Direct Aortic TAVI Stabilization System with Adjustable Cradle
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Solution Overview
Problem
Current direct aortic transcatheter aortic valve implantation (TAVI) methods face challenges such as lack of vascular support, inadequate tools, non-standard procedure orientation, increased personnel requirements, and excessive fluoroscopy exposure, which hinder accurate valve positioning and clinician safety.
Innovation Solution
A stabilization and advancement system comprising an introducer support, cradle mechanism, and adjustment mechanism that provides increased stability, accurate positioning, and reduced manpower needs, featuring a flexible position clamp and adjustable components to facilitate safe and efficient direct aortic TAVI procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If direct aortic TAVI method is used to access patients with contra-indicative anatomy, then access to patients with extreme tortuous/narrow vasculature is enabled, but vascular support for the delivery system is lacking
Solution Approach 1:
The patent introduces a stabilization system with clamps and support structures that act as intermediaries between the delivery system and the patient's body. The introducer clamp secures the introducer to the patient's chest wall, while the stabilization system provides additional support points, creating a reliable connection without relying solely on vascular structures.
2Adaptability or versatility
If direct aortic TAVI procedure is performed with non-standard orientation, then access to aortic valve is achieved, but procedure room orientation becomes non-standard requiring additional personnel
Solution Approach 1:
The stabilization system is designed to be universally applicable regardless of procedure room orientation. The adjustable clamps and support structures can be configured for various orientations (supine, lateral decubitus, etc.), allowing the same system to handle non-standard orientations without requiring specialized equipment or additional personnel.
3Ease of operation
If direct aortic TAVI is performed without stabilization system, then procedure can be initiated, but fluoroscopy exposure increases due to difficulty in valve positioning
Solution Approach 1:
The stabilization system is established before valve positioning begins. The clamps are secured to the patient's body, and the delivery system is stabilized in the correct position prior to initiating the valve deployment sequence. This preliminary stabilization eliminates the need for repeated fluoroscopy adjustments during positioning.
4Ease of manufacture
If traditional delivery system is used for direct aortic TAVI, then existing tools can be utilized, but lack of dedicated tools reduces accuracy and safety
Solution Approach 1:
The system segments the delivery process into distinct functional components: an introducer for access, a stabilization system with clamps for securing, and a delivery system for valve deployment. Each component is optimized for its specific function, with the stabilization system providing dedicated tools for securing and positioning that enhance overall accuracy and safety.
Data Source
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AI summary
A system for stabilizing and advancing a delivery system for direct access TAVi. The system includes an introducer support (102) coupled to an introducer and a stable object, a cradle mechanism (104) coupled to a handle (906) of the delivery system and a stable object, and an adjustment mechanism (106) coupled to the delivery system. Operation of the adjustment mechanism moves the delivery system distal of the handle in a distal or proximal direction. The introducer support may be coupled to a flexible position clamp. The cradle mechanism includes a cradle for the handle, a flexible arm coupled to the cradle, and a clamp coupled to the flexible arm and attached to the stable object. The stable object may be an operating table. The adjustment mechanism may be coupled to the delivery system adjacent the introducer. The adjustment mechanism may include a quick release mechanism.