Biliary tract pressure measuring system in endoscopic duodenal papilla dilatation

Abstract

The invention discloses an endoscopic biliary tract pressure measuring system in duodenal papilla dilatation, which comprises a continuously variable diameter biliary tract dilatation pressure measuring catheter structure and a flow rate control module, the continuously variable diameter biliary tract dilatation pressure measuring catheter structure comprises a catheter body and a plurality of balloons, the balloons are sleeved on the catheter body, and the flow rate control module is connected with the flow rate control module. A circuit cavity channel, a guide wire cavity channel and a plurality of water injection cavity channels which are mutually independent are arranged in the catheter body, and one end of each water injection cavity channel is connected with the flow speed control module. According to the biliary tract pressure measuring system in the endoscopic duodenal papilla dilatation, linkage is conducted through the biliary tract dilatation pressure measuring catheter structure and the flow speed control module, so that pressure measurement in the biliary tract dilatation is achieved, Oddi sphincter is protected against tearing, biliary tract smooth muscle is protected against tearing, and the biliary tract pressure measuring system is suitable for the endoscopic duodenal papilla dilatation. Furthermore, the narrow part of the biliary tract is expanded in a targeted manner in an expansion operation, and the compliance of the biliary tract muscle and the Oddi sphincter is monitored in real time.

Description

Technical Field

[0001] The present invention belongs to the technical field of biliary tract manometry, and particularly relates to a biliary tract manometry system during endoscopic duodenal papilla dilation. Background Art

[0002] Gallstones are common clinical diseases. According to the location of the stones, they can be divided into gallbladder stones, common bile duct stones, and intrahepatic bile duct stones. Among them, the treatment of common bile duct stones is more difficult and more harmful. Most common bile duct stones are secondary stones, which are retained in the common bile duct after being discharged from the gallbladder stones. A small number are primary stones, which are mostly formed due to factors such as gallbladder infection, biliary tract obstruction, and eggs. Such stones usually can cause symptoms such as abdominal pain, chills and high fever, jaundice, pancreatitis, and suppurative cholangitis, and even endanger life in severe cases.

[0003] Endoscopic sphincterotomy (EST) and endoscopic papillary balloon dilation (EPBD) are both common methods for treating common bile duct stones, with advantages such as less trauma and quick recovery. However, since EST cuts off the Oddi sphincter, resulting in the permanent loss of the function of the Oddi sphincter, it will cause long-term complications such as reflux cholangitis and recurrence of common bile duct stones, which is opposed by many domestic scholars. For the treatment of common bile duct stones by EPBD, not only the stone extraction success rate is similar to that of EST, the incidence of intestinal bleeding and intestinal perforation is low, but also the damage to the Oddi sphincter is smaller than that of EST, and partial function of the Oddi sphincter is retained. Therefore, EPBD is increasingly applied in clinical practice.

[0004] During EPBD, a small balloon with a diameter of 6 - 10 mm is used, which has less damage to the function of the Oddi sphincter; however, in recent years, there have been an increasing number of reports on the treatment of common bile duct stones by EPBD using a large balloon with a diameter of 12 - 20 mm. The large balloon dilation makes stone extraction easier, can reduce the usage rate of mechanical lithotripsy, shorten the intubation and stone extraction time, and thus reduce the incidence of postoperative pancreatitis. However, with the increase in the balloon diameter, EPBD will also cause tearing of the Oddi sphincter after surgery, resulting in partial or complete loss of sphincter function.

[0005] Currently, the following problems exist in the prior art:

[0006] Problem 1: Currently, the balloon dilation catheter cannot continuously change its diameter. Generally, there are only 3 diameter changes available, which is clinically called a three-stage dilation balloon.

[0007] Problem 2: Currently, during the operation, when using balloon dilation catheters, one can choose a catheter with a small balloon of 6 - 10 mm or a catheter with a large balloon of 12 - 20 mm. It is impossible to have both a small balloon and a large balloon on the same catheter. If the balloon is not suitable during the operation and needs to be replaced, it is time-consuming and laborious.

[0008] Problem 3: During the operation, there is no pressure measurement and assessment. It is not known how much the duodenal papilla can be maximally enlarged. If it is enlarged too much, there is a risk of tearing the sphincter, causing irreversible damage; however, if it is enlarged too little, it is not conducive to stone extraction.

[0009] Problem 4: Currently, there is no integrated catheter for biliary tract pressure measurement + dilation balloon. Summary of the Invention

[0010] The main purpose of the present invention is to provide a biliary tract pressure measurement system during endoscopic duodenal papilla dilation. Through the linkage of a continuously variable-diameter biliary tract dilation and pressure measurement catheter structure and a flow rate control module, intraoperative pressure measurement during biliary tract dilation is achieved, and the Oddi sphincter is protected from tearing and the biliary tract smooth muscle is protected from tearing. Furthermore, during the dilation operation, the stenotic part of the biliary tract is targeted for dilation, and the compliance of the biliary tract muscle and the Oddi sphincter is monitored in real time.

[0011] To achieve the above objectives, the present invention provides a biliary tract pressure measurement system during endoscopic duodenal papilla dilation, including a continuously variable-diameter biliary tract dilation and pressure measurement catheter structure and a flow rate control module. The continuously variable-diameter biliary tract dilation and pressure measurement catheter structure includes a catheter body and several balloons, and the balloons are sleeved on the distal end of the catheter body. Among them:

[0012] Independent circuit channels, guide wire channels, and several water injection channels are provided inside the catheter body, and one end of the water injection channel is connected to the flow rate control module;

[0013] Each part of the catheter body covered by the balloon is equipped with a set of (strain gauge type) pressure sensors and a pair of electrodes for impedance measurement, and this part is also provided with a water injection port connected to the other end of the internal water injection channel. Thus, liquid is injected into the corresponding balloon through the corresponding water injection channel and water injection port, and the degree of balloon inflation is judged by the volume of the injected liquid; (the liquid can also be a specific electrolyte solution) and through the measurement of the electrodes, the shape change when the balloon squeezes against the biliary tract inner wall is analyzed.

[0014] As a further preferred technical solution of the above technical solution, the specific implementation of the pressure measurement working process of the biliary tract pressure measurement system during endoscopic duodenal papilla dilation is as follows:

[0015] Step S1: Calibrate the pressure of the proximal end of the continuously variable diameter biliary dilation manometry catheter structure through a manometer. With the assistance of a duodenoscope and a guide wire, insert the catheter body into the biliary tract through the duodenal papilla. Through the pressure sensor on the catheter body, accurately measure the pressure changes in the Oddi sphincter and the biliary tract, and gradually inject water into the balloon through the water injection channel, thereby dilating the Oddi sphincter and the stenotic part of the biliary tract;

[0016] Step S2: Control the flow rate Qx (x is the number of the water injection channel, the same below) of each water injection channel through the flow rate control module, so as to inject liquid into the corresponding balloon through each water injection channel of the catheter body. At the same time, record the data including the volume Mx of the injected liquid, the pressure sensor reading Px and the impedance information Zx, and obtain the relevant data of the volume V of the dilated bile duct;

[0017] Step S3: Obtain the compliance of the corresponding contact part of the biliary tract through the dilation of the balloon, and evaluate the overall compliance of the biliary tract according to the channel compliance obtained by each balloon;

[0018] Step S4: Apply the overall compliance of the biliary tract to biliary dilation surgery.

[0019] As a further preferred technical solution of the above technical solution, for step S2, where:

[0020] For the volume Mx of the injected liquid, Mx = ∫Qxdt. According to this volume Mx, evaluate the diameter of the balloon. Considering that the balloon is deformed by the extrusion of the biliary tract, the impedance information Zx is added to correct the calculation of the balloon diameter: Dx = D(Mx, Zx). The specific implementation is as follows:

[0021] When the balloon expands freely without being extruded by the biliary tract, as the liquid is injected (injected volume: M), the balloon expands, the shape of the balloon changes, and the effective diameter increases: D 0 = f(M), and at the same time, the impedance value also changes, and the impedance value decreases: Z 0 = g(M). The subscript 0 represents the case of free state expansion. When expanding in this free state, the effective diameter D 0 and the impedance value Z 0 The change baselines with the increase in volume will be obtained during the pressure calibration process in step S1;

[0022] During the formal operation, due to the extrusion of the biliary tract, the balloon will deform, be squeezed, reducing the effective diameter D. The extrusion causes the impedance value Z to change (for example, the extrusion restricts the transmission path of the carriers, thereby increasing the impedance (Z)). The extrusion coefficient α (α = 0 represents the free state), D = D 0 *(1 - α). At the same time, the extrusion also changes the impedance value where the function K defines the influence relationship of extrusion on impedance, which is obtained from experimental data or calculated by establishing a model for the extrusion profile based on the balloon characteristics. Thus, D = D 0 *K -1 (Z 0 / Z) (where Z, D, Z 0 , D 0 , refer to the values of one of the balloons, and the subscript X is omitted);

[0023] For the pressure sensor reading Px, the change characteristics of Px are used to determine the interaction between the balloon and the biliary tract inner wall, including:

[0024] I: Identify the starting point where the balloon begins to extrude and dilate the biliary tract;

[0025] II: The compliance change of the biliary sphincter;

[0026] III: Evaluate the dilation effect (similar to elastic hysteresis) by recording the asymmetry of pressure or compliance during the two processes of dilation and retraction;

[0027] For the impedance information Zx, the change value of Zx is used to evaluate the volume of liquid entering the balloon and optimize the calculation of the balloon diameter;

[0028] For the bile duct volume V = ∑V x = ∑V(Dx, Mx).

[0029] As a further preferred technical solution of the above technical solution, in step S3:

[0030] The calculation of the channel compliance Cx is: Cx = dVx / dRx;

[0031] The calculation of the overall compliance C is: C = dV / dP, P = MAX(Px).

[0032] As a further preferred technical solution of the above technical solution, step S4 is specifically implemented as the following steps:

[0033] Step S4.1: Determine whether the overall compliance C is between the compliance upper limit value (C_high) and the compliance lower limit value (C_low) (if the compliance is too high, there is a concern that the bile duct is dilated too much; if the compliance is too low, there is a concern that the bile duct is too rigid), where:

[0034] If it is between, it is judged whether the currently expanded bile duct volume V supports the completion of the dilation surgery (i.e., V is greater than or equal to Vtarget). If it supports, after the surgery is completed, the balloon is drained / retracted at a flow rate of Qx', and relevant data is continuously read until all the balloons are drained, and the continuously variable-diameter bile duct dilation and pressure measurement catheter structure is withdrawn; if it does not support, the flow rate is controlled by the flow rate control module (PID) to increase the balloon volume, thereby increasing the bile duct volume until the overall compliance C is between the upper compliance limit value and the lower compliance limit value and the expanded bile duct volume V supports the completion of the dilation surgery;

[0035] If it is not between, the volume and pressure of the bile duct are judged respectively, where:

[0036] Judge whether the expanded bile duct volume V exceeds the volume safety threshold. If it is, the balloon is directly drained / retracted and the operator is notified to intervene. If it is not, the flow rate is controlled by the flow rate control module (PID) to perform an adaptive operation (remind the operator to intervene as appropriate to ensure safety);

[0037] Judge whether the pressure sensor reading Px exceeds the pressure safety threshold. If it is, the balloon is directly drained / retracted and the operator is notified to intervene. If it is not, the flow rate is controlled by the flow rate control module (PID) to perform an adaptive operation (remind the operator to intervene as appropriate to ensure safety). Brief Description of the Drawings

[0038] Figure 1 is a schematic diagram of the continuously variable-diameter bile duct dilation and pressure measurement catheter structure of the present invention.

[0039] Figure 2 is a cross-sectional view of the continuously variable-diameter bile duct dilation and pressure measurement catheter structure of the present invention.

[0040] Figure 3 is a schematic flow diagram of the present invention.

[0041] Figure 4 is a schematic diagram of the dilation surgery of the present invention.

[0042] Figure 5 is a high-resolution pressure measurement image of the Oddi sphincter and bile duct of the present invention.

[0043] The reference numerals include: 1. Catheter body; 2. Circuit cavity; 3. Guide wire cavity; 4. Water injection cavity; 5. Balloon; 6. Pressure sensor; 7. Electrode; 8. Water injection port; 9. Second pressure sensor. Detailed Description of the Invention

[0044] The following description is used to disclose the present invention so that those skilled in the art can implement the present invention. The preferred embodiments in the following description are only examples, and other obvious variations can be conceived by those skilled in the art. The basic principles of the present invention defined in the following description can be applied to other implementation schemes, variant schemes, improvement schemes, equivalent schemes, and other technical schemes without departing from the spirit and scope of the present invention.

[0045] In the preferred embodiment of the present invention, those skilled in the art should note that the biliary tract and Oddi sphincter involved in the present invention can be regarded as prior art.

[0046] Preferred embodiment.

[0047] As Figures 1-5 shown, the present invention discloses a biliary tract manometry system during endoscopic duodenal papilla dilation, which includes a continuously variable diameter biliary tract dilation manometry catheter structure and a flow rate control module. The continuously variable diameter biliary tract dilation manometry catheter structure includes a catheter body and a plurality of balloons 5. The balloons 5 are sleeved on the distal end of the catheter body 1, wherein:

[0048] The catheter body 1 is provided with independent circuit channels 2 (in this channel, there is a circuit connecting the sensors (pressure and impedance) in the catheter balloon to transmit signals back to the front end of the catheter structure), guide wire channels 3, and a plurality of water injection channels 4. One end of the water injection channel 4 is connected to the flow rate control module;

[0049] Each part of the catheter body 1 covered by the balloon 5 is equipped with a set of (strain gauge type) pressure sensors 6 and a pair of electrodes 7 for impedance measurement. And this part is also provided with a water injection port 8 communicating with the other end of the internal water injection channel 4, so as to inject liquid into the corresponding balloon 5 through the corresponding water injection channel 4 and water injection port 8, and judge the expansion degree of the balloon 5 by the volume of the injected liquid; (the liquid can also be a specific electrolyte solution) And through the measurement of the electrodes, analyze the shape change when the balloon squeezes against the inner wall of the biliary tract.

[0050] Specifically, the manometry working process of the biliary tract manometry system during endoscopic duodenal papilla dilation is specifically implemented as follows:

[0051] Step S1: Calibrate the pressure of the proximal end of the continuously variable diameter biliary tract dilation manometry catheter structure through a manometer, and the catheter body is assisted by a duodenoscope and a guide wire (for guiding, smoothly introduce the catheter into the biliary tract. (The guide wire enters the biliary tract first, and the guide wire cavity of the catheter is sleeved on the guide wire and is introduced into the biliary tract)), insert it into the biliary tract through the duodenal papilla, accurately measure the pressure changes in the Oddi sphincter and the biliary tract through the pressure sensor on the catheter body, and gradually inject water into the balloon through the water injection channel, so as to dilate the Oddi sphincter and the stenotic part of the biliary tract;

[0052] Step S2: The flow rate Qx of each water injection channel (where x is the number of the water injection channel, the same below) is controlled by the flow rate control module, so as to inject liquid into the corresponding balloon through each water injection channel of the catheter body. Meanwhile, data including the volume Mx of the injected liquid, the pressure sensor reading Px, and the impedance information Zx are recorded, and relevant data on the volume V of the dilated bile duct are obtained;

[0053] Step S3: The compliance of the corresponding contact part of the biliary tract is obtained through the dilation of the balloon, and the overall compliance of the biliary tract is evaluated based on the channel compliance obtained for each balloon;

[0054] Step S4: Apply the overall compliance of the biliary tract to the biliary tract dilation surgery.

[0055] More specifically, for Step S2, where:

[0056] For the volume Mx of the injected liquid, Mx = ∫Qxdt. Based on this volume Mx, the diameter of the balloon is evaluated. Considering that the balloon is deformed by the biliary tract extrusion, the impedance information Zx is added to correct the calculation of the balloon diameter: Dx = D(Mx, Zx). The specific implementation is as follows:

[0057] When the balloon expands freely without being extruded by the biliary tract, as the liquid is injected (injected volume: M), the balloon expands, the shape of the balloon changes, and the effective diameter increases: D 0 = f(M), and at the same time, the impedance value also changes, and the impedance value decreases: Z 0 = g(M). The subscript 0 represents the case of free-state expansion. When in this free-state expansion, the effective diameter D 0 and the impedance value Z 0 The change baseline with the increase in volume will be obtained during the pressure calibration process in Step S1;

[0058] During the formal operation, due to the extrusion of the biliary tract, the balloon will be deformed and subjected to extrusion, reducing the effective diameter D. The extrusion causes a change in the impedance value Z (for example, the extrusion restricts the carrier transmission path, thus increasing the impedance (Z)). The extrusion coefficient α (α = 0 represents the free state), D = D 0 *(1 - α). At the same time, the extrusion also changes the impedance value where the function K defines the influence relationship of extrusion on impedance, which is obtained through experimental data or calculated by establishing a model for the extrusion profile based on the balloon characteristics. Therefore, D = D 0 *K -1 (Z 0 / Z) (here Z, D, Z 0 , D 0 , refer to the value of one of the balloons, and the subscript X is omitted);

[0059] For the pressure sensor reading Px, the variation characteristics of Px are used to determine the interaction between the balloon and the inner wall of the bile duct, including:

[0060] I: Identifying the starting point where the balloon begins to compress and dilate the bile duct;

[0061] II: The compliance change of the bile duct sphincter;

[0062] III: Evaluating the dilation effect (similar to elastic hysteresis) by recording the asymmetry of pressure or compliance during the two processes of dilation and retraction;

[0063] For the impedance information Zx, the change value of Zx is used to evaluate the volume of liquid entering the balloon and optimize the calculation of the balloon diameter;

[0064] For the bile duct volume V = ∑V x = ∑V(Dx, Mx).

[0065] Furthermore, in step S3:

[0066] The calculation of the channel compliance Cx is: Cx = dVx / dPx;

[0067] The calculation of the overall compliance C is: C = dV / dP, P = MAX(Px).

[0068] Even further, step S4 is specifically implemented as the following steps:

[0069] Step S4.1: Judging whether the overall compliance C is between the compliance upper limit value (C_high) and the compliance lower limit value (C_low) (if the compliance is too high, there is a concern that the bile duct is dilated too much; if the compliance is too low, there is a concern that the bile duct is too rigid), where:

[0070] If it is between them, then judge whether the currently dilated bile duct volume V supports the completion of the dilation surgery (i.e., V is greater than or equal to Vtarget). If it supports, after the surgery is completed, drain / retract the balloon at a flow rate of Qx', and continue to read the relevant data until all the balloons are drained, and then pull out the continuously variable diameter bile duct dilation manometry catheter structure; if it does not support, control the flow rate through the flow rate control module (PID) to increase the balloon volume, thereby increasing the bile duct volume, until the overall compliance C is between the compliance upper limit value and the compliance lower limit value and the dilated bile duct volume V supports the completion of the dilation surgery;

[0071] If it is not between them, then judge the volume and pressure of the bile duct respectively, where:

[0072] Determine whether the volume V of the dilated bile duct exceeds the volume safety threshold. If so, directly drain / retract the balloon and notify the operator for intervention. If not, control the flow rate through the flow rate control module (PID) for adaptive operation (remind the operator to intervene as appropriate to ensure safety).

[0073] Determine whether the pressure sensor reading Px exceeds the pressure safety threshold. If so, directly drain / retract the balloon and notify the operator for intervention. If not, control the flow rate through the flow rate control module (PID) for adaptive operation (remind the operator to intervene as appropriate to ensure safety).

[0074] Preferably, obtain the pressure data of the Oddi sphincter and the bile duct according to the pressure sensor reading Px, so as to obtain high-resolution pressure images of the Oddi sphincter and the bile duct during the operation, as Figure 4 shown.

[0075] Preferably, there are another two groups of second pressure sensors 9 located at the front end of the catheter structure for measuring the basal pressure in the bile duct, and this pressure serves as the reference pressure for measuring the treatment pressure of stenosis dilation in the bile duct and the Oddi sphincter pressure.

[0076] For the present invention:

[0077] The bile duct dilation manometry catheter structure with continuously variable diameter: 1. The catheter is a catheter that can contact the digestive tract mucosa, and the catheter material can withstand the gastric juice and bile environment; 2. There are 3 kinds of cavities inside the catheter: the guide wire cavity, the circuit cavity, and a group of water injection cavities. The guide wire cavity can pass a 0.018-inch zebra guide wire.

[0078] The length of the columnar balloon coating is 10 mm, each balloon is independent, the distance between adjacent balloons is 2 mm, and the distance between the pressure sensors included between each balloon is 12 mm. The distance between the pressure sensors at the front end of the catheter is 5 mm.

[0079] The total length of the catheter structure is 2300 mm, the diameter is 3 mm, and the catheter structure can pass through the endoscope forceps channel. The proximal end of the catheter structure is connected to the measuring instrument. There is a water injection extension tube left at the proximal end of the catheter structure, and a three-way valve is equipped on the extension tube.

[0080] It is worth mentioning that the technical features such as the bile duct and the Oddi sphincter involved in this invention patent application should be regarded as the prior art. The specific structures, working principles, and possible control methods and spatial layout methods involved in these technical features can be selected conventionally in the art, and should not be regarded as the invention points of this invention patent, and this invention patent will not be further specifically elaborated.

[0081] For those skilled in the art, it is still possible to modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements for some of the technical features. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A bile duct pressure measurement system during endoscopic duodenal papilla dilatation, characterized in that: It includes a continuously variable bile duct expansion pressure measuring catheter structure and a flow rate control module. The continuously variable bile duct expansion pressure measuring catheter structure includes a catheter body and a plurality of balloons, wherein the balloons are sleeved on the catheter body, wherein: The catheter body is provided with a circuit cavity, a guidewire cavity and a plurality of water injection cavities which are independent of each other, and one end of the water injection cavity is connected to the flow rate control module; Each portion of the balloon-coated catheter body is equipped with a group of pressure sensors and a pair of electrodes for impedance measurement, and the portion is also provided with a water injection port connected to the other end of the internal water injection cavity, so that liquid is injected into the corresponding balloon through the corresponding water injection cavity and the water injection port, and the degree of expansion of the balloon is judged by the volume of the injected liquid; and the shape change of the balloon when it is squeezed against the inner wall of the bile duct is analyzed through the measurement of the electrodes.

2. The biliary pressure measurement system during endoscopic duodenal papilla dilatation according to claim 1, characterized in that: The specific implementation process of the pressure measurement system of the biliary manometry system during endoscopic duodenal papilla dilatation is as follows: Step S1: The proximal end of the continuously variable diameter bile duct dilatation and pressure measurement catheter structure is pressure-calibrated by a manometer, and the catheter body is inserted into the bile duct from the duodenal papilla with the assistance of a duodenoscope and a guide wire, and the pressure changes of the sphincter of Oddi and the inside of the bile duct are accurately measured by the pressure sensor on the catheter body, and water is gradually injected into the balloon through the water injection channel, thereby dilating the sphincter of Oddi and the narrow bile duct part; Step S2: Control the flow rate Qx of each water injection channel through the flow rate control module, so as to inject liquid into the corresponding balloon through each water injection channel of the catheter body, and simultaneously record data including the volume Mx of the injected liquid, the pressure sensor reading Px and the impedance information Zx, and obtain relevant data of the dilated bile duct volume V; Step S3: obtaining the compliance of the corresponding contact part of the bile duct by expanding the balloon and obtaining the overall compliance of the bile duct according to the channel compliance evaluation obtained by each balloon; Step S4: Applying the overall compliance of the bile duct to the bile duct dilation surgery.

3. The biliary pressure measurement system during endoscopic duodenal papilla dilatation according to claim 2, characterized in that: For step S2, wherein: For the volume Mx of the injected liquid, Mx = ∫Qxdt, the diameter of the balloon is evaluated based on the volume Mx, and considering that the balloon is squeezed and deformed by the bile duct, the impedance information Zx is added to correct the balloon diameter calculation: Dx = D(Mx, Zx), which is specifically implemented as follows: When the balloon is not squeezed by the bile duct and expands freely, as the liquid is injected into the balloon to expand, the shape of the balloon changes, and the effective diameter increases: D0 = f(M), and the impedance value also changes, and the impedance value decreases: Z0 = g(M), and the subscript 0 represents the situation of free state expansion. During this free state expansion, the baseline of the change of the effective diameter D0 and the impedance value Z0 with the increase of volume will be obtained in the pressure calibration process of step S1; In the formal operation, due to the squeezing of the bile duct, the balloon will be deformed and squeezed, reducing the effective diameter D. The squeezing causes the impedance value Z to change. The squeezing coefficient α, D = D0*(1-α), and the squeezing also changes the impedance value. The function K defines the effect of compression on impedance, which is obtained through test data or by calculating the compression profile model based on balloon characteristics, so D = D0*K -1 (Z0 / Z); For the pressure sensor reading Px, the change characteristics of Px are used to determine the interaction between the balloon and the inner wall of the bile duct, including: I: Identify the starting point where the balloon begins to compress and dilate the bile duct; II: changes in compliance of the biliary sphincter; III: Evaluate dilation effectiveness by recording asymmetry of pressure or compliance during dilation and retraction; For the impedance information Zx, the Zx change value is used to evaluate the volume of liquid entering the balloon and to optimize the calculation of the balloon diameter; For bile duct volume V = ∑V x =∑V(Dx,Mx).

4. The biliary pressure measurement system during endoscopic duodenal papilla dilatation according to claim 3, characterized in that: In step S3: The calculation of channel compliance Cx is: Cx = dVx / dPx; The calculation of the overall compliance C is: C = dV / dP, P = MAX(Px).

5. The biliary pressure measurement system during endoscopic duodenal papilla dilatation according to claim 4, characterized in that: Step S4 is specifically implemented as the following steps: Step S4.1: Determine whether the overall compliance C is between the upper compliance limit and the lower compliance limit, where: If it is between, it is determined whether the currently expanded bile duct volume V supports the completion of the expansion surgery. If it is supported, the balloon is drained / retracted after the surgery is completed, the flow rate is Qx', and the relevant data are continuously read until all balloons are drained, and the continuously variable diameter bile duct expansion pressure measurement catheter structure is pulled out; if it is not supported, the flow rate is controlled by the flow rate control module to increase the balloon volume, thereby increasing the bile duct volume, until the overall compliance C is between the upper compliance limit and the lower compliance limit, and the expanded bile duct volume V supports the completion of the expansion surgery; If it is not between the two, the volume and pressure of the bile duct are determined respectively, where: Determine whether the volume V of the dilated bile duct exceeds the volume safety threshold. If yes, drain / retract the balloon directly and notify the operator to intervene. If no, control the flow rate through the flow rate control module to perform adaptive operation. Determine whether the pressure sensor reading Px exceeds the pressure safety threshold. If so, drain / deflate the balloon directly and notify the operator to intervene. If not, control the flow rate through the flow rate control module for adaptive operation.

Images