Achalasia diagnostic device used in conjunction with endoscope and endoscope

Abstract

The present invention discloses an achalasia diagnostic device and an endoscope for use in conjunction with an endoscope. The diagnostic device includes an interventional catheter, a first airbag, and an elastic force-induced color-changing structure; the first airbag is connected to the distal end of the interventional catheter, and the first airbag is adapted to the cardia of the human body; the elastic force-induced color-changing structure is arranged on the interventional catheter, and the elastic force-induced color-changing structure is located on the proximal side of the first airbag; the interventional catheter has an air guide channel, and the air guide channel of the interventional catheter is connected to the air inlet of the first airbag; the interventional catheter, the elastic force-induced color-changing structure, and the first airbag are all adapted to the instrument channel of the endoscope. The present application provides an achalasia diagnostic device for use in conjunction with an endoscope, which is used in conjunction with an endoscope. It not only solves the problem of tight equipment resources, but also has the advantages of simple structure, low cost, easy operation, high diagnostic accuracy, and less pain for patients.

Description

Technical Field

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

[0002] Achalasia is an esophageal motility disorder characterized by impaired relaxation of the lower esophageal sphincter and a lack of propulsive peristalsis in the esophagus, leading to symptoms such as dysphagia and food regurgitation. Accurate diagnosis is a prerequisite for effective treatment, but current clinical diagnostic methods present numerous challenges that need to be addressed.

[0003] Esophageal barium meal radiography requires patients to take an oral contrast agent followed by X-ray observation. This procedure is dependent on patient cooperation, poses radiation hazards, is prone to adverse reactions to the contrast agent, has high equipment and examination costs, and results in long waiting times. High-resolution esophageal manometry measures esophageal pressure changes using a manometric catheter, which is painful for patients and requires high technical skills. The equipment and examination costs are high, and patients have limited access to examinations. While gastroscopy allows for intuitive observation and biopsy, it is associated with high equipment costs, a long training cycle for specialized physicians, and tight patient examination schedules. 24-hour esophageal pH monitoring, used for auxiliary diagnosis, poses challenges such as impacting patients' daily lives, data susceptibility to interference, high costs, and limited application. Ultrasound endoscopic examinations require high equipment and personnel requirements, are costly, time-consuming, and image susceptibility to interference. Furthermore, equipment resources must be prioritized for critically ill patients, making timely examinations difficult for patients with achalasia.

[0004] In summary, the existing examination methods for achalasia not only have problems such as complex operation, great pain for patients, and high cost, but also due to the high cost of equipment 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 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 an achalasia diagnosis device and an endoscope used in conjunction with an endoscope, so as to solve the above-mentioned technical problems in the related art.

[0006] In order to solve the above problems, the present invention adopts the following technical solutions:

[0007] In a first aspect, the present application provides an achalasia diagnostic device for use in conjunction with an endoscope, comprising an interventional catheter, a first airbag, and an elastic force-induced color-changing structural member;

[0008] Wherein, the first airbag is adapted to the cardia of the human body, and the first airbag is connected to the distal end of the interventional catheter;

[0009] The elastic force-induced color-changing structure is arranged on the interventional catheter, and the elastic force-induced color-changing structure is located on the proximal side of the first airbag;

[0010] The interventional catheter has an air guide channel therein, and the air guide channel of the interventional catheter is connected to the air inlet of the first airbag;

[0011] The interventional catheter, the elastic force-induced color-changing structural component, and the first airbag are all adapted to the instrument channel of the endoscope.

[0012] In a second aspect, the present application provides an endoscope, comprising the above-mentioned achalasia diagnostic device used in conjunction with the endoscope.

[0013] The technical solution adopted by the present invention can achieve the following beneficial effects:

[0014] This application provides an achalasia diagnostic device for use with an endoscope. This device, when used in conjunction with an endoscope, not only solves the problem of limited equipment resources, but also has the advantages of simple structure, low cost, easy operation, high diagnostic accuracy, and minimal pain for patients. Specifically:

[0015] (1) This diagnostic device is used in conjunction with an endoscope. There is no need to purchase additional large-scale special inspection equipment. The diagnosis can be carried out by utilizing the hospital's existing endoscope resources. As endoscopes are widely used in hospitals, they can effectively alleviate the problem of achalasia patients having difficulty in obtaining timely diagnosis due to limited equipment resources, allowing patients to receive a diagnosis and treatment more quickly.

[0016] (2) The structure of this diagnostic device is relatively simple, and the manufacturing cost of the interventional catheter, the first airbag, and the elastic force-induced color-changing structural parts is 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 complicated maintenance and upkeep. At the same time, the inspection process does not require the use of complex reagents and consumables, which further reduces the inspection cost. Existing inspection methods such as gastroscopy require the use of disposable biopsy forceps, local anesthetics and other consumables, which increases the inspection cost; this device only requires a small amount of expansion medium during use, and the consumable cost is almost negligible. This greatly reduces the cost of hospitals conducting achalasia inspections, and also reduces the financial burden on patients, allowing more patients to afford the inspection costs, improving the diagnostic coverage of the disease, and has good economic and promotional application value.

[0017] (3) This diagnostic device is used in conjunction with an endoscope. With the help of the visualization function of the endoscope, the first airbag can be quickly and accurately positioned at the cardia position, and the operation process can be observed in real time. The entire inspection process is simple to operate and can usually be completed within 10-15 minutes. The elastic force-induced color-changing structure can intuitively convert the resistance of the cardia into color changes. Combined with the real-time image observation of the endoscope, the doctor can make a diagnosis more quickly, reducing the delay in diagnosis caused by complex operation 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, and the technical requirements for the operator are relatively low, reducing the difficulty and risk of operation. In addition, 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 the occurrence of misdiagnosis and missed diagnosis.

[0018] (4) This diagnostic device intuitively reflects the resistance of the cardia to the first airbag through the elastic force-induced color-changing structure. The cardia of patients with achalasia has abnormalities in both diastolic and systolic function, resulting in resistance to the first airbag that is different from normal. By observing the degree of color change of the elastic force-induced color-changing structure, it is possible to more accurately determine whether the patient has achalasia, providing a reliable basis for clinical diagnosis. Compared with traditional examination methods, this reduces the error of subjective judgment and improves the accuracy of diagnosis.

[0019] (5) The interventional catheter and the first balloon of this diagnostic device are relatively soft, and the operation process is relatively gentle. During the examination, the stimulation to the patient's esophagus and cardia tissue is small, which can effectively reduce the patient's pain and improve the patient's compliance with the examination. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0021] Figure 1 is a schematic structural diagram of an embodiment of the present application (the first airbag is in an unexpanded state);

[0022] Figure 2 yes Figure 1 A magnified schematic diagram of part A in the middle;

[0023] Figure 3 yes Figure 1 Cross-sectional view of the middle BB;

[0024] Figure 4This is a schematic structural diagram of another embodiment of the elastic force-induced color-changing structural member in the embodiment of the present application;

[0025] Figure 5 is a schematic structural diagram of an embodiment of the present application (the first airbag is in an expanded state);

[0026] Figure 6 Is a schematic structural diagram of another embodiment of the present application (the first airbag is in an expanded state);

[0027] Figure 7 This is a schematic diagram of the state in which the diagnostic device and the endoscope are used in conjunction with each other in an embodiment of the present application;

[0028] Figure 8 This is a schematic diagram of another embodiment of the present application, in which a diagnostic device and an endoscope are used in conjunction with each other;

[0029] Figure 9 This is a schematic diagram of the state in which the diagnostic device and the endoscope are used in conjunction with each other in an embodiment of the present application (the second airbag is in an unexpanded state);

[0030] Figure 10 is a schematic diagram of the state in which the diagnostic device and the endoscope are used in conjunction with each other in an embodiment of the present application (the second airbag is in an expanded state);

[0031] Figure 11 2 is a schematic diagram of a state in which the second airbag in an embodiment of the present application is used in conjunction with an endoscope using a diagnostic device of another embodiment (the second airbag is in an unexpanded state);

[0032] Figure 12 2 is a schematic diagram of a state in which the second airbag in an embodiment of the present application is used in conjunction with an endoscope using a diagnostic device of another embodiment (the second airbag is in an expanded state);

[0033] Figure 13 1 is a schematic diagram of a state in which the second airbag in an embodiment of the present application adopts another embodiment of a diagnostic device used in conjunction with an endoscope (the second airbag is in an unexpanded state);

[0034] Figure 14 2 is a schematic diagram of a state in which the second airbag in an embodiment of the present application adopts another embodiment of a diagnostic device used in conjunction with an endoscope (the second airbag is in an expanded state);

[0035] Figure 15 is a schematic diagram of the connection between the diagnostic device and the endoscope in an embodiment of the present application;

[0036] Figure 16 This application Figure 13 Enlarged schematic diagram of the middle C part;

[0037] Figure 17It is a schematic cross-sectional structural diagram of the proximal connector in an embodiment of the present application.

[0038] In the figure: 10, interventional catheter; 101, air guide channel; 20, first airbag; 30, elastic force-induced chromic structure; 301, elastic body; 302, force-induced chromic material layer; 303, transparent lubricating protective film; 40, insertion part; 50, second airbag; 60, circular elastic band; 70, proximal joint; 701, first interface; 702, second interface; 703, tube body; 704, pulling end; 705, snap-fit ​​groove; 706, hard catheter; 707, connector; 80, snap-fit ​​protrusion; 90, memory alloy bracket; 901, connecting ring; 902, connecting strip; 100, instrument channel; 110, instrument channel interface. DETAILED DESCRIPTION

[0039] In each embodiment of the present application, "proximal" and "distal" refer to the distance between each component and the medical user in the use environment, wherein the end closer to the user is designated as the "proximal" and the end farther from the medical user is designated as the "distal".

[0040] In order to facilitate understanding of the achalasia diagnostic device and endoscope provided in an embodiment of the present application for use in conjunction with an endoscope, the relevant technologies are first introduced below in conjunction with application scenarios.

[0041] The resting pressure of the esophageal sphincter (LES) in patients with achalasia is often significantly higher than normal. This is not due to increased active contraction, but rather to a persistent spasm caused by abnormal neural regulation. Normal LES resting pressure is 15-30 mmHg; in patients with achalasia, it is mostly >40 mmHg (and in some patients, it can exceed 100 mmHg). The key difference is that during normal swallowing, the LES should relax to the level of intragastric pressure (approximately 5-10 mmHg). However, due to the lack of inhibitory nerve signals, the LES cannot relax, resulting in functional obstruction.

[0042] In the existing technology, the examination method for achalasia not only has problems such as complex operation, great pain for patients, and high cost, but also due to the high cost of equipment and limited resources, hospitals need to give priority to meeting the examination needs of patients with other more serious diseases, resulting in difficulty for achalasia patients to obtain timely and effective diagnosis. There is an urgent need to develop new examination technologies or devices to solve the above problems.

[0043] To this end, the present application provides an achalasia diagnosis device and an endoscope used in conjunction with an endoscope, as follows: Figures 1-17 The technical solutions disclosed in each embodiment of this application are described in detail.

[0044] Example 1:

[0045] The present application provides an achalasia diagnosis device for use in conjunction with an endoscope, comprising an interventional catheter 10, a first airbag 20, and an elastic force-induced color-changing structural member 30;

[0046] The first airbag 20 is adapted to the cardia of the human body, and the first airbag 20 is connected to the distal end of the interventional catheter 10;

[0047] The elastic force-induced color-changing structure 30 is arranged on the interventional catheter 10;

[0048] The interventional catheter 10 has an air guide channel 101 therein, and the air guide channel 101 of the interventional catheter 10 is connected to the air inlet of the first airbag 20;

[0049] The interventional catheter 10 , the elastic force-induced color-changing structure 30 , and the first airbag 20 are all adapted to the instrument channel 100 of the endoscope.

[0050] In the present application, the first airbag 20 being adapted to the human cardia means that, after the first airbag 20 is expanded by the expansion medium, the tension applied by the interventional catheter 10 can pull the first airbag 20 through the cardia. Because the resting pressure of the LES of patients with achalasia is usually significantly higher than normal, during examination using the diagnostic device of the present application, subjects with achalasia require a greater tension to pull the first airbag 20 through the cardia, while subjects without achalasia can pull the first airbag 20 through the cardia with a smaller tension. Due to the different tensions required, the elastic force-induced color-changing structure 30 can sense this, and a diagnosis of achalasia can be made.

[0051] The achalasia diagnostic device provided in this application is used in conjunction with an endoscope. The specific steps for static examination are as follows:

[0052] S1. Preliminary preparation

[0053] Device pretreatment: Perform a sealing test on the interventional catheter 10 to ensure that its internal air guide channel 101 and signal transmission channel are not blocked or damaged; check whether there is any leakage in the first airbag 20, which can be determined by filling the airbag with a small amount of gas and observing the pressure changes after leaving it alone; confirm that there are no stains or damage on the surface of the elastic force-induced color-changing structure 30, and compare it with an external standard color card to verify that its force-induced color-changing function is normal.

[0054] Endoscope adaptation: Select the appropriate model of endoscope based on the patient's specific condition, measure the inner diameter of the endoscope's instrument channel 100, and compare it with the outer diameter of the interventional catheter 10. Simultaneously, debug the endoscope's image acquisition and transmission systems to ensure a clear and stable presentation of the internal conditions of the esophagus and cardia during subsequent procedures.

[0055] S2. Device placement

[0056] The assembled diagnostic device, consisting of the interventional catheter 10, the first balloon 20, and the elastic force-induced color-changing structure 30, is slowly inserted through the endoscope's instrument channel 100. During the insertion process, the endoscope's real-time image is used to observe the path of the interventional catheter 10 to ensure smooth passage through the esophagus until the first balloon 20 reaches the cardia.

[0057] S3, first airbag 20 operation

[0058] Balloon Positioning and Cardia Passage: After confirming that the first balloon 20 is positioned above the cardia, the interventional catheter 10 is advanced, allowing the first balloon 20 to pass through the cardia and into the stomach. This process allows for precise control of the insertion depth and angle of the interventional catheter 10 based on the endoscopic image, ensuring that the first balloon 20 accurately reaches the intended location. Balloon Dilation: An appropriate amount of dilation medium, such as sterile air, is injected into the first balloon 20 through the air channel 101 of the interventional catheter 10.

[0059] S4. Tensile testing and diagnosis

[0060] Pulling operation: The operator slowly and evenly pulls the interventional catheter 10, allowing the expanded first balloon 20 to pass through the cardia again. During this process, the contraction and relaxation of the cardia muscles create varying resistance to the first balloon 20, which is transmitted through the interventional catheter 10 to the elastic color-changing structure 30.

[0061] Color change observation and diagnosis: When subjected to stress transmitted by the interventional catheter 10, the conjugated structure of the special force-sensitive dye molecules contained in the elastochromic structural component 30 changes, resulting in a different color. The operator observes the color change of the elastochromic structural component 30 through the endoscope's imaging system and compares it to a pre-set standard color chart. If the color change reaches or exceeds a specific threshold, the patient is diagnosed with achalasia. If the color change is not significant, the likelihood of achalasia is low. Furthermore, the inflation and deflation operation can be repeated multiple times to obtain a more accurate diagnosis.

[0062] S5. End the operation

[0063] After the tensile test is completed, the expansion medium in the first balloon 20 is discharged through the air channel 101 of the interventional catheter 10, causing the first balloon 20 to deflate. Subsequently, the interventional catheter 10 and the endoscope are slowly removed from the patient's body, and the diagnostic device is cleaned and disinfected for next use.

[0064] See also Figure 9-10In some embodiments, the diagnostic device further includes a second airbag 50 for simulating the swallowing action of the human body. The second airbag 50 is used to be sheathed on the outside of the endoscope insertion portion 40; and when the interventional catheter 10 is extended, 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 undergo a dynamic examination by simulating the swallowing action through the second airbag 50. The second airbag 50 is sheathed on the outside of the endoscope insertion portion 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. Its 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 changes 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. During 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 provision of 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 degree of relaxation of the cardia of some early-stage patients appears normal in static state, but under the dynamic stimulation of simulated swallowing, the relaxation disorder will be more obvious, which will aggravate the change in resistance when the first airbag 20 passes through the cardia, and the color change of the elastic force-induced color-changing structural member 30 will be more significant, thereby improving the accuracy of diagnosis and reducing missed diagnoses and misdiagnoses. Compared with existing static inspection technology, it can more accurately capture abnormal cardia function and provide a more reliable basis for clinical diagnosis. The second airbag 50 can also improve diagnostic efficiency. Because the second airbag 50 simulates the swallowing action, it can more accurately judge the condition and reduce repeated examinations due to inaccurate diagnosis. In the case of limited existing equipment resources, patients do not need to wait in line for examination again due to misdiagnosis or missed diagnosis, which shortens the overall diagnosis time. At the same time, more accurate diagnostic 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 achalasia patients 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 physical discomfort is significantly reduced.For example, it avoids multiple catheter insertions and other operations required in repeated attempts to obtain accurate diagnostic information, reduces irritation to the esophagus and cardia, improves patient compliance with examinations, and makes patients more willing to cooperate with examinations, which is conducive to early detection and treatment of diseases.

[0065] In some embodiments, the second balloon 50 is connected to an air inlet tube for connection to an external inflation device. Specifically, the air inlet tube can be arranged parallel to the insertion portion 40 and follow the insertion portion 40 into the esophagus. When inflation of the expansion medium is required, the second balloon 50 is inflated through the air inlet tube.

[0066] See also Figure 13-14 In some embodiments, a memory alloy stent 90 is provided on the outside of the second airbag 50, and the memory alloy stent 90 is tightly attached to the outer wall of the second airbag 50, and one end of the memory alloy stent 90 is connected to the proximal end or distal end of the second airbag 50. It is understandable that in the examination of the cardia and the diagnosis of achalasia, accurately simulating the physiological state of the cardia during human swallowing is key. The cardia is the connection between the esophagus and the stomach, and its normal function is closely related to the swallowing process. Patients with achalasia have the problem of the lower esophageal sphincter not being able to relax normally, resulting in difficulty in swallowing. Traditional examination methods may find it difficult to accurately simulate the pressure changes and morphological changes at the cardia during swallowing. Placing the second airbag 50 in the esophagus to simulate the swallowing action and providing the memory alloy stent 90 on its outside can more realistically restore the dynamic changes of the esophagus and cardia during swallowing. The unique shape memory and superelastic properties of the memory alloy ensure highly synchronized movement between the memory alloy stent 90 and the second airbag 50, providing a more physiologically accurate simulation environment for cardiac examination and disease diagnosis, thereby improving diagnostic accuracy and reliability. In this device, when the second airbag 50 is inflated within the esophagus to simulate esophageal expansion during swallowing, the pressure generated by the expansion of the second airbag 50 acts on the memory alloy stent 90. This pressure causes the memory alloy to undergo a phase transformation from martensite to austenite, causing the memory alloy stent 90 to expand, thereby simulating the pressure transmission to the cardia during swallowing. When the airbag is deflated, simulating the contraction of the esophagus after swallowing, the pressure decreases. Under the action of its own restorative force, the memory alloy stent 90 transforms from austenite back to martensite, contracting and following the contraction of the second airbag 50, simulating the changes in the cardia as the esophagus returns to its original shape. In this way, dynamic simulation of swallowing and emulation of the physiological and pathological states of the cardia are achieved. The highly simulated swallowing action and cardia state allow doctors to more intuitively observe the cardia's response during swallowing. In the diagnosis of achalasia, it can clearly show features such as abnormal cardia relaxation and abnormal esophageal pressure, providing richer and more accurate information for disease diagnosis, helping to improve diagnostic efficiency and accuracy, and avoid missed diagnoses and misdiagnoses.

[0067] In some embodiments, the memory alloy bracket 90 includes a connecting ring 901 and several connecting strips 902 connected to the connecting ring 901, the connecting ring 901 is connected to the proximal end or distal end of the second airbag 50, the connecting strips 902 extend from the proximal end of the second airbag 50 to its distal end, and the connecting strips 902 of the memory alloy bracket 90 are tightly attached to the outer wall of the second airbag 50; or, the connecting strips 902 extend from the distal end of the second airbag 50 to its proximal end, and the connecting strips 902 of the memory alloy bracket 90 are tightly attached to the outer wall of the second airbag 50.

[0068] See also Figure 11-12 In some embodiments, at least one annular elastic band 60 is provided over the second airbag 50. It is understood that the annular elastic band 60 has an elastic contraction force, and when placed over the second airbag 50, it locally constrains the airbag. When the second airbag 50 is inflated, gas first accumulates in the relatively loose, less resistive proximal area, filling the air cavities in that area first. As the gas pressure gradually increases, it gradually diffuses to the distal air cavities after overcoming the restraining force of the elastic band, thereby achieving the effect of gradually filling each air cavity from proximal to distal. This process is similar to the principle of esophageal muscles contracting sequentially from proximal to distal to squeeze food. The restraining effect of the elastic band acts like esophageal muscle contraction, restricting the diffusion path and speed of gas, causing the airbag's expansion to exhibit a sequence and rhythm similar to esophageal peristalsis, thereby simulating the dynamic characteristics of esophageal pressure changes during swallowing. The sequential inflation of multiple air cavities in the second airbag 50, achieved by using the annular elastic band 60 as a partitioning mechanism, can closely replicate the process of esophageal muscle peristalsis propelling food and the pattern of esophageal pressure changes during this process. During the cardia function test, this simulation can subject the cardia to pressure stimulation similar to real swallowing, helping doctors to more accurately observe the cardia's opening and closing response, pressure coping ability and other functional states, providing a more reliable basis for the diagnosis of cardia diseases.

[0069] In some embodiments, 2-4 annular elastic bands 60 are provided on the second airbag 50 in a direction from the proximal end to the distal end thereof.

[0070] 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, thereby avoiding harm to the human body. When they come into contact with human tissue, they can form a relatively mild interface with the surrounding tissues, reducing the occurrence of inflammatory reactions and immune responses. In addition, when these two materials are subjected to external forces, the molecular chains can be stretched and twisted, causing the airbag to produce elastic deformation. When inflated, the gas pressure causes the airbag to expand, 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 shrink. By controlling the inflation volume and pressure, the expansion degree and shape of the airbag can be precisely adjusted to simulate different physiological states.

[0071] See also Figure 13-15 In some embodiments, the proximal end of the interventional catheter 10 is connected to a proximal connector 70, which includes a first interface 701 that is detachably connected to the instrument channel interface 110 of the endoscope and a second interface 702 that is connected to an external inflation device. The interventional catheter 10 is connected to the second interface 702. It is understood that when connected to the external inflation device, the air outlet of the inflation device is connected to the second interface 702 through a hose, and the air pressure generated by the inflation device is used to transport the 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 device. When deflation is required, the deflation device can also be connected through the second interface 702 for deflation.

[0072] In some embodiments, the first interface 701 includes a cover body adapted to fit with the endoscope instrument channel interface 110. A snap-fitting protrusion 80 is provided on the outer wall of the endoscope instrument channel interface 110, and a snap-fitting groove 705 adapted to fit with the snap-fitting protrusion 80 is provided on the inner side of the cover body at a position corresponding to the snap-fitting protrusion 80. It is understood that by snapping the snap-fitting protrusion 80 into the snap-fitting groove 705, a detachable connection between the first interface 701 and the instrument channel interface 110 can be achieved; during the examination process using the diagnostic device of the present application, the first interface 701 can be pulled to disengage the first interface 701 from the instrument channel interface 110, and the first interface 701 can be continued to be pulled to drive the interventional catheter 10 to move proximally, thereby pulling the first airbag 20 through the cardia.

[0073] In some embodiments, the proximal connector 70 further includes a tubular body 703;

[0074] The cover of the first interface 701 is sleeved on the distal end of the tube 703;

[0075] The proximal end of the tube body 703 is provided with a pulling end 704;

[0076] The second interface 702 is connected to the side wall of the tube body 703;

[0077] A rigid conduit 706 is disposed within the tubular body 703. One end of the rigid conduit 706 is connected to the second interface 702, and the other end of the rigid conduit 706 is connected to a connector 707 for detachably connecting to the interventional catheter 10. It is understood that the connection between the interventional catheter 10 and the connector 707 may be a plug-in connection, a threaded connection, or the like. It is necessary to ensure that the connection between the interventional catheter 10 and the connector 707 is secure and does not become detached when the proximal connector 70 is pulled during the diagnostic process. The provided pulling end 704 facilitates pulling the interventional catheter 10 during the diagnostic examination.

[0078] In some embodiments, the elastic mechanochromic structural member 30 includes an elastic body 301 and a mechanochromic material layer 302 coated on the outer wall of the elastic body 301. It is understood that in the achalasia diagnostic device, the elastic mechanochromic structural member 30 needs to accurately convert the change in the cardia's resistance to the first airbag 20 into a visible color change, thereby providing a basis for diagnosis. The elastic body 301 is provided to ensure that the elastic mechanochromic structural member 300 can undergo elastic deformation with the pulling of the interventional catheter 10 and the action of the cardia's resistance, thereby accurately transmitting the change in the force to the mechanochromic material layer 302. If the elastic body 301 is missing, the mechanochromic material layer 302 may not be able to effectively sense and transmit external force, resulting in inaccurate or unclear color changes, affecting the diagnostic results. The mechanochromic material layer 302 is the core part of realizing the color change function. By coating it on the outer wall of the elastic body 301, it can produce a color change due to the force when the elastic body 301 is deformed, allowing doctors to intuitively judge the functional status of the cardia through the color change. At the same time, in existing diagnostic technologies, some detection methods have difficulty in visually presenting information on the mechanical state of the cardia. The provision of the elastic force-induced color-changing structural member 30 compensates for this deficiency, providing doctors with a more intuitive and convenient diagnostic method, helping to quickly complete diagnosis and reduce patient waiting time when hospital equipment resources are tight. The elastic 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 resistance of the cardia, the elastic body 301 will undergo elastic deformation. During the deformation process, the molecular chains inside the elastic body 301 will undergo changes such as stretching and twisting. This mechanical change can be effectively transmitted to the force-induced color-changing material layer 302, causing it to produce a color change when it is stressed. At the same time, after being deformed by force, the elastic body 301 can quickly return to its original shape, ensuring that the elastic mechanochromic structural member 300 can continue to function normally under multiple force conditions, thereby ensuring the repeatability and accuracy of the diagnosis. The mechanochromic material in the mechanochromic material layer 302 is typically a polymer material containing a special force-sensitive dye. When the elastic body 301 transmits external force to the mechanochromic material layer 302, the conjugated structure of the force-sensitive dye molecules changes. This structural change affects the dye molecules' absorption and emission properties of light, resulting in a change in color. For example, when the force is relatively small, the conjugated structure of the dye molecules is in a state that absorbs and emits light of a specific wavelength, resulting in a 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 a correspondence between force and color change, doctors can determine the magnitude of the resistance to the cardia based on the color change of the mechanochromic material layer 302, and thus diagnose whether the patient has achalasia.

[0079] In some embodiments, the elastic body 301 is a silicone rubber elastomer or a polyurethane elastomer. It is understood that the elastic body 301 is made of a medical-grade elastic material with high elasticity and good mechanical properties. Of course, the specific material used for the elastic body 301 is not limited by this application, and other medical-grade elastic materials with high elasticity and good mechanical properties may also be used.

[0080] 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, resulting in a color change, when subjected to mechanical forces such as stretching, compression, bending, or friction. The color change mechanism of such materials is primarily based on structural changes within or between molecules. When subjected to external forces, chemical bonds within the material may break or reform, or the molecular conformation may change, thereby affecting its light absorption, reflection, and scattering properties, ultimately manifesting as a color change. For example, the selected transparent biodegradable hydrogel has high sensitivity and a distinct color change effect. It can produce a significant color change under relatively small external forces. The color change is reversible, making it suitable for applications requiring precise detection of subtle force changes. Under external forces, the conjugated structure of the polydiacetylene molecular chain changes, resulting in changes in its electronic band structure, which in turn changes its absorption and reflection properties, resulting in a color change. For example, when subjected to a tensile force, the molecular chain is stretched, the conjugated length increases, and the wavelength of absorbed light red-shifts, causing the material's color to change from blue to red. The magnitude of the applied external force can be intuitively reflected through color changes. Materials that change transmittance or color under stress can be selected for the mechanochromic material layer 302. Examples include rare earth-doped mechanoluminescent PLGA gels and cholesteric liquid crystal-PDMS composite films.

[0081] In some embodiments, the elastic force-induced chromic structure 30 also includes a transparent lubricating protective film 303 coated on the outside of the force-induced chromic material layer 302. It is understood that during the use of the diagnostic device of the present application, the transparent lubricating protective film 303 effectively isolates the force-induced chromic material layer 302 from corrosive substances in the human body's internal environment, reducing the risk of erosion of the material layer. At the same time, it reduces the friction between the elastic force-induced chromic structure 30 and the esophageal wall, avoiding damage caused by wear, thereby significantly extending the service life of the elastic force-induced chromic structure 30. This reduces the frequency of repair or replacement of the diagnostic device due to structural damage, reduces equipment maintenance costs, and improves the efficiency and economy of equipment use in the case of limited hospital equipment resources. In addition, the protective effect of the transparent lubricating protective film 303 can ensure that the force-induced chromic material layer 302 always maintains good performance during multiple diagnostic operations. The conjugated structure of the force-induced chromic material molecules can stably change with changes in force, ensuring the accuracy and stability of the color change. Doctors can judge the size of the resistance to the cardia based on reliable color changes, avoid misdiagnosis or missed diagnosis due to degradation of the material layer performance, improve the accuracy of diagnosis, and help patients receive timely and correct treatment. At the same time, the lubricating properties of the transparent lubricating protective film 303 make the movement of the interventional catheter 10 in the esophagus smoother, reducing the difficulty of operation for doctors. In the actual diagnosis process, doctors do not need to spend too much energy to overcome the resistance of the device movement, can focus more on diagnostic operations, and shorten the examination time. In the case of tight equipment resources and patients waiting in line for examination, the diagnostic efficiency per unit time is improved, more patients can be examined in time, the pressure on patients waiting for diagnosis is alleviated, and the utilization of medical resources is optimized.

[0082] In some embodiments, the transparent lubricating protective film 303 is made of a modified polytetrafluoroethylene material. It is understood that the transparent lubricating protective film 303 can be made of a medical-grade polymer with excellent light transmittance and lubricity. Its compact molecular structure forms a dense barrier, preventing digestive fluids, food residue, and other substances from directly contacting the mechanochromic material layer 302, thereby providing protection. Of course, the specific material used for the transparent lubricating protective film 303 is not limited by this application; other medical-grade polymers with excellent light transmittance and lubricity can also be used.

[0083] See also Figure 3 and Figure 4 In some embodiments, the elastic body 301 is a tubular structure with a circular or elliptical cross-section. Figure 3 , the cross-sectional shape of the elastic body 301 is circular; please refer to Figure 4The cross-section of the elastic body 301 is elliptical. It is understood that the tubular structure design can ensure that the force on the mechanochromic material layer 302 is uniform and stable, allowing the cardia resistance to be accurately and consistently transmitted to the mechanochromic material layer 302, reducing color deviations caused by uneven force, and improving the reliability of diagnostic results. In hospitals with limited equipment resources and high diagnostic efficiency requirements, stable diagnostic results can reduce the probability of repeated examinations, accelerate the patient's diagnostic process, and improve the efficiency of equipment use.

[0084] In some embodiments, the elastic force-induced color-changing structure 30 is arranged along the length direction of the interventional catheter 10, and the elastic force-induced color-changing structure 30 has a first end and a second end, and the first end and the second end of the elastic force-induced color-changing structure 30 are both connected to the interventional catheter 10; the length a of the elastic force-induced color-changing structure 30, the definition of a refers to the length of the elastic force-induced color-changing structure 30 when the elastic force-induced color-changing structure 30 is in a naturally straightened state; the distance between the connection position between the interventional catheter 10 and the first end of the elastic force-induced color-changing structure 30 and the connection position between the interventional catheter 10 and the second end of the elastic force-induced color-changing structure 30 is b, the definition of b refers to the length of the connection position between the interventional catheter 10 and the first end of the elastic force-induced color-changing structure 30 and the connection position between the elastic force-induced color-changing structure 30 and the second end of the elastic force-induced color-changing structure 30 when the interventional catheter 10 is in a naturally straightened state, satisfying b>a. It can be understood that when the interventional catheter 10 is pulled, the position of the elastic force-induced color-changing structure 30 needs to satisfy the requirement that all the pulling force acts on the elastic force-induced color-changing structure 30, which can avoid the influence of the interventional catheter 10 on the force of the elastic force-induced color-changing structure 30, improve the diagnostic efficiency and accuracy, reduce the patient waiting time and the probability of repeated examinations, and make more efficient use of limited medical resources.

[0085] In some embodiments, the length of the cardia is c, satisfying ba>c. It is understandable that in the diagnosis of achalasia, the functional status assessment of the cardia depends on the accurate capture of its resistance changes. The elastic force-induced color-changing structural member 30 is arranged along the length direction of the interventional catheter 10, and the length a of the elastic force-induced color-changing structural member 30 and the distance b between the two end connection points are set to satisfy: ba is greater than the length c of the cardia; the elastic force-induced color-changing structural member 30 can ensure that the force variation range of the cardia area is fully covered, and the resistance information of different parts of the cardia is fully captured. Whether it is the abnormal resistance change at the entrance, middle part or exit of the cardia, it can be intuitively presented through the color change of the elastic force-induced color-changing structural member 30, avoiding the missed diagnosis of local lesions, and can more accurately judge the degree and range of achalasia lesions, providing a more comprehensive and reliable basis for clinical diagnosis.

[0086] In some embodiments, the elastic mechanochromic structure 30 is positioned near the first airbag 20. It will be appreciated that the mechanochromic material in the elastic mechanochromic structure 30 is force-sensitive. When positioned near the first airbag 20, external forces acting on the first airbag 20 are more directly transmitted to the elastic mechanochromic structure 30, causing corresponding physical or chemical changes in the mechanochromic material, resulting in a color change. During an examination using the diagnostic device of this application, the first airbag 20 may encounter resistance when passing through areas such as the cardia. Positioning the elastic mechanochromic structure 30 near the first airbag 20 allows for more accurate and timely sensing of the forces acting on the first airbag 20, thereby more precisely reflecting the mechanical state of areas such as the cardia and providing more accurate information for diagnosis. Therefore, setting the elastic force-induced color-changing structural component 30 close to the first airbag 20 improves the sensitivity and accuracy of the elastic force-induced color-changing structural component 30 in sensing the force of the first airbag 20, and can more accurately capture the changes in the resistance of the cardia and other parts to the first airbag 20 under different conditions, providing a more reliable basis for doctors to judge the condition.

[0087] In some embodiments, the outer walls of the interventional catheter 10, the first balloon 20, and the second balloon 50 are coated with a lubricating layer. It is understood that the provision of a lubricating layer can reduce resistance during insertion, lower the risk of abrasions to tissues in the esophagus, cardia, and other areas, improve patient comfort during examination or treatment, and help doctors more easily manipulate the interventional catheter 10, the first balloon 20, and the second balloon 50, thereby improving the accuracy and efficiency of the operation.

[0088] In some embodiments, the lubricating layer is a silicone oil layer. It will be appreciated that the lubricating layer is typically composed of a medical material with a low coefficient of friction. These materials form a smooth protective film on the surfaces of the interventional catheter 10 and the first balloon 20. When in contact with human tissue, this reduces direct friction between the two, ensuring smoother relative motion. Of course, the specific material used for the lubricating layer is not limited by this application; other medical materials with a low coefficient of friction may also be used.

[0089] In some embodiments, the interventional catheter 10 is provided with an air inlet at a position corresponding to the first airbag 20. It will be appreciated that the air inlet is used to inflate the first airbag 20 so that the first airbag 20 can expand to an appropriate size to fulfill its diagnostic or therapeutic function. Specifically, an external air source can be connected to the air inlet, and the gas passes through the air guide channel 101 of the interventional catheter 10 and then enters the first airbag 20 through the air inlet, where the pressure of the gas inflates the airbag. The degree of expansion of the first airbag 20 can be precisely controlled by controlling the amount of air intake to adapt to the physiological conditions and diagnostic and treatment needs of different patients.

[0090] In some embodiments, the shape of the first airbag 20 includes any one of an olive shape and a spherical shape. It is understandable that the rounded shape can reduce the local pressure when the airbag contacts human tissue, reducing the risk of compression and damage to the tissue. The olive-shaped and spherical structures can expand evenly after inflation, making the pressure distribution more uniform, which is conducive to comprehensive and uniform expansion or pressure testing of parts such as the cardia. Setting the shape of the first airbag 20 to an olive shape or a spherical shape improves the safety and comfort of the airbag operation in the human body, reduces damage to human tissue, and at the same time, the uniform pressure distribution helps to more accurately evaluate the functional status of parts such as the cardia, thereby improving the effectiveness of diagnosis and treatment.

[0091] In some embodiments, the second airbag 50 has an olive-shaped outer shape. It is understood that, after inflation, the olive-shaped airbag can better conform to the internal curves of the human body, evenly distributing pressure across the airbag surface and preventing tissue damage caused by excessive localized pressure. Furthermore, this shape allows for smoother passage through the body's natural channels during movement. The olive-shaped outer shape of the second airbag 50 improves the safety and comfort of its use, reduces adverse effects on human tissue, and provides more precise pressure control and manipulation. For example, during certain treatments, compression or expansion of specific areas can be performed with greater precision.

[0092] In some embodiments, the material of the interventional catheter 10 is polytetrafluoroethylene, nylon, polyurethane, or medical-grade stainless steel. It is understood that the material of the interventional catheter 10 must first be a medical material, and then must meet good biocompatibility, flexibility, and imaging properties, and must also have a certain strength to facilitate propulsion within the human body. If the material of the interventional catheter 10 is polytetrafluoroethylene, due to its good lubricity, 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 materials that meet the requirements can be selected.

[0093] Example 2:

[0094] An endoscope includes the achalasia diagnostic device of embodiment 1 used in conjunction with the endoscope.

Claims

1. A diagnostic device for achalasia used in conjunction with an endoscope, characterized in that: It comprises an interventional catheter (10), a first airbag (20), and an elastic force-induced color-changing structural component (30); wherein, The first airbag (20) is connected to the distal end of the interventional catheter (10), and the first airbag (20) is adapted to the cardia of the human body; The elastic force-induced color-changing structural component (30) is arranged on the interventional catheter (10), and the elastic force-induced color-changing structural component (30) is located on the proximal side of the first airbag (20); The interventional catheter (10) has an air guide channel (101) therein, and the air guide channel (101) of the interventional catheter (10) is connected to the air inlet of the first airbag (20); The interventional catheter (10), the elastic force-induced color-changing structural component (30), and the first airbag (20) are all adapted to the instrument channel (100) of the endoscope; The diagnostic device further comprises a second airbag (50) for simulating a human swallowing action, wherein the second airbag (50) is arranged on the outside of the endoscope insertion portion (40); and when the interventional catheter (10) is extended forward, the first airbag (20) and the second airbag (50) are respectively located at the two ends of the cardia.

2. The achalasia diagnostic device used in conjunction with an endoscope according to claim 1, characterized in that: A memory alloy bracket (90) is provided on the outer side of the second airbag (50), and the memory alloy bracket (90) is closely attached to the outer wall of the second airbag (50), and one end of the memory alloy bracket (90) is connected to the proximal end or the distal end of the second airbag (50); And / or, the second airbag (50) is provided with at least one annular elastic band (60).

3. The achalasia diagnostic device used in conjunction with an endoscope according to claim 2, characterized in that: The proximal end of the interventional catheter (10) is connected to a proximal connector (70), and 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).

4. The achalasia diagnostic device used in conjunction with an endoscope according to claim 3, characterized in that: The elastic mechanochromic structural component (30) comprises an elastic body (301) and a mechanochromic material layer (302) coated on the outer wall of the elastic body (301).

5. The achalasia diagnostic device used in conjunction with an endoscope according to claim 4, characterized in that: The elastic mechanochromic structural component (30) further includes a transparent lubricating protective film (303) coated on the outside of the mechanochromic material layer (302); And / or, the elastic body (301) is a tubular structure, and its cross-sectional shape is circular or elliptical.

6. The achalasia diagnostic device used in conjunction with an endoscope according to claim 5, characterized in that: The elastic force-induced color-changing structural member (30) is arranged along the length direction of the interventional catheter (10), and the elastic force-induced color-changing structural member (30) has a first end and a second end, and the first end and the second end of the elastic force-induced color-changing structural member (30) are both connected to the interventional catheter (10); the length of the elastic force-induced color-changing structural member (30) is a, the distance between the connection position of the interventional catheter (10) and the first end of the elastic force-induced color-changing structural member (30) and the connection position of the interventional catheter (10) and the second end of the elastic force-induced color-changing structural member (30) is b, and the length of the cardia is c, satisfying b>a.

7. The achalasia diagnostic device used in conjunction with an endoscope according to claim 4, characterized in that: The mechanochromic material is selected from transparent biodegradable hydrogels; And / or, the elastic force-induced color-changing structural component (30) is arranged close to the first airbag (20); and / or, the outer walls of the interventional catheter (10), the first airbag (20), and the second airbag (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 airbag (20).

8. The achalasia diagnostic device used in conjunction with an endoscope according to claim 7, characterized in that: The first airbag (20) has an outer shape including an olive shape and a spherical shape; And / or, the outer shape of the second airbag (50) includes an olive shape.

9. An endoscope, characterized in that: A diagnostic device for achalasia according to any one of claims 1 to 8 used in conjunction with an endoscope.

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