Medical Delivery System Post-Sterilization Alignment Adjustment
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Solution Overview
Problem
Existing medical delivery systems for devices like stents lack the ability to adjust components after sterilization and shipment, leading to loose alignment of parts that affect the precision and effectiveness of device deployment.
Innovation Solution
A delivery system with a freely movable bumper and a sheath that can be axially offset to expose a seat, allowing for adjustable positioning of medical devices, along with an actuator and adjustment member to re-align components post-sterilization, ensuring precise deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If components are assembled in close alignment during manufacturing, then manufacturing precision is improved, but after sterilization and shipment, the components become loosely spaced due to longitudinal expansion
Solution Approach 1:
The delivery system incorporates an adjustable mechanism that allows the inner member to be repositioned relative to the sheath after sterilization and shipment. This dynamic adjustment capability compensates for longitudinal expansion that occurs during storage, enabling the physician to restore proper alignment and spacing between components before use.
Solution Approach 2:
The system includes an adjustment mechanism that modifies the longitudinal position of the inner member within the sheath. By changing the positional parameter of the inner member, the system compensates for dimensional changes that occur during sterilization and storage, maintaining proper component alignment.
2Device complexity
If the delivery system is designed with fixed components, then device complexity is reduced, but the system cannot be adjusted after shipment leading to deployment inaccuracy
Solution Approach 1:
The delivery system incorporates an adjustable mechanism that allows the inner member to be repositioned relative to the sheath after sterilization and shipment. This dynamic adjustment capability compensates for longitudinal expansion that occurs during storage, enabling the physician to restore proper alignment and spacing between components before use.
3Manufacturing precision
If multiple delivery systems are used to ensure proper alignment, then manufacturing precision is improved, but the need for multiple systems increases patient trauma and procedural time
Solution Approach 1:
The delivery system integrates both the sheath and the adjustment mechanism into a single multi-functional device. The sheath provides protective coverage while the integrated adjustment mechanism enables post-sterilization alignment correction, eliminating the need for separate alignment devices and reducing procedural steps.
Solution Approach 2:
The delivery system incorporates an adjustable mechanism that allows the inner member to be repositioned relative to the sheath after sterilization and shipment. This dynamic adjustment capability compensates for longitudinal expansion that occurs during storage, enabling the physician to restore proper alignment and spacing between components before use.
Data Source
AI summary
The invention is directed to a delivery system for delivering a medical device. The delivery system includes an inner member having a proximal end and a distal end. The inner member defines a longitudinal axis between the proximal end and the distal end. A tip is formed at the distal end of the inner member. A bumper is freely disposed on the inner member. The bumper has a proximal end and a distal end. A seat is defined between the tip and the distal end of the bumper. Additionally, a sheath is disposed about the inner member, the sheath having a proximal end and a distal end. The sheath is movable from a first sheath position substantially covering the seat, and a second sheath position axially offset to expose the seat. The invention also includes a handle in contact with the proximal end of the inner member.


