Implant Delivery Sleeve With Imaging-Guided Two-Stage Deployment
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Solution Overview
Problem
Existing delivery devices for expandable implants in the prostatic urethra face challenges in accurately positioning and deploying the implants, with issues such as unreliable self-location, susceptibility to accidental deployment, and inadequate imaging during the process, leading to potential misplacement and complications.
Innovation Solution
A delivery device with an inner tube, outer sleeve, and imaging system that allows for controlled, two-stage deployment, enabling precise alignment of the implant relative to anatomical features through uninterrupted imaging, using a handle mechanism for controlled movement of the sleeve and imaging device to ensure accurate positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the expander is designed to self-locate relative to anatomy by virtue of its expansion, then the deployment process is simplified, but the positioning accuracy and reliability deteriorate due to unpredictable self-location
Solution Approach 1:
The patent introduces an imaging device as an intermediary between the expander and the anatomy, allowing direct visualization of the expander's position relative to anatomical landmarks during deployment. This mediator enables precise positioning control while maintaining a simplified single-step deployment process, resolving the contradiction between operational simplicity and positioning accuracy.
2Device complexity
If the delivery device uses a single-step deployment mechanism, then the device complexity is reduced, but the reliability deteriorates due to susceptibility to accidental deployment and inability to pause or reverse
Solution Approach 1:
The patent implements a dynamic two-stage deployment mechanism where the outer sleeve can be retracted to a first position for partial deployment and imaging verification, then further retracted to a second position for full deployment. This dynamic, multi-position control system prevents accidental deployment by requiring deliberate sequential actions, while maintaining manageable device complexity through the use of a single movable outer sleeve component.
3Measurement precision
If the imaging device is positioned to image the expander during deployment, then the positioning accuracy is improved, but the device complexity increases due to additional components and mechanisms
Solution Approach 1:
The patent merges the imaging device with the outer sleeve structure, where the imaging device is positioned at the distal end of the outer sleeve. This integration allows the imaging device to move with the outer sleeve during retraction, providing continuous imaging of the expander's position relative to anatomy without requiring separate mounting mechanisms or additional complex components.
4Productivity
If the outer sleeve is retracted to fully uncover the expander for deployment, then the deployment effectiveness is improved, but the risk of accidental deployment increases
Solution Approach 1:
The patent segments the deployment process into two distinct stages corresponding to two discrete positions of the outer sleeve: a first position for partial uncovering and imaging verification, and a second position for full uncovering and deployment. This segmentation creates deliberate checkpoints that prevent accidental full deployment, as the operator must consciously proceed through both stages, thereby reducing risk while maintaining deployment effectiveness.
Data Source
AI summary
Aspects of the present invention relate to a delivery device for locating an expandable implant for treating BPH within the prostatic urethra of a patient. The delivery device comprises an inner tube and an outer sleeve movable relative to the inner tube between a stored position and a deployed position. The outer sleeve surrounds the inner tube to define an annulus therebetween and the expandable implant is retained within the annulus when the outer sleeve is in the stored position.