WO2024045714A1

WO2024045714A1 - Front-end assembly of ureteral sheath, ureteral sheath, and device inserted into ureter

Info

Publication number: WO2024045714A1
Application number: PCT/CN2023/096798
Authority: WO
Inventors: 周震华
Original assignee: 湖南省华芯医疗器械有限公司
Priority date: 2022-08-31
Filing date: 2023-05-29
Publication date: 2024-03-07
Also published as: CN115531689A

Abstract

Disclosed are a front-end assembly of a ureteral sheath, the ureteral sheath, and a device inserted into the ureter, relating to the technical field of medical instruments, wherein the front-end assembly comprises an expandable section (200). The expandable section (200) is provided with a second inner cavity (230) and a suction port (240) in communication with the second inner cavity (230). The expandable section (200) has a contracted state and an expanded state. The expandable section (200) can be switched between the contracted state and the expanded state. When the expandable section (200) is in the contracted state, the opening size of the second inner cavity gradually decreases in a first direction, and the first direction is an extension direction of the expandable section (200) from the proximal end to the distal end; when the expandable section (200) is in the contracted state, the ureteral sheath can be inserted into the ureter without the assistance of an expander, and the space occupied by the expandable section (200) in the contracted state in a radial direction is small, so that the body can be prevented from being damaged; the expandable section (200) can be switched to the expanded state after being inserted into the human body, so that the opening diameter of the suction port is increased, and broken stones, blood clots, and purulent floccules are easily discharged from the ureteral sheath.

Description

A front-end component of a ureteral sheath, a ureteral sheath and a device for inserting into the ureter

Technical field

The present invention relates to the technical field of medical devices, and in particular to a front-end assembly of a ureteral sheath, a ureteral sheath and a device for inserting into the ureter.

Background technique

The ureteral sheath is used in urological surgery. Before clinical urological surgery, the ureteral sheath must be inserted into the ureter. The flexible ureteroscope enters the ureteral sheath and reaches the upper ureter or renal pelvis for surgical operation. During the operation, the flexible ureteroscope continues to the surgical field of view. Liquid is infused inside, and at the same time, the liquid in the surgical field is continuously discharged out of the body through the ureteral sheath to keep the surgical field clear.

The ureteral sheath in the related art usually requires the use of a dilator to assist in entering the human body. Since the dilator is made of hard material, it is easy to cause damage to the body during the insertion process; and because the dilator needs to be inserted or pulled out, existing There is interference between the sealing valve and the installation position of the dilator, so the doctor must install the sealing valve after removing the dilator, and then insert the endoscope, and the endoscope and the sealing valve are in surface contact, which may easily cause difficulty in inserting the endoscope. The doctor's operation is complex and laborious.

Contents of the invention

Based on this, it is necessary to provide a front-end component of a ureteral sheath, a ureteral sheath and a device for inserting into the ureter to address the above technical problems.

In order to solve the above problems, the present invention adopts the following technical solutions:

In a first aspect, embodiments of the present application provide a front-end component of a ureteral sheath. The disclosed front-end component of a ureteral sheath includes an expandable section. The expandable section is provided with a second lumen and is connected to the second lumen. Connected suction port, the expandable section has a contracted state and an expanded state, the expandable section can be switched between the contracted state and the expanded state, when the expandable section is in the contracted state , the opening size of the second inner cavity gradually decreases in the first direction, and the first direction is the The expandable section extends from the proximal end to the distal end.

Further, the expandable section includes a fixed portion and an expandable wall, and the expandable wall is connected to the fixed portion and defines the second inner cavity therebetween.

Further, the expandable wall is an arc-shaped structure, and the expandable wall is one of an air bag, a memory alloy component, and a stone basket.

Further, the front end component of the ureteral sheath further includes a camera component and a light-emitting component, and the camera component and the light-emitting component are provided on the fixing part.

Further, the front end assembly of the ureteral sheath further includes a temperature measuring probe and/or a pressure measuring probe, and the temperature measuring probe and/or the pressure measuring probe are provided on the fixed part.

Further, when the expandable section is in an expanded state, the opening size of the second inner cavity gradually increases in the first direction.

Further, in the first direction, the outer peripheral wall of the fixing part is inclined toward the axial direction of the expandable section.

In a second aspect, embodiments of the present application also provide a ureteral sheath. The ureteral sheath includes a sheath body and the aforementioned front-end assembly. The front-end assembly is located at the distal end of the sheath body. The sheath body is provided with the The second inner cavity is connected to the first inner cavity.

Further, the sheath body is provided with a partition wall extending along its axial direction, the partition wall divides the first inner cavity into an injection channel and a suction channel, and the distal end of the fixing part is provided with a The liquid injection channel is connected to a liquid injection port, and the suction channel is connected to the second inner cavity.

In a third aspect, embodiments of the present application also provide a device for inserting into the ureter, including a handle and the aforementioned ureteral sheath, and the proximal end of the sheath body is connected to the handle.

The technical solution adopted by the present invention can achieve the following beneficial effects:

First, the front end of the ureteral sheath is provided with an expansion section that can contract or expand. When the expandable section is in a contracted state, the ureteral sheath can be inserted into the ureter without the assistance of a dilator. The expandable section in the contracted state can move in the radial direction. It occupies less space and can avoid damage to the body. After being inserted into the human body, the expandable section can be switched to the expansion state, so that the diameter of the suction port is expanded and gravel, blood clots and purulent floc can be easily discharged from the ureteral sheath. ;

Second, based on the existence of the camera component and the light-emitting component, the ureteral sheath has the function of a nephroscope, eliminating the need for In addition to the method of inserting a nephroscope into the ureteral sheath; at the same time, compared with the traditional way of setting up a suction channel in the nephroscope, the radial size of the suction channel of the ureteral sheath has been expanded to prevent stone fragments, blood clots and purulent The passing capacity of floc is improved, and the ureteral sheath is less likely to be blocked;

Third, the temperature measuring probe can monitor the temperature in the renal pelvis, providing reference information for medical staff to avoid body damage caused by excessive temperature in the renal pelvis; the pressure measuring probe can monitor the pressure in the renal pelvis in real time, making it easier for medical staff to accurately judge and control the operation time. Avoid prolonged increase in pressure in the renal pelvis causing urogenic sepsis.

Description of drawings

In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the drawings needed to be used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings in the following description are only These are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without exerting creative efforts.

Figure 1 is a schematic structural diagram of the expandable section in an expanded state according to the embodiment of the present application;

Figure 2 is a schematic structural diagram of the expandable section in a contracted state according to the embodiment of the present application;

Figure 3 is a schematic structural diagram of the tube sheath body according to the embodiment of the present application;

Figure 4 is a schematic structural diagram of a ureteral sheath according to an embodiment of the present application;

Figure 5 is a partial enlarged schematic diagram of position A in Figure 4;

Figure 6 is a schematic structural diagram of a device for inserting into the ureter according to an embodiment of the present application.

In the picture:

100-tube sheath body, 110-first lumen, 111-injection channel, 112-suction channel, 120-partition wall; 200-expandable section, 210-fixed part, 220-expandable wall, 230-second Inner cavity, 240-suction port, 250-liquid injection port; 310-camera component, 320-light-emitting component, 330-temperature sensor probe, 340-pressure probe; 400-handle.

Detailed ways

In order to make the purpose, technical solutions and advantages of the present invention clearer, the technical solutions of the present invention will be described in detail below. Obviously, the described embodiments are only part of the embodiments of the present invention, and are not are all examples. Based on the embodiments of the present invention, all other implementations obtained by those of ordinary skill in the art without any creative work fall within the scope of protection of the present invention.

The terms "first", "second", etc. in the description and claims of this application are used to distinguish similar objects and are not used to describe a specific order or sequence. It is to be understood that the figures so used are interchangeable under appropriate circumstances so that the embodiments of the present application can be practiced in orders other than those illustrated or described herein, and that "first," "second," etc. are distinguished Objects are usually of one type, and the number of objects is not limited. For example, the first object can be one or multiple. In addition, "and/or" in the description and claims indicates at least one of the connected objects, and the character "/" generally indicates that the related objects are in an "or" relationship.

In the present invention, "proximal end" and "distal end" refer to the far and near position of the structure relative to human body operation in the use environment, so as to facilitate the description of the positional relationship between components and facilitate understanding; "proximal end" The positional relationship with "remote" is relative, not absolute.

The front-end assembly of the ureteral sheath, the ureteral sheath and the device for inserting into the ureter provided by the embodiments of the present application will be described in detail below with reference to the accompanying drawings 1 to 6 through specific embodiments and application scenarios.

Referring to Figures 1 to 6, an embodiment of the present application discloses a front-end assembly of a ureteral sheath. The front-end assembly of the ureteral sheath includes an expandable section 200. The expandable section 200 is provided with a second inner cavity 230 that penetrates along its axial direction. The second inner cavity 230 forms a suction port 240 on the front end surface of the expandable section 200. When the front end component of the ureteral sheath is placed in the human renal pelvis, blood clots, small stones, pus-like floc, etc. in the renal pelvis can be removed. It enters the second inner cavity 230 through the suction port 240 .

In the embodiment of the present application, referring to Figures 1 and 2, the expandable section 200 has a contracted state and an expanded state. When the expandable section 200 is in the contracted state, the opening size of the second inner cavity 230 is in the first direction. gradually decreases. The first direction is the extension direction of the expandable section from the proximal end to the distal end. That is to say, in the contracted state, compared with the proximal end of the expandable section 200, the opening size of the suction port 240 is smaller. Even in the closed state, the distal end of the expandable section 200 occupies less space in its radial direction; when the expandable section 200 is in the expanded state, the opening size of the suction port 240 is larger than that in the contracted state. Size of the opening.

For the front-end assembly of the ureteral sheath in the embodiment of the present application, when the expandable section 200 is in a contracted state, the front end of the expandable section 200 has a smaller outline size in its radial direction. When inserted into the human ureter, It can avoid damage to the base body when the tube is inserted, and also facilitates the insertion of the expandable segment 200 deep into the renal pelvis; after being inserted into the renal pelvis to a suitable position, the expandable segment 200 can be operated to switch to the expansion state. At this time, the suction port 240 has a larger opening. The size is conducive to allowing blood clots, small stones, pus-like flocs, etc. in the renal pelvis to enter the second inner cavity through the expanded suction port 240 and be discharged through the ureteral sheath.

In this embodiment, please refer to Figures 1 to 2 and 4 to 5. The expandable section 200 includes a fixed portion 210 and an expandable wall 220. The fixed portion 210 is the basic component of the expandable section 200 and has A certain rigidity can form a stable support to set the expandable wall 220, and at the same time, the expandable section 200 can have a certain rigidity to prevent the expandable section 200 from random bending deformation. The expandable wall 220 is connected to the fixed part 210, and The aforementioned second inner cavity 230 and suction port 240 are defined between them.

In the embodiment of the present application, the expandable wall 220 has an arc-shaped structure, and both ends of the expandable wall 220 in the circumferential direction are connected to the fixed portion 210 respectively. When the expandable section 200 is in a contracted state, the expandable wall 220 Adhering to the fixing part 210, when the expandable section 200 is in an expanded state, the expandable wall 220 is separated from the fixing part 210 and forms the aforementioned suction port 240.

In an optional embodiment, the expandable wall 220 may be an airbag. When the airbag is not inflated, the airbag is in a deflated state and is in contact with the fixed part 210. At this time, the expandable section 200 is in a contracted state. After the expandable section 200 is placed in the renal pelvis, the air bag is inflated so that the air bag is deformed in a full shape and separated from the fixing part 210, thereby expanding the suction port 240.

In another optional embodiment, the expandable wall 220 can be a memory alloy component. The memory alloy component has a shape memory effect, and one of its important properties is superelasticity. The superelasticity of the memory alloy component will change at a certain temperature. The triggering temperature is determined by the elemental composition of the alloy and its ratio. Therefore, in order to achieve the required superelasticity, it can be achieved through a suitable alloy composition ratio; in this embodiment, an electric current connected to the expandable wall 220 can be set. Before the connected conductive wire is inserted into the human ureter, the memory alloy component is attached to the fixed part 210. After the expandable section 200 is inserted into the human ureter, the conductive wire can be energized to cause the memory alloy component to reach the preset trigger temperature, and the memory alloy component is deformed. And return to the expanded state.

In another optional embodiment, the expandable wall 220 may be a mesh-shaped stone removal basket. The stone removal basket includes a plurality of flexible filaments, which can be expanded or collapsed by applying force. When the stone removal basket collapses, When , the expandable section 200 is in a contracted state, and when it expands, the expandable section 200 is in a contracted state. expansion state. In this embodiment, the stone removal basket may be constructed of at least one of plastics, textile fibers, synthetic fibers, and natural fibers. It should be noted that in this embodiment, a traction device connected to the stone removal basket may be provided. The rope pulls the stone extraction basket through the traction rope to expand or collapse the stone extraction basket.

In the embodiment of the present application, the front-end component of the ureteral sheath may also include a camera component 310 and a light-emitting component 320. The camera component 310 and the light-emitting component 320 are provided on the distal wall of the fixed part 210. The light-emitting component 320 can provide illumination to the camera component 310. Optimize the shooting environment of the camera assembly 310; on the one hand, during the insertion of the expandable section 200 into the human ureter, the insertion process is visualized through the intervention of the camera assembly 310, and the ureteral sheath can be efficiently inserted into the renal pelvis, even to the renal calyce. , while avoiding damage to the renal pelvis caused by the ureteral sheath; on the other hand, after inserting the ureteral sheath, there is no need to insert a nephroscope into the ureteral sheath, and the renal pelvis can be observed directly through the camera assembly 310, which improves the convenience of the operation and reduces the cost of the operation. cost.

During the research process, the inventor found that the suction channel in the related art is usually located in the nephroscope. During use, the nephroscope is inserted into the ureteral sheath. The radial size of the ureteral sheath is limited by the human ureter, while the radial size of the nephroscope is limited by the human ureter. The limitations of the ureteral sheath result in a smaller radial size of the suction channel of the nephroscope and a weaker ability to expel stone fragments; and the ureteral sheath of this embodiment has the function of a nephroscope, so compared with the kidney Mirror, the radial size of the suction channel has been expanded, making the suction channel's ability to discharge stone fragments significantly enhanced and less likely to be blocked.

In a further technical solution, the front-end assembly of the ureteral sheath also includes a temperature measuring probe 330. The temperature measuring probe 330 is provided on the fixed part 210, optionally on the front end wall of the fixed part 210. The temperature measuring probe 330 can be used to measure the inside of the renal pelvis. Temperature; although the laser is cold light, during the laser lithotripsy process, because it has high energy, heat will be generated. Therefore, long-term laser lithotripsy will cause the temperature in the renal pelvis to increase, and the temperature measurement in this embodiment The probe 330 can monitor the temperature in the renal pelvis and provide reference information for medical staff to avoid body damage caused by excessive temperature in the renal pelvis.

In a further technical solution, the front-end assembly of the ureteral sheath also includes a pressure measuring probe 340. The pressure measuring probe 340 is provided on the fixed part 210, optionally on the front end wall of the fixed part 210. The pressure measuring probe 340 can be used to measure the inside of the renal pelvis. Pressure, by detecting the pressure deep in the renal pelvis in real time, it is convenient for medical staff to accurately judge and control the operation time, and to avoid urogenic sepsis caused by excessive pressure increase in the renal pelvis.

As can be seen from the foregoing, when the expandable section is in the expanded state, the opening size of the suction port 240 is larger than that in the contracted state. In the embodiment of the present application, when the expandable section is in the expanded state, the second The opening size of the inner cavity 230 gradually increases in the first direction; that is to say, the caliber of the suction port 240 is larger than the caliber of the proximal end of the expandable segment 200. In this way, after the expandable segment 200 is inserted into the renal pelvis, the opening size of the larger opening becomes larger. The suction port 240 can facilitate the suction of gravel, blood clots and purulent floc in the renal pelvis into the second inner cavity 230.

In a further technical solution, in the first direction, the outer peripheral wall of the fixing part 210 is inclined toward the axial direction of the expandable section 200; with this arrangement, the fixing part 210 has a tapered structure in the first direction, and can be further smaller The distal end of the expandable section 200 occupies space in the radial direction, thereby avoiding damage to the body and making insertion easy.

The embodiment of the present application also discloses a ureteral sheath. Referring to Figures 4 and 5, the disclosed ureteral sheath includes a sheath body 100 and the aforementioned front-end assembly of the ureteral sheath. The front-end assembly is located at the distal end of the sheath body 100. The sheath body 100 is provided with a first lumen 110 connected with the second lumen 230. The first lumen 110 and the second lumen 230 are connected. With this arrangement, gravel, blood clots and pus in the renal pelvis are eliminated. The floc and the like can be discharged through the suction port 240, the second inner cavity 230 and the first inner cavity 110 in sequence.

In the aforementioned embodiments, the first lumen 110 may be a separate lumen structure, which is connected with the second lumen and together form the suction channel of the ureteral sheath. In a further technical solution, the first inner cavity 110 may include two relatively independent cavity structures. Specifically, please refer to Figure 3. A partition wall 120 extending along the axial direction of the sheath body 100 is provided. The partition wall 120 divides the first inner cavity 110 into a liquid injection channel 111 and a suction channel 112. The liquid injection channel 111 and the suction channel 112 are relatively independent. The distal end of the fixed part 210 is provided with a liquid injection port 250 connected with the liquid injection channel 111. , the suction channel 112 is connected with the second inner cavity 230, the injection channel 111 is used to inject medical solution or physiological saline into the renal pelvis, and the suction channel 112 is used to discharge gravel, blood clots and purulent floc in the renal pelvis. etc.; under such arrangement, the injection port 250 and the suction port 240 of the ureteral sheath are at close positions in the renal pelvis, thereby forming a good water circulation at the distal end of the sheath body 100, which not only enables a clear observation field, but also It can avoid the risk of infection caused by increasing the perfusion volume.

It should be noted that in the embodiment of the present application, in addition to the aforementioned injection channel 111 and suction channel 112, the ureteral sheath can also be provided with a cable channel (not shown in the figure), and the cable channel can be used to connect the camera assembly 310 , the cables of the light-emitting component 320, the temperature measurement probe 330 and the pressure measurement probe 340 pass through.

In the embodiment of the present application, the expandable section 200 can be integrally formed on the distal end of the sheath body 100 to form a ureteral sheath, or can be assembled on the distal end of the sheath body 100 using snap connection, threaded connection, etc. to form a ureter. The sheath is not limited in the embodiments of the present application; in addition, in the embodiments of the present application, the sheath body 100 is flexible and can be adaptively bent during insertion into the human ureter. For example, it is made of rubber material, polyurethane, etc. into a tubular structure. Alternatively, the pipe sheath body 100 is a spiral metal pipe covered with an outer coating, which can be flexibly deformed, and the outer coating can be a heat shrink tube.

Referring to FIG. 6 , an embodiment of the present application also discloses a device for inserting into the ureter. The disclosed device for inserting into the ureter includes a handle and the aforementioned ureteral sheath. The proximal end of the ureteral sheath is connected to the handle 400 .

It should be noted that, in this document, the terms "comprising", "comprises" or any other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article or device that includes a series of elements not only includes those elements, It also includes other elements not expressly listed or inherent in the process, method, article or apparatus. Without further limitation, an element defined by the statement "comprises a..." does not exclude the presence of additional identical elements in a process, method, article or apparatus that includes that element. In addition, it should be pointed out that the scope of the methods and devices in the embodiments of the present application is not limited to performing functions in the order shown or discussed, but may also include performing functions in a substantially simultaneous manner or in reverse order according to the functions involved. Functions may be performed, for example, the methods described may be performed in an order different from that described, and various steps may be added, omitted, or combined. Additionally, features described with reference to certain examples may be combined in other examples.

The above are only specific embodiments of the present invention, but the protection scope of the present invention is not limited thereto. Any person familiar with the technical field can easily think of changes or substitutions within the technical scope disclosed by the present invention. should be covered by the protection scope of the present invention.

Claims

A front-end assembly of a ureteral sheath, characterized by comprising an expandable section (200), the expandable section (200) being provided with a second inner cavity (230) and a second inner cavity (230) connected to the second inner cavity (230). Suction port (240), the expandable section (200) has a contracted state and an expanded state, and the expandable section (200) can be switched between the contracted state and the expanded state. When the segment (200) is in a contracted state, the opening size of the second lumen (230) gradually decreases in a first direction, and the first direction is from the proximal end to the expandable segment (200). The direction of distal extension.
The front-end assembly of the ureteral sheath according to claim 1, wherein the expandable section (200) includes a fixed portion (210) and an expandable wall (220), and the expandable wall (220) is connected to the expandable wall (220). The fixing parts (210) are connected and define the second inner cavity (230) therebetween.
The front-end assembly of the ureteral sheath according to claim 2, characterized in that the expandable wall (220) is an arc-shaped structure, and the expandable wall (220) is a balloon, a memory alloy component, and a stone basket. One.
The front-end assembly of the ureteral sheath according to claim 2, characterized in that the front-end assembly of the ureteral sheath further includes a camera assembly (310) and a light-emitting assembly (320), and the camera assembly (310) and the light-emitting assembly (320) is provided on the fixing part (210).
The front-end assembly of the ureteral sheath according to claim 2, characterized in that the front-end assembly of the ureteral sheath further includes a temperature measurement probe (330) and/or a pressure measurement probe (340), and the temperature measurement probe (330) And/or the pressure probe (340) is provided on the fixed part (210).
The front-end assembly of the ureteral sheath according to claim 2, wherein when the expandable section (200) is in an expanded state, the opening size of the second lumen (230) is in the first direction. gradually increase.
The front-end assembly of the ureteral sheath according to any one of claims 2 to 6, characterized in that in the first direction, the outer peripheral wall of the fixing part (210) is directed toward the axis of the expandable section (200). tilt towards.
A ureteral sheath, characterized by comprising a sheath body (100) and a front-end component of the ureteral sheath according to any one of claims 2 to 7, the front-end component being located at the distal end of the sheath body (100) , the sheath body (100) is provided with a first inner cavity (110) connected with the second inner cavity (230).
The ureteral sheath according to claim 8, characterized in that a partition wall (120) extending along the axial direction of the sheath body (100) is provided, and the partition wall (120) separates the first inner The cavity (110) is divided into a liquid injection channel (111) and a suction channel (112). The distal end of the fixed part (210) is provided with a liquid injection port (250) connected with the liquid injection channel (111). The suction channel (112) is connected with the second inner cavity (230).
A device for inserting into the ureter, characterized by comprising a handle (400) and the ureteral sheath according to any one of claims 8 to 9, and the proximal end of the sheath body (100) is connected to the handle (400).