Multi-mode working assembly

Abstract

The embodiment of the utility model provides a multi-mode working assembly which comprises an inner sheath, the inner sheath comprises an inner-layer tube body and an operating handle, and the far end of the inner-layer tube body is provided with a plugging part corresponding to the open end of the far end of an outer sheath in shape; the outer sheath comprises a leading-in sheath tube and a multifunctional assembly, and the inner sheath is located in the outer sheath; the adjusting part is used for connecting and adjusting the outer sheath and the inner sheath; wherein the plugging part comprises an expansion section, a sealing section and a transition section from far to near, the outer diameter of the expansion section is gradually increased from far to near, the outer diameter of the sealing section is not changed, the sealing section is attached to the inner wall of a leading-in sheath tube of the outer sheath, the outer diameter of the transition section is gradually reduced from far to near, and the outer diameter of the transition section is not changed. The expansion section, the sealing section and the transition section are in streamline transition connection.

Description

Technical Field

[0001] This manual relates to the field of instruments and tools, and in particular to a multimodal working component and its method of use. Background Technology

[0002] Current treatments often require the use of medical equipment, such as lithotripsy for ureteral stones, treatment of ureteral adhesions, and treatment of cysts, all of which require the insertion of equipment into the lesion. However, existing equipment has several shortcomings.

[0003] For the treatment of ureteral stones, the two main surgical methods currently used in clinical practice are flexible ureteroscopic lithotripsy and rigid ureteroscopic lithotripsy.

[0004] Rigid ureteroscopy involves using a rigid ureteroscope to reach the ureteral stone location via the urethra and bladder, and then using energy tools to break up the stone. Currently, conventional rigid ureteroscopes have a relatively large outer diameter, and the ureter contracts during the procedure due to stimulation from the rigid ureteroscope, resulting in a very narrow space between the ureter and the rigid ureteroscope. This makes it difficult for fluid instilled through the rigid ureteroscope to return. In holmium laser lithotripsy, the laser energy is converted into heat in addition to breaking up the stone. Without continuous water circulation, prolonged lithotripsy can easily cause thermal damage to the ureter.

[0005] To avoid thermal injury to the ureter and allow for intraoperative fluid reflux, ureteroscopic lithotripsy is performed. First, a rigid ureteroscope is used to examine and initially dilate the affected ureter. The rigid ureteroscope stops at a certain point in the ureter, and a guidewire is inserted through the second channel of the rigid ureteroscope. After withdrawing the rigid ureteroscope, a flexible ureteroscopic sheath is inserted along the guidewire. Once the flexible ureteroscopic sheath is successfully inserted, a flexible ureteroscope is then inserted through the sheath to complete the lithotripsy. However, as mentioned above, ureteroscopic lithotripsy for ureteral stones requires a rigid ureteroscope and guidewire, making the procedure cumbersome. Furthermore, the insertion of the ureteral sheath along the guidewire is performed without direct vision, which can easily cause invasive damage to the ureter, increasing surgical risks and patient discomfort. The use of multiple instruments also increases costs.

[0006] Therefore, there is a need for a multimodal working component that can perform sheath placement and lithotripsy under visual conditions, with a simpler structure, easier and safer operation, and can simplify surgical procedures as much as possible and reduce tissue damage. Summary of the Invention

[0007] This specification provides a multimodal working component, comprising: an inner sheath, the inner sheath including an inner tube and an operating handle, the distal end of the inner tube having a sealing portion corresponding to the shape of the distal opening end of an outer sheath; an outer sheath, the outer sheath including an inlet sheath tube and a multifunctional component, the inner sheath being located within the outer sheath; and an adjustment portion for connecting and adjusting the outer sheath and the inner sheath; wherein the sealing portion includes an expansion section, a sealing section, and a transition section from distal to proximal, the outer diameter of the expansion section gradually increasing from distal to proximal, the outer diameter of the sealing section remaining constant, the sealing section fitting against the inner wall of the inlet sheath tube of the outer sheath, the outer diameter of the transition section gradually decreasing from distal to proximal, and the expansion section, the sealing section, and the transition section being streamlinedly connected. Attached Figure Description

[0008] This specification will be further described by way of exemplary embodiments, which will be described in detail with reference to the accompanying drawings. These embodiments are not limiting; in these embodiments, the same reference numerals denote the same structures, wherein:

[0009] Figure 1 This is an exemplary structural diagram of a multimodal working component according to some embodiments of this specification;

[0010] Figure 2 These are exemplary structural schematic diagrams of the outer sheath shown according to some embodiments of this specification;

[0011] Figure 3 This is an exemplary structural schematic diagram of the inner sheath according to some embodiments of this specification;

[0012] Figure 4 These are exemplary structural schematic diagrams of the sealing portion shown in some embodiments of this specification;

[0013] Figure 5 This is a schematic diagram of the structure of one of the operating modes of the multimodal operating component shown in some embodiments of this specification;

[0014] Figure 6 This is a structural schematic diagram of another operating mode of the multimodal operating component shown in some embodiments of this specification. Detailed Implementation

[0015] To more clearly illustrate the technical solutions of the embodiments in this specification, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are merely some examples or embodiments of this specification. For those skilled in the art, these drawings can be applied to other similar scenarios without creative effort. Unless obvious from the context or otherwise specified, the same reference numerals in the drawings represent the same structures or operations.

[0016] It should be understood that the terms “system,” “device,” “unit,” and / or “module” used herein are one way to distinguish different components, elements, parts, sections, or assemblies at different levels. However, if other terms can achieve the same purpose, they may be replaced by other expressions.

[0017] As indicated in this specification and claims, unless the context clearly indicates otherwise, the words "a," "an," "an," and / or "the" do not specifically refer to the singular and may also include the plural. Generally speaking, the terms "comprising" and "including" only indicate the inclusion of expressly identified steps and elements, which do not constitute an exclusive list, and the method or apparatus may also include other steps or elements.

[0018] Flowcharts are used in this specification to illustrate the operations performed by the system according to embodiments of this specification. It should be understood that the preceding or following operations are not necessarily performed in exact order. Instead, the steps can be processed in reverse order or simultaneously. Furthermore, other operations can be added to these processes, or one or more steps can be removed from them.

[0019] In the following description, in order to clearly demonstrate the structure and working method of this application, a number of directional terms will be used. However, terms such as "front", "back", "left", "right", "outside", "inside", "outward", "inward", "up", and "down" should be understood as convenient terms and not as limiting terms.

[0020] Embodiments of this application are described below with reference to the accompanying drawings.

[0021] One embodiment of this application relates to a multimodal working assembly. The multimodal working assembly can be applied to natural cavities (e.g., the ureter) for performing sheath placement and stone treatment under visualization. The following description uses the application of the multimodal working assembly in the ureter as an example. Understandably, the multimodal working assembly can also be used in other locations.

[0022] Figure 1 This is an exemplary structural diagram of a multimodal working component shown according to some embodiments of this specification. For example... Figure 1 As shown, the multimodal working assembly 100 includes: an inner sheath 1, an outer sheath 2, and an adjustment section 3.

[0023] Figure 2 These are exemplary structural schematic diagrams of the outer sheath shown according to some embodiments of this specification. For example... Figure 2As shown, the outer sheath 2 may include two parts: a distal end and a proximal end. The proximal end of the outer sheath 2 is the multifunctional component 21, and the distal end of the outer sheath 2 is the inlet sheath 22. The inlet sheath 22 communicates with the interior of the multifunctional component 21. In some embodiments, the outer sheath may be made of a flexible material. Unless otherwise specified in this application, the proximal end may refer to the portion closer to the operator, and the distal end may refer to the portion farther from the operator.

[0024] The insertion sheath 22 can be a hollow tubular structure. For example... Figure 2 As shown, the inlet sheath 22 surrounds a first channel 221 extending axially along the outer sheath. The first channel 221 has a uniform diameter through-hole structure, allowing the flow fluid flowing through the first channel 221 to pass smoothly. The flow fluid is the liquid flowing through the multimodal working component. The flow fluid may include liquid within the object body or an infusion fluid. The liquid within the object body may be liquid discharged from the body; in some embodiments, the liquid within the object body may include liquid containing stone particles. The infusion fluid may include a cleaning solution or a medicinal solution. A distal opening 222 is provided at the distal end of the first channel 221 (or inlet sheath 22). The first channel is connected to the object body at its distal end. Unless otherwise specified in this application, axial direction can refer to the direction of extension of the outer sheath.

[0025] Combination Figure 5 The outer diameter of the portion of the sheath 22 near the distal opening 222 gradually decreases from near to far, with the outer diameter being the smallest at the distal end, forming a tapered hollow frustum shape.

[0026] like Figure 2 As shown, the proximal end of the multifunctional component 21 includes a drain port 211, a pressure relief port 212, and a proximal opening end 213. The proximal end of the multifunctional component 21 is connected to the inlet sheath 22.

[0027] The proximal opening 213 is located on the axis of the outer sheath. The inner sheath 1 can be inserted into the first channel of the introductory sheath via the proximal opening 213. The multifunctional component 21 has at least two side openings, one of which can serve as a pressure relief port 212 to reduce the pressure inside the patient's body during surgery. The other side opening serves as a drainage port 211. In some embodiments, the drainage port 211 allows fluid to flow out of the patient's body and supports reverse perfusion. Fluid inside the patient's body can be discharged from the drainage port 211 through the first channel 221 via the distal opening 222, or irrigation fluid or medication can be injected back into the patient's body via the drainage port 211.

[0028] In some embodiments, the inner sheath 1 may include two parts, a distal end and a proximal end, wherein the distal end of the inner sheath is the inner tube 12, and the proximal end of the inner sheath 1 is the operating handle 11. The interior of the inner tube 12 may communicate with the interior of the operating handle 11.

[0029] Figure 3 This is a schematic diagram of an exemplary structure of the inner sheath according to some embodiments of this specification. For example... Figure 3 As shown, the inner tube 12 is a tubular structure, which encloses a second channel 121 extending axially along the inner tube 12. The second channel 121 is a through structure with a constant diameter. In some embodiments, the distal end of the second channel communicates with the internal environment of the object. In some embodiments, an imaging illumination component and / or an instrument tool can be inserted into the second channel. For example, the instrument tool may include a stone crushing tool or a basket. In some embodiments, the second channel may be divided into at least two parallel channels extending axially along the inner tube, one channel for the imaging illumination component to pass through, and the other channel for the instrument tool or flowing fluid to pass through. In some embodiments, the imaging illumination component and / or instrument tool can enter the second channel and then extend from the distal end of the second channel. In some embodiments, the distal end of the second channel may be partially beveled. In some embodiments, the bevel angle ranges from 5° to 85° to balance tip strength and guidance efficiency. The bevel edge is smoothly polished to avoid sharp edges scratching the inner wall of the cavity.

[0030] In some embodiments, the inner tube may be made of a material with a certain degree of rigidity, such as a metal. In some embodiments, the wall thickness of the inner tube may be 0-0.5 mm. In some embodiments, the wall thickness of the inner tube may be 0.1-0.4 mm. In some embodiments, the length of the inner tube may be less than 50 cm. In some embodiments, the wall of the inner tube needs to achieve a balance between rigidity, flexibility, and support. Compared to the thick-walled structure of conventional hard metal endoscopes, the rigid wall of the inner tube can be made relatively thin. On the one hand, this improves bending compliance and reduces mechanical stimulation to the natural cavity; on the other hand, it can retain the basic support rigidity, and the metallic properties ensure axial compressive strength and provide internal support guidance.

[0031] In some embodiments, the rigidity of the inner tube can be higher than that of the outer sheath, forming a "rigid-flexible nested" structure. The outer sheath is more flexible and can conform to the shape of the cavity.

[0032] In some embodiments, the distal end of the inner tube 12 is provided with a sealing portion 13 corresponding to the shape of the inner wall of the distal opening end of the outer sheath. For example... Figure 3 As shown, the sealing part 13 is arranged in a raised ring around the outer periphery of the distal end of the inner tube. Figure 4As shown, the outer diameter of the sealing section varies axially. The sealing section, from far to near, can include a distal section, a middle section, and a proximal section. The distal section is the expansion section 131, the middle section is the sealing section 132, and the proximal section is the transition section 133. The outer diameter of the expansion section 131 gradually increases from far to near, forming a slope. The outer diameter of the farthest end of the expansion section is equal to the outer diameter of the inner tube, and the outer diameter of the nearest end of the expansion section is equal to the outer diameter of the sealing section 132. The sealing section 132 fits against the inner wall of the outer sheath inlet tube, and its outer diameter remains constant, essentially equal to the inner diameter of the outer sheath inlet tube. The outer diameter of the transition section gradually decreases from far to near, forming a slope. The outer diameter of the farthest end of the transition section is equal to the outer diameter of the sealing section 132, and the outer diameter of the nearest end of the transition section is equal to the outer diameter of the inner tube. The expansion section 131, the sealing section 132, and the transition section 133 are connected in a streamlined transition.

[0033] Figure 5 This is a schematic diagram of the structure of one of the operating modes of a multimodal operating component according to some embodiments of this specification. For example... Figure 5 As shown, at least one groove 134 is provided around the periphery of the sealing portion 13 for the passage of flowing fluid. In some embodiments, the number of grooves can be at least one. The number of grooves can be 4-10. The grooves can be uniformly distributed circumferentially. The cross-section of the grooves can include at least one of axial straight grooves, spiral inclined grooves, or corrugated grooves. In some embodiments, the grooves form a microchannel array, generating local turbulence in the gap between the sealing portion and the inner wall of the outer sheath, which can increase the flow velocity of the flowing fluid. In some embodiments, the spiral inclined groove design induces a swirling effect, causing particles in the flowing fluid to accumulate towards the center, reducing the risk of deposition on the pipe wall. It is understood that the arrangement and shape of all grooves provided on the sealing portion at the distal end of the inner tube for the passage of flowing fluid are within the protection scope of this application. In some embodiments, the setting of the groove size can limit the size of stones in the flowing fluid flowing through the groove, and as the number of grooves increases, the depression of the sealing portion corresponding to the groove becomes smaller, which can reduce damage to the tissues in the body.

[0034] In some embodiments, when the multimodal working component enters a natural cavity, its distal end may cause damage to human tissue. To reduce the risk of harm to the human body, the distal end of the inner tube has a rounded guide surface.

[0035] The sealing portion can be made of a flexible material, such as a polymer. In this application, the shape of the side of the sealing portion facing the tissue is not limited to a rounded guide surface. As long as it has the same function as the sealing portion and can reduce the probability of tissue damage, it is within the scope of protection of this application.

[0036] In some embodiments, at least one sensor is provided in the multimodal working component. The sensor may include a pressure sensor or a flow rate sensor.

[0037] In some embodiments, a pressure sensor may be provided on the portion of the outer surface of the sealing section that contacts the internal environment of the object, for real-time monitoring of the pressure in the environment. In some embodiments, the pressure sensor may be located in the expansion section.

[0038] In some embodiments, the flow rate sensor can be positioned at any location in the flow channel of the flowing liquid. The flow channel includes a first channel and / or a second channel.

[0039] In some embodiments, a flow rate sensor may be provided on the outer wall of the inner tube to measure the flow rate of the circulating fluid. In some embodiments, the flow rate sensor may be located on the outer wall of the inner tube near the sealing portion, i.e., behind the sealing portion (in the direction of the inner tube towards the operating handle). Figure 4 As shown, a flow rate sensor 122 can be circumferentially disposed on the outer surface of the inner tube body located behind the sealing section. Alternatively, the flow rate sensor can be disposed on the inner wall of the outer sheath (introducing sheath).

[0040] The proximal end of the operating handle 11 includes a cable port 111 and a liquid inlet 112. The distal end of the operating handle 11 is provided with a connection adapter 113. The proximal end of the operating handle 11 is connected to the inner tube body 12.

[0041] like Figure 3 As shown, a cable port 111 is provided on the proximal end of the operating handle 11 for the passage of a cable for the imaging illumination component. The imaging illumination component is connected to an external light source and / or image processing device via the cable port 111, and the cable can transmit and process optical and image signals. The imaging illumination component can enter the second channel 121 of the inner tube body from the cable port 111.

[0042] like Figure 5 As shown, the imaging illumination component 14 may include an illumination component 141, an imaging component 142, and a cable for the imaging illumination component. The imaging component can acquire an image from the front end of the imaging component. The illumination component can provide illumination. The imaging component can be an electron mirror or an optical mirror. The imaging component can acquire an image from its front end. The cable of the imaging illumination component is connected to the illumination component 141 and the imaging component 142, and can extend from the cable port 111 of the operating handle 11 to be connected to a power supply and / or an image processing device (not shown). In some embodiments, the imaging illumination component can be directly inserted into the outer sheath as an inner tube.

[0043] An injection port 112 is provided along the axis on the proximal end of the operating handle 11. In some embodiments, the injection port 112 can serve as an inlet / outlet for the circulating fluid and / or an inlet / outlet for instruments / tools. The circulating fluid or instruments / tools enter the second channel 121 of the inner tubing through the injection port 112. In some embodiments, the injection port 112 may be provided with a bypass port. Figure 3 As shown, when a bypass port 112-1 is provided on the injection port 112, the injection port 112 located on the axis can be used as the inlet and outlet of the instrument, while the bypass port 112-1 can be used as the inlet and outlet of the circulating fluid.

[0044] A connecting adapter 113 is provided along the axis on the distal end of the operating handle 11. The distal end of the operating handle is connected to the adjusting part 3 via the connecting adapter 113. Figure 3 As shown, the inner side of the connecting adapter 113 is provided with threads. The proximal end of the adjusting part 3 is provided with a mating part that matches the connecting adapter 113. For example, a screw-on locking collar corresponding to the inner thread of the connecting adapter is provided around the mating part.

[0045] The adjusting part 3 is used to connect the outer sheath and the inner sheath. The proximal end of the adjusting part 3 is connected to the inner sheath, and the distal end of the adjusting part 3 is connected to the outer sheath. In some embodiments, the adjusting part can adjust and fix the relative position of the outer sheath 2 and the inner sheath 1 (specific structure not shown), corresponding to different working modes. The adjusting part can adjust the relative position of the outer sheath 2 and the inner sheath 1. In some embodiments, such as the working state Figure 4 or Figure 5 As shown, by adjusting the adjustment part, the sealing part of the inner tube 12 extends completely from the distal end of the outer sheath 2, and the relative positions of the outer sheath 2 and the inner sheath 1 are fixed. In some embodiments, such as the working state... Figure 6 As shown, by adjusting the adjusting part, a portion of the sealing part of the inner tube 12 extends from the distal end of the outer sheath 2, thus fixing the relative position of the outer sheath 2 and the inner sheath 1. Unless otherwise specified, any structure of the adjusting part that can adjust the relative position of the outer sheath 2 and the inner sheath 1, such as a slide rail guide system, threads, knobs, latches, etc., can be included in this application. In some embodiments, the adjusting part may be provided with different markings to indicate the length of the inner sheath extending from the distal end of the outer sheath.

[0046] In some embodiments, the outer sheath, the inner side of the inner sheath, or the outer side of the inner sheath has a hydrophilic coating.

[0047] In some embodiments, the inner sheath and outer sheath can be disposable consumables.

[0048] Understandably, another embodiment of this invention also provides a method for using a multimodal working component. The method of using the multimodal working component includes the following steps, wherein each step can correspond to a working mode.

[0049] Step 100: Insert the inner sheath into the outer sheath, connect the outer sheath and the inner sheath through the adjustment part, and insert the multimodal working component into the target position.

[0050] Figure 6 This is a structural schematic diagram of another operating mode of the multimodal operating component shown in some embodiments of this specification. For example... Figure 6 As shown, the distal end of the inner sheath 1 (inner tube 12) can be inserted through the proximal opening 213 of the multifunctional component 21 of the outer sheath 2 into the first channel 221 of the inlet sheath 22. In some embodiments, the inner tube 12 extends at least partially operably through the first channel 221 from the distal opening 222 to the junction of the sealing section 132 and the expansion section 131 of the sealing portion, and is flush with the distal opening 222 of the outer sheath 2. The outer diameter of the sealing section 132 of the sealing portion matches the inner diameter of the distal opening 222 of the outer sheath 2, so that the outer side of the sealing portion of the inner sheath and the inner side of the outer sheath can be partially and tightly fitted. The outer diameter of the sealing section matches the inner diameter of the distal opening 222 of the outer sheath. This allows the inner tube to be smoothly inserted into the outer sheath. Furthermore, during the process of the multimodal working assembly 100 entering a natural cavity (e.g., the ureter), the sealing portion can minimize the entry of larger tissues or other foreign objects from the natural cavity into the multimodal working assembly (outer sheath). The inner and outer sheaths are connected by an adjusting part, and their relative positions are fixed. The imaging illumination component is then inserted through the cable port 111 of the operating handle 11 into the second channel of the inner sheath. In some embodiments, the imaging illumination component can extend from the distal end of the second channel 121 of the inner tube to acquire an image of the surrounding environment.

[0051] The assembled multimodal working component is then inserted along a natural cavity (e.g., the ureter) and, under visual guidance, reaches the target location, which is the location of the stone within the natural cavity.

[0052] In step 100, the distal boundary of the sealing section is flush with the distal opening of the outer sheath, and the surface of the distal portion of the inner sheath extending beyond the outer sheath and the portion of the outer sheath near the distal opening form a natural transition interface. Together, they form a gradually expanding streamlined gradient structure. Furthermore, since the outer diameter of the sealing section of the plugging part is slightly smaller than or equal to the inner diameter of the distal opening of the outer sheath, the outer surface of the sealing section of the plugging part adheres to the inner wall of the outer sheath, and the expansion section of the plugging part gradually contacts the tissue of the natural cavity, achieving dynamic expansion. Further, the streamlined transition between the expansion section and the sealing section of the plugging part, in conjunction with the outer sheath, forms a gradually expanding gradient structure from distal to proximal, homogenizing the tissue stress distribution, facilitating the entry of the multimodal working component into the natural cavity, reducing damage to the tissue within the object, and improving the success rate of implantation.

[0053] Step 100 can correspond to working mode 1 and may include the process of placing the assembled multimodal working component into the target location. In working mode 1, the imaging illumination component makes the entire placement process visible, which can further reduce damage to the tissues inside the object and improve the success rate of placement.

[0054] In some embodiments, during the placement of the multimodal working component into the target position of the natural cavity, i.e., in working mode 1, injection and drainage can be performed simultaneously. In some embodiments, injection and drainage can be achieved through a reflux system. The injection fluid can enter the second channel through the injection port and flow into the target position. When it is necessary to aspirate fluid from the object, the fluid from the object flows into the first channel through the distal opening of the outer sheath, flows through the first channel and exits through the drainage port, and vice versa, forming a reflux system. Specifically, when the inner sheath passes through the proximal opening of the outer sheath into the first channel of the outer sheath, the first and second channels form a double-channel axial nested structure. One of the first or second channels serves as the injection channel, and the other as the outlet channel, forming a reflux system. Corresponding to the first or second channel, one of the injection port communicating with the second channel or the drainage port communicating with the first channel can serve as the flow fluid outlet, and the other as the flow fluid inlet. For example, the infusion fluid enters the second channel of the inner sheath from the infusion port, enters the body of the object through the distal outlet of the inner sheath, and after the negative pressure device is turned on, the liquid in the body of the object (including blood, stone particles, etc.) enters the first channel through the distal opening of the outer sheath and is discharged from the drain port side.

[0055] In working mode 1, since the outer surface of the sealing section of the sealing part is in contact with the inner wall of the outer sheath, the injection fluid or liquid in the object body can be injected into the object body or extracted from the object body through at least one groove of the sealing part to achieve backflow.

[0056] Step 200: Add tools and equipment to crush the stone.

[0057] Once the target location is reached, instruments are inserted through the injection port or bypass port of the inner sheath operating handle, allowing the instruments to pass through and extend out of the second channel of the inner sheath, enabling operation under visible conditions (e.g., lithotripsy).

[0058] Step 200 corresponds to working mode 2. When the stone at the target location is small, working mode 2 of the multi-modal working component can be used for stone fragmentation. Simultaneously, in working mode 2, injection and drainage can be achieved through a reflux system. For example, the injection fluid can enter the second channel through the injection port of the inner sheath operating handle and then enter the object's body. After the stone fragmentation operation, the liquid inside the object is a flowing fluid containing stone particles, which can enter the first channel through at least one groove in the sealing part and be discharged from the drainage port of the multi-modal component.

[0059] Step 300: Adjust the relative positions of the outer and inner sheaths to crush the stone.

[0060] In some embodiments, the relative positions of the outer sheath and the inner sheath can be adjusted by the adjustment part, so that the inner tube of the inner sheath moves further away, and the sealing part is completely away from the distal opening of the outer sheath and enters the internal environment of the object.

[0061] Step 300 corresponds to working mode 3. In working mode 3, liquid injection and drainage can be achieved through a reflux system. (See working state.) Figure 4 or Figure 5 As shown, when encountering a large stone, in order to increase the stone transport efficiency during the stone fragmentation process, the relative positions of the outer sheath 2 and the inner sheath 1 are adjusted so that the inner tube 12 moves further away and the sealing part 13 moves away from the outer sheath 2 along the axis so that the sealing part 13 extends completely out of the outer sheath 2. At this time, the negative pressure device is turned on, and the circulating fluid at the front end of the multimodal working component can flow into the proximal end of the sealing part through at least one groove 134 on the outer periphery of the sealing part 13, or through the gap between the outer sheath 2 and the inner sheath 1 via the distal opening end 222 of the outer sheath, and then enter the outer sheath 2 (first channel 221).

[0062] In some embodiments, the length of the inner tube extending beyond the outer sheath can be adjusted by the adjustment part, that is, the gap between the inner and outer sheaths at the distal opening end can be adjusted to prevent larger stones from being sucked into the first channel and ensure the smooth flow of the circulating fluid in the first channel.

[0063] Compared to working mode 2, working mode 3 allows the circulating fluid in the internal environment of the object to enter the first channel through the distal opening of the outer sheath. Compared to entering the first channel only through the groove of the sealing part, the flow rate of the circulating fluid into the first channel is significantly increased, resulting in higher stone transport efficiency.

[0064] Understandably, the multimodal working component can break stones in other areas besides the ureteral lithotripsy, and is not limited to the ureteral stone surgery involved in this embodiment.

[0065] As can be seen from the above, the multimodal working component provided in this application can have the following technical effects:

[0066] First, the multimodal working component has a simpler structure and is easier to operate.

[0067] Due to its multimodal working components, the structure is simple and does not require the additional use of a rigid ureteroscope and guidewire. Multiple components are inserted and withdrawn from the ureter in stages, making the operation simple and convenient, saving surgical time. Furthermore, the imaging illumination components provide full intraoperative visualization, ensuring safe operation, reducing the probability of accidental injury, and making the surgery safer and less painful for the patient.

[0068] Secondly, setting up a reflux system makes the operation safer and more efficient.

[0069] The adjusting mechanism allows for adjustment of the axial relative positions of the outer and inner sheaths, thereby creating a continuous reflux system during lithotripsy. Adjusting the injection and drainage directions offers the following advantages:

[0070] 1) Channel Hydraulic Formation: Upon entering a natural cavity, a fluid channel is actively formed by water injection through the reflux system, avoiding tissue damage caused by mechanical expansion; the channel remains open throughout the procedure to ensure smooth instrument movement. 2) Active Reflux: The water circulation system activates simultaneously during operation, keeping the tip temperature of instruments such as laser lithotripters below a safe level, reducing the risk of thermal damage. 3) Pulse Dilution and Removal: It can quickly dilute highly viscous fluids such as pus and blood, enabling simultaneous removal in conjunction with negative pressure aspiration, maintaining surgical field transparency. 4) Visual Operation Guarantee: The imaging component integrated into the second channel allows dynamic observation of changes in fluid turbidity, timely adjustment of irrigation intensity, and observation of lithotripsy particle size distribution, enabling timely adjustment of aspiration parameters and improving lithotripsy efficiency.

[0071] Third, the collaborative working mechanism between the reflux system and the sensor monitoring system enables real-time monitoring of the working process, thereby improving operational safety.

[0072] By installing a flow rate sensor behind the sealing portion on the outer wall of the inner tube, in working modes 1 and 2, the flow rate sensor can measure the flow rate of the fluid drawn from the object body and entering the first channel through at least one groove; in working mode 3, since a portion of the fluid drawn from the object body can also enter the first channel through the distal opening of the outer sheath, the flow rate sensor is installed at the position corresponding to the distal opening on the inner sheath, and the flow rate sensor can measure the total flow rate of the fluid flowing through the groove of the sealing portion and the fluid entering the first channel through the distal opening of the outer sheath.

[0073] By measuring the flow velocity within the first channel, it is possible to detect any blockages (stone-related obstructions) in the reflux system. For example, a sudden or significant decrease in flow velocity indicates a blockage within the first channel. In some embodiments, when a blockage is detected, the problem can be resolved by adjusting the direction of fluid injection and drainage.

[0074] By combining a flow rate sensor with a pressure sensor mounted on the sealing section, the pressure inside the object and the flow rate of the circulating fluid in the return system can be obtained during operation. This overcomes the limitations of single-parameter monitoring, prevents misjudgments of the internal environment of the object during operation, and improves operational safety. For example, when water injection is low or nonexistent, the flow rate measured by the flow rate sensor will be 0 or low, but there is no blockage at this time. In some embodiments, the operating mode can be selected based on the flow rate and pressure values. For example, when the flow rate decreases in operating mode 2 but the pressure is high, it indicates a blockage. In this case, operating mode 2 can be switched to operating mode 3 to increase the flow rate of the circulating fluid from the internal environment of the object. In some embodiments, flow rate thresholds and pressure thresholds can be set for the flow rate and pressure values, corresponding to different operating modes. The flow rate threshold is the minimum flow rate under normal operation. The pressure threshold can be the maximum pressure of the internal environment of the object under normal operation. When the flow rate is below the flow rate threshold and the pressure is above the pressure threshold, an alarm is triggered. At this time, operating mode 3 can be activated, or the water inflow can be reduced to lower the pressure in the internal environment of the object. In some embodiments, the operating mode can be precisely switched by using a marker on the adjustment unit to indicate the length of the inner sheath extending from the distal end of the outer sheath.

[0075] It should be noted that different embodiments may produce different beneficial effects. In different embodiments, the beneficial effects may be any one or a combination of the above, or any other possible beneficial effects.

[0076] The basic concepts have been described above. Obviously, for those skilled in the art, the detailed disclosure above is merely illustrative and does not constitute a limitation of this specification. Although not explicitly stated herein, those skilled in the art may make various modifications, improvements, and corrections to this specification. Such modifications, improvements, and corrections are suggested in this specification and therefore remain within the spirit and scope of the exemplary embodiments described herein.

[0077] Furthermore, this specification uses specific terms to describe embodiments thereof. For example, "an embodiment," "one embodiment," and / or "some embodiments" refer to a particular feature, structure, or characteristic associated with at least one embodiment of this specification. Therefore, it should be emphasized and noted that references to "an embodiment," "one embodiment," or "an alternative embodiment" in different locations throughout this specification do not necessarily refer to the same embodiment. Moreover, certain features, structures, or characteristics in one or more embodiments of this specification can be appropriately combined.

[0078] Furthermore, unless expressly stated in the claims, the order of processing elements and sequences, the use of numbers and letters, or other names described in this specification are not intended to limit the order of the processes and methods described herein. Although various examples have been discussed in the foregoing disclosure of embodiments that are currently considered useful, it should be understood that such details are for illustrative purposes only, and the appended claims are not limited to the disclosed embodiments; rather, the claims are intended to cover all modifications and equivalent combinations that conform to the substance and scope of the embodiments described herein. For example, while the system components described above can be implemented using hardware devices, they can also be implemented solely using software solutions, such as installing the described system on existing servers or mobile devices.

[0079] Similarly, it should be noted that, in order to simplify the descriptions disclosed herein and thus aid in the understanding of one or more embodiments, the foregoing description of embodiments in this specification sometimes combines multiple features into a single embodiment, drawing, or description thereof. However, this method of disclosure does not imply that the subject matter of this specification requires more features than those mentioned in the claims. In fact, the embodiments contain fewer features than all the features of the single embodiments disclosed above.

[0080] In some embodiments, numbers describing the quantity of components and attributes are used. It should be understood that such numbers used in the description of embodiments are modified in some examples with the terms "approximately," "approximately," or "generally." Unless otherwise stated, "approximately," "approximately," or "generally" indicates that the numbers are allowed to vary by ±20%. Accordingly, in some embodiments, the numerical parameters used in the specification and claims are approximate values, which may be changed depending on the characteristics required by individual embodiments. In some embodiments, numerical parameters should take into account specified significant digits and employ a general method of digit reservation. Although the numerical ranges and parameters used to confirm their breadth of range in some embodiments of this specification are approximate values, in specific embodiments, such values ​​are set as precisely as feasible.

[0081] For each patent, patent application, patent application publication, and other material such as articles, books, specifications, publications, and documents referenced in this specification, the entire contents of which are incorporated herein by reference. This excludes historical application documents that are inconsistent with or conflict with the content of this specification, as well as documents that limit the broadest scope of the claims in this specification (currently or subsequently appended to this specification). It should be noted that in the event of any inconsistency or conflict between the descriptions, definitions, and / or terminology used in the supplementary materials to this specification and the content of this specification, the descriptions, definitions, and / or terminology used in this specification shall prevail.

[0082] Finally, it should be understood that the embodiments described in this specification are merely illustrative of the principles of the embodiments described herein. Other variations may also fall within the scope of this specification. Therefore, alternative configurations of the embodiments described herein are intended to be illustrative rather than limiting, and should be considered consistent with the teachings of this specification. Accordingly, the embodiments described herein are not limited to those explicitly introduced and described herein.

Claims

1. A multimodal operating component, characterized in that, include: The inner sheath includes an inner tube and an operating handle, and the distal end of the inner tube is provided with a sealing part that corresponds to the shape of the distal opening end of the outer sheath. An outer sheath, comprising an inlet sheath tube and a multifunctional assembly, wherein an inner sheath is inserted within the outer sheath; An adjustment section is used to connect and adjust the outer sheath and the inner sheath; The sealing section includes an expansion section, a sealing section, and a transition section from far to near. The outer diameter of the expansion section gradually increases from far to near, while the outer diameter of the sealing section remains unchanged. The sealing section is in contact with the inner wall of the inlet sheath of the outer sheath. The outer diameter of the transition section gradually decreases from far to near. The expansion section, the sealing section, and the transition section are connected in a streamlined manner.

2. The multimodal operating component according to claim 1, characterized in that, The inner sheath passes through the outer sheath and includes: The junction of the sealing section and the expansion section of the sealing part is flush with the distal opening end of the outer sheath.

3. The multimodal operating component according to claim 2, characterized in that, The inner sheath is inserted inside the outer sheath, and includes: adjusting the relative position of the outer sheath and the inner sheath through the adjustment part, so that the inner tube moves to a distance, and the sealing part is completely away from the distal opening end of the outer sheath.

4. The multimodal operating component according to claim 1, characterized in that, At least one groove is provided on the outer circumference of the sealing part.

5. The multimodal operating component according to claim 1, characterized in that, A pressure sensor is provided on the outer surface of the inner sheath near the sealing part.

6. The multimodal operating component according to claim 1, characterized in that, A flow rate sensor is installed on the outer wall of the inner tube near the sealing part.

7. The multimodal operating component according to claim 1, characterized in that, The inlet sheath is a tubular structure, and the inlet sheath surrounds a first channel extending along the axial direction of the inlet sheath. The first channel is connected to the body of the object at its distal end.

8. The multimodal operating component according to claim 1, characterized in that, The inner tube is a tubular structure, and the inner tube surrounds a second channel extending along the axial direction of the inner tube. The second channel is connected to the object body at its distal end.

9. The multimodal operating component according to claim 7 or 8, characterized in that, The first channel and the second channel form a reflux system, wherein one of the first channel or the second channel serves as the injection channel and the other channel serves as the outlet channel.

10. The multimodal operating component according to claim 8, characterized in that, The proximal end of the operating handle is provided with a liquid injection port, which serves as the inlet and outlet of the circulating fluid and / or the inlet and outlet of the instrument / tool.

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