Medical Device Coupling Mechanisms for Minimally Invasive Heart Valve Delivery
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Solution Overview
Problem
Current medical devices for delivering and implanting heart valves are often invasive and require significant recovery time, with existing methods being inefficient for diagnosing, treating, and repairing cardiovascular system issues, particularly for defective heart valves.
Innovation Solution
A medical device system that includes an outer shaft, an exoskeleton, and a medical implant, such as a replacement heart valve, which can be advanced percutaneously through the vasculature to a target site, with coupling mechanisms like projections, recesses, and locking collars to securely attach and deploy the implant, allowing for less invasive procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical methods are used for heart valve replacement, then the procedure can be performed with established techniques, but the invasiveness is high and recovery time is prolonged
Solution Approach 1:
The medical device is divided into multiple separable components including an inner shaft, outer shaft, delivery catheter, and implantable heart valve. This segmentation allows the components to be delivered separately through the vasculature and assembled at the target site, enabling percutaneous access without open surgery while maintaining procedural reliability
Solution Approach 2:
The inner shaft is positioned within the outer shaft, and the implantable heart valve is contained within the delivery catheter. This nested configuration allows multiple components to be delivered through a single percutaneous access point, reducing invasiveness while enabling complex valve replacement procedures
2Ease of manufacture
If traditional open surgery is used for heart valve replacement, then the implantation can be performed with direct access, but the recovery time is significantly extended
Solution Approach 1:
The implantable heart valve is pre-assembled within the delivery catheter in a compressed, deliverable state before the procedure. The delivery system is prepared with all necessary components (inner shaft, outer shaft, coupling mechanisms) assembled and ready for percutaneous insertion, eliminating the need for complex intraoperative assembly and reducing overall procedure and recovery time
Solution Approach 2:
The delivery catheter acts as an intermediary device that transports the implantable heart valve through the vasculature to the target site. This intermediary allows the valve to be delivered minimally invasively while maintaining the ability to perform reliable implantation through the catheter's controlled delivery mechanism
3Device complexity
If a single integrated device is used, then the structure is simpler, but the device cannot be adjusted or repaired after implantation
Solution Approach 1:
The medical device comprises separable components including an inner shaft, outer shaft, delivery catheter, and implantable heart valve with coupling members. This segmentation enables the device to be delivered in parts, assembled at the implantation site, and potentially disassembled or adjusted post-implantation, providing adaptability while maintaining manageable structural complexity
Solution Approach 2:
The coupling members include projections and recesses that allow for dynamic assembly and disassembly of the device components. This dynamic coupling mechanism enables the device to transition from a deliverable state to an implanted state and potentially back, providing post-implantation adjustability and repair capability
Data Source
AI summary
Medical devices and methods for making and using medical devices are disclosed. An example system includes an inner shaft having proximal and distal end regions and a first coupling member disposed along the distal end region, wherein the first coupling member includes a first projection and a first recess. The system also includes a support shaft having proximal and distal end regions and a second coupling member disposed along the proximal end region, wherein the second coupling member includes a second projection and a second recess. The system also includes a locking collar coupled to the inner shaft. Additionally, coupling the inner shaft to the support shaft includes placing at least a portion of the first projection into the second recess, placing at least a portion of the second projection into the first recess and positioning the locking collar along a portion of both the first and second coupling members.