Artificial heart device

Abstract

To maintain necessary functions at least temporarily when an abnormality occurs in some pumps.SOLUTION: An artificial heart device includes a power source unit and a pump embedded in a living body. An inflow port of the pump is connected to the right atrium or the vena cava and an outflow port is connected to the pulmonary artery. The pump includes a discharge part for causing blood to flow into the inflow port and causing the blood to be discharged from the outflow port, and a motor for driving the discharge part by receiving power from the power source unit wirelessly.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] The present invention relates to artificial heart devices. [Background technology]

[0002] Implantable artificial hearts are known (Patent Document 1, Non-Patent Documents 1 and 2). When an implantable artificial heart is used, the patient must carry accessories such as a power source. In order to prevent damage to the accessories, the patient must be extremely careful in his or her actions. It is also important to know how to properly and safely hold the drive line that supplies power to drive the motor outside the patient's body. Therefore, when using an artificial heart, many precautions must be observed to prevent breakdowns, and the reality is that patients and their caregivers are subject to significant restrictions in their daily lives. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2011-72533 A [Non-patent literature]

[0004] [Non-Patent Document 1] Japan Society of Mechanical Engineers, Information, Intelligence and Precision Machinery Division, Newsletter No. 28: Development of a Totally Implantable Total Artificial Heart: Current Status of Development at the National Cardiovascular Center,<URL:https: / / www.jsme.or.jp / iip / Japanese / Newsletter / No28 / 03.html> [Non-Patent Document 2] Weekly Medical Newspaper "Interview: New Possibilities for Artificial Heart Development (Yoshiyuki Myonaka)", No. 2329, March 8, 1999, Igaku Shoin, <URL:https: / / www.igaku-shoin.co.jp / paper / archive / old / old_article / n1999dir / n2329dir / n2329_06.htm> Summary of the Invention [Problem to be solved by the invention]

[0005] The technology described in Patent Document 1 above includes a pump for the right heart and a pump for the left heart, but does not take into consideration control in the event that an abnormality occurs in one of the pumps.

[0006] The present invention has been made in consideration of the above circumstances, and one of its objects is to provide an artificial heart device that can maintain necessary functions at least temporarily when an abnormality occurs in one of the pumps. [Means for solving the problem]

[0007] The artificial heart device according to the present invention employs the following configuration.

[0008] (1): An artificial heart device according to one embodiment of the present invention is an artificial heart device comprising: a power supply unit; a pump implanted in the human body; an inlet of the pump connected to the right atrium or the vena cava and an outlet connected to the pulmonary artery; the pump having a discharge unit that causes blood to flow into the inlet and discharges the blood from the outlet; and a motor that receives wireless power from the power supply unit and drives the discharge unit.

[0009] (2): An artificial heart device according to one embodiment of the present invention is an artificial heart device comprising: a power supply unit; a pump implanted in the human body; an inlet of the pump connected to the left atrium or the pulmonary vein and an outlet connected to the aorta; a pump having a discharge unit that causes blood to flow into the inlet and discharges the blood from the outlet; and a motor that receives wireless power from the power supply unit to drive the discharge unit.

[0010] (3): An artificial heart device according to one embodiment of the present invention comprises a power supply unit; a pump implanted in the human body; and a pump having an inlet connected to the left ventricle or the pulmonary vein and an outlet connected to the aorta, respectively, or a pump having an inlet connected to the right ventricle or the vena cava and an outlet connected to the pulmonary artery, respectively, the pump comprising: a discharge unit that causes blood to flow into the inlet and discharges the blood from the outlet; and a motor that receives wireless power from the power supply unit and drives the discharge unit.

[0011] (4): In any one of the above aspects (1) to (3), the power supply unit includes a battery and a power supply unit that receives power wirelessly and supplies power to the battery.

[0012] (5): In the above aspect (4), the artificial heart device includes a cable harness that connects the power supply unit and the battery and supplies power from the power supply unit to the battery, and the power supply unit is disposed at a position different from the battery inside the body.

[0013] (6): In the above aspect (4), the artificial heart device further includes a transmission processing unit that performs processing to wirelessly transmit information indicating that an abnormality has occurred in the pump to outside the body when an abnormality occurs in the pump.

[0014] (7): In the above aspect (4), the battery is housed in a titanium case.

[0015] (8): In the above aspect (4), the artificial heart device includes a cable harness that connects the power supply unit and the battery and supplies power from the power supply unit to the battery, and the cable harness is further covered with a silicone-based material around the outer periphery of the coating. Effect of the Invention

[0016] According to the aspects (1) to (8), when the determining unit determines that an abnormality has occurred in the second pump, the switching mechanism is switched from the first state to the second state and the output of the first pump is increased, thereby making it possible to maintain blood flow from the pulmonary vein to the aorta. Therefore, it is possible to provide an artificial heart device that can at least temporarily maintain necessary functions when an abnormality occurs in some of the pumps. [Brief description of the drawings]

[0017] [Figure 1] 1 is a diagram showing the structure of the heart and blood flow. [Diagram 2] FIG. 1 is a diagram showing an artificial heart device according to an embodiment. [Diagram 3] FIG. 2 is a diagram showing in detail the main parts of the artificial heart device according to the embodiment. [Figure 4] FIG. 4 is a diagram showing the state of each part in a first state. [Diagram 5] FIG. 4 is a diagram showing the state of each part in a second state. [Figure 6] 1 is a schematic diagram simply illustrating normal and abnormal operation. FIG. [Figure 7] 4 is a flowchart of a process for determining an abnormality in a pump. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] Hereinafter, an embodiment of an artificial heart device of the present invention will be described with reference to the drawings.

[0019] FIG. 1 is a diagram showing the structure of the heart and blood flow. Venous blood returning from the entire body flows into the right atrium 3 from the superior and inferior vena cava 1 and 2 (circle A). The blood in the right atrium 3 flows into the right ventricle 5 when the tricuspid valve 4 opens. The blood in the right ventricle 5 flows into the pulmonary artery 7 when the pulmonary valve 6 opens (circle B) and takes in oxygen in the lungs (not shown). The blood that has taken in oxygen flows into the left atrium 10 through two pulmonary veins 8 and 9 from each of the left and right lungs (circle C). The blood in the left atrium 10 flows into the left ventricle 12 when the mitral valve 11 opens (circle D). Here, the blood is subjected to a strong contractile force of the left ventricle 12, passes through the aortic valve 13, and is sent out from the aorta 14 to the entire body (circle E). The cardiac output is about 5 to 6 L per minute, and the heart rate is about 60 to 70 beats per minute. In this way, the heart acts as a pump by repeatedly contracting and expanding to send blood out and circulate it to every corner of the body.

[0020] 2 is a diagram showing an artificial heart device according to an embodiment. The artificial heart device according to an embodiment includes, for example, a pump unit 100, connection mechanisms 110 and 120, an ECU 200, batteries 301 and 302, a wireless power receiving pad 400, and cable harnesses 501 and 502. These components are embedded in the body of a user P, for example. That is, this embodiment assumes a replacement type or total replacement type artificial heart device. The pump unit 100 is a device for circulating blood in the body of a user P in place of the heart or for assisting the heart to circulate blood, and includes two pumps for the left heart and the right heart.

[0021] An ECU (Electronic Control Unit) 200 controls the operations of the pump unit 100 and the connection mechanisms 110 and 120. The processing by the ECU 200 will be described in detail later.

[0022] Each of the batteries 301 and 302 is, for example, a lithium ion battery. The batteries 301 and 302 are preferably stored in a robust case made of, for example, titanium, so that even if an unexpected event such as leakage, fire, or explosion occurs, the battery 301 and 302 will not affect the human body. The receiving pad 400 can receive wireless power from an external wireless charging transmitting pad W and charge the batteries 301 and 302 through a cable harness 501 embedded in the body. Note that it is not essential to embed the batteries 301 and 302 in the body. Also, it is not essential to charge the batteries 301 and 302 by wireless power supply.

[0023] The cable harness 501 is used for power supply, and the cable harness 502 is used for control signal communication. Since these cable harnesses 501 and 502 are passed through the body of the user P, it is preferable to protect them by further covering the periphery of the coating with a silicon-based material.

[0024] The state recognition device 600 is worn, for example, on the arm of the user P. The state recognition device 600 can receive various physiological information transmitted from the ECU 200 inside the body via the antenna 201. The state recognition device 600 can also recognize that a failure has occurred in the artificial heart device (particularly the motor) by communication with the ECU 200. The ECU 200 may be capable of communicating with an external device other than the state recognition device 600, or may be capable of communicating with an external device via the state recognition device 600.

[0025] Also, optical communication may be performed between the state recognition device 600 and the ECU 200 inside the body. Specifically, a transcutaneous optical telemetry system (TOT) may be applied that transmits information inside the body related to the artificial heart drive to the outside of the body without invading the skin. In this case, transcutaneous information transmission is possible by providing a near-infrared LED on the transmitting (inside the body) side and a PD on the receiving (outside the body) side.

[0026] 3 is a diagram showing in detail the main parts of the artificial heart device according to the embodiment. The pump unit 100 is connected to the vena cava, the pulmonary artery, the pulmonary vein, and the aorta via connection mechanisms 110 and 120 and an artificial blood vessel.

[0027] The pump unit 100 is, for example, a centrifugal or spiral pump, and includes a first pump P1 and a second pump P2. The first pump P1 includes, for example, an inlet 101, an outlet 103, a motor 105, and an impeller 107. When the impeller 107 receives a rotational force from the motor 105 and rotates, blood flows into the inlet 101 and is discharged from the outlet 103. The second pump P2 includes, for example, an inlet 102, an outlet 104, a motor 106, and an impeller 108. When the impeller 108 receives a rotational force from the motor 106 and rotates, blood flows into the inlet 102 and is discharged from the outlet 104. The motors 105 and 106 can be controlled separately.

[0028] The bypass pipe BP is provided between the vena cava and the pulmonary artery. The bypass pipe BP may be provided with an anti-reflux valve.

[0029] The connection mechanism 110 is connected to the inlets 101 and 102 of blood in the pump unit 100. The connection mechanism 110 is a valve that can change the combination of the inlet and the outlet by rotating a rotor 117. The connection mechanism 110 includes a casing 116 having holes 111, 112, 113, 114, and 115 that communicate with the internal space, a rotor 117 that rotates inside the casing 116, and an actuator (not shown) that drives the rotor 117. The connection mechanism 110 can be switched between a first state in which the hole 111 communicates with the hole 112 and the hole 113 communicates with the hole 114, and a second state in which the hole 111 is blocked from the hole 112 and the hole 113 communicates with the hole 115. The first state and the second state are switched by rotating the rotor 117.

[0030] The connection mechanism 120 is a valve capable of changing the combination of the inlet and the outlet by rotating the rotor 125. The connection mechanism 120 includes a casing 124 having holes 121, 122, and 123 communicating with the internal space, a rotor 125 that rotates inside the casing 124, and an actuator (not shown) that drives the rotor 125. The connection mechanism 120 can be switched between a first state in which the hole 121 communicates with the hole 122, and a second state in which the hole 121 communicates with the hole 123 and the hole 122 is blocked. The switching between the first state and the second state is performed by rotating the rotor 125.

[0031] The combination of the connection mechanism 110, the connection mechanism 120, and the bypass pipe BP is an example of a "switching mechanism" in the claims.

[0032] An antenna 201 that emits radio waves is connected to the ECU 200, and the antenna 201 is also embedded in the body together with the ECU 200. The ECU 200 also includes, for example, a determination unit 202, a control unit 203, and a transmission processing unit 204.

[0033] These components are realized by, for example, a hardware processor such as a CPU (Central Processing Unit) executing a program (software). Some or all of these components may be realized by hardware (including circuitry) such as an LSI (Large Scale Integration), an ASIC (Application Specific Integrated Circuit), an FPGA (Field-Programmable Gate Array), or a GPU (Graphics Processing Unit), or may be realized by a combination of software and hardware. The program may be stored in advance in a storage device (a storage device having a non-transient storage medium) such as an HDD (Hard Disk Drive) or a flash memory, or may be stored in a removable storage medium (non-transient storage medium) such as a DVD or a CD-ROM, and installed in the storage device by mounting the storage medium in a drive device.

[0034] The determination unit 202 determines whether or not an abnormality has occurred in the second pump P2. Specifically, the determination unit 202 compares the value of the current consumption, coil resistance, or temperature of the motor that drives the second pump P2 with a threshold value, and performs abnormality determination based on the result. The determination unit 202 may make a determination using any one of these values, or may make a comprehensive determination using a plurality of values ​​or all of the values. The determination unit 202 may also make a determination using absolute values ​​or displacement amounts of these values. The determination unit 202 may determine whether or not an abnormality has occurred in the first pump P1. A specific method of abnormality determination may be the same as that for the second pump P2.

[0035] When the judgment unit 202 judges that an abnormality has occurred in the second pump P2, the control unit 203 switches the connection mechanisms 110 and 120 from the first state to the second state and performs control to increase the output of the first pump P1.

[0036] The transmission processing unit 204 performs processing for wirelessly transmitting information indicating that the determination unit 202 has determined that an abnormality has occurred in the second pump P2 to the outside of the body via the antenna 201. In addition, in a case where the determination unit 202 is configured to determine whether or not an abnormality has occurred in the first pump P1, the transmission processing unit 204 performs processing for wirelessly transmitting information indicating that the determination unit 202 has determined that an abnormality has occurred in the first pump P1 to the outside of the body via the antenna 201.

[0037] In the following description, the time when the determination unit 202 has not determined that the second pump P2 is abnormal is referred to as a normal time (or normal time). Also, the time when the determination unit 202 has determined that the second pump P2 is abnormal is referred to as an abnormal time. The first state and the second state will be described with reference to Figs. 4 and 5.

[0038] 4 and 5 show cross sections of the connection mechanisms 110 and 120 so that the blood flow paths can be easily understood. The pump unit 100 may be disposed on the rear side of the connection mechanisms 110 and 120 (toward the rear side of the paper).

[0039] 4 is a diagram showing the state of each part in the first state. In the first state, the connection mechanism 110 connects the vena cava to the inlet of the first pump P1 by communicating the hole 111 with the hole 112. The connection mechanism 120 connects the outlet of the first pump P1 to the pulmonary artery by communicating the hole 121 with the hole 122. The connection mechanism 110 also connects the pulmonary vein to the inlet of the second pump P2 by communicating the hole 113 with the hole 114. The connection mechanism 120 connects the outlet of the second pump P2 to the aorta.

[0040] Therefore, blood from the vena cava is powered by the first pump P1 and travels along the path indicated by the hatched arrows (1) to (8) in Fig. 4 to reach the pulmonary artery. Also, blood from the pulmonary vein is powered by the second pump P2 and travels along the path indicated by the white arrows (1) to (8) in Fig. 4 to reach the aorta.

[0041] 5 is a diagram showing the state of each part in the second state. In the second state, the connection mechanism 110 rotates the rotor 117 to block the hole 111 and the hole 112, thereby blocking the inflow of blood from the vena cava to the first pump P1. The connection mechanism 110 also connects the pulmonary vein to the inlet of the first pump P1 by connecting the hole 113 and the hole 115 to each other. The connection mechanism 120 rotates the rotor 125 to not connect the hole 121 and the hole 122, but connect the hole 121 and the hole 123 to each other, thereby blocking the connection between the output port of the first pump P1 and the pulmonary artery and connecting the outlet of the first pump P1 to the aorta.

[0042] Therefore, blood from the vena cava reaches the pulmonary artery via the path indicated by hatched arrows (1) to (7) in Fig. 5. Also, blood from the pulmonary vein receives the force of the first pump P1 and reaches the aorta via the path indicated by hollow arrows (1) to (8) in Fig. 5.

[0043] FIG. 6 is a schematic diagram showing the operation in a normal state and an abnormal state. In a normal state, the connection mechanism 110 and the connection mechanism 120 are in a first state under the control of the ECU 200. The connection mechanism 110 connects the vena cava to the inlet of the first pump P1 and connects the pulmonary vein to the inlet of the second pump P2. The connection mechanism 120 connects the outlet of the first pump P1 to the pulmonary artery and connects the outlet of the second pump P2 to the aorta. With this configuration, the first pump P1 circulates the blood flow BL1 from the vena cava to the pulmonary artery, and the second pump P2 circulates the blood flow BL2 from the pulmonary vein to the aorta.

[0044] In the event of an abnormality, the connection mechanism 110 and the connection mechanism 120 are in a second state under the control from the ECU 200. The connection mechanism 110 blocks the inflow of blood from the vena cava to the first pump P1 and connects the pulmonary vein to the inlet of the first pump P1. The vena cava is connected to the pulmonary artery through the bypass tube BP. The connection mechanism 120 connects the outlet of the first pump P1 to the aorta. With such a configuration, the blood from the vena cava flows toward the pulmonary artery through the bypass tube BP (blood flow BL1). The first pump P1 circulates the blood flow BL2 from the pulmonary vein to the aorta instead of the second pump P2 that has malfunctioned. Note that a similar function may be realized by other configurations.

[0045] Next, the outputs of the pump unit 100 during normal and abnormal times will be described. The control unit 203 controls the magnitude relationship between the output of the first pump P1, that is, the blood discharge amount per unit time (referred to as "P1 output"), and the output of the second pump P2, that is, the blood discharge amount per unit time (referred to as "P2 output") as follows.

[0046] During normal times, the control unit 203 controls the first pump P1 and the second pump P2 such that P1 output < P2 output. This is because a greater force is required to send blood to the aorta than to the pulmonary artery. During normal times, both the first pump P1 and the second pump P2 are operating. The ECU 200 controls the first pump P1 and the second pump P2 such that the P2 output for the blood flow from the pulmonary vein to the aorta is greater than the P1 output for the blood flow from the vena cava to the pulmonary artery. Thereby, an operation close to that of the heart of the living body can be performed, and the discomfort given to the human body can be reduced.

[0047] In the event of an abnormality, the control unit 203 operates the first pump P1 and stops the second pump P2. Since the determination unit 202 has determined that an abnormality has occurred in the second pump P2 as described above, it is presumed that the second pump P2 is inoperable due to a malfunction or in a state in which the required P2 output cannot be obtained. Furthermore, the control unit 203 switches the states of the connection mechanisms 110 and 120 from the first state to the second state. The control unit 203 also controls the first pump P1 to increase the P1 output to the same level as or higher than the P2 output in the normal state.

[0048] FIG. 7 is a flowchart showing an example of the flow of processing executed by the ECU 200 of the embodiment. First, the determination unit 202 of the ECU 200 determines whether or not an abnormality has occurred in the second pump P2 (step S1). Using the information collected in step S1, the determination unit 202 determines whether or not an abnormality has occurred in the second pump P2 (step S2). If it is determined that an abnormality has occurred in the second pump P2, the control unit 203 of the ECU 200 controls the connection mechanisms 110 and 120 to transition from the first state to the second state, and controls the first pump P1 to increase the P1 output (step S3). If the determination unit 202 determines that there is no abnormality in the second pump P2, the process returns to step S1.

[0049] According to the embodiment described above, the artificial heart device has a first pump P1 and a second pump P2, and the first state in which the inlet of the first pump P1 is connected to the vena cava and the outlet of the first pump P1 is connected to the pulmonary artery, while the inlet of the second pump P2 is connected to the pulmonary vein and the outlet of the second pump P2 is connected to the aorta, respectively; and a second state in which the inlet of the first pump P1 is connected to the pulmonary vein and the outlet of the first pump P1 is connected to the aorta, while the connections between the vena cava and the inlet of the first pump P1 and between the outlet of the first pump P1 and the pulmonary artery are blocked to block the connections between the vena cava and the inlet of the first pump P1 and between the outlet of the first pump P1 and the pulmonary artery ... The system is equipped with connection mechanisms 110 and 120 that can switch between a first state and a second state that connects the first pump P1 to the pulmonary artery, a determination unit 202 that determines whether an abnormality has occurred in the second pump P2, and a control unit 203 that switches the connection mechanisms 110 and 120 from the first state to the second state and increases the output of the first pump P1 when the determination unit 202 determines that an abnormality has occurred in the second pump P2. Therefore, when an abnormality occurs in one of the pumps, necessary functions can be maintained at least temporarily, and blood flow from the pulmonary vein to the aorta can be maintained.

[0050] Although the cardiac function is maintained even in the event of an abnormality according to the embodiment, it is desirable for the patient to recognize that an abnormality has occurred in the pump. For this reason, the transmission processing unit 204 of the ECU 200 may transmit, from the antenna 201, radio waves of information indicating that the determination unit 202 has determined that an abnormality has occurred in the second pump P2. Also, when an abnormality has occurred in the first pump, the first pump P1 cannot perform the above-mentioned operation in the event of an abnormality in place of the second pump, so it is desirable to transmit radio waves of information indicating that an abnormality has occurred in the first pump. The state recognition device 600 that has received the radio waves displays the information or notifies the user P by voice. This allows the user P to recognize the state of the artificial heart device, including the occurrence of an abnormality. Also, the state recognition device 600 may transmit information to a medical center via a network such as the Internet. [Explanation of symbols]

[0051] 100 Pump unit P1: First pump P2: Second pump 101,102...Inlet 103,104...outlet 110,120... Connection mechanism 111,112,113,114,115...hole 116 Casing section 117 Rotating body 121,122,123...hole 124 Casing section 125 Rotating body 200···ECU 201 Antenna 202...Judgment section 203 Control section 204 Transmission processing unit BP ···Bypass pipe

Claims

1. A power supply unit; A pump implanted in the human body; The inlet of the pump is connected to the right atrium or the vena cava, and the outlet is connected to the pulmonary artery, The pump comprises: a discharge unit that causes blood to flow into the inlet and discharges the blood from the outlet; a motor that receives wireless power from the power supply unit to drive the discharge unit; An artificial heart device comprising:

2. A power supply unit; A pump implanted in the human body; The inlet of the pump is connected to the left atrium or the pulmonary vein, and the outlet is connected to the aorta, The early pump is a discharge unit that causes blood to flow into the inlet and discharges the blood from the outlet; a motor that receives wireless power from the power supply unit to drive the discharge unit; An artificial heart device comprising:

3. A power supply unit; A pump implanted in the human body; The inlet of the pump is connected to the left ventricle or the pulmonary vein, and the outlet is connected to the aorta, respectively, or the inlet of the pump is connected to the right ventricle or the vena cava, and the outlet is connected to the pulmonary artery, respectively; Equipped with The early pump is a discharge unit that causes blood to flow into the inlet and discharges the blood from the outlet; a motor that receives wireless power from the power supply unit to drive the discharge unit; An artificial heart device comprising:

4. The power supply unit includes: A battery; a power supply unit that receives power wirelessly and supplies power to the battery; 4. The artificial heart device according to claim 1, further comprising:

5. a cable harness that connects the power supply unit and the battery and supplies power from the power supply unit to the battery; The power supply unit is disposed at a position different from the battery inside the body.

5. The artificial heart device of claim 4.

6. a transmission processing unit that performs processing for wirelessly transmitting information indicating that an abnormality has occurred in the pump to an outside of the body when an abnormality has occurred in the pump; 5. The artificial heart device of claim 4.

7. The battery is housed in a titanium case.

5. The artificial heart device of claim 4.

8. a cable harness that connects the power supply unit and the battery and supplies power from the power supply unit to the battery; The cable harness is further covered with a silicone-based material around the covering.

5. The artificial heart device of claim 4.

Images