Non-constant diameter dilator for prosthetic heart valve delivery
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Solution Overview
Problem
The insertion of dilators and sheaths within the vasculature for prosthetic heart valve delivery is challenging due to difficulties in navigating and expanding the vessel to accommodate larger devices, leading to potential vascular trauma, increased procedure time, and complications such as bleeding and infection.
Innovation Solution
A prosthetic valve delivery assembly featuring a dilator with a non-constant diameter design, comprising a first tapered region, a central region with a constant diameter, and a second tapered region, which radially expands the sheath and vessel by contacting the vessel wall, allowing for the passage of larger devices without the need for sheath upsizing, thereby reducing vascular trauma and procedure time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a traditional constant diameter dilator and sheath are used, then the structure is simple and easy to manufacture, but the insertion into vasculature is difficult and causes vascular trauma
Solution Approach 1:
The dilator is designed with varying diameters in different regions: a smaller distal diameter for easy vascular insertion, a larger central diameter for effective sheath expansion, and an intermediate tapered transition region. This local quality variation allows the single dilator to perform multiple functions without requiring multiple components or sheath upsizing.
2Volume of moving object
If the sheath diameter is increased to accommodate larger devices, then larger devices can be passed, but vascular trauma and procedure time increase
Solution Approach 1:
The dilator performs preliminary expansion of the sheath to the required larger diameter before the large device is passed. This preliminary action creates sufficient space for the large device without requiring a permanently large sheath, thereby minimizing vascular trauma while accommodating larger devices.
3Adaptability or versatility
If multiple sheaths of different sizes are used, then devices of various sizes can be accommodated, but procedure time and complexity increase
Solution Approach 1:
The single dilator with non-constant diameter serves multiple functions: it acts as both a small dilator for initial insertion and a large dilator for sheath expansion, eliminating the need to exchange between multiple sheaths of different sizes. This multi-functionality reduces procedure time while maintaining adaptability to various device sizes.
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 non-constant diameter dilator design facilitates smooth expansion of the sheath and vessel, minimizing trauma and complications, and allows for the passage of larger devices without the need for sheath upsizing, thereby reducing vascular trauma and procedure time.
Implementation Method 1
a first tapered region extending along the dilator axis between the distal end and a first central end, the first tapered region comprising a tapered shape
Implementation Method 2
a central region coaxial with the first tapered region and attached to the first central end, the central region comprising the second diameter that is substantially constant along a central length of the central region
Implementation Method 3
a second tapered region extending along the dilator axis between a second central end and a third central end, the second tapered region comprising a tapered shape
Data Source
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AI summary
A prosthetic valve delivery assembly includes a dilator including a first tapered region extending along a dilator axis. The first tapered region includes a tapered shape with a first diameter at a distal end and a second diameter at a first central end. The second diameter is greater than the first diameter. A central region includes the second diameter that is substantially constant along a central length of the central region. A second tapered region includes a tapered shape with the second diameter at the second central end and a third diameter at a third central end. The third diameter is less than the second diameter. A proximal shaft region extends from the third central end. The proximal shaft region includes the third diameter such that a difference between the second diameter and the third diameter is within a French gauge range from about 3Fr to about 5Fr.