Method and apparatus for catheter-based extracorporeal membrane oxygenation (ECMO)
Inventors
Fischell, Tim A. • Saltiel, Frank • PAYNE, Jeffrey
Assignees
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Publication Number
US-11964091-B1
Publication Date
2024-04-23
Expiration Date
Abstract
A method and system for performing transseptal extracorporeal membrane oxygenation is disclosed. The method may include puncturing a septum between the right atrium and the left atrium and advancing a catheter system through the puncture and into the aorta. A first portion of the catheter system can remove blood from the patient, in some examples near the inferior vena cava. A second portion can return oxygenated blood to the patient, through the transseptal puncture and into the aorta.
Core Innovation
The invention provides a method for performing transseptal extracorporeal membrane oxygenation (ECMO) using a coaxial catheter system advanced through a transseptal puncture into the left atrium and then navigated to the mitral valve and the aortic valve. A first inner catheter or an inner sheath is deflected within the left atrium so that a distal tip is disposed substantially toward a mitral valve, and the distal tip is further deflected toward an aortic valve.
After positioning toward the aortic valve, the method advances the first inner catheter and the second inner catheter so that a distal end of the second inner catheter is in an ascending aorta, or advances a first catheter through the aortic valve and into an ascending aorta. The first inner catheter or inner sheath is withdrawn after positioning, while oxygen-poor blood is received from the patient through an outer catheter or a second catheter and oxygenated blood is returned through the second inner catheter or the first catheter into the ascending aortic arch.
The catheter system geometry includes coaxial, concentric arrangements in which a surrounding element has an outer surface flush with an outer surface of the first inner catheter or inner sheath. Blood exchange is managed using perforation structures: an outer catheter has a plurality of holes to receive oxygen-poor blood, and a second inner catheter or inner catheter includes a plurality of holes disposed around a body to return oxygenated blood; mitral-valve centering is described using a balloon around a distal end of the first inner catheter or inner sheath.
Claims Coverage
The document includes two independent method claims centered on a transseptal ECMO workflow using coaxial catheter or sheath elements and left atrium navigation toward the mitral valve and aortic valve, followed by withdrawal of an inner component and exchange of oxygen-poor and oxygenated blood via outer and inner components. Overall, the inventive features cover catheter coaxial geometry, mitral-valve centering/positioning, large-angle distal tip deflection toward an aortic valve, and the oxygen-poor/oxygenated blood paths.
Coaxial inner-catheter with flush outer surfaces through a transseptal puncture
Advancing a first inner catheter that is distally tapered and a second inner catheter through a transseptal puncture, wherein the second inner catheter is coaxial with and surrounds the first inner catheter and an outer surface of the second inner catheter is flush with an outer surface of the first inner catheter.
Deflect distal tip toward mitral valve and advance through mitral valve
Deflecting the first inner catheter within the left atrium so that a distal tip of the first inner catheter is disposed substantially toward a mitral valve; advancing the first inner catheter and the second inner catheter through the mitral valve.
Large-angle deflection of distal tip toward an aortic valve and positioning into ascending aorta
Deflecting the distal tip of the first inner catheter toward an aortic valve; advancing the first inner catheter and the second inner catheter through the aortic valve so that a distal end of the second inner catheter is in an ascending aorta.
Withdraw first inner catheter after positioning and return oxygenated blood via second inner catheter
Withdrawing the first inner catheter; receiving, from the patient, oxygen-poor blood through an outer catheter and returning oxygenated blood through the second inner catheter to the ascending aortic arch.
Coaxial catheter/sheath system with flush outer surfaces and oxygenated return via first catheter
Advancing a first catheter that includes an inner sheath and an outer sheath through a transseptal puncture, wherein the outer sheath is coaxial with and surrounds the inner sheath and an outer surface of the outer sheath is flush with an outer surface of the inner sheath.
Deflect inner sheath toward mitral valve, advance through mitral valve, and deflect toward an aortic valve
Deflecting the inner sheath within the left atrium so that a distal tip of the inner sheath is disposed substantially toward a mitral valve; advancing the inner sheath through the mitral valve; deflecting the distal tip of the inner sheath toward an aortic valve.
Advance into ascending aorta, withdraw inner sheath, receive oxygen-poor blood via second catheter
Advancing the first catheter through the aortic valve and into an ascending aorta; withdrawing the inner sheath from the first catheter; receiving, from the patient, oxygen-poor blood through the second catheter and returning oxygenated blood through the first catheter into the ascending aorta.
Across both independent claims, the coverage focuses on a transseptal ECMO method that uses coaxial catheter or sheath components with flush outer surfaces, positions a distally tipped inner element toward the mitral valve and then deflects it toward an aortic valve, advances into an ascending aorta, withdraws an inner component, and performs oxygen-poor blood intake from the patient with oxygenated blood return through a catheter component disposed in the ascending aorta.
Stated Advantages
Documented Applications
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