Prefabricated ePTFE Chordae Deployment Mechanism
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Solution Overview
Problem
Current surgical techniques for replacing diseased mitral valve chordae with artificial chordae tendinae are inefficient, requiring complex knotting and crimping procedures, leading to inconsistencies and prolonged surgery times, especially in determining the correct length and attachment to papillary muscles.
Innovation Solution
A rapid deployment system comprising a prosthesis and attachment/delivery device that allows for minimally invasive, trans-catheter deployment of prefabricated artificial chordae tendinae, using ePTFE sutures and a deployment mechanism that eliminates the need for complicated knotting and crimping, enabling quicker and more consistent implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional surgical techniques are used for chordal replacement, then the procedure can be performed with standard surgical tools, but the surgery time is prolonged and the procedure complexity increases due to complex knotting and crimping requirements
Solution Approach 1:
The artificial chordae are pre-measured and pre-fabricated with predetermined lengths before the surgical procedure. The delivery device is pre-loaded with the chordae and equipped with pre-formed flukes, eliminating the need for intraoperative measurement, cutting, knotting, and crimping operations. This preliminary preparation directly reduces surgery time and procedural complexity.
Solution Approach 2:
The delivery device automatically secures the artificial chordae through its integrated fluke structure that engages with the papillary muscle and leaflet tissue upon deployment. The system self-secures without requiring separate knotting or crimping steps by the surgeon, simplifying the procedure and reducing operation time.
2Reliability
If traditional knotting and crimping procedures are used, then the artificial chordae can be securely attached to papillary muscles, but consistency in chordal length adjustment is compromised and surgery duration increases
Solution Approach 1:
The artificial chordae are manufactured with precise, predetermined lengths in the factory setting using controlled processes. This pre-fabrication ensures uniformity and consistency across all chordae of the same specification, eliminating variability introduced by manual measurement and cutting during surgery. The flukes are also pre-formed to ensure consistent engagement geometry.
Solution Approach 2:
The delivery device's fluke structure automatically engages the tissue and secures the chordae at the correct position upon deployment. This self-positioning mechanism ensures consistent attachment reliability without requiring manual adjustment or knotting, which can introduce variability in chordal length and tension.
3Strength
If manual knotting and crimping are performed, then the prosthesis can be secured to the heart tissue, but the surgery time is prolonged and patient recovery is delayed
Solution Approach 1:
The delivery device automatically secures the artificial chordae to the papillary muscle and leaflet through its fluke structure that engages the tissue upon deployment. This self-securing mechanism eliminates the time-consuming manual knotting and crimping operations while maintaining secure attachment strength, directly reducing surgery duration and enabling faster patient recovery.
Data Source
AI summary
An embodiment includes an apparatus comprising: a hollow needle with a narrowed inner diameter in a distal third of the needle; and a flexible chord coupled to proximal and distal conduits; wherein the distal conduit is in the needle and distal to the narrowed inner diameter and the proximal conduit is in the needle and proximal to the narrowed inner diameter; wherein: (a)(i) long axes of the proximal and distal conduits are substantially parallel to a long axis of the needle when the proximal and distal conduits are in the needle, and (a)(ii) the proximal and distal conduits are configured to rotate when deployed from the needle such that their long axes are not parallel to a long axis of the chord when the chord is fully extended. Other embodiments are described herein.