Expandable Implant Delivery Tube With Imaging-Guided Staged Deployment
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing delivery devices for expandable implants in the prostatic urethra are prone to accidental or premature deployment, lack visual verification of correct positioning, and may result in unpredictable positioning due to reliance on self-location, leading to potential adverse outcomes and complex recovery procedures.
Innovation Solution
A delivery device with concentric elements, including an imaging head, implant retainer formations, and an outer sheath, allows for controlled deployment through a handle assembly with a hub carriage and deployment drive, enabling accurate positioning and visual verification before full deployment, using a detent mechanism to prevent inadvertent deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single-step delivery device is used, then the device structure is simple, but accidental or premature deployment may occur and visual verification of correct positioning is not enabled
Solution Approach 1:
The delivery device is divided into multiple concentric elements (inner element with imaging head, intermediate element with implant retainer, outer element with outer sheath) that can be independently controlled. The hub carriage system allows sequential retraction of each element, enabling staged deployment with visual verification opportunities between stages.
Solution Approach 2:
The device enables preliminary positioning and visual verification before final deployment. The imaging head can capture images at intermediate stages to verify correct positioning, and the detent mechanism can be engaged at partial retraction positions to pause and confirm deployment status before proceeding.
2Ease of operation
If the expander relies on self-location, then the deployment process is simple, but positioning accuracy is unpredictable and may lead to adverse outcomes
Solution Approach 1:
The imaging head provides real-time visual feedback to the clinician during the deployment process. Images can be captured and reviewed to confirm the expander is positioned correctly within the prostatic urethra, allowing immediate correction if positioning is inaccurate before final deployment occurs.
Solution Approach 2:
The imaging head acts as an intermediary between the delivery device and the target site anatomy. It provides a visual interface that allows the clinician to verify positioning without direct tactile feedback, enabling precise localization of the expander relative to surrounding structures.
3Productivity
If the outer sheath is retracted fully to deploy the implant, then the implant is released, but the device cannot provide visual verification before deployment
Solution Approach 1:
The concentric element structure allows the inner element with imaging head to be retracted independently from the outer element. This enables visual verification to be performed at an intermediate stage before complete retraction of the outer sheath, providing positioning confirmation without requiring full deployment.
Solution Approach 2:
Visual verification using the imaging head can be performed as a preliminary action before final implant release. The system allows the clinician to review images confirming correct positioning, then proceed with complete outer sheath retraction for final deployment, ensuring informed and accurate implant placement.
Data Source
AI summary
Devices and methods for deploying an implant in a patient's body comprises an elongate delivery tube having an inner element comprising an imaging head, an intermediate element comprising implant retainer formations and an outer element comprising an outer sheath, the inner and outer elements being retractable relative to the intermediate element. A handle at a proximal end of the delivery tube contains a hub assembly comprising hubs of the inner element, the intermediate element and the outer element. A hub carriage that is movable longitudinally within the handle with respect to the intermediate element hub supports the hubs of the inner element hub and the outer element for movement with the hub carriage to retract the inner and outer elements relative to the intermediate element.