Catheter Tissue-Engaging Device for Controlled Pericardial Puncture
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Solution Overview
Problem
Existing catheters used for accessing the pericardial cavity pose a risk of laceration to the myocardium layer due to the difficulty in controlled puncture of the pericardium layer, especially when the pericardial cavity is small or scar tissue is present, leading to invasive procedures with increased risk to the patient.
Innovation Solution
An elongated catheter with a tissue-engaging device that selectively punctures through the pericardium layer without damaging the myocardium, using a distal catheter section with a tissue-engaging device that rotates to engage and stretch the pericardium away from the myocardium, allowing a puncture passage to be formed without impinging the myocardial layer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a needle is used to puncture the pericardium layer to access the pericardial cavity, then access to the pericardial space is achieved, but the risk of laceration to the myocardium layer increases
Solution Approach 1:
The tissue-engaging device is deployed before puncture to预先 engage the pericardium layer and create a controlled attachment point. This preliminary action ensures that the pericardium is securely held by the device's tines or engagement elements, allowing subsequent puncture forces to be directed through the device rather than causing uncontrolled laceration of the underlying myocardium.
Solution Approach 2:
The tissue-engaging device acts as an intermediary between the needle and the pericardium layer. Instead of the needle directly contacting and potentially lacerating the myocardium, the device intermediates by first engaging the pericardium, providing a controlled interface that directs and distributes puncture forces, thereby protecting the underlying heart muscle.
2Ease of operation
If the pericardial cavity is small or scar tissue is present, then controlled puncture becomes more difficult, but the risk of myocardium damage increases
Solution Approach 1:
The tissue-engaging device incorporates feedback mechanisms through its engagement elements that respond to tissue characteristics. As the device encounters varying tissue densities (including scar tissue), the engagement elements adjust their penetration and holding forces, providing real-time feedback to the operator about successful pericardium engagement while preventing excessive force that could damage the myocardium.
Solution Approach 2:
The device employs dynamic engagement elements that can adapt their configuration based on tissue resistance. The tines or engagement structures are designed to flex and adjust their penetration depth and angle, allowing controlled puncture through varying tissue conditions (healthy vs. scarred pericardium) while maintaining a safety margin that prevents myocardium laceration.
3Ease of operation
If the tissue-engaging device punctures through the pericardium layer, then access to pericardial space is achieved, but tissue trauma may occur
Solution Approach 1:
The tissue-engaging device segments the puncture process into distinct phases: initial pericardium engagement by the tines, controlled puncture through the pericardium, and subsequent access to the pericardial cavity. This segmentation allows each phase to be controlled independently, minimizing tissue trauma by ensuring that puncture forces are applied only after secure engagement and are directed precisely through the pericardium without affecting the myocardium.
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
The solution reduces the risk of myocardial damage by creating a controlled puncture passage through the pericardium layer, enhancing the safety and predictability of procedures while minimizing tissue trauma.
Implementation Method 1
the tissue-engaging device is configured to be selectively urged to contact a second surface of the first biological wall after the tissue-engaging device has punctured through the first biological wall; in such a way that the tissue-engaging device, in use, elastically stretches a portion of the first biological wall away from the second biological wall
Data Source
AI summary
An elongated catheter includes a tissue-engaging device configured to be urged to move and contact a first surface of the first biological wall. The tissue-engaging device extends from the distal catheter section. The tissue-engaging device is configured to be urged to puncture through the first biological wall. The tissue-engaging device is also configured to be urged to contact the first biological wall without impinging the second biological wall, after the tissue-engaging device has punctured through the first biological wall.