Ureteral guide sheath

Abstract

This application discloses a ureteral guiding sheath, comprising a first sheath and a second sheath connected to the first sheath. The first sheath has a first diameter and includes a first soft sheath and a first hard sheath. The first soft sheath has a first hardness dimension, and the first hard sheath has a second hardness dimension, wherein the first hardness dimension is smaller than the second hardness dimension. The second sheath includes a second transition sheath and a second flared sheath. A first end of the second transition sheath is connected to the first hard sheath, and the second transition sheath has a second transition diameter dimension, which is greater than or equal to the first diameter dimension. One end of the second flared sheath is connected to the second end of the second transition sheath, and the second flared sheath has a second flared diameter dimension, which is greater than or equal to the second transition diameter dimension. This solution improves the efficiency of lithotripsy removal.

Description

Technical Field

[0001] This disclosure generally relates to the field of medical device technology. More specifically, this disclosure relates to a ureteral guiding sheath. Background Technology

[0002] A ureteral access sheath (UAS) is a commonly used medical device in urological surgery. Its primary function is to establish a pathway from the external urethral orifice to the kidney, allowing endoscopes (such as ureteroscopes and nephroscopes) or other surgical instruments to smoothly enter the urinary tract for examination or treatment. Understandably, in endoscopic surgeries for ureteral diseases, often targeting stones, strictures, foreign bodies, or tumors within the ureter (the tubular structure connecting the bladder and renal pelvis), a ureteral access sheath is necessary to create a pathway, ensuring instruments (such as rigid or flexible ureteroscopes) can reach the lesion site smoothly and minimizing damage to the ureteral mucosa. Specifically, procedures such as ureteral lithotripsy, ureteral stricture dilation / internal incision, and ureteral foreign body removal all require the use of a ureteral access sheath. In addition, in endoscopic surgery for diseases related to the renal pelvis and renal lesions, renal pelvis stones, lesions of the renal pelvis or renal calyces (branching chambers of the renal pelvis) (such as tumor biopsy, polyp removal) also need to be operated through natural orifices, and the ureteral guiding sheath is a key auxiliary device.

[0003] After the ureteral guiding sheath enters the urinary tract through the patient's urethra, it establishes an effective channel, allowing surgical instruments such as the flexible ureteroscope to smoothly enter and exit the urinary tract for lithotripsy. During the procedure, current technology involves water entering the working channel of the endoscope and exiting through the gap between the endoscope and the sheath, creating a negative pressure suction to promptly remove the stone fragments dislodged by the laser. However, because most stones are quite large and often occupy the entire lumen of the sheath, the endoscope needs to be withdrawn from the sheath to remove the fragments. This requires repeated insertion and withdrawal of the endoscope, making the entire process rather cumbersome.

[0004] Therefore, there is an urgent need to provide a ureteral guiding sheath to improve the efficiency of clearing stone fragments. Summary of the Invention

[0005] In order to at least address one or more of the technical problems mentioned above, this disclosure proposes a solution for a ureteral guiding sheath in one aspect.

[0006] In a first aspect, this disclosure provides a ureteral guiding sheath, the ureteral guiding sheath comprising a first sheath and a second sheath connected to the first sheath; wherein the first sheath has a first diameter dimension, the first sheath comprising a first soft sheath and a first hard sheath, wherein the first soft sheath has a first hardness, the first hard sheath has a second hardness, wherein the first hardness is less than the second hardness; the second sheath comprises a second transition sheath and a second flared sheath; a first end of the second transition sheath is connected to the first hard sheath, the second transition sheath having a second transition diameter dimension, the second transition diameter dimension being greater than or equal to the first diameter dimension, wherein the second transition diameter dimension gradually increases along the direction from the first sheath to the second sheath; one end of the second flared sheath is connected to a second end of the second transition sheath, the second flared sheath having a second flared diameter dimension, the second flared diameter dimension being greater than or equal to the second transition diameter dimension.

[0007] In some embodiments, a first channel is formed inside the first sheath, and a second channel is formed inside the second sheath, wherein the size of the second channel is greater than or equal to the size of the first channel.

[0008] In some embodiments, the second flared sheath has a third hardness, which is greater than the second hardness.

[0009] In some embodiments, the first sheath has a first material and the second sheath has a second material; wherein the first material and the second material are the same; or the first material and the second material are different, and the second material is at least partially a metallic material; or the first material and the second material are different, and the second material is at least partially a plastic material.

[0010] In some embodiments, the ureteral guiding sheath further includes a sheath seat, the interior of which is provided with a first sheath seat channel, and the other end of the second flared sheath is disposed within the sheath seat, such that the second flared sheath and the first sheath seat channel form a receiving cavity. The ureteral guiding sheath further includes an irrigation cannula assembly, which is disposed within the receiving cavity. The irrigation cannula assembly includes an irrigation cannula body, within which is formed a suction channel, which is connected to the second channel. Alternatively, an irrigation channel may be formed between the irrigation cannula assembly and the receiving cavity; or an irrigation channel may be formed within the irrigation cannula assembly.

[0011] In some embodiments, a connecting hole is formed on the side wall of the infusion cannula body, the connecting hole connecting the suction channel and the infusion channel, and a connecting channel is provided on the sheath seat, the connecting channel connecting the infusion channel.

[0012] In some embodiments, the outer wall of the infusion cannula body of the infusion cannula assembly is arranged parallel to the axis and forms an infusion channel between it and the receiving cavity. The infusion cannula assembly further includes a first support tube and a first sealing member. The first support tube is sleeved on the end of the infusion cannula body near the sheath seat, and a groove extending axially is formed on the first support tube. The first sealing member is sleeved on the end of the infusion cannula body away from the sheath seat and is used to isolate the suction channel and the infusion channel.

[0013] In some embodiments, the injection sleeve body includes an inner wall and an outer wall of the injection sleeve, an injection channel is formed between the inner wall and the outer wall of the injection sleeve, and a connection hole is formed on the inner wall of the injection sleeve.

[0014] In some embodiments, the infusion cannula assembly further includes a second support tube and a second sealing member; the second support tube is sleeved between the inner wall of the infusion cannula and the outer wall of the infusion cannula, and is disposed on the side near the sheath seat; the second sealing member is disposed on the side away from the sheath seat, and is at least partially disposed within the infusion channel, for isolating the suction channel and the infusion channel.

[0015] In some embodiments, the inner wall of the cannula and the outer wall of the infusion cannula are closed off on the side away from the sheath seat, and a plurality of independent cavities are formed between the inner wall of the cannula and the infusion cannula, the plurality of independent cavities forming an infusion channel.

[0016] In some embodiments, the outer wall of the infusion sleeve body of the infusion sleeve assembly is inclined toward the inner wall of the second flared sheath on the side away from the sheath seat, and abuts against the inner wall of the second flared sheath to achieve a seal of the infusion channel.

[0017] In some embodiments, the outer wall of the infusion cannula body of the infusion cannula assembly extends on the side away from the sheath seat and abuts against the inner wall of the second transition sheath of the second sheath.

[0018] In some embodiments, the infusion sleeve assembly further includes a flow guide disposed at one end of the infusion sleeve body away from the sheath seat, for changing the direction of water flow within the infusion channel.

[0019] In some embodiments, the sheath seat is provided with a connecting channel, and the infusion sleeve body is provided with a notch on the side near the sheath seat. The notch is configured to cooperate with the connecting channel, so that the liquid in the connecting channel can flow into the notch and into the infusion channel.

[0020] By using the ureteral guiding sheath provided above, this application sets the second transition diameter of the second transition sheath to be greater than or equal to the first diameter of the first sheath, and sets the second flaring diameter of the second flaring sheath to be greater than or equal to the second transition diameter of the second transition sheath. This increases the distance between the sheath and the insertion tube in the region of the second flaring sheath and the second transition sheath. In this region, the stone fragments can flow out through the gap between the insertion tube and the endoscope sheath. Therefore, when withdrawing the endoscope, the user only needs to withdraw the aforementioned insertion tube to the position of the second flaring sheath, without having to withdraw the insertion tube to the position of the sheath seat, to achieve stone fragment aspiration. This can accelerate the detachment and flow out of the stone fragments, improve the stone removal efficiency, and reduce the operation time. Furthermore, this application sets the first soft sheath to have a lower first hardness than the second hardness of the first rigid sheath. When the ureteral guiding sheath is inserted into the patient's body, the second transition sheath can be located within the bladder. This transition sheath can straighten the two natural bends in the patient's urethra (e.g., the subpubic curve and the prepubic curve), thus preventing stone fragments from getting stuck at these bends and facilitating their outflow. Furthermore, compared to existing sheaths, the second flared sheath and the second transition sheath have larger internal dimensions, providing more internal space. The increased hardness of the second flared sheath and the second transition sheath allows the area containing them to be straightened instead of curved, facilitating frequent insertion and withdrawal of the endoscope by the physician. Attached Figure Description

[0021] The above and other objects, features, and advantages of exemplary embodiments of this disclosure will become readily apparent upon reading the following detailed description with reference to the accompanying drawings. In the drawings, several embodiments of this disclosure are illustrated by way of example and not limitation, and like or corresponding reference numerals denote like or corresponding parts, wherein:

[0022] Figure 1a An exemplary structural diagram of a ureteral guiding sheath according to some embodiments of this application is shown;

[0023] Figure 1b An exemplary cross-sectional view of a ureteral guiding sheath according to other embodiments of this application is shown;

[0024] Figure 1c An exemplary structural diagram of the ureteral guiding sheath in vivo according to some embodiments of this application is shown;

[0025] Figure 2a An exemplary cross-sectional view of a ureteral guiding sheath according to some embodiments of this application is shown;

[0026] Figure 2b An exemplary structural diagram of the second sheath according to some embodiments of this application is shown;

[0027] Figure 2c An exemplary cross-sectional view of a ureteral guiding sheath according to other embodiments of this application is shown;

[0028] Figure 2d An exemplary cross-sectional view of a ureteral guiding sheath according to some embodiments of this application is shown;

[0029] Figure 3a An exemplary structural diagram of a ureteral guiding sheath including an infusion cannula assembly according to a first embodiment of this application is shown;

[0030] Figure 3b An exemplary structural diagram of the first support tube according to the first embodiment of this application is shown;

[0031] Figure 4 An exemplary structural diagram of a ureteral guide sheath including an infusion cannula assembly according to a second embodiment of this application is shown;

[0032] Figure 5a An exemplary structural diagram of a ureteral guide sheath including an infusion cannula assembly according to a third embodiment of this application is shown;

[0033] Figure 5b An exemplary structural diagram of the infusion cannula assembly according to a third embodiment of this application is shown;

[0034] Figure 6 An exemplary structural diagram of a ureteral guiding sheath including an infusion cannula assembly according to a fourth embodiment of this application is shown;

[0035] Figure 7 An exemplary structural diagram of a ureteral guide sheath including an infusion cannula assembly according to a fifth embodiment of this application is shown;

[0036] Figure 8a Exemplary structural diagrams of different connection holes of the infusion cannula body according to some embodiments of this application are shown;

[0037] Figure 8b Exemplary structural diagrams of different connection holes of the infusion cannula body according to other embodiments of this application are shown;

[0038] Figure 8c Exemplary structural diagrams are shown of the connection holes of the infusion sleeve body in different positions according to some embodiments of this application;

[0039] Figure 8d Exemplary structural diagrams are shown of the connection holes of the infusion sleeve body in different positions according to other embodiments of this application;

[0040] Figure 8eAn exemplary cross-sectional view showing that the connection hole of some embodiments of this application is disposed on the side opposite to the suction connector is shown;

[0041] Figure 9 An exemplary structural diagram of a ureteral guide sheath including an infusion cannula assembly according to a sixth embodiment of this application is shown.

[0042] Tag name

[0043] 1-Insertion tube, 10-First sheath, 101-First channel, 11-First soft sheath, 12-First hard sheath, 20-Second sheath, 201-Second channel, 21-Second transition sheath, 22-Second flared sheath, 30-Sheath seat, 301-First sheath seat through hole, 302-Second sheath seat through hole, 303-Connecting channel, 31-First sheath seat channel, 50-Cannula assembly, 501-Suction channel, 502-Infusion channel, 51-Cannula body, 511-Infusion cannula inner wall, 5111-Connecting hole, 5112-Infusion groove, 512-Infusion cannula outer wall, 52-First support tube, 521-Groove, 53-First sealing element, 54-Second support tube, 55-Second sealing element, 57-Guide element, 571-First surface, 572-Second protrusion. Detailed Implementation

[0044] The technical solutions in the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this disclosure, not all of them. Based on the embodiments in this disclosure, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this disclosure.

[0045] It should be understood that the terms “comprising” and “including” used in this disclosure and claims indicate the presence of the described features, integrals, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, integrals, steps, operations, elements, components and / or collections thereof.

[0046] It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of this disclosure. As used in this disclosure and claims, the singular forms “a,” “an,” and “the” are intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used in this disclosure and claims refers to any combination and all possible combinations of one or more of the associated listed items, and includes such combinations.

[0047] As used in this specification and claims, the term "if" may be interpreted, depending on the context, as "when," "once," "in response to determination," or "in response to detection." Similarly, the phrase "if determined" or "if [described condition or event] is detected" may be interpreted, depending on the context, as "once determined," "in response to determination," "once [described condition or event] is detected," or "in response to detection of [described condition or event]."

[0048] The specific embodiments disclosed herein will now be described in detail with reference to the accompanying drawings.

[0049] Figure 1a An exemplary structural diagram of a ureteral guiding sheath according to some embodiments of this application is shown. Figure 1b An exemplary cross-sectional view of a ureteral guiding sheath according to other embodiments of this application is shown. Figure 1c Exemplary structural diagrams of the ureteral guiding sheath in vivo, representing some embodiments of this application, are shown. Figure 1a , Figure 1b and Figure 1c As shown, a catheter is disposed inside the ureteral guiding sheath. The ureteral guiding sheath includes a first sheath 10 and a second sheath 20 connected to the first sheath 10. The first sheath 10 has a first diameter and includes a first soft sheath 11 and a first hard sheath 12. The first soft sheath 11 has a first hardness, and the first hard sheath 12 has a second hardness, wherein the first hardness is less than the second hardness. The second sheath 20 includes a second transition sheath 21 and a second flared sheath 22. The first end of the second transition sheath 21 is connected to the first hard sheath 12. The second transition sheath 21 has a second transition diameter, which is greater than or equal to the first diameter. The second transition diameter gradually increases along the direction from the first sheath 10 to the second sheath 20. One end of the second flared sheath 22 is connected to the second end of the second transition sheath 21. The second flared sheath 22 has a second flared diameter, which is greater than or equal to the second transition diameter.

[0050] In some embodiments, a first channel 101 is formed in the first sheath 10, and a second channel 201 is formed in the second sheath 20, wherein the size of the second channel 201 is greater than or equal to the size of the first channel 101.

[0051] In some embodiments, the second flared sheath 22 has a third hardness, which is greater than the second hardness.

[0052] In some embodiments, the catheter may include a flexible ureteroscope, a laser fiber, and a capture device. Specifically, the flexible ureteroscope may be a long, thin endoscope that can be actively bent. Further, the flexible ureteroscope may include a body (2-3 mm in diameter) that can bend and rotate within the ureter and kidney. The flexible ureteroscope may also include a high-definition camera and a light source, both located at the top of the aforementioned endoscope body, capable of transmitting video images of the inside of the kidney to an external display screen for direct observation by the user. Furthermore, the flexible ureteroscope may include a working channel, which may be located inside the endoscope body and can be a thin tube, allowing various microsurgical instruments (such as laser fibers, biopsy forceps, etc.) to pass through and reach target locations within the kidney. Additionally, the flexible ureteroscope may include a control handle, which the user can use to control the tip of the lens to bend and rotate at different angles to observe different corners of the kidney.

[0053] In some embodiments, the lithotripsy device may include a holmium laser fiber or a pneumatic ballistic lithotripsy probe, which can pulverize stones of various compositions. The capture device may include a stone retrieval basket or biopsy forceps, wherein the stone retrieval basket can capture and remove larger stone fragments, and the biopsy forceps can grasp larger stone fragments or foreign objects. It is understood that both the aforementioned lithotripsy device and the aforementioned capture device may be disposed within the working channel inside the flexible ureteroscope.

[0054] In some embodiments, the ureteral guiding sheath may include a first sheath 10 and a second sheath 20, wherein the first sheath 10 and the second sheath 20 are connected. In some embodiments, the first sheath 10 may be located at the distal end of the ureteral guiding sheath, and when the ureteral guiding sheath is used, it may be the end furthest from the doctor; the second sheath 20 may be located at the proximal end of the ureteral guiding sheath, and when the ureteral guiding sheath is used, it may be the end closer to the doctor.

[0055] It should be understood that the "proximal end" mentioned in this application can refer to the end of the ureteral guiding sheath that is closer to the doctor during use, i.e., the end that is farther from the patient; the "distal end" mentioned in this application can refer to the end of the ureteral guiding sheath that is closer to the patient during use, i.e., the end that is farther from the doctor.

[0056] In some embodiments, the first sheath 10 may include a first soft sheath 11 and a first hard sheath 12. The first soft sheath 11 may have a first hardness, and the first hard sheath 12 may have a second hardness, wherein the first hardness may be less than the second hardness. In some embodiments, the hardness of the first sheath 10 and the second sheath 20 may be expressed using Shore hardness. Specifically, the first hardness of the first soft sheath 11 may be 15D-45D, and the second hardness of the first hard sheath 12 may be 60D-80D.

[0057] In some embodiments, the second transition sheath 21 may have a third hardness, which may be greater than or equal to the second hardness. For example, when the second hardness is 60D, the third hardness may be 60D, 61D, or 62D, etc. It should be understood that after the ureteral guiding sheath is inserted into the patient's body (e.g., Figure 1c As shown), the second transition sheath 21 can be located inside the bladder. Because the second transition sheath 21 is harder than the first one, it can straighten the two natural bends in the patient's urethra (such as the subpubic curve and the anterior pubic curve), thereby preventing the stones from getting stuck at the bends and facilitating the flow of the stones.

[0058] In some embodiments, the ureteral guiding sheath may be an annular tube, which may include an inner wall and an outer wall. It is understood that the first sheath 10 may also be an annular tube, which may include an inner wall and an outer wall, the inner wall having an inner diameter and the outer wall having an outer diameter.

[0059] It is understandable that a first channel 101 can be formed inside the first sheath 10. Specifically, the channel surrounded by the inner wall of the first sheath 10 can be the first channel 101.

[0060] In some embodiments, the first soft sheath 11 and the first hard sheath 12 may have the same dimensions, that is, the inner diameter of the first soft sheath 11 may be the same as the inner diameter of the first hard sheath 12, and the outer diameter of the first soft sheath 11 may be the same as the outer diameter of the first hard sheath 12.

[0061] In some embodiments, the second sheath 20 may include a second transition sheath 21 and a second flared sheath 22, wherein the second transition sheath 21 may be disposed at the distal end of the second sheath 20, and the second flared sheath 22 may be disposed at the proximal end of the second sheath 20.

[0062] In some embodiments, the first end of the second transition sheath 21 may be the distal end of the second transition sheath 21, and the second end of the second transition sheath 21 may be the proximal end of the second transition sheath 21. In some embodiments, the first end of the second transition sheath 21 may be connected to the first rigid sheath 12, and the second end of the second transition sheath 21 may be connected to the second flared sheath 22.

[0063] In some embodiments, the second transition sheath 21 can also be an annular tube. In some embodiments, the first sheath 10 can have a first diameter, and the second transition sheath 21 can have a second transition diameter, which can be greater than or equal to the first diameter. It is understood that the inner diameter of the second transition sheath 21 can be greater than or equal to the inner diameter of the first sheath 10, and the outer diameter of the second transition sheath 21 can also be greater than or equal to the outer diameter of the first sheath 10.

[0064] Furthermore, the second transition diameter can gradually increase along the direction from the distal end to the proximal end (i.e., along the direction from the first end to the second end of the second transition sheath 21). It is understood that at the point where the second transition sheath 21 connects to the first sheath 10, the second transition diameter and the first diameter of the first sheath 10 can be the same, meaning their inner and outer diameters can be identical. However, along the direction from the distal end to the proximal end, the second transition diameter can be larger than the first diameter.

[0065] It is understood that a second channel 201 can be formed inside the second sheath 20, and this second channel 201 can connect with the first channel 101. Specifically, the channel enclosed by the inner wall of the second transition sheath 21 and the inner wall of the second flared sheath 22 can be the second channel 201. It is understood that, along the direction from the distal end to the proximal end, in the region where the second transition sheath 21 is located, the size of the second channel 201 can gradually increase, while in the region where the second flared sheath 22 is located, the size of the second channel 201 can remain unchanged, and the size of the second channel 201 can be larger than or equal to the size of the first channel 101.

[0066] It is understandable that the ureteral guiding sheath contains a catheter (such as a flexible ureteroscope), meaning the catheter can pass through the aforementioned first channel 101 and second channel 201.

[0067] In the first sheath 10, the distance between the aforementioned insertion tube and the inner wall of the first sheath 10 can remain constant. In the second transition sheath 21, along the direction from the distal end to the proximal end, since the diameter of the second transition gradually increases, that is, both the inner and outer diameters of the second transition sheath 21 gradually increase, the distance between the insertion tube and the inner wall of the second transition sheath 21 can also gradually increase. When gravel flows between the insertion tube and the inner wall of the second transition sheath 21, compared with gravel flowing through the first sheath 10, the accumulation of gravel in the second transition sheath 21 can be reduced.

[0068] It should be understood that the aforementioned gradual increase in the second transition diameter can include either a linear or non-linear increase. When the second transition diameter increases linearly, the magnitude of the increase along the direction from the distal end to the proximal end can remain constant. When the second transition diameter increases non-linearly, the magnitude of the increase along the direction from the distal end to the proximal end can gradually decrease or gradually increase.

[0069] In some embodiments, the distal end of the second flared sheath 22 may be connected to the second end of the second transition sheath 21. The second flared sheath 22 may have a second flared diameter, which may be greater than or equal to the second transition diameter. It is understood that in the region where the second transition sheath 21 and the second flared sheath 22 connect, the second transition diameter may reach its maximum value, at which point the second transition diameter may be equal to the second flared diameter, meaning their inner and outer diameters are equal.

[0070] It is understandable that when the second transition diameter reaches its maximum value, the distance between the inner wall of the second transition sheath 21 and the insertion tube can also reach its maximum value. Therefore, the distance between the second flared sheath 22 and the insertion tube can be the maximum value of the distance between the ureteral guiding sheath and the insertion tube. Thus, when the lithotripsy flows through the second flared sheath 22, it is also less likely to cause blockage.

[0071] In some embodiments, such as Figure 1c As shown, after the ureteral guiding sheath is inserted into the patient's body, the distal end of the second transition sheath 21 can be at least partially located in the renal pelvis, and the proximal end of the second transition sheath 21 and / or the second flaring sheath 22 can be at least partially located in the bladder. The second flaring sheath 22 can guide the patient through the two natural bends in the urethra (such as... Figure 1c Straighten the pubic curve (inferior pubic curve and anterior pubic curve).

[0072] This application, by setting the second transition diameter of the second transition sheath to be greater than or equal to the first diameter of the first sheath, and by setting the second flaring diameter of the second flaring sheath to be greater than or equal to the second transition diameter of the second transition sheath, increases the distance between the sheath and the insertion tube in the region of the second flaring sheath and the second transition sheath. In this region, stone fragments can flow out through the gap between the insertion tube and the endoscope sheath. Therefore, when withdrawing the endoscope, the user only needs to withdraw the aforementioned insertion tube to the position of the second flaring sheath, without having to withdraw the insertion tube to the sheath seat, to achieve stone fragment aspiration, thereby accelerating the detachment and flowout of stone fragments, improving stone clearance efficiency, and reducing operation time. Furthermore, this application, by setting the second hardness to be less than the third hardness of the second transition sheath, allows the second transition sheath and / or the second flaring sheath to be located in the bladder after the ureteral guiding sheath is inserted into the patient's body. This can straighten the two natural bends in the patient's urethra (such as the subpubic curve and the prepubic curve), thereby preventing stone fragments from getting stuck at the bends and facilitating the flowout of stone fragments. Furthermore, compared to existing sheaths, the second flared sheath and the second transition sheath have larger internal dimensions, resulting in more internal space. The second flared sheath and the second transition sheath also have greater rigidity, allowing the area containing them to be straightened instead of bent. This facilitates frequent insertion and withdrawal of the endoscope by the physician.

[0073] Figure 2a An exemplary cross-sectional view of a ureteral guiding sheath according to some embodiments of this application is shown; Figure 2b An exemplary structural diagram of the second sheath according to some embodiments of this application is shown; Figure 2c An exemplary cross-sectional view of a ureteral guiding sheath according to other embodiments of this application is shown; Figure 2d An exemplary cross-sectional view of a ureteral guiding sheath according to some embodiments of this application is shown. Figure 2a , Figure 2b , Figure 2c ,as well as Figure 2d As shown, the first sheath 10 has a first material, and the second sheath 20 has a second material; wherein the first material and the second material are the same; or the first material and the second material are different, and the second material is at least partially a metallic material; or the first material and the second material are different, and the second material is at least partially a plastic material.

[0074] In some embodiments, the aforementioned first sheath 10 can be configured as a multi-layered tube structure, consisting of an inner tube, a metal layer, and an outer tube sequentially arranged from the inner wall to the outer wall of the first sheath 10. The inner tube can be an externally etched PTFE tube, which ensures effective connection between the inner and outer tubes and a smooth inner wall for easy passage of instruments within the first sheath 10. The metal layer can be made of stainless steel flat wire, increasing the overall support performance of the tube wall. The outer tube material can include polyether block amide (pebax) and thermoplastic polyurethane (tpu). Furthermore, the hardness of the first sheath 10 can be adjusted by adjusting the proportion and type of rigid segments of polyamide (e.g., nylon) in Pebax, or by adjusting the proportion and type of rigid segments (e.g., diisocyanate) in TPU. This results in a first soft sheath 11 with lower material hardness, allowing it to bend in the direction of the endoscope's curvature, and a first hard sheath 12 with higher material hardness, facilitating the sheath's insertion into the urethra and ureter.

[0075] like Figure 2a and Figure 2b As shown, the first material and the second material are different, and the second material is at least partially metallic. It is understood that the second sheath 20 can be a single-layer material, and the second material can be metallic (e.g., 304 stainless steel). In this case, the aforementioned second sheath 20 may include a small-diameter section, a transition section, and a flared section. The small-diameter section and the transition section can be formed as a second transition sheath 21, and the flared section can be formed as a second flared sheath 22. It is understood that the size of the second transition sheath 21 can be greater than or equal to the first diameter. Specifically, the size of the small-diameter section can be the same as the first diameter of the first sheath 10, and the size of the transition section can be greater than or equal to the first diameter. Furthermore, the size of the flared section can be greater than the first diameter.

[0076] In some embodiments, the exterior of the first rigid sheath 12 may be provided with the aforementioned metal layer (e.g., it may be a stainless steel flat wire), which may extend axially toward the second sheath 20 and may extend to the small diameter section and transition section of the second sheath 20. Similarly, the outer tube of the first rigid sheath 12 may also extend axially toward the second sheath 20 and be fitted onto the transition section of the second sheath 20.

[0077] Furthermore, the small diameter section can have multiple small holes. When the sheath undergoes rheological changes, the outer tube will seep into the small holes of the small diameter of the metal tube, increasing the strength of the connection between the hard section of the sheath and the metal tube, making the connection firm and preventing it from falling off.

[0078] Understandably, by choosing a metal material for the second sheath 20, when the ureteral guiding sheath is inserted into the patient's body, at least a portion of the second sheath 20 can be located in the bladder. Due to its high rigidity (it is made of metal), it can straighten the two natural bends in the patient's urethra (such as the subpubic curve and the anterior pubic curve), thereby preventing the stones from getting stuck at the bends and facilitating the flow of the stones, thus improving efficiency.

[0079] like Figure 2c As shown, in some embodiments, the first material and the second material are different, and the second material is at least partially a plastic material. It is understood that the second sheath 20 can also be a single-layer material, and the second material of the second sheath 20 can be a plastic material, such as a high-hardness polyamide (PA) or pebax. In forming this ureteral guiding sheath, the first soft sheath 11 and the first hard sheath 12 of the first sheath 10 can be formed first, and then a special flared mandrel can be inserted into the first sheath 10. Then, the aforementioned second sheath 20 is fitted in. The contact area between the second sheath 20 and the first sheath 10 can be formed by hot-melt molding. Compared with using metal materials, it is lighter in weight, and the forming method is simpler, more convenient, and less costly.

[0080] like Figure 2d As shown, the first material of the first sheath 10 and the second material of the second sheath 20 can be the same. It is understood that the second sheath 20 can also be a multi-layered tube structure. Along the inner wall to the outer wall of the second sheath 20, there can be an inner tube, a metal layer, and an outer tube in sequence. The inner tube can be an externally etched PTFE tube, which ensures effective connection between the inner and outer tubes and also ensures a smooth inner wall for easy passage of instruments inside the second sheath 20. The metal layer can use stainless steel flat wire, which increases the overall support performance of the tube wall. The outer tube material can include Pebax and TPU.

[0081] Understandably, at this point, the hardness of the outer tube of the second sheath 20 can be set to be greater than the hardness of the outer tube of the first sheath 10, so that the hardness of the second sheath 20 is greater than the hardness of the first sheath 10, as mentioned above. Figure 2a The scheme shown and the aforementioned Figure 2b Compared to the scheme shown, the second sheath 20 has both higher rigidity and support, and is relatively lighter in weight. In addition, the inner wall of the inner tube is smooth, which facilitates the passage of instruments inside the second sheath 20.

[0082] In some embodiments, the ureteral guiding sheath further includes a sheath seat 30, the interior of which is provided a first sheath seat channel 31. The other end of the second flared sheath 22 is disposed within the sheath seat 30, such that the second flared sheath 22 and the first sheath seat channel 31 form a receiving cavity. The ureteral guiding sheath further includes an infusion cannula assembly 50, which is disposed within the receiving cavity. The infusion cannula assembly 50 includes an infusion cannula body 51, within which is formed a suction channel 501, which is connected to the second channel 201. An infusion channel 502 is formed between the infusion cannula assembly 50 and the receiving cavity; or an infusion channel 502 is formed inside the infusion cannula assembly 50. In some embodiments, a connecting hole 5111 is formed on the sidewall of the infusion cannula body 51, which connects the suction channel 501 and the infusion channel 502.

[0083] In some embodiments, the sheath seat 30 is provided with a connection channel 303, which is connected to the infusion channel 502.

[0084] In some embodiments, the sheath seat 30 may be connected to the proximal end of the second sheath 20, and the sheath seat 30 may be a part that the user directly holds and manipulates. The first sheath seat channel 31 may be a channel for the entry of a ureteroscope and other main instruments, and the diameter of the first sheath seat channel 31 may match the inner diameter of the ureteral guide sheath.

[0085] In some embodiments, the proximal end of the second flared sheath 22 of the second sheath 20 can be connected to the sheath seat 30, such that the inner wall of the second flared sheath 22 and the inner wall of the first sheath seat channel 31 form a receiving cavity. Specifically, the interior of the sheath seat 30 can have a first sheath seat through hole 301 and a second sheath seat through hole 302, the inner diameters of which can be the same or different. Further, the first sheath seat through hole 301 and the second sheath seat through hole 302 can be formed as the first sheath seat channel 31.

[0086] In some embodiments, the second flared sheath 22 may be at least partially inserted into the first sheath seat through hole 301, thereby forming a receiving cavity between the inner wall of the second flared sheath 22 and the inner wall of the first sheath seat through hole 301 of the first sheath seat channel 31.

[0087] In some embodiments, the infusion cannula assembly 50 may be disposed within the aforementioned receiving cavity, and the infusion cannula assembly 50 may include an infusion cannula body 51. It is understood that the infusion cannula body 51 may also be tubular, and an suction channel 501 may be formed inside it, which may be connected to the second channel 201.

[0088] It is understood that the channel enclosed by the inner wall of the second transition sheath 21 and the inner wall of the second flared sheath 22 can be a second channel 201, that is, the second channel 201 can be partially located within the inner wall of the second transition sheath 21 and the second channel 201 can be partially located within the inner wall of the second flared sheath 22. Further, the infusion cannula body 51 is disposed within the receiving cavity. The infusion cannula body 51 can be at least partially disposed within the first sheath seat through hole 301, and the infusion cannula body 51 can also be at least partially disposed within the second channel 201. Furthermore, the infusion cannula body 51 can be located within the second channel 201 corresponding to the second flared sheath 22. The suction channel 501 inside the infusion cannula body 51 can be connected to the second channel 201 corresponding to the second transition sheath 21.

[0089] In some embodiments, an infusion channel 502 may be formed between the infusion cannula assembly 50 and the receiving cavity, or an infusion channel 502 may be formed inside the infusion cannula assembly 50. In some embodiments, a connecting hole 5111 may also be formed on the sidewall of the infusion channel 502, which can connect the suction channel 501 and the infusion channel 502, so that liquid in the infusion channel 502 can flow from the connecting hole 5111 into the suction channel 501.

[0090] It should be understood that a connecting channel 303 is also formed inside the sheath 30. This connecting channel 303 may include a first end and a second end, and the second end can be connected to the proximal end of the infusion channel 502. When water is needed, water can be injected from the first end of the connecting channel, allowing the water to flow along the connecting channel 303 to the second end, and then into the infusion channel 502. The water can then flow into the suction channel 501 through the connecting hole 5111.

[0091] In some embodiments, the aforementioned sheath 30 can be connected to a negative pressure device. Furthermore, the sheath 30 may also be provided with an air intake channel and a sliding switch. The air intake channel can be connected to a second channel, and the sliding switch can be located at the air inlet of the air intake channel. By changing the position of the sliding switch, the size of the air inlet of the air intake channel can be changed, thereby changing the amount of air entering the air intake channel. It is understood that a larger air inlet allows more air to enter the air intake channel, resulting in a weaker suction force from the negative pressure device. Conversely, a larger air inlet allows more air to enter the air intake channel, resulting in a stronger suction force from the negative pressure device, which facilitates the removal of lithotripsy. By adjusting the sliding switch, the suction force of the negative pressure device on the renal calyx can be smoothly adjusted.

[0092] In some embodiments, the suction end of the negative pressure device can be connected to the suction channel 501, and the negative pressure device can extract the stone from the suction channel 501.

[0093] In some embodiments, the aforementioned sheath 30 may be provided with a groove with a flat bottom surface. The protrusion of the sliding switch can engage with the groove and move along it. It is understood that, since the bottom surface of the groove is flat, compared to a groove with a sloped bottom surface, the sliding switch can have a longer sliding distance, and the protrusion of the sliding switch can be prevented from contacting the bottom surface of the inclined groove, thus allowing for smoother adjustment of the sliding switch.

[0094] In some embodiments, the sheath 30 can also be configured to be detachable. When the length of the cannula inside the sheath 30 is not long enough, the sheath 30 can be detached so that more cannula can be inserted into the patient's body.

[0095] Figure 3a An exemplary structural diagram of a ureteral guide sheath including an infusion cannula assembly according to a first embodiment of this application is shown. Figure 3b An exemplary structural diagram of the first support tube according to a first embodiment of this application is shown. Figure 3a and Figure 3b As shown, the outer wall of the infusion sleeve body 51 of the infusion sleeve assembly 50 is arranged parallel to the axis, and an infusion channel 502 is formed between it and the receiving cavity. The infusion sleeve assembly 50 also includes a first support tube 52 and a first sealing member 53. The first support tube 52 is sleeved on the end of the infusion sleeve body 51 near the sheath seat 30, and a groove 521 extending axially is formed on the first support tube 52. A groove channel is formed between the first support tube 52 and the inner wall of the second sheath tube 20. The first sealing member 53 is sleeved on the end of the infusion sleeve body 51 away from the sheath seat 30, and is used to isolate the infusion channel 502 and the second channel 201.

[0096] It's important to understand that the arrows in the diagram represent the direction of water flow, and the solid black spheres represent gravel.

[0097] In the first embodiment, an infusion channel 502 can be formed between the infusion cannula assembly 50 and the receiving cavity. Specifically, the outer wall of the infusion cannula body 51 can be parallel to the axis of the second flared sheath 22, and an infusion channel 502 can be formed between the outer wall of the infusion cannula body 51 and the inner wall of the second flared sheath 22. In the first embodiment, the first sheath seat through hole 301 and the second sheath seat through hole 302 can be formed as a first sheath seat channel 31, and the second flared sheath 22 can be at least partially inserted into the first sheath seat through hole 301. Furthermore, a connecting channel 303 can be connected to the proximal end of the infusion channel 502, and the connecting channel 303 can be connected to the second sheath seat through hole 302.

[0098] Furthermore, at the proximal end of the infusion sleeve body 51, a first support tube 52 can be sleeved on the outside of the infusion sleeve body 51. This first support tube 52 can have multiple notches formed radially, and these notches can extend axially to form a groove 521. Further, this groove 521 forms a groove channel on the inner wall of the second flared sheath 22 of the second sheath 20, allowing water to flow along this groove channel. It is understood that the radial dimension of the aforementioned first support tube 52 is variable, wherein the maximum radial dimension of the first support tube 52 can be equal to or slightly smaller than the inner wall of the second flared sheath 22. Further, the first support tube 52 can be located on the distal side of the connection position between the connecting channel 303 and the second sheath seat through hole 302.

[0099] In the first embodiment, a connection hole 5111 may be provided at the distal end of the infusion channel 502, which can connect the suction channel 501 and the infusion channel 502.

[0100] In the first embodiment, the first sealing member 53 can be disposed at the distal end of the suction channel 501. The first side of the first sealing member 53 can abut against the inner wall of the second flared sheath 22, the second side of the first sealing member 53 can abut against the outer wall of the infusion sleeve body 51, and the third side of the first sealing member 53 can extend within the suction channel 501 along a direction from the distal end to the proximal end to achieve a seal on the infusion channel 502. The first and second sides of the first sealing member 53 can be opposite each other, and the third side of the first sealing member 53 can be perpendicular to the first side and face proximal. Furthermore, a sealing groove can be formed on the first side of the first sealing member 53, and a sealing ring can be disposed within this sealing groove to further seal the infusion channel 502.

[0101] When liquid flows from the connecting channel 303 into the second sheath seat through hole 302 (i.e., the proximal end of the infusion channel 502), the liquid can flow towards the first support tube 52 in the direction from the proximal end to the distal end, and can flow through the groove channel of the first support tube 52, thereby flowing into the distal end of the infusion channel 502. After being blocked by the first sealing member 53, the liquid can flow into the suction channel 501 from the connecting hole 5111 on the distal end of the infusion channel 502.

[0102] In the first embodiment, a cannula may be provided in the ureteral guiding sheath, which can penetrate the aforementioned suction channel 501 and the second channel 201. Stone fragments can flow out from the side of the cannula. It is understood that the direction of stone fragment outflow can be from distal to proximal. Furthermore, the angle between the axis of the connecting hole 5111 and the direction from distal to proximal can be acute. When fluid flows from the connecting hole 5111 on the irrigation channel 502 into the suction channel 501, the angle between the direction of fluid flow and the direction of stone fragment outflow can be acute, thereby flushing out the stone fragments and facilitating their removal. Furthermore, the first sealing member 53 can be inclined towards the distal side, which can increase the intraluminal space and prevent scratching of the endoscope sheath during endoscope withdrawal.

[0103] Figure 4 An exemplary structural diagram of a ureteral guide sheath including an infusion cannula assembly according to a second embodiment of this application is shown. Figure 4 As shown, the injection sleeve body 51 includes an inner wall 511 and an outer wall 512 of the injection sleeve, and an injection channel 502 is formed between the inner wall 511 and the outer wall 512 of the injection sleeve. A connecting hole 5111 is formed on the inner wall of the injection sleeve.

[0104] In the second embodiment, the infusion cannula assembly 50 further includes a second support tube 54 and a second sealing member 55; the second support tube 54 is sleeved between the inner wall of the infusion cannula and the outer wall of the infusion cannula, and is disposed on the side near the sheath seat 30; the second sealing member 55 is disposed on the side away from the sheath seat 30, and is at least partially disposed within the infusion channel 502, for isolating the suction channel 501 and the infusion channel 502.

[0105] In the second embodiment, an infusion channel 502 is formed inside the infusion cannula assembly 50. Specifically, the infusion cannula body 51 may include an inner wall 511 and an outer wall 512, wherein the inner wall 511 can abut against the inner wall of the second flared sheath 22, and an infusion channel 502 can be formed between the inner wall 511 and the outer wall 512.

[0106] In the second embodiment, a second support tube 54 can be provided between the inner wall 511 and the outer wall 512 of the infusion sleeve at the proximal end of the infusion sleeve body 51. This second support tube 54 can have multiple notches formed radially, and these notches can extend axially to form a groove 521. Further, a groove channel can be formed between the groove 521 and the outer wall 512 of the infusion sleeve, allowing water to flow along the groove channel. It is understood that the radial dimension of the aforementioned second support tube 54 is variable, wherein the maximum radial dimension of the second support tube 54 can be equal to or slightly smaller than the dimension of the outer wall of the infusion sleeve. Further, the second support tube 54 can be located on the distal side of the connection position between the connecting channel 303 and the second sheath seat through hole 302.

[0107] In the second embodiment, a connection hole 5111 may be provided on the distal end of the inner wall 511 of the infusion sleeve, which can connect the suction channel 501 and the infusion channel 502.

[0108] In the second embodiment, the second sealing member 55 can be disposed at the distal end of the suction channel 501. The proximal side of the second sealing member 55 can at least partially abut against the distal sidewall of the inner wall 511 of the infusion sleeve and the distal sidewall of the outer wall 512 of the infusion sleeve. The proximal side of the second sealing member 55 can also extend within the suction channel 501 along a direction from the distal end to the proximal end to achieve a seal on the infusion channel 502. Furthermore, the side of the second sealing member 55 facing the second flared sheath 22 can abut against the inner wall of the second flared sheath 22.

[0109] When liquid flows from the connecting channel 303 into the second sheath seat through hole 302 (i.e., the proximal end of the infusion channel 502), the liquid can flow towards the second support tube 54 in the direction from the proximal end to the distal end, and can flow through the groove channel of the second support tube 54, thereby flowing into the distal end of the infusion channel 502. After being blocked by the second sealing member 55, the liquid can flow into the suction channel 501 from the connecting hole 5111 on the distal end of the infusion channel 502.

[0110] In the second embodiment, a catheter may be disposed within the ureteral guiding sheath, which extends through the aforementioned suction channel 501 and the second channel 201. Stone fragments can flow out from the side of the catheter. It is understood that the direction of stone fragment outflow can be from distal to proximal. Furthermore, the angle between the axis of the connecting hole 5111 and the direction from distal to proximal can be acute. When fluid flows from the connecting hole 5111 on the irrigation channel 502 into the suction channel 501, the angle between the direction of fluid flow and the direction of stone fragment outflow can be acute, thereby flushing out the stone fragments and facilitating their removal.

[0111] The solution proposed in this application ensures that the injection water flows entirely out of the inclined injection hole, guaranteeing a stable injection direction. It eliminates concerns about the sealing ring on the plug failing and causing some injection water to deviate from the suction direction, thus improving the efficiency of stone flushing. Furthermore, the absence of an interference fit in the sealing ring makes assembling the inner and outer injection tubes into the flared sheath tube much easier.

[0112] Figure 5a An exemplary structural diagram of a ureteral guide sheath including an infusion cannula assembly according to a third embodiment of this application is shown. Figure 5b An exemplary structural diagram of the infusion cannula assembly according to a third embodiment of this application is shown. Figure 5a and Figure 5b As shown, the inner wall 511 of the infusion sleeve and the outer wall of the infusion sleeve are closed off on the side away from the sheath seat 30, and a plurality of independent cavities are formed between the inner wall 511 of the infusion sleeve and the outer wall of the infusion sleeve, which form an infusion channel 502.

[0113] In the third embodiment, an infusion channel 502 is formed inside the infusion cannula assembly 50. Unlike the second embodiment, multiple isolation components can be provided between the inner and outer walls of the infusion cannula. These isolation components can divide the infusion channel 502 into multiple independent cavities. Further, in the second embodiment, the inner and outer walls of the infusion cannula are sealed at their distal ends by a second support tube 54, thereby isolating the infusion channel 502 and the second channel 201. Unlike the second embodiment, in the third embodiment, the distal sides of the inner wall 511 and the outer wall 512 of the infusion cannula be closed off, meaning they can be directly connected together.

[0114] Furthermore, an injection groove 5112 can be formed on one side of the distal end of the inner wall and outer wall of the injection sleeve. This injection groove 5112 can be connected to the injection channel 502 and the connecting channel 303, allowing liquid in the connecting channel 303 to flow into the injection channel 502 through the injection groove. In the third embodiment, the second flared sheath 22 can be made of metal or plastic.

[0115] After the liquid flows from the connecting channel 303 into the aforementioned filling groove, it can flow into the filling channel 502. Furthermore, the liquid can flow towards the distal end of the filling channel 502 in a direction from the proximal end to the distal end. After being blocked by the inner wall and outer wall of the sealed filling sleeve, the liquid can flow into the suction channel 501 from the connecting hole 5111 at the distal end of the filling channel 502.

[0116] In the third embodiment, a catheter may be disposed in the ureteral guiding sheath, which can penetrate the aforementioned suction channel 501 and the second channel 201. Stone fragments can flow out from the side of the catheter 1. It is understood that the direction of stone fragment outflow can be from distal to proximal. Furthermore, the angle between the axis of the connecting hole 5111 and the direction from distal to proximal can be acute. When fluid flows from the connecting hole 5111 on the irrigation channel 502 into the suction channel 501, the angle between the direction of fluid flow and the direction of stone fragment outflow can be acute, thereby flushing out the stone fragments and facilitating their removal.

[0117] The solution proposed in this application avoids the problem of some irrigation water flowing in the wrong direction due to sealing ring failure, thus improving the efficiency of stone flushing. Furthermore, because there is no interference from the sealing ring, the assembly of the inner and outer irrigation tubes into the flared sheath is much easier. The multi-lumen tube is made of plastic, making it lighter than metal tubes, easier to operate, and less likely to scratch the sheath when removing the endoscope.

[0118] Figure 6 An exemplary structural diagram of a ureteral guide sheath including an infusion cannula assembly according to a fourth embodiment of this application is shown.

[0119] In the fourth embodiment, the outer wall of the infusion sleeve body 51 of the infusion sleeve assembly 50 is inclined toward the inner wall of the second flared sheath 22 on the side away from the sheath seat, and abuts against the inner wall of the second flared sheath 22 to achieve the sealing of the infusion channel 502. The outer wall of the infusion sleeve body 51 can be coaxially arranged with the inner wall of the second flared sheath 22, and the aforementioned inclined arrangement can include: an inclined slope can be provided at the distal end of the outer wall of the infusion sleeve body 51, one end of which can be connected to the outer wall of the infusion sleeve body 51, and the other end of which can be connected to the inner wall of the second flared sheath 22 to achieve the sealing of the infusion channel 502.

[0120] In the fourth embodiment, an infusion channel 502 may be formed between the inner walls of the infusion cannula body 51 and the second flared sheath 22. At the distal end of the infusion cannula body 51, the outer wall of the infusion cannula body 51 may be inclined toward the inner wall of the second flared sheath 22 and abut against the inner wall of the second flared sheath 22.

[0121] In the fourth embodiment, the first sheath seat through hole 301 and the second sheath seat through hole 302 can be formed as a first sheath seat channel 31, and the second flared sheath tube 22 can be at least partially inserted into the first sheath seat through hole 301. The connecting channel 303 can be connected to the proximal end of the infusion channel 502, and the connecting channel 303 can be connected to the second sheath seat through hole 302.

[0122] Furthermore, at the proximal end of the infusion sleeve body 51, a first support tube 52 can be sleeved on the outside of the infusion sleeve body 51. This first support tube 52 can have multiple notches formed radially, and these notches can extend axially to form a groove 521. Further, this groove 521 forms a groove channel on the inner wall of the second flared sheath 22 of the second sheath 20, allowing water to flow along this groove channel. It is understood that the radial dimension of the aforementioned first support tube 52 is variable, wherein the maximum radial dimension of the first support tube 52 can be equal to or slightly smaller than the inner wall of the second flared sheath 22. Further, the first support tube 52 can be located on the distal side of the connection position between the connecting channel 303 and the second sheath seat through hole 302.

[0123] In the fourth embodiment, a connection hole 5111 may be provided at the distal end of the infusion channel 502, which can connect the suction channel 501 and the infusion channel 502.

[0124] Understandably, when the liquid flows to the distal end of the infusion channel 502, it can be blocked by the sealed structure formed by the outer wall of the infusion sleeve body 51 and the inner wall of the second flared sheath 22, and thus flow into the suction channel 501 through the connection hole 5111.

[0125] Compared with the first embodiment, the solution of this application only uses one injection pipeline to realize the injection function, and the manufacturing process is simple, the assembly is convenient, the cost is low, and the operation is convenient.

[0126] Figure 7 An exemplary structural diagram of a ureteral guiding sheath including an infusion cannula assembly according to a fifth embodiment of this application is shown. Figure 7 As shown, in the fifth embodiment, the outer wall of the infusion cannula body 51 of the infusion cannula assembly 50 extends away from the sheath seat and abuts against the inner wall of the second transition sheath 21 of the second sheath 20.

[0127] It is understood that in the second sheath 20, the inner diameter of the second flared sheath 22 can remain constant, while the inner diameter of the second transition sheath 21 can vary. After the infusion sleeve body 51 of the sleeve assembly 50 is placed in the receiving cavity, the length of the infusion sleeve body 51 can be set so that the outer wall of the sleeve body 51 extends distally and abuts against the inner wall of the second transition sheath 21. At this time, the outer wall of the infusion sleeve body 51 and the inner wall of the second transition sheath 21 can form a sealing structure, thereby separating the infusion channel 502 and the second channel 201. It should be understood that the infusion sleeve body 51 can be interference-fitted with the second transition sheath 21. Furthermore, the material of the infusion sleeve body 51 can be stainless steel or rigid plastic tubing.

[0128] In the fifth embodiment, the first sheath seat through hole 301 and the second sheath seat through hole 302 can be formed as a first sheath seat channel 31, and the second flared sheath tube 22 can be at least partially inserted into the first sheath seat through hole 301. The connecting channel 303 can be connected to the proximal end of the infusion channel 502, and the connecting channel 303 can be connected to the second sheath seat through hole 302.

[0129] In the fifth embodiment, a connection hole 5111 may be provided at the distal end of the infusion channel 502, which can connect the suction channel 501 and the infusion channel 502.

[0130] Understandably, when the liquid flows to the distal end of the infusion channel 502, it can be blocked by the sealing structure formed by the outer wall of the infusion sleeve body 51 and the inner wall of the second transition sheath 21, and thus flow into the suction channel 501 through the connection hole 5111.

[0131] The solution proposed in this application can achieve injection using only a single tube, the injection sleeve body 51, without requiring secondary processing as in the injection sleeve body in the embodiment. Its assembly process is simple and the cost is low.

[0132] Figure 8a Exemplary structural diagrams of different connection holes of the infusion cannula body according to some embodiments of this application are shown; Figure 8b Exemplary structural diagrams of different connection holes of the infusion cannula body according to other embodiments of this application are shown. Figure 8c Exemplary structural diagrams are shown of the connection holes of the infusion sleeve body in different positions according to some embodiments of this application; Figure 8d Exemplary structural diagrams are shown of the connection holes of the infusion sleeve body in different positions according to other embodiments of this application; Figure 8e An exemplary cross-sectional view showing a connection hole arrangement on the side opposite to the suction connector in some embodiments of this application is shown.

[0133] like Figure 8a , Figure 8b , Figure 8c , Figure 8d as well as Figure 8eAs shown, connection holes 5111 can be formed on the side wall of the injection sleeve body 51. These connection holes 5111 can be in the shape of inclined circular holes, inclined grooves, or inclined fan shapes, etc., and the axis of these connection holes 5111 can form an acute angle with the water flow direction. Multiple connection holes 5111 can be provided; it is understood that multiple connection holes 5111 can be located at the far end of the injection pipe. Furthermore, the smaller the area of ​​the connection holes 5111, that is, the smaller the cross-sectional area of ​​the injection water flowing through these connection holes 5111, the greater the flow velocity of the injection water flowing through these connection holes 5111. Therefore, depending on the flow of the gravel, smaller connection holes 5111 can be provided in areas prone to accumulation to accelerate the flow of gravel, thereby preventing the accumulation of gravel in these areas.

[0134] In some embodiments, multiple connection holes 5111 can be provided at different locations (e.g., proximal and distal ends) on the sidewall of the infusion cannula body 51, so that the stones are subjected to the thrust of the infusion water flow at each location, preventing stone accumulation. In other embodiments, the number of connection holes 5111 can be gradually reduced along the direction from the distal end to the proximal end.

[0135] In other embodiments, the diameter of the connecting hole 5111 can be gradually reduced along the direction from the distal end to the proximal end, thereby avoiding the situation where too much water flows out from the proximal end of the injection sleeve body 51, resulting in insufficient water flow at the distal end of the injection sleeve body 51.

[0136] In some embodiments, the connection hole 5111 can be located on the side opposite to the suction connector. For example, when the suction connector is located near the bottom of the infusion sleeve body 51, the connection hole 5111 can be located at the top of the infusion sleeve body 51, so that the water flowing out from the connection hole 5111 can flush the stone to a position close to the suction connector, thereby facilitating the stone to flow out from the suction connector.

[0137] Figure 9 An exemplary structural diagram of a ureteral guide sheath including an infusion cannula assembly according to a sixth embodiment of this application is shown.

[0138] In the sixth embodiment, the infusion sleeve assembly 50 further includes a flow guide 57, which is disposed at the end of the infusion sleeve body 51 away from the sheath seat 30, and is used to change the direction of water flow in the infusion channel 502.

[0139] In the sixth embodiment, a guide 57 may be provided at the distal end of the injection channel 502 to change the direction of water flow within the injection channel 502.

[0140] Specifically, the guide member 57 may have a first region and a second region on the proximal side. The first region may have a first surface 571, which may be a plane or an arc surface. The first surface 571 may be perpendicular to the axis of the second flared sheath. Furthermore, the second region may have a second protrusion 572 formed on the proximal side, and the projection of the second protrusion 572 on the axis of the second flared sheath and the projection of the infusion sleeve body on the axis of the second flared sheath may overlap, so that a U-shaped groove can be formed between the inner wall of the second flared sheath 22, the first surface, the second protrusion, and the infusion sleeve body.

[0141] Understandably, the liquid can flow in the infusion channel 502 in a proximal to distal direction. When the liquid flows along the inner wall of the second flared sheath 22 and the outer wall of the infusion sleeve body to the first surface 571, the liquid can flow toward the second protrusion 572. When it flows to the surface of the second protrusion 572, the liquid can flow out along the gap between the second protrusion 572 and the inner wall of the infusion sleeve body. Understandably, at this time, its flow direction can be from distal to proximal and parallel to the direction of the gravel flow.

[0142] With the solution proposed in this application, the direction of the injected water flow is the same as the direction of the gravel flow (i.e., the direction that attracts the gravel). Compared to a solution where the injected water flow direction is inclined to the direction of the gravel flow, the direction of the water pressure on the stones is also completely towards the direction of attracting the gravel. Therefore, the gravel will not be blown off course to the sheath wall, improving the speed and efficiency of gravel removal.

[0143] In summary, the solution of this application has a second transition diameter greater than or equal to the first diameter of the first sheath, and a second flaring diameter greater than or equal to the second transition diameter of the second flaring sheath. This increases the distance between the sheath and the insertion tube in the region of the second flaring sheath and the second transition sheath. In this region, the stone fragments can flow out through the gap between the insertion tube and the endoscope sheath. Therefore, when withdrawing the endoscope, the user only needs to withdraw the aforementioned insertion tube to the position of the second flaring sheath, without having to withdraw the insertion tube to the sheath seat, to achieve stone fragment aspiration. This accelerates the detachment and outflow of the stone fragments, improves stone removal efficiency, and reduces surgical time. Furthermore, this application sets the first hardness of the first soft sheath to be less than the second hardness of the first hard sheath. When the ureteral guiding sheath is inserted into the patient's body, the second transition sheath can be located in the bladder. It can straighten the two natural bends in the patient's urethra (such as the subpubic curve and the prepubic curve), thereby preventing the stone fragments from getting stuck at the bends and facilitating the outflow of the stone fragments. Furthermore, compared to existing sheaths, the second flared sheath and the second transition sheath have larger internal dimensions, resulting in more internal space. The second flared sheath and the second transition sheath also have greater rigidity, allowing the area containing them to be straightened instead of bent. This facilitates frequent insertion and withdrawal of the endoscope by the physician.

[0144] While numerous embodiments of this disclosure have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Many modifications, alterations, and alternatives will occur to those skilled in the art without departing from the spirit and intent of this disclosure. It should be understood that various alternatives to the embodiments of this disclosure described herein may be employed in the practice of this disclosure. The appended claims are intended to define the scope of this disclosure and therefore cover equivalents or alternatives within the scope of these claims.

Claims

1. A ureteral guide sheath having a cannula disposed therein, characterized by, The ureteral guiding sheath includes a first sheath (10) and a second sheath (20) connected to the first sheath (10); wherein, The first sheath (10) has a first diameter dimension, and the first sheath (10) includes a first soft sheath (11) and a first hard sheath (12), wherein the first soft sheath (11) has a first hardness, and the first hard sheath (12) has a second hardness, wherein the first hardness is less than the second hardness; The second sheath (20) includes a second transition sheath (21) and a second flared sheath (22); The first end of the second transition sheath (21) is connected to the first hard sheath (12). The second transition sheath (21) has a second transition diameter dimension, which is greater than or equal to the first diameter dimension. The second transition diameter dimension gradually increases along the direction from the first sheath (10) to the second sheath (20). One end of the second flared sheath (22) is connected to the second end of the second transition sheath (21), and the second flared sheath (22) has a second flared diameter size, which is greater than or equal to the second transition diameter size; A first channel (101) is formed inside the first sheath (10), and a second channel (201) is formed inside the second sheath (20), wherein the size of the second channel (201) is greater than or equal to the size of the first channel (101); The ureteral guiding sheath also includes a sheath seat (30), the interior of which is provided a first sheath seat channel (31). The other end of the second flared sheath (22) is disposed within the sheath seat (30), such that the second flared sheath (22) and the first sheath seat channel (31) form a receiving cavity. The ureteral guiding sheath also includes an infusion cannula assembly (50), which is disposed within the receiving cavity. The infusion cannula assembly (50) includes an infusion cannula body (51), within which is formed a suction channel (501), which is connected to the second channel (201). An infusion channel (502) is formed between the infusion cannula assembly (50) and the receiving cavity; or An injection channel (502) is formed inside the injection sleeve assembly (50).

2. The ureteral guiding sheath according to claim 1, characterized in that, The second flared sheath (22) has a third hardness, which is greater than the second hardness.

3. The ureteral guiding sheath according to claim 1, characterized in that, The first sheath (10) has a first material, and the second sheath (20) has a second material; wherein, The first material and the second material are the same; or The first material and the second material are different, and the second material is at least partially metallic; or The first material and the second material are different, and the second material is at least partially a plastic material.

4. The ureteral guiding sheath according to claim 1, characterized in that, A connecting hole (5111) is formed on the side wall of the infusion sleeve body (51), the connecting hole (5111) connects the suction channel (501) and the infusion channel (502), wherein a connecting channel (303) is provided on the sheath seat (30), the connecting channel (303) and the infusion channel (502) are connected.

5. The ureteral guiding sheath according to claim 4, characterized in that, The outer wall of the injection sleeve body (51) of the injection sleeve assembly (50) is arranged parallel to the axis, and an injection channel (502) is formed between it and the receiving cavity. The infusion sleeve assembly (50) further includes a first support tube (52) and a first sealing element (53); wherein, The first support tube (52) is sleeved on one end of the infusion sleeve body (51) near the sheath seat (30), and a groove (521) extending axially is formed on the first support tube (52). The first sealing element (53) is sleeved on the end of the infusion sleeve body (51) away from the sheath seat (30) to isolate the suction channel (501) and the infusion channel (502).

6. The ureteral guiding sheath according to claim 4, characterized in that, The main body of the injection sleeve (51) includes an inner wall of the injection sleeve and an outer wall of the injection sleeve. An injection channel (502) is formed between the inner wall of the injection sleeve and the outer wall of the injection sleeve. A connecting hole (5111) is formed on the inner wall of the injection sleeve.

7. The ureteral guiding sheath according to claim 6, characterized in that, The infusion sleeve assembly (50) also includes a second support tube (54) and a second sealing element (55); The second support tube (54) is sleeved between the inner wall of the injection sleeve and the outer wall of the injection sleeve, and is located on the side near the sheath seat (30); The second sealing member (55) is disposed on the side away from the sheath seat (30) and is at least partially disposed in the infusion channel (502) to isolate the suction channel (501) and the infusion channel (502).

8. The ureteral guiding sheath according to claim 6, characterized in that, The inner wall of the sleeve and the outer wall of the infusion sleeve are closed off on the side away from the sheath seat (30), and multiple independent cavities are formed between the inner wall of the infusion sleeve and the outer wall of the infusion sleeve, which form an infusion channel (502).

9. The ureteral guiding sheath according to claim 4, characterized in that, The outer wall of the injection sleeve body (51) of the injection sleeve assembly (50) is inclined toward the inner wall of the second flared sheath (22) on the side away from the sheath seat, and abuts against the inner wall of the second flared sheath (22) to achieve sealing of the injection channel (502).

10. The ureteral guiding sheath according to claim 4, characterized in that, The outer wall of the infusion sleeve body (51) of the infusion sleeve assembly (50) extends away from the sheath seat and abuts against the inner wall of the second transition sheath (21) of the second sheath (20).

11. The ureteral guiding sheath according to claim 1, characterized in that, The infusion sleeve assembly (50) also includes a flow guide (57), which is disposed at one end of the infusion sleeve body (51) away from the sheath seat (30) and is used to change the direction of water flow in the infusion channel (502).

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