CN114306922A

CN114306922A - Magnetic control type heart auxiliary system

Info

Publication number: CN114306922A
Application number: CN202111604365.1A
Authority: CN
Inventors: 吕骁; 吕世文; 刘先锋
Original assignee: Shanghai Xuanmai Medical Technology Co ltd
Current assignee: Shanghai Xuanmai Medical Technology Co ltd
Priority date: 2021-12-25
Filing date: 2021-12-25
Publication date: 2022-04-12
Anticipated expiration: 2041-12-25
Also published as: CN114306922B

Abstract

The application relates to the field of medical equipment, in particular to a magnetic control type heart auxiliary system, which comprises: the heart-shaped magnetic control device comprises an inductor, an operation and control mechanism and a magnetic control device attached to the heart, wherein the operation and control mechanism is electrically connected with the inductor and the magnetic control device; and the control mechanism controls the motion states of the first control unit and the second control unit in real time according to the heart rhythm signal received by the sensor.

Description

Magnetic control type heart auxiliary system

Technical Field

The application relates to the field of medical equipment, in particular to a magnetic control type heart auxiliary system.

Background

At present, the morbidity and mortality of heart failure are high, which is a significant cause of death of most patients with cardiovascular diseases, and nearly 1.17 million people all over the world suffer from the disease. The heart failure is called heart failure, which means that venous return blood cannot be sufficiently discharged out of the body due to the occurrence of dysfunction of the systolic function or the diastolic function of the heart, so that blood stasis in a venous system and insufficient blood supply in an arterial system are caused, and finally cardiac circulatory system dysfunction is caused. The development process of heart failure is slow, most of the heart failure is caused by that after various symptoms of a patient accumulate for many years, the heart gradually loses the blood pumping function, all the functions are gradually weakened, the heart is enlarged, and the left ventricle is enlarged, so that the life quality and clinical treatment of the patient are greatly influenced. The existing treatment schemes include drug treatment, auxiliary devices and heart transplantation, but different treatment methods face great challenges, for example, the requirement of the auxiliary devices on the number of movements after entering the body is large, mechanical failure or mechanical hemolysis complications are easy to occur, even the physical quality of some patients does not meet the treatment conditions, so that abnormal reactions of the body occur, and in addition, when the treatment is performed through the heart transplantation, the heart transplantation has the defects of donor shortage, large surgical trauma, high cost and high immune rejection, and is often difficult to widely implement.

Patent CN108273149A describes a ventricular assist device for assisting systole, which comprises at least two magnetic devices capable of attracting each other, a buffer device disposed between the two magnetic devices, and a fixing member for fixing the magnetic devices to the heart, wherein two ends of the buffer device can be respectively contacted with the adjacent magnetic devices, and when the heart contracts, the two magnetic devices attracted to each other approach each other, and the buffer device is compressed to deform the buffer device; when the heart is in diastole, the buffer device can assist the two magnetic devices which are attracted to each other to move away; the technical defects of the scheme are as follows: first, the two magnetic devices are attracted to each other, and although the buffer structure can provide a rebound force, the magnetic devices still limit the normal diastole of the heart when the heart is in diastole, which is equivalent to the ventricular assist device cannot assist the ventricular diastole well; secondly, the magnetic sizes of the two magnetic devices are fixed, and in the process of the heart contracting and relaxing, the attractive force provided by each stage of the magnetic devices is quite stable, namely the contracting and relaxing force and the relaxing force provided by the ventricular assist device cannot be changed greatly, so that the sudden condition of the heart cannot be coped with, and the heart cannot be followed in real time.

Patent CN112933396A discloses an electromagnetic heart beat assisting device, comprising: the heart-stimulating heart comprises an inner membrane, an outer membrane support body, two permanent magnets, an electromagnet, a power supply and a controller, wherein the inner membrane is coated on the surface of the heart, the outer membrane support body covers the outer side of the inner membrane, the two permanent magnets are fixed on the outer side of the inner membrane and respectively correspond to a left ventricle and a right ventricle, the two electromagnets are fixed on the inner side of the outer membrane support body and are arranged opposite to the permanent magnets, and the power supply and the controller are used for supplying power to the electromagnet and adjusting the current magnitude and direction, so that the electromagnet can apply repulsion or suction to the permanent magnets to further drive the heart to contract or relax; the technical defects of the scheme are as follows: firstly, the permanent magnets can have a magnetic attraction effect, and the permanent magnets can also attract or repel each other when the electromagnet applies force to the permanent magnets, so that the auxiliary effect is influenced, and the burden is generated on normal relaxation of the heart; secondly, two permanent magnets and electromagnets are respectively fixed on the left ventricle and the right ventricle, so that the force in the linear direction is generated when the human heart is driven to contract or relax, the non-circumferential driving force is not in accordance with the physiological characteristics, and the secondary damage to the heart is easily generated after long-term use.

Patent US12468228 discloses a heart assist device comprising a first electromagnet configured to be attached to a first location on the heart; a second magnet or magnetic material member configured to attach to a second location on the heart; and a power supply for generating a current in the first electromagnet; a power source electrically coupled to a first electromagnet, wherein the first electromagnet is configured such that a current is generated in the first electromagnet in a first direction using the power source, thereby generating a magnetic field that attracts the second magnet or magnetic material member to the first electromagnet, thereby generating a force configured to pull a first location of the heart toward a second location of the heart, and wherein the second magnet or magnetic material member comprises a paramagnetic or ferromagnetic material member; the technical scheme has the defects that: the second magnet or the magnetic material member comprises a paramagnetic or ferromagnetic material member, that is, the motion of the second magnet needs to be provided with an attractive force or a repulsive force by the first electromagnet, so that the motion of the second magnet is quite passive, and in the process of assisting the heart, the rapid response is difficult to match the motion of the first electromagnet, so that a time delay exists between the motion of the first electromagnet and the second magnet and the heart motion, the heart motion cannot be followed in real time, and even the normal contraction and relaxation of the heart is influenced.

Therefore, those skilled in the art are dedicated to develop a magnetic control type heart assist system, which mainly solves the following problems: how the magnetic control device assists the heart to contract or/and relax in real time along with the action of the heart; how to apply force to the heart without causing interference and harm in the assisting process.

Disclosure of Invention

The present application has been made in view of the above and other more general considerations.

One of the purposes of the present application is to overcome the disadvantages of the prior art, and provide a magnetic control type heart assist system for solving the problems, such as magnetic interference between magnetic control devices, difficulty in assisting the magnetic control devices following the heart rhythm, and incapability of the assist force provided by the magnetic control devices to conform to the physiological structure of the human body.

According to another aspect of the present application, there is provided a magnetically controlled heart assist system comprising: the heart monitoring device comprises a sensor, a control mechanism and a magnetic control device attached to the heart, wherein the control mechanism is electrically connected with the sensor and the magnetic control device; the magnetic control device comprises a first control unit and a second control unit, wherein the first control unit and the second control unit respectively comprise at least one electromagnetic active control magnet; and the control mechanism controls the motion states of the first control unit and the second control unit in real time according to the heart rhythm signal received by the inductor.

According to an embodiment, the motion of the first control unit and the second control unit is synchronized with a heart rate signal.

According to an embodiment, when the heart is in a systolic phase, the first control unit and the second control unit attract each other to provide a contractile force to the heart; when the heart is in diastole, the first control unit and the second control unit repel each other to provide relaxation to the heart.

According to an embodiment, the control mechanism controls the current direction of the first control unit and the second control unit.

According to an embodiment, the control mechanism controls the current levels of the first control unit and the second control unit.

According to an embodiment, when the ventricle contracts, the control mechanism controls the current directions of the first control unit and the second control unit to enable the corresponding surfaces of the first control unit and the second control unit to form opposite magnetic poles (N pole to S pole), the first control unit and the second control unit attract each other to generate magnetic pulling force to assist the contraction of the ventricle, and the control mechanism controls the current magnitudes of the first control unit and the second control unit to adjust the magnitude of the magnetic pulling force; when the ventricle relaxes, the control mechanism controls the current directions of the first control unit and the second control unit so that the corresponding surfaces of the first control unit and the second control unit form like magnetic poles (N pole to N pole or S pole to S pole), the first control unit and the second control unit repel each other to generate magnetic repulsion force to assist the ventricle relaxation, and the control mechanism controls the current magnitudes of the first control unit and the second control unit to adjust the magnitude of the magnetic repulsion force.

According to an embodiment, the electromagnetic active control magnet has an E-shape, U-shape or other non-closed shape; and, the electromagnetism initiative control magnet includes the magnet steel, the appearance of electromagnetism initiative control magnet does the magnet steel concatenation forms or the magnet steel is integrated into one piece.

According to one embodiment, the magnetic steel comprises an arc-shaped portion, which conforms to the shape of the heart; and, the radius of curvature of the arc-shaped part is 20-50 mm.

According to an embodiment, the E-shaped electromagnetic active control magnet comprises a middle magnetic pole and a side magnetic pole, and the size ratio of the width of the middle magnetic pole to the width of the side magnetic pole ranges from 0.1 to 4.

According to one embodiment, the ratio of the cross-sectional areas of the pole shoe and the magnetic pole is 0.1-3; and the pole shoe and the magnetic pole are connected by laser welding or bonding or are integrally processed.

According to an embodiment, the cross-sectional shape of the magnetic steel or the electromagnetic active control magnet is circular, flat, rectangular, sector-shaped, or any other shape.

According to one embodiment, the E-shaped or U-shaped electromagnetic active control magnet is provided with a pole shoe at the free end; and the pole shoe of the first unit is arranged on the opposite surface close to the second unit, and the pole shoe of the second unit is arranged on the opposite surface close to the first unit.

According to an embodiment, the pole shoe is sleeved on the outer circumferential surfaces of the middle magnetic pole and the side magnetic pole, or the pole shoe is fixed on the magnetic pole surfaces of the middle magnetic pole and the side magnetic pole.

According to one embodiment, the pole shoe is made of soft magnetic alloy, and the pole shoe arranged on the electromagnetic active control magnet can improve the magnetic density of a working air gap and increase magnetic force.

According to one embodiment, the magnetic steel portion is curved to conform to the shape of the heart.

According to one embodiment, the sensor monitors heart rhythm, and the control mechanism provides contraction force or relaxation force to the heart in real time according to signals of the sensor.

According to an embodiment, the first control unit and the second control unit are adapted to control the heart muscle in a circumferential motion direction.

According to an embodiment, the electromagnetic active control magnet of the first control unit is a first magnet, the electromagnetic active control magnet of the second control unit is a second magnet, and the first magnet and the second magnet are uniformly or non-uniformly fixed on the surface of the heart.

According to one embodiment, the first and second magnets are distributed on the left and right sides of the interventricular sulcus, avoiding major coronary vessels, anterior descending branches, and great cardiac veins.

According to an embodiment, the first control unit comprises a number of first magnets, the second control unit comprises a number of second magnets, and the number of first magnets is the same or different from the number of second magnets.

According to an embodiment, the adjacent first magnets have the same or different pitches, the adjacent second magnets have the same or different pitches, and the first magnets and the second magnets are arranged radially or axially.

According to an embodiment, under the control of the control mechanism, part or all of the first magnet and the second magnet are electrified, and the current magnitude and the current direction of the electrified first magnet and the electrified second magnet are the same or different.

According to an embodiment, the first control unit and/or the second control unit further comprises a permanent passive control magnet.

According to one embodiment, under the action of the control mechanism, the first control unit and the second control unit approach or separate from each other to assist the heart to complete the actions of contraction or relaxation; and the motion directions of the first control unit and the second control unit are consistent with the circumferential motion direction of the contraction or relaxation of the myocardium.

According to an embodiment, the first and second control units have a contraction or relaxation direction coinciding with a myocardial contraction or relaxation circumferential movement direction.

According to an embodiment, the first control unit and the second control unit are distributed on both sides of the inter-chamber trench, and the first magnet and the second magnet are arranged substantially radially.

According to an embodiment, the heart-shaped magnetic heart further comprises a rotating mechanism, the electromagnetic active control magnet is fixed on the heart through the rotating mechanism, and the control mechanism controls the rotating mechanism to rotate so as to drive the electromagnetic active control magnet to rotate.

According to an embodiment, the electromagnetic active control magnet is changed from a radial arrangement to an axial arrangement when the rotation mechanism rotates.

According to an embodiment, the electromagnetic active control magnet is arranged at an angle θ to the long-diameter axis of the heart, and 35 ≦ θ ≦ 80.

According to a preferred embodiment, the electromagnetic active control magnet is arranged at an angle θ to the long-diameter axis of the heart, and 45 ° ≦ θ ≦ 75 °.

According to one embodiment, the magnetically controlled heart assist system further comprises a net bag, wherein the net bag is fixed on the epicardium or the pericardium and fits the geometric shape of the epicardium or the pericardium, the magnetic control device is fixedly connected to the net bag, when the heart is in a systolic period, the net bag provides a first contractile force, and the magnetic control device provides a second contractile force; when the heart is in the diastole, the heart naturally relaxes, or the magnetic control device cooperates with the net bag to provide relaxation force for the heart.

According to an embodiment, the net bag provides a first contractile force to the heart during a first phase of cardiac contraction; and the control mechanism controls the magnetic control device and provides a second contraction force for the heart in cooperation with the net bag in the first stage and/or the second stage of the heart contraction.

According to one embodiment, the electromagnetic active control magnets are uniformly or non-uniformly fixed to the string bag by embedding, sewing, rivets or anchor hooks.

According to one embodiment, the net bag is a flexible net structure, a ring belt structure or other flexible structures.

According to one embodiment, the material of the net bag, which has high elasticity, large deformation performance and good adhesion and bonding ability, is made of medical high polymer by injection molding or 3D printing, and includes, but is not limited to, polyether polyurethane, polycarbonate polyurethane, silicone, polysiloxane polyurethane, hydrogenated polystyrene-butadiene copolymer, ethylene-propylene and dicyclopentadiene terpolymer and/or hydrogenated poly (styrene-butadiene) copolymer, poly (tetramethylene-ethylene-ether-glycol) urethane, poly (hexamethylene carbonate-ethylene carbonate) urethane elastomer polyurethane, latex, and combinations thereof, and is also made of medical textile by knitting or weaving, and includes, but is not limited to, terylene, nylon, polyethylene terephthalate, expanded polytetrafluoroethylene, and mixtures thereof, Ethylene-tetrafluoroethylene copolymer, polyester, polyurethane.

According to one embodiment, the net bag is customized to fit the heart size of different patients, utilizing a highly elastic adaptation of the material to the epicardial structure of the patient.

According to an embodiment, the electromagnetic active control magnet further comprises an active magnetron housing, a coil, a cover plate and a feedthrough, wherein the active magnetron housing is made of biocompatible metal or non-metal material such as titanium alloy or stainless steel, the coil is wound on the magnetic steel, and the cover plate is butted, welded or lapped on the magnetron housing.

According to one embodiment, the magnetic steel is made of hard and/or soft magnetic materials, including but not limited to neodymium-iron-boron alloys, samarium-cobalt alloys, aluminum-nickel (and with other elements such as cobalt), iron-chromium (and with other elements such as cobalt, molybdenum), iron-cobalt (and with other elements such as vanadium, tungsten), alloys of rare earth elements with cobalt, alloys of rare earth elements with iron, platinum-cobalt alloys, copper-nickel-iron alloys, other iron-containing or cobalt-containing or nickel-containing alloys, manganese-aluminum-carbon alloys, aluminum-manganese-silver alloys, ferrites, iron-silicon species, iron-aluminum species, iron-silicon-aluminum species, pure iron, low carbon steel, amorphous soft magnetic alloys, ultra-crystalline soft magnetic alloys, intermetallic compounds, and the like.

According to one embodiment, the coil is customized individually, different wire diameters, turns and layers are selected according to the required magnetic force, the contradiction between the magnetic force and the power consumption is balanced, and the cruising ability of the device is improved.

According to an embodiment, the feedthrough is fixed anywhere on the cover plate or on the magnetron housing, and the electromagnetic active control magnet is in a single-feedthrough or double-feedthrough form, the electromagnetic active control magnet with a single feedthrough being provided with one pin and the electromagnetic active control magnet with a double feedthrough being provided with two pins.

According to one embodiment, the cover plate is flatly connected to the active magnetron housing and is fixedly connected by soldering, laser welding, ultrasonic welding or any other connection means.

According to one embodiment, one end of the electromagnetic active control magnet (away from the opposite surface of the other electromagnetic active control magnet) is provided with a back iron made of soft magnetic alloy, the back iron has a magnetic gathering effect, the magnetic induction intensity of the electromagnetic active control magnet can be improved, and the magnetic force is increased.

According to one embodiment, pole shoes are fixed to one end or two ends of the electromagnetic active control magnet, and the pole shoes can improve magnetic density and increase magnetic force.

According to one embodiment, the electromagnetic active control magnet is composed of a magnetic steel and a coil, the magnetic steel is made of platinum-cobalt alloy material, the coil is made of biocompatible alloy material such as silver wire, gold wire, MP35N, 35NLT, etc., and a biocompatible coating is coated on the magnetic steel and the coil surface, and the biocompatible coating includes, but is not limited to, Silicone, Parylene or other polymer coating.

According to an embodiment, the electromagnetic active control magnets are connected by a connecting pipe, the connecting pipe is a hollow thin-wall structure, the material of the connecting pipe is the same as that of the active magnetron housing, the connecting pipe and the active magnetron housing are fixedly connected by soldering, laser welding, ultrasonic welding or any other connection method, a lead passes through the connecting pipe, and the lead is connected with the coil of the adjacent electromagnetic active control magnet, so that the design has the advantages that: the feed-through is reduced, the cost is reduced, the process difficulty of welding or other connection modes is reduced, and the reliability of the system is improved.

According to an embodiment, after the sensor collects the electrophysiological signals of the heart, the control mechanism converts analog signals into digital signals (AD conversion), the special program judges that the heart is in a contraction or relaxation stage, then calculates the level of required electromagnetic force, solves the output quantity of control current, outputs the control signals after DA conversion to a controller execution circuit, outputs corresponding control current through electronic components such as capacitance, inductance, MOSET and the like, controls the current to pass through the coil, generates a magnetic induction direction consistent with or opposite to that of a magnetic conductive material according to a right-hand spiral rule, enhances or weakens the original magnetic field of the magnetic conductive material, and generates magnetic attraction force or magnetic repulsion force.

According to an embodiment, the sensor is mounted wholly or partly on the surface of the heart.

According to an embodiment, the first control unit and the second control unit are arranged on the string bag at two sides of a certain distance, and the first magnet and the second magnet are arranged in opposite magnetic poles.

According to an embodiment, the first control unit and the second control unit are arranged on two sides of the string bag at a certain distance, and the first magnet and the second magnet are arranged in the same magnetic pole.

According to an embodiment, the first control unit and the second control unit are arranged on both sides of the string bag at a certain distance, and the first magnet and the second magnet are not electrified.

According to one embodiment, the electromagnetic active control magnet and the permanent magnet passive control magnet are arranged at two sides of a certain distance, forward current or reverse current is conducted to the electromagnetic active control magnet, and the electromagnetic active control magnet and the permanent magnet passive control magnet attract or repel each other.

According to an embodiment, the electromagnetic active control magnet is a soft magnetic alloy and the permanent magnetic passive control magnet is a hard magnetic alloy, the electromagnetic active control magnet having no magnetic poles but being magnetized when the coil is not energized.

According to an embodiment, when the heart chamber contracts, the string bag can make if can with the ventricle follow-up soft magnetic alloy with hard magnetic alloy is close to each other, soft magnetic alloy with produce suction between the hard magnetic alloy, improves string bag shrink power, if suction is not enough, electromagnetism active control magnet can lead to forward current, makes soft magnetic alloy magnetizes, with hard magnetic alloy's opposite face forms the opposite polarity, improves magnetic attraction, when the heart chamber diastole, leads to reverse current in the electromagnetism active control magnet, forms like polarity with the opposite face of permanent magnetism passive control magnet, produces magnetic repulsion, makes the string bag relax.

Compared with the prior art, the technical scheme of the application has the advantages that at least the following steps are included:

1. in the prior art, the auxiliary system drives the heart in a manner of pressing the heart wall, the contraction and the relaxation of the heart are non-uniform, the circumferential degree of freedom exists, the compression mode has a spiral trend, the pressing mode does not accord with physiological characteristics, meanwhile, the auxiliary system cannot follow the cardiac cycle in real time, the intelligence is poor, and the auxiliary system can assist the weak or aged heart in following the rhythm of the weak or aged heart in real time; in an embodiment of the present invention, a magnetic control device, an inductor, and an operation mechanism are cooperatively used to provide a contraction force and/or a relaxation force to a heart, wherein the magnetic control device further includes a first control unit and a second control unit, the first control unit and the second control unit are distributed on two sides of a ventricular sulcus, when the inductor transmits a signal to the operation mechanism according to a received heart rhythm, the operation mechanism changes a motion state of the first control unit and the second control unit, and when the heart is in a contraction period, the first control unit and the second control unit attract each other to provide a circumferential contraction force to the heart; when the heart is in a diastole, the first control unit and the second control unit repel each other to provide circumferential relaxation and tension to the heart, and the contraction or relaxation direction of the first control unit and the second control unit is consistent with the contraction or relaxation circumferential movement direction of the cardiac muscle, so that the bionic action is adopted to simulate the heart contraction, the pulsating blood flow is more consistent with the physiological characteristics, the blood perfusion of peripheral vessels is facilitated, the pseudo-reconstruction of the heart can be caused, the heart function is restored from decompensation to compensation, no wound is caused to the heart and vascular tissues, and the postoperative repair of a patient is facilitated, and the clinical significance is great.

2. According to one concept of the application, the control mechanism can change the current direction and the current magnitude of the first control unit and the second control unit in real time so as to change the direction and the magnitude of the auxiliary force of the first control unit and the second control unit in consideration of the fact that the heart environments of different heart failure patients are different from the real-time heart state; when the ventricles contract, the control mechanism controls the current directions of the first control unit and the second control unit to enable the corresponding surfaces of the first control unit and the second control unit to form opposite magnetic poles (N pole to S pole), the first control unit and the second control unit attract each other to generate magnetic pull force to assist the ventricles to contract and improve the ejection fraction of the heart; when the ventricles are in diastole, the control mechanism controls the current directions of the first control unit and the second control unit to enable the corresponding surfaces of the first control unit and the second control unit to form like magnetic poles (N pole to N pole or S pole to S pole), the first control unit and the second control unit repel each other to generate magnetic repulsion force to assist the diastole of the ventricles, the intelligent control device has intelligence, can adjust the magnetic size and direction of the electromagnetic active control magnet according to the heart state of a patient, and is excellent in application effect.

3. According to one concept of the application, the shape of the electromagnetic active control magnet is E-shaped, U-shaped or other non-closed shapes, the electromagnetic active control magnet comprises magnetic steel, the shape of the electromagnetic active control magnet is formed by splicing the magnetic steel or integrally forming the magnetic steel, and the electromagnetic active control magnet has the advantages that the E-shaped structure is different from a block-shaped structure, the magnetic leakage of the magnet can be reduced, the air gap magnetic flux density is improved, the electromagnetic force is increased, larger auxiliary force is generated, the electromagnetic active control magnet focuses on an auxiliary heart, the direction of the magnetic force generated by the E-shaped electromagnetic active control magnet is better matched with the physiological characteristics of the heart, and the auxiliary contraction force and the auxiliary relaxation force can be better provided for the heart.

4. According to one concept of the application, the electromagnetic active control magnet of the first control unit is a first magnet, the electromagnetic active control magnet of the second control unit is a second magnet, and the first magnet and the second magnet are uniformly or non-uniformly distributed and fixed on the surface of the heart and are arranged in a radial direction, so that the main coronary blood vessels are avoided, the blood perfusion of the cardiac muscle is protected, and the aim of assisting the heart on the premise of not damaging all blood vessels of the heart is fulfilled.

5. According to one concept of the application, the number, the spacing, the arrangement direction and the electrifying condition of the first magnet and the second magnet can be customized according to the actual condition of the heart of the patient, the problem that the heart is not matched with the system due to the individual difference of the heart is solved, and the heart assisting system can be adapted to all human hearts.

6. According to one concept of the application, the invention comprises a rotating mechanism, the rotating mechanism is connected with a heart or a net bag, the rotating mechanism can rotate relative to the surface of the heart, and is fixedly connected with an electromagnetic active control magnet/a permanent magnet passive control magnet.

7. According to one concept of the application, the heart-protecting device comprises a net bag, wherein the net bag is fixed on the epicardium or the pericardium and is attached to the geometric shape of the epicardium or the pericardium, a magnetic control device is arranged on the net bag, the magnetic control device provides contraction force or relaxation force under the control of an operation control mechanism, the contraction force or the relaxation force and the relaxation force are cooperated to realize the function of real-time motion following the cardiac cycle, and the contraction and the relaxation of the heart are quickly and accurately assisted, and meanwhile, the hysteresis effect is eliminated.

8. According to one concept of the application, considering that the heart environments of different heart failure patients are different from the real-time heart states, the net bag and the magnetic control device provide different required contraction force and/or relaxation force for the patients at different moments, according to the signals provided by the sensor, if the auxiliary force required by the heart of the patient is small, the net bag independently performs auxiliary contraction or relaxation on the heart, if the auxiliary force required by the heart of the patient is large, the beating of the heart cannot be realized only by the net bag, then the net bag and the magnetic control device perform auxiliary contraction or relaxation on the heart simultaneously, because the magnetic control device comprises a plurality of electromagnetic active control magnets, each electromagnetic active control magnet is independently controlled, the magnetic control device can provide different sizes and different directions of contraction force and/or relaxation force to the heart, meets the requirement of omnibearing heart beat assistance, and has good clinical significance.

9. According to one concept of the application, the magnetic control device comprises at least two electromagnetic active control magnets, the number of the electromagnetic active control magnets and the arrangement of the electromagnetic active control magnets on the net bag are designed in a customized mode according to the heart condition of a patient, the electromagnetic active control magnets are arranged on the net bag in a non-uniform mode according to the heart, and the electromagnetic active control magnets are designed to have the advantages that: the main coronary vessels are avoided, the physiological structure of the human body is better met, and the matching with the contraction and relaxation actions of the heart is facilitated; meanwhile, when the net bag independently assists in compressing the heart and cannot meet the requirement of ventricular ejection, the combination of the two electromagnetic active control magnets can rapidly perform contraction action, and when the net bag independently assists in compressing the heart and meets the requirement of ventricular ejection, any one of the electromagnetic active control magnets is powered off, so that the system power consumption is effectively reduced.

10. According to an idea of the present application, the magnet steel includes arc portion, the heart appearance of arc portion laminating to, arc portion curvature radius is 20 ~ 50mm, and the benefit of design like this lies in: the electromagnetic active control magnet is completely attached to the surface of the heart, so that the attraction or repulsion force generated by the first control unit and the second control unit is in the tangential direction of the surface of the heart, the utilization rate of the auxiliary force is improved, and meanwhile, the electromagnetic active control magnet is favorable for being matched with the action of the heart and has a good auxiliary effect.

Embodiments of the present application are capable of achieving other advantageous technical effects not listed individually, which other technical effects may be described in part below and are anticipated and understood by those of ordinary skill in the art upon reading the present application.

Drawings

The above features and advantages and other features and advantages of these embodiments, and the manner of attaining them, will become more apparent and the embodiments of the application will be better understood by reference to the following description, taken in conjunction with the accompanying drawings, wherein:

fig. 1a to 1e are schematic diagrams of the overall structure of the magnetic control type heart assist system and the arrangement of the magnetic control device.

FIGS. 2a to 2c are schematic views showing normal, contracted and expanded forms of the string bag of the present invention.

Fig. 3a to 3f are schematic structural views of the electromagnetic active control magnet according to the present invention.

Fig. 4a to 4c show another embodiment of the arrangement of the first magnet and the second magnet of the magnetically controlled heart assist system according to the invention.

Fig. 5a to 5e are functional schematic diagrams of another embodiment and a rotating structure of the arrangement of the first magnet and the second magnet of the magnetically controlled heart assist system of the invention.

Fig. 6a to 6f show another embodiment of the arrangement of the first magnet and the second magnet of the magnetically controlled heart assist system according to the invention.

Fig. 7a to 7d show another embodiment of the arrangement of the first and second magnets of the magnetically controlled heart assist system of the present invention.

FIGS. 8 a-8 h are schematic structural views of an E-shaped electromagnetic active control magnet according to the present invention

The figures in the drawings refer to the following features:

1-a magnetic control device, 11-a first control unit, 12-a second control unit, 13-an electromagnetic active control magnet, 131-a first magnet, 132-a second magnet, 14-a permanent magnet passive control magnet, 2-a string bag, 21-a perforated structure, 3-a control mechanism, 31-a battery, 32-a controller, 33-a percutaneous cable, 4-a sensor, 5-an active magnetic control shell, 51-a magnetic steel, 511-an arc part, 52-a coil, 53-a cover plate, 54-a feed-through, 55-a back iron, 56-a pole shoe, 6-E type electromagnetic active control magnet, 61-a side magnetic pole, 62-a middle magnetic pole and 7-a rotating mechanism.

Detailed Description

The details of one or more embodiments of the application are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the application will be apparent from the description and drawings, and from the claims.

It is to be understood that the embodiments illustrated and described are not limited in application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The illustrated embodiments are capable of other embodiments and of being practiced or of being carried out in various ways. Examples are provided by way of explanation of the disclosed embodiments, not limitation. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments of the present application without departing from the scope or spirit of the disclosure. For instance, features illustrated or described as part of one embodiment, can be used with another embodiment to yield a still further embodiment. Accordingly, the disclosure is intended to cover such modifications and variations as fall within the scope of the appended claims and their equivalents.

Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

The present application will be described in more detail below with reference to various embodiments and examples of several aspects of the application.

In this application, the term "proximal" or "proximal" refers to the end or side closer to the operator, and "distal" or "distal" refers to the end or side farther from the operator.

In the present application, the term "first stage" refers to a stage in which the net bag assists the contraction of the heart, and the term "second stage" refers to a stage in which the contraction of the heart by only the net bag assists the ventricular ejection.

In the prior art, magnetic interference is generated among magnetic control devices, the magnetic control devices are difficult to assist along with heart rhythm, and the assisting force provided by the magnetic control devices does not accord with the physiological structure of a human body.

One of the objects of the embodiments described below is to address the above-mentioned deficiencies, as well as other problems.

Example one

As shown in fig. 1a, a magnetically controlled heart assist system according to an embodiment of the present application is illustrated, comprising: the heart monitoring device comprises an inductor 4, a control mechanism 3 and a magnetic control device 1 attached to the heart, wherein the control mechanism 3 is electrically connected with the inductor 4 and the magnetic control device 1; the magnetic control device 1 comprises a first control unit 11 and a second control unit 12, wherein the first control unit 11 and the second control unit 12 respectively comprise at least one electromagnetic active control magnet 13; and, the control mechanism 3 controls the motion states of the first control unit 11 and the second control unit 12 in real time according to the heart rate signal received by the sensor 4.

In the first embodiment, when the heart is in the systolic phase, the first control unit 11 and the second control unit 12 attract each other to provide a contractile force to the heart; when the heart is in diastole, the first control unit 11 and the second control unit 12 repel each other to provide relaxation to the heart.

In this embodiment, the control mechanism 3 controls the current directions of the first control unit 11 and the second control unit 12.

In this embodiment, the control mechanism 3 controls the current of the first control unit 11 and the current of the second control unit 12.

In the first embodiment, when the ventricle contracts, the control mechanism 3 controls the current directions of the first control unit 11 and the second control unit 12 so that opposite magnetic poles (N pole to S pole) are formed on the corresponding surfaces of the first control unit 11 and the second control unit 12, as shown in fig. 1b, the first control unit 11 and the second control unit 12 attract each other to generate magnetic pull force to assist the ventricle to contract, as shown in fig. 1c, and the control mechanism 3 can control the current magnitudes of the first control unit 11 and the second control unit 12 to adjust the magnitude of the magnetic pull force; when the ventricle is diastolic, the control mechanism 3 controls the current directions of the first control unit 11 and the second control unit 12 such that the corresponding surfaces of the first control unit 11 and the second control unit 12 form like magnetic poles (N pole to N pole or S pole to S pole), the first control unit 11 and the second control unit 12 repel each other to generate magnetic repulsion force to assist the diastole of the ventricle, as shown in fig. 1d, and the control mechanism 3 can control the current magnitudes of the first control unit 11 and the second control unit 12 to adjust the magnitude of the magnetic repulsion force.

In the first embodiment, the electromagnetic active control magnet 13 of the first control unit 11 is a first magnet 131, the electromagnetic active control magnet 13 of the second control unit 12 is a second magnet 132, and the first magnet 131 and the second magnet 132 are uniformly or non-uniformly fixed on the surface of the heart.

In the first embodiment, the first control unit 11 includes six first magnets 131, the second control unit 12 includes six second magnets 132, the adjacent first magnets 131 have the same pitch, and the adjacent second magnets 132 have the same pitch.

In the first embodiment, the first control unit 11 and the second control unit 12 are distributed on two sides of the inter-chamber trench, and the first magnet 131 and the second magnet 132 are arranged in a substantially radial direction.

In the first embodiment, when the first magnet 131 and the second magnet 132 are made of hard magnetic materials, the first magnet 131 and the second magnet 132 are arranged in opposite magnetic levels (N-pole to S-pole) in the initial state, the first magnet 131 and the second magnet 132 are attracted to each other, and the magnetic attraction force of the first magnet 131 and the second magnet 132 cannot make the first magnet 131 and the second magnet 132 move toward each other.

In the first embodiment, under the control of the control mechanism 3, part or all of the first magnet 131 and the second magnet 132 are energized, and the magnitudes and directions of the currents of the energized first magnet 131 and the energized second magnet 132 are the same or different.

In the first embodiment, under the action of the control mechanism 3, the first control unit 11 and the second control unit 12 approach or separate from each other to assist the heart to complete the actions of contraction or relaxation; the movement directions of the first control unit 11 and the second control unit 12 coincide with the circumferential movement direction of the contraction or relaxation of the myocardium.

In the first embodiment, the heart protecting device further comprises a net bag 2, the net bag 2 is fixed on the epicardium or the pericardium and is attached to the geometric shape of the epicardium or the pericardium, the magnetic control device 1 is fixedly connected to the net bag 2, when the heart is in a systole, the net bag 2 provides a first contractile force, and the magnetic control device 1 provides a second contractile force; when the heart is in the diastole, the heart naturally relaxes, or the magnetic control device 1 cooperates with the net bag 2 to provide relaxation force for the heart.

In the first embodiment, the string bag 2 is a flexible net structure, as shown in fig. 2a to 2c, the maximum and minimum sizes of the string bag 2 are respectively a first size and a second size, wherein the first size is smaller than the outer size of the end diastole, and the second size is smaller than the outer size of the end systole due to the size design of the string bag 2 itself, or the string bag 2 is pressed by the magnetic control device 1 so that the second size is smaller than the outer size of the end systole.

In the first embodiment, the net bag 2 provides a first contraction force to the heart at a first stage of heart contraction, and the magnetic control device 1 cooperates with the net bag 2 to provide a second contraction force to the heart, and the control mechanism 3 controls the first magnet 131 and the second magnet 132 to provide a forward current at a second stage of heart contraction, so as to increase the magnetic density of the electromagnetic active control magnet 13, increase the attraction force between the first magnet 131 and the second magnet 132, so that the first magnet 131 and the second magnet 132 approach each other, and drive the net bag 2 to contract to generate pressure on the myocardial wall, as shown in fig. 1 b-1 c and 2 a-2 b, to help the ventricular contraction and improve the cardiac ejection fraction, and the magnitude of the attraction force depends on the magnitude of the current.

In this embodiment, when the heart is in the diastole, the control mechanism 3 controls the first magnet 131 to pass through the reverse current, so that the first magnet 131 and the second magnet 132 have the same magnetic poles (S pole to S pole), as shown in fig. 1d, a repulsive force is generated between the first magnet 131 and the second magnet 132, and the first magnet 131 and the second magnet 132 are away from each other and drive the tuck net 2 to relax, as shown in fig. 2 c.

In this first embodiment, the electromagnetic active control magnet 13 is disposed at an angle θ with respect to the long axis of the heart, and 35 ° ≦ θ ≦ 80 °, as shown in FIG. 1 e.

In the first embodiment, the electromagnetic active control magnet 13 is uniformly or non-uniformly fixed on the string bag 2 by embedding, sewing, riveting or anchoring.

In the first embodiment, the material of the net bag 2 needs to have high elasticity and large deformation performance and good adhesion and bonding ability, and can be made by injection molding or 3D printing of medical high molecular polymer, including but not limited to polyether polyurethane, polycarbonate polyurethane, silicone, polysiloxane polyurethane, hydrogenated polystyrene-butadiene copolymer, ethylene-propylene and dicyclopentadiene terpolymer and/or hydrogenated poly (styrene-butadiene) copolymer, poly (tetramethylene-ethylene-ether-glycol) urethane, poly (hexamethylene carbonate-ethylene carbonate) urethane elastomer polyurethane, latex, and combinations thereof, and can also be made by medical knitting or weaving of textile fabric, including but not limited to polyester, nylon, polyethylene terephthalate, expanded polytetrafluoroethylene, and mixtures thereof, Ethylene-tetrafluoroethylene copolymer, polyester, polyurethane.

In this embodiment one, the string bag 2 is a structure with holes 21, and the porosity of the string bag 2 is 10% -80%, and the purpose of the design is as follows: the perforated structure 21 facilitates cell tissue growth as shown in figure 2 a.

In this embodiment, the porosity of the net bag 2 in the left ventricle is different from the porosity of the right ventricle, and the design is aimed at: is beneficial to assisting the left ventricle without influencing the normal function of the right ventricle.

In this embodiment one, the string bag 2 is compressed in the conveying system, the string bag 2 contains the support structure, and the support structure is a nickel titanium material.

In the first embodiment, the control mechanism 3 includes a battery 31, a controller 32 and a percutaneous cable 33, and the magnetic control device 1 is coupled to the controller 32 through the percutaneous cable 33.

In the first embodiment, the battery 31, the controller 32 and the partial radial skin cable are disposed outside the body.

In this embodiment, the electromagnetic active control magnet 13 includes an active magnetron housing 5, a magnetic steel 51, a coil 52, a cover plate 53 and a feedthrough 54, as shown in fig. 3a and 3b, wherein the active magnetron housing 5 is made of a biocompatible metal or non-metal material such as titanium alloy or stainless steel, the coil 52 is wound on the magnetic steel 51, and the cover plate 53 is butted, welded or lapped on the magnetron housing.

In the first embodiment, the coil 52 forms a winding, and the winding is spirally wound on the magnetic steel 51, and a fixed winding specification can be adopted.

In one embodiment, the magnetic steel 51 is made of hard magnetic material and/or soft magnetic material, including but not limited to neodymium-iron-boron alloy, samarium-cobalt alloy, aluminum-nickel (and with other elements such as cobalt), iron-chromium (and with other elements such as cobalt and molybdenum), iron-cobalt (and with other elements such as vanadium and tungsten), alloys of rare earth elements with cobalt, alloys of rare earth elements with iron, platinum-cobalt alloy, copper-nickel-iron alloy, other alloys containing iron or cobalt or nickel, manganese-aluminum-carbon alloy, aluminum-manganese-silver alloy, ferrites, iron-silicon, iron-aluminum, iron-silicon-aluminum, pure iron, low carbon steel, amorphous soft magnetic alloy, ultra-crystalline soft magnetic alloy, intermetallic compound, etc.

In the first embodiment, the coil 52 can be customized individually, and different wire diameters, turns and layers are selected according to the required magnetic force, so that the contradiction between the magnetic force and the power consumption is balanced, and the cruising ability of the device is improved.

In this embodiment, the feedthrough 54 is fixed at any position on the cover plate 53 or on the magnetron housing, and the electromagnetic active control magnet 13 is in the form of a single feedthrough 54 or a dual feedthrough 54, as shown in fig. 3c and 3d, the electromagnetic active control magnet 13 using the single feedthrough 54 is provided with one pin, and the electromagnetic active control magnet 13 using the dual feedthrough 54 is provided with two pins.

In the first embodiment, the cover plate 53 is butt-jointed to the active magnetron housing 5 and is fixedly connected by soldering, laser welding, ultrasonic welding or any other connection method.

In the first embodiment, one end of the electromagnetic active control magnet 13 (the opposite surface away from the other electromagnetic active control magnet 13) is provided with a back iron 55 made of soft magnetic alloy, as shown in fig. 3f, the back iron 55 has a magnetic gathering effect, so that the magnetic induction intensity of the electromagnetic active control magnet 13 can be improved, and the magnetic force can be increased.

In the first embodiment, pole shoes 56 are fixed to one end or two ends of the electromagnetic active control magnet 13, and the pole shoes 56 can improve magnetic density and increase magnetic force.

In the first embodiment, the electromagnetic active control magnet 13 is rectangular, circular, flat, fan-shaped, or any other shape, as shown in fig. 3 e.

In this embodiment, after the sensor 4 collects the cardiac electrophysiological signal, the control mechanism 3 converts the analog signal into a digital signal (AD conversion), the special program determines that the heart is in the contraction or relaxation stage, then calculates the level of the required electromagnetic force, solves the output of the control current, outputs the control signal after DA conversion to the controller 32 executing circuit, outputs a corresponding control current through electronic components such as a capacitor, an inductor, and a MOSET, and the control current passes through the coil 52, and generates a magnetic induction direction consistent with or opposite to the magnetic conductive material according to the right-hand screw rule, so as to enhance or weaken the original magnetic field of the magnetic conductive material, and generate a magnetic attraction force or a magnetic repulsion force.

An exemplary procedure for implanting the hybrid heart assist system of the first embodiment is as follows:

1. the conveying system enters the body through the chest in a minimally invasive way and pushes out the net bag 2 after reaching the heart;

2. the net bag 2 is propped open by the supporting structure, and the epicardium is coated by the net bag 2;

3. the withdrawing delivery system and the supporting structure, the net bag 2 is fixed on the epicardium to complete the implantation.

Example two

The second embodiment is substantially the same as the first embodiment except for the magnetic arrangement of the first magnet 131 and the second magnet 132.

In the second embodiment, when the first magnet 131 and the second magnet 132 are made of hard magnetic materials, the first magnet 131 and the second magnet 132 are arranged in the same magnetic order (N pole to N pole) in the initial state, the first magnet 131 and the second magnet 132 repel each other, as shown in fig. 4a, and the magnetic repulsion of the first magnet 131 and the second magnet 132 cannot make the first magnet 131 and the second magnet 132 move away from each other.

In the second embodiment, the heart protecting device further comprises a net bag 2, the net bag 2 is fixed on the epicardium or the pericardium and is attached to the geometric shape of the epicardium or the pericardium, the magnetic control device 1 is fixedly connected to the net bag 2, when the heart is in the systole, the net bag 2 provides a first contractile force, and the magnetic control device 1 provides a second contractile force; when the heart is in the diastole, the heart naturally relaxes, or the magnetic control device 1 cooperates with the net bag 2 to provide relaxation force for the heart.

In the second embodiment, the string bag 2 is a flexible net structure, and the maximum and minimum sizes of the string bag 2 are respectively a first size and a second size, wherein the first size is smaller than the outer size of the end diastole, and the second size is smaller than the outer size of the end systole due to the size design of the string bag 2 itself, or the string bag 2 is pressed by the magnetic control device 1 so that the second size is smaller than the outer size of the end systole.

In the second embodiment, the string bag 2 provides a first contraction force to the heart during the first stage of cardiac contraction, the control mechanism 3 controls the first magnet 131 to provide a reverse current (N-pole to S-pole) during the second stage of cardiac contraction, the control mechanism 3 controls the second magnet 132 to have constant or increased magnetic density during the second stage of cardiac contraction, the first magnet 131 and the second magnet 132 have opposite magnetic poles (S-pole to N-pole), and as shown in fig. 4b, the magnets on both sides generate attraction force to approach each other to assist ventricular contraction.

In the second embodiment, when the heart is in the diastole, the control mechanism 3 controls the first magnet 131 to pass through the reverse current, so that the first magnet 131 and the second magnet 132 have the same magnetic poles (N pole to N pole), as shown in fig. 4c, a repulsive force is generated between the first magnet 131 and the second magnet 132, and the first magnet 131 and the second magnet 132 are away from each other and drive the tuck net 2 to relax.

In this regard, the related configuration and concept of the second embodiment are similar to those of the first embodiment, and thus, the description thereof will not be repeated here.

EXAMPLE III

The third embodiment is substantially the same as the first embodiment except for the magnetic arrangement of the first magnet 131 and the second magnet 132.

In the third embodiment, the first magnet 131 and the second magnet 132 are arranged without current and magnetism, as shown in fig. 5 a.

In the third embodiment, when the heart is in the systolic phase, the control mechanism 3 controls the first magnet 131 and the second magnet 132 to provide a forward current and a reverse current, so that the first magnet 131 and the second magnet 132 have opposite magnetic poles (S pole to N pole), and the magnets on both sides generate an attractive force to approach each other, thereby assisting the contraction of the heart chamber, as shown in fig. 5 b.

In the third embodiment, when the heart is in the diastole, the control mechanism 3 controls the first magnet 131 to pass through the reverse current, so that the first magnet 131 and the second magnet 132 have the same magnetic poles (N pole to N pole), as shown in fig. 5c, a repulsive force is generated between the first magnet 131 and the second magnet 132, and the first magnet 131 and the second magnet 132 are away from each other and drive the tuck net 2 to relax.

In the third embodiment, the third embodiment further includes a rotating mechanism 7, as shown in fig. 5d, the electromagnetic active control magnet 13 is fixed on the heart through the rotating mechanism, and the control mechanism 3 controls the rotating mechanism 7 to rotate so as to drive the electromagnetic active control magnet 13 to rotate.

In the third embodiment, when the rotating mechanism 7 rotates, the electromagnetic active control magnet 13 is changed from the radial arrangement to the axial arrangement, as shown in fig. 5 e.

In this regard, the related configuration and concept of the third embodiment are similar to those of the first embodiment, and thus, the description thereof will not be repeated here.

Example four

The fourth embodiment is substantially the same as the first embodiment except for the constituent magnets of the first control unit 11 and the second control unit 12.

In the fourth embodiment, the second control unit 12 further includes a permanent passive control magnet 14, wherein when the first control unit 11 and the second control unit 12 are arranged, the second magnet 132 of the second control unit 12 is not energized, the first control unit 11 and the second control unit 12 form opposite magnetic poles (N-level to S-level), and the magnetic attraction force of the first control unit 11 and the second control unit 12 is not enough to cause the two to move closer.

In the fourth embodiment, when the heart is in the systolic phase, the control mechanism 3 controls the first magnet 131 to provide a forward current, so that the magnetic force between the first magnet 131 and the second magnet 132 is increased, and the magnets at the two sides generate attractive force to approach each other, thereby assisting the contraction of the ventricle, as shown in fig. 6a and 6 b.

In the fourth embodiment, when the heart is in the diastole, the control mechanism 3 controls the first magnet 131 to pass through the reverse current, so that the first magnet 131 and the second magnet 132 have the same magnetic poles (S pole to S pole), as shown in fig. 1d, a repulsive force is generated between the first magnet 131 and the second magnet 132, and the first magnet 131 and the second magnet 132 are away from each other and drive the tuck net 2 to relax.

In the fourth embodiment, the first magnet 131 and the second magnet 132 are arranged transversely or longitudinally, and the first magnet 131 and the second magnet 132 are partially or completely powered on, as shown in fig. 6c to 6 f.

In this regard, the relevant construction and concept of embodiment four is similar to embodiment one and therefore will not be repeated here.

EXAMPLE five

The fifth embodiment is substantially the same as the first embodiment except that the electromagnetic active control magnet 13 is E-shaped in shape.

As shown in fig. 7a, a magnetically controlled heart assist system according to an embodiment of the present application is illustrated, comprising: the heart monitoring device comprises an inductor 4, a control mechanism 3 and a magnetic control device 1 attached to the heart, wherein the control mechanism 3 is electrically connected with the inductor 4 and the magnetic control device 1; the magnetic control device 1 comprises a first control unit 11 and a second control unit 12, wherein the first control unit 11 and the second control unit 12 respectively comprise at least one electromagnetic active control magnet 13; and, the control mechanism 3 controls the motion states of the first control unit 11 and the second control unit 12 in real time according to the heart rate signal received by the sensor 4.

In the fifth embodiment, the first control unit 11 and the second control unit 12 respectively include two electromagnetic active control magnets 13, as shown in fig. 7b and 7 c.

In the fifth embodiment, the electromagnetic active control magnet 13 has an E-shaped, U-shaped or other non-closed shape; and, the electromagnetic active control magnet 13 includes magnetic steel 51, the appearance of the electromagnetic active control magnet 13 is that the magnetic steel 51 is spliced or the magnetic steel 51 is formed as an integral whole.

In the fifth embodiment, the E-shaped electromagnetic active control magnet 13 is the E-shaped electromagnetic active control magnet 6, the E-shaped structure can reduce the magnetic flux leakage of the magnet, improve the air gap magnetic flux density, increase the electromagnetic force, and generate a larger auxiliary force, and the magnetic force is focused on the auxiliary heart, and the direction of the magnetic force generated by the E-shaped electromagnetic active control magnet 13 is better matched with the physiological characteristics of the heart, so as to better provide the auxiliary contraction force and the auxiliary relaxation force for the heart.

In the fifth embodiment, the E-shaped electromagnetic active control magnet 6 is arranged at an angle theta to the long-diameter axis of the heart, and theta is more than or equal to 35 degrees and less than or equal to 80 degrees, as shown in FIG. 7 d.

In the fifth embodiment, the free end of the electromagnetic active control magnet 6 is provided with a pole shoe 56, as shown in fig. 8 a; the pole piece 56 of the first control unit 11 is disposed on the opposite surface close to the second control unit 12, and the pole piece 56 of the second control unit 12 is disposed on the opposite surface close to the first control unit 11.

In this fifth embodiment, the E-shaped electromagnetic active control magnet 6 includes an active magnetron casing 5, a magnetic steel 51, a coil 52, a cover plate 53 and a feedthrough 54, as shown in fig. 8b, wherein the active magnetron casing 5 is made of biocompatible metal or non-metal material such as titanium alloy or stainless steel, the coil 52 is wound on the magnetic steel 51, and the cover plate 53 is butted, welded or lapped on the magnetron casing 5.

In the fifth embodiment, the pole shoe 56 is made of a soft magnetic alloy, and the pole shoe 56 is arranged on the electromagnetic active control magnet 13, so that the magnetic density of a working air gap can be improved, and the magnetic force can be increased.

In the fifth embodiment, the magnetic steel 51 includes an arc portion 511, and the arc portion 511 fits the heart, as shown in fig. 8 c; and, the radius of curvature of the arc portion 511 is 20 to 50 mm.

In the fifth embodiment, the E-shaped electromagnetic active control magnet 6 includes a middle magnetic pole 62 and a side magnetic pole 61, and a size ratio range of a width of the middle magnetic pole 62 to a width of the side magnetic pole 61 is 0.1-4.

In the fifth embodiment, the ratio of the cross-sectional areas of the pole shoe 56 and the side magnetic pole 61 or the middle magnetic pole 61 is 0.1-3; the pole shoe 56 is connected to the side pole 61 or the middle pole 61 by laser welding, bonding, or integral processing.

In the fifth embodiment, under the control of the manipulating mechanism 3, the first magnet 131 and the second magnet 132 are energized, and the magnitude and the direction of the current of the energized first magnet 131 and the energized second magnet 132 are the same or different.

In the fifth embodiment, the heart protecting device further comprises a net bag 2, the net bag 2 is fixed on the epicardium or the pericardium and is attached to the geometric shape of the epicardium or the pericardium, the magnetic control device 1 is fixedly connected to the net bag 2, when the heart is in the systole, the net bag 2 provides a first contractile force, and the magnetic control device 1 provides a second contractile force; when the heart is in the diastole, the heart naturally relaxes, or the magnetic control device 1 cooperates with the net bag 2 to provide relaxation force for the heart.

In this fifth embodiment, the string bag 2 provides a first contraction force to the heart during a first stage of heart contraction, and the magnetic control device 1 cooperates with the string bag 2 to provide a second contraction force to the heart, when in arrangement, the side magnetic pole 61 and the middle magnetic pole 62 of the first magnet 131 are respectively N-stage and S-stage, the side magnetic pole 61 and the middle magnetic pole 62 of the second magnet 132 are respectively S-stage and N-stage, the control mechanism 3 controls the first magnet 131 and the second magnet 132 to provide a forward current during a second stage of heart contraction, so as to increase the magnetic density of the E-type electromagnetic active control magnet 13, increase the attraction force between the first magnet 131 and the second magnet 132, as shown in fig. 8b, so that the first magnet 131 and the second magnet 132 approach each other, and drive the string bag 2 to contract to generate a pressure on the heart muscle wall, thereby assisting the heart chamber to contract, the cardiac ejection fraction is increased, and the magnitude of the attractive force depends on the magnitude of the current.

In this fifth embodiment, when the heart is in the diastole, the control mechanism 3 controls the first magnet 131 to pass through the reverse current, so that the side magnetic pole 61 and the middle magnetic pole 62 of the first magnet 131 are respectively in the S-stage and the N-stage, and have the same magnetism as the side magnetic pole 61 and the middle magnetic pole 62 of the second magnet 131, as shown in fig. 8c, a repulsive force is generated between the first magnet 131 and the second magnet 132, and the first magnet 131 and the second magnet 132 are away from each other and drive the tuck net 2 to be relaxed.

In the fifth embodiment, the pole shoe 56 is sleeved and fixed on the outer circumferential surfaces of the middle magnetic pole 62 and the side magnetic pole 61, as shown in fig. 8d, or the pole shoe 56 is fixed on the magnetic pole surfaces of the middle magnetic pole 62 and the side magnetic pole 61, as shown in fig. 8 e.

In the fifth embodiment, the coil 52 is wound outside the magnetic steel 51, the coil 52 has one or two or more sections, and the coils 52 are combined and connected in a parallel manner or a stacked manner, as shown in fig. 8f and 8 g.

In the fifth embodiment, the cross-sectional shape of the magnetic steel 51 or the electromagnetic active control magnet 13 is circular, flat, rectangular, fan-shaped, or any other shape.

In the fifth embodiment, the E-shaped electromagnetic active control magnets 6 are connected by a connecting pipe 63, the connecting pipe 63 is a hollow thin-walled structure, a conducting wire 64 passes through the connecting pipe 63, and the conducting wire 64 is connected to the coil 52 of the adjacent E-shaped electromagnetic active control magnet 6, as shown in fig. 8 h.

In this regard, the relevant construction and concept of embodiment five is similar to embodiment one and therefore will not be repeated here.

The foregoing description of several embodiments of the application has been presented for purposes of illustration. The foregoing description is not intended to be exhaustive or to limit the application to the precise configuration, configurations and/or steps disclosed, and obviously many modifications and variations are possible in light of the above teaching. It is intended that the scope of the invention and all equivalents be defined by the following claims.

Claims

1. A magnetically controlled heart assist system, comprising: the heart monitoring device comprises a sensor, a control mechanism and a magnetic control device attached to the heart, wherein the control mechanism is electrically connected with the sensor and the magnetic control device; the magnetic control device is characterized by comprising a first control unit and a second control unit, wherein the first control unit and the second control unit respectively comprise at least one electromagnetic active control magnet; and the control mechanism controls the motion states of the first control unit and the second control unit in real time according to the heart rhythm signal received by the inductor.

2. The magnetically controlled heart assist system of claim 1, wherein the steering mechanism controls the direction of current flow of the first control unit and the second control unit.

3. The magnetically controlled heart assist system of claim 1, wherein the control mechanism controls the current levels of the first and second control units.

4. The magnetically controlled heart assist system according to claim 1, wherein the electromagnetically active control magnet is E-shaped, U-shaped, or other non-closed shape in profile; a pole shoe is arranged at the free end of the electromagnetic active control magnet; and, the electromagnetism initiative control magnet includes magnet steel or soft magnetic material, the appearance of electromagnetism initiative control magnet does the magnet steel concatenation forms or the magnet steel is integrated into one piece.

5. The magnetically controlled heart assist system according to claim 4, wherein the magnetic steel includes an arcuate portion that conforms to the shape of the heart; and, the radius of curvature of the arc-shaped part is 20-50 mm.

6. The magnetically controlled heart assist system of claim 1, wherein the electromagnetically active control magnet of the first control unit is a first magnet and the electromagnetically active control magnet of the second control unit is a second magnet, and the first magnet and the second magnet are uniformly or non-uniformly affixed to the surface of the heart.

7. The magnetically controlled heart assist system of claim 6, wherein the first control unit includes a number of first magnets and the second control unit includes a number of second magnets, the number of first magnets being the same or different from the number of second magnets, the spacing between adjacent first magnets being the same or different, the spacing between adjacent second magnets being the same or different; and, the first magnet and the second magnet are arranged radially or axially.

8. The magnetically controlled heart assist system according to claim 6, wherein the first and second control units are distributed across an interventricular sulcus; and, the first magnet and the second magnet are arranged substantially radially.

9. The magnetically controlled heart assist system of claim 1, wherein the first and/or second control units further comprise a permanent passive control magnet.

10. The magnetically controlled heart assist system according to claim 1, wherein under the action of the control mechanism, the first control unit and the second control unit move toward or away from each other to assist the heart in performing the actions of contraction or relaxation; and the motion directions of the first control unit and the second control unit are consistent with the circumferential motion direction of the contraction or relaxation of the myocardium.

11. The magnetically controlled heart assist system according to claim 1, further comprising a rotation mechanism, wherein the electromagnetic active control magnet is fixed to the heart by the rotation mechanism, and the control mechanism controls the rotation mechanism to rotate the electromagnetic active control magnet.

12. The magnetically controlled heart assist system of claim 11, wherein the electromagnetic active control magnet transitions from a radial arrangement to an axial arrangement when the rotation mechanism rotates.

13. The magnetically controlled heart assist system of claim 1, wherein the electromagnetic active control magnet is disposed at an angle θ to a major axis of the heart, and wherein 35 ° ≦ θ ≦ 80 °.

14. The magnetically controlled heart assist system of claim 1, further comprising a net bag, wherein the net bag is fixed to the epicardium or pericardium and conforms to the geometry of the epicardium or pericardium, the magnetically controlled device is fixedly connected to the net bag, and when the heart is in the systolic phase, the net bag provides a first contractile force and the magnetically controlled device provides a second contractile force; when the heart is in the diastole, the heart naturally relaxes, or the magnetic control device cooperates with the net bag to provide relaxation force for the heart.

15. The magnetically controlled heart assist system of claim 14 wherein the net bag provides a first contractile force to the heart during a first phase of cardiac contraction; and the control mechanism controls the magnetic control device and provides a second contraction force for the heart in cooperation with the net bag in the first stage and/or the second stage of the heart contraction.

16. The magnetically controlled heart assist system according to claim 14, wherein the electromagnetically active control magnets are uniformly or non-uniformly secured to the net bag by embedding, sewing, rivets or anchors.

17. The magnetically controlled heart assist system of claim 4, wherein the electromagnetic active control magnet further comprises an active magnetically controlled housing, a cover plate, a coil, and a feedthrough, wherein the active magnetically controlled housing is made of a biocompatible metal or non-metallic material such as titanium alloy or stainless steel, the coil is wound on the magnetic steel, and the cover plate is butted, welded, or lapped on the magnetically controlled housing.

18. The magnetically controlled heart assist system of claim 17 wherein the feedthrough is fixed anywhere on the cover plate or on the magnetically controlled housing; and, electromagnetism active control magnet adopts single feed through or double feed through or many feed through form, adopts single feed through electromagnetism active control magnet is equipped with a pin, adopts two feed through electromagnetism active control magnet is equipped with two pins, adopts many feed through electromagnetism active control magnet is equipped with a plurality of pins.