A urology stone removal device

Abstract

The present invention relates to the field of medical device technology, and specifically to a urology stone removal device, comprising an operating handle and an outer tube; a first guide wire and a second guide wire are arranged in the outer tube; a basket is arranged at the distal end of the first guide wire, and a balloon is arranged at the distal end of the second guide wire; both the basket and the balloon can be retracted in the outer tube and can be released from the distal end of the outer tube; by controlling the relative sliding of the first guide wire and the second guide wire, the balloon can at least partially cover or surround the basket and / or the stone in the basket. When removing the stone, the present invention uses the balloon to cover or surround the basket, confining the stone corners between the balloon and the basket, so that the ureter wall only contacts the outer surface of the balloon during extraction, avoiding direct contact between the stone corners and the ureter wall. The operation mode does not significantly increase the complexity of the operation, but can significantly enhance the interception rate, reduce damage to the ureter wall during surgery, and reduce postoperative residues, making it easy to promote and apply in clinical practice.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a urology stone removal device. Background Art

[0002] The prevalence of urinary stones in adults is high. With the advancement of surgical techniques and equipment, stone surgery is continuously developing towards high stone-free rates and minimally invasive procedures. Ureteroscopic holmium laser lithotripsy is one of the safer and more effective methods for treating ureteral stones, as it is minimally invasive, has a high lithotripsy success rate, and is relatively safe. It is widely used both at home and abroad. However, during the lithotripsy process, stones broken by the laser can easily escape or move upwards to the renal pelvis, resulting in prolonged surgery and even residual stones. To address this issue, please refer to Figures 1 to 3 In clinical practice, N-trap baskets or blockers (such as airbags) are often used for interception: during the operation, the sheath is placed along the side of the stone, and the basket or blocker is deployed at the proximal end of the stone to form a barrier. After the holmium laser breaks the stone into fragments, the barrier is used to intercept the fragments and pull them out of the ureter synchronously with the instrument, thereby effectively curbing the upward displacement of the stone, reducing the risk of ureteral mucosal damage caused by displacement, and significantly shortening the operation time.

[0003] However, existing interception schemes still have certain limitations in clinical practice: although conventional blockers such as airbags can form a barrier to intercept stone fragments and prevent them from shifting upward, they cannot fix or constrain the position of the stone well, resulting in the stone and fragments easily shaking and colliding in the ureter during extraction, increasing the risk of damage to the inner wall of the ureter. Although the basket has improved in terms of fixation and interception performance, for example, the ureteral occlusion and stone removal catheter provided by the Chinese patent application with application number CN202211358408.7, by setting different states of the basket and judging the opening size based on the guidewire ring print, reduces the gap with the ureter and improves the interception effect, there are still some shortcomings: the shape of stone fragments is irregular, and after being captured by the basket, the sharp corners of the broken stones can easily scratch the inner wall of the ureter, causing damage to the ureteral wall. In addition, some small-sized stones will still move to the upper ureter through the basket mesh. Therefore, how to effectively intercept stone fragments while reducing the collision or scratching of the ureteral wall caused by stone extraction is an urgent problem that needs to be solved. Summary of the Invention

[0004] The purpose of the present invention is to provide a urology stone removal device that can solve the deficiencies in the prior art.

[0005] To achieve these objectives, the present application provides the following technical solutions: a urology stone removal device, comprising: an operating handle; an outer tube, one end of which is connected to the operating handle; a guidewire, which at least partially slides within the outer tube, the guidewire comprising a first guidewire and a second guidewire coaxially nested; a basket connected to the distal end of the first guidewire, an inflatable balloon connected to the second guidewire and located at the axial distal end of the basket; a medium channel, at least partially formed within the second guidewire, one end of which is connected to the balloon and the other end of which extends to the operating handle;

[0006] Among them, both the basket and the balloon can be retracted in the outer tube and can be released from the distal end of the outer tube; the basket naturally recovers or actively expands into an expanded mesh after release; the balloon is expanded by injecting a medium through the medium channel; at least one of the first guide wire and the second guide wire can slide along the guide wire axis relative to the other, and the first guide wire and the second guide wire are controlled to slide relative to each other by an operating handle, so that the balloon at least partially covers or surrounds the basket and / or the contents in the basket.

[0007] As a preferred embodiment, the basket wire includes a plurality of basket wires; the basket wire is a shape memory material wire, arranged in a circumferential direction around the first guide wire; when the basket is released from the outer tube, it naturally returns to an expanded mesh shape.

[0008] As a preferred embodiment, the balloon has at least an external surface for contacting the biological wall, a fixing portion fixedly connected to the second guide wire, and a compliant inner surface for contacting the basket and / or the contents in the basket; wherein the medium channel is connected to the balloon from the fixing portion; the inner surface is arranged at the end of the balloon facing the basket, and when the balloon is in an expanded state, the inner surface is gap-matched with the outer wall of the first guide wire so that the balloon covers or surrounds the basket.

[0009] As a preferred embodiment, the inner surface forms a accommodating cavity for covering or surrounding the basket, and the accommodating cavity transitions to the outer surface in an arc shape; when the balloon is in an expanded state, the inner diameter of the accommodating cavity close to the basket is larger than the inner diameter of the end away from the basket, so that the inner wall of the accommodating cavity forms a gradual conical surface as the inner diameter changes, so as to guide the basket into the accommodating cavity.

[0010] As a preferred embodiment, the operating handle is provided with a first operating member and a second operating member, both of which can slide along the axial direction of the guide wire; the first operating member is configured to at least be used to simultaneously push the first guide wire and the second guide wire out of the outer tube; the second operating member is configured to drive the first guide wire and the second guide wire to slide relative to each other along the axial direction.

[0011] As a preferred embodiment, the first operating member is connected to the proximal end of the second guide wire, and the second operating member is connected to the proximal end of the first guide wire; the proximal end of the first guide wire or the second operating member is at least partially located within the sliding range of the first operating member; so that when the first operating member slides axially along the guide wire toward the distal end of the outer tube, its end abuts against the proximal end of the first guide wire and / or the second operating member to synchronously drive the first guide wire and the second guide wire to move toward the distal end of the outer tube; by sliding the second operating member axially along the guide wire, the second guide wire is driven to axially displace relative to the first guide wire, so that the balloon at least partially covers or surrounds the basket and / or the contents in the basket.

[0012] As a preferred embodiment, the first operating member is connected to the proximal end of the second guide wire, and the second operating member is connected to the proximal end of the first guide wire; the maximum static friction between the first guide wire and the second guide wire is greater than the maximum static friction between the first guide wire and the outer tube and the operating handle, so as to ensure that when the first operating member slides along the axial direction of the guide wire toward the distal end of the outer tube, the first guide wire slides out of the outer tube synchronously with the second guide wire; the second operating member drives the first guide wire to axially displace relative to the second guide wire by overcoming the maximum static friction between the first guide wire and the second guide wire.

[0013] As a preferred embodiment, the first operating member is connected to the proximal end of the first guide wire; the proximal end of the second guide wire is connected to the first connecting member, the first connecting member slides in the inner cavity of the operating handle, and is connected to the second operating member; the first connecting member is configured to releasably engage with the first operating member, and when the two are engaged, the sliding first operating member can drive the first guide wire and the second guide wire to be synchronously pushed out or retracted into the outer tube.

[0014] As a preferred embodiment, the first connecting member has a locking groove opened along the circumferential direction of the first connecting member, an avoidance area arranged adjacent to the locking groove, and a clamping end connected to the first operating member; by relatively rotating the first operating member and the first connecting member, the end of the clamping end is selectively clamped into the locking groove or moved to the avoidance area; when the clamping end is clamped into the locking groove, the first connecting member is connected to the first operating member; when the locking groove is moved to the avoidance area, the first connecting member and the first operating member can slide axially relative to the guide wire.

[0015] As a preferred embodiment, a limiting mechanism is provided on the operating handle, and the limiting mechanism includes a plurality of limiting protrusions arranged along the sliding path of the first operating member; the first operating member can squeeze and pass over each limiting protrusion; when the first operating member is stationary, the maximum static friction force between the first operating member and the limiting protrusion is greater than the maximum static friction force between the first guide wire and the second guide wire, so as to ensure that when the second operating member slides axially, the first guide wire and the second guide wire can slide relative to each other axially.

[0016] Compared with the prior art, the present invention has the following advantages:

[0017] First, the present invention utilizes the basket and balloon as a synergistic barrier, improving the interception rate of stone fragments and effectively preventing their upward migration into the renal pelvis. The balloon, when inflated, forms a fixed constraint against the ureter, minimizing unintended fluid movement or shaking of the basket and captured stone fragments during the interception process, reducing the risk of damage to the ureteral wall.

[0018] Secondly, the device of the present invention can limit the sharp corners of the stone between the balloon and the basket by relatively moving the first guide wire and the second guide wire, so that the ureteral wall only contacts the outer surface of the balloon during extraction, avoiding direct contact between the sharp corners of the stone and the ureteral wall and reducing the risk of damage to the ureteral wall.

[0019] Third, the device of the present invention moves the first guide wire and the second guide wire relative to each other, and uses the balloon to cover or wrap the basket and the stones in the basket. It can also stably constrain the stone fragments captured by the basket in the basket, preventing the stone fragments from escaping from the gaps in the basket due to shaking during extraction, reducing damage to the ureteral wall during surgery, and reducing postoperative residues.

[0020] Fourthly, the device of the present invention is easy to operate, and the basket can be configured to naturally return to an expanded mesh shape after being released from the outer tube. Compared with the current use of a balloon alone for interception, the operation steps of the device of the present invention only add the operation step of controlling the relative movement of the first guide wire and the second guide wire to allow the balloon to constrain the basket. This does not significantly increase the complexity of the operation, but can significantly enhance the interception rate and intraoperative safety, and is easy to promote and apply in clinical practice.

[0021] Fifth, the operating handle provided by the present invention can achieve the goal of driving the first guide wire and the second guide wire to be synchronously pushed out or retracted into the outer tube by sliding the first operating member only by setting a friction resistance between the first guide wire and the second guide wire or setting a first connecting member; when repeated positioning is required (such as ureteral curvature or abnormal stone position) and the release position of the basket or balloon is not satisfactory, this method avoids the relative displacement of the basket and the balloon that may be caused by operating the two operating members separately, and has strong operability. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0023] Figures 1 to 3 This is a schematic diagram of using N-trp basket to intercept and crush stones in existing ureteroscopic laser lithotripsy surgery;

[0024] Figure 1 This is a schematic diagram of the placement of the endoscopic sheath along the side of the stone during current laser lithotripsy surgery;

[0025] Figure 2 This is a schematic diagram of the basket deployed at the upstream end of the stone during current laser lithotripsy surgery;

[0026] Figure 3 Schematic diagram of the basket used to intercept stone fragments in current laser lithotripsy surgery;

[0027] Figure 4 A front view of one embodiment of the urology stone removal device provided in Example 1 of the present application;

[0028] Figure 5 for Figure 4 Top view of the stone removal device in the urology department;

[0029] Figure 6 A partial cross-sectional view of one embodiment of the urology stone removal device provided in Example 1 of the present application;

[0030] Figures 7 to 9 A state diagram of the use process of a urology stone removal device is provided for Example 1 of the present application; wherein,

[0031] Figure 7 This is a schematic diagram of the state in which the external tube advances along the ureteral channel to the target position upstream of the stone during laser lithotripsy surgery;

[0032] Figure 8 This is a schematic diagram of the state after the basket and balloon are deployed at the upstream end of the stone during laser lithotripsy;

[0033] Figure 9 This is a schematic diagram of the state of the balloon constraining the basket during laser lithotripsy surgery;

[0034] Figure 10 This is a schematic diagram of the balloon structure provided in Example 2 of the present application;

[0035] Figure 11 This is a schematic structural diagram of one embodiment of the balloon provided in Example 2 of the present application;

[0036] Figure 12 This is a schematic structural diagram of another embodiment of the balloon provided in Example 2 of the present application;

[0037] Figure 13 A schematic structural diagram of one embodiment of the operating handle provided in Example 3 of the present application;

[0038] Figure 14 for Figure 13Schematic diagram of the state after the first operating member slides to release the basket and the balloon;

[0039] Figure 15 for Figure 14 A schematic diagram of a state in which the second operating member slides the balloon to cover or surround the basket;

[0040] Figure 16 This is a schematic structural diagram of another embodiment of the operating handle provided in Example 3 of the present application, where a and b are cross-sectional views at point A in the figure;

[0041] Figure 17 A schematic diagram of the partial structure of another embodiment of the operating handle provided in Example 3 of the present application;

[0042] Figure 18 This is a schematic diagram showing a state in which the engaging end of the first connecting member provided in Example 3 of the present application is engaged with the locking groove;

[0043] Figure 19 A schematic diagram showing a state in which the engaging end of the first connecting member provided in Example 3 of the present application moves to the avoidance area;

[0044] Figures 20 to 22 A state diagram showing a first connecting member for realizing synchronous and relative movement of a guide wire in the urology stone removal device provided in Example 3 of the present application;

[0045] Figure 20 This is a schematic diagram of a state where the basket and the balloon are released from the outer tube by the first operating member;

[0046] Figure 21 For Figure 20 A schematic diagram of the state after the locking groove and the engaging end are separated by circumferentially sliding the second operating member;

[0047] Figure 22 For Figure 21 A schematic diagram of a state where the second operating member slides axially on the base to drive the first guide wire and the second guide wire to move relative to each other;

[0048] Markings in the figure: E-endoscope sheath, U-ureter, S-stone, H-holmium laser device, 10-operating handle, 11-first operating member, 11A-first slide groove, 12-second operating member, 12A-second slide groove, 13-limiting protrusion, 14-first connecting member, 141-locking groove, 142-avoidance area, 15-engaging end, 20-outer tube, 30-guide wire, 31-first guide wire, 32-second guide wire, 40-basket, 50-balloon, 51-external surface, 52-fixing part, 53-inner surface, 54-entrance part, 55-middle part, 56-bottom. DETAILED DESCRIPTION

[0049] The following will clearly and completely describe the technical solutions of the present invention in conjunction with the embodiments. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0050] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, or are the orientation or position relationship in which the product of the invention is usually placed when in use. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, they should not be understood as limiting the present invention.

[0051] Furthermore, terms such as "horizontal" and "vertical" do not necessarily mean that a component must be absolutely horizontal or overhanging, but rather that it can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but rather that it can be slightly tilted.

[0052] In the description of the present invention, it should also be noted that, unless otherwise expressly specified or limited, the terms "disposed," "installed," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integral connections; they may refer to mechanical connections or electrical connections; they may refer to direct connections or indirect connections through an intermediate medium; and they may refer to internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0053] like Figures 1 to 3 As shown, the N-trap basket 40 or the air balloon (not shown in the figure) is often used in current ureteroscopic laser lithotripsy surgery to implement interception: during the operation, after the endoscopic sheath E advances along the ureter U to the stone S, the basket 40 or the air balloon (not shown in the figure) is inserted into the upstream end of the stone S through the outer tube 20 and expanded to form an interception barrier. After the holmium laser device H breaks the stone S into fragments, the expanded basket 40 or the air balloon (not shown in the figure) is used to intercept the stone fragments. The intercepted stone fragments are synchronously extracted from the ureter U along with the instrument, thereby effectively preventing the stone from shifting upward to the renal pelvis.

[0054] However, existing interception solutions still have certain limitations in clinical practice: First, although the N-trap basket 40 or airbag (not shown in the figure) can form a barrier to intercept stone fragments, it cannot effectively fix or constrain the position of stones and fragments; during the extraction process, these fragments are prone to shaking and colliding in the ureter U, directly increasing the risk of damage to the ureter U wall; second, due to the irregular shape of stone fragments (some with sharp edges), the exposed edges during extraction may also directly scrape the inner wall of the ureter U, causing damage.

[0055] Example 1, see Figures 4 to 9 This embodiment provides a urology stone removal device, which can be used in the above-mentioned holmium laser lithotripsy surgery and other minimally invasive techniques that use endoscopes to introduce laser energy to break up urinary stones. The device includes an operating handle 10 and an outer tube 20 fixedly connected to the operating handle 10.

[0056] The overall shape of the operating handle 10 is any shape that is convenient for holding or operating, and can be set as a grip with anti-slip texture, an arc-shaped groove or a raised structure that adapts to the force of the fingers, etc., according to needs, to improve the stability of holding during surgery. This application does not impose specific restrictions on it; in order to facilitate advancement into the ureter, the outer tube 20 is a thin and long flexible tube body, which can be matched with the sheath of an endoscope of any structure in the usual sense, and is guided to the position near the stone in the ureter through the channel of the sheath.

[0057] See Figures 4 to 9 A guide wire 30 is slidably provided in the outer tube 20 and the inner cavity of the operating handle 10; the guide wire 30 is also a thin and long flexible tube body, so that it can be advanced along with the outer tube 20 through the endoscopic sheath to the vicinity of the stone in the ureter, and when the outer tube 20 advances to the target position, the operator can control the guide wire 30 to slide relative to the outer tube 20 through the operating handle 10, so that the guide wire 30 and the configuration on the guide wire 30 are released from the end of the outer tube 20 and continue to extend toward the upstream end of the ureter.

[0058] See Figure 4 、 Figure 6 、 Figure 7 and Figure 8 The distal end of the guidewire 30 is provided with a basket 40 and a balloon 50, which are used to be deployed at the upstream end of the stone S to form a barrier to intercept and / or capture stone fragments pulverized by the laser; the basket 40 and the balloon 50 can be retracted into the outer tube 20 so that the basket 40 and the balloon 50 can pass through the outer tube 20 to bypass the stone;

[0059] Specifically, when the basket 40 and the balloon 50 are inside the outer tube 20, they are constrained into a bundle by the inner wall of the outer tube 20. After the outer tube 20 advances to the upstream end of the stone S, they are released by controlling the guide wire 30 to slide out of the outer tube 20. It should be noted that, in this application, the "distal end" refers to the end that is relatively far away from the operator or the operating handle 10 during operation; and the relative "proximal end" refers to the end that is relatively close to the operator or the operating handle 10 during operation.

[0060] See Figure 6 The guidewire 30 includes a first guidewire 31 and a second guidewire 32 coaxially nested, the first guidewire 31 being sleeved outside the second guidewire 32, the first guidewire 31 slidingly fitting with the inner cavity of the operating handle 10 and the outer tube 20, and the second guidewire 32 slidingly and sealingly fitting with the first guidewire 31; the basket 40 is connected to the distal end of the first guidewire 31, and the distal end of the second guidewire 32 is fixedly connected to the balloon 50, so that the balloon 50 is adjacent to the basket 40 and is at the distal end of the basket 40 in the axial direction of the guidewire 30;

[0061] The basket 40 is formed by weaving a plurality of basket wires made of shape memory material, such as nickel-titanium alloy wires, and arranged circumferentially around the first guide wire 31. When the basket 40 is released from the outer tube 20, it naturally returns to an expanded mesh shape to improve ease of operation. The expanded mesh shape refers to a cage-like space formed by the plurality of basket wires extending circumferentially along the first guide wire 31, converging or intersecting with each other, and capable of capturing or intercepting stone fragments.

[0062] The basket 40 can be a mesh structure of any shape familiar to those skilled in the art, or can be designed according to the needs of those skilled in the art. For example, after the basket 40 is opened, it can be constructed so that the basket wires are sparse at the end close to the stone S and dense at the end away from the stone S, so as to better capture stone fragments. This application does not impose any special restrictions on this.

[0063] The stone removal device also includes a medium channel (not shown in the figure), which is partially formed in the second guide wire 32, one end of which is connected to the balloon 50, and the other end extends to the operating handle 10; when the balloon 50 is released from the outer tube 20, the medium enters the balloon 50 from the operating handle 10 through the medium channel and causes the balloon 50 to expand; here, the medium can be a liquid such as water, saline, or a gas such as carbon dioxide, air, etc., and this application does not impose any special restrictions on it.

[0064] See Figure 7-Figure 8, which shows a method of using the device of the present application. First, the outer tube 20 of the stone removal device is matched with the endoscope sheath E, and is advanced into the ureter U along the channel of the endoscope sheath E, so that the outer tube 20 passes beside the stone S and penetrates into the upstream end of the ureter U. Subsequently, the guide wire 30 is controlled by the operating handle 10 to slide relative to the outer tube 20, and the guide wire 30 is extended from the outer tube 20. At this time, the basket 40 and the balloon 50 are released under the drive of the guide wire 30. The basket 40 automatically unfolds into an expanded mesh shape, and the balloon 50 expands after the medium is injected through the medium channel;

[0065] See Figure 9 When the holmium laser device H breaks the stone into fragments, the stone fragments will move upstream of the ureter U. The stone fragments first pass through the basket 40, which intercepts and captures larger stone fragments, and the balloon 50 can further hinder the passage of small stone fragments; then the basket 40 and the balloon 50 are controlled to move relative to each other by the operating handle 10, so that the balloon 50 covers or surrounds the captured stone fragments, and finally is pulled out of the ureter U together with the outer tube 20, completing the stone removal operation.

[0066] Compared to current solutions, this solution offers the following advantages: First, the basket 40 and balloon 50 work together as a barrier, increasing the interception rate of stone fragments and effectively preventing upward migration of stones into the renal pelvis. Second, after expansion, the balloon 50 forms a fixed constraint against the ureter U, reducing unintended movement or swaying of the basket 40 and stone fragments under the influence of fluid, thereby reducing the risk of damage to the ureteral wall. Third, compared to interception using only the basket 40, the coordinated interception of the basket 40 and balloon 50 reduces the radial dimension of the expanded basket 40, thereby reducing the risk of scratching the inner wall of the ureter U. Specifically, when only the basket 40 is used for interception, in order to effectively prevent the upward displacement of stone fragments, the basket 40 usually needs to be expanded to a size close to the inner wall of the ureter U, which easily increases the risk of scratches. In this solution, the balloon 50 can assist in intercepting small fragments. The basket 40 can achieve effective interception without excessive expansion, and its radial size can be smaller than the inner diameter of the ureter U, reducing direct contact with the inner wall. At the same time, the basket 40 can prevent large-sized fragments from directly hitting the balloon 50, avoiding damage to the balloon 50 due to impact. Fourth, by controlling the relative sliding of the first guide wire 31 and the second guide wire 32 by the operating handle 10, the balloon 50 can cover or wrap around the basket 40, which can limit the sharp corners of the stone fragments. Specifically, when only the basket 40 is used to capture the stone, the metal wire of the basket 40 is difficult to completely wrap around the stone corners. During the extraction process, the exposed corners may directly rub or scratch the ureter wall (especially in the ureteral bend). In this solution, after the balloon 50 wraps around the basket 40, the corners are covered between the balloon 50 and the basket 40, so that during extraction, the ureter wall only contacts the outer surface of the balloon 50, avoiding direct contact between the stone corners and the ureter wall. At the same time, the covering or wrapping of the balloon 50 can also stably constrain the stone fragments in the basket 40, preventing the fragments from escaping from the gaps in the basket 40 due to shaking during extraction and scratching the ureter wall.

[0067] Example 2, see Figure 10 、 Figure 11 and Figure 12 This embodiment provides an implementation of a balloon 50. The balloon 50 is made of an expandable material such as latex rubber, silicone, or other medical-grade elastomers. The balloon 50 is disposed at the distal end of the second guidewire 32 and can be constrained into a slender bundle by the outer tube 20 in an unexpanded state, facilitating delivery to the target location of the ureter U through the outer tube 20. After being inflated by injection, the balloon 50 can expand radially to accommodate ureters of different sizes.

[0068] Specifically, the balloon 50 is constructed to include an outer surface 51, a fixing portion 52, and an inner surface 53; the outer surface 51 and its side surfaces have a smooth transition, and after expansion, they can fit tightly against the ureteral wall to form a sealed barrier; the fixing portion 52 is fixedly connected to the distal end of the second guide wire 32 to ensure that the balloon 50 moves axially synchronously with the second guide wire 32, and the medium channel in the second guide wire 32 is connected to the interior of the balloon 50 through the fixing portion 52, for the injection and release of the expansion medium of the balloon 50; the inner surface 53 is arranged on the side facing the basket 40. When the balloon 50 is in an expanded state, the inner surface 53 is gap-matched with the outer wall of the first guide wire 31, so that when the basket 40 or the balloon 50 is moved, it is convenient for the inner surface 53 of the balloon 50 to cover or wrap around the basket 40, and when it contacts the basket 40 and the stone, it can adaptively deform along with its contour.

[0069] See Figure 11 In an optional embodiment, the inner surface 53 forms a accommodating cavity for covering or surrounding the basket 40, and the accommodating cavity is connected to the outer surface 51 by an arc-shaped transition. When the balloon 50 is in an expanded state, the inner diameter of the accommodating cavity at the end close to the basket 40 (i.e., the entrance) is larger than the inner diameter at the end away from the basket 40 (i.e., the bottom), so that the inner wall of the accommodating cavity forms a gradually changing cone surface as the inner diameter changes. When the basket 40, carrying stone fragments, moves toward the balloon 50, or the balloon 50, carrying the stone, moves toward the basket 40, the conical surface structure conforms to the outer wall of the basket 40. The gradually changing inner diameter guides the basket 40 and the stone into the accommodating cavity, reducing the risk of stone dislodging due to collision between the basket 40 and the entrance of the balloon 50. Simultaneously, the smaller inner diameter of the bottom 56 of the accommodating cavity tightens as the balloon 50 further expands, tightly confining the basket 40 and the stone. Even irregular stone contours can be stably confined within the accommodating cavity, reducing the risk of fragments leaking during retrieval. Furthermore, the curved transition design provides a smooth connection between the accommodating cavity and the outer surface 51. This reduces scratching and damage to the ureteral wall caused by local protrusions during overall movement of the balloon 50, ensuring operational safety.

[0070] See Figure 12In an optional embodiment, the accommodating cavity enclosed by the inner surface 53 includes an entrance portion 54, an intermediate portion 55, and a bottom portion 56 in sequence along the axial direction of the balloon 50. The entrance portion 54 is located near the basket 40, and the bottom portion 56 is located away from the basket 40. The inner diameter of the intermediate portion 55 is larger than that of the entrance portion 54 and the bottom portion 56, and the intermediate portion 55 smoothly transitions to the entrance portion 54 and the bottom portion 56. The entrance portion 54 smoothly transitions to the outer surface 51. When the balloon 50 covers or wraps around the basket 40 and stone fragments, the basket 40 is positioned and guided into the intermediate portion 55 through the entrance portion 54. The larger inner diameter of the intermediate expanded diameter section provides space for the basket 40 and the stone, and cooperates with the entrance portion 54 to enable the inner surface 53 portion to more conformably and closely fit the proximal end of the basket 40, thereby reducing the path for stone leakage and reducing the risk of fragment leakage during the recovery process.

[0071] Example 3, see Figure 7 、 Figure 8 、 Figure 13 、 Figure 14 as well as Figure 15 This embodiment provides an implementation of an operating handle 10, wherein the operating handle 10 has a first operating member 11 and a second operating member 12, and a first sliding groove 11A and a second sliding groove 12A that cooperate with the first operating member 11 and the second operating member 12. The first operating member 11 and the second operating member 12 are slidably disposed in the first sliding groove 11A and the second sliding groove 12A, respectively; see Figure 13 , the first operating member 11 is fixedly connected to the proximal end of the second guide wire 32, and the second operating member 12 is fixedly connected to the proximal end of the first guide wire 31. When the basket 40 and the balloon 50 on the guide wire 30 are not released from the outer tube 20, the proximal end of the first guide wire 31 is located within the sliding range of the first operating member 11. Alternatively, in some embodiments of the present application, the second operating member 12 fixedly connected to the first guide wire 31 may be located within the sliding range of the first operating member 11. In this way, see Figure 13 、 Figure 4 、 Figure 5 and Figure 14 ,in Figure 4 、 Figure 5 and Figure 14 for Figure 13 The state after the first operating member 11 slides toward the distal end of the guide wire 30 is as follows: when the outer tube 20 advances to the target position in the ureter, the first operating member 11 is controlled to slide along the axial direction of the guide wire 30 toward the distal end of the outer tube 20, and the second guide wire 32 connected to the first operating member 11 slides toward the distal end of the outer tube 20. The first operating member 11 abuts against the proximal end of the first guide wire 31, thereby driving the first guide wire 31 and the second operating member 12 to move toward the distal end of the outer tube 20, and the basket 40 and the balloon 50 set on the guide wire 30 are released; for further information, please refer to Figure 12 Taking the position direction in the figure as an example, after the release of the basket 40 and the balloon 50 is completed, the second operating member 12 continues to slide axially along the guide wire 30 to drive the first guide wire 31 to move to the right, so that the balloon 50 covers or surrounds the basket 40 and the stone fragments in the basket 40, and finally is pulled out of the ureter together with the outer tube 20 to complete the stone removal operation.

[0072] In an alternative embodiment, in addition to being arranged within the sliding stroke range of the first operating member 11, the first operating member 11 and the second operating member 12 can also be implemented in the following manner: the first operating member 11 and the second operating member 12 are respectively slidably arranged in the first slide groove 11A and the second slide groove 12A, the first operating member 11 is fixedly connected to the proximal end of the second guide wire 32, the second operating member 12 is fixedly connected to the proximal end of the first guide wire 31, the maximum static friction between the first guide wire 31 and the second guide wire 32 is greater than the maximum static friction between the first guide wire 31 and the outer tube 20 and the operating handle 10, so that when the first guide wire 31 is controlled When the operating member 11 slides axially along the guide wire 30 toward the distal end of the outer tube 20, the first guide wire 31 slides out of the outer tube 20 synchronously with the second guide wire 32 under the action of the friction between the first guide wire 31 and the second guide wire 32; after the first operating member 11 completes sliding, it is limited by the end of the first sliding groove 11A and cannot continue to slide toward the distal end of the guide wire 30; after the stone is captured, the second operating member 12 continues to slide to the right. The second operating member 12 overcomes the maximum static friction between the first guide wire 31 and the second guide wire 32, causing the basket 40 to move closer to the balloon 50, so that the balloon 50 covers or surrounds the basket 40 and the stone fragments captured in the basket 40;

[0073] It can be understood that by controlling the maximum static friction between the first guide wire 31 and the second guide wire 32 to be greater than the maximum static friction between the first guide wire 31 and the outer tube 20 or the operating handle 10, when the release position of the basket 40 or the balloon 50 is not satisfactory during the operation, the guide wire 30 can be synchronously retracted or the position adjusted only by sliding the first operating member 11. The principle is that the first operating member 11 is fixedly connected to the proximal end of the second guide wire 32 that controls the balloon 50. At the same time, a higher static friction is preset between the first guide wire 31 (controlling the basket 40) and the second guide wire 32. The static friction is greater than the resistance of the first guide wire 31 to sliding in the inner cavity of the outer tube 20 and the operating handle 10; therefore, when the first operating member 11 is slid toward the proximal end of the guide wire 30, the second guide wire 32 drives the first guide wire 31 to move synchronously, thereby retracting the basket 40 and the balloon 50 as a whole into the outer tube 20. In situations where repeated positioning is required (such as with a curved ureter or abnormally positioned stones), this method of operation avoids the relative displacement of the basket 40 and balloon 50 that could result from operating the two components separately, resulting in improved operability. However, it should be noted that when achieving synchronous linkage through frictional resistance, the operator must overcome the preset frictional resistance between the two guidewires 30 when sliding the first operating member 11 to drive the two guidewires 30 to move synchronously, which is relatively more likely to cause hand fatigue.

[0074] In another alternative embodiment, see Figures 16 to 19 The first operating member 11 is connected to the proximal end of the first guide wire 31; the proximal end of the second guide wire 32 is connected to the first connecting member 14, the first connecting member 14 slides in the inner cavity of the operating handle 10, and is connected to the second operating member 12; the first connecting member 14 and the first operating member 11 are releasably engaged, and when the two are engaged, sliding the first operating member 11 can drive the first guide wire 31 and the second guide wire 32 to be synchronously pushed out or retracted into the outer tube 20.

[0075] For further information, see Figure 16 a and b, Figure 18 as well as Figure 19 The first connecting member 14 has a locking groove 141 opened along the circumferential direction of the first connecting member 14, an avoidance area 142 arranged adjacent to the locking groove 141, and a clamping end 15 connected to the first operating member 11; by relatively rotating the first operating member 11 and the first connecting member 14, the end of the clamping end 15 is selectively clamped into the locking groove 141 or moved to the avoidance area 142; when the clamping end 15 is clamped into the locking groove 141, the first operating member 11 is connected to the first connecting member 14 and the second guide wire 32, so that only the first operating member 11 is sliding to drive the first guide wire 31 and the second guide wire 32 to be synchronously pushed out or retracted into the outer tube 20; the clamping end 15 moves from the clamping groove 141 to the avoidance area 142, and the first guide wire 31 and the second guide wire 32 can slide axially relative to the guide wire 30.

[0076] In an optional embodiment, the first connecting member 14 is non-rotatable, and the first operating member 11 is rotated circumferentially to selectively engage the end of the engaging end 15 with the locking groove 141 or move to the escape area 142. When the end of the engaging end 15 moves to the escape area 142, the second operating member 12 is slid to allow the balloon 50 to cover or surround the basket 40 and the stone fragments in the basket 40.

[0077] Alternatively, see Figure 16 a and b, Figure 18 as well as Figure 19 The first connecting member 14 is rotatable in a circumferential direction, and the second operating member 12 connected to the first connecting member 14 is circumferentially rotated, so that the end of the engaging end 15 is selectively engaged in the locking groove 141 or moved to the avoidance area 142, for example Figure 16 As shown in a to b, b is the state in a after the second operating member 12 drives the first connecting member 14 to rotate clockwise. At this time, the engaging end 15 moves from the avoidance area 142 to the locking groove 141, the first operating member 11 is connected to the first connecting member 14, and the first operating member 11 is slid to drive the first guide wire 31 and the second guide wire 32 to be simultaneously pushed out or retracted into the outer tube 20;

[0078] For further information, see Figure 18 、 Figure 19 、 Figure 20 、 Figure 21 and Figure 22 , which shows a method of using the solution of this embodiment, taking the illustrated direction as an example, Figure 20 FIG2 is a diagram showing a state where the basket 40 and the balloon 50 are released from the outer tube 20 by the action of the first operating member 11. At this time, the engaging end 15 connected to the first operating member 11 is in the locking groove 141, and the first operating member 11 and the first connecting member 14 are in a connected state; Figure 21 For Figure 20 Based on the above, the state diagram after the second operating member 12 is controlled to slide circumferentially, for example, the second operating member 12 slides upward, at this time, the engaging end 15 connected to the first operating member 11 moves from the locking groove 141 to the avoidance area 142, the first operating member 11 and the first connecting member 14 are in a separated state, and the second operating member 12 can slide axially relative to the guide wire 30; Figure 22 For Figure 21 The state diagram after the second operating member 12 is slid to the right, at this time the balloon 50 moves close to one end of the basket 40 and covers or wraps around the outside of the basket 40.

[0079] Obviously, compared with the above two operating modes: the synchronous action is achieved by the locking state of the engaging end 15 and the locking groove 141, which can ensure the synchronization of the displacement of the first guide wire 31 and the second guide wire 32, and reduce the relative position deviation of the basket 40 and the balloon 50 caused by the sliding delay of the first guide wire 31 or the force deviation during abutment due to insufficient friction resistance, and the operation is more stable; and the switching process is accompanied by tactile feedback of the engaging end 15 engaging in / out of the locking groove 141, which can more clearly perceive the current operating state and has better operability.

[0080] In an alternative embodiment, see Figure 5 、 Figure 14 、 Figure 15 、 Figure 16 and Figure 17 To improve operational stability, the operating handle 10 is further provided with a limiting mechanism, which includes a plurality of limiting protrusions 13 disposed in the first slide groove 11A. Each of the limiting protrusions 13 is distributed along the sliding path of the first operating member 11. The first operating member 11 can axially squeeze and pass over each limiting protrusion 13 in the first slide groove 11A. The maximum static friction between the first operating member 11 and the limiting protrusions 13 when the first operating member 11 is stationary is greater than the maximum static friction between the first guide wire 31 and the second guide wire 32.

[0081] Specifically, when the first guide wire 31 is driven to move axially relative to the second guide wire 32 by sliding the second operating member 12, the friction between the first guide wire 31 and the second guide wire 32 may generate a force on the second guide wire 32, driving the first operating member 11 and the second guide wire 32 to slide; this embodiment provides a limiting protrusion 13 to make the static friction between the first operating member 11 and the limiting protrusion 13 greater, and the first operating member 11 is stably restricted in the first slide groove 11A, so that the second guide wire 32 remains stationary; at this time, the first guide wire 31 only moves relative to the second guide wire 32 under the driving force of the second operating member 12, avoiding the first operating member 11 from accidentally sliding and causing The relative position deviation between the basket 40 and the balloon 50; at the same time, the limiting mechanism, by providing a limiting protrusion 13 in the slide groove of the operating handle 10, helps provide better tactile feedback to the operator. When the first operating member 11 squeezes and passes over the limiting protrusion 13, the elastic deformation of the limiting protrusion 13 squeezing the operating part can facilitate the operator to feel a "stuttering feeling". Each time a protrusion is passed over, it corresponds to a fixed sliding distance of the first operating member 11, without the need to frequently observe the instrument scale. For example, when the basket 40 is released to a certain depth of the ureter, the first operating member 11 can quickly reproduce or adjust to that position by passing over four limiting protrusions 13, thereby improving operating efficiency. In addition, this method also helps prevent the guide wire 30 from being accidentally released. For example, in the curved section of the ureter, the outer tube 20 and the guide wire 30 may be interfered by tissue compression and cause relative sliding. The cooperation between the limiting protrusion 13 and the first operating member 11 can resist such interference, thereby preventing the balloon 50 and / or the basket 40 from being accidentally released due to the spontaneous sliding of the first operating member 11.

[0082] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A urology stone removal device, characterized in that: include: operating handle; an outer tube, one end of which is connected to the operating handle; a guide wire, part of which slides inside the outer tube, the guide wire comprising a first guide wire and a second guide wire coaxially nested; a basket connected to the distal end of the first guide wire, an inflatable balloon connected to the second guide wire and located at the distal end of the basket; a medium channel, at least partially formed in the second guide wire, with one end communicating with the balloon and the other end extending to the operating handle; The basket and the balloon can be retracted inside the outer tube and released from the distal end of the outer tube. After being released, the basket naturally returns to its original shape or actively expands into an expanded mesh; The balloon is expanded by injecting a medium through the medium channel; At least one of the first guide wire and the second guide wire can slide along the guide wire axis relative to the other. The first guide wire and the second guide wire are controlled by an operating handle to slide relative to each other along the guide wire axis, so that the balloon at least partially covers or surrounds the basket and / or the contents in the basket; The operating handle is provided with a first operating member and a second operating member, both of which can slide along the axial direction of the guide wire; The first operating member is configured to at least simultaneously push the first guide wire and the second guide wire out of the outer tube; the second operating member is configured to drive the first guide wire and the second guide wire to slide relative to each other in the axial direction.

2. The urology stone removal device according to claim 1, characterized in that: The basket includes a plurality of basket wires; The basket wire is a shape memory material wire and is arranged in a circumferential direction around the first guide wire; When the basket is released from the outer tube, it naturally returns to the expanded mesh shape.

3. The urology stone removal device according to claim 1, characterized in that: The balloon has at least an outer surface for contacting a biological wall, a fixing portion fixedly connected to the second guide wire, and a conformable inner surface for contacting the basket and / or contents therein; Wherein, the medium channel is connected to the balloon from the fixing portion; The inner surface is arranged at one end of the balloon facing the basket. When the balloon is in an expanded state, the inner surface is loosely matched with the outer wall of the first guide wire so that the balloon covers or surrounds the outside of the basket.

4. The urology stone removal device according to claim 3, characterized in that: The inner surface forms a receiving cavity for covering or surrounding the basket. The accommodating cavity transitions to the outer surface in an arc shape; When the balloon is in an expanded state, the inner diameter of the accommodating cavity near the basket end is larger than the inner diameter of the end away from the basket, so that at least part of the inner wall of the accommodating cavity forms a gradually changing conical surface as the inner diameter changes, so as to guide the basket into the accommodating cavity.

5. The urology stone removal device according to claim 1, characterized in that: The first operating member is connected to the proximal end of the second guide wire, The second operating member is connected to the proximal end of the first guide wire; The proximal end of the first guide wire or the second operating member is at least partially located within the sliding range of the first operating member; When the first operating member slides along the guidewire axis toward the distal end of the outer tube, its end abuts against the proximal end of the first guidewire and / or the second operating member, thereby synchronously driving the first guidewire and the second guidewire to move toward the distal end of the outer tube; The second operating member is axially slid along the guidewire to drive the second guidewire to axially displace relative to the first guidewire, so that the balloon at least partially covers or surrounds the basket and / or the contents in the basket.

6. The urology stone removal device according to claim 1, characterized in that: The first operating member is connected to the proximal end of the second guide wire, The second operating member is connected to the proximal end of the first guide wire; The maximum static friction between the first guide wire and the second guide wire is greater than the maximum static friction between the first guide wire and the outer tube and the operating handle. To ensure that when the first operating member slides along the guide wire axis toward the distal end of the outer tube, the first guide wire slides out of the outer tube synchronously with the second guide wire; The second operating member drives the first guide wire to axially move relative to the second guide wire by overcoming the maximum static friction between the first guide wire and the second guide wire.

7. The urology stone removal device according to claim 1, characterized in that: The first operating member is connected to the proximal end of the first guide wire; The proximal end of the second guide wire is connected to a first connecting member, which slides in the inner cavity of the operating handle and is connected to the second operating member; The first connecting member is configured to releasably engage with the first operating member, When the two are engaged, sliding the first operating member can drive the first guide wire and the second guide wire to be pushed out or retracted into the outer tube synchronously.

8. The urology stone removal device according to claim 7, characterized in that: The first connecting member has a locking groove opened along the circumferential direction of the first connecting member, an escape area disposed adjacent to the locking groove and connected to an engaging end of the first operating member; By relatively rotating the first operating member and the first connecting member, the end of the engaging end is selectively engaged in the locking groove or moved to the avoidance area; When the engaging end is engaged with the locking groove, the first connecting member is connected to the first operating member; The locking groove is inserted into and moved to the avoidance area, and the first connecting member and the first operating member can slide axially relative to the guide wire.

9. The urology stone removal device according to claim 5, 6 or 7, characterized in that: The operating handle is provided with a limiting mechanism. The limiting mechanism includes a plurality of limiting protrusions arranged along the sliding path of the first operating member; The first operating member can press and pass over each of the limiting protrusions; The maximum static friction between the first operating member and each limiting protrusion is greater than the maximum static friction between the first guide wire and the second guide wire. This ensures that when the second operating member slides axially, the first guide wire and the second guide wire can slide axially relative to each other.

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