Steerable Introducer With Twisting Control Wires
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Solution Overview
Problem
Existing steerable introducers for catheter devices face challenges in navigating complex cardiac anatomy, particularly in the mitral space, often requiring multiple shafts which can complicate procedures and increase the risk of device failure and patient risk.
Innovation Solution
A steerable introducer with a flexible distal portion equipped with both steering and twisting control wires, allowing for precise curvature and twisting movements, enabling the introducer to navigate complex anatomy using only two shafts, thereby simplifying the procedure and reducing risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple shafts are used in steerable introducers to navigate complex cardiac anatomy, then the ability to reach target sites is improved, but the device complexity and risk of failure increase
Solution Approach 1:
The single introducer shaft is designed to perform multiple functions: it provides both structural support and steering capability through an integrated flexible distal portion with control wires. This multi-functional design eliminates the need for separate shafts while maintaining the ability to navigate complex cardiac anatomy and reach target sites.
Solution Approach 2:
The introducer incorporates a flexible distal portion that can dynamically change its configuration through control wires, allowing the shaft to adapt to complex anatomical pathways. The flexible portion can be actively steered and twisted to navigate around anatomical obstacles, providing the adaptability of multiple shafts within a single dynamic structure.
2Measurement precision
If traditional steerable introducers are used without twisting capability, then the structure is simpler, but the precision of targeting in complex anatomy is reduced
Solution Approach 1:
The control mechanism is segmented into independent control systems: steering control wires for curving the flexible distal portion and twisting control wires for rotating it. This segmentation allows precise independent control of position and orientation, enabling accurate targeting while keeping each control subsystem relatively simple and manageable.
Solution Approach 2:
The twisting control wires are positioned asymmetrically around the introducer shaft to enable rotational control. This asymmetric arrangement of control elements allows the flexible distal portion to be twisted to specific angles, providing precise angular positioning capability without requiring a symmetric complex mechanism.
3Adaptability or versatility
If the flexible distal portion is made more flexible to navigate complex anatomy, then the ability to navigate is improved, but the control precision may be reduced
Solution Approach 1:
The introducer shaft exhibits local quality variations: the distal portion is flexible to navigate complex anatomy, while the proximal portion remains more rigid for stable control. This gradient in flexibility allows the distal end to adapt to anatomical variations while the proximal end maintains control precision and structural integrity during manipulation.
Solution Approach 2:
The control wires act as intermediaries between the operator's manual control and the flexible distal portion. By tensioning and releasing these wires, the operator can precisely control the position and orientation of the flexible tip, translating small manual adjustments into accurate positioning despite the flexibility of the distal portion.
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 introducer achieves precise targeting and deployment of catheter devices in complex cardiac environments, such as the mitral space, with enhanced control and reduced risk of complications by allowing for both curvature and twisting motions, thus improving procedural efficiency and safety.
Implementation Method 1
Releasing the tension will allow the flexible distal portion to return to its resting position due to elasticity therein
Implementation Method 2
variations in relative tension between the pair of twisting control wires to cause twisting of the flexible distal portion
Data Source
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AI summary
A steerable introducer for a catheter device is disclosed. The steerable introducer comprises: a body portion (12) having a longitudinal axis extending from a proximal end of the introducer toward a distal end (10) of the introducer, wherein the body portion (12) comprises a flexible distal portion (14) extending to the distal end (10). A hollow (35) is located within a part of the body portion (12) for holding the catheter device during a procedure to introduce the catheter device into the body. There is at least one steering control wire (18, 18') extending axially along the body portion (12) and along at least a part of an axial length of the flexible distal portion (14); and a pair of twisting control wires (16) extending axially along the body portion (12) and along at least a part of an axial length of the flexible distal portion (14). The steering control wire (18, 18') has a distal end that is fixed to the flexible distal portion (14) at a first point (23, 23') in a first axial and circumferential position on the flexible distal portion (14), with the introducer being arranged to allow for tension on the at least one steering control wire (18, 18') to cause a curvature of the flexible distal portion (14). The pair of twisting control wires 16 each have a distal end, with the twisting control wire distal ends (24) being fixed to the flexible distal portion (14) at second and third points (24, 26) at respective second and third axial and circumferential positions on the flexible distal portion (14), with the circumferential position of the twisting control wire distal ends being different from each other as well as different from the circumferential position of the steering control wire (18, 18'). The introducer is arranged to allow for variations in relative tension between the pair of twisting control wires (16) to cause twisting of the flexible distal portion (14).