CN114642828A - Drive mechanism for heart beat assist device, use method and heart beat assist system - Google Patents

Abstract

The application provides a driving mechanism for a heart beating assisting device, a using method and a heart beating assisting system, wherein the driving mechanism comprises a flow-limiting gas supply device and a flow-limiting gas storage cavity, the flow-limiting gas supply device is provided with a variable-volume gas storage cavity, the gas storage cavity is in gas communication with a balloon of the heart beating assisting device through a first pipeline, the flow-limiting gas storage cavity is used for storing gas for expanding the volume of the balloon, and the flow-limiting gas storage cavity is used for filling the balloon with the gas or extracting the gas filled in the balloon through volume change; the high-pressure air cavity is communicated with the flow-limiting air supply device through a second pipeline and is used for providing high-pressure driving force for reducing the volume of the air storage cavity; and the low-pressure air chamber is communicated with the flow-limiting air supply device through a third pipeline and is used for providing negative pressure driving force for increasing the volume of the air storage chamber. The driving mechanism can ensure that the volume and the pressure of the gas filled into the saccule or pumped out of the saccule at each time are constant, so that the stress on the surface of the heart is uniform.

Description

Drive mechanism for heart beat assist device, use method and heart beat assist system

Technical Field

The application relates to the technical field of medical instruments, in particular to a driving mechanism for a heart beat assisting device, a using method and a heart beat assisting system.

Background

Heart failure is a common problem in the world today, and is classified into different degrees when the heart is weak and fails to pump blood at a physiological rate commensurate with the needs of the organs and tissues of the human body. The heart failure is extremely serious in the present global condition, the number of the heart failure diseases exceeds 2600 ten thousand, and the growth speed is continuously increased. Heart transplantation is the first choice for the treatment of end-stage heart failure, but is limited by donor deficiency, and only hundreds of heart transplantation operations are performed annually in China. Therefore, the temporary or permanent replacement of heart transplantation with heart beat assist devices is an effective way to prolong survival in many patients.

Most of the conventional power pump type heart beating auxiliary devices adopt a saccule implanted in a body to assist the heart to pump blood, and when the heart contracts, the saccule is inflated to expand towards a ventricle so as to assist the heart to contract; when the heart is in diastole, the saccule is deflated to promote the heart to fully relax, thereby assisting the heart failure heart to realize normal functions. The existing driving mechanism for driving the balloon to inflate and deflate comprises an inflator pump communicated with fluid of the balloon, a gas cylinder filled with medical gas and an inflator pump control device, and has the following defects that firstly, the pressure of gas flow is unstable, the volume of the filled gas is difficult to accurately control, the stress on the surface of a heart is easily uneven, the damage to a biological structure is caused, and secondly, the whole volume and weight of the mechanism are large, so that the wearing of the heart beating assisting device is not facilitated. Therefore, there is a need in the art to develop a higher performance drive mechanism for a cardiac impulse assist device.

Disclosure of Invention

In view of the above-mentioned drawbacks and deficiencies of the prior art, the present application provides a driving mechanism for a heart beat assisting device, a method of using the same, and a heart beat assisting device, so as to quantitatively deliver a constant pressure gas to a balloon in a desired amount, ensure a uniform force applied to the heart, and avoid or reduce discomfort of a patient during a treatment process.

In a first aspect, the present application provides a drive mechanism for a cardiac impulse assist device, according to an embodiment of the present application, comprising:

the flow-limiting gas supply device is provided with a gas storage cavity with variable volume, and the gas storage cavity is in gas communication with a balloon of the heart beating assisting device through a first pipeline, is used for storing gas for expanding the volume of the balloon and is used for filling the balloon with the gas or extracting the gas filled in the balloon through volume change;

the high-pressure air chamber is communicated with the flow-limiting air supply device through a second pipeline and is used for providing high-pressure driving force for reducing the volume of the air storage cavity; and

and the low-pressure air chamber is communicated with the flow-limiting air supply device through a third pipeline and is used for providing a negative pressure driving force for increasing the volume of the air storage chamber.

In one embodiment, the flow-restricted gas supply apparatus comprises:

the gas storage device comprises a body, a first pipeline and a second pipeline, wherein the body is provided with a first opening and a second opening which are oppositely arranged, a deformable adjusting piece is arranged in the body, the adjusting piece divides an inner cavity of the body into a first cavity and a second cavity which are mutually isolated along the direction of the connecting line of the first opening and the second opening, the first cavity is used as a gas storage cavity and is connected with the first pipeline through the first opening, and the second cavity can be selectively communicated with the high-pressure gas cavity or the low-pressure gas cavity through the second opening;

when the second cavity is communicated with the low-pressure air cavity, the negative pressure driving force drives the adjusting piece to deform towards the direction close to the second opening, the volume of the air storage cavity is reduced, and air is filled into the saccule.

In one embodiment, the adjustment member is a flexible membrane.

In one embodiment thereof, the body comprises:

the first opening is positioned on the first body, the second opening is positioned on the second body, and the adjusting piece is positioned between the first body and the second body;

the first body and the second body are both semi-elliptical structures, and the ratio of the major axis to the minor axis of each semi-elliptical structure is 2-5: 1.

In one embodiment, the second pipeline is provided with a first electromagnetic valve for controlling the on-off of the gas path, and the third pipeline is provided with a second electromagnetic valve and a third electromagnetic valve for controlling the on-off of the gas path;

optionally, the first electromagnetic valve and the second electromagnetic valve are normally closed electromagnetic valves, the third electromagnetic valve is a normally open electromagnetic valve, the normally open electromagnetic valve is a normally open two-way electromagnetic valve, the normally open electromagnetic valve is in a closed state when the power is on and is communicated with the output end of the second electromagnetic valve, and the normally open electromagnetic valve is in an open state when the power is off and is communicated with the atmosphere;

optionally, the first pipeline is sequentially provided with a first air filter, a pressure detection element, a condenser and a pressure limiting valve in a direction from the balloon to the flow-limiting air supply device, the condenser is connected with the low-pressure air chamber through a fourth pipeline, and the fourth pipeline is provided with at least one electromagnetic valve for controlling the on-off of the pipeline.

In one embodiment, the high pressure air chamber is connected with a first air pump and a second air filter for providing clean air to the high pressure air chamber, and the high pressure air chamber 20 is provided with at least one pressure limiting valve, and the low pressure air chamber is connected with a second air pump for pumping air from the low pressure air chamber by the second air pump to generate negative pressure in the low pressure air chamber.

In one embodiment, the high-pressure air chamber is further used for filling the air storage chamber with air for expanding the volume of the balloon through the first pipeline, the high-pressure air chamber is communicated with the first pipeline through a fifth pipeline, and at least one electromagnetic valve for controlling the on-off of an air path is arranged on the fifth pipeline.

In one embodiment, the balloon further comprises a compressed gas supply assembly for supplying gas to the gas storage chamber to expand the balloon volume;

optionally, the compressed gas supply assembly comprises a first gas storage tank and a second gas storage tank which are communicated, an outlet end of the second gas storage tank is connected with a gas inlet end of the first pipeline, a pressure reducing valve is arranged on a pipeline connecting the first gas storage tank and the second gas storage tank, and a pressure limiting valve is arranged on the second gas storage tank.

In a second aspect, according to an embodiment of the present application, there is provided a method for using the driving mechanism for a cardiac impulse assist device as described above, including the steps of:

inflating the gas storage chamber with a gas to expand the balloon volume;

controlling the high-pressure air cavity to be communicated with the flow-limiting air supply device during systole, and reducing the volume of the air storage cavity to fill the balloon with the air;

and during diastole, the low-pressure air chamber is controlled to be communicated with the flow-limiting air supply device, and the volume of the air storage chamber is increased to extract the air filled in the balloon.

In a third aspect, according to an embodiment of the present application, there is provided a heart beat assist system, comprising:

a support device having a concave structure that conforms to the interior shape of a heart chamber for wrapping around the exterior of the heart chamber;

at least one balloon disposed between the outer ventricular surface and the inner support device surface; and

the driving mechanism is connected with the balloon through the first pipeline and is positioned outside the body.

The technical scheme provided by the embodiment of the application can have the following beneficial effects:

the drive mechanism of this application can guarantee to fill the sacculus or follow the gaseous volume and the pressure constancy of taking out in the sacculus through introducing current-limiting air feeder at every turn for heart surface atress is even, promotes treatment and patient's comfort level.

Drawings

Other features, objects and advantages of the present application will become more apparent upon reading of the following detailed description of non-limiting embodiments thereof, made with reference to the accompanying drawings in which:

FIG. 1 is a schematic structural view of a drive mechanism according to an embodiment of the present application;

FIG. 2 is a schematic diagram of a flow-limiting gas supply apparatus according to an embodiment of the present application;

FIG. 3 is a schematic structural view of a body according to an embodiment of the present application;

fig. 4 is a schematic structural diagram of a driving mechanism according to another embodiment of the present application.

Reference numerals: the air supply device comprises a flow-limiting air supply device 10, a high-pressure air chamber 20, a low-pressure air chamber 30, a first pipeline 41, a second pipeline 42, a third pipeline 43, a fourth pipeline 44, a fifth pipeline 45, a first solenoid valve K1, a second solenoid valve K2, a third solenoid valve K3, a fourth solenoid valve K4, a fifth solenoid valve K5, a sixth solenoid valve K6, a seventh solenoid valve K7, a solenoid valve K8, a first air pump 51, a second air pump 52, a first air filter 61, a second air filter 62, a pressure limiting valve C1-C4, pressure detecting elements X1-X5, a compressed air supply device 8, a first air storage tank 81, a second air storage tank 82, a pressure reducing valve 83, an air storage chamber 101, a body 102, a regulating element 103, a second chamber 104, a first opening 1051, a second opening 1052, a first body 1021, and a second body 1022.

Detailed Description

The present application will be described in further detail with reference to the following drawings and examples. It is to be understood that the specific embodiments described herein are merely illustrative of the relevant invention and not restrictive of the invention. It should be noted that, for convenience of description, only the portions related to the present invention are shown in the drawings.

It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict. The present application will be described in detail below with reference to the embodiments with reference to the attached drawings.

In addition, in order to facilitate clear description of technical solutions of the embodiments of the present application, in the embodiments of the present application, terms such as "first" and "second" are used to distinguish the same items or similar items having substantially the same functions and actions. Those skilled in the art will appreciate that the terms "first," "second," and the like do not denote any order or importance, but rather the terms "first," "second," and the like do not denote any order or importance.

As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, regions, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and/or groups thereof.

In order to facilitate understanding of the embodiments of the present application, the related concepts related to the embodiments of the present application are first briefly described as follows:

the heart beating assisting device, also called an artificial heart, is a heart assisting device which can partially or completely replace the function of a natural heart and maintain normal blood circulation of a human body, and can help a failing heart to complete the blood circulation function, relieve the heart burden of a patient with cardiac insufficiency and improve the clinical symptoms of the patient. Meanwhile, the oxygen consumption of cardiac muscle of the patient is reduced, the myocardial contractility of the patient is improved, and the recovery of the blood pumping function of the heart of the patient is promoted. The heart beat assisting device of the embodiment of the application comprises a balloon made of elastic telescopic materials, wherein the balloon is implanted in the chest cavity, keeps good contact with the surface of the heart and has a controllable expansion state and a controllable contraction state which retracts from the expansion state to an initial state or a hollow and flat state so as to change the ventricular blood storage volume and pressure periodically synchronously with the beating of the heart. During the period of heart contraction, the saccule is synchronously inflated to enter an expansion state, and expands towards the ventricle to press the ventricle, so that more blood in the ventricle is pressed into the artery, the blood pumping capacity of the heart is auxiliarily improved, and the blood flow of the systemic circulation and the pulmonary circulation is increased. During diastole, the balloon is synchronously deflated to enter a contracted state, assisting diastole to increase the volume of the heart chamber for storing blood and reduce the pressure on the outer surface of the heart chamber, promoting blood backflow, thereby playing a therapeutic role in heart failure.

The driving mechanism refers to a power mechanism for delivering fluid to or extracting fluid from the balloon to drive the balloon to be in an expansion state or a contraction state, i.e. a mechanism for driving the balloon to work so as to alternately switch between the expansion working state and the contraction working state, wherein the fluid is preferably gas, and the driving mechanism is a gas supply device for inflating or evacuating gas into the inner cavity of the balloon so as to expand or contract the volume of the balloon and thus expand or contract the balloon in the radial direction.

The driving mechanism in the prior art comprises an air bottle and a vacuum pump, the balloon is inflated or vacuumized by the vacuum pump to expand or contract, the defect that the volume and pressure of inflation or air exhaust cannot be accurately controlled exists in the periodic inflation and air exhaust process, the air flow is unstable, stress acting on the surface of the heart is uneven, the treatment effect is poor, and the heart can be damaged due to improper pressure control. In addition, the existing driving mechanism is bulky and is inconvenient for patients to carry.

Thus, in a first aspect of the present application, according to an embodiment of the present application, the present application provides a driving mechanism for a cardiac impulse assist device, please refer to fig. 1 and 2, which includes:

the flow-limiting gas supply device 10 comprises a flow-limiting gas supply device 10, a high-pressure gas chamber 20 and a low-pressure gas chamber 30, wherein the flow-limiting gas supply device 10 is provided with a gas storage chamber 101 with variable volume, and the gas storage chamber 101 is in gas communication with a balloon of the heart beat assisting device through a first pipeline 41 and is used for storing gas for expanding the volume of the balloon and filling the gas into the balloon or extracting the gas filled into the balloon through volume change; the high-pressure air chamber 20 is communicated with the flow-limiting air supply device 10 through a second pipeline 42 and is used for providing high-pressure driving force for reducing the volume of the air storage chamber 101; the low pressure air chamber 30 communicates with the restricted flow gas supply 10 through a third conduit 43 for providing a negative pressure driving force to increase the volume of the gas storage chamber 101.

In this embodiment, the first pipeline 41 is open at two ends, one end is connected to the balloon, and the other end extends out of the body and is connected to the flow-limiting gas supply device 10, a certain amount of gas with constant pressure is pre-filled into the gas storage chamber 101 through the first pipeline 41, and the gas or at least a part of the gas is filled into the balloon when balloon expansion is required, so as to inflate the balloon. Wherein, sacculus, first pipeline 41 and gaseous storage chamber 101 three gas circuit intercommunication and airtight, quantitative gas can circulate and can't outwards flow between the three for the gas in the sacculus has invariable pressure and volume respectively under the drive of same high pressure or negative pressure, and wherein, the volume of gaseous storage chamber 101 is far greater than the volume of sacculus.

When the driving mechanism is in a non-working state, the balloon is in an initial state, wherein the initial state refers to a state that a certain amount of air is contained in the balloon and the balloon wall of the balloon is not elastically deformed or has no obvious elastic deformation, namely, obvious shriveling deformation and expansion deformation do not occur. When the heart contracts, the high-pressure air chamber 20 is communicated with the flow-limiting air supply device 10, the high-pressure driving force from the high-pressure air chamber 20 drives the volume of the air storage chamber 101 to be reduced, the air in the air storage chamber 101 is extruded into the balloon to realize the volume expansion of the balloon, when the heart expands, the low-pressure air chamber 30 is communicated with the flow-limiting air supply device 10, the negative-pressure driving force from the negative-pressure air chamber drives the volume of the air storage chamber 101 to be increased, the air filled into the balloon is pumped out and enters the air storage chamber 101 through the first pipeline 41 to realize the contraction of the balloon, and then when the heart contracts next time, the high-pressure driving force drives the volume of the air storage chamber 101 to be reduced, the air entering the air storage chamber 101 is extruded into the balloon again, so that the periodic expansion and contraction of the balloon are realized. During the process, the volume and the pressure of the gas filled into the saccule or extracted from the saccule are the same each time, the gas flow is stable, and the acting force on the surface of the heart is uniform and constant.

The volume of the gas storage cavity 101 can be changed in various ways, for example, the flow-limiting gas supply device 10 is made of an elastic and stretchable material, and the volume of the gas storage cavity 101 can be adjusted by driving the gas storage cavity to be periodically deformed by a high-pressure driving force and a negative-pressure driving force, or one side wall of the gas storage cavity 101 is laterally movable and can be laterally moved by the high-pressure driving force or the negative-pressure driving force, so that the volume of the gas storage can be adjusted.

Further, in a preferred embodiment of the present application, referring to fig. 2, the limited-flow gas supply device 10 includes:

a body 102, the body 102 having a first opening 1051 and a second opening 1052 disposed opposite to each other, a deformable adjusting member 103 being disposed in the body 102, the adjusting member 103 dividing an inner cavity of the body 102 into a first cavity and a second cavity 104 isolated from each other along a connecting line of the first opening 1051 and the second opening 1052, the first cavity serving as a gas storage cavity 101 connected to the first pipeline 41 through the first opening 1051, and the second cavity 104 selectively communicating with the high pressure gas cavity 20 or the low pressure gas cavity 30 through the second opening 1052;

when the second cavity 104 is communicated with the high-pressure air cavity 20, the high-pressure driving force drives the adjusting part 103 to deform towards the direction close to the first opening 1051, the volume of the air storage cavity 101 is reduced, and the air is filled into the balloon, and when the second cavity 104 is communicated with the low-pressure air cavity 30, the negative-pressure driving force drives the adjusting part 103 to deform towards the direction close to the second opening 1052, and the volume of the air storage cavity 101 is increased, and the air filled into the balloon is pumped out.

In this embodiment, the body 102 is made of a rigid material, the first opening 1051 of the body is communicated with the first pipeline 41, the second opening 1052 is selectively communicated with the high pressure air chamber 20 or the low pressure air chamber 30, the regulating member is periodically deformed by the action of the high pressure driving force and the negative pressure driving force to regulate the volume of the gas storage chamber 101, specifically, the high pressure driving force can push the regulating member 103 to be deformed toward the direction close to the first opening 1051, so as to squeeze gas into the balloon, so as to expand the volume of the balloon, the negative pressure driving force can pull the regulating member 103 toward the direction close to the second opening 1052, that is, toward the direction away from the first opening 1051, so as to force the gas to move out of the balloon, so as to make the volume of the balloon shrink. Wherein the rigid material is a substance having a high young's modulus, for example, the high young's modulus may be greater than 100 gigapascals (GPa), greater than 150GPa, greater than 180GPa, greater than 200GPa, and the like. Examples of rigid materials with a high young's modulus may include, for example, copper, brass, bronze, steel, iron, silicon carbide, tungsten carbide, and single-walled carbon nanotubes, among other materials.

Wherein the adjustment member 103 may be integrally formed with the body 102 or may be a separate component from the body 102 and attached within the body 102 by any suitable means, such as adhesive, welding, soldering, using fasteners, etc.

Further, in a preferred embodiment of the present application, the adjusting member 103 is a flexible film, that is, the adjusting member 103 is a film structure made of a flexible material, including but not limited to polyester materials such as Polycarbonate (PC), polymethyl methacrylate (PMMA), polyethylene terephthalate (PET), and the like, and materials such as polyether sulfone (PES), cellulose ester, polyvinyl chloride (PVC), benzocyclobutene (BCB), and acrylic resin, and the thickness of the adjusting member 103 is 1 mm to 1 cm.

Further, in a preferred embodiment of the present application, referring to fig. 3, the body 102 includes:

a first body 1021 and a second body 1022, the first opening 1051 being located on the first body 1021, the second opening 1052 being located on the second body 1022, the adjuster 103 being located between the first body 1021 and the second body 1022; the first body 1021 and the second body 1022 are both semi-elliptical structures, and the ratio of the major axis to the minor axis of the semi-elliptical structures is 2-5: 1.

In the embodiment, the body 102 is configured to be composed of a first body 1021 and a second body 1022 which are symmetrical, so that the adjusting piece 103 can be replaced after being damaged, the first body 1021 and the second body 1022 are configured to be semi-elliptical structures, and the ratio of the major axis to the minor axis of the semi-elliptical structures is 2-5: 1, so that the adjusting piece 103 can drive gas to move enough under the condition of small deformation, and the risk of mechanical fatigue or fracture of the adjusting piece 103 is reduced. Wherein, the adjusting member 103 is also preferably of a semi-elliptical structure.

Further, in a preferred embodiment of the present application, referring to fig. 3, each of the first body 1021 and the second body 1022 includes a semi-elliptical main body and a circular pad, the semi-elliptical main body has a hollow interior, the circular pad is connected to an outer edge of an opening of the semi-elliptical main body, the semi-elliptical main body and the circular pad are integrally formed, wherein a fixing hole is formed in the circular pad, and the first body 1021, the second body 1022 and the adjusting member 103 are fixedly connected by a fixing bolt adapted to the fixing hole.

Further, in a preferred embodiment of the present application, please refer to fig. 1, a first electromagnetic valve K1 for controlling the on-off of the air path is disposed on the second pipeline 42, and a second electromagnetic valve K2 and a third electromagnetic valve K3 for controlling the on-off of the air path are disposed on the third pipeline 43;

optionally, first solenoid valve K1 and second solenoid valve K2 are normally closed solenoid valves, third solenoid valve K3 is normally open solenoid valve, normally open solenoid valve is normally open type two-way solenoid valve, normally open solenoid valve is the closed condition when circular telegram, and with second solenoid valve K2's output communicates with each other, is the open mode when the outage, and communicates with each other with the atmosphere.

The third electromagnetic valve K3 is set to be a normally open electromagnetic valve, and when the driving mechanism is powered off, the third electromagnetic valve K3 will connect the third pipeline 43 with the atmosphere and automatically pump out the gas in the balloon. Regardless of whether the saccule is in an inflation state or an air suction state before power failure, the contraction and relaxation functions of the heart cannot be influenced after the power failure, the safety of the device is improved, for example, the driving mechanism completes inflation, the saccule is in a failure state when in an expansion state to cause the power failure, at the moment, the K3 can be communicated with the atmosphere, the outside atmosphere is communicated with the second cavity of the current-limiting air supply device 10, the air pressure of the first cavity of the current-limiting air supply device 10 is greater than the atmospheric pressure, therefore, the adjusting piece 103 deforms towards the direction close to the second opening 1052 under the action of pressure difference, and the gas filled into the saccule flows out, so that the influence on the diastole cannot be caused.

Further, in a preferred embodiment of the present application, the first pipeline 41 is sequentially provided with a first air filter 61, a pressure detecting element, a condenser 70 and a pressure limiting valve from the balloon to the flow-limiting air supply device 10, and the condenser 70 is connected to the low pressure air chamber 30 through a fourth pipeline 44, wherein the fourth pipeline 44 is provided with at least one solenoid valve for controlling the on/off of the pipeline.

The first air filter 61 is used for filtering impurities in the gas, so that the gas quality meets medical standards.

The pressure detecting element is used to detect the gas pressure in the first pipe 41.

The condenser 70 is used for cooling water vapor in the pipeline to keep the gas dry, because the balloon is attached to the surface of the heart, the environment is humid, the gas in the balloon has a trace amount of water vapor, the water vapor is cooled by the condenser 70, and water drops enter the low-pressure air cavity 30 through the electromagnetic valve and the fourth pipeline 44 and then are discharged into the air. The condenser 70 may be any one of condensers commonly used in the art, preferably made of metal with good heat conductivity, and has cooling fins attached to its side surface, so that when the gas passes through the condenser, the water vapor carried in the gas is cooled into water drops. Because the water vapor content is very low, the water is not required to be drained frequently in the normal working process of the driving mechanism, and the water is drained once every 2 to 3 hours. Wherein, two solenoid valves, a fourth solenoid valve K4 and a fifth solenoid valve K5 are arranged on the fourth pipeline 44, and the fourth solenoid valve K4 and the fifth solenoid valve K5 are both normally closed solenoid valves, and water drops formed after condensation enter the low pressure air chamber 30 through the fourth solenoid valve K4 and the fifth solenoid valve K5. The fourth solenoid valve K4 and the fifth solenoid valve K5 arranged on the fourth pipeline 44 can ensure that one of the solenoid valves normally operates when a fault occurs, and can ensure that water vapor is fully condensed on the other hand, so that the water vapor is prevented from directly entering the low-pressure air chamber 30 due to incomplete condensation and affecting the operation of the driving mechanism.

The pressure limiting valve is used for automatically exhausting and reducing pressure when the pressure in the first pipeline 41 exceeds a specific value, so that the balloon is prevented from being damaged or the diastole is prevented from being blocked or the heart is prevented from being damaged due to overhigh gas pressure.

Further, in a preferred embodiment of the present application, the high pressure air chamber 20 is connected to a first air pump 51 and a second air filter 62 for providing clean air to the high pressure air chamber 20, and at least one pressure limiting valve is disposed on the high pressure air chamber 20, and the low pressure air chamber 30 is connected to a second air pump 52 for generating negative pressure in the low pressure air chamber 30 by pumping air from the low pressure air chamber through the second air pump.

The air outlet end of the second air filter 62 is connected with the air inlet end of the first air pump 51, the air outlet end of the first air pump 51 is connected with the air inlet end of the high-pressure air chamber 20, air is filtered by the second air filter 62 and then is filled into the high-pressure air chamber 20 by the first air pump 51, when the air pressure of the high-pressure air chamber 20 exceeds the set air pressure, the first air pump 51 stops working, otherwise, the first air pump 51 continuously inflates the high-pressure air chamber 20, and finally the air pressure in the high-pressure air chamber 20 is kept consistent with the set pressure. Wherein, two pressure limiting valves are arranged on the high pressure air cavity 20, and the two pressure limiting valves are set to different upper limit pressure values, so as to ensure the stability of the gas pressure of the high pressure air cavity 20.

Wherein, the second air pump 52 forms negative pressure in the low pressure air chamber 30 by extracting air from the low pressure air chamber 30, when the air pressure of the low pressure air chamber 30 is lower than the set air pressure, the second air pump 52 stops working, otherwise, the second air pump 52 continuously extracts air from the low pressure air chamber 30, and finally the air pressure in the low pressure air chamber 30 is kept consistent with the set pressure. Wherein, pressure detecting elements for detecting the gas pressure are provided on the high pressure gas chamber 20, the low pressure gas chamber 30 and the second pipeline 42.

Further, in a preferred embodiment of the present application, as shown in fig. 1, the gas stored in the gas storage chamber 101 to expand the volume of the balloon is performed through the high pressure gas chamber 20, specifically, the high pressure gas chamber 20 is communicated with the first pipeline 41 through a fifth pipeline 45, at least one electromagnetic valve for controlling the on-off of the gas path is arranged on the fifth pipeline 45, and a fixed amount of gas under controlled pressure from the high pressure gas chamber 20 enters the first pipeline 41 through the fifth pipeline 45 and further enters the gas storage chamber 101.

In some embodiments, two solenoid valves, a sixth solenoid valve K6 and a seventh solenoid valve K7, for controlling the on/off of the air path, are disposed on the fifth pipeline 45, and both the sixth solenoid valve K6 and the seventh solenoid valve K7 are normally closed solenoid valves. The arrangement of the sixth solenoid valve K6 and the seventh solenoid valve K7 on the fifth line 45 ensures that the drive mechanism operates properly in the event of a malfunction of one of the solenoid valves.

Further, in another preferred embodiment of the present application, referring to fig. 4, the gas stored in the gas storage chamber 101 to expand the balloon volume is supplied by the compressed gas supply assembly 8, i.e. the driving mechanism of the present application further comprises the compressed gas supply assembly 8, and the compressed gas supply assembly 8 is used for charging the gas storage chamber 101 with the gas to expand the balloon volume.

Referring to fig. 4, the compressed gas supply assembly 8 includes a first gas tank 81 and a second gas tank 82 which are communicated with each other, an outlet end of the second gas tank 82 is connected to an air inlet end of the first pipeline 41, wherein a pressure reducing valve 83 is disposed on a pipeline connecting the first gas tank 81 and the second gas tank 82, a pressure limiting valve is disposed on the second gas tank 82, and the first gas tank 81 may be a compressed air tank or a compressed nitrogen tank. At least one solenoid valve, preferably three normally closed solenoid valves, namely a sixth solenoid valve K6, a seventh solenoid valve K7 and a solenoid valve K8, are arranged on the pipeline connecting the second air tank 82 and the first pipeline 41.

In the present embodiment, the gas supplied by the compressed gas supply assembly 8 is generally a gas that meets medical standards and is relatively clean, so the first air filter 61 on the first pipeline 41 can be omitted to further simplify the structure of the driving mechanism of the present application and reduce the volume.

The utility model provides a actuating mechanism can guarantee to fill the sacculus or follow the gaseous volume and the pressure constancy of taking out in the sacculus through introducing current-limiting air feeder 10 at every turn for heart surface atress is even, promotes treatment and patient's comfort level, and through setting up a plurality of solenoid valves of voltage limiting valve and control gas circuit break-make, makes actuating mechanism's security improve, can effectively prevent the emergence of the accident that the gas pressure is uncontrolled to lead to. In addition, the driving mechanism of the application has a compact structure, is convenient for a patient to wear, can be designed into a cart type or a portable type, and is suitable for different working scenes.

In a second aspect of the present application, according to an embodiment of the present application, there is provided a method for using the driving mechanism for a cardiac impulse assist device as described above, including the steps of:

inflating the gas storage chamber 101 with a gas to expand the balloon volume;

controlling the high-pressure air chamber 20 to be communicated with the flow-limiting air supply device 10 during systole, and reducing the volume of the air storage chamber 101 to charge the air into the balloon;

during diastole, the low pressure air chamber 30 is controlled to communicate with the restricted flow gas supply 10 and the gas storage chamber 101 increases in volume to draw out the gas filled in the balloon.

Specifically, in some preferred embodiments, the use method of the drive mechanism of the present application includes the following processes:

1) controlling gas pressure stabilization of high pressure gas chamber 20

After the pressure limiting value of the pressure limiting valve is set, the driving mechanism is electrified, the first solenoid valve K1, the third solenoid valve K3, the fourth solenoid valve K4, the fifth solenoid valve K5, the sixth solenoid valve K6 and the seventh solenoid valve K7 are closed, and the second solenoid valve K2 is opened.

The outside air inflates the high pressure air chamber 20 through the second air filter and the first air pump, when the air pressure of the high pressure air chamber 20 exceeds the set air pressure, the first air pump stops working, otherwise, the first air pump continuously inflates the high pressure air chamber 20, and finally the air pressure in the high pressure air chamber 20 is consistent with the set pressure.

2) Controlling gas pressure stabilization of the low pressure gas chamber 30

After the driving mechanism is powered on, the second air pump pumps out the air in the low-pressure air chamber 30, when the air pressure of the low-pressure air chamber 30 is lower than the set air pressure, the second air pump stops working, otherwise, the second air pump continuously pumps the air from the low-pressure chamber, and finally the air pressure in the low-pressure air chamber 30 is kept consistent with the set pressure.

3) Charging the gas storage chamber 101

Closing the first solenoid valve K1, the third solenoid valve K3, the fourth solenoid valve K4 and the fifth solenoid valve K5, opening the second solenoid valve K2, the sixth solenoid valve K6 and the seventh solenoid valve K7, at this time, the adjusting member 103 in the limited-flow air supply device 10 is pulled by the negative pressure driving force and deforms in the direction close to the second opening 1052, the air in the high-pressure air chamber 20 enters the first pipeline 41 through the sixth solenoid valve K6 and the seventh solenoid valve K7 and rapidly enters the gas storage chamber 101, after about 10 milliseconds, the sixth solenoid valve K6 and the seventh solenoid valve K7 are closed, the states of the other solenoid valves are unchanged, at this time, the first pipeline 41 and the gas storage chamber 101 are filled with gas, and the gas is in a closed state.

Specifically, in the embodiment of the present application, when the air pressures of the high pressure air chamber 20 and the low pressure air chamber 30 are stabilized, the air storage chamber 101 needs to be previously inflated, and the inflated air is used to inflate the balloon in the subsequent process so as to make the balloon in the expanded state. Wherein the balloon is in an initial state when the drive mechanism is not activated, i.e., when the gas storage chamber 101 is not inflated.

First solenoid valve K1, third solenoid valve K3, fourth solenoid valve K4, and fifth solenoid valve K5 are controlled to be in a closed state, second solenoid valve K2, sixth solenoid valve K6, and seventh solenoid valve K7 are controlled to be in an open state, at this time, the first pipe 41 is communicated with the high pressure air chamber through the sixth solenoid valve K6 and the seventh solenoid valve K7, the second chamber of the air flow-limiting supply device 10 is communicated 30 with the low pressure air chamber through the second solenoid valve K2 and the third solenoid valve K3, the adjusting member 30 is deformed in a direction close to the second opening 1052 under the driving of the pressure difference, i.e., to the right, and at the same time, the high-pressure gas in the high-pressure gas chamber 20 is introduced into the first line 41 through the sixth solenoid valve K6 and the seventh solenoid valve K7, and enters the first chamber (namely the gas storage chamber 101) of the limited gas supply device 10, the first pipeline 41 and the first chamber of the limited gas supply device 10 are filled with gas within 10 milliseconds, the charging is completed, and the sixth electromagnetic valve K6 and the seventh electromagnetic valve K7 are closed. Wherein, the diameter of the first pipeline 41 is smaller, the diameter is within the range of 2-3mm, the diameter of the balloon is within the range of 5-8mm, the long axis of the flow-limiting air supply device is within the range of 13-15 cm, the volume of the balloon and the first pipeline is far smaller than that of the gas storage cavity 101, during the inflation process, the adjusting piece 103 is firstly pulled to the direction close to the second opening 1052, so that the high-pressure gas quickly enters the gas storage cavity 101, wherein a small amount of high-pressure gas enters the balloon, and the balloon is in a state of slightly bulging and not pressing the heart.

4) Assisting cardiac contraction

Second solenoid valve K2, third solenoid valve K3, fourth solenoid valve K4, fifth solenoid valve K5, sixth solenoid valve K6, and seventh solenoid valve K7 are closed, and first solenoid valve K1 is opened.

When the first solenoid valve K1 is opened, the air in the high pressure air chamber 20 pushes the adjusting member 103 to one side facing the first opening 1051 through the first solenoid valve K1, the air in the first pipeline 41 and the first chamber of the flow-limiting air supply device 10 is rapidly extruded into the balloon, because the volume of the air storage chamber 101 is much larger than that of the balloon, a large amount of air rapidly enters the balloon to expand the volume of the balloon, and because the diameter of the first pipeline 41 is smaller, the air in the first pipeline is also extruded into the balloon, but the influence on the expansion of the volume of the balloon is smaller.

5) Assisting diastole

First solenoid valve K1, third solenoid valve K3, fourth solenoid valve K4, fifth solenoid valve K5, sixth solenoid valve K6, and seventh solenoid valve K7 are closed, and second solenoid valve K2 is opened.

When the second solenoid valve K2 is opened, the negative pressure in the low pressure air chamber 30 pulls the regulating member 103 to the side facing the second opening 1052 through the second solenoid valve K2, the inflated air is evacuated from the balloon, the evacuated air enters the first channel 41 and the first chamber of the limited flow air supply device 10, and the balloon is deflated.

In the present application, returning the balloon from the expanded state to its initial state is defined as the balloon being in the contracted state, that is, when the heart is in the limit state of diastole, the balloon is just in its initial state and no significant deflation occurs.

And (5) repeating the step 4) and the step 5), and assisting the heart to perform periodic contraction and expansion, wherein all parts are isolated from the outside in the process, so that the pressure and the volume of the gas filled into the saccule every time are constant.

In the process, the water vapor in the gas is cooled by the condenser, and water drops formed by cooling are discharged through the fourth electromagnetic valve K4 and the fifth electromagnetic valve K5.

Based on the same inventive concept, in a third aspect of the present application, according to an embodiment of the present application, there is provided a cardiac impulse assist system, including:

a support device having a concave structure that conforms to the interior shape of a heart chamber for wrapping around the exterior of the heart chamber;

at least one balloon disposed between the outer ventricular surface and the inner support device surface; and

the driving mechanism of the first aspect, which is connected to the balloon through a first conduit 41 and located outside the body.

Optionally, the supporting device is inelastic and is configured to provide support for inflating the balloon to expand the balloon toward the ventricle to compress the ventricle, wherein one of the two ends of the balloon in the radial direction is fixedly connected to the inner surface of the supporting device, and the other end of the balloon is freely in contact with the surface of the heart, so that the balloon can expand toward the ventricle to compress the heart when the balloon expands and contracts in the radial direction. The fixing of the saccule is not limited to the bonding of the biological glue, and the saccule can be fixed in other modes, and the supporting device can be made of terylene cloth, plastic, even metal and the like, and any rigid material which does not influence the functions of human organs can be adopted.

In an exemplary embodiment of the present application, the heart beat assist system further includes a control device and a display for displaying the heart function and the working state of the heart beat assist device, the control device controls the driving mechanism to work according to a predetermined program, wherein the power mechanism, the control device and the display are arranged outside the human body.

The above description is only a preferred embodiment of the application and is illustrative of the principles of the technology employed. It will be understood by those skilled in the art that the scope of the disclosure herein is not limited to the specific combination of the above-mentioned features, but also encompasses other embodiments in which any combination of the above-mentioned features or their equivalents does not depart from the spirit of the present disclosure, e.g., the replacement of the above-mentioned features with (but not limited to) features disclosed in this application having similar functions, and any modification of the present disclosure is within the scope of the present disclosure.

Claims (10)

1. A drive mechanism for a cardiac impulse assist device, comprising:

the flow-limiting gas supply device is provided with a gas storage cavity with variable volume, and the gas storage cavity is in gas communication with a balloon of the heart beating assisting device through a first pipeline, is used for storing gas for expanding the volume of the balloon and is used for filling the balloon with the gas or extracting the gas filled in the balloon through volume change;

the high-pressure air chamber is communicated with the flow-limiting air supply device through a second pipeline and is used for providing high-pressure driving force for reducing the volume of the air storage cavity; and

and the low-pressure air chamber is communicated with the flow-limiting air supply device through a third pipeline and is used for providing a negative pressure driving force for increasing the volume of the air storage chamber.

2. The drive mechanism for a heart beat assist device according to claim 1, wherein the flow-limited gas supply device comprises:

the gas storage device comprises a body, a first pipeline and a second pipeline, wherein the body is provided with a first opening and a second opening which are oppositely arranged, a deformable adjusting piece is arranged in the body, the adjusting piece divides an inner cavity of the body into a first cavity and a second cavity which are mutually isolated along the connecting line direction of the first opening and the second opening, the first cavity is used as a gas storage cavity and is connected with the first pipeline through the first opening, and the second cavity can be selectively communicated with the high-pressure gas cavity or the low-pressure gas cavity through the second opening;

when the second cavity is communicated with the high-pressure air cavity, the high-pressure driving force drives the adjusting piece to deform towards the direction close to the first opening, the volume of the air storage cavity is reduced, and air is filled into the balloon; when the second cavity is communicated with the low-pressure air cavity, the negative pressure driving force drives the adjusting piece to deform towards the direction close to the second opening, the volume of the air storage cavity is increased, and the air filled in the saccule is pumped out.

3. The drive mechanism for a heart beat assist device according to claim 2, wherein the regulating member is a flexible membrane.

4. The drive mechanism for a cardiac impulse assist device as set forth in claim 2, wherein the body comprises:

the first opening is positioned on the first body, the second opening is positioned on the second body, and the adjusting piece is positioned between the first body and the second body;

the first body and the second body are both semi-elliptical structures, and the ratio of the major axis to the minor axis of each semi-elliptical structure is 2-5: 1.

5. The drive mechanism for a heart beat assist device according to claim 1,

the second pipeline is provided with a first electromagnetic valve for controlling the on-off of the gas path, and the third pipeline is provided with a second electromagnetic valve and a third electromagnetic valve for controlling the on-off of the gas path;

optionally, the first electromagnetic valve and the second electromagnetic valve are normally closed electromagnetic valves, the third electromagnetic valve is a normally open electromagnetic valve, the normally open electromagnetic valve is a normally open two-way electromagnetic valve, the normally open electromagnetic valve is in a closed state when the power is on and is communicated with the output end of the second electromagnetic valve, and the normally open electromagnetic valve is in an open state when the power is off and is communicated with the atmosphere;

optionally, the first pipeline is sequentially provided with a first air filter, a pressure detection element, a condenser and a pressure limiting valve in a direction from the balloon to the flow-limiting air supply device, the condenser is connected with the low-pressure air chamber through a fourth pipeline, and the fourth pipeline is provided with at least one electromagnetic valve for controlling the on-off of the pipeline.

6. The drive mechanism for a heart beat assist device according to claim 1,

the high-pressure air cavity is connected with a first air pump and a second air filter and used for providing clean air for the high-pressure air cavity, and at least one pressure limiting valve is arranged on the high-pressure air cavity;

the low-pressure air chamber is connected with a second air pump and used for exhausting air from the low-pressure air chamber through the second air pump to enable the low-pressure air chamber to generate negative pressure.

7. The driving mechanism for a heart beat assisting device according to claim 1, wherein the high pressure air chamber is further configured to charge the air storage chamber with air for expanding the volume of the balloon through the first pipeline, and the high pressure air chamber is communicated with the first pipeline through a fifth pipeline, and at least one electromagnetic valve for controlling the on/off of an air passage is disposed on the fifth pipeline.

8. The drive mechanism for a heart beat assist device according to claim 1, further comprising a compressed gas supply assembly for inflating the gas storage chamber with gas to expand the balloon volume;

optionally, the compressed gas supply assembly comprises a first gas storage tank and a second gas storage tank which are communicated, an outlet end of the second gas storage tank is connected with a gas inlet end of the first pipeline, a pressure reducing valve is arranged on a pipeline connecting the first gas storage tank and the second gas storage tank, and a pressure limiting valve is arranged on the second gas storage tank.

9. Use of a drive mechanism for a cardiac impulse assist device as defined in any one of claims 1-8, comprising the steps of:

inflating the gas storage chamber with a gas to expand the balloon volume;

controlling the high-pressure air cavity to be communicated with the flow-limiting air supply device during systole, and reducing the volume of the air storage cavity to fill the balloon with the air;

and during diastole, the low-pressure air chamber is controlled to be communicated with the flow-limiting air supply device, and the volume of the air storage chamber is increased to extract the air filled in the balloon.

10. A heart beat assist system, comprising:

a support device having a concave structure that conforms to the interior shape of a heart chamber for wrapping around the exterior of the heart chamber;

at least one balloon disposed between the outer ventricular surface and the inner support device surface; and

the drive mechanism of any of claims 1-8, connected to the balloon via the first conduit and located outside the body.

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