Pre-Formed Lumen Support for Kink-Resistant Heart Delivery Devices
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Solution Overview
Problem
Medical devices with hollow lumens, such as catheters or dilators, are prone to kinking, leading to a loss of lumen patency and reduced functionality when accessing and perforating tissues within the heart, which compromises their effectiveness.
Innovation Solution
A delivery device equipped with a shapeable pre-formed member that maintains lumen patency by being advanced through the elongated body or support lumens, providing flexibility and minimizing kinking, and can be made of materials like stainless steel or nitinol.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a hollow lumen delivery device is used to access heart tissue, then the device can transport fluids and other devices, but the device is susceptible to kinking and loss of lumen patency
Solution Approach 1:
The patent employs a flexible pre-formed member with a specific shape (such as a coil or helix) that can bend and flex without causing kinking of the delivery device. This flexible component maintains the hollow lumen's patency by providing structural support that accommodates the device's curvature during navigation through the body to the heart, thereby resolving the contradiction between maintaining lumen patency and avoiding complex rigid structures.
2Adaptability or versatility
If the delivery device is made flexible to navigate the body, then the device can reach the heart, but the device is more prone to kinking and loss of lumen patency
Solution Approach 1:
The patent incorporates a pre-formed member with a predetermined shape (such as a coil or helix) that is inserted into the delivery device before use. This pre-formed structure provides the necessary flexibility for navigation while simultaneously maintaining lumen patency through its geometric configuration, which prevents kinking. The preliminary shaping of this support member resolves the contradiction by providing both flexibility and structural integrity.
3Reliability
If a rigid structure is used to maintain lumen patency, then the device resists kinking, but the device cannot flex to navigate the body
Solution Approach 1:
The patent utilizes a pre-formed member with a curved or helical geometry (such as a coil) that inherently resists kinking while maintaining flexibility. The curved structure distributes mechanical stress evenly, preventing sharp bends that would compromise lumen patency, while still allowing the device to navigate curved anatomical pathways. This geometric approach resolves the contradiction between rigidity for patency maintenance and flexibility for navigation.
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 pre-formed member ensures consistent lumen patency and reduces kinking, enhancing the device's flexibility and durability, allowing unobstructed flow for medical procedures.
Implementation Method 1
a shapeable pre-formed member longitudinally advanced through the elongated body of the delivery device; wherein the shapeable pre-formed member does not extend longitudinally within the delivery lumen of the delivery device; and wherein the pre-formed member maintains lumen patency of the delivery device
Data Source
AI summary
A system for perforating a tissue within a heart is disclosed. The system includes a delivery device having an elongated body including a body length, a proximal end and a distal end portion terminating in a distal tip. The elongated body defines a delivery lumen extending through the elongate body and dimensioned to slidingly receive at least one or more wires. The system further includes a secondary device having a proximal end and a distal end portion terminating in a distal tip dimensioned to extend longitudinally within the delivery lumen of the delivery device towards the distal tip of the device. The system further includes a shapeable pre-formed member longitudinally advanced through the elongated body of the delivery device. The shapeable pre-formed member does not extend longitudinally within the delivery lumen of the delivery device, and the pre-formed member maintains lumen patency of the delivery device.