Heart Valve Deployment Instrument with Segmented Drive
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Solution Overview
Problem
Existing delivery instruments for expandable heart valve prostheses lack the ability to control deployment elements variably, which is necessary for safe and efficient implantation, particularly in matching the specific anatomy of the implantation site.
Innovation Solution
A deployment instrument featuring a shaft with a handle and a carrier portion, where the carrier portion includes two deployment elements connected to a drive member with opposing drive features, allowing for staged and controlled deployment of the heart valve prosthesis by varying the axial displacement of the deployment elements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a delivery instrument with multiple deployment elements is used to properly hold and deploy the heart valve prosthesis, then the reliability of implantation is improved, but the device complexity increases
Solution Approach 1:
The delivery instrument is divided into multiple deployment elements (first deployment element and second deployment element) that can be independently controlled. Each deployment element is associated with a specific portion of the prosthesis armature (proximal or distal portion), allowing staged deployment while maintaining manageable complexity through functional segmentation
Solution Approach 2:
The drive member incorporates both a first drive feature and a second drive feature that can be selectively engaged or disengaged, enabling dynamic control over which deployment element is activated. This dynamic switching capability allows the operator to control the deployment sequence adaptively, improving reliability without requiring all elements to be permanently complex
2Productivity
If a variable control pattern is implemented to allow slow action during initial positioning and fast action during final deployment, then the productivity is improved, but the device complexity increases
Solution Approach 1:
The drive member is designed with dynamic engagement capabilities where the first and second drive features can be selectively activated. During initial positioning, only the first drive feature is engaged for slow, controlled movement. During final deployment, the second drive feature is engaged to enable fast action, achieving variable control patterns without requiring a permanently complex mechanism
Solution Approach 2:
The control system is segmented into distinct drive features that can be independently operated. This segmentation allows the operator to choose which drive feature to engage at different stages of deployment, enabling slow action during positioning and fast action during final deployment without integrating all control mechanisms simultaneously
Data Source
AI summary
Disclosed herein is a deployment instrument including: a shaft (2) having a longitudinal axis (X1); a handle (3) at a first end of the shaft (2); and a carrier portion (4) at a second end of the shaft (2). The carrier portion (4) is configured for holding an expandable heart valve prosthesis in a radially collapsed condition for delivery to the implantation site. The carrier portion (4) includes a hub (5) fixed to the handle (3) via the shaft (2), a first deployment element (6) and a second deployment element (7), each of said first deployment element (6) and second deployment element (7) configured to hold a corresponding portion of an expandable heart valve N prosthesis in a radially collapsed condition. A drive member (8) is provided which is configured to operate the first deployment element (6) and the second deployment element (7) in first and second opposite directions. The instrument is also provided with a mechanism to allow a displacement of the second deployment element in the second direction independently of the drive member (11).