Wedge-Lock Sheath Retention Mechanism for Controlled Deployment
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Solution Overview
Problem
There is a need for alternative medical devices and methods for securing medical devices within a sheath, particularly for intracorporeal applications, to enhance stability and control during deployment.
Innovation Solution
A medical device system comprising a sheath with slots and a locking element that can slide over the sheath, applying a radially inward compressive force to secure a pusher wire and implant, limiting axial and rotational movement until deployment is desired.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a locking element is used to secure the pusher wire and implant within the sheath, then stability and control during deployment are improved, but device complexity increases
Solution Approach 1:
The locking element is nested within the sheath structure, with the sheath having slots that allow the locking element to engage and secure the pusher wire. The locking element itself contains internal features (protrusions, grooves) that interact with the sheath and pusher wire, creating a compact nested arrangement that provides secure retention without excessive complexity
Solution Approach 2:
The locking element is divided into distinct functional regions: a distal end region for free sliding, a proximal end region for radial compression, and intermediate features like protrusions and grooves for engagement. This segmentation allows each region to perform its specific function independently, improving reliability while maintaining manageable complexity
2Reliability
If the locking element applies radially inward compressive force to secure the medical device, then retention security is improved, but the force required to deploy the device increases
Solution Approach 1:
The locking element is designed to be dynamically movable along the sheath, transitioning from a locked position (where it applies radially inward compressive force through the slots) to an unlocked position (where it can be pulled free). The distal end region allows free sliding for easy deployment, while the proximal end region provides secure retention, creating a dynamic system that adapts its force characteristics based on operational phase
Solution Approach 2:
The locking element is pre-configured with its radially inward compressive force capability before deployment. The slots in the sheath and the corresponding protrusions on the locking element are designed in advance to engage and provide secure retention during insertion and deployment, eliminating the need for additional securing actions during the procedure
3Ease of operation
If the locking element is designed with varying inner diameters to facilitate sliding and compression, then ease of operation is improved, but manufacturing precision requirements increase
Solution Approach 1:
The locking element features non-uniform inner diameter with distinct regions: a larger inner diameter in the distal end region for easy sliding over the sheath, and a smaller inner diameter in the proximal end region for effective radial compression. This local variation in geometry allows each region to optimize its function, making operation easier while the manufacturing precision requirements are confined to specific localized areas rather than the entire component
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 system provides secure retention and controlled release of medical devices, ensuring precise placement and reducing movement during insertion and deployment, enhancing treatment efficacy.
Implementation Method 1
the locking element may be configured to depress the sheath radially inwards... applying a radially inward compressive force to secure a pusher wire and implant, limiting axial and rotational movement
Data Source
AI summary
A medical device system may include a sheath, a pusher wire, and a locking element. The pusher wire may be slidably disposed within a lumen of the sheath. The locking element may have a proximal end, a distal end, an intermediate region disposed between the proximal end and the distal end, and a lumen extending from the proximal end to the distal end. The locking element may have a first inner diameter adjacent to the distal end and a second inner diameter adjacent to the proximal end, the second inner diameter smaller than the first outer diameter. The distal end region of the locking element may be configured to freely slide over the sheath and when a proximal end region of the locking element is disposed over the sheath, the locking element may be configured to depress the sheath radially inwards.