Transcatheter Insertion System With Outer Sheath Guide
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Solution Overview
Problem
Current mechanical circulatory support systems for heart patients are invasive, costly, and have limited clinical potential, with percutaneous systems facing challenges such as limited pump capacity, short-term support, and risks of infection and bleeding, particularly unsuitable for children and elderly patients with anatomical anomalies.
Innovation Solution
A transcatheter insertion system with an outer sheath and guiding means, such as a ring-shaped doughnut-shaped guiding means, facilitates accurate and precise insertion of intracorporeal devices, reducing the risk of injury and trauma, and allowing for more forgiving operator movements, using an all-in-one insertion device with a guide wire, dilator, and delivery sheath for controlled puncture and delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If percutaneous insertion methods are used to reduce invasiveness, then patient trauma and recovery time are reduced, but pump capacity and mechanical stability are limited
Solution Approach 1:
The insertion system is divided into multiple components: outer sheath, inner sheath, guide wire, and deployment device. This segmentation allows each component to be optimized independently - the outer sheath provides structural stability for large pumps while the inner sheath enables precise positioning, resolving the contradiction between reduced trauma and maintained pump capacity.
Solution Approach 2:
The guide wire acts as an intermediary element that facilitates the insertion of the intracorporeal pump through anatomical structures. It provides a stable pathway that maintains mechanical stability during percutaneous insertion, enabling large-capacity pumps to be inserted minimally invasively.
2Power
If larger intracorporeal pumps are inserted surgically to increase pump capacity, then mechanical stability is improved, but patient trauma and procedure complexity increase
Solution Approach 1:
The intracorporeal pump is nested within the inner sheath, which is itself nested within the outer sheath. This nested configuration allows the large pump to be delivered through a percutaneous approach rather than requiring open surgery, reducing procedure complexity while maintaining pump capacity.
Solution Approach 2:
The outer sheath is inserted first to establish a stable pathway through anatomical structures before the inner sheath and pump are deployed. This preliminary action simplifies the overall procedure by creating a prepared route that reduces complexity during pump deployment.
3Object-affected harmful factors
If percutaneous arterial access is used to reduce invasiveness, then patient trauma is reduced, but pump capacity and blood flow capability are limited
Solution Approach 1:
The system employs dynamic sizing where the outer sheath diameter is selected based on the required pump capacity and blood flow needs. This allows optimization of blood flow capability for each patient while maintaining percutaneous insertion benefits, resolving the contradiction between reduced trauma and maintained productivity.
Data Source
AI summary
A transcatheter insertion system is provided for the insertion of an intracorporeal device using an insertion device. The system comprises an outer sheath arranged and configured to form a passageway for the intracorporeal device and/or the insertion device. The outer sheath guides the insertion device. A method of transcatheter insertion with the system is also provided.