Pericardial Access Apparatus with Offset Channels
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Solution Overview
Problem
Current methods for implanting cardiac pacemakers in small children and patients with congenital heart defects face challenges due to anatomical restrictions and the need for invasive surgical approaches, which increase risks and complications, especially when transvenous access is not feasible.
Innovation Solution
A minimally invasive apparatus for transcutaneous delivery of medical therapy, featuring a shell and core with offset working channels and a mutable distal flange for secure anchoring, allowing direct visualization and access to the pericardial space, facilitating the implantation of epicardial devices without the need for extensive surgical incisions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If transvenous approach is used for pacemaker implantation, then the procedure is less invasive, but it becomes infeasible for patients with congenital heart defects and abnormal vasculature
Solution Approach 1:
The patent introduces a percutaneous access device as an intermediary tool that enables epicardial lead implantation without requiring traditional open surgery. This access device provides a minimally invasive pathway through the chest wall to reach the pericardial space, combining the benefits of surgical access with reduced invasiveness. The access device includes a needle, dilator, and introducer sheath that work together to create a controlled access route to the epicardium.
2Ease of operation
If epicardial lead placement is performed via sternotomy and thoracotomy, then direct surgical access to the heart is achieved, but post-operative recovery time increases and risks are elevated
Solution Approach 1:
The patent extracts the essential function of surgical access (reaching the pericardial space) from the complex surgical procedure (sternotomy and thoracotomy). By isolating and implementing only the necessary access component through a percutaneous approach, the patent eliminates the need for extensive surgical incisions, muscle cutting, and bone separation, thereby dramatically reducing recovery time while maintaining direct access to the epicardium.
3Adaptability or versatility
If multiple invasive procedures are performed over a patient's lifetime, then comprehensive cardiac care is provided, but cumulative risk of venous occlusion increases
Solution Approach 1:
The patent inverts the traditional approach by moving from endocardial (internal) access to epicardial (external) access for pacemaker lead implantation. This inversion allows leads to be placed on the outer surface of the heart rather than requiring navigation through venous systems, thereby eliminating the cumulative risk of venous occlusion associated with repeated transvenous procedures while still providing comprehensive cardiac rhythm management.
4Reliability
If fibrotic tissue dissection is required to reach viable cardiac tissue, then acceptable pacing thresholds are achieved, but reoperation complexity increases
Solution Approach 1:
The patent performs preliminary visualization of the epicardial surface and lead placement site through direct viewing during the initial procedure. This allows the operator to identify viable cardiac tissue, avoid fibrotic areas, and optimize lead positioning before implantation. By establishing the correct lead position and verifying pacing thresholds during the initial minimally invasive procedure, the need for complex reoperations to revise lead placement is minimized.
Data Source
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AI summary
The present disclosure relates to devices used to access the pericardial space of the heart. In particular, the present disclosure describes an apparatus to enable an operator to access the pericardial space of the heart, and deliver cardiac therapies to the pericardial space, under direct visualization through a single, small incision.