Expandable Sheath for Minimizing Vessel Damage During Catheter Delivery
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Solution Overview
Problem
Current medical procedures face challenges in accessing small body lumens, such as those in the heart, due to the large cross-section and blunt tips of instruments, which can damage vessel walls and dislodge embolic material, and there is a need for apparatus and methods to deliver instruments and agents safely and effectively into body lumens.
Innovation Solution
The development of an expandable sheath apparatus made from lubricious and elastomeric materials with a thin wall, which can be expanded to define a lumen, allowing for the safe delivery of instruments and agents into body lumens, including those in the coronary, neuro, and peripheral vasculature, and other body tracts, while minimizing damage and embolic risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If instruments with large cross-section and blunt tips are used to access small body lumens, then the ability to perform procedures is maintained, but the risk of vessel wall damage and embolic material dislodgment increases
Solution Approach 1:
The delivery system is divided into multiple components: an inner instrument with a small profile for navigating small vessels, and an outer expandable sheath that remains collapsed during delivery but expands at the target site to provide procedural access. This segmentation allows the instrument to reach small vessels without the outer sheath interfering with vessel access.
Solution Approach 2:
The inner instrument is nested within the outer expandable sheath during delivery. The inner instrument has a smaller cross-section and can pass through small vessels first, while the outer sheath remains collapsed around it. At the target site, the outer sheath expands to provide the necessary working space for procedures.
2Reliability
If instruments with large cross-section are used to access small vessels, then procedural capability is maintained, but the difficulty of advancing instruments into small vessels increases
Solution Approach 1:
The outer sheath transitions from a collapsed state with minimal profile during delivery to an expanded state with large lumen at the target site. This dynamic transformation allows the system to adapt its profile to the requirements of different vessel sizes along the delivery path versus the procedural requirements at the target site.
Solution Approach 2:
The cross-sectional area of the outer sheath changes from a minimal profile during delivery to a large area at the target site. This parameter change is achieved through the expandable structure that remains collapsed during navigation but expands when needed for the procedure.
3Ease of operation
If an expandable sheath is used to minimize delivery profile, then ease of insertion into small lumens is improved, but device complexity increases
Solution Approach 1:
The outer sheath is constructed as a flexible, collapsible structure with thin walls that can be compressed to a minimal profile for delivery. This flexible shell design allows the sheath to collapse around the inner instrument during delivery and then expand at the target site without requiring complex mechanical components.
Data Source
AI summary
Apparatus and methods are provided for delivering a guidewire, agents, and the like through an occlusion in a body vessel or other body lumen. The apparatus includes a flexible catheter or other elongate member including a proximal end, a distal end sized for insertion into a body lumen, and a first lumen extending from the proximal end to a distal region of the tubular member. An expandable sheath is provided on the distal region of the catheter that is expandable from a contracted condition to minimize a profile of the sheath to allow insertion along with the tubular member into a body lumen, to an enlarged condition wherein the sheath at least partially defines a lumen communicating with and extending distally from the first lumen of the tubular member.