Fastener Delivery Tool for Prosthetic Heart Valve Attachment
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current suturing techniques during heart valve replacement procedures are time-consuming and increase the risk of health damage due to prolonged cardiopulmonary bypass, with varying fixturing force and complexity leading to potential mistakes.
Innovation Solution
A fastener delivery tool with a belt assembly, loading chamber, and actuator system that transforms fasteners from a relaxed to a constrained state, allowing for efficient and consistent deployment of fasteners to secure prostheses to tissue or other devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional suturing techniques are used to attach sewing ring to valve member, then the procedure can be completed with simple equipment, but the procedure becomes time-consuming and increases health risks due to prolonged cardiopulmonary bypass
Solution Approach 1:
The fasteners are pre-loaded onto the belt assembly in a relaxed state before the procedure begins. The delivery tool is pre-assembled with all necessary components (belt, fasteners, tongue, pusher member). This preliminary preparation eliminates the need for time-consuming manual suture threading and knot tying during the actual surgery, directly addressing the productivity issue while maintaining procedural simplicity.
Solution Approach 2:
The complex knot-tying process is extracted and replaced by a simplified fastener deployment mechanism. The invention removes the need for manual knot tying by using a belt-driven system that automatically positions and deploys pre-formed fasteners, thereby increasing suturing speed without proportionally increasing device complexity.
2Reliability
If multiple knots are tied per suture to secure the sewing ring, then the attachment becomes more secure, but the procedure time increases significantly
Solution Approach 1:
The invention uses disposable or single-use fasteners that are pre-formed and designed for one-time deployment. Each fastener is engineered to provide secure attachment upon deployment without requiring multiple knots. The fasteners are loaded onto the belt in advance and deployed individually, eliminating the time-consuming repetitive knot-tying process while maintaining reliable attachment security.
Solution Approach 2:
The invention changes the fundamental parameter of attachment from multiple knots per suture to a single fastener deployment event. The fasteners are designed with specific geometric parameters (tines, loops, engagement features) that provide secure attachment when deployed in the constrained state, replacing the need for multiple knots and significantly reducing procedure time.
3Manufacturing precision
If fasteners are delivered manually one by one, then the equipment remains simple, but the fixturing force varies significantly between fasteners
Solution Approach 1:
The belt assembly serves as an intermediary mechanism that standardizes fastener delivery. The belt with its engagement features (recesses, grooves, or protrusions) acts as a mediator between the operator and the fasteners, ensuring that each fastener is positioned and deployed with consistent force and orientation. This intermediary system eliminates manual variability in fixturing force while keeping the overall device complexity manageable through a mechanical belt-driven approach.
Solution Approach 2:
The fasteners are pre-positioned on the belt assembly in a standardized manner before the procedure begins. The belt's engagement features are designed to hold each fastener in a specific orientation and position, ensuring consistent deployment characteristics. This preliminary arrangement of fasteners on the belt eliminates variability in fixturing force during actual use, achieving manufacturing precision without requiring complex real-time control systems.
4Ease of manufacture
If the sewing ring is separate from the valve member, then the valve assembly is more modular and easier to manufacture, but the in vivo assembly process becomes more complex and time-consuming
Solution Approach 1:
The fastener deployment tool serves multiple functions: it attaches the sewing ring to the valve member, secures the valve member to the sewing ring, and provides consistent fixturing force for both operations. This multi-functional tool simplifies the in vivo assembly process of modular prostheses, allowing the separate components to be easily assembled without increasing overall procedural complexity. The same belt-driven mechanism handles both attachment tasks that would otherwise require different manual techniques.
Data Source
Figure 1
Figure 2(a)~3(a)
Figure 3(b)~4(b)
AI summary
A fastener delivery tool includes a belt (208) including pairs of features (286) for releasably engaging tines (6a, 6b) of respective fasteners (6) in a relaxed state defining a loop. The tool includes a loading chamber (218) for receiving a fastener from the belt, a retaining member (220) for limiting movement of the fastener within the loading chamber, an ejection track (223) communicating with the loading chamber, a handle (210) including an actuator (212), and a tongue (26) and pusher member (30) coupled to the actuator. Activation of the actuator advances the tongue to transform the fastener from the relaxed state to a U-shaped constrained state, and advances the pusher member to direct the fastener from the loading chamber down the ejection track. The tool may include a trigger for ejecting the fastener completely from the ejection track. The fastener may be used to secure a prosthetic heart valve or components thereof into surrounding tissue, e.g., within a tissue annulus.