Steerable Occlusive Implant Sheath With Friction-Zoned Wire Control
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Solution Overview
Problem
Existing medical devices, such as guidewires and catheters, lack alternatives in design and manufacturing methods that enhance maneuverability and control during intravascular procedures, particularly for delivering occlusive implants like left atrial appendage closure devices.
Innovation Solution
An access device with an elongate sheath and a steering member, featuring a steering wire with a distal region engaged with the sheath's inner wall and a friction-reduced region, allows for precise deflection and control through a pre-defined deflection point, utilizing friction-reducing tubular members and stop members to limit axial translation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a steering wire is engaged with the inner wall surface of the elongate sheath to enable steering, then maneuverability and control are improved, but friction between the steering wire and sheath increases mechanical interference and reduces efficiency
Solution Approach 1:
The steering wire is designed with differentiated surface properties: a distal region with high friction engagement with the sheath inner wall for effective steering control, and a friction-reduced region proximal to it with lower friction coefficients to minimize mechanical interference. This local quality variation resolves the contradiction by providing high friction where needed for control while reducing friction in other regions to minimize harmful mechanical interference.
2Object-generated harmful factors
If a friction-reducing tubular member is disposed over the friction-reduced region of the steering wire, then mechanical interference is reduced, but device complexity increases
Solution Approach 1:
A friction-reducing tubular member is disposed over the friction-reduced region of the steering wire, creating a nested structure where the tubular member encloses the wire segment. This nesting approach reduces mechanical interference by providing a low-friction interface between the steering wire and the sheath, while integrating the friction-reducing function within the existing device architecture rather than adding external components.
3Measurement precision
If a stop member is coupled to the distal region of the steering wire to limit translation, then positional control is improved, but device complexity increases
Solution Approach 1:
A stop member is coupled to the distal region of the steering wire to preliminarily establish a limit on axial translation before the procedure begins. This preliminary action ensures that the steering wire cannot translate beyond a predetermined position, providing inherent positional control and preventing over-insertion or excessive movement that could compromise the procedure or device integrity.
4Ease of operation
If the distal region of the steering wire is bonded to the inner wall surface of the elongate sheath, then steering effectiveness is improved, but manufacturing complexity increases
Solution Approach 1:
The steering wire is designed with a distal region specifically configured for bonding to the sheath inner wall, with a friction-reduced region proximal to it. This local quality differentiation allows for targeted bonding in the distal region to maximize steering effectiveness, while the friction-reduced region maintains low friction for efficient force transmission. The bonding can be achieved through various methods (adhesive, thermal, mechanical) applied only to the specific distal region, simplifying the manufacturing process compared to bonding the entire wire.
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
Enhances the ability to navigate and deploy occlusive implants accurately within the vascular system, improving procedural efficiency and reducing mechanical interference.
Implementation Method 1
a distal region where the steering wire is engaged with an inner wall surface of the distal end region of the elongate sheath
Implementation Method 2
a friction-reduced region proximal of the distal region
Implementation Method 3
a friction-reducing tubular member disposed over the friction-reduced region of the steering wire
Data Source
AI summary
Access devices for use with an occlusive implant delivery system are disclosed. An example access device may include an elongate sheath having a distal end region, a distal end, and defining a lumen therethrough. A steering member may be coupled to the elongate sheath and disposed adjacent to the distal end of the elongate sheath. A steering wire may be coupled to the steering member and may extend proximally therefrom. The steering wire may have a distal region where the steering wire is engaged with an inner wall surface of the distal end region of the elongate sheath and a friction-reduced region proximal of the distal region.