Introducer Sheath Anchoring and Depth Control
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Solution Overview
Problem
Current vascular sheaths used in hybrid cardiac procedures face challenges such as difficulty in determining exact placement, risk of cardiac perforation due to over-insertion, and sheath migration leading to bleeding, especially in complex anatomies or challenging patient characteristics.
Innovation Solution
An introducer sheath with a tubular shaft, a distal balloon for tissue protection, and a proximal anchoring element, such as a collar, that can be slidably moved along the shaft and locked in place to secure the sheath, along with markings for depth control and a deflectable tip for precise placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a standard vascular sheath is used to access the heart, then access can be obtained, but it is difficult to determine exact placement and risk of cardiac perforation increases
Solution Approach 1:
The patent incorporates radiopaque markings on the sheath that change appearance under fluoroscopic imaging, allowing precise visual determination of sheath placement depth. These markings enable the operator to see exactly how far inside the heart the sheath is placed, preventing over-insertion and cardiac perforation.
Solution Approach 2:
The patent replaces mechanical depth measurement methods with fluoroscopic imaging and radiopaque markings. Instead of relying on tactile feedback or external measurements, the system uses X-ray imaging to visually indicate sheath position, providing more accurate and reliable depth determination.
2Ease of operation
If the sheath is inserted deeply to ensure access, then access is improved, but the risk of myocardium damage and cardiac perforation increases
Solution Approach 1:
The patent incorporates a balloon at the distal end of the sheath that can be inflated before advancing the sheath further into the heart. By inflating the balloon first, the operator can buffer the distal tip away from tissue, preventing damage before it occurs. This preliminary protective action allows safe deep insertion when needed.
Solution Approach 2:
The balloon acts as a cushioning element that can be inflated to protect the distal tip of the sheath from contacting and damaging myocardial tissue. This beforehand cushioning provides a safety buffer that allows the sheath to be positioned deeply for optimal access while preventing direct contact between the rigid tip and sensitive heart tissue.
3Adaptability or versatility
If the sheath is made flexible to navigate complex anatomy, then adaptability improves, but stability and precise positioning become more difficult
Solution Approach 1:
The patent divides the sheath into segments with different mechanical properties - a flexible distal portion for navigating complex anatomy and a more stable proximal portion for positioning. The sheath can be selectively deflected or steered at the distal end while maintaining overall stability, allowing navigation through complex cardiac anatomy followed by stable positioning for device deployment.
4Adaptability or versatility
If the sheath is designed for standard vascular access, then device compatibility is maintained, but migration during retraction causes bleeding
Solution Approach 1:
The balloon acts as an intermediary anchoring element between the sheath and the heart tissue. During device deployment and sheath retraction, the inflated balloon prevents the sheath from migrating out of the heart by providing a blocking interface. This intermediary structure maintains the sheath in place throughout the procedure, preventing bleeding while allowing standard device compatibility.
Data Source
AI summary
An introducer sheath for use in hybrid procedures on the heart comprises a shaft having a distal balloon which is inflated inside the heart wall. A proximal collar is slidable along the shaft and locked to anchor the sheath to the wall of the heart. The sheath has markings visible to both the naked eye and under fluoroscopy to aid in judging the depth of insertion.