WO2021243885A1

WO2021243885A1 - Gate-control radiography injection device and injection method

Info

Publication number: WO2021243885A1
Application number: PCT/CN2020/116108
Authority: WO
Inventors: 刘广志
Original assignee: 苏州润迈德医疗科技有限公司
Priority date: 2020-06-04
Filing date: 2020-09-18
Publication date: 2021-12-09
Also published as: CN112138247A

Abstract

A gate-control radiography injection device and an injection method. The device comprises: a control module (100); a pressure acquisition module (200) and a drive module (300) which are respectively connected to the control module (100); and an injection module (400) connected to the drive module (300). The pressure acquisition module (200) is used for measuring an invasive pressure signal or/and an electrocardiosignal of an aorta in real time. The control module (100) is used for receiving the invasive pressure signal or/and the electrocardiosignal in real time, and controlling, according to the pressure signal and the electrocardiosignal, the drive module (300) to operate and the operating power of the drive module (300). The drive module (300) is used for starting to operate or stopping operating according to an instruction and setting the operating power. The injection module (400) is used for generating a corresponding thrust force along with rotation of the drive module (300), and then controlling the injection rate of liquid. According to the present application, a contrast medium can be injected synchronously in the beginning of diastole, so that the contrast medium and blood flow can rapidly enter a coronary vessel during the diastole; and by controlling the operating power of the drive module (300), the stability of injection efficiency can be effectively controlled, and the quality of radiography can be improved.

Description

Gated contrast injection device and injection method

Technical field

The invention relates to the technical field of coronary artery medicine, in particular to a gated contrast injection device and an injection method.

Background technique

Angiography is a commonly used and effective method for diagnosing vascular lesions. It is a relatively safe and reliable invasive diagnostic technique. It has been widely used in clinical practice and is regarded as the "gold standard" for diagnosing vascular stenosis.

The angiographic images can obtain morphological parameters such as vessel diameter, stenosis, length, blood flow, etc., and can also measure electrocardiogram and aortic pressure during surgery, and measure functional indicators (such as blood flow reserve fractions) through more advanced computational fluid dynamics (FFR) can indicate the influence of coronary artery stenosis on the distal blood flow, and the diagnosis of myocardial ischemia has become a recognized indicator for the functional evaluation of vascular stenosis). A series of diagnosis depends on the blood vessel development displayed by the contrast image, and the quality of the contrast image directly affects the diagnosis effect. Whether the doctor visually inspects the degree of vascular stenosis or makes QCA measurement and caFFR measurement through auxiliary software, high-quality contrast images are required as the basis.

Contrast surgery is to insert the second tube through the femoral artery or radial artery, and send it to the target blood vessel, and inject the contrast agent to visualize the blood vessel. The method for injecting the contrast agent includes manually pushing the syringe or pushing the contrast agent in the syringe by a motor and a mechanical structure through a high-pressure syringe to inject the contrast agent into the blood vessel through the second pipeline. In manual bolus injection, the contrast agent bolus is not concentrated due to the amount of force exerted by the surgeon and the speed of the pushing speed, the contrast agent is not filled, the quality of the contrast image is poor, and the blood flow rate obtained through the flow of the contrast agent also fluctuates. The high-pressure injector can ensure the rapid and stable injection of the contrast agent into the blood vessel by setting a fixed injection speed and pressure, which can improve the quality of the contrast image. However, due to the continuous beating of the heart, the coronary blood supply is mainly in the diastolic phase. During the systole, the blood flow is slow or even stopped due to the compression of the coronary blood vessels by the myocardium, causing the contrast agent to overflow into the aorta. Since the time of the bolus contrast agent is uncertain at the stage of the heartbeat cycle, it cannot guarantee that the contrast agent enters the coronary artery smoothly, which affects the method of calculating the flow rate based on the flow of the contrast agent, such as the TIMI frame counting method.

Summary of the invention

The present application provides a gated contrast injection device and injection method to solve the problem that the manual bolus injection in the prior art has poor control of the force and the pushing speed, and the uncertainty of the bolus time in both high-pressure syringes and manual boluses. It cannot be guaranteed that the contrast agent enters the coronary artery smoothly, which affects the problem of poor accuracy in calculating the flow rate based on the flow of the contrast agent.

In order to achieve the foregoing objective, in the first aspect, the present application provides a gated contrast injection device, comprising: a control module, a pressure acquisition module and a drive module respectively connected to the control module, and a drive module connected to the drive module Injection module

The pressure acquisition module is used to measure the invasive pressure of the aorta or/and the ECG signal in real time;

The control module is configured to receive the invasive pressure or/and the ECG signal sent by the pressure acquisition module in real time, control whether the drive module starts working according to the pressure signal and the ECG signal, and control the The working power of the drive module;

The driving module is used to start or stop work according to the instructions sent by the control module, and to set the working power;

The injection module is used to generate a corresponding thrust with the rotation of the driving module, thereby controlling the injection rate of the liquid.

Optionally, in the gated contrast injection device described above, the pressure acquisition module is an invasive pressure acquisition module for real-time measurement of the invasive pressure of the aorta.

Optionally, in the gated contrast injection device described above, the pressure acquisition module is an ECG acquisition module for real-time measurement of the ECG signal of the aorta, including non-invasive pressure.

Optionally, in the gated contrast injection device described above, the pressure acquisition module includes: an invasive pressure acquisition module and an ECG acquisition module, and the invasive pressure acquisition module is used to measure the invasive pressure of the aorta in real time; The ECG acquisition module is used to measure the ECG signal of the aorta in real time, including non-invasive pressure.

Optionally, the aforementioned gated contrast injection device further includes: a three-way valve, the first branch of the three-way valve is connected to the invasive pressure acquisition module through a first pipeline, and is used for real-time measurement of the The invasive pressure of the aorta; the second branch of the three-way valve is connected to the injection module through a second pipeline, and is used to make the liquid in the second pipeline uniformly driven by the injection module Move; the third branch of the three-way valve is connected to an external contrast catheter through a third pipeline.

Optionally, in the gated contrast injection device described above, the ECG acquisition module is a data transmission module, connected to an external electrocardiograph, and used to transmit the ECG signal collected by the electrocardiograph to the Control module.

Optionally, in the gated contrast injection device described above, the control module is a central processing unit.

Optionally, in the gated contrast injection device described above, the driving module is a driving motor, or/and the injection module is a liquid injector.

Optionally, in the gated contrast injection device described above, the invasive pressure acquisition module includes: a housing, an integrated circuit board, a blood pressure sensor, a PIN connector, a first connection structure and a through tube; the blood pressure sensor, an integrated The circuit board and the PIN connector are both arranged in the housing; the blood pressure sensor is communicatively connected with the integrated circuit board through the PIN connector;

Away from the direction of the first connection structure, the through pipe is arranged on the top of the housing, a through hole is provided on the inner surface of the through pipe, and one end of the through pipe is connected to the first pipeline;

One end of the blood pressure sensor is a pressure collecting end, and the pressure collecting end is sealed in the through hole for collecting the pressure value of the liquid flowing through the through tube;

The first connection structure is respectively connected with the housing, the integrated circuit board, and the control module, and is used to transmit the pressure value collected by the blood pressure sensor to the control module.

Optionally, in the gated contrast injection device described above, the PIN connector includes: a body, and a signal transmission mechanism and a grasping mechanism provided on the body; one end of the signal transmission mechanism is connected to the blood pressure sensor , The other end is connected with the integrated circuit, and the grasping mechanism is detachably mounted on the body.

In the second aspect, this application provides an injection method of a gated contrast injection device, including:

Real-time measurement of the invasive pressure or/and ECG signal of the aorta;

According to the pressure signal or/and the ECG signal, control whether the driving module is turned on and the working power when it is turned on;

With the rotation of the driving module, a corresponding thrust is generated, thereby controlling the injection rate of the liquid.

Optionally, in the injection method of the gated contrast device described above, the method of controlling whether the drive module is turned on according to the pressure signal or/and the ECG signal includes:

Searching for an image interval in which the pressure waveform generated by the invasive pressure signal belongs to the diastolic period, that is, the first image interval;

Searching for an image interval in which the electrocardiogram generated by the electrocardiogram signal is in the diastolic phase, that is, the second image interval;

The first image interval and the second image interval are compared, and the start time of the overlap of the first image interval and the second image interval is determined as the time when the driving module is activated.

The beneficial effects brought about by the solutions provided by the embodiments of the present application include at least:

This application provides a gated contrast injection device that collects the invasive pressure waveform or/and electrocardiogram of the aorta through a pressure acquisition module, and the control module controls the opening or closing of the driving module according to the received pressure waveform or/and the electrocardiogram, and drives The module drives the injection module to move, thereby ensuring that the contrast agent is injected synchronously at the beginning of the diastole, so that the contrast agent and blood flow quickly enter the coronary blood vessels during the diastole, and control the working power of the drive module when it is turned on, the working power and the bolus Corresponding to the pressure, the bolus injection pressure affects the injection rate of the injection module, which can effectively control the stability of the injection efficiency and improve the quality of the contrast. In order to further calculate the FFR, iFR, dPR and IMR, CFR and other functional parameters based on the contrast Provide reliable flow rate measurement, solve the problem of manual bolus injection in the prior art, which is difficult to control the force and pushing speed, and the bolus time is uncertain in both high-pressure syringes and manual boluses, which cannot guarantee the smooth entry of the contrast agent into the coronary artery. This further affects the problem of poor accuracy in calculating the flow rate based on the contrast agent flow.

Description of the drawings

The drawings described here are used to provide a further understanding of the present invention and constitute a part of the present invention. The exemplary embodiments of the present invention and the description thereof are used to explain the present invention, and do not constitute an improper limitation of the present invention. In the attached picture:

Figure 1 is a structural block diagram of an embodiment of a gated contrast injection device;

Fig. 2 is a structural block diagram of another embodiment of a gated contrast injection device;

Figure 3 is a perspective view of the invasive pressure acquisition module;

Fig. 4 is a schematic structural view of Fig. 3 with the lower casing hidden;

Figure 5 is a perspective view of the invasive pressure acquisition module with the upper shell hidden;

Figure 6 is a schematic diagram of the exploded structure of the PIN connector;

Figure 7 is a schematic diagram of the structure of the upper shell and the through pipe;

Fig. 8 is a flowchart of the gated contrast injection method of the present application;

The reference signs are described below:

Control module 100, pressure acquisition module 200, invasive pressure acquisition module 210, housing 211, integrated circuit board 212, blood pressure sensor 213, pressure acquisition terminal 2131, PIN connector 214, body 2141, signal transmission mechanism 2142, grasping mechanism 2143, first connection structure 215, through pipe 216, through hole 217, ECG acquisition module 220, drive module 300, injection module 400, three-way valve 500, first branch 510, second branch 520, third branch 530, The first pipeline 600, the second pipeline 700, and the third pipeline 800.

detailed description

In order to make the objectives, technical solutions, and advantages of the present invention clearer, the technical solutions of the present invention will be clearly and completely described below in conjunction with specific embodiments of the present invention and the corresponding drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of the present invention.

Several embodiments of the present invention will be disclosed in the following drawings. For clear description, many practical details will be described in the following description. However, it should be understood that these practical details should not be used to limit the present invention. That is to say, in some embodiments of the present invention, these practical details are unnecessary. In addition, for the sake of simplification of the drawings, some conventionally used structures and components will be shown in simple schematic ways in the drawings.

As shown in Figure 1, the present application provides a gated contrast injection device, including: a control module 100, a pressure acquisition module 200 and a drive module 300 respectively connected to the control module 100, and a control module connected to the drive module 300 Injection module 400; pressure acquisition module 200, used to measure the invasive pressure or/and ECG signal of the aorta in real time; control module 100 used to receive the invasive pressure or/and ECG signal sent by the pressure acquisition module 200 in real time, according to The pressure signal and the ECG signal control whether the driving module 300 starts to work and the working power of the driving module 300; the driving module 300 is used to start or stop working and set the working power according to the instructions sent by the control module 100; the injection module 400 It is used to generate corresponding thrust with the rotation of the driving module 300, thereby controlling the injection rate of the liquid. In this application, the diastolic pressure waveform or/and the ECG diastolic interval are set in the control module 100 in advance, and then the pressure acquisition module 200 collects the invasive pressure waveform or/and the electrocardiogram of the aorta, and the control module 100 according to the received pressure waveform Or/and the electrocardiogram control the opening or closing of the driving module 300, the driving module 300 drives the injection module 400 to move, thereby ensuring that the contrast agent is injected synchronously at the beginning of the diastole, so that the contrast agent and blood flow quickly enter the coronary artery during the diastole The blood vessel controls the working power of the driving module 300 when it is opened. The working power corresponds to the bolus pressure. The bolus pressure affects the injection rate of the injection module 400, which can effectively control the stability of the injection efficiency and improve the quality of the imaging. The calculation of FFR, iFR, dPR and IMR, CFR and other functional parameters based on angiography provides reliable flow measurement, which solves the problem of manual bolus injection in the prior art. In all injections, the bolus time is uncertain, which cannot guarantee that the contrast agent enters the coronary artery smoothly, which affects the problem of poor accuracy in calculating the flow rate based on the flow of the contrast agent.

As shown in FIG. 2, in an embodiment of the present application, the pressure acquisition module 200 is an invasive pressure acquisition module 210, which is used to measure the invasive pressure of the aorta in real time. Since the pressure of the heart changes in real time, the invasive pressure is The test is more real-time, so the invasive pressure test is more accurate than the non-invasive pressure test. The invasive pressure collection module 210 is a disposable blood pressure collection device, which can avoid blood infection between patients and is safer and more reliable to use.

As shown in FIG. 2, in an embodiment of the present application, the pressure acquisition module 200 is an ECG acquisition module 220, which is used to measure the ECG signal of the aorta in real time, including non-invasive pressure. Preferably, the ECG acquisition module 220 is a data transmission module, connected to an external electrocardiograph, and used to transmit the ECG signal collected by the electrocardiograph to the control module 100. With this arrangement, the patient is subjected to an electrocardiogram examination by the electrocardiogram installed in the catheterization room, and then the examination result is transmitted to the control module 100 through the electrocardiogram acquisition module 220, which has a simple structure and low cost.

As shown in FIG. 2, in an embodiment of the present application, the pressure acquisition module 200 includes: an invasive pressure acquisition module 210 and an ECG acquisition module 220. The invasive pressure acquisition module 210 is used to measure the invasive pressure of the aorta in real time; The ECG acquisition module 220 is used to measure the ECG signal of the aorta in real time, including non-invasive pressure. The preferred method of the present application is to have both the invasive pressure acquisition module 210 and the ECG acquisition module 220. With this configuration, the pressure formed by the invasive pressure acquisition module 210 can be combined with the ECG waveform of the ECG acquisition module 220. By comparison, it is concluded that the time is at the beginning of the diastole, and the time of the bolus injection is more accurate and the error is reduced.

As shown in FIG. 2, an embodiment of the present application further includes: a three-way valve 500. The first branch 510 of the three-way valve 500 is connected to the invasive pressure acquisition module 210 through the first pipeline 600 for real-time measurement. The invasive pressure of the aorta; the second branch 520 of the three-way valve 500 is connected to the injection module 400 through the second pipeline 700, and is used to make the liquid in the second pipeline 700 move uniformly under the push of the injection module 400 ; The third branch 530 of the three-way valve 500 is connected to the external contrast catheter through the third pipeline 800. In this application, the bolus injection pressure matching the bolus injection rate and the working efficiency of the driving module 300 are set in the control module 100 in advance. The bolus injection pressure is controlled by the working efficiency, and the bolus injection pressure determines the bolus injection rate, thereby ensuring that the bolus injection is more stable. Improve the quality of imaging.

In an embodiment of the present application, the control module 100 is a central processing unit. The driving module 300 is a driving motor, such as a servo motor; the injection module 400 is a liquid injector.

As shown in Figures 3, 4, 5 and 6, in an embodiment of the present application, the invasive pressure acquisition module 210 includes: a housing 211, an integrated circuit board 212, a blood pressure sensor 213, a PIN connector 214, and a A connecting structure 215 and a through tube 216; the blood pressure sensor 213, the integrated circuit board 212, and the PIN connector 214 are all arranged in the housing 211; the blood pressure sensor 213 is communicatively connected with the integrated circuit board 212 through the PIN connector 214; away from the first connection In the direction of structure 215, the through pipe 216 is set on the top of the housing 211, the through hole 217 is provided on the inner surface of the through pipe 216, and one end of the through pipe 216 is connected to the first pipeline 600; one end of the blood pressure sensor 213 is the pressure collection end 2131, The end 2131 is sealed in the through hole 217 as shown in FIG. 7 for collecting the pressure value of the liquid flowing through the through pipe 216; the first connection structure 215 is connected to the housing 211, the integrated circuit board 212, and the control module 100, respectively , Used to transmit the pressure value collected by the blood pressure sensor 213 to the control module 100. In this application, the housing 211, the blood pressure sensor 213, the PIN connector 214, and the first connection structure 215 are arranged as a whole, which not only realizes the collection and transmission of the blood pressure sensor 213, but also improves the tightness of the blood pressure sensor 213. All are integrated in In the housing 211, the volume is reduced, and the first connection structure 215 is connected with external equipment, which realizes a detachable arrangement and is convenient to assemble. Since the pressure collection end 2131 of the blood pressure sensor 213 is sealed in the through hole 217, the through hole 217 is connected to the through pipe 216, and the liquid pressure can be collected in real time without contact with the external environment, which improves the accuracy of the measurement; through the PIN connector 214, The first connection structure 215 realizes the transmission of the pressure value. Since the liquid only flows in the sealed structure composed of the through pipe 216, the through hole 217 and the pressure collecting end 2131, it will not contact other structures, which improves the service life of each component and is scrapped. The rate is low, maintenance and production costs are reduced, and it has the advantages of simple structure and simple procedures.

As shown in FIG. 7, in an embodiment of the present application, the PIN connector 214 includes a body 2141, and a signal transmission mechanism 2142 and a grasping mechanism 2143 provided on the body 2141; one end of the signal transmission mechanism 2142 is connected to the blood pressure sensor 213 , The other end is connected to the integrated circuit board 212, and the grasping mechanism 2143 is detachably mounted on the body 2141. Since the length, width, and height of the PIN connector body 2141 are all less than 1cm, the body 2141 has a small volume, which makes it difficult to grasp and install. Because of the small size of the body 2141, it is necessary to grab the body 2141 and prevent it from being grasped. Excessive force damages the main body 2141, so it is difficult to accurately grasp the main body 2141 without damaging the main body 2141. In order to solve the problem of fast and accurate grasping without damaging the main body 2141, the present application is provided with a detachable grasping mechanism 2143 on the main body 2141. If the PIN connector needs to be installed on the invasive pressure acquisition module 210, The grasping mechanism 2143 is installed on the body 2141, and the grasping mechanism 2143 is accurately grasped and installed on the invasive blood pressure collection device manually or through a mechanical structure; if the installation is completed, the grasping mechanism 2143 is manually or through a mechanical structure. Remove from the main body 2141, reduce the occupied volume of the grasping mechanism 2143 on the main body 2141, reduce the volume of the PIN connector, thereby saving the internal space of the invasive pressure acquisition module 210, and facilitate the improvement of the integration of the invasive pressure acquisition module 210 Spend.

As shown in Figure 8, this application provides a gated contrast injection method, including:

S100, real-time measurement of the invasive pressure or/and ECG signal of the aorta;

S200, controlling whether the drive module is turned on and the working power when turned on according to the pressure signal or/and the ECG signal, including:

Comparing the first image interval with the second image interval, and judging that the start time when the first image interval overlaps with the second image interval is determined as the time when the driving module is started;

S300, with the rotation of the driving module, a corresponding thrust is generated, thereby controlling the injection rate of the liquid.

The above-mentioned specific examples of the present invention further describe the purpose, technical solutions and beneficial effects of the present invention in detail. It should be understood that the above are only specific embodiments of the present invention and are not intended to limit the present invention. The invention, any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

A gated contrast injection device, characterized by comprising: a control module, a pressure acquisition module and a driving module respectively connected to the control module, and an injection module connected to the driving module;

The pressure acquisition module is used to measure the invasive pressure of the aorta or/and the ECG signal in real time;

The control module is configured to receive the invasive pressure or/and the ECG signal sent by the pressure acquisition module in real time, control whether the drive module starts working according to the pressure signal and the ECG signal, and control the The working power of the drive module;

The driving module is used to start or stop work according to the instruction sent by the control module, and set the working power;

The injection module is used to generate a corresponding thrust with the rotation of the driving module, thereby controlling the injection rate of the liquid.
The gated contrast injection device according to claim 1, wherein the pressure acquisition module is an invasive pressure acquisition module for real-time measurement of the invasive pressure of the aorta.
The gated contrast injection device according to claim 1, wherein the pressure acquisition module is an ECG acquisition module for real-time measurement of the ECG signal of the aorta, including non-invasive pressure.
The gated contrast injection device according to claim 1, wherein the pressure acquisition module comprises: an invasive pressure acquisition module and an ECG acquisition module, and the invasive pressure acquisition module is used for real-time measurement of the aortic pressure Invasive pressure; the ECG acquisition module is used to measure the ECG signal of the aorta in real time, including non-invasive pressure.
The gated contrast injection device according to claim 2 or 4, further comprising: a three-way valve, the first branch of the three-way valve is connected to the invasive pressure acquisition module through a first pipeline, It is used to measure the invasive pressure of the aorta in real time; the second branch of the three-way valve is connected to the injection module through a second pipeline, and is used to make the liquid in the second pipeline be injected into the The module moves at a uniform speed under the push of the module; the third branch of the three-way valve is connected to the external contrast catheter through the third pipeline.
The gated contrast injection device according to claim 3 or 4, wherein the ECG acquisition module is a data transmission module, which is connected to an external electrocardiograph, and is used to collect the heartbeat collected by the electrocardiograph. The electrical signal is transmitted to the control module.
The gated contrast injection device according to claim 1, wherein the control module is a central processing unit.
The gated contrast injection device according to claim 1, wherein the driving module is a driving motor, or/and the injection module is a liquid injector.
The gated contrast injection device according to claim 5, wherein the invasive pressure acquisition module comprises: a housing, an integrated circuit board, a blood pressure sensor, a PIN connector, a first connection structure and a through pipe; The blood pressure sensor, the integrated circuit board, and the PIN connector are all arranged in the housing; the blood pressure sensor is communicatively connected with the integrated circuit board through the PIN connector;

Away from the direction of the first connection structure, the through pipe is arranged on the top of the housing, a through hole is provided on the inner surface of the through pipe, and one end of the through pipe is connected to the first pipeline;

One end of the blood pressure sensor is a pressure collecting end, and the pressure collecting end is sealed in the through hole for collecting the pressure value of the liquid flowing through the through tube;

The first connection structure is respectively connected with the housing, the integrated circuit board, and the control module, and is used to transmit the pressure value collected by the blood pressure sensor to the control module.
The gated contrast injection device according to claim 9, wherein the PIN connector comprises a body, and a signal transmission mechanism and a grasping mechanism provided on the body; one end of the signal transmission mechanism is connected to the The blood pressure sensor is connected, the other end is connected with the integrated circuit, and the grabbing mechanism is detachably mounted on the body.
The injection method of the gated contrast injection device according to any one of claims 1 to 10, characterized in that it comprises:

Real-time measurement of the invasive pressure or/and ECG signal of the aorta;

According to the pressure signal or/and the ECG signal, control whether the driving module is turned on and the working power when it is turned on;

With the rotation of the driving module, a corresponding thrust is generated, thereby controlling the injection rate of the liquid.
The injection method of a gated radiography device according to claim 11, wherein the method of controlling whether the drive module is turned on according to the pressure signal or/and the ECG signal comprises:

Searching for an image interval in which the pressure waveform generated by the invasive pressure signal belongs to the diastolic period, that is, the first image interval;

Searching for an image interval in which the electrocardiogram generated by the electrocardiogram signal is in the diastolic phase, that is, the second image interval;

The first image interval and the second image interval are compared, and the start time of the overlap of the first image interval and the second image interval is determined as the time when the driving module is activated.