Transseptal Needle Assembly With Spring-Loaded Atraumatic Puncture
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Solution Overview
Problem
Existing transseptal puncture needles face challenges in manufacturing precision, cost, and safety, particularly in maintaining atraumatic performance across varying septal wall fibrousity and thickness, while minimizing skiving and unintended punctures.
Innovation Solution
A transseptal needle design with a 'bird's beak' tip configuration and a spring mechanism, allowing controlled penetration and atraumatic configuration post-puncture, combined with a flexible intermediate portion and crimped two-part construction for reduced manufacturing costs.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a complex multifaceted needle tip configuration (tangential back bevel, reverse tangential back bevel, or conical reverse bevel) is used to improve puncture performance, then the needle can penetrate septal walls more effectively, but the manufacturing cost and complexity increase significantly
Solution Approach 1:
The needle tip is divided into distinct functional zones: a sharp leading edge for initial penetration, a curved intermediate portion for controlled flexing, and a rounded trailing edge to prevent tissue damage. This segmentation allows each portion to perform its specific function while simplifying the overall manufacturing process compared to complex multifaceted configurations.
Solution Approach 2:
The needle tip incorporates a curved intermediate portion that allows dynamic flexing during penetration. This flexible section enables the needle to adapt to varying septal wall thickness and fibrousity while maintaining control, eliminating the need for complex static multifaceted designs.
2Reliability
If the needle tip is made extra sharp to reduce puncture resistance, then penetration of fibrous septal walls is easier, but the risk of unintended punctures and tissue damage increases
Solution Approach 1:
The curved intermediate portion provides dynamic flexibility that allows the needle to bend and absorb shock during penetration. This flexibility prevents sudden rebound and loss of control, thereby reducing the risk of unintended punctures while maintaining sufficient sharpness for effective penetration.
Solution Approach 2:
The rounded trailing edge and flexible intermediate portion act as a cushioning mechanism that distributes forces during penetration. This beforehand cushioning design prevents sudden impacts and rebound effects that could cause tissue damage, while still allowing the sharp leading edge to initiate puncture effectively.
3Strength
If the needle is designed to be rigid to maintain structural strength, then it can withstand insertion forces, but it cannot adapt to varying septal wall fibrousity and thickness
Solution Approach 1:
The needle incorporates a curved intermediate portion that provides dynamic flexibility, allowing the distal portion to bend and adapt to varying septal wall characteristics. This flexible section enables the needle to accommodate different fibrousity and thickness while the proximal portion maintains structural strength for insertion.
Solution Approach 2:
Different portions of the needle have different mechanical properties: the proximal portion is rigid for structural strength and insertion, while the distal intermediate portion is flexible for adaptation to septal wall variations. This local quality differentiation allows the needle to simultaneously achieve strength and adaptability.
4Ease of manufacture
If a single-piece needle construction is used to simplify manufacturing, then production cost decreases, but manufacturing precision and consistency of tip configuration deteriorate
Solution Approach 1:
The needle is constructed as a multi-component assembly with the tip, intermediate portion, and shaft as separate elements that can be manufactured independently with high precision. The curved intermediate portion can be precisely formed and then assembled to the tip and shaft, ensuring consistent tip configuration while maintaining manufacturing simplicity through modular construction.
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
Improves manufacturing precision, reduces skiving and unintended punctures, enhances safety by ensuring controlled penetration, and lowers production costs.
Implementation Method 1
The spring mechanism positions the tip of the needle or stylet in a middle position extending from the distal end of the assembly, allows the needle or stylet to be moved into a spring loaded fully retracted configuration within the assembly as the septal wall is tented, and then releasing the spring loaded needle or stylet as the needle or stylet penetrates the septal wall
Data Source
Figure 1A~2B
Figure 2C~3A
Figure 3B~4
AI summary
A needle or stylet has a tip contour with a reverse back bevel curved toward the longitudinal axis of the needle or stylet. The needle has a flexible intermediate portion and/or a two-part construction in which a distal portion of the needle to crimped onto a proximal portion of the needle. The needle or a stylet is combined with a spring mechanism in the hub of the needle or stylet assembly. The spring mechanism positions the tip of the needle or stylet in a middle position extending from the distal end of the assembly, allows the needle or stylet to be moved into a spring loaded fully retracted configuration within the assembly as the septal wall is tented, and then releasing the spring loaded needle or stylet as the needle or stylet penetrates the septal wall. A method of using a needle or stylet with a spring mechanism is included.