Next-generation total artificial heart

Abstract

A total artificial heart system comprises: at least one artificial ventricle coupled to (or capable of being coupled to) a chamber or a blood vessel of a human heart and at least one drive system coupled to the artificial ventricle, the drive system comprising at least one implanted electric motor. The drive system causes the artificial ventricle to contract and expand.

Description

Technical Field

[0001] The subject matter described herein relates to devices, systems, and methods for portable actuation of an electric motor driven artificial heart. Background Art

[0002] The heart is the muscle that drives the cardiovascular system of humans and other organisms. As a pump, the heart moves blood throughout the body to supply oxygen, nutrients, hormones, and remove waste products. Blood follows two separate paths in the body, the so-called pulmonary circuit and the systemic circuit. In the pulmonary circuit, the heart first pumps blood to the lungs to release carbon dioxide and bind oxygen before returning to the heart. Thus, oxygenated blood is continuously supplied to the heart. In the systemic circuit, the longer of the two, the heart pumps oxygenated blood to the rest of the body to supply oxygen and remove carbon dioxide, a byproduct of metabolic functions performed throughout the body. The heart supplies blood to both circuits through pulses generated by the orderly muscular contractions of its walls.

[0003] To keep blood flowing through these two separate circuits, the human heart has four different chambers that work in pairs. Figure 1 As shown, the heart 10 includes a right atrium 12, a right ventricle 14, a left atrium 16, and a left ventricle 18. The pair of chambers, the right ventricle and the left atrium, are directly connected to the pulmonary circuit, wherein deoxygenated blood from the body is pumped from the right ventricle 14 to the lungs, where it is oxygenated and then pumped back to the left atrium 16.

[0004] In the systemic circuit, another pair of chambers pumps oxygenated blood through the body's organs, tissues, and bones. Blood moves from the left atrium 16 (flowing from the lungs to the left atrium) to the left ventricle 18, which in turn pumps blood throughout the body and all the way back to the right atrium 12. The blood then flows to the right ventricle 14, where the cycle repeats. In each circuit, blood enters the heart through the atria and leaves the heart through the ventricles.

[0005] Thus, the ventricles 14, 18 are essentially two separate pumps that work together to move blood through two circulatory circuits. Four check valves control the flow of blood within the heart and prevent flow in the wrong direction. The tricuspid valve 20 controls the flow of blood from the right atrium 12 into the right ventricle 14. Similarly, the mitral valve 22 controls the flow of blood from the left atrium 16 into the left ventricle 18. Two semilunar valves (the pulmonary semilunar valve 24 and the aortic semilunar valve 26) control the flow of blood out of the heart to the lungs and the systemic circuits, respectively. Thus, in each complete cycle, blood is pumped from the right ventricle 14 through the pulmonary semilunar valve 24 to the lungs and back to the left atrium 16. The blood then flows through the mitral valve 22 to the left ventricle 18, which in turn pumps it to the body through the aortic semilunar valve 26 and back to the right atrium 12. Finally, the blood flows back to the right ventricle 14 through the tricuspid valve 20 and the cycle repeats.

[0006] As the heart muscle squeezes each ventricle, it acts as a pump that exerts pressure on the blood, pushing it out of the heart and through the body. Blood pressure, an indicator of heart function, is measured when the heart muscle contracts and relaxes. So-called systolic pressure is the maximum pressure that the blood exerts on the artery walls as the heart's left ventricle contracts to force blood through the arteries in the systemic circulation circuit. So-called diastolic pressure is the lowest pressure on the blood vessel walls as the left ventricle relaxes and refills with blood. Healthy blood pressure is considered to be about 120 millimeters of mercury systolic and 80 millimeters of mercury diastolic (often expressed as 120 / 80).

[0007] Because the function of the circulatory system is to serve the biological needs of all body tissues (i.e., to deliver nutrients to tissues, carry waste away, distribute hormones from one part of the body to another, and generally maintain a proper environment for optimal function and survival of tissue cells), the rate at which blood is circulated by the heart is a key aspect of its function. The heart has a built-in mechanism (the so-called Frank-Starling mechanism) that allows it to automatically pump out no matter how much blood is flowing in. This cardiac output in a healthy human can vary from about 4 liters to about 15 liters per minute (LPM), and the heart rate can vary from about 50 beats per minute to about 180 beats per minute, depending on the activity the person is engaged in.

[0008] Several artificial devices have been developed over the years to supplement or replace the function of a patient's failing heart. Typically, these artificial devices consist of pumps designed to replicate the pumping function required of the left and right ventricles of the human body. One method of actuating these pumps is by pneumatic action of an external mechanism. For example, see U.S. Patents Nos. 4,611,578 and 5,766,207. Periodic pulses of compressed air drive the pump at the desired pressure and cardiac output rate. A moderate vacuum can be applied between pulses to allow the ventricles to refill more quickly with blood flowing from the corresponding atria.

[0009] The pneumatic drives used to drive all artificial hearts to date are cumbersome and inadequate to provide the patient with any degree of independent mobility. They use a compressor, a vacuum pump, and a tank of air connected to an electric valve, all of which results in a large, heavy device that can only be transported on wheels and with considerable effort. As a result, many attempts have been made over the past two decades to produce portable drives for these devices. However, due to the required functions and the complexity of the hardware required to produce them, pneumatic heart drives remain bulky, require frequent maintenance, and often provide air pulses that do not match the performance of the larger drives they are intended to replace. Even at the currently achieved weights of approximately 15 pounds and dimensions of approximately 0.7 cubic feet, pneumatic drives remain cumbersome and are essentially not portable for patients kept alive by an artificial heart.

[0010] Essentially, a portable driver needs to be reliable, durable, easy to use, and simple enough in design to be affordable. Unfortunately, each of these requirements leads to design complexity, which in turn results in a device that is not small and lightweight enough to be managed in the patient's hands. In addition, it is critical that the pneumatic driver be able to provide the correct pressure balance between the left and right ventricles of the artificial heart to ensure that the pulmonary and systemic circuits have appropriate operating pressures regardless of the operating speed. Typically, this requires that the driver be able to operate to maintain an average right atrial pressure of approximately 9 mmHg, an average pulmonary artery pressure of approximately 35 mmHg, a left atrial pressure of approximately 10 mmHg, and an average aortic pressure of approximately 95 mmHg.

[0011] To date, this need to provide different operating pressures to the left and right chambers (ventricles) of an artificial heart device has not been met by a simple design suitable for a portable actuator. For example, the blood pump described in U.S. Patent No. 4,611,578 includes a configuration in which two reciprocating pistons in a common cylinder can be operated alternately to provide redundancy, or independently to actuate two separate pneumatic blood pumps. The patent does not address this problem, but it describes a complex control system that could supposedly be used to provide the correct operating pressure for each chamber of the artificial heart. However, although described as portable, the complex and multi-component structure of the device necessarily requires a relatively heavy and large device. The commercially available module weighs about 25 pounds and has a volume of about 0.6 cubic feet.

[0012] U.S. Patent No. 5,766,207 describes another portable pneumatic driver for a ventricular assist device that can also be used in an artificial heart. A single pump of this invention can be used to drive both ventricles of the artificial heart, but only at the same pressure and volume flow rate. Therefore, even if modified to meet the other requirements of a portable artificial heart driver, this device is not suitable as a replacement for the fixed modules currently in use.

[0013] In one or more lighter options, the system may include a portable housing weighing approximately fifteen (15) pounds and including one or more compressors that serve as the pneumatic system driver. Because this arrangement involves pushing pulses of air in and out of the artificial heart through tubes, high fluid and / or back pressure losses occur, resulting in limited battery life (i.e., due to the high amperage or current drawn by the compressor). For example, in one or more systems, the device operates for approximately two hours before the battery needs to be replaced or recharged. In addition, the patient is required to carry the system, which limits the activities that the patient may be able to perform since at least one hand or arm must be used to carry the system. Such a system may also include hundreds of individual components, which may have an impact on the reliability of the system. In addition, in order to mimic the displacement of blood, the volumetric airflow through the system needs to be determined (which itself has uncertainties).

[0014] Other systems use an impeller (or a rotating pumping device) to directly pressurize and pump the blood. However, the impact and / or contact between the impeller and the blood can create high shear stresses that can damage the blood.

[0015] Therefore, current options available to patients do not meet the desired characteristics of providing a mobile, highly reliable, lightweight, size-manageable, and portable system for patients in need of a heart transplant. Summary of the invention

[0016] The presently disclosed embodiments include devices, systems, and methods for implementing a next generation total artificial heart that provides enhanced patient flexibility and ease of use. The next generation total artificial heart includes artificial ventricles that are connected to existing chambers and / or blood vessels of the human heart. Each artificial ventricle is connected to a drive system that includes an electric motor implanted in the patient's chest. The electric motor drives a cam and follower system for expanding and contracting the artificial ventricle. One or more sets of wires connect the implanted electric motor (inside the patient's body) to an external power source (outside the patient's body) that is lightweight, easy to carry or wear, and easy to operate.

[0017] In one aspect, the present invention relates to a total artificial heart system, comprising: a right artificial ventricle coupled to a pulmonary artery; a left artificial ventricle coupled to a left atrium; a first drive system coupled to the right artificial ventricle, the first drive system comprising a first implanted motor; and a second drive system coupled to the left artificial ventricle, the second drive system comprising a second implanted motor.

[0018] In some embodiments, the system includes a first lead coupling the first implanted motor to the external power source; and a second lead coupling the second implanted motor to the external power source.

[0019] In some embodiments, the external power source is external to the patient's body.

[0020] In some embodiments, each of the right artificial ventricle, the left artificial ventricle, the first drive system, and the second drive system are inside the patient's body.

[0021] In some embodiments, a portion of the first lead is inside the patient's body and a portion of the first lead is outside the patient's body.

[0022] In some embodiments, the first drive system includes a stator assembly including at least one housing.

[0023] In some embodiments, the first drive system further includes a rotor cam disposed around the at least one housing of the stator assembly, and the rotor cam is electrically coupled to the stator assembly.

[0024] In some implementations, the system includes a cam follower mechanically coupled to the stator assembly and the rotor cam.

[0025] In some embodiments, a rotor cam functions as both a cam in a cam and follower system and as a rotor in a motor assembly.

[0026] In some embodiments, the rotor cam includes at least one permanent magnet.

[0027] In some embodiments, the rotor cam, stator assembly and / or cam follower are coated.

[0028] In some embodiments, the coating comprises at least one biocompatible material.

[0029] In some embodiments, the coating comprises a segmented polyurethane solution, silicone rubber, thermoplastic elastomer (TPE), and / or polyvinyl chloride (PVC).

[0030] In some embodiments, the right artificial ventricle and / or the left artificial ventricle comprises a segmented polyurethane solution, silicone rubber, thermoplastic elastomer (TPE) and / or polyvinyl chloride (PVC).

[0031] In some embodiments, the first implanted motor and the second implanted motor comprise brushless direct current (BLDC) motors.

[0032] In another aspect, the present invention relates to a total artificial heart system, comprising:

[0033] At least one artificial ventricle capable of being coupled to a chamber and / or blood vessel of a human heart. The system also includes at least one drive system coupled to the artificial ventricle and including at least one implanted motor. The drive system causes the artificial ventricle to contract and expand.

[0034] In some embodiments, the drive system includes at least one cam and follower system.

[0035] In some embodiments, the system includes an external power source and at least one lead coupling the implanted motor to the external power source.

[0036] In some embodiments, the external power supply includes a control interface that allows the patient to adjust the cardiac output of the total artificial heart system.

[0037] In another aspect, the present invention relates to a total artificial heart system, comprising:

[0038] At least one artificial ventricle connectable to a chamber and / or blood vessel of a human heart; at least one drive system coupled to the artificial ventricle and comprising at least one implanted electric motor; and at least one diaphragm defining a boundary between the artificial ventricle and the drive system.

[0039] In some embodiments, on the ventricle side, the diaphragm contacts the body's blood, and on the drive system side, the diaphragm contacts air.

[0040] In another aspect, the present invention relates to a drive system for a total artificial heart, comprising: a stator assembly; a rotor cam mechanically and electrically coupled to the stator assembly; and a cam follower mechanically coupled to the stator assembly and the rotor cam.

[0041] In some embodiments, the system includes at least one spring coupling the cam follower to the stator assembly.

[0042] In some embodiments, the stator assembly includes a housing having a shaped cross-section. The cam follower includes a shaft having a shaped cross-section that matches the shaped cross-section of the housing, and the shaft is disposed within the housing.

[0043] In some embodiments, the shaft moves longitudinally within the housing.

[0044] In some embodiments, the shaped cross-section of the housing and the shaft includes at least one of a triangular cross-section, a square cross-section, an elliptical cross-section, a pentagonal cross-section, a hexagonal cross-section, and a rectangular cross-section.

[0045] In some embodiments, the rotor cam includes: a central hole concentric with a centerline of the rotor cam; and a ramp radially disposed around the central hole.

[0046] In some embodiments, the ramp includes at least one drop-off.

[0047] In some embodiments, the ramp includes an inclined portion.

[0048] In some embodiments, the ramp includes a flat portion disposed between the inclined portion and the descending portion.

[0049] In some embodiments, the cam follower includes at least one tooth extending toward the rotor cam and engaging the ramp.

[0050] In some embodiments, the rotor cam includes neodymium iron boron (ND-Fe-B), iron, cobalt, samarium cobalt (SM-Co), aluminum, alnico, bonded Nd-Fe-B, magnetite, ceramic (hard ferrite), ferrite, gadolinium, one or more rare earth elements, strontium, barium and / or iron (III) oxide.

[0051] In some embodiments, the system includes at least one proximity sensor disposed within the stator assembly and / or the cam follower. The proximity sensor detects a position of the cam follower relative to the stator assembly.

[0052] In some embodiments, the system includes at least one damper disposed within the housing.

[0053] In some embodiments, the system includes at least one pressure sensor disposed on or within the stator assembly and / or the rotor cam.

[0054] In some embodiments, the rotor cam includes a central bore, the stator assembly includes a cylindrical housing, and the cylindrical housing is disposed within the central bore such that the rotor cam extends circumferentially around the cylindrical housing and radially outward.

[0055] In some embodiments, the system includes a retaining rim disposed about a top portion of the cylindrical housing that allows the rotor cam to rotate about the cylindrical housing while preventing the rotor cam from translating longitudinally.

[0056] In some embodiments, the stator assembly includes a cylindrical housing, the rotor cam is disposed around the cylindrical housing, and rotation of the rotor cam around the cylindrical housing causes a height change of the cam follower.

[0057] In some embodiments, the cam follower is coupled to at least one artificial ventricle, and a change in height of the cam follower causes the drive system to contract or expand the artificial ventricle to which it is coupled.

[0058] In another aspect, the present invention relates to a drive system for a total artificial heart, comprising: at least one stator assembly; at least one rotor cam coupled to the stator assembly; at least one cam follower coupled to the rotor cam; and at least one artificial ventricle coupled to the cam follower. A change in height of the cam follower causes the artificial ventricle to expand.

[0059] In some embodiments, the amplitude of expansion of the artificial ventricle is inversely proportional to the rotational speed of the rotor cam.

[0060] In another aspect, the present invention relates to an electric motor comprising: an inner stator housing; a plurality of winding groups arranged radially outside the inner stator housing; an outer stator housing arranged radially outside the plurality of winding groups; and a rotor arranged radially outside the outer stator housing.

[0061] In some implementations, the motor comprises a brushless direct current (BLDC) motor.

[0062] In some embodiments, the electric motor includes at least one Hall sensor.

[0063] In some embodiments, the electric motor includes at least six (6) sets of windings.

[0064] In some embodiments, each set of windings includes one or more longitudinally aligned conductive coil wires.

[0065] In some embodiments, the inner stator housing comprises a hexagonal housing and the outer stator housing comprises a cylindrical housing.

[0066] In some embodiments, the rotor includes at least one permanent magnet.

[0067] In some embodiments, the permanent magnet includes neodymium iron boron (NDFe-B), iron, cobalt, samarium cobalt (SM-Co), aluminum, alnico, one or more rare earth elements, bonded Nd-Fe-B, magnetite, ceramic (hard ferrite), ferrite, gadolinium, strontium, barium, and / or iron (III) oxide.

[0068] In some embodiments, the electric motor operates at a power level of from about one (1) Watt to about ten (10) Watts.

[0069] In another aspect, the present invention relates to an electric motor system, comprising: a stator assembly, comprising: a circular base; at least one housing extending longitudinally from the circular base; and a plurality of windings arranged radially inside or outside the housing. The electric motor further comprises at least one rotor arranged radially outside the housing.

[0070] In some embodiments, the housing comprises a hexagonal housing disposed radially inwardly of the set of windings.

[0071] In some embodiments, the housing comprises a cylindrical housing disposed radially outwardly of the set of windings.

[0072] In some embodiments, the rotor includes a cam.

[0073] In some embodiments, the system includes at least one power source electrically coupled to the circular base.

[0074] In some embodiments, the power bank includes an integrated control interface operably coupled to the stator assembly.

[0075] In some embodiments, the power bank includes at least one battery disposed within a circular base, and the circular base includes a cylindrical shape.

[0076] In some embodiments, the integrated control interface controls the rotational speed of the rotor.

[0077] In some embodiments, the integrated control interface selectively controls the rotational speed of the rotor within each rotation of the rotor.

[0078] In some embodiments, the integrated control interface selectively adjusts the rotational speed of the rotor within each rotation of the rotor based on the circumferential orientation of the rotor.

[0079] In some embodiments, the integrated control interface selectively adjusts the rotational speed of the rotor from a first rotational speed within a first circumferential orientation range of the rotor to a second rotational speed within a second circumferential orientation range of the rotor.

[0080] In some embodiments, the integrated control interface selectively adjusts the rotational speed of the rotor from a first rotational speed within a first rotor angle range to a second rotational speed within a second rotor angle range.

[0081] In another aspect, the present invention is directed to a cam and follower system comprising: at least one rotor cam rotating about a centerline, the rotor cam comprising at least two angled ramps extending circumferentially around the rotor cam; and at least one cam follower mechanically connected to the rotor cam.

[0082] In some embodiments, the two angled ramps include: at least one outer ramp; and at least one inner ramp disposed at a smaller radius than the outer ramp.

[0083] In some embodiments, the cam follower includes at least two teeth extending toward the rotor cam. Each tooth contacts at least one of the angled ramps.

[0084] In some embodiments, the at least two teeth include exactly two (2) teeth, and the two (2) teeth are circumferentially spaced approximately one hundred eighty (180) degrees apart.

[0085] In some embodiments, each of the outer ramp and the inner ramp includes at least one drop-off.

[0086] In some embodiments, the declines are circumferentially spaced approximately one hundred eighty (180) degrees apart.

[0087] In some embodiments, the system includes at least three (3) teeth and at least three (3) ramps.

[0088] In some embodiments, each of the outer ramp and the inner ramp includes at least one inclined portion.

[0089] In some embodiments, each of the outer ramp and the inner ramp includes at least one flat portion disposed between the inclined portion and the descending portion.

[0090] In some embodiments, each angled portion extends approximately two hundred and seventy (270) degrees circumferentially and each flat portion extends approximately ninety (90) degrees circumferentially.

[0091] In some embodiments, each angled portion extends circumferentially around the rotor cam through a first angle from about three hundred (300) degrees to about three hundred sixty (360) degrees.

[0092] In some embodiments, each flat portion extends circumferentially around the rotor cam through a second angle from about zero (0) degrees to about sixty (60) degrees.

[0093] In some embodiments, the rotor cam includes at least one radial gap disposed radially outside the inner ramp and radially inside the outer ramp.

[0094] In some embodiments, the rotor cam includes a central hole disposed radially inwardly of the inner ramp.

[0095] In some embodiments, the at least two teeth further include exactly three (3) teeth, and the exactly three (3) teeth are circumferentially spaced approximately one hundred twenty (120) degrees from one another.

[0096] In another aspect, the present invention is directed to a cam and follower system comprising: at least one rotor cam that rotates about a centerline, the rotor cam including at least one longitudinally extending wavy lobe; and at least one cam follower mechanically coupled to the rotor cam.

[0097] In some embodiments, the cam follower includes at least one follower lobe having a profile that matches the wavy lobe of the rotor cam.

[0098] In some embodiments, the rotor cam includes a plurality of wave lobes; and the cam follower includes a plurality of follower lobes.

[0099] In some embodiments, the system includes an equal number of wave lobes and follower lobes.

[0100] In some embodiments, the rotor cam includes at least (4) wave lobes; and the cam follower includes at least four (4) follower lobes.

[0101] On the other hand, the present invention relates to a mobile power supply unit for a total artificial heart, comprising: at least one shell; at least two battery ports arranged in the shell; and at least one set of wires electrically coupling the two battery ports to the total artificial heart.

[0102] In some embodiments, a total artificial heart is implanted in a human patient.

[0103] In some embodiments, a lead set electrically couples two battery ports to at least one electric motor implanted in a human patient.

[0104] In some embodiments, the unit includes a communication module disposed within the housing and wirelessly communicatively coupling the mobile power unit to at least one electronic device.

[0105] In some embodiments, the unit includes at least one display screen that displays the heart rate and at least one battery charge level of the total artificial heart.

[0106] In some embodiments, the unit includes a heart rate control module.

[0107] In some embodiments, the user increases or decreases the heart rate of the total artificial heart via the heart rate control module.

[0108] In some embodiments, the unit includes a volume control module.

[0109] In some embodiments, the user increases or decreases the volume of blood pumped by the total artificial heart via the volume control module.

[0110] In another aspect, the present invention relates to a battery charging system for a total artificial heart, comprising: at least one charger housing including at least two battery ports for receiving one or more rechargeable batteries; at least one display screen disposed within the charger housing and displaying at least one battery charge level; and at least one power source including at least one AC-to-DC converter and electrically coupled to the two battery ports.

[0111] In some embodiments, the system includes at least two rechargeable batteries that receive energy from a battery charging system. The two batteries consume energy in a mobile power source that powers the total artificial heart.

[0112] On the other hand, the present invention relates to an electronic device comprising: at least one display screen; application software for tracking the activity of at least one total artificial heart; and at least one communication module for wirelessly coupling the electronic device to a mobile power source, which is coupled to the total artificial heart.

[0113] In some embodiments, at least one data parameter transmitted from the power bank to the electronic device is displayed on a display screen.

[0114] In some embodiments, the data parameters include heart rate and / or blood pressure of at least one patient implanted with a total artificial heart.

[0115] In some embodiments, the data parameter includes a battery charge level and / or remaining life of at least one battery coupled to the power bank.

[0116] In some embodiments, the data parameters include right ventricular blood volume of at least one patient implanted with a total artificial heart, left ventricular blood volume of a patient implanted with a total artificial heart, an operating mode of the total artificial heart, and / or an operating status of the total artificial heart.

[0117] In some implementations, the electronic device communicates with a second electronic device having application software installed thereon.

[0118] In another aspect, the present invention relates to a total artificial heart system comprising:

[0119] At least one artificial ventricle coupled to a blood vessel and / or a ventricle; at least one drive system coupled to the artificial ventricle and including at least one motor; and at least one power source electrically coupled to the motor. The artificial ventricle, the drive system, and the power source are implanted in the chest cavity of the patient.

[0120] In some embodiments, the electric motor comprises a cylindrical base, and the power source comprises at least one battery. The battery is disposed within the cylindrical base.

[0121] In some embodiments, the system includes at least one external charging port electrically coupled to a power source. The external charging port is disposed outside the patient's body.

[0122] On the other hand, the present invention relates to a method for implanting a total artificial heart, comprising: providing a total artificial heart including at least one motor coupled to at least one drive system and at least one wire; implanting the total artificial heart into the chest cavity of a patient; and connecting the motor to at least one mobile power source.

[0123] In some implementations, the motor comprises a brushless direct current (BLDC) motor.

[0124] In some embodiments, at least one component of the drive system includes at least one segmented polyurethane solution (SPUS).

[0125] In some embodiments, at least one component of the drive system is coated with at least one segmented polyurethane solution (SPUS).

[0126] In some embodiments, the system includes: at least one stator assembly; at least one rotor cam coupled to the stator assembly; and at least one cam follower coupled to the stator assembly and the rotor cam.

[0127] In some embodiments, a rotor cam functions as both a rotor in an electric motor and a cam in a cam and follower system.

[0128] On the other hand, the present invention relates to a method for calibrating a total artificial heart, comprising: setting an initial position of a first Hall sensor in a motor of a drive system that drives the total artificial heart; setting an initial position of a second Hall sensor in the motor; establishing an offset between the initial positions of the first and second Hall sensors; starting operation of the motor; monitoring the positions of the first and second Hall sensors; identifying when the offset changes from the initial offset value; and increasing and / or decreasing the current to the motor so as to adjust the offset to a desired value.

[0129] On the other hand, the present invention relates to a method for operating a total artificial heart, comprising: starting the operation of the total artificial heart; establishing at least one set point at a control interface of the total artificial heart, the set point including a target heart rate of the total artificial heart for a given activity mode; and changing the cardiac output of the total artificial heart based on at least one data parameter received at the control interface.

[0130] In some embodiments, the data parameter includes blood pressure of a patient implanted with a total artificial heart.

[0131] In some embodiments, the data parameter includes a respiratory rate of a patient implanted with a total artificial heart.

[0132] In some embodiments, the data parameter includes a ventricular blood pressure difference in a patient implanted with a total artificial heart.

[0133] In some embodiments, the activity mode comprises a resting activity mode.

[0134] In some embodiments, the activity mode includes a moderate activity mode.

[0135] In some embodiments, the data parameter includes a strenuous activity pattern.

[0136] In some embodiments, the method includes selecting at least one activity mode at a control interface.

[0137] In some embodiments, the method includes evaluating at least one manual input at a control interface.

[0138] In some embodiments, the manual input includes changing the heart rate of the total artificial heart at a heart rate control module coupled to the control interface.

[0139] In some embodiments, the manual input includes changing the volume of blood pumped by the total artificial heart at a volume control module coupled to the control interface.

[0140] Throughout the specification, where an apparatus, system or composition is described as having, including or comprising particular components, or where a method is described as having, including or comprising particular steps, it is contemplated that there are also systems, apparatuses or compositions of the invention that consist essentially of or consist of the components, and there are methods according to the invention that consist essentially of or consist of the process steps.

[0141] It should be understood that the order of steps or the order in which specific actions are performed is not critical as long as the present invention remains operable. In addition, two or more steps or actions may be performed simultaneously.

[0142] The following description is merely illustrative and exemplary of the present disclosure and is not intended to limit the invention to the particular embodiments described.

[0143] Reference herein to any publication (eg, in the Background section) is not an admission that the publication is available as prior art with respect to any of the claims. The Background section is presented for clarity and is not meant as a description of prior art with respect to any claim. BRIEF DESCRIPTION OF THE DRAWINGS

[0144] A full and enabling disclosure of embodiments of the present disclosure, including the best mode thereof, for one of ordinary skill in the art is set forth in the specification with reference to the accompanying drawings, in which:

[0145] Figure 1 shows a cross-sectional front view of a human heart;

[0146] Figure 2 shows a front view of a total artificial heart according to aspects of the present embodiment;

[0147] Figure 3 shows a front view of an implanted total artificial heart according to aspects of the present embodiment;

[0148] Figure 4 shows a front view of an implanted total artificial heart system according to aspects of the present embodiment;

[0149] Figure 5 shows a perspective view of a total artificial heart drive system according to aspects of the present embodiment;

[0150] Figure 6 shows a perspective view of a drive system stator assembly base according to aspects of the present embodiment;

[0151] Figure 7shows a perspective view of a drive system rotor cam according to aspects of the present embodiment;

[0152] Figure 8 shows a perspective view of a drive system cam follower according to aspects of the present embodiment;

[0153] Fig. 9 showing a perspective view of an assembled drive system according to aspects of the present embodiment;

[0154] Fig.10 showing a perspective view of an assembled drive system according to aspects of the present embodiment;

[0155] Fig.11 showing a perspective view of an assembled drive system according to aspects of the present embodiment;

[0156] Fig.12 showing a perspective view of an assembled drive system according to aspects of the present embodiment;

[0157] Fig.13 showing a perspective view of an assembled drive system according to aspects of the present embodiment;

[0158] Fig.14 showing a perspective view of an assembled drive system according to aspects of the present embodiment;

[0159] Fig.15 showing a perspective view of an assembled drive system according to aspects of the present embodiment;

[0160] Fig.16 shows a perspective view of a drive system stator assembly according to aspects of the present embodiment;

[0161] Fig.17 shows a perspective view of a drive system stator assembly according to aspects of the present embodiment;

[0162] Fig.18 shows a top view of a drive system stator assembly according to aspects of the present embodiment;

[0163] Fig.19 A perspective view showing a dual ramp rotor cam of a drive system according to aspects of the present embodiment;

[0164] Fig. 20 shows a perspective view of a dual cam follower of a drive system according to aspects of the present embodiment;

[0165] Fig.21 shows a perspective view of an exploded drive system according to aspects of the present embodiment;

[0166] Fig. 22showing a perspective view of an assembled drive system according to aspects of the present embodiment;

[0167] Fig.23 showing a perspective view of an assembled crown drive system according to aspects of the present embodiment;

[0168] Fig.24 shows a perspective view of a control module according to aspects of the present embodiment;

[0169] Fig.25 shows a perspective view of a battery charging system according to aspects of the present embodiment;

[0170] Fig.26 shows a front view of a mobile device application according to aspects of the present embodiment;

[0171] Fig. 27 shows a front view of an implanted total artificial heart system according to aspects of the present embodiment;

[0172] Fig.28 A schematic diagram showing current versus blood volume characteristics according to aspects of the present embodiment;

[0173] Fig.29 shows a schematic diagram of air volume versus air pressure characteristics according to aspects of the present embodiment;

[0174] Fig.30 A schematic diagram showing blood volume versus blood pressure characteristics according to aspects of the present embodiment;

[0175] Fig.31 shows a schematic diagram of air volume versus air pressure characteristics according to aspects of the present embodiment;

[0176] Fig.32 A schematic diagram showing ramp height versus rotor angle characteristics according to aspects of the present embodiment;

[0177] Fig.33 Schematic diagram showing follower height and rotor speed versus rotor angle characteristics according to aspects of the present embodiment;

[0178] Fig.34 Schematic diagram showing follower height and rotor speed versus rotor angle characteristics according to aspects of the present embodiment;

[0179] Fig.35 A schematic diagram showing a method of implanting a total artificial heart according to aspects of the present embodiment;

[0180] Fig.36 A schematic diagram showing a method of calibrating a total artificial heart according to aspects of the present embodiment; and

[0181] Fig.37 A schematic diagram of a method of operating a total artificial heart according to aspects of an embodiment of the present disclosure is shown.

[0182] Reference will now be made in detail to embodiments of the present disclosure, one or more examples of which are illustrated in the accompanying drawings. The detailed description uses numerical and / or letter designations to refer to features in the drawings. Similar or similar designations in the drawings and description have been used to refer to similar or similar parts of the embodiments. DETAILED DESCRIPTION

[0183] Total artificial heart system

[0184] The total artificial heart of the disclosed embodiments, which is designed to function in much the same manner as a human heart, replaces the two active chambers (i.e., ventricles) of the human heart with corresponding artificial components. Figure 2 As shown, this artificial heart 30 includes two separate chambers or ventricles 32, 34, which replace the right ventricle and left ventricle of the human heart respectively. Each chamber 32, 34 is equipped with a respective diaphragm (36 in the right chamber and 38 in the left chamber, respectively), which has an air contact side and a blood contact side. Each diaphragm 36, 38 is designed as a spherical hemisphere. The total artificial heart 30 is implanted by connecting the top of the right chamber 32 to the right atrium 12 and the top of the left chamber 34 to the left atrium 16. The bottom of each chamber is provided with a drive system (40 in the right chamber and 42 in the left chamber, respectively) embedded in the patient's body, and each drive system includes an electrical wire 48 extending out of the patient's body. Each drive system 40, 42 uses air to push the respective artificial left ventricle 32 and right ventricle 34 through the respective diaphragms 36, 38, and the diaphragms 36, 38 discharge blood from the respective chambers 32, 34, thereby simulating and performing the function of the ventricle. Thus, each septum 36, 38 defines a transition or boundary between a ventricle 32, 34 and a drive system 40, 42. The drive systems 40, 42 may each include a base 50 and one or more ports 52 for allowing wires 48 to pass through to reach the base to reach the interior of the drive system 40, 42. The total artificial heart 30 may also include artificial valves 44a (tricuspid), 46a (bicuspid), 44b (pulmonary), and 46b (aortic), which control the flow of blood from the respective atria into each artificial ventricle 32, 34, and out to the circulatory system.

[0185] Figure 3A perspective view of an implanted artificial heart 30 is shown with the top of the right chamber 32 connected to the right atrium 12 and the top of the left chamber 34 connected to the left atrium 16. A drive system (40 in the right chamber and 42 in the left chamber, respectively) is provided at the bottom of each chamber, which is embedded in the patient's body and includes electrical leads extending out of the patient's body to provide power to each drive system. Since each drive system 40, 42 uses air to push the corresponding artificial left ventricle 32 and right ventricle 34 through the corresponding diaphragm 36, 38, blood is discharged from each chamber 32, 34, thereby pumping blood out of the heart during the systolic or ejection phase. When the pressurized air is discharged from the diaphragm (called the diastolic or filling phase), blood can enter the ventricle from the connected atrium. The rate at which blood enters the ventricle depends on the difference between the atrial pressure and the pressure on the air side of the diaphragm. In order to increase the filling rate, during diastole, a slight vacuum of about 10 mmHg on average can be established in the drive system 40, 42 on the air side of the diaphragm 36, 38. This pressure is higher during systole.

[0186] Figure 4 A front view of a total artificial heart system 60 according to aspects of the present embodiment is shown. The total artificial heart system 60 may include a total artificial heart 30 including a right drive system 40 and a left drive system 42 implanted in the patient's chest. Each drive system 40, 42 may be connected to a mobile power source 54 by one or more wires 48. The mobile power source 54 may include a local interface (not shown) for controlling the functions of the total artificial heart system 60 as well as a battery port and local control buttons. In operation, the local power source 54 may be worn on a belt or tied around the chest, shoulder or waist, or carried in a pocket, so that the patient can move freely without having to carry a mobile compression unit in one or both hands. In addition, the total weight of the mobile power source 54 may be less than about three (3) pounds, or about two (2) pounds to about three (3) pounds, or about one (1) pound to about two (2) pounds, or less than about one (1) pound. In other embodiments, the total weight of the power bank 54 can be from about four (4) ounces to about sixteen (16) ounces, or from about six (6) ounces to about fourteen (14) ounces, or from about eight (8) ounces to about twelve (12) ounces.

[0187] Drive system

[0188] Figure 5A perspective view of an exploded arrangement of components within each drive system 40, 42 of a total artificial heart system 60 according to aspects of an embodiment of the present disclosure is shown. The drive systems 40, 42 can be coupled to the right artificial ventricle 32 and the left artificial ventricle 34, and can include a drive system stator assembly 62, a drive system rotor cam 64, and a drive system cam follower 66. The stator assembly 62 can be electrically coupled to the wire 48 so that electrical energy is provided to the stator assembly 62, which also serves as a base for an electric motor (e.g., a brushless direct current (BLDC) motor). The rotor cam 64 can slide onto the stator assembly 62 around a hexagonal housing 68. The rotor cam 64 serves as both a rotor as part of the motor and a cam as part of the cam and follower system. Therefore, the rotor cam 64 can include one or more permanent magnets, or can be composed of a separate permanent magnetic material. In addition, the rotor cam 64 can include at least one ramp 70 for the cam and follower system. The follower 66 can include at least one tooth 72 for engaging with the ramp of the rotor cam 64. The follower 66 may also include one or more hexagonal shafts 74 for sliding into one or more hexagonal seats 68, thereby preventing the follower 66 from rotating but allowing it to slide up and down within the drive system 40, 42. Each of the right artificial ventricle 32 and the left artificial ventricle 34 may include a lower housing 76 that may extend around the drive system components, allowing the rotor cam 64 and the follower 66 to move therein.

[0189] In operation, charge is passed from the lead 48 into the base 68 and ultimately through one or more motor windings 130 (e.g. Figure 16-18 ), thereby generating an electromagnetic force (i.e., due to the permanent magnets) that causes the rotor cam 64 to rotate. A cylindrical housing 128 (as shown) extending from the stator assembly 62 Figure 16-18 ) can surround the hexagonal housing 68 and the motor winding 130 (as shown Figure 16-18 ) and can be radially disposed within the inner bore 78 of the rotor cam 64, thereby providing a bearing (e.g., a sleeve bearing) around which the rotor cam 64 can rotate. When the rotor cam 64 rotates, the teeth 72 contact the ramp 70, thereby causing the follower 66 to rise and fall as the height (i.e., the inclination) of the ramp 70 changes. A spring 134 (e.g., Fig.17 72) keeps the follower 66 against the stator assembly 62 even when the ramp 70 pushes the follower 66 away from the stator assembly 62 (i.e., by the teeth 72). As the follower 66 moves up and down due to the movement of the rotor cam 64 and the teeth 72, the volume within each drive system 40, 42 and within the right ventricle 32 and the left ventricle 34 increases and decreases, thereby simulating the contraction and expansion of the human heart and allowing blood to flow into the total artificial heart 30 and then be pumped out. The internal air pressure within the drive system 40, 42 can also act as a spring, Figure 7 ) helps draw the cam follower 66 back toward the base 50 after passing under the teeth 72.

[0190] Figure 6 A perspective view of a stator assembly 62 is shown, which includes one or more electrical conductors 48 coupled to a base portion 50 from which a hexagonal housing 68 extends. The hexagonal housing 68 may include a hexagonal cross-section. In other embodiments, the housing 68 may include a square, rectangular, triangular, oval, pentagonal, or other shaped cross-section such that it allows the hexagonal (or other shaped) shaft 74 (e.g., Figure 5 The interior 78 of the hexagonal housing 68 is sized and shaped so that the internal geometry matches that of the hexagonal shaft 74 (although slightly larger to allow for tolerances between components). Figure 6 Also shown is a height 90 of the hexagonal housing 68, and a diameter 92 of the base portion 50. In one or more embodiments, the diameter 92 of the base portion 50 can be about two (2) to about four (4) times the height 90 of the hexagonal housing 68. In another embodiment, the diameter 92 of the base portion 50 can be about 2.5 to about 3.5 times the height 90 of the hexagonal housing 68. In another embodiment, the diameter 92 of the base portion 50 can be about three (3) times the height 90 of the hexagonal housing 68. The hexagonal housing 68 can include a wall thickness 84 ranging from about 0.5 millimeters to about five (5) millimeters, or from about 0.8 millimeters to about three (3) millimeters, or from about one (1) millimeter to about two (2) millimeters. The stator assembly 62 can also include an outer lip 80 extending around the outer diameter of the base portion 50. The outer lip 80 can be attached to the lower housing 76 (e.g., the right artificial ventricle 32 or the left artificial ventricle 34) of the stator assembly 62. Figure 5 The lower housing 76 and the outer lip 80 are engaged with each other (as shown) so that the lower housing 76 extends tightly around the outer lip 80 with a compression fit. The lower housing 76 may also include one or more notches, grooves, slots, slits and / or other features for retaining the outer lip 80, thereby tightly sealing the left drive system component 40 and the right drive system component 42. In operation, neither the lower housing 76 nor the outer lip 80 rotates. Therefore, in some embodiments, the lower housing 76 and the outer lip 80 can be epoxied, welded, brazed, soldered, glued, adhered, bonded, taped, fused, sintered and / or otherwise joined to each other. Other aspects of the stator assembly 62 and the motor architecture are described in detail below. Figure 16-18 Shown in.

[0191] Figure 7A perspective view of a rotor cam 64 is shown including a ramp 70 that may extend circumferentially around the rotor cam 64 radially outward of a central hole 86. The central hole 86 may include a hollow cylindrical space having a height 94 and concentric about a rotor cam centerline 98. The height of the ramp 70 gradually increases until it reaches the full height 94 of the rotor cam 64, at which point the ramp 70 engages with a drop 88, which itself engages with a bottom portion 100 of the ramp 70 (also at Figure 9-11 ). The rotor cam 64 may also include a rounded transition 102 between the top and bottom portions 100 of the descender 88. In one embodiment, the diameter 96 of the rotor cam may be from about two (2) to about ten (10) times the rotor cam height 94. In another embodiment, the diameter 96 may be from about three (3) to about eight (8) times the rotor cam height 94. In another embodiment, the diameter 96 may be from about four (4) to about seven (7) times the rotor cam height 94. In another embodiment, the diameter 96 may be from about five (5) to about six (6) times the rotor cam height 94. The rotor cam 64 may function as a permanent magnet and may be made of neodymium iron boron (ND-Fe-B), iron, cobalt, samarium cobalt (SM-Co), aluminum, aluminum nickel cobalt, bonded Nd-Fe-B, magnetite, ceramic (hard ferrite), ferrite, gadolinium, rare earth elements, strontium, barium, iron (III) oxide, combinations and alloys thereof, and other magnetic materials. By integrating the rotor for the electric motor with the cam, the rotor cam 64 performs two functions simultaneously while also reducing the overall volume of the drive system 40 , 42 and the number of individual parts.

[0192] Figure 8 A perspective view of a cam follower 66 including a tooth 72 and a hexagonal shaft 74 is shown. In other embodiments, the hexagonal shaft 74 may include other shaped cross-sections, including but not limited to square, rectangular, triangular, elliptical, pentagonal, and / or other shaped cross-sections, such that the shaft 74 may slide within the housing 68 without rotating. The tooth 72 may include a rounded taper 104 along a leading edge and a substantially straight (or flat) portion 106 along a trailing edge. The straight portion 106 allows the tooth 72 (and cam follower 66) to be positioned at the lower portion 88 (e.g., Figure 7 and 9 -11) passes under the teeth 72 and then descends toward the base portion 50 (as shown in Figure 6 ). The rounded taper 104 along the leading edge of the tooth 72 increases the effective cross-sectional area of ​​the tooth 72, thereby increasing the strength and robustness of the tooth 72 and reducing the likelihood of it being damaged or broken. The tooth 72 may also include a rounded tip 108, which may help prevent damage to the tooth 72 and / or other components of the drive system 40, 42.

[0193] Still reference Figure 8 The cam follower 66 may also include a follower dome 110, which may include a dome curvature and / or a gradual profile (i.e., a profile of a diameter greater than the diameter of the cam follower 66). The follower dome 110 may bulge toward the left and / or right artificial ventricle 32, 34 (i.e., bulge upward) and may form a barrier and interface between the blood side of the follower dome 110 and the air side of the follower dome 110. At the outer diameter, the load-bearing dome 110 engages an outer edge 124, which may fit within the cylindrical housing 76. Pressure may be exchanged between blood and air through the follower dome 110, while the follower dome 110 simultaneously acts as a barrier between the two fluids, thereby preventing blood from being exposed to air and vice versa. As the follower dome 110 (i.e., and the cam follower 66) moves up and down, the amount of air within each drive system 40, 42 and the amount of blood within the right ventricle 32 and the left ventricle 34 continuously change. In other embodiments, Figure 8 The cam follower 66 may include a plurality of teeth 72 spaced circumferentially around the cam follower 66, and Figure 7 The rotor cam 64 may include a plurality of ramps spaced circumferentially around the rotor cam 64 and corresponding to the spacing and number of teeth 72 of the cam follower 66. Each of the cam follower 66, the rotor cam 64, and the stator assembly 62 may have approximately the same outer diameter. In one or more embodiments, since the cam follower 66 needs to translate up and down within the lower housing 76, and since the rotor cam 64 needs to rotate within the lower housing 76, each of the cam follower 66 and the rotor cam 64 may include an outer diameter slightly smaller than the stator assembly 62. The base portion 50 may fit tightly within the lower housing 76 because it neither rotates nor translates within the lower housing 76, and therefore does not need to move relative to the lower housing 76.

[0194] Fig. 9 An assembled perspective view of the drive system 40, 42 including the stator assembly 62, the rotor cam 64 and the cam follower 66 is shown. The clockwise direction 116 (ie, when viewed from above) indicates the Fig. 9 The axial or longitudinal direction 122 (i.e., Figure 7 as shown, parallel to the cam centerline 98) indicated at Fig. 9In embodiments of the present invention, the direction in which the cam follower 66 translates. The drive system 40, 42 may include a circular portion 102 and a bottom circular portion 89, wherein the circular portion 102 defines a transition between the top of the ramp 70 and the drop 88, and the bottom circular portion 89 defines a transition between the drop 88 and the bottom portion 100. The bottom portion 100 may include a flat portion 112 that transitions to the inclined portion 114. In other embodiments, the bottom portion 100 may include only the inclined portion 114 (i.e., the ramp 70), such that the bottom circular portion 89 forms a transition between the drop 88 and the inclined portion 114 (i.e., without first transitioning to the flat portion 112). Fig. 9 In the embodiment of the present invention, the hexagonal shaft 74 is partially disposed within the hexagonal housing 68, both of which are radially disposed within the central hole 86 of the rotor cam 64. Each of the stator assembly 62, the rotor cam 64 and the cam follower 66 can be disposed within the lower housing 76 (i.e., extending downwardly from the left and / or right ventricles 32, 34 (not shown)) or in an alternative cylindrical housing 76. Fig. 9 In an embodiment of the present invention, the drive system 40, 42 may also include at least one first proximity sensor 118 disposed within the base portion 50 (or outer lip 80) of the stator 62, and at least one second proximity sensor 120 disposed within the cam follower 66. The first and second proximity sensors 118, 120 may be used to determine the distance between the base portion 50 and the outer edge 124 of the cam follower 66. This distance is directly proportional to the amount of air within each drive system 40, 42, which in turn is inversely proportional to the amount of blood within the right ventricle 32 and / or the left ventricle 34 at any given moment. By sensing and tracking the amount of blood pumped through the total artificial heart system 30 via the first and second proximity probes 118, 120, the total cardiac output or production may be estimated and monitored.

[0195] Fig.10 An assembled perspective view of the drive system 40, 42 including the stator assembly 62, the rotor cam 64 and the cam follower 66 is shown. The cam follower 66 may include a rounded portion 102 at the top of the ramp 70 that transitions to a drop 88, which transitions to a bottom rounded portion 89, and then to a bottom portion 100 that includes a flat portion 112 and an inclined portion 114 (or ramp 70). Fig.10In an embodiment, the diaphragms 36, 38 extend from the follower dome 110. The diaphragms 36, 38 can extend axially upward and radially outward from the follower dome 110 so that the leading edge 126 of the diaphragm can contact the right ventricle 32 or the left ventricle 34, thereby providing an additional barrier or seal between the blood chambers (i.e., the ventricles 32, 34) and the air chambers (i.e., the drive system 40, 42) of the total artificial heart 30. The drive system 40, 42 may include one or more pressure sensors 113, which are disposed on the rotor cam 64 and / or the stator assembly 62 (e.g., at the Fig.17 As the cam follower 66 rises and falls due to the rotation of the rotor cam 64, one or more pressure sensors 113 may be used to determine the air pressure within the drive system 40, 42.

[0196] Fig.11 An assembled perspective view of the total artificial heart 30 is shown with the right ventricle 32 and / or the left ventricle 34 coupled to a drive system assembly 40 , 42 including a stator assembly 62 , a rotor cam 64 , and a cam follower 66 . Fig.11 Also shown are the locations of one or more artificial valves including the tricuspid valve 44a, the mitral valve 46a, the pulmonary valve 44b, and the aortic valve 46b. Figure 9-11 In each of the embodiments, one or more teeth 72 of the cam follower 66 generally contact one or more ramps 70 of the rotor cam 64 when the drive system 40 , 42 is in operation.

[0197] Figure 12-15 A progressive perspective view of a total artificial heart 30 in operation according to aspects of the present embodiment is shown. Fig.12 In the embodiment of the present invention, at least one tooth 72 is located on the flat portion 112 of the bottom portion 100 at the bottom of the descending portion 88. Fig.13 In the embodiment of the present invention, at least one tooth 72 is on the inclined portion 114 (or ramp 70). Fig.14 In the embodiment of the present invention, at least one tooth 72 is close to the top of the ramp 70. Fig.15 In the embodiment of the present invention, at least one tooth 72 is located at the top of the ramp 70 at the edge of the descending portion 88. Figure 12-15 In the embodiment of the present invention, the cam follower 66 gradually moves away from the stator assembly 62, which corresponds to the blood being pushed out of the right ventricle 32 or the left ventricle 34 by the cam follower 66 (and the diaphragms 36, 38). Since the hexagonal housing 68 does not allow the hexagonal shaft 74 to rotate therein, the cam follower 66 does not rotate with the rotor cam. The housing 68 and the shaft 74 can similarly be square, triangular, and other shapes (i.e., other than circular) so that the housing 68 retains the shaft 74 but prevents it from rotating with the rotor cam 64.

[0198] In operation, the right ventricle 32 and the left ventricle 34 are normally only partially filled to provide additional capacity when blood flow in the patient increases due to physical activity. In one embodiment, the air side of each ventricle has a volume of approximately from about three (3) to about six (6) cubic inches, or from about four (4) to about five (5) cubic inches, or from about 4.1 to about 4.7 cubic inches. Each of the diaphragms 36, 38 can have an area of ​​from about four (4) to about eight (8) square inches, or from about five (5) to about seven (7) square inches, or from about 5.7 to about 6.6 square inches. The compression ratio (i.e., the ratio of maximum volume to minimum volume for a given operating state) of each drive system 40, 42 on the air side varies from one operating mode to the next. For example, under maximum blood volume conditions (i.e., strenuous exercise), the compression ratio can be about three (3) to one (1), or from about 2.5 to about 3.5 to one (1). In the case of moderate exercise or activity, the compression ratio can be about two (2) to one (1), or from about 1.75 to about 2.5 to one (1). In a resting or sleep mode of operation, the compression ratio can be about 1.5 to one (1), or about 1.25 to about 1.75 to one (1).

[0199] Each component of the drive system 40, 42, including the stator assembly 62, the rotor cam 64, the cam follower 66, the wire 48, and the right artificial ventricle 32 and the left artificial ventricle 34, can be coated with an inert material that does not cause a reaction or response in the human body. In one embodiment, each component of the drive system 40, 42 can be coated with a segmented polyurethane solution (SPUS), which is biocompatible (or bioinert) in the human body (i.e., completely inert) and is also fatigue-resistant and strain-resistant. In one or more embodiments, the right and left artificial ventricles 32, 34 can be composed of SPUS. The SPUS components can be formed as separate components by one or more molding processes and then bonded together. In other embodiments, various components or sub-components can be formed by SPUS by a single injection molding process. One or more components and / or sub-components of the embodiments of the present disclosure may also be composed of other synthetic materials or coated with other synthetic materials (e.g., silicone rubber, thermoplastic elastomer (TPE) and / or polyvinyl chloride (PVC)). The SPUS materials used in conjunction with embodiments of the present disclosure are capable of accommodating tensile loads from about 5000 psi to about 8000 psi, and are capable of accommodating stiffness (i.e., modulus) loads from about 400 psi to about 800 psi or from about 450 psi to about 750 psi. By using SPUS materials in conjunction with components of embodiments of the present disclosure (either as an underlying component material or as a coating on a component composed of other materials), reactions and other responses that occur due to exposure of one or more biological tissues to the components described herein can be avoided.

[0200] BLDC Motor Architecture

[0201] Figure 16-18 A stator assembly 62 ( Fig.16 and 17 ) and the motor assembly 140 ( Fig.18 ) implementation. Fig.16 , the stator assembly 62 may include multiple sets of windings 130, each longitudinally oriented and spaced apart around the hexagonal housing 68. Each of the multiple sets of windings 130 may include longitudinally aligned conductive coil wires 138 wound around one or more cores (not shown; i.e., a solid frame, support, and / or feature that provides a structure on which the wires 138 may be wound). Fig.16 In the embodiment of the present invention, six (6) groups of stator windings 130 are included, but the motor (including a brushless DC (BLDC) motor) according to the present embodiment can include other numbers of windings, including, for example, eight (8), nine (9), twelve (12), twenty-four (24), forty-eight (48), and other numbers of stator windings 130. Each of the multiple groups of stator windings 130 can be made of silicon core iron, copper, aluminum, and other materials. The windings 130 of the corresponding groups (for example, Fig.16 The first and fourth, second and fifth, and third and sixth groups of windings 30 in the embodiment of the present invention can be electrically coupled so that they provide opposite polarity (i.e., north or south) to the surrounding rotor cam 64 (not shown). Adjacent groups of opposing windings 130 can then be electrically activated in succession so that each group exerts an electromagnetic force on the rotor cam 64, causing it to rotate about the stator assembly 62.

[0202] Still reference Fig.16 , the stator assembly 62 may also include a thicker base 50 to accommodate an integrated battery system, motor control and / or circuitry, and other components. The stator assembly 62 may also include one or more Hall effect devices or Hall sensors 136 disposed within the base 50 or radially disposed within the cylindrical housing 128. One or more Hall sensors 136 may be used to sense the presence of a strong and / or changing electromagnetic field (i.e., from the rotor cam 64 as the rotor cam 64 rotates past) in order to determine the rotational position (and therefore the rotational speed) of the rotor cam 64. The Hall sensors 136 may also be used to control the rotational speed (i.e., for example, total revolutions per minute or radians per second) of the rotor cam 64, as well as the instantaneous angular velocity within each revolution, which may also be selectively controlled.

[0203] Fig.1762 according to aspects of the present embodiment. The stator assembly 62 may include one or more springs 134 disposed within a hexagonal housing 68. The springs may be coupled to the stator base 50 and the cam follower 66 (in Figure 5 and 8 -15), for when one or more teeth 72 (such as Figure 5 and 8 -15) through the descending portion 88 (as shown Figure 5 and 8 -15), the cam follower 66 is pulled back toward the stator base 50. In other words, one end of each spring 134 is connected to the bottom of the hexagonal housing 68, and the other end of each spring 134 is connected to the top of the hexagonal shaft 74. One or more springs 134 are disposed within the hexagonal housing 68 and the hexagonal shaft 74. The springs 134 extend as the rotor cam 64 pushes the teeth 72 and the cam follower 66 upward. Then, after the descender 88 passes under the teeth 72, the one or more springs 134 pull the cam follower 66 back toward the stator assembly 62.

[0204] Still reference Fig.17 , the stator assembly 62 may also include a retaining lip 132 extending radially outward from the upper circumference of the cylindrical housing 128. The retaining lip 132 may be annular and may be concentric around the cylindrical housing 128. The retaining lip 132 may be used to retain the rotor cam 64 on the stator assembly 62, thereby allowing the rotor cam 64 to rotate around the cylindrical housing 128 while preventing the rotor cam 64 from translating upward and / or downward (i.e., in the longitudinal direction). In embodiments that do not include the retaining lip 132, the rotor cam 64 may be retained by one or more teeth 72 (such as Figure 5 and 8 -15) is held biased against the stator base 50, and the teeth are pulled downward by one or more springs 134. Because the hexagonal housing 68 is radially disposed within one or more sets of windings 130, the hexagonal housing 68 may also be referred to as an inner stator housing 68. Similarly, because the cylindrical housing 128 is disposed radially outside one or more sets of windings 130, the cylindrical housing 128 may also be referred to as an outer stator housing 128.

[0205] Fig.18 1 shows a top view of a motor assembly 140 (eg, a BLDC motor assembly) according to aspects of the present embodiment. Fig.18As shown, the motor assembly 140 may include a rotor cam 64 disposed about the cylindrical housing 128 and longitudinally held in place by a retaining lip 132. The rotor cam 64 may include a ramp 70 that may include rounded portions 102, 89 at the drop 88 and a flat portion 112 and an inclined portion 114. The motor assembly 140 radially disposed in the cylindrical housing 128 may include multiple sets of windings 130, a hexagonal housing 68, a hexagonal shaft 74, and one or more springs 134. One or more wires 48 may also be electrically connected to the motor assembly 140. In Fig.18 In an embodiment, the motor assembly 140 may include one or more dampers 142 disposed in the hexagonal housing 68 at the bottom of the hexagonal housing 68. The one or more dampers 142 may be compressible and may extend only a fraction or a portion of the length of the height 90 of the hexagonal housing 68. For example, the damper 142 may extend only from about five (5) percent to about fifty (50) percent of the height 90 of the hexagonal housing 68. In other embodiments, the damper 142 may extend from about ten (10) percent to about forty (40) percent of the height 90 of the hexagonal housing 68. In other embodiments, the damper 142 may extend from about fifteen (15) percent to about thirty (30) percent of the height 90 of the hexagonal housing 68. In other embodiments, the damper 142 may extend from about twenty (20) percent to about twenty-five (25) percent of the height 90 of the hexagonal housing 68.

[0206] Still reference Fig.18In operation, the one or more dampers 142 prevent the cam follower 66 (and its one or more teeth 72) from hitting back too hard or quickly against the bottom portion 100 (e.g., flat portion 112) of the rotor cam 64 (i.e., after the drop 88 passes under the one or more teeth 72). Thus, the one or more dampers 142 can prevent wear on the drive system 40, 42, and can also allow for smoother operation of the cam follower 66 within the right ventricle 32 and / or the left ventricle 34. Each time the tooth 72 drops from the drop 88, the central venous pressure helps fill the heart (with blood). The damper 142 helps prevent high changes in pressure that are too rapid, and ensures a smoother and more gradual ramp down. For example, by using the damper 142, pressure drops above a certain threshold (i.e., dP / dT) can be avoided. The motor 140 can also be used to prevent rapid changes in pressure. Because the motor 140 can be selectively controlled to any rotational speed (even within a single rotation), multiple rotational speeds can be selected during each systolic and diastolic phase of each cycle. For example, during systolic phase when the right ventricle 32 and the left ventricle 34 are evacuated, the motor 140 can be controlled so that the rotational speed is higher (thereby raising the cam follower 66 and rapidly contracting the ventricles 32, 34) when one or more teeth 72 are on the inclined portion 114 of the ramp. The motor 140 can then be controlled to a lower speed for the beginning of diastolic phase (when the ventricles 32, 34 are expanding and filling), thereby allowing the teeth 72 and cam follower 66 to drop all the way back to the flat portion 112. In one or more embodiments, the motor 140 can be controlled so that the transition between faster and slower rotational speeds is gradual and / or smooth so that the artificial valves 44a, 44b, 46a, 46b are not overstressed by opening or closing too quickly. By gradually transitioning between slower rotational speeds and faster rotational speeds (and vice versa), a "water hammer" effect can be avoided, thereby reducing potential damage to the artificial valves 44a, 44b, 46a, 46b themselves (i.e., by gently opening and closing them), and also reducing damage to the surrounding blood. In addition, the pressure drop (i.e., dP / dT) can be limited by controlling the rotational speed of the rotor cam 64, thereby minimizing fluid shear stress (i.e., in the blood).

[0207] In operation, from one (1) to five (5) or six (6) inch pounds of torque may be required to rotate the drive systems 40, 42 (the high end of the torque range corresponds to a hypertensive patient whose blood pressure will act externally on the drive systems 40, 42, resulting in increased resistance and friction within the system). As a result, the power of the motor 140 required to power the system may be from about one (1) watt to about ten (10) watts, or from about two (2) watts to about seven (7) watts, or from about three (3) watts to about six (6) watts, or from about four (4) watts to about five (5) watts. In other embodiments, the motor 140 may also operate within other suitable power ranges.

[0208] Other drive system implementations

[0209] Fig.19 A perspective view of the rotor cam 64 in a dual ramp configuration according to aspects of the present embodiment is shown. The rotor cam 64 may include an outer ramp 144, and an inner ramp 146 disposed radially within the outer ramp 144 (and radially outside the rotor cam central hole 86). The outer ramp 144 and the inner ramp 146 may include an outer drop 150 and an inner drop 152 disposed 180 degrees apart from each other. The outer ramp 144 and the inner ramp 146 may also include an outer flat portion and an inner flat portion 112, which are also disposed 180 degrees apart from each other. Fig.19 In the embodiment of the present invention, each flat portion 112 spans approximately 90 degrees of the circumference of the rotor cam 64, while the inclined portion of each of the outer ramp 144 and the inner ramp 146 spans approximately 270 degrees of the circumference of the rotor cam 64. In other embodiments, each flat portion 112 may span approximately 0 degrees to approximately 60 degrees of the circumference of the rotor cam 64, while the inclined portion of each of the outer ramp 144 and the inner ramp 146 may span approximately 300 degrees to approximately 360 degrees of the circumference of the rotor cam 64. In other embodiments, each flat portion 112 may span approximately 60 degrees to approximately 90 degrees of the circumference of the rotor cam 64, while the inclined portion of each of the outer ramp 144 and the inner ramp 146 may span approximately 270 degrees to approximately 300 degrees of the circumference of the rotor cam 64.

[0210] Still refer to Fig.19, the rotor cam 64 may also include a thin radial gap 154 ​​disposed radially outside the inner ramp 146 and radially inside the outer ramp 144. Each of the outer ramp 144 and the inner ramp 146 may be inclined so that the increase in height as a function of the circumferential angle (or rotation) of the rotor cam 64 is constant. In other words, each of the outer ramp 144 and the inner ramp 146 transitions from a minimum height (i.e., at the flat portion 112) to a maximum height (i.e., just before each drop 150, 152) through approximately 270° of rotation. Thus, the increase in height as a function of angle is constant for the outer ramp 144 and the inner ramp 146. As a result, the increase in height as a function of the distance traveled on each ramp is higher on the inner ramp 146 than on the outer ramp 144 because the inner ramp 146 increases the same total height over a shorter distance.

[0211] Fig. 20 A perspective view of the cam follower 66 is shown in a double tooth configuration in accordance with aspects of the present embodiment. Fig. 20 The double-toothed cam follower 66 may include an outer tooth 156 and an inner tooth 158, the inner tooth 158 being arranged at a smaller radius than the outer tooth 156 and being circumferentially spaced apart from the outer tooth 156 by approximately 180 degrees. Each of the outer tooth 156 and the inner tooth 158 is arranged radially outward of the hexagonal shaft 74. In addition, each of the outer tooth 156 and the inner tooth 158 is arranged radially outward of the hexagonal shaft 74. Fig.19 The outer slope 144 and the inner slope 146 of the rotor cam 64 are arranged at radii corresponding to the radii. Therefore, Fig. 20 The outer teeth 156 are Fig.19 The outer ramp 144 of the cam 150 is provided with the same radius as the inner ramp 146, while the inner teeth 158 are provided with the same radius as the inner ramp 146. In operation, since the outer teeth 156 and the inner teeth 158 are engaged with at least one of the outer ramp 144 and the inner ramp 146, the longitudinal force acting on the cam and follower system can be distributed more evenly in the double-tooth / double-ramp configuration than in the single-tooth / single-ramp configuration. According to the present embodiment, three-tooth / three-ramp, four-tooth / four-ramp and other configurations are also possible.

[0212] Fig.21 A perspective view of an exploded drive system 40 , 42 including a stator assembly 62 , a rotor cam 64 , and a cam follower 66 in a dual ramp / dual tooth configuration is shown in accordance with aspects of the present embodiment.

[0213] Fig. 22 A perspective view of the assembled drive system 40 , 42 including the stator assembly 62 , rotor cam 64 , and cam follower 66 in a dual ramp / dual tooth configuration is shown in accordance with aspects of the present embodiment.

[0214] Fig.23A perspective view of the assembled drive system 40, 42 including the stator assembly 62, the rotor cam 64 and the cam follower 66 in an imperial crown configuration is shown in accordance with aspects of the present embodiment. Fig.23 In the embodiment of the present invention, the rotor cam 64 may include one or more cam lobes 160, each of which has a profile that causes the rotor cam 64 to lift the cam follower 66 when the rotor cam 64 rotates. The cam follower 66 may include one or more follower lobes 162, each of which is shaped and spaced to generally match the profile of the cam lobe 160. Fig.23 In the embodiment of the present invention, the rotor cam 64 includes four (4) cam lobes 160, while the cam follower 66 includes four (4) follower lobes 162. In other embodiments, each of the rotor cam 64 and the cam follower 66 may include one (1), two (2), three (3), four (4), five (5), six (6), or more cam lobes 160 and / or follower lobes 162. In one or more embodiments, each of the cam follower lobes 162 may include one or more rollers (not shown) to help facilitate movement of the rotor cam lobe 160 thereunder. A low friction, wear resistant coating may also be provided on each of the cam lobes 160 and the follower lobes 162 to minimize contact friction between the rotor cam 64 and the cam follower 66.

[0215] Power supply and charging system

[0216] Fig.24 A perspective view of a mobile power supply 54 according to aspects of an embodiment of the present disclosure is shown. The mobile power supply 54 can be electrically coupled to one or more wires 48 (or wire groups) for powering the motor assembly 140 of each of the drive systems 40, 42. The mobile power supply 54 can also include a mobile power supply housing 165 and at least one external charging port 164 disposed within the housing 165 (e.g., for plugging the mobile power supply 54 directly into a wall outlet). The mobile power supply 54 can also include one or more battery ports 168 disposed in the housing 165 for plugging a rechargeable battery into the mobile power supply 54. Fig.24In an embodiment, the mobile power supply 54 includes two (2) battery ports 168, which allow at least one battery installed in the mobile power supply 54 to always be powered, even when the second battery is charging. In one or more embodiments and / or use cases, the external charging port 164 can be used to simultaneously power the drive system 40, 42 while also charging the battery. The mobile power supply 54 can also include a heart rate control module 166, which includes a first set of control buttons 170 for adjusting (i.e., increasing or decreasing) the heart rate. According to this embodiment, each heartbeat can be defined as one complete cycle of the cam follower 66 rising along the ramp 70 of the rotor cam 64 and then descending from the descending portion 88 (which corresponds to the contraction and expansion of the right ventricle 32 and / or the left ventricle 34). Therefore, in a single tooth / single ramp embodiment (i.e., similar to Fig. 9 ), the drive system 40, 42 will generate one heartbeat for every 360 degrees of rotation of the rotor cam 64. Similarly, in a double tooth / double ramp embodiment (i.e., similar to Fig.21 and Fig. 22 ), the drive system 40, 42 will generate one heartbeat for every 360 degree rotation of the rotor cam 64. In other dual tooth / dual ramp embodiments, where each ramp 70 spans one hundred eighty (180) degrees and two teeth 72 engage (and are disposed on) both ramps 70, the drive system 40, 42 will generate two heartbeats for every 360 degree rotation of the rotor cam 64. Then, as it applies to the total artificial heart system 60 of the present embodiment, the "heart rate" is simply the number of heartbeats per minute (as defined above).

[0217] Still reference Fig.24, in order to increase the cardiac output of the system, the patient can use the first set of control buttons 170 to increase (or alternatively decrease) the heart rate of the total artificial heart 30. The mobile power supply 54 can also include a capacity control module 174, which includes a second set of control buttons 172 for adjusting (i.e., increasing or decreasing) the capacity (i.e., the amount of blood pumped) of each heartbeat. For example, by allowing the cam follower 66 to travel all the way to the bottom of the drive system 40, 42 (i.e., close to the base 50), each of the right ventricle 32 and the left ventricle 34 can expand to a larger volume, thereby allowing more blood to flow into each of the right ventricle 32 and the left ventricle 34 to be pumped to the lungs or circulatory system. Therefore, both the heart rate control module 166 and the capacity control module 174 can be used to increase or decrease the total cardiac output (or generation). The mobile power supply 54 can also include a display screen 176 for displaying various data and information, such as one or more battery charge levels 178, a heart rate indication 182, and other information. The mobile power 54 may also include a wireless communication module 180 that allows the mobile power 54 to wirelessly connect to Wi-Fi enabled devices and / or network connected devices, such as smartphones, laptops, tablets, desktop computers, networks, servers, chargers, and / or other devices. The mobile power 54 may also include one or more clips, straps, or other connection features (not shown) that enable the mobile power 54 to be worn (e.g., by clipping to a belt) and carried. By including various features in the mobile power 54, the mobile power 54 includes an integrated control interface that is operably coupled to the motor assembly 140 and / or the stator assembly 62.

[0218] Fig.25 A perspective view of a charging system 182 according to an embodiment of the present disclosure is shown. The charging system 182 may include at least one housing 189 including a first battery port 186 and a second battery port 188 for accommodating one or more rechargeable batteries 184 and for electrically coupling them to an external power source 194. The external power source 194 may include one or more alternating current (AC) to direct current (DC) converters 196 so that the external power source 194 may receive alternating current (e.g., from a wall outlet) and also provide direct current to the total artificial heart 30 through the one or more batteries 184. The charging system 182 may include one or more charging ports 192 disposed within the housing 189 for plugging in the external power source 194. The charging system 182 may also include a display screen 190 disposed within the housing 189 for displaying data and other information, such as the charge level of the one or more batteries 184.

[0219] Fig.26A front view of an application software 198 is shown, which can be displayed on one or more electronic devices, such as a smart phone, a desktop computer, a laptop computer, a tablet computer, and / or other device 200. The application software 198 can display information such as heart rate, blood pressure, first and second battery charge levels, remaining time until both batteries are exhausted (i.e., remaining life of one or more batteries), control mode, left and right ventricular pumping capacity, and overall system status (e.g., normal, alarm, warning, etc.). The communication module 202 of the electronic device 200 can be communicatively coupled with the communication module 180 of the mobile power bank 54 so that data and information from the mobile power bank 54 can be transmitted to the electronic device 200 (e.g., wirelessly) in real time or near real time (e.g., in 1, 5, 10, 20, 30, or 60 second increments, etc.). The application software 198 can also include one or more buttons, including (but not limited to) a mode button, a statistics button (e.g., for retrieving statistical operating data), and a menu button. The mode button allows the user to select a control mode, such as: 1) maintaining a constant heart rate and changing only the pumping volume within the right ventricle 32 and left ventricle 34 when a change in cardiac output is required; 2) maintaining a constant volume and changing the heart rate when a change in cardiac output is required; or 3) changing both volume and heart rate simultaneously in a "mixed" operating mode.

[0220] Still reference Fig.26 , the application software 198, by being communicatively coupled to the mobile power source 54, may (in one or more embodiments) allow the user to change the operation of the total artificial heart 30 directly from the electronic device 200. For example, the application software may enable the user to select other operating modes that indicate the overall patient activity level, such as "resting," "moderate," and / or "active." Then, when the user selects the "active" operating mode, the electronic device 200 may send a signal to the mobile power source 54 (which also acts as a control unit and / or control interface in many embodiments) to increase cardiac output (e.g., by increasing the heart rate). The application software 198 may also include an operating mode that allows cardiac output to automatically follow the patient's breathing rate, which may be achieved by one or more accelerometers or motion sensors 82 (in Figure 4), which senses the expansion and contraction of the lungs, stomach, and / or body cavities or diaphragms by direct contact (e.g., when the mobile power source 54 is attached to the patient's waist belt). In other words, by determining the rate or intensity of the patient's breathing using one or more accelerometers or motion sensors 82 mounted near the patient's waist, the patient's overall activity level can be determined and / or estimated, and cardiac output can be adjusted accordingly to match the patient's breathing rate. In one or more embodiments, the application software 198 can also be run on multiple devices simultaneously, so that the patient's friends or family and / or a remote monitoring team can monitor the patient's status and take appropriate action when an emergency or potentially problematic operating condition occurs.

[0221] Fig. 27 FIG. 2 shows a front view of a total artificial heart system 60 according to aspects of the present embodiment. Fig. 27 In an embodiment, the total artificial heart system 60 may include an implanted total artificial heart 30 including one or more drive systems (according to the present embodiment) electrically coupled to an implanted power source 204. The implanted power source 204 may include one or more rechargeable batteries implanted in the patient and housed in, for example, Fig.16 The implanted power source 204 can be connected to one or more external charging ports 206 outside the body. The external charging port allows an external power source or charger (e.g. Figure 4 , Fig.24 and / or Fig.25 ) is connected to an external charging port 206 to recharge the implanted power source 204. By implanting the power source 204 in the patient, the patient has a period of time when he or she can be completely disconnected from the external power source, thereby providing the patient with a period of time with greater flexibility.

[0222] Operational characteristics

[0223] Fig.28 A schematic diagram of current versus blood volume characteristics according to aspects of the present embodiment is shown. As the volume of blood VB being pumped increases, the current drawn by the motor 140 IM also increases. The relationship between VB and IM is approximately linear, but may also change based on small changes in heart rate and blood temperature (the human body typically maintains blood temperature within a narrow temperature range). As the blood temperature changes, even slightly, the blood viscosity (and therefore the power required to pump the blood) may also change slightly. The chemical composition of the blood may also change over time, which may also have a small effect on the viscosity of the blood. Therefore, the data is expected to accumulate in discrete clusters (which may be approximately linear), similar to Fig.28, rather than in a strictly linear fashion. If the clusters change over time such that the data is now accumulated in a second cluster 210 in which more current IM is required to pump the same volume of blood VB, this may indicate that the drive system 40, 42 (or other component of the total artificial heart 30) has degraded and is now operating less efficiently, or that the patient's blood pressure may be elevated, resulting in increased resistance to flow and requiring additional motor power to pump the same volume of blood. Thus, if the IM vs. VB clusters change over time, an alarm may be triggered and appropriate action taken. The motor current IM may be measured at the motor assembly 140 or the power bank 54, and the volume of blood VB pumped per heartbeat may be derived from the minimum and maximum air volumes in the drive system 40, 42, which may be calculated directly from the distance between the proximity sensors 118, 120 (e.g., Fig. 9 The amount of blood VB pumped per heartbeat can also be set by an input control (i.e., the amount of blood pumped per heartbeat (as selected at the capacity control module 174 of the mobile power supply 54) Fig.24 ))Rough estimate.

[0224] Fig.29 1 shows a schematic diagram of air volume versus air pressure characteristics according to aspects of the present embodiment. The air volume VA within the drive system 40, 42 may be determined using one or more proximity sensors 118, 120, while the air pressure PA may be determined using at least one pressure sensor 113 (e.g., Fig.10 Because drive systems 40, 42 are closed, airtight systems, the pressure of the air can also be derived from the volume of air within drive systems 40, 42 VA using Boyle's law (or the ideal gas law), PV = nRT, where P is the pressure, V is the volume, n is the number of air molecules (which is constant), R is a constant, and T is approximately constant because human body temperature is maintained within a narrow temperature range. Therefore, pressure and volume (as it applies to the air in drive systems 40, 42) are more or less inversely proportional to each other, and one can be roughly estimated directly from the other. As volume increases, pressure decreases. As volume decreases, pressure increases. Curve 212 (at Fig.29214 ) shows the volume to pressure characteristics of the air in the drive systems 40, 42 when the system is set to pump a smaller amount of blood. Under operating conditions corresponding to curve 212, because the cam follower 66 does not descend all the way to the bottom portion 100, the volume of air (i.e., below the cam follower 66) is not compressed as much. As a result, the drive systems 40, 42 descend from a maximum air volume to an intermediate air volume and back to a maximum air volume (and the air pressure correspondingly changes from a minimum pressure to an intermediate pressure and back to a minimum pressure). Under operating conditions corresponding to curve 214, the drive systems 40, 42 are set to allow the cam follower 66 to descend all the way to the bottom portion 100, thereby compressing the air to a minimum volume and allowing each of the right ventricle 32 and the left ventricle 34 to expand to a maximum volume (corresponding to a maximum cardiac output). Under operating conditions corresponding to curve 214, the drive systems 40, 42 descend from a maximum air volume to a minimum air volume and back to a maximum air volume (and the air pressure correspondingly changes from a minimum pressure to a maximum pressure and back to a minimum pressure).

[0225] Still reference Fig.29 , under steady-state conditions (i.e., assuming constant temperature), pressure and volume may be inversely proportional in a strictly linear relationship. However, under typical operating conditions of the drive systems 40, 42, volume is continuously changing, and thus these conditions are never truly steady state. As a result, pressure may lag slightly behind volume, at least as sensed by the one or more pressure sensors 113. In other words, as volume changes, it takes time for the pressure to "catch up" so that the pressure sensor 113 "reacts" and sends a signal reflecting the new pressure. This pressure sensor 113 time lag is caused by Figure 29-31 The elliptical shapes of the middle curves 212, 214, 216, 218, 220 and 222 reflect this. In other embodiments, the relationship between volume and pressure can be shown as strictly linear and inversely proportional. The arrows on one or more curves indicate how the relationship between volume and pressure changes when the system is running.

[0226] Fig.30A schematic diagram of blood volume versus blood pressure characteristics according to aspects of the present embodiment is shown. The air volume VA (inversely proportional to the blood volume) within the drive systems 40, 42 can be used to determine the blood volume VB within each of the right ventricle 32 and the left ventricle 34. The total volume of the total artificial heart 30 is constant (or approximately constant), so when the air volume in the drive systems 40, 42 increases, the blood volume in the right ventricle 32 and the left ventricle 34 must decrease. Similarly, as the air volume in the drive systems 40, 42 decreases, the blood volume in the right ventricle 32 and the left ventricle 34 must increase. The blood pressure PB can be determined based on the blood volume VB in each of the right ventricle 32 and the left ventricle 34 using an inverse relationship. When the blood volume in the right ventricle 32 and the left ventricle 34 is at a maximum (such as Fig.29 and 30 ), the air volume VA within the drive system 40, 42 will be at a minimum. Similarly, when the blood volume in the right ventricle 32 and the left ventricle 34 is at a minimum (e.g., Fig.29 and 30 ), the air volume VA within the drive system 40, 42 will be at a maximum. Therefore, curve 218 (at Fig.30 The middle) corresponds to the resting state when the total artificial heart 30 pumps the minimum amount of blood, and Fig.30 Curve 216 corresponds to the active (or maximum cardiac output) state when the total artificial heart 30 pumps the maximum amount of blood.

[0227] Fig.31 FIG. 2 shows a schematic diagram of the air volume VA versus air pressure PA characteristic according to aspects of the present embodiment. Fig.31 In an embodiment of the present invention, if the VA vs. PA characteristic changes from the initial curve 220 to the new curve 222 such that for a given volume, there is additional air pressure, this may indicate that something has changed in the total artificial heart system 60. For example, because the air volume and volume range of the system do not change over time, similar to Fig.31 Changes in the VA vs. PA characteristic may be an indication that external stress is acting on the drive system 40, 42 (e.g., due to increased blood pressure acting on the diaphragms 36, 38 and / or follower dome 110), thereby indicating that mitigating action should be taken (e.g., the patient should see a doctor, or have his or her blood pressure checked using a separate system such as a sphygmomanometer).

[0228] Fig.32A schematic diagram of the ramp height HR versus rotor angle AR characteristics according to aspects of the present embodiment is shown. As the rotor cam 64 rotates through various rotor angles AR, the ramp height HR changes at any given fixed circumferential position. For example, at a rotor angle AR of zero (0) degrees, the ramp height HR may be at a maximum value. When the rotor cam 64 rotates to ninety (90) degrees so that the descender 88 passes under one or more teeth 72, the ramp height is at a minimum value (e.g., at the flat portion 112). As the rotor cam 64 rotates to one hundred and eighty (180) degrees, two hundred and seventy (270) degrees, and finally to three hundred and sixty (360) degrees, the ramp height HR increases steadily over the inclined portion 114, eventually reaching a maximum height at three hundred and sixty (360) degrees (or zero (0) degrees).

[0229] Fig.33 A schematic diagram of follower height HF and rotor speed VR versus rotor angle AR characteristics according to aspects of the present embodiment is shown. Fig.33 The diagram assumes that the system has Fig.32 The same slope height HR curve. Fig.33 In the embodiment of the present invention, the rotor speed VR (represented by the dashed line) is at a higher speed 224 from about zero (0) degrees to about one hundred and eighty (180) degrees, and is at a lower speed 226 from about one hundred and eighty (180) degrees to about three hundred and sixty (360) degrees. The motor 140 can control the rotational speed based on the Hall sensor 118, 120 data (i.e., which can be used to determine the rotational speed VR and the circumferential position of the rotor cam 64), even within a single rotation. When the descending portion 88 of the rotor cam 64 passes under one or more teeth 72, the rotor cam 64 rotates at the higher speed 224. As a result, the teeth 72 do not contact the ramp 70 until the rotor cam 64 has rotated approximately one hundred and eighty (180) degrees. In other words, the height HF of the follower decreases from zero (0) degrees to one hundred and eighty (180) degrees, but because the rotor cam 64 rotates so quickly, the cam follower 66 never contacts the flat portion 112. Instead, cam follower 66 first contacts ramp 70 at inclined portion 114 (i.e., after descender 88 has passed). Fig.33 In the embodiment of , the cam follower 66 does not descend all the way, so the volume of the right ventricle 32 and the left ventricle 34 never reaches a maximum value. Fig.33 An embodiment corresponds to a resting or minimal cardiac output state.

[0230] Fig.34 A schematic diagram of follower height HF and rotor speed VR versus rotor angle AR characteristics according to aspects of the present embodiment is shown. Fig.34 The diagram assumes that the system has Fig.32 (as well as Fig.33) with the same slope height HR curve. Fig.33 In the embodiment of the present invention, the rotor speed VR (indicated by the dashed line) is at a lower rotational speed 226 from about zero (0) degrees to about one hundred and eighty (180) degrees, and is at a higher rotational speed 224 from about one hundred and eighty (180) degrees to about three hundred and sixty (360) degrees. When the descending portion 88 of the rotor cam 64 passes under one or more teeth 72, the rotor cam 64 rotates at the lower speed 226. As a result, the teeth 72 descend and contact the flat portion 112. In other words, the follower height HF is Fig.34 In the implementation method Fig.33 The embodiment of the invention descends much faster. Because the cam follower 66 is Fig.34 In the embodiment of the present invention, the volume of the right ventricle 32 and the left ventricle 34 does reach a maximum value. Fig.34 An embodiment corresponds to an active or maximal cardiac output state.

[0231] refer to Fig.33 and 34 , the area above the follower height HF curve (i.e., the solid line) is proportional to the cardiac output of the total artificial heart 30. Therefore, the lower the cam follower 66 descends, the higher the cardiac output of the total artificial heart 30 will be. As the rotational speed decreases between zero (0) degrees and about one hundred and eighty (180) degrees, the cam follower 66 will descend faster. The rotor angle AR can also be described as the circumferential direction of the rotor cam 64. Fig.33 and 34 In an embodiment, the average rotation speed may be the same for the entire three hundred sixty (360) degree rotation. Fig.33 In FIG. 6 , the rotor cam 64 rotates faster during the first portion of the rotation, resulting in a lower total cardiac output. Conversely, in Fig.34 In the embodiment of the present invention, the rotor cam 64 rotates slower during the first part of the rotation, resulting in a higher total cardiac output. In other words, the expansion amplitude of the right and / or left artificial ventricle 32, 34 is inversely proportional to the rotation speed of the rotor cam 64. Therefore, the cardiac output can be adjusted higher and lower by adjusting the rotation speed within each rotation without changing the overall average rotation speed (i.e., or heart rate).

[0232] Figure 28-34 Each of the operating characteristics shown in can be used (alone and / or in conjunction with each other) to detect changes in one or more conditions related to the patient's health. For example, if Figure 28-34 If any of the operating characteristics shown in changes over time, an alert can be sent to the patient and / or clinician indicating that the patient's blood pressure has changed, or that one or more potentially harmful conditions may exist, such as hypervolemia, pulmonary hypertension, blood clots, etc.

[0233] How to operate

[0234] Fig.35 A schematic diagram of a method 300 of implanting a total artificial heart 30 in a human body according to aspects of the present embodiment is shown. At step 302, the method 300 may include providing a system including a motor (e.g., a BLDC motor 140), the system including a stator assembly 62, a rotor cam 64, a cam follower 66, and a wire 48, wherein at least one system component is coated with a segmented polyurethane solution (SPUS). At step 304, the method 300 may include implanting the system in a patient. At step 306, the method 300 may include connecting a power source to the implanted system.

[0235] Fig.36A schematic diagram of a method 400 for calibrating a total artificial heart 30 according to aspects of the present embodiment is shown. At step 402, the method 400 may include setting an initial Hall sensor 136 position within the rotor cam 64 or stator assembly 62 so that the Hall sensor 136 can detect changes in the electromagnetic field associated with each rotation of the rotor cam 64. At step 404, the method 400 may include establishing an offset between the first drive system 40 and the second drive system 42 so that the right ventricle 32 and the left ventricle 34 can be actuated (or pumped) in an orderly manner in which the contraction of the right ventricle 32 closely follows the contraction of the left ventricle 34 (and vice versa). In other embodiments, the offset may be established by rotationally offsetting the rotor cam 64 within the second drive system 42 from the rotor cam of the first drive system 40 (i.e., setting them at different initial angles) so that even though electricity may be introduced to each drive system at the same time, the first and second drive systems 40, 42 will be at different parts of the pumping cycle. At step 406, the method 400 may include setting a second Hall sensor 136 position corresponding to the position of the second rotor cam 64 (i.e., the rotor cam 64 of the second drive system 42). At step 408, the method 400 may include placing the total artificial heart 30 in operation. At step 410, the method 400 may include tracking the position of each rotor cam 64 within the respective first and second drive systems 40, 42 so that offsets may be monitored. At step 412, the method may include marking (or sending an alarm indication) when the initial offset has drifted. At step 414, the method 400 may include slightly increasing or decreasing the current (thereby controlling the rotational speed) to one of the two drive systems 40, 42 (while maintaining the other at a constant value), thereby adjusting the offset (at step 416) to a new value, or resetting the offset back to the initial value (at step 418). At step 420, the method may include monitoring the position of each rotor cam 64 (and the angular offset between them) to determine whether an offset change has occurred. At step 422 , method 400 may include repeating any of steps 402 - 420 as necessary to achieve a desired rotor cam 64 offset and / or system calibration.

[0236] Fig.37A schematic diagram of a method 500 of operating a total artificial heart 30 according to aspects of an embodiment of the present disclosure is shown. At step 502, the method 500 may include initiating operation of the total artificial heart system 60. At step 504, the method 500 may include establishing a rest set point (e.g., a resting heart rate, a resting blood volume, and / or a resting compression ratio of the drive system 40, 42). At step 506, the method 500 may include establishing a moderate activity set point (i.e., corresponding to a desired cardiac output associated with moderate activity). At step 508, the method 500 may include establishing a vigorous activity set point (e.g., setting a heart rate, blood volume, or compression ratio corresponding to a desired cardiac output for vigorous activity). At step 510, the method 500 may include monitoring overall blood pressure (e.g., as measured by Figure 28-31 or determined by a separate device such as a sphygmomanometer). At step 512, the method 500 may include evaluating a manual input that the patient or user may have made at the control interface or power bank 54 (i.e., at the heart rate control module 166 or the volume control module 174), for example, to increase or decrease cardiac output (i.e., from one of the set points). At step 514, the method 500 may include monitoring the blood pressure within each of the right artificial ventricle 32 and the left artificial ventricle 34 to determine if there is a difference between the two (which may indicate, for example, pulmonary hypertension or a blood clot). At step 516, the method 500 may include monitoring the respiratory rate via one or more accelerometers or motion sensors 82 mounted near the patient's waist (i.e., to assess whether cardiac output should be increased, for example, to match an elevated patient respiratory rate). At step 518, the method 500 may include increasing or decreasing one or more heart rate set points to adjust cardiac output to a desired level based on respiratory rate, manual input, overall blood pressure, ventricular blood pressure difference, and / or other factors. At step 520, the method 500 may include increasing or decreasing one or more blood volume set points to adjust cardiac output to a desired level based on respiratory rate, manual input, overall blood pressure, ventricular blood pressure difference, and / or other factors. At step 522, the method 500 may include selecting a different operating mode (e.g., manual, rest, moderate exercise, respiratory rate matching, vigorous exercise, hybrid control, and / or another control mode). At step 524, the method 500 may include repeating any of steps 502-522 as needed to achieve the desired operating mode of the total artificial heart system 60.

[0237] refer to Figure 35-37, each of the methods 300, 400, 500 may include steps not shown in the respective figures. In addition, in one or more embodiments of each of the methods 300, 400, 500, the steps may be performed in a different order than shown. In other aspects of the present embodiment, each of the methods 300, 400, 500 may also omit one or more steps. In one or more embodiments, each of the methods 300, 400, 500 may include performing at least one step simultaneously with at least one other step.

[0238] Embodiments of the present disclosure provide a total artificial heart system 60 that can enhance patient mobility. By providing power from an external power source 54 to an implanted internal motor assembly 140 that powers the drive system 40, 42, the external hardware that needs to be carried and managed by the patient can be reduced. Aspects of embodiments of the present disclosure include a lightweight external power source 54 that can be worn on a belt or carried in a pocket, thereby freeing up hands. In addition, the external power source can include a convenient control interface that allows the user to easily replace batteries and adjust the operation of the total artificial heart system 60 as needed. The drive system 40, 42 of this embodiment converts the rotary motion of the motor into linear motion and saves space by molding the external rotating "rotor" of the motor, which is molded in such a way that the rotor itself forms a rotating "cam" that pushes the "cam follower" in linear motion, thereby combining the cam function in the cam and follower system with the rotor function in the rotor / stator motor system to form a single rotor cam assembly. By using a selectively controlled motor 140, so that any rotational speed can be dialed in at any angle in the rotation, and then by using a cam and follower system to convert the rotational motion into linear motion, the contraction and expansion of the heart chambers can be quickly and gently controlled as needed at every point within each rotation of the rotor cam (and within each heartbeat). The drive system 40, 42 of the present embodiment includes three (3) major components, including the stator assembly 62, the rotor cam 64, and the cam follower 66, thereby reducing the complexity of the system and improving durability. The drive mechanism has a "pusher" that now mechanically pushes the ventricular septum during systole. And, the drive mechanism is mechanically disengaged at the beginning of diastole, allowing the body to naturally fill the ventricle. In addition, springs and dampers can be optionally used to assist in ventricular filling during diastole. And, because the system is now driven by a motor mounted within the artificial ventricle, the system (battery and controller) can now be completely implanted. In addition, the biocompatible materials and coatings of aspects of the present embodiment ensure that the patient will not have an adverse response or reaction to the implanted components.

[0239] Each of the instruments, devices, and sensors described in this disclosure may include a wired or wireless power source, such as a battery, capacitor, or other suitable mechanism.

[0240] Elements of the different implementations described may be combined to form other implementations not specifically described before. Various elements may be excluded from the described processes as long as they do not generally adversely affect their operation or the operation of the system. In addition, various individual elements may be combined into one or more individual elements to perform the functions described in this specification.

[0241] Other implementations not specifically described in this specification are also within the scope of the following claims.

[0242] These and other features, aspects and advantages of the present invention will be better understood with reference to the foregoing description and appended claims.The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the description, serve to explain the principles of the embodiments.

[0243] Some definitions

[0244] In order to more easily understand the present disclosure, certain terms are first defined below. Additional definitions of the following terms and other terms are set forth throughout the specification.

[0245] The devices, compositions, or methods described herein as "comprising" one or more named elements or steps are open-ended, meaning that the named elements or steps are essential, but other elements or steps may be added within the scope of the composition or method. To avoid verbosity, it should also be understood that any device, composition, or method described as "comprising" one or more specified elements or steps also describes a corresponding, more limited composition or method "consisting essentially of the same named elements or steps," meaning that the composition or method includes the named basic elements or steps, and may also include additional elements or steps that do not materially affect the basic and novel features of the composition or method. It should also be understood that any device, composition, or method described herein as "comprising" one or more named elements or steps or "consisting essentially of one or more named elements or steps" also describes a corresponding, more limited and closed composition or method "consisting of the named elements or steps" without including any other unnamed elements or steps. In any composition or method disclosed herein, a known or disclosed equivalent of any named basic element or step may be substituted for that element or step.

[0246] As used herein, "a" or "an" with respect to claim features means "one or more" or "at least one".

[0247] As used herein, the term "left" is understood to be in a reference frame taken from the patient's perspective, which may be relative to where it appears on the page. Figure 2 In the figure, the left artificial ventricle 34 is located on the right side of the figure.

[0248] As used herein, the term "right" is understood to be in a reference frame taken from the patient's perspective, which may be relative to where it appears on the page. Figure 2 In FIG. 4 , the right artificial ventricle 32 is located on the left side of the figure.

[0249] As used herein, the term "substantially" refers to the qualitative condition of exhibiting the full or nearly full extent or degree of a characteristic or property of interest.

[0250] Equivalent

[0251] It should be understood that although the disclosure has been described in conjunction with the detailed description of the disclosure, the foregoing description is intended to illustrate and not limit the scope of the invention. Other aspects, advantages and modifications are within the scope of the claims.

[0252] This written description uses examples to disclose the invention, including the best mode, and also to enable those skilled in the art to practice the embodiments, including making and using any devices or systems and performing any combined methods. The patent scope of the embodiments is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they include structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements that do not differ substantially from the literal language of the claims.

Claims

1. A total artificial heart system, comprising: at least one artificial ventricle configured to be connected to at least one of a pulmonary artery, a heart vessel, and a ventricle; at least one drive system connected to the at least one artificial ventricle and configured to cause the at least one artificial ventricle to contract and expand, the at least one drive system comprising at least one electric motor, wherein the at least one drive system comprises: at least one stator assembly, at least one rotor cam coupled to the at least one stator assembly, and at least one cam follower coupled to the at least one rotor cam; and at least one power source electrically coupled to the at least one electric motor, wherein the at least one artificial ventricle is coupled to the at least one cam follower, wherein a change in height of at least one of the cam followers causes expansion of at least one of the artificial ventricles, wherein the expansion amplitude of at least one artificial ventricle is inversely proportional to the rotation speed of at least one rotor cam; and The at least one artificial ventricle and the at least one drive system are configured to be implanted in a chest cavity of a patient.

2. The total artificial heart system according to claim 1, in, The at least one artificial ventricle includes a right artificial ventricle configured to be connected to a pulmonary artery; The total artificial heart system also includes: a left artificial ventricle, which is configured to be connected to the left atrium; a first drive system, which is connected to the right artificial ventricle, the first drive system includes a first implanted motor; and a second drive system, which is connected to the left artificial ventricle, the second drive system includes a second implanted motor.

3. The total artificial heart system according to claim 1, further comprising a first lead and / or a second lead, wherein the first lead couples the first implanted motor to an external power source, and the second lead couples the second implanted motor to an external power source; The total artificial heart system is further characterized by one or more of the following features: i) the external power source is outside the patient's body, and each of the right artificial ventricle, the left artificial ventricle, the first drive system, and the second drive system is inside the patient's body; ii) a first portion of the first lead is inside the patient's body and a second portion of the first lead is outside the patient's body; iii) the first drive system comprises said at least one stator assembly, said stator assembly comprising at least one housing; iv) the at least one rotor cam is disposed about at least one housing of the at least one stator assembly, wherein the at least one rotor cam is electrically coupled to the at least one stator assembly, and the at least one cam follower is mechanically coupled to the at least one stator assembly and the at least one rotor cam; v) the at least one rotor cam is configured to function as a cam in a cam and follower system and as a rotor in a motor assembly, and / or wherein the at least one rotor cam comprises at least one permanent magnet; vi) wherein at least one of the rotor cam, the at least one stator assembly, and the at least one cam follower is coated, wherein the coating comprises at least one biocompatible material, the at least one biocompatible material comprising at least one of a segmented polyurethane solution, silicone rubber, a thermoplastic elastomer, and polyvinyl chloride; vii) wherein at least one of the right artificial ventricle and the left artificial ventricle comprises at least one of a segmented polyurethane solution, silicone rubber, a thermoplastic elastomer, and polyvinyl chloride; viii) wherein at least one of the first implanted motor and the second implanted motor comprises a brushless DC motor; and ix) wherein said at least one drive system comprises at least one cam and follower system.

4. The total artificial heart system according to claim 1, further comprising one or both of the following features: (A) at least one septum defining a boundary between at least one artificial ventricle and at least one drive system, in, On the ventricular side, the at least one diaphragm is configured to contact human blood, and wherein, on the drive system side, the at least one diaphragm is configured to contact air; and (B) Electronic equipment, including: at least one display screen; Application software for tracking the activity of at least one total artificial heart system; and at least one communication module configured to wirelessly communicate at least one data parameter between an electronic device and a mobile power source coupled to the at least one total artificial heart system.

5. The total artificial heart system of claim 4, wherein the electronic device is characterized by one or more of the following features: (i) the at least one data parameter transmitted from the mobile power source to the electronic device is displayed on the at least one display screen; (ii) the at least one data parameter comprises at least one of a heart rate and a blood pressure of at least one patient implanted with the at least one total artificial heart system; (iii) the at least one data parameter includes at least one of a battery charge level and a remaining life of at least one battery coupled to the power bank; (iv) the at least one data parameter comprises at least one of: right ventricular blood volume of the at least one patient in which the at least one total artificial heart system is implanted; left ventricular blood volume of the at least one patient in which the at least one total artificial heart system is implanted, an operating mode of the at least one total artificial heart system, and an operating status of the at least one total artificial heart system; (E) wherein the electronic device is configured to communicate with another electronic device having application software installed thereon.

6. The total artificial heart system according to claim 1, It is further characterized by one or more of the following features: (A) at least one spring coupling the at least one cam follower to the at least one stator assembly, wherein the at least one stator assembly includes a housing having a shaped cross-section; wherein the at least one cam follower comprises a shaft having a shaped cross-section that matches a shaped cross-section of the housing, wherein the shaped cross-section of each of the housing and the shaft is one of a triangular cross-section, a square cross-section, an elliptical cross-section, a pentagonal cross-section, a hexagonal cross-section, and a rectangular cross-section, and wherein the shaft is disposed within the housing; wherein the shaft is configured to move longitudinally within the housing; and wherein the housing comprises at least one damper disposed within the housing; (B) The at least one rotor cam comprises: a central bore concentric about a centerline of the at least one rotor cam; and a ramp disposed radially about the central aperture, wherein the ramp comprises: at least one descending portion, an inclined portion, a flat portion disposed between the inclined portion and the descending portion; and / or wherein the at least one cam follower comprises at least one tooth extending toward the at least one rotor cam and engaging at least one portion of the ramp; (C) the at least one rotor lobe comprises at least one of neodymium iron boron, iron, cobalt, samarium cobalt, aluminum, alnico, bonded neodymium iron boron, magnetite, ceramic, ferrite, gadolinium, one or more rare earth elements, strontium, barium, and iron oxide; (D) the total artificial heart system further comprising at least one proximity sensor disposed within at least one of the at least one stator assembly and the at least one cam follower; wherein at least one proximity sensor is configured to detect a position of the at least one cam follower relative to the at least one stator assembly; (E) the total artificial heart system further comprises at least one pressure sensor disposed on at least one of the at least one stator assembly and the at least one rotor cam; (F) the at least one rotor cam includes a central bore, wherein the at least one stator assembly includes a cylindrical housing disposed within the central bore such that the at least one rotor cam circumferentially surrounds the cylindrical housing and extends radially outwardly of the cylindrical housing; and (G) The at least one stator assembly comprises a cylindrical housing, wherein the at least one rotor cam is disposed about the cylindrical housing, and wherein rotation of the at least one rotor cam about the cylindrical housing causes a change in height of the at least one cam follower, wherein the at least one cam follower is coupled to the at least one artificial ventricle.

7. The total artificial heart system according to claim 1, wherein the at least one electric motor comprises: inner stator housing; A plurality of windings are arranged radially outside the inner stator housing; An outer stator housing, which is arranged radially outside the plurality of winding groups; and The rotor is arranged radially outside the outer stator housing.

8. The total artificial heart system of claim 7, wherein the at least one electric motor is further characterized by one or more of the following features: (A) the at least one electric motor comprises a brushless DC motor; (B) the at least one electric motor further comprising at least one Hall sensor; (C) the plurality of windings comprises at least six (6) windings; (D) each of the plurality of windings comprises one or more longitudinally aligned electrically conductive coil wires; (E) the inner stator housing comprises a hexagonal housing, and the outer stator housing comprises a cylindrical housing; and (F) The rotor includes at least one permanent magnet, the at least one permanent magnet including at least one of neodymium iron boron, iron, cobalt, samarium cobalt, aluminum, alnico, one or more rare earth elements, bonded neodymium iron boron, magnetite, ceramic, ferrite, gadolinium, strontium, barium, and iron oxide.

9. The total artificial heart system of claim 1, wherein the at least one stator assembly comprises: Round base; at least one housing extending longitudinally from the circular base; and a plurality of windings disposed radially inside and / or outside of at least one housing; and The at least one electric motor comprises at least one rotor which is arranged radially outside of at least one housing.

10. The total artificial heart system of claim 9, wherein the at least one electric motor is further characterized by one or more of the following features: (A) a hexagonal shell disposed radially inside the plurality of windings, wherein at least one of the shells further comprises a cylindrical shell disposed radially outside the plurality of windings; (B) at least one rotor includes a cam; (C) at least one power source electrically coupled to the circular base, wherein at least one of the mobile power sources includes an integrated control interface operably coupled to the at least one stator assembly, and (D) at least one mobile power source includes at least one battery disposed within a circular base, (E) the circular base comprises a cylindrical shape, wherein the integrated control interface is configured to control the rotational speed of the at least one rotor and the rotational speed of the at least one rotor within each rotation of the at least one rotor and is configured to adjust the rotational speed of the at least one rotor within each rotation of the at least one rotor based on the circumferential orientation of the at least one rotor; (F) the integrated control interface is configured to adjust the rotational speed of the at least one rotor from a first rotational speed in a first range of circumferential orientations of the at least one rotor to a second rotational speed in a second range of circumferential orientations of the at least one rotor; and (G) The integrated control interface is configured to adjust a rotational speed of the at least one rotor from a first rotational speed in a first rotor angle range to a second rotational speed in a second rotor angle range.

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