Heart Support Sleeve with Radiopaque Mark
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Solution Overview
Problem
Current mechanical ventricular assist devices for cardiac insufficiency require complex surgical procedures and often lead to complications such as strokes, hemorrhages, and septicemia, necessitating long-term hospitalization and frequent re-admissions due to the invasive nature of open-chest surgery and the interaction of blood with implanted systems.
Innovation Solution
An implantable heart support system featuring a self-expanding sleeve made of wire mesh or lattice structure, which can be minimally invasively implanted, with a membrane to reduce mechanical stress and enhance biocompatibility, and a method for custom manufacturing based on heart imaging to ensure precise fit and function.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-chest surgery is used to implant mechanical ventricular assist devices, then the devices can be securely implanted and integrated into blood circulation, but the surgical complexity increases and complications such as strokes, hemorrhages, and septicemia occur more frequently
Solution Approach 1:
The patent employs a flexible membrane covering the wire mesh structure to create a biocompatible barrier between the device and blood. This thin film approach allows minimally invasive implantation while maintaining device integration reliability, reducing surgical complications associated with traditional open-chest procedures
2Reliability
If traditional mechanical ventricular assist devices are implanted, then cardiac pumping function can be supported, but the invasive nature of the procedure requires long-term hospitalization and frequent re-admissions
Solution Approach 1:
The self-expanding wire mesh structure automatically assumes its functional configuration upon deployment, eliminating the need for complex post-implantation adjustments or interventions. This self-service characteristic enables minimally invasive implantation with reduced hospitalization requirements while maintaining reliable cardiac support function
3Ease of operation
If a wire mesh or lattice structure is used for the sheath, then minimally invasive implantation is enabled, but the structural complexity of the device increases
Solution Approach 1:
The sheath is constructed from segmented wire mesh or lattice elements that can be compressed together for minimally invasive delivery and automatically expand to form a stable structural configuration upon implantation. This segmentation approach enables simple implantation procedures while the expanded structure provides necessary mechanical support
4Reliability
If the sheath is made to enclose a larger portion of the heart, then better cardiac support is achieved, but the device size and implantation difficulty increase
Solution Approach 1:
The wire mesh sheath exhibits dynamic properties, transitioning from a compressed low-profile state during minimally invasive delivery to an expanded configuration that encloses a larger portion of the heart for effective cardiac support. This dynamic transformation enables comprehensive cardiac coverage without increasing implantation difficulty
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 system allows for minimally invasive implantation, reduces complications by minimizing blood interaction, and improves patient outcomes through enhanced biocompatibility and customized fit, supporting cardiac function with reduced risk of adverse events.
Implementation Method 1
The sheath can be made of a wire mesh, which can have diamond-shaped cells. Preferably, the mesh is made of a shape memory alloy.
Implementation Method 2
The mark may be of a different color than a surface of the support system adjacent the mark, or formed of a more radiopaque material than a surface of the support system adjacent the mark.
Data Source
AI summary
A heart support system featuring a sleeve sized to fit about at least a portion of an adult human heart in a living body, the sleeve having an inner surface arranged to contact the heart in use and a sheath extending about and constraining the sleeve. At least one of the sheath and sleeve carry a discrete mark detectable from outside the body with the sheath and sleeve implanted within the body. The position of the support system about the heart can be determined with reference to the mark.