Implant Loading Apparatus with Pop-Up Inclined Guides
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Solution Overview
Problem
Current methods for inserting breast implants often result in capsular contracture due to microbial contamination during surgery, as endogenous flora from the patient's skin can attach to the implant and form biofilms, leading to chronic inflammatory responses and fibrosis.
Innovation Solution
A loading apparatus that facilitates the proper orientation and fixation of implants within delivery devices, minimizing handling and reducing exposure to contaminants, by using a tray portion with a pop-up mechanism and inclined guide portions to guide the implant into the delivery device, ensuring the leading edge is correctly positioned and the device is anchored during loading.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the implant is handled directly during loading into the delivery device, then the loading process is simple and quick, but the implant is exposed to microbial contamination from surgical handling and environment
Solution Approach 1:
A sterile barrier device is introduced as an intermediary between the implant and the surgical environment. The barrier device has a sterile interior surface that contacts the implant while the exterior surface faces the non-sterile surgical field, allowing loading operations to proceed without direct hand contact with the implant, thus preventing microbial contamination while maintaining operational simplicity
Solution Approach 2:
The sterile barrier device utilizes a flexible membrane or thin film structure that can be manipulated during the loading process. This flexible barrier allows the implant to be positioned and oriented correctly within the delivery device while maintaining the sterile seal, preventing contamination without requiring complex rigid structures
2Manufacturing precision
If the implant is oriented correctly during loading, then insertion precision is improved, but the loading process becomes more complex and time-consuming
Solution Approach 1:
The sterile barrier device incorporates a curved or domed interior surface that naturally guides the implant into the correct orientation as it is loaded. The curvature of the barrier surface works with the implant shape to automatically align the implant's leading edge with the delivery device opening, achieving precise orientation without complex mechanical guidance systems
Solution Approach 2:
The loading apparatus is designed so that the implant can be loaded in any initial orientation position, and the barrier device and delivery device geometry work together to automatically orient the implant correctly during the loading process itself, eliminating the need for pre-orientation steps or complex alignment mechanisms
3Manufacturing precision
If the delivery device is fixed during loading, then implant orientation accuracy is improved, but the ease of handling and positioning the delivery device is reduced
Solution Approach 1:
The delivery device incorporates a dynamic fixation mechanism that can be activated or deactivated as needed. During the loading phase, the device can be fixed to the loading apparatus to ensure precise implant orientation, and then easily released for subsequent handling and insertion operations, providing both precision during loading and ease of operation during insertion
Data Source
AI summary
Apparatuses, methods, systems, and kits for facilitating the loading of a prosthesis implant into an implant delivery device for delivering prosthesis implants into surgically-created implant pockets in a subject and for preventing capsular contracture resulting from surgical insertion of prosthesis implants. The loading apparatus may include a receiving portion and, optionally, at least one inclined guide portion. The receiving portion is operable to receive at least a portion of the implant delivery device while the optional at least one inclined guide portion is operable to receive the implant and guide it toward the recessed receiving portion such that the implant is correctly oriented in the implant delivery device. The at least one inclined guide portion may be deployed by operation of a pop-up portion operable to deploy from a substantially flat configuration to an extended deployed configuration comprising at least one inclined guide portion.


