Central venous catheter and venous infusion port

Abstract

The present application relates to a kind of central venous catheter and intravenous infusion port, comprising: catheter main body, comprising: drug infusion lumen and annular electrode layer;Annular electrode array is embedded in annular electrode layer, is connected to external control unit by wire, external control unit can output pulsed radio frequency energy to annular electrode array, pulsed radio frequency energy can be used to ablate the protein sheath formed on the outer wall of the catheter main body;Venturi section, comprising: infusion channel and adsorption hole, infusion channel is communicated with the drug infusion lumen of catheter main body, the cross-sectional area of infusion channel gradually reduces along the direction of drug delivery and forms tapered structure, adsorption hole is communicated with outside through electrode layer, along infusion channel and enter liquid medicine or cleaning fluid, negative pressure is generated at adsorption hole and can suck the protein sheath ablated by annular electrode array.The central venous catheter and intravenous infusion port of the present application effectively solve the problems of protein sheath accumulation and difficult to remove encountered in long-term use of central venous catheter.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical equipment, in particular to a central venous catheter and a venous infusion port. BACKGROUND

[0002] As an important blood vessel access tool in clinic, central venous catheter (CVC) is widely used in chemotherapy, parenteral nutrition and long-term infusion treatment of critically ill patients. However, the catheter as a foreign body is left in the blood vessel for a long time, which can cause endothelial injury and inflammatory reaction in the blood vessel, resulting in gradual deposition of fibrin on the outer wall of the catheter to form a fibrin sheath wrapping the catheter. Studies have shown that the incidence of protein sheath is more than 60% after 7 days of catheter indwelling, and nearly 100% after 30 days. The protein sheath not only hinders the infusion of liquid medicine (causing catheter dysfunction), but also can become the core of thrombosis, increasing the risk of serious complications such as pulmonary embolism and catheter-related bloodstream infection (CRBSI).

[0003] At present, the clinical treatment methods for protein sheath have significant limitations:

[0004] 1. Thrombolytic drug infusion: thrombolytic agents such as urokinase are injected through the catheter, but only effective for early loose protein sheath, and may cause bleeding risk;

[0005] 2. Mechanical removal procedure: balloon dilation or grabbing device, for example: Chinese invention patent with publication number CN112168338B and invention name "Intracavitary ablation device", discloses a technical solution to eliminate and capture the protein sheath, but the operation of this solution is complex and increases the risk of blood vessel injury and infection.

[0006] The above prior art also has the following defects:

[0007] High intervention dependence: additional instruments are needed for removal, which cannot achieve in-situ treatment of the catheter;

[0008] Lack of real-time monitoring: unable to intervene at the early stage of protein sheath formation, and passively deal with catheter failure;

[0009] Single function: the existing design focuses on the single link of prevention or removal, and does not form a closed loop of "monitoring-removal-protection". SUMMARY

[0010] Therefore, the technical problem to be solved by the present application is to overcome the problem of difficult removal of protein sheath outside the venous catheter in the prior art, and to provide a central venous catheter, which effectively solves the problems of protein sheath accumulation and difficult removal of the central venous catheter in long-term use by combining the structure design of the ring electrode array and the Venturi tube section.

[0011] To solve the above technical problems, the application provides a central venous catheter, which comprises:

[0012] A catheter body, comprising a drug infusion lumen and a ring-shaped electrode layer arranged around the drug infusion lumen;

[0013] A ring-shaped electrode array embedded in the ring-shaped electrode layer, the ring-shaped electrode array being connected to an external control unit through a wire, the external control unit being capable of outputting pulsed radio frequency energy to the ring-shaped electrode array, the pulsed radio frequency energy being capable of being used to ablate a protein sheath formed on the outer wall of the catheter body;

[0014] A Venturi tube section, comprising a liquid infusion channel and a suction hole opened in the side wall of the liquid infusion channel, the liquid infusion channel being in communication with the drug infusion lumen of the catheter body, the cross-sectional area of the liquid infusion channel gradually decreasing along the drug delivery direction to form a tapered structure, the suction hole being in communication with the outside through the electrode layer, and the liquid infusion channel being filled with liquid or cleaning liquid, and the suction hole being capable of inhaling the protein sheath ablated by the ring-shaped electrode array due to the negative pressure generated at the suction hole.

[0015] In an embodiment of the application, the ring-shaped electrode array comprises a plurality of ring-shaped electrodes arranged along the extension direction of the catheter body, and the plurality of ring-shaped electrodes are arranged at equal intervals.

[0016] In an embodiment of the application, the ring-shaped periphery of the ring-shaped electrode is provided with a grid-shaped energy release hole.

[0017] In an embodiment of the application, the external control unit comprises:

[0018] An impedance analysis module capable of measuring the alternating current impedance value between two adjacent ring-shaped electrodes in the ring-shaped electrode array, and calculating the thickness of the protein sheath according to the change rate of the impedance value;

[0019] An energy adjustment module capable of dynamically adjusting the radio frequency output power according to the change rate of the impedance value, and the greater the change rate of the impedance value, the higher the radio frequency output power.

[0020] In an embodiment of the application, the Venturi tube section is integrally formed with the catheter body.

[0021] In an embodiment of the application, a plurality of Venturi tube sections are arranged along the extension direction of the catheter body, the suction holes of the plurality of Venturi tube sections being distributed in a spiral shape around the catheter body, and the plurality of suction holes cooperating to form a ring-shaped vortex suction effect.

[0022] In an embodiment of the application, a bionic one-way valve diaphragm is arranged in the suction hole.

[0023] In one embodiment of the present application, two adhered one-way diaphragms are arranged at the port of the catheter body, the two one-way diaphragms are closed at the ends to block the port of the catheter body, and when the drug solution or the flushing solution is injected into the catheter body, the two one-way diaphragms are separated to form a one-way injection port.

[0024] In one embodiment of the present application, an anti-adhesion coating is further coated on the outer surface of the catheter body.

[0025] To solve the above technical problems, the present application further provides a venous infusion port, comprising the central venous catheter, and further comprising a port seat in communication with the proximal end of the catheter body, and the external control unit is arranged in the port seat, and the drug solution and the cleaning solution can be delivered to the central venous catheter through the port seat.

[0026] The above technical solutions of the present application have the following advantages compared with the prior art:

[0027] The central venous catheter of the present application utilizes the annular electrode array to output pulsed radio frequency energy, which can effectively ablate the protein sheath on the outer wall of the catheter, prevent the accumulation of the protein sheath, and utilize the fluid dynamics principle of the Venturi tube segment to generate negative pressure at the adsorption hole to suck and remove the ablated protein sheath residues;

[0028] Compared with the prior art which needs to intervene additional removal mechanism, the present application integrates the annular electrode array in the catheter body, so that the catheter body has the function of ablating the protein sheath, the structure of the catheter body is simpler, can be applied to thinner intravenous injection, reduces the frequency of manual cleaning or replacement, and reduces the maintenance cost; the ablation and adsorption functions are combined by utilizing the Venturi effect, which avoids the potential harm of the ablated residues to the surrounding tissues, the negative pressure adsorption mechanism ensures the cleanliness of the catheter surface, and reduces the risk of infection and thrombosis. BRIEF DESCRIPTION OF DRAWINGS

[0029] In order to make the content of the present application more easily understood, the present application will be further described in detail below according to specific embodiments of the present application and in conjunction with the drawings, in which:

[0030] Figure 1 is a schematic diagram of the overall structure of the central venous catheter of the present application;

[0031] Figure 2 is a schematic diagram of the partial cross-sectional structure of the central venous catheter of the present application;

[0032] Figure 3 is an ablation control flowchart of the present application;

[0033] Figure 4 is a schematic diagram of the structure of the vortex adsorption formed by the cooperation of the multi-segment Venturi tube segment of the present application;

[0034] Figure 5 is a structural schematic diagram of a one-way membrane at a port of a catheter body of the present application;

[0035] Figure 6 is a structural schematic diagram of a venous infusion port of the present application.

[0036] Description of the Drawings: 100, catheter body; 110, drug infusion lumen; 120, ring electrode layer; 130, anti-adhesion coating; 200, ring electrode array; 300, Venturi tube segment; 310, infusion channel; 320, adsorption hole; 400, one-way membrane; 500, port seat. DETAILED DESCRIPTION

[0037] The present application will be further described below in conjunction with the drawings and specific examples, so that those skilled in the art can better understand the present application and implement it, but the examples are not limiting of the present application.

[0038] Example 1:

[0039] Referring to Figure 1 and Figure 2 , the present application discloses a central venous catheter, which is long-term retained in a venous blood vessel and used for infusion treatment, comprising: a catheter body 100, a ring electrode array 200, and a Venturi tube segment 300.

[0040] Wherein: the catheter body 100 comprises: a drug infusion lumen 110 and a ring electrode layer 120 arranged around the drug infusion lumen 110, the drug infusion lumen 110 serves as a core infusion channel for delivering drug solution, nutrient solution or cleaning solution, and its smooth inner wall design (such as polyurethane material) ensures that the fluid resistance is minimized to avoid drug solution residue; the ring electrode layer 120 serves as a carrier of the ring electrode array 200, which can be the pipe wall of the catheter body 100 or a layer structure wrapped outside the catheter body 100, and its purpose is to form a separate closed space for carrying the ring electrode array 200 to prevent the ring electrode array 200 from contacting the liquid in the drug infusion lumen 110, the catheter body 100 needs to be retained in the venous blood vessel when in use, and the overall diameter of the catheter body 100 needs to be determined according to the diameter of the venous blood vessel at different positions and needs to be smaller than the diameter of the venous blood vessel at the retention position;

[0041] The annular electrode array 200 is embedded in the annular electrode layer 120, and the annular electrode array 200 is connected to an external control unit by a wire, the external control unit can output pulsed radio frequency energy to the annular electrode array 200, which can be used to ablate the protein sheath formed on the outer wall of the catheter body 100; in this embodiment, pulsed radio frequency energy is used, for example: according to the needs, high frequency (300-500 kHz), short pulse width (10-100 ms) pulse mode is used, and protein sheath is selectively ablated by Joule heating effect, radio frequency energy is released in the form of pulse, which avoids damage to surrounding tissues caused by continuous heating, and at the same time ensures enough energy to decompose protein molecular chain, achieves the effect of ablation of protein sheath, and also can avoid continuous high temperature damage to vascular endothelium, and in actual use, the ability to dynamically adjust the radio frequency output power improves the safety and avoids the risk of excessive heating;

[0042] The Venturi tube section 300 includes a liquid delivery channel 310 and an adsorption hole 320 opened in the side wall of the liquid delivery channel 310, the liquid delivery channel 310 communicates with the drug infusion lumen 110 of the catheter body 100, and the cross-sectional area of the liquid delivery channel 310 gradually decreases along the drug delivery direction to form a tapered structure, and the adsorption hole 320 penetrates the electrode layer and communicates with the outside, the tapered structure of the liquid delivery channel 310 can increase the flow rate of the passing liquid, according to Bernoulli's principle, the flow rate increases, and the pressure decreases, thereby forming a local negative pressure at the adsorption hole 320, and the protein sheath residue after ablation is sucked into and removed;

[0043] In actual use, the position of the Venturi tube section 300 corresponds to the ablation area of the annular electrode array 200, and the liquid or cleaning liquid is introduced along the liquid delivery channel 310, and the adsorption hole 320 generates negative pressure to suck the protein sheath ablated by the annular electrode array 200, and circulates into the body with the liquid or cleaning liquid, avoiding deposition on the outside of the catheter, whether the central venous catheter is used to input liquid or is cleaned after long-term retention, the fluid mechanics principle can be used to realize the automatic cleaning function of the protein sheath, without the need for additional equipment, reducing the maintenance cost, and the negative pressure adsorption mechanism ensures the cleanliness of the catheter surface, reducing the risk of infection and thrombosis.

[0044] The central venous catheter disclosed in the embodiment does not increase additional structural features compared with ordinary central venous catheters, the annular electrode array 200 is integrated in the catheter body 100, and the size of the catheter body 100 itself is not changed, so that the central venous catheter is suitable for a thinner intravenous injection scene, widens the clinical application range, and the annular electrode array 200 is arranged to be responsible for ablation of the protein sheath, and the Venturi tube section 300 is responsible for removing the residues after ablation, and the two work together to form a closed loop system of "ablation-removal", from passive response to active prevention, intervention at the initial stage of the protein sheath formation, this design not only solves the problem of protein sheath accumulation, but also avoids the potential harm of residues to the surrounding tissue, and significantly improves the safety and reliability of the catheter use.

[0045] In actual clinical application, the central venous catheter is particularly suitable for special groups such as chemotherapy patients, critically ill patients, and neonatal and pediatric patients, and can solve the following problems:

[0046] 1. Breakthrough solution to in-situ protein sheath removal problem, through the cooperation of electrode ablation and Venturi adsorption, the catheter realizes in-situ self-cleaning, and experiments have verified that the removal efficiency is improved by more than 80%;

[0047] 2. Reduce catheter-related complications, protein sheath is the core inducement of catheter blockage, thrombosis and infection, the present application ablates in real time to prevent protein sheath thickening, the catheter patency rate is increased to 95% (traditional catheter is only 60%), and the negative pressure adsorption reduces the residue of fragments, and the catheter-related infection rate is reduced;

[0048] 3. Prolong the service life of the catheter and simplify the maintenance, the traditional catheter needs to be replaced frequently (average 3-6 months) due to protein sheath accumulation, the self-cleaning function makes the central venous catheter of the embodiment to be left for more than 12 months, and the injection of cleaning fluid and ablation operation can be completed through the port, without surgical intervention.

[0049] 4. Efficient design of fluid and energy cooperation, the Venturi effect utilizes the kinetic energy of infusion to convert into adsorption force, without additional energy consumption, and the pulse radio frequency is only directed to the protein sheath, protecting normal tissues.

[0050] Specifically, in clinical observation, it is found that the catheter long-term residing in the vein vessel will be coated with a layer of protein sheath along its extension direction, therefore, when the ring electrode array 200 is arranged in the present application, it is required to cover the entire catheter body 100 as much as possible along the axial extension direction. In order to solve this problem, in the present embodiment, the ring electrode array 200 comprises a plurality of ring electrodes arranged along the extension direction of the catheter body 100. By arranging a plurality of electrodes longitudinally, a larger range of the outer wall of the catheter body 100 is covered, and the blind area of ablation caused by the position deviation of a single electrode is avoided. This design can adapt to different blood vessel bending shapes, ensure the continuity of energy coverage, avoid incomplete ablation, improve the ablation efficiency and coverage range, and reduce the risk of local overheating or uneven ablation.

[0051] In addition, when the ring electrode is actually arranged, a plurality of ring electrodes are arranged at equal intervals, and uniform distribution of the energy field is realized through a fixed interval (for example, 2-5 mm), so as to prevent local energy from being too high (tissue damage) or too low (incomplete ablation) during the ablation of the protein sheath. The interval design is optimized based on the typical thickness (50-200 pm) of the protein deposition on the inner wall of the blood vessel, and the efficiency and safety are taken into account.

[0052] In the present embodiment, the ring-shaped outer periphery of the ring electrode is provided with a grid-shaped energy release hole. The grid-shaped energy release hole uniformly distributes the radio frequency energy on the outer periphery of the ring electrode, so as to ensure that the energy can act on the protein sheath on the outer wall of the catheter in a more accurate manner. Compared with the traditional electrode sheet which releases energy to a certain area, the grid-shaped design enhances the controllability of energy release, reduces unnecessary energy waste, and reduces the risk of thermal damage to the surrounding tissue.

[0053] In actual application, the grid-shaped energy release hole has a pore size of 50-200 pm. By limiting the pore size range, the size of the local focal point of energy release is accurately controlled. The pore size of 50-200 pm can not only disperse the energy density (avoid burning the endothelium of the blood vessel), but also ensure a sufficient energy coverage area (improve the ablation efficiency of the protein sheath). A pore size less than 50 pm may cause excessive energy focusing (risk of thermal damage), and a pore size greater than 200 pm may reduce the energy transmission efficiency (incomplete ablation). The grid-shaped energy release hole has a hole density of 5-20 per square millimeter, which optimizes the uniformity and continuity of the energy field. Among them, the high-density hole (20 per mm2) is suitable for removing the protein layer in the complex blood vessel bending area, and the low-density hole (5 per mm2) is suitable for efficient ablation of the straight pipe section.

[0054] The equidistant distribution of the plurality of annular electrodes ensures comprehensive coverage of the ablation range, and the grid-shaped energy release holes optimize the energy release mode of each electrode, which together realize efficient and safe protein sheath removal function, and in the embodiment, through the optimized arrangement and structural improvement of the electrodes, the design goal of compact structure and function integration is realized, the problems of inconvenient operation and increased manufacturing cost caused by the complex structure of the traditional catheter are avoided, the operation process is simplified, and the reliability and convenience of the system are improved, which provides a more efficient solution for clinical application.

[0055] The traditional technology lacks real-time monitoring capability for protein sheath formation, and often only when the catheter function is significantly reduced can the problem be found, and then whether there is a protein sheath is determined through image analysis, and then elimination is performed, and in the embodiment, in order to ablate the protein sheath, the annular electrode array 200 has been implanted in the catheter main body 100, and the inventor wants to use the annular electrode array 200 to realize detection of the protein sheath, and in order to realize this detection method, the central venous catheter of the embodiment is further extended.

[0056] The inventor finds through experiments that the change of the impedance value is closely related to the formation of the protein sheath, and as the protein sheath thickens, the impedance value gradually increases, and by using this finding, the inventor improves the central venous catheter, and the external control unit further comprises an impedance analysis module, which can measure the alternating current impedance value between two adjacent annular electrodes in the annular electrode array 200, and according to the change rate of the impedance value, the thickness of the protein sheath can be calculated, that is, when there is no protein sheath formation initially, the impedance between the two annular electrodes is a fixed value, and when the fixed value changes, it indicates that a protein sheath is formed, and through this method, real-time monitoring of the thickness of the protein sheath can be realized, problems can be found in the early stage and measures can be taken, and the occurrence of catheter dysfunction can be avoided.

[0057] On the basis of the above detection, the inventor believes that only detecting whether a protein sheath is formed cannot solve the actual technical problem, and the key lies in ablation after detection, and fixed-power radio frequency ablation may cause problems of insufficient ablation or excessive heating, which affects the ablation effect and safety, and therefore, the inventor further improves the central venous catheter, and the external control unit further comprises an energy adjustment module, and the external control unit further comprises dynamic adjustment of radio frequency output power according to the change rate of the impedance value, and the greater the impedance change rate, the thicker the protein sheath, and higher radio frequency output power is required for ablation, and by dynamically adjusting the radio frequency output power, it is ensured that the ablation process is efficient and safe, and thermal damage to the surrounding tissues is avoided.

[0058] Referring to Figure 3 The protein sheath detection and ablation process of the present application by using the impedance analysis module and the energy adjustment module is as follows:

[0059] S1, initial state monitoring

[0060] In the initial stage of catheter implantation or use, the impedance analysis module measures the initial alternating current impedance value Z0 between two adjacent ring electrodes in the ring electrode array 200; this initial impedance value Z0 is the standard reference value when the catheter outer wall does not form a protein sheath, and this value is stored as baseline data for subsequent comparison with real-time impedance values to determine whether a protein sheath is beginning to form.

[0061] S2, real-time impedance detection

[0062] As the catheter is used for a long time, proteins in the blood may gradually deposit on the catheter outer wall to form a protein sheath. The impedance analysis module continuously monitors the real-time impedance value Z t between two adjacent ring electrodes; if the protein sheath gradually thickens, the impedance value Z t of the catheter outer wall will increase accordingly, and by comparing the difference between Z0 and Z t , the impedance change Z0-Z t is calculated; the formation of the protein sheath is detected in real time, and the thickness of the protein sheath is evaluated by the impedance change; when the impedance change rate reaches a preset threshold, the system triggers an alarm to prompt ablation treatment.

[0063] S3, dynamic power calculation

[0064] According to the impedance change rate, the energy adjustment module dynamically calculates the radio frequency output power by the formula, the greater the impedance change rate, the thicker the protein sheath, and a higher radio frequency output power P is calculated to ensure complete ablation; the radio frequency output power is dynamically adjusted to ensure that the ablation process is efficient and safe, avoiding the problems of insufficient ablation or excessive heating caused by fixed power.

[0065] S4, radio frequency ablation start

[0066] The external control unit outputs pulsed radio frequency energy to the ring electrode array 200 according to the calculated radio frequency output power P, and the ring electrode array 200 releases the radio frequency energy in the form of pulses to the catheter outer wall after receiving the radio frequency energy, and ablates the protein sheath.

[0067] S5, negative pressure generated by adsorption

[0068] At the same time or after radio frequency ablation, the adsorption holes 320 of the Venturi tube section 300 generate negative pressure by using the principle of fluid mechanics to suck and remove the ablated protein sheath residues.

[0069] S6, return to normal operation

[0070] After ablation and removal are completed, the impedance analysis module re-measures the impedance value Zt If Z t When the initial value Z0 is approached, it indicates that the protein sheath has been effectively removed, and the catheter returns to the normal working state. The impedance value is continuously monitored in real time, and the next cycle is entered.

[0071] Specifically, according to the above steps S1-S6, the entire process from examination to ablation is intelligently and dynamically controlled in a closed loop. The protein sheath thickness is monitored in real time by the impedance analysis module, and the radio frequency output power is dynamically adjusted by the energy regulation module to ensure efficient and safe ablation.

[0072] In actual preparation of the central venous catheter of the present application, considering the complexity of the process and the sealing problem of the connecting part, in this embodiment, the Venturi tube segment 300 is combined with the catheter body 100 in one body by an integral molding process, which can be quickly realized by die stamping technology, avoiding the leakage or looseness problem of the connecting part that may be caused by the traditional split design, improving the stability and reliability of the overall structure, and reducing the complexity in the manufacturing and assembly process.

[0073] As mentioned earlier, the catheter that stays in the vein for a long time will be covered with a layer of protein sheath along its extension direction, therefore, a single Venturi tube segment 300 can only handle the residue in the local area, and cannot achieve full coverage of adsorption. In order to solve this problem, a plurality of Venturi tube segments 300 are arranged along the extension direction of the catheter body 100, each of which is arranged between two adjacent ring electrodes, ensuring that the protein sheath after ablation by the ring electrodes can be sucked into the Venturi tube segment 300, improving the adsorption efficiency and coverage, and ensuring the cleanliness of the catheter surface.

[0074] Moreover, as can be seen from the above analysis, the protein sheath is circumferentially wrapped around the outer periphery of the catheter body 100, therefore, the adsorption holes 320 of the Venturi tube segment 300 arranged in a single direction cannot achieve full coverage of adsorption. In order to solve this problem, referring to Figure 4 As shown, the adsorption holes 320 of the plurality of Venturi tube segments 300 are arranged in a spiral around the catheter body 100, and the plurality of adsorption holes 320 cooperate to form a ring vortex adsorption effect around the catheter body 100. This design utilizes the principle of fluid mechanics to generate stronger negative pressure at the adsorption holes 320, enhancing the adsorption capacity.

[0075] It is well known that the central venous catheter is used in the central vein blood vessel, and therefore, in practical application, the one-way flow problem of the central venous catheter also needs to be considered, that is, only the external liquid medicine or cleaning liquid (normal saline) can be ensured to enter the blood from the outside through the central venous catheter, and the blood cannot flow out of the central venous catheter. In this embodiment, in order to solve this problem, the port of the catheter body 100 and the adsorption hole 320 of the Venturi tube need to be sealed in one direction, and the sealing mode of the present application will be described in detail below.

[0076] Specifically, in order to realize the one-way sealing of the adsorption hole 320, in this embodiment, a bionic one-way valve diaphragm is arranged in the adsorption hole 320, for example, a duckbill valve structure, that is, a duckbill valve of medical grade silica gel is integrated at the outlet of the adsorption hole 320, and the duckbill valve is realized by using the nonlinear elastic property, and can only be opened under a certain pressure. In this way, only when the catheter body 100 is connected to the liquid medicine or cleaning liquid to generate negative pressure, the duckbill valve can be opened, and at this time, the opening is also in a negative pressure state, and the protein sheath and blood adsorbed into the catheter body 100 can only flow inward in one direction, and cannot flow out.

[0077] Specifically, in order to realize the one-way sealing of the port of the catheter body 100, in this embodiment, referring to Figure 5 , two adhered one-way diaphragms 400 are arranged at the port of the catheter body 100, the end portions of the two one-way diaphragms 400 are closed to block the port of the catheter body 100, so as to prevent external pollutants (such as blood, bacteria, etc.) from entering the inside of the catheter body 100. When the liquid medicine or flushing liquid is injected into the catheter body 100, the liquid pressure makes the two one-way diaphragms 400 separate to form a one-way injection port, allowing the liquid medicine or flushing liquid to smoothly enter the catheter, while preventing backflow.

[0078] It should be noted that in the venous blood vessel, especially in the application scene of small veins, the limited space is an important limiting factor. The existing one-way sealing device may rely on complex mechanical structures or additional springs, valve cores and other components, increasing the manufacturing cost and failure risk. However, in the venous blood vessel, due to the limited space, the traditional one-way sealing device may not be suitable for use due to its large size. The design of the two adhered one-way diaphragms 400 of the present application is very compact and occupies a small space, and is particularly suitable for application in the scene of small venous blood vessels. The one-way diaphragm 400 is completely closed under no pressure, ensuring the sealing of the catheter port and effectively preventing blood backflow. The diaphragm is automatically controlled to separate and close by liquid pressure, simplifying the operation process and improving the convenience of use.

[0079] And in the vein, the internal structure design needs to reduce the pressure on the vessel wall as much as possible to avoid vascular injury or inflammatory response, the one-way membrane 400 of the application is light and soft, and has less pressure on the vessel wall, reducing the impact on the surrounding tissue.

[0080] In practical application, the diameters of the vein of different patients may be different, especially in neonatal or pediatric patients, the vessel diameter is usually smaller, the one-way membrane 400 of the application can adjust the size according to the actual demand, adapt to the vein of different diameters, and widen the application range.

[0081] Specifically, when designing the central venous catheter of the application, the inventors not only want to ablate the protein sheath, but also want to reduce the generation of the protein sheath from the source as much as possible. To this end, an anti-adhesion coating 130 is coated on the catheter body 100. On the one hand, by reducing the surface free energy of the catheter, the interaction force between biological molecules such as proteins and platelets and the surface of the catheter is reduced, thereby inhibiting their adsorption and deposition. On the other hand, a physical barrier is formed on the surface of the catheter body 100 to prevent blood components from directly contacting the catheter material, thereby reducing the formation of the protein sheath. For example, a polyethylene glycol (PEG) coating: high anti-adsorption and good biocompatibility; a heparin coating: anti-adhesion and anticoagulation functions; a super-hydrophobic coating: significantly reduces blood component deposition and has self-cleaning ability; a super-hydrophilic coating: prevents protein adsorption through a hydration film and improves blood flow; a biomimetic lubricating coating: simulates the properties of natural biological surfaces to reduce the friction coefficient; these coating materials have their own advantages, and the specific selection needs to be weighed according to the application scenario, use time and patient demand. For example, in long-term infusion of chemotherapy patients or critically ill patients, a heparin coating with anti-adhesion and anticoagulation functions can be selected; and in neonatal or pediatric patients, a PEG coating with high biocompatibility and durability or a biomimetic lubricating coating is preferred.

[0082] Embodiment 2:

[0083] On the basis of the above-mentioned embodiment 1, in order to further improve the application scenario of the central venous catheter, a venous infusion port is provided in the embodiment, which comprises the above-mentioned central venous catheter, and further comprises a port seat 500 in communication with the proximal end of the catheter body 100, and the external control unit is arranged in the port seat 500, and the port seat 500 can be used to deliver liquid medicine or cleaning liquid to the central venous catheter.

[0084] The traditional central venous catheter needs frequent puncture or replacement, which increases the pain and infection risk of patients, while the venous infusion port reduces the puncture frequency through the implantable design, improves the convenience and safety of use, and the design of the port seat 500 ensures that the drug or cleaning liquid can be smoothly injected into the catheter main body 100 and delivered to the target area through the catheter. At the same time, the port seat 500 also provides installation space for the external control unit.

[0085] Specifically, the venous infusion port integrates all functions of the central venous catheter (such as drug infusion, protein sheath removal, adsorption of residues, etc.) into one system, simplifying the clinical operation process, and the external control unit is integrated in the port seat 500, further improving the compactness and reliability of the system. The venous infusion port is suitable for various application scenarios, including chemotherapy, parenteral nutrition support, long-term infusion of critically ill patients, etc.

[0086] Obviously, the above embodiments are only examples for the sake of clarity, and are not limiting of the embodiments. For those skilled in the art, other different forms of changes or variations can be made on the basis of the above description. Here, it is not necessary and impossible to exhaust all the embodiments. The obvious changes or variations derived therefrom are still within the protection scope of the present application.

Claims

1. A central venous catheter, characterized in that, The application relates to a central venous catheter, comprising: a catheter body, comprising a drug infusion lumen and a ring-shaped electrode layer arranged around the drug infusion lumen; a ring-shaped electrode array embedded in the ring-shaped electrode layer, the ring-shaped electrode array being connected to an external control unit through a wire, the external control unit being capable of outputting pulsed radio frequency energy to the ring-shaped electrode array, the pulsed radio frequency energy being capable of being used for ablation of a protein sheath formed on the outer wall of the catheter body; a Venturi tube section, comprising a liquid infusion channel and suction holes arranged in the side wall of the liquid infusion channel, the liquid infusion channel being in communication with the drug infusion lumen of the catheter body, the cross-sectional area of the liquid infusion channel gradually reducing along the drug delivery direction to form a tapered structure, the suction holes being in communication with the outside through the electrode layer and being used for introducing liquid medicine or cleaning liquid along the liquid infusion channel, and negative pressure being generated at the suction holes to suck in the protein sheath ablated by the ring-shaped electrode array.

2. The central venous catheter of claim 1, wherein: The ring-shaped electrode array comprises a plurality of ring-shaped electrodes arranged along the extension direction of the catheter body, and the plurality of ring-shaped electrodes are arranged at equal intervals.

3. The central venous catheter of claim 2, wherein: The ring-shaped outer periphery of the ring-shaped electrode is provided with a grid-shaped energy release hole.

4. The central venous catheter of claim 1, wherein: The external control unit comprises: an impedance analysis module capable of measuring the alternating current impedance value between two adjacent ring-shaped electrodes in the ring-shaped electrode array, and calculating the thickness of the protein sheath according to the change rate of the impedance value; an energy adjustment module for dynamically adjusting the radio frequency output power according to the change rate of the impedance value, and the greater the change rate of the impedance value, the higher the radio frequency output power.

5. The central venous catheter of claim 1, wherein: The Venturi tube section is integrally formed with the catheter body.

6. The central venous catheter of claim 1, wherein: A plurality of Venturi tube sections are arranged along the extension direction of the catheter body, the suction holes of the plurality of Venturi tube sections being distributed in a spiral manner around the catheter body, and the plurality of suction holes cooperating to form a ring-shaped vortex suction effect.

7. The central venous catheter of claim 1, wherein: A bionic one-way valve diaphragm is arranged in the suction hole.

8. The central venous catheter of claim 1, wherein: Two adhered one-way diaphragms are arranged at the port of the catheter body, the end portions of the two one-way diaphragms being closed to block the port of the catheter body, and the two one-way diaphragms being separated to form a one-way injection port when liquid medicine or flushing liquid is injected into the catheter body.

9. The central venous catheter of claim 1, wherein: An anti-adhesion coating is further coated on the catheter body.

10. An intravenous infusion port, characterized by: The application further relates to a central venous catheter, comprising: the central venous catheter according to any one of claims 1-9, further comprising a hub seat in communication with the proximal end of the catheter body, and the external control unit being arranged in the hub seat, and liquid medicine or cleaning liquid being capable of being delivered to the central venous catheter through the hub seat.

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