Three-channel biliopancreatic pressure measuring catheter

By designing a three-channel bile-pancreatic pressure measurement catheter, the problems of complex operation, low accuracy and high complications in the existing technology are solved, and efficient, accurate pressure measurement and simplified operation are achieved in the bile-pancreatic system, which is suitable for direct pressure measurement of the bile-pancreatic system.

CN223248192UActive Publication Date: 2025-08-22SHANGHAI RUIFAN MEDICAL TECHNOLOGY CO LTD
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Patent Information

Application Number
CN202422260401.2
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-09-13
Publication Date
2025-08-22
Estimated Expiration
2034-09-13

AI Technical Summary

Technical Problem

The existing bile-pancreatic pressure measurement technology has complex operation, low accuracy and high postoperative complications. The solid-state pressure measurement catheter is difficult to enter the common bile duct or pancreatic duct through the nipple, and the outer diameter is thin and easy to bend and break. It is not seen in the bile-pancreatic system when used in urology.

Method used

A three-channel bile-pancreatic pressure measurement catheter is designed, including multiple catheter segments and channels, with guide wire channels, injection channels and data transmission line channels, with an outer diameter of 5 to 7Fr, and a conical head end. It can guide the pressure measurement through the duodenal papillary sphincter, common bile duct and pancreatic duct, and can inject contrast agent or saline.

Benefits of technology

It realizes accurate pressure measurement in the bile-pancreatic system, simplifies operation and reduces the risk of complications, and the catheter is easy to insert and can measure the maximum tolerated pressure, which is suitable for direct pressure measurement of the bile-pancreatic system.

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Abstract

The utility model provides a three-channel biliopancreatic pressure measuring catheter. The three-channel biliopancreatic pressure measuring catheter comprises a first catheter section, a second catheter section, a third catheter section and a fourth catheter section. A first guide wire channel and a first injection channel are arranged in the first catheter section; a second guide wire channel, a second injection channel and a first data transmission line channel are arranged in the second catheter section; the front end of the second conduit section wraps a metal tube; a pressure sensor is arranged in a groove of the metal tube; a third guide wire channel and a third injection channel are arranged in the third catheter section; a second data transmission line channel is arranged in the fourth conduit section; a guide wire joint and an injection joint are arranged at the tail of the third catheter section; the tail of the fourth catheter section is provided with a pressure sensor interface. The pressure measuring device can be placed into duodenal papilla sphincter, common bile duct and pancreatic duct through a duodenoscope and a gastroscope forceps channel under the guide of a guide wire to measure the pressure in the duodenal papilla sphincter, the common bile duct and the pancreatic duct, contrast agents or saline water can be injected to adjust the pressure of the common bile duct or the main pancreatic duct while the pressure is measured, and the maximum tolerance pressure is measured.
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Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a three-channel bile and pancreatic pressure measuring catheter. Background Art

[0002] The bile duct is a closed lumen system composed of the liver, bile ducts, gallbladder, and sphincter of Oddi (SO). The rhythmic contractions of the SO, in coordination with the gallbladder, effectively control bile storage, concentration, and emptying, and prevent duodenal reflux. Changes in bile duct pressure reflect bile duct dynamics, and measuring bile duct pressure can be used to infer bile duct motility, particularly sphincter of Oddi dysfunction (SOD). In 1887, Oddi discovered the terminal sphincter of the common bile duct, performed the first manometric observations, and pioneered the study of biliary fluid dynamics. In 1974, Vondrasek et al. first used a microtransducer to assess common bile duct pressure and the pressure gradient from the common bile duct to the duodenum. In 1975, Nebel reported measuring bile duct pressure using an infusion catheter. In 1977, Arndorfer et al. improved the infusion system, replacing the water infusion method with low-compliance gas pressure capillary infusion. Professor Zou Shengquan of my country discovered in his early experiments studying biliary fluid mechanics and the causes of gallstones that there is a continuous hydrostatic pressure gradient in the bile duct, with the hepatobiliary duct pressure being 40.18±6.08kPa, the common bile duct pressure being 33.76±5.85kPa, the gallbladder pressure being 26.95±9.34kPa, and the pressure difference between the intrahepatic bile duct and the gallbladder being 13.23kPa.

[0003] Currently, bile and pancreatic pressure measurement primarily utilizes water perfusion. A pressure-measuring catheter with a side hole is inserted through a duodenoscope. Water flows out of the side hole at a constant, low rate (0.15–0.40 mL / min) through the water perfusion system. The resistance that the water must overcome during overflow is the local pressure. This pressure is transmitted through the water column to an external pressure transducer, where it is converted into an electrical signal. After processing by a recorder and a computer, the signal is graphically and numerically generated. Depending on the catheter type, pressure measurement can be categorized as: water-perfusion catheters, aspirable liquid-perfusion catheters, and cuff-type pressure-measuring catheters. Because water-perfusion pressure measurement measures indirect pressure, it has low accuracy, is complex to perform, and has a high incidence of postoperative complications. Consequently, it is rarely used in hospitals in China and has been a slow development.

[0004] Microsensor pressure measurement is a new direct pressure measurement method that has emerged in recent years abroad. It does not require a water perfusion system, is simpler to operate, and provides more accurate measurement data. This method uses a solid-state pressure measuring catheter, which is mainly used in urology to measure renal pelvic pressure during cystoscopy or percutaneous nephrolithotomy. Currently, it is mainly used in urology, and there are no solid-state pressure measuring catheters for the biliary and pancreatic systems. Because the outer diameter of the solid-state pressure measuring catheter is generally 4Fr or 5Fr, it is in the shape of a wire with a thin outer diameter and soft tube wall. The pressure measuring catheter is easily bent and folded when passing through the duodenoscope channel, and may even cause the data cable to break. In addition, it is difficult for the pressure measuring catheter to pass through the papilla into the common bile duct or pancreatic duct. Utility Model Content

[0005] In response to the above technical problems, a three-channel bile and pancreatic pressure measuring catheter is provided. The technical means adopted by the present invention are as follows:

[0006] A three-channel biliary and pancreatic pressure measurement catheter comprises: a first catheter segment, a second catheter segment, a third catheter segment, and a fourth catheter segment, wherein the tail end of the first catheter segment is connected to the head end of the second catheter segment, and the head ends of the third and fourth catheter segments are both connected to the tail end of the second catheter segment;

[0007] A first guidewire channel and a first injection channel are provided inside the first catheter section; the first catheter section is in a tapered structure;

[0008] A second guidewire channel, a second injection channel, and a first data transmission line channel are provided inside the second catheter segment. The second guidewire channel is connected to the first guidewire channel, and the second injection channel is connected to the first injection channel. The front end of the second catheter segment is wrapped with a metal tube. The metal tube is provided with a slot, and a pressure sensor is provided in the slot.

[0009] A third guidewire channel and a third injection channel are provided inside the third catheter section, wherein the third guidewire channel is connected to the second guidewire channel, and the third injection channel is connected to the second injection channel;

[0010] A second data transmission line channel is provided inside the fourth conduit section, and the second data transmission line channel is connected to the first data transmission line channel;

[0011] The tail of the third catheter section is provided with a guidewire connector and an injection connector, a guidewire is inserted through the guidewire connector, and contrast agent or saline is injected through the injection connector;

[0012] A pressure sensor interface is provided at the tail of the fourth conduit section, and the pressure sensor interface is used to connect to a pressure detector.

[0013] Furthermore, the first conduit section is a double-channel tube.

[0014] Furthermore, the second conduit section is a three-channel tube.

[0015] Furthermore, the third conduit section is a double-channel tube.

[0016] Furthermore, the fourth conduit section is a single-channel tube.

[0017] Furthermore, the pressure sensor is fixed in the metal tube slot outside the catheter wall by means of soft glue, and there is a gap between the pressure sensor and the soft glue for communicating with air.

[0018] Furthermore, the third conduit segment and the fourth conduit segment are arranged in a Y shape.

[0019] Compared with the prior art, the utility model has the following advantages:

[0020] 1. The tube section of the present invention is provided with a guidewire channel, which can be inserted into the duodenal sphincter, common bile duct and pancreatic duct under the guidance of a conventional 0.035-inch guidewire to measure the pressure in the duodenal sphincter, common bile duct and pancreatic duct.

[0021] 2. The outer diameter of the present invention is 5 to 7 Fr, and the tip is tapered, making it easier to pass through the duodenal papillary sphincter to enter the common bile duct and pancreatic duct to measure pressure.

[0022] 3. The utility model can inject contrast agent or saline into the common bile duct or pancreatic duct while measuring the pressure, so as to measure the maximum tolerable pressure of the common bile duct and pancreatic duct.

[0023] Based on the above reasons, the present invention can be widely promoted in the fields of medical treatment and the like. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] 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 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 labor.

[0025] Figure 1 It is a structural diagram of the present utility model.

[0026] Figure 2 This is a schematic diagram of inserting a guide wire according to the present invention.

[0027] In the figure: 1. First catheter section; 11. First guidewire channel; 12. First injection channel; 2. Second catheter section; 21. Second guidewire channel; 22. Second injection channel; 23. First data transmission line channel; 24. Metal tube; 25. Pressure sensor; 3. Third catheter section; 31. Third guidewire channel; 32. Third injection channel; 33. Guidewire connector; 34. Injection connector; 4. Fourth catheter section; 41. Second data transmission line channel; 42. Pressure sensor interface; 5. Guidewire. DETAILED DESCRIPTION

[0028] To make the purpose, technical solutions, and advantages of the embodiments of the present invention more clear, 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 embodiments described are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0029] The utility model provides a three-channel bile and pancreatic pressure measuring catheter, which is divided into a first catheter section 1, a second catheter section 2, a third catheter section 3 and a fourth catheter section 4. The tail end of the first catheter section 1 is connected to the head end of the second catheter section 2.

[0030] The first catheter section 1 is a double-channel tube, which is provided with a first guidewire channel 11 and a first injection channel 12 .

[0031] The second catheter section 2 is a three-channel tube, which is equipped with a second guidewire channel 21, a second injection channel 22 and a first data transmission line channel 23 connected to the first catheter section. The first catheter section 1 has a conical structure, and the front end of the second catheter section 2 is wrapped with a metal tube 24. The metal tube 24 is provided with a groove, and a pressure sensor 25 (using an existing pressure sensor) is provided in the groove. The pressure sensor 25 is fixed in the groove of the metal tube 24 outside the catheter wall by soft glue, and there is a gap between the pressure sensor 25 and the soft glue for connecting to the air.

[0032] The third conduit segment 3 and the fourth conduit segment 4 are Y-shaped, and the head ends of the third conduit segment 3 and the fourth conduit segment 4 are connected to the tail end of the second conduit segment 2 .

[0033] The third catheter section 3 is a double-channel tube, which is provided with a third guidewire channel 31 and a third injection channel 32 .

[0034] The fourth conduit section 4 is a single-channel tube, in which a second data transmission line channel 41 is provided.

[0035] The first guidewire channel 11, the second guidewire channel 21 and the third guidewire channel 31 constitute a guidewire channel. The first injection channel 12, the second injection channel 22 and the third injection channel 32 constitute an injection channel. The first data transmission line channel 23 and the second data transmission line channel 41 constitute a data transmission line channel.

[0036] A guidewire connector 33 and an injection connector 34 are provided at the tail of the third catheter section 3 . The guidewire 5 can be inserted or locked through the guidewire connector 33 , and contrast agent or saline can be injected through the injection connector 34 .

[0037] A pressure sensor interface 42 is provided at the tail of the fourth conduit section 4 and is connected to a pressure detector.

[0038] The outer diameter of the catheter body is 5 to 7 Fr, the outer diameter of the head end opening is 4 Fr, the inner diameter of the guidewire channel is 1 mm, the inner diameter of the data transmission line channel is 0.5 mm, and the length is 3 to 4 m.

[0039] The utility model can be inserted into the duodenal sphincter, common bile duct and pancreatic duct through the duodenoscope and gastroscopic forceps under the guidance of a guide wire to measure the pressure in the duodenal sphincter, common bile duct and pancreatic duct. The metal ring can locate the depth of catheter insertion. While measuring the pressure, contrast agent or saline can be injected to adjust the pressure in the common bile duct or main pancreatic duct and measure the maximum tolerable pressure.

[0040] (1) 2 days before surgery, it is forbidden to use drugs that affect the bile duct and SO, such as scopolamine butylbromide and nitroglycerin, and fast for 12 hours before surgery.

[0041] (2) Oral lidocaine or dyclonine jelly is administered as an oropharyngeal mucosal anesthetic before the operation. The body position is the same as that of ERCP, with the patient lying on the left side, biting the mouth, and receiving oxygen through a nasal cannula.

[0042] (3) The examination is performed by a skilled physician. After the duodenoscope is passed through the digestive tract, the duodenoscope is straightened to locate the main duodenal papilla.

[0043] (4) A sphincterotomy or angiographic catheter with a guide wire is inserted into the common bile duct or main pancreatic duct. After a small amount of contrast agent is injected to confirm that it is the bile duct or main pancreatic duct, the guide wire is left in place and the sphincterotomy or angiographic catheter is withdrawn.

[0044] (5) Insert the manometry catheter under the guidance of a guidewire and zero the manometry catheter at the level of the bile duct.

[0045] (6) The pressure measuring catheter is inserted into the upper duodenum of the common bile duct, and the pressure in the common bile duct is recorded after the pressure curve stabilizes.

[0046] (7) Pull back the pressure measuring catheter, withdrawing it 1-2 mm at a 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 base pressure. At the same time, the high-amplitude wave based on the high-pressure zone can be recorded, based on which the amplitude, interval, and propagation direction of the peristaltic wave can be calculated.

[0047] (8) After contrast agent or saline is fully injected into the common bile duct or pancreatic duct through the injection connector, the pressure at which contrast agent or saline overflows from the duodenal papilla is the maximum tolerable pressure of the common bile duct or pancreatic duct.

[0048] (9) Continue to pull the pressure measuring catheter backward. When the pressure measuring catheter enters the duodenum, the pressure in the duodenum can be recorded, and the pressure measurement is completed.

[0049] (10) The SO pressure measurement can be repeated if necessary.

[0050] 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 above embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the above embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A three-channel bile and pancreatic pressure measuring catheter, characterized in that: include: a first conduit segment (1), a second conduit segment (2), a third conduit segment (3) and a fourth conduit segment (4), wherein the tail end of the first conduit segment (1) is connected to the head end of the second conduit segment (2), and the head ends of the third conduit segment (3) and the fourth conduit segment (4) are both connected to the tail end of the second conduit segment (2); A first guidewire channel (11) and a first injection channel (12) are provided inside the first catheter section (1); the first catheter section (1) has a conical structure; A second guidewire channel (21), a second injection channel (22) and a first data transmission line channel (23) are provided inside the second catheter section (2); the second guidewire channel (21) is connected to the first guidewire channel (11), and the second injection channel (22) is connected to the first injection channel (12); the front end of the second catheter section (2) is wrapped with a metal tube (24); the metal tube (24) is provided with a slot, and a pressure sensor (25) is provided in the slot; A third guidewire channel (31) and a third injection channel (32) are provided inside the third catheter section (3), wherein the third guidewire channel (31) is connected to the second guidewire channel (21), and the third injection channel (32) is connected to the second injection channel (22); A second data transmission line channel (41) is provided inside the fourth conduit section (4), and the second data transmission line channel (41) is connected to the first data transmission line channel (23); The tail of the third catheter section (3) is provided with a guide wire connector (33) and an injection connector (34); a guide wire (5) is inserted through the guide wire connector (33); and contrast agent or saline is injected through the injection connector (34); A pressure sensor interface (42) is provided at the tail of the fourth conduit section (4), and the pressure sensor interface (42) is used to connect to a pressure detector.

2. The three-channel biliary and pancreatic pressure measurement catheter according to claim 1, characterized in that: The first conduit section (1) is a double-channel tube.

3. The three-channel biliary and pancreatic pressure measurement catheter according to claim 1, characterized in that: The second conduit section (2) is a three-channel tube.

4. The three-channel biliary and pancreatic pressure measurement catheter according to claim 1, characterized in that: The third conduit section (3) is a double-channel tube.

5. The three-channel biliary and pancreatic pressure measurement catheter according to claim 1, characterized in that: The fourth conduit section (4) is a single-channel tube.

6. The three-channel biliary and pancreatic pressure measurement catheter according to claim 1, characterized in that: The pressure sensor (25) is fixed in a groove of a metal tube (24) outside the catheter wall by means of soft glue, and a gap for communicating air is provided between the pressure sensor (25) and the soft glue.

7. The three-channel biliary and pancreatic pressure measurement catheter according to claim 1, characterized in that: The third conduit section (3) and the fourth conduit section (4) are arranged in a Y shape.