A device to assist in the repositioning of a peritoneal dialysis catheter after displacement

Abstract

The application relates to the technical field of medical devices and discloses a device for assisting in resetting a peritoneal dialysis catheter after displacement, which comprises a flexible protective sheath assembly, a visual guide wire structure and a flexible catching assembly; the flexible protective sheath assembly comprises a hollow sheath pipe body and an operation handle arranged at the tail end of the sheath pipe body; the visual guide wire structure is coaxially and slidably arranged in the sheath pipe body; the visual guide wire structure comprises a guide wire inner core and an ultrasonic imaging layer wrapped outside the guide wire inner core; the side wall of the ultrasonic imaging layer is provided with a depth scale mark in the axial direction; the flexible catching assembly comprises a water bag anchoring head fixedly arranged at the distal end of the sheath pipe body; a plurality of blind hole grooves are arranged in the side wall of the water bag anchoring head; and an inflatable water bag is fixedly arranged in each blind hole groove. The device is provided with an ultrasonic visual guide wire, a water bag flexible anchoring structure and a bidirectional controllable bending structure, is accurate in positioning, safe in minimally invasive operation, stable in self-locking adjustment and capable of reducing the damage of organs and catheters.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a device for assisting in the repositioning of a peritoneal dialysis catheter after displacement. Background Technology

[0002] Peritoneal dialysis is a common renal replacement therapy for patients with end-stage renal disease. The peritoneal dialysis catheter, as the core component of the dialysis pathway, directly determines whether dialysis treatment can be carried out normally. In clinical practice, due to factors such as changes in patient position, abdominal peristalsis, and daily activities, the peritoneal dialysis catheter is prone to displacement. Catheter displacement directly causes poor drainage of dialysate and an imbalance between inflow and outflow fluids, forcing the interruption of peritoneal dialysis. This not only affects the treatment effect but also increases the burden on the patient's body.

[0003] Currently, the treatment methods for peritoneal dialysis catheter displacement are mainly divided into two categories: traditional surgical repositioning and simple instrument repositioning. Traditional repositioning often involves open surgery or minimally invasive surgery. This method is highly invasive, with a high risk of complications such as intraoperative bleeding and abdominal infection. At the same time, it is expensive, and the postoperative recovery period for patients is long. It will seriously interfere with subsequent continuous dialysis treatment and significantly reduce the patient's quality of life.

[0004] Existing simple repositioning devices also have many technical shortcomings: First, most devices lack a visual structure and precise depth markings, making it impossible for medical staff to judge the direction and depth of catheter deviation in real time. The operation relies entirely on personal clinical experience, which can easily lead to problems such as inadequate correction and excessive catheter push-in, resulting in a low repositioning success rate. Second, during the advancement and adjustment of the catheter in the abdominal cavity, the outer wall of the conventional repositioning tool is prone to scraping and tearing the inner wall of the abdominal cavity and organ tissues, which can easily cause serious adverse events such as bleeding and abdominal infection, resulting in poor safety. Third, some temporarily modified repositioning guidewires have a simple structure, lack supporting protective structures and directional adjustment functions, resulting in insufficient flexibility in catheter repositioning and adjustment, high operation difficulty, and poor clinical repeatability. Summary of the Invention

[0005] In view of the above-mentioned shortcomings in the prior art, the present invention provides a peritoneal dialysis catheter displacement assistance repositioning device, which solves the problems of large trauma, low accuracy and insufficient safety of the existing repositioning methods.

[0006] To achieve the above-mentioned objectives, the technical solution adopted by the present invention is as follows: a device for assisting in the repositioning of a peritoneal dialysis catheter after displacement, comprising a flexible protective sheath assembly, a visual guidewire structure, and a flexible capture assembly;

[0007] The flexible protective sheath assembly includes a hollow sheath body and an operating handle located at the tail end of the sheath body; a visual guidewire structure is slidably and coaxially inserted inside the sheath body, the visual guidewire structure includes a guidewire core and an ultrasonic imaging layer covering the outer side of the guidewire core, and the sidewall of the ultrasonic imaging layer is provided with depth scale markings along the axial direction.

[0008] The flexible capture component includes a water bladder anchor head fixedly installed at the distal end of the sheath body. The side wall of the water bladder anchor head has several blind hole grooves, and an expandable water bladder is fixedly embedded in each blind hole groove. The interior of the water bladder anchor head and the tube wall of the sheath body have water injection channels that communicate with the expandable water bladder. The expandable water bladder is configured to expand outward after water injection and embed into the side hole of the side wall of the peritoneal dialysis catheter to form an anchoring connection.

[0009] A controllable bending section is provided on the proximal side of the water balloon anchor head on the main body of the sheath. The controllable bending section includes several serpentine segments that are hinged end to end. A bending control knob is provided on the operating handle. A traction wire is inserted inside the controllable bending section. The traction wire passes through the main body of the sheath and connects the serpentine segments to the bending control knob. Rotating the bending control knob is configured to tighten the traction wire to drive the controllable bending section to bend in a specific direction, thereby driving the peritoneal dialysis catheter to reposition after anchoring.

[0010] Furthermore, the aforementioned peritoneal dialysis catheter displacement assistance repositioning device has a water injection interface inside the operating handle, which is connected to the proximal end of the water injection channel, and a one-way shut-off valve is provided at the water injection interface; the operating handle is also equipped with a guidewire pushing slider, the proximal end of the visualized guidewire structure is connected to the guidewire pushing slider, and the sliding guidewire pushing slider is configured to drive the visualized guidewire structure to move back and forth within the sheath body.

[0011] Furthermore, the aforementioned peritoneal dialysis catheter displacement assistance repositioning device is pivotally hinged between two adjacent serpentine segments; the outer side of each serpentine segment is covered with a transparent medical silicone sealing film, which is used to maintain the tube's seal when the controllable bending section bends.

[0012] Furthermore, the aforementioned peritoneal dialysis catheter displacement assistance repositioning device has two traction wires, which are symmetrically arranged at the edge of the controllable bending section. An inner mandrel is coaxially arranged on the bending control knob, and the proximal ends of the two traction wires are respectively wound around the inner mandrel. When the bending control knob is rotated, one traction wire tightens and the other traction wire is released, so as to achieve bidirectional deflection of the controllable bending section.

[0013] Furthermore, the aforementioned peritoneal dialysis catheter displacement assistance repositioning device has a sheath body comprising an inner layer, a middle layer, and an outer layer. The middle layer is a woven or wound stainless steel wire mesh, and the water injection channel is embedded within the middle layer.

[0014] Furthermore, the aforementioned peritoneal dialysis catheter displacement assistance repositioning device has a tapered inlet head at the distal end of the water balloon anchor head. The maximum outer diameter of the inlet head is the same as the outer diameter of the sheath body. The inlet head is made of radiopaque silicone material to facilitate the display of the distal outline of the entire device under ultrasound.

[0015] Furthermore, in the above-mentioned peritoneal dialysis catheter displacement assistance repositioning device, the outer diameter of the sheath body matches the inner diameter of the peritoneal dialysis catheter, and the outer surface of the sheath body is coated with a hydrophilic super-slippery coating.

[0016] Furthermore, in the aforementioned peritoneal dialysis catheter displacement assistance repositioning device, the ultrasound imaging layer is a barium sulfate mixed silicone layer covering the inner core surface of the guidewire, and the depth scale markings are imaging metal microrings embedded in the surface of the ultrasound imaging layer.

[0017] Furthermore, the peritoneal dialysis catheter displacement assistance device described above has at least three blind hole grooves, which are evenly spaced along the circumference of the water balloon anchor head.

[0018] Furthermore, the aforementioned peritoneal dialysis catheter displacement assistance repositioning device has an anti-slip texture on the outer peripheral sidewall of the bending control knob, and a damping self-locking structure inside the bending control knob.

[0019] The beneficial effects of this invention are as follows: This device is equipped with a visualized guidewire structure with an ultrasonic imaging layer and depth scale markings. The outer layer of the guidewire is formed by a barium sulfate mixed with silicone to form an ultrasonic imaging layer. Combined with the depth scale markings formed by imaging metal microrings, medical staff can use the ultrasound to observe the travel position, insertion depth and catheter displacement direction in real time. This eliminates the limitations of traditional operations that rely on personal experience, effectively avoids problems such as inadequate catheter correction and excessive pushing, and greatly improves the positioning accuracy of the repositioning operation.

[0020] The device features a water-filled anchor head at its distal end, with multiple blind-hole grooves containing expandable water-filled balloons evenly distributed around its circumference. After water is injected through the injection channel, the expandable balloons inflate outwards and embed into the side holes of the peritoneal dialysis catheter to achieve anchoring. This flexible anchoring method provides gentle contact, preventing compression or scratching of the dialysis catheter. Simultaneously, the multi-point circumferential anchoring structure ensures a secure connection between the catheter and the device, preventing slippage or displacement during repositioning and effectively improving the stability of the repositioning process. Compared to rigid clamping structures, this further reduces the risk of catheter breakage.

[0021] The sheath body is equipped with a controllable bending section composed of multiple serpentine segments articulated together. Combined with a traction wire and a bending control knob, it achieves bidirectional directional deflection. Rotating the knob allows for angle and orientation adjustment of the anchored dialysis catheter. The bidirectional deflection structure adapts to different directions and angles of catheter displacement, offering high flexibility. The anti-slip texture and damping self-locking structure of the bending control knob enable positional self-locking after adjustment, eliminating the need for continuous force application. This simplifies clinical procedures, reduces operational difficulty, and enhances ease of use and controllability.

[0022] The sheath body adopts a three-layer composite structure: an inner layer, a stainless steel wire mesh middle layer, and an outer layer. The water injection channel is pre-embedded in the middle layer. The stainless steel wire mesh can enhance the overall structural strength and bending resistance of the sheath, effectively extending the service life of the device. The outer side of the snake bone segment is covered with a transparent medical silicone sealing film, which can ensure that the tube is sealed throughout the controllable bending process during repeated deflection, preventing problems such as leakage of intra-abdominal fluid and intrusion of external contaminants, and ensuring a clean operating environment.

[0023] The operating handle integrates a water injection port, a one-way shut-off valve, and a guidewire pusher slider. The water injection port connects to the entire water injection channel and is equipped with a one-way shut-off valve to prevent water backflow and ensure stable inflation of the water bag. The guidewire pusher slider allows for convenient control of the visual guidewire's forward and backward movement, enabling independent control of guidewire advance and retreat. All functional modules are integrated into the operating end, resulting in a compact structure. Medical staff can perform a series of actions such as water injection, guidewire push, and angle adjustment with one hand, further improving operational smoothness.

[0024] The distal end of the water balloon anchoring head features a cone-shaped, radiopaque silicone guide tip with a smooth, rounded shape, preventing the device from scraping or scratching the abdominal wall and organs during insertion into the abdominal cavity. The outer layer of the sheath is coated with a hydrophilic, super-slippery coating, reducing frictional resistance between the device and human tissues and dialysis catheters, ensuring smooth movement and effectively reducing the probability of complications such as abdominal bleeding and infection. Simultaneously, the guide tip is made of radiopaque material, allowing ultrasound to fully visualize the distal outline of the device, assisting medical staff in determining its overall position, providing double protection for intraoperative safety. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the device mounted on a peritoneal dialysis catheter.

[0026] Figure 2 This is a schematic diagram of the structure of the device;

[0027] Figure 3 A schematic diagram showing the connection structure between the controllable bending section and the bending control knob;

[0028] Figure 4 Schematic diagram of the cross-sectional structure of the water bladder anchor head;

[0029] Figure 5This is a schematic diagram of the structure of a snake bone segment;

[0030] The components are: 1. Sheath body, 2. Operating handle, 3. Guidewire core, 4. Ultrasonic imaging layer, 5. Depth scale marking, 6. Water bag anchor head, 7. Blind hole groove, 8. Expandable water bag, 9. Water injection channel, 10. Controllable bending section, 11. Snake bone segment, 12. Bending control knob, 13. Traction wire, 14. Water injection interface, 15. Guidewire push slider, 16. Pivot, 17. Peritoneal dialysis catheter, 18. Inlet head, 19. Inner core. Detailed Implementation

[0031] The specific embodiments of the present invention are described below to enable those skilled in the art to understand the present invention. However, it should be understood that the present invention is not limited to the scope of the specific embodiments. For those skilled in the art, various changes are obvious as long as they are within the spirit and scope of the present invention as defined and determined by the appended claims. All inventions utilizing the concept of the present invention are protected.

[0032] like Figures 1-5 As shown, this embodiment provides a device for assisting in the repositioning of a peritoneal dialysis catheter 17 after displacement. The device includes a flexible protective sheath assembly, a visual guidewire structure, and a flexible capture assembly. The three components are coaxially matched and adapted to each other. The whole device is used for minimally invasive repositioning of the displaced peritoneal dialysis catheter 17 within the peritoneal cavity. The flexible protective sheath assembly serves as the external support and main operating body of the device. The visual guidewire structure is coaxially slidably inserted inside the flexible protective sheath assembly to achieve intraoperative ultrasound visualization positioning and depth measurement. The flexible capture assembly is located at the distal end of the flexible protective sheath assembly to achieve flexible anchoring and directional traction repositioning of the peritoneal dialysis catheter 17.

[0033] The flexible protective sheath assembly includes a hollow sheath body 1 and an operating handle 2 fixed to the tail end of the sheath body 1; a visual guidewire structure is slidable and coaxially inserted inside the sheath body 1; a flexible capture component is fixedly installed at the distal end of the sheath body 1, and a controllable bending section 10 is integrally formed on the proximal side of the sheath body 1 and the flexible capture component; the operating handle 2 is equipped with a bending control knob 12, a water injection interface 14, and a guidewire pushing slider 15, which respectively realize the angle adjustment of the controllable bending section 10, the water balloon water injection expansion, and the forward and backward pushing of the visual guidewire; the overall outer diameter of the device is adapted to the inner diameter of a standard peritoneal dialysis catheter 17, and it can be inserted into the peritoneal cavity from the external end of the peritoneal dialysis catheter 17. The entire process relies on real-time ultrasound imaging monitoring to complete the entire set of operations of catheter anchoring, angle adjustment, and displacement repositioning.

[0034] The flexible protective sheath assembly consists of two parts: a hollow sheath body 1 and an operating handle 2 located at the tail end of the sheath body 1. The two parts are sealed and heat-fused together, and the internal pipelines are completely connected. This provides a carrier for the visualized guide wire structure and the water injection channel 9, while also providing flexible protection for abdominal operations to prevent instruments from directly scraping against abdominal organs.

[0035] The sheath body 1 adopts a three-layer composite structure, which is formed by an inner layer, a middle layer and an outer layer in sequence. The middle layer is a braided stainless steel wire mesh, and the water injection channel 9 is embedded in the middle layer. The inner layer is a smooth medical polytetrafluoroethylene tube to ensure smooth sliding of the visible guide wire structure. The stainless steel wire mesh of the middle layer is braided around the entire tube to improve the sheath's resistance to bending and tensile strength and avoid bending and blockage during operation. The outer layer is a medical polyurethane flexible layer. The outer surface of the sheath body 1 is coated with a hydrophilic super-slippery coating to reduce the frictional resistance when the device is inserted into the peritoneal dialysis catheter 17 and passes through the peritoneal cavity. The overall outer diameter of the sheath body 1 is precisely matched with the inner diameter of the clinical standard peritoneal dialysis catheter 17, which can be inserted into the peritoneal cavity without resistance along the lumen of the dialysis catheter.

[0036] A water-filled anchor head 6 is provided at the end of the sheath body 1 away from the operating handle 2. A controllable bending section 10 is integrally provided on the proximal side of the water-filled anchor head 6 on the sheath body 1. The controllable bending section 10 is composed of several snake bone segments 11 that are hinged end to end. Adjacent snake bone segments 11 are hinged to each other by a pivot 16. Each snake bone segment 11 is made of medical titanium alloy with hollow forming. The outer side of all snake bone segments 11 is completely covered with a layer of transparent medical silicone sealing film. The silicone sealing film completely covers all the hinge gaps to maintain the tube body sealing when the controllable bending section 10 is bent at any angle, preventing the backflow of peritoneal fluid into the sheath and the intrusion of external contaminants into the peritoneal cavity.

[0037] Two traction wires 13 are symmetrically threaded inside the controllable bending section 10. The two traction wires 13 are symmetrically arranged at the edge of the controllable bending section 10. The traction wires 13 are made of ultra-high molecular weight polyethylene high-strength medical filaments. The traction wires 13 extend backward along the internal channel of the sheath body 1, penetrate the entire length of the sheath body 1, and are connected to the inside of the operating handle 2 to realize the transmission connection between the snake bone segment 11 and the bending control knob 12.

[0038] Operating handle 2 is an ergonomic, curved medical plastic molded part, fixedly and sealed to the tail end of the sheath body 1. The handle integrates multiple control structures, corresponding to water injection, guidewire pushing, and bending angle adjustment functions respectively.

[0039] The operating handle 2 has an internal water injection interface 14, which is sealed and connected to the proximal end of the water injection channel 9 pre-embedded in the sheath wall. The water injection interface 14 has a built-in one-way shut-off valve, which allows only external saline or sterile water to be injected into the water injection channel 9 in one direction, blocking the backflow of liquid and maintaining the continuous expansion and anchoring of the expandable water bag 8. The water injection interface 14 is connected to a medical syringe to complete the water injection operation.

[0040] An axial groove is provided on the side wall of the operating handle 2. A guide wire pusher 15 is installed in the groove. The proximal end of the visual guide wire structure is rigidly fixed to the guide wire pusher 15. By sliding the guide wire pusher 15 back and forth along the groove, the visual guide wire structure can be directly driven to move coaxially back and forth inside the sheath body 1, and the depth of the guide wire inserted into the abdominal cavity can be independently controlled.

[0041] The operating handle 2 has a rotating bending control knob 12 at its tail. The outer periphery of the knob has an integrally formed annular anti-slip texture to increase the friction for finger rotation. Inside the bending control knob 12, an inner core shaft 19 is coaxially fixed, and the proximal ends of two traction wires 13 are respectively wound in opposite directions and fixed to the surface of the inner core shaft 19. The bending control knob 12 integrates a damping self-locking structure. After the knob is rotated to any angle, it can self-lock by the damping friction, without the need for continuous manual gripping to maintain the bending angle. When the bending control knob 12 is rotated, the inner core shaft 19 rotates synchronously. One traction wire 13 is continuously tightened, while the other traction wire 13 is released synchronously. The traction wire 13 pulls the snake bone segment 11 to deflect along the pivot 16, realizing the controllable bending part 10 to deflect in both directions, thereby adjusting the spatial orientation of the distal water bladder anchoring head 6 of the device.

[0042] The visualized guidewire structure is slidable and coaxially inserted inside the sheath body 1. It is a slender and flexible medical guidewire, composed of a guidewire core 3 and an ultrasound imaging layer 4 covering the outer side of the guidewire core 3. The guidewire core 3 is made of a flexible memory metal material of nickel-titanium alloy, which has the characteristics of being flexible, resilient and non-deformable, and can adapt to the complex spatial shape of the peritoneal cavity. The ultrasound imaging layer 4 is a barium sulfate mixed silicone layer that is uniformly covered on the entire surface of the guidewire core 3. The barium sulfate filler is uniformly dispersed inside the silicone substrate, forming a clear and bright imaging signal under ultrasound imaging, and displaying the position of the guidewire in the peritoneal cavity in real time. The sidewall of the ultrasound imaging layer 4 is uniformly embedded with depth scale marks 5 along its own axis. The depth scale marks 5 are annular imaging metal microrings. The metal microrings are set every 5cm along the length of the guidewire and can be clearly identified under ultrasound. They are used to accurately read the depth of the guidewire into the peritoneal cavity and determine the displacement depth of the peritoneal dialysis catheter 17. The proximal end of the visualized guidewire structure is rigidly fixed to the guidewire pusher 15 of the operating handle 2. The entire advance and retreat control is achieved by sliding the slider. The distal end of the guidewire can extend out of the outer side of the distal water balloon anchor head 6 of the sheath body 1 and be pre-entered into the abdominal cavity to complete the ultrasound positioning exploration.

[0043] The flexible capture component is fixedly assembled at the farthest end of the sheath body 1. The core structure includes a water bladder anchoring head 6, a blind hole groove 7, an expandable water bladder 8, a water injection channel 9, and a conical inlet head 18, which are used to complete the flexible anchoring with the side hole of the peritoneal dialysis catheter 17. The catheter is repositioned by pulling with the controllable bending part 10.

[0044] The water-filled balloon anchor head 6 is integrally fixed to the distal end face of the sheath body 1, and the whole is a cylindrical medical silicone rigid base structure. At least three blind hole grooves 7 are evenly spaced along the circumference of the side wall of the water-filled balloon anchor head 6. Each blind hole groove 7 is sealed and fixed with a miniature embedded thin-walled expandable water balloon 8 by medical glue. The water balloon can only expand radially outward along the groove, without axial displacement. The internal cavity of the water balloon itself has limited space. The clinical standard water injection volume is controlled at 2-3 mL of sterile physiological saline. This water injection volume allows the water balloon to fully expand radially and stably embed into the side hole of the dialysis catheter. If the water injection volume is insufficient, the water balloon will not expand sufficiently and will not be able to be locked into the side hole of the catheter, and the anchoring connection is prone to slippage. If the water injection volume exceeds the standard range of 2-3 mL, the water balloon will expand beyond its capacity and rigidly compress the side wall of the peritoneal dialysis catheter 17, which can easily cause catheter deformation and wall cracking.

[0045] An axially connected channel is formed inside the water-filled anchor head 6. The water injection channel 9, which is pre-embedded in the middle layer of the sheath body 1, extends to this connected channel, forming a complete connected water path that passes through the water injection interface 14 of the operating handle 2, the sheath wall, the inside of the water-filled anchor head 6, and the expandable water-filled bags 8 in each blind hole groove 7. After sterile liquid is injected through the water injection interface 14, the liquid fills all the expandable water-filled bags 8 along the water injection channel 9. The water-filled bags expand outward and embed into the side holes of the side wall of the peritoneal dialysis catheter 17. The multi-point circumferential engagement forms a stable and flexible anchoring connection, without the rigid clamping structure squeezing and damaging the dialysis catheter.

[0046] The distal end of the water balloon anchor head 6 is a one-piece molded conical inlet head 18. The tip of the inlet head 18 is rounded and without sharp edges. The maximum outer diameter of the inlet head 18 is exactly the same as the outer diameter of the sheath body 1, ensuring a smooth transition of the overall outer diameter of the device without any steps or protrusions. The inlet head 18 is integrally cast from radiopaque silicone material. The silicone is mixed with barium sulfate radiopaque filler. Under ultrasound imaging, the overall outline of the distal end of the device can be fully displayed, which helps medical staff to determine the relative position of the anchor head to the abdominal organs and dialysis catheter, avoiding instrument puncture and tissue scratching.

[0047] Before the procedure, the entire device is sterilized. A sterile syringe is connected to the water injection port 14 of the operating handle 2. The one-way shut-off valve is confirmed to be sealed properly. The guidewire push slider 15 is slid to completely retract the visualized guidewire structure into the sheath body 1. The bending control knob 12 is rotated to the middle position to keep the controllable bending part 10 in a straight line.

[0048] The conical inlet head 18 of the device is aligned with the outlet of the extracorporeal peritoneal dialysis catheter 17. It is then smoothly pushed into the lumen of the dialysis catheter by relying on the hydrophilic super-slippery coating on the outer layer of the sheath, and slowly pushed into the peritoneal cavity along the catheter channel. During the pushing process, the outline of the inlet head 18 is scanned in real time by ultrasound. The ultrasound imaging layer 4 of the visualized guidewire and the depth scale mark 5 are observed simultaneously to read the insertion depth and determine the displacement position and offset angle of the peritoneal dialysis catheter 17.

[0049] Pull the guidewire push slider 15 backward to extend the visualization guidewire structure from the distal end of the water balloon anchor head 6. After the guidewire enters the abdominal cavity, it is used to explore the spatial position of the displacement catheter using the ultrasound imaging layer 4. The displacement depth and offset direction are accurately recorded by the imaging metal microring scale. After the exploration is completed, push the guidewire push slider 15 forward to retract the visualization guidewire into the sheath body 1.

[0050] Align the water balloon anchoring head 6 with the side hole area on the side wall of the peritoneal dialysis catheter 17, and inject 2-3 mL of sterile saline through the injection port 14. The liquid is delivered to each expandable water balloon 8 through the one-way shut-off valve and the injection channel 9. The water balloon expands radially in the blind hole groove 7 and embeds into the side hole of the dialysis catheter to form circumferential anchoring. After the injection is stopped, the one-way shut-off valve locks the water path to maintain the water balloon expansion and anchoring state. The device is firmly connected to the displacement peritoneal dialysis catheter 17 without slippage.

[0051] Rotating the bend control knob 12 with its anti-slip texture on the operating handle 2 causes the inner spindle 19 to rotate synchronously. One set of traction wires 13 tightens while the other set releases, pulling the snake bone segment 11 to deflect along the pivot 16. The controllable bending section 10 achieves bidirectional directional bending. After adjusting to the target angle, the internal damping self-locking structure of the bend control knob 12 automatically locks the angle, eliminating the need for continuous gripping. The directional bending of the controllable bending section 10 drives the distally anchored peritoneal dialysis catheter 17 to adjust its orientation synchronously, correcting catheter displacement. After repositioning, rotating the bend control knob 12 in the opposite direction restores the controllable bending section 10 to a straight line.

[0052] Liquid is drawn from the syringe at the water injection port 14, and the expandable water balloon 8 retracts back into the blind hole groove 7, releasing the anchoring connection with the side hole of the dialysis catheter. The visual guidewire is extended again, and after ultrasound confirmation that the catheter is repositioned in place and there is no bleeding or damage in the abdominal cavity, the entire device is slowly pulled outward to complete the repositioning operation.

[0053] The device features a barium sulfate mixed silicone ultrasonic imaging layer 4 and a metal microring depth scale marking 5. During the procedure, ultrasound can monitor the device insertion depth and catheter displacement direction in real time, overcoming the limitations of traditional operation that relies on physician experience and blind operation, eliminating problems such as inadequate correction and excessive catheter push, and significantly improving the accuracy of repositioning and positioning.

[0054] The water bladder anchor head 6 adopts a flexible anchoring structure with a circumferentially multi-point expandable water bladder 8. After the water bladder expands, it is embedded in the side hole of the dialysis catheter, with gentle contact and no hard squeezing or scratches. The multi-point uniform engagement ensures that there is no slippage or displacement throughout the repositioning process. Compared with the metal clamping structure, it significantly reduces the risk of dialysis catheter breakage. The water injection channel 9 is equipped with a one-way shut-off valve to continuously maintain the water bladder in an expanded state, and the anchoring stability is controllable throughout the process.

[0055] The controllable bending section 10 adopts a bidirectional transmission structure with a snake bone segment 11 pivot 16 hinge and double traction wire 13. Rotating the bending control knob 12 can adjust the catheter to any angle to the left or right, adapting to various catheter displacements in different directions and to varying degrees. The knob's anti-slip texture facilitates operation and force application. The built-in damping self-locking structure automatically locks the angle after adjustment, eliminating the need for continuous manual fixation, simplifying the clinical operation process and reducing the difficulty of operation.

[0056] The three-layer composite structure of the sheath body 1 relies on the stainless steel wire mesh middle layer to enhance the overall bending strength and extend the service life of the device; the silicone sealing film on the outside of the snake bone segment 11 seals all the hinge gaps, and the controllable bending part 10 can maintain the tube body seal under any bending state, avoiding the leakage of peritoneal fluid and the intrusion of external pollutants, and reducing the risk of peritoneal infection.

[0057] The distal cone-shaped silicone implant 18 of the device has a smooth, rounded shape without any sharp protrusions. The hydrophilic, super-slippery coating on the outer layer of the sheath significantly reduces frictional resistance between the device and the peritoneal tissue and dialysis catheter, preventing scratches or punctures to the abdominal wall and organs during insertion and adjustment. The implant 18 is fully visible, and ultrasound can completely identify the distal contour of the device, avoiding contact with organs in advance and significantly reducing complications such as peritoneal bleeding and infection. It eliminates the need for open surgery, achieving minimally invasive repositioning, greatly reducing surgical trauma and shortening the postoperative recovery period for patients.

Claims

1. A device for assisting in the repositioning of a peritoneal dialysis catheter after displacement, characterized in that, This includes a flexible protective sheath assembly, a visible guide wire structure, and a flexible capture assembly; The flexible protective sheath assembly includes a hollow sheath body (1) and an operating handle (2) located at the tail end of the sheath body (1); the visual guidewire structure is slidably and coaxially inserted inside the sheath body (1), the visual guidewire structure includes a guidewire core (3) and an ultrasonic imaging layer (4) covering the outside of the guidewire core (3), and the sidewall of the ultrasonic imaging layer (4) is provided with depth scale markings (5) along the axial direction. The flexible capture assembly includes a water bladder anchor head (6) fixedly installed at the distal end of the sheath body (1). The side wall of the water bladder anchor head (6) is provided with several blind hole grooves (7). Each blind hole groove (7) is fixedly embedded with an expandable water bladder (8). The interior of the water bladder anchor head (6) and the tube wall of the sheath body (1) are provided with a water injection channel (9) communicating with the expandable water bladder (8). The expandable water bladder (8) is configured to expand outward after water injection and embed into the side hole of the side wall of the peritoneal dialysis catheter (17) to form an anchoring connection. A controllable bending section (10) is provided on the proximal side of the water bag anchor head (6) on the sheath body (1). The controllable bending section (10) includes several serpentine segments (11) with their ends hinged together. A bending control knob (12) is provided on the operating handle (2). A traction wire (13) is passed through the inside of the controllable bending section (10). The traction wire (13) passes through the sheath body (1) and connects the serpentine segments (11) with the bending control knob (12). Rotating the bending control knob (12) is configured to tighten the traction wire (13) to drive the controllable bending section (10) to bend in a specific direction, thereby driving the peritoneal dialysis catheter (17) after anchoring to return to its original position.

2. The peritoneal dialysis catheter repositioning device according to claim 1, characterized in that, The operating handle (2) is provided with a water injection interface (14), which is connected to the proximal end of the water injection channel (9). A one-way shut-off valve is provided at the water injection interface (14). The operating handle (2) is also provided with a guide wire push slider (15). The proximal end of the visual guide wire structure is connected to the guide wire push slider (15). The sliding guide wire push slider (15) is configured to drive the visual guide wire structure to move back and forth in the sheath body (1).

3. The peritoneal dialysis catheter repositioning device according to claim 1, characterized in that, The two adjacent snake segments (11) are hinged by a pivot (16); the outer side of the snake segment (11) is covered with a transparent medical silicone sealing film, which is used to maintain the tube's sealing performance when the controllable bending part (10) is bent.

4. The peritoneal dialysis catheter repositioning device according to claim 3, characterized in that, There are two traction wires (13). The two traction wires (13) are symmetrically arranged on the edge of the controllable bending part (10). An inner mandrel (19) is coaxially arranged on the bending control knob (12). The proximal ends of the two traction wires (13) are respectively wound on the inner mandrel (19). When the bending control knob (12) is rotated, one of the traction wires (13) is tightened and the other traction wire (13) is released, so as to realize the left and right bidirectional deflection of the controllable bending part (10).

5. The peritoneal dialysis catheter repositioning device according to claim 1, characterized in that, The sheath body (1) includes an inner layer, a middle layer and an outer layer. The middle layer is a woven or wound stainless steel wire mesh, and the water injection channel (9) is buried in the middle layer.

6. The peritoneal dialysis catheter repositioning device according to claim 1, characterized in that, The distal end of the water bladder anchor head (6) is provided with a tapered inlet head (18). The maximum outer diameter of the inlet head (18) is the same as the outer diameter of the sheath body (1). The inlet head (18) is made of radiopaque silicone material so that the distal contour of the entire device can be displayed under ultrasound.

7. The peritoneal dialysis catheter repositioning device according to claim 1, characterized in that, The outer diameter of the sheath body (1) matches the inner diameter of the peritoneal dialysis catheter (17), and the outer surface of the sheath body (1) is coated with a hydrophilic super-slippery coating.

8. The peritoneal dialysis catheter repositioning device according to claim 1, characterized in that, The ultrasonic imaging layer (4) is a barium sulfate mixed silicone layer covering the surface of the guide wire core (3), and the depth scale mark (5) is a imaging metal micro-ring embedded in the surface of the ultrasonic imaging layer (4).

9. The peritoneal dialysis catheter repositioning device according to claim 1, characterized in that, The number of blind hole grooves (7) is at least three, and they are evenly spaced along the circumference of the water bladder anchor head (6).

10. The peritoneal dialysis catheter repositioning device according to claim 1, characterized in that, The outer peripheral sidewall of the bending control knob (12) is provided with anti-slip texture, and the bending control knob (12) is provided with a damping self-locking structure.

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