Valve Introducer Adjustable Deployment Mechanism
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Solution Overview
Problem
Current methods for implanting heart valve prostheses often require cardiopulmonary bypass and extensive surgical procedures, leading to prolonged hospitalization and recovery, while minimally invasive approaches may not always ensure accurate positioning without cardiopulmonary bypass.
Innovation Solution
The development of a valve introducer system with an adjustable deployment mechanism and implantation depth controlling element, allowing precise deployment of a tubular delivery member into the body without cardiopulmonary bypass, using an adjustable deployment mechanism with an outer and inner cylinder that can be twisted to set the depth, and a depth gauge for accurate positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If classic sternotomy technique is used, then accurate positioning of prosthetic valve is achieved, but patient requires prolonged hospitalization and extensive recovery
Solution Approach 1:
The valve introducer system segments the implantation procedure into distinct phases: delivery through minimally invasive access, positioning using adjustable deployment mechanism with depth gauge, and deployment. This allows combining minimally invasive approach with accurate positioning capabilities previously only available through sternotomy
Solution Approach 2:
The patent replaces the complex mechanical positioning system required in sternotomy with a controlled deployment mechanism that uses an adjustable outer cylinder, inner cylinder, and depth gauge to achieve precise positioning through minimally invasive access, eliminating the need for direct surgical exposure
2Loss of time
If minimally invasive catheter-based approach is used, then recovery time is reduced, but accurate positioning of prosthetic valve becomes difficult without cardiopulmonary bypass
Solution Approach 1:
The deployment mechanism incorporates dynamic adjustability through the outer cylinder and inner cylinder that can be twisted relative to each other, allowing the delivery system to be extended or retracted to achieve precise positioning. The depth gauge provides real-time feedback on positioning accuracy during the minimally invasive procedure
Solution Approach 2:
The adjustable deployment mechanism acts as an intermediary between the minimally invasive access point and the prosthetic valve, enabling accurate positioning control without requiring cardiopulmonary bypass. The mechanism translates small adjustments at the access site into precise positioning of the valve at the implantation site
3Measurement precision
If adjustable deployment mechanism with depth gauge is used, then positioning accuracy is improved, but device complexity increases
Solution Approach 1:
The deployment mechanism uses a nested structure with an inner cylinder containing the delivery system and an outer cylinder providing adjustment control. The depth gauge is integrated into this nested structure, allowing precise measurement functionality to be incorporated without proportionally increasing overall device complexity
Solution Approach 2:
The adjustable deployment mechanism serves multiple functions: it controls delivery of the prosthetic valve, enables precise positioning through cylinder adjustment, and provides depth measurement via the depth gauge. This multi-functionality consolidates several components into one integrated system, managing complexity while enhancing positioning accuracy
Data Source
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AI summary
Valve introducer systems (100) and methods for implanting heart valve prostheses are disclosed, where a valve introducer (101) includes an adjustable deployment mechanism (102) comprising a deployment element (112) and an implantation depth controlling element (103) having a distal end and an adjustable length. The valve introducer also includes a tubular member (106) having a distal end, configured to deliver a heart valve prosthesis, and a length extending from a fixed reference point. The implantation depth controlling element can comprise an inner and an outer cylinder (118, 120), such as where the outer cylinder has interior threads, and the inner cylinder has exterior threads. The adjustable deployment element can include a depth gauge, wherein the depth gauge (124) indicates the length the tubular member extends beyond a fixed reference point. In certain embodiments, the adjustable deployment element can also be configured to be secured to a cannula (104).