processing: receiving image signals from a camera located at the front end 130 of the endoscope 100 via connector 202, generating a display image based on the image signals, and displaying it on a display device (not shown). Additionally, in Figure 5 In the illustration, the drive control device 200 and the image control device 500 are shown as separate devices, but they can also be composed of a single unit. In this case, connectors 201 and 202 can also be combined into a single connector.

[0050] Figure 6The first step of the surgery in this embodiment is shown. Here, we envision an electric endoscope that motorizes the forward and backward movement of the insertion portion 110 of the endoscope 100, the bending of the bending portion of the insertion portion 110, and the rolling and rotating of the insertion portion 110. However, it is sufficient to motorize at least one of them. "Electrified" means that the endoscope is driven by a motor or the like based on an electrical signal used to control the movement of the endoscope. For example, in the case of manual operation of the electric endoscope, the operation input to the operating device is converted into an electrical signal, and the endoscope is driven based on the electrical signal. In addition, forward and backward movement will be referred to as forward and backward movement below.

[0051] In step S1, the surgeon inserts the insertion part 110 and the cannula 710 of the endoscope 100 into the duodenum. Specifically, with the insertion part 110 inserted into the cannula, the insertion part 110 and the cannula 710 are inserted together into the duodenum. Although the rigidity of the cannula 710 can be variable, it is in a flexible state in step S1. For example, the surgeon can manually advance the insertion part 110 and the cannula 710 into the body without electric power. "Without electric power" means that the endoscope 100 is not electrically driven by a motor or the like, but rather the force applied to the operating part is directly transmitted to the endoscope via a wire or the like, thereby causing the endoscope to move. Furthermore, as an example, in this embodiment, the movements are non-electric up to steps S1 to S4. In this case, at least the forward and backward movements need not be electric; bending, rolling, rotation, or both can be manually operated electrically.

[0052] In step S2, the surgeon inserts the insertion part 110 until the tip 130 reaches near the nipple. For example, if the surgeon inserts it manually (without an electric motor), the surgeon inserts the insertion part 110 until the nipple is captured in the endoscopic image. Additionally, at this stage, the tip of the endoscope 100 may not reach the nipple precisely, or it may reach a position closer to or beyond the nipple.

[0053] In step S3, the surgeon fixes the tip of the cannula 710 to the duodenum. For example, the surgeon inflates a balloon 720 located near the tip of the cannula 710, thereby fixing the tip of the cannula 710 to the duodenum via the balloon 720. In step S4, the surgeon hardens the cannula 710. At this time, the cannula 710 maintains its shape before hardening, i.e., its shape as it is inserted from the mouth into the duodenum. Thus, the insertion portion 110 is held in place by the hardened cannula 710 and the balloon 720, thereby fixing the insertion path of the insertion portion 110. These steps S3 and S4 are referred to as the first positioning.

[0054] In step S5, the endoscope 100 is connected to the motor unit, switching from non-electric to electric. The method of switching between non-electric and electric modes varies depending on the structure of the drive mechanism. For example, when using... Figure 9 In the case of the medical system 10 described later, the forward and backward movement is non-electric, while bending and rolling rotation are electric. In this case, the forward and backward movement can also be switched from non-electric to electric by connecting the endoscope 100 to the forward and backward drive device 800. Alternatively, if the system is configured to perform non-electric bending operations by providing a bending operation dial or the like, the bending operation can be switched from non-electric to electric by connecting the connector 201 to the drive control device 200. Alternatively, even if the motor unit remains connected, the system can be configured to disconnect the motor via a clutch mechanism or the like, thereby switching between non-electric and electric operation. Furthermore, step S5 can also be performed before step S1. For example, if the forward and backward movement is manually operated electrically, the endoscope 100 can be connected to the motor unit before step S1.

[0055] In step S6, the drive control device 200 automatically aligns the tip 130 with the nipple, and the surgeon confirms that the position of the tip 130 is adjusted to capture the nipple at a predetermined position on the endoscopic image. The drive control device 200 acquires the endoscopic image from the image control device 500 and aligns the tip 130 of the endoscope 100 based on the endoscopic image. Specifically, the drive control device 200 controls the electric drive-based forward / backward, bending, or rolling rotation to capture the nipple at a pre-registered position on the endoscopic image. The pre-registered position is, for example, the center of the image. More preferably, alignment can also be performed to capture the opening of the lumen tissue at the pre-registered position. Furthermore, the drive control device 200 can also be electrically controlled based on the endoscopic image to ensure that the camera is directly facing the nipple or captures the nipple at an appropriate field of view. Furthermore, the drive control device 200 can also electrically control the diameter of the balloon 720 based on the endoscopic image, thereby changing the distance between the camera and the nipple without changing the camera's line of sight, and thus adjusting the field of view for capturing the nipple. This step S6 is referred to as the second positioning.

[0056] In step S7, the surgeon inserts the cannula from the insertion port 190 into the treatment instrument channel to begin the cannulation procedure for inserting the cannula into the bile duct.

[0057] In addition, Figure 6In this embodiment, the balloon operation in step S3 and the cannula hardening in step S4 are set to non-electric, but they can also be electrically powered. In this case, the surgeon may input an instruction from the operating device, and the drive control device 200 may use this instruction as a trigger to electrically inflate the balloon and harden the cannula. Alternatively, the drive control device 200 may perform image recognition processing to detect the nipple in the endoscopic image, and use the detection of the nipple in the endoscopic image as a trigger to automatically inflate the balloon and harden the cannula.

[0058] According to the above surgical procedure, in step S3, the balloon 720 is inflated before the cannula 710 is hardened, so that the position of the tip of the cannula 710 will not shift when the cannula 710 is hardened. That is, the position of the tip of the cannula 710 can be accurately positioned. Furthermore, through the first positioning in steps S3 and S4, the balloon 720 and the cannula 710 maintain the insertion path of the insertion part 110. Therefore, in the second positioning in step S6, the forward and backward movement, bending or rolling rotation of the electrically driven endoscope 100 is easily transmitted from the base side of the insertion part 110 to the tip. Regarding this, using Figure 7 Please provide an explanation.

[0059] Figure 7 This diagram compares the cases where the cannula 710 is absent and the cases where the cannula 710 is present. Here, the forward movement of the insertion portion 110 is explained as an example. The forward movement of the insertion portion 110 is achieved by pressing the insertion portion 110 along the axial direction using a sliding mechanism, etc., as described later. As shown in the diagram above, when the insertion portion 110 is not covered by the cannula 710, when the base end side of the insertion portion 110 is pressed along the axial direction, the force is absorbed by the deformation of the insertion portion 110 and is difficult to transmit to the front end of the insertion portion 110. This is because the stomach or duodenum through which the insertion portion 110 passes is soft. As shown in the diagram below, when the insertion portion 110 is covered by the hardened cannula 710, when the base end side of the insertion portion 110 is pressed along the axial direction, the insertion portion 110 uses the hardened cannula 710 as a guide to advance within the cannula 710. Thus, the forward drive from the base end side is efficiently transmitted to the front end of the insertion portion 110. Regarding bending or rolling rotation, the insertion portion 110 is also held by the cannula 710 and the balloon 720, thereby efficiently transmitting the electric drive from the base side to the front end of the insertion portion 110.

[0060] Figure 8 This is a diagram showing the area near the tip of the endoscope, positioned by the cannula 710 and balloon 720. (See diagram below.) Figure 8As shown, the balloon 720 is fixed at a position slightly separated from the nipple towards the pyloric side of the stomach. Specifically, the balloon 720 is located closer to the base of the insertion portion 110 than the base of the curved portion. By combining such a balloon 720 with a cannula 710 of variable stiffness, the curved portion and the anterior end portion 130 of the balloon 720 exposed towards the nipple can move freely without being fixed, and the electric drive from the base side is efficiently transmitted to the anterior end portion 130 of the endoscope.

[0061] The electrically driven endoscope movements are forward and backward as shown in A1, bending as shown in A2, or rolling rotation as shown in A3. Forward movement refers to movement towards the front end along the axis of the insertion part 110, and backward movement refers to movement towards the base end along the axis of the insertion part 110. Bending movement is the movement that changes the angle of the front end 130 by bending the bending part. Bending movement includes bending movements in two orthogonal directions, which can be controlled independently. One of the two orthogonal directions is called the vertical direction, and the other is called the horizontal direction. Rolling rotation is the rotation of the insertion part 110 about its axis.

[0062] in addition, Figure 8 An example is shown where a balloon 720 is mounted at the front end of a cannula 710 and an endoscope protrudes from the front end of the cannula 710. However, the cannula 710 and balloon 720 can be configured such that the portion forward of the base of the bend can move freely. For example, a flexible tube with constant stiffness could extend forward of a cannula with variable stiffness, with the balloon 720 mounted at its boundary. In this case, a portion of the base side of the bend is covered by the flexible tube, but this does not impede its movement.

[0063] 3. Detailed structural example of a medical system

[0064] Figure 9 A detailed structural example of the medical system 10 is shown. The medical system 10 is a system for observing or treating the body of a patient lying on an operating table T. The medical system 10 includes an endoscope 100, a control device 600, an operating device 300, a treatment instrument 400, a forward / backward drive device 800, and a display device 900. The control device 600 includes a drive control device 200 and an image control device 500.

[0065] Endoscope 100 is a device inserted into a patient's lumen to observe the affected area. In this embodiment, the side inserted into the patient's lumen is referred to as the "front end side," and the side assembled with the control device 600 is referred to as the "base end side." Endoscope 100 includes an insertion portion 110, a connecting portion 125, an external flexible portion 145, and connectors 201 and 202. The insertion portion 110, the connecting portion 125, the external flexible portion 145, and the connectors 201 and 202 are sequentially connected from the front end side. The insertion portion 110 is the part inserted into the patient's lumen and is configured to be flexible and elongated. The insertion portion 110 includes a curved portion 102, an external flexible portion connecting the base end of the curved portion 102 to the connecting portion 125, and a front end portion 130 provided at the front end of the curved portion 102. An internal path 101 is provided inside the insertion part 110, the connecting part 125, and the external flexible part 145, and a bending part 102 is connected to the bending part 102 through a bending line of the internal path 101. The drive control device 200 drives the line via the connector 201, thereby causing the bending part 102 to bend. Furthermore, the lifting platform line, which is connected to the lifting platform provided at the front end 130, is connected to the connector 201 through the internal path 101. By driving the lifting platform line through the drive control device 200, the lifting angle of the treatment instrument 400 protruding from the side of the front end 130 changes. A camera, an illumination lens, and an opening for the treatment instrument channel are provided on the side of the front end 130. An image signal line connecting the camera and the connector 202 is provided in the internal path 101, and an image signal is transmitted from the camera to the image control device 500 via this image signal line. The image control device 500 displays the endoscopic image generated based on the image signal on the display device 900.

[0066] The connecting portion 125 is provided with an insertion port 190 for a treatment device and a rolling operation portion 121. A treatment device channel is provided in the internal path 101, with one end opening at the front end portion 130 and the other end opening at the insertion port 190. An extension tube 192 extending from the insertion port 190 to the operating device 300 is connected to the insertion port 190. The treatment device 400 is inserted through the opening on the operating device 300 side of the extension tube 192 and protrudes through the insertion port 190 and the treatment device channel to the opening at the front end portion 130. Alternatively, the extension tube 192 can be omitted, and the treatment device 400 can be inserted directly through the insertion port 190. The rolling operation portion 121 is mounted on the connecting portion 125 such that it can rotate around the axis of the insertion portion 110. By rotating the rolling operation portion 121, the insertion portion 110 is rolled. Furthermore, as described later, the rolling operation portion 121 can also be electrically driven.

[0067] The forward / backward drive device 800 is a drive device that electrically drives the insertion portion 110 forward and backward. The external flexible portion 140 is detachable from the forward / backward drive device 800. When the external flexible portion 140 is attached to the forward / backward drive device 800, the forward / backward drive device 800 causes the external flexible portion 140 to slide along the axial direction, thereby causing the insertion portion 110 to move forward and backward. Furthermore, although... Figure 9 The example shown is that the external flexible part 140 and the forward / backward drive device 800 can be attached and detached, but it is not limited to this. It can also be configured such that the connecting part 125 and the forward / backward drive device 800 can be attached and detached.

[0068] The operating device 300 is detachably connected to the drive control device 200 via an operating cable 301. The operating device 300 can also communicate wirelessly with the drive control device 200 without a wired connection. When the surgeon operates the operating device 300, the input signal is transmitted to the drive control device 200 via the operating cable 301. Based on the input signal, the drive control device 200 electrically drives the endoscope 100, causing endoscopic movements corresponding to the input. The operating device 300 has at least five input channels corresponding to the forward and backward movement, two-way bending and rolling rotation of the endoscope 100, and the lifting of the stage. Alternatively, these input channels can be omitted if any of the movements are not electrically powered. Each input channel may consist of, for example, a dial, joystick, crosshair, button, switch, or touch panel.

[0069] The drive control device 200 electrically drives the endoscope 100 by driving a built-in motor based on the operation input to the operating device 300. Alternatively, if the motor is external to the drive control device 200, the drive control device 200 controls the electric drive by sending a control signal to the external motor based on the operation input to the operating device 300. Furthermore, the drive control device 200 can also drive a built-in pump or the like to perform air delivery and suction on the endoscope 100 based on the operation input to the operating device 300. Air delivery and suction are performed via an air delivery and suction tube provided in the internal path 101. One end of the air delivery and suction tube opens at the front end 130 of the endoscope 100, and the other end is connected to the drive control device 200 via a connector 201. Alternatively, the treatment instrument channel may extend to the connector 201, and this treatment instrument channel may also serve as the air delivery and suction tube.

[0070] Figure 10 A detailed structural example of the drive control device 200 is shown. The drive control device 200 includes an image acquisition unit 270, a storage unit 280, a drive controller 260, an operation receiving unit 220, a line drive unit 250, an air delivery / suction drive unit 230, a communication unit 240, and an adapter 210.

[0071] The adapter 210 has an adapter 211 for the operating device that can be detachably connected to the operating cable 301, and an adapter 212 for the endoscope that can be detachably connected to the connector 201 of the endoscope 100.

[0072] The wire drive unit 250 drives the bending action of the bending section 102 of the endoscope 100 or the lifting stage of the treatment device 400 based on control signals from the drive controller 260. The wire drive unit 250 includes a bending action motor unit for driving the bending section 102 of the endoscope 100 and a lifting stage motor unit for driving the lifting stage. The endoscope adapter 212 has a bending action coupling mechanism for connecting to the bending wire on the endoscope 100 side. The coupling mechanism is driven by the bending action motor unit, thereby transmitting its driving force to the bending wire on the endoscope 100 side. Furthermore, the endoscope adapter 212 has a lifting stage coupling mechanism for connecting to the lifting stage wire on the endoscope 100 side. The coupling mechanism is driven by the lifting stage motor unit, thereby transmitting its driving force to the lifting stage wire on the endoscope 100 side.

[0073] The air supply and suction drive unit 230 drives the air supply and suction of the endoscope 100 based on control signals from the drive controller 260. The air supply and suction drive unit 230 is connected to the air supply and suction tube of the endoscope 100 via the endoscope adapter 212. The air supply and suction drive unit 230 includes a pump or the like to supply air to the air supply and suction tube or to draw air from the air supply and suction tube 172.

[0074] The communication unit 240 communicates with a drive device located outside the drive control device 200. The communication can be either wireless or wired communication. The external drive device may be a forward / backward drive device 800, a rolling drive device for rolling rotation, a sleeve drive device for changing the hardness of the sleeve 710, or a balloon drive device for changing the diameter of the balloon 720, etc.

[0075] The drive controller 260 controls the forward and backward movement, bending motion, and rolling rotation of the endoscope 100, the lifting angle of the treatment device 400 based on the lifting platform, and the air delivery and suction based on the endoscope 100. Furthermore, the drive controller 260 performs these controls when the stiffness control of the cannula 710 or the diameter control of the balloon 720 is electrified. The drive controller 260 is, for example, a processor such as a CPU (Central Processing Unit), GPU (Graphics Processing Unit), or DSP (Digital Signal Processor). For example, the storage unit 280 stores a computer-readable program, which is executed by the processor to perform the functions of the drive controller 260. However, the hardware of the drive controller 260 is not limited to the above-mentioned hardware and can be constructed from circuits of various structures.

[0076] The electric control performed by the drive controller 260 includes a manual mode where the surgeon manually operates the electric drive of the endoscope 100, etc., and an automatic control mode where the electric drive of the endoscope 100, etc., is automatically controlled based on the endoscope image. In the automatic mode of this embodiment, the electric drive of the endoscope 100, etc., is automatically controlled. Figure 2 The alignment steps described herein are automated. Furthermore, in automatic mode, at least one of the forward / reverse movement, bending motion, and rolling rotation of the endoscope 100 can be automated. That is, the lifting angle of the lifting stage-based treatment device 400, the stiffness control of the cannula 710, the diameter control of the balloon 720, the air delivery and suction of the endoscope 100, or a portion of the forward / reverse movement, bending motion, or rolling rotation of the endoscope 100 can also be manually operated.

[0077] First, the manual mode will be explained. The operation receiving unit 220 receives operation input signals from the operation device 300 via the operation cable 301 mounted on the operation device adapter 221. When the operation device 300 and the drive control device 200 communicate wirelessly, the operation receiving unit 220 may also be a wireless communication circuit.

[0078] The drive controller 260 controls the electric drive based on the operation input signal from the operation receiver 220. Specifically, during a bending operation, the drive controller 260 outputs a control signal indicating the bending direction or bending angle to the line drive unit 250, which drives the bending line so that the bending section 102 bends according to the bending direction or bending angle. Furthermore, during a forward / backward operation, the drive controller 260 sends a control signal indicating the forward / backward direction or forward / backward movement amount to the forward / backward drive device via the communication unit 240. The forward / backward drive device moves the external flexible section 140 forward and backward, causing the endoscope 100 to move forward and backward according to the forward / backward direction or forward / backward movement amount. Furthermore, during a rolling / rotating operation, the drive controller 260 sends a control signal indicating the rolling / rotating direction or rolling / rotating angle to the rolling drive device via the communication unit 240. The rolling drive device causes the insertion section 110 to roll / rotate, causing the endoscope 100 to roll / rotate according to the rolling / rotating direction or rolling / rotating angle. Other electric drives are controlled in the same way.

[0079] Next, the automatic control mode will be explained. The image acquisition unit 270 is a communication interface that receives image data of endoscopic images from the image control device 500 via wired or wireless communication. The image acquisition unit 270 outputs the received endoscopic image data to the drive controller 260.

[0080] The storage unit 280 stores a reference image of the nipple, which serves as a positioning reference relative to the nipple. The reference image is an image of the nipple taken in a manner that captures the opening of the luminal tissue at a predetermined position. The predetermined position is, for example, the center of the image, corresponding to the aforementioned "pre-registered position." The storage unit 280 may also store images related to... Figure 3 or Figure 4 The diagram shows multiple reference images corresponding to various configurations. The storage unit 280 is a storage device such as a semiconductor memory or a magnetic storage device. The semiconductor memory can be a volatile memory such as SRAM or DRAM, or a non-volatile memory such as EEPROM.

[0081] The drive controller 260 controls the endoscope movement or the diameter of the balloon 720 in a manner that makes the position of the nipple captured in the endoscopic image close to the position of the nipple captured in the reference image. For example, the drive controller 260 extracts image features of the nipple from the endoscopic image and the reference image, and determines the position of the nipple captured in the endoscopic image based on the comparison result of these image features. More preferably, the drive controller 260 controls the endoscope movement or the diameter of the balloon 720 in a manner that makes the position of the opening of the lumen tissue in the endoscopic image close to a predetermined position. For example, the storage unit 280 pre-stores a reference image in which the opening of the lumen tissue is located at a predetermined position. The drive controller 260 aligns the opening of the lumen tissue by aligning the nipple. Even if the opening of the lumen tissue is closed and cannot be identified from the image, by aligning the nipple, it is aligned to a state in which the opening exists in the predetermined position within the image. Alternatively, the storage unit 280 may store image features extracted from the reference image instead of the reference image.

[0082] Alternatively, the drive controller 260 can control the endoscopic movement or the lifting angle of the device 400 based on the endoscopic image, such that the tip of the device 400 faces the opening of the luminal tissue. Or, the drive controller 260 can also control the endoscopic movement or the lifting angle of the device 400 based on the endoscopic image, such that the tip of the device 400 faces the direction of travel of the bile duct. For example, information about the direction of travel of the bile duct can be provided to the reference image, and based on this information, the device 400 can be controlled to face the direction of travel of the bile duct. Here, the direction of travel is a two-dimensional direction on the endoscopic image. That is, on the endoscopic image, the endoscopic movement or the lifting angle of the device 400 is controlled so that the direction of travel of the bile duct is approximately parallel to the direction in which the device 400 faces. However, if three-dimensional information about the direction of travel of the bile duct is obtained through CT images or the like, the direction of travel of the bile duct can also be controlled so that the direction of travel of the bile duct is approximately parallel to the direction in which the device 400 faces in three dimensions.

[0083] Alternatively, the drive controller 260 may also perform control based on the results of image recognition processing using machine learning, so that the position of the opening of the lumen in the endoscopic image becomes the pre-registered position. Specifically, the storage unit 280 stores the learned model, and the drive controller 260 performs processing based on the learned model to perform the aforementioned positioning control. For example, the learned model is learned by inputting an endoscopic image and outputting information such as endoscopic movements, such as the position of the opening of the lumen in the endoscopic image becoming a predetermined position. Alternatively, the learned model may be learned by inputting an endoscopic image and outputting information about the direction of bile duct travel based on the endoscopic image. The drive controller 260 estimates information such as endoscopic movements based on the endoscopic image through processing based on the learned model, and outputs control signals such as those controlling endoscopic movements or the lifting angle of the treatment instrument to the line drive unit 250, etc., based on this information. In this example, the storage unit 280 may not store a reference image or image feature quantities, and the "pre-registered position" of the opening of the lumen is reflected in the learned model through learning.

[0084] As described above, during bile duct cannulation, it is difficult to determine the insertion position and direction based on the endoscopic image of the papilla. Regarding this, according to this embodiment, in the second positioning after the first positioning using the cannula 710, the electric drive for endoscopic movement is automatically controlled based on the endoscopic image, thereby automatically positioning the tip 130 of the endoscope 100 relative to the papilla. This eliminates the need for fine-tuning through non-electric manual operation, enabling ERCP surgery to be performed with the assistance of less experienced surgeons. Furthermore, through automatic control, the position of the papilla in the endoscopic image is automatically controlled to a pre-registered position, making it easier for the surgeon to determine the insertion position and direction of the cannula based on the endoscopic image. For example, since automatic control is performed with the opening of the ductal tissue at a predetermined position in the image, the surgeon can easily determine the position of the opening even if the state of the opening cannot be visually confirmed from the image.

[0085] 4. Detailed structural examples of various parts of the medical system

[0086] Figure 11 An endoscope 100 including a bend 102 and its drive mechanism is schematically shown. The endoscope 100 includes the bend 102, a flexible portion 104, and a connector 201. Additionally, the flexible portion 104 corresponds to... Figure 9 The internal soft tissue and external soft tissue 145 described in the text are in... Figure 11 The diagram of the connecting part 125 is omitted.

[0087] The curved portion 102 and the flexible portion 104 are covered by an outer sheath 111. The inner surface of this outer sheath 111 is equivalent to... Figure 9 The internal path 101. The bending portion 102 includes a plurality of bending blocks 112 and a front end portion 130 connected to the front end of the bending blocks 112. The plurality of bending blocks 112 and the front end portion 130 are connected in series from the base end side to the front end side by rotatable connecting portions 114, forming a multi-joint structure. The connector 201 is provided with an endoscope-side connecting mechanism 162 that is connected to the connecting mechanism on the drive control device 200 side. By assembling the connector 201 to the drive control device 200, an electric drive can be used to perform bending operations. In addition, a bending line 160 is provided inside the outer sheath 111. One end of the bending line 160 is connected to the front end portion 130. The bending line 160 passes through the plurality of bending blocks 112 and through the flexible portion 104, folds back in the connecting mechanism 162 and passes through the flexible portion 104 again and through the plurality of bending blocks 112. The other end of the bending line 160 is connected to the front end portion 130. The driving force from the line drive unit 250 is transmitted to the curved line 160 as the traction force of the curved line 160 via the connecting mechanism 162.

[0088] When the upper line on the drawing is pulled, as shown by the solid arrow in B2, the lower line is pressed, thereby causing the multi-joint of the bending block 112 to bend upwards on the drawing. Consequently, the bending portion 102 bends upwards on the drawing, as shown by the solid arrow in A2. Similarly, when the lower line on the drawing is pulled, as shown by the dashed arrow in B2, the bending portion 102 bends downwards on the drawing, as shown by the dashed arrow in A2. Furthermore, as... Figure 8 As described above, the bending portion 102 can be bent independently in two orthogonal directions. Figure 11 The diagram shows a bending mechanism in one direction, but in reality, it has two sets of bending lines, each of which is independently pulled by the connecting mechanism 162, thereby enabling bending to be performed independently in two directions.

[0089] Furthermore, the mechanism for electrifying the bending is not limited to the aforementioned mechanism. For example, a motor unit may be provided instead of the connecting mechanism 162. Specifically, the drive control device 200 may send a control signal to the motor unit via the connector 201, and the motor unit may drive the bending action by pulling or relaxing the bending line 160 based on the control signal.

[0090] Figure 12 A detailed structural example of the forward / reverse drive device 800 is shown. The forward / reverse drive device 800 includes a motor unit 816, a base 818, and a slider 819.

[0091] As shown in the upper and middle views, an accessory 802, detachable from the motor unit 816, is provided on the external flexible part 140 of the endoscope 100. As shown in the middle view, by assembling the accessory 802 to the motor unit 816, it can be electrically driven to move forward and backward. As shown in the lower view, a slider 819 supports the motor unit 816 in a manner that allows linear movement relative to the base 818. This slider 819 is fixed to... Figure 9 The operating table T. As shown in B1, the drive control device 200 sends a forward or backward control signal to the motor unit 816 via wireless communication. Based on this control signal, the motor unit 816 and the accessory 802 move linearly on the slider 819. Thus, [the following is achieved / implemented]... Figure 8 The endoscope 100 shown in A1 moves forward and backward. Additionally, the drive control device 200 and the motor unit 816 can also be wired together.

[0092] Figure 13 A perspective view of a connecting portion 125 including a rolling drive device 850 is shown. The connecting portion 125 includes a connecting portion body 124 and a rolling drive device 850.

[0093] An insertion port 190 for the treatment device is provided in the connecting body 124 and connects to the treatment device channel inside the connecting body 124. The connecting body 124 is cylindrical, and a cylindrical component coaxial with the cylinder is rotatably disposed inside the connecting body 124. The base end of the inner soft part 119 is fixed to the outside of the cylindrical component, and this base end becomes the rolling operation part 121. Thus, the inner soft part 119 and the cylindrical component can rotate relative to the connecting body 124 about the axis of the inner soft part 119. The rolling drive device 850 is a motor unit disposed inside the connecting body 124. As shown in B3, the drive control device 200 sends a rolling rotation control signal to the rolling drive device 850 via wireless communication. Based on the control signal, the rolling drive device 850 rotates the base end of the inner soft part 119 relative to the connecting body 124, thereby causing the inner soft part 119 to roll. Thus, Figure 8 The endoscope 100 shown in A3 is rotated. Alternatively, the rotation drive 850 may include a clutch mechanism to switch between non-electric and electric rotation. Furthermore, the drive control device 200 and the rotation drive 850 may be wiredly connected via a signal line through the internal path 101.

[0094] Figure 14This diagram shows a detailed structural example of the front end portion 130 of an endoscope containing a lifting platform for treatment instruments. The upper figure shows an external view of the front end portion 130. An opening 131 for the treatment instrument channel, a camera 132, and an illumination lens 133 are provided on the side of the front end portion 130. As shown in the lower figure, the direction parallel to the axial direction of the front end portion 130 is defined as the z-direction, the direction parallel to the line of sight of the camera 132 is defined as the y-direction, and the direction orthogonal to both the z-direction and the y-direction is defined as the x-direction. The lower figure shows a cross-sectional view of the front end portion 130 in a plane parallel to the yz plane and passing through the opening 131 of the treatment instrument channel.

[0095] The front end portion 130 includes a lifting platform 134 and a lifting platform cable 135. The lifting platform 134 is capable of swinging about an axis parallel to the x-direction. One end of the lifting platform cable 135 is connected to the lifting platform 134, and the other end is connected to the drive control device 200 via a connector 201. As shown in B4, the lifting platform 134 is swung by pushing and pulling the lifting platform cable 135 through the cable drive unit 250 of the drive control device 200, and as shown in A4, the lifting angle of the treatment device 400 changes. The lifting angle is the angle of the treatment device 400 protruding from the opening 131, and can be defined, for example, by the angle between the treatment device 400 protruding from the opening 131 and the z-direction.

[0096] Figure 15 A detailed structural example of the treatment device 400 is shown. Here, as an example of the treatment device 400, an intubation cannula capable of being bent at its tip is illustrated. The treatment device 400 includes an insertion portion 402 of an elongated strip extending along the axial direction, a bending action portion 403 capable of bending, a first operation portion 404 for operating the bending action portion 403, and a second operation portion 405 for injecting contrast agent or inserting a guidewire.

[0097] The insertion part 402 has a tube 421, and a bending action part 403 is connected to the front end of the tube 421. Additionally, in Figure 15 In the enlarged view, the front end of tube 421 is shown. Tube 421 is also referred to as a sheath. The surgeon holds tube 421 of the instrument 400 inserted in the instrument channel of the endoscope 100 and moves the instrument 400 forward and backward by pushing and pulling tube 421.

[0098] A connector 422 is connected to the base end of tube 421. A first operating part 404 and a second operating part 405 are connected to connector 422. The first operating part 404 includes a connecting tube 442 connected to connector 422 at one end, a first operating body 441 connected to the other end of connecting tube 442, a handle 444 fixed to the base end of the first operating body 441, and a slider 443 configured to move forward and backward along the axial direction of the first operating body 441. Inside tube 421, connector 422, connecting tube 442, and the first operating body 441, a wire is provided to connect the bending action part 403 to the slider 443. The surgeon holds the handle 444 and pulls the slider 443 to pull the wire, causing the bending action part 403 to bend.

[0099] The second operating unit 405 includes a connecting tube 452 connected to a connector 422 at one end, a second operating body 451 connected to the other end of the connecting tube 452, a first opening 453 opening along the axis of the connecting tube 452 at the base end of the second operating body, a second opening 454 opening on the outer surface of the second operating body 451, and a hook 455 provided on the second operating body 451. The hook 455 is elastic and formed in a generally C-shape for securing the treatment device 400 to the endoscope 100, etc. The first opening 453 and the second opening 454 are connected to the tube 421 via the second operating body 451, the connecting tube 452, and the connector 422. By injecting contrast agent or inserting a guidewire through the first opening 453 or the second opening 454, contrast agent can be injected into the body or a guidewire can be inserted from the tip of the treatment device 400.

[0100] Furthermore, while an example of manually operating the treatment device 400 in a non-electric manner has been described here, the operation of the treatment device 400 can also be electrically powered. For example, the advance, retreat, tip bending, or rolling rotation of the treatment device 400 can be electrically powered using the same method as the powering of the endoscope 100.

[0101] Figure 16 An example of the structure of the drive system 701 for the bushing 710 is shown. As shown in the figure above, the drive system 701 includes the bushing 710 and the bushing drive device 715.

[0102] The sleeve 710 is configured to freely change its hardness; its shape can be freely changed when softened, and it can maintain its shape when hardened. Here, an example using a shape memory polymer whose hardness changes with temperature is shown, but the method of making the hardness variable is not limited to this. For example, a structure using a multi-joint structure that connects multiple block components in series can also be used to make the hardness variable. As shown in the figure above, the sleeve 710 includes an insertion part 705s and an operating part 705t. A connecting part 705a is provided in the operating part 705t, and a sleeve drive device 715 is connected via the connecting part 705a.

[0103] The figure below shows a cross-sectional view of the insertion portion 705s in a section parallel to the insertion direction S. Additionally, two tube walls are present in the cross-section, but only one is shown. The other wall has the same structure. The insertion portion 705s includes a tube component 705p and a shape memory polymer tube 705i.

[0104] The shape memory polymer tube 705i hardens when supplied with a fluid at a temperature lower than its glass transition temperature and softens when supplied with a fluid at a temperature higher than its glass transition temperature. The shape memory polymer tube 705i is covered by a tube component 705p. A supply path 705k and a recovery path 705b connected to the front end of the supply path 705k are provided between the inner walls of the shape memory polymer tube 705i and the tube component 705p. The sleeve drive device 715 is a fluid supply device including a pump, which supplies fluid at a set temperature to the supply path 705k and recovers it from the recovery path 705b. The drive control device 200 sends a control signal controlling the hardness of the sleeve 710 to the sleeve drive device 715 via wireless communication. The sleeve drive device 715 sets the fluid temperature based on this control signal, thereby changing the hardness of the sleeve 710. Furthermore, in Figure 16 In the bushing 710, the supply path 705k is located on the inner side and the recovery path 705b is located on the outer side, but alternatively, the supply path 705k can be located on the outer side and the recovery path 705b can be located on the inner side. Furthermore, the drive control device 200 and the bushing drive device 715 can also be wired together.

[0105] Furthermore, the mechanism for electrically changing the hardness of the sleeve is not limited to the mechanism described above. For example, multiple connecting parts can be connected in series, and the change in the tightness of the connecting parts can be electrically driven. Specifically, the sleeve can be softened by making adjacent connecting parts in a fan-like state, and hardened by making adjacent connecting parts in contact to make them difficult to fan.

[0106] Figure 17 This illustrates a structural example of the drive system 721 for the balloon 720. The drive system 721 includes the balloon 720, the connecting tube 722, and the balloon drive device 725.

[0107] The balloon 720, composed of a telescopic component, is located near the front end of the cannula 710. The balloon 720 has an annular shape arranged to surround the outer periphery of the front end of the cannula 710. A balloon vent 723 is provided at the base end of the cannula 710, and the balloon vent 723 is connected to the balloon 720 via a tubing (not shown). Furthermore, the balloon vent 723 is connected to the balloon drive device 725 via a connecting tube 722. The balloon drive device 725 includes a pump or the like, which inflates the balloon 720 by supplying air to it via the connecting tube 722, or contracts it by drawing air from it. The drive control device 200 sends a control signal to the balloon drive device 725 via wireless communication to control the diameter of the balloon 720. Based on this control signal, the balloon drive device 725 inflates or contracts the balloon 720, thereby controlling the diameter of the balloon 720. In addition, the drive control device 200 and the balloon drive device 725 can also be connected by wire.

[0108] 5. Variations

[0109] Several variations are shown below. These variations can also be combined with any of the embodiments described above.

[0110] Figure 18 A first modification of the retaining component is shown. In this modification, a balloon 730 is provided at the anterior endpiece 130 of the endoscope 100. The balloon 730 can change its diameter by inflating and contracting. The diameter of the balloon 730 can be operated non-electrically, or it can be electrically controlled using the same method as the balloon 720. Alternatively, the electric control can be manual or based on automatic control using an endoscopic image. By fixing the anterior endpiece 130 of the endoscope 100 to the duodenum with the balloon 730, the positional relationship between the anterior endpiece 130 and the nipple can be stabilized during cannulation. Furthermore, as shown in B5, by adjusting the diameter of the balloon 730, the distance between the anterior endpiece 130 and the nipple can be adjusted without changing the angle of the anterior endpiece 130.

[0111] Figure 19 A second variation of the retaining component is shown. In this variation, a suction cap 740 is provided at the front end 130 of the endoscope 100. A suction port 741 is provided on the side of the suction cap 740 in the same direction as the line of sight of a camera or similar device. Air is drawn from the suction port 741, pulling the duodenal wall towards the front end 130. This allows adjustment of the distance between the front end 130 and the nipple. The suction can be either non-electric or electric. Alternatively, the electric operation can be manual or automatic control based on the endoscopic image.

[0112] As a third variation of the retaining component, the balloon 720 or 730 can be replaced with a basket. The basket, composed of multiple bundled lines, expands or closes to achieve the same function as the balloon. As a fourth variation of the retaining component, a gripper or retractor can be provided at the anterior end 130 of the endoscope 100. The gripper or retractor grasps the duodenal wall and pushes or pulls against it. This retains the anterior end 130 in the duodenum and adjusts the distance between the anterior end 130 and the papilla.

[0113] Next, we will explain a variation where endoscopes of different lengths are used based on individual patient differences. The structure of organs varies from patient to patient; therefore, it is difficult to use the same endoscope, cannula, or accessories for all patients. As an example of individual differences in organ structure, Figure 20 The diagram illustrates the organ structure of a patient who underwent gastric bypass surgery based on the Roux-en-Y method. In the Roux-en-Y method, the stomach is separated into a pouch connected to the esophagus and a pouch connected to the duodenum. The ileum is connected to the pouch connected to the esophagus, and the duodenum is connected midway through the ileum. The insertion distance from the mouth to the papilla differs between patients who underwent this procedure and those who did not.

[0114] Therefore, the endoscope or cannula inserted into the body can be designed for semi-reusability, single use, or extension via attachments, allowing for selection based on individual patient needs. For example, reusable components may include control devices, motor units, or air delivery / suction devices. Semi-reusable, single-use, or attachable components may include endoscopes, treatment devices, or cannulas. Endoscopes, treatment devices, or cannulas of varying lengths or balloon placements can be prepared.

[0115] Figure 21 A modified example of an operating device for manually operating an electric endoscope is shown. Figure 9 The image shows a handheld operating device 300, but it can also be used as... Figure 21 The operating device 320 is shown as a console-style device. The operating device 320 includes a monitor 325 displaying an endoscopic image, a right-hand operated operating unit 321, a left-hand operated operating unit 322, and one or more foot switches 323. The operating units 321 and 322 can, for example, perform up, down, left, and right directional inputs. For example, the up, down, left, and right directional operations of the operating unit 321 can be assigned to the bending operation of the endoscope 100 in all directions; the up, down, left, and right directional operations of the operating unit 322 can be assigned to the forward, backward, and rolling / rotating operations of the endoscope 100; and the foot switches can be assigned to the up and down operation of the lifting platform of the treatment instrument 400. However, the allocation of functions is not limited to this.

[0116] As explained above, the information obtained during ERCP is only an endoscopic image of the papilla. Due to individual differences in the morphology of the papilla and ductal tissues, it is difficult to determine the insertion position and direction of the cannula solely based on the endoscopic image. To more accurately estimate the location of the opening and the direction of bile duct travel, alignment is desired to capture the papilla at a predetermined position in the image. However, difficulties arise in adjusting the position of the endoscope's tip due to the difficulty in transmitting manipulations performed at the base of the insertion site to the tip, or due to vibrations of the endoscope's tip relative to the papilla. Furthermore, while U.S. Patent Application Publication No. 2017 / 0086929 discloses examples of applying robotic catheter systems to ERCP, it does not disclose or suggest solutions to the aforementioned problems.

[0117] Therefore, the medical system 10 of this embodiment includes an endoscope 100 and a control device 600. The endoscope 100 electrically drives the endoscope movement to capture endoscopic images. The endoscope movement is at least one of forward and backward movement of the insertion part 110, adjustment of the bending angle of the bending portion 102 of the insertion part 110, and rolling rotation of the insertion part 110. The control device 600 controls the electrically driven endoscope movement. After performing a first positioning of the insertion part 110 relative to the papilla of the duodenum, the control device 600 controls the electrically driven endoscope movement based on the endoscopic images, thereby performing a second positioning of the front end portion 130 of the insertion part 110 relative to the papilla.

[0118] According to this embodiment, the insertion portion 110 can be positioned relative to the nipple through the first positioning. Furthermore, by performing a second positioning based on the positional relationship between the insertion portion 110 and the nipple after this positioning, the movement of the endoscope near the tip can be freely controlled by electric drive. In addition, during the second positioning, the electric drive for endoscope movement, etc., is automatically controlled based on the endoscopic image, thereby automatically positioning the tip 130 of the insertion portion 110 relative to the nipple. Therefore, fine-tuning based on non-electric manual operation is unnecessary, assisting in catheterization procedures for less experienced surgeons.

[0119] In addition, through "2. Surgical Procedure and Medical System of This Embodiment" Figure 8 The procedure for endoscopy was explained. Furthermore, the section "1. About ERCP" provides further details. Figure 1 The duodenal papillae will be described. Furthermore, the surgical procedure and medical system of this embodiment will be explained in section 2. Figure 6 The first and second positioning were explained.

[0120] Alternatively, in this embodiment, the medical system 10 may also include a retaining member for first positioning of the insertion portion 110 by retaining the insertion portion 110.

[0121] According to this embodiment, by holding the insertion portion 110 by the holding member in the first positioning, the electric drive for endoscope movement can be easily transmitted from the base end side to the front end side of the insertion portion 110 in the second positioning, and the insertion portion 110 is held so that the front end portion 130 of the endoscope 100 does not vibrate relative to the nipple.

[0122] Additionally, the retaining component corresponds to... Figure 5 , Figure 8 , Figure 16 or Figure 17 The cannula 710, balloon 720, or both, as described in the document. Alternatively, the retaining component may also be... Figure 18 The balloon 730 described in the text or Figure 19 The description includes suction cap 740, etc.

[0123] In addition, in this embodiment, the control device 600 can also perform the following second positioning: by moving the endoscope on the front end 130 of the insertion part 110 closer to the front end of the retaining member of the insertion part 110, the position of the insertion part 110 is finely adjusted.

[0124] According to this embodiment, in the first positioning, the position of the tip 130 relative to the nipple is coarsely adjusted and the insertion portion 110 is held by the holding member. This allows for accurate electrically driven endoscope movements without vibration of the tip 130 relative to the nipple. Therefore, in the second positioning, the position of the tip 130 of the endoscope 100 relative to the nipple can be finely adjusted by endoscope movements that are closer to the front end than the holding member.

[0125] Furthermore, "nearer than the retaining member" means that the portion of the retaining member that restricts endoscopic movement, such as the hardened or fixed part, is closer to the front end. This is explained in "2. Surgical Procedure and Medical System of this Embodiment". Figure 8 Explanations were provided for these items.

[0126] In addition, in this embodiment, the control device 600 may also perform the following second positioning: control the electrically driven endoscope movement so that the nipple is captured at a pre-registered location on the endoscope image.

[0127] According to this embodiment, an endoscopic image of the nipple located at a pre-registered position is obtained. This allows the nipple to be captured at a common location easily compared to past cases or experience, enabling the surgeon to easily determine the location of the opening of the luminal tissue and the direction of bile duct travel by observing the endoscopic image. Furthermore, since alignment is performed electrically, an endoscopic image of the nipple at the pre-registered position can be obtained without requiring delicate manipulation by the surgeon. Additionally, the control device 600 can also perform a second positioning: controlling the electrically driven endoscope movement to capture the opening of the luminal tissue at a pre-registered position on the endoscopic image. By observing this endoscopic image, the surgeon can determine the location of the opening of the luminal tissue. For example, even if the opening of the luminal tissue is closed in the nipple image and difficult to visually confirm, the surgeon can estimate that the opening of the luminal tissue exists at a predetermined location within the endoscopic image.

[0128] In addition, through "2. Surgical Procedure and Medical System of This Embodiment" Figure 6 Or "3. Detailed structural example of a medical system" Figure 10 The locations that were registered in advance were explained.

[0129] Alternatively, in this embodiment, the papilla may also include an opening of tubular tissue. In the duodenal papilla, the opening of the tubular tissue may be the opening of a common duct where the bile duct and pancreatic duct merge, or the opening of the bile duct itself.

[0130] Within the duodenal papillae, there are various individual differences in the shape of the papillae and the structure of the luminal tissue. According to this embodiment, the anterior endpiece 130 of the endoscope 100 can be positioned using first and second positioning techniques for the duodenal papillae, which exhibit various individual differences. Furthermore, by automating the positioning of the papillae, the cannulation procedure in ERCP can be assisted.

[0131] In addition, the papillae of the duodenum, the openings of the luminal tissues, and their relationships are explained in sections such as “1. About ERCP”.

[0132] In this embodiment, the medical system 10 includes a treatment device 400. The treatment device 400 is inserted into the insertion port 190 of the endoscope 100, and is raised inside the front end 130, protruding from the side of the front end 130. The control device 600 performs a second positioning by controlling at least one of the endoscope movement and the raising angle of the treatment device 400, such that the treatment device 400 is oriented toward the bile duct's direction of travel estimated based on the endoscopic image of the nipple.

[0133] According to this embodiment, by means of the second positioning, at least one of the endoscopic movement and the lifting angle of the instrument 400 is automatically controlled, so that the instrument 400 is oriented toward the direction of travel of the bile duct. As a result, the estimation of the direction of travel of the bile duct, which is difficult to perform due to individual differences in the nipple, is automated, and therefore, it is possible to perform ERCP procedures assisted by less experienced surgeons.

[0134] In addition, through "4. Detailed structural examples of various parts of the medical system" Figure 14 The lifting of the treatment device 400 was explained. Furthermore, for example, through "3. Detailed Structural Example of a Medical System"... Figure 10 The control of the movement of the treatment device 400 toward the bile duct was explained.

[0135] Alternatively, in this embodiment, the retaining member may also include a first retaining member that retains the insertion portion 110 in an organ where a nipple is present.

[0136] Specifically, the first retaining member can also be a member that retains the insertion part 110 in the duodenum when the anterior end 130 of the endoscope 100 reaches the papilla of the duodenum.

[0137] In addition, the first retaining member may also be located at a position closer to the base end of the insertion portion 110 than the base end of the bent portion 102.

[0138] Alternatively, the first retaining component may be a balloon 720 that expands to connect with the organ, thereby retaining the insertion portion 110 in the balloon 720 of the organ.

[0139] The insertion port 190 is held in the organ by these first retaining components, thereby performing a first positioning of the insertion portion 110 relative to the nipple present in the organ. In the subsequent second positioning, the movement of the endoscope near the tip can be freely controlled by electric drive.

[0140] Additionally, the first retaining component corresponds to... Figure 5 , Figure 8 or Figure 17 The balloon 720 described in the document. Alternatively, the first retaining component may also be... Figure 18 The balloon 730 described in the text or in Figure 19 The description includes suction cap 740, etc.

[0141] Alternatively, in this embodiment, the retaining member may also include a second retaining member that retains the path of the insertion portion 110 up to the first retaining member that holds the insertion portion in the organ.

[0142] In addition, the second retaining member may also be a sleeve 710 with variable hardness that retains the path of the insertion part 110 by hardening.

[0143] The insertion port 190 is held in the organ by these second retaining components, thereby performing a first positioning of the insertion portion 110 relative to the opening of the lumen tissue present in the organ. In the subsequent second positioning, the endoscopic movement of the tip 130 can be freely controlled by electric drive.

[0144] Additionally, the second retaining component corresponds to... Figure 5 , Figure 8 , Figure 16 or Figure 17 The cannula 710 is described in section 4. (See "Detailed Structural Examples of Various Components of a Medical System"). Figure 16 The variable hardness of the sleeve 710 was explained.

[0145] Furthermore, in the medical system 10, the electric drive for the bending action of the endoscope 100 is not limited to the structure of this embodiment. For example, a structure in which an accessory equipped with an electric motor can be attached and detached relative to the bending operation knob of a non-electric endoscope may also be used. The drive control device 200 and the accessory are configured to communicate, and when a bending control signal is received from the drive control device 200, the accessory is driven to perform bending. In this case, manual control and automatic control can be switched by attaching and detaching the accessory. Alternatively, a structure in which a handle that controls the drive of the drive control device 200 can be attached and detached relative to a motor unit that acts as the drive control device 200 and is used for bending control may also be used. In this case, manual control and automatic control can be switched by attaching and detaching the handle.

[0146] This embodiment can also be implemented as an intubation method as follows. That is, the intubation method uses an endoscope 100. The endoscope 100 electrically drives endoscopic movements to capture endoscopic images. The endoscopic movements are at least one of forward and backward movement of the insertion portion 110, adjustment of the bending angle of the bending portion 102 of the insertion portion 110, and rolling rotation of the insertion portion 110. The intubation method includes the step of inserting the insertion portion 110 of the endoscope 100 into the body. The intubation method includes a first positioning step, in which the insertion portion 110 is positioned relative to the papilla of the duodenum. After the first positioning step, the intubation method includes a second positioning step, in which the electrically driven endoscopic movements are controlled according to the endoscopic images, thereby positioning the anterior portion 130 of the insertion portion 110 relative to the papilla. After the second positioning step, the intubation method includes the step of intubating from the papilla into the bile duct.

[0147] Alternatively, in this embodiment, the first positioning of the insertion part 110 may be performed by holding the holding member of the insertion part 110 during the first positioning step.

[0148] Alternatively, in this embodiment, during the second positioning step, the position of the front end portion 130 of the endoscope 100 can be finely adjusted by the endoscope movement of the endoscope on the front end side of the holding member of the holding insertion portion 110.

[0149] Alternatively, in this embodiment, during the second positioning step, the movement of the electrically driven endoscope can be controlled so that the nipple is captured at a pre-registered location on the endoscope image.

[0150] Alternatively, in this embodiment, the instrument 400 may be inserted into the insertion port 190 of the endoscope 100 and lifted inside the front end 130, protruding from the side of the front end 130. Alternatively, during the second positioning step, at least one of the endoscope movement and the lifting angle of the instrument 400 may be controlled, such that the instrument 400 is oriented toward the direction of travel of the bile duct, which is estimated based on an endoscopic image of the nipple.

[0151] Alternatively, this embodiment can also be implemented as a method of operating the medical system 10 as follows. That is, the method of operating the medical system 10 uses an endoscope 100. The endoscope 100 electrically drives the endoscope movement to capture endoscopic images. The endoscope movement is at least one of forward and backward movement of the insertion portion 110, adjustment of the bending angle of the bending portion 102 of the insertion portion 110, and rolling rotation of the insertion portion 110. The method of operating the medical system 10 includes a first positioning step, in which the insertion portion 110 is positioned relative to the papilla of the duodenum. After the first positioning step, the method of operating the medical system 10 includes a second positioning step, in which the electrically driven endoscope movement is controlled based on the endoscopic images, thereby positioning the front end portion 130 of the insertion portion 110 relative to the papilla. Furthermore, in the method of operating the medical system 10, the main body of each step is the medical system 10.

[0152] The embodiments and variations thereof applying this disclosure have been described above. However, this disclosure is not directly limited to each embodiment and variation thereof. During implementation, structural elements can be modified and specified without departing from the spirit of the disclosure. Furthermore, various disclosures can be formed by appropriately combining multiple structural elements disclosed in the above embodiments and variations. For example, several structural elements may be deleted from all structural elements described in each embodiment and variation. In addition, structural elements described in different embodiments and variations may be appropriately combined. Thus, various modifications and applications can be made without departing from the spirit of the disclosure. Furthermore, in the specification or drawings, a term described at least once with a different term that is more general or synonymous can be replaced with that different term anywhere in the specification or drawings.

Claims

1. A medical system, characterized in that, The medical system includes: An endoscope that captures endoscopic images; the endoscopic action of the endoscope is at least one of the following: forward and backward movement of the insertion part, adjustment of the bending angle of the bending part of the insertion part, and rolling rotation of the insertion part. A retaining member performs a first positioning of the insertion portion by retaining the position of the insertion portion relative to the papilla of the duodenum; as well as A control device that controls the electrically driven movement of the endoscope. After the retaining member has been positioned, the control device performs the following second positioning: controls the endoscope movement based on the electric drive according to the endoscope image, and adjusts the position of the front end of the insertion part relative to the retaining member based on the comparison result by comparing the position of the duodenal papilla in the endoscope image with the pre-registered position, so that the papilla is captured at the pre-registered position in the endoscope image.

2. The medical system according to claim 1, characterized in that, The nipple includes an opening of tubular tissue, which is either the opening of a common duct where the bile duct and pancreatic duct merge, or the opening of the bile duct itself.

3. The medical system according to claim 2, characterized in that, The medical system includes a treatment device that is inserted through a treatment device insertion port of the endoscope, is lifted inside the anterior end, and protrudes from the side of the anterior end. The control device performs the second positioning as described below: controlling at least one of the endoscope movement and the lifting angle of the treatment instrument, such that the treatment instrument is oriented toward the direction of travel of the bile duct, the direction of travel of the bile duct being estimated based on the endoscopic image of the nipple captured.

4. The medical system according to claim 1, characterized in that, The retaining member includes a first retaining member that retains the insertion portion in the organ where the nipple is located.

5. The medical system according to claim 4, characterized in that, The first retaining component is a component that retains the insertion portion in the duodenum when the anterior end of the endoscope reaches the nipple.

6. The medical system according to claim 4, characterized in that, The first retaining member is positioned closer to the base end of the insertion portion than the base end of the curved portion.

7. The medical system according to claim 4, characterized in that, The first retaining component is a balloon that inflates to connect with the organ, thereby retaining the insertion portion in the organ.

8. The medical system according to claim 4, characterized in that, The retaining member includes a second retaining member that retains the path of the insertion portion up to the first retaining member that holds the insertion portion in the organ.

9. The medical system according to claim 8, characterized in that, The second retaining component is a sleeve with variable hardness that retains the path of the insertion portion by hardening.

10. A storage medium, characterized in that, It stores a program for causing the control device of a medical system to perform the following processes, wherein the medical system includes: an endoscope that captures endoscopic images, and endoscopic actions of the endoscope including at least one of forward and backward movement of an insertion portion, adjustment of the bending angle of a curved portion of the insertion portion, and rolling rotation of the insertion portion. The control and holding components perform a first positioning of the insertion portion of the endoscope relative to the duodenal papilla; After performing the first positioning step, the medical system performs the following second positioning: controlling the electrically driven endoscope movement based on the endoscope image, and adjusting the position of the front end of the insertion part relative to the holding member based on the comparison result by comparing the position of the duodenal papilla in the endoscope image with the pre-registered position, so that the papilla is captured at the pre-registered position in the endoscope image.

11. The storage medium according to claim 10, characterized in that, In the second positioning step, the medical system controls at least one of the endoscope movement and the lifting angle of the treatment device, such that the treatment device, inserted from the treatment device insertion port of the endoscope and lifted inside the anterior end and protruding from the side of the anterior end, is directed toward the direction of travel of the bile duct, wherein the direction of travel of the bile duct is estimated based on the endoscopic image of the nipple.

Images