Medical instrument system

Abstract

A medical instrument system that prohibits reuse of a medical instrument inserted into a body is provided. The medical instrument system according to the present invention includes a medical instrument inserted into a body and a control device having a processor, the medical instrument having information for determining whether the medical instrument is unused, the processor performing processing of: acquiring the information from the medical instrument; determining whether the medical instrument is unused based on the information; and in a case where it is determined that the medical instrument is used, performing an action control for prohibiting reuse of the medical instrument.

Description

Technical Field

[0001] This invention relates to a medical device system comprising a medical device that is inserted into the body. Background Technology

[0002] In the past, the following manual procedures were performed in the medical field: inserting the endoscope into the large and small intestines to observe, diagnose, and treat the intestinal wall.

[0003] Patent Document 1 discloses an endoscope system comprising an endoscope, an outer tube into which the insertion portion of the endoscope is inserted, and a balloon control device. Inflatable and deflatable balloons are respectively installed on the insertion portion of the endoscope and the outer tube. These balloons are inflated by air supplied from the balloon control device and deflated by air drawn from the balloon control device.

[0004] According to the endoscope system in Patent Document 1, the insertion part is inserted into the deep part of the bent intestine by controlling the expansion and contraction of each balloon by a balloon control device.

[0005] Patent Document 1: Japanese Patent Application Publication No. 2023-180472

[0006] The outer sheath (insertion aid) disclosed in Patent Document 1, etc., becomes contaminated with bodily fluids during surgery and is therefore discarded after use. However, the insertion aid can be removed from the insertion part after use without damaging its shape and function as an insertion aid, and is therefore sometimes reused.

[0007] Therefore, the use of medical devices inserted into the body, such as sheaths, should be prohibited. Summary of the Invention

[0008] The present invention was made in view of this situation, and its object is to provide a medical device system that prohibits the use of medical devices inserted into the body.

[0009] To achieve the above objectives, the medical device system according to the first aspect of the present invention comprises: a medical device inserted into the body; and a control device having a processor, wherein the medical device has information for determining whether the medical device is not used, and the processor performs the following processing: acquiring information from the medical device; determining whether the medical device is not used based on the information; and, if it is determined that the medical device has been used, performing action control to prohibit further use of the medical device.

[0010] In the medical device system according to the second aspect of the present invention, which is the same as that according to the first aspect, the medical device preferably has an insertion part inserted into the body and a balloon disposed on the insertion part, and the processor controls the balloon to prevent inflation as an action control when it determines that the medical device has been used.

[0011] In the medical device system according to the third aspect of the present invention, in the medical device system according to the first or second aspect, preferably, the information is identification information for identifying the medical device.

[0012] In the medical device system according to the fourth aspect of the present invention, which is the same as that according to the third aspect, the control device preferably has a memory that stores correspondence information indicating whether the medical device corresponding to the identification information is not used.

[0013] In the medical device system of the fifth aspect of the present invention, which is the same as that of the fourth aspect, the processor preferably determines whether the medical device is not in use based on the identification information and correspondence information obtained from the medical device.

[0014] In the medical device system according to the sixth aspect of the present invention, in the medical device system according to the first or second aspect, preferably, the information is usage status information indicating whether the medical device is not in use, and the processor determines whether the medical device is not in use based on the usage status information.

[0015] In the medical device system according to the seventh aspect of the present invention, which is the same as that according to the sixth aspect, the processor is preferably capable of changing the usage status information of the medical device from unused to used.

[0016] In the medical device system according to the eighth aspect of the present invention, in any of the medical device systems according to the first to seventh aspects, the control device preferably has a reading device for reading information in a non-contact manner.

[0017] In the medical device system according to the ninth aspect of the present invention, in any of the medical device systems according to the first to seventh aspects, preferably, the processor acquires information when the medical device is connected to the control device.

[0018] In the medical device system according to the 10th aspect of the present invention, which is the same as that according to the 9th aspect, the medical device has a conductive component, which has characteristic information that shows different conductive characteristics when the medical device is not in use and when it is in use. When the medical device is connected to the control device, the processor determines whether the medical device is not in use based on the characteristic information obtained from the medical device.

[0019] In the medical device system according to the 11th aspect of the present invention, which is the same as that according to the 10th aspect, the conductive component preferably exhibits conductive characteristics when the medical device is not in use and non-conductive characteristics when the medical device is in use.

[0020] In the medical device system according to the 12th aspect of the present invention, which is the same as that according to the 10th aspect, the conductive components preferably exhibit different resistance characteristics when the medical device is not in use and when it is in use.

[0021] In the medical device system according to the 13th aspect of the present invention, in any of the medical device systems according to the 1st to 12th aspects, it is preferred that the information has the irreversible characteristic of being able to transition from the 1st state to the 2nd state, but not from the 2nd state to the 1st state.

[0022] In the medical device system according to the 14th aspect of the present invention, in the medical device system according to the 13th aspect, it is preferable that the processor determines that the medical device is not used when the information is in the first state, and determines that the medical device is used when the information is in the second state.

[0023] In the medical device system according to the 15th aspect of the present invention, in the medical device system according to the 13th aspect, the control device preferably has a reading device for reading information by an optical sensor, the information being printed by ink whose transmittance of visible light increases due to external action, and the information changing from a first state that can be read by the reading device to a second state that cannot be read by the reading device when the ink is subjected to external action.

[0024] In the medical device system according to the 16th aspect of the present invention, in the medical device system according to the 13th aspect, the control device preferably has a reading device for reading information by an optical sensor, the information is covered by ink whose transmittance of visible light decreases due to external action, and the information changes from a first state that can be read by the reading device to a second state that cannot be read by the reading device when the ink is subjected to external action.

[0025] In the medical device system according to the 17th aspect of the present invention, in the medical device system according to the 13th aspect, the control device preferably includes a reading device for reading information by an optical sensor, the information is displayed on an attachment member, and the information changes from a first state that can be read by the reading device to a second state that cannot be read by the reading device when the attachment member attached to the medical device is detached from the medical device.

[0026] The medical device system according to the 18th aspect of the present invention is preferably a remote operation device comprising a remote operation control device in any of the medical device systems according to the 1st to 17th aspects.

[0027] The remote operating device has a reading device for reading information.

[0028] The medical device system according to the 19th aspect of the present invention is preferably a medical device system according to any one of the 1st to 18th aspects, preferably, it includes a display device, and the processor, as an action control, controls the display device to show a warning message prohibiting the further use of the medical device when it is determined that the medical device has been used.

[0029] In the medical device system according to the 20th aspect of the present invention, in any of the medical device systems according to the 1st to 19th aspects, preferably, the medical device has an insertion passage that allows other medical devices different from the medical device to be inserted.

[0030] The medical device system according to the 21st aspect of the present invention is preferably, in the medical device system according to the 20th aspect, equipped with other medical devices.

[0031] In the medical device system of the 22nd aspect of the present invention, which is the same as that of the 21st aspect, the other medical device is preferably an endoscope.

[0032] In the medical device system according to the 23rd aspect of the present invention, in any of the medical device systems according to the 1st to 19th aspects, the medical device is preferably an endoscope.

[0033] Invention Effects

[0034] According to the present invention, it is possible to prohibit the use of medical devices inserted into the body. Attached Figure Description

[0035] Figure 1 This is a system structure diagram of an endoscope system.

[0036] Figure 2 This is a side view of the outer tube.

[0037] Figure 3 This is a cross-sectional view of the outer tube with the insertion part in the open position.

[0038] Figure 4 This is a block diagram showing the electrical structure of the medical device system according to the first embodiment.

[0039] Figure 5 This is a flowchart illustrating the steps of the operation method of the medical device system according to the first embodiment.

[0040] Figure 6 This is a block diagram illustrating the electrical structure of the medical device system according to the second embodiment.

[0041] Figure 7 This is a flowchart illustrating the steps of the operation method of the medical device system according to the second embodiment.

[0042] Figure 8 This is a block diagram illustrating the electrical structure of the medical device system according to the third embodiment.

[0043] Figure 9 This is a diagram used to illustrate the conductive components of the outer sheath.

[0044] Figure 10 This is a flowchart illustrating the steps of the operation method of the medical device system according to the third embodiment.

[0045] Figure 11 This is a flowchart illustrating the steps of the operation method of the medical device system according to the first modification of the third embodiment.

[0046] Figure 12 This is a side view of the outer tube according to the fourth embodiment.

[0047] Figure 13 This is a perspective view of the base end side of the outer sleeve according to the fifth embodiment.

[0048] Figure 14 This is a perspective view of the balloon control device according to the sixth embodiment.

[0049] Figure 15 This is a diagram showing the display content of the display device according to the seventh embodiment.

[0050] Explanation of reference numerals in the attached figures:

[0051] 1-Endoscope system, 2-Medical device system, 2A-Medical device system, 2B-Medical device system, 10-Endoscope, 12-Handheld operating part, 14-Insertion part, 14A-Outer peripheral surface, 16-Universal cable, 18-Connector device, 20-Front end, 22-Insufflation / water supply button, 24-Suction button, 26-Bend button, 28-Insertion part of treatment device, 30-Flexible part, 32-Bend part, 40-Balloon, 42-Ventilation port, 44-Air inlet, 50-Outer tube, 50A-Outer tube, 50B-Outer tube, 50C-Outer tube, 50D-Outer tube, 52-Tube Body, 52A-Outer peripheral surface, 52B-Inner peripheral surface, 53-Lubricating coating part, 54-Front end opening, 56-Base end opening, 58-Holding part, 60-Balloon, 60A-Tube part, 60B-Tube part, 60C-Bulging part, 62-Insertion tube, 64-Air tube, 66-Liquid tube, 68-Ventilation hole, 70-Hook part, 72-Air tube, 74-Air inlet part, 76-Tube, 78-Liquid tube, 80-Liquid supply port, 82-Adhesive fixing part, 84-Adhesive fixing part, 100-Connecting tube, 100A-Connecting part, 100B-Connecting part, 110-Connecting tube 120-Balloon control device, 120A-Balloon control device, 120B-Balloon control device, 120C-Balloon control device, 122-Air inlet, 124-Air inlet, 200-Processor, 202-Memory, 204-Correspondence information, 210-Allow button, 212-Reading device, 214-Writing device, 216-Remote operating device, 218-Cable, 220-Display device, 220A-Display device, 222-Warning display, 230-Identifier, 232-Identification information, 232A-Identification information, 232B-Identification information, 234-Usage status Status information, 236-conductive component, 238-conductive wiring, 238A-first wiring, 238B-second wiring, 300-Luer lock connector, 302-female Luer connector, 304-male Luer connector, 320-base end cap, 322-leakage prevention valve, 324-opening, 330-attachment component, A-central shaft, S1~S6-steps of the operating method of the medical device system, S11~S15-steps of the operating method of the medical device system, S21~S24-steps of the operating method of the medical device system, S31~S34-steps of the operating method of the medical device system. Detailed Implementation

[0052] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. In this specification, the same reference numerals are used to denote the same constituent elements, and repeated descriptions are omitted where appropriate.

[0053] <Endoscopic System>

[0054] Figure 1This is a system structure diagram of endoscope system 1. (See diagram for example.) Figure 1 As shown, the endoscope system 1 includes an endoscope 10, an outer cannula 50, two connecting tubes 100 and 110, and a balloon control device 120. Furthermore, the endoscope system 1 is an example of the "medical device system" of the present invention.

[0055] [Endoscope]

[0056] The endoscope 10 includes a handheld operating part 12 and an insertion part 14 connected to the handheld operating part 12. Furthermore, the endoscope 10 is an example of "other medical devices" of the present invention.

[0057] A universal cable 16 is connected to the handheld operating unit 12. The universal cable 16 contains a light guide (not shown), a signal cable (not shown), and an air supply / exhaust pipe (not shown) for supplying and drawing air into the balloon 40 (described later). A connector device 18 is also connected to the universal cable 16.

[0058] Connector device 18 is connected to an endoscope processor device (not shown). The endoscope processor device includes a light source device and an image processing device (not shown). A display device, such as a monitor (not shown), is connected to the image processing device to display the image processed by the image processing device.

[0059] When the connector device 18 is connected to the endoscope processor device, the illumination light from the light source device is transmitted by the aforementioned light guide and shines towards the observation area from the illumination window (not shown) provided at the front end portion 20 of the insertion portion 14. Furthermore, an observation window and an observation unit (not shown) are provided on the front end portion 20. The optical image of the observation area entering through the observation window is converted into an image signal by the imaging element of the observation unit. The image signal is transmitted to the image processing device via the aforementioned signal cable, and is processed by the image processing device to be displayed on the display as an image of the observation area.

[0060] The handheld operating unit 12 is equipped with an air / water supply button 22, a suction button 24, a pair of angle buttons 26, and a treatment device insertion part 28.

[0061] The insertion part 14 is inserted into the intestines, such as the large and small intestines, through the anus. The insertion part 14 has a flexible portion 30, a curved portion 32, and a front end portion 20 from its base side towards its front end side. The flexible portion 30 is flexible. The curved portion 32 can be remotely bent by operating a pair of curved buttons 26 provided on the handheld operating part 12. This allows the front end portion 20 to be oriented in a desired direction.

[0062] An endoscope balloon 40 is mounted on the outer peripheral surface of the bend 32. A vent 42 is provided on the outer peripheral surface of the bend 32 in the mounting area of ​​the balloon 40. The vent 42 is connected to the air supply and exhaust pipe that is inserted from the air port 44 of the connector device 18 via the universal cable 16, the handheld operating part 12 and the flexible part 30.

[0063] One end of a connecting tube 110 is connected to the air inlet 44, and the other end of the connecting tube 110 is connected to the air inlet 122 of the balloon control device 120. The balloon control device 120 can be switched between air supply operation for supplying air to the endoscope 10 and the outer tube 50 and air suction operation for evacuating air.

[0064] Regarding the endoscope 10, when the balloon control device 120 is switched to air supply operation, air from the balloon control device 120 is introduced from the air port 122 through the connecting tube 110 to the air port 44 of the connector device 18. The air introduced into the air port 44 is then ejected from the vent hole 42 through the air supply and exhaust tube into the interior of the balloon 40. As a result, the balloon 40 inflates.

[0065] On the other hand, regarding the endoscope 10, when the balloon control device 120 is switched to air suction operation, the air inside the balloon 40 is drawn from the vent 42 through the air supply and exhaust pipe, the air inlet 44 and the connecting pipe 110, and then through the air inlet 122 to the balloon control device 120. As a result, the balloon 40 contracts.

[0066] [Outerwear]

[0067] Figure 2 This is a side view of the outer tube 50. Furthermore, Figure 3 This is a cross-sectional view of the outer tube 50 with the insertion part 14 inserted. Furthermore, the outer tube 50 is an example of the "medical device" of this invention.

[0068] like Figure 2 and Figure 3 As shown, the outer tube 50 has a tube body 52. ​​The tube body 52 is formed into a cylindrical shape from a flexible material and has a front opening 54, a base opening 56, and a central axis A. The insertion portion 14 of the endoscope 10 is inserted through the base opening 56 toward the front opening 54. The tube body 52 has an inner diameter slightly larger than the outer diameter of the insertion portion 14. In the following description of each part of the outer tube 50, "front end side" refers to the side facing the front opening 54, and "base end side" refers to the side facing the base opening 56.

[0069] The tube body 52 has a gripping portion 58 at its base end for the surgeon to hold. On the other hand, a balloon 60 made of elastic material is mounted on the outer peripheral surface 52A of the tube body 52 at its front end. Furthermore, the tube body 52 is an example of an "insertion member inserted into the body" according to the present invention, and the balloon 60 is an example of a "balloon disposed on an insertion member" according to the present invention.

[0070] Furthermore, the tube body 52 has an outer peripheral surface 52A and an inner peripheral surface 52B, and an insertion passage 62 is formed through the inner peripheral surface 52B, through which the insertion part 14 of the endoscope 10 can be inserted. In addition, the insertion passage 62 is an example of the "insertion passage" of the present invention.

[0071] Furthermore, the tube body 52 includes an air conduit 64. The air conduit 64 extends from the base end of the tube body 52 toward the front end, forming along the central axis A between the outer peripheral surface 52A and the inner peripheral surface 52B. The front end of the air conduit 64 is connected to a vent 68. The vent 68 is formed on the outer peripheral surface 52A located inside the balloon 60.

[0072] Furthermore, the tube body 52 includes a liquid conduit 66. The liquid conduit 66 is formed at the base end of the tube body 52, extending from the outer peripheral surface 52A through the inner peripheral surface 52B. The liquid conduit 66 is a conduit for supplying a lubricant such as water to the gap between the inner peripheral surface 52B of the tube body 52 and the outer peripheral surface 14A of the insertion portion 14.

[0073] Furthermore, a lubricating coating portion 53 is provided on the inner peripheral surface 52B of the tube body 52, which serves as the inner wall surface of the insertion conduit 62. The lubricating coating portion 53 reduces the frictional resistance between the inner peripheral surface 52B of the tube body 52 and the outer peripheral surface 14A of the insertion portion 14, allowing the insertion portion 14 to smoothly perform insertion and removal operations in the insertion conduit 62.

[0074] Furthermore, the tube body 52 has a bayonet portion 70. The bayonet portion 70 is provided on the outer peripheral surface 52A of the outer peripheral surface 52A of the tube body 52 on the side of the holding portion 58, protruding toward the base end. The bayonet portion 70 has an air pipe 72 communicating with the air pipe 64 inside, and an air outlet portion 74 is provided at the end of the air pipe 72.

[0075] A connection is made to the air inlet 74. Figure 1 The connecting portion 100A of the connecting tube 100 is shown in the figure. Then, the connecting portion 100B of the connecting tube 100 is connected to the air port 124 of the balloon control device 120.

[0076] Furthermore, the tube body 52 includes a tube 76. The tube 76 protrudes from the outer peripheral surface 52A of the tube body 52 on the side of the holding portion 58. The tube 76 has a liquid conduit 78 that communicates with the liquid conduit 66, and a liquid supply port 80 is provided at the end of the liquid conduit 78. A lubricant supply component such as a syringe (not shown) is connected to the liquid supply port 80, and lubricant (water) from the lubricant supply component is supplied from the liquid conduit 78 through the liquid conduit 66 to the insertion conduit 62.

[0077] The balloon 60 is mounted on the outer peripheral surface 52A with the tube body 52 passing through it. The balloon 60 has a central bulge 60C, a tube portion 60A formed at the front end of the bulge 60C, and a tube portion 60B formed at the base end of the bulge 60C.

[0078] A portion of the front end of the tube 60A folds back towards the base end towards the inner side of the tube 60A. This portion of the inwardly folded-back tube 60A is fixed to the outer peripheral surface 52A of the tube body 52 by an adhesive fixing part 82 formed by wire and adhesive. The adhesive fixing part 82 is formed in a ring shape along the circumference of the outer peripheral surface 52A, covering the inwardly folded-back portion of the tube 60A and its surrounding outer peripheral surface 52A. Furthermore, the adhesive fixing part 82 is formed inside the balloon 60 and therefore is not exposed to the outside.

[0079] A portion of the base end of the tube 60B folds back towards the front end. This folded-back portion of the base end of the tube 60B is secured to the outer peripheral surface 52A of the tube body 52 by an annular adhesive fixing portion 84 based on a thread and adhesive. The adhesive fixing portion 84 is formed in an annular shape along the circumferential direction of the outer peripheral surface 52A, covering the folded-back portion of the base end of the tube 60B and its surrounding outer peripheral surface 52A. Furthermore, the adhesive fixing portion 84 is formed on the outer side of the balloon 60 and is therefore exposed to the outside.

[0080] Regarding the outer tube 50 with the above-described structure, when the balloon control device 120 switches to air supply operation, air from the balloon control device 120 is introduced from the gas channel 124 through the connecting pipe 100 to the air inlet 74 of the outer tube 50. The air introduced into the air inlet 74 is then ejected from the air pipe 72 through the air pipe 64 and out of the vent 68 into the interior of the balloon 60. As a result, the balloon 60 inflates.

[0081] On the other hand, regarding the outer tube 50, when the balloon control device 120 switches to air suction operation, air inside the balloon 60 is drawn from the vent 68 through the air pipe 64, air pipe 72, air inlet 74, and connecting pipe 100, and then through the air inlet 124 to the balloon control device 120. This causes the balloon 60 to contract. Furthermore, the balloon control device 120 is an example of the "control device" of the present invention.

[0082] As described above, the balloon control device 120 is a device that enables the endoscope 10 and the outer sleeve 50 to be switched between air supply operation and air suction operation, respectively. This balloon control device 120 is known (for example, see Japanese Patent Application Publication No. 2023-180472), so detailed description is omitted here.

[0083] The balloon control device 120 can be integrated into the endoscope processor device.

[0084] Here, the distribution configuration (at the time of product shipment) of the outer tube 50 and the connecting tube 100 will be explained. The outer tube 50 is a single-use medical device that is not intended for reuse. On the other hand, the connecting tube 100 is a medical device intended for reuse. Therefore, the outer tube 50 and the connecting tube 100 are distributed as separate items, and the connecting tube 100 is distributed as a tubing kit. Therefore, when using the outer tube 50, the air inlet 74 of the outer tube 50 is connected to the connecting portion 100A of the connecting tube 100.

[0085] Next, several embodiments for preventing the reuse of the outer sleeve 50 will be described. These embodiments are implemented by determining whether the outer sleeve 50 is unused based on information contained in the outer sleeve 50.

[0086] <First Embodiment>

[0087] [Structure of Medical Device Systems]

[0088] Figure 4 This is a block diagram showing the electrical structure of the medical device system according to the first embodiment. The medical device system 2 includes an outer sheath 50 and a balloon control device 120.

[0089] The outer sheath 50 has an identifier 230. The identifier 230 includes identification information 232. The identification information 232 is inherent information used to uniquely identify the outer sheath 50. The identifier 230 may be an RF-ID (Radio Frequency Identification) tag whose identification information 232 can be read via contactless communication. The identifier 230 may be a barcode or QR code whose identification information 232 can be read optically.

[0090] The balloon control device 120 includes a processor 200, a memory 202, an enable button 210, a reading device 212, and a display device 220.

[0091] The processor 200 includes a CPU (Central Processing Unit). The processor 200 centrally controls the balloon control device 120 and executes various programs stored in the memory 202, thereby realizing various functions.

[0092] The memory 202 is a storage device that includes RAM (Random Access Memory). The memory 202 may be one or more of the following storage devices: flash memory, ROM (Read-only Memory), hard disk drive, solid-state drive, and removable recording media.

[0093] The memory 202 stores correspondence information 204. Correspondence information 204 indicates whether the outer sleeve 50 corresponding to the identification information 232 is unused. In correspondence information 204, the identification information 232 of the outer sleeve 50 that has been used so far can be stored as the identification information 232 of the used outer sleeve 50. Furthermore, if unregistered identification information 232 is read, that identification information 232 is registered in correspondence information 204.

[0094] The permission button 210 is an operating component for the surgeon to operate the balloon control device 120.

[0095] The reading device 212 is a device that reads the identification information 232 of the identifier 230 of the outer sleeve 50 in a non-contact manner. If the identifier 230 is an RF-ID tag, the reading device 212 can be an RF-ID reader that transmits and receives information with the RF-ID tag. If the identifier 230 is a QR code, the reading device 212 can be a code reader that reads the QR code using an optical sensor. Furthermore, the reading device 212 can be an input device for inputting codes, such as a keyboard or touch panel.

[0096] Display device 220 is a device for displaying information related to the balloon control device. The enable button 210 may be a GUI (Graphical User Interface) button displayed on display device 220 and operable using a user interface not shown.

[0097] How Medical Device Systems Work

[0098] Figure 5 This is a flowchart illustrating the steps of the operation method of the medical device system according to the first embodiment. The operation method of the medical device system is implemented by the processor 200 of the balloon control device 120 executing a control program stored in the memory 202. The operation method of the medical device system can be performed during a leak test of the balloon 60 before using the outer tube 50.

[0099] The surgeon connects the desired outer tube 50 to the balloon control device 120 via the connecting tube 100. In step S1, the processor 200 obtains inherent identification information 232 from the identifier 230 of the outer tube 50. For example, by bringing the outer tube 50 close to the reading device 212, the reading device 212 can read the identification information 232 of the identifier 230 in a non-contact manner and output the read identification information 232 to the processor 200.

[0100] In step S2, the processor 200 retrieves the correspondence information 204 from the memory 202. Here, the correspondence information 204 is the identification information 232 of the used outer sleeve 50.

[0101] In step S3, the processor 200 determines whether the outer tube 50 is unused based on the identification information 232 obtained in step S1 and the correspondence information 204 obtained in step S2. The processor 200 may determine that the outer tube 50 is unused if the identification information 232 obtained in step S1 is not included in the correspondence information 204 obtained in step S2, and determine that the outer tube 50 is used if it is included in the correspondence information 204.

[0102] If the determination in step S3 is "No," that is, if it is determined that the outer tube 50 has been used, the process proceeds to step S4. In step S4, the processor 200 performs control to prevent the balloon 60 of the outer tube 50 from inflating, and the process of this flowchart ends. The control to prevent the balloon 60 from inflating can be to prevent the supply of air from the balloon control device 120 to the balloon 60. Thus, the reuse of the outer tube 50 can be prevented.

[0103] If the determination in step S3 is "yes," that is, if it is determined that the outer tube 50 is not used, the process proceeds to step S5. In step S5, the processor 200 controls the inflation of the balloon 60, which is controlled by the outer tube 50. The control of allowing the balloon 60 to inflate may be the control of supplying air to the balloon 60 from the balloon control device 120. Thus, a leak test of the balloon 60 is performed. Furthermore, after the leak test, an endoscopic examination using the outer tube 50 can be performed.

[0104] Next, in step S6, the processor 200 updates the correspondence information 204 and ends the processing of this flowchart. The processor 200 can store the identification information 232 obtained in step S1 as the identification information 232 of the used outer sheath 50 in the memory 202, as an update to the correspondence information 204. The processing of step S6 is preferably performed after the endoscopy examination is completed.

[0105] By updating the corresponding relationship information 204, if the surgeon intends to reuse the same outer tube 50, it is determined that the outer tube 50 has been used, and the inflation of the balloon 60 is prohibited. Thus, the reuse of the outer tube 50 can be prevented.

[0106] Here, an example of connecting the outer tube 50 to the balloon control device 120 before performing the processing of this flowchart has been described, but it is also possible to connect the outer tube 50 to the balloon control device 120 after performing the processing of this flowchart. Even in this case, balloon inflation is prohibited when the outer tube 50 is in use, and balloon inflation is permitted when the outer tube 50 is not in use.

[0107] Thus, according to the medical device system of the first embodiment, by using the identification information 232 and the correspondence information 204, it is possible to determine whether the outer sheath 50 is unused. Therefore, it is possible to prevent the reuse of the used outer sheath 50.

[0108] Furthermore, even if balloon 60 inflation is prohibited in step S4, balloon 60 inflation can be permitted by the surgeon operating the allow button 210. That is, the processor 200 prioritizes the operation of the allow button 210 to allow balloon 60 inflation. Thus, as an exception, the outer tube 50 can be used in an emergency. In this case, the processor 200 can store the usage history of emergency use via the operation of the allow button 210 in the memory 202. Therefore, users other than the surgeon can monitor for misuse of the outer tube 50. Furthermore, the processor 200 can display the situation of emergency use via the operation of the allow button 210 on the display device 220.

[0109] <Second Implementation>

[0110] [Structure of Medical Device Systems]

[0111] Figure 6 This is a block diagram illustrating the electrical structure of the medical device system according to the second embodiment. The medical device system 2A includes an outer sheath 50A and a balloon control device 120A.

[0112] The identifier 230A of the outer casing 50A includes usage status information 234. Usage status information 234 indicates whether the outer casing 50A is unused. Usage status information 234 can represent either "unused" or "used" usage status of the outer casing 50A. Identifier 230A can be an RF-ID tag whose usage status information 234 is changed via contactless communication.

[0113] The balloon control device 120A includes a writing device 214. The writing device 214 is a means of adding, rewriting, and deleting usage status information 234 of the identifier 230A on the outer sleeve 50 in a non-contact manner. When the identifier 230A is an RF-ID tag, the writing device 214 can be an RF-ID writer. The processor 200 can change the usage status information 234 of the identifier 230 from "unused" to "used" via the writing device 214.

[0114] The balloon control device 120A may have the same enable button 210 and display device 220 as the balloon control device 120.

[0115] How Medical Device Systems Work

[0116] Figure 7 This is a flowchart illustrating the steps of the operation method of the medical device system according to the second embodiment.

[0117] In step S11, the processor 200 obtains usage status information 234 from the identifier 230A of the outer casing 50A. For example, the reading device 212 can obtain the usage status information 234 non-contactly with the identifier 230A and output the obtained usage status information 234 to the processor 200. Here, the usage status information 234 is information indicating either "unused" or "used" usage status of the outer casing 50A.

[0118] In step S12, the processor 200 determines whether the outer tube 50A is unused based on the usage status information 234 obtained in step S11. The processor 200 can determine that the outer tube 50A is unused if the usage status information 234 is "unused", and determine that the outer tube 50A is used if the usage status information 234 is "used".

[0119] If it is determined in step S12 that the outer tube 50A has been used, the process proceeds to step S13. In step S13, the processor 200 controls the inflation of the balloon 60 of the outer tube 50A to prevent inflation, and the process of this flowchart ends.

[0120] If it is determined in step S12 that the outer tube 50A is not used, the process proceeds to step S14. In step S14, the processor 200 controls the inflation of the balloon 60 of the outer tube 50A.

[0121] Next, in step S15, the processor 200 changes the usage status information 234 from "unused" to "used" by the writing device 214, and ends the processing of this flowchart. Thus, if the surgeon wants to use the same outer tube 50A again, it is determined that the outer tube 50A has been used, and the balloon 60 of the outer tube 50A is prohibited from inflating.

[0122] Thus, according to the medical device system of the second embodiment, by using the usage status information 234, it is possible to determine whether the outer sheath 50A is unused. Therefore, it is possible to prevent the reuse of the used outer sheath 50A.

[0123] <Third Implementation>

[0124] [Structure of Medical Device Systems]

[0125] Figure 8 This is a block diagram showing the electrical structure of the medical device system according to the third embodiment. The medical device system 2B includes an outer sheath 50B and a balloon control device 120B.

[0126] The outer sheath 50B includes a conductive component 236. The conductive component 236 has characteristic information indicating that it exhibits different conductive properties when the outer sheath 50B is unused and when it is in use. The conductive component 236 can exhibit conductive characteristics when the outer sheath 50B is unused and non-conductive characteristics when the outer sheath 50B is in use. The conductive component 236 can be a circuit, which includes a fuse or counter (not shown), and its state changes when energized, thereby changing its response characteristics.

[0127] The medical device system 2B includes a conductive wiring 238 that electrically connects the reading device 212 of the balloon control device 120B to the conductive component 236 of the outer sheath 50B. The balloon control device 120B, like the balloon control device 120, may also include an enable button 210 and a display device 220.

[0128] When the balloon control device 120B is connected to the outer tube 50B, the reading device 212 acquires characteristic information of the conductive component 236. The reading device 212 can read whether the conductive component 236 is conductive or non-conductive via the conductive wiring 238.

[0129] [Structure of conductive components]

[0130] Figure 9 This is a diagram illustrating an example of the conductive component 236 of the outer sheath 50B. Figure 9The diagram shows a cross-section of the air inlet 74 of the bayonet portion 70 connecting the outer sleeve 50B to one end of the connecting tube 100, which is a Luer lock type connector 300. The Luer lock type connector 300 includes a female Luer connector 302 connected to one end of the connecting tube 100 and a male Luer connector 304 connected to the air inlet portion 74.

[0131] Conductive wiring 238 is provided in the connecting tube 100 and the female Luer connector 302. Conductive wiring 238 includes a first wiring 238A and a second wiring 238B that respectively connect the air port 124 of the balloon control device 120B to the open end of the female Luer connector 302. The first wiring 238A and the second wiring 238B are input to the reading device 212 via the air port 124.

[0132] A conductive component 236 made of conductive material is disposed in the male Luer connector 304. The conductive component 236 is positioned in the male Luer connector 304 at a point abutting against the open end of the female Luer connector 302 and short-circuiting the first wiring 238A and the second wiring 238B. The conductive component 236 can be a metal foil attached to the male Luer connector 304 or a metal layer printed on the male Luer connector 304. The conductive component 236 constitutes a vulnerable part that is irreversibly damaged when a physical force is applied to the Luer lock connector 300.

[0133] With the outer sleeve 50B connected to the connecting tube 100, that is, with the female Luer connector 302 connected to the male Luer connector 304, the first wiring 238A and the second wiring 238B are short-circuited through the conductive component 236. Therefore, the reading device 212 can detect that the conductive component 236 exhibits continuity characteristics.

[0134] If the connection between the female Luer connector 302 and the male Luer connector 304 is removed from the state where they are connected, the conductive component 236 will break.

[0135] Then, even if the male Luer connector 304 of the used outer tube 50B is reconnected to the female Luer connector 302 of the connecting tube 100, the first wiring 238A and the second wiring 238B will not short-circuit due to the breakage of the conductive component 236. Therefore, the reading device 212 is able to detect that the conductive component 236 exhibits non-conductive characteristics.

[0136] Thus, the conductive component 236 has the following irreversible characteristic: it can switch from a first state that connects the first wiring 238A and the second wiring 238B to a second state that de-connects the first wiring 238A and the second wiring 238B, but it cannot switch from the second state back to the first state.

[0137] How Medical Device Systems Work

[0138] Figure 10 This is a flowchart illustrating the steps of the operation method of the medical device system according to the third embodiment.

[0139] In step S21, when the outer tube 50B is connected to the balloon control device 120B, the processor 200 acquires the conductivity characteristics of the conductive component 236 of the outer tube 50B. The reading device 212 can determine whether the conductive component 236 is conductive or non-conductive by detecting the continuity between the first wiring 238A and the second wiring 238B of the conductive wiring 238, and outputs the acquired conductivity characteristics to the processor 200.

[0140] In step S22, the processor 200 determines whether the outer sleeve 50B is unused based on the conduction characteristics obtained in step S21. The processor 200 can determine that the outer sleeve 50B is unused if the conduction characteristics are on, and determine that the outer sleeve 50B is used if the conduction characteristics are not on.

[0141] If it is determined in step S22 that the outer tube 50B has been used, the process proceeds to step S23. In step S23, the processor 200 controls the inflation of the balloon 60 of the outer tube 50B to prevent inflation and ends the process of this flowchart.

[0142] If it is determined in step S22 that the outer tube 50B is not used, the process proceeds to step S24. In step S24, the processor 200 controls the inflation of the balloon 60 of the outer tube 50B and ends the processing of this flowchart.

[0143] Thus, according to the medical device system of the third embodiment, by using the conductive properties of the conductive component 236, it can be determined that the outer sheath 50B has been used. Therefore, the reuse of the used outer sheath 50B can be prevented.

[0144] <First variation of the third embodiment>

[0145] [Structure of Medical Device Systems]

[0146] The electrical structure of the medical device system in the first modification of the third embodiment is the same as that of the medical device system 2B in the third embodiment. The conductive component 236 in the modification of the third embodiment exhibits different resistance characteristics when the outer sheath 50B is unused and when it is in use. The resistance value of the conductive component 236 when unused may be less than R [ohms], and the resistance value when in use may be greater than R [ohms].

[0147] In the Luer lock type connector 300 according to the third embodiment, if the connection between the female Luer connector 302 and the male Luer connector 304 is removed from the state of connection between the female Luer connector 302 and the male Luer connector 304, sometimes the broken conductive part 236 is attached to the female Luer connector 302.

[0148] Then, if the male Luer connector 304 of the used outer tube 50B and the female Luer connector 302 of the used connecting tube 100 are reconnected, it is possible that the first wiring 238A and the second wiring 238B will become conductive due to the conductive part 236 attached to the female Luer connector 302. However, in this case, the resistance value between the first wiring 238A and the second wiring 238B becomes an abnormal value. For example, when the outer tube 50B is not used, the resistance characteristic is less than R [ohms], and when the resistance value becomes an abnormal value due to the conductive part 236, the resistance characteristic is greater than R [ohms]. That is, the conductive part 236 exhibits different resistance characteristics when the outer tube 50B is not used and when it is used.

[0149] How Medical Device Systems Work

[0150] Figure 11 This is a flowchart illustrating the steps of the operation method of the medical device system according to the first modification of the third embodiment.

[0151] In step S31, the processor 200 acquires the conductivity characteristics of the conductive component 236 of the outer sheath 50B. The reading device 212 can acquire the resistance characteristics of the conductive component 236 connected via the conductive wiring 238 and output the acquired resistance characteristics to the processor 200.

[0152] In step S32, the processor 200 determines whether the outer tube 50B is unused based on the conduction characteristics obtained in step S32. The processor 200 can determine that the outer tube 50B is unused if the resistance characteristic is less than R [ohms], and determine that the outer tube 50B is used if the resistance characteristic is greater than R [ohms].

[0153] If it is determined in step S32 that the outer tube 50B has been used, the process proceeds to step S33. In step S33, the processor 200 controls the inflation of the balloon 60 of the outer tube 50B to prevent inflation, and the process of this flowchart ends.

[0154] If it is determined in step S32 that the outer tube 50B is not used, the process proceeds to step S34. In step S34, the processor 200 controls the inflation of the balloon 60 of the outer tube 50B and ends the processing of this flowchart.

[0155] Thus, according to the medical device system of the first modification of the third embodiment, it is possible to determine whether the outer sheath 50B is unused by using the resistance characteristics of the conductive component 236. Therefore, it is possible to prevent the reuse of the used outer sheath 50B.

[0156] <Second variation of the third embodiment>

[0157] The outer sheath 50B may also replace the conductive component 236 with an ID (Identifier) ​​chip (not shown). The ID chip is a semiconductor chip that stores inherent information, i.e., identification information, used to uniquely identify the outer sheath 50B. The reading device 212 can be communicatively connected to the conductive component 236 via a communication wiring (not shown). The determination of whether the outer sheath 50B using the identification information is unused can be implemented using correspondence information in the same way as in the first embodiment.

[0158] Thus, according to the medical device system of the second modification of the third embodiment, by using the identification information stored in the ID chip, it is possible to determine whether the outer sheath 50B is unused. Therefore, it is possible to prevent the reuse of the used outer sheath 50B.

[0159] <Fourth Implementation>

[0160] Figure 12 This is a side view of the outer sheath of the medical device system according to the fourth embodiment. The outer sheath 50C has identification information 232A containing information about the outer sheath 50C on the surface of the gripping portion 58. The identification information 232A can be a QR code. The location of the identification information 232A is not limited to the gripping portion 58, and can also be located at any other location on the outer sheath 50C besides the gripping portion 58.

[0161] The information contained in the identification information 232A has an irreversible property that it can transition from the first state to the second state, but cannot transition from the second state to the first state.

[0162] For example, identification information 232A is printed with ink whose visible light transmittance increases due to external effects. External effects refer to the action of at least one of moisture, oxygen, light, heat, and pressure. Increased visible light transmittance means a decrease in the concentration of the pigment contained in the ink. Ink whose visible light transmittance increases due to external effects can be a so-called disappearing ink. Furthermore, identification information 232A can also use ink whose color develops through external effects. In this case, by setting the low-concentration area to the same concentration as the high-concentration area through external effects, or by covering the entire identification information 232A, it can be made unreadable.

[0163] The information contained in the identification information 232A is in a first state, which is readable by the reading device 212 when the outer sleeve 50C is not used. If the outer sleeve 50C is used, the transmittance of visible light increases due to external forces affecting the ink on which the identification information 232A is printed. Therefore, the information contained in the identification information 232A becomes unreadable by the reading device 212, resulting in a second state. This second state can be described as the disappearance of the identification information 232A. The process does not transition from the second state to the first state.

[0164] Therefore, based on the identification information 232A read from the reading device 212, the processor 200 can determine whether the outer tube 50C is not in use. For example, if the identification information 232A cannot be read from the reading device 212, the processor 200 determines that the outer tube 50C is in use. In this case, the processor 200 performs control to prevent the balloon 60 of the outer tube 50C from inflating.

[0165] Furthermore, the identification information 232A can be covered by an ink whose visible light transmittance decreases due to external action. Decreased visible light transmittance refers to an increase in the concentration of colorant contained in the ink. The ink whose visible light transmittance decreases due to external action can be an ink that produces a dark color to the extent that it obscures the visual recognition of the identification information 232A covered by external action.

[0166] The information contained in the identification information 232A is in a first state, which is readable in the reading device 212 when the outer sleeve 50C is not used. If the outer sleeve 50C is used, the transmittance of visible light to the ink covering the identification information 232A decreases due to external forces. Therefore, the information contained in the identification information 232A becomes a second state, which is unreadable in the reading device 212. The second state can be a state where the identification information 232A is completely covered in a dark color. The process does not transition from the second state to the first state.

[0167] Therefore, based on the identification information 232A read from the reading device 212, the processor 200 can determine whether the outer tube 50C is not in use. For example, if the identification information 232A cannot be read from the reading device 212, the processor 200 determines that the outer tube 50C is in use. In this case, the processor 200 performs control to prevent the balloon 60 of the outer tube 50C from inflating.

[0168] Thus, according to the medical device system of the fourth embodiment, by using the identification information 232A that cannot be read in the reading device 212 through external action, it is possible to determine whether the outer tube 50C is unused. Therefore, the reuse of the used outer tube 50C can be prohibited.

[0169] <Fifth Implementation>

[0170] Figure 13 This is a perspective view of the base end of the outer sheath of the medical device system according to the fifth embodiment. Figure 13 As shown in Figure 1000, the base end opening 56 of the outer sleeve 50D is formed by a base end cap 320. The base end opening 56 is formed on the base end cap 320. A leak-proof valve 322 is provided inside the base end cap 320.

[0171] The anti-leak valve 322 is a valve component designed to prevent leakage at the insertion portion 14 of the endoscope 10 (see reference). Figure 1 ) Insert the connecting pipe 62 into the outer sleeve 50D (reference) Figure 3 When the insertion part 14 is inserted into the body in the state described above, bodily fluids (liquids) flowing into the body from the front end of the insertion tube 62 flow out from the base opening 56. The leak-proof valve 322 is composed of an elastic member, and an opening 324 for inserting the insertion part 14 is formed in its center. When the insertion part 14 is inserted into the insertion tube 62, the leak-proof valve 322 seals tightly against the outer peripheral surface of the insertion part 14, thereby preventing bodily fluids from flowing out through the insertion tube 62.

[0172] like Figure 13 As shown in 1001, in the unused outer sleeve 50D, in the opening 324 of the leak-proof valve 322 of the plugged base cap 320 (in Figure 13 An attachment component 330 is attached to a location (not shown in 1001). The location where the attachment component 330 is attached is not limited to the location where the opening 324 of the leak-proof valve 322 is blocked, but can also be the location where it is peeled off when using the outer sleeve 50D.

[0173] The attachment component 330 has an adhesive layer (not shown) on one side, which is used to attach it to the base cap 320. Furthermore, the attachment component 330 has identification information 232B printed on its other side, containing information about the outer sleeve 50D. The identification information 232B may be a QR code. The attachment component 330 may also be a so-called opening seal capable of determining whether the attachment has peeled off.

[0174] The information contained in the identification information 232B has the irreversible property of being able to transition from state 1 to state 2, but not from state 2 to state 1.

[0175] The information contained in identification information 232B is in a first state that can be read in the reading device 212 when the attachment part 330, indicating that the outer sleeve 50D is not in use, is attached to the base end cap 320. If the attachment part 330 is peeled off from the base end cap 320 when the outer sleeve 50D is in use, the identification information 232B printed on the attachment part 330 is deformed or damaged. As a result, the information contained in identification information 232B becomes a second state that cannot be read in the reading device 212. It does not transition from the second state to the first state.

[0176] Therefore, based on the result of reading the identification information 232B in the reading device 212, the processor 200 can determine that the outer tube 50D is not in use. For example, if the identification information 232B cannot be read in the reading device 212, the processor 200 determines whether the outer tube 50D is in use. In this case, the processor 200 performs a function to disable the outer tube 50D using the balloon 60 ( Figure 13 (Not shown in the diagram) Control of expansion.

[0177] Thus, according to the medical device system of the fifth embodiment, by using the identification information 232B indicating deformation or damage during use, it is possible to determine whether the outer sheath 50D is unused. Therefore, it is possible to prevent the reuse of the used outer sheath 50D.

[0178] <Sixth Implementation>

[0179] Figure 14 This is a perspective view of the balloon control device included in the medical device system according to the sixth embodiment. The balloon control device 120C includes a remote operating device 216 for remotely operating the balloon control device 120C. The balloon control device 120C and the remote operating device 216 are communicatively connected via a cable 218. The remote operating device 216 can remotely operate the balloon control device 120C via wireless communication.

[0180] The remote operating device 216 is equipped with various operating components such as operating buttons. An enable button 210 may be provided in the remote operating device 216 (see reference). Figure 4 ).

[0181] Furthermore, the remote operation device 216 includes a reading device 212. The reading device 212 may be an RF-ID reader or a code reader that reads the identification information 232 in a non-contact manner. The reading device 212 may be a device that is electrically connected to the conductive component 236 to read whether the conductive component 236 is conducting or not, or a device that reads the resistance value of the conductive component 236.

[0182] Thus, according to the medical device system of the sixth embodiment, by having the reading device 212 provided in the remote operation device 216, information for determining whether the outer sheath 50 is not in use can be easily obtained.

[0183] <Seventh Implementation>

[0184] The processor 200 can control the display of a warning message prohibiting the use of the outer tube 50 on the display device 220 as an action control when it is determined that the outer tube 50 has been used.

[0185] Figure 15 This diagram illustrates the display content of the display device included in the medical device system according to the seventh embodiment. A warning display 222 indicating that the outer sleeve 50 has been used is displayed on the display device 220A. The warning display 222 can be displayed on a display device connected to an endoscope processor device.

[0186] Thus, according to the medical device system of the seventh embodiment, by displaying warning display 222, the surgeon can identify that the outer tube 50 has been used and prohibit the further use of the outer tube 50.

[0187] <Processor>

[0188] In each implementation, the various processes are executed by any computer. Furthermore, any computer can execute these processes via a processor, a program, or a combination thereof. This arbitrary computer can be a general-purpose computer, a purpose-built computer, a workstation, or other hardware capable of executing programs.

[0189] A processor can consist of one or more hardware components, and there are no restrictions on the type of hardware. For example, a processor can be composed of programmable logic devices such as CPU (Central Processing Unit), MPU (Micro Processing Unit), FPGA (Field Programmable Gate Array), ASIC (Application Specific Integrated Circuit) and other dedicated circuits for performing specific processing, GPU (Graphics Processing Unit) or NPU (Neural Processing Unit), etc.

[0190] Furthermore, the processor has units or means that execute various processes in each embodiment. The hardware can be a combination of different types of hardware. When multiple hardware components are configured to execute one or more processes of a processor, these multiple hardware components can exist in physically separate devices or in the same device. Furthermore, in any embodiment, the order of the processes performed by the processor is not limited to the above order and can be appropriately varied. Additionally, the hardware is composed of circuits, such as those combining semiconductor elements.

[0191] Furthermore, each implementation can be carried out using hardware, software, firmware, microcode, or a combination thereof. Software, firmware, and microcode consist of programs. Furthermore, a program can be, for example, a group of program modules, each of which can be implemented by a processor configured to perform its respective function. A program can also be program code and multiple code segments stored on one or more non-transitory computer-readable media (e.g., storage media and other storage devices). A program can also be segmented and stored on multiple non-transitory computer-readable media existing in physically separate devices. Program code or code segments can represent any combination of procedures, functions, subroutines, routines, subroutines, modules, software packages, classes, or commands, data structures, or program statements. Program code or code segments can also be connected to other code segments or hardware circuitry by sending and receiving information, data, arguments, parameters, or memory contents.

[0192] <Examples of applicability to programs and program products>

[0193] The operating method of the medical device system involved in each embodiment can be configured as a program or program product that enables a processor or a computer containing a processor to perform the functions of each step. A program product refers to a tangible, non-transitory information storage medium, i.e., a computer-readable medium, on which a program is recorded.

[0194] The program that enables the computer to perform some or all of the processing functions in the balloon control device is recorded on an optical disc, a magnetic disk, or other tangible, non-transitory storage medium, i.e., a computer-readable medium, and is provided through that storage medium.

[0195] Furthermore, instead of providing the program by storing it in a tangible, non-transitory computer-readable medium, the program signal can be provided as a download service via telecommunications lines such as the Internet.

[0196] <Other>

[0197] Thus far, an example of the outer cannula 50 as an insertion aid has been described as a "medical device" of the present invention. However, the reuse prevention technology of the present invention can also be preferably applied to disposable medical devices other than the outer cannula 50. For example, the "medical device" of the present invention can also be an endoscope 10. The endoscope 10 may include at least one of the following: identifier 230, identifier 230A, conductive component 236, identification information 232A, and identification information 232B. The processor 200 can control the balloon 40 to prevent its inflation when it is determined that the endoscope 10 has been used, thereby preventing the endoscope 10 from being reused.

[0198] The scope of the present invention is not limited to the scope described in the above embodiments. Without departing from the spirit of the present invention, the structures and other components of each embodiment can be appropriately combined between the embodiments.

Claims

1. A medical device system comprising: Medical devices, inserted into the body; and Control device, having a processor The medical device has information for determining whether the medical device is not in use. The processor performs the following processing: Obtain the information from the medical device; Based on the information provided, determine whether the medical device is not in use; and If it is determined that the medical device has been used, action control is performed to prohibit the further use of the medical device.

2. The medical device system according to claim 1, wherein, The medical device has an insertion component that is inserted into the body and a balloon disposed in the insertion component. When the processor determines that the medical device has been used, it controls the balloon to prevent inflation as part of the action control.

3. The medical device system according to claim 1, wherein, The information is identification information for the medical device.

4. The medical device system according to claim 3, wherein, The control device has a memory. The memory stores correspondence information indicating whether the medical device corresponding to the identification information is not in use.

5. The medical device system according to claim 4, wherein, The processor determines whether the medical device is not in use based on the identification information and the corresponding relationship information obtained from the medical device.

6. The medical device system according to claim 1, wherein, The information refers to the usage status information indicating whether the medical device is not in use. The processor determines whether the medical device is not in use based on the usage status information.

7. The medical device system according to claim 6, wherein, The processor can change the usage status information set on the medical device from unused to used.

8. The medical device system according to claim 1, wherein, The control device has a reading device for reading the information in a non-contact manner.

9. The medical device system according to claim 1, wherein, The processor acquires the information when the medical device is connected to the control device.

10. The medical device system according to claim 9, wherein, The medical device has conductive components. The conductive component has characteristic information indicating that it exhibits different conductive properties when the medical device is not in use and when it is in use. When the medical device is connected to the control device, the processor determines whether the medical device is not in use based on the characteristic information obtained from the medical device.

11. The medical device system according to claim 10, wherein, The conductive component exhibits conductive characteristics when the medical device is not in use, and non-conductive characteristics when the medical device is in use.

12. The medical device system according to claim 10, wherein, The conductive components exhibit different resistance characteristics when the medical device is not in use and when it is in use.

13. The medical device system according to claim 1, wherein, The information has the irreversible characteristic of being able to transition from the first state to the second state, but not from the second state back to the first state.

14. The medical device system according to claim 13, wherein, The processor determines that the medical device is not used when the information is in the first state, and determines that the medical device is used when the information is in the second state.

15. The medical device system according to claim 13, wherein, The control device has a reading device that reads the information using an optical sensor. The information is printed using ink whose transmittance of visible light is increased through external processes. When the ink is subjected to the external action, the information changes from the first state, which can be read by the reading device, to the second state, which cannot be read by the reading device.

16. The medical device system according to claim 13, wherein, The control device has a reading device that reads the information using an optical sensor. The information is covered by ink whose transmittance of visible light is reduced by external action. When the ink is subjected to the external action, the information changes from the first state, which can be read by the reading device, to the second state, which cannot be read by the reading device.

17. The medical device system according to claim 13, wherein, The control device includes a reading device that reads the information using an optical sensor. The information is displayed on the attachment component. When the adhesive component attached to the medical device is detached from the medical device, the information transitions from the first state, which can be read by the reading device, to the second state, which cannot be read by the reading device.

18. The medical device system according to claim 1, wherein, The medical device system has a remote operation device for remotely operating the control device. The remote operating device has a reading device for reading the information.

19. The medical device system according to claim 1, wherein, The medical device system includes a display device. When the processor determines that the medical device has been used, it controls the display device to show a warning message prohibiting further use of the medical device as part of the action control.

20. The medical device system according to any one of claims 1 to 19, wherein, The medical device has an insertion pathway that allows other medical devices different from the medical device to be inserted.

21. The medical device system according to claim 20, wherein, The medical device system includes the other medical devices.

22. The medical device system according to claim 21, wherein, The other medical device mentioned is an endoscope.

23. The medical device system according to any one of claims 1 to 19, wherein, The medical device is an endoscope.

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