Variable diameter ureteral flexible scope dilation negative pressure suction sheath

Abstract

The application discloses a variable-diameter ureteral flexible mirror dilating negative pressure suction sheath, which comprises a sheath pipe body, the sheath pipe body is rolled by an arc-shaped sheet, the arc-shaped sheet is provided with a first opening edge and a second opening edge, the first opening edge and the second opening edge have an overlapping area between them, a proximal end of the sheath pipe body is provided with an adjusting assembly, and the adjusting assembly is a rotary operating part; the width of the overlapping area is changed by rotating the first opening edge to slide relative to the second opening edge, so that the continuous adjustment of the inner diameter of the sheath pipe body is realized. Compared with the scheme depending on the elastic deformation of the material, the application is accurate, controllable, has a larger range and is stable and reliable in long-term use; meanwhile, the inner diameter of the sheath pipe can be locked at the current size after the inner diameter adjustment is completed through the rotation of the locking ring, so that the accidental change of the inner diameter caused by the operation of the instrument or the extrusion of the tissue during the operation is avoided, and the stability and safety of the operation channel are ensured.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a variable diameter flexible ureteroscope dilation negative pressure suction sheath. Background Technology

[0002] Ureteroscopic surgery is an important minimally invasive procedure for treating diseases such as upper urinary tract stones. During the procedure, a ureteral guide sheath is first inserted to establish a working channel, and then the ureteroscope, laser fiber, stone removal instruments, etc. are introduced through the channel to perform the surgery.

[0003] The existing flexible ureteroscope sheaths mainly have the following technical problems: First, the fixed diameter of the sheath makes it impossible to balance ease of insertion with the need for intraoperative operating space. To ensure smooth passage through the ureteral stricture during insertion, the outer diameter of the sheath needs to be as small as possible (e.g., F10 / 12); however, if the inner diameter of the sheath is too small after insertion, it restricts the range of motion of the flexible endoscope and the passage of instruments, affecting surgical efficiency. Existing products usually only offer a fixed size (e.g., F12 / 14), which results in high insertion resistance and is prone to causing damage to the ureteral mucosa.

[0004] Secondly, some variable diameter sheaths rely on the elastic deformation of the material to expand their diameter, mainly using the stress relaxation or superelastic properties of polymer materials to provide support. However, the deformation of the material and the change in inner diameter are prone to inconsistency between the actual inner diameter and the expansion and contraction process. It is difficult to achieve precise diameter control through simple operations during surgery, making it difficult to meet the span requirements from F10 to F14. At the same time, after repeated loading and unloading, it is easy to cause problems such as elastic fatigue, permanent deformation and insufficient rebound force, which in turn affects the stability of the channel during surgery, significantly shortens the effective service life of the product, and even poses a potential risk of accidental collapse of the sheath due to the decay of support force during long-term surgery.

[0005] Third, existing adjustable sheaths often employ complex mechanical structures such as precision gear transmission or double-lumen nesting to achieve deformation function. However, these structures are expensive to manufacture, and in a sterile surgical environment filled with bodily fluids and tissue debris, moving parts are prone to jamming due to foreign body intrusion. Furthermore, the complex mechanical structure greatly increases the difficulty of cleaning and disinfection, and residual biofilm is difficult to remove, thus limiting its clinical promotion and popularization in primary healthcare institutions.

[0006] Therefore, we need to design a variable diameter flexible ureteroscope dilation negative pressure suction sheath to solve the problems mentioned above. Summary of the Invention

[0007] The purpose of this invention is to provide a variable diameter flexible ureteroscope dilation negative pressure suction sheath to solve the problems mentioned in the background art, such as large diameter sheaths leading to high resistance and high risk of tissue damage during insertion.

[0008] To achieve the above objectives, the present invention provides the following technical solution: a variable diameter ureteroscopic dilatation negative pressure suction sheath, comprising a sheath body, the sheath body being formed by rolling an arc-shaped sheet, the arc-shaped sheet having a first opening edge and a second opening edge, an overlapping area between the first opening edge and the second opening edge, an adjustment component being provided at the proximal end of the sheath body, the adjustment component being a rotating operating component, the width of the overlapping area being changed by rotating the first opening edge and the second opening edge relative to each other, thereby realizing continuous adjustment of the inner diameter of the sheath body, a rotating locking ring being provided inside the sheath body, an annular balloon being connected to the outer wall of the sheath body, an inflation channel being provided inside the sheath body communicating with the annular balloon, a negative pressure suction interface being connected to one end of the sheath body, and the negative pressure suction interface communicating with the lumen inside the sheath body, and an inflation interface being provided at one end of the negative pressure suction interface.

[0009] Preferably, the negative pressure suction port is provided with a pressure limiting valve, and the pressure limiting valve automatically releases pressure when the pressure inside the annular balloon exceeds a preset threshold.

[0010] Furthermore, the pressure-limiting valve is integrated into the flow channel of the inflation port or independently installed on the bypass branch of the inflation port. It is a spring-loaded pressure relief valve or a rupture diaphragm safety valve. The pressure-limiting valve has a preset opening pressure threshold, which is preset according to the pressure tolerance of the ureteral wall and clinical safety requirements. When the balloon is inflated through the inflation port and the internal pressure gradually increases, the pressure-limiting valve continuously monitors the pressure value inside the balloon. Once the pressure inside the balloon exceeds the preset safety threshold, the valve core of the pressure-limiting valve opens under pressure, overcoming the spring preload, and discharges the excess gas or liquid inside the balloon through the pressure relief port, so that the pressure inside the balloon quickly drops below the threshold. Then the valve core automatically resets and closes.

[0011] Preferably, the rotating operating component of the adjusting assembly is provided with a tube diameter indicator mark to indicate the current inner diameter value of the sheath body.

[0012] Furthermore, the adjustment component, as the core of the control of the inner diameter of the sheath, adopts a ring-shaped rotary operating component, which is sleeved on the outer periphery of the proximal end of the sheath body. The rotary operating component is connected to the first and second opening edges of the arc-shaped plate through a helical transmission mechanism or a gear and rack mechanism. When the operator rotates the operating component clockwise or counterclockwise, the rotational motion is converted into axial helical sliding or circumferential relative sliding of the first opening edge relative to the second opening edge through the transmission mechanism, thereby precisely changing the width of the overlapping area. Preferably, the minimum inner diameter of the sheath body when inserted is F10 / 12, and the working inner diameter after intraoperative adjustment is F12 / 14.

[0013] Furthermore, by adjusting the width of the overlapping area of ​​the arc-shaped plate, a continuous stepless change in the inner diameter of the sheath is achieved between F10 / 12 and F12 / 14. During the initial insertion stage, the operator rotates the adjustment component to the minimum inner diameter setting F10 / 12. At this setting, the outer diameter of the sheath body is at its minimum, and the cross-section is at its minimum, allowing it to pass smoothly through the ureteral orifice and various natural stenotic segments of the ureter with minimal insertion resistance, significantly reducing friction and irritation to the ureteral wall and the risk of tearing. Once the sheath is in place, the operator rotates the adjustment component as needed to gradually increase the inner diameter to the working state F12 / 14.

[0014] Preferably, the annular balloon is folded and fits against the outer wall of the sheath when it is not inflated, and expands radially to dilate the ureter after inflation.

[0015] Furthermore, in its non-working state, the annular balloon undergoes multi-fold or corrugated folding to closely conform to the outer contour of the sheath body. Its folded outer diameter is essentially equal to the outer diameter of the sheath wall, without creating any additional radial protrusions. This conformal design ensures that the balloon does not increase additional insertion resistance or cause scratching to the ureteral wall during sheath insertion and withdrawal.

[0016] Preferably, one end of the sheath body is connected to an inlet head, and the inlet head has a conical or blunt structure with a guide wire through hole in the center.

[0017] Furthermore, the insertion tip is fixedly connected to the distal end of the sheath body and is made of medical soft polyurethane or silicone rubber material with a Shore hardness of 30A to 60A. It forms a smooth transition connection with the distal end of the sheath body through heat sealing, bonding, or overmolding processes. The overall shape of the insertion tip is conical or blunt, with its distal diameter smaller than its proximal diameter, forming a smooth tapered guide surface. During insertion, it can gradually widen the ureteral orifice and ureteral wall, guiding the sheath body forward smoothly and avoiding cutting and scratching of the ureteral mucosa by the sharp edge of the distal end of the sheath. A guidewire passage hole is provided axially through the center of the insertion tip.

[0018] Preferably, the outer wall of the sheath body is provided with a hydrophilic lubricating coating.

[0019] Furthermore, the outer wall surface of the sheath body is coated with a hydrophilic lubricating coating. This coating can be made of polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), or hyaluronic acid-based lubricating coating materials, and is uniformly adhered to the outer wall surface of the sheath through dip coating, spraying, or UV curing processes. The hydrophilic lubricating coating is non-sticky in the dry state, facilitating product packaging and handling.

[0020] Preferably, the pressure relief threshold of the pressure relief valve is adjustable in multiple ranges.

[0021] Furthermore, the pressure relief valve adopts an adjustable spring preload structure or a replaceable pressure threshold module structure, which allows the pressure relief threshold to be selected in multiple levels or continuously adjusted according to individual patient differences before clinical use.

[0022] Compared with the prior art, the beneficial effects of the present invention are: 1. By employing an arc-shaped rolled sheath structure, the width of the overlapping area is changed by rotating the adjustment component to drive the relative sliding of the opening edge, achieving continuous and stepless adjustment of the inner diameter. During insertion, it is adjusted to the minimum diameter (F10 / 12), significantly reducing insertion resistance and minimizing ureteral injury. After reaching the desired position, it is rotated to expand to the working diameter (F12 / 14), providing ample operating space for the flexible endoscope and instruments. Compared to solutions that rely on material elastic deformation, this invention offers precise and controllable adjustment, a wider range, and long-term stability and reliability. Simultaneously, the rotating locking ring can lock the inner diameter of the sheath at the current size after adjustment, preventing unexpected changes in the inner diameter caused by instrument operation or tissue compression during surgery, ensuring the stability and safety of the surgical channel. 2. The circular balloon is integrated into the distal end of the sheath. Once in place, it can be inflated through the inflation port to actively dilate the ureteral stenosis without the need for an additional balloon dilation catheter. The circular balloon design provides both dilation and anchoring, preventing sheath displacement during the procedure. The pressure limiting valve ensures that the pressure inside the balloon remains within a safe range, avoiding over-dilation. The negative pressure suction port is connected to the sheath lumen, allowing for real-time removal of lithotripsy and blood clots during the procedure, maintaining a clear field of vision. This invention achieves inner diameter adjustment through a mechanically rolled arc-shaped structure, without relying on expensive materials such as shape memory alloys or special polymers. It can be manufactured using conventional medical polymers or metal materials, making it suitable for large-scale production of disposable products. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0024] Figure 1 This is a schematic diagram of the overall three-dimensional structure of the present invention; Figure 2 This is a front view structural diagram of the present invention; Figure 3 This is a frontal cross-sectional view of the present invention. Figure 4 This is a schematic diagram of the rear view structure of the present invention; Figure 5 This is a top view of the structure of the present invention; Figure 6 This is a schematic diagram of the structure of the annular balloon of the present invention in its uninflated state.

[0025] The reference numerals in the diagram are as follows: 1. Sheath body; 2. Adjustment component; 3. Negative pressure suction port; 4. Inflation port; 5. Rotary locking ring; 6. Annular balloon; 7. Inflation channel; 8. Pressure limiting valve; 9. Inlet head. Detailed Implementation

[0026] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0027] Example 1 To address the issues of high resistance and risk of tissue damage caused by the large diameter of existing sheaths during insertion, the following proposed solution is disclosed, as follows: Figure 1 , Figure 2 , Figure 4 and Figure 5 As shown: A variable diameter ureteroscope with dilatation and negative pressure suction sheath, a sheath body 1, the sheath body 1 being rolled from an arc-shaped sheet, the arc-shaped sheet having a first opening edge and a second opening edge, with an overlapping area between the first opening edge and the second opening edge, an adjustment component 2 being provided at the proximal end of the sheath body 1, the adjustment component 2 being a rotating operating component, the width of the overlapping area being changed by rotating the first opening edge and the second opening edge relative to each other, realizing continuous adjustment of the inner diameter of the sheath body 1, a rotating locking ring 5 being provided inside the sheath body 1, an annular balloon 6 being connected to the outer wall of the sheath body 1, an inflation channel 7 being provided inside the sheath body 1 communicating with the annular balloon 6, a negative pressure suction port 3 being connected to one end of the sheath body 1, and the negative pressure suction port 3 communicating with the lumen inside the sheath body 1, an inflation port 4 being provided at one end of the negative pressure suction port 3.

[0028] A pressure limiting valve 8 is provided on the negative pressure suction port 3, and the pressure limiting valve 8 automatically releases pressure when the pressure inside the annular balloon 6 exceeds a preset threshold.

[0029] The rotating operating component of the adjusting assembly 2 is equipped with a tube diameter indicator mark, which indicates the current inner diameter value of the sheath body 1.

[0030] The minimum inner diameter of the sheath body 1 when inserted is F10 / 12, and the working inner diameter after intraoperative adjustment is F12 / 14.

[0031] Example 2 This embodiment differs from Embodiment 1 in that it uses the circular balloon 6, eliminating the need for an additional balloon dilation catheter. Specifically, as shown below... Figure 3 and Figure 6 As shown: When the circular balloon 6 is not inflated, it folds and fits against the outer wall of the sheath. When inflated, it expands radially to dilate the ureter. One end of the sheath body 1 is connected to an inlet head 9, and the inlet head 9 has a conical or blunt structure with a guide wire through hole in the center; The outer wall of the sheath body 1 is provided with a hydrophilic lubricating coating; The pressure relief threshold of pressure relief valve 8 is adjustable in multiple ranges.

[0032] Working principle: First, before the surgery begins, the surgeon places the rotating locking ring 5 in the unlocked state and rotates the adjusting component 2 to the minimum inner diameter position. At this time, the overlap area between the first and second opening edges of the arc-shaped plate is the widest, and the effective inner and outer diameters of the sheath body 1 are both the minimum value F10 / 12. Then, the guidewire at the insertion tip 9 is inserted through the hole along the pre-inserted guidewire. Under the guidance of the guidewire, the sheath body 1 is pushed along the ureteral lumen towards the renal pelvis. In the minimum outer diameter state, the sheath body 1 has the smallest cross-section. Combined with the super-slippery hydrogel layer formed after the hydrophilic lubricating coating on the outer wall comes into contact with water, the sheath can pass smoothly through the ureteral orifice and various natural narrow sections of the ureter with extremely low frictional resistance, significantly reducing the risk of frictional stimulation and tearing of the ureteral mucosa during insertion. Secondly, once the inlet tip 9 reaches the renal pelvis or target location, the operator connects a syringe or air pump through the inflation port 4 and injects gas or liquid into the circular balloon 6 through the inflation channel 7 within the sheath wall. Under fluid pressure, the circular balloon 6 gradually expands and inflates radially and uniformly, generating a uniform expansion force from the inside out at the ureteral stenosis, effectively dilating the narrowed area. During this process, the pressure limiting valve 8 integrated on the inflation port 4 continuously monitors the pressure inside the balloon. Once the pressure exceeds a preset safety threshold, the pressure limiting valve 8 automatically opens to release pressure, preventing excessive balloon inflation and damage to the ureteral wall. After inflation, the balloon fits tightly against the ureteral wall, simultaneously anchoring the sheath body 1 to the target position. Subsequently, the operator rotates the adjusting component 2 counterclockwise or clockwise, driving the first opening edge and the second opening edge to slide relative to each other, reducing the width of the overlapping area and gradually expanding the effective inner diameter of the sheath body 1 from F10 / 12 to the working diameter F12 / 14. During rotation, the operator adjusts the component 2... The tube diameter indicator reads the current inner diameter value in real time, enabling precise and controllable continuous adjustment. After adjustment, the rotating locking ring 5 is switched to the locked state, locking the rotational freedom of the adjustment component 2 and firmly locking the inner diameter of the sheath to the working size, ensuring that the inner diameter remains stable during flexible endoscopic operation and instrument exchange. On this basis, a negative pressure suction device is connected to the negative pressure suction port 3. The mixture of lithotripsy powder, blood clots and irrigation fluid generated during the operation enters the central lumen through the distal opening of the sheath under negative pressure and is continuously discharged from the body through the proximal negative pressure suction port 3, maintaining a clear surgical field and controlling the pressure in the renal pelvis within a safe range.

[0033] Finally, after the surgical procedure is completed, the gas or liquid inside the circular balloon 6 is first expelled through the inflation port 4, and the circular balloon 6 returns to its folded and fitted state under its own elastic recoil force. Then, the rotating locking ring 5 is unlocked, and the adjusting component 2 is rotated in the opposite direction to readjust the inner diameter of the sheath to the minimum F10 / 12, so that the outer diameter of the sheath is reduced to the minimum state, effectively avoiding secondary damage to the ureteral wall during sheath removal.

[0034] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0035] The device embodiments described above are merely illustrative. The units described as separate components may or may not be physically separate, and the components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the modules can be selected to achieve the purpose of this embodiment according to actual needs. Those skilled in the art can understand and implement this without any creative effort.

[0036] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A variable diameter flexible ureteroscope dilation negative pressure suction sheath, comprising a sheath body (1), characterized in that: The sheath body (1) is made of an arc-shaped sheet, and the arc-shaped sheet has a first opening edge and a second opening edge. There is an overlapping area between the first opening edge and the second opening edge. The proximal end of the sheath body (1) is provided with an adjustment component (2), and the adjustment component (2) is a rotating operating component. The width of the overlapping area is changed by rotating the first opening edge and the second opening edge relative to each other, so as to realize the continuous adjustment of the inner diameter of the sheath body (1). The interior of the sheath body (1) is provided with a rotating locking ring (5). The outer wall of the sheath body (1) is connected with an annular balloon (6). The interior of the sheath body (1) is provided with an inflation channel (7) connected to the annular balloon (6). One end of the sheath body (1) is connected with a negative pressure suction port (3), and the negative pressure suction port (3) is connected to the lumen inside the sheath body (1). One end of the negative pressure suction port (3) is provided with an inflation port (4).

2. The variable diameter ureteroscope dilation negative pressure suction sheath according to claim 1, characterized in that: The negative pressure suction port (3) is equipped with a pressure limiting valve (8), and the pressure limiting valve (8) automatically releases pressure when the pressure in the annular balloon (6) exceeds a preset threshold.

3. The variable diameter ureteroscope dilation negative pressure suction sheath according to claim 2, characterized in that: The adjustment component (2) has a tube diameter indicator mark on its rotating operating part, indicating the current inner diameter value of the sheath body (1).

4. The variable diameter ureteroscope dilation negative pressure suction sheath according to claim 1, characterized in that: The minimum inner diameter of the sheath body (1) when inserted is F10 / 12, and the working inner diameter after intraoperative adjustment is F12 / 14.

5. The variable diameter ureteroscope dilation negative pressure suction sheath according to claim 1, characterized in that: When the annular balloon (6) is not inflated, it is folded and fits against the outer wall of the sheath. When inflated, it expands radially to dilate the ureter.

6. The variable diameter ureteroscope dilation negative pressure suction sheath according to claim 1, characterized in that: One end of the sheath body (1) is connected to an inlet head (9), and the inlet head (9) has a conical or blunt structure with a guide wire through hole in the center.

7. The variable diameter ureteroscope dilation negative pressure suction sheath according to claim 1, characterized in that: The outer wall of the sheath body (1) is provided with a hydrophilic lubricating coating.

8. The variable diameter ureteroscope dilation negative pressure suction sheath according to claim 2, characterized in that: The pressure relief threshold of the pressure relief valve (8) is adjustable in multiple levels.

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