CN116392664A - Reperfusion system for myocardial perfusion coronary artery and control method - Google Patents

Reperfusion system for myocardial perfusion coronary artery and control method Download PDF

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CN116392664A
CN116392664A CN202310198847.4A CN202310198847A CN116392664A CN 116392664 A CN116392664 A CN 116392664A CN 202310198847 A CN202310198847 A CN 202310198847A CN 116392664 A CN116392664 A CN 116392664A
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catheter
reperfusion
host
heat exchange
peristaltic pump
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陈明惠
闫小响
孙天宇
钱志文
何龙喜
於天祥
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University of Shanghai for Science and Technology
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University of Shanghai for Science and Technology
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3613Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion

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Abstract

The invention relates to an interventional medical device, in particular to a reperfusion system and a control method for myocardial perfusion coronary artery, comprising a host machine and an off-machine tube group; the outer tube group comprises a main machine drainage tube, a main machine return tube, a three-way joint, a catheter sheath and a pressurizing reperfusion catheter; one port of the three-way joint is connected with the host drainage tube, the other end of the host drainage tube is connected with the host, the two ports are connected with the catheter sheath, the catheter sheath coaxially penetrates through the pressurizing reperfusion catheter, the head end of the pressurizing reperfusion catheter extends out of the three ports, and the host return tube is connected with the host and the pressurizing reperfusion catheter; the tail end of the catheter is provided with a pressure sensor and an infusion hole; a temperature control box, a peristaltic pump and a controller are arranged in the host; the host drainage tube is connected with the inlet of the peristaltic pump, the outlet is connected with the inlet of the temperature control box, and the outlet is connected with the host reflux tube; the controller is electrically connected with the peristaltic pump, the temperature control box and the pressure sensor. Compared with the prior art, the invention realizes the accurate control of pressurization to reperfusion of the heart coronary artery.

Description

Reperfusion system for myocardial perfusion coronary artery and control method
Technical Field
The invention relates to an interventional medical device, in particular to a reperfusion system for myocardial perfusion coronary artery and a control method.
Background
Acute Myocardial Infarction (AMI) is typically caused by a blockage of the heart by a thrombus, prolonged ischemia and hypoxia, which, if not recovered quickly, can cause irreversible damage to the heart. Percutaneous Coronary Intervention (PCI) has become the standard treatment for Acute Myocardial Infarction (AMI) for 25 years, but more than 30% of AMI patients still develop heart failure within five years after treatment, a major view of which is that there is no "back flow", i.e. no restoration of blood flow from the microvascular.
The current methods for pressurizing blood are as follows:
first kind: in a way of controlling the motor to rotate so as to drive the blood to flow and realize pressurization. Taking Impella5.0 as an example, the control principle is that in operation, a catheter is inserted percutaneously, a meshed part is arranged in the left ventricle at the far end, an axial flow pump is arranged in the aortic valve, the near end is arranged in the aorta, and a control system is externally connected with an interface. The blood in the left ventricle is sucked into the catheter through the mesh on the distal end of the catheter, and then the blood is discharged into the aorta from the outlet of the axial flow pump, so that auxiliary blood supply is realized, and pressure is formed. In this method, the patient requires an open chest procedure, and an axial flow pump is positioned by the physician on the heart for the patient.
Second kind: blood is pressurized in an in vitro oxygenation mode to form high-oxygen blood, and the high-oxygen blood is sent into a coronary artery through a catheter. For example, super Saturated Oxygen (SSO) produced by Therox company of the United states 2 ) For example, an extracorporeal membrane oxygenator in a device having a three-chamber housing for generating SSO from hospital supplied oxygen and saline inputs 2 Solution and carry SSO in the blood path 2 The solution was mixed with arterial blood to a pressure of 760-1000mmHg and the coronary artery was continuously refilled at 100mL/min for 1 hour.
The existing devices for pressurizing coronary vessels of the heart are divided into two types:
the first is pulse pressurization, which is usually used in emergency treatment of heart failure patients, and can be performed in synchronization with heart rhythm to assist the heart in pulse and raise blood pressure.
The second is continuous pressurization, that is, the heart is pressurized and maintained in a certain range by using an axial flow pump, and the patient needs to be put on after the doctor performs the chest opening operation.
At present, clinical experiments prove that the bionic pulsating pressurization has more obvious myocardial protection effect, can effectively reduce complications such as inflammation and the like, and can effectively improve the physiological index of myocardial activity by reducing the blood temperature to sublow temperature (34 ℃).
Chinese patent CN202220177087.X discloses an in vitro perfusion device and system, which adopts the mode of gradually and slowly perfusing mixed venous blood/arterial blood/medicine into heart muscle, and then performing in vitro perfusion by expanding a narrow part through a balloon or a bracket after the function of the heart muscle is recovered. However, this method cannot take the form of bionic pulsating compression, and although the damage to the myocardium is reduced by slow perfusion, it requires a long treatment time and cannot be used for acute patients.
In view of the foregoing, there is a need for a perfusion system that combines sub-low temperature with biomimetic pulsatile compression.
Disclosure of Invention
The invention aims to solve at least one of the problems and provide a reperfusion system and a control method of myocardial perfusion coronary artery, which are used for solving the problems that a bionic pulsating pressurized perfusion system is lack in the prior art, so that the damage of cardiac muscle is difficult to avoid in the treatment process, realizing the accurate control of pressurization to reperfusion of the cardiac coronary artery, promoting the circulation of heart micro-blood vessels, protecting cardiac muscle, improving the activity function of cardiac muscle and reducing micro-blood vessel inflammation and cyst.
The aim of the invention is achieved by the following technical scheme:
the first aspect of the invention discloses a reperfusion system for myocardial perfusion coronary artery, comprising a host machine and an off-machine tube group;
the machine outer tube group comprises a main machine drainage tube, a main machine return tube, a three-way joint, a catheter sheath and a pressurizing reperfusion catheter;
the first port of the three-way joint is connected with one end of the host drainage tube, the other end of the host drainage tube is connected with the host, the second port of the three-way joint is connected with the catheter sheath, the catheter sheath coaxially penetrates through the pressurizing reperfusion catheter, the head end of the pressurizing reperfusion catheter extends out of the third port of the three-way joint, and the host return tube is connected with the host and the pressurizing reperfusion catheter;
the end of the pressure reperfusion catheter is provided with a pressure sensor and an infusion hole;
a temperature control box, a peristaltic pump and a controller are arranged in the host;
the host drainage tube is connected with the inlet end of the peristaltic pump, the outlet end of the peristaltic pump is connected with the inlet end of the temperature control box, and the outlet end of the temperature control box is connected with the host reflux tube;
the controller is electrically connected with the peristaltic pump, the temperature control box and the pressure sensor.
Preferably, the temperature control box comprises a heat exchange assembly and a heat dissipation assembly;
the heat exchange assembly comprises a heat exchange conduit, a first temperature sensor, a heat exchange clamping plate and a Peltier semiconductor;
the heat exchange conduit is connected with the peristaltic pump and the host return pipe;
the heat exchange guide pipe is clamped between the heat exchange clamping plates; the first temperature sensor is arranged in the heat exchange conduit and is electrically connected with the controller; the cold end of the Peltier semiconductor is attached to the heat exchange clamping plate, the heat dissipation assembly is arranged at the hot end of the Peltier semiconductor, and the Peltier semiconductor is electrically connected with the controller.
Preferably, the heat dissipation assembly comprises a heat dissipation fin, a fan and a second temperature sensor;
one side of the radiating fin is attached to the hot end of the Peltier semiconductor, and the other side of the radiating fin is provided with a fan; the second temperature sensor is arranged in the radiating fins and is electrically connected with the controller; the fan is electrically connected with the controller.
Preferably, the heat exchange conduit is made of medical 316L stainless steel and is arranged in a coiled structure; the heat exchange clamping plate consists of a pair of heat exchange plate groupsThe surface of the heat exchange plate is provided with a groove matched with the heat exchange conduit, and the heat exchange plate is made of Al 2 O 3 A ceramic material; the first temperature sensor is a patch type temperature sensor and is respectively arranged at the inlet, the outlet and the middle point of the heat exchange pipe.
Preferably, the side of the peltier semiconductor is coated with a heat insulation pad, and a wire channel is formed in the heat insulation pad.
Preferably, the end of the catheter of the pressurized reperfusion catheter is of a three-section structure, the first section is a flexible opening tip, the middle section is a hard supporting section, and the rear section is a flexible bending section.
Preferably, the wall of the pressurized reperfusion catheter is of a three-layer structure, the inner layer is made of PTEE material, the outer layer is made of polyurethane material, the middle layer is a hollow cavity with the end part provided with a supporting steel wire, and the signal wire of the pressure sensor passes through the middle layer.
Preferably, the pressurized reperfusion catheter is a 5F catheter; the tip diameter of the catheter sheath is larger than that of the pressurized reperfusion catheter; the pressure sensor is a miniature invasive pressure sensor, and the size of the pressure sensor is not more than 1mm multiplied by 1mm; the infusion holes are arranged in a plurality, the centers of the infusion holes are symmetrically arranged, the adjacent intervals of the infusion holes are 2cm, and the diameter of the infusion holes is 0.4mm.
Preferably, the main machine drainage tube and the main machine return tube are respectively provided with a one-way valve.
Preferably, a sensor is further arranged in the host machine, and the host machine has the functions of monitoring flow, bubbles and the like.
The second aspect of the present invention discloses a control method of a reperfusion system for myocardial perfusion coronary artery as described in any one of the above, the peristaltic pump comprises two operation modes:
the first mode of operation is constant speed pumping;
the second operation mode is bionic pulsating pressurized pumping, and specifically comprises the following steps: the controller feedback controls the rotating speed of the peristaltic pump according to the pressure signal of the pressure sensor, so that pumping of synchronous heart rate is realized;
the controller controls the peristaltic pump to switch between two operation modes according to the operation time length of the peristaltic pump.
Preferably, in the bionic pulsating pressurized pumping, the peristaltic pump is controlled by a fuzzy PID control mode by the controller, and the objective function is
Figure BDA0004108275840000041
Where k is the sampling period, e (k) is the sampling value of the kth sampling period, u (k) is the controller output of the kth sampling period, k P Is a proportionality coefficient, k I Is an integral coefficient, k D Is a differential coefficient.
Compared with the prior art, the invention has the following beneficial effects:
1. the device for the pressure perfusion auxiliary treatment of myocardial infarction is divided into two parts, wherein one part is a pressure reperfusion catheter which enters a myocardial coronary artery port along a femoral artery, and can monitor the intra-coronary blood pressure in real time. The other part is an external host machine which comprises a controller, a peristaltic pump, a temperature control box and a sensor. The controller regulates the peristaltic pump to work by receiving the pressure signal of the blood pressure, and the sensor can monitor the flow, the temperature and the bubbles of the blood flow in the tank. The pressure can be precisely controlled to reperfusion the heart coronary artery, so that the coronary artery perfusion pressure is maintained to be 90-120mmHg, the accuracy reaches +/-2 mmHg, and the maximum deviation is less than +/-10 mmHg. Can promote heart micro-vascular circulation, protect cardiac muscle, and reduce micro-vascular inflammation and cyst by lowering reperfusion blood temperature to 34 deg.c.
2. According to the myocardial reperfusion device, the Peltier semiconductor is used in the temperature control box of the host, refrigeration and temperature rising can be realized, the accurate temperature control of variable-speed flowing blood temperature can be realized by matching with the temperature sensor, the catheter which is inserted into the body and can detect the blood pressure in the coronary artery blood vessel can be realized, and the pressure sensor is arranged at the tail end of the catheter which is inserted into the body, so that the intravascular pressurization process can be reflected in real time, and the beneficial guarantee is provided for the treatment safety and effectiveness. The pressure sensor with quick response receives the blood pressure fluctuation signal, and can accurately adjust the rotating speed of the peristaltic pump at the end of one cardiac cycle in a fuzzy PID control mode, so that the peristaltic pump can automatically control the pressurizing process in the process of matching the heart pump blood of the next cardiac cycle.
Drawings
FIG. 1 is a schematic diagram of a reperfusion system;
FIG. 2 is a schematic view of the structure of the catheter tip of the pressurized reperfusion catheter in the heart;
FIG. 3 is a schematic diagram of the logic of a controller controlling a peristaltic pump;
FIG. 4 is a schematic view of the structure of the catheter tip;
FIG. 5 is an exploded view of the catheter tip;
FIG. 6 is a schematic cross-sectional view of a configuration of a pressurized reperfusion catheter;
FIG. 7 is a schematic view of a heat exchange conduit;
FIG. 8 is a schematic view of a heat exchange clamping plate;
FIG. 9 is a schematic view of a heat exchanger plate;
fig. 10 is a schematic structural diagram of a peltier semiconductor;
fig. 11 is a schematic structural view of a heat sink fin;
FIG. 12 is a pictorial view of a pressure sensor at the distal end of a catheter;
in the figure: 1-a temperature control box; 2-a controller; 3-peristaltic pump; 4-a sensor; 5-a one-way valve; 6-a three-way joint; 7-signal conductors; 8-pressurizing reperfusion catheter; 9-catheter sheath; 10-catheter tip; 11-a main machine drainage tube; 12-host return pipe; 13-an infusion well; 14-a pressure sensor; 15-heat exchange conduit; 16-a first temperature sensor; 17-a heat exchange clamping plate; 18-grooves; 19-limiting holes; 20-heat exchange plates; a 21-peltier semiconductor; 22-heat insulation pad; 23-wire channels; 24-heat dissipation fins; 25-a second temperature sensor.
Detailed Description
The invention will now be described in detail with reference to the drawings and specific examples.
Example 1
A reperfusion system for myocardial perfusion coronary artery, as shown in figures 1-12, comprises a host and an off-board tube set;
the outer tube set comprises a main machine drainage tube 11, a main machine return tube 12, a three-way joint 6, a catheter sheath 9 and a pressurizing reperfusion catheter 8;
the first port of the three-way joint 6 is connected with one end of a host drainage tube 11, the other end of the host drainage tube 11 is connected with a host, the second port of the three-way joint 6 is connected with a catheter sheath 9, the catheter sheath 9 coaxially penetrates through the pressurizing reperfusion catheter 8, the head end of the pressurizing reperfusion catheter 8 extends out of the third port of the three-way joint 6, and the host return tube 12 is connected with the host and the pressurizing reperfusion catheter 8;
the catheter tip 10 of the pressurized reperfusion catheter 8 is provided with a pressure sensor 14 and an infusion hole 13;
a temperature control box 1, a peristaltic pump 3 and a controller 2 are arranged in the host;
the host drainage tube 11 is connected with the inlet end of the peristaltic pump 3, the outlet end of the peristaltic pump 3 is connected with the inlet end of the temperature control box 1, and the outlet end of the temperature control box 1 is connected with the host return tube 12;
the controller 2 is electrically connected with the peristaltic pump 3, the temperature control box 1 and the pressure sensor 14.
More specifically, in the present embodiment:
a device for reperfusion of coronary arteries to the myocardium comprises two parts, one part is a main body part and the other part is an in-body catheter part (an off-board tube group). An overall schematic of the system is shown in fig. 1. The 5F pressurized reperfusion catheter 8 is provided with a pressure sensor 14, infusion port 13 on the surface of the catheter tip 10, as shown in endocardial schematic figure 2.
The main machine part comprises a temperature control box 1, a controller 2, a peristaltic pump 3 and a sensor 4, and is connected with a three-way joint 6 and a pressurizing reperfusion catheter 8 through a main machine drainage tube 11 and a main machine return tube 12 outside the main machine to form extracorporeal circulation.
The temperature control box 1 is composed of a heat exchange component and a heat dissipation component.
The heat exchange assembly consists of a heat exchange conduit 15, a first temperature sensor 16, a heat exchange clamping plate 17 and a temperature control device.
The heat exchange conduit 15 inside the temperature control box 1 uses a medical metal conduit, so that heat transfer and temperature measurement are facilitated, and the medical 316L stainless steel is particularly used. The heat exchange conduit 15 is a cylindrical tube body, and is arranged in a serpentine shape, an elbow is arranged at the turning position, and a first temperature sensor 16 is arranged at the inlet and outlet and the middle point of the heat exchange conduit 15 for monitoring the temperature of blood in the tube, as shown in fig. 7, the first temperature sensor 16 is electrically connected with the controller 2 again, so as to feed back the temperature data in the heat exchange conduit 15. The first temperature sensor 16 is a film patch type temperature sensor, and is small in size and convenient to install. The model is an ultrathin surface patch PT100 platinum thermal resistance temperature sensor, the temperature acquisition range is-200 ℃ to +650 ℃, the precision can reach +/-0.1 ℃, and the response time is less than or equal to 0.05s. Three first temperature sensors 16 are arranged at the outlet, the inlet and the middle of the heat pipe 15, so that feedforward-feedback common control can be effectively formed, and the accuracy and timeliness of temperature control are ensured.
The heat exchange clamping plates 17 are formed by combining a pair of round-corner rectangular heat exchange plates 20, and grooves 18 matched with the shape and the size of the heat exchange guide pipes 15 are formed in the inner sides of the heat exchange plates 20, as shown in fig. 9, so that the heat exchange guide pipes 15 can be clamped, limited and fully wrapped between the heat exchange clamping plates 17. The two heat exchange plates 20 pass through the limiting holes 19 through the limiting piece to realize limiting fixation, as shown in fig. 8. The heat exchange plate 20 adopts Al 2 O 3 The ceramic plate has good insulating heat conduction performance, is convenient for heat transfer and insulation, has a heat conduction coefficient within the range of 23-32W/(m.K), and has good heat conduction performance. The heat exchange time can be calculated by the following formula: 1) Heating:
Figure BDA0004108275840000061
2) And (3) cooling: />
Figure BDA0004108275840000062
Wherein τ: heat transfer time, C M : specific heat capacity of heated material, M: mass of heated material, K: overall heat transfer coefficient, a: heat transfer area, T: heating temperature T 1 : initial temperature of heated material, T 2 : end temperature of the heated material.
The temperature control device is used for controlling temperature by using the peltier semiconductor 21, and has two functions of refrigeration and heating at the same time, so that high-precision temperature control is realized. The Peltier semiconductor 21 is electrically connected with the controller 2, and can adjust current to adjust refrigerating capacity, the model is TEC1-12705, the maximum working voltage is 15.2V, the maximum current is 5A, the maximum temperature difference is 67 ℃, the maximum refrigerating power is 52.1W, the size specification is 40 multiplied by 4 (mm), and the resistance range is 2.2-2.6Ω. After the peltier semiconductor 21 is electrified, one node dissipates heat and the other node absorbs heat, the cold end is attached to the heat exchange clamping plate 17, so that the temperature of blood flowing through the heat exchange conduit 15 can be reduced, and the blood is basically maintained at a sub-low temperature through the feedback of a plurality of first temperature sensors 16 arranged in the heat exchange conduit 15 and the adjustment of the current passing through the peltier semiconductor 21 by the controller 2, so that the myocardial activity physiological index is improved, and the inflammation and cyst of tiny blood vessels are reduced; the heat generated at the hot end of the peltier semiconductor 21 is dissipated by the heat dissipating component. A circle of heat insulation pad 22 is wrapped around the peltier semiconductor 21, and as shown in fig. 10, the heat insulation pad 22 closely fits the peltier semiconductor 21 to reduce heat loss. A wire passage 23 is formed in the heat insulating pad 22 for the wires connected to the peltier semiconductor 21 to pass through.
The heat sink assembly is composed of heat sink fins 24, a fan and a second temperature sensor 25, as shown in fig. 11. The heat radiation fins 24 are closely attached to the peltier semiconductor 21 at one end surface, and the other end surface is subjected to air blowing and heat radiation by a fan, and the fan is electrically connected with the controller 2. The second temperature sensor 25 is disposed in the heat dissipation fin 24, and is electrically connected with the controller 2, and controls the rotation speed of the fan to dissipate heat by comparing the set temperature with the temperature collected by the second temperature sensor 25 in the heat dissipation fin 24, so as to ensure the refrigeration efficiency and the heat exchange efficiency of the peltier semiconductor 21.
In this embodiment, the sensor 4 is a plurality of sensors 4 integrated in the host, and has the function of monitoring the blood flow and bubbles in the tube.
Peristaltic pump 3 has two modes of operation, one being steady operation when not beating the heart beat and the other being accelerated operation when beating the heart beat. The pressure of the peristaltic pump 3 during steady-speed operation and the pressure during heartbeat pulsation can be set by the controller 2When the peristaltic pump 3 is controlled by the controller 2 according to the pressure signal fed back by the pressure sensor 14, so that the heart rate can be synchronized to pressurize the heart and coronary artery blood vessels, the schematic diagram of the peristaltic pump 3 controlled by the controller 2 is shown in fig. 3, and the basis is provided for the controller 2 to adjust the rotation speed and the acceleration period of the peristaltic pump 3 according to the pressure signal reflected in real time. More specifically, the pressure sensor 14, which responds sensitively and rapidly, receives the blood pressure fluctuation signal, and can accurately regulate the rotation speed of the peristaltic pump 3 at the end of one cardiac cycle in a fuzzy PID control mode, so that the peristaltic pump can automatically control the pressurizing process in the process of matching the cardiac pumping of the next cardiac cycle, and the objective function of the fuzzy PID control is that
Figure BDA0004108275840000071
Where k is the sampling period, e (k) is the sampling value of the kth sampling period, u (k) is the output of the controller 2 of the kth sampling period, k P Is a proportionality coefficient, k I Is an integral coefficient, k D Is a differential coefficient.
The body inlet catheter section includes a three-way fitting 6, a 5F pressurized reperfusion catheter 8 and a catheter sheath 9.
The three-way joint 6 is provided with a switch valve on the pipe wall, the two ports of the three-way joint can be opened by rotating the switch, the two ports respectively correspond to the host drainage pipe 11 and the host return pipe 12, and the other port is connected with the catheter sheath 9. The catheter sheath 9 is at the tip of the introducer and has a diameter that meets the coaxial requirements of the 5F pressure reperfusion catheter 8, i.e., an internal diameter that is at least greater than the diameter of the 5F pressure reperfusion catheter 8, while ensuring sufficient blood flow that can be drawn out of the outer annulus, and the rear end port of the catheter sheath 9 can be inserted over a finger guide wire so that the 5F pressure reperfusion catheter 8 can nest over the guide wire for delivery into the coronary arteries. Specifically, one port (first port) of the three-way joint 6 is connected to the main drain tube 11, one port (second port) is connected to the catheter sheath 9, the remaining one port (third port) is connected to the main return tube 12 through the 5F pressurized reperfusion catheter 8, and the 5F pressurized reperfusion catheter 8 is further connected to the main return tube 12.
The main machine drainage tube 11 and the main machine return tube 12 are respectively provided with a one-way valve 5 for preventing the blood in the tube from flowing backwards. The host drainage tube 11 is connected with one port of the three-way joint 6, and introduces the blood led out of the catheter sheath 9 into the host. The main machine reflux tube 12 can be connected with the 5F pressurizing reperfusion catheter 8 to input the blood after pressurizing and cooling into the heart coronary artery blood vessel, and improve the blood pressure of the target blood vessel.
The 5F pressurized reperfusion catheter 8 is provided with a plurality of infusion holes 13 and one or more pressure sensors 14 at the catheter tip 10, see fig. 4, 5. The infusion holes 13 are centrally symmetrical throughout the catheter tip 10, with an optimal diameter of 0.4mm, and the front and rear infusion holes 13 are spaced about 2cm. The size of the pressure sensor 14 is not more than 1mm multiplied by 1mm, the pressure sensor has better biocompatibility, and the surface of the pressure sensing chip is slightly recessed downwards, so that the impact signal of the blood pressure can be received more easily. Preferably, the pressure sensor 14 is an intra-sensor micro-invasive pressure sensor 14 (see FIG. 12), which is disposed at the catheter tip 10 as the pressure sensor 14 for monitoring the blood pressure in the coronary artery blood vessel, the size of which is 0.75mm by 0.22mm by 0.8mm, the clinically effective range of-300 mmHg to +500mmHg can be accurately measured at 10-60 ℃, the pressure sensitivity is 5.5uV/V/mmHg,
Figure BDA0004108275840000081
sampling frequency 2kHz, < >>
Figure BDA0004108275840000082
The response time is 0.5ms, and the process of heart blood pressure pulsation can be accurately and timely reflected. The pressure sensor 14 and the peristaltic pump 3 are matched for use, so that the pressurization can be accurately controlled to reperfusion the heart coronary artery, the coronary artery perfusion pressure is kept at 90-120mmHg, the accuracy reaches +/-2 mmHg, and the maximum deviation is less than +/-10 mmHg.
The structure of the 5F pressurized reperfusion catheter 8 is divided into three layers and three segments.
Wherein the three layers of finger tube walls are respectively: the inner smooth material is nylon PTEE, which is used for conveying blood and can also pass through a finger guide wire; the middle layer is supported by a steel wire fine wire at the tail end 10 of the catheter, so that the catheter cavity cannot collapse, and a signal wire 7 connected with the pressure sensor 14 can be used; the outer layer is made of polyurethane tube, and the end 10 of the catheter is in a convex opening cone shape, and has the characteristics of smoothness and easy passage through blood vessels, as shown in figure 5. The signal wire 7 connected with the pressure sensor 14, namely the pressure output signal wire, can extend to the outside of the rear port of the catheter sheath 9 along the middle layer of the catheter and is connected with the controller 2 to reflect the intracardiac coronary blood pressure in real time, and can also provide a judgment basis for a doctor to accept the treatment effect of a patient.
The three sections are for the catheter tip 10, divided into: an ultra-soft tip port section for facilitating passage through a blood vessel; the support section with X-visibility and medium hardness can maintain the shape of the catheter and is easy for doctors to extend the catheter into a target blood vessel; the flexible coaxial segment is easily bendable, see fig. 6. The three-section arrangement allows the catheter tip 10 of the pressurized reperfusion catheter 8 to exhibit a curved nature that can be supported within the aortic arch during pressurization, as shown in fig. 2, allowing the pressurization process to run smoothly, reducing jitter at the catheter tip 10.
The controller 2 selects a programmable controller, the pressure during operation and the pressure during heart beat can be set through the controller 2, and the rotating speed of the peristaltic pump 3 can be controlled according to the pressure signal fed back by the pressure sensor 13, so that the peristaltic pump 3 can pressurize coronary artery blood vessels in a heart rate synchronous mode; the current passing through the peltier semiconductor 21 can also be feedback-controlled by the temperature signal of the first temperature sensor 16 to adjust the cooling temperature, and thus accurate and real-time temperature control of the variable-speed flowing blood temperature can be achieved.
The method for using the device for reperfusion of coronary artery to cardiac muscle is as follows:
including but not limited to within 6 hours after percutaneous coronary intervention and other conditions of applicable heart failure.
The distal end and the proximal end refer to the positions of the distal end and the proximal end relative to the position of a doctor.
Firstly, the femoral artery puncture is carried out on a patient, the tip of the arterial sheath is put into the femoral artery vessel of the patient,
blood flows to the three-way connection 6 and after purging air, the three-way connection 6 is closed.
Next, a 5F pressure reperfusion catheter 8 is passed coaxially through the arterial sheath trailing end using a finger guide wire and into the ostium of the heart coronary artery as shown in endocardial schematic 2.
Next, the finger guide wire is withdrawn, and the withdrawn signal wire 7 is connected to the controller 2.
Next, the system host is started, the peristaltic pump 3 starts to work, one port of the three-way joint 6 is connected with the host drainage tube 11, the valve of the three-way joint 6 is opened, blood enters the heat exchange conduit 15 in the temperature control box 1 from the host drainage tube 11 through the peristaltic pump 3 until reaching the set temperature, and the blood reaches the host return tube 12 to empty the air in the tube.
Next, the main return tube 12 is connected to the 5F pressurized reperfusion catheter 8 and blood is pumped into the heart ischemic coronary artery blood vessel.
Next, the reperfusion pressure is set by the controller 2, and the reperfusion pressure setting is divided into two parts, one part setting a constant operating pressure and the other part setting a pressure that is pressurized when the heart beats.
At the end of the 5F pressurizing reperfusion catheter 8, the catheter wall is provided with an infusion hole 13, so that the pressure can be reasonably infused into the coronary artery of the heart of a patient, at the moment, the pressure sensor 14 can detect the pressure in the blood vessel of the coronary artery of the heart of the patient in real time, and the pressure is fed back to the controller 2 of the host computer to form a closed-loop control system, so that the damage of the excessive reperfusion pressure to the blood vessel is avoided. After the set reperfusion time period is reached, the controller 2 can automatically reduce the reperfusion pressure, control the peristaltic pump 3 to run at a low rotation speed so as to maintain the blood pressure in a slow running mode, and simultaneously, the one-way valve 5 prevents the backflow of the pressurization reperfusion catheter 8 of the blood path 5F.
The previous description of the embodiments is provided to facilitate a person of ordinary skill in the art in order to make and use the present invention. It will be apparent to those skilled in the art that various modifications can be readily made to these embodiments and the generic principles described herein may be applied to other embodiments without the use of the inventive faculty. Therefore, the present invention is not limited to the above-described embodiments, and those skilled in the art, based on the present disclosure, should make improvements and modifications without departing from the scope of the present invention.

Claims (10)

1. A reperfusion system for myocardial perfusion coronary artery, which is characterized by comprising a host machine and an off-machine tube group;
the outer tube set comprises a main machine drainage tube (11), a main machine return tube (12), a three-way joint (6), a catheter sheath (9) and a pressurizing reperfusion catheter (8);
the first port of the three-way joint (6) is connected with one end of a host drainage tube (11), the other end of the host drainage tube (11) is connected with a host, the second port of the three-way joint (6) is connected with a catheter sheath (9), the catheter sheath (9) coaxially penetrates through a pressurizing reperfusion catheter (8), the head end of the pressurizing reperfusion catheter (8) extends out from the third port of the three-way joint (6), and the host return tube (12) is connected with the host and the pressurizing reperfusion catheter (8);
the catheter tail end (10) of the pressurizing reperfusion catheter (8) is provided with a pressure sensor (14) and an infusion hole (13);
a temperature control box (1), a peristaltic pump (3) and a controller (2) are arranged in the host;
the host drainage tube (11) is connected with the inlet end of the peristaltic pump (3), the outlet end of the peristaltic pump (3) is connected with the inlet end of the temperature control box (1), and the outlet end of the temperature control box (1) is connected with the host return tube (12);
the controller (2) is electrically connected with the peristaltic pump (3), the temperature control box (1) and the pressure sensor (14).
2. Reperfusion system of the myocardial perfusion coronary artery according to claim 1, characterized in that the temperature control box (1) comprises a heat exchange assembly and a heat radiation assembly;
the heat exchange assembly comprises a heat exchange conduit (15), a first temperature sensor (16), a heat exchange clamping plate (17) and a Peltier semiconductor (21);
the heat exchange conduit (15) is connected with the peristaltic pump (3) and the host return pipe (12);
the heat exchange conduit (15) is clamped between the heat exchange clamping plates (17); the first temperature sensor (16) is arranged in the heat exchange pipe (15) and is electrically connected with the controller (2); the cold end of the Peltier semiconductor (21) is attached to the heat exchange clamping plate (17), the heat dissipation assembly is arranged at the hot end of the Peltier semiconductor (21), and the Peltier semiconductor (21) is electrically connected with the controller (2).
3. A reperfusion system for myocardial perfusion coronary artery according to claim 2, wherein the heat sink assembly comprises heat sink fins (24), a fan and a second temperature sensor (25);
one side of the radiating fin (24) is attached to the hot end of the Peltier semiconductor (21), and the other side of the radiating fin is provided with a fan; the second temperature sensor (25) is arranged in the radiating fins (24) and is electrically connected with the controller (2); the fan is electrically connected with the controller (2).
4. Reperfusion system of the myocardial perfusion coronary artery according to claim 2, characterized in that the heat exchange catheter (15) is made of medical 316L stainless steel and is arranged in a serpentine structure; the heat exchange clamping plate (17) consists of a pair of heat exchange plates (20), grooves (18) matched with the heat exchange guide pipes (15) are formed in the surfaces of the heat exchange plates (20), and the heat exchange plates (20) are made of Al 2 O 3 A ceramic material; the first temperature sensor (16) is a patch type temperature sensor and is respectively arranged at the inlet, the outlet and the middle point of the heat exchange pipe (15).
5. The reperfusion system of myocardial perfusion coronary artery according to claim 2, wherein the side edge of the peltier semiconductor (21) is covered with a heat insulation pad (22), and a wire channel (23) is arranged in the heat insulation pad (22).
6. Reperfusion system of a myocardial perfusion coronary artery according to claim 1, characterized in that the catheter tip (10) of the pressurized reperfusion catheter (8) is of a three-section structure, the first section being a flexible open tip, the middle section being a rigid support section, the rear section being a flexible curved section.
7. Reperfusion system of a myocardial perfusion coronary artery according to claim 6, characterized in that the wall of the pressure reperfusion catheter (8) is of a three-layer structure, the inner layer is of PTEE material, the outer layer is of polyurethane material, the middle layer is a hollow cavity with a supporting steel wire at the end, and the signal wire (7) of the pressure sensor (14) passes through the middle layer.
8. Reperfusion system of the myocardial perfusion coronary artery according to claim 7, characterized in that the pressurized reperfusion catheter (8) is a 5F catheter; the tip diameter of the catheter sheath (9) is larger than that of the pressurized reperfusion catheter (8); the pressure sensor (14) is a miniature invasive pressure sensor, and the size is not more than 1mm multiplied by 1mm; the infusion holes (13) are arranged in a plurality, the centers of the infusion holes (13) are symmetrically arranged, the adjacent intervals of the infusion holes (13) are 2cm, and the diameter of the infusion holes is 0.4mm.
9. A method of controlling a reperfusion system for myocardial perfusion coronary artery according to any one of claims 1-8, wherein the peristaltic pump (3) comprises two modes of operation:
the first mode of operation is constant speed pumping;
the second operation mode is bionic pulsating pressurized pumping, and specifically comprises the following steps: the controller (2) feedback controls the rotating speed of the peristaltic pump (3) according to the pressure signal of the pressure sensor (14) to realize synchronous heart rate pumping;
the controller (2) controls the peristaltic pump (3) to switch between two operation modes according to the operation time of the peristaltic pump (3).
10. The method according to claim 9, wherein in the bionic pulsating pressurized pumping, the control mode of the peristaltic pump (3) controlled by the controller (2) is fuzzy PID control, and the objective function is
Figure FDA0004108275830000031
Where k is the sampling period and e (k) is the kth sampleThe sampled value of the period, u (k), is the controller output for the kth sampling period, k P Is a proportionality coefficient, k I Is an integral coefficient, k D Is a differential coefficient.
CN202310198847.4A 2023-03-03 2023-03-03 Reperfusion system for myocardial perfusion coronary artery and control method Pending CN116392664A (en)

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CN202310198847.4A CN116392664A (en) 2023-03-03 2023-03-03 Reperfusion system for myocardial perfusion coronary artery and control method

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202310198847.4A CN116392664A (en) 2023-03-03 2023-03-03 Reperfusion system for myocardial perfusion coronary artery and control method

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CN116392664A true CN116392664A (en) 2023-07-07

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