CN115040063A - Cholangiography catheter system and method of use - Google Patents

Abstract

The present application relates to a choledochography catheter system and a method of use, wherein the choledochography catheter system includes: a camera head, a connecting component, an insertion catheter, a handle and a steering rod connected in sequence; the camera head includes a camera housing and a The lens module at the front end of the camera housing, the rear end of the camera housing is connected with a steering wire, and the steering wire passes through the insertion conduit and the handle in sequence and is connected with the steering rod. It can change the angle of the camera and perform multi-angle and multi-directional fine diagnosis of the lesion, effectively avoiding the operator and the patient operator from receiving high-dose X-ray radiation.

Description

Cholangiography catheter system and method of use

technical field

The present application relates to the technical field of medical devices, and in particular, to a cholangiography catheter system and a method of using the same.

Background technique

Endoscopic retrograde cholangiopancreatography (ERCP) is the most important diagnosis and treatment technique for biliary and pancreatic diseases, and is widely used in the diagnosis and treatment of bile duct stones, bile duct tumors, pancreatic duct stones, pancreatitis and other diseases. However, this technology can only be realized with the help of X-ray fluoroscopy, which cannot be performed under direct vision like gastroenteroscopic surgery, and the operator and patient must passively receive large doses of X-ray radiation.

In addition, most of the existing imaging systems for the internal cavity of the organ can only adjust the camera in the front and rear telescopic positions, and cannot rotate in the cavity of the organ, resulting in limited photographic field of view and inability to effectively diagnose the lesion.

SUMMARY OF THE INVENTION

The purpose of the present application is to provide a cholangiophotographic catheter system and a method of use, which can directly observe the mucosal surface structure in the pancreaticobiliary duct and the size and position of stones/tumors by electronic photography, and can change the angle of the camera to perform imaging on the lesions. The multi-angle and multi-directional fine diagnosis can effectively avoid the operator and the patient operator from receiving high-dose X-ray radiation.

In order to achieve the above object, in a first aspect, the present invention provides a cholangiophotographic catheter system, comprising: a camera head, a connecting assembly, an insertion catheter, a handle and a steering rod connected in sequence; the camera head includes a camera housing and a The lens module at the front end of the camera housing, the rear end of the camera housing is connected with a steering wire, and the steering wire passes through the insertion conduit and the handle in sequence and is connected with the steering rod.

In an optional embodiment, the steering wire is connected to an edge on the rear end surface of the camera housing, and the connecting assembly includes a A spring that elastically returns the camera housing after adjustment.

In an optional embodiment, the lens module is connected with a transmission cable, the connection assembly includes a connection conduit for the transmission cable to pass through, and a transmission cable cavity is provided inside the insertion conduit, The transmission cable passes through the camera housing, the connection conduit, and the transmission cable lumen in sequence and protrudes laterally from the front end of the handle.

In an optional embodiment, the insertion catheter is provided with a steering wire cavity, the handle is provided with a steering wire channel, and the steering wire can be pulled through the steering wire cavity. and the steering wire channel, and is connected with the front end of the steering rod.

In an optional implementation manner, a wire loop for passing a guide wire is provided on the side wall of the camera housing, a guide wire lumen for passing a guide wire is provided inside the insertion catheter, and the The side wall of the handle is provided with a guide wire lead-out tube for the guide wire to pass through. Tube sticks out.

In an optional embodiment, a water injection and air injection cavity is provided inside the insertion catheter, a water injection and air injection channel communicated with the water injection and air injection cavity is provided inside the handle, and a side wall of the handle is provided with a water injection and air injection channel. There is a water injection pipe.

In an optional embodiment, the front end of the insertion catheter includes a chamfered surface, and the steering wire lumen, the guide wire lumen and the water injection and air injection lumen respectively include ellipses located on the chamfered surface. Oblique cut.

In an optional embodiment, the lens module includes a lens, an image sensor and a PCBA board, a plurality of LED lamp beads are evenly distributed in the circumferential direction of the lens, and the lens module and the LED lamp beads are respectively connected to the Transmission cable electrical connection;

The transmission cable is connected to a host, an image processor is arranged inside the host, and a high-definition video display is connected to the host.

In an optional embodiment, the diameter of the camera housing is less than or equal to 2.3 mm, the diameter of the transmission cable is less than or equal to 0.6 mm, and the diameter of the insertion conduit is less than or equal to 2.8 mm.

In a second aspect, the present invention provides a method for using a cholangiography catheter system, comprising the following steps:

Indwelling guide wire for cholangiopancreatography;

Insert the camera, connecting components and inserting catheter into the target bile duct through the threading of the guide wire;

Rotate and pull the steering rod to change the angle of the camera to diagnose the lesion.

The lens module set at the front end of the camera housing can directly diagnose the lesions in the pancreaticobiliary duct, and the mucosal surface structure in the pancreaticobiliary duct and the size and position of the stone/tumor can be directly observed by means of electronic photography. Live images improve diagnostic accuracy and surgical precision.

Through direct diagnosis, X-ray fluoroscopy can be omitted or less used, and the operator and the patient operator can be prevented from receiving high-dose X-ray radiation.

Combined with the manipulation of the steering rod, the angle of the camera can be adjusted through the steering wire connected to the steering rod, so as to realize the variable angle and multi-directional fine diagnosis of the lesion.

Other features and advantages of the present application will be described in detail in the detailed description that follows.

Description of drawings

In order to illustrate the technical solutions of the embodiments of the present application more clearly, the following drawings will briefly introduce the drawings that need to be used in the embodiments. It should be understood that the following drawings only show some embodiments of the present application, and therefore do not It should be regarded as a limitation of the scope, and for those of ordinary skill in the art, other related drawings can also be obtained according to these drawings without any creative effort.

1 is a schematic diagram of the overall structure of the cholangiography catheter system in the application;

2 is a schematic structural diagram of a camera in the application;

3 is a schematic structural diagram of a connection assembly in the application;

4 is a schematic cross-sectional structure diagram of a catheter inserted in the application;

5 is a schematic structural diagram of a handle and a steering rod in the application;

Fig. 6 is the working schematic diagram of the camera in the process of orientation adjustment in the application;

FIG. 7 is a schematic structural diagram of the connection between the cholangiography catheter system and external equipment in the present application.

icon:

1-camera; 11-lens module; 12-LED lamp beads; 13-camera housing; 14-wire loop; 15-transmission cable;

2-connection assembly; 21-connection conduit; 22-spring;

3-insertion catheter; 31-transmission cable lumen; 32-guide wire lumen; 33-water injection and air injection lumen; 34-steering wire lumen;

4-handle; 41-transmission cable outlet; 42-water injection pipe; 43-guide wire lead-out pipe; 44-direction wire outlet;

5-direction component; 51-direction wire; 52-direction rod;

6-host;

7- HD video monitor.

Detailed ways

In order to make the purposes, technical solutions and advantages of the embodiments of the present application more clear, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are some, but not all, embodiments of the present application. The components of the embodiments of the present application generally described and illustrated in the drawings herein may be arranged and designed in a variety of different configurations.

In the description of this application, it should be noted that the orientation or positional relationship indicated by the terms "inside", "outside", etc. is based on the orientation or positional relationship shown in the accompanying drawings, or is usually placed when the product of the application is used. The orientation or positional relationship is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the indicated device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the present application. Furthermore, the terms "first", "second", etc. are only used to differentiate the description and should not be construed to indicate or imply relative importance.

In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "arrangement" and "connection" should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection, or Connected integrally; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the internal communication of two elements. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood in specific situations.

The bile duct photography catheter system in the present application is mainly used to directly observe the intraluminal structure of the bile duct and the location of mucosal lesions, especially for early tumors and minor lesions, which can improve the accuracy of bile duct disease diagnosis.

Referring to FIG. 1 , and in conjunction with FIGS. 2 to 7 , the cholangiography catheter system in the present invention mainly includes a camera head 1 , a connecting assembly 2 , an insertion catheter 3 , a handle 4 and a direction-adjusting assembly 5 , which are connected in sequence.

The camera 1 is mainly used to collect the image information of the internal cavity of the biliary tract, including the camera housing 13 and the lens module 11 arranged at the front end of the camera housing 13 . The steering rod 52 makes the steering wire 51 pull the camera housing 13, which can change the angular direction of the camera housing 13, so that the lens module 11 located at the front end of the camera housing 13 has a wider and wider field of view, so that it can pass through the camera housing 13. Electronic imaging means for refined diagnosis.

The connecting assembly 2 is disposed between the camera head 1 and the insertion catheter 3 . The connecting assembly 2 itself can be elastically deformed and has certain bending flexibility.

The steering wire 51 does not have a connection relationship with the connecting assembly 2, and is arranged on the outside of the connecting assembly 2 to avoid interference between the two. When the steering wire 51 pulls the camera housing 13, the connecting assembly 2 accompanies the camera housing 13 The orientation changes and bends. At the same time, since the camera head 1 only needs to change the angular direction at the front end of the system, the insertion catheter 3 does not need to change in shape and angle during the operation, and only needs to be able to pass the steering wire 51 . The steering wire 51 passes through the insertion catheter 3 and the handle 4 in turn and is connected to the steering rod 52. By applying a pulling force to the steering rod 52, the steering wire 51 drives the camera 1 at the front end to generate an angle difference. Adjustment to achieve a variable angle and multi-directional fine diagnosis of the lesion.

In one specific embodiment, the steering wire 51 is connected to the edge of the rear end surface of the camera housing 13, which can effectively apply the pulling force to the edge of the camera housing 13, so as to facilitate the pulling of the camera 1 to a wider range angle change.

The connecting assembly 2 includes a spring 22 connected between the camera housing 13 and the insertion catheter 3 , wherein the spring 22 can make the camera housing 13 elastically return after being adjusted. When the direction is not adjusted, the spring 22 maintains a straight state; when the angle of the camera 1 is adjusted, since it is no longer bound by the direction-adjusting wire 51, the spring 22 can be elastically reset to drive the camera 1 back to positive, realizing the angle adjustment of the camera 1 At the same time, the flexibility of use is enhanced.

The lens module 11 is connected with a transmission cable 15 for information transmission and power supply. The connection assembly 2 includes a connection conduit 21 for the transmission cable 15 to pass through. The connection conduit 21 is arranged inside the spring 22 . A transmission cable lumen 31 is provided inside the insertion catheter 3, and the transmission cable 15 passes through the camera housing 13, the connecting catheter 21 and the transmission cable lumen 31 in sequence and protrudes laterally from the front end of the handle 4. During use, The handle 4 is located outside the body, and the transmission cable 15 can be connected to an external device after extending from the handle 4, so as to transmit the image information obtained by the camera 1 to the outside.

The insertion catheter 3 is provided with a steering wire cavity 34, and the handle 4 is provided with a steering wire 51 channel. The direction-adjusting wire 51 is channeled and connected to the front end of the direction-adjusting rod 52 , and the camera head 1 can be adjusted to adjust the angle by pulling the direction-adjusting wire 51 by the direction-adjusting rod 52 .

The cholangiophotographic catheter system in the present invention is mainly guided by a guide wire reserved for cholangiopancreatography and enters the bile duct. A wire loop 14 for guiding the guide wire is provided on the side wall of the camera housing 13. The insertion catheter 3 is provided with a guide wire lumen 32 for the guide wire to pass through, and a guide wire lead-out tube 43 for the guide wire to pass through is provided on the side wall of the handle 4 . When placing the choledochography catheter system, the tail end of the guide wire exposed outside the body is made to pass through the wire loop 14 on the camera housing 13 in reverse order, the guide wire lumen 32 inserted into the catheter 3 and the handle 4, and then lead out by the guide wire. Tube 43 is extended and the catheter system is then guided into the bile duct by the guide wire.

In order to keep the vision clear, in the present invention, the bile duct is flushed by water injection and air injection, the water injection and air injection cavity 33 is arranged inside the insertion catheter 3, and the water injection and air injection channel 33 communicated with the water injection and air injection cavity 33 is arranged inside the handle 4. 4 is provided with a water injection and air injection pipe 42 on the side wall. During the cleaning operation, the injected water or gas passes through the water injection and air injection pipes 42 , the water injection and air injection channels, and the water injection and air injection channels 33 in sequence from the outside to the inside, and is sprayed through the water injection and air injection holes at the front end of the water injection and air injection channels 33 . into the bile duct, so as to achieve the technical purpose of flushing the bile duct.

In order to improve the smoothness of the insertion catheter 3 extending forward and reduce the push resistance, the front end of the insertion catheter 3 includes a chamfered surface. The cross section on the oblique cut surface is an oval oblique cut. Specifically, the oblique cut includes a direction-adjusting wire hole, a guide wire hole, and a water injection and air injection hole corresponding to the above-mentioned different cavities respectively.

In another specific embodiment, the lens module 11 includes a lens, an image sensor and a PCBA board, and a plurality of LED lamp beads 12 are evenly distributed in the circumferential direction of the lens, which can provide a certain brightness for the position that can be detected by the lens. The sensor is used to obtain the image information collected by the lens. The lens module 11 and the LED lamp beads 12 are electrically connected to the transmission cable 15 respectively, which can provide power guarantee and ensure reliable transmission of transmission information.

The transmission cable 15 is connected to the host 6 after extending laterally from the front end of the handle 4. The host 6 is internally provided with an image processor, and the host 6 is connected with a high-definition video display 7, which can display the collected images in the internal cavity of the bile duct in real time. .

The cholangiography catheter system in the present invention is an ultra-thin cholangiography catheter system, which will be described below with specific different components.

The camera 1 includes a lens module 11, LED lamp beads 12, a camera housing 13, a wire loop 14 and a transmission cable 15. The lens module 11 includes a lens, an image sensor and a PCBA board, and its pixels are greater than or equal to 160,000 pixels, and its The viewing angle is greater than or equal to 120°, and the transmission speed is 30fps; the LED lamp beads 12 include 2-4 LED lamp beads 12, which are symmetrically arranged around the lens and are electrically connected to each other; the lens module 11 and the LED lamp beads 12 are electrically connected to the transmission cable 15. Connected and packaged in a camera housing 13; the camera housing 13 is made of metal material, the length is ≤6mm, the outer diameter is ≤2.3mm, and the outer wall is provided with a wire loop 14 made of medical nylon wire for passing the guide wire , the wire loop 14 is a thin wire loop 14 for threading the guide wire, the inner diameter is ≥ 1mm; the transmission cable 15 is a six-core shielded wire, the cable diameter is ≤ 0.6mm, and the length is ≤ 4000mm, including two LED power supplies Line and four module power supply and signal transmission lines, the surface of the transmission cable 15 has an insulating layer and a waterproof layer. 21 and the transmission cable lumen 31 inserted into the conduit 3 pass through the cable outlet on the side of the front end of the handle 4 and connect to the host 6 through a plug.

The connecting conduit 21 of the connecting assembly 2 includes a Teflon conduit with an outer diameter of about 1.2 mm, an inner diameter of ≥ 8 mm, and a length of about 10 mm. The outer wall of the tube is wound with a thin spring 22 steel wire to form a spring 22, and the head end of the connecting conduit 21 is connected to the camera 1. In the sealing connection, the tail end of the connecting catheter 21 is sealed and connected with the transmission cable lumen 31 inserted into the catheter 3, and the transmission cable 15 is passed through the lumen.

The insertion catheter 3 is a four-lumen catheter made of medical Teflon material. The total length of the catheter is about 2000mm, and the outer diameter is ≤2.8mm. The cavity 32, the water injection and air injection cavity 33 and the steering wire cavity 34, the inner diameter of the transmission cable cavity 31 is ≤0.8mm, the inner diameter of the guide wire cavity 32 is ≤1.4mm, the inner diameter of the water injection and air injection cavity 33 is ≤0.7mm, The inner diameter of the steered wire channel 34 is less than or equal to 0.5mm. The head end of the insertion catheter 3 has four lumen openings, wherein the transmission cable lumen 31 is sealed with the tail end of the connecting catheter 21, the guide wire lumen 32, the water injection and air injection lumen 33 and the openings for the wire lumen 34 Open and beveled surface treatment can facilitate the insertion operation of the guide wire and the steering wire 51 , and the tail end of the inserted catheter 3 is sealed and connected to the head end of the handle 4 .

The handle 4 is an integral functional structural part pressed from medical plastics, and is provided with four cavities. The outlet or branch pipe, namely: the transmission cable outlet 41 , the guide wire lead-out pipe 43 , the water injection and air injection pipe 42 and the directional wire outlet 44 .

The direction-adjusting assembly 5 includes a direction-adjusting wire 51 and a direction-adjusting rod 52 connected with the direction-adjusting wire 51. The direction-adjusting wire 51 is a stainless steel wire with a diameter less than or equal to 0.3mm, and is inserted into the direction-adjusting wire cavity of the catheter 3. 34. Pass through the head end of the insertion catheter 3, and weld it under the camera housing 13 on the camera head 1. The tail passes through the outlet of the tail end of the handle 4 and is fixedly connected with the steering rod 52. The steering rod 52 is made of medical plastic injection molding .

Pulling the direction adjusting rod 52 can make the camera housing 13 bend downward. After the pulling is removed, the elasticity of the spring 22 in the connecting assembly 2 makes the camera case 13 automatically reset. Rotating the direction adjusting rod 52 can drive the direction adjusting wire 51 and the camera body The housing 13 rotates 0-360° synchronously, so as to realize the function of multi-directional and multi-angle direction adjustment. The guide wire is inserted through the guide wire lead-out tube 43 of the handle 4, passed through the guide wire lumen 32 of the insertion catheter 3, and passed through the head end. The outlet is pierced, and the overall photography catheter system is inserted into the corresponding lumen in the bile duct along the guide wire. If necessary, the guide wire can also be passed through the wire loop 14 to make the camera housing 13 and the guide wire as a whole, which is convenient for the camera housing 13 to follow the guide wire. The silk accurately enters the target lumen in the biliary tract.

The host 6 connected by the transmission cable 15 is internally provided with a dedicated image processor for endoscopes and related software programs, and the host 6 is connected with the high-definition video display 7, and the image information collected by the transmission cable 15 is processed by the special software program in the high-definition. The video display 7 is shown in real time.

The present invention also provides a method for using the above-mentioned bile duct photography catheter system. Taking the operation process as an example, the duodenoscope is inserted into the duodenal papilla, and ERCP intubation imaging is routinely performed. After entering the target bile duct, indwelling guide wire. Insert the tail end of the guide wire into the wire loop 14 and the guide wire lumen 32 retrogradely and pass it out from the guide wire outlet tube 43, insert the choledochography catheter system into the target bile duct along the guide wire, and inject water through the water injection and air injection lumen 33 to perform the bile duct. Flush to ensure a clear view of the biliary tract. Turn on the camera switch, fully observe the target bile duct, and take pictures. According to needs, the direction of the guide wire is adjusted or the direction rod 52 is rotated or pulled to change the angle of the camera 1, so as to perform a multi-angle and multi-directional fine diagnosis of the lesion. When necessary, the guide wire was withdrawn, and a special biopsy forceps was inserted through the guide wire hole for mucosal tissue biopsy.

The photographic catheter system in the present invention can directly observe the intraluminal structure of the bile duct and mucosal lesions, thereby improving the accuracy of the diagnosis of bile duct diseases, especially early tumors and minor lesions.

In addition, through the form of direct observation, the dose of X-ray radiation passively received by the operator and the patient is reduced; the diameter of the photographic catheter is thinner and more flexible, and under the guidance of the guide wire, thinner cholangiopancreatic duct lesions can be observed, and even It can enter the gallbladder through the cystic duct for inspection. The camera head 1 at the tip of the photographic catheter can be bent to one side by pulling the steering rod 52. After relaxing the pulling, the spring 22 of the connecting assembly 2 can automatically reset it; rotating the steering rod 52, the camera 1 can be rotated to conduct multi-angle diagnosis of the lesion; water can be injected into the trachea 42 to flush the bile duct to keep the field of vision clear, and a contrast agent can be injected when necessary to perform contrast examination under X-ray; if necessary, the diameter ≤ Biopsy was taken with a 1.2mm biliary special biopsy forceps.

The choledochography catheter in the present invention is disposable, has no risk of intraoperative cross-infection, is easy to operate, and has controllable cost, and can be popularized and applied in vast grass-roots hospitals.

It should be pointed out that in addition to being applied to the bile duct, the photographic catheter in the present invention can also be used for the inspection of other cavities such as the pancreatic duct, cystic duct, gallbladder cavity and appendix. Changing to a three-lumen catheter can also achieve the technical purpose of guiding the wire and cleaning the lumen, which will not be repeated here.

It should be noted that the features in the embodiments of the present application may be combined with each other without conflict.

The above descriptions are only preferred embodiments of the present application, and are not intended to limit the present application. For those skilled in the art, the present application may have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of this application shall be included within the protection scope of this application.

Claims (10)

1. A biliary tract photography catheter system, comprising: the camera, the connecting component, the inserting conduit, the handle and the direction adjusting rod are connected in sequence; the camera is in including making a video recording the casing and setting the camera lens module of casing front end makes a video recording, the rear end of casing of making a video recording is connected with the accent and to the steel wire, transfer to the steel wire and pass in proper order insert the pipe reach the handle and with transfer to the pole and connect mutually.

2. The biliary tract photography catheter system according to claim 1, wherein the direction-adjusting wire is connected to an edge on a rear end face of the camera housing, and the connection assembly comprises a spring which is arranged between the camera housing and the insertion catheter and can elastically return the camera housing after being adjusted backwards.

3. The biliary tract photography catheter system according to claim 1, wherein the lens module is connected to a transmission cable, the connection assembly includes a connection catheter for the transmission cable to pass through, a transmission cable channel is disposed inside the insertion catheter, and the transmission cable sequentially passes through the camera housing, the connection catheter and the transmission cable channel and extends out of the front end of the handle.

4. The biliary tract photography catheter system according to claim 3, wherein a direction-adjusting wire channel is provided inside the insertion catheter, a direction-adjusting wire channel is provided inside the handle, and the direction-adjusting wire is inserted through the direction-adjusting wire channel and the direction-adjusting wire channel in a drawable manner and connected to a front end of the direction-adjusting rod.

5. The biliary tract photography catheter system according to claim 4, wherein a wire ring for passing a guide wire is disposed on a side wall of the imaging housing, a guide wire lumen for passing the guide wire is disposed inside the insertion catheter, a guide wire exit tube for passing the guide wire is disposed on a side wall of the handle, and a tail end of the guide wire passes through the wire ring, the guide wire lumen and the handle in sequence and extends from the guide wire exit tube.

6. The biliary tract photography catheter system according to claim 5, wherein the insertion catheter is internally provided with a water injection and air injection channel, the handle is internally provided with a water injection and air injection channel communicated with the water injection and air injection channel, and a water injection and air injection pipe is arranged on a side wall of the handle.

7. The biliary tract photographic catheter system according to claim 6, wherein the insertion catheter comprises a beveled cut at a front end thereof, and the direction-adjusting wire channel, the guide wire channel, and the water-injection and gas-injection channel each comprise an oval beveled cut on the beveled cut.

8. The biliary tract photography catheter system according to any one of claims 3-7, wherein the lens module comprises a lens, an image sensor and a PCBA board, a plurality of LED lamp beads are uniformly distributed on the circumference of the lens, and the lens module and the LED lamp beads are respectively electrically connected with the transmission cable;

the transmission cable is connected with a host, an image processor is arranged in the host, and the host is connected with a high-definition video display.

9. The biliary tract photography catheter system according to any one of claims 3-7, wherein the camera housing has a diameter of 2.3mm or less, the transmission cable has a diameter of 0.6mm or less, and the insertion catheter has a diameter of 2.8mm or less.

10. A method of using a biliary tract photography catheter system, comprising the steps of:

carrying out pancreaticocholangiography to keep the guide wire;

inserting the camera, the connecting assembly and the insertion catheter into the target bile duct through threading of the guide wire;

the rotating drawing direction adjusting rod can change the angle of the camera to examine the focus.

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