Pivotable Tissue Engagement Arms for Pericardial Separation
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Solution Overview
Problem
Existing minimally invasive methods for accessing the pericardial space through the pericardium are difficult, time-consuming, and risky due to the close proximity of the epicardium, requiring high skill and often failing to create sufficient separation between the pericardium and epicardium, especially with varying tissue conditions and interference from fat and connective tissue.
Innovation Solution
A mechanical engagement device with pivotable arms that pierce the tissue layer to create separation, allowing for safe and controlled access, facilitating the passage of needles or guidewires, and enabling procedures such as epicardial ablation, lead placement, and drug delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a needle is inserted through the pericardium to access the pericardial space, then access to the pericardial space is achieved, but the risk of injuring the epicardium, heart muscles, and other structures increases due to close proximity
Solution Approach 1:
The patent introduces a tissue engagement device with arms as an intermediary tool between the needle and the pericardium. The arms engage and separate the pericardium from the epicardium before needle insertion, creating a safe pathway that prevents direct contact between the needle and underlying structures, thus reducing injury risk while maintaining access capability
Solution Approach 2:
The device performs preliminary separation of the pericardium from the epicardium using engagement arms before the needle is inserted. This preliminary action creates sufficient space and tissue separation to ensure that subsequent needle penetration occurs in a controlled manner, preventing inadvertent injury to the epicardium and other structures
2Reliability
If traditional needle insertion methods are used, then access to pericardial space can be achieved, but the procedure becomes time-consuming and requires high skill due to difficulty in creating sufficient tissue separation
Solution Approach 1:
The engagement device with movable arms serves as a mediator that automatically creates tissue separation when actuated. This mechanical intermediary eliminates the need for manual, skill-dependent techniques to separate the pericardium, thereby reducing procedure time and making the access method more reliable and easier to perform
Solution Approach 2:
The device incorporates movable engagement arms that can dynamically adjust to engage and separate the tissue layers. This dynamic mechanism allows the device to adapt to varying tissue conditions and automatically create the necessary separation, reducing the skill level required and decreasing procedure time compared to static needle insertion methods
3Ease of operation
If the pericardium and epicardium remain in close proximity, then natural anatomical structure is maintained, but safe access to the pericardial space cannot be achieved
Solution Approach 1:
The device uses movable engagement arms that can be actuated to dynamically separate the pericardium from the epicardium. This dynamic separation creates a temporary working space that facilitates easy needle passage while being reversible - the tissue layers can return to their natural close proximity after the procedure, maintaining anatomical stability when not under mechanical manipulation
Data Source
AI summary
Devices and related methods to engage tissue layers to access the space between the layers are provided. The access devices include engagement arms that can be deployed and retracted to easily engage the top tissue layer and allow it to be separated from the underlying layer. The engagement arms are coupled to an actuation rod that is in turn coupled to a switch or lever that allows a user to control the actuation from outside the patient. The engagement arms and coupling to the actuation rod are unique and compact to ensure the entire mechanism fits in a small diameter shaft.