Novel choledochoscope guiding device used in laparoscopic surgery and using method

Abstract

The invention discloses a novel choledochoscope guiding device used in laparoscopic surgery and a using method, and relates to the technical field of medical auxiliary equipment. Three independent channels are arranged in the rubber hose, the tail end of the water injection channel is connected with the expandable balloon, the developing ring is connected to the tail end of the rubber hose, pressure is formed between the balloon and the inner wall of the bile duct after the balloon is expanded, and stable anchoring is achieved; the developing ring is formed by a platinum-iridium alloy wire and rubber in a common mode, and has an X-ray and ultrasonic dual-mode developing function; a three-layer rubber first air leakage prevention valve is arranged in the trocar buckle cap, and the leakage rate is reduced. The use method comprises the following steps: placing a hose into a target bile duct during an operation, anchoring the balloon, then pushing the choledochoscope, synchronously injecting water to control liquid flow, performing targeted radiography and development, and performing real-time debridement through the drainage channel.

Description

Technical Field

[0001] The present invention relates to the technical field of medical auxiliary devices, and specifically to a choledochoscope guiding device and a using method thereof used in a new type of laparoscopic surgery. Background Art

[0002] In laparoscopic choledochal surgery, as a core instrument, the choledochoscope needs to enter the patient's body through the trocar channel to explore the bile duct system and complete operations such as stone removal. At the current stage, laparoscopic surgery relies on the flexibility of the choledochoscope itself to advance in complex bile duct branches. However, since the intrahepatic bile ducts are in a multi-level tree-like branch structure, and the choledochoscope body is soft, it is difficult to effectively transmit the advancing force during external operation, resulting in the mirror body being easily bent and stuck at the bile duct bifurcation, and it is difficult to reach the target area directionally. In addition, problems such as the flow of intraoperative irrigation fluid, stone displacement, and contrast agent diffusion further increase the surgical difficulty.

[0003] In the prior art, surgeons often face two core problems: First, the choledochoscope lacks a fixed fulcrum in the intrahepatic bile duct branches, and it is easy to deviate from the target bile duct when repeatedly entering and exiting. Especially when dealing with stones in bile ducts with branches above the second level, the angle of the mirror body needs to be adjusted multiple times, prolonging the operation time and increasing the risk of tissue damage; Second, the flow of intraoperative irrigation fluid or contrast agent is likely to cause small stones to shift or even flush into non-target bile ducts, resulting in stone residue or secondary cholangitis.

[0004] In the current stage of laparoscopic surgery, the flexibility characteristic of the choledochoscope has instead become a defect: when the mirror body is advanced externally, the force cannot be effectively transmitted to the head end. When it is necessary to enter a specific branch of the intrahepatic bile duct reversely, the mirror body is easily bent ineffectively at the porta hepatis, resulting in the lens being unable to advance in the preset direction. In addition, relying solely on the direct vision of the choledochoscope has a visual blind area, and stones hidden at the corners or branches of the bile duct are easily missed. For the evaluation of distal common bile duct stenosis, it is necessary to repeatedly advance and retreat the mirror body to observe the flow direction of the contrast agent, with low operation efficiency and significant interference of the imaging effect by the liquid flow. These problems directly lead to fluctuations in the surgical success rate and an increase in the incidence of postoperative complications. Therefore, there is an urgent need for a choledochoscope guiding device used in a new type of laparoscopic surgery to solve the above problems. Summary of the Invention

[0005] The main purpose of the present invention is to provide a choledochoscope guiding device and a using method thereof used in a new type of laparoscopic surgery, which can effectively solve the problems in the background art.

[0006] To achieve the above object, the technical solution adopted by the present invention is as follows: A choledochoscope guiding device used in a new type of laparoscopic surgery. The upper end of the trocar is connected to the trocar snap cap through a snap fastener. The rubber hose passes through the trocar and the trocar snap cap. A rubber tube assembly is provided at the tail of the rubber hose. A first air leakage prevention valve is provided at the top of the trocar snap cap. A liquid discharge port is provided at the bottom of the rubber tube assembly. The inside of the liquid discharge port is communicated with a liquid discharge channel. A balloon hole is provided at the tail of the rubber tube assembly. A choledochoscope hole is provided at the tail of the rubber tube assembly. A contrast agent hole is provided at the tail of the rubber tube assembly. A balloon is provided at the head end of the rubber hose. A developing ring is provided at the top of the balloon. A second air leakage prevention valve is provided at the tail end of the choledochoscope hole;

[0007] An injection channel is provided inside the balloon hole. A balloon two-way seal valve is provided at the terminal of the injection channel. The other end of the injection channel is connected to the balloon;

[0008] A choledochoscope channel is provided inside the choledochoscope hole. A choledochoscope outlet is provided at the other end of the choledochoscope channel;

[0009] A contrast agent channel is provided inside the contrast agent hole. A contrast agent two-way seal valve is provided at the terminal of the contrast agent channel. The other end of the contrast agent channel is connected to the contrast agent outlet.

[0010] Furthermore, the rubber hose is made of rubber with a Shore hardness of 60A - 70A, and a spiral steel wire reinforcement layer is embedded in the pipe wall. The wire diameter is Φ0.1 ± 0.02 mm, the spiral angle is 30° ± 5°, and the pitch is 2.0 - 3.0 mm.

[0011] Furthermore, the rubber layer thickness of the first air leakage prevention valve is 0.8 - 1.2 mm, the Shore hardness is 40A - 50A, its sealing contact surface is a conical structure with an angle of 15° - 25°, and the surface roughness Ra of the conical surface ≤ 0.4 μm.

[0012] Furthermore, the inner diameter of the injection channel is 1.5 - 2.0 mm, the inner diameter of the contrast agent channel is 1.0 - 1.2 mm, and the ratio of the pipe wall thicknesses of the two channels is 1:1.2 - 1.5.

[0013] Furthermore, the outer diameter of the balloon in the contracted state is 3.0 - 3.5 mm, the expansion limit outer diameter is 8 - 10 mm, the wall thickness is 0.05 - 0.08 mm, and the axial elongation rate ≤ 5%.

[0014] The present invention also provides a method for using a choledochoscope guiding device used in a new type of laparoscopic surgery, including the following steps:

[0015] S1: Check and confirm the integrity of the device before surgery, ensure that all components are firmly connected and have good airtightness, and the choledochoscope can pass smoothly through the choledochoscope channel;

[0016] S2: Insert the trocar into the abdominal cavity through the abdominal wall incision during the operation, slowly advance the rubber hose to the entrance of the target bile duct, adjust the position and slowly enter the target area of the bile duct;

[0017] S3: After confirming the position, slowly inject normal saline through the balloon hole, and the balloon expands until it tightly fits the inner wall of the bile duct;

[0018] S4: After the balloon is stably fixed, gradually advance the choledochoscope through the choledochoscope channel, observe the inside of the bile duct in real time, and confirm the location of the lesion or stone;

[0019] S5: Inject contrast agent into the bile duct through the contrast agent channel to accurately visualize the lesion area;

[0020] S6: Activate the drainage channel during the operation, perform real-time negative pressure suction, and continuously clean the blood and tissue debris in the surgical field;

[0021] S7: After the operation is completed, gradually drain the normal saline in the balloon to make the balloon return to the contracted state, and slowly withdraw the device.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] 1. After the balloon of the present invention is filled in the target bile duct branch, the outer wall of the balloon forms a contact pressure of ≥0.5 N / cm with the inner wall of the bile duct, providing a stable axial support point for the choledochoscope. This design enables the operator to accurately control the advancing direction of the choledochoscope outside the body. Especially for the bile duct branches above the third level in the liver, the advancing efficiency of the endoscope body is improved, and the single stone extraction operation time is shortened. 2 2. Through the cooperation of the independent contrast agent channel and the balloon, the device realizes targeted imaging of the lesion area. When the balloon seals the target bile duct, the contrast agent fully fills the stenotic segment of the bile duct, improving the stone detection rate, and at the same time, it can clearly show whether there is stenosis in the sphincter of Oddi and whether its function is normal.

[0024] 3. The rigid channel structure of the guiding device reconstructs the transmission path of the external operating force. When the operator advances the choledochoscope, more than 70% of the axial thrust can be directly transmitted to the lens end through the channel wall. This improves the one-time positioning rate of the choledochoscope in complex branches. Especially for the bile duct bends with an angle ≥90°, the turning time of the endoscope body is reduced.

[0025] 4. The three-channel integrated design fundamentally solves the problem of air leakage caused by the alternating operation of traditional multi-instruments. The rubber laminated structure of the first air leakage prevention valve ensures the control of the air leakage pressure fluctuation range. At the same time, the negative pressure suction function of the drainage channel can clear the bleeding and tissue debris in the surgical area in real time.

[0026] 5. The accompanying drawings Description of the Drawings

[0027] Figure 1Schematic diagram of the overall structure of the present invention;

[0028] Figure 2 Schematic diagram of the rubber hose structure of the present invention;

[0029] Figure 3 Schematic diagram of the puncture snap cap of the present invention;

[0030] Figure 4 Enlarged view of part A of the present invention;

[0031] Figure 5 Enlarged view of part B of the present invention;

[0032] Figure 6 Schematic diagram of the internal structure of the rubber tube assembly of the present invention;

[0033] Figure 7 Enlarged view of part C of the present invention;

[0034] Figure 8 Enlarged view of part D of the present invention.

[0035] In the figure: 1. Puncture card; 2. Puncture snap cap; 3. Rubber tube assembly; 4. Rubber hose; 5. First anti-air leakage valve; 6. Drainage port; 601. Drainage channel; 7. Balloon hole; 701. Water injection channel; 702. Balloon two-way seal valve; 8. Choledochoscope hole; 801. Choledochoscope channel; 802. Choledochoscope outlet; 9. Contrast agent hole; 901. Contrast agent channel; 902. Contrast agent outlet; 903. Contrast agent two-way seal valve; 10. Balloon; 11. Imaging ring. Detailed implementation manners

[0036] Now, the subject matter described herein will be discussed with reference to exemplary embodiments. It should be understood that discussing these embodiments is only to enable those skilled in the art to better understand and thus implement the subject matter described herein, and is not a limitation on the scope of protection, applicability, or examples set forth in the claims. Changes can be made to the functions and arrangements of the elements discussed without departing from the scope of protection of the content of this specification. Each example can omit, substitute, or add various processes or components as needed. For example, the methods described can be performed in an order different from the described order, and each step can be added, omitted, or combined. Additionally, the features described relative to some examples can also be combined in other examples.

[0037] As used herein, the term "comprising" and variations thereof refer to open terms meaning "including but not limited to". The term "based on" means "at least partially based on". The term "one embodiment" and "an embodiment" mean "at least one embodiment". The term "another embodiment" means "at least one other embodiment". The terms "first", "second", etc. may refer to different or the same objects. Other definitions may be included below, whether explicit or implicit. Unless explicitly specified in the context, the definition of a term is consistent throughout the specification.

[0038] Embodiment 1

[0039] Please refer to Figure 1-8 , the present invention provides a technical solution:

[0040] A choledochoscope guiding device used in a new type of laparoscopic surgery. The upper end of the trocar 1 is connected to the trocar snap cap 2 through a snap connection. The rubber hose 4 passes through the trocar 1 and the trocar snap cap 2. The tail of the rubber hose 4 is provided with a rubber hose assembly 3. The top of the trocar snap cap 2 is provided with a first anti-air leakage valve 5. The bottom of the rubber hose assembly 3 is provided with a drainage port 6. The inside of the drainage port 6 is connected to a drainage channel 601. The tail of the rubber hose assembly 3 is provided with a balloon hole 7. The tail of the rubber hose assembly 3 is provided with a choledochoscope hole 8. The tail of the rubber hose assembly 3 is provided with a contrast agent hole 9. The head end of the rubber hose 4 is provided with a balloon 10. The top of the balloon 10 is provided with a developing ring 11. The tail end of the choledochoscope hole 8 is provided with a second anti-air leakage valve 12;

[0041] The inside of the balloon hole 7 is provided with a water injection channel 701. The terminal of the water injection channel 701 is provided with a balloon two-way seal valve 702. The other end of the water injection channel 701 is connected to the balloon 10;

[0042] The inside of the choledochoscope hole 8 is provided with a choledochoscope channel 801. The other end of the choledochoscope channel 801 is provided with a choledochoscope outlet 802;

[0043] The inside of the contrast agent hole 9 is provided with a contrast agent channel 901. The terminal of the contrast agent channel 901 is provided with a contrast agent two-way seal valve 903. The other end of the contrast agent channel 901 is connected to a contrast agent outlet 902.

[0044] The puncture card is the main part of this device. The upper end is fixedly connected to the puncture snap cap through a snap, forming a sealed structure. The puncture snap cap and the rubber tube assembly are connected by an M8×1.0 thread, with a screwing length of 8 - 10 mm and a fit clearance ≤ 0.05 mm, achieving a firm and airtight connection. The rubber hose passes through the puncture card and the puncture snap cap, and the tail end is connected to the rubber tube assembly to form an integrated multi-channel structure. The rubber hose is made of rubber with a Shore hardness of 60A - 70A, and a spiral steel wire is embedded inside to improve the rigidity of the tube body and the axial thrust conduction efficiency. The first anti-air leakage valve is provided at the top of the puncture snap cap, with a rubber layer thickness of 0.8 - 1.2 mm, a Shore hardness of 40A - 50A, and a conical sealing contact surface, so that the abdominal cavity gas will not leak. A drainage port is provided at the bottom of the rubber tube assembly, which is internally connected to the drainage channel 601. The drainage channel is connected through a negative pressure suction device, and intraoperative blood oozing and tissue debris in the surgical area can be cleared in real time to keep the field of view clear. Three holes are provided at the tail of the rubber tube assembly: the balloon hole, the choledochoscope hole, and the contrast agent hole. The balloon hole is connected to the water injection channel, with a two-way seal valve for the balloon in the middle, and the other end is connected to the balloon. The outer diameter of the balloon is 3.0 - 3.5 mm when contracted and reaches 8 - 10 mm when inflated, with a wall thickness of 0.05 - 0.08 mm, and it firmly supports in the bile duct after inflation. The choledochoscope channel is provided in the choledochoscope hole, and a choledochoscope outlet is provided at the tail end, facilitating the precise insertion of the choledochoscope into the bile duct for treatment. The contrast agent hole is connected to the contrast agent channel, with a two-way seal valve for the contrast agent in the middle, and the end is the contrast agent outlet, with an outlet diffusion angle of 60° - 90° and a pore diameter of 0.3 - 0.5 mm, and the contrast agent is evenly distributed.

[0045] Example 2

[0046] The present invention also provides a technical solution: a method for using a choledochoscope guiding device used in a new type of laparoscopic surgery, including the following steps:

[0047] S1: Check and confirm the integrity of the device before surgery, ensure that all components are firmly connected and have good airtightness, and the choledochoscope can smoothly pass through the choledochoscope channel 801;

[0048] S2: During the operation, insert the puncture card 1 into the abdominal cavity through the abdominal wall incision, slowly push the rubber hose 4 to the target bile duct entrance, adjust the position and slowly enter the target area of the bile duct;

[0049] S3: After confirming the position, slowly inject normal saline through the balloon hole 7, and the balloon 10 expands until it tightly fits the inner wall of the bile duct;

[0050] S4: After the balloon 10 is stably fixed, gradually push the choledochoscope through the choledochoscope channel 801, observe the inside of the bile duct in real time, and confirm the location of the lesion or stone;

[0051] S5: Inject the contrast agent into the bile duct through the contrast agent channel 901 to accurately visualize the lesion area;

[0052] S6: During the operation, activate the drainage channel 601, perform real-time negative pressure suction, and continuously clean the blood and tissue debris in the surgical field;

[0053] S7: After the operation, gradually drain the normal saline in the balloon 10 to restore the balloon 10 to its contracted state, and slowly withdraw the device.

[0054] In S1, screw the puncture snap cap and the rubber tube assembly together through threads, use an airtight detector to pressurize the water injection channel to 100 mmHg, and the pressure drop within 3 minutes ≤ 2 mmHg to verify that the three-layer rubber structure of the first anti-air leakage valve can maintain the pneumoperitoneum leakage rate < 1.5 ml / min. Insert a 3.2 mm simulated endoscope body into the choledochoscope channel, and the propulsion resistance ≤ 2 N. Confirm that the friction coefficient of the guiding protrusions on the inner wall of the channel < 0.2 to solve the problem of traditional endoscope body jamming.

[0055] In S2, under direct vision of the laparoscope, push the rubber hose at a speed of 5 mm / s. The embedded spiral steel wire in it provides a bending stiffness of 0.15 N / mm 2 so that the hose can still maintain the axis stability when the angle at the hepatic hilum is > 90°. Through the X-ray imaging characteristics of the imaging ring, locate it within 2 cm of the target bile duct under DSA.

[0056] In S3, inject normal saline in stages: initially 3 ml to form a pre-fixation, and then add up to 8 ml to expand the balloon to a diameter of 8 mm. The double-layer structure ensures that the bursting pressure ≥ 300 mmHg. Use ultrasonic Doppler to detect that the balloon-bile duct contact pressure ≥ 0.5 N / cm 2 and increase the stone displacement inhibition rate to 95% to solve the problem of stone escape caused by fluid flow.

[0057] In S4, insert the endoscope body along the choledochoscope channel. The increased channel rigidity enables 80% of the axial thrust to be transmitted to the end of the endoscope. The intubation time for grade III bile ducts is shortened from 8.2 min to 2.5 min. Synchronously open the water injection channel to form a reverse flushing at a flow rate of 3 ml / s, and the fluid flow velocity gradient ≤ 0.5 m / s to ensure that the stones are stably retained within the operation range of the stone basket.

[0058] In S5, inject iohexol through the contrast agent channel at a pressure of 150 kPa. The microporous diffusion structure makes the contrast agent distributed at a 60° atomization angle, and the contrast of the imaging area is increased by 60%. Dynamic DSA acquisition (3 frames / second) can identify hidden stones ≤ 2 mm, and the diagnostic coincidence rate of distal common bile duct stenosis is increased from 78% to 98%.

[0059] In S6, the drainage channel performs negative pressure suction at -50 kPa. The 45° inclined guide groove enables the debris removal efficiency to reach 20 ml / min, and the clarity of the surgical field is maintained for > 30 min. When blood is detected, it automatically switches to the -80 kPa pulse mode, and the tissue damage rate is reduced by 70% compared with the traditional aspirator.

[0060] In S7, the balloon is emptied in a stepped manner at a speed of 1 ml / s, and the gradient decompression design enables the wall stripping force ≤ 0.3 N / cm 2 . When withdrawing, keep the included angle of the bile duct axis < 30°, and the ultrasonic monitoring shows that the separation distance of the tube wall ≤ 0.1 mm. Inject methylene blue to verify no leakage, and achieve non-invasive tube withdrawal.

[0061] Those skilled in the art should understand that various changes and modifications can be made to the above-disclosed embodiments without departing from the essence of the invention. Therefore, the protection scope of the present invention should be defined by the appended claims.

[0062] It should be noted that not all steps and units in the above processes are necessary, and some steps or units can be ignored according to actual needs. The execution order of each step is not fixed and can be determined according to needs. The device structures described in the above embodiments can be physical structures or logical structures, that is, some units may be implemented by the same physical entity, or some units may be implemented by multiple physical entities respectively, or some components in multiple independent devices may be jointly implemented.

[0063] The specific embodiments described above illustrate exemplary embodiments, but do not represent all embodiments that can be implemented or fall within the protection scope of the claims. The term "exemplary" used throughout this specification means "serving as an example, instance, or illustration", and does not mean "preferred" or "advantageous" over other embodiments. For the purpose of providing an understanding of the described technology, the specific embodiments include specific details. However, these technologies can be implemented without these specific details. In some instances, well-known structures and devices are shown in block diagram form to avoid obscuring the concepts of the described embodiments.

[0064] The above description of the present disclosure is provided to enable any ordinary person skilled in the art to implement or use the present disclosure. Various modifications to the present disclosure are obvious to those of ordinary skill in the art, and the general principles defined herein can also be applied to other variations without departing from the protection scope of the present disclosure. Therefore, the present disclosure is not limited to the examples and designs described herein, but is consistent with the broadest scope that conforms to the principles and novel features disclosed herein.

Claims

1. A choledochoscope guiding device used in a new type of laparoscopic surgery, comprising a trocar (1), a rubber hose (4), a balloon hole (7), a contrast agent hole (9), a developing ring (11), and a second air leakage prevention valve (12), characterized in that: The upper end of the trocar (1) is connected to a trocar snap cap (2) through a snap fastener. The rubber hose (4) passes through the trocar (1) and the trocar snap cap (2). A rubber hose assembly (3) is provided at the tail of the rubber hose (4). A first air leakage prevention valve (5) is provided at the top of the trocar snap cap (2). A liquid discharge port (6) is provided at the bottom of the rubber hose assembly (3). A liquid discharge channel (601) is internally connected to the liquid discharge port (6). A balloon hole (7) is provided at the tail of the rubber hose assembly (3). A choledochoscope hole (8) is provided at the tail of the rubber hose assembly (3). A contrast agent hole (9) is provided at the tail of the rubber hose assembly (3). A balloon (10) is provided at the head end of the rubber hose (4). A developing ring (11) is provided at the top of the balloon (10). A second air leakage prevention valve (12) is provided at the tail end of the choledochoscope hole (8); An injection channel (701) is provided inside the balloon hole (7). A balloon two-way sealing valve (702) is provided at the terminal of the injection channel (701). The other end of the injection channel (701) is connected to the balloon (10); A choledochoscope channel (801) is provided inside the choledochoscope hole (8). A choledochoscope outlet (802) is provided at the other end of the choledochoscope channel (801); A contrast agent channel (901) is provided inside the contrast agent hole (9). A contrast agent two-way sealing valve (903) is provided at the terminal of the contrast agent channel (901). The other end of the contrast agent channel (901) is connected to a contrast agent outlet (902).

2. The choledochoscope guiding device used in a new type of laparoscopic surgery according to claim 1, characterized in that: The rubber hose (4) is made of rubber with a Shore hardness of 60A - 70A, and a spiral steel wire reinforcement layer is embedded in the pipe wall. The wire diameter is Φ0.1 ± 0.02 mm, the spiral angle is 30° ± 5°, and the pitch is 2.0 - 3.0 mm.

3. A choledochoscope guiding device used in a new type of laparoscopic surgery according to claim 1, characterized in that: The rubber layer thickness of the first air leakage prevention valve (5) is 0.8 - 1.2 mm, the Shore hardness is 40A - 50A, its sealing contact surface is a conical structure of 15° - 25°, and the surface roughness of the cone is Ra ≤ 0.4 μm.

4. The bile duct scope guiding device used in a new type of laparoscopic surgery according to claim 1, wherein: The inner diameter of the injection channel (701) is 1.5 - 2.0 mm, the inner diameter of the contrast agent channel (901) is 1.0 - 1.2 mm, and the pipe wall thickness ratio of the two channels is 1:1.2 - 1.

5.

5. A choledochoscope guiding device used in a new type of laparoscopic surgery according to claim 1, characterized in that: The outer diameter of the balloon (10) in the contracted state is 3.0 - 3.5 mm, the expansion limit outer diameter is 8 - 10 mm, the wall thickness is 0.05 - 0.08 mm, and the axial elongation rate ≤ 5%.

6. A choledochoscope guiding device used in a new type of laparoscopic surgery according to claim 1, characterized in that: The diffusion angle of the contrast agent outlet (902) is 60° - 90°, the outlet aperture is 0.3 - 0.5 mm, and the hole length-diameter ratio is 2:1 - 3:

1.

7. A method for using a choledochoscope guiding device used in a new type of laparoscopic surgery, characterized in that, Including the following steps: S1: Check and confirm the integrity of the device before the operation, ensure that all components are firmly connected and have good airtightness, and the choledochoscope can pass smoothly through the choledochoscope channel (801); S2: During the operation, insert the trocar (1) into the abdominal cavity through the abdominal wall incision, slowly push the rubber hose (4) to the target bile duct inlet, adjust the position and slowly enter the target area of the bile duct; S3: After confirming the position, slowly inject normal saline through the balloon hole (7), and the balloon (10) expands until it fits tightly against the inner wall of the bile duct; S4: After the balloon (10) is stably fixed, gradually advance the choledochoscope through the choledochoscope channel (801), observe the inside of the bile duct in real time, and confirm the position of the lesion or stone; S5: Inject contrast agent into the bile duct through the contrast agent channel (901) to accurately visualize the lesion area; S6: Activate the drainage channel (601) during the operation, perform real-time negative pressure suction, and continuously clean the blood and tissue debris in the surgical field; S7: After the operation is completed, gradually drain the normal saline in the balloon (10) to restore the balloon (10) to the contracted state, and slowly withdraw the device.

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