Fistula Formation Device Using Nested Sheath Delivery
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Solution Overview
Problem
Conventional fistula formation procedures are highly invasive, posing challenges in minimizing surgical invasiveness and ensuring improved patency and structural integrity.
Innovation Solution
The development of minimally invasive fistula formation devices and methods involving first and second engagement members, such as plates with retention members or magnetic disks, that are delivered through sheaths to form and secure openings between vessels, allowing for fluid communication with minimal tissue disruption.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If conventional surgical procedures are used for fistula formation, then the fistula can be formed between vessels, but the procedure is highly invasive causing significant tissue disruption
Solution Approach 1:
The fistula formation device is divided into multiple engagement members (first engagement member with plate and opening, second engagement member with retention members) that can be delivered separately through sheaths and then assembled together to form the fistula. This segmentation allows each component to be introduced through minimally invasive percutaneous access rather than requiring open surgical exposure.
Solution Approach 2:
The engagement members are delivered through nested sheaths that are advanced through the vasculature. The first sheath delivers the first engagement member, and the second sheath delivers the second engagement member. This nested delivery system enables minimally invasive percutaneous access to the target vessels without requiring large surgical incisions.
2Reliability
If engagement members are secured together to form a fistula, then fluid communication is established between vessels, but structural integrity must be maintained
Solution Approach 1:
The engagement members are designed with pre-formed geometric shapes (plate with opening, base plate with retention members) that provide inherent structural strength. The retention members are pre-configured to engage with the first engagement member in a specific orientation, ensuring proper alignment and secure attachment before the fistula is fully formed. This preliminary structuring ensures both patency and structural integrity.
Solution Approach 2:
The engagement members appear to be constructed from materials with appropriate mechanical properties to withstand vascular forces. The combination of the plate, base plate, and retention members creates a composite structure that maintains structural integrity while allowing fluid flow through the openings. The materials are selected to provide both strength for structural support and porosity for fluid communication.
3Stability of the object's composition
If retention members are used to secure engagement members, then the fistula structure is stabilized, but the device complexity increases
Solution Approach 1:
The retention members are integrated as part of the second engagement member rather than being separate components. The base plate and retention members form a unified structure that is delivered as a single unit through the sheath. This merging reduces the number of separate parts that need to be handled and assembled, simplifying the overall device while maintaining structural stability.
Solution Approach 2:
The retention members are designed to automatically engage with the first engagement member through their geometric configuration. The retention members extend through the plate and secure the engagement members together through their inherent structural design, without requiring additional fastening mechanisms or complex assembly steps. The structure stabilizes itself through the natural interaction of its components.
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
These devices enable the formation of fistulas with reduced invasiveness, improved patency, and structural integrity, facilitating effective fluid flow between vessels while minimizing tissue damage and surgical complexity.
Implementation Method 1
Each of the first and second magnetic disks are magnetically attracted to one another such that the first opening is axially aligned with the second opening
Data Source
AI summary
A fistula formation device includes a first engagement member and a second engagement member. The first engagement member is configured to be positioned within a first vessel. The first engagement member includes a plate defining a first opening therethrough. The second engagement member is configured to be positioned within a second vessel. The second engagement member includes a base plate having a second opening extending therethrough, and one or more retention members extending from the base plate around the second opening, wherein the one or more retention members are configured to extend through the plate of the first engagement member to secure the first engagement member to the second engagement member and form an open conduit through the first engagement member and the second engagement member between the first vessel and the second vessel.