Balloon-Expandable Heart Valve Delivery for Transaortic Access
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Solution Overview
Problem
There is a need for improved methods and apparatuses to replace a heart valve without open-heart surgery or cardiopulmonary bypass, particularly for patients in frail conditions.
Innovation Solution
A transaortic approach using a balloon-expandable prosthetic heart valve delivery system with a distal tapered tip and introducer sheath, allowing minimally-invasive implantation while the heart remains beating, with optional use of a guidewire and purse string sutures for hemostatic sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional open-heart surgery is performed to replace a heart valve, then the valve replacement can be completed reliably, but the patient experiences significant trauma and requires cardiopulmonary bypass
Solution Approach 1:
The invention divides the heart valve replacement procedure into two separate stages: first delivering and positioning an expandable stent framework through a minimally invasive transaortic approach, then subsequently implanting the bioprosthetic valve within the pre-positioned stent. This segmentation allows each component to be optimized independently and reduces the complexity of single-step procedures, enabling reliable valve replacement without open-heart surgery
Solution Approach 2:
The expandable stent is delivered and positioned at the aortic valve site before the actual valve implantation. This preliminary action creates a prepared framework that guides and supports the subsequent valve placement, ensuring proper positioning and reducing the risk of complications during the valve implantation phase
2Device complexity
If a single-piece stent-valve device is used for transaortic delivery, then the device structure is simplified, but the delivery profile becomes too large for minimally-invasive access
Solution Approach 1:
The device is divided into two separate components: an expandable stent delivered first, followed by a bioprosthetic valve delivered second. This segmentation reduces the profile of each individual delivery system, allowing both components to pass through small transaortic access sites while maintaining the functional integrity of the complete valve replacement system
Solution Approach 2:
The bioprosthetic valve is designed to be implanted within the previously deployed expandable stent, creating a nested configuration where the valve resides inside the stent framework. This nesting approach allows the complete valve assembly to be delivered through a small profile while providing structural support from the outer stent and functional valve tissue from the inner bioprosthetic component
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
Enables minimally-invasive heart valve replacement without open-heart surgery, reducing trauma and potential complications, especially suitable for frail patients.
Implementation Method 1
an expandable prosthetic heart valve in an expanded state and a delivery catheter having a distal end. The heart valve is crimped to a contracted state over the delivery catheter distal end
Implementation Method 2
A transaortic approach using a balloon-expandable prosthetic heart valve delivery system with a distal tapered tip
Data Source
AI summary
A delivery system and method for delivering a prosthetic heart valve to the aortic valve annulus via a transaortic approach. The system includes a balloon catheter for delivering a balloon-expandable prosthetic heart valve through an introducer from an approach from outside the patient, through a minimally-invasive opening in the chest cavity through an incision in the aorta, and into the aorta and aortic annulus. The balloon catheter includes a flexible, tapered tip just distal of the balloon to facilitate positioning of the prosthetic heart valve in the proper orientation within the aortic annulus. The prosthetic heart valve may be installed over the existing calcified leaflets, and a pre-dilation valvuloplasty procedure may also be utilized.