PICC (Peripherally Inserted Central Catheter) tip accurate positioning and maintaining device based on ultrasound and IC-ECG (Integrated Circuit-Electrocardiograph) fusion

Abstract

The invention belongs to the field of medical instruments, and discloses a PICC catheter tip precise positioning and maintaining device based on ultrasound and IC-ECG fusion, and the PICC catheter tip precise positioning and maintaining device comprises an infusion connector body, an electrode needle and an electrode outer terminal. After conventional maintenance and flushing are completed, stable electrocardio conduction can be achieved through continuous saline columns in the catheter, clear IC-ECG signals are rapidly collected, and the position of the tip end of the catheter is judged in real time; when the electrocardio judges that the tip does not deviate but unsmooth blood return occurs, the overall trend of the ultrasonic examination catheter is triggered, and accurate distinguishing of tip deviation, catheter distortion or compression is achieved; according to the scheme, on the premise that extra traumatic operation is not needed, the ultrasonic and X-ray inspection frequency is effectively reduced, the catheter maintenance efficiency is improved, discomfort of a patient and consumption of medical resources are reduced, and the defects that catheter state evaluation depends on iconography, operation is tedious and response is not timely are comprehensively overcome.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, and in particular to a PICC catheter tip precise positioning and maintenance device based on ultrasound and IC-ECG fusion. BACKGROUND

[0002] A PICC catheter is a central venous catheter that is inserted through peripheral venous puncture and finally reaches the superior vena cava or the junction of the vena cava-right atrium, commonly used for long-term intravenous infusion, chemotherapy or intravenous nutrition therapy. The positioning technology of the existing PICC catheter is mainly completed in the catheterization stage, and the commonly used methods include X-ray fluoroscopy, ultrasound navigation and intracardiac electrocardiogram (IC-ECG) positioning technology. Among them, ultrasound can be used to observe the catheter direction and puncture blood vessel state during puncture or catheterization, and IC-ECG technology can determine the catheter tip position by analyzing the P-wave change of the electrocardiogram signal obtained from the conductive characteristics of the liquid in the catheter lumen. The existing PICC catheter is usually flushed by medical staff during maintenance, and the catheter is aspirated back and the infusion connector is replaced to maintain the patency of the catheter and prevent infection.

[0003] However, during the use and maintenance of the catheter, the catheter tip may be offset due to changes in the patient's body position, activity pulling or venous blood flow impact, and the catheter as a whole may be twisted, compressed or partially blocked. The existing maintenance methods mainly rely on aspiration back, liquid flushing and visual observation, which makes it difficult to accurately determine whether the catheter tip is offset or the overall direction is abnormal. Once the backflow is not smooth or the resistance increases, medical staff often need to arrange X-ray examination or ultrasound examination for confirmation, which increases the operation complexity and patient discomfort. At the same time, the existing IC-ECG and ultrasound positioning technology is mostly limited to the catheterization stage, and there is a lack of effective means for quickly evaluating the catheter position and patency in the maintenance stage.

[0004] Therefore, the existing technology lacks a device that can simultaneously achieve precise positioning of the catheter tip and auxiliary evaluation of the overall direction without relying on complex imaging examinations during the catheter maintenance stage. If the IC-ECG and ultrasound technology can be combined to quickly determine the catheter position during routine catheter flushing and connector replacement operations, it will significantly improve the safety and efficiency of PICC catheter maintenance and reduce the risk of complications. SUMMARY

[0005] The present application intends to provide a PICC catheter tip precise positioning maintenance device based on ultrasonic and IC-ECG fusion to solve the problems in the background art. The present application integrates an electrode needle and an electrode external terminal in the infusion connector body, which can realize stable electrocardio conduction by using the continuous saline column in the catheter after the conventional maintenance flushing is completed, quickly collect clear IC-ECG signals, and instantly determine the position of the catheter tip. When the electrocardio determination shows that the tip is not deviated but the blood return is not smooth, ultrasonic examination is triggered to check the overall trend of the catheter, so as to accurately distinguish the tip deviation, catheter distortion or pressure. The present application effectively reduces the frequency of ultrasonic and X-ray examination without additional traumatic operation, improves the catheter maintenance efficiency, reduces the discomfort of patients and the consumption of medical resources, and comprehensively solves the defects of relying on imaging, complicated operation and delayed response in catheter state evaluation.

[0006] To achieve the above-mentioned purpose, the present application provides the following technical scheme:

[0007] A PICC catheter tip precise positioning maintenance device based on ultrasonic and IC-ECG fusion, comprising an infusion connector body, an electrode needle and an electrode external terminal, wherein the infusion connector body is internally connected with a positive pressure needleless valve core and is provided with a fluid cavity, the electrode needle is connected to the inner wall of the infusion connector body and extends along the axial direction thereof, the electrode needle insertion section extends to the interface inner cavity, and the electrode external terminal penetrates the infusion connector body and is in conduction with the electrode needle for connecting an IC-ECG cable, wherein the device is used to collect IC-ECG signals after physiological saline is injected into the catheter during the catheter maintenance stage, and to realize the overall trend examination of the catheter by cooperating with ultrasonic after the catheter tip is positioned.

[0008] Preferably, the electrode needle end is a round blunt end face, and the electrode needle side wall and end face are gold plated to avoid scratching the interface inner wall and enhance the conductivity.

[0009] Preferably, the length of the electrode needle insertion section is 2-3 mm less than the length of the catheter interface inner cavity, so as to ensure that the electrode needle end only contacts the liquid in the interface inner cavity without directly contacting the catheter body.

[0010] Preferably, the electrode needle is fixed to the inner wall of the infusion connector body by the insert method, so that it maintains a stable position and does not shake or displace during injection or pulling out the syringe.

[0011] Preferably, the electrode external terminal is a ring-shaped terminal, the outer end of the infusion connector body is provided with a receiving groove matched with the electrode external terminal, and the ring-shaped terminal can be folded into the receiving groove by pressing to avoid contacting the patient's skin.

[0012] A PICC catheter tip precise positioning maintenance device based on ultrasonic and IC-ECG fusion is used in the following maintenance process:

[0013] S1: remove the original infusion connector during catheter maintenance, install a new infusion connector body, and inject normal saline into the catheter through a syringe;

[0014] S2: collect IC-ECG signals through the electrode outer terminal to determine whether the catheter tip is deviated;

[0015] S3: when the catheter tip is not deviated but the blood return is not smooth when the syringe is pulled back, check the overall direction of the catheter by ultrasound;

[0016] S4: output the catheter state evaluation conclusion according to the IC-ECG and ultrasound results.

[0017] Preferably, the IC-ECG collection of step S2 is performed under positive pressure after the syringe is pulled out to ensure continuous conduction of saline in the catheter.

[0018] Preferably, the ultrasound examination of step S3 is triggered only when the IC-ECG determines that the catheter tip is not deviated and the blood return is not smooth, to reduce the frequency of ultrasound use.

[0019] Preferably, the output catheter state evaluation conclusion includes:

[0020] (1) the catheter tip is deviated;

[0021] (2) the catheter is twisted or pressed as a whole;

[0022] (3) the catheter position and patency are normal.

[0023] The technical solution compared with the prior art produces the beneficial effects:

[0024] The present solution integrates the electrode needle and the electrode outer terminal in the infusion connector body, which can realize stable ECG conduction using the continuous saline column in the catheter after the conventional maintenance flushing is completed, quickly collect clear IC-ECG signals, and instantly determine the position of the catheter tip; when the ECG determines that the tip is not deviated but the blood return is not smooth, ultrasound is triggered to check the overall direction of the catheter, which realizes accurate differentiation of tip deviation, catheter twisting or pressure; without additional traumatic operation, the solution effectively reduces the frequency of ultrasound and X-ray examination, improves the catheter maintenance efficiency, reduces patient discomfort and medical resource consumption, and solves the defects of catheter state evaluation relying on imaging, complicated operation and delayed response. BRIEF DESCRIPTION OF DRAWINGS

[0025] Figure 1 The infusion connector body provided by the present application and the structure diagram of the catheter and its connector;

[0026] Figure 2A cross-sectional view of the infusion connector body, catheter, and connector provided by the present invention;

[0027] Figure 3 The catheter maintenance operation flowchart provided by the present invention;

[0028] Figure 4 The flowchart of the catheter status determination logic provided by the present invention.

[0029] Reference numerals: 1. Infusion connector body; 2. Positive pressure needleless valve core; 3. Electrode needle; 4. Electrode external terminal; 5. Storage slot. Detailed Implementation

[0030] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments:

[0031] Example 1:

[0032] like Figures 1-4 The device shown is a PICC catheter tip precision positioning and maintenance device based on ultrasound and IC-ECG integration. It includes an infusion connector body 1, an electrode needle 3, and an external electrode terminal 4. The infusion connector body 1 is internally connected to a positive pressure needleless valve core 2 and has a fluid cavity. The electrode needle 3 is connected to the inner wall of the infusion connector body 1 and extends along its axial direction. The insertion section of the electrode needle 3 extends into the interface cavity. The external electrode terminal 4 passes through the infusion connector body 1 and is in communication with the electrode needle for connecting the IC-ECG cable. The device is used to collect IC-ECG signals after injecting physiological saline into the catheter during the catheter maintenance stage, and to check the overall direction of the catheter after positioning the catheter tip with ultrasound.

[0033] In this solution, the infusion connector body 1 maintains positive pressure and serves as a fluid delivery channel, the electrode needle 3 is used to conduct ECG signals through saline in the catheter, and the external electrode terminal 4 facilitates quick connection to the ECG machine. By collecting IC-ECG signals after injecting saline during the catheter maintenance stage, the tip position can be determined. Combined with ultrasound, the overall catheter route can be checked without additional X-ray fluoroscopy, which improves maintenance efficiency and patient safety.

[0034] The end of electrode needle 3 is rounded and blunt, and the sidewalls and end face of electrode needle 3 are gold-plated to avoid scratching the inner wall of the interface and to enhance conductivity.

[0035] In this design, the rounded end face of electrode needle 3 can avoid damage to the catheter interface from sharp parts. The gold plating treatment can significantly improve the conductivity of the liquid, reduce the contact resistance, make the IC-ECG signal acquisition clearer and more stable, and enhance the corrosion resistance, so that it can withstand long-term clinical use.

[0036] The length of the electrode needle 3 insertion section is less than the length of the catheter connector inner cavity 2mm, to ensure that the electrode needle 3 end only contacts the liquid in the connector and does not directly contact the catheter body.

[0037] In this scheme, by controlling the insertion depth of the electrode needle 3, the end is kept apart from the catheter body, which can not only contact the saline column to realize the conduction of the electrocardiogram signal, but also avoid damage to the catheter caused by mechanical friction or pressure. This design can significantly improve the safety of catheter maintenance operation and reduce the risk of leakage or blockage caused by catheter wall wear.

[0038] The electrode needle 3 is fixed to the inner wall of the infusion connector body 1 by the insert method, so that it remains in a stable position during injection or removal of the syringe and does not shift or displace.

[0039] In this scheme, the electrode needle 3 is fixed by the insert method, which can ensure that the electrode needle does not loosen due to liquid impact or operation shaking during the insertion and removal of the syringe, flushing or suction, which can avoid fluctuations in the electrocardiogram signal and prolong the service life of the device.

[0040] The electrode outer terminal 4 is a ring-shaped terminal, and the infusion connector body 1 has a receiving groove 5 matching the electrode outer terminal 4 at the outer end, and the ring-shaped terminal can be folded into the receiving groove by pressing to avoid contacting the patient's skin.

[0041] In this scheme, the ring-shaped terminal is convenient for direct connection with the IC-ECG clip, and can be folded into the receiving groove 5 after use to avoid long-term exposure. This design improves patient comfort, prevents skin irritation caused by terminal friction, and reduces the risk of accidental hooking or contamination, which is a beneficial improvement in structural safety.

[0042] A PICC catheter tip precise positioning and maintenance device based on the fusion of ultrasound and IC-ECG is used in the following maintenance process:

[0043] S1: During catheter maintenance, remove the original infusion connector, install a new infusion connector body 1, and inject normal saline into the catheter through a syringe;

[0044] S2: Collect IC-ECG signals through the electrode outer terminal 4 to determine whether the catheter tip is offset;

[0045] S3: When the catheter tip is not offset but the blood return is not smooth when the blood is drawn back through the syringe, check the overall direction of the catheter through ultrasound;

[0046] S4: Output the catheter state evaluation conclusion according to the IC-ECG and ultrasound results.

[0047] In this scheme, by synchronizing IC-ECG acquisition with catheter flushing, tip position confirmation can be completed in routine maintenance, and ultrasound examination is only performed when blood return is not smooth, thereby reducing unnecessary imaging operations, improving maintenance efficiency and reducing the burden on patients.

[0048] The IC-ECG acquisition of step S2 is performed in a positive pressure state after the syringe is pulled out, to ensure that the saline in the catheter is continuously conducted.

[0049] In this scheme, the cardiac electrical signal is collected in a positive pressure state after the syringe is pulled out, which can avoid blood reflux and ensure that the saline in the catheter forms a continuous liquid column, and the conductivity is best, so that a clearer and more stable IC-ECG signal is obtained, and the accuracy of tip positioning is improved.

[0050] The ultrasound examination of step S3 is only triggered when the IC-ECG determines that the catheter tip is not deviated and blood return is not smooth, to reduce the frequency of ultrasound use.

[0051] In this scheme, by using the triggering strategy, the number of ultrasound operations can be reduced under the premise of ensuring safety. Only when the tip is normal according to the electrocardiogram and the clinical manifestations indicate a problem, ultrasound is used, avoiding the discomfort of patients and the waste of medical resources caused by frequent examinations.

[0052] The output catheter state evaluation conclusion includes:

[0053] (1) catheter tip deviation;

[0054] (2) catheter overall distortion or compression;

[0055] (3) catheter position and patency are normal.

[0056] In this scheme, by combining IC-ECG and ultrasound, the device can output clear conclusions of three types of catheter states, guiding the subsequent clinical treatment: when deviated, it can be adjusted or re-catheterized in time; when the overall is compressed, the position can be optimized according to the body position or the compression can be removed; if it is normal, it can be used safely.

[0057] Example 2:

[0058] I. Explanation of the catheter maintenance method in the prior art

[0059] In the prior art, PICC (peripherally inserted central catheter) is widely used for patients who need long-term intravenous infusion or chemotherapy. During the placement of such catheters, medical staff usually complete tip positioning and fixation by the following methods:

[0060] 1. Positioning in the catheter placement stage

[0061] (1) Ultrasound: used to guide puncture and observe the direction of blood vessels, and assist in judging the overall position of the catheter during catheterization.

[0062] (2)IC-ECG (Intracardiac electrocardiogram): After filling the catheter lumen with physiological saline, the saline conductive performance at the catheter tip can conduct the electrocardiogram signal to the external electrocardiograph. When the catheter tip gradually approaches the junction of the vena cava and the right atrium, the P wave amplitude on the electrocardiogram is significantly increased, and medical personnel can determine whether the catheter tip reaches the ideal position.

[0063] 2. Routine operation of catheter maintenance stage

[0064] During the clinical use of the PICC catheter, routine maintenance needs to be performed every 7-14 days, and the typical process includes:

[0065] S1: Remove the original infusion connector on the catheter external interface, and disinfect the catheter interface;

[0066] S2: Connect a new infusion connector with a syringe, and connect it with the catheter interface. Suck a small amount of backflow blood with the syringe to confirm the patency of the catheter, but do not suck the blood into the syringe;

[0067] S3: Pulse injection of physiological saline in the syringe into the catheter to flush the catheter and maintain positive pressure to prevent blood backflow from causing blockage;

[0068] S4: Remove the syringe, and keep the new infusion connector on the catheter interface.

[0069] In the existing maintenance process, if backflow blood is found to be not smooth or flushing resistance is increased, medical personnel usually need to arrange ultrasonic examination, or perform X-ray fluoroscopy to confirm the catheter position if necessary, which not only increases patient discomfort and operation complexity, but also is difficult to distinguish the catheter tip deviation from the catheter overall distortion or local pressure.

[0070] II. Structure and design idea of the device

[0071] In order to solve the above problems, the present application provides a PICC catheter tip precise positioning and maintenance device based on the fusion of ultrasound and IC-ECG, which can quickly evaluate the catheter tip position and overall trend in the routine catheter maintenance operation.

[0072] As shown in Figures 1-4 , the device of the present application comprises the following structures:

[0073] 1. Infusion connector body 1: internally provided with a positive pressure needleless valve core 2 to ensure that the positive pressure state of the catheter can be maintained after the syringe is pulled out, preventing blood backflow; a fluid cavity is opened inside for physiological saline or drug solution to pass through.

[0074] 2. The electrode needle 3 is fixed on the inner wall of the infusion connector body 1 and extends along the axial direction; the insertion section of the electrode needle 3 enters the inner cavity of the catheter connector, but the length is 2-3 mm less than the total depth of the connector, so as to ensure that the end of the electrode needle only contacts the liquid in the catheter connector and does not directly contact the catheter body, thereby avoiding damage to the catheter; the end of the electrode needle is a round blunt face, and is subjected to gold plating treatment, so as to improve the conductivity and reduce the liquid conduction resistance.

[0075] 3. The electrode outer terminal 4 penetrates the infusion connector body and is in electrical conduction with the electrode needle, and is used for external connection of the IC-ECG cable; the electrode outer terminal 4 is a ring-shaped terminal, and the outer end of the infusion connector body is provided with a matching receiving groove 5, so that after use, the ring-shaped terminal can be bent and received in the receiving groove 5, thereby avoiding contact with the patient's skin or accidental hooking.

[0076] Beneficial effects brought by the structural design:

[0077] (1) The insertion depth of the electrode needle is controlled, and mechanical damage to the catheter can be avoided;

[0078] (2) The positive pressure needleless valve core is used to ensure that the saline in the catheter is continuously conducted after the syringe is pulled out, which is beneficial to IC-ECG signal acquisition;

[0079] (3) The receiving groove structure avoids interference of the exposed terminal with the patient's activities or produces a sense of panic, thereby improving the use comfort.

[0080] III. Use method of the device in catheter maintenance

[0081] The use method of the device in the catheter maintenance stage is as follows:

[0082] S1: The medical staff removes the original infusion connector on the catheter connector, and disinfects the catheter connector;

[0083] S2: The syringe is connected to the infusion connector body 1 in the present application, and is connected with the catheter connector, a small amount of backflow blood is sucked by the syringe to confirm that the catheter is unobstructed, but the blood will not be sucked into the syringe;

[0084] S3: The physiological saline is injected into the catheter in a pulse mode through the syringe, the flushing and replacement of the original liquid in the catheter are completed, and at this time, a continuous saline column is formed in the catheter, which can be used as a conductive medium for the electrocardio signal.

[0085] S4: The syringe is pulled out, and the infusion connector body 1 is retained on the catheter connector, and the positive pressure needleless valve core 2 ensures that the saline in the catheter does not backflow;

[0086] S5: clamp the IC-ECG cable to the electrode outer terminal 4, collect the corresponding ECG signal of the catheter tip, and determine whether the catheter tip remains in the original ideal position by observing the P-wave amplitude change (arranging IC-ECG detection after new saline injection can obtain clearer and more stable ECG signal, and improve the positioning accuracy of the tip).

[0087] S6: if the IC-ECG determines that the catheter tip is not shifted, but the suction backflow is not smooth or the flushing resistance is increased, trigger the ultrasound examination, and the ultrasound can quickly check the overall distortion, pressure or local blockage of the catheter (only use ultrasound when necessary to reduce the operation burden and patient discomfort).

[0088] S7: according to the results of IC-ECG and ultrasound examination, the following three kinds of catheter state evaluation conclusions can be given:

[0089] (1) the catheter tip is shifted;

[0090] (2) the catheter is twisted or pressed as a whole;

[0091] (3) the catheter position and patency are normal.

[0092] Through the above process, the present application can complete the tip positioning and overall trend checking in the conventional catheter maintenance operation without relying on X-ray perspective, thereby improving the safety and efficiency of PICC catheter maintenance.

[0093] Four, comprehensive beneficial effects

[0094] 1. The present application is compatible with the conventional maintenance process, and no additional traumatic operation is needed;

[0095] 2. The ECG signal is collected under the positive pressure state after the syringe is pulled out, so that the signal is clear and stable;

[0096] 3. The design of short insertion of the electrode needle, gold-plated end face and annular terminal storage groove takes into account safety, reliability and patient comfort;

[0097] 4. Through "IC-ECG rapid positioning + ultrasound condition verification", unnecessary ultrasound and X-ray examination is reduced, and the maintenance efficiency is improved.

[0098] The above is only an embodiment of the present application, and well-known specific technical solutions and / or common knowledge in the scheme are not described in detail. It should be noted that for those skilled in the art, without departing from the technical solutions of the present application, a number of modifications and improvements can be made, which should be regarded as the protection scope of the present application, and these will not affect the effect and practicality of the present application. The protection scope of the present application should be subject to the content of its claims, and the specific implementation mode and the like in the description can be used to explain the content of the claims.

Claims

1. A PICC catheter tip precision positioning and maintenance device based on the fusion of ultrasound and IC-ECG, characterized in that, include: The infusion connector body (1) is internally connected to a positive pressure needleless valve core (2) and has a fluid cavity. Electrode needle (3), the electrode needle (3) is connected to the inner wall of the infusion connector body (1) and extends along its axial direction, the insertion section of the electrode needle (3) extends into the interface cavity; External electrode terminal (4) passes through the infusion connector body (1) and is connected to the electrode needle for connecting IC-ECG cable; The device is used to collect IC-ECG signals by injecting saline solution into the catheter during the catheter maintenance phase, and to perform an overall catheter trajectory inspection in conjunction with ultrasound after locating the catheter tip.

2. The PICC catheter tip precision positioning and maintenance device based on ultrasound and IC-ECG fusion as described in claim 1, characterized in that: The electrode needle (3) has a rounded end face, and the side wall and end face of the electrode needle (3) are gold-plated to avoid scratching the inner wall of the interface and to enhance the conductivity.

3. The PICC catheter tip precision positioning and maintenance device based on ultrasound and IC-ECG fusion as described in claim 1, characterized in that: The length of the electrode needle (3) insertion section is 2-3 mm shorter than the length of the inner lumen of the catheter interface, so as to ensure that the end of the electrode needle (3) only contacts the liquid inside the interface and does not directly contact the catheter body.

4. The PICC catheter tip precision positioning and maintenance device based on ultrasound and IC-ECG fusion as described in claim 1, characterized in that: The electrode needle (3) is fixed to the inner wall of the infusion connector body (1) by means of an insert, so that it maintains a stable position during injection or removal of the syringe and does not shake or shift.

5. The PICC catheter tip precision positioning and maintenance device based on ultrasound and IC-ECG fusion as described in claim 1, characterized in that: The electrode external terminal (4) is a ring terminal. The outer end of the infusion connector body (1) is provided with a storage groove (5) that matches the electrode external terminal (4). The ring terminal can be pressed and folded into the storage groove to avoid contact with the patient's skin.

6. The PICC catheter tip precision positioning and maintenance device based on ultrasound and IC-ECG fusion as described in claim 1, characterized in that, Used for the following maintenance processes: S1: When maintaining the catheter, remove the original infusion connector, install the new infusion connector body (1), and inject physiological saline into the catheter through a syringe; S2: Collect IC-ECG signals through the external electrode terminal (4) to determine whether the catheter tip is deviated; S3: When the catheter tip is not deviated but poor blood return is observed when blood is drawn back with a syringe, the overall course of the catheter is examined by ultrasound. S4: Output the catheter status assessment conclusion based on IC-ECG and ultrasound results.

7. The PICC catheter tip precision positioning and maintenance device based on ultrasound and IC-ECG fusion as described in claim 6, characterized in that: The IC-ECG acquisition in step S2 is performed under positive pressure after the syringe is withdrawn to ensure continuous conduction of saline solution in the catheter.

8. The PICC catheter tip precision positioning and maintenance device based on ultrasound and IC-ECG fusion as described in claim 6, characterized in that: The ultrasound examination in step S3 is triggered only when IC-ECG determines that the catheter tip is not deviated and poor blood return is present, in order to reduce the frequency of ultrasound use.

9. A PICC catheter tip precision positioning and maintenance device based on the fusion of ultrasound and IC-ECG as described in claim 6, characterized in that, The output catheter condition assessment conclusions include: (1) Catheter tip deviation; (2) The catheter is twisted or compressed; (3) The catheter position and patency are normal.

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