Ureteral access device and methods of use thereof, ureteral access system

Abstract

This invention discloses a ureteral recanalization device and its application method, comprising a metal guidewire, a nickel-titanium alloy sheath, and a nickel-titanium alloy drilling device. In application, the metal guidewire, the nickel-titanium alloy sheath, and the nickel-titanium alloy drilling device form different components, and are used in conjunction with a ureteroscope to perform corresponding operations at different stages. After ureteral recanalization, a double-J stent is inserted into the ureter via the metal guidewire. After the metal guidewire is withdrawn, ureteral recanalization is achieved. This device has a simple structure, is easy to operate, and effectively solves the clinical problem of ureteral recanalization, achieving ureteral recanalization and avoiding the need for renal biopsy. For specific clinical applications, the ureteroscope is matched with optimal dimensions, and different components are combined to quickly achieve ureteral recanalization without surgery.

Description

Technical Field

[0001] This invention belongs to the field of clinical application devices for the ureter, specifically relating to a ureteral recanalization device and its application method, and a ureteral recanalization system. Background Technology

[0002] The incidence of advanced malignant tumors is currently on the rise every year. Advanced malignant tumors, including gastrointestinal tumors, gynecological tumors, and other malignant tumors of abdominal organs, are very likely to invade the ureter, causing ureteral obstruction, hydronephrosis, and a series of problems such as infection and decreased kidney function.

[0003] The characteristics of these malignant tumors invading the ureter are: the malignant tumor invades the ureteral wall and grows inside the ureter, blocking the entire lumen, often affecting a length of several centimeters, and these metastatic tumors are relatively hard in texture. Figure 1 Once blocked, it is very difficult to reopen the obstruction using ureteroscopic techniques. In such cases, the only way to relieve the obstruction is through renal biopsy, but the patient needs to have a nephrostomy tube placed in their lower back for a long period of time, which requires regular replacement and significantly impacts their quality of life. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a ureteral recanalization device and its application method, which solves the problem of difficulty in recanalization after malignant tumors invade the ureter in the prior art.

[0005] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:

[0006] A ureteral recanalization device includes a metal guidewire, a nickel-titanium alloy sheath, and a nickel-titanium alloy drilling device. In application, the metal guidewire, the nickel-titanium alloy sheath, and the nickel-titanium alloy drilling device are used to form different components. In conjunction with a ureteroscope, corresponding operations are performed at different stages. After the ureter is unblocked, a double-J stent is inserted into the ureter through the metal guidewire. After the metal guidewire is removed, ureteral recanalization is achieved.

[0007] One end of the metal guide wire is pointed.

[0008] The diameter of the metal guide wire is smaller than the inner diameter of the nickel-titanium alloy sheath, and its length is greater than the length of the nickel-titanium alloy sheath.

[0009] The nickel-titanium alloy drilling device includes a tubular body and a pointed threaded cutter located at the front end.

[0010] The maximum diameter of the pointed thread cutter is 2-4 mm.

[0011] The application method of the ureteral recanalization device includes the following steps:

[0012] Step 1: Insert the ureteroscope into the ureter, pass the metal guidewire through the nickel-titanium alloy sheath to form an assembly, and insert the assembly under direct vision until it passes through the ureter at the blockage to reach the predetermined depth;

[0013] Step 2: Remove the metal guidewire, leaving the nickel-titanium alloy sheath inside the ureter. Determine whether the nickel-titanium alloy sheath has passed through the blocked ureter and reached the dilated ureteral lumen. If so, proceed to step 3.

[0014] Step 3: Insert the metal guidewire into the nickel-titanium alloy sheath, then remove the nickel-titanium alloy sheath, leaving the metal guidewire in the ureter;

[0015] Step 4: Guided by a metal guidewire, insert a flexible endoscope sheath;

[0016] Step 5: Guided by a metal guide wire, insert the nickel-titanium alloy drilling device until it reaches the blockage, and rotate the nickel-titanium alloy drilling device to gradually pass through the blocked section of the ureter.

[0017] Step 6: Remove the metal guide wire. After the urine is drained through the nickel-titanium alloy drilling device, insert the metal guide wire inside the nickel-titanium alloy drilling device and rotate it out of the device.

[0018] Step 7: Insert a double-J stent through a metal guidewire, then remove the metal guidewire to achieve ureteral recanalization.

[0019] In step 2, the metal guidewire is withdrawn. If urine is seen being drawn out through the nickel-titanium alloy sheath, it is determined that the nickel-titanium alloy sheath has passed through the blocked ureter and reached the dilated ureteral lumen.

[0020] A ureteral recanalization system includes a ureteral recanalization device, a ureteroscope used in conjunction with the device, and an external display and control terminal. The ureteral recanalization device is used in conjunction with the ureteroscope to achieve ureteral recanalization. The external display and control terminal is used to display images or parameter data of the ureteral recanalization process in real time, and output stage results for analysis.

[0021] The external display control terminal includes multiple types, enabling data sharing and transmission with the ureteroscope.

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

[0023] 1. This device is designed to work in conjunction with a ureteroscope using a metal guidewire, a nickel-titanium alloy sheath, and a nickel-titanium alloy drilling device. It has a simple structure, is easy to operate, and effectively solves the clinical problem of ureteral recanalization, achieving ureteral recanalization and avoiding the need for renal biopsy.

[0024] 2. This device is designed to be compatible with ureteroscopes for specific clinical applications, with optimal specifications and dimensions, and combined with different components to quickly achieve ureteral recanalization without surgery.

[0025] 3. It has a simple structure, no technical bottlenecks in design and manufacturing, and is easy to operate. It can achieve precise ureteral recanalization, filling the technical gap in achieving ureteral recanalization under endoscopy. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of the components of the ureteral recanalization device of the present invention.

[0027] Figure 2 This is a side view of a component of the ureteral recanalization device of the present invention.

[0028] Figure 3 This is a side view of another component of the ureteral recanalization device of the present invention.

[0029] Figure 4 This is a flowchart of the ureteral recanalization method of the present invention.

[0030] The markings in the diagram are as follows: 1-Metal guide wire; 2-Ni-titanium alloy sheath; 3-First Ni-titanium alloy drilling device; 4-Second Ni-titanium alloy drilling device; 5-First pointed thread cutter; 6-Second pointed thread cutter. Detailed Implementation

[0031] To enable those skilled in the art to better understand the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present application, and not all embodiments.

[0032] Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of this application.

[0033] A ureteral recanalization device includes a metal guidewire, a nickel-titanium alloy sheath, and a nickel-titanium alloy drilling device. In application, the metal guidewire, the nickel-titanium alloy sheath, and the nickel-titanium alloy drilling device are used to form different components. In conjunction with a ureteroscope, corresponding operations are performed at different stages. After the ureter is unblocked, a double-J stent is inserted into the ureter through the metal guidewire. After the metal guidewire is removed, ureteral recanalization is achieved.

[0034] Specific embodiments, such as Figures 1 to 4 As shown:

[0035] A ureteral recanalization device includes a metal guidewire 1, a nickel-titanium alloy sheath 2, and a nickel-titanium alloy drilling device. In application, the metal guidewire 1, the nickel-titanium alloy sheath 2, and the nickel-titanium alloy drilling device are respectively used to form different components. In conjunction with a ureteroscope, corresponding operations are performed at different stages. After the ureter is unblocked, a double-J stent is inserted into the ureter through the metal guidewire. After the metal guidewire is removed, ureteral recanalization is achieved.

[0036] One end of the metal guide wire 1 is a sharp point.

[0037] The diameter of the metal guide wire 1 is smaller than the inner diameter of the nickel-titanium alloy sheath 2, and the length is greater than the length of the nickel-titanium alloy sheath 2. In this embodiment, the diameter of the metal guide wire 1 is 1.2 mm and the length is 150 cm. The inner diameter of the nickel-titanium alloy sheath is 1.4 mm, the outer diameter is 1.6 mm, and the length is 140 cm.

[0038] The nickel-titanium alloy drilling device includes a tubular body and a pointed threaded cutter at the front end. There are two types of nickel-titanium alloy drilling devices: a first nickel-titanium alloy drilling device 3 and a second nickel-titanium alloy drilling device 4. The first nickel-titanium alloy drilling device 3 has a first pointed threaded cutter 5, and the second nickel-titanium alloy drilling device 4 has a second pointed threaded cutter 6. The first pointed threaded cutter 5 is a blade with a split front end, while the second pointed threaded cutter 6 is a blade with an integrated front end. Both types of pointed threaded cutters serve the same purpose: to facilitate faster and easier penetration of the ureteral obstruction segment. The specific type can be chosen based on the specific application. In this embodiment, the diameter of the pointed threaded cutter is set to 3mm.

[0039] The application method of this ureteral recanalization device, such as Figure 4 As shown, it includes the following steps:

[0040] Step 1: Insert the ureteroscope into the ureter. If the lumen is blocked, insert the metal guidewire into the nickel-titanium alloy sheath to form an assembly. Insert the assembly under direct vision until it passes through the blocked ureter to a predetermined depth (the depth of insertion is determined by preoperative assessment).

[0041] Step 2: Remove the metal guidewire, leaving the nickel-titanium alloy sheath inside the ureter. Determine whether the nickel-titanium alloy sheath has passed through the blocked ureter and reached the dilated ureteral lumen. If urine is seen being drained, it means that the sheath has passed through the blocked segment. Proceed to Step 3.

[0042] Step 3: Insert the metal guidewire into the nickel-titanium alloy sheath, then remove the nickel-titanium alloy sheath, leaving the metal guidewire in the ureter;

[0043] Step 4: Guided by a metal guidewire, insert a flexible endoscope sheath;

[0044] Step 5: Guided by a metal guide wire, insert the nickel-titanium alloy drilling device until it reaches the blockage, and rotate the nickel-titanium alloy drilling device to gradually pass through the blocked section of the ureter.

[0045] Step 6: Remove the metal guide wire. After the urine is drained through the nickel-titanium alloy drilling device, insert the metal guide wire inside the nickel-titanium alloy drilling device and rotate it out of the device.

[0046] Step 7: Insert a double-J stent through a metal guidewire, then remove the metal guidewire to achieve ureteral recanalization.

[0047] To further illustrate the convenience and advantages of this device in clinical applications, the following is a detailed explanation of its application background and effects: This device is mainly used in cases of ureteral obstruction caused by advanced tumors involving the ureter. These cases are characterized by hard tumors and often involve a long ureter. Therefore, it is difficult to achieve ureteral recanalization through techniques such as endoscopic laser ablation (unguided, blind laser ablation of tumors in the ureter, which can easily lead to ureteral damage, or even ureteral perforation and damage to surrounding tissues and organs). At the same time, it can easily increase the occurrence of surgical complications.

[0048] This method achieves precise ureteral recanalization by guiding a metal guidewire inside the ureter, which is effective and avoids complications such as ureteral perforation and damage to surrounding tissues and organs.

[0049] To further enhance the ease of application of this device, a ureteral recanalization system is also disclosed, including a ureteral recanalization device, a ureteroscope used in conjunction with the device, and an external display and control terminal. The ureteral recanalization device is used in conjunction with the ureteroscope to achieve ureteral recanalization, and the external display and control terminal is used to display images or parameter data of the ureteral recanalization process in real time, output stage results, and perform analysis.

[0050] The external display control terminal includes multiple types, enabling data sharing and transmission with the ureteroscope.

[0051] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this application are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate for the embodiments of this application described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0052] In this application, the terms "upper," "lower," "left," "right," "front," "rear," "top," "bottom," "inner," "outer," "middle," "vertical," "horizontal," "lateral," and "longitudinal" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. These terms are primarily for the purpose of better describing this application and its embodiments, and are not intended to limit the indicated device, element, or component to having a specific orientation, or to be constructed and operated in a specific orientation.

[0053] Furthermore, in addition to indicating location or positional relationship, some of the aforementioned terms may also have other meanings. For example, the term "above" may also be used in some cases to indicate a certain dependency or connection relationship. Those skilled in the art can understand the specific meaning of these terms in this application based on the specific circumstances.

[0054] Furthermore, the terms "installation," "setup," "equipped with," "connection," "linking," and "socketing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral structure; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium, or an internal connection between two devices, components, or parts. Those skilled in the art can understand the specific meaning of these terms in this application based on the specific circumstances.

[0055] It should be understood that this solution is not limited to the specific embodiments described above. Devices and structures not described in detail herein should be understood as being implemented in a manner common to the art. Any person skilled in the art can make many possible variations and modifications to this solution, or modify it into equivalent embodiments, without departing from the scope of this solution, using the methods and techniques disclosed above. This does not affect the substantive content of this solution. Therefore, any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of this solution, without departing from its scope, still fall within the protection scope of this solution.

Claims

1. A ureteral recanalization device, characterized by: It includes a metal guidewire, a nickel-titanium alloy sheath, and a nickel-titanium alloy drilling device. In application, the metal guidewire, nickel-titanium alloy sheath, and nickel-titanium alloy drilling device are used to form different components. In conjunction with a ureteroscope, corresponding operations are performed at different stages. After the ureter is unblocked, a double-J stent is inserted into the ureter through the metal guidewire. After the metal guidewire is removed, the ureter is reopened.

2. The ureteral recanalization device according to claim 1, characterized in that: One end of the metal guide wire is pointed.

3. The ureteral recanalization device according to claim 1, characterized in that: The diameter of the metal guide wire is smaller than the inner diameter of the nickel-titanium alloy sheath, and its length is greater than the length of the nickel-titanium alloy sheath.

4. The ureteral recanalization device according to claim 1, characterized in that: The nickel-titanium alloy drilling device includes a tubular body and a pointed threaded cutter located at the front end.

5. The ureteral recanalization device according to claim 5, characterized in that: The maximum diameter of the pointed thread cutter is 2-4 mm.

6. A method of applying the ureteral recanalization device according to any one of claims 1 to 5, characterized in that: Includes the following steps: Step 1: Insert the ureteroscope into the ureter, pass the metal guidewire through the nickel-titanium alloy sheath to form an assembly, and insert the assembly under direct vision until it passes through the ureter at the blockage to reach the predetermined depth; Step 2: Remove the metal guidewire, leaving the nickel-titanium alloy sheath inside the ureter. Determine whether the nickel-titanium alloy sheath has passed through the blocked ureter and reached the dilated ureteral lumen. If so, proceed to step 3. Step 3: Insert the metal guidewire into the nickel-titanium alloy sheath, then remove the nickel-titanium alloy sheath, leaving the metal guidewire in the ureter; Step 4: Guided by a metal guidewire, insert a flexible endoscope sheath; Step 5: Guided by a metal guide wire, insert the nickel-titanium alloy drilling device until it reaches the blockage, and rotate the nickel-titanium alloy drilling device to gradually pass through the blocked section of the ureter. Step 6: Remove the metal guide wire. After the urine is drained through the nickel-titanium alloy drilling device, insert the metal guide wire inside the nickel-titanium alloy drilling device and rotate it out of the device. Step 7: Insert a double-J stent through a metal guidewire, then remove the metal guidewire to achieve ureteral recanalization.

7. The method of applying the ureteral recanalization device according to claim 6, characterized in that: In step 2, the metal guidewire is withdrawn. If urine is seen being drawn out through the nickel-titanium alloy sheath, it is determined that the nickel-titanium alloy sheath has passed through the blocked ureter and reached the dilated ureteral lumen.

8. A ureteral recanalization system based on the ureteral recanalization device according to any one of claims 1 to 5, characterized in that: It includes a ureteral recanalization device, a ureteroscope used in conjunction with the device, and an external display and control terminal; wherein, the ureteral recanalization device is used in conjunction with the ureteroscope to realize the recanalization of the ureter, and the external display and control terminal is used to display images or parameter data of the ureteral recanalization process in real time, and output stage results and perform analysis.

9. The ureteral recanalization system according to claim 8, characterized in that: There are various types of external display and control terminals, which enable data sharing and transmission with the ureteroscope.

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