Tissue Engagement Device for Safe Pericardial Access

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Solution Overview

Problem

Existing systems for accessing the space beneath a tissue layer, such as the pericardial space, face challenges including difficulty in safely gaining access due to the thinness of the pericardium and the proximity to underlying structures like the epicardium, which can lead to risks of injury and require high skill and time.

Innovation Solution

The development of tissue engagement devices and systems that include a tunneler cannula, an obturator, and a tissue engagement device, which can engage and pierce the pericardium to create or enlarge the pericardial space, reducing the risk of puncturing underlying tissues and allowing for safer access.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional access methods are used to reach the pericardial space, then access can be obtained, but the risk of puncturing underlying tissues increases due to the thinness of the pericardium and proximity to the epicardium

Engineering Contradiction:

Improvesafety of accessVSAvoidrisk of tissue injury

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces an intermediary device (the access system with needle and sheath assembly) that mediates between the external environment and the pericardial space. The needle is guided through the pericardium at an optimized angle and position, and the sheath provides a protective pathway, reducing direct harm to underlying tissues while enabling safe access to the pericardial space for fluid collection or injection procedures

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If conventional access methods are used, then access to the pericardial space can be achieved, but the procedure requires high skill and time

Engineering Contradiction:

Improveprocedure simplicityVSAvoidprocedure time

Core Design Contradiction:

Ease of operationVSLoss of time

Solution Approach 1:

The patent employs preliminary action by pre-positioning the needle and sheath assembly in an optimized configuration before accessing the pericardial space. The device is designed with predetermined geometry and positioning features that guide the operator through the procedure, reducing the need for complex manual manipulation and decreasing procedure time while maintaining ease of operation

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent replaces complex mechanical manipulation techniques with a designed device system that incorporates geometric constraints and guiding features. This substitution reduces reliance on operator skill for complex manual positioning while streamlining the access procedure, thereby reducing both skill requirements and procedure time

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS12274428B2Tissue engagement devices, systems, and methods

Publication Date: 2025.04.15 CIRCA SCIENTIFIC LLC

AI summary

A method can include engaging the pericardium of a patient at two engagement positions of the pericardium. The method can further include moving the two engagement positions of the pericardium away from each other to tension a portion of the pericardium. The method can further include advancing an access device through the tensioned portion of the pericardium to introduce the access device into the pericardial space of the patient. Other and further methods are also disclosed.