CN114392482B - External cardiac pacemaker wire fixing and checking device - Google Patents
External cardiac pacemaker wire fixing and checking device Download PDFInfo
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- CN114392482B CN114392482B CN202210213826.0A CN202210213826A CN114392482B CN 114392482 B CN114392482 B CN 114392482B CN 202210213826 A CN202210213826 A CN 202210213826A CN 114392482 B CN114392482 B CN 114392482B
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- China
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- wire
- lead
- pulling device
- wire pulling
- collimator
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/3625—External stimulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0472—Structure-related aspects
- A61N1/0488—Details about the lead
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N3/00—Investigating strength properties of solid materials by application of mechanical stress
- G01N3/08—Investigating strength properties of solid materials by application of mechanical stress by applying steady tensile or compressive forces
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2203/00—Investigating strength properties of solid materials by application of mechanical stress
- G01N2203/0001—Type of application of the stress
- G01N2203/0003—Steady
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2203/00—Investigating strength properties of solid materials by application of mechanical stress
- G01N2203/0014—Type of force applied
- G01N2203/0016—Tensile or compressive
- G01N2203/0017—Tensile
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
Technical Field
The invention belongs to the field of medical appliances, and particularly relates to an in-vitro cardiac pacemaker lead wire fixing and checking device.
Background
Cardiac pacemakers are commonly used endocardial surgical medical devices, and are effective therapeutic devices for patients with bradycardia. Typically, electrodes are implanted intravenously in the heart and the pacemaker host is sutured subcutaneously in the patient. However, the operation requires a lot of preparation time and the operation process is long, and for some emergency situations, the permanent fixation of the electrode and the host computer is not performed, and only the external cardiac pacemaker can be installed for the patient. The electrode of the external pacemaker is sewed on the cardiac muscle, extends out of the body through a lead and is connected with the pacemaker host. Therefore, the main unit and the lead are usually required to be firmly fixed in vitro, otherwise, the lead is pulled due to the movement of the patient, and the electrode is detached or the dangerous situations such as bleeding, thrombus and the like are caused.
To avoid this, various methods of securing the host and lead have been used in clinical practice. However, no method for checking whether the wire is fixed firmly exists, and only the experience of doctors and nurses or manual touching and pulling are relied on to check whether the wire is fixed firmly. Therefore, objective and accurate operation is difficult.
This problem is not only present in clinical surgery, but is more serious for the teaching of the clinician. At present, the teaching of cardiac pacemaker operation is mostly focused on the development of operation, and related teaching tools only relate to the operation of heart and the suturing of skin, but no instrument can objectively and accurately check the last step of final ending wire fixation, so that whether the wire fixation of a medical student is firm or not cannot be fed back, namely, an accurate and quantitative evaluation result is very important for the learning and exercise process of doctors.
Disclosure of Invention
An in-vitro cardiac pacemaker lead wire fixing and checking device comprises a base, a reel, a circular ring track, 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.
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.
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.
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.
The lower portion of the base has a removable semi-flexible semi-rigid pad.
The upper part of the wire pulling device can be provided with a universal joint.
A system comprising the apparatus further comprises a cloud platform.
The cloud platform is used for storing the maximum rotation angle set of the rotation sensor in each inspection。
The cloud platform is in communication connection with the controller.
The invention has the innovation points and the technical effects that:
1. it is proposed that the firmness degree of the external pacemaker lead wire fixation needs to be checked, so that the clinical safety and the comprehensiveness of learning and training are ensured. The inspection device is designed to realize tension simulation by using the winding wire, instantaneous traction simulation by using the sliding rail, and multi-angle inspection function by using the mutual cooperation of a plurality of parts, so that the wire fixing firmness degree can be comprehensively and accurately inspected, quantitative evaluation can be realized, and the reference property is stronger.
2. Four inspection modes are provided, the tension applying mode of each mode is optimized, the system is ensured to be capable of accurately inspecting, and false alarm is reduced. Especially for the simulation of instantaneous traction, the action instantaneity and the reverse traction effect of the host on the lead are considered, the clinical actual situation can be reflected more truly, the accuracy of inspection is ensured, the false alarm rate is reduced, and the quantitative evaluation is more comprehensive.
3. The strategy of obtaining more accurate threshold conditions through historical corner data learning and adjusting the threshold conditions in real time is provided, and the accuracy of the whole system is ensured.
Drawings
Fig. 1 is a top view of the structure of the inspection apparatus.
Fig. 2 is a front view of the inspection apparatus.
Fig. 3 is a schematic view of a connector structure.
Detailed Description
Inspection device structure
Comprises a base 1, a reel 2, a circular ring track 3, a wire pulling device 4, a collimator 5, a lead 6 and a connecting piece 7.
The winding wheel is fixed at one end of the base and driven by the driving motor, so that the lead is driven to wind or relax, and the winding and paying-off are realized. The lower part of the base is provided with a detachable semi-flexible semi-rigid liner which is used for closely contacting and matching with a body or a similar experimental model. The bottom side has removable straps for securing to the person's body or to the exercise model.
The circular ring track is fixed in the middle of the base, the wire pulling device is embedded in the track and is cylindrical, and the miniature motor is arranged in the wire pulling device, so that the wire pulling device is driven to move along the track, and 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. As a preferred mode, the upper part of the wire pulling device can be provided with a universal joint, and the round hole is arranged on the universal joint, so that undesirable stress on the lead wire caused by the wire pulling device when pulling in different directions is avoided. The circular orbit radius is typically 1-5cm. 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 wires is realized. The collimator is also provided with a lifting device so as to change the height of the collimator in the vertical direction, thereby realizing the lead wire traction in different directions on the vertical plane. As a preferred way, the collimator is also provided with rollers in the vertical direction, so that smooth movement of the wire is ensured. Meanwhile, the roller is connected with a rotation sensor for sensing the rotation angle of the roller and then judging the stretched distance of the lead, so that whether the lead is fixed or not meets the requirement is judged.
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 connector comprises a cylindrical housing 7-2 which is open at one end, and a ball 7-1 which is located in the housing. One end of the shell is fixed on the lead, and the diameter of the open end of the shell is smaller than the overall diameter of the shell and smaller than the diameter of the ball. Thus, the ball can be engaged with the housing without falling off. The pacemaker lead is fixed with the ball by a clip after passing through a hole in the center of the ball. Thus, no matter in which direction the lead is pulled from the horizontal or vertical plane, the lead can be freely connected with the lead without being subjected to fixed stress when the direction is changed. This structure ensures the feasibility and accuracy of the subsequent various inspection modes, which is also one of the contributions of the present invention. It will be appreciated that the side of the housing is provided with holes for the ball to enter and exit, facilitating the installation of the ball. After installation, the hole is closed.
Inspection method
For pacemaker leads, which have electrodes inserted into the heart connected at one end, even if the lead is pulled slightly, it can cause damage in the heart, even be life threatening, and require more fixation of the lead, as opposed to conventional medical catheter fixation. Thus, a more accurate, comprehensive, and rigorous inspection is needed. For this purpose, the present invention proposes the following various inspection modes.
After the lead of the external pacemaker is fixed, the lead is connected with the connecting piece when the lead is not connected with the pacemaker host, so that the lead is connected to the checking device, and the checking device is started to check as follows:
(1) General examination
The wire pulling device is positioned in the middle of the track and is opposite to the winding wheel. The collimator is not raised. At this time, the motor drives the reel to take up the wire, so that the lead wire pulls the wire, and the wire is pulled outwards along the axial direction of the wire.
At this time, the driving force of the motor is:
wherein F is the driving force of the motor, a is an empirical coefficient, and t is time.
If the rotation angle of the rotation sensor exceeds the threshold value beta within 5 seconds, judging that the wire fixation does not meet the standard requirement.
Through the inspection, whether the wire falls off or not can be judged rapidly and simply when the wire is subjected to longitudinal tensile force. Such an examination can be used to simulate the pulling force on the wire caused by small movements of the body on a daily basis.
(2) Step check
The wire pulling device is positioned in the middle of the track and is opposite to the winding wheel. The collimator is not raised. At this time, the motor drives the reel to take up the wire, so that the wire is pulled by the lead wire and is subjected to an outward pulling force.
At this time, the driving force of the motor is:
wherein F is the driving force of the motor, a is an empirical coefficient, and t is time.
If the rotation angle of the rotation sensor exceeds the threshold value beta within 3 seconds, judging that the wire fixation does not meet the standard requirement.
Through the inspection, whether the wire falls off or not can be judged rapidly and simply when the wire is subjected to sudden pulling force along the longitudinal direction. Such an examination can be used to simulate the pulling force on the wire caused by sudden movements of the daily body. This is in contrast to the slow and long lasting pull force of the former case, which is often transient in nature, which results in a failure to fully inspect the wire fixture if the former inspection alone is not used to accurately simulate the situation.
(3) Horizontal inspection
In the initial state, the wire pulling device is positioned at the middle position of the track and is opposite to the winding wheel. 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:
wherein, the liquid crystal display device comprises a liquid crystal display device,for the rotation angle around the circle center of the track, t is time, m is a control coefficient, and m is more than or equal to 0.3 and less than or equal to 1.
Meanwhile, the motor drives the reel to take up, so that the pulling force of the wire is simulated when the real wire is pulled by the transverse wire, and a host connected with the wire gives the wire. Since the host is also fixed, but typically flexible to the body, its tension on the wire is not constant.
At this time, the driving force of the motor is:
wherein F is the driving force of the motor, b is an empirical coefficient, and t is time.
If the rotation angle of the rotation sensor exceeds the threshold value beta when the rotation angle of the wire pulling device reaches 45 degrees, the wire fixing is judged to be not in accordance with the standard requirement, and meanwhile, the inspection device is stopped.
Through the inspection, whether the wire falls off or not can be rapidly and simply judged when the wire is subjected to oblique tension. Such an examination may be used to simulate the tension that may be applied to the lead when the limb is rotated substantially on a daily basis. This is different from the first two straight line pull situations, which are often more common in the daily life and also cause greater damage to the heart. The conventional tension test is linear, and the oblique tension condition is not tested. Therefore, if the former two kinds of inspection are used only, the situation cannot be accurately simulated, so that the wire fixing cannot be accurately and comprehensively inspected more practically. The above effect is achieved by the cooperation of the rotation of the wire pulling device and the motor pulling force, and the checking mode is also one of the contributions of the invention.
(4) Vertical inspection
The wire pulling device is positioned in the middle of the track and is opposite to the winding wheel. The collimator is raised to a predetermined height h. At this time, the motor drives the reel to take up the wire, so that the wire is pulled by the lead wire and is subjected to an outward pulling force.
At this time, the driving force of the motor is:
wherein F is the driving force of the motor, a is an empirical coefficient, and t is time.
If the rotation angle of the rotation sensor exceeds the threshold value beta within 5 seconds, judging that the wire fixation does not meet the standard requirement.
By this examination, the lead pull from limb movement in the vertical direction can be simulated. While this is less of a circumstance in clinical practice (patients are often required to lie in bed), in extreme cases, it may occur that the patient does not follow the prescribed action resulting in the lead being pulled. For this reason, it is necessary to check the fixation of the wire under such conditions.
The experimental coefficients can be determined according to actual use conditions and can be calibrated before delivery. Through the four modes, the conditions of the external cardiac pacemaker when in use can be accurately simulated, and the fixation of a doctor in clinical practice is ensured to be firm. Although similar fixing inspection devices exist in the prior art, no special inspection aiming at the fixing of the cardiac pacemaker lead wire exists, and the inspection mode and specific parameters are greatly different from those of the invention. This is also due to the specific requirements of an external cardiac pacemaker.
Controller for controlling a power supply
The inspection device further has a controller for controlling each motor of the inspection device to implement the inspection mode and feeding back the inspection result to the user.
After the user performs operation exercise, the wire is connected with the inspection device, the wire is inspected in the four modes under the action of the controller, and if the inspection in the four modes is passed, the wire fixing in the operation is considered to meet the requirement. If a certain mode is not passed, reporting the failed mode to a user, and analyzing the problems existing in the fixed mode of the user by combining a history database to provide perfect advice for the user.
In particular, the maximum rotation angle of the rotation sensor at each mode inspection can also be used as a set of dataAnd storing the optimal rotation angle threshold beta into a cloud platform as a sample, establishing a neural network learning model, and updating the threshold stored in the controller. Thus, it is ensured that the judgment of the system is more accurate, which is one of the contributions of the present invention.
The above embodiments are merely descriptions of detailed solutions of the invention, and do not constitute a specific limitation of the invention. The technical problems and the technical effects mentioned in the embodiments are all problems which can be solved by the scheme of the embodiment of the invention, and are also the invention points.
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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210213826.0A CN114392482B (en) | 2022-03-07 | 2022-03-07 | External cardiac pacemaker wire fixing and checking device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210213826.0A CN114392482B (en) | 2022-03-07 | 2022-03-07 | External cardiac pacemaker wire fixing and checking device |
Publications (2)
| Publication Number | Publication Date |
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| CN114392482A CN114392482A (en) | 2022-04-26 |
| CN114392482B true CN114392482B (en) | 2023-09-05 |
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| CN202210213826.0A Active CN114392482B (en) | 2022-03-07 | 2022-03-07 | External cardiac pacemaker wire fixing and checking device |
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Citations (4)
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| CN206058731U (en) * | 2016-08-01 | 2017-03-29 | 重庆医科大学附属第一医院 | A kind of pacemaker instruments used for education device |
| CN108135521A (en) * | 2015-10-23 | 2018-06-08 | 心脏起搏器股份公司 | It is monitored for the signal quality of multiple sensing vectors in heart equipment |
| CN209437892U (en) * | 2018-09-19 | 2019-09-27 | 中国医学科学院北京协和医院 | The fixation device of the external impulse sender of temporary cardiac pacemaker and Pacing lead |
| CN113384329A (en) * | 2021-05-28 | 2021-09-14 | 中国医学科学院阜外医院 | Traction device for pulling out lead of temporary cardiac pacemaker |
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| EP2572751B1 (en) * | 2011-09-21 | 2014-10-29 | Sorin CRM SAS | Probe for stimulation in an extended region of a cardiac chamber, which can be implanted by wire guidance in the deep coronary network |
| US20220047292A1 (en) * | 2019-02-27 | 2022-02-17 | Mdsg Innovation Ltd. | Cardiac lead extraction device |
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2022
- 2022-03-07 CN CN202210213826.0A patent/CN114392482B/en active Active
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| CN108135521A (en) * | 2015-10-23 | 2018-06-08 | 心脏起搏器股份公司 | It is monitored for the signal quality of multiple sensing vectors in heart equipment |
| CN206058731U (en) * | 2016-08-01 | 2017-03-29 | 重庆医科大学附属第一医院 | A kind of pacemaker instruments used for education device |
| CN209437892U (en) * | 2018-09-19 | 2019-09-27 | 中国医学科学院北京协和医院 | The fixation device of the external impulse sender of temporary cardiac pacemaker and Pacing lead |
| CN113384329A (en) * | 2021-05-28 | 2021-09-14 | 中国医学科学院阜外医院 | Traction device for pulling out lead of temporary cardiac pacemaker |
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| Title |
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