Implantable artificial heart

Abstract

The invention discloses an implantable total artificial heart. The prosthetic heart includes a first pump chamber, a second pump chamber, and an actuator disposed between the first pump chamber and the second pump chamber. The actuator is configured to operate between a first operating state and a second operating state. Further, the prosthetic heart includes a plurality of first wires wound around the first pump chamber and the actuator and / or a plurality of second wires wound around the second pump chamber and the actuator. Each of the plurality of first wires and the plurality of second wires is configured to compress the first pump chamber and the second pump chamber in association with operation of the actuator for receiving fluid into and pumping fluid out of the first pump chamber and the second pump chamber. The configuration of the artificial heart is compact, improves durability, and simulates natural movement of human tissue, thereby reducing stress of blood and causing side effects to be reduced.

Description

Technical Field

[0001] The present disclosure generally relates to an artificial heart, and more particularly to an implantable artificial heart. Background Art

[0002] Heart failure is a clinical condition whose symptoms include shortness of breath, lack of energy, swollen ankles, etc. Gradually, severe cases of heart failure include deteriorating health and eventually death due to severe weight loss, muscle atrophy, failure of other organs (especially kidney or liver), impaired immune response, and risk of infection. Usually, heart failure is triggered by impaired pumping function of heart muscle tissue, which leads to reduced blood supply to tissues and organs, thereby insufficient supply of nutrients (especially oxygen) to the body.

[0003] The current treatment of heart failure is mainly based on drugs and cardiac surgical treatment methods such as heart transplantation, heart bypass surgery, etc. Specifically, in drug-based treatments, some drugs have been found to be ineffective or even harmful, and the benefits of drug therapy for severely damaged myocardium are limited. In addition, the mortality rate of patients with heart failure has not changed. Other treatments include cardiac resynchronization therapy. The gold standard treatment for end-stage heart failure is a donor-based heart transplant. Due to the shortage of donor organs, many patients are on the waiting list, but they still cannot receive organs. In addition, despite intensive research in the fields of cell therapy and gene therapy, the clinical application of these therapies seems to be far away.

[0004] In view of the above, artificial hearts configured to replace the functions of the human heart have been studied and developed. Mechanical circulatory support devices are mainly used to support one side of the heart (mainly the left side). These devices can be used as a bridge-to-transplant therapy or a destination therapy. Biventricular heart failure requires assistance or replacement of both ventricles ("total artificial heart"). The traditional total artificial heart is configured as a temporary treatment and implanted as a bridge therapy to overcome the waiting time for heart transplantation. In addition, due to the use of complex medical devices, the configuration of this artificial heart is complicated, thereby limiting the use of the artificial heart as a permanent solution. In addition, the general total artificial heart has biocompatibility issues, which causes blood to interact with rigid components, resulting in undesirable negative side effects, such as the risk of bleeding events and thromboembolic events.

[0005] The present disclosure is intended to overcome one or more of the limitations set forth above or any other limitations associated with devices known in the art. Summary of the invention

[0006] One object is to provide an implantable total artificial heart that is compact, durable, and simulates the natural movement of human tissue, thereby potentially reducing the stress on the blood and resulting in fewer side effects.

[0007] In order to better solve one or more of these problems, in a first aspect of the present disclosure, an implantable total artificial heart (hereinafter referred to as an artificial heart) is provided. The artificial heart includes a first pump chamber, which is defined by a first inlet and a first outlet. In addition, the artificial heart includes a second pump chamber, which is positioned adjacent to the first pump chamber and is defined by a second inlet and a second outlet. In addition, the artificial heart includes an actuator, which is arranged between the first pump chamber and the second pump chamber. The actuator is configured to operate between a first operating state and a second operating state. In addition, the artificial heart includes a plurality of first wires and / or a plurality of second wires, which are wound around the first pump chamber and the actuator, and which are wound around the second pump chamber and the actuator. Each of the plurality of first wires and / or a plurality of second wires is configured to be associated with the operation of the actuator between the first operating state and the second operating state to compress the first pump chamber and / or the second pump chamber, for receiving fluid in the first pump chamber and the second pump chamber and pumping fluid out of the first pump chamber and the second pump chamber. The configuration of the artificial heart helps improve the durability of the artificial heart and simulates the natural movement of human tissue, thereby potentially reducing the stress on the blood and resulting in fewer side effects.

[0008] In one embodiment, the artificial heart includes at least one check valve disposed in each of the first inlet, the first outlet, the second inlet, and the second outlet. The check valve facilitates fluid to selectively flow through the first inlet, the first outlet, the second inlet, and the second outlet based on the operating sequence of the artificial heart.

[0009] In an embodiment, the outer surface of the first pump chamber, the outer surface of the second pump chamber and the outer surface of the actuator define a plurality of channels. Each of the plurality of channels is configured to fix at least one of the plurality of first wires and at least one of the plurality of second wires. In addition, each of the plurality of channels is configured to guide at least one first wire and at least one second wire in association with the operation of the actuator between the first operating state and the second operating state.

[0010] In one embodiment, the first operating state corresponds to a contracted state of the actuator, which is associated with a decompression state of the first pump chamber and the second pump chamber for passively drawing fluid into the first pump chamber and the second pump chamber, and the second operating state corresponds to an expansion of the actuator, which is associated with a compression state of the first pump chamber and the second pump chamber for pumping fluid out of the first pump chamber and the second pump chamber.

[0011] In one embodiment, the first pump chamber and the second pump chamber are made of fluid-tight, non-stretchable materials. These materials help the artificial heart to simulate the work of a natural heart and also improve the durability of the artificial heart.

[0012] In one embodiment, the inner surfaces of the first pump chamber and the second pump chamber that are in contact with the fluid are made of a biocompatible material. When implanted in the body, the biocompatible material helps to reduce complications.

[0013] In one embodiment, an artificial heart includes a pump fluidly coupled to an actuator, wherein the pump is configured to selectively operate the actuator between a first operational state and a second operational state in a pulsatile manner.

[0014] In one embodiment, the artificial heart comprises a control unit communicatively coupled to the pump, wherein the control unit is configured to control actuation of the pump to provide a pulsating flow of driving fluid to the actuator.

[0015] The foregoing summary is illustrative only and is not intended to be limiting in any way. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The present invention is set forth in the appended claims, while covering equivalents of the claims and various modifications routine to those skilled in the art. The disclosure itself, as well as its modes of use, advantages and further objects, will be best understood by reference to the following detailed description of the embodiments when read in conjunction with the accompanying drawings. One or more embodiments will now be described, by way of example only, with reference to the exemplary drawings, wherein like reference numerals represent like elements, and in the drawings:

[0017] Figure 1 A schematic diagram of an implantable artificial heart according to an embodiment of the present disclosure is shown, depicting a first operating state of an actuator.

[0018] Figure 2 Shows Figure 1 A top view of an implantable artificial heart.

[0019] Figure 3 shows a schematic diagram of an implantable artificial heart according to an embodiment of the present disclosure, depicting a second operating state of the actuator;

[0020] Figure 4 Shows Figure 3 A top view of an implantable artificial heart.

[0021] Figure 5a , Figure 5b and Figure 5c A schematic diagram of an implantable artificial heart according to another embodiment of the present disclosure is shown, wherein a first operating state of an actuator is depicted.

[0022] Figure 6a , Figure 6b and Figure 6c A schematic diagram of an implantable artificial heart according to another embodiment of the present disclosure is shown, wherein a first operating state of an actuator is depicted.

[0023] The accompanying drawings depict embodiments of the present disclosure for illustrative purposes only. Those skilled in the art will readily recognize from the following description that alternative embodiments of the structures and methods shown herein may be employed without departing from the principles of the present disclosure described herein. DETAILED DESCRIPTION

[0024] Although the embodiments of the present disclosure may have various modifications and alternative forms, the specific embodiments thereof have been shown by way of example in the accompanying drawings and will be described below. However, it should be understood that this is not intended to limit the present disclosure to the specific forms disclosed, but on the contrary, the present disclosure is intended to cover all modifications, equivalents and alternatives falling within the scope of the present disclosure.

[0025] It should be noted that those skilled in the art will be inspired by this disclosure and modify various features of the implantable artificial heart. Therefore, such modifications are part of this disclosure. Therefore, the accompanying drawings only show those specific details relevant to understanding the embodiments of the present disclosure so as not to obscure the present disclosure due to details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.

[0026] The terms "comprises," "comprising," or any other variation thereof, as used in this disclosure, are intended to cover a non-exclusive inclusion, such that an implantable artificial heart comprising a list of components includes not only those components, but may also include other components not expressly listed or inherent to such a device. In other words, without further limitations, one or more elements in a device introduced by "comprising ... one" does not exclude the presence of other elements or additional elements in the system or device.

[0027] In the following detailed description, embodiments of the present disclosure are explained with reference to the accompanying drawings that form a part of the present disclosure, and these drawings are shown by way of illustration and in the form of specific embodiments in which the present disclosure can be implemented. These embodiments are described in sufficient detail to enable those skilled in the art to implement the present disclosure, and it should be understood that other embodiments may be utilized and may be changed without departing from the scope of the present disclosure. Therefore, the following description should not be understood to be limiting.

[0028] Figure 1 A schematic diagram of an implantable total artificial heart (100) (hereinafter referred to as an artificial heart) is shown. The artificial heart (100) can be implanted in the circulatory system of a human body. The artificial heart (100) can include a first pump chamber (101) and a second pump chamber (102) positioned adjacent to each other. The first pump chamber (101) can be defined with a first inlet (108) and a first outlet (109), and the second pump chamber (102) can be defined with a second inlet (110) and a second outlet (111). The first inlet (108) and the second inlet (110) can be configured to allow a fluid flow to enter the first pump chamber (101) and the second pump chamber (102), respectively. Here, the fluid flow can refer to blood and blood vessels that contribute to the blood circulation in the entire body of the object (i.e., the patient). In addition, the first outlet (109) and the second outlet (111) can be configured to allow a fluid flow to leave the first pump chamber (101) and the second pump chamber (102), respectively. In one embodiment, the first pump chamber (101) and the second pump chamber (102) can be made of a fluid-tight, soft and inextensible material, and the inner surface in contact with the fluid (therefore, blood) can be made of a biocompatible material that can exhibit properties similar to those of human tissue. As an example, the soft inextensible material can be, but is not limited to, braided Goretex (as used in aortic grafts for clinical use), braided Dyneema fibers, etc. The size of the first pump chamber (101) and the second pump chamber (102) of the artificial heart can be customized according to the needs of the object (i.e., the patient). In an illustrated embodiment, the first pump chamber (101) and the second pump chamber (102) include a U-shaped cross-sectional profile, and this cannot be interpreted as a limitation because the first pump chamber (101) and the second pump chamber (102) can have any geometric profile or cross section based on requirements.

[0029] As from Figure 1As is apparent from the figure, the artificial heart (100) may further include at least one check valve (106) disposed in each of the first inlet (108), the first outlet (109), the second inlet (110), and the second outlet (111). The at least one check valve (106) may be selectively operable such that during the flow of fluid into the first pump chamber (101) and the second pump chamber (102), the check valves (106) disposed at the first inlet (108) and the second inlet (110) are configured to be opened, and the check valves (106) disposed at the first outlet (109) and the second outlet (111) are configured to be closed, and vice versa. In one embodiment, the at least one check valve (106) may be passively operated based on the pressure acting on the check valve (106). As an example, when the pressure after the at least one check valve is higher than the pressure before the check valve, the at least one check valve (106) may be closed, and vice versa. In one illustrated embodiment, a check valve is disposed in each of the first inlet (108), the first outlet (109), the second inlet (110), and the second outlet (111). However, this should not be construed as a limitation, as more than one check valve (106) may be disposed in each of the first inlet (108), the first outlet (109), the second inlet (110), and the second outlet (111). As an example, at least one check valve (106) may be, but is not limited to, a biological valve or a mechanical valve for clinical use. In addition, the artificial heart (100) may include an actuator (103), which may be disposed between the first pump chamber (101) and the second pump chamber (102). The actuator (103) may be configured to operate between a first operating state and a second operating state. In one illustrated embodiment, as Figure 1 and Figure 3 As seen in FIG. 1 , the actuator (103) is defined as having a cylindrical profile, and this should not be considered a limitation as the actuator (103) may include any other geometric profile based on the requirements. In one embodiment, the first operating state may correspond to a contracted state of the actuator (103) (e.g., Figure 1 ), and the second operating state may correspond to an expanded state of the actuator (103) (as seen in Figure 2 In one embodiment, the artificial heart (100) may include a pump (not shown in the figure) that may be fluidly coupled to the actuator (103). The pump may be configured to direct a driving fluid (such as medical grade liquid or air) from and into the actuator (103) for operating the actuator (103) to the first operating state and the second operating state, respectively.

[0030] Further references Figure 1, the artificial heart (100) may include a plurality of first wires (104) and a plurality of second wires (105). The plurality of first wires (104) are wound around the first pump chamber (101) and the actuator (103), and the plurality of second wires (105) are wound around the second pump chamber (102) and the actuator (103). In one embodiment shown, Figure 2 and Figure 4 As best seen in the figure, the plurality of first wires (104) and the plurality of second wires (105) are wound around the first pump chamber (101), the second pump chamber (102), and the actuator (103) in a crisscross configuration, wherein the plurality of first wires (104) and the plurality of second wires (105) cross at portions between the first pump chamber (101) and the actuator (102) and between the second pump chamber (102) and the actuator (102). However, this should not be construed as a limitation, as the plurality of first wires (104) and the plurality of second wires (105) can be wound around the first pump chamber (101), the second pump chamber (102), and the actuator (103) in any configuration such as a spiral, etc., based on requirements. The plurality of first wires (104) and the plurality of second wires (105) can be configured to selectively compress and decompress the first pump chamber (101) and the second pump chamber (102) corresponding to the operation of the actuator (103) between the first operating position and the second operating position. That is, the plurality of first wires (104) and the plurality of second wires (105) can be configured to decompress the first pump chamber (101) and the second pump chamber (102) when the actuator (103) is in the first operating position (i.e., the contracted state) for passively sucking the fluid into the first pump chamber (101) and the second pump chamber (102). In addition, the plurality of first wires (104) and the plurality of second wires (105) are configured to compress the first pump chamber (101) and the second pump chamber (102) when the actuator (103) is in the second operating position (i.e., the expanded state) for pumping the fluid out of the first pump chamber (101) and the second pump chamber (102).

[0031] In one embodiment, the first pump chamber (101), the second pump chamber (102) and the actuator (103) may define a plurality of channels (107) on the outer surface. As an example, the plurality of channels (107) may be, but are not limited to, slots, grooves, passages, tubes, etc. The plurality of channels (107) may be configured to fix at least one first wire of the plurality of first wires (104) and at least one second wire of the plurality of second wires (105). In addition, the plurality of channels (107) may be configured to guide at least one first wire and at least one second wire in association with the operation of the actuator (103) between the first operating state and the second operating state to selectively compress and decompress the first pump chamber (101) and the second pump chamber (102), thereby generating a pulsating fluid flow.

[0032] In one embodiment, the artificial heart (100) may include a control unit (not shown in the figure) that may be communicatively coupled to the pump. The control unit may be configured to control the operation of the pump to provide a pulsating flow of driving fluid to the actuator (103). This configuration helps the artificial heart (100) simulate the heartbeat of a natural human heart.

[0033] In one embodiment, the first pump chamber (101) and the second pump chamber (102) can be used as the right ventricle of a human heart, and the second pump chamber (102) can be used as the left ventricle of a human heart, and the actuator (103) can be used as a diaphragm. The actuator (103) can be operated between its first operating position and second operating position at a desired interval, so that the first pump chamber (101) and the second pump chamber (102) are decompressed and compressed corresponding to the operating interval of the actuator (103), thereby simulating the pulsation of a natural heart.

[0034] Unlike a general total artificial heart that employs heavy machined parts, the configuration of the artificial heart (100) of the present disclosure makes the artificial heart (100) compact.

[0035] In one embodiment, the first pump chamber (101) and the second pump chamber (102) may include an inner layer or an outer layer. The inner layer that may contact the fluid may be made of a biocompatible material, and the outer layer may be made of a soft, non-stretchable material.

[0036] In one operational embodiment, Figure 1As shown in the figure, the actuator (103) can be in a first operating position, wherein the actuator (103) is in a contracted state. Due to the contracted state of the actuator (103), a plurality of first wires (104) and a plurality of second wires (105) can be in a relaxed state, thereby applying a minimum pressure or no pressure on the first pump chamber (101) and the second pump chamber (102). This makes the first pump chamber (101) and the second pump chamber (102) in a decompressed state, thereby facilitating the passive suction of the fluid into the first pump chamber (101) and the second pump chamber (102). The fluid is passively sucked into the first pump chamber (101) and the second pump chamber (102) through the first inlet (108) and the second inlet (110), respectively, wherein the check valve (106) arranged in the first inlet (108) and the second inlet (110) is opened, and the check valve (106) arranged in the first outlet (109) and the second outlet (111) is closed. As an example, when the artificial heart (100) is installed in a human body, the first pump chamber (101) can be configured to pump deoxygenated blood from the body, and the second pump chamber (102) can be configured to pump oxygenated blood from the lungs. In one embodiment, the first pump chamber (101) and the second pump chamber (102) can be continuously in a decompressed state until the fluid is filled in the first pump chamber (101) and the second pump chamber (102). When the first pump chamber (101) and the second pump chamber (102) are filled with fluid, the actuator (103) can be operated from the first operating position to the second operating position (such as Figure 3 ).

[0037] In the second operating position, the actuator (103) can expand so that the surface area of ​​the actuator (103) increases. This can cause the plurality of first wires (104) and the plurality of second wires (105) to be tensioned to apply force to the first pump chamber (101) and the second pump chamber (102), respectively. Due to the application of force, the first pump chamber (101) and the second pump chamber (102) can undergo compression, thereby applying pressure to the fluid in the first pump chamber (101) and the second pump chamber (102). This causes the stored fluid to be pumped out of the first pump chamber (101) and the second pump chamber (102). As an example, in a state where the artificial heart (100) is installed in a human body, the first pump chamber (101) can be configured to pump deoxygenated blood into the lungs, and the second pump chamber (102) can be configured to pump oxygenated blood to the body. Furthermore, the selective compression and decompression operations of the first pump chamber (101) and the second pump chamber (102) may occur continuously for pumping and pumping fluid (ie, blood) in a pulsating manner, thereby simulating the function of a natural heart.

[0038] Now go to Figure 5a to Figure 5c , which shows a schematic diagram of an implantable artificial heart (100) according to another embodiment of the present disclosure. Figure 4 a to Figure 4 As shown in FIG. 3 , the implantable artificial heart (100) may include a first pump chamber (101), a second pump chamber (102), and an actuator (103) disposed between the first pump chamber (101) and the second pump chamber (102). In addition, the artificial heart (100) may include a plurality of wires wound around the first pump chamber (101) and the actuator (103), and a plurality of second wires (105) wound around the actuator (103) and the second pump chamber (102). Figure 5a , Figure 5b and Figure 5c As seen in , the actuator (103) may include a circular profile, a triangular profile, an inverted triangular profile, and any other geometric profile based on requirements. Figure 5a to Figure 5c The working mode of the artificial heart (100) described in the embodiment is combined with Figures 1 to 4 The artificial heart (100) described works in a similar manner.

[0039] Reference now Figures 6a to 6c , which shows a schematic diagram of an implantable artificial heart (100) according to another embodiment of the present disclosure. Figures 6a to 6c As shown in , the implantable artificial heart (100) may include a first pump chamber (101), a second pump chamber (102), and an actuator (103) disposed between the first pump chamber (101) and the second pump chamber (102). In addition, the artificial heart (100) may include a plurality of wires wound around the first pump chamber (101) and the actuator (103), and a plurality of second wires (105) wound around the actuator (103) and the second pump chamber (102). As shown in Figures 6a to 6c As seen in FIG. 1 , the first pump chamber ( 101 ) and the second pump chamber ( 102 ) may include a bowl-shaped profile, an inverted triangular profile, and a triangular profile. Figures 6a to 6c The working mode and combination of the artificial heart (100) depicted in Figures 1 to 4 The artificial heart (100) described works in a similar manner.

[0040] Examples:

[0041] Various experiments have been conducted on the implantable total artificial heart of the present disclosure. Several in vitro tests were conducted on the implantable total artificial heart. In an exemplary iteration of these tests, it was found that the implantable total artificial heart could pump at a cardiac output of 5.7 l / min under normal hemodynamic conditions in vitro. It was also found that the beat rate was in the range of between 60 bpm and 80 bpm. In addition, it was also noted that the implantable total artificial heart is related to preload, that is, the stroke volume (the amount of blood pumped from the ventricle of the implantable total artificial heart per beat) increases when the preload increases, and this is comparable to the natural human heart. In addition, we also found that the implantable total artificial heart is related to afterload to a certain extent. Afterload is the pressure that the heart must overcome to eject blood during ventricular contraction.

[0042] In vitro experiments have been performed on implantable total artificial hearts in a simulated circulatory loop (MCL) developed based on a wind-kessel model that simulates various systemic and pulmonary afterloads and preloads of the human heart, as well as various systemic and pulmonary peripheral resistances and compliances.

[0043] In another iteration, also in order to determine the preload sensitivity of implantable total artificial heart under preload in the range of 4mmHg to 18mmHg. Use MCL setting filled with tap water to adjust preload. Place a tube as a shunt between two preload tanks to keep the same liquid level in the two tanks. After each test of a preload setting, by adding more tap water to the preload tank, increase the preload pressure with an increment of 1mmHg. For each preload value, three runs are performed with a beating rate of 60 beats per minute (BPM) and a contraction time of 0.35 seconds, and each run consists of 25 to 30 beats. Pulmonary afterload and systemic afterload remain constant at an average pressure of 25mmHg and 90mmHg, respectively. Since stroke volume changes under different preload values, the resistance valve is adjusted during the experiment to maintain a constant afterload. For each run in three runs, the average stroke volume is calculated based on 6 beats, so for each preload increment, a total of 18 beats are calculated. In order to determine the afterload sensitivity of the implantable total artificial heart, the MCL setting filled with tap water has been used to adjust the range of the average left afterload between 50mmHg and 120mmHg. A shunt is arranged between two preload tanks, and the total volume of water in the system remains constant. The test is carried out in a single run, and during the test, the left afterload is increased in increments of about 10mmHg by adjusting the resistance element that simulates the system resistance. For each afterload, about 30 to 40 beats are recorded under the conditions of a beat rate of 60 beats per minute and a contraction time of 0.3 seconds (the time period when ventricular contraction occurs). The preload (6mmHg) and the pulmonary resistance element remain constant. The average stroke volume is calculated based on 3 sections of 6 beats per section, so each afterload increment corresponds to a total of 18 beats. A variable heart beat rate test has also been carried out to determine the effects of various beat rates (30BPM to 100BPM) on cardiac output. The MCL was filled with tap water and a shunt was placed between the two front load tanks. The test was started at 60 BPM and 0.30 s contraction time, which is the optimal condition for pulsatile pressure, stroke volume and the afterload generated. The test determined the settings of pulmonary and systemic peripheral resistance. Then, we tested all beat rates (30 BPM to 100 BPM and 0.30 s contraction time) without changing the resistance. The average stroke volume was calculated based on 10 beats per run.

[0044] Under physiological hemodynamic conditions (Table 1, Figure 1), found that the implantable total artificial heart can achieve a maximum cardiac output of 5.7 L / min on the left and 5.0 L / min on the right. The intention is to intentionally give the left ventricle a higher cardiac output compared to the right ventricle's cardiac output. This is due to the higher aortic pressure (left afterload) compared to the pulmonary artery pressure (right afterload) and the shunting of some of the blood ejected by the left ventricle directly back to the left ventricle via the bronchial circulation. By adjusting the length of the wire surrounding the right ventricle, the left cardiac output can be increased relative to the right cardiac output.

[0045] The human heart balances its cardiac output via the Frank-Starling mechanism. When venous return (preload) in the human heart increases, its contractile force increases, resulting in an increase in stroke volume. An implantable total artificial heart needs to have a similar mechanism to allow for increased cardiac output when preload increases, otherwise serious complications can occur. Ideally, this mechanism should work passively to avoid the use of bulky hardware and sensors that are prone to failure. In implantable total artificial hearts, soft materials have been used and are designed to cause the ventricles to incompletely expand and fill at the end of diastole during normal operation, essentially increasing the compliance of the ventricles. It has been found that implantable total artificial hearts are sensitive to changes in preload and passively increase stroke volume ( ) when venous return increases. Figures 7a to 7f ). For every 1 mmHg increase in preload, the implantable total artificial heart ejects an additional 198 ml / min. This is within the range of the native human heart (241 ml / min / mmHg) (see Figures 7a to 7f ). For every 1 mmHg increase in afterload, the left ventricle reduces ejection by 20 ml / min, which is lower than the afterload sensitivity of the human heart (41 ml / min / mmHg). The lower the afterload sensitivity of the implantable total artificial heart, the better it can ensure sufficient cardiac output within a wide afterload range. The relevant experimental results obtained have been Figures 7a to 7f Recorded in the form of a graphical representation.

[0046] Figure 7a Pressure curves measured during operation of an implantable total artificial heart in a simulated circulatory circuit are shown. AOP = aortic pressure, PAP = pulmonary artery pressure, LAP = left atrial pressure, RAP = right atrial pressure. Figure 7b The cardiac output curve measured during operation of an implantable total artificial heart in a simulated circulatory circuit is shown. LCO = Left cardiac output, RCO = Right cardiac output. Figure 7c The relationship between varying left preload and left stroke volume measured during operation of an implantable total artificial heart in a simulated circulatory circuit is shown (solid line), similar to native heart preload sensitivity (dashed line). Figure 7dShown is the relationship between varying systemic afterload and left stroke volume measured during operation of an implantable total artificial heart in a simulated circulatory circuit (solid line) compared to that of a native heart (dashed line). Figure 7e The relationship between the varying beat rate and left stroke volume measured during operation of an implantable total artificial heart in a simulated circulatory circuit is shown. The stroke volume decreases as the beat rate increases. Figure 7f The relationship between the varying beat rate and left heart output measured during operation of an implantable total artificial heart in a simulated circulatory circuit is shown. Optimal performance is obtained between 60 bpm and 80 bpm.

[0047] In addition, a study was conducted to confirm the effect of wire arrangement on ventricular output during various tests in a dual-circulation simulation circuit. By changing the wire length of the right ventricle, the right stroke volume of the implantable total artificial heart is reduced compared to the left stroke volume of the implantable total artificial heart. Three prototypes that are exactly the same as each other have been tested. First, we have tested these prototypes with similar wire configurations, and the wire lengths of the two ventricles are similar. Each ventricle has 5 parallel-extending wires that are spaced at similar distances. Under physiological conditions, we tested these prototypes in a dual-circulation simulation circuit, where we noticed that the measured stroke volume of each prototype was different (Table 1). For these three prototypes, the left stroke volume was 76ml, 68ml, and 91ml, respectively, and the right stroke volume was 84ml, 76ml, and 125ml, respectively. In addition, it should be noted that for the left and right ventricles with similar wire configurations, the right ventricular output of all three prototypes is greater than the left ventricular output. By relaxing the wire in the right ventricle, the right stroke volume was reduced. This will allow the right ventricle to fill completely and reduce ejection. We found that we could successfully reduce the right stroke volume to 79 ml, 66 ml, and 83 ml in the relaxed wire condition (Table 1). By relaxing the wire in the right ventricle, the left stroke volume was increased in all cases to 79 ml, 84 ml, and 95 ml, respectively (Table 1).

[0048]

[0049] SV = stroke volume. L = left. R = right. CO = cardiac output. Aft = afterload.

[0050] Table 1

[0051] For almost all plural and / or singular terms used herein, those skilled in the art can change the plural to the singular and / or the singular to the plural when it is appropriate for the context and / or application. For clarity, various singular / plural arrangements may be explicitly set forth herein.

[0052] Those skilled in the art will understand that, in general, the terms used herein, and particularly in the appended claims (e.g., the bodies of the appended claims), are generally intended to be "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "comprising" should be interpreted as "including but not limited to," etc.). Those skilled in the art will also understand that if a specific number of an introduced claim recitation is intended, such intent will be explicitly recited in the claim, and in the absence of such a recitation, no such intent is present. For example, to aid understanding, the appended claims may contain the use of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, even when the same claim contains the introductory phrases "one or more" or "at least one" and an indefinite article such as "a" or "an" (e.g., "a" and / or "an" should generally be interpreted as meaning "at least one" or "one or more"), the use of such phrases should not be interpreted as implying that the introduction of a claim recitation by the indefinite article "a" or "an" limits any particular claim containing such introduced claim recitation to an invention containing only one such recitation; the same applies to the use of definite articles to introduce claim recitations. In addition, even if a specific number of introduced claim recitations is explicitly recited, those skilled in the art will recognize that such recitation should generally be interpreted as meaning at least the recited number (e.g., the unmodified recitation of "two recitations" in the absence of other modifiers generally means at least two recitations, or two or more recitations). Furthermore, in those cases where a convention similar to “at least one of A, B, and C, etc.” is used, generally, such construction is intended to be a convention in the sense understood by those skilled in the art (e.g., “a system having at least one of A, B, and C” would include, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or both A, B, and C, etc.). In those cases where a convention similar to “at least one of A, B, or C, etc.” is used, generally, such construction is intended to be a convention in the sense understood by those skilled in the art (e.g., “a system having at least one of A, B, or C” would include, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or both A, B, and C, etc.). Those skilled in the art will also understand that, in practice, any transitional conjunction and / or phrase presenting two or more alternative terms, whether in the specification, claims, or drawings, should be understood to contemplate the possibility of including one, either, or both of these terms.For example, the phrase "A or B" will be understood to include the possibilities of "A" or "B" or "A and B." Although various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for illustrative purposes and are not intended to be limiting.

[0053] Reference numerals:

[0054]

[0055]

Claims

1. An implantable total artificial heart (100), the artificial heart (100) comprising: A first pump chamber (101) defining a first inlet and a first outlet; a second pump chamber (102) positioned adjacent to the first pump chamber (101) and defining a second inlet and a second outlet; an actuator (103) disposed between the first pump chamber (101) and the second pump chamber (102), wherein the actuator (103) is configured to operate between a first operating state and a second operating state; a plurality of first wires (104) wound around the first pump chamber (101) and the actuator (103); and / or A plurality of second wires (105) wound around the second pump chamber (102) and the actuator (103); Wherein, each of the plurality of first wires (104) and / or the plurality of second wires (105) is configured to selectively compress and decompress the first pump chamber (101) and / or the second pump chamber (102) in association with the operation of the actuator (103) between the first operating state and the second operating state, so as to draw fluid into the first pump chamber (101) and the second pump chamber (102) and pump fluid out of the first pump chamber and the second pump chamber.

2. The artificial heart (100) according to claim 1, comprising at least one check valve (106) arranged in each of the first inlet, the first outlet, the second inlet and the second outlet.

3. The artificial heart (100) according to claim 1, wherein: The outer surface of the first pump chamber (101), the outer surface of the second pump chamber (102), and the outer surface of the actuator (103) define a plurality of channels (107).

4. The artificial heart (100) according to claim 3, wherein: Each channel of the plurality of channels (107) is configured to secure at least one first wire of the plurality of first wires (104) and at least one second wire of the plurality of second wires (105).

5. The artificial heart (100) according to claim 3, wherein: Each channel of the plurality of channels (107) is configured to guide at least one first wire and at least one second wire in association with operation of the actuator (103) between the first operating state and the second operating state.

6. The artificial heart (100) according to claim 1, wherein: The first operating state corresponds to a contracted state of the actuator (103), and the first operating state is associated with a decompressed state of the first pump chamber (101) and the second pump chamber (102) for passively sucking fluid into the first pump chamber (101) and the second pump chamber (102).

7. The artificial heart (100) according to claim 1, wherein: The second operating state corresponds to an expanded state of the actuator (103), and the second operating state is associated with a compressed state of the first pump chamber (101) and the second pump chamber (102) for pumping fluid out of the first pump chamber (101) and the second pump chamber (102).

8. The artificial heart (100) according to claim 1, wherein: The first pump chamber (101) and the second pump chamber (102) are configured to store fluid.

9. The artificial heart (100) according to claim 1, wherein: The first pump chamber (101) and the second pump chamber (102) are made of a fluid-tight, inextensible material.

10. The artificial heart (100) according to claim 1, wherein: The inner surface of the first pump chamber (101) and the inner surface of the second pump chamber (102) are made of biocompatible materials.

11. The artificial heart (100) according to any one of the preceding claims, comprising a pump, the pump being fluidically coupled to the actuator (103), wherein: The pump is configured to selectively operate the actuator (103) between the first operating state and the second operating state in a pulsating manner.

12. The artificial heart (100) according to any one of the preceding claims, comprising a control unit, the control unit being communicatively coupled to the pump, wherein: The control unit is configured to control the actuation of the pump to provide a pulsating flow of driving fluid / driving gas to the actuator (103).

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