Transseptal ECMO Catheter System for Limb Ischemia Reduction
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Solution Overview
Problem
Conventional ECMO procedures using large bore cannulas are associated with complications such as critical limb ischemia, occurring in up to ten percent of procedures and linked to higher mortality, highlighting a need for improved catheter-based cardiopulmonary bypass/ECMO technologies.
Innovation Solution
The development of apparatuses and methods for transseptal extracorporeal membrane oxygenation (ECMO) using percutaneously delivered catheters advanced to the heart region, including a distally tapered inner catheter and a coaxial outer catheter with lateral holes for blood exchange, allowing for efficient oxygenation and perfusion without the need for large bore cannulas.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If large bore cannulas are used for conventional ECMO, then high flow blood removal and oxygenation can be achieved, but critical limb ischemia and mortality increase
Solution Approach 1:
The patent employs a nested catheter configuration where an inner catheter is positioned within an outer catheter. The inner catheter delivers oxygenated blood to the aorta while the outer catheter removes deoxygenated blood from the inferior vena cava. This nested arrangement allows both functions to be achieved through a single percutaneous access site, eliminating the need for large bore arterial cannulas and preventing limb ischemia while maintaining effective blood flow rates.
Solution Approach 2:
The patent uses a percutaneous access sheath as an intermediary device that enables the passage of catheters through the femoral vein without requiring direct arterial cannulation. This intermediary approach allows blood to be diverted through venous access and an external membrane oxygenator, achieving oxygenation without the harmful effects of large bore arterial cannulas on limb perfusion.
2Object-affected harmful factors
If percutaneous catheter-based ECMO is used, then limb ischemia risk is reduced, but effective blood flow and oxygenation may be compromised
Solution Approach 1:
The patent utilizes a membrane oxygenator that operates under controlled pressure and flow parameters to achieve efficient gas exchange. The system maintains adequate blood flow rates by optimizing the pump flow parameters and membrane oxygenator surface area, ensuring sufficient oxygenation and blood return while using smaller bore catheters that prevent limb ischemia.
3Ease of operation
If transseptal approach is used to advance catheters through mitral valve, then direct aortic access is achieved, but procedural complexity increases
Solution Approach 1:
The patent performs a transseptal puncture as a preliminary action to create an access pathway from the right atrium through the interatrial septum into the left atrium. This preliminary opening allows subsequent easy passage of the catheter through the mitral valve into the aorta, simplifying the overall procedure despite the initial puncture step.
Data Source
AI summary
Apparatuses and methods for performing transseptal extracorporeal membrane oxygenation are 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. The catheter system may include coaxially arranged and independently moveable venus and arterial sheaths having independently positionable openings for removing blood from the patient and for returning oxygenated blood to the patient, e.g., within the aorta.