WO2024202395A1 - Wireless auxiliary artificial heart system - Google Patents

Abstract

Provided is a novel wireless artificial heart system (100) that uses a hybrid pump (21) in which it is possible to switch between two drive modes of a magnetic drive mode and an electric drive mode using one pump, and to which power can be supplied without an external coil for power supply. An auxiliary artificial heart device (1) that assists the activity of the heart is provided with: a hybrid pump (21) that is connected to the heart and the aorta via an artificial blood vessel (10) and that assists the activity of the heart by being driven by either an extracorporeal rotating magnetic body (53) or intracorporeal battery power; a control unit that controls switching of the hybrid pump (21) between the magnetic drive mode by the extracorporeal rotating magnetic body (53) and the electric drive mode by the intracorporeal battery power; an intracorporeal rotating magnetic body system (31) that transmits magnetic torque generated by the extracorporeal rotating magnetic body (53) to the hybrid pump (21) in a contactless manner; and a power generator (43) that charges the intracorporeal battery during the magnetic drive mode.

Description

Wireless artificial heart assist system

The present invention relates to an implantable wireless artificial heart assist system that does not require a power supply cable extending percutaneously from the patient's body.

Existing implantable ventricular assist devices (e.g., Left Ventricular Assist Devices (LVADs), a type of auxiliary circulatory device used to treat patients with end-stage heart failure) are powered by current supplied from an implanted rechargeable battery or an external or internal power source. Typically, these devices are directly connected to an internal or external power source through a power supply cable that extends percutaneously from inside the patient's body.

However, this technique carries the risk of driveline infection, which is a bacterial infection from sites around the driveline such as cables, and the associated complications of sepsis and coagulation disorders, which significantly reduce the patient's quality of life.
Therefore, there is a demand for a wireless artificial heart assist system that does not use a drive line such as a cable wire percutaneously.

One of the wireless artificial heart assist systems that does not use a drive line such as a cable is the transcutaneous energy transmission system (TETS), which uses an electromagnetic induction method to transmit and transfer energy via the skin to supply power.
These methods mainly include a method of using an external transmitter to transmit high-frequency energy to power the implanted device, and a method of using an electromagnetic transmitting coil. The former has poor energy transmission efficiency due to losses caused by passing through the skin. The latter utilizes electromagnetic induction between a primary coil placed on the body surface and a secondary coil implanted inside the body to transmit electrical energy into the body percutaneously. This electrical energy can be used to charge an internal battery and drive an internal auxiliary artificial heart (for example, Patent Document 1).

Another approach to wireless artificial heart assist systems is a magnetically driven pump, which rotates an implantable artificial heart with an impeller connected to a permanent magnet using a rotating magnetic body placed on the body surface (for example, Patent Document 2).

Special Publication No. 2000-505681 International Publication No. 2012-008383

The transcutaneous energy transmission system described in Reference 1 etc. cannot supply power if there is a distance between the coils. For this reason, it is used close to the epidermis, but since power is supplied while the heart is in operation, a large amount of power of nearly 15 W must be continuously supplied to the heart assist device, which causes problems such as a drop in output due to misalignment of the coils and skin burns due to heat generated by the coils. In addition, the implanted device is prone to malfunction, and when malfunctions occur, they can only be addressed by invasive procedures such as thoracotomy. These problems are preventing the practical application of wireless heart assist devices using transcutaneous energy transmission systems.

On the other hand, the implantable magnetic drive pump described in Reference 2 etc. does not cause burns and has a simple structure so there is no risk of breakdown, but it requires the patient to carry a rotating magnetic body that applies a magnetic field from the outside at all times, which limits activities such as sports and bathing, impairing the patient's quality of life.

The present invention aims to solve the above problems by providing a new wireless artificial heart assist system that uses a hybrid pump that can switch between two drive modes, magnetic drive mode and electric drive mode, and can be powered without an external power supply coil.

The wireless artificial heart assist device of the present invention is an artificial heart assist device that assists cardiac activity, and is characterized by having a hybrid pump that is connected to the heart and aorta via an artificial blood vessel and is driven by either an extracorporeal rotating magnetic body or an internal battery power to assist cardiac activity, a control unit that controls switching between a magnetic drive mode using the extracorporeal rotating magnetic body of the hybrid pump and an electric drive mode using internal battery power, an internal rotating magnetic body system that transmits magnetic torque generated by the extracorporeal rotating magnetic body to the hybrid pump in a non-contact manner, and a generator that charges the internal battery in the magnetic drive mode.

The wireless assisted artificial heart system of the present invention can provide patients with a safe wireless assisted artificial heart that does not impair their quality of life.

1 is a configuration diagram of a wireless assist artificial heart system 100 according to an embodiment of the present invention. FIG. 2 is a schematic diagram of a hybrid pump 21, an internal rotating magnetic body system 31, an electromagnetic coil 43, and an external rotating magnetic body 53 in the auxiliary artificial heart device 1 of the present invention. FIG. 1 is a schematic diagram of a wireless assist artificial heart system 100 according to the present invention actually connected to a patient.

Below, the mode for carrying out the present invention will be explained with reference to the drawings. Note that the embodiment of the present invention is not limited to the matters described below, and can be modified as appropriate depending on the situation in which the invention is applied, within the scope of the invention described in the claims.

[Assisted artificial heart system according to the first embodiment]
FIG. 1 is a configuration diagram of a wireless assist artificial heart system 100 according to the present invention.
As shown in FIG. 1, the wireless assist artificial heart system 100 comprises an assist artificial heart device 1 and an extracorporeal rotating magnetic control device 4 .

First, the assist artificial heart device 1 will be described.
The ventricular assist device 1 is for use in a left ventricular assist device (LVAD) and comprises an artificial blood vessel 10, a hybrid pump 21, an internal rotating magnetic system 31 that transmits magnetic torque from an extracorporeal rotating magnetic control device 4 to the hybrid pump 21, an internal control unit 41 that controls the internal rotating magnetic system 31, an internal battery 42, and an electromagnetic coil 43. The electromagnetic coil 43 acts as a generator that supplies power to the internal battery 42 in the magnetic drive mode of the hybrid pump 21, and acts as a motor in the electric drive mode of the hybrid pump 21.

The artificial blood vessel 10 is connected to the outlet and inlet of the hybrid pump 21. As shown in FIG. 3, the artificial blood vessel 10 connected to the outlet is connected to the aorta 16 near the heart, and the artificial blood vessel 10 connected to the inlet is connected to the left ventricle 12 of the heart.
The artificial blood vessel 10 is made of a stable biocompatible material such as polyester or tetrafluoroethylene.

FIG. 2 is a schematic diagram of the hybrid pump 21, the internal rotating magnetic body system 31, the electromagnetic coil 43, and the external rotating magnetic body 53 in the auxiliary artificial heart device 1 of the present invention.
FIG. 2 is a cross-sectional view taken along the central axis of the auxiliary artificial heart device 1. As shown in FIG.

[Hybrid pump]
As shown in FIG. 2, the hybrid pump 21 is made up of a housing 22, an impeller 23, a permanent magnet 24 of the impeller, and a permanent magnet holder 25.

The hybrid pump 21 is a centrifugal pump that has two drive modes: an electric drive mode and a magnetic drive mode. It can switch between the two drive modes depending on the situation.

[Electric drive mode]
In the electric drive mode, the electromagnetic coil 43 functions as a motor using power supplied from the internal battery 42 to drive the hybrid pump 21 .

The impeller 23 shown in FIG. 2 is a rotor consisting of a permanent magnet holding section 25 that holds multiple impeller permanent magnets 24, and a section in which multiple blades are arranged radially around a rotating shaft with a gap provided at the bottom to serve as a flow path. The permanent magnet holding section 25 has multiple sections that hold multiple impeller permanent magnets 24 radially around the rotating shaft. The impeller permanent magnets 24 are embedded with alternating south and north poles in each holding section adjacent in the circumferential direction. The impeller permanent magnets 24 are provided in a position facing the hybrid pump side permanent magnet 33 provided on the internal rotor 32, with the housing 22 in between. In addition, a permanent magnet 35 on the electromagnetic coil side of the internal rotor 32 is provided in a position facing the electromagnetic coil 43. When current is passed through the electromagnetic coil 43 from the internal battery 42, a rotational force is applied according to the principle of a brushless motor, and the internal rotor 32 rotates. When the internal rotor 32 rotates, the impeller's permanent magnets 24 and the hybrid pump side permanent magnets 33 of the internal rotor 32 are magnetically coupled to generate a magnetic torque, causing the impeller 23 to rotate as well. The impeller's permanent magnets 24 can have any number, but since they need to be magnetically coupled with the hybrid side permanent magnets 33 of the opposing internal rotating magnetic body, the number is usually the same. The number of electromagnetic coils 43 can be more or less than the opposing permanent magnets 35 on the electromagnetic coil side of the internal rotor 32, and there is no limit to the number as long as they function as a rotor.

The shape of the blades of the impeller 23 may be any shape as long as it can function as a pump. The material of the impeller 23 is preferably acrylic resin, but is not limited to this, and any material that is biocompatible may be used.
When a current is applied to the electromagnetic coil 43, the impeller 23 is rotated within the housing 22 based on the principle of a brushless motor, thereby pushing out blood and functioning as a pump.

The housing 22 shown in FIG. 2 has an intake port extending in the axial direction and an exhaust port extending in the centrifugal direction, constitutes the outer shape of the hybrid pump 21, and contains the impeller 23. The intake port is provided in the center of the central axis, and the exhaust port is provided in the centrifugal direction around the blades of the impeller 23. The material used is preferably acrylic resin, but is not limited to this, and any biocompatible material can be used.

2, the electromagnetic coil 43 is provided and held within an electromagnetic coil casing 44. A plurality of electromagnetic coils 43 are provided within the electromagnetic coil casing 44.
The electromagnetic coil 43 is formed by winding a copper wire around an iron core. A coil used in an electromagnetic motor may be used.

Also, as shown in FIG. 2, a rotation speed detection means 36 for detecting the rotation speed of the impeller 23 is provided near the internal rotating magnetic casing 37. The rotation speed detection means 36 may be any device that detects the rotation speed of a motor or the like, such as a Hall element. The rotation speed detection means 36 may be attached anywhere as long as it can detect the magnetic field of a rotating permanent magnet. The rotation speed detection means 36 is connected to the internal control unit 41, and sends the rotation speed of the internal rotor 32 to the internal control unit 41.

The electromagnetic coil casing 44 holds multiple electromagnetic coils 43 inside, and covers the portion of the internal rotating magnetic body casing 37 where the permanent magnets 35 on the electromagnetic coil side of the internal rotor 32 are held. The electromagnetic coil casing 44 contains multiple electromagnetic coils 43 so that, when covering the internal rotating magnetic body casing 37, they are positioned opposite the permanent magnets 35 on the electromagnetic coil side of the internal rotor 32. Any number of electromagnetic coils 43 may be provided inside the electromagnetic coil casing 44. The number may be the same as the number of permanent magnets 35 on the electromagnetic coil side of the internal rotor 32, or it may be more or less, and there is no limit to the number as long as it can rotate the impeller 23.

When a current is passed through the electromagnetic coil 43, the internal rotor 32 rotates using the same principle as an existing brushless motor, causing the impeller 23, which is magnetically coupled to the internal rotor 32 by a permanent magnet, to rotate, and the hybrid pump 21 functions as a centrifugal pump. By attaching an artificial blood vessel to a designated location near the left ventricle 12 and flowing blood through the hybrid pump 21, it becomes an artificial heart.

[Magnetic drive mode]
In the magnetic drive mode, no electrical circuit (electrical driving force) is required, and the magnetic torque generated by the rotation of the extracorporeal rotating magnetic body 53 is transmitted to the impeller's permanent magnet 24 via the internal rotor 32, thereby rotating the impeller 23 and driving the hybrid pump 21.

The permanent magnet 34 on the external rotating magnetic body side shown in Fig. 2 is provided inside the member on the external rotating magnetic body side of the rotor that constitutes the internal rotor 32. The permanent magnet is used by joining two permanent magnets with different magnetic poles at the position of the rotating surface, with half of the permanent magnet having an N pole and the other half having an S pole, but the number of permanent magnets is not important as long as sufficient magnetic torque can be transmitted. Note that as the permanent magnet, a magnet with strong magnetic force such as a neodymium magnet is used.
The permanent magnet 34 on the external rotating magnetic body side of the internal rotor 32 and the permanent magnet 54 of the external rotating magnetic body are magnetically coupled, and when the external rotating magnetic body 53 rotates, the internal rotor 32 is also driven to rotate by the magnetic torque.

The impeller's permanent magnet 24 and the hybrid pump side permanent magnet 33 of the internal rotor 32 are magnetically coupled, so that when the internal rotor 32 rotates, the impeller 23 of the hybrid pump 21 is also driven to rotate, just as in the case of the electric drive mode.

The extracorporeal rotating magnetic body 53 of the extracorporeal rotating magnetic body control device 4 installed on the outer surface of the skin 11 is rotated by a rotation drive mechanism 52, and by synchronizing this rotation with the permanent magnet group of the internal rotating magnetic body system 31 and the permanent magnet 24 of the impeller of the hybrid pump 21, the impeller 23 of the hybrid pump 21 rotates and functions as a centrifugal pump.
The artificial blood vessel is attached to a predetermined location and blood is made to flow through the hybrid pump 21 to create an artificial heart.

As described above, a preferred example of the hybrid pump 21 has been described, but the hybrid pump 21 is not necessarily limited to this form. In the present invention, a centrifugal pump has been described, but an axial pump may also be used. Any blood pump may be used as long as it is driven to rotate by external electric power or magnetic force and functions as an auxiliary artificial heart.

[Intracellular rotating magnetic system]
Next, the internal rotating magnetic body system 31 will be described.
The internal rotating magnetic body system 31 is a system that transmits to the hybrid pump 21 the magnetic torque generated by the external magnetic body rotation control device 4 in the magnetic drive mode and the magnetic torque generated by the electromagnetic coil 43 in the electric drive mode.

As shown in FIG. 2, the internal rotating magnetic system 31 comprises an internal rotor 32, a permanent magnet 33 on the hybrid pump side of the internal rotor 32, a permanent magnet 34 on the external rotating magnetic side of the internal rotor 32, a permanent magnet 35 on the electromagnetic coil side of the internal rotor 32, a rotation speed detection means 36, and an internal rotating magnetic casing 37.

The internal rotating magnetic system 31 is fixed through the sternum and between the ribs as shown in Figures 2 and 3. As shown in Figure 2, the permanent magnet 34 on the external rotating magnetic system side is placed outside the thorax with its magnetic pole surface facing outward. The permanent magnet 33 on the hybrid pump side is placed inside the thorax and is placed opposite the permanent magnet 24 of the impeller of the hybrid pump 21. The permanent magnet 35 on the electromagnetic coil side is placed inside the thorax in Figures 2 and 3, but it may be placed outside the thorax.

The permanent magnet 33 on the hybrid pump side is magnetically coupled to the permanent magnet 24 of the impeller with opposing magnetic poles facing each other through attractive force. Similarly, the permanent magnet 34 on the extracorporeal rotating magnetic body side is magnetically coupled to the permanent magnet 54 of the extracorporeal rotating magnetic body. There is no limit to the number of permanent magnets that are magnetically coupled, but they must be the same in number. The permanent magnet 35 on the electromagnetic coil side is positioned to face the electromagnetic coil 43. There is no limit to the number of permanent magnets 35 and electromagnetic coils 43 on the electromagnetic coil side, and they do not need to be the same in number.

In the magnetic drive mode, the permanent magnet 54 of the extracorporeal rotating magnetic body rotates, and the permanent magnet 34 on the magnetically coupled extracorporeal rotating magnetic body side receives a magnetic torque, thereby rotating the internal rotor 32. In the electric drive mode, a current is passed through the electromagnetic coil 43, and the permanent magnet 35 on the electromagnetic coil side receives a magnetic torque, thereby rotating the internal rotor 32. The permanent magnet 33 on the hybrid pump side also rotates together with the internal rotor 32, and the permanent magnet 24 of the impeller receives the magnetic torque and rotates, thereby driving the impeller 23 to rotate, in both the magnetic drive mode and the electric drive mode.
In order to reduce the frictional force that accompanies the rotation of the internal rotor 32 , a bearing may be disposed on the shaft of the internal rotor 32 .

Also, as shown in FIG. 2, a rotation speed detection means 36 for detecting the rotation speed of the internal rotor 32 is provided near the internal rotating magnetic casing 37 of the internal rotating magnetic system 31. Since the rotation speed of the internal rotor 32 and the rotation speed of the impeller 23 are the same, this is equivalent to detecting the rotation speed of the impeller 23, that is, the rotation speed of the hybrid pump 21. The rotation speed detection means 36 may be any device that detects the rotation speed of a motor, such as a Hall element. The rotation speed detection means 36 may be attached anywhere as long as it can detect the magnetic field of a rotating permanent magnet. The rotation speed detection means 36 is connected to the internal control unit 41, and sends the rotation speed of the hybrid pump 21 to the internal control unit 41.

[Internal control unit]
The internal control unit (controller) 41 is a part that controls the auxiliary artificial heart device 1. The internal control unit 41 is composed of a one-board microcomputer such as a central processing unit (CPU). The internal control unit 41 is not limited to a CPU, and any device that can perform similar control may be used. The internal control unit 41 may also include a storage medium such as a memory (not shown). The storage medium may store a control program, control information for the auxiliary artificial heart device 1, information on the rotation speed from the rotation speed detection means 36, and the like.

The internal control unit 41 switches between the electric drive mode and the magnetic drive mode based on the information on the rotation speed from the rotation speed detection means 36. A reference rotation speed range is set for the hybrid pump 21, and the drive mode does not change if the rotation speed is within the reference range. If the rotation speed becomes higher than the reference range, the drive mode switches to the magnetic drive mode if it is the electric drive mode, and the magnetic drive mode continues as it is if it is the magnetic drive mode. If the rotation speed slightly drops below the reference range, the drive mode switches to the electric drive mode if it is the magnetic drive mode, and the electric drive mode continues as it is if it is the electric drive mode. When switching from the magnetic drive mode to the electric drive mode, the drive is initially driven at the same rotation speed as the magnetic drive mode immediately before the switch, that is, at a rotation speed slightly lower than the rotation speed in the reference range, but the rotation speed is slowly increased to near the median value of the rotation speed in the reference range over a dozen seconds. However, if the rotation speed drops significantly during the magnetic drive mode, that is, if the rotating magnetic body loses synchronization and the hybrid pump 21 stops, the drive mode immediately switches to the electric drive mode and increases the rotation speed to the reference range in a few seconds, thereby maintaining the circulating plasma volume in the body. This is an example of switching the drive mode based on the rotation speed. Conversely, it is also possible to switch from electric drive mode to magnetic drive mode when the rotation speed is higher than the reference range, and switch from magnetic drive mode to electric drive mode when the rotation speed is lower than the reference range.

　The drive mode may also be switched using indicators other than the rotation speed, such as the pressure or flow rate of the hybrid pump. The drive mode may also be switched by sending electromagnetic waves, such as infrared rays, from outside the body as a signal to the inside of the body.

The rotation speed of the internal rotor 32 is the same as the rotation speed of the hybrid pump 21, but the rotation speed of the internal rotor 32 in the magnetic drive mode can be controlled by manually adjusting the rotation speed of the rotary drive mechanism outside the body. The rotation speed of the internal rotor 32 in the electric drive mode is automatically controlled by the internal control unit 41 based on the rotation speed in the magnetic drive mode so that it falls within the reference range.

The internal control unit 41 contains or is connected to an internal battery 42 and is powered by the electrical energy of the internal battery 42.

The internal battery 42 supplies power to the internal control unit 41 and the electromagnetic coil 43 in the electric drive mode, and is charged by receiving power from the electromagnetic coil 43 in the magnetic drive mode. A specific internal battery 42 is preferably a small, high-capacity secondary battery that can be charged and discharged, and a lithium-ion secondary battery is preferably used.

The electromagnetic coil 43 is connected to the internal battery 42, but the connection point is different between the magnetic drive mode and the electric drive mode.

In the magnetic drive mode, the electromagnetic coil 43 acts as a generator and is connected to the input port of the internal battery 42. Electromagnetic induction between the permanent magnet 35 on the electromagnetic coil side of the internal rotating magnetic body system 31 and the electromagnetic coil 43 is used to generate an induced electromotive force, which can supply power to the internal battery 42.
In the magnetic drive mode, power from the internal battery 42 is not consumed, so that the electromagnetic coil 43 can be charged by supplying power at a low power of 3 W or less, which is not much higher than body temperature. Therefore, unlike conventional transcutaneous energy transmission systems (TETS) that continuously apply high power of nearly 10 to 15 W, the risk of burns to the patient can be almost eliminated.

In the electric drive mode, the electromagnetic coil 43 acts as a motor and is connected to the output port of the internal battery 42. When the output current from the internal battery 42 flows through the electromagnetic coil 43, a magnetic torque is applied to the permanent magnet 35 on the electromagnetic coil side of the internal rotating magnetic system 31, driving the internal rotor 32 to rotate, and the impeller 23 of the hybrid pump 21 also rotates.

In order to switch the connection of the electromagnetic coil 43 according to the drive mode, a wiring switching device is required between the electromagnetic coil 43 and the internal battery 42. The wiring switching device can be any type, such as a relay switch or reed switch, as long as it can be electronically controlled by the internal control unit 41.

[Extracorporeal rotating magnetic device]
Next, the extracorporeal rotating magnetic body control device 4 will be described.
The extracorporeal rotating magnetic body control device 4 comprises an external power source 51 , a rotation drive mechanism 52 , an extracorporeal rotating magnetic body 53 , a permanent magnet 54 of the extracorporeal rotating magnetic body, and an extracorporeal rotating magnetic body casing 55 .
In the magnetic drive mode, the extracorporeal rotating magnetic body control device 4 drives and rotates the hybrid pump 21 via the internal rotating magnetic body system 31, and at the same time charges the internal battery 42 using the induced electromotive force generated by the electromagnetic coil 43. It is not used in the electric drive mode.

The external power source 51 is the power source for the extracorporeal rotating magnetic body control device 4, and may be any power source capable of supplying power. To increase portability, a battery or the like may be used.

As shown in Figs. 1 and 3, the rotation drive mechanism 52 is a mechanism that rotates using power from an external power source 51. The rotation can rotate the extracorporeal rotating magnetic body 53. The rotation drive mechanism 52 can be configured, for example, with an electric motor or the like.

The extracorporeal rotating magnetic body 53 is a member that rotates by a rotation drive mechanism 52, as shown in Fig. 1 and Fig. 3. The extracorporeal rotating magnetic body 53 has a permanent magnet 54 of the extracorporeal rotating magnetic body embedded therein, as shown in Fig. 2. The embedded permanent magnet 54 of the extracorporeal rotating magnetic body is arranged so that the magnetic field of the magnet surface pressed against the skin 11 via the extracorporeal rotating magnetic body casing 55 has different poles, such as a south pole and a north pole, and is magnetically coupled with the permanent magnet 34 on the extracorporeal rotating magnetic body side of the internal rotating magnetic body system 31. The permanent magnet is preferably one with a strong magnetic force, such as a neodymium magnet. Note that the number of permanent magnets 54 of the embedded extracorporeal rotating magnetic body may be any number as long as they are magnetically coupled with the permanent magnet 34 on the extracorporeal rotating magnetic body side, but usually the number is the same.

The extracorporeal rotating magnetic body 53 is brought close to the skin 11 where the permanent magnet 34 on the extracorporeal rotating magnetic body side of the internal rotating magnetic body system 31 is located, and a magnetic field is applied transcutaneously to magnetically couple with the permanent magnet 34, causing the internal rotor 32 to rotate by magnetic torque, which in turn rotates the impeller 23 to drive the hybrid pump 21. Therefore, in the magnetic drive mode, power from the internal battery 42 is not required.

[Actual use of the ventricular assist system]
FIG. 3 is a schematic diagram of the wireless assist artificial heart system 100 according to the present invention when actually connected to a patient.

The skin 11 shown in FIG. 3 indicates the skin in the vicinity of where the auxiliary artificial heart device 1 is embedded, with the right side representing the inner side of the body and the left side representing the outer side.
The sternum 18 shown in Fig. 3 indicates the sternum constituting the thorax in which the auxiliary artificial heart device 1 is embedded, with the right side being outside the thorax or subcutaneous, and the left side being inside the thorax. Reference numerals 12 to 17 in Fig. 3 are schematic diagrams of the area surrounding the heart, and represent the left ventricle 12, the right ventricle 13, the left atrium 14, the right atrium 15, the aorta 16, and the pulmonary artery 17.

In FIG. 3, the opposite end of the artificial blood vessel 10 connected to the intake port of the hybrid pump 21 of the ventricular assist device 1 of the present invention is connected to the left ventricle 12, and the opposite end of the artificial blood vessel 10 connected to the exhaust port of the hybrid pump 21 is connected to the aorta 16.

In Figure 3, the internal rotating magnetic system 31 is fixed so that a part of it protrudes outside the thoracic cage by drilling a hole through the sternum or penetrating between the ribs.

In FIG. 3, the hybrid pump 21 is fixed inside the thorax in close contact with the internal rotating magnetic system 31.

In Figure 3, the internal control unit 41 and electromagnetic coil 43 are fixed inside the thoracic cage, but there is no problem with placing them outside the thoracic cage (subcutaneously). Considering that the space outside the thoracic cage (subcutaneously) is smaller than that inside the thoracic cage and considering the need to protect the device from external shocks, placing them inside the thoracic cage is preferable to placing them outside the thoracic cage (subcutaneously), but considering the risk of bacterial infection from the internal prosthesis after implantation, placing them outside the thoracic cage (subcutaneously) is preferable.

In Figure 3, the artificial blood vessel 10 of the auxiliary artificial heart device 1 of the present invention is connected between the left ventricle 12 and the aorta 16, and blood flows through the artificial blood vessel 10 and the hybrid pump 21. In this state, the hybrid pump 21 is driven by the method described above, and becomes a centrifugal pump, fulfilling the role of an auxiliary artificial heart.

In the present invention, with regard to the wireless assisted artificial heart system 100, the introduction of the internal rotating magnetic body system 31 has placed the permanent magnet 34 on the external rotating magnetic body side subcutaneously, shortening the distance to the permanent magnet 54 of the external rotating magnetic body of the external rotating magnetic body control device 4. This has increased the magnetic attraction force, stabilizing the magnetic drive mode and enabling the device to be made smaller by miniaturizing the permanent magnet.

In the present invention, the internal battery 42 is charged in the magnetic drive mode, which does not consume power from the internal battery 42, so it can be charged slowly at low power. Therefore, unlike conventional TETS, which required a large amount of power to simultaneously charge and discharge, the temperature rise of the electromagnetic coil 43 can be suppressed. Even if the temperature becomes too high, charging can be stopped at any time, and stopping charging does not affect blood circulation in the magnetic drive mode. Therefore, there is little risk of internal burns.

In this invention, the principle of the magnetic drive mode is a simple structure in which an internal and external permanent magnet is coupled, and the rotation of one magnet causes the magnetic torque generated by the rotation of the other magnet to rotate. Therefore, in the magnetic drive mode, the internal electronic circuit is only required for the charging system, and the internal electronic circuit is not required for blood circulation, which is the most important function of the ventricular assist device. Therefore, malfunctions due to disconnection or failure of electronic components are unlikely to occur. Even if a malfunction does occur, it is due to the positional relationship of the magnets, and there is a high possibility that it can be dealt with without invasive procedures involving incisions.

In the present invention, in the electrically driven mode, since the internal battery 42 is present inside the body, the external device of the extracorporeal rotating magnetic control device 4 is not required during the electrically driven mode, and the user's movements are not restricted.

In the present invention, one blood pump is a hybrid pump that operates in different drive modes, a magnetic drive mode and an electric drive mode. This allows for space saving compared to using two different pumps, a magnetic drive pump and an electric drive pump. Furthermore, in a system using two pumps, there is a high possibility that a blood clot will form inside the pump while one of the pumps is stopped, causing thrombosis, but in a hybrid pump, the impeller is constantly rotating, so there is a low risk of blood clot formation.

In this invention, magnetism is used to transmit energy, and in principle, no heat is generated. This eliminates the problem of heat generation in the coils of conventional TETS, which transmits energy by coupling an external coil with an internal coil. In this invention, a blood pump that can be driven by either external magnetic force or power from an internal battery is used as the artificial heart. The coil used in this artificial heart works as a motor when electrically driven by the internal battery, but when magnetically driven, it works as a generator to charge the internal battery. By combining the functions into one pump, the impeller is constantly rotating, reducing the risk of blood clot formation, and there is no longer a need for a transcutaneous energy transmission system to charge the internal battery, making it possible to reduce the weight of the entire system.

Description of the Reference Number 1: Assist artificial heart device 4: Extracorporeal rotating magnetic material control device 10: Artificial blood vessel 11: Skin 12: Left ventricle 13: Right ventricle 14: Left atrium 15: Right atrium 16: Aorta 17: Pulmonary artery 21: Hybrid pump 22: Housing 23: Impeller 24: Permanent magnet of impeller 25: Permanent magnet holder 31: Internal rotating magnetic material system 32: Internal rotor 33: Permanent magnet on hybrid pump side 34: Permanent magnet on extracorporeal rotating magnetic material side 35: Permanent magnet on electromagnetic coil side 36: Rotation speed detection means 37: Internal rotating magnetic material casing 41: Internal control unit 42: Internal battery 43: Electromagnetic coil 44: Electromagnetic coil casing 51: External power source 52: Rotation drive mechanism 53: Extracorporeal rotating magnetic material 54: Extracorporeal rotating magnetic permanent magnet 55: Extracorporeal rotating magnetic casing 100: Wireless assisted artificial heart system

Claims (7)

In an artificial heart assist device that assists the activity of the heart,
A hybrid pump that is connected to the heart and aorta via an artificial blood vessel and is powered by either an external rotating magnetic body or an internal battery to assist the activity of the heart;
a control unit that controls switching between a magnetic drive mode using the external rotating magnetic body and an electric drive mode using power from an internal battery of the hybrid pump;
an internal rotating magnetic body system that transmits magnetic torque generated by the external rotating magnetic body to the hybrid pump in a non-contact manner;
a generator that charges the internal battery when in the magnetic drive mode;
A wireless artificial heart assist device having the same. The wireless artificial heart assist device according to claim 1, characterized in that the hybrid pump is a pump that is implanted in the body. The hybrid pump includes a hybrid pump housing having an intake port and a discharge port;
a hybrid pump impeller that is rotatably accommodated in the housing of the hybrid pump and has permanent magnets arranged so that different poles appear alternately on the outer circumference when the hybrid pump rotates;
A rotation drive mechanism that rotates the impeller;
2. The wireless assist artificial heart device according to claim 1, wherein the pump is provided with: The internal rotating magnetic body system includes an internal rotating magnetic body having a rotation axis common with the impeller and having permanent magnets disposed at both ends and around the axis;
An internal rotating magnetic body case that accommodates the internal rotating magnetic body;
A rotation speed detection means for detecting the rotation speed of the internal rotating magnetic body;
2. The wireless assist artificial heart device according to claim 1, further comprising: The generator includes an electromagnetic coil disposed radially outward relative to the rotation axis of the internal rotating magnetic body;
A permanent magnet arranged around the axis of the internal rotating magnetic body;
5. The wireless assist artificial heart device according to claim 4, further comprising: The wireless assisted artificial heart device according to claim 4, characterized in that the rotation speed detection means for detecting the rotation speed of the internal rotating magnetic body of the internal rotating magnetic body system includes a coil that detects changes in the magnetic field resulting from the rotation of the internal rotating magnetic body and generates an alternating current. The wireless assisted artificial heart device of claim 1, characterized in that the control unit controls an internal microcomputer to turn on and off the electric drive mode of the hybrid pump based on an increase or decrease in the number of rotations of the internal rotating magnetic body, which can be calculated from the frequency of the generated alternating current.

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