Telescoping Seal Assembly for Minimally Invasive Cardiac Delivery
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Solution Overview
Problem
Current medical devices for delivering implantable devices to the cardiovascular system are often invasive and require significant recovery time, and there is a need for less invasive methods to treat conditions like defective heart valves effectively.
Innovation Solution
A medical device system featuring a telescoping seal assembly that includes an outer sheath seal assembly, a first fixed seal assembly, and an actuation seal assembly, allowing for the translation of the outer sheath to expose and deploy a medical implant, which can be self-expanding or expanded using a handle to reduce the profile for navigation through tortuous paths while maintaining strength and flexibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If traditional invasive methods are used to deliver implantable devices, then the device can be delivered to the cardiovascular system, but the procedure is invasive and requires significant recovery time
Solution Approach 1:
The patent employs a telescoping seal assembly where multiple seal components are nested within each other. The outer sheath seal assembly contains the first fixed seal assembly, which in turn contains the actuation seal assembly. This nested configuration allows the seals to be delivered in a compact, low-profile state through minimally invasive access while maintaining the capability to deploy and seal effectively at the target site in the cardiovascular system
2Strength
If the outer sheath is made stronger to maintain structural integrity during delivery, then the device can navigate tortuous paths, but the profile increases making navigation more difficult
Solution Approach 1:
The outer sheath is designed with dynamic properties that allow it to transition between a compressed delivery state and an expanded deployed state. During delivery, the sheath maintains sufficient structural integrity to protect internal components while flexing to navigate tortuous vascular paths. Upon deployment at the target site, the sheath expands to provide structural support for the seal assembly and implantable device, effectively managing the strength-profile tradeoff through state transformation
3Reliability
If the seal assembly is made more complex to prevent fluid leakage, then sealing reliability improves, but the device complexity increases
Solution Approach 1:
The seal assembly is segmented into three distinct functional components: the outer sheath seal assembly that seals the outer sheath, the first fixed seal assembly that seals the compression shaft, and the actuation seal assembly that seals the actuation shaft. Each segment is optimized for its specific sealing function, allowing reliable fluid leakage prevention while maintaining manageable complexity through modular design and clear functional differentiation
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 percutaneous delivery of medical implants, such as heart valves, with reduced invasiveness, allowing for efficient deployment and implantation with minimal tissue disruption and rapid recovery, addressing the limitations of traditional invasive procedures.
Implementation Method 1
the first fixed seal assembly includes a first alignment surface and a compression shaft coupled to the first fixed seal assembly. Additionally, first alignment surface is designed to align the compression shaft with at least a portion of the outer sheath
Implementation Method 2
The seal assembly includes an outer sheath seal assembly coupled to an outer sheath, the outer sheath covering at least a portion of the implantable medical device, the outer sheath seal assembly being translatable relative to the handle
Implementation Method 3
an actuation seal assembly translatable relative to the handle, and wherein actuation of the actuation seal assembly is designed to shift the implantable medical device between a first position and a second expanded position
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 an outer sheath seal assembly coupled to an outer sheath, the outer sheath including a curved portion, the outer sheath seal assembly being translatable relative to the handle. The seal assembly also includes a first fixed seal assembly fixed relative to the handle, the first fixed seal assembly including a first alignment surface and a compression shaft coupled to the first fixed seal assembly. Additionally, first alignment surface is designed to align the compression shaft with at least a portion of the outer sheath.