CN114392482A - Lead fixing and checking device of external cardiac pacemaker - Google Patents
Lead fixing and checking device of external cardiac pacemaker Download PDFInfo
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- CN114392482A CN114392482A CN202210213826.0A CN202210213826A CN114392482A CN 114392482 A CN114392482 A CN 114392482A CN 202210213826 A CN202210213826 A CN 202210213826A CN 114392482 A CN114392482 A CN 114392482A
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- wire
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- track
- collimator
- inspection
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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 a lead fixing and checking device of an external cardiac pacemaker, which comprises a base, a reel, a circular ring track, a wire poking device, a collimator, a lead, a connecting piece and a controller, wherein the base is provided with a plurality of guide rails; the controller executes four inspection modes, so that the fixation condition of the external cardiac pacemaker lead can be accurately and comprehensively inspected, the inspection is accurate, and the false alarm rate is low.
Description
Technical Field
The invention belongs to the field of medical instruments, and particularly relates to a lead fixing and checking device of an external cardiac pacemaker.
Background
The cardiac pacemaker is a common cardiology department cardiac surgery medical instrument and is an effective therapeutic instrument for patients with bradycardia. The electrodes are typically implanted intravenously into the heart and the pacemaker host is sutured under the patient's skin. However, the operation needs a lot of preparation time, the operation process is long, and for some emergency situations, the permanent fixation of the electrode and the host computer is not time to be carried out, and only the installation of the external cardiac pacemaker can be carried out for the patient. The electrodes of the external pacemaker are sewed on the cardiac muscle, and the electrodes extend out of the body through a lead and are connected with the pacemaker host. Therefore, the main body and the lead are usually required to be firmly fixed in vitro, otherwise, the patient moves to cause the lead to be pulled, the electrode falls off or dangerous situations such as bleeding and thrombus occur.
To avoid this, various methods are used in clinical practice to secure the host and the lead. However, there is no method for checking whether the lead is firmly fixed, and currently, the fixing can be checked only by the experience of doctors and nurses, or by manual touching and pulling. Therefore, it is difficult to achieve objectivity and accuracy.
This problem is not only present in clinical surgery, but is even more serious for the clinician to teach. At present, most of teaching for cardiac pacemaker surgery focuses on the development of the surgery, related teaching tools only relate to the operation on the heart and the suture of the skin, but no instrument can be objectively and accurately checked in the step of fixing the lead which is finally ended, so that whether the lead is fixed firmly by medical students cannot be fed back, namely, an accurately quantized evaluation result is very important for the study and practice process of doctors.
Disclosure of Invention
A lead fixing and checking device of an external cardiac pacemaker comprises a base, a reel, a circular ring track, a wire poking device, a collimator, a lead, a connecting piece and a controller;
the reel is rotationally fixed at one end of the base and is driven by the driving motor, so that the lead is driven to realize wire winding and wire releasing; the circular track is fixed in the middle of the base, the wire shifting device is embedded in the track and is driven to move along the track, and lead wires in different directions on the horizontal plane are pulled; the upper part of the wire poking device is provided with a round hole through which a lead passes; the collimator is arranged at the other end of the base and consists of two rollers, so that the smooth in-and-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 therefore wire drawing in different directions in the vertical plane is achieved; the roller is connected with a rotation sensor and used for sensing the rotation angle of the roller so as to judge the stretched distance of the lead, thereby judging whether the lead is fixed to meet the requirement; one end of the lead is fixed on the reel, penetrates through the wire poking 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 poking device is positioned in the middle of the track and is opposite to the winding wheel; the collimator is not raised; at this moment, the wire poking device is driven to rotate on the track, and the rotating angle is as follows:
meanwhile, the motor drives the reel to take up the wire, and the driving force of the motor is as follows:
wherein F is the driving force of the motor, b is an empirical coefficient, 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.
The controller is further configured to perform the following inspection modes: it is generally checked that the wire puller is located at the middle position of the rail and the wire is wound up by the reel with a smooth force so that the lead wire pulls the wire outward along the wire axis.
The controller is further configured to perform the following inspection modes: and step checking, wherein the wire poking device is positioned in the middle position of the track, and the wire coiling wheel is used for coiling the wire with step force, so that the lead wire is pulled outwards along the axis of the lead wire.
The controller is further configured to perform the following inspection modes: and in the vertical direction inspection, the wire poking device is positioned in the middle position of the track, the collimator is lifted to a preset height h, and the wire is wound up by the winding wheel with smooth force, so that the lead wire is pulled outwards along a vertical plane at a certain deflection angle.
The lower portion of the base has a removable semi-flexible semi-rigid liner.
The upper part of the wire poking device can be provided with a universal joint.
A system comprising the device 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 innovation point and the realized technical effect of the invention are as follows:
1. the need of checking the fixing firmness of the external pacemaker lead is firstly proposed to ensure the clinical safety and the comprehensiveness of learning and training. And designed inspection device according to this and utilized the spiral to realize the pulling force simulation, utilized the slide rail to realize instantaneous tractive simulation to utilize a plurality of parts to mutually support and realized the function of multi-angle inspection, can be comprehensive, accurate inspection wire fixed firm degree, and can quantify the aassessment, the referential is stronger.
2. Four inspection modes are provided, the tension applying mode of each mode is optimized, the system can be accurately inspected, and the misinformation is reduced. Particularly, for the simulation of instantaneous traction, the instantaneous action and the reverse traction action of the host on the lead are considered, the clinical actual condition can be reflected more truly, the inspection accuracy is ensured, the false alarm rate is reduced, and the quantitative evaluation is more comprehensive.
3. The method provides a strategy for obtaining more accurate threshold conditions through historical corner data learning and adjusting the threshold conditions in real time, and ensures the accuracy of the whole system.
Drawings
FIG. 1 is a plan view of the structure of an inspection apparatus.
Fig. 2 is a front view of the inspection apparatus.
Fig. 3 is a schematic view of the connector structure.
Detailed Description
Inspection device structure
Comprises a base 1, a reel 2, a circular ring track 3, a wire poking device 4, a collimator 5, a lead 6 and a connecting piece 7.
The reel rotates and is fixed at one end of the base and is driven by the driving motor, so that the lead is driven to be wound or loosened, and winding and unwinding are achieved. The lower part of the base is provided with a detachable semi-flexible semi-rigid liner which is used for being tightly contacted with a body or a similar experimental model to be mutually inosculated. The bottom side has a removable strap for securing to a person's body or to an exercise model.
The ring track is fixed in the middle of the base, the wire shifting device is embedded in the track and is cylindrical, and the micro motor is arranged in the wire shifting device, so that the wire shifting device is driven to move along the track, and the lead traction in different directions of the horizontal plane is realized. The upper part of the wire poking device is provided with a round hole through which the lead wire passes. As an optimal mode, the universal joint can be arranged on the upper portion of the wire poking device, and the round holes are formed in the universal joint, so that the wire poking device is prevented from causing undesirable stress to the lead wires when the lead wires are pulled in different directions. The circular orbit has a radius of typically 1-5 cm. The collimator is arranged at the other end of the base and consists of two rollers, so that smooth in and 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 therefore wire drawing in different directions in the vertical plane is achieved. Preferably, the collimator is also provided with rollers in the vertical direction to ensure smooth movement of the wire. Meanwhile, the roller is connected with a rotation sensor for sensing the rotation angle of the roller and further judging the distance of the lead wire stretched, so that whether the lead wire is fixed or not is judged.
One end of the lead is fixed on the reel, penetrates through the wire poking device and the collimator and is connected with the lead through the connecting piece.
The connector comprises a cylindrical housing 7-2 open at one end, and a ball 7-1 located in the housing. One end of the shell is fixed on the lead, and the diameter of the opening end of the shell is smaller than the overall diameter of the shell and also smaller than the diameter of the ball. Thus, the ball can be engaged in the housing without falling off. The pacemaker lead is fixed with the ball through a clip after passing through a hole in the center of the ball. Thus, no matter which direction the lead is pulled from the horizontal or vertical plane, the lead and the lead can be freely connected without fixed stress when the direction is changed. This structure ensures the feasibility of a plurality of subsequent inspection modes and the accuracy of inspection, and is also one contribution of the invention. It can be understood that the side surface of the shell is provided with a ball inlet and outlet hole, so that the ball is convenient to install. After installation, the hole is closed.
Inspection method
In the case of a pacemaker lead, one end of which is connected with an electrode inserted into the heart, even if the lead is pulled slightly, the lead can cause damage in the heart and even endanger life, and the requirement for lead fixation is higher, which is completely different from the common medical catheter fixation. Thus, a more accurate, comprehensive and rigorous inspection is required. For this purpose, the present invention proposes the following various inspection modes.
After the wire of external pacemaker is fixed, when not being connected with pacemaker host computer, it is connected with the connecting piece to be connected to inspection device with the wire, start inspection device, carry out following inspection:
(1) general examination
The wire poking device is located in the middle of the track and is opposite to the winding wheel. The collimator is not raised. At the moment, the motor drives the winding wheel to take up the wire, so that the lead pulls the wire, and the wire is subjected to outward pulling force along the axial direction of the wire.
At this time, the driving force of the motor is:
where F is the driving force of the motor, a is an empirical coefficient, and t is time.
And if the rotation angle of the rotation sensor exceeds a threshold value beta within 5 seconds, the lead is judged to be fixed and not meet the standard requirement.
Through the inspection, whether the wire falls off when being subjected to the pulling force along the longitudinal direction can be quickly and simply judged. Such an examination can be used to simulate the pulling force on the lead caused by small daily body movements.
(2) Step check
The wire poking device is located in the middle of the track and is opposite to the winding wheel. The collimator is not raised. At the moment, the motor drives the winding wheel to take up the wire, so that the lead pulls the wire, and the wire is subjected to outward tension.
At this time, the driving force of the motor is:
where F is the driving force of the motor, a is an empirical coefficient, and t is time.
And if the rotation angle of the rotation sensor in 3 seconds exceeds a threshold value beta, the wire fixation is judged to be not in accordance with the standard requirement.
Through the inspection, whether the wire falls off when being subjected to the sudden pulling force along the longitudinal direction can be quickly and simply judged. Such an examination may be used to simulate the pulling force on the lead caused by sudden movements of the body during the day. This is in contrast to the slow and sustained pulling force of the former case, which is often transient and can not be accurately simulated by the former inspection alone, resulting in an inability to perform a complete inspection of the wire fixation.
(3) Horizontal direction inspection
In the initial state, the wire poking device is located in the middle of the track and is opposite to the winding wheel. The collimator is not raised.
At this moment, the wire poking device is driven to rotate on the track, and the rotating angle is as follows:
wherein the content of the first and second substances,
the rotation angle around the center of the track is shown, 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 winding wheel to take up the wire, so that the pulling force of the wire is given by a main machine connected with the wire when the real wire is pulled by the transverse wire. Since the host is also fixed, but is usually flexibly fixed to the body, the tension it applies to the lead 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 wire poking device rotates to 45 degrees, the wire is judged to be fixed and not meet the standard requirement, and the inspection device is stopped at the same time.
Through the inspection, whether the wire can fall off or not when the wire is subjected to oblique tension can be quickly and simply judged. Such an examination may be used to simulate the pulling forces that may be applied to the lead during a daily significant rotation of the limb. This is in contrast to the first two straight pull situations, which are generally more common on a daily basis and which can cause more damage to the heart. The conventional tension test is linear, and the oblique tension condition cannot be tested. Therefore, if the former two kinds of inspection are used, the condition can not be simulated accurately, so that the more practical accurate and comprehensive inspection can not be carried out on the lead fixation. The above effect is achieved by the mutual cooperation of the rotation of the wire poking device and the pulling force of the motor, and the inspection mode is also one of the contributions of the invention.
(4) Vertical direction inspection
The wire poking device is located in the middle of the track and is opposite to the winding wheel. The collimator is raised to a predetermined height h. At the moment, the motor drives the winding wheel to take up the wire, so that the lead pulls the wire, and the wire is subjected to outward tension.
At this time, the driving force of the motor is:
where F is the driving force of the motor, a is an empirical coefficient, and t is time.
And if the rotation angle of the rotation sensor exceeds a threshold value beta within 5 seconds, the lead is judged to be fixed and not meet the standard requirement.
By this examination, it is possible to simulate a wire pulling due to a movement of the limb in the vertical direction. While this is less common in clinical practice (the patient is usually required to be in bed), in extreme cases it can also happen 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 empirical coefficients of the inspection in the above four modes can be determined according to actual use conditions, and can also be calibrated by experiments before leaving the factory. Through the four modes, the condition that the external cardiac pacemaker meets in use can be accurately simulated, and the fixation of a doctor in clinical practice is ensured to be firm. Although similar fixed examination devices exist in the prior art, no examination is available for pacemaker lead fixation, and the examination mode and specific parameters thereof are greatly different from those of the invention. This is also determined by the special requirements of an external cardiac pacemaker.
Controller
The inspection device also 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 practices the surgical operation, the lead is connected with the inspection device, the four modes of inspection are carried out on the lead under the action of the controller, and if the four modes of inspection are passed, the lead is considered to be fixed and meet the requirements in the surgery. If a certain mode fails, reporting the failed mode to the user, analyzing the problems of the user fixing mode by combining a historical database, and providing a perfect suggestion for the user.
In particular, the maximum rotation angle of the rotation sensor at the time of each mode check may be set as a set of data
And storing the data into a cloud platform as a sample, establishing a neural network learning model so as to obtain an optimal rotation angle threshold value beta, and updating the threshold value stored in the controller. Therefore, the judgment of the system can be ensured to be more accurate, which is also one contribution of the invention.
The above examples are merely illustrative of the detailed embodiments of the invention and do not constitute specific limitations of the invention. The technical problems and the technical effects mentioned in the embodiments are all the problems that can be solved by the scheme of the embodiment of the invention, and the invention point of the invention is also the technical problem and the technical effect mentioned in the embodiments.
Claims (10)
1. The utility model provides an external cardiac pacemaker lead fixed inspection device which characterized in that: comprises a base, a reel, a circular ring track, a wire poking device, a collimator, a lead, a connecting piece and a controller;
the reel is rotationally fixed at one end of the base and is driven by the driving motor, so that the lead is driven to realize wire winding and wire releasing; the circular track is fixed in the middle of the base, the wire shifting device is embedded in the track and is driven to move along the track, and lead wires in different directions on the horizontal plane are pulled; the upper part of the wire poking device is provided with a round hole through which a lead passes; the collimator is arranged at the other end of the base and consists of two rollers, so that the smooth in-and-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 therefore wire drawing in different directions in the vertical plane is achieved; the roller is connected with a rotation sensor and used for sensing the rotation angle of the roller so as to judge the stretched distance of the lead, thereby judging whether the lead is fixed to meet the requirement; one end of the lead is fixed on the reel, penetrates through the wire poking 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 poking device is positioned in the middle of the track and is opposite to the winding wheel; the collimator is not raised; at this moment, the wire poking device is driven to rotate on the track, and the rotating angle is as follows:
meanwhile, the motor drives the reel to take up the wire, and the driving force of the motor is as follows:
wherein F is the driving force of the motor, b is an empirical coefficient, t is time,
is the rotation angle around the center of the track, m is the control coefficient, 0.3≤m≤1。
2. The apparatus of claim 1, wherein: the controller is further configured to perform the following inspection modes: it is generally checked that the wire puller is located at the middle position of the rail and the wire is wound up by the reel with a smooth force so that the lead wire pulls the wire outward along the wire axis.
3. The apparatus of claim 1, wherein: the controller is further configured to perform the following inspection modes: and step checking, wherein the wire poking device is positioned in the middle position of the track, and the wire coiling wheel is used for coiling the wire with step force, so that the lead wire is pulled outwards along the axis of the lead wire.
4. The apparatus of claim 1, wherein: the controller is further configured to perform the following inspection modes: and in the vertical direction inspection, the wire poking device is positioned in the middle position of the track, the collimator is lifted to a preset height h, and the wire is wound up by the winding wheel with smooth force, so that the lead wire is pulled outwards along a vertical plane at a certain deflection angle.
5. The apparatus of claim 1, wherein: the lower portion of the base has a removable semi-flexible semi-rigid liner.
6. The apparatus of claim 1, wherein: the upper part of the wire poking device can be provided with a universal joint.
7. The apparatus of claim 1, wherein: the wire poking device is provided with a round hole.
8. A system comprising the apparatus of claims 1-7, wherein: also included is a cloud platform.
9. The system of 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 of 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 |
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| Publication Number | Publication Date |
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| CN114392482A true CN114392482A (en) | 2022-04-26 |
| CN114392482B 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 (6)
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| US20130073022A1 (en) * | 2011-09-21 | 2013-03-21 | Sorin Crm Sas | Pacing Lead In An Extended Area Of A Heart Cavity, Implantable By Over The Wire Technique In The Deep Coronary Network |
| 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 |
| US20220047292A1 (en) * | 2019-02-27 | 2022-02-17 | Mdsg Innovation Ltd. | Cardiac lead extraction device |
-
2022
- 2022-03-07 CN CN202210213826.0A patent/CN114392482B/en active Active
Patent Citations (6)
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| US20130073022A1 (en) * | 2011-09-21 | 2013-03-21 | Sorin Crm Sas | Pacing Lead In An Extended Area Of A Heart Cavity, Implantable By Over The Wire Technique In The Deep Coronary Network |
| 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 |
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