Negative pressure guide sheath for urinary minimally invasive intervention

Abstract

The invention provides a negative pressure guide sheath for urinary minimally invasive intervention, which comprises a tube body, a tube seat and a negative pressure joint, and the tube body longitudinally extends from the near end to the far end; the tube base is arranged at the near end of the tube body, and the tube base and the tube body jointly define a channel penetrating through the near end and the far end. The negative pressure joint is arranged on the side wall of the tube seat and is communicated with the channel; the pressure regulating assembly is arranged at the near end of the tube seat, the pressure regulating assembly comprises an axially through gas passage, the pressure regulating assembly has a closed state and a pressure relief state, and when the pressure regulating assembly is in the closed state, after an external instrument enters the passage from the near end of the tube seat, a closed space is formed in a body cavity of a patient and the passage; and when the pressure regulating assembly is in a pressure relief state, external gas enters the channel through the gas passage.

Description

Technical Field

[0001] The present invention relates to the field of minimally invasive urological interventional surgery, and in particular to a negative pressure guide sheath for minimally invasive urological interventional surgery. Background Art

[0002] Minimally invasive interventional urology procedures utilize a flexible ureteral guide sheath, which creates a pathway for an endoscope and other instruments to enter the urinary tract. The flexible ureteral guide sheath can be used in conjunction with an irrigation and suction pump to achieve negative pressure suction, drawing fluid from the renal pelvis into a collection device within the body. Existing flexible ureteral guide sheaths consist of a tube body, a tube seat, and a negative pressure connector. The negative pressure connector is located on the side wall of the tube seat. The tube seat is equipped with a fixed sealing valve or a removable flexible cap. The endoscope enters the tube seat and tube body through the sealing valve or flexible cap. When the negative pressure connector is connected to the negative pressure device via a connecting tube, a sealed negative pressure suction channel is formed between the natural urinary cavity, the tube body, the tube seat, and the negative pressure connector. During the procedure, the dilator is removed from the guide sheath, and the endoscope's tube is inserted into the guide sheath. Under the guidance of the endoscope, the tube is passed through the urethra to the renal pelvis. The irrigation and suction pump is connected to the endoscope's water inlet at the irrigation end and to the guide sheath's suction channel at the suction end. Under the action of the perfusion and suction pump, normal saline enters the endoscope at the water inlet, then flows along the endoscope tube until it flows out at the tip of the tube and into the renal pelvis. At the same time, under the suction of the perfusion and suction pump, the liquid inside the renal pelvis will carry the stones into the gap between the outside of the endoscope tube and the inside of the tube body, and then continue to flow along the tube body toward the suction channel of the guide sheath until it flows out of the suction channel into the waste bag. In order to maintain stable pressure in the urinary system cavity during the operation and avoid serious complications caused by excessive pressure, the doctor is usually required to adjust the magnitude of the negative pressure attraction in real time during the process.

[0003] In existing technology, to achieve regulation of the negative pressure suction force, a pressure relief port is typically provided on the side wall (negative pressure connector) or the tube body of the guide sheath. A sliding cover is then placed on the pressure relief port to adjust the air intake. However, this sliding cover pressure regulation method cannot precisely adjust the negative pressure suction force, and outside air can easily flow in through the gap between the pressure relief port and the sliding cover, colliding with the liquid in the suction cavity and causing the liquid to splash out of the tank, affecting surgical efficiency and the safety of the surgeon.

[0004] Furthermore, the surgeon needs to hold the guide sheath with one hand while operating other instruments, such as a laser or advancing and retracting an endoscope, with the other. Adjusting the slide requires moving the fingers, which can cause the guide sheath to shift position, compromising surgical precision. Frequent finger movements and adjustments increase muscle strain. This process also causes direct contact between the hands and waste fluids, leading to contamination. Summary of the Invention

[0005] The present invention provides a negative pressure guide sheath for minimally invasive urological intervention, comprising a tube body, a tube seat and a negative pressure connector, wherein the tube body extends longitudinally from the proximal end toward the distal end; the tube seat is arranged at the proximal end of the tube body, and the tube seat and the tube body jointly define a channel running through the proximal and distal ends; the negative pressure connector is arranged on the side wall of the tube seat and is connected to the channel; a pressure regulating assembly is arranged at the proximal end of the tube seat, and the pressure regulating assembly includes a gas passage running through in the axial direction, and the pressure regulating assembly has a closed state and a pressure relief state. When the pressure regulating assembly is in the closed state, an external instrument enters the channel from the proximal end of the tube seat, forming a closed space in the patient's body cavity and the channel. When the pressure regulating assembly is in the pressure relief state, external gas enters the channel through the gas passage. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Figure 1 A schematic structural diagram of an introducer sheath (in conjunction with a dilator) provided in one embodiment of the present invention;

[0007] Figure 2 for Figure 1 A cross-sectional view of the structure of the introducer sheath is provided;

[0008] Figure 3 for Figure 1 A cross-sectional view of the working state of the guide sheath and endoscope is provided;

[0009] Figure 4-Figure 9 A schematic structural diagram of an introducer sheath provided in another embodiment of the present invention;

[0010] Figure 10 for Figure 1 Provided schematic diagram of the structural breakdown of the introducer sheath;

[0011] Figure 11 for Figure 1 A top view of a hub of a provided introducer sheath;

[0012] Figure 12 and Figure 13 It is a structural diagram of the voltage regulating part;

[0013] Figure 14 and Figure 15 It is a structural diagram of the operating unit;

[0014] Figure 16 and Figure 17 It is a structural diagram of the tube seat;

[0015] Figure 18 for Figure 16 An enlarged view of part I;

[0016] Figure 19 A schematic structural diagram of a tube socket provided in another embodiment of the present invention;

[0017] Figure 20A schematic structural diagram of an introducer sheath provided in another embodiment of the present invention;

[0018] Figure 21 and Figure 22 A schematic structural diagram of an operating unit provided in another embodiment of the present invention;

[0019] Figure 23 A schematic structural diagram of a tube socket provided in yet another embodiment of the present invention;

[0020] Figure 24 A schematic structural diagram of an introducer sheath provided in yet another embodiment of the present invention;

[0021] Figure 25 A schematic structural diagram of an introducer sheath provided in an embodiment of the present invention;

[0022] Figure 26 and Figure 27 Schematic diagram of the operation of the introducer sheath according to an embodiment of the present invention.

[0023] Figures marked: 11-tube seat, 12-tube body, 13-negative pressure connector, 200-gas passage, 14-sealing valve, 15-operating member, 151-operating part, 152-pressure regulating part, 151-connecting member, 2-expander, 21-elastic arm; 111-annular wall, 1110-first inlet, 1111-air inlet groove, 1520-second inlet, 1112-sealing platform, 1410-valve port, 1521-sealing sheet, 1522-avoidance gap, 1523-glue groove, 1501-rotating cap, 1502 cover body, 1503-third inlet, 1504-slot, 1505-pressing ring, expansion section 113, 114 -contraction section; 1512-limiting protrusion, 1513-locking portion, 1515-friction surface; 112-limiting groove, 1121-locking position, 1122-proximal limiting surface, 1123-distal limiting surface, 1125-axial groove, 1126-circumferential extension groove, 1127-L-shaped stop edge, 1128-stop side wall, 1513'-locking groove, locking column-1513"; 16-ring, 120-flat surface, 121-hard segment, 122-soft segment, 123-first color segment, 124-second color segment, 125-transparent segment, 100-channel, 3-endoscope, 1200-gap, 200-gas passage. DETAILED DESCRIPTION

[0024] The embodiments of the present invention are described in detail below, and examples of the embodiments are shown in the accompanying drawings. The embodiments described below with reference to the accompanying drawings are exemplary and intended to be used to explain the present invention, but should not be understood as limiting the present invention.

[0025] Reference below Figure 1-Figure 27 A negative pressure introducer sheath according to an embodiment of the present invention is described.

[0026] In the description of the present invention, "proximal end" refers to the end of the medical device that is closest to the doctor during normal operation, and "distal end" refers to the end that first enters the patient's body. "Multiple" means more than two.

[0027] See also Figure 1-Figure 3 According to an embodiment of the present invention, a negative pressure guide sheath for minimally invasive urinary intervention includes a tube seat 11, a tube body 12 and a negative pressure connector 13. The tube body 12 extends longitudinally from the proximal end to the distal end to form a hollow tubular structure. The tube seat 11 is arranged at the proximal end of the tube body 12. The tube seat 11 and the tube body 12 jointly define a channel 100 passing through the proximal and distal ends. The side wall of the tube seat 11 is provided with a negative pressure connector 13 connected to the channel. The dilator 2 and the proximal end of the guide sheath are locked by a locking assembly and then enter the urinary cavity. The dilator 2 is removed, the endoscope 3 is inserted into the guide sheath, and the negative pressure connector 13 is connected to the negative pressure suction device through a connecting tube. During the operation, under the action of the perfusion suction pump, physiological saline enters the endoscope 3 through the water inlet of the endoscope 3, and then flows along the endoscope tube 3 until it flows out at the head end of the endoscope tube and flows into the renal pelvis. At the same time, under the suction of the perfusion suction pump, the liquid inside the renal pelvis, carrying the stones, is sucked into the gap 1200 between the endoscope tube and the tube body 12, and then flows along the tube body 12 toward the proximal direction, and flows out through the negative pressure connector 13 to a collection device such as a waste liquid bag.

[0028] See also Figure 3The negative pressure guide sheath provided by an embodiment of the present invention also includes a pressure regulating component, which is arranged at the proximal end of the tube seat 11. The pressure regulating component includes a gas passage 200 that runs through the axial direction. The pressure regulating component has a closed state and a pressure relief state. When the pressure regulating component is in the closed state, an external instrument such as an endoscope 3 enters the channel 100 from the proximal end of the tube seat 11, forming a sealed space in the patient's body cavity and the channel. There is a gap 1200 between the tube body 12 and the endoscope 3. The gap 1200 and the negative pressure connector 13 constitute a negative pressure suction path. Driven by the negative pressure suction pump, the stones enter the external collection device through the negative pressure suction path. When stones or waste liquid accumulate in the gap 1200, or the negative pressure attraction force needs to be adjusted, the pressure regulating component is switched to the pressure relief state. At this time, external gas quickly enters the channel through the axially extending gas passage 200. Compared with the traditional method of providing a pressure regulating port on the negative pressure connector 13, the guide sheath provided in this embodiment allows air to enter the channel from the gas passage 200 at the proximal end of the tube seat when adjusting the negative pressure suction pressure, thereby avoiding the problem of waste liquid in the negative pressure suction path splashing from the gas passage, such as the pressure port, and ensuring the cleanliness and safety of the surgical environment. In addition, since stones are prone to accumulate in the gap 1200 to form a stuck point, the momentum carried by the axially entering air can directly act on the stones stuck in the gap 1200, pushing the stones to move distally to free them from the stuck point, ensuring the smooth flow of the negative pressure suction path, and improving surgical efficiency and stone removal effect. In addition, the axial end control can have better sealing performance; the operation form of the axial end air intake is more in line with the doctor's gesture operation and is more convenient to operate.

[0029] In one embodiment of the present invention, the pressure regulating assembly includes a sealing valve 14 and an operating member 15. The sealing valve 14 is used to seal the passageway for external instruments, such as an endoscope 3. In some examples, the sealing valve 14 provided in this embodiment also allows for the sealed passage of the dilator 2. The operating member 15 is movably disposed at the proximal end of the tube holder 11 and is used to adjust the opening of the gas passage 200. Specifically, the operating member 15 can be movable, such as by sliding or rotating, to close or open the gas passageway. The amount of gas entering the gas passageway 200 can be controlled by adjusting the opening of the gas passageway 200. In some examples, the operating member can move radially, in other examples, along the X-axis; in other examples, along the Y-axis; and in other examples, circumferentially. The radial direction refers to the direction perpendicular to the axis of the tube body, the X-axis and the Y-axis are directions perpendicular to the tube body, and the circumferential direction refers to the circumferential direction around the axis of the tube body. The movement of the operating member closes or adjusts the amount of gas entering the tube body.

[0030] The operating member 15 is assembled at the proximal end of the tube base 11, so that Figure 26 and Figure 27During use, the doctor holds the introducer sheath with their thumb resting on the operating element 15 and their index and middle fingers clamping the tube holder 11. To adjust the negative pressure, the thumb operates the operating element 15, rotating it to open or close the gas passage. Adjustment is achieved at the end of the main channel, making it easier for the doctor to operate. The channel itself is the center of the product, making it more ergonomic and convenient to place the fingers there.

[0031] In some embodiments of the present invention, see Figure 2 The operating member 15 includes an operating portion 151 and a pressure regulating portion 152. The operating portion 151 and the pressure regulating portion 152 are movably arranged at the proximal end of the tube seat 11. The operating portion 151 is used to drive the pressure regulating portion 152 to move so as to adjust the opening area of the gas passage; wherein, the connection method between the pressure regulating portion 152 and the sealing valve 14 is selected from one of the following: detachable mechanical connection, split assembly, integrated fixed connection, and one-piece molding structure. In this embodiment, the pressure regulating portion 152 and the sealing valve 14 are integrally molded, and both are elastic parts, which can be silicone parts. The present invention realizes the adjustment of the air intake volume through the operating portion 151. Since the amount of air intake is adjusted at the proximal end of the guide sheath, the adjustment area range can be accurately measured to ultimately achieve the maximum opening of the air intake volume to enter from the gas passage, thereby achieving full control of the suction volume from 0% to 100%.

[0032] In some embodiments of the present invention, the endoscope enters the channel 100 through the sealing valve 14, and the pressure regulating part 152 covers and presses the endoscope to further seal it. During the operation of the endoscope, a gap may appear between the endoscope and the pressure regulating part 152, causing liquid to flow out. The air intake at the axial end can just take away the liquid in the channel, thereby avoiding liquid outflow caused by the operation of the endoscope.

[0033] It can be understood that the proximal end of the tube wall of the tube seat 11 has at least one air inlet groove 1111 that is connected to the channel, and the operating member 15 is a seal that can move radially, along the X-axis direction, along the Y-axis direction or circumferentially, wherein the radial direction refers to the plane perpendicular to the axial direction of the tube body, the X-axis and the Y-axis are the directions perpendicular to the extension of the tube body, and the circumferential direction refers to the circumferential direction around the axis of the tube body. The air intake volume is closed or adjusted by moving the pressure regulating part.

[0034] In some embodiments, see Figure 4 and Figure 5 The proximal end of the tube wall of the tube seat 11 has at least one air inlet groove 1111 that is connected to the channel. The operating member 15 is a pressure-adjusting slider 155 that can move along the Y direction. The air inlet area of the air inlet groove is closed or adjusted by the translation of the pressure-adjusting slider 155 along the Y direction.

[0035] In other embodiments, see Figure 6 and Figure 7 The operating member 15 is a pressure regulating cap 156 that can move along the axial direction, driving the pressure regulating cap 156 to move toward the distal side. External gas can enter from the air inlet passage and press the pressure regulating cap 156 downward to seal the air inlet passage.

[0036] In other embodiments, see Figure 8 and Figure 9 The proximal end of the tube wall of the tube seat 11 has at least one air inlet groove 1111 that is connected to the channel. The operating part is a pressure-adjusting rotating block 158 that can move along the circumferential direction. The pressure-adjusting rotating block 158 seals the air inlet groove 1111 when it is in the sealing position. By rotating the pressure-adjusting rotating block 158, it moves away from the air inlet groove 1111 to adjust the opening of the air inlet groove 1111.

[0037] The proximal end of the operating portion 151 is provided with a connector 1511 suitable for connecting to the expander 2, and the connection method includes but is not limited to a snap connection, a threaded connection, etc. In some examples, the proximal end of the operating portion 151 is provided with a snap 1511 connected to the expander, and the snap 1511 is detachably engaged with the elastic arm 21 of the expander.

[0038] In this embodiment, please refer to Figure 11 The proximal end of the tube base 11 has an annular wall 111, which defines a first inlet 1110 for the passage of the instrument. The annular wall 111 is provided with at least one air inlet groove 1111 communicating with the channel 100. In this embodiment, two air inlet grooves 1111 are radially symmetrically provided on the annular wall 111. Figure 12 and Figure 13 The pressure regulating portion 152 defines a second inlet 1520 for passage of instruments. The pressure regulating portion 152 is rotatably disposed at the first inlet 1110 of the tube base 11. The second inlet 1520 is coaxially disposed with the first inlet 1110. External instruments, such as the dilator 2 or the endoscope 3, pass through the second inlet 1520 and are sealed by the sealing valve to enter the interior of the tube base. In this embodiment, the pressure regulating portion 152 is sealed against the end surface of the annular wall 111. This allows the proximal annular wall 111 of the tube base 11 to be sealed even when the pressure regulating portion 152 rotates. The sealing valve 14 is located at the distal end of the pressure regulating portion 152 and is located within the tube base 11. The sealing valve 14 defines a valve port 1410, which is provided for at least the endoscope 3 to pass through in a sealed manner. In this manner, when the pressure regulating portion 152 rotates relative to the tube base 11, it establishes a sealed passage between the guide sheath and the patient's natural cavity. The pressure regulating part 152 has two positions: closed and open. When the pressure regulating part 152 is in the closed position, the pressure regulating part 152 seals the air inlet groove 1111. At this time, external gas such as air cannot enter the channel of the guide sheath. The size of the negative pressure attraction is determined by the suction pump.

[0039] Optionally, see Figure 12 The pressure regulating portion 152 has at least one sealing sheet 1521 and at least one avoidance notch 1522. The sealing sheet is used to completely close the air inlet groove in a sealed state, and the avoidance notch 1522 is used to expose the air inlet groove 1111 in a pressure relief state. When there is only one sealing sheet 1521 and only one avoidance notch 1522, the sealing sheet 1521 and the avoidance notch 1522 are adjacent to each other. When there are multiple sealing sheets 1521 and avoidance notches 1522, the sealing sheets 1521 and the avoidance notches 1522 are spaced apart to form a tooth-like structure. When the pressure regulating part 152 is in the open position, the avoidance notch 1522 at least partially overlaps with the air inlet groove 1111, and the sealing sheet 1521 is partially or completely removed from above the air inlet groove 1111. External gas enters the channel through the avoidance notch 1522 and the air inlet groove 1111. The opening of the air inlet groove 1111 is controlled by adjusting the rotation angle of the pressure regulating part 152, thereby adjusting the air intake area of the air inlet groove 1111.

[0040] In some examples, the operating unit 151 is connected to the voltage regulating unit 152. For details, see Figure 14 and Figure 15 The operating portion 151 includes a rotating cap 1501 and a cover 1502. The rotating cap 1501 is coaxially and rotatably mounted on the proximal end of the tube holder 11. The cover 1502 is connected to the radially inner side of the rotating cap 1501. The cover 1502 defines a third inlet 1503 for instruments to enter. The rotating cap 1501 is rotatably connected to the proximal side wall of the tube holder 11. The cover 1502 is connected to the pressure regulating portion 152. The cover 1502 is provided with a slot 1504 to avoid exposing the notch 1522. In some embodiments, the sealing valve 14 is a silicone conical ring. The distal end of the cover 1502 has a hard pressing ring 1505 pressed against the inner wall of the sealing valve 14. The pressing ring 1505 is pressed against the inner wall of the conical ring to prevent the soft conical ring from turning outward when an external instrument is withdrawn from the sealing valve 14.

[0041] It is understood that the slot 1504, the avoidance notch 1522, the sealing sheet 1521, and the air inlet groove 1111 are provided in a one-to-one correspondence. As the operating member 15 rotates, the slot 1504 and the avoidance notch 1522 begin to overlap with the air inlet groove 1111. The exposed area of the air inlet groove 1111 is the air inlet area. When the slot 1504 and the avoidance notch 1522 completely overlap with the air inlet groove 1111, the air inlet area is maximized, i.e., the air intake volume is maximized.

[0042] Specifically, the end face of the annular wall 111 at the proximal end of the tube seat has N sealing platforms 1112 and N air inlet grooves 1111 along its circumference, and the N air inlet grooves 1111 are symmetrically arranged along the center of the annular wall 111, and two adjacent sealing platforms 1112 are spaced apart and a gap is provided between them to form the air inlet groove 1111; the pressure regulating part 152 has N sealing plates 1521 and N avoidance gaps 1522, and two adjacent sealing plates 1521 are spaced apart and the gap provided between them constitutes the avoidance gap 1522. When the pressure regulating part 152 is in the closed position, the N sealing plates 1521 seal the N air inlet grooves 1111 one by one, and when the operating part 15 is rotated, the N avoidance gaps 1522 begin to overlap with the N air inlet grooves 1111 one by one. Where N is at least 1, the major diameter of the air inlet groove 1111 is R, the minor diameter of the avoidance gap 1522 is r, and when the pressure regulating portion 152 rotates from the closed position to the open position by an angle α, the air inlet area of the channel entering through the air inlet groove 1111 is calculated as follows: N×π(R 2 -r 2 )×α / 360. The number of slots 1504 and avoidance notches 1522 is the same as the number of tube base air inlet slots 1111 and can overlap one-to-one. When the doctor wishes to increase the air intake, the maximum air intake area should be greater than or equal to the cross-sectional area of the suction channel. When the air intake area is opened to the maximum, the full suction force of the suction channel will draw the outside air from the air inlet slot 1111 into the suction channel, and the suction channel will stop sucking the liquid in the renal pelvis. The operating unit 15 and pressure regulating unit 152 provided in this embodiment can adjust the suction force of the suction channel between 100% and 0%, greatly increasing the convenience and accuracy of the doctor's surgery. Based on the above description, those skilled in the art can increase the air intake area by increasing the major diameter R of the air inlet slot 1111 and reducing the minor diameter r of the avoidance notch 1522. However, due to the limitations of the structural size and the difficulty of actual operation, this is difficult to achieve. The air intake area can also be increased by increasing the rotatable angle. Since the avoidance notch 1522 and the air inlet slot 1111 on the tube holder switch between complete offset and complete overlap, theoretically, the maximum sum of the opening angles of the air inlet slot 1111 is 360° / 2=180°, that is, the maximum angle the doctor can rotate is 180° / N. When rotating at the same angle, the fewer the number N of air inlet slots 1111, the smaller the air inlet area, and the higher the accuracy of the doctor's adjustment of the air intake volume; the more the number N of air inlet slots 1111, the larger the air inlet area, and the faster and more efficient the doctor's adjustment of the air intake volume. Considering that the doctor holds the guide sheath with one hand and rotates the rotating cap 1501 to adjust the air volume, a large rotation angle is not conducive to the doctor's operation. In some embodiments of the present invention, the number N of air inlet slots 1111 is set to 2-4. In this way, the rotation angle does not exceed 90°, ensuring surgical efficiency while taking into account precision and practicality.

[0043] The sealing platform 1112, air inlet groove 1111, sealing sheet 1521, avoidance notch 1522 and slot 1504 are all fan-shaped, wherein the sealing platform 1112 and the air inlet groove 1111 are alternately arranged at intervals to form a toothed structure on the end face of the annular wall 111, and the sealing sheet 1521 and the avoidance notch 1522 are correspondingly arranged on the pressure regulating part 152 with the same circumferential pitch; the central angle of each fan-shaped structure is (360 / 2N)°, wherein N is the number of air inlet grooves 1111, which corresponds to the number of sealing platform 1112 / air inlet groove 1111 groups arranged on the end face of the annular wall 111 and the number of sealing sheet 1521 / avoidance notch 1522 groups on the pressure regulating part 152, ensuring that during the rotation of the pressure regulating part 152, each fan-shaped sealing sheet 1521 can accurately cover or stagger the corresponding fan-shaped air inlet groove 1111, thereby forming a progressively adjustable air flow channel cross-section.

[0044] The sealing valve 14 and the pressure regulating part 152 are elastic parts, preferably silicone parts, and the tube seat 11 and the operating part 151 are hard parts. The pressure regulating part 152 is pressed between the tube seat 11 and the operating part 151. The proximal end face of the sealing sheet 1521 is connected to the cover body 1502 by gluing or the like, and its distal end face is axially pressed against the sealing platform 1112 on the end face of the annular wall 111 of the tube seat 11.

[0045] The negative pressure guide sheath is also provided with a limit assembly for limiting the rotation angle of the sealing piece 1521. Figure 15 The limiting assembly includes a limiting protrusion and a limiting groove 112. The structural form of the limiting protrusion includes but is not limited to a limiting block and a limiting column. In this embodiment, please refer to Figure 14 The cover 1502 is provided with a plurality of limit blocks 1512 at intervals along the circumference thereof to limit the rotation angle. Figure 16 The tube seat 11 is provided with a circumferentially extending limiting groove 112. When the rotating cap 1501 rotates to a predetermined angle, the side wall of the limiting block 1512 and the side wall of the limiting groove 112 stop each other. Figure 18The limiting groove 112 is provided with a plurality of stop positions 1121 so that the rotating cap 1501 can be paused at a certain position. The limiting groove 112 has a proximal limiting surface 1122 and a distal limiting surface 1123. The proximal limiting surface 1122 and the distal limiting surface 1123 respectively cooperate with the proximal and distal end surface stops of the limiting block 1512. For example, the limiting groove 112 has an axial groove 1125 extending axially along the annular wall 111 and a circumferential extension groove 1126 extending circumferentially along the annular wall 111. The distal end of the axial groove 1125 is connected to the circumferential extension groove 1126. The cover body 1502 forms a plurality of limiting columns or limiting blocks 1512 toward the annular wall 111 of the tube seat 11. There are multiple limiting grooves 112, which are spaced apart around the circumference of the tube seat 11, and there are correspondingly multiple limiting posts or limiting blocks 1512. The proximal and distal end surfaces of the axial groove 1125 are respectively pressed against the proximal end of the limiting protrusion.

[0046] Optionally, see Figure 16-Figure 18 The circumferential extension groove 1126 has an initial end and a stop terminal along its circumferential extension direction. The stop terminal forms a stop side wall 1128, and an L-shaped stop edge 1127 is provided at the initial end to prevent the rotating part from directly falling out of the circumferential extension groove 1126 when the doctor rotates the rotating part, thereby increasing protection during the operation.

[0047] For example, see Figure 19 and Figure 20 The tube seat 11 includes an annular wall 111, an expansion section 113 and a contraction section 114 from the proximal end to the distal end. The annular wall 111 is radially contracted inwardly compared to the expansion section 113 to form a step. The negative pressure joint 13 is arranged on the side wall of the contraction section 114. The distal end of the rotating cap 1501 cooperates with the step stop. The annular wall 111 has an axial groove 1125 extending axially along the annular wall 111 and a circumferential extension groove extending circumferentially along the annular wall 111.

[0048] 1126, the distal end of the axial groove 1125 is connected to the circumferentially extending groove 1126, see Figure 21-22 The rotating cap 1501 includes a limiting post or limiting block 1512 that cooperates with the axial groove 1125 and the circumferentially extending groove 1126. There are multiple limiting grooves 112, which are spaced apart around the circumference of the tube seat 11, and the number of limiting posts or limiting blocks 1512 corresponds to the number of limiting posts or limiting blocks 1512. The proximal and distal end surfaces of the axial groove 1125 are respectively press-fitted with the proximal end of the limiting block 1512.

[0049] In some embodiments, after the operating portion 15 is connected to the proximal end surface of the pressure regulating portion 152, the limiting protrusion of the rotating cap 1501 is inserted into the axial groove 1125 along the side wall of the tube base 11 and enters the circumferential extension groove 1126. At this time, the sealing plate 1521 is pressed against the sealing platform 1112, and the sealing plate 1521 is in a state of maximum interference. Continuing to rotate the rotating cap 1501, the limiting protrusion enters the interior of the circumferential extension groove 1126, and also drives the pressure regulating portion 152 to rotate. At this time, the sealing plate 1521 completely covers the sealing platform 1112 around the air inlet groove 1111 of the tube base 11, and the sealing plate 1521 is still in an interference state, so that the guide sheath channel is completely sealed. The rotating member continues to rotate along the circumferential extension groove 1126, and the avoidance notch 1522 begins to overlap with the air inlet groove 1111 of the tube base 11. The area of the exposed air inlet groove 1111 is the air inlet area.

[0050] When the avoidance notch 1522 completely overlaps with the air inlet groove 1111 of the tube base 11, the air inlet area is maximized and the air inlet volume is maximized. During the rotation of the rotating cap 1501, the locking portion 1513 on the limiting protrusion will be locked into a plurality of locking positions 1121, so that the rotating cap 1501 can remain relatively stable at different air inlet area sizes. The structural form of the locking portion and the locking position includes but is not limited to the locking groove 1513' (see Figure 21 ) and the stop block (1121), the stop column 1513" (please refer to Figure 23 ) and limit blocks, etc.

[0051] In some embodiments, see Figure 24 The upper end surface of the enlarged section 113 is a plane or an arc surface. The rotating cap 1501 has a friction surface 1515 for finger rotation operation.

[0052] For instructions on use during surgery, see Figure 11 , pull out the dilator 2 from the guide sheath, insert the tube of the endoscope 3 into the guide sheath, and under the guidance of the endoscope 3, pass through the urethra to reach the renal pelvis. Under the action of the perfusion and suction pump, physiological saline enters the endoscope 3 at the water inlet of the endoscope 3, and then flows along the tube of the endoscope 3 until it flows out at the tip of the tube and into the renal pelvis. At the same time, under the suction effect of the perfusion and suction pump, the liquid inside the renal pelvis will carry the stones into the gap 1200 between the outside of the tube and the inside of the tube body 12, and then flow along the tube body 12 towards the guide sheath suction channel until it flows out of the suction channel into the waste liquid bag.

[0053] During this procedure, the surgeon can rotate the guide sheath's rotating cap 1501 to adjust the size of the air intake area, thereby conveniently controlling the suction force, enabling adjustment from 100% to 0% suction force, enabling more efficient and precise stone aspiration surgery. When the guide sheath is in a sealed state, the perfusion and suction pump exerts maximum suction force on the renal pelvis fluid, with only fluid flowing through the suction channel, maximizing stone removal efficiency. When the guide sheath is in an air intake state, air is drawn into the guide sheath by the perfusion and suction pump. Since the suction force of the perfusion and suction pump is relatively constant, the suction force exerted by the perfusion and suction pump on the renal pelvis fluid is reduced, thereby achieving the desired effect of reducing suction force. When the guide sheath is in a maximum air intake state, since the guide sheath's air intake area is equal to or greater than the cross-sectional area of the suction channel, and the suction force of the perfusion and suction pump prioritizes attracting media with less resistance, the entire suction force of the perfusion and suction pump is used to attract air, which has less resistance, rather than the renal pelvis fluid. At this point, the suction force exerted by the perfusion and suction pump on the renal pelvis fluid is almost zero, and the suction channel is filled entirely with air. Through the above three states, the guide sheath achieves the adjustment of the attraction force to the liquid inside the renal pelvis from 100% to 0.

[0054] See also Figure 24 The handle is provided below the tube base 11, and the handle includes but is not limited to a finger ring 16. Figure 27 During use, the doctor holds the introducer sheath with their thumb against the operating portion 15, their middle finger positioned through the ring, and their index finger clamping the tube holder 11. To adjust the negative pressure, the doctor rotates the operating member 15 with their thumb, which in turn rotates the pressure regulating portion 152, thereby adjusting the opening of the air inlet slot 1111. During this process, the doctor's finger stays away from the negative pressure connector 13, preventing direct contact with waste fluid and significantly improving operational efficiency.

[0055] See also Figure 25In terms of hardness, the tube body 12 consists of a soft segment 122 and a hard segment 123. In terms of appearance, the tube body is made of three different colors of tubing, from the distal end to the proximal end: a transparent segment 125, a first color segment (dark blue segment 124), and a second color segment (bright color segment 123). The transparent section 125 is inside the soft section. The purpose of the transparent section 125 is: after the endoscope head reaches the transparent section, the situation outside the tube body can be observed without extending the tube body, thereby increasing the convenience of surgical operation; the bright section refers to a bright color that is obviously different from dark blue. It is located at the tail end of the tube body. The purpose is: when the doctor encounters a large stone, it is necessary to withdraw the endoscope inside the tube body until the endoscope head enters the main channel of the tube body so that the stone can enter the suction channel and be sucked away. Usually, the doctor's operating time is very precious. When withdrawing the endoscope, it is very likely that the endoscope will be accidentally pulled out of the tube base. In order to avoid this situation, a bright section is specially set at the tail end of the tube body to remind the doctor that the endoscope head is about to reach the tube base channel, so as to slow down the withdrawal speed and prevent the endoscope from being pulled out of the tube base. This reduces the risk of surgery and improves surgical efficiency.

[0056] Compared to the slider type that adjusts the amount of air intake, this guide sheath adjusts the air intake position not at the tube body wall or side wall (negative pressure joint), so the sucked liquid will hardly flow out through the air intake position, so it can greatly reduce the situation where the sucked liquid splashes out from the air intake channel, and this position is more conducive to complete sealing, and there will be no air leakage. Compared to the slider type, the guide sheath of this solution can be completely sealed in the closed state, and no gas will enter, thus improving the safety and efficiency during the operation. The doctor only needs to rotate, slide or press the proximal end of the guide sheath to achieve sealing and adjust the amount of air intake, which greatly improves the accuracy of the doctor's surgery and the convenience of operation.

[0057] The present invention arranges the air intake regulating device on the tube seat and realizes precise air intake regulation by rotation, sliding or pressing, thereby achieving both precise regulation and complete sealing, while avoiding liquid splashing caused by air intake in the main liquid circulation channel.

Claims

1. A negative pressure guide sheath for minimally invasive urological intervention, characterized in that: include: a tubular body extending longitudinally from the proximal end toward the distal end; A tube seat is provided at the proximal end of the tube body, and the tube seat and the tube body together define a passage running through the proximal and distal ends; a negative pressure connector is provided on the side wall of the tube seat and communicates with the passage; A pressure regulating assembly is provided at the proximal end of the tube seat. The pressure regulating assembly includes a gas passage extending axially therethrough. The pressure regulating assembly has a closed state and a pressure relief state. When the pressure regulating assembly is in the closed state, an external instrument enters the passage from the proximal end of the tube seat, forming a closed space between the patient's body cavity and the passage. When the pressure regulating assembly is in the pressure relief state, external gas enters the passage through the gas passage.

2. The negative pressure introducer sheath according to claim 1, characterized in that: The voltage regulating assembly includes: A sealing valve for sealing external instruments from entering the channel; The operating member is movably arranged at the proximal end of the tube seat and is used to adjust the opening of the gas passage.

3. The negative pressure introducer sheath according to claim 2, characterized in that: The operating element includes: An operating portion movably disposed at the proximal end of the tube seat, the operating portion being used to drive the pressure regulating portion to move so as to adjust the opening area of the gas passage; The pressure regulating part is movably arranged at the proximal end of the pipe seat; the connection mode between the pressure regulating part and the sealing valve is selected from one of the following: detachable mechanical connection, split assembly, integrated fixed connection, and one-piece molding structure.

4. The negative pressure introducer sheath according to claim 3, characterized in that: The proximal end of the operating part is provided with a connecting piece suitable for connecting with the expander.

5. The negative pressure introducer sheath according to claim 3, characterized in that: The pressure regulating part is a seal that can move radially, along the X-axis, along the Y-axis or circumferentially, wherein the radial direction refers to the plane perpendicular to the axial direction of the tube body, the X-axis and the Y-axis are the directions perpendicular to the extension of the tube body, and the circumferential direction refers to the circumferential direction around the axis of the tube body.

6. The negative pressure introducer sheath according to claim 5, characterized in that: The proximal end of the tube base wall has at least one air inlet groove communicated with the channel, and the pressure regulating part defines a second inlet for the passage of instruments. The pressure regulating part is rotatably arranged at the proximal end of the tube base.

7. The negative pressure introducer sheath according to claim 6, characterized in that: The pressure regulating portion includes: at least one sealing sheet for completely closing the air inlet groove in a sealed state; At least one relief gap is provided for exposing the air intake slot in a depressurized state.

8. The negative pressure introducer sheath according to claim 7, characterized in that: The operating part is connected to the pressure regulating part, and the operating part includes a rotating cap and a cover body. The rotating cap is rotatably connected to the proximal side wall of the tube seat, and the cover body is connected to the pressure regulating part. The cover body is provided with a groove that allows the notch to be exposed.

9. The negative pressure introducer sheath according to claim 8, characterized in that: The proximal end of the tube seat wall has an annular wall, and the end face of the annular wall has N sealing platforms and N air inlet grooves along its circumference, N is 2-4, and the N air inlet grooves are symmetrically arranged along the center of the annular wall, and two adjacent sealing platforms are spaced apart and a gap is provided between them to form an air inlet groove; the pressure regulating part has N sealing plates and N avoidance gaps, and two adjacent sealing plates are spaced apart and the gap provided between them constitutes an avoidance gap. When the pressure regulating part is in the closed position, the N sealing plates seal the N air inlet grooves one by one, and when the operating part is rotated, the N avoidance gaps and the N air inlet grooves are switched from the staggered position to the overlapping position in a one-to-one correspondence.

10. The negative pressure introducer sheath according to claim 1, characterized in that: The sealing platform, air inlet groove, sealing sheet and avoidance gap are all fan-shaped. The sealing platform and the air inlet groove are alternately arranged at intervals, and the sealing sheet and the avoidance gap are correspondingly arranged on the pressure regulating part with the same circumferential pitch.

11. The negative pressure introducer sheath according to claim 1, characterized in that: The pressure regulating part and the sealing valve are connected and are both elastic parts, the pipe seat and the operating part are hard parts, and the sealing element is pressed tightly between the pipe seat and the operating part.

12. The negative pressure introducer sheath according to claim 1, characterized in that: The pressure regulating part and the sealing valve are made of silicone rubber.

13. The negative pressure introducer sheath according to claim 7, characterized in that: The negative pressure guide sheath is also provided with at least one set of limiting components for limiting the rotation angle of the sealing piece. The limiting components include a limiting protrusion and a limiting groove. One of the limiting protrusion and the limiting groove is provided on the operating part, and the other is provided on the tube seat.

14. The negative pressure introducer sheath according to claim 13, characterized in that: The plurality of limiting grooves are spaced apart and distributed in the circumferential direction of the tube seat, and the number of the limiting protrusions is correspondingly multiple.

15. The negative pressure introducer sheath according to claim 14, characterized in that: The rotating cap or cover body is provided with a plurality of limit blocks at circumferential intervals to limit its rotation angle, and the tube seat is provided with a circumferentially extending limit groove. When the rotating cap rotates a predetermined angle, the side walls of the limit blocks and the side walls of the limit groove stop each other. The limit groove has a proximal limit surface and a distal limit surface, and the proximal limit surface and the distal limit surface respectively cooperate with the proximal and distal end surface stops of the limit protrusion.

16. The negative pressure introducer sheath according to claim 14, characterized in that: The limiting groove is provided with a plurality of locking positions that engage with the limiting protrusion along its circumferential extension direction, so that the rotating cap can be suspended at the reserved position of the limiting groove.

17. The negative pressure introducer sheath according to claim 16, characterized in that: The tube seat includes an annular wall, an expansion section and a contraction section from the proximal end to the distal end. The annular wall contracts radially inward compared to the expansion section to form a step. The negative pressure joint is arranged on the side wall of the contraction section. The distal end of the rotating cap cooperates with the step stop. The annular wall has an axial groove extending axially along the annular wall and a circumferential extension groove extending circumferentially along the annular wall. The distal end of the axial groove is connected to the circumferential extension groove. The rotating cap has a limiting protrusion that cooperates with the axial groove and the circumferential extension groove. The proximal end face and the distal end face of the axial groove are respectively pressed together with the proximal end of the limiting protrusion.

18. The negative pressure introducer sheath according to claim 1, characterized in that: A hand-held portion is provided below the tube seat.

19. The negative pressure introducer sheath according to claim 1, characterized in that: The upper end surface of the tube seat is a plane or an arc surface.

20. The negative pressure introducer sheath according to claim 1, characterized in that: The tube body is composed of a soft segment at the distal end and a hard segment at the proximal end. From the distal end toward the proximal end, the tube body is composed of a transparent segment, a first color segment and a second color segment in sequence. The colors of the first color segment and the second color segment are different.

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