T-Bar Soft Tissue Anchor for Minimally Invasive Heart Repair
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Solution Overview
Problem
Existing minimally invasive heart valve repair techniques, such as those described in WO2012/167120 and WO2016/042022, are complex and risky, with components like clips and sutures potentially coming loose and causing embolization, and do not effectively simulate natural chordae tendineae.
Innovation Solution
A soft tissue anchor system featuring a tubular cap member with a central line fixation, allowing passage through soft body tissue via a wire guide, minimizing trauma by reducing the size of the implantation site and securing the anchor with minimal tissue disruption, using a 'T-bar' configuration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing minimally invasive techniques (WO2012/167120, WO2016/042022) are used, then heart valve repair can be performed without open heart surgery, but the procedures become complex with multiple components (clips, sutures, artificial chordae lines) that increase the risk of embolization and do not effectively simulate natural chordae tendineae
Solution Approach 1:
The patent combines multiple separate components (anchor, artificial chordae line, and fixation mechanism) into a single integrated device. The artificial chordae line is pre-attached to the anchor, eliminating the need for separate clips and sutures that were required in previous techniques. This integration reduces the number of components that could potentially come loose and cause embolization.
Solution Approach 2:
The device is designed with a specific T-bar anchor configuration that segments the fixation function from the chordae line function. The T-bar anchor provides a simple geometric structure with a shaft and transverse bar that can be inserted through a minimally invasive approach, while the artificial chordae line is separately attached. This segmentation allows each component to be optimized for its specific function while reducing overall complexity.
2Ease of operation
If existing minimally invasive techniques are used, then surgical intervention is less invasive than open heart surgery, but the implantation process requires multiple complex steps that increase procedure time and risk
Solution Approach 1:
The artificial chordae line is pre-attached to the T-bar anchor during manufacturing, rather than requiring attachment during the surgical procedure. This preliminary action eliminates several complex surgical steps including suture placement, clip application, and multiple anchoring operations. The device is ready for immediate implantation as a complete unit.
Solution Approach 2:
Multiple functions (anchoring to papillary muscle, providing chordae line attachment, and securing the leaflet) are merged into a single integrated device. The T-bar anchor simultaneously provides tissue anchoring and serves as the attachment point for the artificial chordae line, eliminating the need for separate anchoring and fixation procedures.
3Reliability
If existing techniques with clips and sutures are used, then artificial chordae lines can be attached to anchors, but the components may come loose and cause embolization
Solution Approach 1:
The artificial chordae line is integrated with the T-bar anchor as a single unit, eliminating the interface between separate components that could fail. The chordae line is securely attached to the transverse bar of the T-bar anchor, creating a monolithic structure that cannot come loose during implantation or thereafter.
Solution Approach 2:
The patent removes the problematic clips and sutures from the system, replacing them with a direct integration of the artificial chordae line to the T-bar anchor. By taking out the intermediate fixation components (clips and sutures), the design eliminates the potential failure points where these components could detach and cause embolization.
Data Source
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AI summary
Disclosed herein are various soft tissue anchor systems for heart repair; catheter devices for implanting a soft tissue anchor system in heart tissue; methods of implanting soft tissue anchor systems in soft body tissue; and methods of manufacturing soft tissue anchor systems. A soft tissue anchor system (200) for implantation in soft body tissue (12) to hold an artificial line (214) comprises: a U-shaped fabric body (201) comprising a base portion (202) and at least two arm portions (204) extending from the base portion (202); wherein each arm portion (204) is configured to collapse in folds towards the base portion (202) such that, in use, the body tissue (12) is sandwiched between the base portion (202) and each of the arm portions (204).