Duodenal papilla dilating balloon catheter with pressure measurement function

Abstract

The utility model provides a duodenum papilla dilatation balloon catheter with pressure measurement function, including outer sheath, combination and a plurality of branch pipes, the outer sheath includes drainage pipe section I, drainage pipe section II and drainage pipe section III connected in proper order from head to tail, the surface of drainage pipe section II is wrapped double -deck cylindrical dilatation film, double -deck cylindrical dilatation film includes inner layer film and outer layer film, and the outer layer film is equipped with opening, and the opening is equipped with pressure sensor, the combination is connected with the tail end of drainage pipe section III, and a plurality of branch pipes are connected with the combination, the utility model can be under the assistance of guide wire and carry out common bile duct or pancreatic duct intubation, can detect the pressure between balloon and duodenum papilla sphincter while dilating duodenum papilla sphincter, and the size of papilla dilatation is determined through pressure value, avoids the incidence of complications such as papilla sphincter laceration hemorrhage, bile leakage, intestinal bile reflux etc.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and more specifically, to a duodenal papilla dilation balloon catheter with pressure measurement function. Background Technology

[0002] Endoscopic retrograde cholangiopancreatography (ERCP) is an important surgical procedure for treating diseases such as common bile duct stones, obstructive jaundice, acute pancreatitis, bile duct stricture, and bile leakage. It offers advantages such as less trauma, faster recovery, and high repeatability. Endoscopic papillary balloon dilation (EPBD) is a key technique in therapeutic ERCP. By dilating the duodenal papillary sphincter, it relieves papillary sphincter stricture, facilitating stone removal and the placement of biliary stents and other accessories. To achieve a specific dilation diameter, EPBD requires inflating the balloon to a certain pressure; however, the pressure measured at this point is the intraballoon pressure, not the pressure between the balloon and the papillary sphincter.

[0003] EPBD also carries certain complications. If the duodenal papilla is dilated too little, it hinders stone removal and accessory placement, leading to a higher incidence of postoperative pancreatitis. If the duodenal papilla is dilated too much, there is a risk of intraoperative bleeding and bile leakage, and damage to the bile duct's closure can even lead to reflux cholangitis, bile duct stones, and bile duct cancer. Therefore, the dilation diameter of EPBD varies from 6mm to 20mm, primarily depending on the diameter of the common bile duct and the size of the stones. Generally, the EPBD dilation diameter does not exceed 20% of the common bile duct diameter. However, there is significant individual variation in the size of the duodenal papilla sphincter, and the incidence of postoperative complications differs depending on the papilla dilation diameter. Currently, there is no unified standard for EPBD to address these individual differences.

[0004] The duodenal papillary sphincter (EPBD) is a crucial structure for maintaining the biliary duct's tightness. Factors such as EPBD hypertrophy, stenosis, or excessive length can lead to increased pressure in the bile and pancreatic ducts, causing EPBD relaxation. Large EPBDs can result in decreased EPBD pressure. Therefore, bile and pancreatic duct pressure is an important indicator of EPBD tightness, and the extent of EPBD dilation can be determined by measuring EPBD pressure.

[0005] Currently, biliary and pancreatic manometry mainly uses water irrigation. A manometry catheter with a side hole is inserted through a duodenoscope. Water flows out of the side hole at a constant low speed (0.15–0.40 mL / min) through the irrigation system. The resistance that the water needs to overcome when overflowing is the local pressure. This pressure is transmitted through the water column to an external pressure transducer and converted into an electrical signal. After processing by a recorder and computer, graphical and numerical values ​​can be obtained. Depending on the type of catheter, manometry can be divided into: water irrigation catheters, aspirable fluid irrigation catheters, and cuff-type manometry catheters. Because water irrigation manometry measures indirect pressure, its accuracy is low, and the operation is complex with a high rate of postoperative complications. Therefore, few hospitals in China have adopted this method, and its development has been slow. Miniature sensor manometry is a new direct manometry method that has emerged abroad in recent years. It does not require a water irrigation system, is simpler to operate, and provides more accurate measurement data. This method uses a solid-state manometry catheter and is mainly used in urology to measure renal pelvis pressure during cystoscopy or percutaneous nephrolithotomy. Currently, it is mainly used in urology, and there are no solid-state manometry catheters for the biliary and pancreatic systems. Even with the availability of endoscopic bile and pancreatic manometry catheters, it is impossible to monitor changes in bile duct pressure in real time during EST incision. The size of the duodenal papillary sphincter incision is determined by EPBD-manometry-EPBD, which is a cumbersome procedure. Utility Model Content

[0006] In response to the aforementioned technical problems, a duodenal papilla dilation balloon catheter with pressure measurement function is provided.

[0007] The technical means adopted in this utility model are as follows:

[0008] A duodenal papilla dilation balloon catheter with pressure measurement function includes: an outer sheath, the anterior wall of which is wrapped with a double-layered cylindrical dilation membrane, the double-layered cylindrical dilation membrane including an inner membrane and an outer membrane, the outer membrane having an opening, and a pressure sensor being disposed within the opening.

[0009] Furthermore, the outer sheath includes drainage tube segment I, drainage tube segment II, and drainage tube segment III connected sequentially from head to tail, with the double-layer cylindrical expansion membrane wrapping around the surface of drainage tube segment II.

[0010] Furthermore, it also includes a conjoint and multiple branch pipes, the conjoint being connected to the tail end of drainage pipe segment III, and the multiple branch pipes being connected to the conjoint.

[0011] Furthermore, the drainage tube segment I is a dual-channel tube, with a guidewire channel I and an injection channel I inside. The opening of the guidewire channel I is located in the middle of the front end of the drainage tube segment I, and the opening of the injection channel I is located in the side wall of the drainage tube segment I.

[0012] Furthermore, the drainage tube segment I is a conical structure that tapers from tail to head.

[0013] Furthermore, the drainage tube segment II is a dual-channel tube, with a guidewire channel II and an injection channel II inside. The guidewire channel II is connected to the guidewire channel I of the drainage tube segment I, and the injection channel II is connected to the injection channel I of the drainage tube segment I.

[0014] Furthermore, the drainage tube section II is concave and its diameter is smaller than that of the drainage tube sections I and III.

[0015] Furthermore, the drainage tube segment III is a four-channel tube, internally containing a guidewire channel III, an injection channel III, a balloon channel, and a data cable channel. The guidewire channel III is connected to the guidewire channel I of the drainage tube segment I and the guidewire channel II of the drainage tube segment II. The injection channel III is connected to the injection channel I of the drainage tube segment I and the injection channel II of the drainage tube segment II. The balloon channel is connected to a double-layer cylindrical dilatation membrane. The data cable channel contains a data cable, which is connected to a pressure sensor.

[0016] Furthermore, the outer wall of the assembly is provided with a data cable connector for connecting to the data cable.

[0017] Furthermore, all of the multiple branch tubes are single-channel tubes, including a guidewire tube, an injection tube, and a balloon tube. The guidewire tube, injection tube, and balloon tube are respectively connected to the guidewire channel III, the injection channel III, and the balloon channel of the drainage tube segment III. The tail ends of the guidewire tube, the injection tube, and the balloon tube are all provided with connectors.

[0018] Compared with the prior art, the present invention has the following advantages:

[0019] 1. The duodenal papilla dilation balloon catheter with pressure measurement function provided by this utility model can be used for duodenal papilla balloon dilation and can also be used as a stone removal balloon to remove common bile duct stones.

[0020] 2. The duodenal papilla dilation balloon catheter with pressure measurement function provided by this utility model can perform duodenal papilla sphincter pressure measurement, common bile duct pressure measurement and pancreatic duct pressure measurement to determine whether there is preoperative bile / pancreatic juice outflow obstruction.

[0021] 3. The duodenal papilla dilation balloon catheter with pressure measurement function provided by this utility model can measure the pressure of the duodenal papilla during the papilla balloon dilation procedure, determine the diameter of the duodenal papilla dilation, avoid the occurrence of complications caused by over-dilation, and achieve truly precise duodenal papilla balloon dilation.

[0022] Based on the above reasons, this utility model can be widely promoted in fields such as medicine. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0024] Figure 1 This is a schematic diagram of the structure of this utility model.

[0025] Figure 2 This is a partial structural diagram of the pressure sensor of this utility model.

[0026] Figure 3 This is a schematic diagram of the guide wire insertion according to the present invention.

[0027] Figure 4 This is a schematic diagram of balloon dilation according to the present invention.

[0028] In the diagram: 11. Drainage tube segment I; 11.1. Guidewire channel I; 11.2. Injection channel I; 12. Drainage tube segment II; 12.1. Guidewire channel II; 12.2. Injection channel II; 13. Drainage tube segment III; 13.1. Guidewire channel III; 13.2. Injection channel III; 13.3. Balloon channel; 13.4. Data cable channel; 2. Assembly; 21. Data cable connector; 31. Guidewire tube; 32. Injection tube; 33. Balloon tube; 4. Double-layer cylindrical dilatation membrane; 5. Pressure sensor. Detailed Implementation

[0029] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0030] This invention provides a duodenal papilla dilation balloon catheter with pressure measurement function, comprising: an outer sheath, a conjoint 2, and multiple branch tubes. The outer sheath is divided into drainage segment I11, drainage segment II12, and drainage segment III13 connected sequentially from head to tail. The surface of drainage segment II12 is wrapped with a double-layer cylindrical dilation membrane 4, which includes an inner membrane and an outer membrane. The outer membrane has an opening, and a pressure sensor 5 is installed inside the opening. The pressure sensor 5 adopts an existing medical pressure sensor. The conjoint 2 is connected to the tail end of drainage segment III13, and the multiple branch tubes are connected to the conjoint 2.

[0031] In a preferred embodiment, the drainage tube segment I11 is a conical dual-channel tube with the conical structure tapering from tail to head. The drainage tube segment I11 has a guidewire channel I11.1 and an injection channel I11.2 inside. The opening of the guidewire channel I11.1 is located at the front end of the drainage tube segment I11, and the opening of the injection channel I11.2 is located on the side wall of the drainage tube segment I11.

[0032] In a preferred embodiment, the drainage tube segment II12 is a dual-channel tube, with a guidewire channel II12.1 and an injection channel II12.2 inside. The guidewire channel II12.1 is connected to the guidewire channel I11.1 of the drainage tube segment I11, and the injection channel II12.2 is connected to the injection channel I11.2 of the drainage tube segment I11.

[0033] In a preferred embodiment, the drainage tube section II12 is concave and its diameter is smaller than that of the drainage tube section I11 and the drainage tube section III13.

[0034] In a preferred embodiment, the drainage tube segment III13 is a four-channel tube, internally having a guidewire channel III13.1, an injection channel III13.2, a balloon channel III13.3, and a data cable channel III13.4. The guidewire channel III13.1 is connected to the guidewire channel I11.1 of the drainage tube segment I11 and the guidewire channel II12.1 of the drainage tube segment II12. The injection channel III13.2 is connected to the injection channel I11.2 of the drainage tube segment I11 and the injection channel II12.2 of the drainage tube segment II12. The balloon channel III13.3 is connected to the double-layer cylindrical dilatation membrane 4. The data cable channel III13.4 is internally equipped with a data cable, which is connected to the pressure sensor 5. The pressure sensor 5 can output the monitored pressure value through the data cable.

[0035] In a preferred embodiment, the conjoint 2 encloses the tail end of the drainage tube segment III13, and the outer wall of the conjoint 2 is provided with a data cable connector 21 connected to the data cable.

[0036] In a preferred embodiment, all branch tubes are single-channel tubes, including a guidewire tube 31, an injection tube 32, and a balloon tube 33. The guidewire tube 31, the injection tube 32, and the balloon tube 33 are respectively connected to the guidewire channel Ⅲ13.1, the injection channel Ⅲ13.2, and the balloon channel 13.3 of the drainage tube segment Ⅲ13. The tail ends of the guidewire tube 31, the injection tube 32, and the balloon tube 33 are all provided with connectors.

[0037] The guidewire channels I 11.1, II 12.1, and III 13.1 are connected in sequence to form a guidewire channel for guidewire insertion. The injection channels I 11.2, II 12.2, and III 13.2 are connected in sequence to form an injection channel.

[0038] The outer diameter of the catheter of this utility model is 7Fr, the outer diameter of the opening at the head end of the drainage tube segment I11 is 5Fr, the inner diameter of the guidewire channel is 1mm, the inner diameter of the data cable channel is 0.5mm, and the length is 3-4m.

[0039] This invention allows for the insertion of cannula into the common bile duct or pancreatic duct with the assistance of a guidewire. While dilating the duodenal papillary sphincter, it can also detect the pressure between the balloon and the duodenal papillary sphincter, using the pressure value to determine the extent of papillary dilation, thus avoiding complications such as sphincter tearing and bleeding, bile leakage, and intestinal bile reflux.

[0040] The working method of this utility model:

[0041] (1) Do not use drugs that affect the bile duct and SO for 2 days before the operation, such as scopolamine bromide, nitroglycerin, etc. Fast for 12 hours before the operation.

[0042] (2) Before the operation, oral lidocaine or dacronin gel was administered to the oropharyngeal mucosa. The patient was in the same position as in ERCP, lying prone on the left side, biting down on the mouth and receiving oxygen via nasal cannula.

[0043] (3) The examination is performed by a skilled physician. After the duodenoscope is inserted into the digestive tract, the endoscope is straightened to locate the main duodenal papilla.

[0044] (4) The scalpel with guide wire was inserted into the common bile duct and a small amount of contrast agent was injected to confirm that it was the common bile duct.

[0045] (5) Insert a guidewire and remove the sphincter cutter. Insert a sphincter dilation balloon under the guidance of the guidewire. Measure the pressure in the duodenum, sphincter, and common bile duct. If necessary, pancreatic duct cannulation can be performed and pancreatic duct pressure can be measured.

[0046] (6) Insert the guidewire, remove the nipple dilation balloon, insert the nipple sphincter under the guidance of the guidewire to perform EST, insert the guidewire and remove the nipple sphincter.

[0047] (6) Insert a papillary balloon dilator under the guidance of a guidewire, and measure the pressure of the duodenum, papillary sphincter and common bile duct again. If necessary, pancreatic duct cannulation can be performed and pancreatic duct pressure can be measured.

[0048] (7) Pull the dilation balloon from the papilla behind the common bile duct, withdrawing 1-2 mm each time, and measure the pressure at each point for 30-60 seconds. The high-pressure area seen when the catheter is pulled back is the SO baseline pressure. At the same time, the high amplitude wave on the basis of the high-pressure zone can be recorded, and the amplitude, interval, and propagation direction of the peristaltic wave can be calculated.

[0049] (7) Gradually increase the balloon pressure and dynamically record the SO pressure changes. When the pressure reaches the maximum pressure that the nipple sphincter can withstand, stop increasing the balloon pressure.

[0050] (8) After the pressure stabilizes, leave the guidewire in place, empty and remove the nipple dilation balloon.

[0051] (9) If necessary, SO pressure measurement or pancreatic duct cannulation measurement of pancreatic duct pressure can be repeated.

[0052] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this utility model, and are not intended to limit it. Although the utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this utility model.

Claims

1. A duodenal papilla dilating balloon catheter with pressure measurement function, characterized by, include: The outer sheath has a double-layered cylindrical expansion membrane (4) wrapped around the front wall of the outer sheath. The double-layered cylindrical expansion membrane (4) includes an inner membrane and an outer membrane. The outer membrane has an opening, and a pressure sensor (5) is installed in the opening.

2. The pressure-measured duodenal bulb dilating balloon catheter of claim 1, wherein, The outer sheath includes drainage tube segment I (11), drainage tube segment II (12) and drainage tube segment III (13) connected sequentially from head to tail, and the double-layer cylindrical expansion membrane (4) is wrapped around the surface of drainage tube segment II (12).

3. The pressure-measured duodenal papilla dilation balloon catheter according to claim 2, characterized by, It also includes a conjoint (2) and multiple branch pipes, the conjoint (2) being connected to the tail end of the drainage pipe segment III (13), and the multiple branch pipes being connected to the conjoint (2).

4. The pressure-measured duodenal papilla dilation balloon catheter according to claim 2, characterized by, The drainage tube segment I (11) is a dual-channel tube with a guide wire channel I (11.1) and an injection channel I (11.2) inside. The opening of the guide wire channel I (11.1) is located in the middle of the front end of the drainage tube segment I (11), and the opening of the injection channel I (11.2) is located on the side wall of the drainage tube segment I (11).

5. The pressure-measured duodenal papilla dilation balloon catheter according to claim 2, characterized by, The drainage tube section I (11) is a conical structure that gradually narrows from tail to head.

6. The pressure-measured duodenal papilla dilation balloon catheter according to claim 2, characterized by, The drainage tube section II (12) is a dual-channel tube with a guide wire channel II (12.1) and an injection channel II (12.2) inside. The guide wire channel II (12.1) is connected to the guide wire channel I (11.1) of the drainage tube section I (11), and the injection channel II (12.2) is connected to the injection channel I (11.2) of the drainage tube section I (11).

7. The pressure-measured duodenal papilla dilation balloon catheter according to claim 2, characterized by, The drainage tube section II (12) is concave and its diameter is smaller than that of the drainage tube section I (11) and the drainage tube section III (13).

8. The pressure-measured duodenal bulb dilating balloon catheter of claim 2, wherein, The drainage tube segment III (13) is a four-channel tube, which has a guidewire channel III (13.1), an injection channel III (13.2), a balloon channel (13.3), and a data cable channel (13.4). The guidewire channel III (13.1) is connected to the guidewire channel I (11.1) of the drainage tube segment I (11) and the guidewire channel II (12.1) of the drainage tube segment II (12). The injection channel III (13.2) is connected to the injection channel I (11.2) of the drainage tube segment I (11) and the injection channel II (12.2) of the drainage tube segment II (12). The balloon channel (13.3) is connected to the double-layer cylindrical dilatation membrane (4). The data cable channel (13.4) is equipped with a data cable, which is connected to the pressure sensor (5).

9. The pressure-measured duodenal papilla dilation balloon catheter according to claim 3, characterized by, The outer wall of the assembly (2) is provided with a data cable connector (21) for connecting to the data cable.

10. The pressure-measured duodenal bulb dilating balloon catheter of claim 3, wherein, The multiple branch tubes are all single-channel tubes, including a guidewire tube (31), an injection tube (32), and a balloon tube (33). The guidewire tube (31), the injection tube (32), and the balloon tube (33) are respectively connected to the guidewire channel III (13.1), the injection channel III (13.2), and the balloon channel (13.3) of the drainage tube segment III (13). The tail of the guidewire tube (31), the injection tube (32), and the balloon tube (33) are all provided with connectors.

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