Transapical Heart Access Port With Removable Hemostatic Valve
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Solution Overview
Problem
Existing transapical heart ports and hemostatic valves fail to effectively separate a wet zone from a dry zone within a patient's body, leading to blood leakage and difficulty in attaching larger medical devices, while also complicating access to heart chambers for repairs or replacements.
Innovation Solution
The development of transapical access devices with removable hemostatic valve units and apical base plates that create a secure, sealed passage through the heart apex, allowing for a wet-dry zone separation and enabling the attachment of larger medical devices, including cardiac assist units, with features like magnetic couplings and bellows for movement and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a transapical heart port is used to access the heart chamber, then access to the heart is enabled, but blood leakage occurs and wet-dry zone separation is not achieved
Solution Approach 1:
The device divides the internal space into separate wet zone and dry zone compartments using internal septa and valve structures. The heart chamber access is segmented from the external environment through multiple sealing interfaces, allowing controlled fluid passage while preventing uncontrolled leakage.
Solution Approach 2:
A removable hemostatic valve unit acts as an intermediary component between the heart chamber and external environment. This valve unit provides a controlled interface that prevents direct communication between blood-filled chambers and external space, enabling sealing while maintaining access capability.
2Adaptability or versatility
If a hemostatic valve with fixed orifice is used, then blood leakage is prevented, but attachment of larger medical devices is difficult
Solution Approach 1:
The hemostatic valve unit is designed to be removable and replaceable, transforming the static orifice into a dynamic access point. Different valve units with varying orifice sizes can be exchanged based on the specific medical device requirements, enabling adaptability while maintaining hemostatic function.
Solution Approach 2:
The base plate structure serves multiple functions: providing structural support, enabling valve attachment, facilitating device passage, and allowing future access. The universal interface design accommodates various medical devices of different sizes through the removable valve mechanism.
3Reliability
If a permanent sealing structure is implanted, then access to heart chamber is secured, but future repairs or replacements become difficult
Solution Approach 1:
The hemostatic valve unit is designed as a temporary, removable component rather than a permanent implant. After serving its hemostatic function during the procedure, it can be removed without compromising the base plate structure, allowing future access for repairs or device replacements while maintaining secure access during the procedure.
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 solution provides a secure, leak-proof access to the heart chamber, facilitating the attachment of larger medical devices and enabling easy access for repairs or replacements, while maintaining a gaseous environment separate from the wet zone, reducing bleeding and complications.
Implementation Method 1
A bellows may be provided for transferring a movement longitudinally across the apex
Implementation Method 2
features like magnetic couplings and bellows for movement and sealing
Data Source
AI summary
An access device for a heart chamber, a removable hemostatic valve unit, and a system and a method of creating a transapical passage on a beating heart are disclosed. In examples, the access device (1) includes an apical base plate (100) and a sealing unit (3) configured to provide a separation of a wet zone from a heart chamber and a dry zone with a gaseous environment outside of said heart chamber inside a patient body at the same time.