Pericardial Access Device with Integrated Camera and Balloon
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Solution Overview
Problem
Existing medical devices are inadequate for accessing and treating conditions on the outside of the heart, as they lack direct visualization, stabilization, and precise navigation capabilities, particularly due to their design for internal heart procedures and reliance on indirect imaging.
Innovation Solution
The development of access devices equipped with integrated visualization, illumination, stabilization, and safety features, including a camera, balloon inflation, and suction, to facilitate safe and precise delivery of instruments like EP ablation catheters to the pericardial space of the heart, allowing for direct visualization and stabilization during procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If existing endocardial devices are used to access the pericardial space, then the devices can be inserted through the pericardium, but they cannot create space, navigate, or remain stable between the pericardium and epicardium
Solution Approach 1:
The access device is divided into multiple functional segments: a pericardial space creation component (balloon or hinged shell) that separates the pericardium from the epicardium, creating a stable working space; a shaft with instrument channels for delivering catheters; and a head portion with camera and illumination. This segmentation allows each component to perform its specific function effectively.
Solution Approach 2:
The device performs preliminary actions by first creating the pericardial space using the balloon or hinged shell before instrument delivery. The balloon is inflated or the shell is deployed to separate the pericardium from the epicardium, establishing a stable working environment before the ablation catheter or other instruments are advanced through the instrument channels to the treatment site.
2Loss of information
If indirect imaging systems are used for heart procedures, then imaging equipment is available, but adequate identification of anatomical structures on the outside of the heart is not enabled
Solution Approach 1:
A camera positioned within the pericardial space acts as an intermediary to provide direct visualization of the epicardial surface and anatomical structures. The camera captures real-time images and video of the treatment area, allowing the operator to clearly identify coronary arteries, fat pads, lesions, and other structures that are difficult to see with indirect imaging systems like fluoroscopy or external echocardiography.
Solution Approach 2:
The camera provides a new dimensional perspective by positioning the imaging source within the pericardial space itself, looking directly at the epicardial surface from the treatment viewpoint. This intra-pericardial imaging dimension reveals anatomical structures with clarity and detail that external imaging systems cannot achieve, transforming the visualization capability from indirect 2D fluoroscopy to direct optical imaging.
3Object-generated harmful factors
If endocardial EP ablation catheters are used within the pericardium, then ablation procedures can be performed, but there is no pericardial space creation, illumination, or direct visualization of the heart surface
Solution Approach 1:
The device merges multiple previously separate functions into a single integrated platform: pericardial space creation (balloon or hinged shell), illumination (fiber optic cables or LEDs), direct visualization (camera), and instrument delivery (shaft with instrument channels). This combination ensures that all safety and visualization functions are available simultaneously during the ablation procedure, eliminating the need for separate devices or procedures.
Solution Approach 2:
The camera provides real-time visual feedback of the epicardial surface, coronary arteries, and ablation catheter position. This feedback allows the operator to continuously monitor the procedure, confirm correct catheter placement, identify anatomical structures to avoid, and verify ablation lesion formation, thereby enhancing procedural safety and reducing the risk of complications.
4Measurement precision
If the ablating end of the EP catheter is not stabilized relative to the heart surface, then the catheter can be delivered, but precise ablation treatment cannot be delivered
Solution Approach 1:
The device segments the stabilization function from the delivery function by providing a rigid shaft with a stable head portion that acts as a platform. The ablation catheter is delivered through the instrument channels while the head portion remains stabilized against the epicardial surface, allowing precise ablation treatment to be delivered from this stable platform.
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
These access devices enable safer and more efficient treatment of ventricular tachycardia and other conditions on the heart's surface by providing direct visualization, stabilization, and precise navigation, reducing procedural time and risk, and improving treatment outcomes.
Implementation Method 1
a balloon fluidly connected to the balloon inflation line and configured to separate the pericardium and provide downward pressure towards the myocardium when inflated
Implementation Method 2
a camera positioned within the pericardial space and oriented for imaging of instruments that extend beyond the head portion
Implementation Method 3
illumination is provided through one or more fiber optic cables that provide light for the camera
Implementation Method 4
a vacuum line configured to provide suction to remove fluid from the pericardial space
Data Source
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AI summary
Disclosed are access devices that can be used to safely guide instruments, such as EP ablation catheters, to a therapy site such one within the pericardial space of the heart. The access devices include integrated visualization, illumination, stabilization, and safety features in a single platform that can, for example, more safely and efficiently identify and ablate several ventricular tachycardia (VT) locations on the left ventricle of the heart.