Double guide wire four-chamber papillotomy knife

Abstract

To provide a double guide wire four-chamber papillotomy knife.SOLUTION: A double guide wire four-chamber papillotomy knife includes a handle assembly 1, a sheath assembly 2, and a head assembly 3. The handle assembly includes a handle body and an electrode. A cutting wire is electrically connected to the electrode. The sheath assembly includes a four-chamber tube. The four-chamber tube is provided with: an injection chamber penetrating the four-chamber tube in an axial direction; a cutting wire chamber; and two guide wire chambers. The four-chamber tube is provided with an injection inlet communicating with the injection chamber, and two guide wire inlets respectively communicating with the two guide wire chambers. The head assembly includes a head tube. The head tube is provided with an injection outlet communicating with the injection chamber, and two guide wire outlets respectively communicating with two guide wire chambers. An end portion distant from the electrode of the cutting wire passes the cutting wire chamber, exits from the head tube, and is fixedly connected to the head tube.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to the technical field of medical devices, and in particular to a double guidewire four-lumen papillotomy knife. [Background technology]

[0002] With the continuous development of endoscopic technology and the continuous improvement of its accessories, endoscopic retrograde cholangiopancreatography (ERCP) has become an important tool in the diagnosis and treatment of hepatobiliary and pancreatic diseases, such as common bile duct stones, bile duct injuries, bile duct strictures, and biliary complications after liver transplantation. The key to successful ERCP surgery is successful selective cannulation of the pancreaticobiliary duct and successful sphincterotomy. In some patients, failed cannulation directly leads to ERCP failure. Repeated cannulation of the duodenal papilla not only prolongs the procedure and increases the surgical risk, but also increases the risk of acute pancreatitis, further increasing treatment costs, hospital stays, significant patient suffering, and a certain mortality rate. In clinical practice, to improve the success rate of cannulation of the duodenal papilla during ERCP, guidewire-assisted sphincterotomy knife and pancreatic duct occupation techniques are often used for bile duct cannulation.

[0003] Most clinically applicable papillotomy knives are equipped with a single guidewire. When using this type of papillotomy knife for assisted intubation, only one guidewire can be placed, making it difficult to control the guidewire's insertion direction during assisted intubation. Consequently, the guidewire may enter the pancreatic duct during bile duct intubation, or the bile duct during pancreatic duct intubation. This not only reduces the success rate of selective biliary and pancreatic intubation, but also prolongs the surgical procedure, potentially leading to duodenal papilla edema and an increased incidence of complications such as intraoperative bleeding and postoperative pancreatitis. This type of papillotomy knife can also be used to treat both the right and left hepatic ducts. For example, if the guidewire is in the right hepatic duct and the lesion is located in the left hepatic duct, an additional guidewire must be inserted. This step results in repeated assisted intubation with the papillotomy knife. However, because one guidewire is already in the bile duct, it becomes even more difficult to efficiently insert the second guidewire into the left hepatic duct, prolonging the surgical procedure and increasing the incidence of ERCP complications.

[0004] In the prior art, patent publication number CN112587230A discloses a double-guidewire sphincterotomy knife, which includes a main tube and a handle. The main tube has an opening I at its tip, a first guidewire passage, a second guidewire passage, and a third passage within it, and two extension tubes are installed at the tail of the main tube. The head opening end of the first guidewire passage is opening I, and the head opening ends I and II of the second and third guidewire passages all open into the side wall of the main tube. Guidewire I passes through the extension tubes into the first guidewire passage, and guidewire II passes through the extension tubes into the second guidewire passage. One end of an electrocautery wire is fixed to the outer wall of the main tube, passes from the outside of the main tube through opening end II into the third passage, and then passes into and through the extension tubes before being connected to the handle. When the above technical solution is used for papillary intubation or bile duct super-selection, guide wire I passes through the tip opening into the pancreatic duct or one intrahepatic bile duct, and then by adjusting its direction, guide wire II can be easily inserted into the common bile duct or another intrahepatic bile duct through the side opening, but the sphincterotomy knife tube in this technical solution does not have an injection function. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Chinese patent with publication number CN112587230A Summary of the Invention [Problem to be solved by the invention]

[0006] In view of this, an object of the present invention is to provide a double guidewire four-lumen papillotomy knife that can more easily guide the guidewire into the bile duct and pancreatic duct simultaneously or into the right hepatic duct and left hepatic duct simultaneously during intubation, and that also has an injection function. [Means for solving the problem]

[0007] The present invention solves the above problems by the following technical means. The double guidewire four-lumen papillotomy knife comprises a handle assembly, a sheath assembly, and a head assembly connected in sequence. The handle assembly comprises a handle body and an electrode mounted on the handle body, with a cutting wire electrically connected to the electrode. The sheath assembly comprises a four-lumen tube, with an injection lumen, a cutting wire lumen, and two guidewire lumens extending axially therethrough. The four-lumen tube has an injection inlet communicating with the injection lumen and two guidewire inlets communicating with the two guidewire lumens, respectively. The head assembly comprises a head tube, with an injection outlet communicating with the injection lumen and two guidewire outlets communicating with the two guidewire lumens, respectively. The end of the cutting wire remote from the electrode passes through the cutting wire lumen and exits the head tube, and is fixedly connected to the head tube.

[0008] Furthermore, the outer diameter of the head tube gradually decreases from the sheath assembly toward the end, and the end of the head tube away from the four-lumen tube is hemispherical, which makes it easier to insert the head assembly into the patient's body, and the hemispherical end makes insertion into the patient's body smoother and prevents injury to the patient's body.

[0009] Furthermore, the injection inlet is an injection adapter provided on a four-lumen tube, and the injection adapter is connected to the injection lumen; the two guidewire inlets are respectively a first guidewire adapter and a second guidewire adapter; the two guidewire lumens are respectively a first guidewire lumen and a second guidewire lumen; the first guidewire adapter is connected to the first guidewire lumen and the second guidewire adapter is connected to the second guidewire lumen; the two guidewire outlets are respectively a first guidewire outlet and a second guidewire outlet; the first guidewire outlet is connected to the first guidewire lumen and the second guidewire outlet is connected to the second guidewire lumen. During surgery, two guidewire lumens can be inserted into two guidewires. When one guidewire is placed in the pancreatic duct, another can be inserted directly into the bile duct. Or, when one guidewire is placed in the right hepatic duct, another can be inserted directly into the left hepatic duct. This greatly improves the success rate of intubation. In addition, the injection inlet can be set as an injection adapter, and the guidewire inlet can be set as a guidewire adapter, making it even more convenient to use.

[0010] Furthermore, the first guidewire outlet and injection outlet are located at the end of the head tube farthest from the four-lumen tube, and the second guidewire outlet is located at a side end of the head tube, with the distance between the first and second guidewire outlets being 3 to 5 mm. With this arrangement, one guidewire emerges from the first guidewire outlet in a direction that is aligned with the entire dissection knife, allowing it to be inserted into, for example, the pancreatic duct, while another guidewire emerges from the second guidewire outlet at the side end, with its extension direction forming a certain inclination angle with respect to the dissection knife. This facilitates insertion of the guidewire into bile ducts other than the pancreatic duct, making the guidewire insertion process faster and more accurate.

[0011] Furthermore, the handle body includes a core rod, one end of which is provided with a thumb loop, the other end of which is provided with an end cap, the four-lumen tube is fixedly connected to the end cap, a sliding handle is provided on the core rod, the sliding handle is provided with an electrode holder, the electrodes are attached to the electrode holder, and the head tube is made of a bendable material. In use, the index finger and middle finger can be inserted into the sliding handle, the thumb can be inserted into the thumb loop, and the sliding handle can be slid, and the cutting wire can be used to bend the head tube into a certain arc, which, in cooperation with the rotation of the colonoscope, makes it easier to insert the second guidewire lumen and the guidewire into the second guidewire lumen.

[0012] Furthermore, a limit block is provided at the end of the slide handle near the thumb loop, and the limit block is slidably mounted on the rod, so that the slide handle can be prevented from sliding excessively on the rod.

[0013] Furthermore, the second guidewire exit is provided with an arc-shaped notch, which allows the subsequent guidewire to form a specific bevel angle after exiting, making operation more convenient.

[0014] Furthermore, the distance from the first guidewire adapter communicating with the first guidewire outlet to the end of the head tube is greater than the distance from the second guidewire adapter to the end of the head tube. With this arrangement, the first guidewire adapter is positioned near the handle assembly, and the guidewire inserted from the first guidewire adapter always exits from the end of the head tube, while another guidewire exits from the side end of the head tube, reducing the likelihood of a doctor making a mistake when performing surgery.

[0015] Furthermore, the four-lumen tube has a circular structure, and has first and second symmetry axes that are perpendicular to each other, the first guidewire lumen and the second guidewire lumen are respectively symmetrically arranged on both sides of the first symmetry axis, and the injection lumen and the cutting wire lumen are respectively symmetrically arranged on both sides of the second symmetry axis, so that the first guidewire lumen and the second guidewire lumen are located on both sides of the second symmetry axis, which facilitates the two guidewires to exit at different angles.

[0016] Furthermore, the cutting wire is covered with an insulating sleeve, and the part of the cutting wire close to the head tube is exposed. In this technical solution, only the cutting wire close to the head tube is exposed, which can avoid large wounds when the doctor makes a surgical incision, and is therefore safer for the patient. [Effects of the Invention]

[0017] The beneficial effects of the present invention are as follows: 1. The present invention provides a four-lumen tube with four cavities, including an injection cavity, a cutting cavity, and two guide wire cavities. During use, the injection cavity of the papillotomy knife of the present invention can be directly used to inject contrast medium, and the cutting wire in the cutting cavity can be used to perform cutting surgery. Two guide wires can be inserted using the two guide wire cavities, making it easier to simultaneously intubate the bile duct and pancreatic duct or simultaneously guide the guide wires through the right and left hepatic ducts during intubation, making it more convenient to use. 2. When using the present invention, medical personnel insert their index and middle fingers into the sliding handle, insert their thumb into the thumb loop, slide the sliding handle in the direction of the thumb loop, and use the cutting wire to bend the head tube into a certain arc. In cooperation with rotating the colonoscope, this allows for insertion of one end of the head tube into the patient's body. Because the present invention has two guidewire lumens, a first guidewire lumen and a second guidewire lumen, two guidewires can be inserted through the first and second guidewire Luer adapters. When one guidewire is positioned in the pancreatic duct through the first guidewire outlet, another can be inserted obliquely directly into the bile duct through the second guidewire outlet at the side end. Alternatively, when one guidewire is positioned in the right hepatic duct through the first guidewire outlet, another can be inserted obliquely directly into the left hepatic duct through the second guidewire outlet. This significantly improves the success rate of intubation and reduces the incidence of ERCP complications. [Brief explanation of the drawings]

[0018] [Figure 1] 1 is a schematic diagram of the structure of a double guidewire four-lumen papillotomy knife according to the present invention. [Figure 2] FIG. 2 is a structural schematic diagram of the handle assembly of FIG. 1. [Figure 3] FIG. 2 is a structural schematic diagram of the sheath assembly of FIG. 1. [Figure 4] FIG. 4 is a schematic diagram of the cross-sectional structure of the four-lumen tube of FIG. 3. [Figure 5] FIG. 2 is a structural schematic diagram of the head assembly in FIG. 1 when the second guide wire exit is on the left side. [Figure 6] FIG. 2 is a structural schematic diagram of the head assembly in FIG. 1 when the second guide wire exit is on the right side. [Figure 7] FIG. 7 is a schematic diagram of the top structure of the head assembly of FIG. 6. [Figure 8]FIG. 1 is a schematic diagram showing the application of the double guidewire four-lumen papillotomy knife of the present invention to the bile duct and pancreatic duct. [Figure 9] FIG. 1 is a schematic diagram showing the application of the double guidewire four-lumen papillotomy knife of the present invention to the left and right hepatic ducts. DETAILED DESCRIPTION OF THE INVENTION

[0019] The present invention will now be described in detail with reference to the drawings.

[0020] As shown in FIG. 1, the double guidewire four-lumen papillotomy knife of this embodiment includes a handle assembly 1, a sheath assembly 2, and a head assembly 3 connected in this order. As shown in FIG. 2, the handle assembly 1 includes a handle body and a handle electrode 1-6. A cutting wire 3-3 is electrically connected to the electrode 1-6. The handle body includes a core rod 1-2. A thumb loop 1-1 is snap-connected to the left end of the core rod 1-2. An end cap 1-7 is attached to the right end of the core rod 1-2. A sliding handle 1-4 is axially slidably fitted onto the core rod 1-2. An electrode holder 1-5 is screw-connected to the sliding handle 1-4. The electrode 1-6 is screwed into the electrode holder 1-5. A limit block 1-3 is provided at the end of the sliding handle 1-4. The limit block 1-3 is slidably mounted on the core rod 1-2.

[0021] As shown in Figures 3 and 4, the sheath assembly 2 includes a four-lumen tube 2-1, which is attached to an end cap 1-7. The four-lumen tube 2-1 is provided with an injection lumen 2-1-1, a cutting wire lumen 2-1-4, and two guidewire lumen assemblies that axially penetrate the four-lumen tube 2-1. The four lumen assemblies do not communicate with each other. The four-lumen tube 2-1 is provided with an injection luer adapter 2-3 that communicates with the injection lumen 2-1-1 and two guidewire inlets that communicate with the two guidewire lumens, respectively. The two guidewire inlets are a first guidewire luer adapter 2-2 and a second guidewire luer adapter 2-4, and heat-shrink tubing 2-5 is installed at the connection portions of the injection luer adapter 2-3, the first guidewire luer adapter 2-2, and the second guidewire luer adapter 2-4 with the four-lumen tube 2-1. The two guidewire lumens are the first guidewire lumen 2-1-2 and the second guidewire lumen 2-1-3, respectively; the first guidewire luer adapter 2-2 is connected to the first guidewire lumen 2-1-2, and the second guidewire luer adapter 2-4 is connected to the second guidewire lumen 2-1-3; the two guidewire outlets are the first guidewire outlet 3-5 and the second guidewire outlet 3-6, respectively; the first guidewire outlet 3-5 is connected to the first guidewire lumen 2-1-2, and the second guidewire outlet 3-6 is connected to the second guidewire lumen 2-1-3. The four-lumen tube 2-1 has a circular structure, and is provided with a first symmetry axis 2-1-5 and a second symmetry axis 2-1-6 that are perpendicular to each other. The first guide wire lumen 2-1-2 and the second guide wire lumen 2-1-3 are symmetrically arranged on both sides of the first symmetry axis 2-1-5, and the injection lumen 2-1-1 and the cutting wire lumen 2-1-4 are symmetrically arranged on both sides of the second symmetry axis 2-1-6.

[0022] The head assembly 3 includes a head tube made of a bendable material such as medical rubber. In this embodiment, the head tube and the four-lumen tube 2-1 are integrally formed. The distance from the first guidewire luer adapter 2-2, which communicates with the first guidewire outlet 3-5, to the end of the head tube is greater than the distance from the second guidewire luer adapter 2-4 to the end of the head tube, meaning that the first guidewire luer adapter 2-2 is closer to the handle assembly 1. In this embodiment, the inner diameter of the injection lumen 2-1-1 passage is φ0.7 mm, the inner diameter of the cutting wire lumen 2-1-4 passage is φ0.6 mm, and the inner diameters of the first guidewire lumen 2-1-2 and the second guidewire lumen 2-1-3 passage are all φ0.75 mm.

[0023] As shown in Figures 5-7, the outer diameter of the head tube gradually decreases from the sheath assembly 2 toward the end. The right end of the head tube is hemispherical. The first guidewire outlet 3-5 and the injection outlet 3-7 are located at the hemispherical end of the tube head. The second guidewire outlet 3-6 is located at the side end of the head tube. As shown in Figures 5 and 7, the side end here can be the left or right end of the cutting wire 3-3. An arc-shaped notch is drilled into the second guidewire outlet 3-6 using a soldering iron or other heating tool. The distance between the first guidewire outlet 3-5 and the second guidewire outlet 3-6 is 3-5 mm, preferably 4 mm in this embodiment. The end of the cutting wire 3-3 away from the electrode 1-6 passes through the cutting wire lumen 2-1-4 and exits the head tube, where it is fixedly connected to the head tube. The cutting wire 3-3 is covered with an insulating sleeve, and a portion of the cutting wire 3-3 near the head tube is exposed. The head tube is also provided with a first colored ink graduation line 3-2 and a second colored ink graduation line 3-4 to help medical personnel understand the depth to which the head tube is inserted into the body.

[0024] The method of using the double guidewire four-lumen papillotomy knife according to the present invention is as follows.

[0025] In use, medical personnel insert their index and middle fingers into the sliding handle 1-4, insert their thumb into the thumb loop 1-1, slide the sliding handle 1-4 in the direction of the thumb loop 1-1, and use the cutting wire 3-3 to bend the head tube into a certain arc in cooperation with the rotation of the colonoscope, at which time the limit block 1-3 can prevent the sliding handle 1-4 from sliding excessively on the mandrel 1-2. When one end of the head tube is inserted into the patient's body through the duodenoscope, medical personnel can check the depth of the head tube inserted into the body through the first colored scale line 3-2 and the second colored scale line 3-4. The papillotomy knife of this embodiment has two guidewire lumens, a first guidewire lumen 2-1-2 and a second guidewire lumen 2-1-3, allowing for the insertion of two guidewires. The guidewires are inserted through the first guidewire luer adapter 2-2 and the second guidewire luer adapter 2-4. As shown in FIG. 8, when the first guidewire 4 is positioned in the pancreatic duct through the first guidewire outlet 3-5, the second guidewire 5 can be inserted obliquely directly into the bile duct through the second guidewire outlet 3-6 at the side end. Alternatively, as shown in FIG. 9, when the first guidewire 4 is positioned in the right hepatic duct through the first guidewire outlet 3-5, the second guidewire 5 can be inserted obliquely directly into the left hepatic duct through the second guidewire outlet 3-6. This significantly shortens the surgical time and reduces the incidence of ERCP complications.

[0026] The above examples are only used to explain the technical solutions of the present invention and do not limit the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art will understand that the technical solutions of the present invention can be modified or equivalently replaced without departing from the purpose and scope of the technical solutions of the present invention. All of these should be encompassed within the scope of the claims of the present invention. It should be noted that the techniques, shapes, and components not described in detail in the present invention are all well-known technologies. [Explanation of symbols]

[0027] 1 Handle Assembly 2 Sheath Assembly 3 Head Assembly 4 First guide wire 5 Second guidewire 1-1 Thumb loop 1-2 Core rod 1-3 Limit Block 1-4 Slide handle 1-5 Electrode holder 1-6 electrode 1-7 End cap 2-1 Four-lumen tube 2-2 First guidewire luer adapter 2-3 Injection Luer Adapter 2-4 Second guidewire luer adapter 2-5 Heat shrink tubing 2-1-1 Injection cavity 2-1-2 First guidewire lumen 2-1-3 Second guidewire lumen 2-1-4 Cutting wire cavity 2-1-5 First axis of symmetry 2-1-6 Second axis of symmetry 3-1 Insulating sleeve 3-2 First color ink scale line 3-3 Cutting wire 3-4 Second color ink scale line 3-5 First guidewire exit 3-6 Second guidewire exit 3-7 Injection outlet

Claims

1. a head assembly including a head tube, an injection outlet port connected to the injection lumen, and two guidewire outlet ports connected to the two guidewire lumens, the head assembly including a head tube, an injection outlet port connected to the injection lumen, and two guidewire outlet ports connected to the two guidewire lumens, the end of the cutting wire remote from the electrode passing through the cutting wire lumen and exiting the head tube, the end of the cutting wire fixedly connected to the head tube.

2. 2. The double guidewire four-lumen papillotomy knife of claim 1, wherein the outer diameter of the head tube gradually decreases from the sheath assembly toward the end, and the end of the head tube remote from the four-lumen tube is hemispherical.

3. 2. The double-guidewire four-lumen papillotomy knife according to claim 1, wherein the injection inlet is an injection adapter provided on the four-lumen tube, the injection adapter communicating with the injection lumen, the two guidewire inlets are a first guidewire adapter and a second guidewire adapter, respectively, the two guidewire lumens are a first guidewire lumen and a second guidewire lumen, the first guidewire adapter communicates with the first guidewire lumen and the second guidewire adapter communicates with the second guidewire lumen, the two guidewire outlets are a first guidewire outlet and a second guidewire outlet, respectively, the first guidewire outlet communicates with the first guidewire lumen and the second guidewire outlet communicates with the second guidewire lumen.

4. 4. The double-guidewire four-lumen papillotomy knife according to claim 3, wherein the first guidewire outlet and the injection outlet are located at an end of the head tube away from the four-lumen tube, the second guidewire outlet is located at a side end of the head tube, and the distance between the first guidewire outlet and the second guidewire outlet is 3 to 5 mm.

5. The double guidewire four-lumen papillotomy knife according to claim 1, characterized in that the handle body includes a core rod, one end of the core rod is provided with a thumb loop, the other end of the core rod is provided with an end cap, the four-lumen tube is fixedly connected to the end cap, a sliding handle is provided on the core rod, an electrode holder is provided on the sliding handle, the electrode is attached to the electrode holder, and the head tube is made of a bendable material.

6. 6. The double guidewire four-lumen papillotomy knife according to claim 5, wherein a limit block is provided at the end of the sliding handle near the thumb loop, and the limit block is slidably mounted on the mandrel.

7. 5. The double guidewire four-lumen papillotomy knife according to claim 4, wherein the second guidewire outlet is provided with an arc-shaped notch.

8. 5. The double guidewire four-lumen papillotomy knife according to claim 4, wherein the distance from the first guidewire adapter communicating with the first guidewire outlet to the end of the head tube is greater than the distance from the second guidewire adapter to the end of the head tube.

9. 4. The double guidewire four-lumen papillotomy knife according to claim 3, wherein the four-lumen tube has a circular structure, has first and second symmetry axes that are perpendicular to each other, the first guidewire lumen and the second guidewire lumen are respectively symmetrically arranged on both sides of the first symmetry axis, and the injection lumen and the cutting wire lumen are respectively symmetrically arranged on both sides of the second symmetry axis.

10. A double guide wire four-lumen papillotomy knife as described in any one of claims 1 to 9, characterized in that the cutting wire is covered with an insulating sleeve and a portion of the cutting wire near the head tube is exposed.

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