Nested Delivery Catheter Support for Large-Bore Introducer Sheaths
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Solution Overview
Problem
Existing percutaneous intravascular medical procedures using access introducer sheaths with large internal channel diameters face increased surgical complications and complexity due to the need for thicker, more rigid walls, which can lead to vessel dissections and perforations.
Innovation Solution
A delivery system integrating an access introducer sheath with a delivery catheter, where the catheter provides internal structural support, allowing for a thinner sheath wall and simplified construction, reducing the risk of complications and procedural steps.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Area of moving object
If the access introducer sheath is formed with larger sizes to accommodate large payloads, then the channel diameter is increased, but the wall thickness must be increased and structural complexity increases
Solution Approach 1:
The delivery catheter is nested within the access introducer sheath, with the catheter providing internal structural support to the sheath. This nested configuration allows the sheath to have a larger channel diameter while relying on the catheter's structural elements (such as the distal end segment and radiopaque members) to maintain sheath integrity, thereby avoiding the need for increased wall thickness or complex strengthening materials.
2Strength
If the wall thickness is increased to support larger channel diameter, then the structural strength is improved, but the risk of surgical complications increases
Solution Approach 1:
By nesting the delivery catheter within the access introducer sheath, the catheter's structural components (distal end segment, radiopaque members) provide internal support to the sheath. This allows the sheath to maintain adequate structural strength with reduced wall thickness, thereby minimizing the risk of vessel dissections, perforations, and other surgical complications associated with thicker sheaths.
3Stability of the object's composition
If strengthening materials such as braided strands or coiled strands are added, then the structural rigidity is improved, but the device complexity and procedural steps increase
Solution Approach 1:
The delivery catheter nested within the access introducer sheath provides the necessary structural rigidity through its own design features (distal end segment, radiopaque members) rather than requiring the sheath to incorporate complex strengthening materials like braided strands or coiled strands. This simplifies the overall device structure and reduces procedural complexity.
4Adaptability or versatility
If the access introducer sheath is designed with larger sizes, then it can accommodate large payloads, but the risk of vessel dissections and perforations increases
Solution Approach 1:
The nested configuration allows the access introducer sheath to have a larger channel diameter suitable for accommodating large payloads (such as catheter-based valve replacement devices or leadless pacing devices) while the delivery catheter's structural components provide internal support to prevent vessel dissections and perforations, thereby enabling large payload accommodation without increasing the risk of vascular injuries.
Data Source
AI summary
A delivery system and method are described that include an access introducer sheath and a delivery catheter. The access introducer sheath defines a channel through a body thereof from a proximal end to a distal end. The delivery catheter is disposed within the channel of the access introducer sheath, and defines a lumen that extends along a central axis of the delivery catheter. A distal end segment of the delivery catheter projects beyond the distal end of the access introducer sheath. The lumen is configured to receive a dilator therein that projects beyond the distal end of the delivery catheter so that the distal end segment of the delivery catheter is disposed between a tip segment of the dilator and the distal end of the access introducer sheath along the central axis.