Vascular Implant Delivery System with Expansion Limiter
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Solution Overview
Problem
Current implant delivery systems for vascular disorders, such as cranial aneurysms, face challenges in maintaining flexibility during insertion and decoupling implant release from catheter retraction, often resulting in irreversible deployment and limited repositioning capabilities.
Innovation Solution
A delivery system featuring an elongated core element with a proximal end accessible externally and a distal end for engaging the implant in a collapsed state, along with an expansion limiter that allows for controlled release of the implant by proximal movement, enabling flexibility and retraction of the implant after deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the delivery catheter is withdrawn to release the implant, then the implant can be deployed, but the implant becomes irreversibly deployed and cannot be repositioned
Solution Approach 1:
The delivery system is divided into separate functional components: a delivery catheter for positioning, a core element with engagement features for implant retention, and an expansion limiter for controlled deployment. This segmentation allows independent control of implant release and positioning, enabling the implant to be deployed and then repositioned by manipulating the core element and expansion limiter separately from the catheter.
Solution Approach 2:
The system transitions from a static delivery configuration to a dynamic control mechanism where the expansion limiter can be moved proximally to release the implant, and the core element can be manipulated to recapture and reposition the implant. This dynamic control allows the implant to transition between deployed and recaptured states, providing adaptability for repositioning.
2Ease of operation
If the delivery catheter is manipulated to allow partial expansion, then the distal portion can expand while retaining the distal tip, but the device becomes fully expanded and cannot be recaptured
Solution Approach 1:
The expansion limiter acts as an intermediary component between the delivery catheter and the implant. It controls the expansion process by allowing the distal portion to expand while maintaining engagement with the core element, preventing full expansion that would lose recapture capability. The engagement features on the core element serve as another intermediary that maintains control over the implant throughout the deployment and recapture process.
3Device complexity
If the delivery system uses a simple sheath-type introducer, then the structure is simple, but the implant cannot be selectively released and repositioned
Solution Approach 1:
The delivery system is segmented into multiple functional components: a delivery catheter, a core element with engagement features, and an expansion limiter. This segmentation enables selective release and repositioning capabilities while maintaining reasonable structural complexity. Each component performs a specific function, allowing independent manipulation for implant control.
Solution Approach 2:
The core element is pre-configured with engagement features (protrusions and recesses) that are positioned to engage the implant in a collapsed state. The expansion limiter is pre-positioned to control the proximal portion of the implant. These preliminary configurations enable selective release and repositioning without requiring complex real-time manipulation during deployment.
Data Source
AI summary
A system for delivering an expandable implant into the vasculature of a patient, including an elongated core element having a proximal end accessible exterior to the patient and a distal end including at least one feature for engaging a proximal portion of the implant in a collapsed state. The system further includes an expansion limiter having an inner diameter and a length sufficient to cover the proximal portion of the implant and to retain the proximal portion in the collapsed state, and at least one elongated member having a distal end connected to the expansion limiter and a proximal end accessible exterior to the patient to enable proximal movement of the expansion limiter to release the implant.