Electromagnetically driven heart pump

Abstract

A novel implantable transapical expandable cardiac pump, comprising an external motor, battery, and microprocessor, and incorporating a valve, is disclosed herein. [Solution] The pump can be placed via transapical puncture, eliminating the need for cardiac incision. The device can function on the left side of the heart by expanding within the left ventricle and extending across the aortic valve to the ascending aorta, and on the right side of the heart by expanding within the right ventricle and entering the main pulmonary artery by expanding across the pulmonary valve. When implanted bilaterally, the device can replace the entire cardiac function.

Description

TECHNICAL FIELD

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 539,784, filed on September 21, 2023, entitled "A Novel Fully Implantable Transapical Expandable Heart Pump with Extracorporeal Motor and Battery", and U.S. Patent Application No. 18 / 891,378, filed on September 20, 2024, entitled "Electromagnetically-Driven Heart Pump", the entire contents of which are incorporated herein by reference in their entirety for all purposes.

[0002] The present disclosure is directed to at least the fields of surgery, medicine, and medical devices, and more particularly to medical devices for supporting or replacing a heart in a blood circulation state, and methods for implanting and operating such medical devices. BACKGROUND ART

[0003] A heart pump is a medical device that supports a failing or failed heart by transporting fluid from one location in the human body to another, such as transporting fluid from the left ventricle to the aorta or from the right ventricle to the pulmonary artery. Heart pumps can be used to support patients until a transplant becomes available, or as destination therapy for patients who currently have no other options.

[0004] Implantation of a cardiac pump requires a surgical procedure. Conventional cardiac pump implantation requires an incision in the apex of the left ventricle to accommodate the pump inflow cannula. The surgical procedure also requires creating an opening in the ascending aorta to connect the pump outflow cannula. Performing this large and complex surgical procedure necessitates the use of cardiopulmonary bypass, which carries risks and potential adverse outcomes. Conventional cardiac pumps require wires that penetrate the skin for connection to and power supply of the pump motor. [Overview of the project] [Problems that the invention aims to solve]

[0005] Conventional placement techniques for cardiac pumps have at least two major drawbacks. First, implantation requires access to the inside of the heart using an incision for cardiac pump placement. This is a major intrusion into the heart and can lead to complications and poor patient outcomes. Second, conventional cardiac pumps require elements such as wires or cables that penetrate the skin for external connections. Wires and / or cables that penetrate the skin in this way are a source of infection and complications. Furthermore, cardiac pumps or left ventricular assist devices (LVADs) have a metal inlet tube inserted into the left ventricle and an outlet cannula that connects to the aorta by a major surgical procedure that requires the patient to be connected to a cardiopulmonary bypass machine.

[0006] The drawbacks described herein are representative only and are included simply to emphasize the need for improvements in cardiac pumps and surgical techniques. The embodiments described herein address some of the drawbacks, but do not necessarily address all of the drawbacks described herein or known in the art. Furthermore, the embodiments described herein may offer benefits other than those of the surgical techniques described above, and may be used in ways other than those of the surgical techniques described above. For example, an embodiment of a cardiac pump according to this disclosure includes a geometric housing fixed to the outside of the patient, which wirelessly supplies power to a geometric plate. The geometric plate, connected to the proximal end of a cannula, is positioned within the patient's body. The distal end of the cannula is inserted into the heart through a catheter. Once inside the heart, the cannula expands and can move fluid from its position within the heart to another position as needed for effective cardiovascular flow. Such embodiments of cardiac pumps offer many advantages. For example, such a cardiac pump can be positioned without using surgical incisions in cardiac tissue and / or without using protruding elements that penetrate the skin. Furthermore, such interventions can be performed without connecting the patient to a cardiopulmonary bypass machine, thereby avoiding complications associated with cardiopulmonary bypass use, such as stroke, heart attack, aortic dissection, aortic valve insufficiency, and even death. [Means for solving the problem]

[0007] This disclosure covers solutions to problems related to the placement and operation of cardiac pumps. In some embodiments, this disclosure can be used in cardiac procedures that include cardiac pump placement. In some embodiments, this disclosure is a transapical expandable cardiac pump that houses the motor and battery outside the body and incorporates a self-expanding ventricular-arterial valve conduit, as well as a cannula valve for replacing and enhancing natural valve function. In some embodiments, the cardiac pump can transport fluid from one location to another using centrifugal or axial flow. In some embodiments, the cardiac pump can utilize an electromagnetic field to propel the impeller via electromagnetic coupling.

[0008] This disclosure further relates to a system for inserting a cardiac pump into a patient's heart using a novel tissue-penetrating placement mechanism. The cardiac pump system comprises at least one geometric housing; at least one geometric plate coupled to the geometric housing, wherein the geometric housing is located outside the patient's body (e.g., outside the patient's body) and the geometric plate is located inside the patient's body, with a skin barrier positioned between the geometric housing and the geometric plate; and at least one cannula element coupled to the geometric plate, wherein at least one cannula is configured to penetrate at least one cardiac chamber of the heart and at least one cannula is configured to drain blood from inside at least one cardiac chamber of the heart to the outside of at least one cardiac chamber of the heart. The cardiac pump system and its various elements are replaceable or removable.

[0009] In various embodiments, the cannula comprises a membrane-covered frame, which is coated with a pharmaceutical agent, such as a drug-eluting anticoagulant, but is not limited to this. The cannula can be positioned inside a delivery sheath. The delivery sheath can be coupled to the tip of an introducer. The cannula may be a self-expanding cannula. After placement, a self-expanding cannula can transition from a first formation to a second formation. For example, one element of the cannula, such as the frame, can transition from a compressed position to an expanded position after the sheath is removed. In the expanded position, the frame can contact a cardiac valve. The cannula comprises at least one of a double cannula or an axial cannula. A double cannula comprises at least one of a frame, an outflow conduit, an inflow conduit, an impeller housing, one or more valves, one or more sensors, or an impeller housing ventricular interface. An axial flow cannula comprises at least one of a frame, an outflow conduit, an impeller, an axial shaft, a connector connecting at least one axial shaft to at least one bend drive shaft, one or more valves, and one or more sensors. The impeller housing comprises at least one impeller. The impeller comprises at least one of a centrifugal impeller or an axial flow impeller. The geometric housing comprises at least one of a motor, a battery, a microprocessor, a chest frame mounting mechanism, a geometric motor interface, or a body plate motor connector. The geometric plate comprises at least one of a ventricular magnetic driver housing, a ventricular magnetic impeller driver connector, or a ventricular magnetic impeller interface. The geometric housing may have a shape comprising one or more of triangular, circular, right-angled, hexagonal, or different geometric shapes. A double cannula is connected to a geometric plate by a bend drive, which can bend to accommodate different anatomical shapes of the patient.The chest frame mounting mechanism includes one or more electrically driven magnets or a mechanical mounting mechanism for holding a geometric housing in place.

[0010] In some examples, the introducer tip may include a needle, catheter, dilator, or sheathing needle. The introducer tip may include a catheter and / or needle having sizes 6G, 7G, 8G, 9G, 10G, 11G, 12G, 13G, 14G, 15G, 16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G, 32G, 33G, 34G, and any range in between, where "G" refers to the gauge as the size of the wire diameter. The cannula may include a needle and / or catheter having lengths of 0.1in, 1in, 2in, 3in, 4in, 5in, 6in, and any range in between. The cannula is equipped with a trowel needle having sizes of 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, and any range in between. The cannula is equipped with a dilator having lengths of 0.1 in, 1 in, 2 in, 3 in, 4 in, 5 in, 6 in, 7 in, 8 in, 9 in, 10 in, 11 in, 12 in, 13 in, 14 in, 15 in, 16 in, 17 in, and any range in between.

[0011] In various examples, the frame can have wall thicknesses ranging from 0.01 mm to 10 mm. The frame has wall thicknesses having sizes of 0.01 mm, 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, and any range in between. The operating diameter of the frame can range from 0.1 mm to 35 mm, preferably from 11 mm to 22 mm. The frames have operating diameters of 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm, 25mm, 26mm, 27mm, 28mm, 29mm, 30mm, 31mm, 32mm, 33mm, 34mm, 35mm, and any range in between. The frames can be compressed to smaller diameters. The compressed diameter can range from 0.1mm to 25mm, preferably 8mm. The frame has compression diameters of 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm, 25mm, and any range in between.

[0012] In some embodiments, the axial conduit, the outflow conduit and / or inflow conduit of the double cannula may have a wall thickness ranging from 0.01 mm to 2 mm, preferably in the range of 0.08 to 0.20 mm. The wall thicknesses of the axial conduit, the outflow conduit and / or inflow conduit of the double cannula can be 0.01 mm, 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.10 mm, 0.11 mm, 0.12 mm, 0.13 mm, 0.14 mm, 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm, 0.19 mm, 0.20 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, 0.25 mm, 0.26 mm, and 0.27 mm. , 0.28mm, 0.29mm, 0.30mm, 0.31mm, 0.32mm, 0.33mm, 0.34mm, 0.35mm, 0.36mm, 0.37mm, 0.38mm, 0.39mm, 0.40mm, 0.41mm, 0.42mm, 0.43mm , 0.44mm, 0.45mm, 0.46mm, 0.47mm, 0.48mm, 0.49mm, 0.50mm, 0.51mm, 0.52mm, 0.53mm, 0.54mm, 0.55mm, 0.56mm, 0.57mm, 0.58mm, 0.59mm , 0.60mm, 0.61mm, 0.62mm, 0.63mm, 0.64mm, 0.65mm, 0.66mm, 0.67mm, 0.68mm, 0.69mm, 0.70mm, 0.71mm, 0.72mm, 0.73mm, 0.74mm, 0.75mm , 0.76mm, 0.77mm, 0.78mm, 0.79mm, 0.80mm, 0.81mm, 0.82mm, 0.83mm, 0.84mm, 0.85mm, 0.90mm, 0.91mm, 0.92mm, 0.93mm, 0.94mm, 0.95mm , 0.96mm, 0.97mm, 0.98mm, 0.99mm, 1mm, 1.01mm, 1.02mm, 1.03mm, 1.04mm, 1.05mm, 1.06mm, 1.07mm, 1.08mm, 1.09mm, 1.10mm, 1.11mm, 1. 12mm, 1.13mm, 1.14mm, 1.15mm, 1.16mm, 1.17mm, 1.18mm, 1.19mm, 1.20mm, 1.21mm, 1.22mm, 1.23mm, 1.24mm, 1.25mm, 1.26mm, 1.27mm, 1.28mm, 1.29mm, 1.30mm, 1.31mm, 1.32mm, 1.33mm, 1.34mm, 1.35mm, 1.36mm, 1.37mm, 1.38mm, 1.39mm, 1.40mm, 1.41mm, 1.42mm, 1.43mm, 1.44mm, 0.45mm , 1.46mm, 1.47mm, 1.48mm, 1.49mm, 1.50mm, 1.51mm, 1.52mm, 1.53mm, 1.54mm, 1.55mm, 1.56mm, 1.57mm, 1.58mm, 1.59mm, 1.60mm, 1.61mm, 1.62mm, 1.63 The range includes mm, 1.64mm, 1.65mm, 1.66mm, 1.67mm, 1.68mm, 1.69mm, 1.70mm, 1.71mm, 1.72mm, 1.73mm, 1.74mm, 1.75mm, 1.76mm, 1.77mm, 1.78mm, 1.79mm, 1.80mm, 1.81mm, 1.82mm, 1.83mm, 1.84mm, 1.85mm, 1.90mm, 1.91mm, 1.92mm, 1.93mm, 1.94mm, 1.95mm, 1.96mm, 1.97mm, 1.98mm, 1.99mm, 2mm, and any range between them.

[0013] In some examples, physiological measurements may include cannula sensors that measure one or more of the following: pressure in the cardiac chambers, pumping force, blood pressure, blood oxygen level, blood pH level, blood lactate level, troponin level, blood carbon dioxide level, partial pressure of oxygen, partial pressure of carbon dioxide, blood bicarbonate level, hemoglobin level, blood sodium level, blood magnesium level, blood potassium level, blood calcium level, blood chloride level, blood phosphate level, blood glucose level, blood procalcitonin level, or blood type B natriuretic peptide level. Physiological measurements can be used by healthcare professionals and / or artificial intelligence algorithms to determine historical values ​​based on previous physiological measurements. The healthcare professionals and / or artificial intelligence algorithms can then determine thresholds based on these historical values. In addition, the healthcare professionals and / or artificial intelligence algorithms can adjust the motor speed based on a comparison between the physiological measurement and the threshold.

[0014] In one example, the geometric housing comprises one or more polymers, one or more metals, one or more ceramics, or a combination thereof. The polymers may consist of polytetrafluoroethylene (PTFE) and polyurethane (PU), ultra-high molecular weight polyethylene, polyether ether ketone (PEEK), polystyrene, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, polymethyl methacrylate, or a combination thereof. The metals may consist of stainless steel, nitinol, aluminum, copper, titanium, cobalt chromium, magnesium, gold, platinum, silver, iridium, tantalum, or a combination thereof. The ceramics may consist of alumina, zirconia, calcium orthophosphate, bioactive glass, silicon carbide, or a combination thereof.

[0015] In some embodiments, the geometric plate may comprise one or more polymers, one or more metals, one or more ceramics, or a combination thereof. The polymers may consist of polytetrafluoroethylene (PTFE) and polyurethane (PU), ultra-high molecular weight polyethylene, polyether ether ketone (PEEK), polystyrene, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, polymethyl methacrylate, or a combination thereof. The metals may consist of stainless steel, nitinol, aluminum, copper, titanium, cobalt chromium, magnesium, gold, platinum, silver, iridium, tantalum, or a combination thereof. The ceramics may consist of alumina, zirconia, calcium orthophosphate, bioactive glass, silicon carbide, or a combination thereof.

[0016] For example, a cannula plate may comprise one or more polymers, one or more metals, one or more ceramics, or a combination thereof. Polymers may consist of polytetrafluoroethylene (PTFE) and polyurethane (PU), ultra-high molecular weight polyethylene, polyether ether ketone (PEEK), polystyrene, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, polymethyl methacrylate, or a combination thereof. Metals may consist of stainless steel, nitinol, aluminum, copper, titanium, cobalt chromium, magnesium, gold, platinum, silver, iridium, tantalum, or a combination thereof. Ceramics may consist of alumina, zirconia, calcium orthophosphate, bioactive glass, silicon carbide, or a combination thereof.

[0017] In other embodiments, the frame may comprise one or more polymers, one or more metals, one or more ceramics, or a combination thereof. The polymers may consist of polytetrafluoroethylene (PTFE) and polyurethane (PU), ultra-high molecular weight polyethylene, polyether ether ketone (PEEK), polystyrene, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, polymethyl methacrylate, or a combination thereof. The metals may consist of stainless steel, nitinol, aluminum, copper, titanium, cobalt chromium, magnesium, gold, platinum, silver, iridium, tantalum, or a combination thereof. The ceramics may consist of alumina, zirconia, calcium orthophosphate, bioactive glass, silicon carbide, or a combination thereof.

[0018] In some embodiments, the impeller and / or impeller housing may consist of one or more biologically inert material polymers, one or more metals, one or more ceramics, or a combination thereof. Polymers may consist of polytetrafluoroethylene (PTFE) and polyurethane (PU), ultra-high molecular weight polyethylene, polyether ether ketone (PEEK), polystyrene, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, polymethyl methacrylate, or a combination thereof. Metals may consist of stainless steel, nitinol, aluminum, copper, titanium, cobalt chromium, magnesium, gold, platinum, silver, iridium, tantalum, or a combination thereof. Ceramics may consist of alumina, zirconia, calcium orthophosphate, bioactive glass, silicon carbide, or a combination thereof. The impeller housing may be manufactured using additive manufacturing such as 3D printing.

[0019] In some embodiments, the geometric motor interface to the body plate motor connector and ventricular magnetic impeller driver interface can be manufactured from polymers, metals, ceramics, or combinations thereof. Polymers can consist of polytetrafluoroethylene (PTFE) and polyurethane (PU), ultra-high molecular weight polyethylene, polyether ether ketone (PEEK), polystyrene, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, polymethyl methacrylate, or combinations thereof. Metals can consist of stainless steel, nitinol, aluminum, copper, titanium, cobalt chromium, magnesium, gold, platinum, silver, iridium, tantalum, or combinations thereof. In some embodiments, ceramics can consist of alumina, zirconia, calcium orthophosphate, bioactive glass, silicon carbide, or combinations thereof.

[0020] In one embodiment, the sheath may consist of one or more polymers, one or more metals, one or more ceramics, or a combination thereof. The polymers may consist of polytetrafluoroethylene (PTFE) and polyurethane (PU), ultra-high molecular weight polyethylene, polyether ether ketone (PEEK), polystyrene, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, polymethyl methacrylate, or a combination thereof. The metals may consist of stainless steel, nitinol, aluminum, copper, titanium, cobalt chromium, magnesium, gold, platinum, silver, iridium, tantalum, or a combination thereof. The ceramics may consist of alumina, zirconia, calcium orthophosphate, bioactive glass, silicon carbide, or a combination thereof.

[0021] For example, the frame may comprise a pharmaceutically acceptable compound coating consisting of one or more of the following: heparin, warfarin, apixaban, dabigatran, rivaroxaban, enoxaparin, thrombin inhibitors, edoxaban, fondaparinux, aspirin, ticagrelor, tyrofiban, borapaxar, clopidogrel, sirolimus, everolimus, zotarolimus, paclitaxel, biolimus, messenger RNA, or a combination thereof.

[0022] In some examples, a double cannula may comprise at least one impeller housing ventricular interface; at least one impeller housing coupled to the impeller housing ventricular interface; at least one inflow conduit coupled to the impeller housing ventricular interface; an outflow conduit having a proximal and distal end, the proximal end of which is coupled to the inflow conduit; and at least one valve coupled to the distal end of the outflow conduit.

[0023] In some embodiments, the axial flow cannula may comprise at least one shield; at least one axial flow impeller positioned within the shield; at least one cannula shaft coupled to the axial flow impeller; at least one connector connecting the at least one axial flow shaft to at least one bent drive shaft; and at least one conduit having a proximal end and a distal end, the proximal end of which is coupled to the axial flow impeller and the distal end of which is coupled to one or more valves.

[0024] In one embodiment, the outflow conduit, inflow conduit, and one or more valves may be made of one or more polymers, one or more biomaterials, or a combination of one or more polymers and one or more biomaterials. The polymers may consist of polyether ether ketone (PEEK), polytetrafluoroethylene (PTFE) and polyurethane (PU), ultra-high molecular weight polyethylene, polystyrene, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, polymethyl methacrylate, or a combination thereof. The biomaterials may consist of mammalian pericardium such as bovine pericardium, sheep pericardium, pig pericardium, horse pericardium, or kangaroo pericardium, or other biomaterials such as mammalian placenta, fish cornea, or a combination thereof.

[0025] In one example, the motor assembly may comprise at least one ventricular impeller driver connector; at least one ventricular magnetic driver housing coupled to at least one ventricular impeller driver connector; at least one motor interface plate coupled to at least one ventricular magnetic driver housing; and at least one housing element coupled to the motor interface plate, wherein the skin extends between the housing element and the motor interface plate, and the housing element comprises at least one of an external motor, a microprocessor, a battery, a chest frame mounting mechanism, or a motor magnet, and the ventricular magnetic driver housing comprises at least one of an impeller driver magnet or a ventricular driver, and the motor magnet is coupled without contact with the impeller driver magnet.

[0026] In some embodiments, the heart pump receives a cardiovascular pressure reading from a first sensor of an inlet conduit, and receives a cardiovascular context from one or more second sensors of the inlet conduit, wherein the cardiovascular context includes at least one of a blood pressure level, oxygen partial pressure, carbon dioxide partial pressure, lactic acid level, blood glucose level, blood pH level, or any combination thereof. A processor determines a minimum cardiovascular pressure reading based on the cardiovascular context, the processor determines whether the cardiovascular pressure reading is below a minimum threshold, and when the cardiovascular pressure reading is below the minimum threshold, the processor adjusts the pump output force of an outlet conduit.

[0027] In various embodiments, a flex drive can comprise at least one thoracic magnetic housing; at least one shaft housing element having a proximal end and a distal end, wherein the shaft housing element is capable of bending in all directions, and the proximal end of the flex housing element is coupled to the at least one thoracic magnetic housing; and at least one ventricular magnetic driver housing coupled to the distal end of the flex housing element.

[0028] For example, the present disclosure is also directed to a method for inserting a heart pump into a patient's heart using a novel tissue penetration deployment mechanism. Aspects of the present method can be combined with the aspects of the systems disclosed above, such as when the method for inserting a heart pump is applied to insert a heart pump according to embodiments of the present disclosure. A method for deploying a heart pump within an individual, comprising cannulating a cardiac chamber of the heart through one or more punctures in the patient's heart, connecting a cannula to a geometric plate, and coupling the geometric plate to a geometric housing.

[0029] In some embodiments, the cardiac pump receives a cardiovascular pressure reading from a first sensor in the inflow conduit, and a cardiovascular context from one or more second sensors in the inflow conduit, which includes at least one of blood pressure level, oxygen partial pressure, carbon dioxide partial pressure, lactate level, blood glucose level, blood pH level, or any combination thereof. The processor determines a minimum cardiovascular pressure reading based on the cardiovascular context, determines whether the cardiovascular pressure reading is below a minimum threshold, and if the cardiovascular pressure reading is below a minimum threshold, the processor adjusts the pumping force of the outflow conduit.

[0030] In some embodiments, the method includes one or more of the following steps: Exposing the ribs using surgical means and thereby accessing the heart; After accessing the heart, a medical professional inserts a needle first through cardiac tissue to allow access to the cardiac chambers; A guidewire is threaded through the needle and advanced so that the distal end of the guidewire passes over the target heart valve; The needle is removed from the cardiac tissue by passing over the guidewire proximal. Correct placement of the guidewire and removal of the needle are confirmed via anatomical ultrasound techniques and radiographic guidance. A series of dilators advanced over the wire may precede the insertion of the sheath advanced over the guidewire. After the sheath has crossed the target heart valve, unsheathing is initiated so that the frame can expand and make contact with the target heart valve; A shield is used in contact with the lateral portion of the target cardiac chamber; A cardiac mesh is sutured over the apex; The base of the cannula is joined to a geometric plate. The geometric housing is positioned outside the body so that it can supply wireless power through the geometric plate towards the cannula.

[0031] In some cases, the left ventricle insertion method includes one or more of the following steps: Exposing the ribs using surgical means and thereby gaining access to the heart. After gaining access to the heart, a medical professional inserts a needle first through the cardiac tissue to gain access to the left ventricle of the heart. A guidewire is threaded through the needle and advanced so that the distal end of the guidewire passes over the aortic valve. The needle is removed from the cardiac tissue by passing over the guidewire proximal to the needle. Correct placement of the guidewire and removal of the needle are confirmed via anatomical ultrasound techniques and radiographic leads. The sheath is advanced over the guidewire. After the sheath has crossed the aortic valve, unsheasing is initiated, thereby allowing the frame to expand and make contact with the aortic valve. A shield is used that is in contact with the lateral portion of the left ventricle. A cardiac mesh is sutured over the apex. The base of the cannula is coupled to a geometric plate. The geometric housing is positioned outside the body so that it can supply wireless power through the geometric plate in the direction of the cannula.

[0032] In some embodiments, a right ventricle insertion method includes one or more of the following steps: Exposing the ribs using surgical means and thereby accessing the heart; After accessing the heart, a medical professional first inserts a needle through cardiac tissue to allow access to the right ventricle of the heart; A guidewire is threaded through the needle and advanced so that the distal end of the guidewire passes over the pulmonary valve; The needle is removed from cardiac tissue by passing over the guidewire proximal. Correct placement of the guidewire and removal of the needle are confirmed via anatomical ultrasound techniques and radiographic leads; After a series of dilators are advanced over the wire, the sheath is then advanced over the guidewire; After the sheath has crossed the pulmonary valve, unsheasing is initiated, thereby allowing the frame to expand and contact the aortic valve; A shield is used in contact with the lateral portion of the right ventricle; A cardiac mesh is sutured over the apex; The base of the cannula is joined to a geometric plate. The geometric housing is positioned outside the body so that it can supply wireless power through the geometric plate towards the cannula.

[0033] In one example, a right atrium insertion procedure includes one or more of the following steps: Exposing the ribs using surgical means, thereby gaining access to the heart. After gaining access to the heart, a medical professional first inserts a needle through cardiac tissue to gain access to the right atrium of the heart. A guidewire is threaded through the needle and advanced so that the distal end of the guidewire passes over the right atrioventricular (AV) valve. The needle is removed from cardiac tissue by passing it proximal over the guidewire. Correct placement of the guidewire and removal of the needle are confirmed via anatomical ultrasound techniques and radiographic guidance. The sheath is advanced over the guidewire. After the sheath has crossed the right AV valve, unsheasing is initiated, thereby allowing the frame to expand and make contact with the right AV valve. A shield is used that makes contact with the lateral portion of the right atrium. The cardiac mesh is then sutured over the heart. The base of the cannula is coupled to a geometric plate. The geometric housing is positioned outside the body so that it can supply wireless power through the geometric plate towards the cannula.

[0034] In some embodiments, a left atrial insertion method includes one or more of the following steps: Exposing the ribs using surgical means and thereby gaining access to the heart; After gaining access to the heart, a medical professional first inserts a needle through cardiac tissue to gain access to the left atrium of the heart; A guidewire is threaded through the needle and advanced so that the distal end of the guidewire passes over the left atrioventricular (AV) valve; The needle is removed from cardiac tissue by passing over the guidewire proximal to the needle. Correct placement of the guidewire and removal of the needle are confirmed via anatomical ultrasound techniques and radiographic leads; The sheath is advanced over the guidewire; After the sheath has crossed the left AV valve, the unsheath allows the frame to expand and make contact with the left AV valve; The shield can make contact with the lateral portion of the left AV and the cardiac mesh can be sutured over the heart; The base of the cannula is coupled to a geometric plate; The geometric housing can be positioned outside the body so that it can supply wireless power through the geometric plate in the direction of the cannula.

[0035] In various embodiments, the cannula comprises a membrane-covered frame, the frame being coated with a pharmaceutical agent, such as a drug-eluting anticoagulant, but not limited to these. The cannula can be positioned inside a delivery sheath. The delivery sheath can be coupled to the tip of an introducer. The cannula comprises at least one of a double cannula or an axial flow cannula. The double cannula comprises at least one of a frame, an outflow conduit, an inflow conduit, an impeller housing, one or more valves, one or more sensors, or an impeller housing ventricular interface. The axial flow cannula comprises at least one of a frame, an outflow conduit, an impeller, an axial flow shaft, a connector coupling at least one axial flow shaft to at least one bent drive shaft, one or more valves, or one or more sensors. The impeller housing comprises at least one impeller. The impeller comprises at least one of a centrifugal impeller or an axial flow impeller. The geometric housing comprises at least one of a motor, battery, microprocessor, chest frame mounting mechanism, geometric motor interface, or body plate motor connector. The geometric plate comprises at least one of a ventricular magnetic driver housing, ventricular magnetic impeller driver connector, or ventricular magnetic impeller interface. The geometric housing may have a shape comprising one or more of the following: triangular, circular, right-angled, hexagonal, or different geometric shapes. The double cannula is coupled to the geometric plate by a flex drive, which can be bent to accommodate different anatomical shapes of the patient. The chest frame mounting mechanism includes one or more electrically driven magnets, or a mechanical mounting mechanism for holding the geometric housing in place.

[0036] In some examples, the introducer tip may include a needle, catheter, dilator, or sheathing needle. The introducer tip may include a catheter and / or needle, but is not limited to micropuncture needles or Cook needles, with sizes 6G, 7G, 8G, 9G, 10G, 11G, 12G, 13G, 14G, 15G, 16G, 17G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G, 31G, 32G, 33G, 34G, and any range in between. The cannula may include a needle and / or catheter with lengths of 0.1in, 1in, 2in, 3in, 4in, 5in, 6in, and any range in between. The cannula is equipped with a dilator or trowel needle having sizes of 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, and any range in between. The cannula is equipped with a dilator or trowel needle having lengths of 0.1 in, 1 in, 2 in, 3 in, 4 in, 5 in, 6 in, 7 in, 8 in, 9 in, 10 in, 11 in, 12 in, 13 in, 14 in, 15 in, 16 in, 17 in, and any range in between.

[0037] For example, the frame may have a wall thickness of 0.01 mm to 10 mm. The frame may have wall thicknesses of 0.01 mm, 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, and any range in between. The operating diameter of the frame may be in the range of 0.1 mm to 35 mm, preferably 11 mm to 22 mm. The frames have operating diameters of 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm, 25mm, 26mm, 27mm, 28mm, 29mm, 30mm, 31mm, 32mm, 33mm, 34mm, 35mm, and any range in between. The frames can be compressed to smaller diameters. The compressed diameter can range from 0.1mm to 25mm, preferably 8mm. The frame has compression diameters of 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm, 25mm, and any range in between.

[0038] In some embodiments, the axial flow conduit, the outflow conduit and / or inflow conduit of the double cannula may have a wall thickness ranging from 0.01 mm to 2 mm, preferably in the range of 0.08 to 0.20 mm. The wall thickness of the axial flow conduit, the outflow conduit and / or inflow conduit of the double cannula can be 0.01 mm, 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 1.0 mm, 0.11 mm, 0.12 mm, 0.13 mm, 0.14 mm, 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm, 0.19 mm, 0.20 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, 0.25 mm, 0.26 mm, 0.27 mm, 0.28 mm. mm, 0.29mm, 0.30mm, 0.31mm, 0.32mm, 0.33mm, 0.34mm, 0.35mm, 0.36mm, 0.37mm, 0.38mm, 0.39mm, 0.40mm, 0.41mm, 0.42mm, 0.43mm, 0.44m m, 0.45mm, 0.46mm, 0.47mm, 0.48mm, 0.49mm, 0.50mm, 0.51mm, 0.52mm, 0.53mm, 0.54mm, 0.55mm, 0.56mm, 0.57mm, 0.58mm, 0.59mm, 0.60mm, 0.61mm, 0.62mm, 0.63mm, 0.64mm, 0.65mm, 0.66mm, 0.67mm, 0.68mm, 0.69mm, 0.70mm, 0.71mm, 0.72mm, 0.73mm, 0.74mm, 0.75mm, 0.76mm, 0 .77mm, 0.78mm, 0.79mm, 0.80mm, 0.81mm, 0.82mm, 0.83mm, 0.84mm, 0.85mm, 0.90mm, 0.91mm, 0.92mm, 0.93mm, 0.94mm, 0.95mm, 0.96mm, 0.9 7mm, 0.98mm, 0.99mm, 1mm, 1.01mm, 1.02mm, 1.03mm, 1.04mm, 1.05mm, 1.06mm, 1.07mm, 1.08mm, 1.09mm, 1.10mm, 1.11mm, 1.12mm, 1.13mm, 1.14mm, 1.15mm, 1.16mm, 1.17mm, 1.18mm, 1.19mm, 1.20mm, 1.21mm, 1.22mm, 1.23mm, 1.24mm, 1.25mm, 1.26mm, 1.27mm, 1.28mm, 1.29mm, 1.30mm, 1.31mm, 1.32mm, 1.33mm, 1.34mm, 1.35mm, 1.36mm, 1.37mm, 1.38mm, 1.39mm, 1.40mm, 1.41mm, 1.42mm, 1.43mm, 1.44mm, 0.45mm, 1.46mm, 1.4 7mm, 1.48mm, 1.49mm, 1.50mm, 1.51mm, 1.52mm, 1.53mm, 1.54mm, 1.55mm, 1.56mm, 1.57mm, 1.58mm, 1.59mm, 1.60mm, 1.61mm, 1.62mm, 1.63mm, 1.64 The range includes mm, 1.65mm, 1.66mm, 1.67mm, 1.68mm, 1.69mm, 1.70mm, 1.71mm, 1.72mm, 1.73mm, 1.74mm, 1.75mm, 1.76mm, 1.77mm, 1.78mm, 1.79mm, 1.80mm, 1.81mm, 1.82mm, 1.83mm, 1.84mm, 1.85mm, 1.90mm, 1.91mm, 1.92mm, 1.93mm, 1.94mm, 1.95mm, 1.96mm, 1.97mm, 1.98mm, 1.99mm, 2mm, and any range between them.

[0039] For example, physiological measurements may include cannula sensors that measure one or more of the following: pressure in the cardiac chambers, pumping force, blood pressure, blood oxygen level, blood pH level, blood lactate level, troponin level, blood carbon dioxide level, partial pressure of oxygen, partial pressure of carbon dioxide, blood bicarbonate level, hemoglobin level, blood sodium level, blood magnesium level, blood potassium level, blood calcium level, blood chloride level, blood phosphate level, blood glucose level, blood procalcitonin level, or blood type B natriuretic peptide level. Physiological measurements can be used by healthcare professionals and / or artificial intelligence algorithms to determine historical values ​​based on previous physiological measurements. The healthcare professionals and / or artificial intelligence algorithms can then determine thresholds based on these historical values. In addition, the healthcare professionals and / or artificial intelligence algorithms can adjust the motor speed based on a comparison between the physiological measurements and the thresholds.

[0040] In some examples, the geometric housing may comprise one or more polymers, one or more metals, one or more ceramics, or a combination thereof. The polymers may consist of polytetrafluoroethylene (PTFE) and polyurethane (PU), ultra-high molecular weight polyethylene, polyether ether ketone (PEEK), polystyrene, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, polymethyl methacrylate, or a combination thereof. The metals may consist of stainless steel, nitinol, aluminum, copper, titanium, cobalt chromium, magnesium, gold, platinum, silver, iridium, tantalum, or a combination thereof. The ceramics may consist of alumina, zirconia, calcium orthophosphate, bioactive glass, silicon carbide, or a combination thereof.

[0041] For example, a geometric plate may comprise one or more polymers, one or more metals, one or more ceramics, or a combination thereof. Polymers may consist of polytetrafluoroethylene (PTFE) and polyurethane (PU), ultra-high molecular weight polyethylene, polyether ether ketone (PEEK), polystyrene, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, polymethyl methacrylate, or a combination thereof. Metals may consist of stainless steel, nitinol, aluminum, copper, titanium, cobalt chromium, magnesium, gold, platinum, silver, iridium, tantalum, or a combination thereof. Ceramics may consist of alumina, zirconia, calcium orthophosphate, bioactive glass, silicon carbide, or a combination thereof.

[0042] In one embodiment, the cannula plate may comprise one or more polymers, one or more metals, one or more ceramics, or a combination thereof. The polymers may consist of polytetrafluoroethylene (PTFE) and polyurethane (PU), ultra-high molecular weight polyethylene, polyether ether ketone (PEEK), polystyrene, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, polymethyl methacrylate, or a combination thereof. The metals may consist of stainless steel, nitinol, aluminum, copper, titanium, cobalt chromium, magnesium, gold, platinum, silver, iridium, tantalum, or a combination thereof. The ceramics may consist of alumina, zirconia, calcium orthophosphate, bioactive glass, silicon carbide, or a combination thereof.

[0043] For example, the frame may comprise one or more polymers, one or more metals, one or more ceramics, or a combination thereof. The polymers may consist of polytetrafluoroethylene (PTFE) and polyurethane (PU), ultra-high molecular weight polyethylene, polyether ether ketone (PEEK), polystyrene, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, polymethyl methacrylate, or a combination thereof. The metals may consist of stainless steel, nitinol, aluminum, copper, titanium, cobalt chromium, magnesium, gold, platinum, silver, iridium, tantalum, or a combination thereof. The ceramics may consist of alumina, zirconia, calcium orthophosphate, bioactive glass, silicon carbide, or a combination thereof.

[0044] In some embodiments, the impeller and / or impeller housing may consist of one or more bioinert polymer materials, one or more metals, one or more ceramics, or a combination thereof. Polymers may consist of polytetrafluoroethylene (PTFE) and polyurethane (PU), ultra-high molecular weight polyethylene, polyether ether ketone (PEEK), polystyrene, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, polymethyl methacrylate, or a combination thereof. Metals may consist of stainless steel, nitinol, aluminum, copper, titanium, cobalt chromium, magnesium, gold, platinum, silver, iridium, tantalum, or a combination thereof. Ceramics may consist of alumina, zirconia, calcium orthophosphate, bioactive glass, silicon carbide, or a combination thereof. The impeller housing may be manufactured using additive manufacturing such as 3D printing.

[0045] In some embodiments, the geometric motor interface to the body plate motor connector and ventricular magnetic impeller driver interface can be manufactured from polymers, metals, ceramics, or combinations thereof. Polymers can consist of polytetrafluoroethylene (PTFE) and polyurethane (PU), ultra-high molecular weight polyethylene, polyether ether ketone (PEEK), polystyrene, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, polymethyl methacrylate, or combinations thereof. Metals can consist of stainless steel, nitinol, aluminum, copper, titanium, cobalt chromium, magnesium, gold, platinum, silver, iridium, tantalum, or combinations thereof. In some embodiments, ceramics can consist of alumina, zirconia, calcium orthophosphate, bioactive glass, silicon carbide, or combinations thereof.

[0046] For example, the sheath may consist of one or more polymers, one or more metals, one or more ceramics, or a combination thereof. The polymers may consist of polytetrafluoroethylene (PTFE) and polyurethane (PU), ultra-high molecular weight polyethylene, polyether ether ketone (PEEK), polystyrene, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, polymethyl methacrylate, or a combination thereof. The metals may consist of stainless steel, nitinol, aluminum, copper, titanium, cobalt chromium, magnesium, gold, platinum, silver, iridium, tantalum, or a combination thereof. The ceramics may consist of alumina, zirconia, calcium orthophosphate, bioactive glass, silicon carbide, or a combination thereof.

[0047] For example, the frame may comprise a pharmaceutically acceptable compound coating consisting of one or more of the following: heparin, warfarin, apixaban, dabigatran, rivaroxaban, enoxaparin, thrombin inhibitors, edoxaban, fondaparinux, aspirin, ticagrelor, tyrofiban, borapaxar, clopidogrel, sirolimus, everolimus, zotarolimus, paclitaxel, biolimus, messenger RNA, or a combination thereof.

[0048] In one embodiment, the double cannula may comprise at least one impeller housing ventricular interface; at least one impeller housing coupled to the impeller housing ventricular interface; at least one inflow conduit coupled to the impeller housing ventricular interface; an outflow conduit having a proximal end and a distal end, the proximal end of which is coupled to the inflow conduit; and at least one valve coupled to the distal end of the outflow conduit.

[0049] In some embodiments, the axial flow cannula may comprise at least one shield; at least one axial flow impeller positioned within the shield; at least one cannula shaft coupled to the axial flow impeller; at least one connector connecting the at least one axial flow shaft to at least one bent drive shaft; and at least one conduit having a proximal end and a distal end, the proximal end of which is coupled to the axial flow impeller and the distal end of which is coupled to one or more valves.

[0050] For example, the outflow conduit, inflow conduit, and one or more valves may be made from one or more polymers, one or more biomaterials, or a combination of one or more polymers and one or more biomaterials. The polymers may consist of polyether ether ketone (PEEK), polytetrafluoroethylene (PTFE) and polyurethane (PU), ultra-high molecular weight polyethylene, polystyrene, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, acrylonitrile butadiene styrene, polystyrene, polyethylene terephthalate glycol, polymethyl methacrylate, or a combination thereof. The biomaterials may include mammalian pericardium such as bovine pericardium, sheep pericardium, pig pericardium, horse pericardium, and kangaroo pericardium, mammalian placentas, fish corneas, or a combination thereof.

[0051] In one example, the motor assembly may comprise at least one ventricular impeller driver connector; at least one ventricular magnetic driver housing coupled to at least one ventricular impeller driver connector; at least one motor interface plate coupled to at least one ventricular magnetic driver housing; and at least one housing element coupled to the motor interface plate, wherein the skin extends between the housing element and the motor interface plate, and the housing element comprises at least one of an external motor, a microprocessor, a battery, a chest frame mounting mechanism, or a motor magnet, and the ventricular magnetic driver housing comprises at least one of an impeller driver magnet or a ventricular driver, and the motor magnet is coupled without contact with the impeller driver magnet.

[0052] In some embodiments, the cardiac pump receives a cardiovascular pressure reading from a first sensor in the inflow conduit, and a cardiovascular context from one or more second sensors in the inflow conduit, which includes at least one of blood pressure level, oxygen partial pressure, carbon dioxide partial pressure, lactate level, blood glucose level, blood pH level, or any combination thereof. The processor determines a minimum cardiovascular pressure reading based on the cardiovascular context, determines whether the cardiovascular pressure reading is below a minimum threshold, and if the cardiovascular pressure reading is below a minimum threshold, the processor adjusts the pumping force of the outflow conduit.

[0053] In some embodiments, the flexible drive may comprise at least one thoracic magnetic housing; at least one shaft housing element having a nearest end and a distal end, wherein the shaft housing element is flexible in all directions, and the nearest end of the flexible housing element is coupled to at least one thoracic magnetic housing; and at least one ventricular magnetic driver housing coupled to the distal end of the flexible housing element.

[0054] In some embodiments, the cardiac pump receives a cardiovascular pressure reading from a first sensor in the inflow conduit, and a cardiovascular context from one or more second sensors in the inflow conduit, which includes at least one of blood pressure level, oxygen partial pressure, carbon dioxide partial pressure, lactate level, blood glucose level, blood pH level, or any combination thereof. The processor determines a minimum cardiovascular pressure reading based on the cardiovascular context, determines whether the cardiovascular pressure reading is below a minimum threshold, and if the cardiovascular pressure reading is below a minimum threshold, the processor adjusts the pumping force of the outflow conduit.

[0055] For a more complete understanding of this disclosure, please refer to the following description in conjunction with the attached drawings.

[0056] Herein, embodiments of the present invention will be discussed in detail, with an emphasis on highlighting their advantageous features. These embodiments are for illustrative purposes only and are not to a consistent scale; instead, the emphasis is on the principles of the present disclosure. These drawings include the following figures, in which similar numbers may indicate similar parts. [Brief explanation of the drawing]

[0057] [Figure 1A] This figure shows an exemplary embodiment of the arrangement of the heart pump inside the human body, as well as an external motor and battery outside the human body.

[0058] [Figure 1B] This is an isometric view of a device according to some embodiments of the present disclosure.

[0059] [Figure 2A] This is a side view of a motor and battery on the outside of the human body, according to some embodiments of the present disclosure.

[0060] [Figure 2B]This is a side view of a motor and battery according to some embodiments of the present disclosure after connection outside the human body.

[0061] [Figure 3A] This is a side view of a heart pump according to some embodiments of the present disclosure.

[0062] [Figure 3B] This is a top view of a heart pump according to some embodiments of the present disclosure.

[0063] [Figure 3C] Figure 3B shows the division diagram between sections AA.

[0064] [Figure 4A] This is a side view of a motor and battery outside the human body, as well as a flexible drive, according to some embodiments of the present disclosure.

[0065] [Figure 4B] This is a side view of a motor and battery connected to the outside of the human body in the case of a centrifugal heart pump according to some embodiments of the present disclosure.

[0066] [Figure 5A-5B] This is an isometric exploded view of one embodiment of the present disclosure.

[0067] [Figure 5C] This is a side view of a bent drive according to some embodiments of the present disclosure.

[0068] [Figure 6A] This is a side view of an exemplary device equipped with a flexible drive.

[0069] [Figure 6B] This is a side view divided between sections AA in Figure 6A.

[0070] [Figures 7A-7F]This figure shows an example of an insertion method for a cardiac pump according to some embodiments of the present disclosure.

[0071] [Figure 8A] This is a top view of a double cannula according to some embodiments of the present disclosure.

[0072] [Figure 8B] This is a partial side view divided between the FF cross sections in Figure 8A.

[0073] [Figure 8C] This is a partial side view divided between the FF cross sections of Figure 8A, showing the inflow and outflow, as well as the flow profile inside the double cannula 243, after the frame has been removed.

[0074] [Figure 8D] Figure 8A is an isometric view divided between the FF cross-sections, with the frame and outflow conduit removed, showing the inflow and outflow flow profiles of the device.

[0075] [Figure 8E] This is a side view of an impeller housing according to some embodiments of the present disclosure, with the dotted lines indicating the internal cavity.

[0076] [Figure 8F] Side views of impeller housings according to several embodiments of the present disclosure, as well as three segmented views BB-BB, BC-BC, and BD-BD showing the internal cavity.

[0077] [Figure 9A] This is a side view of an axial flow cardiac pump according to some embodiments of the present disclosure.

[0078] [Figure 9B] This is a side view of the axial flow cardiac pump divided between cross-sections A and B in Figure 9A.

[0079] [Figure 9C] This is a top view of an example of an axial flow cardiac pump.

[0080] [Figure 10] This figure shows flow profiles illustrating the inflow and outflow of an axial flow pump according to some embodiments of the present disclosure.

[0081] [Figure 11A-11B] These are side views of motor and battery connections for circular and geometric shapes, respectively, connected to the outside of the human body, in the case of a cardiac pump with an axial flow cannula, according to some embodiments of the present disclosure.

[0082] [Figure 11C] This figure shows the arrangement of a cardiac pump according to some embodiments of the present disclosure, with an axial flow cannula inside the human heart.

[0083] [Figure 12] This figure shows an example of wireless charging and wireless connectivity for a cardiac pump according to some embodiments of the present disclosure.

[0084] [Figure 13] Block diagram showing a power transmission network using resonant magnetic coupling, ultrasonic frequencies, and / or radio frequencies for wireless power transmission and communication from a power source to a cardiac pump system, according to some embodiments of the present disclosure. [Modes for carrying out the invention]

[0085] It should be understood that the figures are not necessarily drawn to a consistent scale, and the objects in the figures are not necessarily drawn to a consistent scale in relation to each other. The figures are depictions intended to provide clarity and understanding of the various embodiments of the apparatus, systems, and methods disclosed herein. Wherever possible, the same reference numerals are used throughout the drawings to refer to the same or similar parts. Furthermore, it should be understood that the drawings are not intended to limit the scope of the teachings of the invention in any way.

[0086] In this specification, the terms “proximal” and “distal” are used in relation to the operator (e.g., a doctor, nurse, or technician), with the proximal side referring to the side closer to the operator and the distal side referring to the side further away from the operator. For example, the blade end of a knife used by a surgeon to make an incision in a patient's body would be the distal end, while the handle end held by the doctor would be the proximal end.

[0087] In this specification, the term "endothelialization" refers to the development and growth of endothelial tissue.

[0088] In this specification, the term "cardiovascular context" refers to understanding the various cardiovascular stressors applied to the cardiovascular system at any given point in time.

[0089] In this specification, the term “external” refers to anything that is anatomically outside the body.

[0090] In this specification, the term “healthcare professional” means, but does not limit, at least one or more of the following: physicians, including surgeons; first surgical assistants; physician's assistants; nurse practitioners; medical residents; medical students; nurses; nursing students; or any combination thereof.

[0091] While the teachings of the present invention will be described in relation to various embodiments, the teachings of the present invention are not intended to be limited to such various embodiments. On the contrary, as will be understood by those skilled in the art, the teachings of the present invention encompass various alternative forms, modifications, and equivalents.

[0092] When used in the specification of this Specification, "a" or "an" may mean one or more. When used in the claims of this Specification, the words "a" or "an" may mean one or more when used with the word "equipped with". Some embodiments of this Disclosure may consist of, or essentially consist of, one or more elements, method steps, and / or methods of this Disclosure. It is intended that any method or composition described herein may be implemented in relation to any other method or composition described herein, and that different embodiments may be combined.

[0093] In describing various embodiments, methods and / or processes may be presented as steps in a specific sequence. However, unless a method or process depends on a specific sequence of steps described herein, it will be readily apparent to those skilled in the art that the sequence can be changed and still remain within the spirit and scope of various embodiments.

[0094] In this specification, the phrase “at least one of the following” means, when used with a list of items, that different combinations of one or more items from the listed items may be used, and that only one of the items in the list may be required. An item can be a specific object, thing, step, action, process, or category. In other words, “at least one of the following” means that any combination or any number of items from the list may be used, but not necessarily all of the items in the list may be required. For example, though not limited, “at least one of item A, item B, or item C” means item A; item A and item B; item B; item A, item B, and item C; item B and item C; or item A and C. In some cases, “at least one of item A, item B, or item C” means, though not limited, two item A, one item B, and ten item C; four item B, and seven item C; or any other appropriate combination.

[0095] The use of the term “or” in the claims is used to mean “and / or” unless it is expressly indicated that it refers only to the options, or unless the options are mutually exclusive; however, this disclosure supports the definitions of options only and “and / or” as referring to “and / or.” For example, “x, y, and / or z” could mean “x” only, “y” only, “z” only, “x, y, and z,” “(x and y) or z,” “x or (y and z),” or “x or y or z.” It is specifically conscientious that x, y, or z can be specifically excluded from one embodiment. In this specification, “another” could mean at least a second or subsequent one.

[0096] Throughout this specification, unless otherwise required by context, the terms “comprise,” “comprises,” and “comprising” are understood to include the steps or elements or groups of steps or elements described, but not to exclude any other steps or elements or groups of steps or elements. Furthermore, the words “comprising” (and any form of “comprising,” such as “comprise” or “comprises”), “having” (and any form of “having,” such as “have” or “has”), “including” (and any form of “including,” such as “includes” or “include”), “characterized by” (and any form of “including,” such as “characterized as”), or “containing” (and any form of “containing,” such as “contains” or “contain”) are inclusive or open-ended and do not exclude any additional elements or method steps not listed. “Composed of” means to include and be limited to everything that follows the phrase “composed of.” Therefore, the phrase “composed of ~” indicates that the listed elements are required or essential, and that other elements may not be present. “Essentially composed of ~” means including any elements listed after the phrase, and being limited to other elements that do not interfere with or contribute to the activity or action of the listed elements as expressed in this disclosure. Therefore, the phrase “essentially composed of ~” indicates that the listed elements are required or essential, but that other elements are not optional and may or may not be present, depending on whether they affect the activity or action of the listed elements.Throughout this specification, whenever the terms “one embodiment,” “such embodiment,” “an embodiment,” “a particular embodiment,” “a related embodiment,” “a certain embodiment,” “an additional embodiment,” or “a further embodiment,” or any combination thereof, are used, it means that any particular feature, structure, or characteristic described in relation to that embodiment is included within at least one embodiment of the embodiments of the present invention. Therefore, where the preceding phrases appear in various places throughout this specification, they do not necessarily all refer to the same embodiment. Furthermore, any particular feature, structure, or characteristic can be combined in any suitable manner in various embodiments.

[0097] For the purposes of this disclosure, a computer system may include any means or set of means capable of operating to computer compute, calculate, determine, classify, process, transmit, receive, retrieve, generate, switch, store, display, communicate, reveal, detect, record, reproduce, handle, or utilize any form of information, intelligence, or data for business, scientific, control, or other purposes. For example, a computer system may be a personal computer (e.g., a desktop or laptop), a tablet computer, a two-in-one laptop / tablet computer, a mobile device (e.g., a personal digital assistant (PDA), a smartphone, a tablet computer, or a smartwatch), a server (e.g., a blade server or a rack server), a network storage device, or any other suitable device, which may vary in size, shape, performance, function, and price. A computer system may include one or more processing resources such as random access memory (RAM), a central processing unit (CPU), and hardware-controlled or software-controlled logic, ROM, and / or other types of non-volatile memory. Further components of the computer system may include one or more disk drives, one or more network ports for communicating with external devices, and various input and output (I / O) devices such as a keyboard, mouse, touchscreen, and / or video display. An information handling system may also include one or more virtual or physical buses capable of transmitting communications between various hardware and / or software components.

[0098] Aspects of this disclosure include systems and / or methods for reducing infection after cardiac pump placement, reducing cardiac implantation trauma, mitigating the effects of cardiac pump motor failure, and / or enabling rapid upgrades of cardiac pump motors and / or batteries. For example, a cardiac pump may comprise multiple parts that communicate wirelessly with one another. When such a system is implanted in a patient, the need for wires extending from inside to outside the body is eliminated. Eliminating such wires eliminates a major potential source of infection. As another example, cardiac damage is greatly reduced by placing the cardiac pump cannula inside the heart via a catheter instead of a surgical incision. Also, placing the cardiac pump motor outside the body allows for timely, non-surgical replacement in the event of motor failure, thereby mitigating what could otherwise be a fatal catastrophic event. Similarly, if motor or battery technology improves, motors and / or batteries can be upgraded without requiring surgical intervention.

[0099] Other embodiments of the systems and / or methods of this disclosure may include replacing unilateral or bilateral cardiac ejection function. In one example, an embodiment of the cardiac pump can be placed in the patient's left ventricle to replace the left ventricular ejection function of the heart. In another example, an embodiment of the cardiac pump can be located in the patient's right ventricle to replace the right ventricular ejection function. In one embodiment, an embodiment of the cardiac pump can be placed in both the right and left ventricles of the heart, and the embodiments of the cardiac pump can work together to replace both the right and left ventricular ejection functions of the heart.

[0100] Figures 1A and 1B illustrate implantable cardiac pump devices. Referring to Figure 1A, according to some embodiments of the present disclosure, the geometric housing can be fixed to the outside of the patient's skin, but within a surgically formed cavity, and the geometric plate can be implanted in the patient. Figure 1A further shows the proximal end of the cannula attached to the geometric plate and the distal end of the cannula inserted into the patient's heart. Figure 1B shows how the geometric housing, geometric plate, and cannula can be joined together according to some embodiments of the present disclosure.

[0101] Referring to Figure 1A, power can be wirelessly transmitted from a geometric housing 235, which may be located outside the body, to an impeller housing 204 implanted in the body, which in turn powers a cannula that can be inserted into the heart 313, thereby enabling normal cardiac flow. For this purpose, viewed from a side view perspective, from the outside to the inside of the patient 300's body, the patient 300 includes a notched torso, heart 313, ribs 320, and skin 321. The centrifugal heart pump 200 can be placed inside the patient 300. For example, as shown in Figure 3C, the geometric housing 235 containing the battery can be placed outside the body, but within a surgically formed cavity. On one side of the geometric housing 235, there may be a geometric motor interface 236 that fits warmly against the skin 321 of the patient 300 without penetrating it. Within the body of patient 300, the geometric plate 233 can be warmly attached to the inner surface of the cavity skin. The body plate motor connector 237 can be connected to the geometric plate 233. Then, the impeller housing 204, which can be connected to the cannula 243 shown in Figure 1B, which can be inserted into the heart 313, can be connected to the body plate motor connector 237.

[0102] An example of a partially disassembled cardiac pump is shown in Figure 1B. The cardiac pump 200 can be divided into at least three parts: a double cannula 243, a geometric plate 233, and a geometric housing 235. The double cannula 243 may include an impeller housing ventricular interface 230, an impeller housing 204, an inflow conduit 203, an outflow conduit 202, and a frame 201. The geometric plate 233 may include a ventricular magnetic driver housing 205, a ventricular magnetic impeller driver connector 232, and a ventricular magnetic impeller driver interface 231. The geometric housing 235 may have a geometric interface 236. In some embodiments, the geometric plate 233 and the geometric housing 235 may have triangular, circular, right-angled, hexagonal, or any other different geometric shape. Figures 2A-B show illustrative side views of how the geometric housing 235 may be fixed in a cavity.

[0103] Next, moving to Figures 3A-C, the centrifugal heart pump 200 has a frame 201 with an outflow conduit 202. The frame 201 can be made of a collapsible polymer, metal, or ceramic of various dimensions. For this purpose, the dimensions of the frame 201 can include a wall thickness of 0.10 mm to 2 mm. The open dimension of the frame 201 can be in the range of 8 mm to 25 mm, preferably 11 to 22 mm. However, the compressed diameter of the frame 201 can be in the range of 4 to 15 mm, preferably 8 mm. Details of the geometric housing 235 and the impeller housing 204 are broadly covered in Figures 6A-6B.

[0104] Referring to Figures 4A-B, the geometric housing 208 (235 in Figures 1-3) has moved from outside the patient cavity into the patient cavity, enabling a wireless connection between the geometric housing 208 and the heart 313 via the flex drive 244. The geometric housing 208 can be fixed in place by magnets in the chest magnetic housing 207 and placed within the cavity. In some examples, the geometric housing 208 can be cubic or rectangular in shape. The skin 321 may be located between the geometric housing 208 and the chest magnetic housing 207. The chest magnetic housing 207 of the flex drive 244 may have a shaft housing 206 that can be attached to a ventricular magnetic driver housing 205. The ventricular magnetic driver housing 205 can be attached to an impeller housing 204. The impeller housing 204 can be coupled to a cardiac mesh 238. The impeller housing 204 can be attached to the heart 313 by suture using the cardiac mesh 238.

[0105] Figures 5A-5C show the flexible drive 244 positioned within the centrifugal heart pump 200. In Figure 5A, the flexible drive 244 is shown attached to the thoracic magnetic housing 207 at its proximal end and to the double cannula 243 at its distal end. Referring to Figure 5B, the centrifugal heart pump 200 can be separated into the motor housing 208, the flexible drive 244, and the double cannula 243. In Figure 5C, the flexible drive 244 is curved or bent, thereby allowing the centrifugal heart pump 200 to accommodate the different anatomical shapes of the patient 300.

[0106] Figures 6A-6B show a side view and a cutaway side view of a centrifugal heart pump 200 equipped with a bend drive 244. Referring to Figure 6A, the frame 201 has an inflow section 229. This allows fluid to enter the inflow conduit 203, and in small or collapsed ventricles, the inflow section 229 can prevent obstruction of the inflow conduit 203. The frame 201 may have one or more inflow sensors 601. In one embodiment, one or more inflow sensors 601 can measure at least intracardiac pressure and cardiac ejection force, blood oxygen level, blood pH level, and blood lactate level, etc. Pressure measurement may also include inflow pressure and ventricular force. Ventricular force can provide information about cardiac recovery. Long-term use of ventricular assist devices can improve ventricular function. Force sensors can be used to measure when ventricular recovery occurs in a patient. In addition, one or more outflow sensors 607 are used to measure intracardiac pressure and cardiac ejection force, blood oxygen levels, blood pH levels, and blood lactate levels, etc. One or more outflow sensors can be placed on the frame 201 near one or more valves 214, or on the outflow conduit 202 within the conduit. These sensors 601, 607 can be powered by radio frequency (RF) and can transmit data via RF.

[0107] Figure 6B shows a segmented view between section A and C of Figure 6A, with the chest magnet housing 207 covering the impeller housing 204, ventricular magnetic driver housing 205, shaft housing 206, and geometric housing 208 at the bottom. Looking first at the impeller housing 204, the impeller housing 204 can be cradle-supported by the ventricular magnetic driver housing 205. The impeller housing 204 houses the centrifugal impeller 209. Next, the ventricular magnetic driver housing 205 houses the ventricular driver 215. For example, the ventricular driver 215 can drive the centrifugal impeller 209, thereby generating fluid flow. As another example, the ventricular driver 215 can house an impeller driver magnet 216 that can drive the centrifugal impeller 209. Furthermore, the shaft housing 206 houses a shaft 219 that can be connected to the ventricular driver 215. In one embodiment, the shaft 219 can be connected to or attached to the chest magnet housing 222. The shaft 219 can be held in place using one or more stabilizers 217, 218, 220. For example, one or more stabilizers 217, 218, 220 consist of bearings or magnets used to stabilize the shaft 219 with minimal vibration. In addition, the chest magnet housing 207 can house chest magnets. The chest magnet housing 207 can be coupled to the geometric housing 208. Furthermore, the geometric housing element 208 can house an external motor 224, which may have a motor shaft 226 that can be attached to the motor magnet housing 245. The motor magnet housing 245 can house motor magnets 223. The motor magnets 223 can be coupled to the chest magnet housing 222 by magnetic force without contact. These magnets do not require physical connection. This allows the geometric housing 208, the bending drive 244, and the dual cannula 243 to be independent.

[0108] The geometric housing 208 can also house a microprocessor 225 and a battery 227. For example, the microprocessor 225 can drive an external motor 224, communicate with an external device to provide data, and wirelessly charge the battery 227. In some embodiments, the battery 227 can power the external motor 224 and the microprocessor 225. The battery 227 may consist of one or more batteries, allowing the patient 300 or a healthcare worker to replace the battery without the heart pump losing power. In another example, the heart pump may also be charged using a wire leading to the battery 227 by a cable such as, but not limited to, Universal Serial Bus (USB), USB Type A, USB Type B, USB Type C, USB 3.0, USB Mini, USB Micro A, USB Micro B, Lightning, Thunderbolt, etc.

[0109] Figures 7A–7D show an example of the method of inserting and deploying a double cannula 243 into the heart 313. The heart 313 contains several anatomical points of interest to be recognized during such insertion, including the ascending aorta 303, right atrium 304, tricuspid valve 305, right ventricle 306, aortic valve 307, left atrium 308, mitral valve 309, pulmonary valve 316, inferior vena cava 317, superior vena cava 318, and pulmonary artery 319, which are labeled. In this example, the left ventricle 310 of the heart 313 can be punctured using a needle 253. As shown in Figure 7A, a guidewire 340 can be advanced through the needle into the left ventricle 310 and onto the ascending aorta 303. The needle 253 can then be removed from the guidewire 340. As shown in Figure 7B, the double cannula 243 can be collapsed within the sheath 250, and the double cannula 243 may have an introducer tip 252 at its distal end. As shown in Figure 7B, the double cannula 243 within the sheath 250 is advanced along the guidewire 340, thereby allowing the double cannula 243 within the sheath 250 to cross the aortic valve 307 and enter the ascending aorta 303. The sheath 250 may have a sheath handle 251, thereby allowing a medical professional to easily remove the sheath. By using the sheath handle 251, the medical professional can begin to unsheathe or retract the sheath 250. Next, referring to Figure 7C, this process may allow the frame 201 and / or outflow conduit 202 to self-expand and engage with the aortic valve 307. The sheath 250 may have a peel-away wire 254, which may be thin or have a pre-perforated wire to facilitate removal. If the sheath 250 is removed, the remaining section of the frame 201 may self-expand as shown in Figure 7D. However, the impeller housing 204 may remain outside the heart 313. The double cannula 243 may have a cardiac mesh 238 that can be used to fix the impeller housing 204 in place using sutures.

[0110] In another example, referring to Figure 7E, the double cannula 243 can be positioned on the right side of the heart 313, possibly within the right ventricle 306. The introduction of the double cannula 243 into the right side of the heart 313 may be similar to the process on the left side. In this example, the double cannula 243 can extend through the pulmonary valve 316 and be introduced into the right ventricle 306. The double cannula 243 can be fixed in place by suturing to the apex 315 or to any wall of the heart 313. Furthermore, the double cannula 243 can be endothelialized to improve the biological response and device lifespan.

[0111] Referring to Figure 7F, one or more double cannulas 243 can be placed on both the left and right sides of the heart, thereby replacing the entire cardiac function. Two or more double cannulas 243 can work in conjunction to replace cardiac ejection function. In such embodiments, a double extracorporeal motor 224 can be used with one or more geometric housings 235 and one or more geometric plates 233, or with one or more geometric housings 208 and one or more bending drives 244.

[0112] Figures 8A–8F show top and cutaway views of the outflow conduit 202 and impeller housing 204. Moving to Figure 8A, the double cannula 243 can be closed by one or more valves 214 and can accommodate one or more inflow sensors 601. Figures 8B–D show partial side and isometric views divided between the FF sections of Figure 8A and show an example of the flow profile of the double cannula 243 through the helical conduit. In this example, the fluid can enter the inflow conduit 203 between the inflow section 228 and the outflow conduit 202. The fluid can continue toward the vortex chamber 241, where it can come into contact with the centrifugal impeller 209. The rotating centrifugal impeller 209 can be held in place by the impeller stabilizer 242. The centrifugal impeller 209 can rotate as its name suggests to generate centrifugal force, which then propels the flow radially into channel-1 210. The propelled fluid continues through channel-2 211, passes through channel-3 212, and upward to channel-4 213, where it can exit through the outflow conduit 202 and one or more valves 214 of the double cannula 243. Figure 8C shows an example of the inflow and outflow of the double cannula 243 with the frame 201 removed for a better understanding of the flow profile. Figure 8D shows a split, enlarged view of the flow in Figure 8A with the frame 201 and outflow conduit 202 removed. Notably, the junctions 240 are spaced at equal intervals to allow the flow to enter the vortex chamber 241. Figures 8E-8F show top and side views of the helical conduit. Figure 8E shows a side view of the helical conduit indicated by a dotted line within the impeller housing 204. The helical conduit can be further identified in Figure 8F, which shows top views of three cross-sections BB-BB, BC-BC, and BD-BD.

[0113] Moving away from the embodiment of the centrifugal cardiac pump 200 discussed above, another example of a cardiac pump may include an axial-flow cardiac pump 106. The axial-flow cardiac pump 106 may comprise either a geometric housing 235 and a geometric plate 233, or a geometric housing 208 and a bend drive 244.

[0114] Figures 9A-C show top, side, and side cross-cut views of an example of an axial flow cardiac pump 106. Referring to Figure 9A, the axial flow cardiac pump 106 can be coupled to an axial flow cannula 100. The axial flow cannula 100 consists of an axial flow conduit 104, a frame 201, a shield 101, an axial flow shaft 102, an axial flow impeller 103, and a cardiac mesh 238. Furthermore, the axial flow conduit 104 may have one or more valves 214. One or more valves 214 can open and close when the pressure around the valve changes. One or more valves 214 open when the pressure inside the axial flow conduit 104 may be greater than the pressure outside the one or more valves 214. When the pressure outside the one or more valves 214 may be greater, one or more valves 214 can close to prevent valvular regurgitant flow, a life-threatening situation. One or more valves 214 continue to function naturally, depending on the patient's ventricular pulsatility, or until the healthcare provider enables the extracorporeal motor 224 and the pumping function begins. In one example, the axial flow impeller 103 can be deflated. The axial flow impeller 103 can be deflated by bending the blade or vane. The axial flow impeller 103 can be mounted on an axial flow shaft 102 and driven by the axial flow shaft 102. The axial flow shaft 102 can be made of polymer, metal alloy, or a combination thereof.

[0115] Next, moving to Figure 9B, the bent drive 244 is connected to the axial flow conduit 104 and the frame 201. Sections of the frame 201 that are not covered by the axial flow conduit 104 can be covered by the shield 101. The shield 101 can have a larger diameter than the axial flow conduit 104 and can partially interact with the ventricle to allow for force measurement and reduction of flow obstruction.

[0116] Continuing to refer to Figure 9B, the flex drive 244 may not have a ventricular magnetic driver housing 205, as shown in some embodiments. For example, the cannula 100 may be connected to the flex drive 244 by a connector 105 instead. The connector 105 can be attached to the cannula 100 and drive an axial flow shaft 102. The axial flow shaft 102 can communicate with the shaft 219 of the flex drive 244. The shaft 219 of the flex drive 244 may be coupled with one or more stabilizers 217, 218, 220 that provide stability during operation and minimize vibration. One or more stabilizers 217, 218, 220, as well as the shaft 219 of the flex drive 244, may be located within a shaft housing 206. In one example, the flex drive 244 may have a circular magnetic housing 207 that can be connected to a geometric housing 208. The shaft 219 can be connected to a chest magnet housing 222, which can house chest magnets 221. These chest magnets 221 can interact with motor magnets 223, which can be housed inside a geometric housing 208. The chest magnets 221 and motor magnets 223 can consist of one or more magnets. The motor magnets 223 can be mounted on a motor shaft 226, which can be driven by an external motor 224. In another example, the geometric housing 208 can house a microprocessor 225 and a battery 227. The microprocessor 225 and battery 227 can operate the external motor 224. The battery 227 and microprocessor 225 can collect data from one or more inflow sensors 601 and one or more outflow sensors 607.

[0117] Referring to Figure 9C, the axial flow cannula 100 can be sealed by one or more valves 214. One or more inlet sensors 601 and one or more outlet sensors 607 can be coupled to or located near one or more valves 214.

[0118] Figure 10 shows the flow profile of the axial flow cannula. When the axial flow impeller 103 rotates, it can generate an attractive force from outside the shield 101. The flow 354 from outside the cannula can be propelled by the axial flow impeller 103 through the inside of the axial flow conduit 104. The flow 355 can advance toward one or more valves 214 to reach the outlet. Endothelination of the axial flow cannula 100 can improve the biological response and device lifespan.

[0119] As can be seen in Figures 11A-11B, the axial flow cardiac pump 106 can be coupled to the bending drive 244, or it can be coupled to the geometric plate 233 in the same way that the centrifugal cardiac pump 200 is coupled, as can be seen in Figures 2A-2B.

[0120] Referring to Figure 11C, the axial flow cannula 100 can be positioned inside the heart 313 via the same insertion process as the double cannula 243 shown in Figures 7A-D. In one example, the axial flow cannula is positioned within the right ventricle 310 and extends through the ascending aorta 303. The shield can press against nearby cardiac tissue, allowing the axial flow impeller 103 to rotate freely. In another example, the axial flow cannula 100 can be positioned within the right ventricle 306, or simultaneously within both ventricles 306 and 310.

[0121] Referring to Figure 12, the patient 300 may have the ability to communicate with the cardiac pumps 200, 106 and the communication device 600. For example, the patient 300 may be in bed 502, and the communication device 600 may be on the top surface of a nightstand 503. The communication device 600 may have a wireless connection 500 to the cardiac pump, and the cardiac pump battery may enjoy wireless charging 501.

[0122] Figure 13 is a block diagram of the wireless connectivity and charging device 600, the heart pump microprocessor 225, and the computer 602. In another example, the heart pump 200 106 may have a microprocessor 225 that can operate an external motor 224 and communicate with external devices such as the communication device 600 and the computer 602 (Figures 12-13). The computer may consist of a tablet or a phone. The microprocessor 225 may have authentication modules, data encryption, data decryption, power management, and data processing capabilities. For example, the computer system network interface may include, but is not limited to, cellular, satellite, wide area network, fiber, broadband, cable, DSL, Wireless Fidelity (Wi-Fi) and Bluetooth (2.4GHz ISM band) at 2.4GHz and 5GHz frequencies. In some embodiments, an auxiliary wired electrical cable may be used for charging and communication. Wireless charging may be resonant inductive coupling 604, 605, 606. Power can also be supplied to the rechargeable battery 227 in Figure 6B in the form of radio frequency (RF) 603. Furthermore, RF 603 can also be used for communication.

[0123] One embodiment may include a cardiac pump system comprising a cannula having a ventricular interface coupled to an impeller housing, the impeller housing being coupled to a conduit, and the impeller housing comprising an impeller. One example may include a cannula 100 comprising a ventricular interface 230 connected to an impeller housing 204, the impeller housing 204 being subsequently connected to a conduit. In another example, the impeller housing may include a centrifugal impeller 209 or an axial flow impeller 103. Another embodiment may include a ventricular interface comprising an impeller driver magnet, the impeller driver magnet configured to rotate a centrifugal impeller or an axial flow impeller in the presence of a magnetic field. For example, the ventricular interface 230 may include an impeller driver magnet 216 capable of rotating a centrifugal impeller 209 or an axial flow impeller 103 in the presence of a magnetic field. In some embodiments, a motor housing comprises a motor and a motor magnet, wherein the motor is coupled to the motor magnet and configured to rotate the motor magnet, and the motor housing is configured to generate a magnetic field that rotates an impeller. In one example, the motor housing 208 may include a motor 224 configured to rotate a motor magnet 223 to generate a magnetic field that can subsequently rotate a centrifugal impeller 209 or an axial flow impeller 103.

[0124] While the present disclosure and its merits have been described in detail above, it should be understood that various changes, substitutions, and modifications can be made herein without departing from the intent and scope of the design defined by the appended claims. Furthermore, the scope of this application is not intended to be limited to specific embodiments of the processes, machines, manufactures, compositions, means, methods, and steps described herein. As will be readily apparent to those skilled in the art from this disclosure, processes, machines, manufactures, compositions, means, methods, or steps that currently exist or will be developed in the future, performing substantially the same functions as or achieving substantially the same results as the corresponding embodiments described herein, can be utilized in accordance with this disclosure. Accordingly, the appended claims are intended to include such processes, machines, manufactures, compositions, means, methods, or steps within their scope.

[0125] Many modifications and other embodiments of the inventions described herein will be conceivable to those skilled in the art who benefit from the teachings presented in the foregoing description and the accompanying drawings. Therefore, it should be understood that these inventions should not be limited to the specific embodiments disclosed, and that modifications and other embodiments are intended to fall within the scope of the appended claims. Furthermore, while the foregoing description and the accompanying drawings describe exemplary embodiments in the context of certain exemplary combinations of elements and / or functions, it should be understood that alternative embodiments may provide different combinations of elements and / or functions without departing from the scope of the appended claims. In this regard, for example, combinations of elements and / or functions different from those explicitly described above are also intended to be described within the appended claims. Where advantages, benefits, or solutions to problems are described herein, it should be understood that such advantages, benefits, and / or solutions may apply to some exemplary embodiments, but not necessarily to all exemplary embodiments. Therefore, any advantages, benefits, or solutions described herein should not be considered critically important, necessary, or essential for all embodiments or for the embodiments claimed herein. Certain terms are used herein, but only in a general and descriptive sense, not for limitation.

Claims

1. A cannula comprising a ventricular interface coupled to an impeller housing, the impeller housing coupled to a conduit, the impeller housing comprising an impeller, the ventricular interface comprising an impeller driver magnet, and the impeller driver magnet configured to rotate the impeller in the presence of a magnetic field, A motor housing comprising a motor and a motor magnet, wherein the motor is coupled to the motor magnet and configured to rotate the motor magnet, and the motor housing is configured to generate the magnetic field that rotates the impeller, and A heart pump system equipped with [a specific feature].

2. The cardiac pump system according to claim 1, wherein the impeller comprises a centrifugal impeller or an axial flow impeller.

3. The cardiac pump system according to claim 1, wherein the motor housing is configured to rotate the impeller using the motor without contacting the ventricular interface.

4. The heart pump system according to claim 1, wherein the motor housing comprises a battery coupled to the motor, and the energy stored in the battery is used to rotate the impeller.

5. A plate comprising a first side and a second side, wherein the impeller driver connector is located on the second side, and the impeller driver connector is configured to align the impeller driver magnet of the ventricular interface with the motor magnet of the motor housing when the motor housing is positioned along the first side. The cardiac pump system according to claim 1, further comprising the following:

6. The cardiac pump system according to claim 1, wherein the conduit comprises a spiral conduit.

7. The cardiac pump system according to claim 1, wherein the ventricular interface is connected to the cannula via a flexible shaft.

8. The cardiac pump system according to claim 6, wherein the cannula comprises a centrifugal impeller and a stabilizer coupled to the centrifugal impeller.

9. The cardiac pump system according to claim 1, wherein the cannula comprises a self-expandable cannula.

10. The cardiac pump system according to claim 1, wherein the conduit is provided with a valve at the end of the conduit opposite to the impeller.

11. The cardiac pump system according to claim 1, wherein the motor housing is located outside the body and is replaceable or removable.

12. The cardiac pump system according to claim 1, wherein the cannula comprises one or more of a plurality of physiological sensors.

13. The motor housing includes a processor, and the processor is The steps include receiving physiological measurements from the physiological sensor, The process involves the processor determining whether the physiological measurement is below a threshold value, The process involves adjusting the speed of the motor using a processor based on the determination by an artificial intelligence algorithm that the physiological measurement value is below the threshold. The cardiac pump system according to claim 12, configured to perform a step including the following:

14. The aforementioned processor, The steps include receiving a first physiological measurement from the physiological sensor, The steps include receiving a second physiological measurement from the physiological sensor, The processor performs the steps of determining a historical value based on the first physiological measurement and the second physiological measurement, The processor performs the steps of determining the threshold value based on the historical value. The cardiac pump system according to claim 13, configured to perform a step including the following:

15. A cannula comprising a ventricular interface coupled to an impeller housing, the impeller housing being coupled to a conduit, and the impeller housing comprising an impeller coupled to an impeller, The ventricular interface comprises an impeller driver magnet, and the impeller driver magnet is configured to rotate the impeller in the presence of a magnetic field, A device equipped with the following features.

16. The apparatus according to claim 15, further comprising a flexible shaft coupled to the ventricular interface.

17. The apparatus according to claim 15, wherein the cannula comprises a stabilizer coupled to the impeller.

18. The apparatus according to claim 15, wherein the ventricular interface is connected to the cannula via a flexible shaft, and the cannula comprises a centrifugal impeller and a stabilizer connected to the centrifugal impeller.

19. The steps involve accessing the individual's pleural cavity through a surgical incision in the chest wall, A step of implanting a cannula into the heart through the thoracic cavity, wherein the cannula comprises a ventricular interface coupled to an impeller housing, and the impeller housing comprises an impeller coupled to an impeller driver magnet, The steps include: coupling the external motor housing of the individual to the ventricular interface of the cannula in order to rotate the impeller driver magnet by applying a magnetic field that rotates the impeller; Methods that include...

20. The method according to claim 19, wherein the cannula is advanced within the heart through a target cardiac valve.

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