Cardiac Access Catheter System for Pericardial Drug Delivery
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Solution Overview
Problem
Current methods for local drug delivery to the heart, such as endoluminal delivery, face challenges like inconsistent delivery, low efficiency, and rapid washout, especially in diseased or dilated hearts, where accessing the pericardial space is difficult due to the stiff pericardial sac and increased risk of puncturing cardiac structures.
Innovation Solution
A system comprising an engagement catheter with a suction port and a delivery catheter that allows for percutaneous, intravascular access to the pericardial space by aspirating and retracting the atrial wall or atrial appendage, creating a larger space for drug delivery, and includes a needle for piercing the tissue to inject substances directly into the pericardial space, while using a vacuum source for suction and an injection channel for fluid administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the percutaneous transventricular method or transthoracic approach is used to access the pericardial space, then local drug delivery to the heart is achieved, but the risk of puncturing cardiac structures increases especially in diseased or dilated hearts
Solution Approach 1:
The catheter system is divided into multiple functional segments: a collapsible balloon portion for creating space, a delivery portion for drug administration, and a navigation portion for positioning. This segmentation allows each component to perform its specific function safely without compromising the heart structure
Solution Approach 2:
The collapsible balloon is inflated within the ventricular chamber before attempting to access the pericardial space. This preliminary action creates a buffer zone that pushes the pericardium away from the heart wall, establishing a safer pathway for subsequent needle penetration and reducing the risk of cardiac structure damage
2Reliability
If the pericardial space is accessed in diseased or dilated hearts, then local drug delivery is needed, but the pericardial space is significantly smaller and access is more difficult
Solution Approach 1:
The collapsible balloon is inflated within the ventricular chamber to create additional pericardial space before needle insertion. This preliminary space-creating action overcomes the naturally reduced pericardial space in diseased hearts, making subsequent drug delivery feasible and safe
Solution Approach 2:
The system dynamically changes the volume parameter of the pericardial space by inflating and deflating the collapsible balloon. During the procedure, the balloon is inflated to create access space, then deflated to allow safe withdrawal of the catheter system, adapting to the constrained anatomical conditions of diseased hearts
3Productivity
If endoluminal drug delivery is used, then drugs can be delivered to the heart, but delivery is inconsistent and there is rapid washout into circulation
Solution Approach 1:
The system extracts the drug delivery location from the endoluminal space (inside blood vessels) and positions it directly at the epicardial surface of the heart. By delivering drugs through the pericardial space directly onto the heart surface, the system eliminates the problems of inconsistent delivery and rapid washout associated with endoluminal approaches
Solution Approach 2:
The pericardial space serves as an intermediary medium between the blood circulation and the epicardial tissue. Drugs are delivered into this intermediate space, allowing them to diffuse directly onto the heart surface with prolonged exposure, bypassing the rapid washout that occurs with direct endoluminal injection into the circulation
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
This method provides a safer, more efficient, and consistent local drug delivery to the heart with reduced risk of cardiac structure puncture, enabling prolonged drug exposure and improved therapeutic outcomes, particularly in diseased hearts where traditional methods are limited.
Implementation Method 1
a vacuum source, and the system is capable of enlarging a pericardial space between the targeted tissue and a pericardial sac that surrounds the heart by retracting the targeted tissue away from the pericardial sac
Implementation Method 2
includes a needle for piercing the tissue to inject substances directly into the pericardial space
Data Source
AI summary
Devices, systems, and methods for accessing the internal and external tissues of the heart are disclosed. At least some of the embodiments disclosed herein provide access to the external surface of the heart through the pericardial space for localized delivery of substances to the heart tissue. In addition, various disclosed embodiments provide access to the internal surface of the heart for aspiration and delivery of substances to a targeted region without disturbing or interfering with nearby structures or surfaces.