Percutaneous Valve Repair Thread Deployment
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Solution Overview
Problem
Current methods for percutaneous valve repair and replacement face challenges in efficiently deploying and securing implants, such as annuloplasty rings and valves, within the heart, particularly in accurately positioning and anchoring them to the valve annulus without causing tissue damage or leakage.
Innovation Solution
A thread-deployment apparatus comprising an annular assembly of tubes with flexible guides and expandable structures, coupled with control wires and arced needles, allows for precise expansion and positioning over the valve annulus, deploying threads and anchors to secure the implant, and a locking mechanism to prevent migration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional percutaneous valve repair methods are used, then implantation can be performed, but positioning accuracy and anchoring security are insufficient
Solution Approach 1:
The device is divided into multiple functional components: an expandable frame that segments into radial support structures, multiple independent anchors that can be deployed separately, and a locking mechanism that segments the securing function. This segmentation allows each component to be optimized for its specific function, improving overall positioning accuracy and anchoring security.
Solution Approach 2:
The expandable frame is pre-configured with attachment points for anchors and positioning elements before deployment. The locking mechanism is pre-assembled in a constrained state within the delivery catheter, allowing it to be rapidly activated once the frame is positioned. This preliminary preparation ensures accurate positioning and secure anchoring without requiring complex in-situ assembly.
2Reliability
If expandable structures are used to improve positioning, then anchoring capability is enhanced, but device complexity increases
Solution Approach 1:
The delivery system employs a nested configuration where the expandable frame is contained within a delivery catheter, which in turn is positioned over a guidewire. The locking mechanism is nested within the frame structure, and anchors are nested within the frame or delivery catheter. This nested arrangement minimizes the overall profile during delivery while allowing full deployment of complex functions at the implantation site.
Solution Approach 2:
The frame transitions from a compressed static state during delivery to an expanded dynamic state at the implantation site. The locking mechanism transitions from a constrained state to an engaged state that secures the frame to the annulus. This dynamic transformation allows the device to achieve complex anchoring functionality without requiring equally complex structures throughout the entire device length.
3Measurement precision
If multiple control wires are used to position tubes precisely, then positioning accuracy improves, but ease of operation decreases
Solution Approach 1:
Multiple control wires are merged into a single integrated control mechanism or shared control catheter system. The control wires are bundled or mechanically linked such that a single operator action can coordinate the positioning of multiple tubes simultaneously. This merging maintains precise positioning capability while reducing the number of independent control inputs required from the operator.
Solution Approach 2:
The control wires serve multiple functions: they provide positioning control, serve as deployment actuators, and may provide structural support for the tubes. This multi-functionality reduces the need for separate control mechanisms for each function, simplifying the overall operation while maintaining positioning accuracy. The same control wire that positions the tube also triggers its deployment and provides mechanical support.
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
Enables precise and secure implantation of annuloplasty rings and valves by accurately positioning and anchoring them to the valve annulus, reducing tissue damage and leakage, and ensuring long-term stability of the implant.
Implementation Method 1
an expandable annular structure coupled to the tube guides, configured to expand the assembly of tubes, from a collapsed configuration, over tissue of a subject, by moving the tube guides radially outward
Implementation Method 2
a plurality of control wires coupled to the tube guides, configured to position the tubes, subsequently to the expansion of the assembly, for deployment of the threads from the tubes and into the tissue, by flexing the tube guides
Data Source
Figure 1A
Figure 1B
Figure 2
AI summary
Described embodiments include an apparatus (20, 20a), including a plurality of flexible tube guides (35), an annular assembly of tubes (34), each of the tubes being slidably disposed within a respective one of the tube guides, a plurality of threads (58), each of which comprising a distal end that is carried by a respective one of the tubes, and an expandable annular structure (36) coupled to the tube guides, configured to expand the assembly of tubes, from a collapsed configuration, over tissue (42) of a subject, by moving the tube guides radially outward. The apparatus further includes a plurality of control wires (40) coupled to the tube guides, configured to position the tubes, subsequently to the expansion of the assembly, for deployment of the threads from the tubes and into the tissue, by flexing the tube guides. Other embodiments are also described.