Fastener Delivery Tool for Heart Valve Replacement
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current suturing techniques during heart valve replacement procedures are time-consuming and complex, leading to prolonged cardiopulmonary bypass and increased health risks due to inconsistent fixturing force and the tedious process of securing sewing rings to tissue orifices.
Innovation Solution
A fastener delivery tool with a loading chamber, releasable retaining member, ejection track, and lever mechanism that transforms fasteners from a relaxed to a constrained state, allowing for efficient ejection and secure attachment to tissue or prosthetic components, enabling rapid deployment of multiple fasteners without the need for constant reloading.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional suturing techniques are used to secure sewing rings to tissue orifices, then the sewing ring can be attached to the tissue, but the procedure becomes time-consuming and complex, leading to prolonged cardiopulmonary bypass
Solution Approach 1:
The fastening system is divided into separate components: a fastener with tines for tissue engagement, a delivery tool for precise placement, and a releasable retaining member for controlled deployment. This segmentation allows each component to perform its specific function efficiently, reducing overall procedural time while maintaining reliable attachment.
Solution Approach 2:
The fastener is pre-loaded into the delivery tool in a constrained state within a loading chamber. The releasable retaining member holds the fastener in place until deployment. This preliminary preparation eliminates the need for constant reloading during the procedure and allows for rapid sequential deployment of multiple fasteners.
2Reliability
If multiple component prostheses are assembled in vivo, then the valve can be secured to the sewing ring, but the process becomes complex and time-consuming, increasing health risks
Solution Approach 1:
The fastening function is extracted from the complex in vivo assembly process and implemented through a dedicated delivery tool with a specialized fastener design. The fastener with tines provides direct tissue engagement, separating the securing function from the valve assembly process and simplifying the overall procedure.
Solution Approach 2:
The delivery tool acts as an intermediary device between the surgeon and the fastener. It provides controlled delivery, positioning, and deployment of the fastener through the sewing ring into the tissue annulus, mediating the connection between prosthetic components and tissue without requiring complex in vivo assembly.
3Reliability
If traditional knot tying is used to secure sutures, then the sewing ring can be attached to tissue, but the procedure requires three to ten knots per suture, significantly increasing time consumption
Solution Approach 1:
The traditional mechanical knot-tying process is replaced with a mechanical fastening system consisting of a fastener with tines that engage tissue directly. The releasable retaining member and delivery tool provide controlled deployment, eliminating the need for multiple knots and significantly increasing suturing speed while maintaining attachment strength.
4Reliability
If the fastener is delivered in a constrained state, then the fastener can be securely attached to tissue, but the fastener must be transformed from relaxed to constrained state, adding procedural steps
Solution Approach 1:
The fastener is pre-constrained within the loading chamber of the delivery tool before deployment. The releasable retaining member holds the fastener in this constrained state. During the procedure, the fastener is delivered already in the correct constrained configuration, eliminating the need for intra-procedural transformation and reducing procedural complexity.
Solution Approach 2:
The delivery tool is designed to automatically maintain the fastener in the correct constrained state through its loading chamber and releasable retaining member mechanism. The system self-regulates the fastener configuration without requiring manual intervention or complex transformation steps during deployment.
Data Source
AI summary
A fastener delivery tool includes a loading chamber for receiving a fastener having a pair of tines overlapping one another to define a loop in a parent or relaxed state. A retaining member retains the fastener in the loading chamber. The fastener delivery tool also includes a tongue, pusher member, and an ejection track communicating with the loading chamber. An actuator causes the tongue to move to engage the tines of the fastener to transform the fastener from the relaxed state to a constrained state defining a U-shape. The actuator also causes the pusher member to release the retaining member and advance the fastener down the ejection track in the constrained state. The tool also includes 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.