WO2019024111A1 - Cardiac simulation device - Google Patents

Cardiac simulation device Download PDF

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Publication number
WO2019024111A1
WO2019024111A1 PCT/CN2017/096093 CN2017096093W WO2019024111A1 WO 2019024111 A1 WO2019024111 A1 WO 2019024111A1 CN 2017096093 W CN2017096093 W CN 2017096093W WO 2019024111 A1 WO2019024111 A1 WO 2019024111A1
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WO
WIPO (PCT)
Prior art keywords
chamber
pulsating
outlet
volume
cardiac simulation
Prior art date
Application number
PCT/CN2017/096093
Other languages
French (fr)
Chinese (zh)
Inventor
孙兴国
Original Assignee
中国医学科学院阜外医院
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Filing date
Publication date
Application filed by 中国医学科学院阜外医院 filed Critical 中国医学科学院阜外医院
Priority to PCT/CN2017/096093 priority Critical patent/WO2019024111A1/en
Publication of WO2019024111A1 publication Critical patent/WO2019024111A1/en

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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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40Details relating to driving
    • A61M60/424Details relating to driving for positive displacement blood pumps
    • A61M60/427Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
    • 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/122Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/178Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
    • 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20Type thereof
    • A61M60/247Positive displacement blood pumps
    • A61M60/253Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/258Piston pumps
    • GPHYSICS
    • G09EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09BEDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine

Definitions

  • the present invention is in the field of medical devices, and in particular, the present invention relates to a cardiac simulation device.
  • Heart disease has always been a disease that is difficult to cure and has a high mortality rate. In recent years, the number of patients suffering from heart disease has increased, and heart disease has become one of the most important diseases affecting human health. In heart disease, heart failure is the most threatening condition to the patient's life. Heart disease can eventually cause heart failure.
  • heart failure can be controlled to a certain extent, it cannot be cured. If you want permanent treatment, you can only use a heart transplant or a heart assist device. Heart transplants need to find the right heart and are more difficult. In recent years, mechanical assisted circulation equipment has gradually become an alternative treatment for heart failure, and it is expected to gradually develop into a permanent treatment for heart failure.
  • the existing ventricular assisted blood pump is mainly a flat flow blood pump according to the blood supply mode.
  • Common advection blood pumps include centrifugal and axial flow ventricular assisted blood pumps. These advection blood pumps use blade rotation as a power mode to provide flow of blood to the flow.
  • the shear stress generated by the high-speed rotation of the blade has a strong destructive force on blood cells such as red blood cells, and it is easy to form a thrombus, causing severe consequences such as stroke and multiple organ failure.
  • a cardiac simulation apparatus comprising:
  • a chamber configured to have a variable volume, the chamber having an inlet and an outlet configured to enable liquid to flow from the outside into the chamber, the outlet being configured to enable liquid Flowing out of the chamber to the outside;
  • a pulsating member configured to expand or contract the volume of the chamber, the chamber for drawing liquid from the inlet when the pulsating member enlarges the volume of the chamber, and the pulsating member reducing the volume of the chamber when the pulsating member is reduced
  • the chamber pumps liquid from the outlet;
  • the pulsating member is configured to reduce the volume of the chamber by 10% to 90% of the maximum volume to which the pulsating member expands the chamber.
  • the cardiac simulation device includes a sealing member, the chamber is located inside the sealing member, the inlet and the outlet are disposed on the sealing member, and the inlet and the outlet respectively connect the chamber to the outside Space connectivity.
  • the sealing member comprises a cylinder body, one end of the cylinder body is a closed end, the pulsating component protrudes into the cylinder body and is slidably sealed with an inner wall of the cylinder body, and the chamber is located from the pulsating component To the area between the sealed ends, the pulsating member is configured to slide in the cylinder.
  • a soft film is disposed between the beating member and the sealing end, and an edge of the soft film is sealingly connected to the sealing member, and an area enclosed between the soft film and the sealing end is used as The chamber.
  • the sealing member comprises a cover plate sealed at one end of the cylinder to form the closed end.
  • the inlet and the outlet are disposed on the cover plate;
  • the inlet and outlet are disposed on the cylinder.
  • the sealing member comprises a cover plate sealed at one end of the cylinder body to form the closed end,
  • the edge of the soft film is attached to the inner wall of the cylinder;
  • the edge of the soft film is attached to the cover.
  • the inlet is provided with an admission flap mechanism configured to allow only liquid to enter the chamber from the outside, the outlet being provided with a predetermined flap mechanism,
  • the quasi-valve mechanism is configured to only allow liquid to flow from the chamber to the outside.
  • the amount of reduction accounts for 40%-50% of the maximum volume to which the pulsating component expands the chamber
  • the amount of reduction is from 55% to 70% of the maximum volume to which the pulsating member expands the chamber.
  • the pulsating component is a piston
  • the cardiac simulation device further includes a rotating machine and a connecting rod assembly
  • the connecting rod assembly and the piston constitute a crank linkage mechanism
  • the rotating machine and the connecting rod assembly Connected the piston is configured to reciprocate within the cylinder as the rotating machine rotates.
  • the connecting rod assembly is distributed with a connecting hole, and the connecting hole is pivotally connected to the connecting rod assembly.
  • the inventors of the present invention have found that in the prior art, those skilled in the art recognize the concept of cardiac minute output, but have not found cardiac diastolic volume, end systolic volume, stroke volume, ejection fraction.
  • Heart rate function indicators have important interrelated effects on blood circulation and respiration. If the cardiac assist device does not provide at least a similar ejection fraction to the heart, it may also cause neurological disorders in the human body, which may cause symptoms such as tidal breathing.
  • the inventors of the present invention found the correlation therein and provided a cardiac simulation device. In addition to realizing the traditional device to regulate the amount of blood transported per unit time (cardiac output), the cardiac simulation device can at least achieve adjustment and control under high simulation conditions of the ejection fraction.
  • FIG. 1 is a schematic structural view of a cardiac simulation device according to an embodiment of the present invention.
  • FIG. 2 is a schematic structural diagram of a cardiac simulation device according to another embodiment of the present invention.
  • FIG. 3 is a schematic structural diagram of a cardiac simulation apparatus according to another embodiment of the present invention.
  • the present invention provides a cardiac simulation device that is a functionally high bionic heart function simulation device. These include the chamber and the pulsating components.
  • the volume of the chamber is variable and can be used to simulate the contraction and relaxation of the ventricle.
  • the chamber has an inlet and an outlet for allowing liquid to flow from the outside into the chamber. The outlet is for allowing liquid to flow out of the chamber to the outside.
  • the pulsating member is for expanding or reducing the volume of the chamber.
  • the pulsating member may be driven by a rotating mechanism, a swinging mechanism, or a retracting mechanism to cause the chamber to reciprocate and expand.
  • the pulsating member controls the chamber
  • the volume is enlarged, the chamber is capable of drawing blood into the chamber from the inlet.
  • the dial member controls the volume of the chamber to be reduced, blood in the chamber can be pumped from the outlet to the outside.
  • the cardiac simulation device can at least simulate the contraction and relaxation of the ventricle and can replace the ventricular structure of the heart.
  • the present invention can change the amount of reduction that can be produced by the pulsating member by adjusting the pulsating member.
  • the volume of the chamber is reduced by 10% to 90% of the maximum volume to which the pulsating member can expand.
  • the amount of reduction in the volume of the chamber can be adjusted from 14.5 ml to 130.5 ml.
  • the proportion of the reduction amount may be adjusted within a range of 10% to 90% depending on the ventricle corresponding to the cardiac simulation device and the corresponding abnormal heart of the different situation.
  • the amount of reduction can be adjusted to account for 40%-80% of the maximum capacity that the chamber can expand; for a cardiac simulation device to simulate an abnormal ventricle or only
  • the amount of reduction can be adjusted to occupy a maximum capacity of 10% to 40%, or 80% to 90%, which the chamber can be expanded.
  • the invention is not limited thereto.
  • the cardiac simulation device provided by the present invention can also adjust the reduction amount to 0%-100% of the maximum capacity of the chamber.
  • the reduction of the limit of 0%, 1%, and 99%, 100% can also be achieved by the cardiac simulation device, which can be applied to the special case of simulating the heart, which is not limited by the present invention.
  • the cardiac simulation device provided by the present invention can be used to simulate a situation in which the ventricle has various ejection fractions. Whether in medical research or clinical use, it can provide good ejection fraction regulation.
  • the cardiac simulation device can adjust the amount of reduction to a value corresponding to the ejection fraction of the actual heart to simulate the actual heart's pulsation action and ejection fraction.
  • the inventors of the present invention have found that the ejection fraction of the ventricle is related to the human body's triggering of the breathing action. Normally, a person performs a complete breathing session with approximately 6 heartbeats during the period.
  • the inventors of the present invention have found that when the human body performs an "inhalation” action, the oxygen in the blood from the lungs to the aorta gradually rises under the push of the heart pumping function. Pivotal, In the case of a normal ejection fraction of the left ventricle, after about three beats in the left ventricle, the sensory system (aortic arch, carotid peripheral chemoreceptor) pumped from the left ventricle to the human body detects an increase in oxygen in the blood ( The result of lung inhalation), thus ending the "inhalation” action and starting the “exhalation” action; in the "exhalation” action, the oxygen content in the blood pumped from the left ventricle due to no oxygen inhalation Will be reduced one by one.
  • the left ventricular pumped blood carries a drop in oxygen (pulmonary exhalation) signal that reaches the aorta.
  • the human body's sensing system in the aorta detects the decrease in oxygen in the blood pumped by the left ventricle (the result of lung exhalation), thereby ending the "exhalation” action and starting the "inhalation” action.
  • the dynamic switching of the suction-call and the call-sucking is repeated, thereby achieving continuous and stable breathing of the human body.
  • the oxygen content of the pumped blood will reach a high value. This cycle is repeated.
  • the inventors of the present invention have found that the breathing and heartbeat of the human body have the above-mentioned associated operational relationship, thereby completing regular breathing and heartbeat movements.
  • the main feature controlling this association is the ejection fraction of the ventricles. If the ejection fraction is too high, it will cause fewer ventricular beats, and the oxygen content in the blood will reach a high or low value, which may cause the respiratory rate to rise. If the ejection fraction is too low, it will cause more ventricular beats, and the oxygen content in the blood can reach a high value or a low value, which will cause the respiratory rate to decrease.
  • the ejection fraction of the ventricle is an important condition in the whole heart and lung function.
  • the existing cardiac mechanical assisted circulation device does not reflect the ejection fraction of the heart, but continuously delivers the blood outward. This way of continuously outputting blood neglects the relationship between heartbeat and respiration, so it may cause disorder of the human nervous system, and can not trigger the respiratory action normally, thereby causing symptoms such as respiratory disorder and tidal breathing.
  • the inventors of the present invention have recognized this problem, and in turn have exhibited pulsation characteristics in the cardiac assisting device provided by the present invention. Also, in a preferred embodiment, the cardiac simulation device limits the amount of reduction of the chamber to between 40% and 80% to achieve a better simulated normal ventricular beat effect.
  • the normal ejection fraction of the left ventricle is between 55% and 70%
  • the normal ejection fraction of the right ventricle is between 40% and 50%. Therefore, in the present invention
  • the volume of the chamber can be reduced by 40%-50% of the maximum volume to which the pulsating component expands the chamber. This embodiment corresponds to the physiological normal condition of the cardiac simulation device simulation instead of the right ventricular functional state.
  • the volume of the chamber can be reduced by 55% to 70% of the maximum volume to which the pulsating member expands the chamber, and the embodiment corresponds to the cardiac simulation device simulation instead of the left ventricular function state.
  • the normal condition of physiology is the volume of the chamber.
  • the patient's ejection fraction may be reduced to 20%-30% or even lower.
  • the amount of reduction of the cardiac simulation device can be adjusted in the range of 10% to 90%, and can basically simulate all the states of the left ventricular function, including the above-mentioned physiological normal conditions and severe pathophysiological abnormalities in heart failure. It is thus possible to study the extent to which all states of left ventricular function affect the respiratory function of the human body.
  • the cardiac simulation device of the present invention can also realize physiological function indexes such as end-diastolic volume, end-systolic volume, stroke volume, ejection fraction, heart rate, and the like. Adjustment and control under high simulation conditions.
  • the cardiac simulation device may comprise a sealing member having a lumen for constituting the chamber.
  • the chamber may occupy the entire inner cavity or a partial area occupying the inner cavity, which is not limited by the present invention.
  • the inner cavity of the sealing member may be substantially closed, with only the necessary openings for communicating with the outside and for assembling other components.
  • the inlet and outlet are disposed on the sealing member, and the inlet and outlet respectively communicate the chamber with an external space.
  • the sealing member may include a cylinder block 31 having a cylindrical or other shaped inner cavity therein.
  • One end of the cylinder block 31 is a closed end, and the closed end is substantially closed to the inner cavity, and only the necessary functional holes or fitting openings are provided.
  • the pulsating member 2 projects into the inner cavity of the cylinder block 31, and the side surface of the pulsating member 2 is slidably and sealingly connected to the inner wall of the cylinder block 31.
  • the pulsating member 2 is slidable within the cylinder block 31 and is kept sealed from the inner wall of the cylinder block 31.
  • the chamber 1 is located in the region from the pulsating member 2 to the sealing end, may be completely occupied by this portion, or may be provided with other components such that the chamber 1 occupies only a portion of the above region.
  • the pulsating member 2 slides in the cylinder block 31, the volume of the chamber 1 changes, Thereby simulating the pulsation of the ventricle.
  • a soft film 32 may be disposed between the pulsating member 2 and the sealing end, and an edge of the soft film 32 is sealingly connected to the sealing member.
  • encapsulation between the soft film 32 and the sealed end forms a substantially sealed area that acts as the chamber 1.
  • the pulsating member 2 can be directly connected to the soft film 32, so that when the pulsating member 2 is moved, the soft film 32 can be deformed to change the volume of the chamber 1.
  • the pulsating member 2 since the pulsating member 2 is sealingly fitted to the inner wall of the cylinder block 31, the pulsating member 2 may not be directly connected to the soft film 32.
  • the soft film 32 Due to the action of the air pressure, when the pulsating member 2 moves in the cylinder block 31, the soft film 32 is also deformed, and the volume of the chamber 1 is changed.
  • An advantage of configuring the soft film is that the blood flowing into the chamber may not be in direct contact with the pulsating member.
  • the gap fit between the pulsating member and the inner wall of the cylinder may damage blood cells as it moves.
  • the blood cells flow only in the space between the soft film and the closed end, and are not damaged by the beating parts.
  • one end of the cylinder 31 to form a closed end is itself open.
  • the sealing member may further comprise a cover plate 33.
  • the cover plate 33 is sealed on the end surface of the cylinder block 31 to form the closed end.
  • both the inlet and the outlet 12 may be formed on the cover plate 33 as shown in FIG.
  • an inlet and an outlet 12 may be provided on the cylinder block 31.
  • the choice of product structure and performance can be selected according to the specific implementation.
  • Fig. 1 shows the manner in which the inlet and outlet 12 are directly disposed on the cylinder block 31 without the cover plate 33.
  • the edge of the soft film 32 may be directly sealed and connected to the cover plate 33.
  • a space between the cover 33 and the soft film 32 serves as the chamber 1.
  • the edge of the soft film 32 is also It can be sealingly connected to the cylinder block 31.
  • Figure 1 shows the manner in which the edge of the soft film 32 is directly attached to the cylinder 31 without the cover 33.
  • the present invention is not limited to the embodiment in which only the cylinder can be used as the sealing member to constitute a cardiac simulation device.
  • other configurations may be employed to form the chamber.
  • the chamber may be formed directly from the interior space of the elastic spherical container, which is sandwiched on the outside of the spherical container, and the pulsating action is achieved by clamping and relaxing.
  • the chamber may be constructed of a box-like deformable mechanical mechanism with a sealing layer disposed therein for encapsulating blood. The box-shaped mechanism can perform a reciprocating deformation action to realize the control of the chamber volume and realize the pulsation action.
  • the inlet is for allowing blood to enter the chamber 1, so that the inlet may be provided with an access flap mechanism.
  • the access flap mechanism is configured to only allow liquid to enter the chamber 1 from the outside.
  • a flap mechanism may be a biomimetic valve, or may be other devices such as a solenoid valve that can restrict one-way flow, etc., which is not limited by the present invention.
  • an outlet flap mechanism 121 is also provided at the outlet 12, the quasi-valve mechanism 121 being configured to only allow liquid to flow out of the chamber 1 to the outside.
  • the admission flap mechanism and the quasi-valve mechanism may be one-way flaps.
  • one end of the one-way flap is connected to the inner wall of the inlet, and the other end of the one-way flap is a free end.
  • the inner wall of the inlet 11 is provided with a rib that prevents the free end of the one-way flap from moving to the outside of the inlet.
  • the one-way flap at the inlet is configured to only allow liquid, blood to flow into the chamber.
  • a rib is also provided on the inner wall of the outlet 12, the rib being able to prevent the free end of the one-way flap from moving to the inside of the outlet, so that the one-way flap at the outlet is configured to only allow Liquid and blood flow to the outside of the chamber.
  • the pulsating member 2 is preferably a piston.
  • the cardiac simulation device can also include a rotary machine and a linkage assembly 41 that forms a crank linkage with the piston.
  • the rotating machine is coupled to the link assembly 41.
  • the link assembly 41 can The rotary motion is converted into a linear motion that urges the piston to reciprocate within the cylinder block 31.
  • the volume of the chamber 1 can be repeatedly contracted and expanded.
  • the rotational frequency of the rotating machine is the beat frequency of the cardiac analog device.
  • the piston is in the process of enlarging the chamber 1; in the case shown in Fig. 2, the piston is in a state of narrowing the chamber 1 to a minimum.
  • the connecting rod assembly 41 may further have a connecting hole 42 , and the connecting hole 42 extends along the connecting rod assembly 41 .
  • the connecting hole is pivotally connected to the two links of the connecting rod assembly.
  • the two links in the link assembly 41 are end-connected such that the difference between the lowest position and the highest position of the pulsating member 2 when the rotary machine is rotated Larger, the resulting reduction is larger and the maximum chamber capacity is greater.
  • the two links can also be pivotally connected by connection holes 42 at different positions.
  • the maximum capacity of the chamber by adjusting the assembly position of the rotation center of the link assembly in the cylinder.
  • the lower end portion of the link assembly 41 in Figs. 1 and 2 is coupled to the rotating machine, and if the lower end portion and the rotating machine as a whole are moved upward, the maximum capacity of the chamber is reduced. Conversely, if the lower end of the linkage assembly and the rotating machine as a whole are moved downward, the maximum capacity of the chamber is increased.
  • the cylinder block 31 may be provided with an adjustment mechanism such as a rail or a rotating center mounting hole for adjusting the position of the link assembly and its center of rotation and the rotating machine.
  • the center of rotation of the link assembly and the rotating machine can slide along the track to adjust the position of the center of rotation; or the output shaft of the rotating machine can be inserted in the center of rotation assembly hole at different positions to adjust the position of the center of rotation .
  • the invention is not limited to the use of a piston as a pulsating member.
  • a pneumatic device, a hydraulic device, a clamping device, or the like may be used as a power source for driving the cardiac simulation device to perform a pulsating motion.
  • the pulsating member 2 may be a hydraulic device.
  • a soft rubber film 32 is provided in the cylinder block 31, and the soft rubber film 32 is used to form a chamber with an upper region of the cylinder block 31.
  • the lower end of the cylinder block 31 is closed.
  • the region of the soft film 32 to the lower end of the cylinder block 31 is the pressure chamber 35.
  • a pulsation inlet and outlet 34 for the inflow and outflow of the pressurized fluid is opened in the pressure chamber 35.
  • the hydraulic device may preferably be disposed outside the cylinder block 31, and the hydraulic device may pump pressurized fluid into the pressure chamber 35 by a hydraulic pump; and the pressure pump may pressurize the fluid from the pressure chamber 35. Extracted in the middle.
  • the soft film 32 Since the soft film 32 has a deforming ability, when the pressure liquid is continuously charged into the pressure chamber 35, the soft film 32 is deformed upward by the hydraulic action, thereby reducing the space of the chamber 1. The liquid and blood in the chamber 1 are caused to flow out from the outlet 12. Conversely, when the hydraulic device draws the pressure fluid outward, the soft film 32 is deformed downward by the hydraulic action, thereby increasing the space of the chamber. Liquid and blood outside the inlet 11 can be drawn into the chamber 1.
  • the advantage of using the hydraulic device as the pulsating member is that the liquid is difficult to be compressed, so that the capacity, the stroke amount, and the reduction amount of the chamber can be accurately controlled by controlling the amount of the pressure liquid to be filled or sucked out of the pressure chamber.
  • the amount of liquid charged into the pressure chamber is substantially the same as the amount of liquid that is drawn from the chamber.
  • the use of the hydraulic device as the pulsating component can more reliably ensure the accuracy of the chamber capacity, and reduce the functional abnormality caused by the abnormality of the volume and the stroke volume.
  • only one pulsating inlet and outlet 34 may be opened on the pressure chamber 35, and the pressure fluid enters and exits the pressure chamber 35 through the pulsating inlet and outlet 34.
  • the pulsation inlet and the pulsation outlet may be separately provided for respectively filling the pressure chamber into the pressure chamber and withdrawing the pressure chamber.
  • the hydraulic device may not perform an extraction operation.
  • the pressure chamber can be separately provided with an air outlet.
  • the vent opening opens to release the pressurized gas, thereby reducing the pressure in the pressure chamber.
  • the hydraulic device can also control the speed at which the pressurized fluid is pumped into the pressure chamber, and the feed rate affects the pressure in the pressure chamber.
  • the pulsating device 2 is a pneumatic device.
  • the overall structure of the cardiac simulation device is similar to that shown in Fig. 3, so the present embodiment still illustrates the structure of the cardiac simulation device in Fig. 3.
  • a soft film 32 is also required to be provided in the cylinder block 31.
  • the lower end of the cylinder block 31 is closed, and the region of the soft film 32 to the lower end of the cylinder block 31 is a pressure chamber 35.
  • the pressure chamber 35 is provided with a pulsation inlet and outlet 34 for filling and discharging pressurized gas.
  • the air pressure device may be disposed outside the cylinder block 31, and the air pressure device may charge the pressure gas into the pressure chamber 35 by means of a gas pump or the like; or extract the pressure gas from the pressure chamber 35.
  • the pneumatic device may not perform a pumping operation.
  • the pressure chamber can be separately provided with an air outlet.
  • the vent opening opens to release the pressurized gas, thereby reducing the pressure in the pressure chamber.
  • the advantage of using a pneumatic device as the pulsating member is that the pneumatic device is pressure controlled. Due to the pressure in the chamber, when the pneumatic device pumps the pressurized gas into the pressure chamber 35, the soft film 32 does not immediately deform and compress the chamber. The pressurized gas will first appear to be compressed. When the pressure of the pressure gas in the pressure chamber 35 is greater than the pressure in the chamber, the pressure gas deforms the soft film 32 upward, compressing the space of the chamber. When the air pressure device sucks out the pressure gas, the pressure gas first appears to expand in volume and decrease in pressure. Then, a negative pressure is generated in the pressure chamber 35 to deform the soft film 32 downward.
  • the compression and expansion process of the pressurized gas can form a pressure buffer for the stroke and suction action of the chamber 1, so that the blood pressure at the outlet and the inlet of the chamber can be maintained at an appropriate pressure without sudden increase or sudden decrease in pressure.
  • the pneumatic device can also control the speed at which the pressurized gas is pumped into the pressure chamber, and the intake speed affects the pressure in the pressure chamber.
  • the magnitude of the pressure output by the air pressure device can be limited to a predetermined value, which is the upper limit of the safe blood pressure at the outlet of the chamber. If the blood pressure of the chamber and its outlet reaches a predetermined value, the air pressure device cannot further inject the pressure gas into the pressure chamber 35, thereby preventing the blood pressure of the outlet from rising further and improving safety.
  • a pressure monitoring device may also be provided at the outlet or outside of the outlet.
  • the pressure monitoring device is configured to form a circuit connection with the pulsating component or to effect transmission of a signal control signal by the control module.
  • the pressure monitoring device is configured to detect blood pressure at or outside the outlet. If the blood pressure is detected to be too high and the safety range is exceeded, an alarm signal indicating that the blood pressure is too high may be transmitted to the pulsating member; or the alarm signal may be sent to the control module, which then sends a signal to the pulsating member.
  • the pulsating member is configured to stop or slow the stroke of blood in the chamber after receiving an alarm signal from the pressure monitoring device or the control unit; or, the execution of the stroke action may be postponed. In this way, the pressure or blood pressure at the outlet of the chamber can be alleviated, preventing blood pressure from exceeding the safe range and causing harm.
  • the cardiac simulation device provided by the invention uses a pulsating output to pump out liquid or blood, which can better simulate the blood supply law of a normal heart.
  • the damage to blood cells is small.
  • the cardiac simulation device of the present invention introduces the concept of ejection fraction, which controls the amount of reduction in the chamber, thereby reducing the likelihood of adverse effects in the human body.

Abstract

A cardiac simulation device comprises: a chamber (1) having a variable volume, the chamber having an entrance (11) and an exit (12), the entrance (1) being configured to allow a liquid to flow into the chamber (1) from the exterior, and the exit (12) being configured to allow the liquid to flow from the chamber (1) to the exterior; and a pulsating component (2) configured to increase or decrease the volume of the chamber (1). When the pulsating component (2) increases the volume of the chamber (1), the chamber (1) sucks in a liquid from the entrance (11). When the pulsating component (2) decreases the volume of the chamber (1), the chamber (1) pumps out the liquid from the exit (12). The pulsating component (2) is configured such that a contraction volume of the chamber (1) accounts for 10-90% of the maximum volume of the chamber (1) when stretched by the pulsating component (2).

Description

心脏模拟设备Cardiac analog device 技术领域Technical field
本发明属于医疗设备领域,具体地,本发明涉及一种心脏模拟设备。The present invention is in the field of medical devices, and in particular, the present invention relates to a cardiac simulation device.
背景技术Background technique
心脏疾病一直是难以治愈、死亡率较高的疾病。近年来,患心脏疾病的患者数量增加,心脏疾病已经成为影响人类健康的重要疾病之一。在心脏疾病中,心力衰竭是对患者的生命威胁最大的病症。各类心脏疾病最终都有可能造成心力衰竭。Heart disease has always been a disease that is difficult to cure and has a high mortality rate. In recent years, the number of patients suffering from heart disease has increased, and heart disease has become one of the most important diseases affecting human health. In heart disease, heart failure is the most threatening condition to the patient's life. Heart disease can eventually cause heart failure.
虽然心力衰竭在一定程度上能够得到控制,但是无法根治。如果希望获得永久性的治疗,只能通过心脏移植或采用心脏辅助设备。心脏移植需要找到合适的心脏,难度较大。近年来,通过机械辅助循环设备逐渐成为治疗心力衰竭的可选方案,有望逐渐发展为治疗心力衰竭的永久治疗手段。Although heart failure can be controlled to a certain extent, it cannot be cured. If you want permanent treatment, you can only use a heart transplant or a heart assist device. Heart transplants need to find the right heart and are more difficult. In recent years, mechanical assisted circulation equipment has gradually become an alternative treatment for heart failure, and it is expected to gradually develop into a permanent treatment for heart failure.
现有的心室辅助血泵按照血液供给方式主要为平流式血泵。常见的平流式血泵包括离心式和轴流式心室辅助血泵。这些平流式血泵均采用叶片旋转作为动力模式为血液提供流动的动力。但是,由于叶片高速旋转产生的剪切应力对红细胞等血细胞具有很强的破坏力,很容易形成血栓,引发中风,多器官衰竭等严重后果。The existing ventricular assisted blood pump is mainly a flat flow blood pump according to the blood supply mode. Common advection blood pumps include centrifugal and axial flow ventricular assisted blood pumps. These advection blood pumps use blade rotation as a power mode to provide flow of blood to the flow. However, the shear stress generated by the high-speed rotation of the blade has a strong destructive force on blood cells such as red blood cells, and it is easy to form a thrombus, causing severe consequences such as stroke and multiple organ failure.
另一方面,心力衰竭的患者常伴随有潮式呼吸的病症。即使在患者采用了机械辅助循环设备后,仍有可能出现潮式呼吸病症。On the other hand, patients with heart failure are often accompanied by a condition of tidal breathing. Tidal breathing conditions can occur even after the patient has used mechanical assisted circulation equipment.
可见,现有的心脏辅助设备还存在较多缺陷,有必要对心脏辅助设备进行改进。 It can be seen that the existing cardiac assisted devices still have many defects, and it is necessary to improve the cardiac assisted devices.
发明内容Summary of the invention
本发明的一个目的是提供一种心脏模拟设备的新技术方案。It is an object of the present invention to provide a new technical solution for a cardiac simulation device.
根据本发明的第一方面,提供了一种心脏模拟设备,包括:According to a first aspect of the present invention, a cardiac simulation apparatus is provided, comprising:
腔室,所述腔室被配置为容积可变,所述腔室具有入口和出口,所述入口被配置为能使液体从外部流入所述腔室中,所述出口被配置为能使液体从所述腔室中流出至外部;a chamber configured to have a variable volume, the chamber having an inlet and an outlet configured to enable liquid to flow from the outside into the chamber, the outlet being configured to enable liquid Flowing out of the chamber to the outside;
搏动部件,所述搏动部件被配置为能扩大或缩小所述腔室的容积,当搏动部件扩大腔室的容积时,所述腔室从所述入口吸入液体,当搏动部件缩小腔室的容积时,所述腔室从所述出口泵出液体;a pulsating member configured to expand or contract the volume of the chamber, the chamber for drawing liquid from the inlet when the pulsating member enlarges the volume of the chamber, and the pulsating member reducing the volume of the chamber when the pulsating member is reduced The chamber pumps liquid from the outlet;
所述搏动部件被配置为:对所述腔室的容积的缩小量,占搏动部件使腔室扩大到的最大容积的10%-90%。The pulsating member is configured to reduce the volume of the chamber by 10% to 90% of the maximum volume to which the pulsating member expands the chamber.
可选地,所述心脏模拟设备包括密封构件,所述腔室位于所述密封构件内部,所述入口和出口设置在所述密封构件上,所述入口和出口分别将所述腔室与外部空间连通。Optionally, the cardiac simulation device includes a sealing member, the chamber is located inside the sealing member, the inlet and the outlet are disposed on the sealing member, and the inlet and the outlet respectively connect the chamber to the outside Space connectivity.
可选地,所述密封构件包括缸体,所述缸体的一端为封闭端,所述搏动部件伸入缸体内并与缸体的内壁滑动密封,所述腔室位于从所述搏动部件到密封端之间的区域,所述搏动部件被配置为能在缸体中滑动。Optionally, the sealing member comprises a cylinder body, one end of the cylinder body is a closed end, the pulsating component protrudes into the cylinder body and is slidably sealed with an inner wall of the cylinder body, and the chamber is located from the pulsating component To the area between the sealed ends, the pulsating member is configured to slide in the cylinder.
可选地,所述搏动部件与密封端之间设置有软胶膜,所述软胶膜的边缘密封连接在所述密封构件上,所述软胶膜与密封端之间包封的区域作为所述腔室。Optionally, a soft film is disposed between the beating member and the sealing end, and an edge of the soft film is sealingly connected to the sealing member, and an area enclosed between the soft film and the sealing end is used as The chamber.
可选地,所述密封构件包括盖板,所述盖板封在所述缸体的一端,形成所述封闭端。Optionally, the sealing member comprises a cover plate sealed at one end of the cylinder to form the closed end.
可选地,所述入口和出口设置在所述盖板上;Optionally, the inlet and the outlet are disposed on the cover plate;
或者,所述入口和出口设置在所述缸体上。Alternatively, the inlet and outlet are disposed on the cylinder.
可选地,所述密封构件包括盖板,所述盖板封在所述缸体的一端,形成所述封闭端,Optionally, the sealing member comprises a cover plate sealed at one end of the cylinder body to form the closed end,
所述软胶膜的边缘连接在所述缸体的内壁上;The edge of the soft film is attached to the inner wall of the cylinder;
或者,所述软胶膜的边缘连接在所述盖板上。 Alternatively, the edge of the soft film is attached to the cover.
可选地,所述入口处设置有准入活瓣机构,所述准入活瓣机构被配置为仅允许液体从外部进入所述腔室,所述出口处设置有准出活瓣机构,所述准出活瓣机构被配置为仅允许液体从腔室流出至外部。Optionally, the inlet is provided with an admission flap mechanism configured to allow only liquid to enter the chamber from the outside, the outlet being provided with a predetermined flap mechanism, The quasi-valve mechanism is configured to only allow liquid to flow from the chamber to the outside.
可选地,所述缩小量占搏动部件使腔室扩大到的最大容积的40%-50%;Optionally, the amount of reduction accounts for 40%-50% of the maximum volume to which the pulsating component expands the chamber;
或者,所述缩小量占搏动部件使腔室扩大到的最大容积的55%-70%。Alternatively, the amount of reduction is from 55% to 70% of the maximum volume to which the pulsating member expands the chamber.
可选地,所述搏动部件为活塞,所述心脏模拟设备还包括转动机和连杆组件,所述连杆组件与所述活塞构成曲柄连杆机构,所述转动机与所述连杆组件连接,当所述转动机旋转时,所述活塞被配置为能在所述缸体内做往复运动。Optionally, the pulsating component is a piston, the cardiac simulation device further includes a rotating machine and a connecting rod assembly, the connecting rod assembly and the piston constitute a crank linkage mechanism, the rotating machine and the connecting rod assembly Connected, the piston is configured to reciprocate within the cylinder as the rotating machine rotates.
可选地,所述连杆组件上分布有连接孔,所述连接孔供连杆组件的连杆枢转连接。Optionally, the connecting rod assembly is distributed with a connecting hole, and the connecting hole is pivotally connected to the connecting rod assembly.
本发明的发明人发现,在现有技术中,本领域技术人员虽然认识到了心脏分钟输出量这一概念,但是并没有发现心脏的心脏舒张末容积、收缩末容积、每搏量、射血分数、心率功能指标对于血液循环和呼吸有着重要的相互关联作用。如果心脏辅助设备不能至少提供与心脏相似的射血分数,也有可能造成人体内的神经混乱,进而造成潮式呼吸等病症。而本发明的发明人发现了其中的关联性,并提供了一种心脏模拟设备。该心脏模拟设备除了实现传统设备调节单位时间运输血液量(心排血量)外,还可以至少实现对射血分数的高仿真条件下的调节和控制。以高度高仿生的形式,模拟正常或异常的心脏的射血分数等指标。因此,本发明所要实现的技术任务或者所要解决的技术问题是本领域技术人员从未想到的或者没有预期到的,故本发明是一种新的技术方案。The inventors of the present invention have found that in the prior art, those skilled in the art recognize the concept of cardiac minute output, but have not found cardiac diastolic volume, end systolic volume, stroke volume, ejection fraction. Heart rate function indicators have important interrelated effects on blood circulation and respiration. If the cardiac assist device does not provide at least a similar ejection fraction to the heart, it may also cause neurological disorders in the human body, which may cause symptoms such as tidal breathing. The inventors of the present invention found the correlation therein and provided a cardiac simulation device. In addition to realizing the traditional device to regulate the amount of blood transported per unit time (cardiac output), the cardiac simulation device can at least achieve adjustment and control under high simulation conditions of the ejection fraction. Simulates the ejection fraction of a normal or abnormal heart in a highly high-bionic form. Therefore, the technical task to be achieved by the present invention or the technical problem to be solved is not thought of or expected by those skilled in the art, so the present invention is a new technical solution.
通过以下参照附图对本发明的示例性实施例的详细描述,本发明的其它特征及其优点将会变得清楚。Other features and advantages of the present invention will become apparent from the Detailed Description of the <RTIgt;
附图说明DRAWINGS
被结合在说明书中并构成说明书的一部分的附图示出了本发明的实 施例,并且连同其说明一起用于解释本发明的原理。The drawings incorporated in the specification and which form a part of the specification The examples, together with the description thereof, are used to explain the principles of the invention.
图1是本发明的一种实施方式提供的心脏模拟设备的结构示意图;1 is a schematic structural view of a cardiac simulation device according to an embodiment of the present invention;
图2是本发明另一种实施方式提供的心脏模拟设备的结构示意图;2 is a schematic structural diagram of a cardiac simulation device according to another embodiment of the present invention;
图3是本发明另一种实施方式提供的心脏模拟设备的结构示意图。FIG. 3 is a schematic structural diagram of a cardiac simulation apparatus according to another embodiment of the present invention.
具体实施方式Detailed ways
现在将参照附图来详细描述本发明的各种示例性实施例。应注意到:除非另外具体说明,否则在这些实施例中阐述的部件和步骤的相对布置、数字表达式和数值不限制本发明的范围。Various exemplary embodiments of the present invention will now be described in detail with reference to the drawings. It should be noted that the relative arrangement of the components and steps, numerical expressions and numerical values set forth in the embodiments are not intended to limit the scope of the invention unless otherwise specified.
以下对至少一个示例性实施例的描述实际上仅仅是说明性的,决不作为对本发明及其应用或使用的任何限制。The following description of the at least one exemplary embodiment is merely illustrative and is in no way
对于相关领域普通技术人员已知的技术、方法和设备可能不作详细讨论,但在适当情况下,所述技术、方法和设备应当被视为说明书的一部分。Techniques, methods and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail, but the techniques, methods and apparatus should be considered as part of the specification, where appropriate.
在这里示出和讨论的所有例子中,任何具体值应被解释为仅仅是示例性的,而不是作为限制。因此,示例性实施例的其它例子可以具有不同的值。In all of the examples shown and discussed herein, any specific values are to be construed as illustrative only and not as a limitation. Thus, other examples of the exemplary embodiments may have different values.
应注意到:相似的标号和字母在下面的附图中表示类似项,因此,一旦某一项在一个附图中被定义,则在随后的附图中不需要对其进行进一步讨论。It should be noted that similar reference numerals and letters indicate similar items in the following figures, and therefore, once an item is defined in one figure, it is not required to be further discussed in the subsequent figures.
本发明提供了一种心脏模拟设备,该心脏模拟设备是功能上高仿生的心脏功能模拟设备。其中包括了腔室和搏动部件。所述腔室的容积是可变化的,可以用于模拟心室的收缩和舒张动作。所述腔室具有入口和出口,所述入口用于使液体从外部流入到所述腔室中。所述出口用于使液体从腔室中流出到外部。The present invention provides a cardiac simulation device that is a functionally high bionic heart function simulation device. These include the chamber and the pulsating components. The volume of the chamber is variable and can be used to simulate the contraction and relaxation of the ventricle. The chamber has an inlet and an outlet for allowing liquid to flow from the outside into the chamber. The outlet is for allowing liquid to flow out of the chamber to the outside.
所述搏动部件用于扩大或缩小所述腔室的容积。例如,所述搏动部件可以通过转动机构、摆动机构或收缩机构驱动,从而使所述腔室进行出往复的收缩和扩大动作。在实际的应用中,当所述搏动部件控制所述腔室 的容积扩大时,所述腔室能够从入口处将血液吸入腔室内。而当拨动部件控制所述腔室的容积缩小时,所述腔室中的血液能够从所述出口处泵出到外部。这样,所述心脏模拟设备至少能够模拟心室的收缩和舒张动作,能够代替心脏的心室结构。The pulsating member is for expanding or reducing the volume of the chamber. For example, the pulsating member may be driven by a rotating mechanism, a swinging mechanism, or a retracting mechanism to cause the chamber to reciprocate and expand. In a practical application, when the pulsating member controls the chamber When the volume is enlarged, the chamber is capable of drawing blood into the chamber from the inlet. And when the dial member controls the volume of the chamber to be reduced, blood in the chamber can be pumped from the outlet to the outside. Thus, the cardiac simulation device can at least simulate the contraction and relaxation of the ventricle and can replace the ventricular structure of the heart.
特别地,本发明可以通过对搏动部件的调整,改变搏动部件所能产生的缩小量。在搏动部件对腔室进行缩小操作时,腔室容积的缩小量占搏动部件使腔室能够扩大到的最大容积的10%-90%。例如,若搏动部件能够使腔室的容积扩大到145ml,则腔室容积的缩小量的可调节范围为14.5ml-130.5ml。根据所述心脏模拟设备对应的心室不同,以及所对应的不同情况的异常心脏,所述缩小量的占比可以在10%-90%的范围内调节。In particular, the present invention can change the amount of reduction that can be produced by the pulsating member by adjusting the pulsating member. When the pulsating member performs a reduction operation on the chamber, the volume of the chamber is reduced by 10% to 90% of the maximum volume to which the pulsating member can expand. For example, if the pulsating member is capable of expanding the volume of the chamber to 145 ml, the amount of reduction in the volume of the chamber can be adjusted from 14.5 ml to 130.5 ml. The proportion of the reduction amount may be adjusted within a range of 10% to 90% depending on the ventricle corresponding to the cardiac simulation device and the corresponding abnormal heart of the different situation.
例如,对于心脏模拟设备用于模拟正常的心室的情况,所述缩小量可以调节成占腔室能够扩大到的最大容量的40%-80%;对于心脏模拟设备用于模拟异常的心室或者只提供一部分心室的功能的情况,所述缩小量可以调节成占腔室能够扩大到的最大容量10%-40%,或者80%-90%。本发明不对此进行限制。For example, in the case of a cardiac simulation device for simulating a normal ventricle, the amount of reduction can be adjusted to account for 40%-80% of the maximum capacity that the chamber can expand; for a cardiac simulation device to simulate an abnormal ventricle or only In the case where a part of the function of the ventricle is provided, the amount of reduction can be adjusted to occupy a maximum capacity of 10% to 40%, or 80% to 90%, which the chamber can be expanded. The invention is not limited thereto.
另外,本发明提供的心脏模拟设备也可以将缩小量调节到占腔室最大容量的0%-100%。0%、1%以及99%、100%这种极限的缩小量所述心脏模拟设备也可以实现,可以应用于模拟心脏的特殊情况,本发明并不对此进行限制。In addition, the cardiac simulation device provided by the present invention can also adjust the reduction amount to 0%-100% of the maximum capacity of the chamber. The reduction of the limit of 0%, 1%, and 99%, 100% can also be achieved by the cardiac simulation device, which can be applied to the special case of simulating the heart, which is not limited by the present invention.
本发明提供的心脏模拟设备可以用于模拟心室具有各种不同射血分数的情况。无论是在医学研究还是在临床使用方面,都能够提供良好的射血分数调控效果。The cardiac simulation device provided by the present invention can be used to simulate a situation in which the ventricle has various ejection fractions. Whether in medical research or clinical use, it can provide good ejection fraction regulation.
更重要的在于,所述心脏模拟设备可以将所述缩小量调节到与实际心脏的射血分数对应的数值,以模拟实际心脏的搏动动作和射血分数。本发明的发明人发现,心室的射血分数与人体触发呼吸动作存在关联性。通常情况下,人进行一次完整的呼吸动作,期间会有大约6次心跳动作。More importantly, the cardiac simulation device can adjust the amount of reduction to a value corresponding to the ejection fraction of the actual heart to simulate the actual heart's pulsation action and ejection fraction. The inventors of the present invention have found that the ejection fraction of the ventricle is related to the human body's triggering of the breathing action. Normally, a person performs a complete breathing session with approximately 6 heartbeats during the period.
本发明的发明人发现,在人体进行一次“吸气”动作时,在心脏泵血功能推动下,从肺部继之心脏到大动脉处血液中的氧逐渐上升。关键的, 在左心室的射血分数正常的情况下,左心室经过约三次跳动后,从左心室泵出到人体的传感系统(主动脉弓、颈动脉体外周化学感受器)会检测到血液中氧的上升(肺吸气的结果),从而结束这次“吸气”动作,开始“呼气”动作;在进行“呼气”动作时,由于没有氧气吸入,从左心室中泵出的血液中的氧含量会逐次降低。左心室泵出的血液携带氧下降(肺呼气)信号会到达大动脉。此时,人体在大动脉的传感系统会检测到左心室泵出的血液中氧下降(肺呼气结果),从而结束这次“呼气”动作,开始“吸气”动作。由此吸-呼、呼-吸的动态切换,周而复始,从而实现人体连续稳定的呼吸。关键的,在左心室的射血分数正常的情况下,左心室经过约三次跳动后,泵出的血液的氧含量会达到高值。如此反复循环。The inventors of the present invention have found that when the human body performs an "inhalation" action, the oxygen in the blood from the lungs to the aorta gradually rises under the push of the heart pumping function. Pivotal, In the case of a normal ejection fraction of the left ventricle, after about three beats in the left ventricle, the sensory system (aortic arch, carotid peripheral chemoreceptor) pumped from the left ventricle to the human body detects an increase in oxygen in the blood ( The result of lung inhalation), thus ending the "inhalation" action and starting the "exhalation" action; in the "exhalation" action, the oxygen content in the blood pumped from the left ventricle due to no oxygen inhalation Will be reduced one by one. The left ventricular pumped blood carries a drop in oxygen (pulmonary exhalation) signal that reaches the aorta. At this time, the human body's sensing system in the aorta detects the decrease in oxygen in the blood pumped by the left ventricle (the result of lung exhalation), thereby ending the "exhalation" action and starting the "inhalation" action. Thereby, the dynamic switching of the suction-call and the call-sucking is repeated, thereby achieving continuous and stable breathing of the human body. Critically, in the case of a normal ejection fraction of the left ventricle, after about three beats in the left ventricle, the oxygen content of the pumped blood will reach a high value. This cycle is repeated.
本发明的发明人发现,人体的呼吸和心跳存在上述关联运作关系,进而完成规律的呼吸和心跳动作。控制这种关联关系的主要特征是心室的射血分数。如果射血分数过高,会造成心室跳动更少的次数,血液中的含氧量就达到了高值或低值,可能会造成呼吸频率上升。而如果射血分数过低,会造成心室跳动更多的次数,血液中的含氧量才能达到高值或低值,会造成呼吸频率下降。在射血分数降低的情况较严重时,有可能无法使左心室泵出的血液中的含氧量减低到低值,从而无法触发下一次“吸气”动作。可见,心室的射血分数是整个心肺功能中十分重要的条件。The inventors of the present invention have found that the breathing and heartbeat of the human body have the above-mentioned associated operational relationship, thereby completing regular breathing and heartbeat movements. The main feature controlling this association is the ejection fraction of the ventricles. If the ejection fraction is too high, it will cause fewer ventricular beats, and the oxygen content in the blood will reach a high or low value, which may cause the respiratory rate to rise. If the ejection fraction is too low, it will cause more ventricular beats, and the oxygen content in the blood can reach a high value or a low value, which will cause the respiratory rate to decrease. When the ejection fraction is lowered, the oxygen content in the blood pumped by the left ventricle may not be reduced to a low value, so that the next "inhalation" action cannot be triggered. It can be seen that the ejection fraction of the ventricle is an important condition in the whole heart and lung function.
然而,现有的心脏机械辅助循环设备并不能体现出心脏的射血分数,只是持续的将血液向外输送。这种持续输出血液的方式忽视了心跳与呼吸之间的关联关系,所以有可能造成人体神经系统的紊乱,无法正常触发呼吸动作,从而造成呼吸紊乱、潮式呼吸等症状。However, the existing cardiac mechanical assisted circulation device does not reflect the ejection fraction of the heart, but continuously delivers the blood outward. This way of continuously outputting blood neglects the relationship between heartbeat and respiration, so it may cause disorder of the human nervous system, and can not trigger the respiratory action normally, thereby causing symptoms such as respiratory disorder and tidal breathing.
本发明的发明人意识到了这一问题,进而在本发明提供的心脏辅助设备中体现出了搏动特点。并且,在优选的实施方式中,心脏模拟设备将腔室的缩小量限制在40%-80%范围内,以达到更好的模拟正常的心室搏动效果。The inventors of the present invention have recognized this problem, and in turn have exhibited pulsation characteristics in the cardiac assisting device provided by the present invention. Also, in a preferred embodiment, the cardiac simulation device limits the amount of reduction of the chamber to between 40% and 80% to achieve a better simulated normal ventricular beat effect.
在上述对心跳、呼吸循环的描述中,左心室的正常射血分数在55%-70%之间,右心室的正常射血分数在40%-50%之间。所以,在本发明 的一种优选实施方式中,腔室容积的缩小量可以占搏动部件使腔室扩大到的最大容积的40%-50%,该实施方式对应心脏模拟设备模拟代替右心室功能状态的生理学正常情况。在本发明的另一种优选实施方式中,腔室容积的缩小量可以占搏动部件使腔室扩大到的最大容积的55%-70%,该实施方式对应心脏模拟设备模拟代替左心室功能状态的生理学正常情况。In the above description of the heartbeat and respiratory cycle, the normal ejection fraction of the left ventricle is between 55% and 70%, and the normal ejection fraction of the right ventricle is between 40% and 50%. Therefore, in the present invention In a preferred embodiment, the volume of the chamber can be reduced by 40%-50% of the maximum volume to which the pulsating component expands the chamber. This embodiment corresponds to the physiological normal condition of the cardiac simulation device simulation instead of the right ventricular functional state. . In another preferred embodiment of the present invention, the volume of the chamber can be reduced by 55% to 70% of the maximum volume to which the pulsating member expands the chamber, and the embodiment corresponds to the cardiac simulation device simulation instead of the left ventricular function state. The normal condition of physiology.
在心力衰竭情况下病人的射血分数可能降低到20%-30%、甚至更低。本心脏模拟设备的缩小量在10%-90%的范围内可以调节,基本能够模拟代替出左心室功能的所有状态,包括上述生理学正常情况和心力衰竭时的严重病理生理学异常极限情况。由此可以研究左心室功能的所有状态对人体呼吸功能的影响程度。In the case of heart failure, the patient's ejection fraction may be reduced to 20%-30% or even lower. The amount of reduction of the cardiac simulation device can be adjusted in the range of 10% to 90%, and can basically simulate all the states of the left ventricular function, including the above-mentioned physiological normal conditions and severe pathophysiological abnormalities in heart failure. It is thus possible to study the extent to which all states of left ventricular function affect the respiratory function of the human body.
本发明的心脏模拟设备除了实现调节单位时间运输血液量(心排血量)的功能外,还可以实现对心脏舒张末容积、收缩末容积、每搏量、射血分数、心率等生理学功能指标的高仿真条件下的调节和控制。In addition to realizing the function of regulating blood volume (cardiac blood output) per unit time, the cardiac simulation device of the present invention can also realize physiological function indexes such as end-diastolic volume, end-systolic volume, stroke volume, ejection fraction, heart rate, and the like. Adjustment and control under high simulation conditions.
可选地,所述心脏模拟设备可以包括密封构件,所述密封构件具有内腔,内腔用于构成所述腔室。所述腔室可以占据整个内腔,也可以是占据内腔的部分区域,本发明不对此进行限制。所述密封构件的内腔可以是基本封闭的,其上只设置有必要的用于与外界连通孔道和用于装配其它部件的开口。所述入口和出口设置在所述密封构件上,所述入口和出口分别将所述腔室与外部空间连通。Alternatively, the cardiac simulation device may comprise a sealing member having a lumen for constituting the chamber. The chamber may occupy the entire inner cavity or a partial area occupying the inner cavity, which is not limited by the present invention. The inner cavity of the sealing member may be substantially closed, with only the necessary openings for communicating with the outside and for assembling other components. The inlet and outlet are disposed on the sealing member, and the inlet and outlet respectively communicate the chamber with an external space.
可选地,本实用新型给出了一种实施方式,如图1所示,所述密封构件可以包括缸体31,所述缸体31中具有圆柱形或其它形状的内腔。所述缸体31的一端为封闭端,所述封闭端处是基本将内腔封闭的,仅设置有必要的功能性孔道或装配开口。所述搏动部件2伸入到所述缸体31的内腔中,并且搏动部件2的侧面与缸体31内壁滑动密封连接。所述搏动部件2可以在缸体31内滑动,且与缸体31内壁保持密封状态。所述腔室1位于从所述搏动部件2到密封端之间的区域内,可以是完全占据这部分区域,也可以是配置有其它部件,使腔室1只占据一部分上述区域。这样,当所述搏动部件2在缸体31中滑动时,所述腔室1的容积会发生改变, 从而模拟心室的搏动动作。Alternatively, the present invention provides an embodiment. As shown in FIG. 1, the sealing member may include a cylinder block 31 having a cylindrical or other shaped inner cavity therein. One end of the cylinder block 31 is a closed end, and the closed end is substantially closed to the inner cavity, and only the necessary functional holes or fitting openings are provided. The pulsating member 2 projects into the inner cavity of the cylinder block 31, and the side surface of the pulsating member 2 is slidably and sealingly connected to the inner wall of the cylinder block 31. The pulsating member 2 is slidable within the cylinder block 31 and is kept sealed from the inner wall of the cylinder block 31. The chamber 1 is located in the region from the pulsating member 2 to the sealing end, may be completely occupied by this portion, or may be provided with other components such that the chamber 1 occupies only a portion of the above region. Thus, when the pulsating member 2 slides in the cylinder block 31, the volume of the chamber 1 changes, Thereby simulating the pulsation of the ventricle.
进一步优选地,如图1所示,所述搏动部件2与密封端之间还可以设置有软胶膜32,所述软胶膜32的边缘密封连接在所述密封构件上。这样,在所述软胶膜32与密封端之间包封形成了一片基本密封的区域,该区域作为所述腔室1。所述搏动部件2可以直接与软胶膜32连接,这样,当搏动部件2移动时,能够带动软胶膜32产生形变,从而改变腔室1的容积。当然,由于所述搏动部件2与缸体31的内壁时密封配合的,所以搏动部件2也可以不与软胶膜32直接连接。由于气压的作用,当搏动部件2在缸体31中移动时,软胶膜32也会产生形变,腔室1的容积被改变。配置软胶膜的优点在于,流入腔室的血液可以不与搏动部件直接接触。搏动部件与缸体内壁之间的缝隙配合关系,在其移动时有可能使血细胞受损。配置有软胶膜后,血细胞仅在软胶膜与封闭端之间的空间中流动,不会受到搏动部件的损伤。Further preferably, as shown in FIG. 1, a soft film 32 may be disposed between the pulsating member 2 and the sealing end, and an edge of the soft film 32 is sealingly connected to the sealing member. Thus, encapsulation between the soft film 32 and the sealed end forms a substantially sealed area that acts as the chamber 1. The pulsating member 2 can be directly connected to the soft film 32, so that when the pulsating member 2 is moved, the soft film 32 can be deformed to change the volume of the chamber 1. Of course, since the pulsating member 2 is sealingly fitted to the inner wall of the cylinder block 31, the pulsating member 2 may not be directly connected to the soft film 32. Due to the action of the air pressure, when the pulsating member 2 moves in the cylinder block 31, the soft film 32 is also deformed, and the volume of the chamber 1 is changed. An advantage of configuring the soft film is that the blood flowing into the chamber may not be in direct contact with the pulsating member. The gap fit between the pulsating member and the inner wall of the cylinder may damage blood cells as it moves. When a soft film is placed, the blood cells flow only in the space between the soft film and the closed end, and are not damaged by the beating parts.
可选地,在本发明的一种实施方式中,如图2所示,所述缸体31要形成封闭端的一端本身是开口的。相应的,所述密封构件还可以包括盖板33。所述盖板33封在所述缸体31的端面上,从而形成所述封闭端。这种结构设计便于心脏模拟设备自身的装配和加工。在其它的实施方式中,如图1所示,所述缸体31自身用于形成封闭端的一端本身可以是封闭的,则通常无需额外设置盖板33。可以根据实际生产、使用的情况,对缸体31的结构特征进行调整。Alternatively, in an embodiment of the present invention, as shown in Fig. 2, one end of the cylinder 31 to form a closed end is itself open. Correspondingly, the sealing member may further comprise a cover plate 33. The cover plate 33 is sealed on the end surface of the cylinder block 31 to form the closed end. This structural design facilitates the assembly and processing of the cardiac simulation device itself. In other embodiments, as shown in FIG. 1, the end of the cylinder 31 itself for forming the closed end may itself be closed, and generally no additional cover 33 is required. The structural characteristics of the cylinder block 31 can be adjusted according to actual production and use.
进一步地,在密封构件包括盖板33的实施方式中,所述入口和出口12都可以开设在所述盖板33上,如图2所示。或者,入口和出口12也可以设置在所述缸体31上。可以根据具体实施时对产品结构和性能的要求进行选择。图1则示出了没有盖板33的情况下入口和出口12直接设置在缸体31上的方式。Further, in the embodiment in which the sealing member includes the cover plate 33, both the inlet and the outlet 12 may be formed on the cover plate 33 as shown in FIG. Alternatively, an inlet and an outlet 12 may be provided on the cylinder block 31. The choice of product structure and performance can be selected according to the specific implementation. Fig. 1 shows the manner in which the inlet and outlet 12 are directly disposed on the cylinder block 31 without the cover plate 33.
另一方面可选的,如图2所示,在密封构件包括盖板33的实施方式中,所述软胶膜32的边缘可以直接密封连接在所述盖板33上。盖板33与软胶膜32之间的空间作为所述腔室1。或者,所述软胶膜32的边缘也 可以密封连接在所述缸体31上。可以根据具体实施时对产品结构和性能的要求进行选择。图1则示出了没有盖板33的情况下软胶膜32的边缘直接连接在缸体31上的方式。Alternatively, as shown in FIG. 2, in the embodiment in which the sealing member includes the cover plate 33, the edge of the soft film 32 may be directly sealed and connected to the cover plate 33. A space between the cover 33 and the soft film 32 serves as the chamber 1. Alternatively, the edge of the soft film 32 is also It can be sealingly connected to the cylinder block 31. The choice of product structure and performance can be selected according to the specific implementation. Figure 1 shows the manner in which the edge of the soft film 32 is directly attached to the cylinder 31 without the cover 33.
本发明并不限制只能采用缸体作为密封构件这种实施方式构成心脏模拟设备。在其它实施方式中,也可以采用其它结构形成所述腔室。例如,在一种实施方式中,所述腔室可以直接由弹性球状容器的内部空间构成,所述搏动部件则为夹在球状容器的外侧,通过夹紧和放松实现搏动动作。或者,在另一种实施方式中,所述腔室可以由盒状可变形机械机构构成,盒状机构中设置有密封层,用于包封血液。盒状机构可以做往复的变形动作,实现对腔室容积的控制,实现搏动动作。The present invention is not limited to the embodiment in which only the cylinder can be used as the sealing member to constitute a cardiac simulation device. In other embodiments, other configurations may be employed to form the chamber. For example, in one embodiment, the chamber may be formed directly from the interior space of the elastic spherical container, which is sandwiched on the outside of the spherical container, and the pulsating action is achieved by clamping and relaxing. Alternatively, in another embodiment, the chamber may be constructed of a box-like deformable mechanical mechanism with a sealing layer disposed therein for encapsulating blood. The box-shaped mechanism can perform a reciprocating deformation action to realize the control of the chamber volume and realize the pulsation action.
可选地,如图1、2所示,所述入口用于使血液进入到腔室1中,所以,所述入口处可以设置有准入活瓣机构。所述准入活瓣机构被配置为仅允许液体从外部进入所述腔室1。这种活瓣机构可以是仿生瓣膜,也可以是其它装置,例如可以限制单向流动的电磁阀等,本发明不对此进行限制。相应地,所述出口12处也设置有准出活瓣机构121,所述准出活瓣机构121被配置为仅允许液体从腔室1流出至外部。Alternatively, as shown in Figures 1 and 2, the inlet is for allowing blood to enter the chamber 1, so that the inlet may be provided with an access flap mechanism. The access flap mechanism is configured to only allow liquid to enter the chamber 1 from the outside. Such a flap mechanism may be a biomimetic valve, or may be other devices such as a solenoid valve that can restrict one-way flow, etc., which is not limited by the present invention. Correspondingly, an outlet flap mechanism 121 is also provided at the outlet 12, the quasi-valve mechanism 121 being configured to only allow liquid to flow out of the chamber 1 to the outside.
在本发明的一种实施方式中,所述准入活瓣机构和准出活瓣机构可以是单向活瓣。如图1、2所示,在入口11处,单向活瓣的一端与入口内壁连接,单向活瓣的另一端是自由端。入口11的内壁上设置有挡沿,挡沿能够阻止单向活瓣的自由端向入口的外侧移动。这样,所述入口处的单向活瓣被配置为只允许液体、血液向腔室内流动。相应地,在所述出口12的内壁上也设置有挡沿,所述挡沿能够阻止单向活瓣的自由端向出口的内侧移动,使出口处的单向活瓣被配置为只能允许液体、血液向腔室外流动。In an embodiment of the invention, the admission flap mechanism and the quasi-valve mechanism may be one-way flaps. As shown in Figures 1 and 2, at the inlet 11, one end of the one-way flap is connected to the inner wall of the inlet, and the other end of the one-way flap is a free end. The inner wall of the inlet 11 is provided with a rib that prevents the free end of the one-way flap from moving to the outside of the inlet. Thus, the one-way flap at the inlet is configured to only allow liquid, blood to flow into the chamber. Correspondingly, a rib is also provided on the inner wall of the outlet 12, the rib being able to prevent the free end of the one-way flap from moving to the inside of the outlet, so that the one-way flap at the outlet is configured to only allow Liquid and blood flow to the outside of the chamber.
在采用缸体31形成腔室1的实施方式中,如图1、2所示,所述搏动部件2优选为活塞。相应地,所述心脏模拟设备还可以包括转动机和连杆组件41,所述连杆组件41与所述活塞构成曲柄连杆机构。所述转动机与所述连杆组件41连接。当所述转动机转动时,所述连杆组件41能够将 旋转动作转换成直线运动,驱使所述活塞在缸体31内做往复运动。使腔室1的容积能够反复收缩、扩大。所述转动机的转动频率即为心脏模拟设备的搏动频率。在图1所示情况下,所述活塞处在扩大所述腔室1的过程中;图2所示的情况下,所述活塞处在将腔室1缩小到最小的状态。In the embodiment in which the chamber 1 is formed using the cylinder 31, as shown in Figs. 1, 2, the pulsating member 2 is preferably a piston. Accordingly, the cardiac simulation device can also include a rotary machine and a linkage assembly 41 that forms a crank linkage with the piston. The rotating machine is coupled to the link assembly 41. When the rotating machine rotates, the link assembly 41 can The rotary motion is converted into a linear motion that urges the piston to reciprocate within the cylinder block 31. The volume of the chamber 1 can be repeatedly contracted and expanded. The rotational frequency of the rotating machine is the beat frequency of the cardiac analog device. In the case shown in Fig. 1, the piston is in the process of enlarging the chamber 1; in the case shown in Fig. 2, the piston is in a state of narrowing the chamber 1 to a minimum.
可选地,如图1、2所示,所述连杆组件41上还可以具有连接孔42,所述连接孔42沿着所述连杆组件41延伸分布。所述连接孔供连杆组件的两支连杆枢转连接。在图1、2所示的实施方式中,所述连杆组件41中的两支连杆是端部相连,这样,转动机转动时,搏动部件2的最低位置与最高位置之间的差值较大,产生的缩小量更大,而且腔室的最大容量也更大。在其它的实施方式中,两支连杆也可以通过不同位置的连接孔42枢转连接。通过调节两支连杆的连接位置,可以对心脏模拟设备的腔室的容量、缩小量等参数进行调整,以适应于模拟不同功能状态、不同容量的心室。Optionally, as shown in FIG. 1 and FIG. 2 , the connecting rod assembly 41 may further have a connecting hole 42 , and the connecting hole 42 extends along the connecting rod assembly 41 . The connecting hole is pivotally connected to the two links of the connecting rod assembly. In the embodiment shown in Figures 1 and 2, the two links in the link assembly 41 are end-connected such that the difference between the lowest position and the highest position of the pulsating member 2 when the rotary machine is rotated Larger, the resulting reduction is larger and the maximum chamber capacity is greater. In other embodiments, the two links can also be pivotally connected by connection holes 42 at different positions. By adjusting the connection position of the two connecting rods, the parameters such as the capacity and the reduction amount of the chamber of the cardiac simulation device can be adjusted to adapt to the ventricles simulating different functional states and different capacities.
另外,在图1、2所示的实施方式中,还可以通过调整连杆组件的转动中心在缸体中的装配位置,调节所述腔室的最大容量。例如,图1、2中连杆组件41的下端部连接在转动机上,若将该下端部以及转动机整体向上移动,则会减小所述腔室的最大容量。相反的,如果将该连杆组件的下端部以及转动机整体向下移动,则会增大所述腔室的最大容量。所述缸体31上可以设置有轨道或转动中心装配孔等调节机构,用于对连杆组件和其转动中心以及转动机的位置进行调节。例如,连杆组件的转动中心和转动机可以沿着轨道滑动,从而调节转动中心的位置;或者,转动机的输出轴可以插在不同位置处的转动中心装配孔中,从而调节转动中心的位置。Further, in the embodiment shown in Figs. 1, 2, it is also possible to adjust the maximum capacity of the chamber by adjusting the assembly position of the rotation center of the link assembly in the cylinder. For example, the lower end portion of the link assembly 41 in Figs. 1 and 2 is coupled to the rotating machine, and if the lower end portion and the rotating machine as a whole are moved upward, the maximum capacity of the chamber is reduced. Conversely, if the lower end of the linkage assembly and the rotating machine as a whole are moved downward, the maximum capacity of the chamber is increased. The cylinder block 31 may be provided with an adjustment mechanism such as a rail or a rotating center mounting hole for adjusting the position of the link assembly and its center of rotation and the rotating machine. For example, the center of rotation of the link assembly and the rotating machine can slide along the track to adjust the position of the center of rotation; or the output shaft of the rotating machine can be inserted in the center of rotation assembly hole at different positions to adjust the position of the center of rotation .
当然,本发明并不限制只能采用活塞作为搏动部件。在其它实施方式中,例如还可以采用气压装置、液压装置、夹紧装置等部件作为动力源,用以驱动心脏模拟设备进行搏动动作。Of course, the invention is not limited to the use of a piston as a pulsating member. In other embodiments, for example, a pneumatic device, a hydraulic device, a clamping device, or the like may be used as a power source for driving the cardiac simulation device to perform a pulsating motion.
在本发明的一种实施方式中,所述搏动部件2可以为液压装置。如图3所示,在该实施方式中,所述缸体31中设置有软胶膜32,所述软胶膜32用于与缸体31的上部区域形成腔室。所述缸体31的下端是封闭的, 例如可以通过封闭板扣合封闭,或者缸体的下端本身就是封闭结构,本发明不对此进行限制。特别地,所述软胶膜32至缸体31下端的区域为压力腔35。在压力腔35上开设有供压力液流入和流出的搏动出入口34。所述液压装置优选可以设置在所述缸体31之外,所述液压装置可以通过液压泵将压力液泵入所述压力腔35中;并且,所述压力泵可以将压力液从压力腔35中抽出。In an embodiment of the invention, the pulsating member 2 may be a hydraulic device. As shown in FIG. 3, in this embodiment, a soft rubber film 32 is provided in the cylinder block 31, and the soft rubber film 32 is used to form a chamber with an upper region of the cylinder block 31. The lower end of the cylinder block 31 is closed. For example, it can be closed by a closure plate, or the lower end of the cylinder itself is a closed structure, which is not limited by the present invention. Specifically, the region of the soft film 32 to the lower end of the cylinder block 31 is the pressure chamber 35. A pulsation inlet and outlet 34 for the inflow and outflow of the pressurized fluid is opened in the pressure chamber 35. The hydraulic device may preferably be disposed outside the cylinder block 31, and the hydraulic device may pump pressurized fluid into the pressure chamber 35 by a hydraulic pump; and the pressure pump may pressurize the fluid from the pressure chamber 35. Extracted in the middle.
由于软胶膜32具有形变能力,所以当压力液持续充入所述压力腔35后,软胶膜32会受液压作用向上变形,从而减小所述腔室1的空间。使腔室1中的液体、血液从出口12流出。相反地,当液压装置向外抽出压力液时,所述软胶膜32会受到液压作用向下变形,从而增大所述腔室的空间。使所述入口11外的液体、血液能够被抽入所述腔室1中。采用液压装置作为搏动部件的优点在于,液体难以被压缩,所以能够通过控制压力液充入或吸出压力腔的量,对所述腔室的容量、搏出量和缩小量进行精确的控制。充入压力腔中的液体的量与从腔室搏出的液体量基本一致。在心脏模拟设备用于替代正常心脏的应用环境下,采用液压装置作为搏动部件能够更可靠的保证腔室容量的准确性,减小由于容量、搏出量的异常所造成的功能异常现象。Since the soft film 32 has a deforming ability, when the pressure liquid is continuously charged into the pressure chamber 35, the soft film 32 is deformed upward by the hydraulic action, thereby reducing the space of the chamber 1. The liquid and blood in the chamber 1 are caused to flow out from the outlet 12. Conversely, when the hydraulic device draws the pressure fluid outward, the soft film 32 is deformed downward by the hydraulic action, thereby increasing the space of the chamber. Liquid and blood outside the inlet 11 can be drawn into the chamber 1. The advantage of using the hydraulic device as the pulsating member is that the liquid is difficult to be compressed, so that the capacity, the stroke amount, and the reduction amount of the chamber can be accurately controlled by controlling the amount of the pressure liquid to be filled or sucked out of the pressure chamber. The amount of liquid charged into the pressure chamber is substantially the same as the amount of liquid that is drawn from the chamber. In the application environment where the cardiac simulation device is used to replace the normal heart, the use of the hydraulic device as the pulsating component can more reliably ensure the accuracy of the chamber capacity, and reduce the functional abnormality caused by the abnormality of the volume and the stroke volume.
可选地,所述压力腔35上可以只开设有一个搏动出入口34,压力液进出所述压力腔35都通过这一个搏动出入口34。或者,也可以分别开设搏动入口和搏动出口,分别用于压力液充入压力腔和抽出压力腔。Optionally, only one pulsating inlet and outlet 34 may be opened on the pressure chamber 35, and the pressure fluid enters and exits the pressure chamber 35 through the pulsating inlet and outlet 34. Alternatively, the pulsation inlet and the pulsation outlet may be separately provided for respectively filling the pressure chamber into the pressure chamber and withdrawing the pressure chamber.
在另一种实施方式中,所述液压装置可以不进行抽出操作。相应的,所述压力腔上可以单独开设有出气孔。当需要降低所述压力腔中的压力时,所述出气孔打开,将压力气体释放,从而降低压力腔的压力。In another embodiment, the hydraulic device may not perform an extraction operation. Correspondingly, the pressure chamber can be separately provided with an air outlet. When it is desired to reduce the pressure in the pressure chamber, the vent opening opens to release the pressurized gas, thereby reducing the pressure in the pressure chamber.
进一步地,所述液压装置还可以对压力液泵入压力腔时的速度进行控制,进液速度会影响到压力腔中的压力大小。Further, the hydraulic device can also control the speed at which the pressurized fluid is pumped into the pressure chamber, and the feed rate affects the pressure in the pressure chamber.
在本发明的另一种实施方式中,所述搏动装置2为气压装置。在采用气压装置作为搏动部件的实施方式中,所述心脏模拟设备的整体结构与图3所示的结构相近,所以本实施方式仍以图3示意心脏模拟设备的结构。 在该实施方式中,所述缸体31中也需要设置有软胶膜32。缸体31的下端是封闭的,所述软胶膜32至缸体31下端的区域为压力腔35。相似的,所述压力腔35上开设有供压力气体充入和泄出的搏动出入口34。所述气压装置可以设置在所述缸体31之外,气压装置可以通过气泵等装置将压力气体充入压力腔35;或者将压力气体从压力腔35中抽出。In another embodiment of the invention, the pulsating device 2 is a pneumatic device. In the embodiment in which the pneumatic device is used as the pulsating member, the overall structure of the cardiac simulation device is similar to that shown in Fig. 3, so the present embodiment still illustrates the structure of the cardiac simulation device in Fig. 3. In this embodiment, a soft film 32 is also required to be provided in the cylinder block 31. The lower end of the cylinder block 31 is closed, and the region of the soft film 32 to the lower end of the cylinder block 31 is a pressure chamber 35. Similarly, the pressure chamber 35 is provided with a pulsation inlet and outlet 34 for filling and discharging pressurized gas. The air pressure device may be disposed outside the cylinder block 31, and the air pressure device may charge the pressure gas into the pressure chamber 35 by means of a gas pump or the like; or extract the pressure gas from the pressure chamber 35.
与采用液压装置的实施方式类似的,当向压力腔35中持续充入压力气体致使压力上升时,软胶膜32会受气压作用向上变形,压缩所述腔室的空间,使腔室1中的液体、血液从出口12流出。相反的,气压装置向外抽出压力气体时,软胶膜32受到负压作用向下变形,从而增大了腔室的空间,使液体、血液能够从所述入口11抽入腔室1中。Similar to the embodiment in which the hydraulic device is used, when the pressure gas is continuously charged into the pressure chamber 35 to cause the pressure to rise, the soft film 32 is deformed upward by the air pressure, and the space of the chamber is compressed to make the chamber 1 The liquid and blood flow out from the outlet 12. Conversely, when the air pressure device draws out the pressure gas outward, the soft film 32 is deformed downward by the negative pressure, thereby increasing the space of the chamber, so that liquid and blood can be drawn into the chamber 1 from the inlet 11.
在另一种实施方式中,所述气压装置可以不进行抽气操作。相应的,所述压力腔上可以单独开设有出气孔。当需要降低所述压力腔中的压力时,所述出气孔打开,将压力气体释放,从而降低压力腔的压力。In another embodiment, the pneumatic device may not perform a pumping operation. Correspondingly, the pressure chamber can be separately provided with an air outlet. When it is desired to reduce the pressure in the pressure chamber, the vent opening opens to release the pressurized gas, thereby reducing the pressure in the pressure chamber.
采用气压装置作为搏动部件的优点在于,气压装置属于压力控制。由于所述腔室中具有一定压力,气压装置将压力气体泵入压力腔35时,软胶膜32不会立即产生形变并压缩所述腔室。压力气体会先出现被压缩的现象。当压力腔35中压力气体的气压大于腔室中的压力后,压力气体才会使软胶膜32向上变形,压缩所述腔室的空间。当气压装置将压力气体吸出时,压力气体的会先出现体积膨胀、压力减小的情况。而后,再在压力腔35中产生负压,使软胶膜32向下变形。压力气体的压缩和膨胀过程能够对腔室1的搏出和吸入动作形成压力缓冲,使腔室的出口和入口处的血压能够保持在适当的压力,不会出现压力突然增大或突然减小的现象。进一步地,所述气压装置还可以对压力气体泵入压力腔时的速度进行控制,进气速度会影响到压力腔中的压力大小。通过对进气速度的控制,可以将气压装置输出的压力大小限制在一个预定值,该预定值是腔室的出口处的安全血压上限值。如果腔室及其出口的血压达到了预定值,则气压装置无法进一步向压力腔35中充入压力气体,避免出口的血压进一步上升,提高安全性。 The advantage of using a pneumatic device as the pulsating member is that the pneumatic device is pressure controlled. Due to the pressure in the chamber, when the pneumatic device pumps the pressurized gas into the pressure chamber 35, the soft film 32 does not immediately deform and compress the chamber. The pressurized gas will first appear to be compressed. When the pressure of the pressure gas in the pressure chamber 35 is greater than the pressure in the chamber, the pressure gas deforms the soft film 32 upward, compressing the space of the chamber. When the air pressure device sucks out the pressure gas, the pressure gas first appears to expand in volume and decrease in pressure. Then, a negative pressure is generated in the pressure chamber 35 to deform the soft film 32 downward. The compression and expansion process of the pressurized gas can form a pressure buffer for the stroke and suction action of the chamber 1, so that the blood pressure at the outlet and the inlet of the chamber can be maintained at an appropriate pressure without sudden increase or sudden decrease in pressure. The phenomenon. Further, the pneumatic device can also control the speed at which the pressurized gas is pumped into the pressure chamber, and the intake speed affects the pressure in the pressure chamber. By controlling the intake air speed, the magnitude of the pressure output by the air pressure device can be limited to a predetermined value, which is the upper limit of the safe blood pressure at the outlet of the chamber. If the blood pressure of the chamber and its outlet reaches a predetermined value, the air pressure device cannot further inject the pressure gas into the pressure chamber 35, thereby preventing the blood pressure of the outlet from rising further and improving safety.
另外,在本发明的一种可选实施方式中,所述出口处或者出口外侧还可以设置有压力监控装置。所述压力监控装置被配置为与搏动部件形成电路连接,或者通过控制模块实现信号控制信号的传递。所述压力监控装置配置为用于检测出口处或出口外侧的血压。如果监测到血压过高,超出了安全范围,则可以将血压过高的报警信号发送给搏动部件;或者,可以将报警信号发送给控制模块,所述控制模块再向搏动部件发送信号。所述搏动部件则配置为,当收到来自压力监控装置或控制单元的报警信号后,能够停止或减缓对腔室中血液的搏出动作;或者,也可以推迟搏出动作的执行。这样,所述腔室出口处的压力或血压能够得到缓解,避免血压超出安全范围,造成危害。In addition, in an alternative embodiment of the invention, a pressure monitoring device may also be provided at the outlet or outside of the outlet. The pressure monitoring device is configured to form a circuit connection with the pulsating component or to effect transmission of a signal control signal by the control module. The pressure monitoring device is configured to detect blood pressure at or outside the outlet. If the blood pressure is detected to be too high and the safety range is exceeded, an alarm signal indicating that the blood pressure is too high may be transmitted to the pulsating member; or the alarm signal may be sent to the control module, which then sends a signal to the pulsating member. The pulsating member is configured to stop or slow the stroke of blood in the chamber after receiving an alarm signal from the pressure monitoring device or the control unit; or, the execution of the stroke action may be postponed. In this way, the pressure or blood pressure at the outlet of the chamber can be alleviated, preventing blood pressure from exceeding the safe range and causing harm.
本发明提供的心脏模拟设备采用了搏动式输出的方式泵出液体或血液,能够更好的模拟正常心脏的供血规律。对血细胞的破坏较小。重要的,本发明的心脏模拟设备引入了射血分数的概念,对腔室的缩小量进行了控制,从而减小人体出现不良反应的可能性。The cardiac simulation device provided by the invention uses a pulsating output to pump out liquid or blood, which can better simulate the blood supply law of a normal heart. The damage to blood cells is small. Importantly, the cardiac simulation device of the present invention introduces the concept of ejection fraction, which controls the amount of reduction in the chamber, thereby reducing the likelihood of adverse effects in the human body.
虽然已经通过例子对本发明的一些特定实施例进行了详细说明,但是本领域的技术人员应该理解,以上例子仅是为了进行说明,而不是为了限制本发明的范围。本领域的技术人员应该理解,可在不脱离本发明的范围和精神的情况下,对以上实施例进行修改。本发明的范围由所附权利要求来限定。 While the invention has been described in detail with reference to the preferred embodiments of the present invention, it is understood that It will be appreciated by those skilled in the art that the above embodiments may be modified without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.

Claims (10)

  1. 一种心脏模拟设备,其特征在于,包括:A cardiac simulation device, comprising:
    腔室,所述腔室被配置为容积可变,所述腔室具有入口和出口,所述入口被配置为能使液体从外部流入所述腔室中,所述出口被配置为能使液体从所述腔室中流出至外部;a chamber configured to have a variable volume, the chamber having an inlet and an outlet configured to enable liquid to flow from the outside into the chamber, the outlet being configured to enable liquid Flowing out of the chamber to the outside;
    搏动部件,所述搏动部件被配置为能扩大或缩小所述腔室的容积,当搏动部件扩大腔室的容积时,所述腔室从所述入口吸入液体,当搏动部件缩小腔室的容积时,所述腔室从所述出口泵出液体;a pulsating member configured to expand or contract the volume of the chamber, the chamber for drawing liquid from the inlet when the pulsating member enlarges the volume of the chamber, and the pulsating member reducing the volume of the chamber when the pulsating member is reduced The chamber pumps liquid from the outlet;
    所述搏动部件被配置为:对所述腔室的容积的缩小量,占搏动部件使腔室扩大到的最大容积的10%-90%。The pulsating member is configured to reduce the volume of the chamber by 10% to 90% of the maximum volume to which the pulsating member expands the chamber.
  2. 根据权利要求1所述的心脏模拟设备,其特征在于,所述心脏模拟设备包括密封构件,所述腔室位于所述密封构件内部,所述入口和出口设置在所述密封构件上,所述入口和出口分别将所述腔室与外部空间连通。The cardiac simulation apparatus according to claim 1, wherein the cardiac simulation apparatus includes a sealing member, the chamber is located inside the sealing member, and the inlet and the outlet are provided on the sealing member, The inlet and the outlet respectively communicate the chamber with the external space.
  3. 根据权利要求1或2所述的心脏模拟设备,其特征在于,所述密封构件包括缸体,所述缸体的一端为封闭端,所述搏动部件伸入缸体内并与缸体的内壁滑动密封,所述腔室位于从所述搏动部件到密封端之间的区域,所述搏动部件被配置为能在缸体中滑动。The cardiac simulation apparatus according to claim 1 or 2, wherein the sealing member comprises a cylinder body, one end of the cylinder body is a closed end, and the pulsating member protrudes into the cylinder body and faces the inner wall of the cylinder block A sliding seal, the chamber being located in an area from the pulsating member to the sealed end, the pulsating member being configured to slide in the cylinder.
  4. 根据权利要求1-3任意之一所述的心脏模拟设备,其特征在于,所述搏动部件与密封端之间设置有软胶膜,所述软胶膜的边缘密封连接在所述密封构件上,所述软胶膜与密封端之间包封的区域作为所述腔室。The cardiac simulation device according to any one of claims 1 to 3, characterized in that a soft film is disposed between the pulsating member and the sealing end, and an edge of the soft film is sealingly connected to the sealing member. The area enclosed between the soft film and the sealed end serves as the chamber.
  5. 根据权利要求1-4任意之一所述的心脏模拟设备,其特征在于,所述密封构件包括盖板,所述盖板封在所述缸体的一端,形成所述封闭端。A cardiac simulation apparatus according to any one of claims 1 to 4, wherein the sealing member comprises a cover plate which is sealed at one end of the cylinder to form the closed end.
  6. 根据权利要求1-5任意之一所述的心脏模拟设备,其特征在于,所述入口和出口设置在所述盖板上;A cardiac simulation apparatus according to any one of claims 1 to 5, wherein said inlet and outlet are provided on said cover plate;
    或者,所述入口和出口设置在所述缸体上。Alternatively, the inlet and outlet are disposed on the cylinder.
  7. 根据权利要求1-6任意之一所述的心脏模拟设备,其特征在于, 所述密封构件包括盖板,所述盖板封在所述缸体的一端,形成所述封闭端,A cardiac simulation apparatus according to any one of claims 1 to 6, wherein The sealing member includes a cover plate sealed at one end of the cylinder to form the closed end,
    所述软胶膜的边缘连接在所述缸体的内壁上;The edge of the soft film is attached to the inner wall of the cylinder;
    或者,所述软胶膜的边缘连接在所述盖板上。Alternatively, the edge of the soft film is attached to the cover.
  8. 根据权利要求1-7任意之一所述的心脏模拟设备,其特征在于,所述入口处设置有准入活瓣机构,所述准入活瓣机构被配置为仅允许液体从外部进入所述腔室,所述出口处设置有准出活瓣机构,所述准出活瓣机构被配置为仅允许液体从腔室流出至外部。A cardiac simulation apparatus according to any one of claims 1 to 7, wherein the inlet is provided with an admission flap mechanism, the admission flap mechanism being configured to allow only liquid to enter the exterior from the outside A chamber, the outlet being provided with a quasi-valve mechanism configured to only allow liquid to flow from the chamber to the exterior.
  9. 根据权利要求1-8任意之一所述的心脏模拟设备,其特征在于,所述缩小量占搏动部件使腔室扩大到的最大容积的40%-50%;The cardiac simulation apparatus according to any one of claims 1-8, wherein the reduction amount accounts for 40% to 50% of a maximum volume to which the pulsating member expands the chamber;
    或者,所述缩小量占搏动部件使腔室扩大到的最大容积的55%-70%。Alternatively, the amount of reduction is from 55% to 70% of the maximum volume to which the pulsating member expands the chamber.
  10. 根据权利要求1-9任意之一所述的心脏模拟设备,其特征在于,所述搏动部件为活塞,所述心脏模拟设备还包括转动机和连杆组件,所述连杆组件与所述活塞构成曲柄连杆机构,所述转动机与所述连杆组件连接,当所述转动机旋转时,所述活塞被配置为能在所述缸体内做往复运动所述连杆组件上分布有连接孔,所述连接孔供连杆组件的连杆枢转连接。 A cardiac simulation apparatus according to any one of claims 1-9, wherein said pulsating member is a piston, said cardiac simulation device further comprising a rotating machine and a connecting rod assembly, said connecting rod assembly and said piston Forming a crank linkage mechanism, the rotary machine being coupled to the linkage assembly, the piston being configured to reciprocate within the cylinder when the rotary machine rotates A connecting hole for pivotally connecting the links of the link assembly.
PCT/CN2017/096093 2017-08-04 2017-08-04 Cardiac simulation device WO2019024111A1 (en)

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