Multifunctional intelligent anti-thrombus PICC (peripherally inserted central catheter) for tumor chemotherapy

Abstract

The invention provides a multifunctional intelligent anti-thrombus PICC (peripherally inserted central catheter) for tumor chemotherapy, which comprises a catheter body, a catheter tip, a main infusion cavity, a first auxiliary cavity and a second auxiliary cavity, and the first auxiliary cavity and the second auxiliary cavity are arranged around the main infusion cavity to form a spiral structure; a micro pressure sensor array is embedded in the pipe wall of the first auxiliary cavity; a biological impedance measuring electrode pair is embedded in the pipe wall of the second auxiliary cavity; and the micro pressure sensor array, the biological impedance measuring electrode pair, the micro ultrasonic transducer and the temperature sensor are connected with a processor. According to the method, active thrombus prevention is achieved, passive treatment is changed into active prevention through a triple mechanism, and the thrombus occurrence rate is greatly reduced; meanwhile, the tube body is formed by mutually winding, fusing and extruding three independent cavities (a main infusion cavity, a first auxiliary cavity and a second auxiliary cavity) like a DNA double helix (triple helix is provided herein); and the mechanical stimulation and damage to the inner wall of the blood vessel are reduced.

Description

Technical Field

[0001] This invention relates to the medical field, specifically to a multifunctional intelligent anti-thrombotic PICC catheter for tumor chemotherapy. Background Technology

[0002] PICC lines are an important channel for cancer patients to undergo long-term intravenous chemotherapy and nutritional support. However, existing PICC catheter technologies have many problems in clinical application:

[0003] 1. High risk of thrombosis: Cancer patients' blood is already in a hypercoagulable state. After the catheter is inserted into the blood vessel as a foreign body, the risk of damage to the inner lining of the blood vessel wall and thrombosis is further increased, especially at the puncture site. Thrombosis can lead to catheter dysfunction, limb swelling, and even fatal complications such as pulmonary embolism.

[0004] 2. Infection issues: Catheter-related bloodstream infection (CRBSI) is another serious complication. Bacteria often invade along the outer wall of the catheter or from the catheter interface, which is especially dangerous for chemotherapy patients with weakened immune function. Summary of the Invention

[0005] The problem to be solved by the present invention is to provide a multifunctional intelligent anti-thrombotic PICC catheter for tumor chemotherapy that effectively reduces thrombosis by combining a sensor with a structure that addresses the above-mentioned shortcomings of the prior art.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: a multifunctional intelligent anti-thrombotic PICC catheter for tumor chemotherapy, comprising a catheter body and a catheter tip, wherein the catheter tip is located at the front end of the catheter body, the catheter body has a multi-lumen structure, including a main infusion lumen, a first secondary lumen and a second secondary lumen, the first secondary lumen and the second secondary lumen being arranged in a spiral structure around the main infusion lumen; a micro pressure sensor array is embedded in the wall of the first secondary lumen; a pair of bioimpedance measurement electrodes is embedded in the wall of the second secondary lumen; a micro ultrasonic transducer and a temperature sensor are integrated in the catheter tip, the catheter body has a built-in communication channel, the built-in lines of the communication channel are connected to the micro pressure sensor array, the bioimpedance measurement electrode pair, the micro ultrasonic transducer and the temperature sensor, and the micro pressure sensor array, the bioimpedance measurement electrode pair, the micro ultrasonic transducer and the temperature sensor are connected to a processor.

[0007] Furthermore, it includes a puncture structure and a conical structure. The puncture structure is used for puncture, and its front end is conical and corresponds to the conical structure. The inner wall of the front end of the puncture structure has a groove. The conical structure is located within the tube channel of the puncture structure. The tail end of the conical structure has a protrusion located within the groove. A spring is wound around the conical structure, and the two ends of the spring are respectively connected to the outer wall of the conical structure and the inner wall of the groove. The puncture structure and the conical structure are respectively provided with a first through hole and a second through hole. When the spring is in its natural state, the first through hole and the second through hole are misaligned and do not correspond. A pair of side ears are provided on opposite sides of the outer wall of the catheter tip. The inner wall of the conical structure has a pair of spirally arranged grooves, and the grooves correspond to the side ears. When the side ears slide out of the grooves, the first through hole and the second through hole correspond exactly.

[0008] Furthermore, the first and second secondary cavities corresponding to the outer wall of the tube protrude outward to form a spiral first and second convex portions, and the first and second convex portions respectively correspond to the two grooves.

[0009] Furthermore, the conical structure has a conduit cavity, which includes a straight cavity and a conical cavity that are interconnected. The conical cavity is connected to the second through hole, and the straight cavity is connected to the tube body channel. The inner wall of the conical cavity is provided with an arc-shaped protrusion corresponding to the second through hole.

[0010] Furthermore, the inner and outer surfaces of the catheter are coated with a composite functional coating, which includes an anticoagulant coating and a pH-responsive polymer gel coating from the inside out, and an antibacterial coating is also coated on the outer surface of the catheter; the pH-responsive polymer gel coating is a polyacrylic acid or cellulose derivative that can produce a swelling response to a specific pH value of the chemotherapy drug.

[0011] Furthermore, it also includes an external host, a display, and an intelligent algorithm module; the external host has a processor that receives and processes signals from the micro pressure sensor array, bioimpedance measurement electrode pair, temperature sensor, and micro ultrasonic transducer; the intelligent algorithm module analyzes multimodal sensing data based on a machine learning model and provides graded early warnings for catheter displacement, thrombosis, and infection risk.

[0012] Furthermore, the intelligent algorithm module identifies the early formation of fibrous sheaths by analyzing the trend changes in bioimpedance values ​​and the morphological characteristics of pressure waveforms.

[0013] Compared with existing technologies, this invention has the following beneficial effects: This invention actively prevents thrombosis by employing a triple mechanism of "anticoagulant coating + impedance / pressure monitoring and early warning + pH buffer protection," transforming passive treatment into active prevention and significantly reducing the incidence of thrombosis. Simultaneously, the tube body is formed by three independent lumens (main infusion lumen, first secondary lumen, and second secondary lumen) intertwined and fused together like a "DNA double helix" (here, a triple helix). This structure is not a simple binding but a one-time integral structure formed during extrusion molding. The helical structure gives the tube body excellent lateral flexibility and longitudinal support, allowing it to conform to the bends and pulsations of blood vessels like a "climbing vine," greatly reducing mechanical stimulation and damage to the vascular endothelium, thereby physically reducing the risk of thrombosis caused by damage to the vascular endothelium. Furthermore, its resistance to collapse is far superior to traditional catheters.

[0014] Other advantages, objectives and features of the present invention will become apparent in part from the following description, and in part from those skilled in the art through study and practice of the invention. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the structure of a multifunctional intelligent anti-thrombotic PICC catheter used for tumor chemotherapy.

[0016] Figure 2 This is a schematic diagram of a multifunctional intelligent anti-thrombotic PICC catheter module used for tumor chemotherapy.

[0017] Figure 3 This is a schematic diagram of the tube structure.

[0018] Figure 4 This is a cross-sectional view of the conical structure. Detailed Implementation

[0019] To make the technical means, creative features, objectives, and effects of this invention clearer and easier to understand, the invention will be further described below in conjunction with the accompanying drawings and specific embodiments:

[0020] This invention proposes a multifunctional intelligent anti-thrombotic PICC catheter for tumor chemotherapy, comprising a catheter body 1 and a catheter tip 2, wherein the catheter tip 2 is located at the front end of the catheter body 1. The catheter body 1 has a multi-lumen structure, including a main infusion lumen 11, a first secondary lumen 12, and a second secondary lumen 13, which are arranged in a spiral structure around the main infusion lumen 11. The wall of the first secondary lumen 12 is embedded with a miniature pressure sensor array 121. The wall of the second secondary lumen 13 is embedded with a pair of bioimpedance measurement electrodes 131. The catheter tip 2 integrates a miniature ultrasonic transducer 21 and a temperature sensor 22. The catheter body 1 has a built-in communication channel, and the built-in circuit of the communication channel is connected to the miniature pressure sensors. The micro-pressure sensor array 121, bioimpedance measurement electrode pair 131, micro-ultrasound transducer 21, and temperature sensor 22 are connected to processor 3. The micro-ultrasound transducer (21) is integrated at the foremost tip of the catheter tip 2 and is used to transmit and receive micro-ultrasound signals during catheter placement. It works with an external host to realize real-time intracavitary ultrasound navigation and positioning, replacing frequent X-ray confirmation. The temperature sensor (22) monitors the local blood temperature at the catheter tip 2. Abnormal temperature rise is an important early sign of infection. At the same time, an anti-reflux valve is added to the catheter tip 2 and placed at the infusion port of the tube body 1 to prevent blood reflux and reduce the risk of tube blockage.

[0021] When the liquid flows in the spiral channel, it generates a slight eddy effect. This effect can more effectively flush the catheter tip 2 and sidewalls, disrupt the stagnant blood flow in the "boundary layer", prevent the deposition and adhesion of blood components, and achieve "active fluid anti-clogging catheter".

[0022] The device includes a puncture structure 4 and a conical structure 5. The puncture structure 4 is used to leave a 2cm-5cm long section at the puncture site after puncturing the skin. The puncture structure 4 is used for puncture, and its front end is conical, corresponding to the conical structure 5. The inner wall of the front end of the puncture structure 4 has a groove 41. The conical structure 5 is located within the tube channel 43 of the puncture structure 4. The tail end of the conical structure 5 has a protrusion 21 located within the groove 41. A spring 6 is wound around the conical structure 5, and the two ends of the spring 6 are respectively connected to the outer wall of the conical structure 5 and the inner wall of the groove 41. The puncture structure 4 and the conical structure 5 are respectively provided with a first through hole 42 and a second through hole 52. When the spring 6 is in its natural state, the first through hole 42 and the second through hole 52 are misaligned and do not correspond. To achieve double air isolation and prevent thrombosis, a pair of side ears 23 are provided on opposite sides of the outer wall of the catheter tip 2. A pair of spirally arranged grooves 54 are provided on the inner wall of the conical structure 5. The grooves 54 correspond to the side ears 23. When the side ears 23 slide out of the grooves, the first through hole 42 and the second through hole 52 are exactly aligned. The length and width of the side ears 23 are less than or equal to the diameter of the grooves. When the spring 6 is in its natural state, it causes the first through hole 42 and the second through hole 52 to be misaligned, thereby preventing blood clots from forming and blocking the puncture structure 4 during puncture. It can only be used when in use. The spring 6 also has the function of increasing the resistance of the tube body 1 when it passes through the first through hole 42, thus preventing injury to the patient due to excessively rapid entry into the body.

[0023] In use: When the tube body 1 extends from the tube body channel 43 of the puncture structure 4 and passes through the catheter lumen 54 of the conical structure 5, the side ear 23 drives the conical structure 5 to rotate, so that the second through hole 52 slowly aligns with the first through hole 42 until they are connected. At this time, the side ear 23 leaves the groove, and then the catheter tip 2 just passes through the first through hole 42 and the second through hole 52.

[0024] The maximum inner diameter of the chute 41 is greater than the inner diameter of the pipe channel 43, and the inner diameter of the pipe channel 43 is less than the minimum inner diameter of the chute 41.

[0025] The first secondary cavity 12 and the second secondary cavity 13 corresponding to the outer wall of the tube body 1 protrude outward to form a spiral first convex part 14 and a spiral second convex part 15. The first convex part 14 and the second convex part 15 correspond to the two grooves 54 respectively. When the distance between the front end of the first convex part 14 and the second convex part 15 and the side ear 23 is greater than or equal to the length of the conical structure 5, the first convex part 14 and the second convex part 15 move exactly to the groove 54 or a distance of 1 to 2 cm when the tip of the catheter 2 passes through the first through hole 42. The tube body 1 is advanced by rotating in the spiral direction. When the designated position is reached, the tube body 1 is rotated in the opposite direction so that the first convex part 14 and the second convex part 15 are press-fitted with the inner wall of the conical structure 5, which also helps to lock the tube body 1.

[0026] To facilitate the smooth entry of the catheter tip 2 of the tube body 1 into the second through hole 52, the tapered structure 5 has a catheter cavity 54, which includes a straight cavity and a tapered cavity that are interconnected. The tapered cavity is connected to the second through hole 52, and the straight cavity is connected to the tube body channel 43. The inner wall of the tapered cavity is provided with an arc-shaped protrusion 53 that corresponds to the second through hole 52. When the catheter tip 2 moves to the arc-shaped protrusion 53, the upward orientation changes and corresponds to the second through hole 52. At the same time, since the first through hole 42 and the second through hole 52 correspond, the horizontal corresponding distance is actually increased, so that the tube body 1 after passing through the first through hole 42 and the second through hole 52 can move forward horizontally.

[0027] The inner and outer surfaces of the catheter are coated with a composite functional coating, which includes an anticoagulant coating and a pH-responsive polymer gel coating from the inside out. The outer surface of the catheter is also coated with an antibacterial coating. The pH-responsive polymer gel coating 33 is a polyacrylic acid or cellulose derivative that can swell in response to the specific pH value of the chemotherapy drug. The outer surface of the tube body 1 is coated with an antibacterial coating (such as chlorhexidine or silver ion coating). Both the inner and outer surfaces of the tube body 1 are coated with an anticoagulant coating (such as heparin or hirudin derivative coating). In addition to the anticoagulant coating, there is also a pH-responsive polymer gel coating. When the chemotherapy drug (usually with a specific pH value) flows through, the gel layer will swell slightly, dynamically adjusting the drug release rate and buffering the blood vessel wall, reducing the stimulation of the vascular endothelium by the chemotherapy drug.

[0028] It also includes an external host, a display, and an intelligent algorithm module 203; the external host has a processor 3 that receives and processes signals from the miniature pressure sensor array 121, the bioimpedance measurement electrode pair 131, the temperature sensor 22, and the miniature ultrasonic transducer 21; the intelligent algorithm module 203 analyzes multimodal sensor data based on a machine learning model and provides graded warnings for catheter displacement, thrombosis, and infection risk; the external host is used to process signals from various sensors inside the catheter 1; the handheld terminal / display allows medical staff to view data in real time; the intelligent algorithm module 203 has a built-in machine learning-based algorithm that continuously learns the pressure, impedance, and temperature data patterns under normal conditions; when the monitoring data deviates abnormally, the system can immediately issue graded alarms (such as yellow warnings and red warnings) through the display, indicating the types of complications that may occur (such as "apex adhesion warning", "suspected fibrin sheath formation", "increased infection risk"), thereby achieving early detection and intervention of complications; the intelligent algorithm module 203 identifies the early formation of fibrin sheaths by analyzing the trend changes in bioimpedance values ​​and the morphological characteristics of pressure waveforms.

[0029] 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 multifunctional intelligent anti-thrombotic PICC catheter for tumor chemotherapy, characterized in that: The device includes a tube body (1) and a catheter tip (2), the catheter tip (2) being located at the front end of the tube body (1). The tube body (1) has a multi-lumen structure, including a main infusion lumen (11), a first secondary lumen (12), and a second secondary lumen (13). The first secondary lumen (12) and the second secondary lumen (13) are arranged in a spiral structure around the main infusion lumen (11). The wall of the first secondary lumen (12) is embedded with a micro pressure sensor array (121); the wall of the second secondary lumen (13) is embedded with a pair of bioimpedance measurement electrodes (131). The catheter tip (2) integrates a miniature ultrasonic transducer (21) and a temperature sensor (22). The tube body (1) has a built-in communication channel. The built-in lines of the communication channel connect the miniature pressure sensor array (121), the bioimpedance measurement electrode pair (131), the miniature ultrasonic transducer (21), and the temperature sensor (22). The miniature pressure sensor array (121), the bioimpedance measurement electrode pair (131), the miniature ultrasonic transducer (21), and the temperature sensor (22) are connected to the processor (3).

2. The multifunctional intelligent anti-thrombotic PICC catheter for tumor chemotherapy according to claim 1, characterized in that: The device includes a puncture structure (4) and a conical structure (5). The puncture structure (4) is used for puncture. The front end of the puncture structure (4) is conical and corresponds to the conical structure (5). The inner wall of the front end of the puncture structure (4) has a groove (41). The conical structure (5) is located in the tube channel (43) of the puncture structure (4). The tail end of the conical structure (5) has a protrusion (21) located in the groove (41). A spring (6) is wound around the conical structure (5). The two ends of the spring (6) are respectively connected to the outer wall of the conical structure (5) and the groove (41). The inner wall of the puncture structure (4) and the conical structure (5) are respectively provided with a first through hole (42) and a second through hole (52); when the spring (6) is in its natural state, the first through hole (42) and the second through hole (52) are misaligned and do not correspond; a pair of side ears (23) are provided on opposite sides of the outer wall of the catheter tip (2); a pair of spirally arranged grooves (54) are provided on the inner wall of the conical structure (5); the grooves (54) correspond to the side ears (23); when the side ears (23) pass through the grooves (54) until they slide out, the first through hole (42) and the second through hole (52) correspond exactly to each other.

3. The multifunctional intelligent anti-thrombotic PICC catheter for tumor chemotherapy according to claim 2, characterized in that: The first secondary cavity (12) and the second secondary cavity (13) corresponding to the outer wall of the tube body (1) protrude outward to form a spiral first convex part (14) and a spiral second convex part (15), and the first convex part (14) and the second convex part (15) respectively correspond to the two grooves (54).

4. The multifunctional intelligent anti-thrombotic PICC catheter for tumor chemotherapy according to claim 2, characterized in that: The conical structure (5) has a conduit cavity (54), which includes a straight cavity and a conical cavity that are interconnected. The conical cavity is connected to the second through hole (52), and the straight cavity is connected to the tube body channel (43). The inner wall of the conical cavity is provided with an arc-shaped protrusion (53) corresponding to the second through hole (52).

5. The multifunctional intelligent anti-thrombotic PICC catheter for tumor chemotherapy according to claim 1, characterized in that: The inner and outer surfaces of the catheter are coated with a composite functional coating, which includes an anticoagulant coating and a pH-responsive polymer gel coating from the inside out. The outer surface of the catheter is also coated with an antibacterial coating. The pH-responsive polymer gel coating (33) is a polyacrylic acid or cellulose derivative that can produce a swelling response to a specific pH value of the chemotherapy drug.

6. The multifunctional intelligent anti-thrombotic PICC catheter for tumor chemotherapy according to claim 1, characterized in that: It also includes an external host, a display and an intelligent algorithm module (203); the external host has a processor (3) that receives and processes signals from the micro pressure sensor array (121), the bioimpedance measurement electrode pair (131), the temperature sensor (22) and the micro ultrasonic transducer (21); the intelligent algorithm module (203) analyzes multimodal sensing data based on a machine learning model and provides graded early warnings for catheter displacement, thrombosis and infection risk.

7. The multifunctional intelligent anti-thrombotic PICC catheter for tumor chemotherapy according to claim 6, characterized in that: The intelligent algorithm module (203) identifies the early formation of fibrous sheath by analyzing the trend changes in bioimpedance values ​​and the morphological characteristics of pressure waveforms.

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