A disintegrable sinus sheath for a PTCS and a PTCS assembly

Abstract

The present application relates to a kind of sinus protection sheath, in particular to a kind of crushable sinus protection sheath for PTCS and PTCS assembly, including inner core and sheath tube of being sleeved in the outer of inner core, sheath tube is divided into sheath tube head section, sheath tube middle section, sheath tube tail section and communicating section in order from head to tail;The head end of sheath tube head section is connected with metal ring;The cross section of metal ring is triangular structure;The material stiffness of sheath tube middle section is greater than the material stiffness of sheath tube head section;Steel pipe is embedded in the inside of sheath tube tail section;Cavity is formed in the inside of communicating section, and the inner diameter of cavity is greater than the inner diameter of sheath tube tail section.Compared with prior art, the present application solves the deformation of sinus protection sheath in prior art after stone basket is grabbed multiple times, and the displacement of sinus protection sheath in the process of operation is prone to occur.The present scheme realizes the strengthening of end strength by the setting of metal ring, and the improvement of single-person operation convenience by the cooperation of fixing device based on the simple lithotripsy function.

Description

Technical Field

[0001] This invention relates to a sinus tract protection sheath, specifically to a litholytic sinus tract protection sheath for PTCS and a PTCS assembly. Background Technology

[0002] Percutaneous transhepatic cholangioscopic lithotripsy (PTCS) is one of the minimally invasive treatment methods for intrahepatic bile duct stones, with advantages such as high stone clearance rate and minimal trauma. However, PTCS treatment requires first inserting a 6Fr PTCD tube into the target bile duct under ultrasound guidance, then dilating the sinus tract to 16Fr in stages; subsequently, the 16Fr PTCD tube needs to be left in place for a full month (the duration may be extended for patients with weak constitutions) to allow the sinus tract (a pathway constructed from skin, fat layer, muscle layer, parietal peritoneum, peritoneum, liver capsule, liver parenchyma, and bile duct) to mature. At this point, adhesions form between the layers of the sinus tract, making separation difficult, before the cholangioscope can be inserted to enter the sinus tract and reach the intrahepatic and extrahepatic bile ducts for cholangioscopic stone removal. Therefore, this procedure has the following drawbacks: it requires multiple dilations of the sinus tract and the retention of the PTCD tube for a relatively long period to allow the sinus tract to mature.

[0003] Currently, vascular sheaths or percutaneous nephrolithotomy sheaths are commonly used in clinical practice as sinus tract protection sheaths. Specifically, a sinus tract protection sheath is a disposable consumable consisting of an inner core and a sheath tube, acting as a dilator: a guidewire passes through the inner core, and the sheath and inner core are inserted into the sinus tract together under the guidance of the guidewire to dilate it; after dilation, the inner core is removed, while the sheath tube remains to support the sinus tract, allowing instruments such as choledochoscopes to pass through the channel formed by the sheath tube for stone removal; after the procedure, the guidewire is left in place, the sheath is removed, and a PTCD tube (for elective follow-up surgery) may be placed depending on the situation. Therefore, using a sinus tract protection sheath allows for stone removal during dilation, shortening the preoperative waiting time; especially with the advent of disposable ultra-thin percutaneous choledochoscopes (outer diameter less than 10 Fr), PTCS can now be performed after dilating the sinus tract to 10-12 Fr, significantly reducing patient waiting time and allowing the surgery to be completed in a single hospital stay.

[0004] In the existing technology, some researchers have made improvements to the sinus tract protection sheath.

[0005] For example, CN119587843A discloses a surgical instrument for percutaneous transhepatic cholangioscopy. However, this design is complex in structure, difficult to operate by a single person, and its pointed front makes it difficult to perform stone removal and can only achieve drainage function.

[0006] For example, CN109091176A and CN109091175A disclose protective sheaths for gallbladder-preserving stone removal / polyp removal. However, this solution only uses silicone material to avoid damage during the stone removal process and achieves hemostasis of the incision by compressing the upper and lower balloons. It is difficult to remove large stones. Moreover, because the silicone material is relatively soft, it is easy to deform and shift during the insertion process, making it difficult to accurately place the tube.

[0007] For example, CN211132596U discloses a negative pressure suction sheath for percutaneous hepatic cholangioscopy that can crush stones. It uses a single-sided serration at the end to cut and crush stones. However, the guide sheath of this design is made entirely of polyethylene material. After the stone retrieval basket grabs the stone and goes in and out multiple times, it is prone to deformation. For example, a funnel-shaped structure may appear due to stone impaction, making it difficult to remove the sheath in subsequent operations.

[0008] In addition, the vascular sheath and the sinus tract sheath used in percutaneous nephrolithotomy are currently the most commonly used in clinical practice. Regardless of whether it is a vascular sheath, nephrolithotomy sheath or cholangioscopic sheath, they all lack a fixation device. During the stone removal process, the sheath is prone to displacement or even detachment from the sinus tract. An assistant is often needed to help fix the sheath, resulting in a narrow surgical operating space. Summary of the Invention

[0009] The purpose of this invention is to address at least one of the aforementioned problems by providing a lithotripsy sinus tract protection sheath and a PTCS assembly for PTCS, thereby overcoming the shortcomings of existing sinus tract protection sheaths, such as easy deformation after repeated insertion and removal of stones by the stone retrieval basket, and easy displacement of the sinus tract protection sheath during surgery. This solution, while providing simple lithotripsy functionality, enhances end strength through the inclusion of a metal ring and improves ease of single-person operation through the use of a fixation device.

[0010] The objective of this invention is achieved through the following technical solution: The first aspect of the present invention discloses a litholytic sinus tract protection sheath for PTCS, comprising an inner core and a sheath tube sleeved outside the inner core, wherein the sheath tube is divided into a sheath tube head section, a sheath tube middle section, a sheath tube tail section and a connecting section from head to tail. The sheath head section is connected to a metal ring at its head end; the cross-section of the metal ring is a triangular structure, wherein the head end of the metal ring is a pointed tip, and the outer diameter of the metal ring increases from the head end to the tail end. The material stiffness of the middle section of the sheath is greater than that of the head section of the sheath; A steel tube is embedded inside the tail section of the sheath, making the stiffness of the tail section of the sheath greater than that of the middle section of the sheath. The connecting section has a cavity inside, and the inner diameter of the cavity is larger than the inner diameter of the tail section of the sheath.

[0011] Preferably, the metal ring is made of a developing material.

[0012] Preferably, the sheath head section is made of TPU, silicone, LDPE, or low-hardness PEBAX, etc.; the sheath middle section is made of PP, PEEK, PTFE, or high-hardness PEBAX, etc.; the sheath tail section is made of the same material as the sheath middle section, and a metal tube liner is provided on the inner side of the sheath tail section to further increase its hardness.

[0013] Preferably, the lithotripsy sinus tract protection sheath is provided with a protective sleeve at the diameter-changing connection between the tail section of the sheath tube and the connecting section; The protective sleeve is fitted over the outside of the protective sheath for the lithotripsy sinus tract.

[0014] Preferably, the connecting segment adopts a three-way structure.

[0015] Preferably, a negative pressure connector is provided at an angle on the side of the connecting segment; The negative pressure connector is equipped with a negative pressure regulating valve.

[0016] Preferably, the tail end of the connecting section is detachably provided with an air-blocking valve. The air-blocking valve has a valve inside for separating the cavity from the atmosphere.

[0017] Preferably, the tail end of the inner core is provided with a connecting thread, and the air-blocking valve is connected and fixed to the inner core through the connecting thread.

[0018] Preferably, the connecting segment is made of a transparent material.

[0019] A second aspect of the present invention discloses a PTCS assembly, including a fixation device and a litholytic sinus tract protection sheath as described above; The fixing device includes a fixing film, a rubber seat ring, and a tension adjuster; The rubber seat ring has an axially penetrating insertion hole; The rubber seat ring is disposed on the surface of the fixing film, and the fixing film has a through insertion hole at the position corresponding to the insertion hole on the rubber seat ring; The rubber seat ring is provided with a neck, and the tension adjuster is sleeved on the neck of the rubber seat ring; The fixing device is fitted onto the outside of the litholytic sinus tract protective sheath through the insertion hole, and the sheath can be locked and unlocked within the fixing device by adjusting the tension adjuster.

[0020] Preferably, the outer wall surface of the sheath tail section is provided with anti-slip microstructures, such as pitting and / or rough surface.

[0021] Preferably, the tension adjuster adopts a snap-fit ​​structure.

[0022] The working principle of this invention is as follows: The metal ring at the head end not only serves as an expander and a stone crusher, but also provides a certain degree of hardness and fatigue resistance, ensuring smooth and accurate insertion and preventing the end from deforming during stone extraction, which could make the sheath difficult to pull out.

[0023] The three sections of the sheath are made of different materials, with the stiffness increasing sequentially from the head to the tail section. This ensures the overall structural strength and sufficient flexibility, facilitating the precise insertion of the sinus tract protection sheath and preventing damage to the bile duct during insertion.

[0024] The large inner diameter structure of the connecting segment provides a certain amount of retention space for stone fragments, avoiding blockage and compression damage.

[0025] The fixation device provides positional fixation for the inserted sinus tract protection sheath, ensuring that the stone removal operation will not cause the sinus tract protection sheath to shift, and allowing the PTCS assembly to be operated by a single person.

[0026] Compared with the prior art, the present invention has the following beneficial effects: This patented solution proposes a cholangioscope sheath that is more suitable for actual clinical practice: 1) The metal ring at the tip not only increases the durability of the sheath, but also enables simple lithotripsy and helps the operator locate the tip of the sheath during surgery, improving the accuracy of the insertion position.

[0027] 2) The sheath adopts a multi-segment design with different materials to meet the performance requirements of different parts and also meet the needs of actual operation, increasing safety while ensuring the convenience of insertion.

[0028] 3) The fixation device used in conjunction with the procedure also facilitates single-person operation of PTCS. The operator does not need to worry about the sheath shifting or even falling off during the stone removal process, which greatly saves operation time and reduces the pain for the patient.

[0029] 4) Finally, the design of the tail end has also been optimized for choledochoscopy stone removal, which can quickly and easily attract stone fragments and sludge. When encountering larger stones, the lumen can be cleaned by removing the air valve separately without replacing the sheath. Attached Figure Description

[0030] Figure 1 A schematic diagram of the structure of the sheath tube in the sinus tract protection sheath; Figure 2 A schematic diagram of the inner core of the sinus tract protective sheath; Figure 3This is a side view of the fixing device in the PTCS assembly. Figure 4 This is a schematic diagram of the tension adjuster in the PTCS assembly; Figure 5 This is a top view of the fixing device in the PTCS assembly. In the diagram: 1-Metal ring; 2-Sheath head section; 3-Sheath middle section; 4-Sheath tail section; 5-Protective sleeve; 6-Connecting section; 7-Air shut-off valve; 8-Negative pressure connector; 9-Negative pressure regulating valve; 10-Valve; 11-Inner core; 12-Connecting thread; 13-Fixing film; 14-Rubber seat ring; 15-Tightness adjuster; 16-Insertion hole. Detailed Implementation

[0031] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments.

[0032] Example 1 In existing technologies, the tip of most sinus tract protection sheaths is made of plastic, just like the body. Due to structural requirements, the tip is relatively thin, making it prone to deformation after repeated insertions and removals of stones by the stone retrieval basket. Stone impaction can even cause the tip to deform into a flared shape, making subsequent sheath removal difficult and potentially requiring emergency lithotripsy or surgery. Furthermore, due to the uniformity of the material, to balance insertion accuracy and safety, the tip of the sheath is often relatively rigid (potentially damaging the bile duct), while the body and tail lack sufficient support, making it difficult to control and guarantee the insertion precision of the sinus tract protection sheath.

[0033] Furthermore, the existing sheaths lack fixation devices, which can easily lead to sheath displacement or even detachment from the sinus tract during stone removal. This often requires an assistant to help fix the sheath, significantly limiting the surgical operating space. In addition, the space at the tail end of the existing sheath (where it connects to the negative pressure suction device) is narrow, which means that the suction tube can only be designed to be small. This makes the suction tube prone to blockage by stone fragments, affecting the surgical process.

[0034] This embodiment discloses a lithotripsy sinus tract protection sheath for PTCS, such as Figure 1 , 2 As shown, it includes an inner core 11 and a sheath sleeved outside the inner core 11. The sheath is divided into a sheath head section 2, a sheath middle section 3, a sheath tail section 4 and a connecting section 6 from head to tail. The sheath head section 2 is connected to a metal ring 1 at its head end; the cross-section of the metal ring 1 is a triangular structure, wherein the head end of the metal ring 1 is a pointed tip, and the outer diameter of the metal ring 1 increases from the head end to the tail end. The material stiffness of the middle section 3 of the sheath is greater than that of the head section 2 of the sheath; A steel tube is embedded inside the tail section 4 of the sheath tube, making the stiffness of the tail section 4 greater than that of the middle section 3 of the sheath tube. The connecting segment 6 has a cavity inside, and the inner diameter of the cavity is larger than the inner diameter of the tail segment 4 of the sheath.

[0035] This embodiment also discloses a PTCS component, such as Figure 3-5 As shown, it includes a fixing device and a lithotripsy sinus tract protection sheath as described above; The fixing device includes a fixing film 13, a rubber seat ring 14, and a tension adjuster 15; The rubber seat ring 14 has an axially penetrating insertion hole 16; The rubber seat ring 14 is disposed on the surface of the fixing film 13, and the fixing film 13 has a through insertion hole 16 at the position corresponding to the insertion hole 16 on the rubber seat ring 14. The rubber seat ring 14 is provided with a neck, and the tension adjuster 15 is sleeved on the neck of the rubber seat ring 14; The fixing device is fitted onto the outside of the litholytic sinus tract protection sheath through the insertion hole 16, and the sheath can be locked and unlocked within the fixing device by adjusting the tension adjuster 15.

[0036] More specifically, in this embodiment: This embodiment of the invention provides a sinus tract protection sheath for cholangioscopy that combines safety, durability, practicality, and convenience. Specifically, it includes a sheath tube, an inner core 11, and a fixing device used in conjunction with the sinus tract protection sheath.

[0037] The sheath is divided into a head section 2, a middle section 3, a tail section 4, and a connecting section 6 from head to tail. The head section 2, middle section 3, and tail section 4 are preferably connected by heat fusion or internal / external nesting bonding. The tail section 4 and connecting section 6 can be connected by interlocking a pre-set boss in the connecting section 6 and a pre-opened flared opening in the tail section 4, followed by sealing with adhesive. Alternatively, a conical slope can be pre-set inside the connecting section 6, with the tail section 4 pre-opened into a flared opening, and the tail section 4 passing through the conical slope, where the flared opening engages with the conical slope to achieve connection, fixation, and sealing.

[0038] First, a metal ring 1 is designed into the sheath head section 2. This metal ring 1 can be connected to the sheath head section 2 by any suitable method such as adhesive bonding, heat fusion, or threading. The cross-section of the metal ring 1 is a triangular structure that matches the end face of the head section, and the inner diameter of the metal ring 1 is consistent with the inner diameter of the sheath; more specifically, the cross-section of the metal ring 1 is usually a right-angled triangle, such as... Figure 1As shown, the bevel of the metal ring 1 faces outward (away from the central axis of the sheath), and the head of the metal ring 1 forms a pointed tip. This allows the metal ring 1 to function as both a dilator and a lithotripter. Simultaneously, the metal ring 1 is preferably made of a radiopaque material, enabling it to provide good visualization and positioning under fluoroscopy, facilitating the surgeon's determination of the sheath's position. During actual insertion and stone retrieval, when a hard stone, due to its large size or sharp edges, cannot pass directly through the sheath, the metal ring 1 can function as a lithotripter, using its high hardness to assist the stone retrieval basket in breaking up the stone, thus enabling the removal of difficult-to-remove stones. Furthermore, the metal ring 1 itself has high structural strength and is not easily deformed under pressure, preventing the sheath from becoming stuck due to stone impaction, thereby increasing the safety and durability of the sheath.

[0039] Secondly, the material of the sheath is optimized. The stiffness of the sheath head section 2, the middle section 3, and the tail section 4 increases sequentially to achieve effective force transmission and facilitate insertion during use. In some embodiments, the sheath head section 2 can be made of materials such as TPU, silicone, LDPE, or low-hardness PEBAX, typically with a hardness controlled between 15-65D. The middle section 3 can be made of materials such as PP, PEEK, PTFE, or high-hardness PEBAX, typically with a hardness controlled between 50-90D, and the material hardness of the middle section 3 is greater than that of the sheath head section 2. The tail section 4 can be made of the same material as the middle section 3, with an internal metal liner added to effectively increase its stiffness. In addition, it should be noted that the selected materials should meet biocompatibility requirements. The use of a flexible sheath tip 2 facilitates sheath insertion and swivel, preventing damage to the bile duct during insertion and manipulation. A metal ring 1, possessing both rigidity and fatigue resistance, is placed at the weakest point of the tip, ensuring precise positioning and safety during insertion. The middle section 3, with higher rigidity and toughness than the tip 2, maintains a certain level of rigidity while also allowing for flexibility, facilitating sheath insertion into the bile duct and enabling effective conduction. The tail section 4 incorporates an embedded steel tube, effectively enhancing its structural strength and preventing deformation and displacement of the sheath during manipulation.

[0040] Furthermore, the connecting segment 6, connected to the sheath tail section 4, is structurally optimized by adopting an enlarged tee structure. The inner diameter of its internal cavity is larger than that of the sheath tail section 4, allowing for the configuration of a larger diameter negative pressure connector 8. This enables more efficient suction of stone fragments to the outside of the sheath, avoiding the risk of some stone fragments remaining in the sheath lumen due to obstruction by the air valve 7 during cholangioscopic stone removal. In some embodiments, the inner diameter of the sheath tail section 4 can be controlled at approximately 10-16 Fr, and the inner diameter of the connecting segment 6 can be set to 1.5 cm. The negative pressure connector 8 is further equipped with a negative pressure regulating valve 9, which can adjust the negative pressure according to the actual situation during the suction process, further facilitating fluid filling of the bile duct to maintain intraoperative visibility. The end of the connecting section 6 is sealed by a detachable air-blocking valve 7. If a threaded connection is used, it is preferable to provide a boss with external threads in the connecting section 6, which can be threadedly engaged with the air-blocking valve 7. Specifically, the air-blocking valve 7 has a valve 10 inside to isolate the atmosphere from the sheath cavity, and further achieves structural sealing at the connection point through sealing elements (such as sealing rings or sealing gaskets). In addition, the air-blocking valve 7 also forms a threaded connection with the connecting thread 12 provided at the tail of the inner core 11 (the inner core 11 is located inside the sheath, and its structure is as follows). Figure 2 As shown, it can be installed inside the sheath in the conventional manner to enhance the reliability of the air-blocking valve 7 fixedly installed at the tail end of the sheath. In addition, the three-way structure of the connecting section 6 is preferably made of transparent material, which can facilitate the surgeon to detect stone residue in time. If large fragments are found, they can be cleaned by timely disassembly of the air-blocking valve 7 with valve 10. Furthermore, in order to enhance the structural strength of the connection between the tail section 4 of the sheath and the connecting section at the variable diameter structure, the sinus tract protection sheath is also fitted with a protective sleeve 5 on the outside of the connection between the two. It is set to fit the outer wall and has a thickened structure at the connection position (forming a continuous transition of the outer wall), thereby forming local reinforcement and preventing it from being easily broken during use.

[0041] Finally, the sinus tract protection sheath is used in combination with the fixation device, which specifically consists of a rubber seat ring 14, a tension adjuster 15 (buckle structure), and a fixing film 13. The rubber seat ring 14 and the fixing film 13 have corresponding through insertion holes 16, such as... Figure 3 , 5As shown, the insertion hole 16 can cooperate with the sinus tract protection sheath, allowing the sheath to pass through the insertion hole 16 and be fixed to the patient's skin surface by the fixing film 13. The insertion hole 16 is usually located at the center of the fixing film 13 and the rubber seat ring 14. The rubber seat ring 14 is fixed to the non-adhesive surface of the fixing film 13, and the two are usually fixed by adhesive. Its overall cross-section is "I" shaped, forming a neck in its axial middle. The tension adjuster 15 is detachably fitted into this neck. By squeezing and pressing the rubber seat ring 14, it deforms and presses against the outer wall of the sheath, thereby increasing the frictional resistance to limit the position of the sinus tract protection sheath. To further enhance frictional resistance, anti-slip microstructures, such as pitted or rough surfaces, are provided on the outer wall of the sheath tail section 4 (the part that just fits against the rubber seat ring 14). This further increases frictional resistance and prevents the sinus tract protection sheath from sliding or moving freely after being positioned. When adjusting the insertion depth of the sinus tract protection sheath, the tension adjuster 15 is first removed, and then fixed again after adjustment. The tension adjuster 15 is as follows: Figure 3 , 4 As shown, the neck position of the tension adjuster 15 is fitted onto the rubber seat ring 14. Therefore, the tension adjuster 15 is designed as a ring structure with an opening. To better maintain its ability to apply a stable force to the rubber seat ring 14 after locking, a pair of side branches extend outward on both sides of the opening, and auxiliary branches extend towards each other (towards the opening side) near the end of the side branches to form auxiliary branches (the auxiliary branches can also be set as an arc structure with the center of the tension adjuster 15 as the arc). The two auxiliary branches are staggered, and on either side of the auxiliary branch facing the center of the tension adjuster 15 (inner surface) and on the opposite side of the annular structure facing away from the center (outer surface), there are interlocking tooth structures (located on both sides of the opening). Ratchets are preferred, ensuring a stable lock-on within the plane after locking and engaging (this structure can be adjusted to a suitable locking size by creating a height difference between the two auxiliary branches during locking and unlocking, and then the corresponding tooth structures can be interlocked). If further enhancement of locking stability is necessary, additional tooth structures can be added, such as interlocking tooth structures on the inner and outer surfaces of the pair of auxiliary branches. However, the tooth spacing between the two sets of tooth structures should be controlled to allow for simultaneous engagement and cooperation. Reliable fixation and limiting of the sinus tract protection sheath ensures that the sheath remains relatively fixed to the body during stone removal and does not shift during the insertion and removal of the cholangioscope, facilitating single-person operation.

[0042] The sinus tract protection sheath and PTCS assembly of this embodiment are used in percutaneous transhepatic cholangioscopic lithotripsy to protect the sinus tract and facilitate early surgical intervention. In actual use, the sinus tract can be dilated to 10Fr 2-3 days after percutaneous liver puncture (using a 6Fr PTCD tube). Then, 2-3 days later, the PTCS assembly can be used to dilate the sinus tract to 12Fr, with the sheath in place and the inner core 11 removed. Simultaneously, the sinus tract protection sheath is locked and limited by a fixation device attached to the skin surface. Then, the cholangioscope can be inserted through the sheath to begin lithotripsy and stone removal.

[0043] The above description of the embodiments is provided to enable those skilled in the art to understand and use the invention. It will be apparent to those skilled in the art that various modifications can be made to these embodiments, and the general principles described herein can be applied to other embodiments without inventive effort. Therefore, the present invention is not limited to the above embodiments, and any improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the invention should be within the protection scope of the present invention.

Claims

1. A protective sheath for fractured sinus tracts in PTCS, comprising an inner core (11) and a sheath tube sleeved outside the inner core (11), characterized in that, The sheath is divided into the head section (2), the middle section (3), the tail section (4), and the connecting section (6) from head to tail. The sheath head section (2) is connected to a metal ring (1); the cross section of the metal ring (1) is a triangular structure, wherein the head end of the metal ring (1) is a pointed tip, and the outer diameter of the metal ring (1) increases from the head end to the tail end. The material stiffness of the middle section (3) of the sheath is greater than that of the head section (2) of the sheath; The sheath tail section (4) is embedded with a steel pipe, making the stiffness of the sheath tail section (4) greater than that of the middle section (3). The connecting segment (6) has a cavity inside, and the inner diameter of the cavity is larger than the inner diameter of the sheath tail segment (4).

2. The lithotripsy sinus tract protection sheath for PTCS according to claim 1, characterized in that, The metal ring (1) is made of a developing material.

3. A protective sheath for fractured sinus tracts in PTCS according to claim 1, characterized in that, The protective sleeve (5) is provided at the variable diameter connection between the tail section (4) and the connecting section (6) of the lithotripsy sinus tract protective sheath. The protective sleeve (5) is fitted over the outside of the protective sheath for the fractured stone sinus tract.

4. A litholytic sinus tract protection sheath for PTCS according to claim 1, characterized in that, The connecting segment (6) adopts a three-way structure.

5. A litholytic sinus tract protection sheath for PTCS according to claim 1, characterized in that, The side of the connecting section (6) is provided with a negative pressure connector (8) at an angle. The negative pressure connector (8) is equipped with a negative pressure regulating valve (9).

6. A litholytic sinus tract protection sheath for PTCS according to claim 1, characterized in that, The tail end of the connecting section (6) is detachably equipped with an air-blocking valve (7). The air-blocking valve (7) is provided with a valve (10) inside for separating the cavity from the atmosphere.

7. A litholytic sinus tract protection sheath for PTCS according to claim 6, characterized in that, The inner core (11) is provided with a connecting thread (12) at its tail end, and the air-blocking valve (7) is connected and fixed to the inner core (11) through the connecting thread (12).

8. A protective sheath for fractured sinus tracts in PTCS according to claim 1, characterized in that, The connecting segment (6) is made of transparent material.

9. A PTCS component, characterized in that, Includes a fixation device and a litholytic sinus tract protection sheath as described in any one of claims 1-8; The fixing device includes a fixing film (13), a rubber seat ring (14), and a tension adjuster (15). The rubber seat ring (14) is provided with an axially penetrating insertion hole (16). The rubber seat ring (14) is disposed on the surface of the fixing film (13), and the fixing film (13) has a through insertion hole (16) at the position corresponding to the insertion hole (16) on the rubber seat ring (14). The rubber seat ring (14) is provided with a neck, and the tension adjuster (15) is sleeved on the neck of the rubber seat ring (14); The fixing device is fitted onto the outside of the litholytic sinus tract protective sheath through the insertion hole (16), and the sheath can be locked and unlocked within the fixing device by adjusting the tension adjuster (15).

10. A PTCS component according to claim 9, characterized in that, The outer wall surface of the sheath tail section (4) is provided with anti-slip microstructures.

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