A bile duct pressure measuring device used during surgery

By designing a biliary pressure measurement device for intraoperative use, using detection resistance and detection circuit, the problems of inaccurate results and complex operation of existing biliary pressure measurement methods are solved, and the effect of accurately reading out the pressure values ​​of various parts of the biliary system and the duodenal papillary sphincter in endoscopic retrograde cholangiopancreatography is achieved.

CN118436332BActive Publication Date: 2025-04-11FIRST AFFILIATED HOSPITAL OF DALIAN MEDICAL UNIV
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Patent Information

Application Number
CN202410690623.X
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-05-30
Publication Date
2025-04-11
Estimated Expiration
2044-05-30

AI Technical Summary

Technical Problem

The existing biliary pressure measurement methods have problems with inaccurate results or complex operation, especially in endoscopic retrograde cholangiopancreatography, which is difficult to accurately read out the pressure values ​​of various parts of the biliary system and the duodenal papillary sphincter.

Method used

A biliary pressure measuring device is designed, including a tube body device and a pressure measuring device. The pipe body device consists of an inner pipe body, a first outer pipe and a second outer pipe. The pressure measuring device includes a detection resistor and a detection circuit. The detection resistor is made of an ITO/PET composite conductive film. It deforms it by the pressure of bile on the detection resistor, so that the resistance value is read on the multimeter to represent the pressure value.

Benefits of technology

The device can accurately read out the pressure values ​​of each part of the bile system and the duodenal papillary sphincter without draining bile, avoiding the problems of inaccurate results and complex operation in the prior art, and improving the accuracy and safety of diagnosis.

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Abstract

The present invention provides a bile duct pressure measuring device for intraoperative use, comprising an inner tube body, a first outer tube and a second outer tube; the first outer tube and the second outer tube have openings on their side walls, and a detection resistor arranged between the first outer tube and the second outer tube is arranged at the opening, the detection resistor is connected to a multimeter through a wire, the detection resistor is a flexible material of an ITO / PET composite conductive film, and is deformed by the pressure of bile at the opening, so that the multimeter can read the resistance change and detect the pressure in the bile duct system. The present invention can accurately read the pressure of different parts in the bile duct without draining bile from the body.
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Description

Technical Field

[0001] The invention relates to the technical field of bile duct pressure measurement, in particular to a bile duct pressure measurement device used during surgery. Background Art

[0002] The bile duct is divided into intrahepatic bile duct and extrahepatic bile duct. The intrahepatic bile duct originates from the capillary bile duct and converges into interlobular bile duct, segmental bile duct, lobar bile duct and left and right hepatic ducts in the liver. Normally, the left hepatic duct is formed by the confluence of the left internal lobe and left external lobe bile ducts, and the right hepatic duct is formed by the confluence of the right anterior lobe and right posterior lobe bile ducts. The left and right hepatic ducts are first-level branches, the left internal lobe, left external lobe, right anterior lobe, and right posterior lobe bile ducts are second-level branches, and the bile ducts of each liver segment are tertiary branches. The extrahepatic bile duct is composed of the left and right hepatic ducts, the common hepatic duct, the gallbladder, the cystic duct and the common bile duct. The left hepatic duct is slender, about 2.5 to 4 cm long, and the right hepatic duct is short and thick, about 1 to 3 cm long. The diameter of the common hepatic duct is usually 0.4 to 0.6 cm and about 3 cm long. The common bile duct is about 4 to 8 cm long and 0.6 to 0.8 cm in diameter. The common bile duct is divided into four sections: ① Upper duodenum: about 1.4 cm long, it descends along the right edge of the hepatoduodenal ligament and is a common site for common bile duct exploration and drainage in clinical practice. ②Posterior duodenum: about 2 cm long, runs behind the first duodenum, with the inferior vena cava behind it, and the portal vein and gastroduodenal artery on the left. ③Pancreatic segment: about 1 to 2 cm long, runs down in the bile duct groove behind the pancreas or in the pancreatic parenchyma. ④Intraduodenal wall segment: about 1 cm long, runs to the middle of the descending duodenum, and obliquely enters the posterior medial wall of the intestinal duct. The common bile duct and the main pancreatic duct merge in the intestinal wall, expanding into a pot shape, also known as the ampulla of Vater. The ampulla is surrounded by the sphincter of Oddi, and the end usually opens at the duodenal papilla. The cystic duct is 1 to 5 cm long, and its diameter is 0.2 to 0.4 cm. In normal people, the common bile duct pressure is about 0.66 kPa, the pancreatic duct pressure is 1.26 kPa, the Oddi sphincter pressure is 1.33 kPa, the wave frequency is 2.6 / min, the amplitude is 13.73 kPa, the duration is 4.8 s, the average forward wave is 59%, the spontaneous wave is 28%, and the retrograde wave is 14%. The gallbladder wall muscle contracts to drive the bile to flow into the duodenum, while the Oddi sphincter contracts to prevent the bile from flowing into the duodenum. The bile in the bile duct passes according to the fluid mechanics in the bile duct. If stones or other space-occupying lesions appear, the pressure in the bile duct will increase abnormally, leading to a series of biliary diseases such as obstructive jaundice. Pathological changes at the end of the common bile duct may still be missed only by angiography during surgery, increasing the risk of postoperative disease recurrence.

[0003] For this type of examination, bile duct manometry is one of the effective methods to reduce diagnostic errors. Under normal physiological conditions, bile flows along the pressure gradient in the bile duct, and the pressure in the bile duct is at a normal value. If there are stones, polyps, or abnormal anatomical structures, functional lesions, etc. in the bile duct, it will cause changes in bile duct pressure, resulting in a series of clinical symptoms including abdominal pain, jaundice, fever, etc. Therefore, bile duct manometry can be combined with duodenoscope in endoscopic retrograde pancreaticocholangiopancreatography to monitor the pressure of the bile-pancreatic junction, thereby diagnosing pancreaticobiliary reflux disease, and can evaluate the degree of pre-cutting of the duodenal papilla to achieve the expected effect of treatment. At the same time, it can reduce the omission of pathological changes at the end of the common bile duct and achieve accurate diagnosis and treatment. The application of bile duct pressure monitoring technology in laparoscopic biliary lithotomy for intrahepatic and extrahepatic bile duct stones can effectively reduce damage to the patient's liver function and inflammatory response, with fewer postoperative complications and higher safety.

[0004] At present, bile duct pressure measurement is rarely used in hospitals at all levels. The main method is to drain bile from the body into a U-shaped tube. Under the action of atmospheric pressure on the other side, the bile duct pressure is read according to the scale. After the pressure reading is completed, the bile drained out needs to be transported back to the bile duct. This method may cause inaccurate results due to insufficient height of the U-shaped tube, or a small amount of bile reflux during pressure measurement, and changes in the patient's body position during pressure measurement. The second method is to use a pressure measuring catheter, connect a pressure sensor outside the body, and connect it to the pressure measurement module interface of the monitor; the third method is to use a choledochoscope with a pressure measurement function, which requires the use of additional equipment during endoscopic retrograde pancreaticocholangiopancreatography. The above methods have the disadvantages of inaccurate results or complicated operations.

[0005] Therefore, there is a need for a device that can be compatible with a duodenoscope during endoscopic retrograde pancreatic cholangiopancreatography, which is small in size, can freely enter and exit the bile duct, and is easy to operate. It can accurately read the pressure values ​​of various parts of the human biliary system and the duodenal papillary sphincter without draining bile from the body, and by comparing the pressure values ​​during and after the operation, the patient's recovery can be observed from a new perspective. Summary of the invention

[0006] In view of the above technical problems, a bile duct pressure measuring device for use during surgery is provided.

[0007] The technical means adopted by the present invention are as follows:

[0008] A bile duct pressure measuring device used during surgery, comprising a tube body device and a pressure measuring device;

[0009] One end of the tube device is used to enter the bile duct system, and the tube device comprises an inner tube body, a first outer tube and a second outer tube; the first outer tube is sleeved outside the inner tube body, and the second outer tube is sleeved outside the first outer tube;

[0010] The pressure measuring device comprises a first opening, a second opening, a detection resistor and a detection circuit;

[0011] The first opening is processed on the first outer tube and is close to the end of the first outer tube entering the biliary system, and the second opening is processed on the second outer tube and is directly opposite to the first opening; the detection resistor is installed between the first outer tube and the second outer tube, and is located at the first opening and the second opening, and covers the first opening; the detection resistor is a flexible resistor, and bile generates pressure on the detection resistor after entering the biliary system, causing the detection resistor to deform; the detection resistor is a flexible ITO / PET composite conductive film; the ITO / PET composite conductive film is a composite material composed of indium tin oxide (ITO) and polyethylene terephthalate (PET), and is usually manufactured by vacuum deposition technology, which involves using physical vapor deposition or chemical vapor deposition methods on a PET substrate to deposit an ITO film on its surface. Physical vapor deposition usually includes ion beam sputtering or electron beam evaporation, while chemical vapor deposition includes chemical vapor deposition or thermal evaporation. These methods can ensure the formation of a uniform, dense and well-conductive ITO film on a PET substrate. Among them, indium tin oxide (ITO) is a transparent conductive oxide with excellent conductivity and transparency, and is often used to manufacture transparent electronic devices such as touch screens, liquid crystal displays, etc. Polyethylene terephthalate (PET) is a common plastic material with excellent mechanical properties and heat resistance, and is often used as a substrate material. By combining these two materials, a conductive and flexible thin film material can be obtained, which is suitable for the manufacture of various electronic devices.

[0012] The detection circuit includes a wire and a display system. The display system is located outside the human body and is connected to the detection resistor through the silver wire. The silver wire is located between the first outer tube and the second outer tube and passes through the first outer tube and the second outer tube to connect to the display system.

[0013] Preferably, the inner tube body is a hollow plastic tube, and during the operation, a guide wire can be inserted into the hollow cavity, and under the guidance of the guide wire, the pressure measuring device is extended into the bile duct system through the duodenoscope, and the first outer tube and the second outer tube are heat shrink tubes.

[0014] Preferably, the ITO in the detection resistor is arranged in a serpentine shape on the PET to increase the contact area and make the detection more sensitive.

[0015] Preferably, the conductive ITO side of the detection resistor faces the first outer tube and does not contact the bile, and the insulating PET side faces the second outer tube and contacts the bile at the second opening.

[0016] Preferably, the wire is a silver wire.

[0017] Preferably, the display system is a multimeter.

[0018] Preferably, the inner edges of the first opening and the second opening are connected to the detection resistor via ultraviolet photosensitive adhesive.

[0019] Preferably, the multimeter is connected to or has a transmission module, and the transmission module is used to send the detection information to a computer or a display. The transmission module can be a wired transmission module or a wireless transmission module, and the wireless transmission module can adopt a wireless method such as Bluetooth transmission.

[0020] Preferably, a size of the first opening is larger than a size of the second opening.

[0021] Preferably, both the first opening and the second opening are circular openings.

[0022] After one end of the biliary pressure measuring device enters the biliary system, the bile generates pressure on the detection resistor, causing the detection resistor to deform. The reading of the multimeter is then observed. Since there is a relationship between the resistance value and the pressure value, the pressure value can be directly observed from the change in the resistance value.

[0023] Compared with the prior art, the present invention has the following advantages:

[0024] The device is mainly used in endoscopic retrograde pancreatic cholangiopancreatography. Through the setting of the tube body device, the detection resistor can be effectively delivered into the bile duct, and the bile pressure in the bile duct at this time can be effectively detected. There is no need to use the existing bile duct pressure measurement method, and during the detection process, the bile is led out to the U-tube to cause the problem of bile reflux and a series of problems caused by the pipeline being too high or not high enough. Instead, during the detection process, the bile in the bile duct squeezes the detection resistor, causing the detection resistor to deform inward and thus change its resistance value. The resistance change signal is output to the multimeter through the metal silver wire connected to the two ends of the detection resistor, thereby achieving a good bile duct pressure measurement effect and accurate readings, avoiding a series of problems in the prior art such as inaccurate detection results and complicated operations.

[0025] Based on the above reasons, the present invention can be widely promoted in the fields of bile duct pressure measurement and the like. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0027] Figure 1 It is a structural schematic diagram of a bile duct pressure measuring device in a specific implementation manner of the present invention.

[0028] Figure 2 It is a schematic diagram of the inner tube structure in a specific implementation manner of the present invention.

[0029] Figure 3 It is a schematic diagram of the structure of the first outer tube in a specific implementation manner of the present invention.

[0030] Figure 4 Schematic diagram of the detection resistor structure in a specific implementation manner of the present invention.

[0031] Figure 5 It is a schematic diagram of the structure after the first outer tube and the inner tube body are assembled in a specific implementation manner of the present invention.

[0032] Figure 6 It is a schematic diagram of the structure after the first outer tube, the second outer tube and the inner tube body are assembled in a specific embodiment of the present invention.

[0033] Figure 7 It is a schematic diagram of signal transmission in a specific implementation manner of the present invention.

[0034] In the figure: 1, inner tube body; 2, first outer tube; 3, second outer tube; 4, first opening; 5, second opening; 6, detection resistor; 7, wire; 8, multimeter. DETAILED DESCRIPTION

[0035] It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0036] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. The following description of at least one exemplary embodiment is actually only illustrative and is by no means intended to limit the present invention and its application or use. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0037] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit exemplary embodiments according to the present invention. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprising" and / or "including" are used in this specification, it indicates the presence of features, steps, operations, devices, components and / or combinations thereof.

[0038] Unless otherwise specifically stated, the relative arrangement, numerical expressions and numerical values ​​of the parts and steps set forth in these embodiments do not limit the scope of the present invention. Meanwhile, it should be clear that, for ease of description, the sizes of the various parts shown in the accompanying drawings are not drawn according to the actual proportional relationship. The technology, method and equipment known to those of ordinary skill in the relevant art may not be discussed in detail, but in appropriate cases, the technology, method and equipment should be considered as a part of the specification. In all examples shown and discussed here, any specific value should be interpreted as being merely exemplary, rather than as a limitation. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters represent similar items in the following drawings, and therefore, once a certain item is defined in an accompanying drawing, it does not need to be further discussed in subsequent drawings.

[0039] In the description of the present invention, it is necessary to understand that the directions or positional relationships indicated by directional words such as "front, back, up, down, left, right", "lateral, vertical, perpendicular, horizontal" and "top, bottom" are usually based on the directions or positional relationships shown in the drawings. They are only for the convenience of describing the present invention and simplifying the description. Unless otherwise specified, these directional words do not indicate or imply that the device or element referred to must have a specific direction or be constructed and operated in a specific direction. Therefore, they cannot be understood as limiting the scope of protection of the present invention: the directional words "inside and outside" refer to the inside and outside relative to the contours of each component itself.

[0040] For ease of description, spatially relative terms such as "above", "above", "on the upper surface of", "above", etc. may be used here to describe the spatial positional relationship between a device or feature and other devices or features as shown in the figure. It should be understood that spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation described in the figure. For example, if the device in the accompanying drawings is inverted, the device described as "above other devices or structures" or "above other devices or structures" will be positioned as "below other devices or structures" or "below their position devices or structures". Thus, the exemplary term "above" can include both "above" and "below". The device can also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatially relative descriptions used here are interpreted accordingly.

[0041] In addition, it should be noted that the use of terms such as "first" and "second" to limit components is only for the convenience of distinguishing the corresponding components. If not otherwise stated, the above terms have no special meaning and therefore cannot be understood as limiting the scope of protection of the present invention.

[0042] like Figures 1 to 7 As shown, a bile duct pressure measuring device used during surgery includes a tube device and a pressure measuring device;

[0043] The tube device is a flexible tube, one end of which is used to enter the bile duct system, and the tube device includes equal lengths ( Figure 5 and Figure 6 In order to show its structure more clearly, the outer tube at the end face is cut, and the inner tube body 1, the first outer tube 2 and the second outer tube 3 are actually equal in length; the inner tube body 1 is a hollow plastic tube with a diameter of 7Fr, the first outer tube 2 is sleeved outside the inner tube body 1, and the second outer tube 3 is sleeved outside the first outer tube 2; the first outer tube 2 and the second outer tube 3 are both heat shrink tubes. After the first outer tube 2 is sleeved outside the inner tube body 1, a hot air gun is used to heat the first outer tube 2 to tightly wrap the inner tube body 1. After the second outer tube 3 is sleeved on the first outer tube 2, the second outer tube 3 is also heated to tightly wrap the first outer tube 2. After heating, the thickness of the first outer tube 2 is 0.26mm, and the thickness of the second outer tube 3 is 0.12mm.

[0044] The pressure measuring device comprises a first opening 4, a second opening 5, a detection resistor 6 and a detection circuit;

[0045] The first opening 4 is processed on the first outer tube 2 and is close to the end of the first outer tube 2 entering the biliary system. The second opening 5 is processed on the second outer tube 3 and is opposite to the first opening 4. The first opening 4 and the second opening 5 are both circular holes, and the aperture of the first opening 4 is larger than the aperture of the second opening 5. The detection resistor 6 is installed between the first outer tube 2 and the second outer tube 3, and is located at the first opening 4 and the second opening 5, and covers the upper part of the first opening 4 and the lower part of the second opening 5. The detection resistor 6 is an ITO / PET composite conductive film with a resistance of 100 ohms, a length of 8.5 mm, a width of 5 mm, and a thickness of 0.05 mm. The ITO in the detection resistor 6 is arranged in a serpentine shape on the PET. The ITO faces the first outer tube 2 and does not contact the bile, and the PET faces the second outer tube 3 and contacts the bile at the second opening 5. The inner edges of the first opening 4 and the second opening 5 are connected to the detection resistor 6 via ultraviolet photosensitive adhesive, which not only adheres and fixes the detection resistor 6 but also plays a sealing role to prevent bile from entering between the first outer tube 2 and the second outer tube 3 .

[0046] The detection circuit includes a wire 7 and a display system. The display system uses a multimeter 8, and the wire 7 uses a silver wire. The multimeter 8 is located outside the human body. One end of the silver wire is connected to the enlarged pin electrode at the end of the detection resistor 6, and the other end is arranged between the first outer tube 2 and the second outer tube 3 and then passes through, and is connected to the multimeter 8 to form a closed loop. The multimeter 8 is connected to or has a transmission module, and the transmission module is used to send the detection information to a computer or a display. The transmission module can be a wired transmission module or a wireless transmission module. The wireless transmission module can use a wireless method such as Bluetooth transmission to simplify the operation.

[0047] After one end of the biliary pressure measuring device enters the biliary system, the bile generates pressure on the detection resistor 6, causing the detection resistor 6 to deform. Then the reading of the multimeter 8 is observed. Because the resistance value and the pressure value are related, after a simulated substitution experiment is carried out in vitro and the data is integrated by a computer to obtain the resistance-pressure relationship, the multimeter dial is modified, and the pressure value can be directly observed from the change in the resistance value.

[0048] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A bile duct pressure measuring device for intraoperative use, characterized in that: It includes a pipe body device and a pressure measuring device; One end of the tube device is used to enter the bile duct system, and the tube device comprises an inner tube body, a first outer tube and a second outer tube; the first outer tube is sleeved outside the inner tube body, and the second outer tube is sleeved outside the first outer tube; The pressure measuring device comprises a first opening, a second opening, a detection resistor and a detection circuit; The first opening is processed on the first outer tube and is close to the end of one end of the first outer tube entering the biliary system, and the second opening is processed on the second outer tube and is directly opposite to the first opening; the detection resistor is installed between the first outer tube and the second outer tube, and is located at the first opening and the second opening, and covers the first opening; the size of the first opening is larger than the size of the second opening; the detection resistor is a flexible ITO / PET composite conductive film, and after entering the biliary system, the bile exerts pressure on the detection resistor, causing the detection resistor to deform; the ITO in the detection resistor is arranged in a serpentine shape on the PET; one side of the ITO faces the first outer tube and does not contact the bile, and the one side of the PET faces the second outer tube and contacts the bile at the second opening; The detection circuit includes a wire and a display system. The display system is located outside the human body and is connected to the detection resistor through the wire. The wire is located between the first outer tube and the second outer tube and passes through the first outer tube and the second outer tube to connect to the display system.

2. A bile duct pressure measuring device for intraoperative use according to claim 1, characterized in that: The inner tube body is a hollow plastic tube, and the first outer tube and the second outer tube are heat shrink tubes.

3. A bile duct pressure measuring device for intraoperative use according to claim 1, characterized in that: The wire is a silver wire.

4. A bile duct pressure measuring device for intraoperative use according to claim 1, characterized in that: The display system is a multimeter.

5. The device for measuring bile duct pressure during surgery according to claim 1, characterized in that: The inner edges of the first opening and the second opening are connected to the detection resistor via ultraviolet photosensitive adhesive.

6. A bile duct pressure measuring device for intraoperative use according to claim 4, characterized in that: The multimeter is connected with a transmission module, and the transmission module is used to send the detection information to a computer or a display to realize wireless transmission of data.

7. The device for measuring bile duct pressure during surgery according to claim 1, characterized in that: The first opening and the second opening are both circular openings.

Citation Information

Patent Citations

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