CN114392482B - An external cardiac pacemaker wire fixation inspection device - Google Patents

Abstract

The invention relates to an in-vitro cardiac pacemaker lead wire fixing and checking device, which comprises a base, a reel, a circular ring track, a wire pulling device, a collimator, a lead wire, a connecting piece and a controller, wherein the base is provided with a wire pulling device; four inspection modes are executed by the controller, so that the fixation condition of the external cardiac pacemaker lead can be accurately and comprehensively inspected, and the inspection is accurate and the false alarm rate is low.

Description

An external cardiac pacemaker wire fixation inspection device

technical field

The invention belongs to the field of medical devices, and in particular relates to a device for fixing and inspecting lead wires of an external cardiac pacemaker.

Background technique

Cardiac pacemaker is a commonly used medical device in the Department of Cardiology and Cardiac Surgery, and it is an effective therapeutic device for patients with bradycardia. Usually, the electrodes are implanted into the heart along the vein, and the pacemaker host is sutured under the patient's skin. However, the operation requires a lot of preparation time, and the operation process is long. For some emergencies, it is too late to permanently fix the electrodes and the host, so the external cardiac pacemaker can only be installed for the patient. The electrodes of the external pacemaker are sutured on the myocardium, and the electrodes extend out of the body through wires and are connected with the pacemaker host. Therefore, it is usually necessary to firmly fix the main body and the wires outside the body, otherwise the wires will be pulled due to the movement of the patient, causing the electrodes to fall off or causing dangerous situations such as bleeding and thrombus to occur.

In order to avoid this situation, various methods have been used in clinical practice to fix the main frame and the lead. However, there is no method for checking whether the wire is firmly fixed. At present, it can only rely on the experience of doctors and nurses, or manually touch and pull to check whether it is firmly fixed. Therefore, it is difficult to be objective and accurate.

This problem not only exists in clinical operations, but also is more serious for the teaching of clinicians. At present, the teaching of cardiac pacemaker surgery is mostly focused on the operation itself, and the relevant teaching tools only involve the operation of the heart and the suturing of the skin. However, there is no instrument that can objectively and accurately check the final step of wire fixation. Therefore, it is impossible to give feedback to medical students whether the wire is firmly fixed, that is, accurate and quantitative evaluation results are very important for doctors to learn and practice.

Contents of the invention

An external cardiac pacemaker wire fixing inspection device, including a base, a winding wheel, a circular track, a wire puller, a collimator, a lead wire, a connector and a controller;

The reel is rotated and fixed at one end of the base, which is driven by the drive motor, thereby driving the lead wire to realize winding and unwinding; the circular track is fixed in the middle of the base, and a wire wiper is embedded inside the track, which drives the wire wiper to move along the track to realize The lead wires are pulled in different directions on the horizontal plane; the upper part of the wire wiper has a round hole through which the lead wires pass; the collimator is set at the other end of the base and is composed of two rollers, so as to realize the smooth entry and exit of the lead wires; the collimator also has Lifting device, so that the height of the collimator can be changed in the vertical direction, thereby realizing the lead pulling in different directions on the vertical plane; the roller is connected with a rotation sensor, which is used to sense the rotation angle of the roller and then judge the stretched distance of the lead , so as to judge whether the wire fixing meets the requirements; one end of the lead wire is fixed on the reel, and after passing through the wire wiper and collimator, it is connected to the wire through the connector;

The controller is used to perform the following inspection modes: the wire wiper is located in the middle of the track, facing the winding wheel; the collimator is not raised; at this time, the wire wiper is driven to rotate on the track, and the rotation angle is:

At the same time, the motor drives the winding wheel to take up the wire, and the driving force of the motor is:

Among them, F is the driving force of the motor, b is the empirical coefficient, t is the time, is the rotation angle around the orbit center, m is the control coefficient, 0.3≤m≤1.

The controller is also used to perform the following inspection mode: general inspection, the wire wiper is located in the middle of the track, and the winding wheel takes up the wire with a smooth force, so that the lead wire pulls the wire outward along the wire axis.

The controller is also used to perform the following inspection mode: step inspection, the wire wiper is located in the middle of the track, and the winding wheel takes up the wire with a step force, so that the lead wire pulls the wire outward along the wire axis.

The controller is also used to execute the following inspection mode: vertical inspection, the wire wiper is located in the middle of the track, the collimator is raised to a predetermined height h, and the winding wheel takes up the wire with a smooth force, so that the lead wire is fixed along the vertical plane. The deflection angle pulls the wire outward.

The lower part of the base has a removable semi-flexible and semi-rigid liner.

Universal joints can be set on the top of the wiper.

A system including the device further includes a cloud platform.

The cloud platform is used to store the maximum rotation angle set of the rotation sensor in each inspection .

The cloud platform communicates with the controller.

The technical effect of innovation point and realization of the present invention:

1. It is the first to propose the need to check the firmness of the lead wire fixation of the external pacemaker, so as to ensure the safety of the clinic and the comprehensiveness of the learning and training. And based on this, the inspection device is designed to simulate the pulling force by using the coiled wire, and realize the instantaneous pulling simulation by using the slide rail, and realize the multi-angle inspection function by using multiple components to cooperate with each other, which can comprehensively and accurately inspect the firmness of the wire fixation, and can Quantitative assessment is more referential.

2. Four inspection modes are proposed, and the pulling force application method of each mode is optimized to ensure that the system can accurately inspect and reduce false alarms. Especially for the simulation of instantaneous pulling, taking into account the instantaneousness of the action and the reverse pulling effect of the host on the wire, it can more truly reflect the actual clinical situation, ensure the accuracy of the inspection, reduce the false alarm rate, and make the quantitative evaluation more accurate. comprehensive.

3. A strategy of obtaining more accurate threshold conditions through historical corner data learning and adjusting the threshold conditions in real time is proposed to ensure the accuracy of the entire system.

Description of drawings

Figure 1 is a top view of the structure of the inspection device.

Fig. 2 is a front view of the inspection device.

Fig. 3 is a schematic diagram of the structure of the connector.

Detailed ways

Check device structure

It includes a base 1, a reel 2, a circular track 3, a wire puller 4, a collimator 5, a lead wire 6, and a connector 7.

Wherein the winding wheel rotates and is fixed at one end of the base, which is driven by a drive motor, thereby driving the lead wire to wind or relax, so as to realize take-up and pay-off. The lower part of the base has a detachable semi-flexible and semi-rigid liner, which is used for close contact with the body or similar experimental models. Bottom side features detachable straps for attachment to a human body or practice manikin.

The ring track is fixed in the middle of the base, and a wire puller is embedded inside the track. The wire puller is cylindrical, and a micro motor is installed inside, so as to drive the wire puller to move along the track, and realize the lead wire pulling in different directions on the horizontal plane. The upper part of the wire wiper has a round hole through which the lead wires pass. As a preferred manner, the upper part of the wire wiper can be provided with a universal joint, and the round hole is arranged on the universal joint, so as to avoid the undesired stress caused by the wire wiper to the lead wire when pulled in different directions. The radius of the circular orbit is usually 1-5 cm. The collimator is set at the other end of the base and consists of two rollers, so as to realize the smooth entry and exit of the lead wire. The collimator also has a lifting device, so that the height of the collimator can be changed in the vertical direction, thereby realizing the lead wire pulling in different directions on the vertical plane. As a preferred manner, the collimator is also provided with rollers in the vertical direction, so as to ensure the smooth movement of the lead wires. At the same time, the roller is connected with a rotation sensor, which is used to sense the rotation angle of the roller and then judge the stretched distance of the lead wire, thereby judging whether the wire fixing meets the requirements.

One end of the lead wire is fixed on the reel, and after passing through the wire wiper and the collimator, it is connected with the wire through the connecting piece.

The connector includes a cylindrical housing 7-2 with one end open, and a ball 7-1 located in the housing. One end of the shell is fixed on the lead wire, and the diameter of the open end of the shell is smaller than the overall diameter of the shell and also smaller than the diameter of the ball. As a result, the ball can be engaged in the housing without falling out. The pacemaker leads are secured to the ball by clips after passing through the hole in the center of the ball. Therefore, no matter which direction the lead wire is pulled from the horizontal or vertical plane, it can be ensured that the wire and the lead wire are freely connected when the direction is changed, without being subject to fixed stress. This structure ensures the practicability and accuracy of various subsequent inspection modes, and is also one of the contributions of the present invention. It can be understood that a hole for the ball to enter and exit is provided on the side of the shell to facilitate the installation of the ball. After installation, the hole is closed.

Inspection Method

For the pacemaker wire, one end of it is connected to the electrode inserted into the heart. Even if the wire is slightly pulled, it will cause damage to the heart, and even endanger life. different. Therefore, a more accurate, comprehensive and strict inspection is required. To this end, the present invention proposes the following multiple inspection modes.

After fixing the lead wire of the external pacemaker, connect it to the connector when it is not connected to the main unit of the pacemaker, so as to connect the lead wire to the inspection device, start the inspection device, and perform the following inspections:

(1) General inspection

The wire wiper is located in the middle of the track, facing the reel. Collimator not raised. At this time, the motor drives the winding wheel to take up the wire, so that the lead wire pulls the wire, and the wire is subjected to an outward pulling force along the wire axis.

At this time, the driving force of the motor is:

Among them, F is the driving force of the motor, a is the empirical coefficient, and t is the time.

If the rotation angle of the rotation sensor exceeds the threshold β within 5 seconds, it is determined that the wire fixing does not meet the specification requirements.

Through the above inspection, it can be quickly and simply judged whether the wire will fall off when it is subjected to the pulling force along the longitudinal direction. This check can be used to simulate the tension on the wire caused by small daily body movements.

(2) Step check

The wire wiper is located in the middle of the track, facing the reel. Collimator not raised. At this time, the motor drives the winding wheel to take up the wire, so that the lead wire pulls the wire, and the wire is subjected to an outward pulling force.

At this time, the driving force of the motor is:

Among them, F is the driving force of the motor, a is the empirical coefficient, and t is the time.

If the rotation angle of the rotation sensor exceeds the threshold β within 3 seconds, it is determined that the wire fixing does not meet the specification requirements.

Through the above inspection, it can be quickly and simply judged whether the wire will fall off when it is subjected to a sudden pulling force along the longitudinal direction. This check can be used to simulate the tension on the wire caused by sudden daily body movements. This is different from the slow and persistent pulling force of the previous situation, which is usually instantaneous and sudden. If only the former inspection can not accurately simulate this situation, it will not be possible to conduct a comprehensive inspection of the wire fixing.

(3) Horizontal inspection

In the initial state, the wire wiper is located in the middle of the track, facing the winding wheel. Collimator not raised.

At this time, the wire wiper is driven to rotate on the track, and the angle of rotation is:

in, is the rotation angle around the center of the orbit, t is the time, m is the control coefficient, 0.3≤m≤1.

At the same time, the motor drives the winding wheel to take up the wire, thereby simulating the pulling force given to the wire by the host connected to the wire when the real wire is pulled by the horizontal wire. Since the main unit is also fixed, but it is usually fixed flexibly with the body, the pulling force it gives to the wire is not constant.

At this time, the driving force of the motor is:

Among them, F is the driving force of the motor, b is the empirical coefficient, and t is the time.

If the rotation angle of the rotation sensor exceeds the threshold β when the wire wiper rotates to 45°, it is judged that the wire fixation does not meet the specification requirements, and the inspection device is stopped at this time.

Through the above inspection, it can be quickly and simply judged whether the wire will fall off when it is subjected to oblique pulling force. This check can be used to simulate the strain that can be exerted on the wire during daily large movements of the limb. This is different from the previous two cases of straight pull, which are generally more common in everyday situations and are more damaging to the heart. The usual tensile tests are linear and do not test oblique tension. Therefore, if only the first two inspections are used, this situation cannot be accurately simulated, resulting in the inability to conduct a more realistic, accurate and comprehensive inspection of wire fixing. The above-mentioned effect is achieved through the mutual cooperation of the rotation of the wire wiper and the pulling force of the motor, and this inspection mode is also one of the contributions of the present invention.

(4) Vertical inspection

The wire wiper is located in the middle of the track, facing the reel. The collimator is raised to a predetermined height h. At this time, the motor drives the winding wheel to take up the wire, so that the lead wire pulls the wire, and the wire is subjected to an outward pulling force.

At this time, the driving force of the motor is:

Among them, F is the driving force of the motor, a is the empirical coefficient, and t is the time.

If the rotation angle of the rotation sensor exceeds the threshold β within 5 seconds, it is determined that the wire fixing does not meet the specification requirements.

This check simulates wire pull due to limb movement in the vertical direction. Although this situation is rare in clinical practice (patients are usually required to stay in bed), in extreme cases, it can also happen that the patient does not follow the doctor's order and the lead is pulled. For this reason, it is necessary to check the fixation of the wire under this condition.

For the inspection of the above four modes, the empirical coefficients can be determined according to the actual use conditions, and can also be calibrated experimentally before leaving the factory. Through the above four modes, it can accurately simulate the situation encountered by the external cardiac pacemaker during use, and ensure that the doctor is firmly fixed in clinical practice. Although there are similar fixed inspection devices in the prior art, there has never been a special inspection for cardiac pacemaker wire fixation, and its inspection mode and specific parameters are also quite different from the present invention. This is also determined by the special requirements of external cardiac pacemakers.

controller

The inspection device also has a controller, which is used to control each motor of the inspection device to implement the above inspection mode, and to feed back the inspection results to the user.

After performing surgical operation practice, the user connects the wire to the inspection device, and performs the above four modes of inspection on the wire under the action of the controller. If the four modes of inspection pass, it is considered that the wire fixation in the operation meets the requirements. If a certain mode fails, report the failed mode to the user, analyze the problems existing in the user's fixing method in combination with the historical database, and provide users with perfect suggestions.

In particular, the maximum rotation angle of the rotation sensor at the time of each mode check can also be used as a set of data Store it in the cloud platform as a sample, and establish a neural network learning model to obtain the best rotation angle threshold β, and update the threshold stored in the controller. Therefore, it can ensure that the judgment of the system is more accurate, which is also one of the contributions of the present invention.

The above embodiments are only descriptions of the detailed solutions of the invention, and do not constitute specific limitations on the invention. The technical problems and technical effects mentioned in the embodiments are problems that can be solved by the solutions of the embodiments of the invention, and are also the invention points of the present invention.

Claims (10)

1. An external cardiac pacemaker lead wire fixing and checking device is characterized in that: comprises a base, a reel, a circular ring rail, a wire shifter, a collimator, a lead wire, a connecting piece and a controller;

the winding wheel is fixed at one end of the base and driven by the driving motor, so that the lead is driven to realize wire winding and wire unwinding; the circular ring rail is fixed in the middle of the base, and a wire pulling device is embedded in the rail to drive the wire pulling device to move along the rail, so that lead wire pulling in different directions on a horizontal plane is realized; the upper part of the wire pulling device is provided with a round hole through which the lead passes; the collimator is arranged at the other end of the base and is composed of two rollers, so that smooth in-out of the lead is realized; the collimator is also provided with a lifting device, so that the height of the collimator can be changed in the vertical direction, and the lead wire traction in different directions on the vertical plane is realized; the roller is connected with a rotation sensor and is used for sensing the rotation angle of the roller and judging the stretched distance of the lead, so as to judge whether the lead is fixed to meet the requirement; one end of the lead is fixed on the reel, passes through the wire pulling device and the collimator and is connected with the lead through the connecting piece;

the controller is configured to perform the following inspection modes: the wire pulling device is positioned in the middle of the track and is opposite to the reel; the collimator is not raised; at this time, the wire pulling device is driven to rotate on the track, and the rotating angle is as follows:

meanwhile, the motor drives the reel to take up, and the driving force of the motor is as follows:

wherein F is the driving force of the motor, b is the empirical coefficient, t is the time,for the rotation angle around the circle center of the track, m is a control coefficient, and m is more than or equal to 0.3 and less than or equal to 1.

2. The apparatus of claim 1, wherein: the controller is further configured to perform the following inspection mode: in general, it is checked that the wire pulling device is located at the middle of the track and the reel is wound up with a smooth force so that the wire is pulled outwardly along the wire axis.

3. The apparatus of claim 1, wherein: the controller is further configured to perform the following inspection mode: step checking, wherein the wire pulling device is positioned at the middle position of the track, and the winding wheel is used for winding wires with step force, so that the lead wires are pulled outwards along the axis of the lead wires.

4. The apparatus of claim 1, wherein: the controller is further configured to perform the following inspection mode: when the wire pulling device is in the middle of the track in the vertical direction, the collimator is lifted to a preset height h, and the wire winding wheel is used for winding wires with smooth force, so that the wires are pulled outwards along the vertical plane by a certain deflection angle.

5. The apparatus of claim 1, wherein: the lower portion of the base has a removable semi-flexible semi-rigid pad.

6. The apparatus of claim 1, wherein: the upper part of the wire pulling device can be provided with a universal joint.

7. The apparatus of claim 1, wherein: the wire pulling device is provided with a round hole.

8. A system comprising the apparatus of claims 1-7, wherein: the cloud platform is also included.

9. The system as recited in claim 8, wherein: the cloud platform is used for storing the maximum rotation angle set of the rotation sensor in each inspection。

10. The system as recited in claim 9, wherein: the cloud platform is in communication connection with the controller.