Cardia achalasia diagnosis device used in cooperation with endoscope and endoscope

Abstract

The invention discloses a cardia achalasia diagnosis device used in cooperation with an endoscope and the endoscope. The diagnostic device comprises an intervention catheter, a first air bag and an elastic force-induced discoloration structural member, the first air bag is connected to the far end of the interventional catheter, and the first air bag is matched with the cardia of the human body; the elastic force-induced discoloration structural member is arranged on the intervention catheter, and the elastic force-induced discoloration structural member is located on the near-end side of the first air bag; an air guide channel is arranged in the interventional catheter, and the air guide channel of the interventional catheter is connected with the air inlet of the first air bag; the interventional catheter, the elastic force-induced discoloration structural member and the first air bag are all matched with an instrument channel of the endoscope. The invention provides a cardia achalasia diagnosis device used in cooperation with an endoscope. The cardia achalasia diagnosis device is used in cooperation with the endoscope. The device solves the problem of shortage of equipment resources, and has the advantages of simple structure, low cost, simplicity and convenience in operation, high diagnosis accuracy and small pain of patients.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a diagnosis device for achalasia of the cardia used in conjunction with an endoscope and an endoscope. Background Art

[0002] Achalasia of the cardia is an esophageal motility disorder disease in which patients have symptoms such as dysphagia and food reflux due to the relaxation disorder of the lower esophageal sphincter and the lack of propulsive peristalsis in the esophageal body. Accurate diagnosis is the premise of effective treatment, but there are many problems to be solved urgently in the current clinical examination methods.

[0003] For esophageal barium meal radiography, X-ray observation is required after the patient takes an oral contrast agent. There are problems such as relying on patient cooperation, radiation hazards, the contrast agent is likely to cause adverse reactions, high equipment costs and examination fees, and long patient waiting times. Esophageal high-resolution manometry measures the esophageal pressure changes through a manometry catheter, which causes great pain to the patient, has high operation requirements, high equipment costs and examination fees, and the patient has few examination opportunities. Although gastroscopy can directly observe and biopsy, there are problems such as high equipment costs, long training cycles for professional physicians, and tight patient examination schedules. 24-hour esophageal pH monitoring is used for auxiliary diagnosis, and there are problems such as affecting the patient's daily life, the data is easily interfered, high costs, and limited applications. Endoscopic ultrasonography has high requirements for equipment and personnel, high costs, long time-consuming, the images are easily interfered, and the equipment resources need to give priority to critically ill patients, resulting in the problem that patients with achalasia of the cardia are difficult to be examined in a timely manner.

[0004] In summary, the existing examination methods for achalasia of the cardia not only have problems such as complex operation, great pain to the patient, and high costs, but also due to high equipment costs and limited resources, hospitals need to give priority to meeting the examination needs of patients with other more serious diseases, resulting in patients with achalasia of the cardia being difficult to obtain timely and effective diagnosis. There is an urgent need to develop new examination technologies or devices to solve the above problems. Summary of the Invention

[0005] The present invention discloses a diagnosis device for achalasia of the cardia used in conjunction with an endoscope and an endoscope to solve the above technical problems in the related art.

[0006] To solve the above problems, the present invention adopts the following technical solutions: In a first aspect, the present application provides a diagnosis device for achalasia of the cardia used in conjunction with an endoscope, including an intervention catheter, a first balloon, and an elastic force-induced color change structural member; Wherein, the first balloon is adapted to the cardia of the human body, and the first balloon is connected to the distal end of the intervention catheter; The elastic force-induced color change structural member is disposed on the intervention catheter, and the elastic force-induced color change structural member is located on the proximal side of the first balloon; The intervention catheter has an air guiding channel therein, and the air guiding channel of the intervention catheter is connected to the air inlet of the first balloon. The intervention catheter, the elastic force-induced color change structural member, and the first balloon are all adapted to the instrument channel of the endoscope.

[0007] In a second aspect, the present application provides an endoscope, including the achalasia diagnosis device for use in conjunction with the endoscope as described above.

[0008] The technical solution adopted by the present invention can achieve the following beneficial effects: The present application provides an achalasia diagnosis device for use in conjunction with an endoscope. When used in conjunction with the endoscope, it not only solves the problem of tight equipment resources, but also has the advantages of simple structure, low cost, simple operation, high diagnostic accuracy, and less pain for patients. Specifically: (1) This diagnostic device is used in conjunction with the endoscope. There is no need to purchase additional large-scale dedicated inspection equipment, and the diagnostic work can be carried out only by using the existing endoscope resources in the hospital. Since endoscopes are widely used in hospitals, it can effectively alleviate the problem that patients with achalasia are difficult to obtain timely diagnosis due to tight equipment resources, enabling patients to be diagnosed and treated more quickly.

[0009] (2) The structure of this diagnostic device is relatively simple, and the manufacturing costs of the intervention catheter, the first balloon, and the elastic force-induced color change structural member are relatively low. Compared with some large-scale inspection equipment (such as high-resolution esophageal manometry), it does not require high equipment purchase and maintenance costs, and does not require complex maintenance and upkeep. At the same time, complex reagents and consumables are not needed during the inspection process, further reducing the inspection cost. Existing inspection methods such as gastroscopy require the use of a variety of consumables such as disposable biopsy forceps and local anesthetics, increasing the inspection cost; only a small amount of expansion medium is needed during the use of this device, and the consumable cost can be almost ignored. This greatly reduces the cost of the hospital for carrying out achalasia inspections, and at the same time reduces the economic burden on patients, enabling more patients to afford the inspection cost, improving the diagnostic coverage rate of the disease, and having good economic efficiency and popularization and application value.

[0010] (3) This diagnostic device is used in conjunction with an endoscope. With the aid of the endoscope's visualization function, it can quickly and accurately position the first airbag at the cardia position and observe the operation process in real time. The entire inspection process is simple to operate and usually can be completed within 10 - 15 minutes. The elastic force-induced chromogenic structural member can intuitively convert the resistance situation of the cardia into color changes. Combining with the real-time image observation of the endoscope, doctors can make diagnostic judgments more quickly, reducing diagnostic delays caused by complex operations and difficult data interpretation. At the same time, the structural design of the device enables it to pass smoothly through the instrument channel of the endoscope. The operation process is simple and convenient, with relatively low technical requirements for operators, reducing the operation difficulty and risk. Moreover, the three-dimensional pressure distribution data collected by the pressure sensing layer inside the first airbag can also provide a more comprehensive reference basis for diagnosis, further improving the accuracy of diagnosis and avoiding misdiagnosis and missed diagnosis.

[0011] (4) This diagnostic device intuitively reflects the resistance of the cardia to the first airbag through the elastic force-induced chromogenic structural member. The cardia of patients with achalasia has abnormal diastolic and systolic functions, resulting in different resistance to the first airbag compared to normal conditions. By observing the degree of color change of the elastic force-induced chromogenic structural member, it is possible to relatively accurately determine whether a patient has achalasia, providing a reliable basis for clinical diagnosis. Compared with traditional examination methods, it reduces the error of subjective judgment and improves the accuracy of diagnosis.

[0012] (5) The intervention catheter and the first airbag of this diagnostic device are relatively soft, and the operation process is relatively gentle, causing less irritation to the patient's esophageal and cardia tissues during the examination, effectively reducing the patient's pain and improving the patient's compliance with the examination. Brief Description of the Drawings

[0013] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the following-described drawings are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0014] Figure 1 is a schematic structural diagram of an embodiment of the present application (the first airbag is in an unexpanded state); Figure 2 is Figure 1 an enlarged schematic diagram of part A in Figure 3 is Figure 1 a cross-sectional view taken along B - B in Figure 4 is a schematic structural diagram of another embodiment of the elastic force-induced chromogenic structural member in the embodiment of the present application; Figure 5 is a schematic structural diagram of an embodiment of the present application (the first airbag is in an expanded state); Figure 6 is a schematic structural diagram of another embodiment of the present application (the first airbag is in an expanded state); Figure 7 is a schematic diagram of the state of the diagnostic device and the endoscope used in combination in an embodiment of the present application; Figure 8 is a schematic diagram of the state of another embodiment of the diagnostic device and the endoscope used in combination in an embodiment of the present application; Figure 9 is a schematic diagram of the state of the diagnostic device and the endoscope used in combination in an embodiment of the present application (the second airbag is in an unexpanded state); Figure 10 is a schematic diagram of the state of the diagnostic device and the endoscope used in combination in an embodiment of the present application (the second airbag is in an expanded state); Figure 11 is a schematic diagram of the state of the diagnostic device and the endoscope used in combination in an embodiment of the present application with another embodiment of the second airbag (the second airbag is in an unexpanded state); Figure 12 is a schematic diagram of the state of the diagnostic device and the endoscope used in combination in an embodiment of the present application with another embodiment of the second airbag (the second airbag is in an expanded state); Figure 13 is a schematic diagram of the state of the diagnostic device and the endoscope used in combination in an embodiment of the present application with yet another embodiment of the second airbag (the second airbag is in an unexpanded state); Figure 14 is a schematic diagram of the state of the diagnostic device and the endoscope used in combination in an embodiment of the present application with yet another embodiment of the second airbag (the second airbag is in an expanded state); Figure 15 is a schematic connection diagram of the diagnostic device and the endoscope in an embodiment of the present application; Figure 16 is the present application Figure 13 an enlarged schematic diagram of part C; Figure 17 is a schematic cross-sectional structure diagram of the proximal joint in an embodiment of the present application.

[0015] In the figure: 10, intervention catheter; 101, gas conduction channel; 20, first balloon; 30, elastic force-induced color change structural member; 301, elastic main body; 302, force-induced color change material layer; 303, transparent lubricating protective film; 40, insertion part; 50, second balloon; 60, annular elastic band; 70, proximal connector; 701, first interface; 702, second interface; 703, tube body; 704, pulling end; 705, clamping groove; 706, rigid catheter; 707, connecting head; 80, clamping protrusion; 90, shape memory alloy stent; 901, connecting ring; 902, connecting bar; 100, instrument channel; 110, instrument channel interface. Detailed implementation manners

[0016] In the embodiments of the present application, "proximal" and "distal" refer to the relative distances of each component from the medical staff user in the usage environment. Among them, the end closer to the user is designated as "proximal", and the end farther from the medical staff user is designated as "distal".

[0017] To facilitate the understanding of a diagnosis device for achalasia of the cardia and an endoscope provided in the embodiments of the present application and used in cooperation with the endoscope, the related technologies thereof will be first introduced below in conjunction with the application scenario.

[0018] The resting pressure of the lower esophageal sphincter (LES) in patients with achalasia of the cardia is usually significantly higher than the normal value. However, it is not an increase in active contractile force, but a persistent spasm state caused by abnormal neural regulation. Normal LES resting pressure: 15 - 30 mmHg; LES resting pressure in patients with achalasia of the cardia: most > 40 mmHg (in some patients, it can reach more than 100 mmHg). The key difference is that during normal swallowing, the LES should relax to the level of gastric pressure (about 5 - 10 mmHg), but due to the lack of inhibitory nerve signals in patients, the LES cannot relax, forming a functional obstruction.

[0019] In the prior art, the examination methods for achalasia of the cardia not only have problems such as complex operation, great pain for patients, and high cost, but also due to the high equipment cost and limited resources, hospitals need to give priority to meeting the examination needs of patients with other more serious diseases, resulting in difficulty for patients with achalasia of the cardia to obtain timely and effective diagnosis. There is an urgent need to develop new examination technologies or devices to solve the above problems.

[0020] For this reason, the present application provides a diagnosis device for achalasia of the cardia and an endoscope used in cooperation with the endoscope. The following combines Figures 1 - 17 to detail the technical solutions disclosed in each embodiment of the present application.

[0021] Embodiment 1: The present application provides a diagnosis device for achalasia of the cardia for use in conjunction with an endoscope, including an intervention catheter 10, a first balloon 20, and an elastic force-induced color-changing structural member 30; Wherein, the first balloon 20 is adapted to the cardia of the human body, and the first balloon 20 is connected to the distal end of the intervention catheter 10; The elastic force-induced color-changing structural member 30 is disposed on the intervention catheter 10; The intervention catheter 10 has a gas conduction channel 101 therein, and the gas conduction channel 101 of the intervention catheter 10 is connected to the air inlet of the first balloon 20; The intervention catheter 10, the elastic force-induced color-changing structural member 30, and the first balloon 20 are all adapted to the instrument channel 100 of the endoscope.

[0022] In the present application, the adaptation of the first balloon 20 to the cardia of the human body means that after the first balloon 20 is expanded by an expansion medium, through the pulling force applied by the intervention catheter 10, the first balloon 20 can be pulled through the cardia. Because the resting pressure of the lower esophageal sphincter (LES) of patients with achalasia of the cardia is usually significantly higher than the normal value, during the examination using the diagnosis device in the present application, an examiner with achalasia of the cardia needs a greater pulling force to pull the first balloon 20 through the cardia, while an examiner without achalasia of the cardia can pull the first balloon 20 through the cardia with a smaller pulling force; due to the different magnitudes of the required pulling forces, it can be sensed by the elastic force-induced color-changing structural member 30, and thus a diagnosis of whether achalasia of the cardia is present can be made.

[0023] The diagnosis device for achalasia of the cardia provided by the present application is used in conjunction with an endoscope, and the specific operation steps for static examination are as follows: S1. Preliminary preparation Device pretreatment: Conduct a sealing test on the intervention catheter 10 to ensure that its internal gas conduction channel 101 and signal transmission channel are unblocked and undamaged; check whether the first balloon 20 has air leakage, which can be judged by filling a small amount of gas into the balloon and observing the pressure change after standing; confirm that the surface of the elastic force-induced color-changing structural member 30 has no stains or damage, and conduct a control test with an external standard color card to verify that its force-induced color-changing function is normal.

[0024] Endoscope adaptation: Select an appropriate model of endoscope according to the specific situation of the patient, measure the inner diameter size of the instrument channel 100 of the endoscope, and compare it with the outer diameter of the intervention catheter 10. At the same time, debug the image acquisition and transmission system of the endoscope to ensure that the internal conditions of the esophagus and cardia can be clearly and stably presented during subsequent operations.

[0025] S2. Device placement Insert the assembled diagnostic device, including the interventional catheter 10, the first balloon 20, and the elastomeric force-responsive color-changing structural member 30, as a whole, slowly through the instrument channel 100 of the endoscope. During the insertion process, use the real-time image of the endoscope to observe the traveling path of the interventional catheter 10 to ensure that it passes smoothly through the esophagus until the first balloon 20 reaches the cardia position.

[0026] S3. Operation of the first balloon 20 Balloon positioning and passing through the cardia: After confirming that the first balloon 20 is above the cardia, continue to push the interventional catheter 10 to make the first balloon 20 pass through the cardia and enter the stomach. During this process, the pushing depth and angle of the interventional catheter 10 can be precisely controlled according to the image displayed by the endoscope to ensure that the first balloon 20 accurately reaches the predetermined position. Balloon dilation: Through the gas conduction channel 101 of the interventional catheter 10, an appropriate amount of dilation medium such as sterile air is filled into the first balloon 20.

[0027] S4. Tensile test and diagnostic judgment Pulling operation: The operator slowly and uniformly pulls the interventional catheter 10 to make the expanded first balloon 20 pass through the cardia again. During this process, the muscle contraction force and relaxation degree of the cardia will produce different resistances to the first balloon 20, and this resistance is transmitted through the interventional catheter 10 to the elastomeric force-responsive color-changing structural member 30.

[0028] Color change observation and diagnosis: When subjected to the stress transmitted by the interventional catheter 10, the conjugated structure of the special force-sensitive dye molecules contained in the elastomeric force-responsive color-changing structural member 30 changes, thus presenting different colors. The operator observes the color change of the elastomeric force-responsive color-changing structural member 30 through the imaging system of the endoscope and compares it with the pre-set standard color card. If the color change reaches or exceeds a specific threshold, it is judged that the patient may have achalasia; if the color change is not obvious, it indicates that the possibility of the patient having achalasia is relatively low. At the same time, inflation-deflation can be repeated multiple times and the pulling operation can be carried out to obtain a more accurate judgment result.

[0029] S5. End operation After completing the tensile test, the dilation medium in the first balloon 20 is discharged through the gas conduction channel 101 of the interventional catheter 10 to make the first balloon 20 contract. Subsequently, slowly remove the interventional catheter 10 and the endoscope from the patient's body, and clean and disinfect the diagnostic device for the next use.

[0030] Please refer to Figures 9 - 10In some embodiments, the diagnostic device further includes a second airbag 50 for simulating human swallowing action, and the second airbag 50 is used to be sleeved on the outside of the endoscope insertion part 40; and when the interventional catheter 10 is extended forward, the first airbag 20 and the second airbag 50 can be respectively located at the two ends of the cardia, that is, when the first airbag 20 passes through the cardia, the second airbag 50 is located in the esophagus near the cardia. It is understandable that after the static examination is completed, the patient can perform a dynamic examination by simulating the swallowing action through the second airbag 50. The second airbag 50 is sleeved on the outside of the endoscope insertion part 40, and its position is designed so that when the first airbag 20 passes through the cardia, the second airbag 50 is just located in the esophagus near the cardia. Its expansion and contraction can be controlled by an external inflation and deflation device. The setting principle is based on the physiological mechanism of esophageal swallowing: when the second airbag 50 is inflated, the expansion of the airbag will generate pressure on the surrounding esophageal wall, simulating the pressure change caused by the esophageal peristaltic wave during swallowing, stimulating the contraction of the esophageal muscles, and prompting the cardia to make a corresponding relaxation response; when deflated, the pressure is released, simulating the relaxation state of the esophagus after swallowing. Through this inflation-deflation cycle operation, multiple swallowing actions can be simulated. In this process, the change in resistance encountered by the first airbag 20 when passing through the cardia again will more realistically reflect the actual functional state of the cardia during swallowing, and then intuitively present the color change of the color-changing structural member 30 through the elastic force, providing a reliable basis for diagnosis. The second airbag 50 can significantly improve the accuracy of diagnosis. By simulating the swallowing action, the second airbag 50 allows the cardia to be examined in a state close to the real physiological state. For example, the relaxation degree of the cardia of some early patients seems normal under static conditions, but under the dynamic stimulation of simulated swallowing, the relaxation disorder will be more obvious, making the resistance change when the first airbag 20 passes through the cardia more severe, and the color change of the elastic force-induced color-changing structural member 30 more significant, thereby improving the accuracy of diagnosis and reducing missed diagnosis and misdiagnosis. Compared with the existing static inspection technology, it can more accurately capture the abnormal function of the cardia and provide a more reliable basis for clinical diagnosis. The second airbag 50 can also improve the efficiency of diagnosis. Because the second airbag 50 simulates the swallowing action, it can more accurately judge the condition and reduce repeated inspections caused by inaccurate diagnosis. In the case of tight existing equipment resources, patients do not need to wait in line for examination again due to misdiagnosis and missed diagnosis, shortening the overall diagnosis time. At the same time, more accurate diagnosis results can also help doctors quickly formulate treatment plans, improve the utilization efficiency of medical resources, and to a certain extent alleviate the problem of delayed diagnosis of patients with achalasia caused by the hospital's equipment resources giving priority to the examination needs of critically ill patients. The second airbag 50 is provided to optimize the patient's examination experience. By simulating the natural swallowing action through the second airbag 50, the examination process is more in line with the physiological feelings of the human body, and the patient's psychological and physiological discomfort is significantly reduced.For example, multiple operations such as repeatedly inserting a catheter to obtain accurate diagnostic information are avoided, the irritation to the esophagus and cardia is reduced, the compliance of the patient with the examination is improved, the patient is more willing to cooperate with the examination, which is beneficial to the early detection and treatment of diseases.

[0031] In some embodiments, an air inlet pipe is connected to the second airbag 50, and the air inlet pipe is used to connect to an external inflation device. Specifically, the air inlet pipe can be arranged in parallel with the insertion part 40 and enter the esophagus following the insertion part 40; when it is necessary to inflate the expansion medium, the second airbag 50 is inflated with gas through the inlet pipe.

[0032] Please refer to Figures 13 - 14 , in some embodiments, a shape memory alloy stent 90 is provided outside the second airbag 50, and the shape memory alloy stent 90 is closely attached to the outer wall of the second airbag 50, and one end of the shape memory alloy stent 90 is connected to the proximal or distal end of the second airbag 50. It can be understood that in the examination of the cardia and the diagnosis of achalasia of the cardia, accurately simulating the physiological state of the cardia during human swallowing is the key. The cardia, as the connection part between the esophagus and the stomach, its normal function is closely related to the swallowing process. Patients with achalasia of the cardia have problems with the inability of the lower esophageal sphincter to relax normally, resulting in dysphagia. Traditional examination methods may be difficult to accurately simulate the pressure changes, morphological changes, etc. at the cardia during swallowing. Placing the second airbag 50 in the esophagus to simulate the swallowing action and setting the shape memory alloy stent 90 outside it can more realistically restore the dynamic changes of the esophagus and cardia during swallowing. The unique shape memory and superelastic properties of the shape memory alloy ensure that the shape memory alloy stent 90 and the second airbag 50 move in high synchronization, providing a simulation environment more in line with human physiological characteristics for cardia examination and disease diagnosis, thereby improving the accuracy and reliability of diagnosis. In this device, when the second airbag 50 is inflated in the esophagus to simulate the esophageal dilation action during swallowing, the pressure generated by the inflation of the second airbag 50 acts on the shape memory alloy stent 90. This pressure causes the shape memory alloy to undergo a phase change, changing from the martensite phase to the austenite phase, and the shape memory alloy stent 90 extends accordingly, thereby simulating the pressure conduction received by the cardia during swallowing. When the airbag deflates to simulate the contraction state of the esophagus after swallowing, the pressure decreases, and the shape memory alloy stent 90 returns from the austenite phase to the martensite phase under the action of its own restoring force, and the shape memory alloy stent 90 contracts, following the contraction action of the second airbag 50, simulating the state change of the cardia when the esophagus returns to its original state. In this way, the dynamic simulation of the swallowing action and the simulation of the physiological and pathological states of the cardia are realized. Highly simulating the swallowing action and the cardia state enables doctors to more intuitively observe the reaction of the cardia during swallowing. In the diagnosis of achalasia of the cardia, characteristics such as the inability of the cardia to relax normally and abnormal esophageal pressure can be clearly presented, providing richer and more accurate information for disease diagnosis, helping to improve the diagnosis efficiency and accuracy, and avoiding missed diagnosis and misdiagnosis.

[0033] In some embodiments, the shape memory alloy stent 90 includes a connecting ring 901 and a plurality of connecting bars 902 connected to the connecting ring 901. The connecting ring 901 is connected to the proximal or distal end of the second airbag 50. The connecting bars 902 extend from the proximal end of the second airbag 50 to its distal end, and the connecting bars 902 of the shape memory alloy stent 90 are closely attached to the outer wall of the second airbag 50; alternatively, the connecting bars 902 extend from the distal end of the second airbag 50 to its proximal end, and the connecting bars 902 of the shape memory alloy stent 90 are closely attached to the outer wall of the second airbag 50.

[0034] Please refer to Figures 11 - 12 , in some embodiments, at least one annular elastic band 60 is sleeved on the second airbag 50. It can be understood that the annular elastic band 60 has an elastic contraction force. After being sleeved on the second airbag 50, it will form a restraint on a part of the airbag. When the second airbag 50 is inflated, the gas will first accumulate in the relatively loose and less resistant area at the proximal end, making the air cavity in this area fill first. As the gas pressure gradually increases, after overcoming the restraint force of the elastic band, it will then diffuse to the air cavities at the distal end in sequence, so as to achieve the effect of gradually filling each air cavity from the proximal end to the distal end. This process is similar to the principle that the esophageal muscles contract and squeeze food from the proximal end to the distal end in sequence. The restraint effect of the elastic band is like the contraction of the esophageal muscles, restricting the diffusion path and speed of the gas, making the inflation of the airbag show a sequence and rhythm similar to esophageal peristalsis, and then simulating the dynamic characteristics of the pressure change in the esophagus during the swallowing process. The sequential inflation of multiple air cavities of the second airbag 50 achieved by the annular elastic band 60 in this application can highly restore the process of esophageal muscle peristalsis pushing food and the change law of the pressure in the esophagus during this process. During the cardia function examination, this simulation can make the cardia receive a pressure stimulus similar to real swallowing, helping doctors more accurately observe the functional states such as the opening and closing response and pressure coping ability of the cardia, and providing a more reliable basis for the diagnosis of cardia diseases.

[0035] In some embodiments, 2 - 4 annular elastic bands 60 are sleeved on the second airbag 50 along the direction from its proximal end to its distal end.

[0036] In some embodiments, the materials of the first airbag 20 and the second airbag 50 are both silicone rubber or polyurethane. The molecular structures of silicone rubber and polyurethane are relatively stable, and they will not release harmful substances in the human physiological environment, nor will they react chemically with human tissues, thus avoiding harm to the human body. When they come into contact with human tissues, they can form a relatively gentle interface with the surrounding tissues, reducing the occurrence of inflammatory reactions and immune reactions. Moreover, when these two materials are subjected to external forces, the molecular chains can be stretched and twisted, causing the airbag to undergo elastic deformation. When inflated, the gas pressure expands the airbag, and the molecular chains of the material are pulled apart; when deflated, the molecular chains return to their original state under the action of their own elastic force, causing the airbag to contract. By controlling the inflation volume and pressure, the degree of expansion and shape of the airbag can be precisely adjusted to simulate different physiological states.

[0037] Please refer to Figures 13 - 15 , in some embodiments, a proximal connector 70 is connected to the proximal end of the interventional catheter 10. The proximal connector 70 includes a first interface 701 detachably connected to the instrument channel interface 110 of the endoscope and a second interface 702 connected to an external inflation device, and the interventional catheter 10 is connected to the second interface 702. It can be understood that when connected to an external inflation device, the air outlet of the inflation device is docked with the second interface 702 through a hose, and the air pressure generated by the inflation device is used to transport gas through the air guide channel 101 of the interventional catheter 10 to the first airbag 20 for inflation. The external inflation device can be a syringe, an air pump, or other inflatable devices; when deflation is required, a deflation device can also be connected through the second interface 702 for deflation.

[0038] In some embodiments, the first interface 701 includes a cover body adapted to the instrument channel interface 110 of the endoscope. A clamping protrusion 80 is provided on the outer wall of the instrument channel interface 110 of the endoscope, and a clamping groove 705 adapted to the clamping protrusion 80 is provided at a position corresponding to the clamping protrusion 80 on the inner side of the cover body. It can be understood that the detachable connection between the first interface 701 and the instrument channel interface 110 can be achieved by snapping the clamping protrusion 80 into the clamping groove 705; during the process of using the diagnostic device of the present application for examination, the first interface 701 can be pulled to separate the first interface 701 from the instrument channel interface 110, and by continuing to pull the first interface 701, the interventional catheter 10 can be driven to move proximally, thereby pulling the first airbag 20 through the cardia.

[0039] In some embodiments, the proximal connector 70 further includes a tube body 703; wherein, the cover body of the first interface 701 is sleeved on the distal end of the tube body 703; a pulling end 704 is provided at the proximal end of the tube body 703; The second interface 702 is connected to the side wall of the tube body 703; A rigid catheter 706 is provided in the tube body 703. One end of the rigid catheter 706 is connected to the second interface 702, and the other end of the rigid catheter 706 is connected with a connector 707 for detachably connecting with the interventional catheter 10. It can be understood that the connection between the interventional catheter 10 and the connector 707 can be a plug connection, a threaded connection, etc. It is necessary to ensure that when the proximal connector 70 is pulled during the diagnosis process, the connection between the interventional catheter 10 and the connector 707 is firm and does not become detached; the provided pulling end 704 can make it more convenient to pull the interventional catheter 10 during the diagnostic examination.

[0040] In some embodiments, the elastic force-induced color change structural member 30 includes an elastic main body 301 and a force-induced color change material layer 302 coated on the outer wall of the elastic main body 301. It can be understood that in the achalasia diagnosis device, the elastic force-induced color change structural member 30 needs to accurately convert the resistance change of the cardia to the first airbag 20 into a visible color change, providing a basis for diagnosis. The elastic main body 301 is provided to ensure that the elastic force-induced color change structural member 30 can undergo elastic deformation with the pulling of the interventional catheter 10 and the action of the cardia resistance, so as to accurately transmit the change in the force received to the force-induced color change material layer 302. Without the elastic main body 301, the force-induced color change material layer 302 may not be able to effectively sense and transmit external forces, resulting in inaccurate or unclear color changes and affecting the diagnosis result. The force-induced color change material layer 302 is the core part for realizing the color change function. By coating it on the outer wall of the elastic main body 301, when the elastic main body 301 deforms, it will change color due to the force, enabling the doctor to intuitively judge the functional state of the cardia through the color change. At the same time, in the existing diagnostic techniques, some detection means are difficult to directly present the mechanical state information of the cardia. The setting of the elastic force-induced color change structural member 30 makes up for this deficiency, providing a more intuitive and convenient diagnostic method for the doctor, which helps to quickly complete the diagnosis and reduce the patient's waiting time in the case of tight hospital equipment resources. The elastic main body 301 is made of a medical-grade elastic material with high elasticity and good mechanical properties, such as silicone rubber elastomer. Its molecular chain has good flexibility and stretchability. When the interventional catheter 10 is pulled by the cardia resistance, the elastic main body 301 will undergo elastic deformation accordingly. During the deformation process, the molecular chains inside the elastic main body 301 will undergo stretching, twisting and other changes, and this mechanical change can effectively be transmitted to the force-induced color change material layer 302, causing it to change color under force. At the same time, after being deformed under force, the elastic main body 301 can quickly return to its original state, ensuring that the elastic force-induced color change structural member 30 can still work normally under multiple forces, and ensuring the repeatability and accuracy of the diagnosis. The force-induced color change material in the force-induced color change material layer 302 is usually a polymer material containing special force-sensitive dyes. When the elastic main body 301 transmits the external force to the force-induced color change material layer 302, the conjugated structure of the force-sensitive dye molecules will change. This structural change will affect the absorption and emission characteristics of the dye molecules to light, resulting in a color change. For example, when the force is small, the conjugated structure of the dye molecules is in a certain state, absorbing and emitting light of a specific wavelength, presenting a certain color; when the force increases, the conjugated structure changes, the wavelength of the absorbed and emitted light changes, and the color also changes accordingly. By pre-establishing the correspondence between the force and the color change, the doctor can judge the magnitude of the resistance received by the cardia according to the color change of the force-induced color change material layer 302, and then diagnose whether the patient has achalasia.

[0041] In some embodiments, the elastic body 301 is a silicone rubber elastomer or a polyurethane elastomer. It is understandable that the elastic body 301 is made of a medical grade elastic material with high elasticity and good mechanical properties. Of course, the material specifically used for the elastic body 301 is not limited by the present application, and other medical grade elastic materials with high elasticity and good mechanical properties can also be used.

[0042] In some embodiments, the mechanochromic material layer 302 is selected from a transparent biodegradable hydrogel. It is understood that mechanochromic materials generally refer to materials whose optical properties change when subjected to mechanical forces such as stretching, compression, bending, and friction, thereby causing color changes. The color change principle of such materials is mainly based on structural changes within or between molecules. When subjected to external forces, the chemical bonds inside the material may break, reorganize, or the conformation of the molecules may change, thereby affecting its absorption, reflection, and scattering properties of light, which ultimately manifests as a change in color. For example, the selected transparent biodegradable hydrogel has a high sensitivity and an obvious color change effect, can produce a significant color change under a small external force, and the color change is reversible, which is suitable for scenes that require accurate detection of small force changes. Under the action of external forces, the conjugated structure of the polydiacetylene molecular chain changes, resulting in changes in its electronic band structure, which in turn causes changes in the absorption and reflection properties of light, resulting in color changes. For example, when subjected to a tensile force, the molecular chain is elongated, the conjugated length increases, the wavelength of the absorbed light is red-shifted, and the material color changes from blue to red. The magnitude of the external force can be directly reflected by the color change. For the selection of the material of the mechanochromic material layer 302, materials whose light transmittance changes due to force and materials whose color changes due to force can be selected. For example: rare earth doped mechanoluminescent PLGA gel, cholesteric liquid crystal-PDMS composite film, etc.

[0043] In some embodiments, the elastic force-induced color change structural member 30 further includes a transparent lubricating protective film 303 coated on the outer side of the force-induced color change material layer 302. It can be understood that during the use of the diagnostic device in the present application, the transparent lubricating protective film 303 effectively isolates the force-induced color change material layer 302 from corrosive substances in the internal environment of the human body, reducing the risk of erosion of the material layer. At the same time, it reduces the friction between the elastic force-induced color change structural member 30 and the esophageal wall, avoiding damage caused by wear, thus significantly extending the service life of the elastic force-induced color change structural member 30. This reduces the frequency of repair or replacement required for the diagnostic device due to structural damage, reduces the equipment maintenance cost, and improves the usage efficiency and economy of the equipment in the case of limited hospital equipment resources. Moreover, the protective effect of the transparent lubricating protective film 303 can ensure that the force-induced color change material layer 302 always maintains good performance during multiple diagnostic operations, and the conjugated structure of the force-induced color change material molecules can stably change with the applied force, ensuring the accuracy and stability of the color change. Doctors can judge the resistance received by the cardia based on the reliable color change, avoiding misdiagnosis or missed diagnosis caused by the degradation of the material layer performance, improving the diagnostic accuracy, and helping patients receive timely and correct treatment. At the same time, the lubricating property of the transparent lubricating protective film 303 makes the movement of the interventional catheter 10 in the esophagus smoother, reducing the operation difficulty of doctors. During the actual diagnosis process, doctors do not need to spend too much energy overcoming the resistance of the device movement and can focus more on the diagnostic operation, shortening the examination time. In the case of tight equipment resources and patients queuing for examination, the diagnostic efficiency per unit time is improved, enabling more patients to receive examinations in a timely manner, relieving the pressure of patients waiting for diagnosis, and optimizing the utilization of medical resources.

[0044] In some embodiments, the transparent lubricating protective film 303 is made of a polytetrafluoroethylene modified material. It can be understood that the transparent lubricating protective film 303 can be made of a medical-grade polymer material with good light transmittance and lubricating performance. Its molecular structure is compact, and it can form a dense barrier to prevent substances such as digestive juices and food residues from directly contacting the force-induced color change material layer 302, thus playing a protective role. Of course, the specific material used for the transparent lubricating protective film 303 is not limited by the present application, and other medical-grade polymer materials with good light transmittance and lubricating performance can also be used.

[0045] Please refer to Figure 3 and Figure 4 , in some embodiments, the elastic main body 301 is a tubular structure, and its cross-sectional shape is circular or oval. Please refer to Figure 3 , the cross-sectional shape of the elastic main body 301 is circular; Please refer to Figure 4, the cross-sectional shape of the elastic body 301 is oval. It can be understood that the design of the tubular structure can ensure that the force-induced color change material layer 302 is uniformly and stably stressed, enabling the cardia resistance to be accurately and consistently transmitted to the force-induced color change material layer 302, reducing the color change deviation caused by uneven stress, and improving the reliability of the diagnostic results. In the case of tight hospital equipment resources and high requirements for diagnostic efficiency, stable diagnostic results can reduce the probability of repeated examinations, speed up the patient's diagnostic process, and improve the utilization efficiency of the equipment.

[0046] In some embodiments, the elastic force-induced color change structural member 30 is arranged along the length direction of the interventional catheter 10. The elastic force-induced color change structural member 30 has a first end and a second end, and both the first end and the second end of the elastic force-induced color change structural member 30 are connected to the interventional catheter 10; the length a of the elastic force-induced color change structural member 30, for the definition of a, refers to the length of the elastic force-induced color change structural member 30 when the elastic force-induced color change structural member 30 is in a natural straight state; the distance between the connection position of the interventional catheter 10 and the first end of the elastic force-induced color change structural member 30 and the connection position of the interventional catheter 10 and the second end of the elastic force-induced color change structural member 30 is b, for the definition of b, refers to the length between the connection position of the interventional catheter 10 and the first end of the elastic force-induced color change structural member 30 and the connection position of the second end of the elastic force-induced color change structural member 30 when the interventional catheter 10 is in a natural straight state, and b > a. It can be understood that when the interventional catheter 10 is pulled, the position where the elastic force-induced color change structural member 30 is located needs to satisfy that all the pulling forces act on the elastic force-induced color change structural member 30, which can avoid the influence of the interventional catheter 10 on the stress of the elastic force-induced color change structural member 30, improve the diagnostic efficiency and accuracy, reduce the patient's waiting time and the probability of repeated examinations, and make more efficient use of limited medical resources.

[0047] In some embodiments, the length of the cardia is c, and b - a > c is satisfied. It can be understood that in the diagnosis of achalasia of the cardia, the assessment of the functional state of the cardia depends on the accurate capture of its resistance change. The elastic force-induced color change structural member 30 is arranged along the length direction of the interventional catheter 10, and it is set that the length a of the elastic force-induced color change structural member 30 and the distance b between the two connection points satisfy: b - a is greater than the length c of the cardia; the elastic force-induced color change structural member 30 can ensure complete coverage of the stress change range of the cardia area and comprehensively capture the resistance information of different parts of the cardia. Whether it is the abnormal resistance change at the cardia entrance, the middle part or the exit, it can be intuitively presented through the color change of the elastic force-induced color change structural member 30, avoiding the missed diagnosis of local lesions, and being able to more accurately judge the degree and scope of the achalasia of the cardia, providing a more comprehensive and reliable basis for clinical diagnosis.

[0048] In some embodiments, the elastic force-induced color change structural member 30 is disposed close to the first airbag 20. It can be understood that the force-induced color change material in the elastic force-induced color change structural member 30 is sensitive to force. When close to the first airbag 20, the external force received by the first airbag 20 can be more directly transmitted to the elastic force-induced color change structural member 30, causing a corresponding physical or chemical change in the force-induced color change material, thereby resulting in a color change. During the process of examining using the diagnostic device of the present application, the first airbag 20 will encounter resistance when passing through parts such as the cardia. The elastic force-induced color change structural member 30 is disposed close to the first airbag 20, which can more accurately and timely sense the force received by the first airbag 20, thus more precisely reflecting the mechanical state of parts such as the cardia and providing more accurate information for diagnosis. Therefore, disposing the elastic force-induced color change structural member 30 close to the first airbag 20 improves the sensitivity and accuracy of the elastic force-induced color change structural member 30 in sensing the force on the first airbag 20, and can more precisely capture the resistance change of parts such as the cardia to the first airbag 20 in different states, providing a more reliable basis for doctors to judge the condition.

[0049] In some embodiments, the outer walls of the interventional catheter 10, the first airbag 20, and the second airbag 50 are all coated with a lubricating layer. It can be understood that the setting of the lubricating layer reduces the resistance during the insertion process, reduces the risk of abrasion to tissues of parts such as the esophagus and cardia, improves the comfort of the patient during the examination or treatment process, and also helps the doctor to more easily manipulate the interventional catheter 10, the first airbag 20, and the second airbag 50, improving the accuracy and efficiency of the operation.

[0050] In some embodiments, the lubricating layer is a silicone oil layer. It can be understood that the lubricating layer is usually composed of medical materials with a low coefficient of friction. These materials form a smooth protective film on the surfaces of the interventional catheter 10 and the first airbag 20. When in contact with human tissues, they can reduce the direct friction between the two, making the relative movement smoother. Of course, the specific material used for the lubricating layer is not limited by the present application, and other medical materials with a low coefficient of friction can also be used.

[0051] In some embodiments, the interventional catheter 10 is provided with an air inlet hole at a position corresponding to the first airbag 20. It can be understood that the provided air inlet hole is used to inflate the first airbag 20 so that the first airbag 20 can expand to an appropriate size to achieve its function in diagnosis or treatment. Specifically, an external gas source can be connected to the air inlet hole, and the gas passes through the air guiding channel 101 of the interventional catheter 10 and then enters the first airbag 20 through the air inlet hole, using the pressure of the gas to inflate the airbag. The degree of inflation of the first airbag 20 can be precisely controlled by controlling the intake air volume to adapt to the physiological conditions of different patients and the needs of diagnosis and treatment.

[0052] In some embodiments, the outer shape of the first airbag 20 includes any one of an olive shape and a spherical shape. It can be understood that a rounded outer shape can reduce the local pressure when the airbag contacts human tissues, reducing the risk of compression and damage to the tissues. The olive-shaped and spherical structures can expand uniformly after inflation, making the pressure distribution more uniform, which is beneficial for comprehensively and uniformly expanding or performing pressure tests on parts such as the cardia. Setting the outer shape of the first airbag 20 as an olive shape or a spherical shape improves the safety and comfort of the airbag during operation in the human body, reduces damage to human tissues, and at the same time, the uniform pressure distribution helps to more accurately evaluate the functional state of parts such as the cardia, improving the diagnostic and therapeutic effects.

[0053] In some embodiments, the outer shape of the second airbag 50 includes an olive shape. It can be understood that after the olive-shaped airbag is inflated, its shape can better conform to the curved surface inside the human body, making the pressure evenly distributed on the surface of the airbag and avoiding damage to tissues caused by excessive local pressure. At the same time, this shape can also pass more smoothly through the natural channels of the human body during movement. Setting the outer shape of the second airbag 50 as an olive shape improves the safety and comfort of using the second airbag 50, reduces the adverse effects on human tissues, and the uniform pressure distribution helps to achieve more precise pressure control and operation. For example, during some treatment processes, it can more precisely perform operations such as compressing or expanding specific parts.

[0054] In some embodiments, the material of the interventional catheter 10 is polytetrafluoroethylene, nylon, polyurethane, or medical-grade stainless steel. It can be understood that the material of the interventional catheter 10 first needs to be selected as a medical material, and then it also needs to meet good biocompatibility, flexibility, radiopacity, etc., and also needs to have a certain strength to facilitate pushing forward in the human body. If the material of the interventional catheter 10 is selected as polytetrafluoroethylene, due to its good lubrication performance, the interventional catheter 10 may not be provided with a lubricating layer. Of course, the material selection of the interventional catheter 10 is not limited to the materials disclosed in this application, and other compliant materials can also be selected.

[0055] Embodiment 2: An endoscope includes the achalasia diagnosis device used in conjunction with the endoscope in Embodiment 1.

Claims

1. A diagnosis device for achalasia cardiae used in cooperation with an endoscope, characterized in that It includes an interventional catheter (10), a first balloon (20), and an elastomeric force-chromic structural member (30); Among them, the first balloon (20) is connected to the distal end of the interventional catheter (10), and the first balloon (20) is adapted to the cardia of the human body; The elastomeric force-chromic structural member (30) is disposed on the interventional catheter (10), and the elastomeric force-chromic structural member (30) is located on the proximal side of the first balloon (20); The interventional catheter (10) has a gas conduction channel (101) therein, and the gas conduction channel (101) of the interventional catheter (10) is connected to the air inlet of the first balloon (20); The interventional catheter (10), the elastomeric force-chromic structural member (30), and the first balloon (20) are all adapted to the instrument channel (100) of the endoscope.

2. The achalasia diagnosis device used in conjunction with an endoscope according to claim 1, wherein, The diagnostic device further includes a second balloon (50) for simulating the swallowing action of the human body. The second balloon (50) is used to sleeve the outside of the insertion part (40) of the endoscope; and when the interventional catheter (10) extends forward, the first balloon (20) and the second balloon (50) can be respectively located at both ends of the cardia.

3. The achalasia diagnosis device for use in conjunction with an endoscope according to claim 2, wherein A shape memory alloy stent (90) is provided on the outside of the second balloon (50), and the shape memory alloy stent (90) is closely attached to the outer wall of the second balloon (50). One end of the shape memory alloy stent (90) is connected to the proximal or distal end of the second balloon (50); And / or, at least one annular elastic band (60) is sleeved on the second balloon (50).

4. The achalasia diagnosis device for use in conjunction with an endoscope according to claim 3, wherein The proximal end of the interventional catheter (10) is connected with a proximal connector (70). The proximal connector (70) includes a first interface (701) detachably connected to the instrument channel interface (110) of the endoscope and a second interface (702) connected to an external inflation device. The interventional catheter (10) is connected to the second interface (702).

5. The achalasia diagnosis device for use in conjunction with an endoscope according to claim 4, characterized in that, The elastomeric force-chromic structural member (30) includes an elastic main body (301) and a force-chromic material layer (302) coated on the outer wall of the elastic main body (301).

6. The achalasia diagnosis device for use in conjunction with an endoscope according to claim 5, wherein The elastomeric force-chromic structural member (30) further includes a transparent lubricating protective film (303) coated on the outside of the force-chromic material layer (302); And / or, the elastic main body (301) is a tubular structure, and its cross-sectional shape is circular or elliptical.

7. The achalasia diagnosis device for use in conjunction with an endoscope according to claim 6, wherein The elastomeric force-chromic structural member (30) is disposed along the length direction of the interventional catheter (10). The elastomeric force-chromic structural member (30) has a first end and a second end. Both the first end and the second end of the elastomeric force-chromic structural member (30) are connected to the interventional catheter (10); the length of the elastomeric force-chromic structural member (30) is a, the distance between the connection position of the first end of the interventional catheter (10) and the elastomeric force-chromic structural member (30) and the connection position of the second end of the interventional catheter (10) and the elastomeric force-chromic structural member (30) is b, and the length of the cardia is c, satisfying b > a.

8. The achalasia diagnosis device for use in conjunction with an endoscope according to claim 5, wherein The force-chromic material is selected from transparent biodegradable hydrogels; And / or, the elastomeric force-chromic structural member (30) is disposed close to the first balloon (20); And / or, the outer walls of the interventional catheter (10), the first balloon (20) and the second balloon (50) are all coated with a lubricating layer; And / or, the interventional catheter (10) is provided with an air inlet hole at a position corresponding to the first balloon (20).

9. The achalasia diagnosis device for use in conjunction with an endoscope according to claim 8, wherein, The outer shape of the first balloon (20) includes any one of an olive shape and a spherical shape; And / or, the outer shape of the second balloon (50) includes an olive shape.

10. An endoscope, characterized in that, Comprising the achalasia diagnosis device for use in conjunction with an endoscope according to any one of claims 1-9.

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