Self-Expanding Implant Stent with Bendable Struts for Pulmonary Vein Positioning
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Solution Overview
Problem
Current implant devices for pulmonary vein isolation (PVI) face challenges in accurately transporting and positioning themselves at the antrum of pulmonary veins, leading to high recurrence rates, prolonged procedural times, and intraprocedural complications due to difficulty in maintaining correct placement and fixation.
Innovation Solution
A self-expanding implant device with radially self-expanding structures and longitudinally oriented struts allows for easy transport, accurate positioning, and secure fixation at the target site, combined with external energy-providing means for ablation, utilizing a circumferential diamond-like ablation structure and support structure to ensure effective signal-blocking lesions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a self-expanding implant device is used for PVI, then the ablation effectiveness is improved, but the difficulty of transporting and positioning the device at the target location increases
Solution Approach 1:
The implant device is divided into multiple segments or struts that can be collapsed together for transport and then separated or expanded at the target site. This segmentation allows the device to be easily navigated through catheters while maintaining the capability for effective ablation when deployed.
Solution Approach 2:
The self-expanding implant device is nested within a delivery catheter system, allowing it to be transported in a compressed state and then deployed at the target location. The nested configuration enables easy transport while preserving the device's ablation functionality when expanded.
2Stability of the object's composition
If the implant device is designed for secure fixation at the target zone, then the stability of placement is improved, but the complexity of the device structure increases
Solution Approach 1:
The implant device incorporates fixation elements such as hooks, barbs, or expanded radial structures at specific locations (e.g., distal and proximal ends) while keeping other portions relatively simple. This localized complexity provides secure anchoring without requiring the entire device to be complex.
Solution Approach 2:
The device employs dynamic fixation mechanisms that transition from a compressed transport state to an expanded or anchored deployed state. This allows the device to achieve stable fixation through structural transformation rather than requiring complex fixed mechanisms throughout.
3Ease of operation
If the strut length is increased to allow distal portion expansion, then the ease of positioning is improved, but the risk of device shifting or movement increases
Solution Approach 1:
The device incorporates preliminary fixation elements or anchoring structures that engage with the vessel wall before full expansion occurs. This preliminary action secures the device in place, preventing shifting even as the struts expand to their full length for optimal positioning.
Solution Approach 2:
The device uses flexible struts or membranes that can bend and conform to the vessel geometry while maintaining positional stability. This flexibility allows the device to accommodate vessel movements without shifting, while still achieving the necessary expansion for effective ablation.
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
The solution enables precise and stable placement of the implant device at the antrum of pulmonary veins, reducing recurrence rates and procedural complications by ensuring complete circumferential signal-blocking paths, thus effectively addressing the limitations of existing PVI methods.
Implementation Method 1
The proximal portion and the distal portion each comprise a radially self-expanding structure
Implementation Method 2
The connecting portion comprises longitudinally oriented bendable struts
Implementation Method 3
external energy-providing means for ablation, utilizing a circumferential diamond-like ablation structure
Data Source
AI summary
The present invention concerns a self-expanding implant device comprising a proximal portion at a first longitudinal end, a distal portion at a second longitudinal opposite the first longitudinal end, and a connecting portion between the proximal portion and the distal portion, wherein the proximal portion and the distal portion each comprise a radially self-expanding structure, wherein the connecting portion comprises longitudinally oriented bendable struts, preferably at least 4 struts, more preferably 6 struts or more, which connect the self-expanding structure of the proximal portion with the self-expanding structure of the distal portion, wherein in a fully expanded state, the implant device comprises a maximum implant diameter along a direction perpendicular to the longitudinal direction and wherein the struts of the connecting portion comprise a strut length along the longitudinal direction, characterized in that the strut length is such that when the self-expanding structure of the proximal portion is in a compacted state and the self-expanding structure of the distal portion is not constrained radially, the self-expanding structure of the distal portion reaches a semi-expanded state comprising a diameter which is at least 60% of the maximum implant diameter.