Peritoneal dialysis catheter subcutaneous tunnel needle

Abstract

The invention relates to a peritoneal dialysis catheter subcutaneous tunnel needle, which belongs to the technical field of medical instruments and comprises a puncture needle main body, an expandable balloon module, a light guide navigation unit and a negative pressure cooperative control module. Precise subcutaneous tunnel forming and dynamic hemostasis are achieved through the expandable balloon, the integrated light guide navigation unit recognizes blood vessels and nerves in real time, and a puncture path is guided to avoid obstacles; the hematocele is synchronously removed in combination with negative pressure suction, and tissue damage is avoided through pressure monitoring and a pressure relief mechanism. The instrument adopts double-channel handle integrated operation, supports single-hand controlled puncture, hemostasis and illumination switching, and is adaptive to open and minimally invasive surgery. According to the design, the limitation of traditional step-by-step operation is broken through, the operation efficiency and safety are improved, the risks of catheter displacement, leakage and infection are reduced, and a high-precision integrated solution is provided for implantation of the peritoneal dialysis catheter.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a subcutaneous tunneling needle for peritoneal dialysis catheter. BACKGROUND

[0002] In peritoneal dialysis catheter implantation surgery, establishing a subcutaneous tunnel with regular structure and complete hemostasis is the key to ensuring long-term patency of the catheter and reducing postoperative complications. The ideal tunnel should have precise diameter control capability: too narrow tunnel will compress the catheter and affect dialysis flow, and too wide tunnel may cause catheter displacement or peritoneal dialysis fluid leakage; at the same time, incomplete hemostasis during surgery can easily form intratunnel hematoma, which not only increases the risk of infection and catheter-related peritonitis, but also causes tunnel stenosis after hematoma organization. Therefore, the subcutaneous tunnel forming process must achieve the dual goals of "accurate shape" and "reliable hemostasis".

[0003] The current clinical standard procedure still relies on a step-by-step, multi-instrument operation process: first, a puncture needle is used to establish a subcutaneous initial tunnel, then the puncture needle is withdrawn and a compression instrument is replaced for manual hemostasis, and finally a balloon catheter is introduced for tunnel expansion. This operation mode has significant limitations: multiple instrument exchanges not only prolong the operation time, but also easily cause tunnel wall tissue damage or path deviation; the effectiveness of manual compression hemostasis completely depends on the experience of the operator, insufficient pressure will result in incomplete hemostasis, and excessive pressure may cause tissue ischemia and edema; the design of traditional balloon catheters is based on the expansion of blood vessels, which has high rigidity and lacks dynamic adjustment capability for the mechanical properties of subcutaneous soft tissue, easily causing under-expansion or over-expansion; in addition, the existing instruments are functionally fragmented, and the removal of accumulated blood during surgery requires the use of additional suction devices, which not only interferes with the operation field of view, but also may cause secondary damage to the tunnel wall.

[0004] The root cause of the above problems lies in the essential contradiction between the technical paths of different surgical steps: puncture operation requires the instrument to have sufficient sharpness and rigidity to achieve tissue penetration, while compression hemostasis requires blunt structures with large contact surfaces and pressure controllability; balloon expansion requires maintaining uniform radial pressure in a closed tunnel, but blood removal and surgical field observation require an open channel and visible space; the fluid disturbance caused by negative pressure suction can destroy the structural stability of the newly formed tunnel, which conflicts with the mechanical goal of balloon expansion. Under the existing technical framework, any attempt to integrate functions by locally improving a single instrument cannot simultaneously meet safety and effectiveness due to these underlying contradictions, and may even introduce new clinical risks. Therefore, there is an urgent need for a new type of instrument that can fundamentally coordinate multiple target operations and achieve puncture-forming-hemostasis-wound healing integration. SUMMARY

[0005] Therefore, the present application aims to provide a peritoneal dialysis catheter subcutaneous tunnel needle, which realizes accurate puncture and expansion of a subcutaneous tunnel, dynamic and synchronous hemostasis and blood removal, real-time obstacle avoidance of blood vessels and nerves, and intelligent control of intraoperative risks by integrating an axial mechanical shaping unit of an inflatable balloon, a multi-modal coordinated control unit of inflation pressure and negative pressure suction flow, an embedded real-time navigation unit of a light guide, a closed-loop safety protection unit, and a modular human-machine collaborative operation unit, thereby fundamentally solving the systematic problems of low operation efficiency, insufficient hemostasis stability, poor tunnel shaping precision, and high risk of intraoperative tissue damage caused by the contradiction between function and path in the prior art.

[0006] The present application is implemented by the following technical solutions:

[0007] A peritoneal dialysis catheter subcutaneous tunnel needle, comprising a puncture needle body, an inflatable balloon, a diameter adjusting mechanism, a double-channel handle, and a light guide fiber assembly, the puncture needle body is a hollow tubular structure, the tip end thereof is provided with a lateral opening, the inflatable balloon is covered in the middle part of the outer wall of the puncture needle body, the diameter adjusting mechanism is arranged at the tail end of the puncture needle body and communicates with the inflatable balloon, the double-channel handle is fixedly connected to the tail end of the puncture needle body, and the light guide fiber assembly is embedded in the wall of the puncture needle body and extends to the tip end.

[0008] Further, the outer side wall of the double-channel handle is provided with an inflation control valve and a negative pressure control valve, the inflation control valve communicates with the inflation channel to adjust the balloon pressure, and the negative pressure control valve communicates with the negative pressure suction channel to control the suction strength.

[0009] Further, the inflatable balloon is made of medical silica gel material, the outer surface thereof is provided with an anti-skid pattern, and the maximum expansion diameter of the balloon is set by the knob scale of the diameter adjusting mechanism.

[0010] Further, the diameter adjusting mechanism comprises a knob assembly and a limiting clamping groove, the knob assembly is connected to the tail end of the puncture needle body by screw threads, and the limiting clamping groove is distributed along the axial direction of the puncture needle body, the knob is rotated to drive the length of the balloon catheter to change to control the expansion diameter of the balloon.

[0011] Further, the light guide fiber assembly comprises a fiber bundle and a light source interface, the fiber bundle extends to the lateral opening at the tip end along the guide groove pre-set in the wall of the puncture needle body, and the light source interface is arranged at the end of the double-channel handle and connected with an external cold light source.

[0012] Further, a one-way valve is arranged in the catheter of the negative pressure suction channel, the one-way valve allows liquid to flow from the hollow cavity of the puncture needle to the negative pressure interface at the end of the handle.

[0013] Furthermore, the lateral opening edge of the puncture needle body is a blunt arc-shaped structure, and the opening direction is aligned with the illumination area of ​​the optical fiber assembly.

[0014] Furthermore, the inflation pressure threshold of the inflatable balloon is monitored by a pressure sensor on the handle, and the pressure relief valve is automatically triggered when the pressure exceeds the set value.

[0015] The beneficial effects of this invention are as follows:

[0016] This invention integrates the functions of puncture tunnel establishment, controllable balloon expansion, and simultaneous intraoperative hemostasis and hematoma removal, facilitating simultaneous tunnel formation and hemostasis in a single puncture procedure. This significantly shortens surgical time and reduces the risk of tissue damage and contamination due to instrument changes. The built-in real-time visual navigation structure allows surgeons to clearly identify subcutaneous blood vessels and nerve pathways during puncture and expansion, effectively avoiding important tissues and greatly improving surgical safety. The combination of balloon pressure monitoring and automatic adjustment mechanisms enables precise control of the tunnel diameter, avoiding catheter dysfunction or postoperative leakage caused by insufficient or excessive expansion in traditional procedures. The modular collaborative operation design allows surgeons to flexibly adjust operating parameters according to individual patient differences, improving surgical standardization while reducing the surgeon's workload. This provides a safe, efficient, and integrated new solution for peritoneal dialysis catheter implantation. Attached Figure Description

[0017] Figure 1 For the overall assembly structure drawing;

[0018] Figure 2 This is a front view of the overall structure;

[0019] Figure 3 This is a top view of the overall structure;

[0020] Figure 4 A magnified diagram of the puncture needle body without a diameter adjustment mechanism;

[0021] Figure 5 This is a sectional view of the dual-channel handle section;

[0022] Figure 6 This is an enlarged view of the bottom of the diameter adjustment mechanism.

[0023] Explanation of reference numerals in the attached figures:

[0024] 1. Puncture needle body; 101. Lateral opening; 102. Outer wall groove; 103. Sealing ring; 2. Inflatable balloon; 201. Anti-slip texture; 202. Inflation conduit; 3. Diameter adjustment mechanism; 301. Knob assembly; 302. Limiting slot; 303. Slider; 4. Dual-channel handle; 401. Inflation channel; 402. Negative pressure suction channel; 403. Pressure sensor; 5. Optical fiber assembly; 501. Fiber bundle; 502. Light source interface; 503. Annular illumination area; 6. Inflation control valve; 7. Negative pressure control valve; 8. Negative pressure suction device; 9. Thread; 10. One-way valve. Detailed Implementation

[0025] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0026] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0027] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0028] In the above description of the present invention, it should be noted that the terms "one side," "the other side," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of the invention is conventionally placed during use. These terms are used only for the convenience of describing the present invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention. Furthermore, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0029] Furthermore, terms such as "identical" do not imply that components must be absolutely identical; minor differences are permissible. The term "perpendicular" simply means that the positional relationship between components is more perpendicular than "parallel," not that the structure must be perfectly perpendicular; a slight tilt is acceptable.

[0030] like Figures 1-6As shown, one embodiment of the present invention provides a subcutaneous tunneling needle for peritoneal dialysis catheters, comprising a puncture needle body 1, an expandable balloon 2, a diameter adjustment mechanism 3, a dual-channel handle 4, and an optical fiber assembly 5.

[0031] The puncture needle body 1 is a hollow tubular structure made of medical-grade stainless steel. A groove 102 is precisely machined along the circumference of its outer wall, and a medical-grade silicone sealing ring 103 is nested within the groove 102. The inflatable balloon 2 is made of highly elastic medical-grade silicone, and its two ends are fixedly fitted onto the outside of the groove 102 using a heat-sealing process, achieving an airtight seal through the sealing ring 103. The outer surface of the inflatable balloon 2 is integrally formed with anti-slip texture 201 using a laser engraving process. The inflation catheter 202 is made of flexible polyurethane material, with one end connected to the interior of the inflatable balloon 2, and the other end extending to the tail end along a pre-set microchannel within the wall of the puncture needle body 1.

[0032] The diameter adjustment mechanism 3 is screwed to the tail end of the puncture needle body 1 via a precision thread 9. Limiting grooves 302 are evenly distributed along the axial direction of the puncture needle body 1 at 0.5mm intervals on the outer wall of the tail end. The knob assembly 301 has an internal thread that matches the thread 9, and an engineering plastic slider 303 is fixedly installed inside. The slider 303 precisely engages with the limiting groove 302. When the knob assembly 301 is rotated, the slider 303 slides axially along the limiting groove 302, causing a change in the length of the inflation tube 202, thereby precisely adjusting the inflation volume within the inflatable balloon 2.

[0033] The dual-channel handle 4 is fixed to the tail end of the puncture needle body 1 by laser welding. Its interior is divided into an inflation channel 401 and a negative pressure suction channel 402 by a medical-grade stainless steel partition. One end of the inflation channel 401 is connected to the distal end of the inflation catheter 202, and the other end extends to the standard Luer connector at the end of the dual-channel handle 4. One end of the negative pressure suction channel 402 is connected to the hollow cavity of the puncture needle body 1, and the other end extends to the negative pressure interface at the end of the dual-channel handle 4. A medical-grade one-way valve 10 is embedded within the channel, and its flow direction is strictly limited to flow from the hollow cavity of the puncture needle body 1 to the end of the handle.

[0034] An inflation control valve 6 and a negative pressure control valve 7 are respectively installed on the outer wall of the dual-channel handle 4 via precision threads. The inflation control valve 6 is connected to the inflation channel 401, and the negative pressure control valve 7 is connected to the negative pressure suction channel 402. A high-precision pressure sensor 403 is embedded in the inner wall of the inflation channel 401 of the dual-channel handle 4, and its detection end is in direct contact with the gas in the channel to monitor the inflation pressure of the inflatable balloon 2 in real time.

[0035] The fiber bundle 501 of the optical fiber assembly 5 extends along a pre-set guide groove inside the wall of the puncture needle body 1, with its front end extending to the lateral opening 101 and its rear end connected to the light source interface 502. The light source interface 502 is fixed to the end of the dual-channel handle 4 by a medical clip, allowing for quick docking with a standard cold light source. The front end of the fiber bundle 501 forms an annular illumination area 503, whose illumination direction is precisely aligned with the lateral opening 101. The lateral opening 101 is located on the side wall of the tip of the puncture needle body 1, and its edges are specially passivated and polished to form an arc-shaped structure.

[0036] The negative pressure suction device 8 is connected to the negative pressure interface at the end of the dual-channel handle 4 through a medical silicone tubing. After activation, it can aspirate subcutaneous blood through the negative pressure suction channel 402 and the hollow cavity of the puncture needle body 1 from the side opening 101.

[0037] In this embodiment, the light source interface 502 is first connected to the cold light source, and the negative pressure suction device 8 is connected to the negative pressure interface of the dual-channel handle 4 via a flexible tube. Based on the required tunnel diameter for the surgery, the knob assembly 301 is rotated, and the position of the slider 303 in the limiting slot 302 is observed to set the maximum expansion diameter of the inflatable balloon 2. A safety pressure threshold is preset via the pressure sensor 403; if this value is exceeded, the mechanical pressure relief valve inside the dual-channel handle 4 is automatically triggered.

[0038] After confirming that all connections are properly sealed, the operator holds the dual-channel handle 4 and aligns the tip of the puncture needle body 1 with the puncture point. The cold light source is activated, and the fiber optic bundle 501 forms a ring-shaped illumination area 503 to illuminate the subcutaneous tissue. The distribution of blood vessels and nerves can be observed in real time through the lateral opening 101. While slowly advancing the puncture needle body 1, the knob assembly 301 is rotated. The slider 303 slides along the limiting groove 302, pushing the inflation catheter 202 to inflate. The pressure sensor 403 displays the pressure value in real time, and the inflatable balloon 2 gradually inflates. The anti-slip texture 201 on its surface increases tissue friction.

[0039] Open the negative pressure control valve 7 to activate the negative pressure suction device 8. Accumulated blood is drawn in through the negative pressure suction channel 402 from the side opening 101. The one-way valve 10 prevents fluid backflow. During the procedure, continuous observation is conducted through the annular illumination area 503. If the pressure exceeds the threshold, the pressure relief valve automatically opens. After the procedure, rotate the knob assembly 301 counterclockwise to release the gas. Once the balloon has fully contracted, remove the puncture needle body 1. Finally, disassemble all components for sterilization.

[0040] This embodiment integrates inflation and suction functions through a dual-channel handle 4, enabling simultaneous puncture, dilation, hemostasis, and debridement. The diameter adjustment mechanism 3, through the precise cooperation between the limiting slot 302 and the knob assembly 301, ensures that the balloon dilation diameter error is controlled within a minimal range. The annular illumination area 503 provides real-time visual guidance, and the pressure sensor 403 and pressure relief valve constitute a safety protection system. The modular design supports rapid disassembly and sterilization, adapting to different surgical needs.

[0041] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A subcutaneous tunneling needle for peritoneal dialysis catheters, characterized in that: The device includes a puncture needle body, an inflatable balloon, a diameter adjustment mechanism, a dual-channel handle, and an optical fiber assembly. The puncture needle body is a hollow tubular structure with a lateral opening at its tip. The inflatable balloon covers the middle of the outer wall of the puncture needle body. The diameter adjustment mechanism is located at the tail end of the puncture needle body and communicates with the inflatable balloon. The dual-channel handle is fixedly connected to the tail end of the puncture needle body. The optical fiber assembly is embedded in the tubular wall of the puncture needle body and extends to the tip. The dual-channel handle is internally divided into an inflation channel and a negative pressure suction channel. The inflation channel communicates with the inflatable balloon through a conduit, and the negative pressure suction channel communicates with the hollow cavity of the puncture needle body through a conduit.

2. The subcutaneous tunneling needle for peritoneal dialysis catheter according to claim 1, characterized in that: The outer wall of the dual-channel handle is provided with an inflation control valve and a negative pressure control valve. The inflation control valve is connected to the inflation channel to adjust the balloon pressure, and the negative pressure control valve is connected to the negative pressure suction channel to control the suction intensity.

3. The subcutaneous tunneling needle for peritoneal dialysis catheter according to claim 2, characterized in that: The inflatable balloon is made of medical-grade silicone material, with anti-slip texture on its outer surface, and the maximum expansion diameter of the balloon is set by the knob scale of the diameter adjustment mechanism.

4. The subcutaneous tunneling needle for peritoneal dialysis catheter according to claim 3, characterized in that: The diameter adjustment mechanism includes a knob assembly and a limiting groove. The knob assembly is threaded to the tail end of the puncture needle body, and the limiting groove is distributed along the axial direction of the puncture needle body. When the knob is rotated, it drives the length of the balloon catheter to change in order to control the balloon dilation diameter.

5. A subcutaneous tunneling needle for peritoneal dialysis catheters according to claim 4, characterized in that: The optical fiber assembly includes an optical fiber bundle and a light source interface. The optical fiber bundle extends along a pre-set guide groove inside the main body of the puncture needle to the lateral opening at the tip. The light source interface is located at the end of the dual-channel handle and is connected to an external cold light source.

6. A subcutaneous tunneling needle for peritoneal dialysis catheters according to claim 5, characterized in that: The negative pressure suction channel is equipped with a one-way valve inside the conduit, which allows liquid to flow from the hollow cavity of the puncture needle to the negative pressure port at the end of the handle.

7. A subcutaneous tunneling needle for peritoneal dialysis catheters according to claim 6, characterized in that... The lateral opening edge of the puncture needle body is a blunt arc-shaped structure, and the opening direction is aligned with the illumination area of ​​the optical fiber assembly.

8. A subcutaneous tunneling needle for peritoneal dialysis catheters according to claim 7, characterized in that... The inflation pressure threshold of the inflatable balloon is monitored by a pressure sensor on the handle, and the pressure relief valve is automatically triggered when the pressure exceeds the set value.

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