Intracardiac device
Inventors
Assignees
Publication Number
US-12364855-B2
Publication Date
2025-07-22
Expiration Date
2039-06-13
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Abstract
The present invention provides intracardiac devices and methods of implanting the same. The intracardiac devices have a collapsible stent design and include an axial pump to support cardiac function. The axial pump can feature a shaftless fluid actuator for enhanced efficiency in fluid transfer while reducing blood cell trauma. The intracardiac devices include valves that are closeable to seal implanted devices from a subject's anatomy. The intracardiac devices include a cleaning system configured to introduce and circulate cleaning solutions and therapeutics to implanted devices. The intracardiac devices are wirelessly powered and controlled. The intracardiac devices can be implanted using minimally invasive procedures without the need for open heart surgery.
Core Innovation
The present invention provides intracardiac devices and methods of implanting the same, which feature a collapsible stent design and include an axial pump to support cardiac function. The axial pump can have a shaftless fluid actuator for enhanced efficiency in fluid transfer while reducing blood cell trauma. These intracardiac devices also include valves that are closeable to seal the implanted devices from a subject's anatomy as well as a cleaning system configured to introduce and circulate cleaning solutions and therapeutics to the implanted devices. The devices are wirelessly powered and controlled and can be implanted using minimally invasive procedures without the need for open heart surgery.
The problem being addressed is that current left ventricular assist devices (LVADs) have adverse events including stroke, driveline infections, and pump thrombosis. Existing impeller designs in artificial heart pumps have remained fundamentally unchanged since 1982, forcing blood cells to pass over limited spaces within rapidly alternating blades attached to a central hub, creating a fundamentally non-physiological flow that can contribute to hemolysis and thrombosis. There is a need for ventricular assist devices with less traumatic impellers that improve hemodynamic performance while minimizing blood damage and complications.
The invention provides an intracardiac device comprising an elongate tubular body with a lumen, axial and centrifugal pumps positioned within or fluidly connected to the body, valves at each end capable of sealing the device, and a cleaning system with ports and a pump to circulate cleaning solutions or therapeutics. Wireless power and control systems enable modulating the pump speeds and valve positions. Additionally, methods of minimally invasive implantation through specific heart apertures secure the device to form a fluid pathway between the left atrium and the aorta, enabling cardiac support without open heart surgery.
Claims Coverage
The claims identify 8 main inventive features related to an intracardiac device system including a collapsible tubular body, a shaftless pump design, wireless power and control, valves at each end, and a cleaning system with an implantable centrifugal pump.
Intracardiac device with collapsible tubular body and rotatable housing pump
An intracardiac device comprising an elongate tubular collapsible body with first and second ends and an internal lumen; a pump within the lumen featuring a rotatable housing with open ends and helical blades coupled to the inner surface; and an actuator configured to rotate the housing.
Wireless power system with transmitting and receiving coils
A wireless power system having a transmitting coil connected to a battery and an implantable receiving coil electrically connected to the pump to supply power wirelessly.
Collapsible stent construction with membrane covering
The device's tubular body having a collapsible stent construction covered by a membrane, wherein the membrane can be pericardium, a polymer, or combinations thereof.
Pump actuator coupled to housing by motor or magnets
An actuator for rotating the pump housing comprising a motor coupled to the housing (externally or internally at an open end), or one or more magnets coupled to the housing.
Adjustable helical blades on the rotatable housing
The rotor comprising a plurality of helical blades extending from the inner surface of the housing, each blade having a length less than half the inner diameter of the housing, with adjustable pitch for modulation.
Valves positioned at tubular body ends movable between open and sealed states
First and second valves positioned at or near the first and second ends of the tubular body, movable between an open fluid-passage position and a fully closed position to seal the ends substantially.
Implantable cleaning device with centrifugal pump connected to lumen
A cleaning device including an implantable centrifugal pump having an inlet and outlet fluidly connected to the internal lumen of the tubular body to introduce and circulate cleaning fluids or therapeutics.
Tubular body configured for implantation to form pathway between left atrium and aorta
The tubular body configured for implantation within the right atrium of a patient’s heart to form a fluid pathway between the left atrium and the aorta, with anchors securing the ends to the fossa ovalis and sinotubular junction.
The claims cover an intracardiac assistance system featuring a collapsible tubular device implanted to form a cardiac fluid pathway, a shaftless axial pump with adjustable helical blades, wireless power and control systems, valves capable of sealing the device ends, and a cleaning system employing an implantable centrifugal pump to maintain device patency and function.
Stated Advantages
Enhanced efficiency in fluid transfer due to a shaftless fluid actuator design reducing blood cell trauma.
Minimally invasive implantation without the need for open heart surgery.
Ability to seal the intracardiac device via closeable valves to protect from biological and chemical fouling when not in use.
Incorporation of a cleaning system with centrifugal pump and access ports to maintain device cleanliness and deliver therapeutics without removal.
Wireless power transfer and control allowing external modulation of the device, improving patient comfort and device reliability.
Optimized impeller design inspired by avian heart valves that improves flow rates and reduces shear stress, enabling physiological blood flow.
Documented Applications
Cardiac support for early class III heart failure patients by increasing cardiac output while avoiding adverse events common to current LVADs.
Minimally invasive insertion of an intracardiac device to provide an on-demand recovery device that pumps blood from the left atrium to the ascending aorta via the right atrium.
Use of the device to reduce prothrombotic events by employing a novel impeller that reduces hemolysis through physiological flow patterns.
Injection and circulation of cleaning solutions and therapeutics within the implanted device to prevent biological or chemical fouling.
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