Add-on Sheath Collapsing for Single Access Site
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Solution Overview
Problem
Medical diagnostic and interventional procedures often require multiple access sites, increasing the risk and complexity of procedures and prolonging the time needed, especially when accessing the cardiac region.
Innovation Solution
A sheath assembly that includes a first sheath and a second sheath configured to transition between expanded and collapsed states, allowing for a single access site use by collapsing during insertion and expanding at the region of interest to accommodate instruments, thereby reducing the number of access sites required.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple access sites are used for medical procedures, then the capacity to traverse instrument payloads to the cardiac region is improved, but the risk and complexity of the procedure increase
Solution Approach 1:
The add-on sheath is nested within or attached to the existing sheath, creating a multi-lumen configuration that allows multiple instruments to be delivered through a single access site. The first sheath contains a first lumen and the add-on second sheath contains a second lumen, enabling dual instrument delivery through one puncture site rather than requiring two separate access sites.
Solution Approach 2:
The invention merges the function of two separate sheaths (each requiring its own access site) into a single integrated sheath assembly. By attaching the second sheath to the first sheath, the system combines multiple instrument delivery pathways into one unified access point, reducing the number of punctures needed while maintaining the ability to deliver multiple instruments.
2Adaptability or versatility
If multiple access sites are used, then the functionality for separate diagnostic and interventional instruments is improved, but the procedure time is prolonged
Solution Approach 1:
The add-on sheath is pre-configured and attached to the existing sheath before the procedure begins. This preliminary preparation allows both lumens to be ready for simultaneous instrument delivery, eliminating the time that would otherwise be spent establishing a second access site and sheath during the procedure.
Solution Approach 2:
The nested configuration of the add-on sheath within the first sheath allows both diagnostic and interventional instruments to be prepared and delivered through a single access point, streamlining the procedure workflow and reducing the time required compared to managing two separate access sites.
3Adaptability or versatility
If a second access site is created, then the ability to perform separate diagnostic and interventional procedures is improved, but the invasiveness of the procedure increases
Solution Approach 1:
The invention merges multiple instrument delivery functions into a single access site, reducing the number of vascular punctures required. By attaching the second sheath to the first sheath, the system provides dual-lumen capability through one puncture, thereby reducing invasiveness while maintaining full procedural capability.
Solution Approach 2:
The nested sheath configuration allows multiple instruments to be delivered through a single access site, minimizing the number of times the vessel wall must be punctured. This reduces trauma to the vessel and surrounding tissues while maintaining the ability to perform both diagnostic and interventional procedures.
4Length of moving object
If the sheath profile is reduced for insertion, then the ability to traverse through vessels is improved, but the capacity to accommodate instruments at the destination is limited
Solution Approach 1:
The add-on sheath incorporates a shape-memory alloy structure that allows it to dynamically change its configuration. During insertion, the sheath maintains a compressed, low-profile state to facilitate easy delivery through the vascular system. Once deployed at the destination, the shape-memory material causes the sheath to expand or transition to a configuration that provides adequate lumens for instrument accommodation.
Solution Approach 2:
The add-on sheath is nested within or attached to the first sheath in a space-efficient manner during insertion. The nested configuration minimizes the overall profile during delivery, while at the destination, the add-on sheath can be deployed or expanded to provide the necessary instrument accommodation capacity.
Data Source
AI summary
A sheath assembly includes a first sheath, a second sheath, and an attachment mechanism. The attachment mechanism secures the second sheath to the first sheath such that a first portion of a second sheath outer surface interfaces with a portion of a first sheath outer surface. The second sheath is configured to transition between an expanded state and a collapsed state such that the profile of the sheath assembly can be reduced when the second sheath is in the collapsed state. This can allow the sheath assembly to become more compact, for instance, during insertion, but yet expandable, for instance, once in place within a patient to suitably accommodate an instrument within the second sheath.