Percutaneous Tubular Shunt Prosthesis for Cavopulmonary Bypass
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Solution Overview
Problem
Children with single ventricle physiology (SVP) require invasive and traumatic surgical procedures like the Bi-directional Glenn operation and Fontan procedure, which are burdensome and have significant recuperation times, with no commercial alternatives for transcatheter interventions.
Innovation Solution
A percutaneously deliverable tubular prosthesis is used to create a shunt between the Superior Vena Cava and the main pulmonary artery, featuring distal and proximal sealing flanges with laterally extending projections to secure the prosthesis in place, allowing for a nonsurgical transcatheter approach.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical procedures (Glenn shunt or Fontan procedure) are performed to establish cavopulmonary bypass, then the required blood flow balance between systemic and pulmonary circulation is achieved, but the procedure becomes invasive and traumatic with significant recuperation time
Solution Approach 1:
The patent replaces the mechanical surgical intervention (open heart surgery with direct suturing and vascular anastomosis) with a transcatheter-based delivery system that uses a self-expanding or balloon-expandable tubular prosthesis. The prosthesis is delivered via catheter through the lumen, avoiding external incisions and direct surgical manipulation of vessels, thereby substituting traumatic mechanical surgery with a less invasive catheter-based mechanical system
Solution Approach 2:
The patent introduces a tubular prosthesis as an intermediary device that establishes the cavopulmonary bypass connection without requiring direct surgical anastomosis between vessels. The prosthesis acts as a mediator that can be delivered through the catheter lumen and deployed to create the necessary blood flow pathway, avoiding direct contact between surgical instruments and the patient's vascular system
2Reliability
If traditional surgical procedures are used for cavopulmonary anastomosis, then a functional shunt is created between vessels, but the procedure requires excessive burden and lifelong medication intake
Solution Approach 1:
The patent replaces the complex surgical procedure requiring multiple stages and lifelong medication with a single-stage transcatheter deployment of a self-expanding or balloon-expandable prosthesis. The prosthesis is delivered via catheter and deployed to immediately establish functional cavopulmonary bypass, eliminating the need for prolonged recuperation and lifelong medication that would be required after traditional surgical intervention
Solution Approach 2:
The patent incorporates sealing flanges with laterally extending projections on the prosthesis that are pre-configured to engage with the vessel wall and prevent pull-through during deployment. This preliminary structural design ensures immediate secure attachment and sealing upon deployment, eliminating the need for post-procedure medication to prevent complications and reducing recuperation time
3Ease of operation
If a tubular prosthesis is deployed through a catheter to create a shunt, then the surgical burden is reduced, but the prosthesis must be securely anchored to resist being pulled through the ostium
Solution Approach 1:
The patent adds a lateral dimension to the anchoring mechanism by incorporating laterally extending projections on the sealing flanges. These projections extend radially outward from the main body of the prosthesis in a direction perpendicular to the longitudinal axis, creating anchoring points that engage with the vessel wall in three-dimensional space. This dimensional addition provides resistance against longitudinal pull-through forces while maintaining the percutaneous delivery approach
Solution Approach 2:
The patent employs asymmetric sealing flange designs where the flanges have different structures at their proximal and distal ends, with laterally extending projections positioned to provide differential anchoring. The asymmetric configuration allows the prosthesis to be securely anchored in one direction (resisting pull-through) while maintaining compliance and sealing in other directions, optimizing both ease of delivery and anchoring strength
Data Source
AI summary
The disclosure provides various embodiments of prostheses and delivery systems to permit an interventional cardiologist to create shunts between various blood vessels. Moreover, the disclosed shunts can be used to shunt between various hollow organs, as set forth in the present disclosure.