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Publication Number
US-11602627-B2
Publication Date
2023-03-14
Expiration Date
Abstract
A minimally invasive circulatory support platform that utilizes an aortic stent pump or pumps. The platform uses a low profile catheter-based techniques and provides temporary and chronic circulatory support depending on the needs of the patient. Also described is a catheter-based temporary assist pump to treat patients with acute decompensated heart failure and provide circulatory support to subjects undergoing high risk percutaneous coronary intervention (“PCI”). Further described is a wirelessly powered circulatory assist pump for providing chronic circulatory support for heart failure patients. The platform and system are relatively easy to place, have higher flow rates than existing systems, and provide improvements in the patient's renal function.
Core Innovation
The invention relates to a circulatory assist pump system that maintains arterial pulsatility. The system includes a distal tip and a proximal end removably connectable to a catheter, with an impeller system positioned between and connected to the distal tip and the proximal end. The pivotally mounted arm-like impeller blades are foldable and retractable and rotate during operation to draw blood down a subject’s aorta from the subject’s heart.
The pump is encaged by a stent cage having wire-like elements with ends secured to the distal tip and the proximal end. The stent cage is sized and shaped to allow a highly open flow of blood therethrough, and it expands and compresses. When expanded, the stent cage has an expanded circumference sized to be stable against the subject’s aortic wall, and the wire-like elements distend the subject’s aortic wall to positionally affix the stent cage while still allowing the subject’s aorta to maintain its natural pulsatility.
In particular, when the system is positioned and operated in the aorta proximal and above the renal arteries of the subject, natural aortic wall pulsatility is maintained. The platform also includes an option to switch from catheter/drive to wireless powering, and may optionally include a removable upper aortic pulsating stent graft/cuff with pulsatile bands timed to native cardiac pulses.
Additional features described include potential thrombosis mitigation using harmonic vibration and/or an electric charge surface treatment, and optional wireless micro-coils for protein expression or release.
Claims Coverage
The partial content provides one independent claim (clm-00001). It includes three core inventive features that define an aortic-positioned, pulsatility-maintaining circulatory assist pump system with a catheter-connected pump, a pivotally deployed impeller blade set, and an expansile highly open stent cage for stabilization while maintaining natural aortic pulsatility.
Catheter-connected aortic circulatory assist pump maintaining pulsatility
A system for a circulatory assist pump that maintains arterial pulsatility, comprising a distal tip and a proximal end removably connectable to a catheter, and an impeller system between and connected to the distal tip and the proximal end, where the pivotally mounted arm-like impeller blades are foldable and retractable and rotate to draw blood down a subject’s aorta from the subject’s heart.
Highly open expansile stent cage distending the aortic wall for affixation while maintaining pulsatility
A stent cage encaging the circulatory assist pump, comprising wire-like elements having ends secured to the distal tip and the proximal end, wherein the stent cage expands and compresses and is sized and shaped to allow a highly open flow of blood therethrough; and wherein, when expanded, an expanded circumference is sized to be stable against the subject’s aortic wall such that the wire-like elements distend the subject’s aortic wall to positionally affix the stent cage during operation while allowing the subject’s aorta to maintain its natural pulsatility.
Proximal aortic placement above the renal arteries for maintained natural aortic pulsatility
A positioning and operation limitation in which, when the system is positioned and operated in the aorta proximal and above the renal arteries of the subject, natural aortic wall pulsatility is maintained.
The claim coverage centers on maintaining natural aortic pulsatility during circulatory assistance in the proximal aorta above the renal arteries, using pivotally mounted foldable/retractable arm-like impeller blades and a highly open, expansile/compressible stent cage that distends and stabilizes against the aortic wall without preventing natural pulsatility.
Stated Advantages
Maintains arterial pulsatility / natural aortic wall pulsatility while the system is positioned and operated in the aorta proximal and above the renal arteries.
Allows highly open flow of blood through the stent cage when placed within the subject’s aorta.
Stabilizes the stent cage against the subject’s aortic wall by distending the subject’s aortic wall to positionally affix the stent cage during operation.
Potential for reduced hemolysis, reduced heat and turbulence.
Potential for reduced infection risk versus drive lines.
Improved renal outcomes and hemodynamics.
Minimized aortic valve crossing.
Potential thrombosis mitigation using harmonic vibration and/or an electric charge surface treatment.
Wireless powering capability (switching from catheter/drive to wireless powering).
Optional protein expression/release using wireless micro-coils.
Documented Applications
Temporary (acute heart failure/high-risk PCI) circulatory support using an aortic stent pump platform.
Chronic circulatory support using wireless powering (wirelessly powered circulatory support).
Circulatory assist pump operation in the aorta proximal and above the renal arteries to maintain natural pulsatility and relate to improved renal function.
Use of an optional removable upper aortic pulsating stent graft/cuff with pulsatile bands timed to native cardiac pulses to reduce required impeller RPM and improve renal function [application described in partial content summary].
Wireless powering demonstration and associated test/validation context using performance and example studies (including animal studies and CFD/mock circulation loop testing) [application described in partial content summary].
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