WO2023286241A1

WO2023286241A1 - Medical device, and method for controlling medical device

Info

Publication number: WO2023286241A1
Application number: PCT/JP2021/026614
Authority: WO
Inventors: 裕樹数野
Original assignee: オリンパス株式会社
Priority date: 2021-07-15
Filing date: 2021-07-15
Publication date: 2023-01-19

Abstract

This medical device includes: a suction tube 21 for suctioning solid matter from a body together with liquid; valves 27, 37 that are provided in either the suction tube 21 or a branch tube 31 branched from the suction tube 21 and having an opening to the outside where the pressure is higher than the inside of the suction tube; and a control unit 41 for controlling the opening and closing of the valves 27, 37.

Description

MEDICAL DEVICE AND METHOD OF CONTROLLING MEDICAL DEVICE

The present invention relates to a medical device and a method of controlling a medical device, particularly a medical device that collects solid matter in the body and a method of controlling a medical device that collects solid matter in the body.

Japanese Patent Application Laid-Open No. 2015-198790 discloses an endoscope system for lithotripsy treatment. A laser beam is emitted from a laser probe inserted through a treatment instrument channel of an endoscope to finely pulverize the calculus. Crushed stones (crushed stones) are grasped with forceps and removed from the body.

International Publication No. 2019/176171 shows a stone treatment system that delivers water and suction to collect debris. The crushed stone is withdrawn from the body together with water through a suction tube. However, debris can clog the suction tube. To clear the blockage of the suction pipe, switch the water supply route and send water from the suction pipe instead of the water supply pipe. That is, crushed stones are discharged from the suction pipe by discharging water from the suction pipe.

However, in order to clear the blockage of the suction tube, complicated operations such as switching the water supply route were required, and a relatively large amount of water was required.

JP 2015-198790 A WO2019/176171

An object of the present invention is to provide a medical device that can easily unblock a suction tube, and a control method for a medical device that can easily unblock a suction tube.

A medical device according to an embodiment of the present invention includes an aspiration tube for aspirating solid matter in the body together with a liquid, the aspiration tube, or a branch branching from the aspiration tube and having an opening to the outside where the pressure is higher than that in the aspiration tube. It comprises a valve provided in any one of the pipes, and a controller for controlling opening and closing of the valve.

Further, the method for controlling a medical device according to an embodiment of the present invention includes the step of sucking solid matter in the body together with liquid through a suction tube; and a step of controlling to generate a water hammer phenomenon in the suction pipe by opening and closing a valve provided in one of the branch pipes having a high external opening.

According to the present invention, it is possible to provide a medical device that can easily unblock a suction tube, and a control method for a medical device that can easily unblock a suction tube.

1 is an external view of an endoscope system including a medical device according to a first embodiment; FIG. FIG. 4 is a schematic external view for explaining treatment by the medical device of the first embodiment; 1 is a configuration diagram for explaining the configuration of a medical device according to a first embodiment; FIG. FIG. 5 is a configuration diagram for explaining the configuration of a medical device according to a second embodiment; FIG. 11 is a configuration diagram for explaining the configuration of a medical device according to a third embodiment; FIG. 11 is a configuration diagram for explaining the configuration of a medical device according to a fourth embodiment;

<First embodiment>
First, a medical system 8 including the medical device 1 of this embodiment will be described with reference to FIGS. 1 and 2. FIG.

The drawings based on the embodiments are schematic. The relationship between the thickness and width of each portion, the thickness ratio of each portion, and the like are different from the actual ones. Even between the drawings, there are portions with different dimensional relationships and ratios. Also, the illustration and reference numerals of some components are omitted.

As shown in FIG. 1, the medical system 8 includes a medical device 1, an endoscope 9, a laser device 2, a processor 80, a light source device 81, and a monitor 82. The endoscope 9 has an insertion portion 90 inserted into an organ of a subject, such as a kidney 100 (see FIG. 2), and outputs an imaging signal.

The insertion section 90 of the endoscope 9 includes a rigid distal end portion 90A, a bending portion 90B connected to the proximal end side of the rigid distal end portion 90A, and a flexible portion 90C connected to the proximal end portion of the bending portion 90B. It is composed by The endoscope 9 may have a rigid insertion section instead of the flexible section 90C. An operation portion 91 having various buttons for operating the endoscope 9 is provided at the proximal end portion of the insertion portion 90 . The bending portion 90</b>B bends by operating the operation portion 91 . The operating portion 91 has a channel insertion opening 91A having an opening 91B in the rigid distal end portion 90A.　

A universal cord 92 extending from the operation unit 91 is connected to the processor 80 and the light source device 81 .

The processor 80 controls the entire medical system 8, and also performs signal processing on imaging signals output by an imaging unit (not shown) and outputs them as image signals. A monitor 82 displays an endoscopic image.

The light source device 81 has, for example, a white LED. Illumination light emitted by the light source device 81 is guided to the rigid distal end portion 90A via a light guide (not shown) inserted through the universal cord 92 and the insertion portion 90 .

As shown in FIG. 1, the water pipe 11 and the suction pipe 21 of the medical device 1 and the laser probe 2A of the laser device 2 are inserted from the insertion port 91A of the channel of the operation unit 91. As shown in FIG. It protrudes from the opening 91B of the rigid tip 90A inserted into the.

The water pipe 11 feeds the liquid (for example, physiological saline) in the water tank 19 , and the liquid is spouted from the tip of the water pipe 11 to the kidney 100 . The liquid sent to the kidney 100 is sucked by the suction tube 21 and sent to the suction tank 29 . The water pipe and the suction pipe arranged outside the main body of the medical device 1 are configured by attaching a disposable type tube to a tube pump provided in a pump unit included in the medical device 1. good too. Also, the water pipe 11, the suction pipe 21, and the laser probe 2A may be inserted into the multi-lumen tube.

The illumination light guided by the light guide illuminates the subject via the illumination window 93 . Reflected light from the object is received by the imaging unit via the imaging window 94 and displayed on the monitor 82 as an endoscopic image. The endoscopic image confirms the positions of the laser probe 2A and the calculus 101 . By irradiating the laser from the tip of the laser probe 2A, the calculus 10 is pulverized into a crushed stone 102. - 特許庁A small calculus or crushed stone 102 is sucked together with liquid through the suction tube 21 and collected outside the body.

When it is difficult to insert the rigid distal end portion 90A of the endoscope 9 into the organ, for example, only the multi-lumen tube in which the water pipe 11, the suction pipe 21 and the laser probe 2A are inserted is inserted into the organ. may In this case, the positions of the laser probe 2A, the calculus 101, and the like are confirmed by, for example, X-ray imaging.

A laser probe 2A with a small outer diameter may be inserted into the aspiration tube 21 with a large inner diameter. At least one of the water pipe 11, the suction pipe 21 and the laser probe 2A may be inserted into a sheath provided in the insertion section 90 of the endoscope 9.

As shown in FIG. 3, the medical device 1 includes a water pump 12 (first pump 12), a water pipe 11 (first pipe 11), and a suction pump 22 (pump 22, second pump 22). , a suction tube 21 (second tube 21 ), a valve 27 (first valve 27 ), and a control section (controller) 31 .

The liquid is sent to the kidney 100 via the water pipe 11 by the water pump 12 . Body tissues (fragments 102 ) of the patient's kidney 100 are aspirated together with liquid by the aspiration pump 22 via the aspiration tube 21 .

A water pump 12, a check valve 13, a pressure gauge 15, and a flow meter 14 are arranged in the water pipe 11 for sending the liquid. The water supply system such as the water supply pump 12 may be included in a device other than the medical device 1, such as the laser device 2, for example.

A suction pump 22, a check valve 23, a pressure gauge 25, a flow meter 24, a strainer 26, and a valve 27 are arranged in the suction pipe 21 for sucking liquid. The strainer 26 collects the sucked crushed stone. The strainer 26 may be a filter or a device containing a filter. The suction pump 22 is a water suction pump that directly sucks water, but it may be an exhaust pump as long as it can suck water. The exhaust pump is disposed after the suction tank 29 and absorbs water by sucking the gas in the space above the water in the sealed suction tank 29 .

The medical device 1 is a calculus treatment device. A laser is used to crush stones 101 while pumping water to kidney 100 . The crushed calculus pieces (fragments) 102 are then collected outside the body by being sucked together with the liquid.

In pipelines where fluid flows, the "water hammer phenomenon" occurs when the flow suddenly changes due to the opening and closing of valves. Water hammer, which may damage pipelines, is considered a phenomenon that should be avoided.

As already explained, the tip of the suction tube 21 may be clogged with crushed stones 102 and the like. In the medical device 1 , the control unit 41 controls the suction tube 21 to generate a water hammer phenomenon. When the water hammer phenomenon occurs in the suction pipe 21 , a rapid reverse flow (reverse injection) occurs at the tip of the suction pipe 21 . The crushed stones 102 blocking the suction pipe 21 are released from the suction pipe 21 by the reverse injection. Note that "clogging" means a state in which crushed stone 102 blocks a pipeline and the pipeline resistance ΔP (resistance when fluid flows in the pipeline) increases, for example, the pipeline resistance ΔP increases by 25% or more compared to normal. This means that the

The pipeline resistance ΔP is calculated by the following formula.
ΔP = (64/Re) x (L/D) x ((ρ x v2)/ ² )
where Re is the Reynolds number, L is the length of the tube, D is the inner diameter of the tube, ρ is the density of the fluid, and v is the flow velocity.

That is, the control method of the medical device 1 includes a step of sucking body tissue together with a liquid through a suction tube; and controlling the opening and closing of a valve provided in any of the pipes to generate a water hammer phenomenon in the suction pipe.

The control unit 41 generates a water hammer phenomenon by controlling the opening and closing of the valve 27. In order to generate the water hammer phenomenon, it is preferable that the time required for the valve 27 to move from the fully closed state to the fully opened state, that is, the operating speed is, for example, less than 0.1 seconds. As the valve 27, a pinch valve that closes the flow path by pressing a flexible tube or the like from the outside is preferable in order to prevent contamination. The driving method of the valve 27 may be electromagnetic driving, pneumatic driving, or the like, or may be a combination of these driving methods with automatic control.

Since the medical device 1 uses reverse injection of fluid due to the water hammer phenomenon, blockage of the suction tube 21 can be easily eliminated with a simple configuration.

The inner diameter of the tip of the suction tube 21 is smaller than the inner diameter of the other portion. The narrowed portion may be tapered. Therefore, the crushed stone 102 that has passed through the tip of the suction tube 21 with the smallest diameter does not clog the suction tube 21 . In addition, at the tip of the suction tube 21 where the crushed stone 102 is sucked, the force or flow velocity of the liquid due to the reverse injection is increased, so the blockage can be released efficiently.

It is preferable that the control unit 41 automatically repeats opening and closing of the valve 27 at predetermined time intervals regardless of the blockage of the suction tube 21 (automatic control mode 1). In this case, the time (opening time) during which the valve 27 is open is preferably more than 0.2 seconds and less than 0.5 seconds in order to perform suction efficiently. On the other hand, it is preferable that the time during which the valve 27 is closed (closed time) is more than 2 seconds and less than 5 seconds. That is, the opening/closing cycle period is preferably more than 2.2 seconds and less than 5.5 seconds.

It should be noted that the reverse injection occurs for a short time due to the water hammer phenomenon, so the reverse injection does not affect the temperature rise inside the kidney 100 . Therefore, even if the valve 27 is repeatedly opened and closed, the kidney 100 is not burdened. The water supply amount may be adjusted according to the reverse injection.

In order to efficiently generate the water hammer phenomenon, the control unit 41 may control the second pump 22 to stop while the valve 27 is closed. The synergistic effect of the opening and closing actions of the valve 27 and the stopping/starting action of the second pump allows the liquid flow to change more rapidly than the action of the valve 27 alone.

<Second embodiment>
Since the medical device 1A of this embodiment is similar to the medical device 1 and has the same effects, the same reference numerals are given to the components having the same functions, and the description thereof is omitted.

A medical device 1A shown in FIG. 4 has a branch tube 31 branched from the middle of the suction tube 21 . A valve 37 (second valve 37 ) is arranged in the branch pipe 31 . The branch pipe 31 has an opening to the outside (atmospheric pressure) where the pressure is higher than that in the suction pipe. That is, the branch pipe 31 has a first end inserted through the suction pipe 21 and a second end exposed to the atmosphere. A valve 37 is disposed between the first end and the second end.

In the medical device 1A, the control unit 41 controls opening and closing of the valve 37 to generate a water hammer phenomenon.

The configuration of the valve 37 is the same as the configuration of the valve 27. Further, the control of the control unit 41 is automatic control mode 1, which is the same as in the first embodiment. For example, the controller 41 may control the second pump 22 to stop while the valve 37 is closed.

The branch pipe 31 is preferably provided with a check valve 33 to prevent the sucked liquid from contacting the valve 27 .

By repeating the opening and closing of the valve 37, the flow rate of the suction pipe 21 decreases. In order to reduce this effect, the volume from the connecting portion of the branch pipe 31 to the suction pipe 21 to the valve 37 should be made as small as possible so that the pressure in the suction pipe 21 tends to be negative when the valve 37 is closed. desirable. That is, it is desirable to make the length from the connecting portion of the suction pipe 21 of the branch pipe 31 to the valve 37 as short as possible and the inner diameter as small as possible.

For example, when the inner diameter of the branch pipe 31 is 4 mm and the valve 37 is provided at a position of 40 cm from the suction pipe 21 when the pump is driven to flow 40 mL/min into the suction pipe 21 when the valve 37 is closed. And when the closing time was 5 seconds, the flow rate of the suction tube 21 was 24 mL/min. On the other hand, when it was provided at a position 4 cm from the suction tube 21, the flow rate of the suction tube 21 was 38.5 mL/min on average for one minute.

From the results of experiments, in order to ensure that the flow rate of the suction tube 21 when the valve 37 is repeatedly opened and closed exceeds 90% of the flow rate of the suction tube 21 when the valve 37 is closed, the suction tube 21 It can be said that the pipeline volume of the branch pipe 31 between the valve 37 and the valve 37 is required to be less than 1200 mm ³ . Since a volume of 1200 mm ³ corresponds to 10 cm for a general-purpose tube with an inner diameter of 4 mm, the length of the conduit between suction tube 21 and valve 37 is preferably less than 10 cm.

<Third Embodiment>
Since the medical device 1B of this embodiment is similar to the medical device 1A and has the same effects, the same reference numerals are given to the components having the same functions, and the description thereof is omitted.

The medical device 1B shown in FIG. 5 has a detection unit that detects clogging from the state of the liquid flow in the suction tube 21 . In the medical device 1</b>B, the detection unit is the pressure sensor 51 that detects the pressure applied to the tip of the suction tube 21 . When a crushed stone 102 larger than the tip opening is sucked into the tip of the suction tube 21, pressure is applied to the pressure sensor 51, so blockage of the suction tube 21 is detected.

The control unit 41 performs control so that a water hammer phenomenon occurs in the suction pipe 21 when the pressure sensor 51 detects that the suction pipe 21 is blocked (automatic control mode 2). For example, the controller 41 closes the valve 37 .

The control unit 41 repeats opening/closing control of the valve 27 based on the detection information of the pressure sensor 51 until the blockage of the suction tube 21 is cleared.

The detection unit includes an image detection unit (not shown) that detects blockage based on image information of the liquid, a flow meter that detects the flow velocity of the liquid in the suction tube 21, and a flow rate that detects the flow rate of the liquid in the suction tube 21. The gauge 24 or the pressure gauge 25 that detects the pressure of the liquid in the suction tube 21 may be used. Aside from the flowmeter 24 and the pressure gauge 25, a flowmeter and a pressure gauge for detecting clogging may be provided.

The image detection section acquires an image near the tip of the insertion section 90 and detects occlusion based on this image. For example, the image detection unit uses the imaging unit to photograph the tip of the suction tube 21 and determines from the image that a broken stone has stuck to the tip.

In addition, occlusion may be detected from X-ray images or endoscopic images. If a predetermined suction is made, the kidney maintains a constant swollen state. On the other hand, when the suction tube 21 is blocked and the suction flow rate is reduced, the kidney expands. The image detection unit detects blockage of the suction tube 21 from the size of the kidney.

It should be noted that the medical device 1B may cause the water hammer phenomenon by controlling the valve 27 of the suction tube 21 with the control unit 41 like the medical device 1 . Also, the medical device 1B may continuously repeat the opening and closing of the valve like the medical device 1A. Then, when the detector detects the blockage, the valve may be opened and closed in addition to the normal opening and closing operations. Also, the controller 41 may control the second pump 22 to stop while the valve 37 is closed.

<Fourth Embodiment>
Since the medical device 1C of the present embodiment is similar to the medical device 1B and has the same effects, the same reference numerals are given to the components having the same functions, and the description thereof is omitted.

The medical device 1C shown in FIG. 6 further includes a display section 42 and a valve operation section 43. The display unit 42 displays to the operator the occurrence of occlusion detected by the pressure sensor 51, which is the detection unit. The display unit 42 may be a lamp indicating the occurrence of blockage, or the monitor 82 of the endoscope 9 may also serve as the display unit.

The valve operation unit 43 is an operation switch that outputs an operation signal instructing opening and closing of the valve 37 based on the operator's operation. The controller 41 controls opening and closing of the valve 37 based on the operation signal.

The medical device 1C controls the opening and closing of the valve 37 based on the operation signal from the valve operation unit 43 according to the operator's operation (manual control mode). In addition, it is desirable that the opening/closing time for one time is the same as that in the first embodiment. The control unit 41 may repeat opening/closing control of the valve 37 for a predetermined period of time, using an operation signal from the valve operation unit 43 by the operator as a trigger.

With the medical device 1C, the operator can reverse-inject water based on his/her own judgment. Therefore, the crushed stone 102 in the kidney 101 can be moved not only by releasing the obstruction but also by using the water flow by the reverse injection. For example, if the crushed stone 102 is not positioned at a predetermined site where the crushed stone 102 is easily sucked, for example, the renal calyx, the crushed stone 102 cannot be sucked efficiently. With the medical device 1C, the operator can move the crushed stone 102 to the kidney calyx by using the water flow caused by the reverse injection by generating a water hammer phenomenon in an arbitrary direction at an arbitrary timing.

In particular, in order to prevent the crushed stone 102 from scattering due to water supply, when the tip of the water supply pipe 11 is configured to eject fluid not in the central axis direction (forward) of the water supply pipe 11 but in an oblique direction or a lateral direction, Water supply alone may not collect crushed stones 102 in the kidney calyx. However, in the medical device 1C, the crushed stones 102 can be moved by using the water flow caused by the reverse jetting by jetting water back from the water suction tube 11 at an arbitrary timing by the operator.

The

medical devices

1, 1A, and 1B may also be configured so that the manual control mode of the medical device 1C and the automatic control modes 1 and 2 can be arbitrarily switched.

In addition, the medical device for recovering crushed stones pulverized using a laser has been described as an example, but the medical device of the present invention may be a medical device for recovering crushed stones pulverized by shock waves from outside the body. A medical device called a debriter or morcellator for resecting and recovering solids in the body such as thrombi, bones, mucous membranes, uterine fibroids, prostate glands, polyps, and tumors may also be used.

The present invention is not limited to the above-described embodiments, etc., and various modifications, combinations, and applications are possible within the scope of the invention.

Claims

a suction tube for sucking solid matter in the body together with liquid;
a valve provided in either the suction pipe or a branch pipe branching from the suction pipe and having an opening to the outside where the pressure is higher than in the suction pipe;
and a control unit that controls opening and closing of the valve.
The medical device according to claim 1, wherein the solid matter is calculus or crushed stone obtained by pulverizing the calculus.
The medical device according to claim 1, wherein the control unit performs control so that a water hammer phenomenon occurs in the suction pipe.
The medical device according to claim 1, wherein the inner diameter of the tip of the suction tube is narrower than the inner diameter of the other portion.
The medical device according to claim 1, wherein the valve is a pinch valve.
The medical device according to claim 1, further comprising a check valve arranged in the branch pipe.
The medical device according to claim 1, characterized in that the valve is provided at a position less than 10 cm from the suction tube.
2. The medical device according to claim 1, wherein the conduit volume of the branch pipe to the position where the valve is provided is less than 1200 mm< 2 >.
The medical device according to claim 1, characterized in that the opening time of the valve is more than 0.2 seconds and less than 0.5 seconds.
2. The apparatus according to claim 1, wherein the control unit is connected to a pump for sucking the liquid, and controls the pump to stop at the same time when the valve is closed. medical device.
The medical device according to claim 1, wherein the control unit repeats opening and closing of the valve at predetermined time intervals.
The medical device according to claim 11, characterized in that the closing time of the valve is more than 2 seconds and less than 5 seconds.
a valve operation unit that outputs an operation signal instructing opening and closing of the valve,
2. The medical apparatus according to claim 1, wherein the control unit performs control such that a water hammer phenomenon occurs in the suction tube based on the operation signal.
A pressure sensor that detects the pressure applied to the tip of the suction tube, an image detection unit that detects image information of the liquid in the suction tube, a velocity meter that detects the flow velocity of the liquid in the suction tube, or 2. The medical device according to claim 1, further comprising a flow meter that detects the flow rate of the liquid in the suction tube, and further comprising a detection unit that detects blockage of the suction tube.
The medical device according to claim 14, wherein the control unit controls opening and closing of the valve when the detection unit detects blockage of the aspiration tube.
a display unit that displays blockage detection to a user when the detection unit detects blockage of the aspiration tube;
a valve operation unit that outputs an operation signal instructing opening and closing of the valve,
16. The medical device according to claim 15, wherein the controller controls opening and closing of the valve based on the operation signal.
further comprising a valve operation unit that outputs an operation signal instructing opening and closing of the valve;
2. The medical apparatus according to claim 1, wherein the controller controls opening and closing of the valve based on the operation signal.
further comprising a water line that delivers the liquid into the body;
The medical device according to claim 1, wherein the water pipe ejects the fluid from its tip in a direction deviating from the central axis direction of the water pipe.
aspirating solids in the body along with the liquid through the aspiration tube;
A water hammer phenomenon occurs in the suction pipe by opening and closing a valve provided in either the suction pipe or a branch pipe branching from the suction pipe and having an opening to the outside where the pressure is higher than in the suction pipe. A control method for a medical device, comprising: