Pericardial Access Device with Tissue Engaging Member
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Solution Overview
Problem
Current methods for accessing the pericardial space are challenging, especially for inexperienced physicians, as they require precise puncture of the pericardium without damaging the heart, and existing techniques may not be effective for larger devices or external heart structures.
Innovation Solution
The development of devices comprising a tissue-engaging member, a tissue-piercing member, and a guide element that engage and manipulate the pericardium to create a safe access pathway into the pericardial space, using various mechanisms such as mechanical cutting, chemical etching, electrical weakening, or thermal methods, and incorporating features like textured surfaces and coatings to enhance friction and control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a needle is advanced towards the heart by tactile feedback to pierce the pericardium, then pericardial access may be achieved, but the risk of piercing the heart increases significantly
Solution Approach 1:
A pericardial tissue engaging member is introduced as an intermediary tool between the needle and the pericardium. This engaging member grasps and pulls the pericardial tissue away from the heart surface, creating a safety buffer that allows the needle to pierce the pericardium without directly contacting or damaging the heart. The intermediary tissue engaging member thus mediates the dangerous interaction between the piercing needle and the heart.
Solution Approach 2:
The pericardium is engaged and pulled away from the heart surface before the needle piercing action is performed. This preliminary action of tissue engagement and displacement creates a safe working space in advance, ensuring that when the needle pierces the pericardium, the heart is already positioned at a safe distance, thereby preventing heart piercing.
2Object-affected harmful factors
If the pericardium is grasped and suctioned prior to puncturing to reduce heart damage risk, then safety improves, but the presence of epicardial fat and irregularities prevents direct access to the pericardium
Solution Approach 1:
The pericardial tissue engaging member serves as an intermediary that can penetrate through epicardial fat and irregularities to grasp the pericardium. This specialized engaging member is designed to overcome the barriers of fat and tissue irregularities, providing reliable pericardial engagement even when direct access is difficult, thereby maintaining both safety and operational capability.
Solution Approach 2:
The traditional mechanical approach of direct needle advancement is replaced with a two-step mechanism: first using the tissue engaging member to grasp and pull the pericardium, then using the needle to pierce the engaged pericardium. This substitution of the direct mechanical piercing approach with a staged engagement-and-pierce approach overcomes the problem of fat and irregularities blocking direct access.
3Object-affected harmful factors
If a tissue-engaging member is deployed to engage the pericardium without engaging the epicardial surface, then safe pericardial access is enabled, but the device complexity increases
Solution Approach 1:
The access device is segmented into distinct functional components: a pericardial tissue engaging member for grasping and pulling the pericardium, a separate needle for piercing, and a guide element for positioning. This segmentation allows each component to perform its specific function optimally while maintaining overall device manageability. The modular design reduces complexity by assigning single-purpose functions to individual elements rather than requiring a single complex multi-functional device.
Solution Approach 2:
The tissue engaging member, needle, and guide element are nested within a delivery catheter structure. The engaging member and needle can be advanced through the catheter lumen in a nested configuration, then deployed in sequence to perform the pericardial engagement and piercing functions. This nesting approach consolidates multiple components into a single deliverable unit, reducing operational complexity while maintaining the benefits of segmented functionality.
Data Source
AI summary
Devices and methods for accessing the pericardial space of a heart are described here. Access devices may generally comprise a tissue-engaging member, a tissue-piercing member, and a guide element. The access device may be introduced to the surface of a pericardium, where the tissue-engaging member may be deployed to engage a portion of the pericardium without engaging the epicardial surface of the heart. Once the access device has engaged the pericardium, the device may manipulate the pericardium to increase the distance between a portion of the pericardium and the epicardial surface of the heart. Once a sufficient space has been created, the tissue-piercing member may be advanced to pierce the pericardium and enter the pericardial space. The guide element may then be introduced into the pericardial space to provide an access pathway to the heart for other devices.