Atrial Closure System with Dynamic Retention Sheath
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Solution Overview
Problem
Current intracardiac intervention methods, such as invasive cardiology and transaortic valve implantation, face limitations including restricted access due to vessel anatomy, risk of vessel puncture, and complications like bleeding and scarring, especially in elderly or frail patients.
Innovation Solution
An assembly and method for introducing catheters or instrumentation into the right or left atrium through a thoracic passage, allowing multiple concurrent insertions without needing to arrest or bypass the heart, using a puncturing instrument and elongated sheath with a buffer and restricting assembly to maintain intracardiac length and prevent removal, and a closure assembly for sealing the entry site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If invasive cardiology is used to access the heart through peripheral vessels, then surgical risks are avoided, but catheter access is limited by vessel anatomy and size
Solution Approach 1:
The patent introduces a thoracic passage as an intermediary access route between peripheral vessels and the heart. This new pathway allows catheters to reach the heart when peripheral vessels are unsuitable, combining the safety of non-surgical approaches with improved access versatility.
2Adaptability or versatility
If multiple catheters are inserted through a common blood vessel, then remote access is achieved, but torque transmission and maneuverability are severely limited
Solution Approach 1:
The patent creates separate access pathways through the thoracic wall for each catheter, rather than forcing multiple catheters through a single vessel. This segmentation restores full maneuverability and torque transmission to each catheter while still enabling multiple simultaneous accesses to the heart.
3Ease of operation
If the distal end of the sheath is allowed to move freely within the atrium, then positioning flexibility is improved, but the risk of inadvertent removal or displacement increases
Solution Approach 1:
The patent employs a dynamic retention system where the retention structure can be deployed to engage atrial tissue when stability is needed, and retracted when positioning flexibility is required. This dynamic mechanism resolves the contradiction between fixed stability and movable flexibility.
4Ease of operation
If a large opening is made in the chest cavity for cardiac surgery, then direct access to the heart is achieved, but the risk of infection and scarring increases
Solution Approach 1:
The patent uses a flexible sheath that passes through a small puncture in the thoracic wall rather than requiring a large surgical incision. This thin-film approach maintains good tissue coverage over the access site, minimizing infection risk and scarring while still enabling direct catheter access to the heart.
Data Source
AI summary
A closure system, assembly and attended method for closing and opening in the tissue of the patient includes first and second closure members each including a biased construction operative for disposition of the closure members into an out of retracted and expanded orientations. A connector is disposed in interconnecting relation with the closure members and structured to establish at least a partial spacing there between. The biased construction and the interconnection of the closure members facilitate con current disposition of the closure members with one another into and through an introductory instrument as well as independent and successive disposition of the first and second closure members into a closing relation to the tissue opening upon exiting the introductory instrument.