A gallstone extractor for hepatobiliary surgery

Abstract

This invention relates to the field of medical device technology, and in particular to a stone retrieval device for hepatobiliary surgery, comprising a catheter assembly and a stone retrieval device assembly. The catheter assembly is a flexible sheath that is bendable and steerable. The stone retrieval device assembly is fixedly installed at the upper end of the catheter assembly. Both the catheter assembly and the stone retrieval device assembly are hollow structures to facilitate stone removal. The catheter assembly includes a main sheath, which is integrally formed with the stone retrieval device assembly. The main sheath includes a main channel, as well as channel one and channel two. This invention achieves synchronous pneumatic drive closure of multiple clamping claws by setting an air injection end two, channel two, and multiple clamping plates evenly arranged circumferentially. The multiple clamping plates can form a 360° encircling wrap around the stone, resulting in a larger contact area and more uniform force distribution. In particular, the inner surface of the clamping plates is designed with a non-smooth surface, which increases the friction with the stone surface and effectively prevents the stone from slipping or escaping during dragging.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a stone removal device for hepatobiliary surgery. Background Technology

[0002] Intrahepatic bile duct stones are a common and complex disease of the biliary system, with a particularly high incidence in Asia. Due to the complex anatomy of the intrahepatic bile ducts, with numerous branches, narrow lumens, and high tortuosity, stones tend to form in the secondary or higher branches of the bile ducts within the liver lobe or segment. Currently, minimally invasive treatment for intrahepatic bile duct stones in clinical practice mainly relies on choledochoscopy combined with stone retrieval baskets, balloon dilation, or laser lithotripsy for stone removal.

[0003] However, existing stone removal instruments and methods still have significant shortcomings and clinical pain points in practical applications: 1. Most existing stone retrieval baskets have a two- or three-claw structure, which has limited effect on encapsulating stones. Since intrahepatic bile duct stones are often characterized by smooth surfaces, hard textures, or irregular shapes, coupled with the lubricating effect of continuous flushing fluid in the bile duct, the stones are very easy to slip out of the gaps in the basket during the dragging process after the basket is retrieved.

[0004] 2. For large or impacted intrahepatic bile duct stones, direct retrieval is not possible; lithotripsy must be performed first. The commonly used method is to first insert a laser fiber or pneumatic ballistic lithotripsy probe to fragment the stone. After the stone is fragmented, the lithotripsy instrument is withdrawn, and then the stone retrieval basket is reinserted to remove the fragments one by one. This step-by-step operation mode of "fracture first, then remove" requires repeated entry and exit of the instrument channel, which is not only cumbersome and time-consuming, but also increases the risk of bile duct injury and infection due to the risk of the cholangioscope and guidewire deviating from their original path during repeated instrument exchanges. At the same time, the fine particles generated during lithotripsy cannot be cleaned up in time and may flow to deeper parts of the liver with the bile duct irrigation fluid, further increasing the difficulty of stone removal.

[0005] In addition, during the lithotripsy process, due to the lack of an effective fixation device, the stones are prone to move under the impact force, which makes it impossible for the lithotripsy energy to be accurately applied to the target stone. This not only reduces the lithotripsy efficiency, but may also cause thermal or mechanical damage to the surrounding normal bile duct wall due to probe slippage.

[0006] To address the aforementioned problems, this invention proposes a stone removal device for hepatobiliary surgery that can stably hold stones and achieve simultaneous stone fragmentation and removal. Summary of the Invention

[0007] To address the problems existing in the background art, the present invention proposes a stone removal device for hepatobiliary surgery.

[0008] The stone removal device for hepatobiliary surgery provided in this application adopts the following technical solution: A stone retrieval device for hepatobiliary surgery includes a catheter assembly and a stone retrieval device assembly. The catheter assembly is a flexible sheath that is flexible and steerable. The stone retrieval device assembly is fixedly installed at the upper end of the catheter assembly. Both the catheter assembly and the stone retrieval device assembly are hollow structures to facilitate stone removal. The conduit assembly includes a main sheath, which is integrally formed with the stone extractor assembly. The main sheath includes a main channel, as well as channel one and channel two inside. The main channel is connected to the middle of the stone extractor assembly to form a negative pressure channel. An air injection end one and an air injection end two are fixedly installed at the lower end of the conduit assembly. The air injection end one is connected to the inside of the stone extractor assembly through channel one, and the air injection end two is connected to the inside of the stone extractor assembly through channel two.

[0009] Furthermore, the stone extractor assembly includes a flexible end, a telescopic mechanism, and a clamping mechanism. The upper end of the main sheath is equipped with a flexible end, which has a cylindrical hollow structure. A telescopic mechanism is installed on the inner wall of the flexible end, and clamping mechanisms are evenly installed on the telescopic mechanism along its circumference. The first air injection end can drive the telescopic mechanism to move along the length direction of the flexible end through the first channel, and the second air injection end can drive multiple clamping mechanisms to clamp synchronously through the second channel.

[0010] Furthermore, the telescopic mechanism includes a guide rail, a guide slider, and a telescopic airbag. An annular groove is formed on the inner wall of the flexible end, and vertically arranged guide rails are evenly installed on the annular groove. The upper end of the guide rail is integrally formed with the flexible end. A guide slider is slidably arranged on the guide rail, and a telescopic airbag is installed at the lower end of the guide slider. The telescopic airbag is connected to the interior of the channel.

[0011] Furthermore, the clamping mechanism includes a fixed rod, a fixed seat, a clamping plate, and an injection tube. An annular groove is formed at the upper end of the guide slider. The upper end of the second channel is connected to the inside of the annular groove. Fixed rods are evenly installed on the upper end of the guide slider. A fixed seat is installed on the upper end of the fixed rod. A clamping plate is installed on the fixed seat through a pin. An injection tube is installed on the outer surface of the clamping plate. The other end of the injection tube passes through the fixed rod and is connected to the inside of the annular groove.

[0012] Furthermore, the clamping plate is made of medical-grade silicone, the inner side of the clamping plate is non-smooth, and the edge of the clamping plate is smooth.

[0013] Furthermore, the clamping plate is filled with a thin, elastic metal plate.

[0014] Furthermore, the injection tube is an elastic tube, and a metal braided mesh is wrapped around the outer surface of the injection tube.

[0015] Beneficial effects Compared with the prior art, the present invention provides a stone removal device for hepatobiliary surgery, which has the following beneficial effects: 1. In this invention, by setting up an air injection end two, a channel two, and multiple clamping plates evenly arranged circumferentially, the synchronous air pressure drive closure of multiple clamping claws is realized. The multiple clamping plates can form a 360° encircling wrap around the stone, with a larger contact area and more uniform force. In particular, the inner side of the clamping plate adopts a non-smooth surface design, which increases the friction with the stone surface and effectively prevents the stone from slipping or escaping during dragging. At the same time, the elastic metal plate filled inside the clamping plate not only ensures the clamping rigidity, but also gives it good elastic restoring ability, so that the instrument can firmly grasp complex stones with various irregular shapes and smooth surfaces, improving the success rate of one-time removal of complex intrahepatic bile duct stones.

[0016] 2. In this invention, by using a clamping mechanism to hold and fix the stone, the lithotripsy instrument can be directly introduced through the main channel for intracavitary lithotripsy, and negative pressure suction can be activated simultaneously to remove debris. Therefore, unlike existing technologies, it is not necessary to replace the stone retrieval basket for secondary retrieval after lithotripsy. This reduces the number of times the instrument enters and exits the channel, lowering the risk of bile duct mucosal damage and infection. At the same time, because the stone is pre-fixed, the energy transmission of lithotripsy is more accurate, avoiding lithotripsy failure or damage to surrounding tissues caused by stone slippage. Thus, while ensuring the lithotripsy effect, the overall operation time is shortened.

[0017] 3. In this invention, by independently setting up one inflation end and the telescopic balloon, and another inflation end and the injection tube, independent and precise control of the axial extension / retraction action of the telescopic mechanism and the radial opening / closing action of the clamping mechanism is achieved. The operator can flexibly adjust the opening range and extension length of the clamping plate according to the actual situation under the intraoperative cholangioscopic field of view. This can not only meet the needs of grasping stones of different sizes, but also safely retract the stone into the flexible end after grasping, avoiding the stone from scraping the bile duct wall during the withdrawal of the instrument, thus further improving the safety and adaptability of the operation. Attached Figure Description

[0018] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0019] Figure 1 This is a three-dimensional structural diagram of this application.

[0020] Figure 2 This is a three-dimensional cross-sectional structural diagram of this application.

[0021] Figure 3 This is a cross-sectional structural diagram of the catheter assembly of this application.

[0022] Figure 4 This is a cross-sectional structural diagram of the main sheath of this application.

[0023] Figure 5This is a cross-sectional structural diagram of the main sheath and the stone-collecting device assembly in this application.

[0024] Figure 6 This is a three-dimensional structural diagram of the clamping mechanism of this application.

[0025] Explanation of reference numerals in the attached drawings: 1. Conduit assembly; 11. Main sheath; 111. Main channel; 112. Channel one; 113. Channel two; 12. Injection end one; 13. Injection end two; 2. Stone extractor assembly; 21. Flexible end; 22. Telescopic mechanism; 221. Guide rail; 222. Guide slider; 223. Telescopic airbag; 23. Clamping mechanism; 231. Fixing rod; 232. Fixing seat; 233. Clamping plate; 234. Injection tube. Detailed Implementation

[0026] 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, and 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] like Figures 1 to 6 As shown, the present invention provides a stone retrieval device for hepatobiliary surgery, including a catheter assembly 1 and a stone retrieval device assembly 2. The catheter assembly 1 is a flexible sheath that is bendable and steerable. Its proximal end (operating end) is connected to an external operating handle and an air source and a negative pressure source, and the stone retrieval device assembly 2 is fixedly installed at its distal end (working end). Both the catheter assembly 1 and the stone retrieval device assembly 2 are hollow structures to facilitate the removal of stones or stone fragments.

[0028] Specifically, the catheter assembly 1 includes a main sheath 11, which is made of medical-grade flexible polymer material (such as polyurethane or block polyamide). The main sheath 11 has three independent cavities arranged axially inside: a main channel 111, a first channel 112, and a second channel 113. The distal end of the main channel 111 is connected to the middle of the stone retrieval assembly 2, forming the main passage for negative pressure suction, used to simultaneously aspirate fragments and fluid during stone retrieval. The lower end (proximal end) of the catheter assembly 1 is fixedly equipped with an air injection end 12 and an air injection end 13. The air injection end 12 is connected to the internal telescopic drive component of the stone retrieval assembly 2 through the first channel 112; the air injection end 13 is connected to the internal clamping drive component of the stone retrieval assembly 2 through the second channel 113.

[0029] During the surgical preparation phase, the main sheath 11 is inserted into the intrahepatic bile duct along the guide wire under the guidance of a cholangioscope. Through the flexibility of the main sheath 11 itself and the directional control of its distal end, it is made to follow the tortuous path of the bile duct until the stone retrieval component 2 reaches the location of the stone.

[0030] like Figures 3-4 As shown, the stone extractor assembly 2 includes a flexible end 21, a telescopic mechanism 22, and a clamping mechanism 23. The upper end of the main sheath 11 is fixedly connected to the flexible end 21 or integrally formed. The flexible end 21 has a cylindrical hollow structure. The telescopic mechanism 22 is installed on the inner wall of the flexible end 21. Multiple (preferably 4 to 6) clamping mechanisms 23 are evenly installed on the telescopic mechanism 22 along its circumference. When not in use, the clamping mechanism 23 can be completely retracted inside the flexible end 21.

[0031] The first gas injection end 12 injects or extracts gas through the first channel 112 to drive the telescopic mechanism 22 to reciprocate along the length direction (i.e., axial direction) of the flexible end 21; the second gas injection end 13 injects gas through the second channel 113 to drive multiple clamping mechanisms 23 to expand or contract radially synchronously, thereby achieving a ring-shaped clamping of the stone.

[0032] like Figure 5 As shown, the telescopic mechanism 22 includes a guide rail 221, a guide slider 222, and a telescopic airbag 223. An annular positioning groove is provided on the inner wall of the flexible end 21. Vertically arranged guide rails 221 are uniformly fixed in the annular groove. The upper end of the guide rail 221 is integrally formed with the distal inner wall of the flexible end 21. The lower end of the guide rail 221 is at the bottom of the annular groove. The guide slider 222 is slidably arranged on the guide rail 221. The lower end of the guide slider 222 is fixedly connected to the telescopic airbag 223. The air inlet of the telescopic airbag 223 is sealed and connected to the distal outlet of the channel 112.

[0033] When gas is injected into channel 112 through injection end 12, the telescopic airbag 223 expands and elongates axially, pushing the guide slider 222 to slide upward along guide rail 221, thereby causing the entire clamping mechanism 23 to extend outside the flexible end 21, ready to grasp; when gas is extracted through injection end 12, the telescopic airbag 223 contracts, pulling the guide slider 222 downward, causing the clamping mechanism 23 to retract into the flexible end 21, so as to facilitate the removal of the instrument or protect the clamped stone.

[0034] like Figure 6As shown, the clamping mechanism 23 includes a fixed rod 231, a fixed seat 232, a clamping plate 233, and a pressure injection tube 234. The upper end of the guide slider 222 is provided with an annular gas collection groove. The upper end of the channel 2 113 is connected to the interior of the annular gas collection groove. Multiple fixed rods 231 are uniformly fixedly installed circumferentially on the upper end face of the guide slider 222. A fixed seat 232 is fixedly installed on the upper end of each fixed rod 231. A clamping plate 233 is hinged to each fixed seat 232 by a pin. The pressure injection tube 234 is fixedly connected to the outer side of each clamping plate 233. The other end of the pressure injection tube 234 passes through the interior of the fixed rod 231 and is connected to the interior of the annular gas collection groove.

[0035] Preferably, the injection tube 234 is an elastic corrugated tube or rubber tube, with a metal braided mesh wrapped around its outer surface to enhance radial compressive strength and ensure axial expansion and contraction guidance. When the injection tube 234 is under negative pressure, it can freely contract and deform, causing the clamping plate 233 to flip outward under its own elasticity and the pull of the injection tube 234, thereby increasing the expansion angle between the clamping plates 233 and facilitating the inclusion of the stone into the clamping range. When gas is injected into the injection tube 234 through the second gas injection end 13 and the second channel 113 to increase the gas pressure, the injection tube 234 expands axially, causing the clamping plate 233 to flip inward around the pin on the fixed seat 232. Multiple clamping plates 233 flip inward and close simultaneously, achieving a 360° circumferential clamping of the stone.

[0036] It should be noted that if the stone is too large and exceeds the complete closing range of the clamping plate 233, the clamping plate 233 will first wrap around and fix the stone at the maximum stroke. At this time, a crushing device (such as a pneumatic ballistic lithotripter or laser fiber) can be introduced into the negative pressure channel (i.e., the main channel 111). Since the stone has been wrapped around and fixed, the crushing device can accurately impact and crush large stone particles, and effectively prevent the stone from shifting or escaping during the crushing process.

[0037] In a preferred embodiment, the clamping plate 233 is made entirely of medical-grade silicone to ensure its biocompatibility and softness when in contact with the bile duct wall or stones, and to avoid scratching tissue. To enhance clamping stability, the inner surface of the clamping plate 233 (i.e. the surface in contact with the stones) is set as a non-smooth surface, for example, by using a coarse grinding surface or by uniformly arranging multiple anti-slip grooves. This structure can significantly increase the friction between the clamping plate 233 and the stone surface, effectively preventing the stones from slipping during the stone removal process.

[0038] Meanwhile, the edges of the clamping plate 233 are all designed with a smooth arc shape to ensure that the outer edge will not pierce or scratch the wall of the intrahepatic bile duct during the opening or closing of the clamping plate 233, thereby reducing the risk of iatrogenic bile duct injury.

[0039] To further improve the clamping force on hard stones and prevent excessive deformation of the clamping plate 233 during the clamping process, the clamping plate 233 is also filled or embedded with a layer of elastic metal sheet (such as nickel-titanium alloy sheet). The elastic metal sheet can provide sufficient radial support force for the clamping plate 233 and ensure that the clamping plate 233 has good elastic recovery ability under air pressure, thereby significantly improving the clamping reliability of stones with complex shapes.

[0040] Based on the above structure, the stone removal device for hepatobiliary surgery provided by the present invention operates according to the following steps: S1. Insertion and Positioning: The catheter assembly 1 is inserted through the percutaneous liver puncture channel or the oral cholangioscopy channel. Under X-ray or cholangioscopy monitoring, the steering mechanism of the main sheath 11 is manipulated to align the flexible end 21 with the stone in the target bile duct.

[0041] S2, Extending and Enclosing: Inflate the telescopic airbag 223 through the air injection end 12, push the guide slider 222 forward, and make the six clamping plates 233 extend beyond the flexible end 21. At this time, there is no positive pressure in the injection tube 234, and the clamping plates 233 are in an outward opening state (petal-like unfolding).

[0042] S3, Encircling Clamping: The position is adjusted so that the stone is in the center of multiple clamping plates 233. Air is slowly injected into the channel 113 and the pressure tube 234 through the air injection end 213. The pressure tube 234 expands and drives the six clamping plates 233 to flip inward simultaneously, so that they fit the stone surface from six directions at the same time. The anti-slip texture locks the stone in the clamping space.

[0043] S4. Crushed stone and simultaneous removal: If the stone is of moderate size, the telescopic mechanism 22 pulls the stone into the flexible end 21, and the clamping mechanism 23 keeps it in a clamping state, directly removing the stone from the body along with the instrument. At the same time, negative pressure suction is applied through the main channel 111 to clean up any remaining fragments of stone in the bile duct. If the stone is too large to be removed directly, a lithotripsy probe is inserted through the main channel 111 to perform intracavitary lithotripsy, while the stone is fixed by the clamping plate 233. During the lithotripsy process, the main channel 111 is kept under negative pressure to promptly remove the fragments and prevent debris from blocking the bile duct.

[0044] S5. Withdraw the device: After the stone fragmentation is completed, the gas in the telescopic airbag 223 is extracted through the air injection end 12, causing the guide slider 222 to retract, and the clamping mechanism 23, along with the remaining stone fragments, is retracted into the flexible end 21 and the main sheath 11. Finally, the entire device is removed from the body as a whole.

[0045] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

Claims

1. A stone removal device for hepatobiliary surgery, characterized in that, It includes a catheter assembly (1) and a stone retrieval assembly (2). The catheter assembly (1) is a flexible sheath that is flexible and steerable. The stone retrieval assembly (2) is fixedly installed at the upper end of the catheter assembly (1). Both the catheter assembly (1) and the stone retrieval assembly (2) are hollow structures to facilitate stone removal. The conduit assembly (1) includes a main sheath (11), which is integrally formed with the stone-collecting tool assembly (2). The main sheath (11) includes a main channel (111), a channel one (112), and a channel two (113). The main channel (111) is connected to the middle of the stone-collecting tool assembly (2) and forms a negative pressure channel. The lower end of the conduit assembly (1) is fixedly equipped with an air injection end one (12) and an air injection end two (13). The air injection end one (12) is connected to the inside of the stone-collecting tool assembly (2) through the channel one (112), and the air injection end two (13) is connected to the inside of the stone-collecting tool assembly (2) through the channel two (113).

2. The stone removal device for hepatobiliary surgery according to claim 1, characterized in that: The stone extractor assembly (2) includes a flexible end (21), a telescopic mechanism (22), and a clamping mechanism (23). The upper end of the main sheath (11) is equipped with a flexible end (21), which has a cylindrical hollow structure. The telescopic mechanism (22) is installed on the inner wall of the flexible end (21). The clamping mechanism (23) is evenly installed on the telescopic mechanism (22) along its circumference. The first air injection end (12) can drive the telescopic mechanism (22) to move along the length direction of the flexible end (21) through the first channel (112). The second air injection end (13) can drive multiple clamping mechanisms (23) to clamp synchronously through the second channel (113).

3. The stone removal device for hepatobiliary surgery according to claim 2, characterized in that: The telescopic mechanism (22) includes a guide rail (221), a guide slider (222), and a telescopic airbag (223). An annular groove is provided on the inner wall of the flexible end (21). Vertically arranged guide rails (221) are evenly installed on the annular groove. The upper end of the guide rail (221) is integrally formed with the flexible end (21). A guide slider (222) is slidably arranged on the guide rail (221). A telescopic airbag (223) is installed at the lower end of the guide slider (222). The telescopic airbag (223) is connected to the inside of the channel (112).

4. The stone removal device for hepatobiliary surgery according to claim 3, characterized in that: The clamping mechanism (23) includes a fixed rod (231), a fixed seat (232), a clamping plate (233), and a pressure injection tube (234). The upper end of the guide slider (222) is provided with an annular groove. The upper end of the second channel (113) is connected to the inside of the annular groove. Fixed rods (231) are evenly installed on the upper end of the guide slider (222). A fixed seat (232) is installed on the upper end of the fixed rod (231). A clamping plate (233) is installed on the fixed seat (232) through a pin. A pressure injection tube (234) is installed on the outer surface of the clamping plate (233). The other end of the pressure injection tube (234) passes through the fixed rod (231) and is connected to the inside of the annular groove.

5. A stone removal device for hepatobiliary surgery according to claim 4, characterized in that: The clamping plate (233) is made of medical-grade silicone. The inner side of the clamping plate (233) is non-smooth, and the edge of the clamping plate (233) is smooth.

6. A stone removal device for hepatobiliary surgery according to claim 5, characterized in that: The clamping plate (233) is filled with a thin, elastic metal plate.

7. A stone removal device for hepatobiliary surgery according to claim 4, characterized in that: The injection tube (234) is an elastic tube, and the outer surface of the injection tube (234) is wrapped with a metal braided mesh.

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