Medical device, connection tube and medical device system

Abstract

The present invention provides a medical device, a connecting tube, and a medical device system that renders a used medical device unusable. The medical device (outer tube (50)) inserted into the body has the following structure: the state changing part (thin-walled part (160)) can change from the state before damage (first state) to the state after damage (second state), but cannot change from the second state to the first state.

Description

Technical Field

[0001] This invention relates to a medical device, a connecting tube, and a medical device system that can be 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 tube disclosed in Patent Document 1 is discarded after use because it becomes contaminated with bodily fluids during surgery. However, since the outer tube can sometimes be removed from the insertion point after use without damaging its shape and function as an outer tube, it is sometimes reused.

[0007] Here, issues relating to the outer sheath as a specific example of a medical device have been explained, but the same issues may also occur in other medical devices besides the outer sheath. Summary of the Invention

[0008] The present invention was made in view of this situation, and its object is to provide a medical device, connecting tube and medical device system that renders an already used medical device unusable.

[0009] The medical device according to the first aspect of the present invention is inserted into the body to achieve the above-mentioned purpose. The medical device has a state changing part that can switch from a first state to a second state, but cannot switch from a second state to a first state.

[0010] In the first embodiment of the medical device, the state-changing part of the second embodiment of the present invention can be switched from a first state to a second state by physical or chemical action that is associated with the use of the medical device.

[0011] In the third aspect of the present invention, the medical device, in the first or second aspect, has a state-changing part composed of a fragile part that can be irreversibly deformed or destroyed when a physical force is applied.

[0012] In the third aspect, the medical device according to the fourth aspect of the present invention has a vulnerable part provided on a fixing part that is fixed to other components. The first state is the state before the vulnerable part is deformed or destroyed and the connection with other components is fixed. The second state is the state after the vulnerable part is deformed or destroyed and the connection with other components has been released.

[0013] In the second aspect, the state-changing part of the medical device according to the fifth aspect of the present invention is composed of a liquid-soluble component that can dissolve when given a dissolving liquid.

[0014] The medical device according to the sixth aspect of the present invention, in the fifth aspect, includes: a first conduit for insertion into other medical devices different from the medical device; and a second conduit separately configured from the first conduit, wherein a leakage hole sealed by a liquid-soluble component is provided in the second conduit.

[0015] The medical device according to the seventh aspect of the present invention, in the sixth aspect, includes an inflatable and contractible balloon, a second conduit for supplying and venting air to the balloon, and a leakage hole for connecting the second conduit and the first conduit.

[0016] In the second aspect, the medical device according to the eighth aspect of the present invention has a state-changing section consisting of an expansion section that can irreversibly expand through an expansion medium.

[0017] In the 8th aspect, the medical device according to the 9th aspect of the present invention has a first conduit for insertion of other medical devices different from the medical device, and the expansion portion has a hole that forms part of the first conduit. The first state is the state before the expansion portion expands, and the hole is the size that allows other medical devices to be inserted. The second state is the state after the expansion portion expands, and the hole is the size that prevents other medical devices from being inserted.

[0018] The medical device according to the tenth aspect of the present invention, in the eighth or ninth aspect, includes a valve body disposed in the first pipeline to prevent fluid from flowing out to the outside, and at least a portion of the valve body is composed of an expansion portion.

[0019] In the second aspect, the medical device according to the eleventh aspect of the present invention includes a first conduit for insertion into other medical devices different from the medical device. The state change section is composed of a coating portion disposed on the inner wall surface of the first conduit and capable of being dissolved by a liquid. The first state is the state before the coating portion dissolves and the coating portion has a thickness that allows other medical devices to move in and out of the first conduit. The second state is the state after at least a portion of the coating portion dissolves and the coating portion has a thickness that prevents other medical devices from moving in and out of the first conduit.

[0020] In any of the first to eleventh embodiments of the present invention, the medical device is an insertion aid for guiding another medical device, different from the medical device, into the body.

[0021] The connecting tube according to the 13th aspect of the present invention connects a medical device having a balloon inserted into the body and a balloon control device for inflating and deflating the balloon. The connecting tube has a state changing section that can switch from a first state to a second state, but cannot switch from a second state to a first state.

[0022] In the 13th embodiment, the connecting tube according to the 14th embodiment of the present invention can be switched from the first state to the second state by physical or chemical action associated with the use of the medical device.

[0023] In the 13th or 14th embodiment of the present invention, the connecting tube of the 15th embodiment of the present invention has a first connecting portion for connecting to a medical device, and a state change portion is provided on the first connecting portion.

[0024] In any of the 13th to 15th embodiments of the present invention, the connecting tube of the 16th embodiment of the present invention has a second connecting portion connected to the balloon control device, and a state change portion is provided in the second connecting portion.

[0025] In any of the 13th to 16th embodiments, the connecting tube involved in the 17th embodiment of the present invention is integrally formed with the medical device.

[0026] The medical device system according to the 18th aspect of the present invention includes the medical device according to any one of the 1st to 11th aspects, wherein the medical device is an insertion aid for guiding other medical devices different from the medical device into the body, and the medical device system also includes other medical devices.

[0027] In the 18th embodiment, the other medical device involved in the medical device system of the 19th embodiment of the present invention is an endoscope.

[0028] The medical device system according to the 20th aspect of the present invention comprises: a connecting tube according to any one of the 13th to 17th aspects; a medical device; and a balloon control device.

[0029] In the 20th embodiment, the medical device system according to the 21st embodiment of the present invention is an insertion aid for guiding other medical devices, different from the medical device, into the body.

[0030] In the 21st embodiment, the other medical device involved in the medical device system of the 22nd embodiment of the present invention is an endoscope.

[0031] Invention Effects

[0032] According to the present invention, it is possible to render a medical device that has already been used unusable. Attached Figure Description

[0033] Figure 1 This is a system structure diagram of the endoscope system involved in the implementation method.

[0034] Figure 2 This is a side view of the outer tube.

[0035] Figure 3 This is a cross-sectional view of the outer tube with the insertion part in the open position.

[0036] Figure 4 This is a 3D view of the connector that connects the outer tube and the connecting tube.

[0037] Figure 5 yes Figure 4 The connector shown is a cross-sectional view.

[0038] Figure 6 yes Figure 4 The diagram illustrates that the connector has been damaged.

[0039] Figure 7 This is a 3D view of the connector that connects the outer tube and the connecting tube.

[0040] Figure 8 This is an enlarged sectional view of the main part of the outer tube.

[0041] Figure 9 This is a 3D view of the leak-proof valve installed on the outer casing.

[0042] Figure 10 This is a cross-sectional view of the main part of the connector that connects the outer tube and the connecting tube.

[0043] Figure 11 yes Figure 10 An enlarged cross-sectional view of the main part of the connector shown.

[0044] Figure 12This is a 3D assembly diagram of the connector that connects the outer tube and the connecting tube.

[0045] Figure 13 It is shown in cross-section Figure 12 The diagram illustrates the operation of the connector.

[0046] Figure 14 This is a structural diagram showing a portion of the connector that connects the outer sleeve and the connecting tube in cross-section.

[0047] Figure 15 yes Figure 14 A 3D view of the connector shown.

[0048] Figure 16 It means Figure 14 An enlarged perspective view of the main structural components of the drive mechanism of the locking pawl shown.

[0049] Figure 17 This is an enlarged 3D view of the main part of the connector that connects the outer tube and the connecting tube.

[0050] Figure 18 This is a cross-sectional view of a Luer lock type connector that connects the outer tube and the connecting tube.

[0051] Figure 19 yes Figure 18 A perspective view of the connector housing shown.

[0052] Figure 20 This is an illustration of a ratchet-type connector that connects the outer tube and the connecting tube.

[0053] Figure 21 This is a cross-sectional view of a Luer lock type connector that connects the outer tube and the connecting tube.

[0054] Figure 22 This is a cross-sectional view of the main part of the outer tube equipped with a water-absorbing kit.

[0055] Figure 23 This is an explanatory diagram showing the attachment position of the pressure measuring membrane in the outer tube.

[0056] Explanation of reference numerals in the attached figures:

[0057] 1-Endoscope system, 10-Endoscope, 12-Handheld operating part, 14-Insertion part, 14A-Outer peripheral surface, 16-Universal cable, 18-Connector device, 20-Front end, 22-Air / 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 port, 50-Outer sleeve, 52-Tube body, 52A-Outer peripheral surface, 52B-Inner peripheral surface, 54-Tip opening, 55-Front end, 56-Base opening, 58-Holding part, 60-Balloon, 60A-Tube part, 60B-Tube part, 60C-Bulging part, 62-Insertion tube, 64-Air tube, 65-Orifice, 66-Liquid tube, 6 8-Ventilation port, 70-Hook-and-loop part, 72-Air line, 74-Air supply port, 76-Tube, 78-Liquid line, 80-Liquid supply port, 82-Adhesive fixing part, 84-Adhesive fixing part, 100-Connecting tube, 100A-Connecting part, 100B-Connecting part, 102-Flange part, 110-Connecting tube, 120-Balloon control device, 122-Air port, 124-Air port, 150-Connector, 152-Cylinder part, 152A-End, 152B-End, 154-Knob part, 156-Fixing groove part, 158-Slit part, 160-Thin wall part, 170-Connector, 172-Cylinder part, 174-Connecting port, 176-Plug body, 178-Knob part, 180-Slot, 182- Fractured part, 190-bolt body, 200-leakage prevention valve, 202-sheet, 210-connector, 212-connector, 212A-outer peripheral surface, 214-connector, 216-slide cylinder, 216A-inner peripheral protrusion, 216B-inner peripheral recess, 218-anti-detachment component, 218A-base, 218B-connecting part, 218C-claw, 220-shaft part, 222-outer peripheral inclined surface, 224-protrusion, 226-recess, 240-connector, 242-connector, 244-threaded cylinder, 246-connector, 248-protruding part, 250-protruding part, 252-through hole, 254-external thread, 256-ball, 260-claw, 262-recess, 264-protrusion, 266-recess, 2 68 - Internal thread, 270 - O-ring, 272 - V-groove, 274 - Flange, 280 - Connector, 282 - Connector, 284 - Connector, 286 - Connection opening, 288 - Locking claw, 290 - Button, 292 - Cover, 294 - Drive mechanism, 296 - Locking piece, 298 - Arm, 300 - Guide pin, 302 - Spring support, 304 - Rod, 306 - Claw, 308 - Engaging part, 310 - Pipe, 312 - Base, 314 - Guide groove, 316 - Spring, 318 - Abutment, 320 - Through hole, 330 - Connector, 332 - Connector, 334 - Connector, 336 - Damaged bridge, 340 - Connector, 342 - Connector, 343 - Flange344-Connector, 346-Housing, 347-Claw, 348-Connecting part, 350-Connecting part, 352-Damaged part, 354-Slit, 356-Gap, 360-Connector, 362-Gear, 364-Claw, 366-Claw, 368-Connecting passage, 370-Connector, 372-Luer connector, 374-Luer connector, 376-Sealing component, 378-Sealing component, 380-Pointed component, 382-Pointed component, 390-Absorbent kit, 392-Tube, 394-Absorbent sponge, 395-Hole, 396-Reservoir, 398-Insertion port, 400-Leak-proof valve, 410-Pressure measuring diaphragm, A-Central shaft, a-Groove, b-Groove, c-Groove, F1-Spring force, F2-Spring force. Detailed Implementation

[0058] Hereinafter, embodiments of the medical device, connecting tube, and medical device system involved in the present invention will be described with reference to the accompanying drawings. Figure 1 This is a system structure diagram of the endoscope system 1 involved in the implementation method.

[0059] like Figure 1 As shown, the endoscope system 1 includes an endoscope 10, an outer tube 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.

[0060] [Endoscope]

[0061] 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 another example of a medical device according to the present invention.

[0062] 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.

[0063] 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. A display (not shown) is connected to the image processing device to display the image processed by the image processing device.

[0064] If 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 monitor as an image of the observation area.

[0065] The handheld operating unit 12 is equipped with an air / water supply button 22, a suction button 24, two corner buttons 26, and a treatment device insertion part 28.

[0066] 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 two curved buttons 26 provided on the hand-held operating part 12. This allows the front end portion 20 to be oriented in a desired direction.

[0067] 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.

[0068] 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.

[0069] For endoscope 10, if balloon control device 120 switches to air supply operation, air from balloon control device 120 is introduced from air port 122 through connecting tube 110 to air port 44 of connector device 18. The air introduced into air port 44 is ejected from vent hole 42 through air supply and exhaust tube into the interior of balloon 40. As a result, balloon 40 inflates.

[0070] On the other hand, for the endoscope 10, if the balloon control device 120 switches to air suction operation, the air inside the balloon 40 is drawn into the balloon control device 120 from the vent 42 through the air supply and exhaust pipe, the air port 44, the connecting pipe 110, and the air port 122. As a result, the balloon 40 contracts.

[0071] [Outerwear]

[0072] Figure 2 This is a side view of the outer tube 50. Furthermore, Figure 3 This is a cross-sectional view of the outer sleeve 50 with the insertion portion 14 inserted. The outer sleeve 50 is used to guide the insertion portion 14 of the endoscope 10 into the body. Furthermore, the outer sleeve 50 is an example of the medical device and insertion aid of the present invention.

[0073] 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.

[0074] 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 balloon 60 is an example of a balloon included in the medical device of the present invention.

[0075] Furthermore, the tube body 52 has an outer peripheral surface 52A and an inner peripheral surface 52B, and an insertion passage 62 for the insertion portion 14 of the endoscope 10 to pass through is formed through the inner peripheral surface 52B. In addition, the insertion passage 62 is an example of the first passage of the present invention.

[0076] Furthermore, the tube body 52 includes an air conduit 64. The air conduit 64 extends from the base end of the tube body 52 towards 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 communicates with a vent 68. The vent 68 is a connecting hole that connects the outer peripheral surface 52A located inside the balloon 60 with the air conduit 64. Additionally, the air conduit 64 is an example of the second conduit of the present invention.

[0077] Furthermore, the tube body 52 includes a liquid conduit 66. The liquid conduit 66 is a connecting hole at the base end of the tube body 52 that connects the outer peripheral surface 52A and the inner peripheral surface 52B. The liquid conduit 66 is a conduit for supplying lubricant such as water to the insertion conduit 62 of the tube body 52. ​​When lubricant is supplied to the insertion conduit 62, the lubricant is located in the gap between the inner peripheral surface 52B of the tube body 52 and the outer peripheral surface 14A of the insertion portion 14 inserted into the insertion conduit 62.

[0078] Furthermore, a lubricating coating 53 is formed on the inner circumferential surface 52B of the tube body 52, which serves as the inner wall surface of the insertion conduit 62. The coating 53 and the aforementioned lubricant reduce the frictional resistance between the inner circumferential surface 52B of the tube body 52 and the outer circumferential surface 14A of the insertion part 14 inserted into the insertion conduit 62, thus facilitating the insertion of the insertion part 14 into the insertion conduit 62.

[0079] 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.

[0080] A connection is made to the air inlet 74. Figure 1 The connecting tube 100 shown has a connecting portion 100A at one end. Then, the connecting portion 100B at the other end of the connecting tube 100 is connected to the air port 124 of the balloon control device 120. Furthermore, the connecting tube 100 is an example of the connecting tube of the present invention. Moreover, the connecting portion 100A of the connecting tube 100 is an example of being connected to the first connecting portion of the medical device of the present invention, and the connecting portion 100B of the connecting tube 100 is an example of being connected to the second connecting portion of the balloon control device of the present invention.

[0081] 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.

[0082] 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.

[0083] A portion of the front end of the tube 60A folds back towards the base end of the outer tube 50. This folded-back portion of the front end of the tube 60A is fixed to the outer peripheral surface 52A of the tube body 52 by an adhesive fixing part 82 made of 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 folded-back portion of the front end of the tube 60A and its surrounding outer peripheral surface 52A. Furthermore, the adhesive fixing part 82 is formed inside the balloon 60 and is therefore not exposed to the outside.

[0084] A portion of the base end of the tube 60B folds back towards the front end of the outer tube 50. 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 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 portion of the folded-back base end of the tube 60B and its surrounding outer peripheral surface 52A. Furthermore, the adhesive fixing portion 84 is formed on the outside of the balloon 60 and is therefore exposed to the outside.

[0085] Regarding the outer tube 50 with the above-described structure, if 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.

[0086] On the other hand, regarding the outer tube 50, if 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, connecting pipe 100, and air outlet 124 to the balloon control device 120. As a result, the balloon 60 contracts. Furthermore, the balloon control device 120 is an example of the balloon control device of the present invention.

[0087] 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.

[0088] Here, an example of the flow configuration (the configuration when the product is shipped) of the outer sleeve 50 and the connecting sleeve 100 will be explained.

[0089] First, the first flow configuration is one in which the outer sleeve 50 and the connecting pipe 100 are integrally formed as a single component. In this configuration, the air inlet 74 of the outer sleeve 50 and the connection portion 100A of the connecting pipe 100 are pre-connected.

[0090] Next, the second flow configuration is one in which the outer sleeve 50 and the connecting sleeve 100 flow as separate items. In this configuration, when using the outer sleeve 50, the air inlet 74 of the outer sleeve 50 is connected to the connecting portion 100A of the connecting sleeve 100.

[0091] Next, several embodiments for rendering the used outer sleeve 50 unusable will be described. These embodiments are achieved by providing a state-changing section in the outer sleeve 50 or the connecting pipe 100. As will be described later, a state-changing section refers to a component or part that can be switched from a first state to a second state but cannot be switched from a second state to a first state, which corresponds to the state-changing section of the present invention. Hereinafter, several embodiments with a state-changing section will be described, but in these embodiments, the outer sleeve 50 and the connecting pipe 100 will be referred to by the same reference numerals.

[0092] [Implementation Method 1]

[0093] exist Figures 4 to 6 The first embodiment of implementation method 1 is shown in the figure. Figure 4 This is a perspective view of the connector 150 that connects the outer sleeve 50 and the connecting tube 100. Figure 5 yes Figure 4 The diagram shows a cross-sectional view of the connector 150, and also a cross-sectional view of the connection portion 100A including the connecting tube 100. Figure 6 This is an explanatory diagram showing the state of the connecting tube 100 being removed from the connector 150.

[0094] In this example, the outer sleeve 50 has a connector 150 on its air inlet 74. The connector 150 functions as one of the components constituting the outer sleeve 50.

[0095] like Figure 4 and Figure 5 As shown, the connector 150 has a cylindrical portion 152, which, for example, is made of plastic material.

[0096] At one end 152A of the cylindrical portion 152, the air inlet portion 74 of the outer sleeve 50 is connected by a fixing component such as an adhesive. Thus, a connector 150 is provided on the air inlet portion 74.

[0097] An annular fixing groove 156 is formed on the inner periphery of the cylindrical portion 152, and a flange portion 102 provided on the connecting portion 100A of the connecting pipe 100 is fitted into the fixing groove 156. The flange portion 102 is fitted into the fixing groove 156 by pressing it in from the opening on the end 152B side of the cylindrical portion 152 toward the opening on the end 152A side.

[0098] The connecting portion 100A of the connecting tube 100 is connected to the connector 150 by fitting the flange portion 102 into the fixing groove portion 156. Thus, the outer sleeve 50 and the connecting tube 100 are connected via the connector 150, and the outer sleeve 50 and the connecting tube 100 are integrally formed. Furthermore, the flange portion 102 is an example of another component, and the fixing groove portion 156 is an example of a fixing portion for fixing connections to other components of the present invention.

[0099] A knob portion 154 is provided extending laterally at the end 152B of the cylindrical portion 152. The knob portion 154 is provided on the cylindrical portion 152 via two cutouts 158 formed on both sides of the knob portion 154.

[0100] Two destructible thin-walled portions 160 are formed on the cylindrical portion 152, extending from two cutouts 158 toward the end portion 152A. The two thin-walled portions 160 are disposed radially on the outer side of the fixing groove 156 of the cylindrical portion 152. Furthermore, the thin-walled portions 160 are an example of the state-changing portion of the present invention, and an example of a fragile portion that is irreversibly destructible when subjected to the physical force of the present invention.

[0101] According to the connector 150 with the above structure, such as Figure 6 As shown, if the knob portion 154 is pinched and pulled with fingers, starting from the two cut portions 158, the two thin-walled portions 160 split open from the end portion 152B toward the end portion 152A, and a portion of the fixing groove portion 156, which is fitted with the flange portion 102, disengages from the flange portion 102. Thus, the connecting tube 100 can be removed from the connector 150.

[0102] Thus, the thin-walled portion 160 changes from a state before destruction and in which the connection with the flange portion 102 is fixed (first state) to a state after destruction and in which the connection with the flange portion 102 is released (second state).

[0103] That is, the thin-walled portion 160 transitions from the first state to the second state by the destructive effect generated when it is released from its fixation to the flange portion 102 (a physical effect associated with the use of the outer sleeve 50). However, the thin-walled portion 160 cannot transition from the second state to the first state. In other words, if the thin-walled portion 160 is damaged, it will not return to its state before the damage.

[0104] Therefore, according to Figures 4 to 6 The outer tube 50 of the embodiment shown in the figure has a structure in which the thin-walled portion 160 of the connector 150 can transition from the first state before damage to the second state after damage, but cannot transition from the second state to the first state, so that the used outer tube 50 can no longer be used.

[0105] Furthermore, by observing the connector 150 where the thin-walled portion 160 is damaged, the surgeon can identify whether the outer tube 50 connected to the connector 150 is no longer usable (i.e., whether the outer tube 50 is unused or used).

[0106] In addition, Figures 4 to 6In the embodiment shown, the connector 150, whose thin-walled portion 160 has been damaged and rendered unusable, remains in the air inlet portion 74 of the outer sleeve 50. Therefore, the outer sleeve 50 can no longer be used, but the connecting tube 100 can still be used.

[0107] and, Figures 4 to 6 In the embodiment shown, the connector 150 is provided at the air inlet 74 of the outer tube 50, but it is not limited thereto; the connector 150 may also be provided at the connection portion 100A of the connecting tube 100. In this case, the unusable connector 150 remains in the connection portion 100A of the connecting tube 100, thus enabling identification of whether the connecting tube 100 is no longer usable. Furthermore, in the outer tube 50, the connector 150 detaches from the air inlet 74, thus enabling identification of whether the outer tube 50 is no longer usable.

[0108] exist Figure 7 The second embodiment of implementation method 1 is shown in the figure. Figure 7 In the illustrated embodiment, also with Figures 4 to 6 Similarly, in the embodiments shown, the used outer tube or connecting tube becomes unusable by destroying the vulnerable part of the connector.

[0109] Figure 7 The connector 170 shown has a connection portion 100A on the connecting tube 100 and functions as one of the constituent components of the connecting tube 100. The connecting tube 100 flows in a state where the connector 170 is connected to the connection portion 100A. That is, in Figure 7 In the second embodiment shown, the connecting tube 100 and the outer tube 50, which are connected by the connector 170, circulate as different items from each other.

[0110] like Figure 7 As shown, the connector 170 includes a cylindrical portion 172 made of plastic material and a plug 176 with a connection port 174 formed at one end of the cylindrical portion 172. The connector 170 has an air inlet 74 of an outer sleeve 50 connected to the connection port 174, which is opened through the plug 176 (see reference). Figure 2 ).

[0111] A knob portion 178 extends from the plug body 176. Furthermore, a fracture portion 182, having two grooves 180, is provided on the cylindrical portion 172 and connected to the plug body 176. The two grooves 180 of the fracture portion 182 are formed at intervals approximately the same width as the knob portion 178, extending from the flange 184 on the other end side of the plug body 176 toward the cylindrical portion 172. Additionally, the grooves 180 are an example of a state-changing portion of the present invention, and an example of a fragile portion that is irreversibly destructible when subjected to the physical force of the present invention.

[0112] According to the connector 170 with the above structure, as Figure 7 As shown, if the knob 178 is pinched and pulled with fingers, the two grooves 180 split open toward the flange 184, the plug 176 disengages from the connection port 174, and the connection port 174 is opened. Thus, the air inlet 74 of the outer sleeve 50 can be connected to the connection port 174.

[0113] Thus, the groove 180 transitions from the state before destruction (state 1) to the state after destruction (state 2).

[0114] That is, the groove 180 transitions from the first state to the second state through the damaging effect generated when connecting with the outer sleeve 50 (the physical effect associated with the use of the outer sleeve 50). However, the groove 180 cannot transition from the second state to the first state. That is, if the groove 180 is damaged, it will not return to its state before the damage.

[0115] After using the outer sleeve 50, in order to remove the outer sleeve 50 from the connecting pipe 100, the air inlet 74 is removed from the connection port 174 of the connector 170. In this case, the groove 180 is destroyed.

[0116] Therefore, according to Figure 7 The connecting tube 100 of the embodiment shown in the figure has a structure in which the slot 180 provided by the connector 170 can be switched from the first state before the damage to the second state after the damage, but cannot be switched from the second state to the first state. Therefore, the used connecting tube 100 can be made unusable.

[0117] Furthermore, by observing the damaged connector 170 in the cutting groove 180, the surgeon can identify whether the connecting tube 100 connected to the connector 170 is no longer usable (i.e., whether the connecting tube 100 is unused or used).

[0118] in addition, Figure 7 The embodiment is an example in which a connector 170 is provided on the connection portion 100A of the connecting pipe 100, but it is not limited to this. Hereinafter, two modified examples will be described.

[0119] The first modification is an example in which a connector 170 is provided on the air inlet 74 of the outer tube 50, and the connection portion 100A of the connecting tube 100 is connected to the connection port 174 of the connector 170. In this modification, the surgeon can identify whether the outer tube 50 to which the connector 170 is connected is no longer usable by observing the connector 170 that is damaged in the cutting groove 180.

[0120] The second variation is in the connection portion 100B of the connecting pipe 100 (see reference). Figure 1In this modified example, a connector 170 is provided on the balloon, and the connection port 174 of the connector 170 is connected to the air port 124 of the balloon control device 120. In this modified example, the surgeon can identify whether the connecting tube 100 to which the connector 170 is connected is no longer usable by observing the connector 170 that is damaged in the cutting groove 180.

[0121] [Implementation Method 2]

[0122] Figure 8 This is an enlarged sectional view of the main part of the outer tube 50. (See image.) Figure 8 As shown, a hole 65 is provided on the air line 64 of the outer sleeve 50. This hole 65 is a connecting hole between the insertion line 62 and the air line 64. For example, it is provided near the liquid line 66, that is, at the base end of the air line 64.

[0123] The hole 65 is sealed by the plug body 190. The plug body 190 is formed of a water-soluble component (liquid-soluble component). Furthermore, the hole 65 and the plug body 190 are examples of the leakage hole and the state change part of the present invention, respectively.

[0124] As an example, the suppository 190 is formed from the material that constitutes the capsule of the capsule formulation (e.g., gelatin, agar, starch, or cellulose). When the outer tube 50 is used, the suppository 190 is dissolved by water (dissolving liquid) supplied from the liquid line 66 to the insertion line 62.

[0125] Thus, the plug 190 changes from its state before being dissolved by water (state 1) to its state after being dissolved by water (state 2).

[0126] That is, the plug 190 transitions from the first state to the second state through dissolution caused by the supply of water (a chemical reaction associated with the use of the outer sleeve 50). However, the plug 190 cannot transition from the second state to the first state. In other words, once the plug 190 dissolves, it will not revert to its state before dissolution.

[0127] A leak test of the balloon 60, which was performed on the used outer tube 50 before the use of the outer tube 50, is conducted. The leak test is performed by supplying air from the balloon control device 120 to the air line 64.

[0128] During the leak test, the plug 190 sealing the orifice 65 dissolved due to the water supplied when using the outer tube 50, causing air supplied from the balloon control device 120 to the air line 64 to leak through the orifice 65 into the insertion line 62. As a result, the balloon 60 did not inflate.

[0129] Therefore, according to Figure 8The outer sleeve 50 of Embodiment 2 shown has a structure in which the plug 190 of the hole 65 of the liquid conduit 66 can be switched from the first state before dissolution to the second state after dissolution, but cannot be switched from the second state to the first state. Therefore, the used outer sleeve 50 can be made unusable.

[0130] Furthermore, by confirming that the balloon 60 does not inflate during the leak test, the surgeon can identify whether the outer tube 50 is no longer usable (i.e., whether the outer tube 50 is unused or has been used).

[0131] Figure 9 This is a perspective view showing a leak-proof valve 200 installed in the insertion pipe 62 from the base opening 56 of the outer sleeve 50.

[0132] A sheet 202 is attached to the outer peripheral surface of the leak-proof valve 200. This sheet 202 is printed with the word "USED" (e.g., water-based printing) so that it is wetted with water (lubricant). Furthermore, the sheet 202 is an example of a state-changing part of the present invention.

[0133] When the outer sleeve 50 is used, the sheet 202 of the leak-proof valve 200 is wetted by water supplied from the liquid line 66 to the insertion line 62 through the gap between the inner circumferential surface 52B of the tube body 52 and the outer circumferential surface of the leak-proof valve 200. Therefore, the used outer sleeve 50 displays the word "USED" on the sheet 202 of the leak-proof valve 200.

[0134] Thus, the sheet 202 transitions from a state where it never displays the characters before being wetted (state 1) to a state where it displays the "used" characters after being wetted (state 2).

[0135] That is, the sheet 202 transitions from the first state to the second state through a chemical reaction caused by the supply of water (a chemical reaction associated with the use of the outer sleeve 50). However, the sheet 202 cannot transition from the second state back to the first state. In other words, once the sheet 202 displays characters, it will not return to the state before the display.

[0136] If the leak-proof valve 200 is removed from the used outer sleeve 50, the word "USED" will be displayed on the sheet 202 of the leak-proof valve 200.

[0137] Therefore, according to Figure 9The outer sleeve 50 shown has a structure where the sheet 202 of the leak-proof valve 200 can transition from a first state (before the characters are displayed) to a second state (when the characters are displayed after being wetted) to a second state (when the characters are displayed after being wetted), but cannot transition from the second state back to the first state. Therefore, by checking the characters displayed on the leak-proof valve 200, the surgeon can identify whether the outer sleeve 50 is no longer usable (i.e., whether the outer sleeve 50 is unused or used). Thus, the surgeon's use of the outer sleeve 50 can be substantially prevented, resulting in the outer sleeve 50 being rendered unusable after use.

[0138] In addition, when the outer tube 50 is made of a transparent material (including a translucent material), the “used” character displayed on the sheet 202 can be viewed through the outer tube 50 without removing the leak-proof valve 200 from the outer tube 50.

[0139] [Implementation Method 3]

[0140] exist Figure 10 and Figure 11 The first embodiment of implementation method 3 is shown in the figure. Figure 10 This is a cross-sectional view of the main part of the connector 210 that connects the outer sleeve 50 and the connecting tube 100. Figure 11 This is an enlarged cross-sectional view of the main part of connector 210.

[0141] like Figure 10 As shown, the connector 210 includes a female connector 212 provided on the air outlet portion 74 of the outer sleeve 50 and a male connector 214 provided on the connecting portion 100A of the connecting tube 100.

[0142] The connector 212 has a release slide 216 for inserting the connector 214, and an anti-detachment member 218 configured in an annular shape is disposed on the inner side of the slide 216.

[0143] Slide 216 relative to connector 212 is able to Figure 10 The locked position shown is the first position and Figure 11 Slide between the lock release position shown, i.e., the second position.

[0144] The anti-detachment component 218 has an annular base 218A, a plurality of (e.g., four) connecting portions 218B protruding from the base 218A, and a plurality of claws 218C protruding from the plurality of connecting portions 218B respectively.

[0145] Even when the slide 216 is in position 1 (reference) Figure 10 ) and the 2nd position (reference) Figure 11 When sliding between the two parts, the base 218A also abuts against the inner circumferential protrusion 216A of the slide cylinder 216, thus restricting its movement.

[0146] The connecting portion 218B is flat. The connecting portion 218B extends from the base 218A toward the connector 214. Figure 10 The connecting portions 218B are integrally provided on the base 218A in a manner extending to the left side. The connecting portions 218B are arranged at approximately equal intervals in the circumferential direction of the base 218A.

[0147] Claw 218C is flat. Claw 218C extends from the front end of the connecting portion 218B toward the connector 212 side ( Figure 10 The claw 218C is integrally provided with the connecting part 218B in a manner that is located to the right of the base 218A and the connecting part 218B.

[0148] The connecting portion 218B and the claw 218C are configured to elastically deform in the radial direction of the base 218A. When the slide cylinder 216 is in the first position (see reference...), Figure 10 In the case of the connecting part 218B being subjected to force (elastic deformation) in the radially inward direction by abutting against the inner peripheral protrusion 216A, its movement is restricted. Therefore, when the slide 216 is in the first position, the deformation of the connecting part 218B and the claw 218C in the radially outward direction (deformation back to the original shape) is restricted by the inner peripheral protrusion 216A.

[0149] Furthermore, when the slide 216 is in the first position, the front end of the claw 218C abuts against the outer peripheral inclined surface 222 formed on the shaft portion 220 of the connector 214. As a result, the connector 210 is in a locked state where the connector 214 cannot be removed from the connector 212.

[0150] On the other hand, as the slide 216 moves from position 1 to position 2 (reference) Figure 11 When the connector 214 is in the second position, the connecting portion 218B faces the inner circumferential recess 216B of the slide cylinder 216. Therefore, when the slide cylinder 216 is in the second position, the connecting portion 218B and the claw 218C deform radially outwards as if releasing the aforementioned force and approaching the inner circumferential recess 216B. That is, the anti-detachment member 218 returns to its original shape. As a result, the tip of the claw 218C retracts from the outer circumferential inclined surface 222 of the connector 214, thus the connector 210 is in a locked, released state where the connector 214 can be removed from the connector 212.

[0151] Thus, the slide 216 can transition from the locked state (first state) as the first position to the unlocked state (second state) as the second position.

[0152] Here, on the inner circumferential surface of the end of the slide cylinder 216 on the side of the outer sleeve 50 (the right end of the slide cylinder 216), a protrusion 224 is provided that protrudes radially inward toward the slide cylinder 216. This protrusion 224... Figure 10The position abuts against the outer peripheral surface 212A of the connector 212 and is subjected to force (elastic deformation) radially outward toward the slide cylinder 216. Furthermore, as... Figure 11 As shown, when the slide cylinder 216 reaches the second position, the protrusion 224 engages with the recess 226 formed on the outer peripheral surface 212A of the connector 212 by its elastic restoring force. In this case, the movement of the slide cylinder 216 from the second position to the first position is restricted.

[0153] Thus, the slide 216 cannot transition from the second position of the unlocked state to the first position of the locked state. That is, once the slide 216 moves to the second position, it will not return to the first position.

[0154] According to the connector 210 with the above structure, when the slide 216 is moved from the first position to the second position, the lock between the connector 212 and the connector 214 is released, so the connector 214 can be removed from the connector 212.

[0155] However, in the second position, the protrusion 224 engages with the recess 226, therefore the slide cylinder 216 will not return from the second position to the first position. When the slide cylinder 216 does not return to the first position, the anti-drop component 218 does not return to its original shape. Figure 10 Therefore, connectors 212 and 214 cannot be locked together. Consequently, connector 214 cannot be connected (reconnected) to connector 212.

[0156] Therefore, according to Figure 10 and Figure 11 The outer sleeve 50 of the embodiment shown has a structure in which the slide 216 of the connector 210 can switch from the first state of the locked state to the second state of the unlocked state, but cannot switch from the second state to the first state. Therefore, the used outer sleeve 50 can be made unusable.

[0157] Furthermore, by observing the disconnected connector 212, the surgeon can identify whether the outer tube 50 connected to the connector 212 is no longer usable (i.e., whether the outer tube 50 is unused or used).

[0158] Furthermore, in this example, the connector 210 is configured such that the front end of the claw 218C abuts against the outer peripheral inclined surface 222 to connect the connector 212 and the connector 214 simply by inserting the connector 214 into the connector 212, thus making it easy to connect the outer sleeve 50 and the connecting tube 100.

[0159] In addition, as Figure 10 and Figure 11In a variation of the embodiment shown, a connector 214 may be provided on the outer sleeve 50 side and a connector 212 may be provided on the connecting tube 100 side. In this variation, the surgeon can identify whether the connecting tube 100 connected to the connector 212 (the connector 212 that cannot be connected) is no longer usable.

[0160] exist Figure 12 and Figure 13 The second embodiment of implementation method 3 is shown in the figure. Figure 12 This is a three-dimensional assembly view of the connector 240 that connects the outer sleeve 50 and the connecting tube 100. Figure 13 This is an explanatory diagram showing the operation of connector 240 in cross-section.

[0161] like Figure 12 and Figure 13 As shown, the connector 240 includes a connector 242 provided at the air outlet 74 of the outer sleeve 50, a threaded sleeve 244 connected to the connector 242, and a connector 246 provided at the connection portion 100A of the connecting tube 100.

[0162] Connector 242, threaded sleeve 244, and connector 246 are each configured as a cylindrical shape with different diameters. Specifically, the inner diameter of connector 242 is larger than the outer diameter of connector 246, and the inner diameter of threaded sleeve 244 is larger than the outer diameter of connector 242.

[0163] The connector 242 is connected to the air inlet 74 at its base end. On its outer periphery, the connector 242 has a protrusion 248, a protrusion 250, a through hole 252 and an external thread 254 formed from the base end side toward the front end side (connector 246 side). A ball 256 for locking is inserted into the through hole 252.

[0164] The threaded cylinder 244 has two claws 260, a recess 262, a protrusion 264, a notch 266, and an internal thread 268 formed on its inner circumference from the base end side (connector 242 side) towards the front end side (connector 246 side). The connector 242 is inserted into the threaded cylinder 244, and the external thread 254 engages with the internal thread 268, thereby connecting the threaded cylinder 244 to the connector 242 (see reference). Figure 13 (XIIIA).

[0165] Furthermore, the two claws 260 are arranged opposite each other in the circumferential direction of the threaded cylinder 244. The two claws 260 are elastically deformed in the direction of separation (radial outward of the threaded cylinder 244) to expand the inner diameter of the threaded cylinder 244. As a result, the connector 242 can be inserted into the threaded cylinder 244.

[0166] Here, for reference Figure 13 The protruding parts 248 and 250 and the claw 260 will be described.

[0167] like Figure 13 As shown, the protruding portion 248 has a front end side facing the connector 242 ( Figure 13 The roughly parallelogram-shaped cross-section (on the right side) of the connector 242 has interior angles (interior angles on the outer peripheral surface side of the connector 242) that are axially opposed to each other. Specifically, among the pair of inclined surfaces constituting the protrusion 248, the base end side of the connector 242 ( Figure 13 The inner angle of the inclined surface on the left side of connector 242 is acute, while the inner angle of the inclined surface on the front end side of connector 242 is obtuse. Additionally, the protrusion 250 has the same shape as the protrusion 248.

[0168] On the other hand, the claw 260 has a base end side facing the threaded cylinder 244 ( Figure 13 The approximately parallelogram-shaped cross-section (on the left side) of the threaded cylinder 244 has interior angles (interior angles on the outer peripheral surface side of the connector 242) that are axially opposed to each other. Specifically, in the pair of inclined surfaces constituting the claw 260, the base end side of the threaded cylinder 244 ( Figure 13 The interior angle of the inclined surface on the left side of the threaded cylinder 244 is acute, and the interior angle of the inclined surface on the front end side of the threaded cylinder 244 is obtuse. Furthermore, the pair of inclined surfaces constituting the claw 260 are parallel to the pair of inclined surfaces constituting the protrusions 248 and 250.

[0169] Based on the protruding portions 248, 250 and claw 260 configured as described above, the threaded cylinder 244 is positioned relative to the connector 242. Figure 13 When the screw 260 moves to the right, it can pass over the protrusions 248 and 250 through the contact between the obtuse angles of the parts, thus allowing it to move. On the other hand, when the threaded cylinder 244 moves relative to the connector 242... Figure 13 When the claw moves to the left, it is restricted from crossing the protrusion 248 or the protrusion 250 by the contact between the acute angles of each part.

[0170] Furthermore, this example shows the protrusions 248, 250, and claw 260 having a generally parallelogram-shaped cross-section. However, as long as the threaded cylinder 244 can move in one direction relative to the connector 242 while restricting movement in the other direction, the protrusions 248, 250, and claw 260 can have other shapes different from this example. Moreover, structures other than the protrusions 248, 250, and claw 260 can achieve the same function.

[0171] The connector 246 is connected to the connection portion 100A on its base end side (the side opposite to the connector 242). The connector 246 has a flange portion 274, a V-groove 272 and an O-ring 270 on its outer periphery from the base end side toward the front end side (the connector 242 side).

[0172] Next, refer to Figure 13 The function of connector 240 will be explained.

[0173] First, such as Figure 13 As shown in XIIIA, if connector 246 is inserted into connector 242, the flange 274 of connector 246 abuts against the front end 242A of connector 242, and O-ring 270 contacts the inner circumferential surface 242B of connector 242. In the radial direction of connector 240, V-groove 272 is opposite to through hole 252.

[0174] exist Figure 13 In the connector 240 shown in XIIA, the V-groove 272, the through hole 252, and the recess 266 are located radially along the connector 240. Therefore, the ball 256 is in a state where it can move freely within the space defined by the V-groove 272, the through hole 252, and the recess 266. That is, Figure 13 The state of connector 240 shown in XIIIA is the locked-out state in which connector 246 can be removed from connector 242.

[0175] Next, when the threaded cylinder 244 is rotated and moved to the right, as follows: Figure 13 As shown in XIIIB, the claw 260 of the threaded cylinder 244 passes over the protrusion 248 of the connector 242, and the protrusion 264 of the threaded cylinder 244 is positioned radially opposite the V-groove 272 of the connector 240. Thus, the ball 256 is pressed against the V-groove 272 by the protrusion 264, and therefore the connectors 242 and 246 cannot move relative to each other axially relative to each other in the connector 240.

[0176] Right now, Figure 13 As shown in XIIIB, connector 240 is in a locked state where connector 246 cannot be removed from connector 242. Furthermore, since the claw 260 engages with the protrusion 248, the leftward movement of the threaded sleeve 244 is restricted at this time. The outer sleeve 50 is used in this state.

[0177] After using the outer sleeve 50, in order to remove the outer sleeve 50 from the connecting tube 100, the connector 246 is removed from the connector 242. This operation is performed by further rotating the threaded cylinder 244 in the same direction and moving it to the right.

[0178] Specifically, such as Figure 13As shown in XIIIC, the claw 260 of the threaded cylinder 244 passes over the protrusion 250 of the connector 242, and the recess 262 of the threaded cylinder 244 is positioned radially opposite the through hole 252 of the connector 240. Thus, the ball 256 is able to move freely within the space defined by the V-groove 272, the through hole 252, and the recess 262. Therefore, Figure 13 The state of connector 240 shown in XIIIC is a locked-out state in which connector 246 can be removed from connector 242. In this state, connector 246 is removed from connector 242.

[0179] Then, when connector 246 is to be connected (reconnected) to connector 242 after connector 246 has been removed, as follows: Figure 13 As shown in XIIIC, the two claws 260 engage with the protrusion 250. Therefore, the threaded cylinder 244 cannot return from its locked-out state (second state) to the left. Figure 13 The locking release state (first state) is shown in XIIIA. That is, connector 246 cannot be connected to connector 242 after connector 246 has been removed.

[0180] Therefore, according to Figure 12 and Figure 13 The outer sleeve 50 of the embodiment shown in the figure, due to having a threaded sleeve 244 provided by the connector 240, can be drawn from... Figure 13 The first state of the unlocked state shown in XIIIA transitions to... Figure 13 The structure shown in XIIIC is in the second state of the lock release state, but cannot transition from the second state to the first state, thus making the used outer tube 50 unusable.

[0181] Furthermore, by observing the disconnected connector 242, the surgeon can identify whether the outer tube 50 connected to the connector 242 is no longer usable (i.e., whether the outer tube 50 is unused or used).

[0182] In addition, as Figure 12 and Figure 13 In a variation of the illustrated embodiment, a connector 246 may be provided on the outer sleeve 50 side, and a connector 242 may be provided on the connecting tube 100 side. In this variation, the surgeon can identify whether the connecting tube 100 connected to the connector 242 (or a connector 242 that cannot be connected) is no longer usable.

[0183] [Implementation Method 4]

[0184] Figure 14 This is a structural diagram showing a portion of the connector 280 that connects the outer sleeve 50 and the connecting tube 100 in cross-section.

[0185] like Figure 14 As shown, the connector 280 includes a male connector 282 provided at the air outlet 74 of the outer sleeve 50 and a cylindrical female connector 284 provided at the connection portion 100A of the connecting tube 100.

[0186] Figure 15 This is a perspective view of connector 282. Connector 282 is capable of engaging with... Figure 14 The connector 284 shown includes two locking claws 288 on the periphery of the connection opening 286, two buttons 290 for operating the two locking claws 288, and a drive mechanism 294 for the locking claws 288 (see reference). Figure 16 ), and a frustum-shaped cover 292 covering the drive mechanism section 294. Additionally, the locking claw 288 is an example of the state-changing part of the present invention.

[0187] Figure 16 This is an enlarged perspective view showing the main part of the drive mechanism 294 of the locking pawl 288, specifically the drive mechanism 294 of one of the two locking pawls 288. The drive mechanism of the other locking pawl 288 has the same structure as the drive mechanism 294, so its description is omitted here.

[0188] like Figure 16 As shown, the drive mechanism 294 includes a locking piece 296. The locking piece 296 includes a locking claw 288, an arm 298, a guide pin 300, and a spring receiving part 302.

[0189] A rod 304 is connected to the locking claw 288. The rod 304 bends outward toward the cover 292 in the middle, and a button 290 is provided at its end. Furthermore, two claws 306 protrude from the rod 304 near the button 290. When the button 290 is pressed in the direction of arrow F, the two claws 306 can engage with the engaging portion 308 formed on the inner side of the green part of the cover 292.

[0190] on the other hand, Figure 16 The pipe 310 shown is connected to the air inlet 74 to form an airflow path between connector 282 and connector 284. (As shown) Figure 16 As shown, arm 298 is formed in an L-shape to avoid pipe 310.

[0191] Furthermore, the drive mechanism 294 has a base 312. The base 312 has a guide groove 314 for inserting a guide pin 300 to guide the movement of the locking piece 296 in the direction of the arrow, an abutment portion 318 for a spring 316 to abut, and a through hole 320 for inserting a pipe 310.

[0192] Spring 316 is held between spring receiving portion 302 and abutment portion 318. Locking piece 296, under the force of spring 316, moves relative to base 312 toward the outside of cover 292. Figure 16 The left side is subjected to force, and is able to resist the force of spring 316 towards the inside of cover 292. Figure 16 (Move to the right)

[0193] Next, the function of connector 280 will be explained.

[0194] If the cover 292 of connector 282 is pressed into the connection opening 286 of connector 284, the two locking claws 288 press against the edge of the connection opening 286, thereby resisting the force of spring 316 and moving towards each other (inside the cover 292).

[0195] Then, if the two locking claws 288 pass through the edge of the connecting opening 286, the two locking claws 288 move toward the direction of separation from each other (outside the cover 292) by the force of the spring 316, so that the two locking claws 288 are locked at the edge of the connecting opening 286 of the connector 284.

[0196] Thus, connector 282 is connected to connector 284, and outer sleeve 50 is connected to connecting tube 100 via connector 280. Outer sleeve 50 is used in this state. In addition, in the above connection state, the claw 306 moves toward the inside of cover 292, but only moves to the front of engagement part 308 and does not engage with engagement part 308.

[0197] After using the outer sleeve 50, in order to remove the outer sleeve 50 from the connecting tube 100, the connector 284 is removed from the connector 282. This is done by pressing the button 290 toward the inside of the cover 292.

[0198] When button 290 is pressed towards the inside of cover 292, locking piece 296 moves towards the inside of cover 292 against the force of spring 316. Then, lever 304 tilts (elastically deforms) due to the force of spring 316, and claw 306 passes over engaging portion 308 and engages with engaging portion 308. In addition, lever 304 is constructed with a strength that allows it to elastically deform under the force of spring 316.

[0199] With the claw 306 engaged with the engagement portion 308, the locking claw 288, which is locked to the edge of the connection opening 286 of the connector 284, moves to a retracted position (lock-out position) that retracts from its edge, thus allowing the connector 284 to be removed from the connector 282. At this time, since the claw 306 is engaged with the engagement portion 308, the locking claw 288 remains in the aforementioned lock-out position.

[0200] Then, when connector 284 is to be connected (reconnected) to connector 282 after connector 284 has been removed, the locking claw 288 cannot return to the locking position where it can lock with connector 284 because the claw 306 of connector 282 is engaged with the locking portion 308. That is, connector 284 cannot be connected to connector 282 after connector 284 has been removed.

[0201] Therefore, according to Figures 14 to 16 The outer tube 50 of Embodiment 4 shown in the figure has a structure in which the locking claw 288 of the connector 280 can switch from the first state of the locked state to the second state of the unlocked state, but cannot switch from the second state to the first state. Therefore, the used outer tube 50 can be made unusable.

[0202] Furthermore, by observing the disconnected connector 282, the surgeon can identify whether the outer tube 50 connected to the connector 282 is no longer usable (i.e., whether the outer tube 50 is unused or has been used).

[0203] Furthermore, in this example, the connector 280 is structured such that the locking claw 288 engages with the edge of the connection opening 286 simply by inserting the connector 282 into the connector 284, thereby connecting the connector 284 and the connector 282. Therefore, the connection between the outer tube 50 and the connecting tube 100 can be easily performed.

[0204] In addition, as Figures 14 to 16 In a variation of embodiment 4 shown, a connector 284 may be provided on the outer sleeve 50 side, and a connector 282 may be provided on the connecting tube 100 side. In this variation, the surgeon can identify whether the connecting tube 100 connected to the connector 282 (the connector 282 that cannot be connected) is no longer usable.

[0205] [Implementation Method 5]

[0206] Figure 17 This is an enlarged perspective view of the main part of a partial cross-section of the bottle cap type connector 330, including the connecting outer tube 50 and the connecting tube 100.

[0207] like Figure 17 As shown, connector 330 includes a cylindrical female connector 332, a cylindrical male connector (also called a die) 334, and a damaged bridge 336 connecting connector 332 and connector 334. In this connector 330, connector 332 is connected to the connection portion 100A of the connecting tube 100, and connector 334 is connected to the air inlet portion 74. Furthermore, the damaged bridge 336 is an example of a state-changing part of the present invention, and an example of a fragile part that is irreversibly destructible when subjected to the physical force of the present invention.

[0208] Figure 17 The outer sleeve 50 shown is integrally formed with the connecting tube 100 via the connector 330.

[0209] After using the outer sleeve 50, the connecting tube 100 is removed from the outer sleeve 50. This is done by rotating the connector 332 relative to the connector 334.

[0210] If connector 332 is rotated, the bridge 336 is destroyed like a bottle cap, thus allowing connector 332 to be removed from connector 334.

[0211] Thus, the damaged bridge 336 transitions from the state before the damage, in which the connection between connector 332 and connector 334 is fixed (state 1), to the state after the damage, in which the connection between connector 332 and connector 334 is released (state 2).

[0212] That is, the damaged bridge 336 transitions from a first state before being damaged by the destructive effect (the physical effect associated with the use of the outer sleeve 50) caused by disconnecting connector 332 from connector 334 to a second state after being damaged. However, once the damaged bridge 336 is damaged, it will not return to the state before the damage.

[0213] Therefore, according to Figure 17 The outer tube 50 of embodiment 5 shown can be rendered unusable because the damaged bridge 336 of the connector 330 can switch from the first state before damage to the second state after damage, but cannot switch from the second state to the first state.

[0214] Furthermore, by observing the state of the damaged bridge 336 and the connector 334 remaining in the air inlet 74, the surgeon can identify whether the outer tube 50 is no longer usable (i.e., whether the outer tube 50 is unused or used).

[0215] Furthermore, regarding connector 332, by configuring it to have a destructible vulnerable portion (thin-walled portion 160) as shown in embodiment 1, the connecting tube 100 can be removed from connector 332 and reused.

[0216] In addition, as Figure 17 In a variation of embodiment 5 shown, a connector 332 may be provided on the outer sleeve 50 side, and a connector 334 may be provided on the connecting tube 100 side. In this variation, the surgeon can identify whether the connecting tube 100 connected to the connector 334 (the damaged connector 334) is no longer usable.

[0217] [Implementation Method 6]

[0218] Figure 18 This is a cross-sectional view of the Luer lock type connector 340 that connects the outer sleeve 50 and the connecting tube 100.

[0219] like Figure 18 As shown, the connector 340 includes a connector 342 provided in the air outlet 74 of the outer sleeve 50, a connector 344 provided in the connection portion 100A of the connecting tube 100, and a cylindrical housing 346 for retaining the connector 342.

[0220] Connector 342 has a Luer lock type connection portion 348. Connector 344 has a Luer lock type connection portion 350 that can be connected to the connection portion 348. The outer tube 50 and the connecting tube 100 are connected via connector 340, which are connected to each other through connector 342 and connector 344.

[0221] The connector 342 has a plurality of damaged portions 352. These damaged portions 352 are damaged when the connecting portion 350 is excessively rotated relative to the connecting portion 348 while the connecting portion 348 is connected to the connecting portion 350.

[0222] When the damaged part 352 is damaged, the connecting part 348 is damaged, thereby causing connector 342 and connector 344 to enter a state of relative free rotation. In addition, the damaged part 352 is an example of a state-changing part of the present invention, and an example of a fragile part that is irreversibly destructible when subjected to the physical force of the present invention.

[0223] According to the connector 340 with the above structure, connectors 342 and 344 are connected by screwing connecting portion 348 and connecting portion 350 together, and outer sleeve 50 and connecting tube 100 are connected via connector 340 (first state). Then, the damaged portion 352 is damaged by excessively rotating connecting portion 350 relative to connecting portion 348, thereby damaging connecting portion 348 (second state). The damaged connecting portion 348 is held by housing 346. Outer sleeve 50 is used in this state.

[0224] After using the outer sleeve 50, the connecting pipe 100 is removed from the outer sleeve 50. This is done by rotating the connecting part 350 relative to the connecting part 348 in the opposite direction to the previous threading direction.

[0225] However, even if the connecting part 350 is rotated in the opposite direction to the aforementioned engagement direction, the connecting part 348 is damaged, and therefore the connecting part 350 spins freely. As a result, the connector 344 cannot be removed from the connector 342, and consequently, the connecting tube 100 cannot be removed from the outer sleeve 50.

[0226] Therefore, according to Figure 18 The outer tube 50 of Embodiment 6 shown has a structure in which the damaged part 352 of the connector 340 can be switched from the first state before the damage to the second state after the damage, but cannot be switched from the second state to the first state. Therefore, the used outer tube 50 can be made unusable.

[0227] Furthermore, by observing the outer tube 50, which cannot be removed from the connecting tube 100, the surgeon can identify whether the outer tube 50 is no longer usable (i.e., whether the outer tube 50 is unused or has been used).

[0228] Furthermore, the used outer tube 50 is connected to the connecting tube 100 via the damaged connector 340, so the surgeon is unaware that the outer tube 50 is already in use, and it is possible that the outer tube 50 could be reused. From this perspective, the outer tube 50 of Embodiment 5 preferably has the following structure to prevent the reuse of the outer tube 50.

[0229] First, the connector 344 on the connecting tube 100 side is configured to have a destructible vulnerable portion (thin-walled portion 160) as shown in Embodiment 1. The vulnerable portion is destroyed, and the connector 344 is removed from the connector 342. Since the connecting portion 348 is destroyed, the connector 342, after removing the connector 344, cannot be connected to the connector 344 (reconnected). Therefore, the reuse of the outer tube 50 can be prevented.

[0230] Furthermore, it is configured such that the housing 346 can be removed from the connector 342. For example, as... Figure 19 As shown in the perspective view of the housing 346, an opening or slit 354 is provided on the housing 346, which allows the housing 346 to be enlarged. When the housing 346 is enlarged, the locking between the flange portion 343 of the connector 342 and the claw 347 of the housing 346 is released, so the housing 346 can be removed from the connector 342, and then the connector 344 can be removed from the connector 342. Since the connecting portion 348 is damaged, the connector 342, after removing the connector 344, cannot be connected to the connector 344 (reconnection). Therefore, the reuse of the outer sleeve 50 can be prevented. In addition, in this case, the connecting tube 100 connected to the connector 344 can be reused.

[0231] And, as Figure 18As shown, a clamp is inserted into the connection portion 348 through the gap 356 between the connection portion 348 and the connection portion 350, so that the clamp abuts against the connection portion 348 to prevent the connection portion 348 from rotating. In this state, the connection portion 350 is rotated, and the connector 344 is removed from the connector 342. Since the connection portion 348 is damaged, the connector 342, after removing the connector 344, cannot be reconnected to the connector 344 (reconnection). Therefore, the reuse of the outer tube 50 can be prevented. In addition, in this case, the connecting tube 100 with the connector 344 connected can also be reused.

[0232] [Implementation Method 7]

[0233] Figure 20 XXA to XXE are illustrations of the ratchet (one-way clutch) type connector 360 that connects the outer sleeve 50 and the connecting tube 100.

[0234] like Figure 20 As shown in XXA to XXE, connector 360 includes a gear 362 and two claws 364 and 366. Furthermore, gear 362 is an example of the state-changing part of the present invention.

[0235] Gear 362 is disposed in a male connector (not shown) provided at the connection portion 100A of the connecting pipe 100, and has an air inlet portion 74 (see reference) for connection with the outer sleeve 50. Figure 3 A connecting passage 368 is provided. Two claws 364 and 366 are provided at a female connector (not shown) located at the air outlet 74 of the outer sleeve 50. The male connector and the female connector are connected to each other by screw-based engagement. Alternatively, the aforementioned female connector may be provided at the connection portion 100A of the connecting tube 100, and the aforementioned male connector may be provided at the air outlet 74 of the outer sleeve 50.

[0236] like Figure 20 As shown in XXA to XXE, gear 362 has three toothed grooves a, b, and c connected in the circumferential direction of gear 362. Furthermore, gear 362 has a toothed groove d at a position approximately 180° apart from toothed groove a in the circumferential direction of gear 362. Of the two pawls 364 and 366, pawl 364 is positioned to selectively engage with one of the three toothed grooves a, b, and c by rotation based on a screw, and pawl 366 is positioned to engage with toothed groove d by rotation based on a screw.

[0237] Furthermore, the connector 360 includes: an unshown force-applying component (e.g., a spring) that applies force to the claws 364 and 366 toward the gear 362 and applies force through spring forces F1 and F2 respectively, and an unshown release component (e.g., a rod provided in the connector 360) that can release the spring forces F1 and F2 respectively.

[0238] Next, the function of connector 360 will be explained.

[0239] Figure 20 The connector 360 shown in XXA is in a state where only the female and male connectors are installed on each other, that is, in an unconnected state before the outer sleeve 50 is connected to the connecting tube 100. In this state, the claw 364 is subjected to a spring force F1 toward the gear 362 by a force-applying component. The claw 366 retracts from the gear 362 and is not subjected to a spring force F2 from a force-applying component not shown.

[0240] Next, begin connecting the outer sleeve 50 to the connecting sleeve 100. That is, as follows: Figure 20 As shown in XXB, gear 362 (male connector) is connected from... Figure 20 The installation position shown in XXA is towards R1 ( Figure 20 The gear 362 rotates clockwise so that the pawl 364 engages with the tooth groove a. At this time, the rotation of the gear 362 in the R2 direction (counterclockwise direction) is restricted by the action of the one-way clutch.

[0241] Next, as Figure 20 As shown in XXC, gear 362 is made to... Figure 20 The position shown in XXB is further rotated in the R1 direction to engage the pawl 364 with the tooth groove c. This position also restricts the rotation of the gear 362 in the R2 direction. At this position, the male connector and female connector are connected, and the outer sleeve 50 and connecting tube 100 are connected via the connector 360. The outer sleeve 50 is used in this state.

[0242] Then, after using the outer tube 50, firstly, as... Figure 20 As shown in XXD, the aforementioned release component is operated to release the spring force F1 of the pawl 364, causing the pawl 364 to retract from the gear 362 in the direction of the arrow. After the release operation is performed, the release component is fixed in its operating position. Furthermore, in conjunction with the release operation of the release component, the force-applying component applies a spring force F2 to the pawl 366.

[0243] Next, as Figure 20 As shown in XXE, gear 362 is caused to... Figure 20 The position shown in XXD is rotated in the R2 direction so that the tooth groove d engages with the pawl 366. In this position, the outer sleeve 50 is disconnected from the connecting tube 100, but the rotation of the gear 362 in the R1 direction is restricted by the action of the one-way clutch, so the male connector and the female connector cannot be connected.

[0244] Therefore, according to embodiment 7, the outer tube 50 has a structure in which the gear 362 of the connector 360 can switch from the first state before being connected to the second state after being connected, but cannot switch from the second state to the first state, so that the used outer tube 50 (connecting tube 100) can no longer be used.

[0245] Furthermore, by observing the connector 360 that cannot connect the male and female connectors, the surgeon can identify whether the outer tube 50 (connecting tube 100) connected to the connector 360 is no longer usable (i.e., whether the outer tube 50 (connecting tube 100) is unused or has been used).

[0246] Alternatively, it can be configured such that by providing a rotation stop to gear 362, it is possible to... Figure 20 Rotate within the range of rotation shown in XXA to XXE.

[0247] [Implementation Method 8]

[0248] Figure 21 This is a cross-sectional view of the Luer lock type connector 370 that connects the outer sleeve 50 and the connecting tube 100.

[0249] like Figure 21 As shown, the connector 370 includes a female Luer connector 372 connected to the air inlet 74 of the outer sleeve 50, and a male Luer connector 374 connected to the connection portion 100A of the connecting tube 100.

[0250] The connector 370 has sealing components 376 and 378 on the Luer connector 372 side and two pointed components 380 and 382 on the Luer connector 374 side.

[0251] Sealing components 376 and 378 are, for example, O-rings or liquid gaskets internally filled with silicone gel. Furthermore, sealing components 376 and 378 are examples of the state-changing parts of the present invention, and examples of fragile parts that are irreversibly destructible when subjected to the physical forces of the present invention.

[0252] When Luer connectors 372 and 374 are connected, the pointed parts 380 and 382 and the sealing parts 376 and 378 are positioned opposite each other. Thus, when Luer connectors 372 and 374 are connected, the pointed parts 380 and 382 destroy the sealing parts 376 and 378 by piercing them.

[0253] Next, the function of connector 370 will be explained.

[0254] Connect Luer connectors 372 and 374, and connect outer tube 50 and connecting tube 100 via connector 370. At this time, sealing components 376 and 378 are destroyed by pointed components 380 and 382.

[0255] That is, the sealing components 376 and 378 transition from a first state before being damaged by the destructive effect (physical effect associated with the use of the outer sleeve 50) generated when connecting the Luer connector 372 and the Luer connector 374 to a second state after being damaged. However, the sealing components 376 and 378 cannot transition from the second state back to the first state. In other words, once the sealing components 376 and 378 are damaged, they will not return to their state before the damage.

[0256] Additionally, in the second state, the liquid (e.g., silicone gel) sealed in the sealing components 376 and 378 is filled into the connection between the Luer connector 372 and the Luer connector 374, thus maintaining the airtightness of the connector 370. The outer sleeve 50 is used in this state.

[0257] After using the outer tube 50, in order to remove the connecting tube 100 from the outer tube 50, remove the Luer connector 374 from the Luer connector 372.

[0258] Furthermore, if the outer sleeve 50 is to be reused, because the sealing components 376 and 378 provided in the Luer connector 372 are damaged, airtightness cannot be obtained during the leakage test when connecting the Luer connector 372 and the Luer connector 374, and air leaks from the connector 370.

[0259] Therefore, according to Figure 21 The outer sleeve 50 shown in Embodiment 8 has a structure in which the sealing members 376 and 378 of the connector 370 can be switched from the first state before being damaged to the second state after being damaged, but cannot be switched from the second state to the first state. Therefore, the used outer sleeve 50 can be made unusable.

[0260] Furthermore, by confirming that air leaks from connector 370 during the leak test, the surgeon can identify whether the outer tube 50 connected to the Luer connector 372 is no longer usable (i.e., whether the outer tube 50 is unused or used).

[0261] In addition, as Figure 21 In a variation of embodiment 8 shown, a Luer connector 374 may be provided on the outer sleeve 50 side and a Luer connector 372 may be provided on the connecting tube 100 side. In this variation, the surgeon can identify whether the connecting tube 100 to which the Luer connector 372 (the Luer connector 372 to which the sealing components 376 and 378 are damaged) is no longer usable.

[0262] Furthermore, a silicone oil compound can be applied to at least one side of Luer connectors 372 and 374. In this case, the silicone oil compound adheres to the other side when Luer connectors 372 and 374 are connected. Therefore, when Luer connectors 372 and 374 are reconnected, an airtight seal cannot be obtained during a leak test, and air leakage occurs, thus enabling identification of whether the outer sleeve 50 is no longer usable.

[0263] [Implementation Method 9]

[0264] Figure 22 This is a cross-sectional view of the main part of the outer tube 50, which includes the absorbent kit 390. Additionally, regarding... Figure 22 The outer tube 50 shown is due to its relationship with... Figure 3 The outer sleeve 50 shown in the figure has the same structure, therefore in Figure 22 Only the main part with the absorbent kit 390 is shown in the image.

[0265] like Figure 22 As shown, the absorbent kit 390 is disposed at the base opening 56 of the outer sleeve 50. The absorbent kit 390 has a tube portion 392 connected to the base opening 56 of the outer sleeve 50 at its front end, a spherical liquid reservoir portion 396 that accommodates a spherical absorbent sponge 394 in its central portion, an insertion port 398 for insertion of the insertion portion 14 of the endoscope 10, and an annular leak-proof valve 400 disposed at the insertion port 398. Furthermore, the absorbent sponge 394 is an example of the expansion portion of the present invention.

[0266] The absorbent sponge 394 absorbs liquid (water or bodily fluid (expansion medium)) flowing from the base opening 56 of the outer sleeve 50 into the absorbent kit 390. The absorbent sponge 394 has a hole 395 extending along the central axis A. The hole 395 forms part of the insertion conduit 62 (first conduit).

[0267] As the absorbent sponge 394, a compressed cellulose sponge is suitable, for example. According to this absorbent sponge 394, it has the property of being able to change from a non-expanded state (first state) before absorbing liquid to an expanded state (second state) after absorbing liquid, and it also has the property of not being able to change from the expanded state to the non-expanded state.

[0268] In its first state before expansion, the pore 395 of the absorbent sponge 394 is large enough to allow insertion of the insertion part 14 of the endoscope 10, another medical device. However, in its second state after the absorbent sponge 394 absorbs liquid and expands, it becomes too small to allow insertion of the insertion part 14. That is, the diameter (inner diameter) of the pore 395 is relatively larger than the diameter (outer diameter) of the insertion part 14 in the first state and relatively smaller in the second state.

[0269] Furthermore, the size of the hole 395 can be substituted for the frictional resistance (insertion resistance) generated between the inner circumferential surface of the hole 395 and the outer circumferential surface 14A of the insertion portion 14 to define the relationship between the first and second states. In this case, the frictional resistance in the second state is greater than the frictional resistance in the first state, as long as it is large enough to prevent the insertion portion 14 from being inserted. In other words, the frictional resistance in the second state can also be described as the size at which the inner circumferential surface of the hole 395 becomes excessively large due to damage caused by the insertion portion 14.

[0270] Next, the function of the absorbent kit 390 will be explained.

[0271] First, the tube portion 392 of the absorbent kit 390 is connected to the base opening 56 of the outer tube 50, thus putting the outer tube 50 into a usable state. Then, the insertion portion 14 of the endoscope 10 is inserted into the outer tube 50 through the insertion port 398 of the absorbent kit 390 via the leak-proof valve 400. In this case, the size of the hole portion 395 of the absorbent sponge 394 allows the insertion portion 14 to pass through, so the insertion portion 14 is smoothly inserted into the outer tube 50 without encountering resistance from the absorbent sponge 394.

[0272] When using the outer tube 50, the liquid flowing from the base opening 56 of the outer tube 50 to the absorbent kit 390 is absorbed by the absorbent sponge 394 of the absorbent kit 390. Then, the absorbent sponge 394 gradually changes from a non-expanded state (state 1) to an expanded state (state 2).

[0273] That is, the absorbent sponge 394 transitions from the first state to the second state through the swelling effect caused by absorbing liquid (a chemical reaction associated with the use of the outer sleeve 50). However, the absorbent sponge 394 cannot transition from the second state back to the first state. In other words, once the absorbent sponge 394 swells, it will not return to its unswollen state.

[0274] After using the outer tube 50, the insertion part 14 is pulled out from the outer tube 50 equipped with the absorbent kit 390. Moreover, when it is desired to use the outer tube 50 equipped with the absorbent kit 390 again, the hole 395 of the absorbent sponge 394 changes from the size of the first state (the size that allows the insertion part 14 to pass through) to the size of the second state (the size that does not allow the insertion part 14 to pass through), so the insertion part 14 cannot be inserted into the outer tube 50.

[0275] Therefore, according to Figure 22 The outer tube 50 of Embodiment 9 shown has a structure in which the water-absorbing sponge 394 provided by the water-absorbing kit 390 can be switched from the first state of non-expanded state to the second state of expanded state, but cannot be switched from the second state to the first state. Therefore, the used outer tube 50 can be made unusable.

[0276] Furthermore, by observing the outer tube 50 that cannot be inserted into the insertion part 14, the surgeon can identify whether the outer tube 50 is no longer usable (i.e., whether the outer tube 50 is unused or has been used).

[0277] On the other hand, the leak-proof valve 400 provided at the insertion port 398 is a valve body that prevents liquid from flowing out of the insertion port 398 of the absorbent kit 390, and is an example of the valve body of the present invention. In this leak-proof valve 400, it may also be formed from compressed cellulose sponge, similar to the absorbent sponge 394. Furthermore, the leak-proof valve 400 is an example of the state-changing part of the present invention.

[0278] In this case, the opening of the leak-proof valve 400 through which the insertion part 14 is inserted is a size that allows the insertion part 14 to be inserted in the first state before the leak-proof valve 400 expands, but becomes a size that prevents the insertion part 14 from being inserted in the second state after the leak-proof valve 400 expands.

[0279] Therefore, when the surgeon wishes to reuse the outer sleeve 50, the opening of the leak-proof valve 400 changes from the size of the first state (the size that allows the insertion part 14 to pass through) to the size of the second state (the size that prevents the insertion part 14 from passing through), thus preventing the insertion part 14 from being inserted into the leak-proof valve 400. Therefore, the surgeon can confirm that the outer sleeve 50 is no longer usable.

[0280] Furthermore, the absorbent kit 390 in this example is configured to include an absorbent sponge 394 and a leak-proof valve 400 as a state-changing unit, but it can also be configured to include only one of the absorbent sponge 394 and the leak-proof valve 400. Moreover, as a leak-proof valve provided at the base opening 56 of the outer sleeve 50, a leak-proof valve (state-changing unit) having the same function as the leak-proof valve 400 in this example can be used.

[0281] [Implementation Method 10]

[0282] exist Figure 3 In the outer sleeve 50 shown, the coating portion 53, which is coated on the inner circumferential surface 52B of the tube body 52, is coated with a lubricating coating that can be dissolved in water (liquid). Furthermore, the coating portion 53 is an example of the state-changing portion of the present invention.

[0283] As the coating part 53, PVP (Polyvinylpyrrolidone) can be used, for example. According to this coating part 53, the coating can be changed from a thick state before being dissolved by water (first state) to a thin state after being dissolved by water (second state).

[0284] In a first state before the coating portion 53 dissolves, the insertion portion 14 has a thickness that allows it to move in and out of the insertion conduit 62. However, in a second state after at least a portion of the coating portion 53 has dissolved, the insertion portion 14 becomes a thickness that prevents it from moving in and out. That is, the frictional resistance of the insertion portion 14 relative to the coating portion 53 is relatively greater in the second state than in the first state.

[0285] Furthermore, the relationship between the first and second states can be defined instead of the thickness of the coating portion 53, using, for example, the frictional resistance (insertion resistance) generated between the inner circumferential surface 52B of the insertion conduit 62 and the outer circumferential surface 14A of the insertion portion 14. In this case, the frictional resistance in the second state is greater than the frictional resistance in the first state, as long as it is large enough to hinder the insertion of the insertion portion 14. In other words, it can also be said that the frictional resistance in the second state is the size that becomes excessive when the coating portion 53 is removed by the insertion portion 14.

[0286] When using the outer sleeve 50, in order to reduce the frictional resistance between the inner circumferential surface 52B of the outer sleeve 50 and the outer circumferential surface 14A of the insertion part 14, water (liquid) is supplied from the liquid conduit 66 to the insertion conduit 62. Therefore, the thickness of the water-soluble coating 53 gradually changes from the thickness of the state before water dissolution (first state) to the thickness of the state after at least part of dissolution (second state).

[0287] That is, the coating portion 53 transitions from the first state to the second state through a dissolving effect caused by the liquid (a chemical reaction associated with the use of the outer sleeve 50). However, the coating portion 53 cannot transition from the second state to the first state. In other words, once the coating portion 53 is dissolved, it will not revert to its state before dissolution.

[0288] After using the outer tube 50, the insertion part 14 is pulled out of the outer tube 50. Moreover, when the outer tube 50 is to be used again, the thickness of the coating part 53 changes from the thickness of the first state (the thickness that allows the insertion part 14 to move in and out) to the thickness of the second state (the thickness that prevents the insertion part 14 from moving in and out), so the insertion part 14 cannot be inserted into the outer tube 50.

[0289] Therefore, according to the outer tube 50 of embodiment 10, since the coating portion 53 provided by the insertion conduit 62 can be switched from a first state where the thickness is thick enough to be inserted into the insertion portion 14 to a second state where the thickness is thin enough to be inserted into the insertion portion 14, but cannot be switched from the second state to the first state, the used outer tube 50 can be made unusable.

[0290] Furthermore, by observing the outer tube 50 that cannot be inserted into the insertion part 14, the surgeon can identify whether the outer tube 50 is no longer usable (i.e., whether the outer tube 50 is unused or has been used).

[0291] Furthermore, the thickness of the coating portion 53 in the first state when PVP is applied as the coating portion 53 is, for example, 1 μm to 3 μm, and the thickness of the coating portion 53 in the second state is less than 1 μm.

[0292] [Implementation Method 11]

[0293] exist Figure 3 In the outer tube 50 shown, the adhesive fixing parts 82 and 84 in which the balloon 60 is fixed to the tube body 52 are formed of water-soluble material and come into contact with body fluids during endoscopic examination.

[0294] When using the outer sleeve 50, the adhesive fixing part 84 is easily dissolved by being wetted by body fluid.

[0295] If the outer tube 50 is to be used again after its initial use, air leaks from the area where the adhesive fixing part 84 dissolved during the leak test. That is, the balloon 60 does not inflate.

[0296] Therefore, according to embodiment 11, the outer tube 50 has a structure in which the adhesive fixing part 84 for fixing the balloon 60 can be changed from the first state before dissolution to the second state after dissolution, but cannot be changed from the second state to the first state, so that the used outer tube 50 can no longer be used.

[0297] Furthermore, by observing that the balloon 60 does not inflate during the leakage test, the surgeon can identify whether the outer tube 50 is no longer usable (i.e., whether the outer tube 50 is unused or has been used).

[0298] In addition, even if the balloon 60 cannot be airtight due to the dissolution of the adhesive fixing part 84 during the use of the outer tube 50, the balloon 60 remains bonded to the tube body 52 by the adhesive fixing part 82, thus preventing the balloon 60 from detaching from the tube body 52.

[0299] [Implementation Method 12]

[0300] Figure 23 This is a side view of the outer tube 50 to which the pressure measuring membrane 410 is attached.

[0301] The pressure measuring membrane 410 is a known type of membrane, including, for example, two-sheet and single-sheet types. A two-sheet type refers to a sheet formed by overlapping the coated surfaces of a chromogenic agent and a chromogenic agent. A single-sheet type is made by coating a single sheet with both a chromogenic agent and a chromogenic agent. In this example, Prescale (trade name; registered trademark) is used as the pressure measuring membrane 410 attached to the outer sleeve 50.

[0302] By attaching the pressure-measuring membrane 410 to the location in the outer sleeve 50 where pressure is applied, the pressure-measuring membrane 410 changes color (e.g., from white to red) upon pressure detection.

[0303] That is, the pressure measuring membrane 410 changes color from white (state 1) to red (state 2) due to a color change caused by the detected pressure (a chemical reaction associated with the use of the outer tube 50). However, the pressure measuring membrane 410 cannot change from state 2 back to state 1. That is, once the pressure measuring membrane 410 changes color, it will not return to its original state before the color change. The attachment position of the pressure measuring membrane 410 will be described below.

[0304] exist Figure 23 In the middle, a pressure measuring membrane 410 is attached at the position corresponding to the leak-proof valve 90. The leak-proof valve 90 is the part that is pressurized by contacting the insertion part 14 of the endoscope 10 when using the outer tube 50, and is provided in the inner circumferential surface 52B of the tube body 52 located on the front end side from the base opening 56 (see reference). Figure 3 ).

[0305] The pressure measuring membrane 410 is attached to the outer peripheral surface 52A of the tube body 52, located radially outside the leak-proof valve 90, and changes color to detect the pressure generated when the outer tube 50 is used.

[0306] Therefore, according to Figure 23 The outer tube 50 of Embodiment 12 shown has a structure in which the pressure measuring membrane 410 of the tube body 52 can transition from a first state before discoloration to a second state after discoloration, but cannot transition from the second state back to the first state. Therefore, by checking whether the pressure measuring membrane 410 has changed color, the surgeon can identify whether the outer tube 50 is no longer usable (i.e., whether the outer tube 50 is unused or has been used). Thus, the use of the outer tube 50 by the surgeon can be substantially suppressed, and as a result, the used outer tube 50 can be rendered unusable.

[0307] Furthermore, the location where the pressure measuring membrane 410 is attached to the outer tube 50 is not limited to the positions described above. For example, the pressure measuring membrane 410 can also be attached to the air inlet 74 where it is connected to the connecting portion 100A of the connecting tube 100 and is pressurized, the adhesive fixing portions 82, 84 where air pressure is applied when the balloon 60 is inflated, the front end portion 55 of the tube body 52 where it is in contact with the insertion portion 14 and is pressurized, or the outer peripheral surface 52A of the tube body 52 where it is pressurized when held by the surgeon during use of the outer tube 50. Furthermore, if a rigid front end ring constituting the front opening 54 is provided at the front end portion 55 of the tube body 52, the pressure measuring membrane 410 can be attached to this front end ring. The front end ring is the portion where pressure is applied when it contacts the insertion portion 14 of the endoscope 10 during use of the outer tube 50.

[0308] In the embodiments 1 to 12 of the present invention described above, an outer cannula (insertion aid) is illustrated as a medical device of the present invention, but it is not limited thereto. That is, the technology used to render the present application unusable can also be adapted to other disposable medical devices (e.g., endoscopes or treatment devices).

[0309] The embodiments described above are described in detail. However, without departing from the spirit of the present invention, the present invention may be improved or modified.

Claims

1. A medical device inserted into the body, The medical device includes a state-changing unit that can switch from a first state to a second state, but cannot switch from the second state back to the first state.

2. The medical device according to claim 1, wherein, The state-changing unit can transition from the first state to the second state through physical or chemical actions associated with the use of the medical device.

3. The medical device according to claim 2, wherein, The state-changing part is composed of a fragile part that can be irreversibly deformed or destroyed when a physical force is applied.

4. The medical device according to claim 3, wherein, The vulnerable part is located in the fixing part that connects to other components. The first state refers to the state before the vulnerable part deforms or breaks, and is the state in which it is fixedly connected to the other components. The second state is the state after the vulnerable part has been deformed or damaged, and the fixation to the other components has been released.

5. The medical device according to claim 2, wherein, The state change section is composed of a liquid-soluble component that can dissolve when given a dissolving liquid.

6. The medical device according to claim 5, wherein, The medical device has the following features: The first conduit is used for connection to other medical devices different from the stated medical device; and The second pipeline is constructed separately from the first pipeline. A leak hole, sealed by the liquid-soluble component, is provided in the second pipeline.

7. The medical device according to claim 6, wherein, The medical device has an inflatable and contractible balloon. The second conduit is used for supplying and deflating the balloon. The leakage hole is a connecting hole that connects the second pipeline and the first pipeline.

8. The medical device according to claim 2, wherein, The state change section is composed of an expansion section that can expand irreversibly through an expansion medium.

9. The medical device according to claim 8, wherein, The medical device has a first conduit for insertion into other medical devices different from the medical device itself. The expansion section has a hole that forms part of the first pipeline. The first state refers to the state before the expansion portion expands, and the hole is sized to allow other medical devices to pass through. The second state is the state after the expansion portion has expanded, and the hole is the size at which other medical devices cannot be inserted.

10. The medical device according to claim 9, wherein, The medical device includes a valve body disposed in the first pipeline to prevent fluid from flowing out to the outside. At least a portion of the valve body is formed by the expansion portion.

11. The medical device according to claim 2, wherein, The medical device has a first conduit for insertion into other medical devices different from the medical device itself. The state-changing section is composed of a coating portion disposed on the inner wall surface of the first pipeline that is soluble in liquid. The first state is the state before the coating dissolves and the state in which the coating has a thickness that allows the other medical device to move in and out relative to the first tubing. The second state is the state after at least a portion of the coating has dissolved and the coating has a thickness that prevents the other medical device from moving in or out of the first conduit.

12. The medical device according to any one of claims 1 to 11, wherein, The medical device is an insertion aid used to guide other medical devices, different from the medical device itself, into the body.

13. A connecting tube for connecting a medical device inserted into the body and having a balloon to a balloon control device for inflating and deflating the balloon. The connecting pipe has a state changing section that can switch from a first state to a second state, but cannot switch from the second state to the first state.

14. The connecting pipe according to claim 13, wherein, The state-changing unit can transition from the first state to the second state through physical or chemical actions associated with the use of the medical device.

15. The connecting pipe according to claim 14, wherein, The connecting tube has a first connecting portion that connects to the medical device. The state change section is disposed in the first connection section.

16. The connecting pipe according to claim 14, wherein, The connecting tube has a second connecting portion that connects to the balloon control device. The state change section is located in the second connection section.

17. The connecting pipe according to claim 14, wherein, The connecting tube is integrally formed with the medical device.

18. A medical device system comprising the medical device according to any one of claims 1 to 11, The medical device is an insertion aid used to guide other medical devices, different from the medical device mentioned above, into the body. The medical device system also includes the other medical devices.

19. The medical device system according to claim 18, wherein, The other medical device mentioned is an endoscope.

20. A medical device system comprising: The connecting pipe according to any one of claims 13 to 17; The medical device; and The balloon control device.

21. The medical device system according to claim 20, wherein, The medical device is an insertion aid used to guide other medical devices, different from the medical device itself, into the body.

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

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