Expandable Trans-septal Sheath Single Puncture Access
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Solution Overview
Problem
Current medical procedures for accessing the left atrium require multiple catheter and guidewire passes, leading to increased procedure time, risk of complications, and higher costs, with the need for multiple atrial septal punctures and limited ability to use larger instruments due to restricted access lumen sizes.
Innovation Solution
An expandable endovascular access sheath that can be percutaneously introduced and advanced to the right atrium, allowing for a single trans-septal puncture and dilation of the atrial septum to accommodate larger instruments, enabling minimally invasive access to the left atrium with a single septal penetration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple catheter and guidewire passes are used to access the left atrium, then access can be achieved, but procedure time increases and risk of complications increases
Solution Approach 1:
The sheath is pre-assembled with an integrated dilator and positioning features that enable single-pass transseptal puncture. The dilator is pre-positioned within the sheath to facilitate immediate dilation of the atrial septum upon insertion, eliminating the need for separate dilation steps and multiple passes.
Solution Approach 2:
The dilator is nested within the sheath in a telescopic configuration, allowing the dilator to be advanced through the sheath to dilate the atrial septum and then retracted back through the sheath. This nested arrangement enables multiple functions (puncture, dilation, instrument passage) through a single integrated device.
2Reliability
If multiple atrial septal punctures are performed, then access can be obtained, but tissue damage and residual defects increase
Solution Approach 1:
The sheath incorporates a compliant distal portion that can radially expand from a compressed delivery configuration to an expanded working configuration. This parameter change allows the sheath to accommodate larger instruments while minimizing the initial puncture size, thereby reducing tissue damage.
Solution Approach 2:
The sheath transitions from a static compressed state during delivery to a dynamic expanded state at the target site. The compliant distal portion is designed to expand radially to accommodate instruments while maintaining a small profile during insertion, enabling single-puncture access with minimal tissue disruption.
3Ease of operation
If restricted access lumen sizes are used, then minimally invasive access is achieved, but ability to use larger instruments is limited
Solution Approach 1:
The sheath employs radial expansion to increase the access lumen dimension perpendicular to the delivery axis. The distal portion expands radially outward to create a larger working lumen while maintaining a small delivery profile, enabling passage of larger instruments through a minimally invasive access route.
Solution Approach 2:
The sheath's cross-sectional area is dynamically changed from a small compressed configuration during delivery to a large expanded configuration at the target site. This parameter change enables the sheath to accommodate instruments of varying sizes while maintaining minimally invasive access characteristics.
4Adaptability or versatility
If larger instruments are used to facilitate sophisticated treatments, then treatment capability improves, but access lumen size requirements increase
Solution Approach 1:
The sheath transitions from a compressed delivery state with small cross-sectional area to an expanded working state with large cross-sectional area. This dynamic transformation allows large instruments to pass through the expanded lumen while the sheath maintains a small profile during delivery, enabling sophisticated treatments through minimally invasive access.
Solution Approach 2:
The sheath utilizes radial expansion to increase the access lumen area in the radial dimension while maintaining a small delivery profile in the axial dimension. This dimensional transformation enables passage of large-bore instruments through a minimally invasive access route.
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 expandable sheath reduces procedure time, minimizes complications, and allows for the use of larger instruments, facilitating more sophisticated treatments while minimizing tissue damage and residual defects, thus improving patient outcomes and procedural efficiency.
Implementation Method 1
The obturator is a balloon dilator capable of expanding the distal region of the sheath from a collapsed configuration to an expanded configuration
Data Source
AI summary
Disclosed is an expandable transluminal sheath, for introduction into the body while in a first, low cross-sectional area configuration, and subsequent expansion of at least a part of the distal end of the sheath to a second, enlarged cross-sectional configuration. The sheath is configured for use in the vascular system. The access route is through the inferior vena cava to the right atrium, where a trans-septal puncture, followed by advancement of the catheter is completed. The distal end of the sheath is maintained in the first, low cross-sectional configuration during advancement through the atrial septum into the left atrium. The distal end of the sheath is expanded using a radial dilator. In one application, the sheath is utilized to provide access for a diagnostic or therapeutic procedure such as electrophysiological mapping of the heart, radio-frequency ablation of left atrial tissue, placement of atrial implants, valve repair, or the like.