Loading Capsule Coupling for Stable Prosthetic Device Delivery
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Solution Overview
Problem
Existing coupling interfaces between loading assemblies and delivery apparatuses for prosthetic medical devices, such as prosthetic heart valves, often result in degradation and lack security, leading to unstable connections during delivery.
Innovation Solution
A loading assembly with a loading capsule featuring axially extending flexible members that couple with channels on the delivery apparatus, secured by a collar to create a stable connection, and a device housing to surround the prosthetic device before delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a prosthetic device is made expandable to adapt to different patient anatomies, then adaptability is improved, but device complexity increases due to additional expansion mechanisms
Solution Approach 1:
The prosthetic device is divided into multiple expandable segments or struts that can independently adjust in length. This segmentation allows the device to adapt to different anatomical configurations while maintaining a relatively simple basic structure that can be scaled and configured for various patient needs.
Solution Approach 2:
The expandable mechanism employs nested components where smaller elements are contained within larger ones, allowing compact storage and simplified deployment. The expansion elements are housed within the main device structure, reducing overall complexity while enabling adaptability.
2Ease of operation
If delivery catheter diameter is reduced for better patient comfort, then ease of operation is improved, but the ability to deliver larger prosthetic devices is limited
Solution Approach 1:
The prosthetic device is designed to nest within the delivery catheter in a compressed state, allowing it to pass through smaller catheters. The device then expands to its full size after delivery, enabling the use of smaller catheters without limiting the final prosthetic device dimensions.
Solution Approach 2:
The prosthetic device transitions from a static compressed state during delivery to an expanded functional state after implantation. This dynamic transformation allows the device to fit through smaller catheters while maintaining the capability to expand to larger final dimensions for effective treatment.
3Device complexity
If manual expansion control is used to simplify the system, then device complexity is reduced, but expansion precision and reliability decrease
Solution Approach 1:
The expansion mechanism incorporates feedback elements that monitor the expansion state and provide information to the operator. This feedback ensures reliable and controlled expansion while maintaining a relatively simple overall system design that does not require complex automated control systems.
Solution Approach 2:
The expansion mechanism is designed to be self-regulating, where the expansion force and progression are inherently controlled by the device's mechanical design rather than requiring complex external control systems. This self-service approach maintains simplicity while ensuring reliable expansion through built-in mechanical constraints and progression control.
Data Source
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Figure 3A~3B
AI summary
Systems and methods for securely connecting a loading assembly to a delivery apparatus for loading a prosthetic medical device into the delivery apparatus are disclosed. As one example, a medical system can include a delivery apparatus for implanting a prosthetic medical device in a patient's body and a loading system. The delivery apparatus can comprise a flexible shaft, a coupling attached to a distal end of the flexible shaft, and a delivery capsule coupled to the coupling and extending distally from the coupling. The loading assembly can comprise a loading capsule comprising a plurality of axially extending flexible members configured to couple to an outer surface of the coupling and flex radially outward and a collar disposed around the loading capsule and configured to lock the plurality of flexible members in engagement with the coupling such that the plurality of flexible members cannot flex radially outward.