Two-Stage Braid-Ball Aneurysm Implant Staged Deployment
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Solution Overview
Problem
Current aneurysm treatment devices lack the ability to confirm the final size and configuration of embolization implants under medical imaging before full deployment, leading to potential sizing issues and the need for device retrieval and exchange.
Innovation Solution
The development of braid-ball implants with a subject hub region architecture that allows for staged deployment, where the bulb is deployed first, followed by a self-actuating hub region that can be visualized under medical imaging to confirm sizing, enabling precise placement and configuration before full release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the implant is fully deployed outside the delivery catheter for size confirmation, then the final size can be visualized under medical imaging, but the device cannot be retrieved or exchanged if sizing is incorrect
Solution Approach 1:
The implant is divided into two functional segments: a distal bulb portion that is deployed first for size confirmation, and a proximal hub region that remains retained within the delivery catheter. This segmentation allows the distal portion to be visualized for sizing while the proximal portion maintains control and retrievability through the catheter.
Solution Approach 2:
The distal bulb portion is deployed in advance of the proximal hub region, allowing preliminary visualization and size confirmation under medical imaging before complete deployment. This preliminary action enables size verification while the implant is still partially contained, maintaining the option for retrieval or exchange if sizing is incorrect.
2Measurement precision
If the implant is partially deployed within the aneurysm for size check, then sizing can be confirmed under medical imaging, but the deployment point cannot be precisely controlled or marked
Solution Approach 1:
A radiopaque marker is introduced as an intermediary element between the implant structure and the medical imaging system. This marker is positioned at a known location on the delivery catheter, allowing precise correlation between the visualized implant size and the actual deployment position within the aneurysm under fluoroscopic guidance.
Solution Approach 2:
The radiopaque marker provides visual contrast under medical imaging, enabling precise identification of the deployment point and correlation with implant size. This visual indicator allows the physician to confirm both the size and position of the deployed portion simultaneously.
3Quantity of substance
If a large implant is used to fill a high aspect ratio aneurysm, then the aneurysm can be adequately filled, but the implant cannot be compressed sufficiently to fit within the delivery catheter
Solution Approach 1:
The implant is segmented into a distal bulb portion and a proximal hub region, allowing the bulk of the implant volume to be deployed and visualized first, while the proximal portion remains compressed within the catheter. This segmentation enables adequate aneurysm filling with large implants while maintaining a compact delivery profile.
Solution Approach 2:
The distal bulb portion is deployed in advance to fill the aneurysm sac, allowing the majority of the implant volume to be positioned and visualized before complete deployment. This preliminary deployment of the volume-critical portion enables adequate aneurysm filling while the proximal hub region remains compressed for delivery.
4Measurement precision
If the implant is fully deployed for size confirmation, then the final configuration can be visualized, but recapture and exchange become difficult or impossible
Solution Approach 1:
The implant structure is segmented such that only the distal bulb portion is deployed for configuration verification, while the proximal hub region remains retained within the delivery catheter. This segmentation maintains the ability to recapture and exchange the implant if configuration is incorrect, as the undeployed proximal portion can be pulled back into the catheter.
Solution Approach 2:
The distal portion is deployed in advance for configuration verification, but the proximal hub region is held back within the catheter. This preliminary deployment allows configuration visualization while preserving the ability to recapture and exchange the implant by pulling the retained proximal portion back into the delivery system.
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 approach minimizes delivery profile complexity, allows for larger implant sizes within a given profile, and facilitates easier recapture and procedural safety by ensuring accurate sizing and configuration confirmation during deployment.
Implementation Method 1
braid-balls for aneurysm or other embolization through blood flow disruption and thrombus formation
Implementation Method 2
The body of the subject implants may be constructed of NiTi alloy that is superelastic at human body temperature
Implementation Method 3
The forming method for a LUNA-style hidden hub implant is detailed herein in two heatsetting stages
Data Source
Figure 1~3B
Figure 4A~4D
Figure 5A~5F
AI summary
Embolic implants, delivery systems and methods of manufacture and delivery are disclosed. The subject implants are deployed in two stages. If sized properly as observed in the first stage, they are deployed to the second stage and detached. If not sized properly in/at the first stage, the implants are designed to be withdrawn and replaced with a more appropriately sized implant or another treatment option selected. Some of the implant configurations may be withdrawn even after the second stage deployment as well.