Self-Expandable Coupler for Minimally Invasive VAD Implantation
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Solution Overview
Problem
Existing methods for implanting ventricular assist devices (VADs) are invasive, time-consuming, and costly due to the need for substantial access to the heart and localized trauma caused by coring or cutting to create openings for blood extraction.
Innovation Solution
A self-expandable coupler is deployed through a delivery device to form a conduit for blood extraction from the ventricle, allowing for minimally invasive implantation with reduced access to the heart, accommodating various VAD inlet sizes and shapes, and facilitating tissue ingrowth for a natural seal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If coring or cutting is used to create an opening in the heart wall for VAD implantation, then access to the ventricle is achieved, but localized trauma to the heart wall increases and the procedure becomes more invasive
Solution Approach 1:
A delivery device acts as an intermediary tool to create a controlled aperture in the heart wall and deploy a self-expandable coupler. The delivery device penetrates the heart wall, dilates the aperture, and releases the coupler which then self-expands to form a stable conduit, eliminating the need for direct coring or cutting while achieving the required access.
Solution Approach 2:
The coupler is designed to be self-expanding after deployment. Once released from the delivery device, the coupler automatically expands to its full size to engage the aperture and form a stable conduit, eliminating the need for additional manual expansion steps and reducing procedural complexity.
2Productivity
If traditional coring or cutting methods are used to create heart wall openings, then VAD implantation is achieved, but the procedure becomes time-consuming and complicated
Solution Approach 1:
The coupler is pre-loaded in a compressed state within the delivery device. All necessary components are prepared and positioned before insertion, allowing for rapid deployment once the delivery device is positioned. The self-expanding nature of the coupler further eliminates the need for additional expansion steps during the procedure.
Solution Approach 2:
The traditional mechanical coring or cutting system is replaced with a delivery device that uses controlled penetration and dilation to create the aperture, followed by self-expanding coupler deployment. This substitution reduces the complexity and time required for heart wall opening creation.
3Reliability
If substantial access to the heart is required for VAD implantation, then proper coupling can be achieved, but the invasive nature and complexity of the procedure increases
Solution Approach 1:
The coupler is nested within the delivery device during insertion. The delivery device contains the compressed coupler, and upon deployment, the coupler expands outward from the delivery device to engage the heart wall aperture. This nested arrangement allows for minimal access while achieving stable coupling.
Solution Approach 2:
The coupler transitions from a compressed state during delivery to an expanded state during operation. This dynamic transformation allows the coupler to pass through a small aperture in its compressed form and then expand to provide stable coupling and adequate access to the ventricle, reducing the overall procedural complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The method enables faster, simpler, and less invasive VAD implantation with reduced trauma to the heart, minimizing blood leakage and clot formation, and accommodating different VAD configurations.
Implementation Method 1
A self-expandable coupler, such as an anchor, stent, scaffold, shunt, or other expandable structure, is deployed from the delivery device to engage the aperture and form an access conduit
Implementation Method 2
Penetrating may comprise dilating the aperture with the delivery device, such as a catheter, so as to expand the diameter of the aperture while minimizing complications such as excessive blood leakage or unintended damage to adjacent structures or vessels
Data Source
AI summary
Methods and devices for implanting a ventricular assist device employ a coupler that engages an aperture formed in a heart wall and provides a conduit by which blood is pumped from the ventricle via the ventricular assist device. A method includes penetrating a distal end of a delivery device through a wall of a heart into a ventricle of the heart to form an aperture having a diameter in the wall. A coupler is deployed from the delivery device so that the coupler engages the aperture, expands the diameter of the aperture, and forms a conduit for a flow of blood from the ventricle. The delivery device is removed from the ventricle by retracting the delivery device through the conduit. The ventricular assist device is coupled to the coupler to receive the flow of blood from the ventricle and pump the flow of blood to assist circulation in the patient.