Occlusive Implant Hub Dynamics for LAA Sealing

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Solution Overview

Problem

The left atrial appendage (LAA) in patients with atrial fibrillation experiences stagnant blood leading to thrombi formation, which can break loose and cause stroke or heart attack, as existing medical devices have limitations in effectively sealing the LAA to prevent thrombi entry into the bloodstream.

Innovation Solution

An occlusive implant with an expandable framework that shifts between expanded and collapsed configurations, maintaining a constant height and exerting a consistent radial force, is designed to conform to the LAA geometry, featuring a central hub and support members that bend radially inward to deepen the recess, ensuring effective sealing and accommodation of varying LAA sizes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the expandable framework is designed to shift between expanded and collapsed configurations to accommodate varying LAA sizes, then the adaptability to patient-specific anatomy is improved, but the device complexity increases

Engineering Contradiction:
Improveadaptability to LAA geometryVSAvoiddevice complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The framework is designed with movable support members that can dynamically shift between expanded and collapsed configurations. The support members include curved portions with central recessed regions that allow the hub member to move relative to them, enabling the device to adapt to different LAA geometries while maintaining a manageable structural complexity through controlled dynamic movement rather than complex multi-component mechanisms

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The hub member is positioned within the central recessed region formed by the curved portions of the support members. This nested arrangement allows the hub to move relative to the support members while remaining contained within the overall framework structure, enabling configuration changes without requiring external adjustment mechanisms or increasing overall device complexity

Inventive Principle:
Principle #7Nested doll (Nesting)

2Reliability

If the support members are configured to bend radially inward to maintain constant height during configuration shifts, then the sealing effectiveness is improved, but the manufacturing precision requirements increase

Engineering Contradiction:
Improvesealing effectivenessVSAvoidmanufacturing precision
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The support members incorporate curved portions with central recessed regions that are specifically shaped to guide the bending motion radially inward. This curvature design naturally directs the support members to bend in the desired manner during configuration shifts, maintaining constant height and improving sealing effectiveness while the curved geometry provides inherent guidance that reduces the need for extremely tight manufacturing tolerances on the bending paths

Inventive Principle:
Principle #14Spheroidality (Curvature)

Solution Approach 2:

The framework maintains constant height as a fixed parameter while allowing the radial position and recess depth to change during configuration shifts. By decoupling the height parameter from the radial configuration changes, the design ensures consistent sealing performance across both expanded and collapsed states without requiring precise control of multiple simultaneous dimensional parameters during manufacturing

Inventive Principle:
Principle #35Parameter changes

3Adaptability or versatility

If the central hub member shifts relative to the proximal end region during configuration changes, then the flexibility in accommodation of varying LAA sizes is improved, but the reliability of hub positioning may worsen

Engineering Contradiction:
Improveflexibility in accommodationVSAvoidhub positioning reliability
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The central recessed region is pre-formed in the curved portions of the support members to provide a defined pathway and stopping point for the hub member during its relative movement. This预先设计的 recess structure acts as a mechanical guide and limit stop, ensuring the hub remains properly positioned within the framework throughout configuration changes, thereby maintaining positioning reliability while enabling the flexibility needed for varying LAA sizes

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

Data Source

PatentEP3752075B1Occlusive medical device
Publication Date: 2024.06.12 BOSTON SCIENTIFIC SCIMED INC
  • EP3752075B1 patent drawingFigure 1
  • EP3752075B1 patent drawingFigure 2
  • EP3752075B1 patent drawingFigure 2A

AI summary

An example occlusive implant is disclosed. The example occlusive implant includes an expandable framework including a height and a plurality of support members defining a proximal end region of the expandable framework and a central hub member attached to the plurality of support members. Additionally, the expandable framework is configured to shift between a first configuration and a second configuration, wherein the height of the expandable framework remains substantially the same in both the first configuration and the second configuration. Further, the central hub member is configured to shift relative to the proximal end region while the expandable framework shifts between the first configuration and the second configuration.