Deformable Sterile Holder for Spinal Implant Removal
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Solution Overview
Problem
Current methods for handling sterile surgical implants during spinal fusion procedures often result in contamination due to manual handling, leading to a risk of infection, as surgeons need to touch the implants to remove them from their packaging, and unused implants are repeatedly sterilized, causing waste and increased costs.
Innovation Solution
A deformable, ergonomically designed sterile holder that mimics the shape of the implant, allowing it to be retrieved using a sterile tool without direct contact, maintaining sterility and reducing the need for repeated sterilization of unused implants.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual handling of implants is used to remove them from packaging, then ease of operation is improved, but contamination risk increases
Solution Approach 1:
The patent introduces a sterile holder as an intermediary device between the implant packaging and the surgeon's hands. The holder maintains a sterile barrier (such as a sterile drape or envelope) that prevents direct contact between the surgeon's hands and the implant, while still allowing the implant to be accessed and used. This mediator eliminates the contamination risk associated with manual handling while preserving ease of operation.
Solution Approach 2:
The system is segmented into distinct sterile and non-sterile zones. The implant remains in a sterile container or envelope that is separated from the surgeon's hands. The holder itself may have portions that are sterile and portions that are non-sterile, with the sterile portion containing the implant and the non-sterile portion being handled by the surgeon. This segmentation allows easy operation while preventing contamination.
2Reliability
If repeated sterilization of unused implants is performed, then sterility is maintained, but loss of time and increased costs occur
Solution Approach 1:
The holder is pre-packaged with the implant in a sterile state before the surgical procedure. The sterile barrier is already in place and maintained throughout the procedure, eliminating the need for repeated sterilization of unused implants. The sterility is established in advance and preserved through the use of the holder, saving time and reducing costs.
3Reliability
If double container packaging is used to prevent contamination, then sterility is improved, but device complexity increases
Solution Approach 1:
The patent merges the holder with the sterile packaging system. Rather than using separate double containers, the holder itself incorporates or is integrated with the sterile barrier. The holder may have the implant embedded in or attached to a sterile drape or envelope, combining the support function of the holder with the protective function of the packaging into a single integrated 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
The solution effectively prevents contamination and reduces waste by allowing sterile implants to be handled without direct contact, maintaining sterility and minimizing the need for repeated sterilization, thereby lowering infection risks and costs.
Implementation Method 1
The body is deformable and the portion that covers the implant on the face surface can be forced to move or expand by applying pressure to the body, so that the implant can be easily pried out of the cavity by deforming the body.
Data Source
AI summary
A sterile holder for sterile surgical implants. The implant holder is an ergonomically shaped body of deformable material having an implant-receiving cavity similar in size and shape to the implant. To remove the implant from the holder, the surgeon mates a sterile tool to the implant and gently pries the implant out of the holder by deforming the body. Preferably the tool used to pry the implant out of the body is an insertion tool mated to the implant which is also used to insert the implant in a patient. In this way the surgeon retrieves the implant from its container without touching the container and directly inserts the implant in the patient without risking contamination: sterility is maintained for both the surgeon and the implant. In a preferred embodiment, the implant holder is configured to hold two pedicle screws and their set-screws.