Intracardiac Pacemaker Cover with Bioresorbable Layer for Safe Explantation
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Solution Overview
Problem
The explantation of intracardiac pacemakers is complicated due to tissue overgrowth, making their removal difficult after implantation.
Innovation Solution
A system comprising an intracardiac pacemaker surrounded by a biostable cover with a fixation element and a bioresorbable inner layer, allowing for tissue ingrowth and easy opening for explantation, using a marker element and opening means like a filament for safe retrieval, and potentially collapsing to minimize residual volume.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the intracardiac pacemaker is implanted and left in situ, then the implant provides continuous cardiac pacing function, but the implant becomes overgrown with tissue making explantation difficult
Solution Approach 1:
The system divides the implant into two separable components: the intracardiac pacemaker and the cover. The cover remains in the heart and becomes overgrown with tissue, providing secure anchoring, while the pacemaker can be independently removed through the opening in the cover, simplifying explantation procedures
Solution Approach 2:
The cover acts as an intermediary structure between the pacemaker and the heart tissue. It provides a stable anchor point through tissue overgrowth while allowing controlled access to the pacemaker via its opening, thus mediating between the need for secure fixation and easy removal
2Reliability
If the cover is made biostable to remain in the heart, then the implant is securely fixed through tissue overgrowth, but the residual volume in the heart increases
Solution Approach 1:
The cover is constructed as a thin-walled structure that can collapse to a minimal volume after the pacemaker is removed. This flexible shell design allows the cover to maintain its structural integrity for fixation while minimizing the residual volume occupying heart space after explantation
3Reliability
If the cover completely surrounds the implant, then the implant is well protected and anchored, but the implant cannot be accessed for explantation
Solution Approach 1:
The cover is segmented with an opening that separates its enclosing function from its protective function. The opening allows access to the pacemaker for removal while the surrounding portions of the cover maintain protection and provide tissue anchoring
Solution Approach 2:
The design extracts the access function from the cover structure by creating an opening. This allows the pacemaker to be removed through the cover rather than requiring complete removal of the cover, simplifying the explantation process while maintaining cover integrity
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
Facilitates simplified and safe explantation of intracardiac pacemakers by allowing tissue ingrowth for fixation and easy opening of the cover, reducing the volume of the cover remaining in the heart after removal.
Implementation Method 1
An inner surface of the cover, which is facing the implant, may comprise an inner layer comprising a bioresorbable material. The bioresorbable material may be a bioresorbable polymer, e.g. RESOMER® provided by Evonik. After the implant is removed from the cover, the bioresorbable material is resorbed. This leads to a reduced volume of the cover remaining in the heart.
Data Source
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AI summary
A system with an intracardiac implant (110) and a cover (150) is provided. The cover (150) at least partially surrounds the implant (110).