Cardiac Tissue Cinching via Percutaneous Tether Anchors
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Solution Overview
Problem
Current treatments for functional tricuspid and mitral regurgitation are limited, with surgical options being invasive and only applicable to a small percentage of patients, leaving many with moderate-to-severe regurgitation without effective percutaneous treatment options.
Innovation Solution
A tissue-anchor system comprising a torque-delivery tool, a tether, and a tissue anchor, which allows for percutaneous implantation and tensioning of tethers in cardiac tissue to repair tricuspid and mitral valves, using a torque-delivery cable to implant the anchor and lock the tether, thereby reducing regurgitation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical treatment is used for functional tricuspid and mitral regurgitation, then effective repair can be achieved, but the treatment is invasive and only applicable to a small percentage of patients
Solution Approach 1:
The patent replaces the mechanical surgical intervention (direct surgical repair requiring incisions and anesthesia) with a percutaneous mechanical system that delivers anchors and tethers through catheters inserted via blood vessels. This substitution maintains repair effectiveness while dramatically reducing invasiveness and expanding patient eligibility.
Solution Approach 2:
The patent introduces intermediary devices (catheters, delivery systems, and percutaneous anchors) that mediate between the operator and the cardiac tissue. These intermediaries enable the transmission of tension forces to cinch the annulus without requiring direct surgical access to the heart, thereby reducing invasiveness while maintaining therapeutic effectiveness.
2Reliability
If a tether-locking mechanism is implemented in the tissue anchor, then the tether can be securely locked after tensioning, but the device complexity increases
Solution Approach 1:
The tissue anchor incorporates a self-locking mechanism where the tether itself activates the locking function. When the tether is tensioned, it automatically engages with the locking mechanism (such as a cam or wedge structure) within the anchor, securing itself without requiring additional components or complex external locking procedures. This self-service approach enhances reliability while minimizing device complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This method provides a minimally invasive approach for treating tricuspid and mitral regurgitation, allowing for effective reduction of valve regurgitation through tether tensioning, offering a simpler and cost-effective treatment option for a broader range of patients.
Implementation Method 1
The spring is in an axially-expanded state, in which state the spring presses the tether against the outer tether-securing element, such as against a perimeter of the lateral opening
Implementation Method 2
The torque-delivery tool comprises (a) a torque-delivery cable, which comprises a distal torque-delivery head
Data Source
Figure 1A
Figure 1B
Figure 1C
AI summary
A method is provided including making an opening (300) through an atrial septum (302) at a septal site (304) at least 5 mm from a fossa ovalis (330). A first tissue anchor (204) is endovascularly advanced to a left-atrial site (306) on an annulus of a mitral valve (310) or a wall of a left atrium (308) above the annulus. The first tissue anchor (204) is implanted at the left-atrial site (306). A second tissue anchor (24) is endovascularly advanced to a right-atrial site (320) on an annulus of a tricuspid valve (207) or a wall of a right atrium (200) above the annulus. The second tissue (24) anchor is implanted at the right-atrial site (320). The left-atrial site (306) and the right-atrial site (320) are approximated by tensioning a tether (22) that passes through the opening (300) of the atrial septum (302) and connects the first and the second tissue anchors (204, 24). Other embodiments are also described.