Integrated visual high-frequency incision knife

Abstract

The invention relates to an integrated visual high-frequency incision knife, which comprises an outer tube assembly, a handle assembly, a knife wire assembly, a balloon assembly, a visual assembly and a guide wire assembly, and is characterized in that the outer tube assembly is provided with a guide wire channel, a visual channel and a knife wire channel; the outer tube assembly is connected to the front end of the handle assembly, the knife wire assembly is arranged in the knife wire channel and is suitable for stretching out, drawing back and rotating so as to drive the outer tube assembly to bend and rotate, and the balloon assembly is arranged on the outer side of the outer tube assembly and is used for fixing the outer tube assembly. The visual assembly is arranged in the visual channel and extends to the head end of the outer tube assembly, and the guide wire assembly is suitable for being arranged in the guide wire channel and extends to the head end of the outer tube assembly.

Description

Technical Field

[0001] The invention relates to the technical field of nipple incision knives, and in particular to an integrated visualized high-frequency incision knives. Background Art

[0002] Sphincterotomy (EST) is a surgical procedure performed under endoscopy. The sphincterotomy is an important structure that controls the flow of bile and pancreatic juice into the duodenum. The procedure is mainly performed by using endoscopic retrograde cholangiopancreatography (ERCP) technology to cut a part of the sphincterotomy with special instruments to achieve the purpose of treating certain bile duct and pancreatic diseases, such as bile duct stones, bile duct stenosis and pancreatic duct diseases.

[0003] Traditional sphincterotomy requires the following steps: 1. Endoscope insertion: The patient usually takes the left side lying position, and the doctor inserts the duodenoscope into the esophagus through the mouth, and then slowly passes through the lower esophagus, stomach, and finally enters the descending duodenum. During this process, the doctor will observe the internal conditions of the esophagus, stomach, and duodenum through the imaging system of the endoscope, and pay attention to avoid damage to the digestive tract mucosa. 2. Papillary positioning and intubation: The duodenal papilla is the opening of the bile duct and pancreatic duct in the duodenum. After finding the papilla, insert the angiography catheter through the working channel of the endoscope, and insert the catheter into the bile duct or pancreatic duct under the guidance of the guide wire. 3. Insertion of the sphincterotomy knife: After successful intubation, insert the sphincterotomy knife into the bile duct or pancreatic duct through the working channel of the endoscope, so that the front end of the knife wire is located in the appropriate position in the papillary sphincter. 4. Sphincterotomy: After confirming that the blade is in the correct position, turn on the electrocoagulation cutting function and use a mixed current (including coagulation current and cutting current) to slowly cut the papillary sphincter. The length of the incision is usually determined by the patient's condition and the specific situation of the bile duct, generally about 1-2 cm. 5. Observe the patency of the bile duct or pancreatic duct to confirm whether the stones can be discharged smoothly or whether the stenosis has been improved.

[0004] The trocar is a necessary surgical instrument in duodenal papillary sphincterotomy. Traditional trocars have the following defects. On the one hand, the trocars currently used in clinical practice do not have an endoscopic camera and can only rely on the field of view fed back by the duodenoscope to complete the superselection of the bile and pancreatic duct cannulation. After the trocar is inserted into the bile and pancreatic duct, the field of view in the cavity cannot be obtained, and the position can only be determined by DSA (digital subtraction technology), which exposes the doctor to a large amount of radiation hazards. On the other hand, when performing operations such as stone removal, a stone removal balloon is required. During the operation, after the papillary sphincter is cut by the trocar, the trocar needs to be withdrawn first, and then the stone removal balloon is inserted. The replacement process between the trocar and the stone removal balloon increases the patient's pain, increases the chance of biliary infection, and increases the difficulty of surgery and operation. Summary of the invention

[0005] One advantage of the present invention is that it provides an integrated visualized high-frequency incision knife, which is provided with a balloon assembly and a blade assembly, and can perform cutting operations and stone removal operations, avoiding the replacement process between surgical instruments, alleviating the patient's pain, and reducing the chance of infection.

[0006] Another advantage of the present invention is that it provides an integrated visualized high-frequency incision knife, which is provided with a visual component to observe the movement of the integrated visualized high-frequency incision knife in real time, thereby improving the surgical field of view, facilitating the operation of medical staff and improving safety.

[0007] Another advantage of the present invention is that it provides an integrated visualized high-frequency incision knife, the blade assembly of which can be extended and rotated, which is conducive to medical personnel to achieve more precise operations and better adapt to surgical needs.

[0008] Another advantage of the present invention is that it provides an integrated visualization high-frequency incision knife, wherein a first outer tube portion of the integrated visualization high-frequency incision knife is suitable for bending and rotating through the extension and rotation of the blade wire assembly to reach a predetermined lesion.

[0009] Another advantage of the present invention is that it provides an integrated visualized high-frequency incision knife, which integrates the functions of duodenal papilla sphincter incision, compression hemostasis and stone removal by balloon, etc., which can reduce the chance of biliary infection and facilitate the patient's postoperative recovery.

[0010] Another advantage of the present invention is that it provides an integrated visualized high-frequency incision knife. The use of the integrated visualized high-frequency incision knife can avoid medical staff from being exposed to a large amount of radiation hazards as they have to rely on DSA to determine the position after the incision knife is inserted into the bile and pancreatic duct as with existing papillotomies.

[0011] Another advantage of the present invention is that it provides an integrated visualized high-frequency incision knife, wherein a guidewire channel, a visual channel and a balloon channel of the integrated visualized high-frequency incision knife are independently arranged and will not affect the operation of each instrument.

[0012] Another advantage of the present invention is that it provides an integrated visualized high-frequency incision knife, which is provided with a guide wire assembly to play a guiding role, thereby facilitating the integrated visualized high-frequency incision knife to perform surgical operations accurately.

[0013] Another advantage of the present invention is that it provides an integrated visualized high-frequency incision knife, which has a simple overall structure, is easy to manufacture and maintain, is relatively simple to operate, and is easy for medical staff to master and use.

[0014] Another advantage of the present invention is that it provides an integrated visualization high-frequency incision knife that is less expensive to produce than would otherwise be required with multiple separate instruments.

[0015] According to another aspect of the present invention, the present invention further provides an integrated visualization high-frequency incision knife, the integrated visualization high-frequency incision knife comprising:

[0016] an outer tube assembly, the outer tube assembly having a guide wire channel, a visual channel and a knife wire channel;

[0017] a handle assembly, the outer tube assembly being connected to the front end of the handle assembly;

[0018] a knife wire assembly, the knife wire assembly being disposed in the knife wire channel, the knife wire assembly being adapted to be telescopic and rotatable, so as to drive the outer tube assembly to bend and rotate;

[0019] a balloon assembly, the balloon assembly being arranged outside the outer tube assembly;

[0020] a visual component, the visual component is disposed in the visual channel and extends to the head end of the outer tube component; and

[0021] A guidewire assembly is adapted to be placed in the guidewire channel and extends to the head end of the outer tube assembly.

[0022] According to one embodiment of the present invention, the outer tube assembly includes a first outer tube portion, a second outer tube portion and a third outer tube portion, the third outer tube portion is connected to the front end of the handle assembly, the two outer tube portions are integrally connected between the first outer tube portion and the third outer tube portion, and the first outer tube portion is suitable for bending.

[0023] According to one embodiment of the present invention, the balloon assembly includes a lithotripsy balloon, a balloon connecting tube and a balloon channel, the lithotripsy balloon is arranged on the outside of the second outer tube portion, the balloon connecting tube is arranged on the outside of the outer tube assembly and connected to the lithotripsy balloon, and the balloon channel is located between the balloon connecting tube and the outer tube assembly.

[0024] According to one embodiment of the present invention, the first outer tube portion has a first side wall hole, the second outer tube portion has a second side wall hole, the knife wire assembly extends from the handle assembly to the second outer tube portion, and passes through the second side wall hole of the second outer tube portion and extends to the first side wall hole of the first outer tube portion.

[0025] According to one embodiment of the present invention, the first tube body portion further includes a head end portion, the head end portion has a knife wire hole, the first side wall hole is connected to the knife wire hole to form a fixed channel, and the head end of the knife wire assembly is fixed in the fixed channel.

[0026] According to one embodiment of the present invention, the knife wire assembly further includes a knife wire, a telescopic control member and a rotation control member, wherein the telescopic control member is slidably disposed on the handle assembly and connected to the knife wire, and the rotation control member is rotatably disposed on the handle assembly and connected to the knife wire.

[0027] According to one embodiment of the present invention, the blade wire assembly further includes a snap-fitting member, which is disposed at the front end of the blade wire, and the first outer tube portion further includes a fixing member, which is disposed in the fixing channel to be fixedly connected to the snap-fitting member.

[0028] According to one embodiment of the present invention, the handle assembly includes a handle body portion, having a guidewire port, a balloon connection port and a visual port, and the guidewire port, the balloon connection port and the visual port are all arranged on the handle body portion to be connected to the guidewire channel, the balloon channel and the visual channel respectively.

[0029] According to an embodiment of the present invention, the head end portion further has a guide wire hole and a visual hole, the guide wire hole is connected to the guide wire channel, and the visual hole is connected to the visual channel.

[0030] According to one embodiment of the present invention, the knife wire channel, the balloon channel, the visual channel and the guide wire channel are independent of each other.

[0031] Further objects and advantages of the present invention will be fully apparent from an understanding of the following description and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 This is one of the overall structural schematic diagrams of an integrated visualized high-frequency incision knife according to an embodiment of the present invention.

[0033] Figure 2 This is the second schematic diagram of the overall structure of an integrated visualized high-frequency incision knife according to an embodiment of the present invention.

[0034] Figure 3 This is one of the partially enlarged views of an integrated visualized high-frequency incision knife according to an embodiment of the present invention.

[0035] Figure 4 This is a second partial enlarged view of an integrated visualized high-frequency incision knife according to an embodiment of the present invention.

[0036] Figure 5 The diagram is a schematic diagram of the transition between the bending state and the vertical state of a first outer tube portion of an integrated visualized high-frequency incision knife according to an embodiment of the present invention.

[0037] Figure 6 It is a schematic diagram of the rotation of the first outer tube portion of an integrated visualized high-frequency incision knife according to an embodiment of the present invention.

[0038] Figure 7 It is a schematic diagram of another possible implementation of a handle assembly of an integrated visualization high-frequency incision knife according to an embodiment of the present invention. DETAILED DESCRIPTION

[0039] The following description is used to disclose the present invention so that those skilled in the art can implement the present invention. The preferred embodiments described below are only examples, and those skilled in the art can think of other obvious variations. The basic principles of the present invention defined in the following description can be applied to other embodiments, variations, improvements, equivalents, and other technical solutions that do not deviate from the spirit and scope of the present invention.

[0040] Those skilled in the art should understand that, in the disclosure of the present invention, the terms "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicating the orientation or position relationship are based on the orientation or position relationship shown in the drawings, which are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation. Therefore, the above terms should not be understood as limiting the present invention.

[0041] It is to be understood that the term "one" should be understood as "at least one" or "one or more", that is, in one embodiment, the number of an element may be one, while in another embodiment, the number of the element may be multiple, and the term "one" should not be understood as a limitation on the quantity.

[0042] Reference Figure 1 To Attachment Figure 7 As shown, an integrated visualization high-frequency incision knife according to a preferred embodiment of the present invention is schematically shown. The integrated visualization high-frequency incision knife 1 is used for duodenal papillary sphincterotomy. In the present application, the integrated visualization high-frequency incision knife 1 integrates the functions of visualization, duodenal papillary sphincterotomy, compression hemostasis and stone removal balloon stone removal, which is not only conducive to more precise operation by medical staff, but also avoids the replacement process between surgical instruments, relieves the pain of patients, and reduces the chance of infection.

[0043] For ease of explanation, in this embodiment, the end of the integrated visualized high-frequency incision knife 1 that is placed at the lesion during use is used as the front end of the integrated visualized high-frequency incision knife 1, and the end opposite to the front end of the integrated visualized high-frequency incision knife 1 is used as the rear end of the integrated visualized high-frequency incision knife 1, that is, the end for medical staff to hold is used as the rear end of the integrated visualized high-frequency incision knife 1.

[0044] Figure 1 and Figure 2 1 is a schematic diagram of the overall structure of the integrated visualized high-frequency incision knife 1 according to the first preferred embodiment of the present invention. In this embodiment, the integrated visualized high-frequency incision knife 1 includes an outer tube assembly 10 and a handle assembly 20, the outer tube assembly 10 is connected to the front end of the handle assembly 20, the outer tube assembly 10 is suitable for being placed in the patient's lesion for surgery, and the handle assembly 20 is connected to the rear end of the outer tube assembly 10 for medical staff to hold.

[0045] The integrated visualized high-frequency incision knife 1 also includes a blade wire assembly 30, a balloon assembly 40, a visual assembly 50 and a guide wire assembly 60. The blade wire assembly 30 is arranged in the outer tube assembly 10 for incising a nipple sphincter of a patient. The balloon assembly 40 is arranged on the outside of the outer tube assembly 10. After the nipple sphincter is incised by the incision knife, compression hemostasis and stone removal operations are performed. The visual assembly 50 is installed on the outer tube assembly 10 to provide a field of view, so that medical staff can observe the movement of the integrated visualized high-frequency incision knife 1 in real time, improve the surgical field of view, facilitate the operation of medical staff and improve safety. The guide wire assembly 60 is suitable for being placed in the outer tube assembly 10 to guide the integrated visualized high-frequency incision knife 1 to enter the predetermined lesion for surgery.

[0046] Based on this, the integrated visualization high-frequency incision knife 1 integrates the functions of visualization, duodenal papillary sphincterotomy, compression hemostasis and stone removal balloon stone removal, which is not only conducive to medical staff to achieve more precise operations, real-time observation of the movement of the integrated visualization high-frequency incision knife 1, improves the surgical field of view, facilitates medical staff's operation and improves safety, but also avoids the replacement process between surgical instruments, alleviates patients' pain, and reduces the chance of infection.

[0047] Specifically, the outer tube assembly 10 has a knife wire channel 101, a visual channel 102 and a guide wire channel 103. The knife wire channel 101, the visual channel 102 and the guide wire channel 103 are all arranged in the outer tube assembly 10. The knife wire assembly 30 is arranged in the knife wire channel 101. The knife wire assembly 30 is suitable for telescoping and rotating to drive the outer tube assembly 10 to bend and rotate, which is conducive to medical staff to achieve more precise operations and better adapt to surgical needs. The visual assembly 50 is arranged in the visual channel 102 and extends to the head end of the outer tube assembly 10 to provide a field of view. The guide wire assembly 60 is suitable for being placed in the guide wire channel 103 and extending to the head end of the outer tube assembly 10.

[0048] In the embodiment of the present application, the knife wire channel 101, the visual channel 102 and the guide wire channel 103 are independently arranged and will not affect the operation of each device. That is, the knife wire channel 101, the visual channel 102 and the guide wire channel 103 are not connected to each other.

[0049] The outer tube assembly 10 also includes a first outer tube portion 11, a second outer tube portion 12 and a third outer tube portion 13, wherein the second outer tube portion 12 is connected between the first outer tube portion 11 and the third outer tube portion 13, that is, the two ends of the second outer tube portion 12 are respectively connected to the first outer tube portion 11 and the third outer tube portion 13, and the other end of the third outer tube portion 13 is connected to the handle assembly 20. The first outer tube portion 11 is shorter and suitable for bending and rotating, and the third outer tube portion 13 is longer. In the process of applying to the sphincterotomy of the duodenal papilla, due to the presence of the third outer tube portion 13, the handle assembly 20 will not touch other parts of the patient, so as to avoid inconvenience in operation and discomfort to the patient. And due to the presence of the first outer tube portion 11, medical staff do not need to change the direction by bending their wrists during operation, and the operation is simpler.

[0050] It is worth mentioning that the first outer tube portion 11, the second outer tube portion 12 and the third outer tube portion 13 respectively form part of the knife wire channel 101, the visible channel 102 and the guide wire channel 103. In other words, the knife wire channel 101, the visible channel 102 and the guide wire channel 103 are arranged in the first outer tube portion 11, the second outer tube portion 12 and the third outer tube portion 13.

[0051] It is worth mentioning that, in the embodiment of the present application, the first outer tube portion 11 is suitable for bending and rotating through the extension and rotation of the blade wire assembly 30, that is, when the blade wire assembly 30 is stretched backward, the first outer tube portion 11 is bent under the pulling force of the blade wire assembly 30, and when the blade wire assembly 30 moves forward, the first outer tube portion 11 is straightened under the action of the blade wire assembly 30, wherein the bending angle of the first outer tube portion 11 is related to the stretching degree of the blade wire assembly 30. In addition, in the embodiment of the present application, the first outer tube portion 11 is made of ductile material, so that the first outer tube portion 11 is easier to bend and control the direction under the control of the blade wire assembly 30, so as to facilitate the operation of medical staff. The specific bending structure of the first outer tube portion 11 is not a limitation of the present invention.

[0052] Specifically, the blade wire assembly 30 includes a blade wire 31, a telescopic control member 33 and a rotation control member 34. The blade wire 31 is disposed in the blade wire channel 101. The telescopic control member 33 and the rotation control member 34 are disposed in the handle assembly 20. Specifically, the telescopic control member 33 is slidably disposed in the handle assembly 20 and connected to the blade wire 31. The rotation control member 34 is rotatably disposed in the handle assembly 20 and connected to the blade wire. The telescopic control member 33 is used to control the telescopic movement of the blade wire 31, and the rotation control member 34 is used to control the rotation of the blade wire 31. That is, when the telescopic control member 33 moves backward from the handle assembly 20, the first outer tube portion 11 is bent under the tension of the blade wire 31. When the telescopic control member 33 moves forward from the handle assembly 20, the first outer tube portion 11 is straightened under the action of the blade wire 31. The blade wire 31 of the integrated visualized high-frequency incision knife 1 can be extended and rotated, which is conducive to more precise operation by medical staff and better meets surgical needs. The first outer tube 31 is suitable for bending and rotating through the extension and rotation of the blade wire 31 to reach the predetermined lesion.

[0053] Figure 5 The diagram is a schematic diagram of the bending state and vertical state transition of a first outer tube portion of an integrated visualized high-frequency incision knife according to an embodiment of the present invention. The first outer tube portion 11 is defined as having a bending state and a vertical state, that is, when the telescopic control member 33 moves backward from the handle assembly 20, the first outer tube portion 11 bends under the pulling force of the knife wire 31, and the first outer tube portion 11 changes from the vertical state to the bending state; when the telescopic control member 33 moves forward from the handle assembly 20, the first outer tube portion 11 straightens under the action of the knife wire 31, and the first outer tube portion 11 changes from the bending state to the vertical state.

[0054] More specifically, in an embodiment of the present application, the bending angle of the first outer tube portion 11 is preferably set to 0° to 90°. Since the first outer tube portion 11 can be bent and rotated, the first outer tube portion 11 forms a three-dimensional space when entering a predetermined lesion in the patient's body, so as to accurately reach the predetermined lesion.

[0055] In an embodiment of the present application, the second outer tube portion 12 includes a second tube body 121 and a second side wall hole 122 , wherein the second side wall hole 122 is disposed in the second tube body 121 , and the second side wall hole 122 extends inwardly from the side wall of the second tube body 121 to be connected to the blade wire channel 101 .

[0056] The first outer tube portion 11 includes a first tube body 111 and a first side wall hole 112, wherein the first side wall hole 112 is provided in the first tube body 111, wherein the knife wire 31 extends from the handle assembly 20 to the second outer tube portion 12, and passes through the second side wall hole 122 of the second outer tube portion 12 to extend to the first side wall hole 112 of the first outer tube portion 11. Based on this, when the telescopic control member 33 moves backward from the handle assembly 20, the knife wire 31 is pulled up, driving the first tube body 111 to bend, so that the first tube body 111 forms an arched structure, the direction and position of the knife head are controlled by the rotation control member 34, and then the knife wire 31 is energized through the electrode to cut the duodenal papillary sphincter.

[0057] It is worth mentioning that the first outer tube part 11 further includes a head end 115, the head end 115 has a knife wire hole 1151, a visual hole 1152 and a guide wire hole 1153, the first side wall hole 112 is connected to the knife wire hole 1151 to form a fixed channel 16, the head end of the knife wire 31 is fixed in the fixed channel 116, that is, the knife wire 31 extends from the handle assembly 20 to the second outer tube part 12, and passes through the second side wall hole 122 of the second outer tube part 12 to extend to the first side wall hole 112 of the first outer tube part 11, and the end of the knife wire 31 is fixed to the handle assembly 20, and the front end of the knife wire 31 is fixed in the fixed channel 116. The visual hole 1152 is connected to the visual channel 102, and the guide wire hole 1153 is connected to the visual channel 103.

[0058] It is worth mentioning that the knife wire assembly 30 further includes a snap-fitting member 32, which is disposed at the front end of the knife wire 31, and the first outer tube portion 11 further includes a fixing member 117, which is disposed in the fixing channel 116 to be fixedly connected to the snap-fitting member 32, so that the front end of the guide wire 31 is fixed in the fixing channel 116. In one embodiment, the snap-fitting member 32 extends outward from the front end of the knife wire 31, and the fixing member 117 is recessed inward from the inner wall of the fixing channel 116, and the size of the snap-fitting member 32 matches the size of the fixing member 117, so that the snap-fitting member 32 can be fixedly connected to the fixing member 117. In another possible implementation manner, the engaging member 32 extends outward from the front end of the cutting wire 31, and the fixing member 117 is implemented as a capillary. The engaging member 32 can also be fixed to the fixing member 117. Those skilled in the art should understand that the fixing method between the engaging member 32 and the fixing member 117 is not a limitation of the present invention.

[0059] The first outer tube 11 also has a first curved surface 113 and a second curved surface 114, wherein the first curved surface 113 and the second curved surface 114 form two corresponding side surfaces of the first tube 111, and both the first curved surface 113 and the second curved surface 114 are bendable. The first side wall hole 112 is disposed on the first curved surface 113.

[0060] In an embodiment of the present application, the first side wall hole 112 is arranged at the front part of the first curved surface 113 of the first tube body 111, and the second side wall hole 122 is arranged at the front part of the second tube body 121. Therefore, when the knife wire 31 extends from the handle assembly 20 to the second outer tube portion 12, and passes through the second side wall hole 122 of the second outer tube portion 12 and extends to the first side wall hole 112 of the first outer tube portion 11, when the knife wire 31 is pulled up by the telescopic control member 33, the knife wire 31 can extend to the entire first tube body 111.

[0061] The balloon assembly 40 includes a stone removal balloon 41, a balloon connecting tube 42 and a balloon channel 42, wherein the stone removal balloon 41 is arranged outside the second outer tube portion 12, and the balloon connecting tube 42 is arranged outside the outer tube assembly 10 and connected to the stone removal balloon 41. In detail, the stone removal balloon 41 is arranged outside the end of the second outer tube portion 12, and the balloon connecting tube 42 is arranged outside the third outer tube portion 13 of the outer tube assembly 10 and part of the second outer tube portion 12. The balloon channel 43 is located between the balloon connecting tube 42 and the outer tube assembly 10, and the balloon channel 43 is connected to the interior of the stone removal balloon 41, so as to inflate or fill the stone removal balloon 41 with liquid, so that the stone removal balloon 41 is expanded. When in use, when the stone removal balloon 41 is needed to remove stones in the common bile duct, the stone removal balloon 41 is directly delivered to the bile duct, and the stones are removed from the common bile duct after being filled. It should be understood by those skilled in the art that in order to expand the stone removal balloon 41, the choice of inflating or filling the stone removal balloon 41 with gas is not a limitation of the present invention, and can be selected according to the actual needs of the duodenal papillary sphincterotomy.

[0062] Due to the position setting of the stone removal balloon 41 and the balloon connecting tube 42, the second side wall hole 122 is set at the front of the second tube body 121, so the balloon assembly 40 will not affect the work of the knife wire assembly 30, and the knife wire assembly 30 will not affect the work of the balloon assembly 40. The integrated visualization high-frequency incision knife 1 is provided with the balloon assembly 40 and the knife wire assembly 30, and can perform cutting operations and stone removal operations, avoiding the replacement process between surgical instruments, alleviating the pain of patients, and reducing the chance of infection.

[0063] The handle assembly 20 includes a handle body 21, a guide wire port 22, a balloon connection port 23 and a visual port 24, wherein the guide wire port 22, the balloon connection port 23 and the visual port 24 are all arranged on the handle body 21 to be connected to the guide wire channel 103, the balloon channel 43 and the visual channel 102 respectively. The guide wire assembly 60 is suitable for entering from the guide wire port 22, passing through the guide wire channel 103 to reach the guide wire hole 1153, and gas or liquid that can expand the stone removal balloon 41 enters the balloon channel 43 through the balloon connection port 23, reaches the inside of the stone removal balloon 41, and expands the stone removal balloon 41. The visual assembly 50 enters from the visual port 24, passes through the visual channel 102 and reaches the visual hole 1152. In other words, the guide wire channel 103 is connected to the guide wire port 22 and the guide wire hole 1153 respectively, and the visual channel 102 is connected to the visual port 24 and the visual hole 1152 respectively.

[0064] In particular, the guidewire port 22, the balloon connection port 23 and the visual port 24 are arranged at specific positions of the handle body 21, which is not a limitation of the present invention. As shown in the figure, in one embodiment, the balloon connection port 23 and the visual port 24 are arranged on the same side of the handle body 21, and the guidewire port 22 is arranged separately on the other side of the handle body 21. In another embodiment, the guidewire port 22, the balloon connection port 23 and the visual port 24 are all arranged on the same side of the handle body 21. In this regard, it should be understood by those skilled in the art that the guidewire port 22, the balloon connection port 23 and the visual port 24 are arranged at specific positions of the handle body 21, which is not a limitation of the present invention.

[0065] The following is an exemplary introduction to the method of using the integrated visualization high-frequency incision knife 1 for duodenal sphincterotomy.

[0066] First, an endoscope is inserted into the predetermined lesion. The patient usually lies on his left side. The medical staff inserts a duodenoscope through the mouth into the esophagus, then slowly passes through the lower esophagus, stomach, and finally into the descending duodenum. During this process, the medical staff will observe the internal conditions of the esophagus, stomach, and duodenum through the imaging system of the endoscope, and pay attention to avoid damage to the digestive tract mucosa.

[0067] Then, the nipple is positioned and the integrated visualization high-frequency incision knife 1 is inserted, that is, the duodenal papilla is the opening of the bile duct and the pancreatic duct in the duodenum. After finding the nipple, the guide wire assembly 60 enters the predetermined position through a working channel of the duodenoscope, and then the integrated visualization high-frequency incision knife 1 reaches the predetermined lesion according to the guidance of the guide wire assembly 60. When the integrated visualization high-frequency incision knife 1 enters, the first outer tube portion 11 is kept in a vertical state through the control of the telescopic control member 33 to facilitate the entry of the integrated visualization high-frequency incision knife 1, so as to avoid inconvenience in operation and discomfort to the patient.

[0068] Finally, the sphincterotomy is performed, that is, when the integrated visualized high-frequency incision knife 1 reaches the predetermined lesion, the bending angle and direction of the blade wire 31 are adjusted through the telescopic control member 33 and the rotating control member 34. After confirming that the blade wire 31 is in the correct position, the electrocoagulation cutting function is turned on, and a mixed current (including coagulation current and cutting current) is used to slowly incise the papillary sphincter. The length of the incision is usually determined according to the patient's condition and the specific conditions of the bile duct, and is generally about 1-2 cm. If the stone removal balloon 41 is needed to remove stones in the common bile duct, the stone removal balloon 41 can be directly delivered to the bile duct, and the stones can be removed from the common bile duct after filling.

[0069] Compared with traditional incision knives, the incision knives currently used in clinical practice do not have an endoscopic camera and can only rely on the field of view fed back by the duodenoscope to complete the superselection of the intubation of the bile and pancreatic duct. After the incision knives are inserted into the bile and pancreatic duct, the field of view in the cavity cannot be obtained, and the position can only be determined by DSA (digital subtraction technology), which causes doctors to suffer a lot of radiation hazards. In the integrated visualization high-frequency incision knives 1 of the present invention, the visual component 50 is provided to observe the movement of the integrated visualization high-frequency incision knives in real time, improve the surgical field of view, facilitate the operation of medical staff and improve safety. On the other hand, when performing operations such as stone removal, a stone removal balloon is needed. During the operation, after the papillary sphincter is cut by the incision knives, the incision knives need to be withdrawn first, and then the stone removal balloon is inserted. The replacement process between the incision knives and the stone removal balloons increases the pain of the patients, increases the probability of biliary infection, and also increases the difficulty of surgery and operation. In the integrated visualized high-frequency incision knife 1 of the present invention, the integrated visualized high-frequency incision knife 1 is provided with the balloon assembly 40 and the blade wire assembly 30, which can perform cutting operations and stone removal operations, avoiding the replacement process between surgical instruments, alleviating the patient's pain, and reducing the chance of infection.

[0070] In summary, the integrated visualized high-frequency incision knife 1 is provided with the visual component 50, which can observe the movement of the integrated visualized high-frequency incision knife in real time, improve the surgical field of view, facilitate the operation of medical staff and improve safety. The integrated visualized high-frequency incision knife 1 is provided with the balloon component 40 and the blade wire component 30, which can perform cutting and stone removal operations, avoid the replacement process between surgical instruments, reduce the pain of patients, and reduce the chance of infection.

[0071] It should be understood by those skilled in the art that the embodiments of the present invention described above and shown in the accompanying drawings are only examples and do not limit the present invention. The purpose of the present invention has been fully and effectively achieved. The functional and structural principles of the present invention have been demonstrated and explained in the embodiments, and the embodiments of the present invention may be deformed or modified in any way without departing from the principles.

Claims

1. An integrated visualized high-frequency incision knife, characterized in that: include: an outer tube assembly, the outer tube assembly having a guide wire channel, a visual channel and a knife wire channel; a handle assembly, the outer tube assembly being connected to the front end of the handle assembly; a knife wire assembly, the knife wire assembly being disposed in the knife wire channel, the knife wire assembly being adapted to be telescopic and rotatable, so as to drive the outer tube assembly to bend and rotate; a balloon assembly, the balloon assembly being arranged outside the outer tube assembly; a visual component, the visual component is disposed in the visual channel and extends to the head end of the outer tube component; and A guidewire assembly is adapted to be placed in the guidewire channel and extends to the head end of the outer tube assembly.

2. The integrated visualized high-frequency incision knife according to claim 1, wherein the outer tube assembly comprises a first outer tube portion, a second outer tube portion and a third outer tube portion, the third outer tube portion is connected to the front end of the handle assembly, the two outer tube portions are integrally connected between the first outer tube portion and the third outer tube portion, and the first outer tube portion is suitable for bending.

3. An integrated visualized high-frequency incision knife according to claim 2, wherein the balloon assembly includes a lithotripsy balloon, a balloon connecting tube and a balloon channel, the lithotripsy balloon is arranged on the outside of the second outer tube portion, the balloon connecting tube is arranged on the outside of the outer tube assembly and connected to the lithotripsy balloon, and the balloon channel is located between the balloon connecting tube and the outer tube assembly.

4. The integrated visualized high-frequency cutting knife according to claim 3, wherein the first outer tube portion has a first side wall hole, the second outer tube portion has a second side wall hole, the blade wire assembly extends from the handle assembly to the second outer tube portion, and passes through the second side wall hole of the second outer tube portion and extends to the first side wall hole of the first outer tube portion.

5. The integrated visualized high-frequency incision knife according to claim 4, wherein the first tube body portion further comprises a head end portion, the head end portion has a knife wire hole, the first side wall hole is connected to the knife wire hole to form a fixed channel, and the head end of the knife wire assembly is fixed in the fixed channel.

6. An integrated visualized high-frequency incision knife according to claim 5, wherein the blade wire assembly further comprises a blade wire, a telescopic control member and a rotation control member, the telescopic control member is slidably disposed on the handle assembly and connected to the blade wire, and the rotation control member is rotatably disposed on the handle assembly and connected to the blade wire.

7. The integrated visualized high-frequency incision knife according to claim 6, wherein the blade wire assembly further comprises a snap-fit ​​piece, which is disposed at the front end of the blade wire, and the first outer tube portion further comprises a fixing piece, which is disposed in the fixing channel to be fixedly connected to the snap-fit ​​piece.

8. An integrated visualized high-frequency incision knife according to claim 7, wherein the handle assembly comprises a handle body portion, having a guidewire port, a balloon connection port and a visual port, the guidewire port, the balloon connection port and the visual port are all arranged on the handle body portion to be connected to the guidewire channel, the balloon channel and the visual channel respectively.

9. The integrated visualized high-frequency incision knife according to claim 8, wherein the head end portion further has a guide wire hole and a visual hole, the guide wire hole is connected to the guide wire channel, and the visual hole is connected to the visual channel.

10. The integrated visualized high-frequency incision knife according to claim 9, wherein the knife wire channel, the balloon channel, the visual channel and the guide wire channel are independent of each other.

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