A ureteral delivery sheath assembly that reduces ureteral injury during insertion

Abstract

This invention discloses a ureteral delivery sheath assembly that reduces ureteral injury during insertion, belonging to the field of ureteral delivery sheath technology. It includes: a flexible inner core, a flexible outer sheath located outside the flexible inner core, a channel between the flexible inner core and the flexible outer sheath for a guidewire pre-inserted into the ureter to pass through, a detection mechanism, and a control mechanism. One end of the flexible inner core has an outward-facing groove, and a flexible film is disposed at the opening of the groove. The flexible film is a cylindrical structure closed at one end. The detection mechanism includes an angle detector, a connecting rod, an adjustment part, and a connecting part. The control mechanism includes four airbags and an air pump connected to each airbag via tubing. By actively adjusting the end of the delivery sheath assembly, it adapts to the curvature of the ureter, reducing friction between the sheath and the ureter at the bend, thus reducing damage to the ureter.

Description

Technical Field

[0001] This invention relates to the field of ureteral delivery sheath technology, and more specifically to a ureteral delivery sheath assembly that reduces ureteral injury during insertion. Background Technology

[0002] When performing ureteral surgery requiring flexible endoscopy, a ureteral delivery sheath must first be inserted into the ureter. Then, the flexible endoscope is inserted. Typically, the ureteral delivery sheath consists of an outer sheath and an inner core, also known as an obturator. The inner core is inserted into the outer sheath. During the insertion process, a guidewire is first inserted into the ureter, exhibiting a curvature consistent with the ureter. The ureteral delivery sheath, consisting of the outer sheath and inner core, is then inserted into the ureter along the guidewire. When the flexible endoscope is needed, the inner core is removed from the outer sheath, and then the flexible endoscope is inserted into the outer sheath.

[0003] In actual surgeries requiring flexible endoscopy, although the ureteral delivery sheath itself is flexible, the ureter has multiple bends of varying degrees. During insertion, the delivery sheath is bent by the bends in the ureter to achieve insertion. However, when passively acting, the delivery sheath exerts greater pressure on the ureteral wall than during straight insertion, increasing friction at the bends and making the ureter more susceptible to damage. This increases the risk of ureteral infection later on. Therefore, there is an urgent need to design a ureteral delivery sheath assembly that reduces ureteral damage during insertion to solve the above problems. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to actively adjust the end of the delivery sheath assembly to adapt to the curvature of the ureter, reduce the friction between the ureter and the ureter at the bend, and reduce damage to the ureter.

[0005] The technical solution adopted by the present invention to solve the technical problem is: a ureter delivery sheath assembly that reduces ureteral injury during insertion, comprising: a flexible inner core, a flexible outer sheath located outside the flexible inner core, a channel located between the flexible inner core and the flexible outer sheath for passing through a guidewire pre-inserted into the ureter, a detection mechanism, and a control mechanism.

[0006] The flexible inner core has an outward-facing groove at one end, and a flexible film is provided at the opening of the groove. The flexible film is a cylindrical structure with one end closed, and the detection mechanism is located in the sealed space between the groove and the flexible film.

[0007] The detection mechanism includes an angle detector, a connecting rod, an adjustment part, and a connecting part. The connecting rod is movably connected to the groove through the connecting part. The angle detector is fixed to the end of the connecting rod facing the flexible film, and the adjustment part is fixed to the end of the connecting rod facing the groove.

[0008] The control mechanism includes four airbags and an air pump that is connected to each airbag via a pipeline. The four airbags are set in the groove and are evenly distributed on the outside of the adjustment part and abut against the adjustment part. The air pump is set at one end of the flexible inner core away from the groove.

[0009] The flexible inner core is provided with a guide wire groove extending along the direction of the flexible inner core, and the guide wire is confined within the guide wire groove;

[0010] The control mechanism also includes a controller, which is located at one end of the flexible inner core away from the groove. The angle detector and the air pump are electrically connected to the controller. The angle detector obtains the angle signal of the guidewire relative to the central axis of the flexible outer sheath in real time and transmits the angle signal to the controller. The controller controls the air pump to inflate or deflate the corresponding airbag, thereby changing the direction of the force acting on the adjustment part, which in turn drives the connecting rod to deflect. This allows the delivery sheath assembly to adjust its direction of travel according to the direction of the ureter to reduce ureteral injury.

[0011] As a preferred embodiment of the present invention, the connecting part includes a ring body, two connecting shafts (first type) and two connecting shafts (second type). The two connecting shafts (first type) are rotatably connected to the groove wall and are arranged in a relatively coaxial manner. The ring body is connected to the two connecting shafts (first type) and is located between the two connecting shafts (first type). The two connecting shafts (second type) are rotatably connected to the inner wall of the ring body and are arranged in a relatively coaxial manner. The connecting rod passes through the inner side of the ring body and is connected to the two connecting shafts (second type).

[0012] In a preferred embodiment of the present invention, the extension direction of the first connecting shaft is perpendicular to the extension direction of the second connecting shaft.

[0013] In a preferred embodiment of the present invention, two of the airbag positions correspond to the first connecting shaft, and the remaining two airbag positions correspond to the second connecting shaft.

[0014] As a preferred embodiment of the present invention, the flexible inner core is provided with an air tube serving as a conduit for connecting the airbag and the corresponding air pump.

[0015] As a preferred embodiment of the present invention, the flexible inner core is provided with an electrical connecting wire, one end of which extends into the groove and is electrically connected to the angle detector, and the other end of the electrical connecting wire is electrically connected to the controller.

[0016] As a preferred embodiment of the present invention, a limiting plate is provided on the outer periphery of the flexible inner core near the air pump.

[0017] As a preferred embodiment of the present invention, the guide wire is made of metal.

[0018] As a preferred embodiment of the present invention, the adjustment part is a frustum structure.

[0019] In a preferred embodiment of the present invention, the angle detector is in contact with the flexible thin film.

[0020] The beneficial effects of this invention are reflected in:

[0021] 1. By setting an angle detector, the angular information of the guidewire's offset angle relative to the central axis of the flexible outer sheath is obtained. By setting an air pump and a corresponding airbag, the direction of the force acting on the adjustment part is changed by inflating and deflating the air, which in turn causes the connecting rod to deflect. This allows the delivery sheath assembly to adjust its direction of travel according to the direction of the ureter, so as to smoothly pass through the parts of the ureter with a large degree of curvature. During the insertion process, the active direction adjustment reduces the resistance of the delivery sheath assembly when passing through the curved parts, thereby reducing damage to the ureter.

[0022] 2. By setting four air bladders and combining them with the four rotating shafts in the connecting part, the connecting rod can be deflected in four directions to adapt to the bending tendency of the ureter.

[0023] 3. By setting a limiting plate, the flexible inner core is prevented from being inserted too much when assembling the flexible inner core and the flexible outer sheath. Attached Figure Description

[0024] Figure 1 This is a cross-sectional view of the front part of the present invention;

[0025] Figure 2 This is a schematic diagram of the front view of the flexible inner core of the present invention;

[0026] Figure 3 This is a front view schematic diagram of the flexible inner core of the present invention;

[0027] Figure 4 This is a schematic diagram of the flexible outer sheath of the present invention;

[0028] Figure 5 This is a bottom cross-sectional view of the insertion end of the present invention;

[0029] Figure 6 This is a front view schematic diagram of the detection mechanism of the present invention;

[0030] Figure 7 This is a side view schematic diagram of the ring body and other parts of the present invention.

[0031] In the diagram: 1. Flexible inner core; 11. Groove; 12. Flexible film; 13. Guide wire groove; 14. Limiting plate; 2. Flexible outer sheath; 3. Guide wire; 4. Detection mechanism; 41. Angle detector; 42. Connecting rod; 43. Adjustment part; 44. Ring body; 45. Connecting shaft one; 46. Connecting shaft two; 5. Airbag; 6. Air pump; 7. Air tube; 8. Electrical connection inner wire; 9. Controller. Detailed Implementation

[0032] The invention will now be described in further detail with reference to the accompanying drawings.

[0033] Combined with appendix Figure 1-7 As shown, a ureteral delivery sheath assembly for reducing ureteral injury during insertion includes a flexible inner core 1, a groove 11, a flexible film 12, a guide wire groove 13, a limiting plate 14, a flexible outer sheath 2, a guide wire 3, a detection mechanism 4, an angle detector 41, a connecting rod 42, an adjustment part 43, a ring body 44, a connecting shaft one 45, a connecting shaft two 46, an airbag 5, an air pump 6, an air tube 7, an electrical connection inner wire 8, and a controller 9.

[0034] Combined with appendix Figure 1-7 As shown, a ureteral delivery sheath assembly for reducing ureteral injury during insertion includes: a flexible inner core 1, a flexible outer sheath 2 located outside the flexible inner core 1, a channel between the flexible inner core 1 and the flexible outer sheath 2 for passing a guidewire 3 pre-inserted into the ureter, a detection mechanism 4, and a control mechanism. The guidewire 3 is made of metal. Before inserting the flexible inner core 1 and the flexible outer sheath 2, the guidewire 3 is pre-inserted into the ureter, and then the subsequent insertion of the flexible inner core 1 and the flexible outer sheath 2 is achieved with the assistance of the guidewire 3. One end of the flexible inner core 1 has an outward-facing groove 11, and a flexible film is provided at the opening of the groove 11. 12. Preferably, the groove 11 is a deep groove structure, and the flexible film 12 is a cylindrical structure closed at one end. Specifically, the cylindrical structure includes a cylinder and a hemisphere. The hemisphere is disposed at one end of the cylinder for closure, and the unclosed end of the cylinder is fitted into the opening of the groove 11. The detection mechanism is located in the sealed space between the groove 11 and the flexible film 12. Preferably, the flexible film 12 is made of an elastic material, and some air can be retained between the groove 11 and the flexible film 12 so that a buffer space is retained between the detection mechanism and the ureter during insertion, so as to drive the flexible film 12 to deflect without affecting the deflection of the detection mechanism.

[0035] The detection mechanism 4 includes an angle detector 41, a connecting rod 42, an adjustment part 43, and a connecting part. The connecting rod 42 is movably connected to the groove 11 via the connecting part. The connecting part includes a ring body 44, two connecting shafts 45 (first type) and two connecting shafts 46 (second type). The two connecting shafts 45 (first type) are rotatably connected to the groove wall of the groove 11 and are arranged coaxially. The ring body 44 is connected to the two connecting shafts 45 and is located between them. The two connecting shafts 46 (second type) are rotatably connected to the inner wall of the ring body 44 and are arranged coaxially. The connecting rod 42 passes through the ring body 44. 4. The inner side of the connecting rod 42 is connected to two connecting shafts 46. Preferably, the cross-section of the connecting rod 42 in the plane perpendicular to the insertion direction is circular, and the cross-sectional diameter at the connection between the connecting rod 42 and the connecting shaft 46 is smaller than the cross-sectional diameter at other positions. The angle detector 41 is fixed to the end of the connecting rod 42 facing the flexible film 12, and the adjustment part 43 is fixed to the end of the connecting rod 42 facing the groove 11. Preferably, the angle detector 41 is a miniature electromagnetic positioning sensor, or a miniature capacitive angular displacement sensor, a light sensor, a giant magnetoresistance effect sensor, etc., to ensure that its miniaturization can meet the needs of ureter use.

[0036] The control mechanism includes four airbags 5 and air pumps 6 connected to each airbag 5 via pipes. The flexible inner core 1 contains air pipes 7 that connect the airbags 5 to their corresponding air pumps 6. The four airbags 5 are disposed within the groove 11 and evenly distributed outside the adjustment part 43, abutting against it. The air pumps 6 are located at one end of the flexible inner core 1 away from the groove 11. The control mechanism also includes a controller 9, located at one end of the flexible inner core 1 away from the groove 11. The angle detector 41 and the air pumps 6 are electrically connected to the controller 9. Specifically, the flexible inner core (1) contains an electrical connection wire (8), one end of which extends into the groove (11) and is electrically connected to the angle detector (41). The other end of the electrical connection wire (8) is electrically connected to the controller (9). The adjustment part 43 and... Each connecting rod 42 has a hole for inserting an electrical connecting wire 8 so that the electrical connecting wire 8 can be electrically connected to the angle detector 41. Preferably, the adjustment part 43 is a frustum structure. The extension direction of the first connecting shaft 45 is perpendicular to the extension direction of the second connecting shaft 46. The positions of two airbags 5 correspond to the first connecting shaft 45, and the positions of the remaining two airbags 5 correspond to the second connecting shaft 46. Specifically, along the extension direction of the flexible inner core 1, the lines connecting the extension lines of the two first connecting shafts 45 and the corresponding positions of the two airbags 5 are in the same plane. Correspondingly, the lines connecting the extension lines of the two second connecting shafts 46 and the corresponding positions of the other two airbags 5 are in the same plane, so that when the airbags 5 are inflated or deflated, they can cooperate with the first connecting shaft 45 and the second connecting shaft 46 to achieve the deflection of the connecting rod 42 in four directions.

[0037] The flexible inner core 1 is provided with a guide wire groove 13 extending along the direction of the flexible inner core 1. The guide wire 3 is confined within the guide wire groove 13. By providing the guide wire groove 13, the guide wire 3 is confined, preventing the guide wire 3 from sliding between the flexible inner core 1 and the flexible outer sheath 2, and reducing the impact of its own sliding on the detection effect of the angle detector 41.

[0038] The angle detector 41 obtains the angle signal of the guidewire 3 relative to the central axis of the flexible outer sheath 2 in real time, and transmits the angle signal to the controller 9. The controller 9 controls the air pump 6 to inflate or deflate the corresponding airbag 5, thereby changing the direction of the force acting on the adjustment part 43, which in turn causes the connecting rod 42 to deflect. This allows the delivery sheath assembly to adjust its direction of travel according to the direction of the ureter to reduce ureteral injury. Specifically, based on the relevant content of human anatomy, the overall curvature of the ureter at different stages can be known in advance. Based on the known overall curvature, the ureteral bending tendency and the selection of the insertion angle can be determined. The degree of curvature of the airbag 5 pushing the end of the delivery sheath assembly during a single inflation or deflation is determined according to the degree of ureteral curvature. Preferably, the air pump 6 performs one operation to make the delivery sheath assembly deflect an angle range of 5-15° relative to the central axis of the flexible outer sheath 2, preferably 10°. The operation logic of the four air pumps 6 is divided into levels, preferably four levels. Taking the angle corresponding to the insertion direction of the delivery sheath assembly as an example... For ease of understanding, from this perspective, the four air pumps 6 correspond to four airbags 5 located at the top, bottom, left, and right. In the first position, the upper airbag 5 inflates while the lower airbag 5 deflates; in the second position, the lower airbag 5 inflates while the upper airbag 5 deflates; in the third position, the left airbag 5 inflates while the right airbag 5 deflates; and in the fourth position, the right airbag 5 inflates while the left airbag 5 deflates. In all four positions, the deflection angle of the end of the delivery sheath assembly relative to the central axis of the flexible outer sheath 2 after the airbags 5 inflate or deflate is... The angle detector 41 is in contact with the flexible film 12 so that the angle detector 41 can better drive the flexible film 12 to deflect after deflection, thereby realizing the deflection of the end of the delivery sheath assembly. The angle detector 41 is the same and the range is 5-15°, preferably 10°. By setting the deflection drive in the four main directions, it can adapt to more ureteral bending parts. At the same time, by using a simple gear corresponding to the direction, a balance is made between complexity and easy control, that is, active bending control is achieved, while avoiding the cost increase caused by complex structure and algorithm. The angle detector 41 abuts against the flexible film 12 so that after the angle detector 41 deflects, it can better drive the flexible film 12 to deflect, thereby realizing the deflection of the end of the delivery sheath assembly.

[0039] The controller 9 includes at least operation buttons for charging and discharging air pump 6 at different gear levels, as well as a display unit for displaying the guide wire deflection angle, so as to obtain the deflection angle information and perform the corresponding operation of air pump 6 based on the information;

[0040] A limiting plate 14 is provided on the outer periphery of the flexible inner core 1 near the air pump 6. By setting the limiting plate 14, the flexible inner core 1 is prevented from being inserted too much. The installation position of the limiting plate 14 can be selected based on experience or the detection requirements of the angle detector 41.

[0041] Working principle: The guidewire 3 is pre-inserted, the flexible outer sheath 2 is fitted over the guidewire 3, and the flexible inner core 1 is inserted into the flexible outer sheath 2, ensuring the guidewire 3 is located within the guidewire groove 13. This completes the combination of the flexible inner core 1 and the flexible outer sheath 2, forming a delivery sheath assembly. At this time, all four airbags 5 are in a medium-inflation state. In this state, the airbags 5 abut against the adjustment part 43. Subsequently, the flexible inner core 1 and the flexible outer sheath 2 are inserted into the ureter under the protection of lubricating fluid. During insertion, the flexible inner core 1 and the flexible outer sheath 2 are aligned with the bending direction of the main bend of the ureter, ensuring that the extension direction of the line connecting at least two airbags 5 is consistent with the main bending direction. Preferably, the two airbags 5 selected are the first and second gear corresponding airbags. After insertion, the angle detector 41 obtains the offset angle of the guidewire 3 relative to the central axis of the flexible outer sheath 2 in real time. As the flexible inner core 1 and the flexible outer sheath 2... 2. During insertion, when the guide wire 3 deviates along the main bending direction, the first or second gear is selected according to the specific direction of the guide wire 3 deviates, and the end of the delivery sheath assembly is driven to deflect. When the guide wire 3 deviates in a direction perpendicular to the main bending direction, the third or fourth gear is selected according to the specific direction of the guide wire 3 deviates, and the end of the delivery sheath assembly is driven to deflect. When the guide wire 3 deviates in both the main bending direction and the direction perpendicular to the main bending direction, the gear is selected according to the tendency of the deviation at this time. Specifically, if the deviation is more inclined to the main bending direction, the first or second gear is selected. If the deviation is more inclined to the direction perpendicular to the main bending direction, the third or fourth gear is selected. After the insertion is completed, the gas in the four airbags 5 returns to its original state. In this state, the four airbags 5 abut against the adjustment part 43.

[0042] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely preferred examples and are not intended to limit the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the invention as claimed. The scope of protection of this invention is defined by the appended claims and their equivalents.

Claims

1. A ureteral delivery sheath assembly for reducing ureteral injury during insertion, comprising: The flexible inner core (1), the flexible outer sheath (2) located outside the flexible inner core (1), the channel between the flexible inner core (1) and the flexible outer sheath (2) for passing through the guidewire (3) pre-inserted into the ureter, the detection mechanism (4), and the control mechanism are characterized in that: The flexible inner core (1) has an outward-facing groove (11) at one end. A flexible film (12) is provided at the opening of the groove (11). The flexible film (12) is a cylindrical structure with one end closed. The detection mechanism is located in the sealed space between the groove (11) and the flexible film (12). The detection mechanism (4) includes an angle detector (41), a connecting rod (42), an adjustment part (43), and a connecting part. The connecting rod (42) is movably connected to the groove (11) through the connecting part. The angle detector (41) is fixed to the end of the connecting rod (42) facing the flexible film (12). The adjustment part (43) is fixed to the end of the connecting rod (42) facing the groove (11). The control mechanism includes four airbags (5) and an air pump (6) that is connected to the airbags (5) one by one through a pipeline. The four airbags (5) are set in the groove (11) and are evenly distributed on the outside of the adjustment part (43) and abut against the adjustment part (43). The air pump (6) is set at one end of the flexible inner core (1) away from the groove (11). The flexible inner core (1) is provided with a guide wire groove (13) extending along the direction of the flexible inner core (1), and the guide wire (3) is limited to the guide wire groove (13); The control mechanism also includes a controller (9), which is located at one end of the flexible inner core (1) away from the groove (11). The angle detector (41) and the air pump (6) are electrically connected to the controller (9). The angle detector (41) obtains the angle signal of the guide wire (3) relative to the central axis of the flexible outer sheath (2) in real time and transmits the angle signal to the controller (9). The controller (9) inflates or deflates the corresponding airbag (5) by controlling the air pump (6), so that the direction of the force acting on the adjustment part (43) changes, thereby causing the connecting rod (42) to deflect. This allows the delivery sheath assembly to adjust its direction of travel according to the direction of the ureter to reduce ureteral damage.

2. The ureteral delivery sheath assembly for reducing ureteral injury during insertion according to claim 1, characterized in that: The connecting part includes a ring body (44), two connecting shafts (45) and two connecting shafts (46). The two connecting shafts (45) are rotatably connected to the groove wall of the groove (11) and are arranged in a relatively coaxial manner. The ring body (44) is connected to the two connecting shafts (45) and is located between the two connecting shafts (45). The two connecting shafts (46) are rotatably connected to the inner wall of the ring body (44) and are arranged in a relatively coaxial manner. The connecting rod (42) passes through the inner side of the ring body (44) and is connected to the two connecting shafts (46).

3. A ureteral delivery sheath assembly for reducing ureteral injury during insertion according to claim 2, characterized in that: The extension direction of the first connecting shaft (45) is perpendicular to the extension direction of the second connecting shaft (46).

4. A ureteral delivery sheath assembly for reducing ureteral injury during insertion according to claim 3, characterized in that: Two of the airbags (5) are located at positions corresponding to the first connecting shaft (45), and the remaining two airbags (5) are located at positions corresponding to the second connecting shaft (46).

5. A ureteral delivery sheath assembly for reducing ureteral injury during insertion according to claim 1, characterized in that: The flexible inner core (1) is provided with an air pipe (7) which serves as a conduit for connecting the airbag (5) and the corresponding air pump (6).

6. A ureteral delivery sheath assembly for reducing ureteral injury during insertion according to claim 1, characterized in that: The flexible inner core (1) is provided with an electrical connection inner wire (8), one end of which extends into the groove (11) and is electrically connected to the angle detector (41). The other end of the electrical connection inner wire (8) is electrically connected to the controller (9).

7. A ureteral delivery sheath assembly for reducing ureteral injury during insertion according to claim 1, characterized in that: A limiting plate (14) is provided on the outer periphery of the flexible inner core (1) near the air pump (6).

8. A ureteral delivery sheath assembly for reducing ureteral injury during insertion according to claim 1, characterized in that: The guide wire (3) is made of metal.

9. A ureteral delivery sheath assembly for reducing ureteral injury during insertion according to claim 1, characterized in that: The adjustment part (43) is a frustum structure.

10. A ureteral delivery sheath assembly for reducing ureteral injury during insertion according to claim 1, characterized in that: The angle detector (41) abuts against the flexible film (12).

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