Heart Valve Delivery Catheter With Offset Mandrel Alignment
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Solution Overview
Problem
Existing medical devices for delivering replacement heart valve implants are invasive and require significant recovery times, and there is a need for less invasive methods and devices for precise alignment and deployment.
Innovation Solution
A system comprising a replacement heart valve implant with an expandable framework and a delivery device featuring an inner shaft and orientation mandrel, allowing for precise alignment of commissural posts with native heart valve commissures through rotational mechanisms and pre-formed catheter curves to conform to the aortic arch.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If traditional surgical methods are used for heart valve replacement, then the procedure can be performed, but patient trauma and recovery time are significant
Solution Approach 1:
The delivery device employs a nested structure where the inner shaft containing the replacement heart valve is positioned within the outer catheter. The inner shaft can move relative to the outer catheter, allowing the valve to be delivered through a percutaneous approach while maintaining control over deployment. This nested configuration enables less invasive access compared to traditional surgical methods.
Solution Approach 2:
The delivery device acts as an intermediary tool that facilitates the replacement of the heart valve through a minimally invasive percutaneous approach. The device includes an inner shaft with an orientation lumen and orientation mandrel that mediate the positioning and alignment of the replacement valve with the native valve commissures, enabling precise deployment without full surgical exposure.
2Manufacturing precision
If precise alignment of replacement valve commissural posts with native valve commissures is achieved, then proper valve function is ensured, but the complexity of the delivery device increases
Solution Approach 1:
The delivery device is segmented into distinct functional components: an outer catheter for delivery, an inner shaft for positioning, an orientation lumen for rotational control, and an orientation mandrel for alignment. This segmentation allows each component to perform its specific function while contributing to the overall alignment precision of the replacement valve with the native valve commissures.
Solution Approach 2:
The orientation lumen extends laterally offset from the central longitudinal axis of the inner shaft, providing a rotational degree of freedom. The orientation mandrel can rotate within this offset lumen, enabling the replacement valve to be rotated independently to achieve precise alignment with the native valve commissures in the angular dimension, while the inner shaft maintains axial positioning.
3Shape
If the orientation mandrel is positioned along the inside bend of the catheter arch, then the catheter conforms to the aortic arch, but rotational adjustment range is limited
Solution Approach 1:
The orientation mandrel is configured to be movable within the orientation lumen, allowing dynamic adjustment of the replacement valve's rotational position. The mandrel can be advanced or retracted along the orientation lumen and rotated to achieve the desired alignment, providing adaptability in positioning while the catheter maintains its pre-formed curve configuration to conform to the aortic arch.
Data Source
AI summary
A system for delivering a replacement heart valve implant may include the implant including an expandable framework and leaflets coupled to the framework, and a delivery device including a handle and an elongate catheter extending from the handle. The catheter includes an outer sheath and an inner shaft movably disposed within the outer sheath. The implant is releasably coupled to the inner shaft. The inner shaft includes an orientation lumen extending longitudinally within the inner shaft, the orientation lumen being offset from a central guidewire lumen of the inner shaft. The delivery device includes an orientation mandrel disposed within the orientation lumen, the orientation mandrel extending distally from the handle to a distal end proximate a closed distal end of the orientation lumen. The orientation mandrel is operably coupled to an orientation mechanism of the handle configured to apply compressive force or tensile force to the orientation mandrel.