Introducer Sheath Seal Dynamics for Leakage Control
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Solution Overview
Problem
Existing introducer sheaths used to access the vasculature or heart often experience blood leakage around the device, and there is a need for a small diameter solution to minimize the puncture site size during procedural device delivery.
Innovation Solution
An introducer sheath system comprising a body portion, a distal tip portion, and a seal portion, where a dilator is used to transition the seal portion from a neutral configuration with a larger outer diameter to an extended configuration with a smaller diameter, preventing blood leakage and maintaining a small sheath diameter for minimally invasive procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a larger diameter introducer sheath is used to seal the puncture site, then blood leakage is prevented, but the puncture site size increases and minimally invasive benefits are reduced
Solution Approach 1:
The seal portion is designed to dynamically change its outer diameter between two configurations: a first configuration with a larger outer diameter for sealing the puncture site, and a second configuration with a smaller outer diameter for delivery through the puncture site. This dynamic transformation allows the same component to satisfy both sealing effectiveness and minimally invasive requirements at different operational stages.
Solution Approach 2:
The seal portion undergoes parameter changes in its outer diameter based on operational requirements. The ability to transition between a larger diameter (for sealing) and a smaller diameter (for delivery) represents a controlled parameter change that resolves the contradiction between sealing effectiveness and puncture site size.
2Area of stationary object
If a smaller diameter introducer sheath is used to minimize puncture site size, then minimally invasive benefits are achieved, but blood leakage around the sheath increases
Solution Approach 1:
The seal portion dynamically adjusts its outer diameter to match the operational requirements. During delivery, it maintains a smaller diameter to minimize puncture site size, and during sealing, it transitions to a larger diameter to prevent blood leakage, thus resolving the contradiction between minimally invasive benefits and sealing effectiveness.
Solution Approach 2:
The controlled change in the seal portion's outer diameter parameter allows the system to optimize for puncture site size during delivery and then optimize for sealing effectiveness during the sealing phase, effectively resolving the contradiction between these two opposing requirements.
3Reliability
If the seal portion maintains a large outer diameter throughout delivery, then sealing effectiveness is ensured, but device complexity and delivery difficulty increase
Solution Approach 1:
Rather than maintaining a permanently large diameter structure, the seal portion is designed to be dynamic, transforming from a compact delivery configuration to an expanded sealing configuration only when needed. This reduces the overall device complexity and facilitates easier delivery while ensuring sealing effectiveness when required.
4Area of stationary object
If the seal portion is made collapsible to reduce delivery profile, then minimally invasive delivery is facilitated, but manufacturing complexity increases
Solution Approach 1:
The seal portion utilizes a flexible structure that can collapse during delivery and expand during sealing. This flexible shell design allows the seal portion to be compressed to a smaller profile for minimally invasive delivery while maintaining the capability to expand to an larger diameter for effective sealing, balancing delivery requirements with manufacturing feasibility.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system effectively seals the puncture site during device delivery, reducing blood leakage and allowing for the use of smaller introducer sheaths, thereby minimizing puncture site size and facilitating more precise medical interventions.
Implementation Method 1
The seal portion can be moved from a neutral configuration to an extended configuration. The seal portion can have a larger outermost diameter in the neutral configuration than in the extended configuration.
Implementation Method 2
The dilator can be configured to be inserted into a lumen defined by the introducer sheath such that the dilator can engage with the distal tip portion and translate the distal tip portion relative to the body portion
Data Source
AI summary
In some embodiments, an apparatus includes an introducer sheath and a dilator. The introducer sheath can include a body portion and a tip portion. The body portion can be coupled to the tip portion via a seal portion. The dilator can be configured to be inserted into a lumen defined by the introducer sheath such that the dilator can engage with the tip portion and translate the tip portion relative to the body portion such that the tip portion moves the seal portion from a biased neutral configuration to an extended configuration for delivery of the apparatus to a location in a patient's body. The seal portion can have a larger outermost diameter in the neutral configuration than in the extended configuration.