Improved ureter guiding sheath

Abstract

The utility model provides an improved ureter guiding sheath, which comprises an operation part and an intubation tube suitable for being inserted into a ureter, the operation part is connected to the near end of the intubation tube, and a central channel extending from the near end to the far end is defined in the intubation tube. An inlet communicated with a central channel of the cannula is defined by the operating portion, a sealing valve is arranged at the position of the inlet so that an instrument can penetrate through the inlet in a sealed mode and then enter the central channel, a negative pressure connector communicated with the central channel is arranged on the operating portion, and the central axis of the inlet of the operating portion and the central axis of the central channel are arranged in an eccentric mode. The negative pressure connector is arranged on the side, away from the central axis of the channel, of the operation part.

Description

Technical Field

[0001] This utility model relates to a ureteral sheath, specifically a ureteral guiding sheath. Background Technology

[0002] Currently, natural orifice pyelolithotomy primarily utilizes a ureteral guiding sheath and a flexible ureteroscope. The ureteral guiding sheath is inserted into the urinary tract through the patient's urethra to establish an effective channel for the smooth entry and exit of surgical instruments such as the flexible ureteroscope for the lithotomy procedure. During the procedure, current techniques involve introducing water into the working channel of the endoscope and draining it from the gap between the endoscope and the sheath, creating a negative pressure suction to promptly remove the laser-dislodged stone fragments. However, due to the small gap between the endoscope and the sheath, stone fragments can easily become lodged between them. Therefore, the endoscope needs to be withdrawn from the sheath to remove the fragments promptly. This requires repeated insertion and withdrawal of the endoscope during the procedure, making the entire process quite cumbersome. Utility Model Content

[0003] This invention provides an improved ureteral guiding sheath, comprising an operating part and a cannula suitable for insertion into the ureter. The operating part is connected to the proximal end of the cannula, and the cannula defines a central channel extending from the proximal end to the distal end. The operating part defines an inlet communicating with the central channel of the cannula. A sealing valve is provided at the inlet to allow instruments to pass through and enter the central channel in a sealed manner. The operating part has a negative pressure connector communicating with the central channel. The invention is characterized in that the central axis of the inlet of the operating part is eccentrically positioned relative to the central axis of the central channel, and the negative pressure connector is located on the side of the operating part away from the central axis of the channel.

[0004] In some embodiments, the cannula includes a large-diameter section and a small-diameter section connected together, with the large-diameter section connected to the proximal end of the small-diameter section. The interior of the large-diameter section defines a large channel, and the interior of the small-diameter section defines a small channel. The diameter of the large channel is larger than the diameter of the small channel to accelerate fluid flow.

[0005] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0006] Figure 1 A schematic diagram of the structure of the variable-diameter ureteral guide sheath (with dilator) provided in Example 1;

[0007] Figure 2 A cross-sectional view of the variable-diameter ureteral guide sheath provided in Example 1;

[0008] Figure 3 A schematic diagram of the combination of variable-diameter ureteral guide sheath and endoscope provided in Example 1;

[0009] Figure 4 for Figure 3 A magnified view of a portion of the image;

[0010] Figure 5 This is a schematic diagram of the structure of the variable-diameter ureteral guide sheath provided in Example 1;

[0011] Figure 6 This is a schematic diagram of the flexible variable-diameter ureteral guide sheath provided in Example 1;

[0012] Figure 7 for Figure 2 A magnified view of a portion of the image;

[0013] Figure 8 This is a schematic diagram of the urethra.

[0014] Figure 9 The existing design provides a schematic diagram of the ureteral guide sheath entering the renal pelvis;

[0015] Figure 10 A schematic diagram showing the state of the variable-diameter ureteral guide sheath entering the renal pelvis as provided in Example 1.

[0016] Figure 11 A cross-sectional view of the pressure-measurable variable-diameter ureteral guide sheath structure provided in Example 2;

[0017] Figure 12 for Figure 11 A partial cross-sectional schematic diagram;

[0018] Figure 13 This is a schematic diagram of another pressure-measurable variable-diameter ureteral guide sheath structure provided in Example 2;

[0019] Figure 14 This is a cross-sectional view of the variable-diameter ureteral guide sheath provided in Example 3;

[0020] Figure 15 This is a schematic diagram of the interaction between the variable-diameter ureteral guide sheath and the endoscope provided in Example 3;

[0021] Figure 16 for Figure 15 A magnified view of a portion of the image. Detailed Implementation

[0022] The present invention or its technical solution will be further described in detail below through specific embodiments and in conjunction with the accompanying drawings;

[0023] In the description of this invention, "proximal" and "proximal side" refer to the end of the medical device that is closer to the doctor during normal operation, while "distal" and "distal side" usually refer to the end that first enters the patient's body.

[0024] In the description of this invention, it should be noted that, unless otherwise specified and limited, the terms "installation" and "connection" should be interpreted broadly. For example, they can refer to mechanical or electrical connections, or internal connections between two components. They can be direct connections or indirect connections through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms according to the specific circumstances.

[0025] Please see Figures 1-4 The existing design of the ureteral guiding sheath includes an operating part 1 and a cannula 2 suitable for insertion into the ureter. The operating part 1 is connected to the proximal end of the cannula 2. The cannula 2 defines a central channel 100 extending from the proximal end to the distal end. The operating part 1 defines an inlet 12 communicating with the central channel 100 of the cannula 2 for instrument entry. A sealing valve 121 is provided at the inlet 12 for instruments such as an endoscope 3 to pass through in a sealed manner. The operating part 1 has a negative pressure connector 11 communicating with the central channel. During pyelonephrosis, the guiding sheath is inserted into the ureter through a dilator 5, and external instruments such as an endoscope 3 pass through. The central channel of cannula 2 reaches the target position. The negative pressure connector 11 connects to the negative pressure suction device. A laser or other instruments enter the cavity through endoscope 3 to perform lithotripsy or cutting of the target object or other tissue within the cavity. The irrigation device injects physiological saline into the cavity through the endoscope channel. The gap between endoscope 3 and the central channel 100 forms a suction channel. The negative pressure suction device aspirates the liquid containing the target object out of the body through the suction channel. In this way, the lithotripsy and stone removal work is completed. The distal end of the cannula needs to reach the renal pelvis and be able to bend freely to align with the target object; therefore, its dimensions are subject to strict requirements. The "target object" here includes, but is not limited to, stones, polyps, tumors, and blood clots.

[0026] Further, please refer to Figure 3 and Figure 4 In this embodiment, the central axis of the inlet 12 of the operating part 1 is eccentrically set relative to the central axis of the central channel 100. The negative pressure connector 111 is set on the side of the operating part 1 away from the central axis of the central channel 100. In this way, the stones on the opposite side of the suction channel are avoided from having to go around the endoscope to the suction channel, which can shorten the target material outflow path of the operating end, speed up the outflow of the target material, and further improve the target material outflow efficiency.

[0027] This embodiment further provides a variable-diameter ureteral guiding sheath, the cannula comprising a large-diameter segment 22 and a small-diameter segment 21, the large-diameter segment 22 and the small-diameter segment 21 being connected, the large-diameter segment 22 being connected to the proximal end of the small-diameter segment 21, the interior of the large-diameter segment 22 defining a large channel 220, the interior of the small-diameter segment 21 defining a small channel 210, the diameter of the large channel 220 being larger than the diameter of the small channel 210 to accelerate fluid passage. Thus, the small-diameter segment 21 is suitable for entering the target position in the renal pelvis and can move freely, while the large channel defined by its large-diameter segment 22 increases the radial dimension of the suction channel, facilitating the rapid passage of the target object, accelerating its detachment and outflow, and greatly improving efficiency.

[0028] In a further embodiment of this utility model, the distal segment 211 of the small-diameter section is a flexible pipe segment; see below. Figure 6 After the flexible endoscope enters the central channel, its flexible tube 211 bends flexibly with the curved part of the flexible endoscope, bending straight to the renal calyx. This design is crucial for lithotripsy and stone removal in the lower calyx and for improving the efficiency of flexible endoscope stone removal.

[0029] Furthermore, the large-diameter section 22 of the cannula is a rigid segment, while the distal section of the small-diameter section is a flexible segment, allowing it to bend. This flexible segment can be actively controlled by the user, the physician. For example, a pull cord can be placed on the cannula wall to actively control the bending of the flexible segment relative to the rigid segment. The movement of the pull cord can also be dynamically or intelligently controlled to control the bending angle or repositioning of the flexible segment. In addition, the proximal side of the cannula uses a rigid component to facilitate the physician's insertion of the guide sheath into the cavity, while simultaneously protecting the sheath from deformation.

[0030] In some examples, please refer to Figure 5 The large-diameter section 22 is a rigid pipe section, and the small-diameter section 21 includes a flexible pipe section 211 and a transition section 212. The transition section 212 connects the rigid pipe section and the flexible pipe section, and its rigidity is between that of the rigid pipe section and the flexible pipe section. In other examples, the large-diameter section 22 is a rigid pipe section, and the entire small-diameter section 21 is a flexible pipe section.

[0031] Optionally, both the large-diameter section 22 and the small-diameter section 21 can be multi-layer pipes; please refer to [link / reference]. Figure 7The multi-layer tube, from its inner to outer side, comprises an inner tube 201, a support layer 202, and an outer tube 203. The support layer 202 is disposed between the inner tube 201 and the outer tube 203, thus facilitating the bending of the small-diameter section. For example, the inner tube 201 is often an externally etched PTFE tube, ensuring both effective connection between the inner tube 201 and the outer tube 203 and a smooth inner wall for easy instrument passage. For instance, both the large-diameter section 22 and the small-diameter section 21 are multi-layer tubes, forming an integrated structure. In this way, the support layer 202 increases in size synchronously with the increase in the outer diameter of the large-diameter section 22, resulting in a stable, reliable, and aesthetically pleasing integrated structure. In other examples, the large-diameter segment 22 and the small-diameter segment 21 are separate structures, with multiple layers ending at the diameter change point. The large-diameter segment uses an independent structure, such as a pure plastic tube or a metal tube (stainless steel tube, nickel-titanium tube), connected by rheological bonding or adhesive bonding. The small-diameter segment 21 is generally made of Pebax material, while the large-diameter segment 22 can be made of Pebax material or other materials, or the same material or different materials. The large-diameter segment can be distinguished by different colors or transparency, making it easier for doctors to identify the positions of the large-diameter segment 22 and the small-diameter segment 21 without having to retract the endoscope.

[0032] In this embodiment, the outer diameter of the large-diameter segment 22 is larger than that of the small-diameter segment 21, meaning that both the inner and outer diameters of the large-diameter segment 22 are larger. The large-diameter segment 22 is configured to support the curved channel within the ureter, allowing it to straighten from a curved shape. Specifically, the outer diameter and rigidity of the large-diameter segment 22 are designed to support the cavity, thus strengthening the curvature and allowing for straightening deformation. Its length is also longer than the curved cavity to achieve this straightening deformation. Compared to existing ureteral sheaths, where the target object needs to bypass the curved cavity to be expelled, and due to the inherent size limitations of the suction channel, the target object is easily stuck at the bend. This invention deforms the curved cavity during surgery, and combined with the enlargement of the suction channel, accelerates the expulsion efficiency of the target object and eliminates the risk of the target object easily getting stuck at the bend. For example, please refer to [link to relevant documentation]. Figure 8 The bladder (a) is bordered by the urethra (b) posterior to it and the ureter (d) anterior to it. The renal pelvis (e) is anterior to the ureter. The urethra has two curves: the prepubic curve (b1) and the subpubic curve (b2). Please refer to [link / reference]. Figure 9 Existing ureteral guide sheaths, when inserted into the ureter, have an overall gap design, making it highly susceptible to the target object becoming stuck at the bend, causing suction blockage. Please refer to... Figure 10The large-diameter section 22 of the variable-diameter ureteral guiding sheath provided in this embodiment is a rigid tube section. It does not deform in the two physiological bends of the male urethra, and directly straightens the two physiological bends. In this way, the flow process of the target object, such as gravel, which originally had to go through two large bend angles to flow out can now be reduced by reducing the flow process of the two bend angles, and the occurrence of the target object getting stuck at the bend is eliminated.

[0033] In this embodiment, the cannula is positioned at the junction of the large diameter section 22 and the small diameter section 21 to enter the bladder without contacting the ureteral orifice. Thus, the variable diameter design satisfies the requirement for the small diameter section 21 to penetrate the bladder while also allowing for the expulsion of stones.

[0034] Example 2

[0035] like Figure 11 and Figure 12 As shown, the inner side of the cannula 2 defines a pressure measuring channel 61 extending longitudinally from the proximal side to the distal side. The distal end of the pressure measuring channel has a pressure measuring port for sensing the pressure of the cavity. The pressure measuring channel is equipped with a pressure sensor 62 to detect the pressure inside the cavity. The operating end is equipped with a pressure measuring interface 60 that communicates with the pressure measuring channel to facilitate signal transmission.

[0036] In this embodiment, the pressure sensor 62 is an optical fiber sensor, which is installed through the pressure measurement channel and connected to the pressure measurement device through the pressure measurement interface. In other embodiments, please refer to... Figure 12 and Figure 13 The pressure sensor 65 can be installed inside the operating part 1 and can detect the pressure of the pressure measuring channel 61; more preferably, the operating part is also provided with a control button 66 to control the infusion and aspiration states, and the negative pressure connector is installed at the lower part of the operating part and is perpendicular to the suction channel to facilitate drainage.

[0037] In this embodiment, the entire cannula is a multi-layered tube structure, and the pressure measurement channel is composed of a sensor outer tube, which can be made of PI or PTFE material. The sensor is installed between the support layer and the outer tube, ensuring a stable and reliable structure. Correspondingly, a pressure measurement port 63 corresponding to the pressure measurement channel is provided on the outer wall of the cannula. This embodiment innovatively combines a variable-diameter ureteral guide sheath with pressure measurement functionality, increasing the outflow efficiency of the target fluid without affecting the performance of the original sheath, while simultaneously monitoring the intrarenal pelvis pressure in real time, thus achieving safe and reliable surgical procedures.

[0038] Example 3

[0039] Please see Figures 14-16This embodiment improves upon embodiment 1 by modifying the variable-diameter ureteral guiding sheath. The inner wall of the cannula defines at least one irrigation channel 71 extending from the proximal end to the distal end, and the irrigation channel has an irrigation port 72.

[0040] Specifically, at least one injection channel 71 is defined within the pipe wall of the large-diameter section 22, and the injection channel 71 has an injection port 72 communicating with the central channel. The operating end 1 is provided with an injection port 73 communicating with the injection channel 71. In this way, the sudden increase in water pressure through the injection channel 71 can accelerate the flow of the target object and improve the cleaning efficiency of the target object.

[0041] Furthermore, the infusion port 72 is located at the transition point between its large-diameter section 22 and small-diameter section 21, and the infusion channel 71 is located inside the wall of the large-diameter section 22. Thus, due to the larger size of the large-diameter section 22, the flushing volume can be increased, preventing excessive suction pressure and potential saline shortage. In addition, adding one or more infusion ports 72 within the suction channel can alter the water flow pattern, increasing turbulence and making it less likely for the target object to suddenly become stuck in a certain position.

[0042] In this embodiment, the large-diameter section 22 and the small-diameter section 21 are integrally formed structures, both of which are multi-layer pipe structures, and the injection channel 71 is located between the outer pipe 203 of the large-diameter section 22 and the support layer 202.

[0043] In the description of this specification, references to terms such as "one embodiment," "some embodiments," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0044] Although embodiments of the invention have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. An improved ureteral introducer sheath comprising a handle portion and a cannula adapted for insertion into a ureter, said handle portion being connected to a proximal end of the cannula, said cannula defining a central passageway extending from the proximal end toward a distal end, said handle portion defining an inlet port in communication with the central passageway of the cannula, said inlet port being provided with a sealing valve for sealing passage of instruments into the central passageway, said handle portion having a negative pressure port in communication with the central passageway, characterized in that, The center axis of the inlet of the operation part is eccentric to the center axis of the central channel, and the negative pressure connector is arranged on the side of the operation part away from the center axis of the channel.

2. The ureteral guide sheath of claim 1, wherein, The cannula includes a large diameter section and a small diameter section, the large diameter section and the small diameter section are connected, the large diameter section is connected to the proximal end of the small diameter section, the inside of the large diameter section defines a large channel, the inside of the small diameter section defines a small channel, and the diameter of the large channel is larger than the diameter of the small channel to accelerate the fluid passing through.

3. The ureteral guide sheath of claim 2, wherein, At least the distal section of the small diameter section is a flexible tube section.

4. The ureteral guide sheath of claim 2, wherein, The large diameter section of the cannula is a rigid tube section, and at least the distal section of the small diameter section is a flexible tube section so that the flexible tube section is bendable compared to the rigid tube section.

5. The ureteral guide sheath of claim 2, wherein, The outer diameter of the large diameter section is larger than the outer diameter of the small diameter section, and the large diameter section is configured to support the curved channel in the ureter to deform it from a curved shape to a straightened shape.

6. The ureteral guide sheath of claim 2, wherein, The cannula is adapted to enter the bladder without contacting the ureteral orifice at the variable diameter between the large diameter section and the small diameter section.

7. The ureteral guide sheath of claim 2, wherein, The large diameter section is a rigid tube section, the small diameter section includes a flexible tube section and a transition section, and the transition section is connected between the rigid tube section and the flexible tube section.

8. The ureteral guide sheath of claim 2, wherein, The large diameter section is a rigid tube section, and the small diameter section is a flexible tube section.

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