CN-121971739-A - PICC pipe of antithrombotic and infection early warning function of integrated form

CN121971739ACN 121971739 ACN121971739 ACN 121971739ACN-121971739-A

Abstract

The invention discloses a PICC catheter with integrated antithrombotic and infection early warning functions, which is characterized in that a flexible integrated impedance, temperature and pH sensor is embedded in the catheter wall, a bionic polymer brush antithrombotic layer with hydrophilic lubrication and nitric oxide controlled release functions is covalently grafted on the surface of the catheter, and a proximal intelligent processing unit is used for carrying out real-time fusion analysis on multisource signals.

Inventors

LU DANDAN
WANG JIAYAN
WANG YE
LI BING

Assignees

中国人民解放军总医院第五医学中心

Dates

Publication Date: 20260505
Application Date: 20260211

Claims (10)

1. PICC pipe of antithrombotic and infection early warning function of integrated form, its characterized in that including: A catheter body made of a biocompatible polymer having a proximal end, a distal end, and a main lumen therethrough; The antithrombotic functional layer is combined on the outer surface of the catheter body and the inner surface of the main channel, the functional layer is a covalent grafted polymer brush layer, the polymer brush is formed by copolymerizing a zwitterionic monomer and a nitric oxide donor monomer through a surface-initiated atom transfer radical polymerization technology, and the double antithrombotic and anti-biofilm effects of continuous hydrophilic lubrication and controllable release of nitric oxide are realized; A multi-parameter biosensing module integrated in a distal region of a catheter body, comprising: an impedance sensor comprising a pair of annular microelectrodes spaced apart by a micron-scale distance for continuously monitoring changes in interface impedance caused by catheter-vessel interface biofilm formation; The temperature sensor is a micro thermocouple or a thermistor, is attached to the outer wall of the catheter and is used for monitoring the local temperature of the tissue around the tip of the catheter; The pH sensor is a miniature solid sensitive film based on polyaniline or iridium oxide and is arranged on the side wall of the distal end of the catheter and used for detecting the decrease of the pH value of the tissue microenvironment caused by infection; The flexible circuit carrier and the signal wires, wherein each sensor of the multi-parameter biological sensing module is integrated on a flexible polyimide film through a micro-nano processing technology, the flexible polyimide film is embedded into the pipe wall of the catheter body, and the signal wires extend from the flexible film and penetrate through independent micro-channels in the pipe wall of the catheter to the proximal end of the catheter; a proximal extracorporeal treatment and early warning unit detachably connected to the proximal end of a catheter body, the unit comprising: the signal conditioning circuit is used for amplifying, filtering and analog-to-digital converting the original signals of the impedance, temperature and pH sensors; an embedded microprocessor, which is internally provided with an infection risk algorithm, wherein the algorithm is used for judging a high risk infection early-warning state; And the early warning output module is used for sending out visible and audible alarm signals and wirelessly transmitting data to the remote monitoring terminal when the high risk state is judged.
2. The PICC catheter with integrated antithrombotic and infection pre-warning function of claim 1, wherein the infection risk algorithm receives and fuses the multi-sensor signals in real time, and determines a high risk infection pre-warning state when at least two correlation conditions of ' impedance value continuously rises above a first threshold value within a preset time window ', ' local temperature exceeds a base value by more than 0.5 ℃ and ' pH value drops by more than 0.3 units ' are simultaneously satisfied.
3. The PICC catheter with integrated antithrombotic and infection warning function of claim 2, wherein the zwitterionic monomer is sulfobetaine methacrylate or carboxylic betaine methacrylate and the nitric oxide donor monomer is selenocysteine methacrylate or N- (beta-acryloyloxyethyl) -N-nitrosohydroxyethylamine.
4. The PICC catheter with integrated antithrombotic and infection warning function of claim 3, wherein the annular microelectrode pair of the impedance sensor is made of biocompatible platinum iridium alloy or boron-doped diamond, and the electrode surface is subjected to nanostructured treatment to increase the effective sensing area.
5. The PICC catheter integrated with antithrombotic and infection warning function as defined in claim 4, wherein the distal end region of the catheter body is further integrated with a biomolecular sensor for detecting specific infection markers released by blood flow or attached biofilm on the catheter surface, including but not limited to C-reactive protein, procalcitonin or Staphylococcus aureus surface protein, by specific antibodies or aptamers covalently immobilized on a flexible polyimide film.
6. The PICC catheter with integrated antithrombotic and infection warning function of claim 5, wherein the biomolecular sensor is an electrochemical impedance spectroscopy type or field effect transistor type sensor, and the signal output terminal is connected to a microprocessor of the proximal extracorporeal treatment and warning unit.
7. The PICC catheter of integrated antithrombotic and infection pre-warning function of claim 6, wherein the embedded microprocessor's infection risk algorithm further comprises a machine learning module that is trained with historical data to adjust the decision threshold and weight of the impedance, temperature, and pH signals and stage pre-warning the risk of infection.
8. The PICC catheter of integrated antithrombotic and infection warning function of claim 7, wherein the catheter body has a multi-lumen needleless connector at its proximal end, wherein an independent lumen is dedicated to accommodate and protect the outgoing interface of the signal harness, which is fast connected to the proximal extracorporeal treatment and warning unit by means of a snap-fit connection.
9. The PICC catheter of integrated antithrombotic and infection warning function of claim 8, wherein the proximal extracorporeal treatment and warning unit is further communicatively coupled to a remote data management platform for receiving data wirelessly transmitted from the warning unit, providing long term trend analysis and generating clinical reports.
10. The PICC catheter with integrated antithrombotic and infection warning function of any of claims 1 to 9, wherein the catheter is used by first placing the catheter body into a predetermined position of the superior vena cava via the peripheral vein, then connecting the proximal extracorporeal treatment and warning unit to the proximal end of the catheter, and starting continuous monitoring, wherein the microprocessor continuously receives and fuses the multi-sensor data, performs an infection risk algorithm, and when the algorithm determines that a high risk infection warning state is reached, immediately starts the warning output module to inform medical staff of intervention assessment and treatment.

Description

PICC pipe of antithrombotic and infection early warning function of integrated form Technical Field The invention relates to the technical field of medical instruments, in particular to a PICC catheter with integrated antithrombotic and infection early warning functions. Background In clinical practice, central venous catheters (PICCs) are widely used in patients in need of long-and-medium-term venous therapy via peripheral veins, and in order to reduce catheter-related complications, the prior art has been mainly improved from two directions, namely, performing functional modification on catheter materials or surfaces, such as coating or blending antibiotics, heparin, silver ions and other substances, in order to endow catheters with anti-infective or antithrombotic passive defense properties, and developing independent monitoring technologies in vitro, such as detecting biomarkers through regular blood or using an extracorporeal imaging device, to indirectly judge whether catheter-related complications exist. On the one hand, the prior art has a limited effective acting time of a simple surface functional coating (such as an antibiotic coating), and can not provide early and in-situ early warning information of the occurrence of complications, so that a clinician can only passively respond according to clinical symptoms such as fever, pain and the like appearing in the later stage of a patient, and the best intervention time is often missed. On the other hand, in-vitro indirect monitoring methods (such as blood drawing assays) have hysteresis and non-continuity, and cannot distinguish systemic infection from local infection of a catheter, so that real-time and accurate judgment on the state of the catheter is difficult to realize. The current lack of an intelligent catheter system capable of deeply integrating an active and long-acting complication prevention mechanism with in-situ and real-time complication early-stage sensing capability, which results in that the management of the PICC complications is still in a passive reaction mode, and the transition from post-treatment to pre-early warning and active intervention cannot be realized. Therefore, in view of the above-mentioned problems, the present invention provides a PICC catheter with integrated antithrombotic and infection pre-warning functions. Disclosure of Invention In order to solve the problems that in the prior art, the passive defense and in-vitro delay monitoring of a catheter are disjointed and the active prevention of complications and early in-situ early warning are not integrated, the invention provides a PICC catheter with integrated antithrombotic and infection early warning functions, which integrates a long-acting antithrombotic/anti-biofilm functional layer and a multi-parameter in-situ biological sensing module and performs fusion analysis on multi-source signals by combining an intelligent algorithm, so that the synchronous prevention of related thrombus and infection of the catheter and the active early warning of early risk are realized. The technical scheme of the invention is that the PICC catheter with integrated antithrombotic and infection early warning functions comprises: a catheter body made of a biocompatible polymer having a proximal end, a distal end, and a main lumen therethrough; The antithrombotic functional layer is combined on the outer surface of the catheter body and the inner surface of the main channel, the functional layer is a covalent grafted polymer brush layer, the polymer brush is formed by copolymerizing a zwitterionic monomer and a nitric oxide donor monomer through a surface-initiated atom transfer radical polymerization technology, wherein the zwitterionic monomer is sulfobetaine methacrylate or carboxylic betaine methacrylate, and the nitric oxide donor monomer is selenocysteine methacrylate, and is used for realizing the double antithrombotic and anti-biofilm effects of continuous hydrophilic lubrication and nitric oxide controllable release; A multi-parameter biosensing module integrated in a distal region of a catheter body, comprising: an impedance sensor comprising annular microelectrode pairs which are spaced at a micron-sized distance, are made of biocompatible platinum iridium alloy or boron-doped diamond and are subjected to nanostructured treatment on the surfaces, and are used for continuously monitoring interface impedance changes caused by catheter-vessel interface biofilm formation; The temperature sensor is a micro thermocouple or a thermistor, is attached to the outer wall of the catheter and is used for monitoring the local temperature of the tissue around the tip of the catheter; The pH sensor is a miniature solid sensitive film based on polyaniline or iridium oxide and is arranged on the side wall of the distal end of the catheter and used for detecting the decrease of the pH value of the tissue microenvironment caused by infection; A biomolecular sensor for detecting a specifi