Medical Device Seal Assembly Turnbuckle Compression
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Solution Overview
Problem
There is a need for medical devices and manufacturing methods that can effectively deliver and deploy medical implants, such as heart valves, with reduced invasiveness and improved fluid sealing to prevent leakage, while navigating tortuous and narrow body lumens with sufficient strength and flexibility.
Innovation Solution
A medical device system featuring a handle member with a seal assembly, including a turnbuckle assembly with a cap and stationary member, an exoskeleton, and a hypotube, which compresses the exoskeleton to maintain strength and flexibility, and includes seals to prevent fluid leakage, allowing for percutaneous delivery and deployment of medical implants like heart valves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a seal assembly is implemented to prevent fluid leakage, then fluid sealing is improved, but device complexity increases
Solution Approach 1:
The seal assembly employs a nested structure where the exoskeleton is compressed within the hypotube, and the turnbuckle assembly is integrated into the handle member. The stationary member is positioned within the hypotube, with the exoskeleton surrounding it. This nesting arrangement achieves effective fluid sealing while minimizing the overall device footprint and reducing complexity.
Solution Approach 2:
The seal assembly utilizes flexible sealing elements including a first seal positioned between the hypotube and the exoskeleton, and a second seal between the exoskeleton and the stationary member. These flexible seals conform to the compressed exoskeleton surface, creating effective fluid barriers while accommodating the compressed configuration.
2Strength
If the exoskeleton is compressed to maintain strength and flexibility, then structural integrity is improved, but the compression mechanism complexity increases
Solution Approach 1:
The turnbuckle assembly provides a dynamic compression mechanism where the cap can shift relative to the stationary member along the longitudinal axis. This shifting action compresses the exoskeleton between the cap and the stationary member, allowing the structure to adapt to different compression states while maintaining strength and flexibility.
Solution Approach 2:
The exoskeleton is divided into discrete segments that can be compressed relative to each other. The first segment is between the cap and the stationary member, with additional segments extending distally. This segmentation allows the exoskeleton to be compressed in a controlled manner while maintaining overall structural integrity.
3Force
If the cap shifts distally to compress the exoskeleton, then compression force is improved, but the mechanism for controlling the shift complexity increases
Solution Approach 1:
The turnbuckle assembly is designed such that the cap can shift distally relative to the stationary member through simple longitudinal movement. This self-service mechanism generates the necessary compression force on the exoskeleton without requiring complex control systems, as the compression is directly result of the cap's position change.
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 enables less invasive delivery and deployment of medical implants, maintaining strength and flexibility while preventing fluid leakage, thus reducing patient invasiveness and improving treatment efficacy.
Implementation Method 1
the cap is designed to shift relative to the stationary member such that the exoskeleton is put in compression
Implementation Method 2
the seal assembly includes a turnbuckle assembly... designed to prevent fluid leakage within the medical device
Data Source
AI summary
Medical devices and methods for making and using medical devices are disclosed. An example system for delivering an implantable medical device includes a handle member including a seal assembly, wherein the seal assembly includes a turnbuckle assembly including a stationary member and a cap coupled to the stationary member. Further, the stationary member is coupled to an inner member and the cap is coupled to an exoskeleton disposed along an outer surface of the inner member. Additionally, the cap is designed to shift relative to the stationary member such that the exoskeleton is put in compression.