Heart Pump Assembly With Self-Expanding Securing Device
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Solution Overview
Problem
Current implantation systems for heart pumps in ventricular assistance devices cause damage to the ventricular wall during installation, limit mechanical strength, risk blood loss, and have complex installation and removal processes, leading to suboptimal hemodynamic output and increased risks of complications.
Innovation Solution
An assembly for fitting and removing a heart pump with a guide element and a gripping unit that allows secure manipulation and displacement of the pump, featuring a sealing element and stabilization device to minimize wall damage and optimize positioning, along with a securing device that self-expands to form a retention flange for secure anchoring without sutures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If flanges are compressed against the ventricular wall to secure the implantation system, then the pump is retained in position, but damage to the ventricular wall occurs including local tearing
Solution Approach 1:
The securing mechanism is divided into multiple independent securing points distributed around the pump circumference. Instead of relying on a single compression force that causes wall damage, the system uses multiple discrete securing elements that distribute the retention force, preventing localized tearing while maintaining position stability.
Solution Approach 2:
Different regions of the pump-ventricular wall interface are treated differently: the pump body maintains compression for sealing, while separate securing elements provide retention without compressing the wall. This local differentiation allows position retention without causing ventricular wall damage.
2Ease of operation
If flange dimensions are reduced to pass through the orifice, then implantation is enabled, but mechanical strength is limited and substantial forces cannot be applied
Solution Approach 1:
The mechanical strength requirement is segmented across multiple independent securing elements rather than relying on a single large flange. Each securing element contributes to the overall strength, allowing the system to withstand substantial forces while maintaining a compact profile that can pass through the orifice.
Solution Approach 2:
Instead of increasing flange area in the radial dimension, the system adds securing elements in the longitudinal dimension along the pump shaft. This dimensional transition allows the system to achieve high mechanical strength while maintaining a compact cross-sectional profile suitable for orifice passage.
3Device complexity
If the pump is placed at the end of the tubular portion on the exterior of the heart, then the structure is simplified, but blood loss risk increases due to forces applied to the ventricular wall
Solution Approach 1:
The pump assembly is segmented into the pump body and separate securing elements positioned along the tubular portion. This segmentation allows the pump to be positioned at the distal end for simplicity while the securing elements distributed along the shaft provide wall retention without requiring large compressive forces that would cause blood loss.
4Ease of operation
If positioning of the pump relative to the aortic valve is imperfect, then installation is easier, but hemodynamic output is not optimized and blood expulsion is not directed
Solution Approach 1:
The pump positioning system incorporates adjustable elements that allow dynamic optimization of the pump's position relative to the aortic valve after installation. The securing elements can be adjusted along the tubular portion to achieve optimal hemodynamic alignment, transforming a static, fixed-position system into one that can be dynamically optimized for each patient's anatomy.
Data Source
AI summary
Disclosed is an assembly for fitting/removing a heart pump in a sleeve secured in an opening in a ventricular wall, the assembly including a guide element with a distal end, a proximal end, and a lumen extending between, and opening at, the distal and proximal ends, the heart pump having a pump body. With this pump body including an assembly element, the assembly includes a gripping unit which can slide in the lumen, the gripping unit having at its free end an assembly part which is complementary with the assembly element, which part is configured to cooperate with the assembly element, and to join this free end to the pump body, in order to permit the gripping and displacement of the heart pump.