Sterile Intraoperative Implant Customization for Patient-Specific Fit
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Solution Overview
Problem
Existing medical implants, whether standard or customized, often fail to precisely match patient-specific needs due to variations in anatomy, requiring time-consuming and imprecise intraoperative customization, and have long lead times and high costs associated with traditional fabrication and shipping.
Innovation Solution
An apparatus and method for intraoperative on-demand implant customization using a sterile environment with a storage portion, implant customization portion, and interface to manipulate implant blanks into patient-specific implants through bending and cutting mechanisms, utilizing CT, X-ray, or fluoroscopy data, and flexible templates.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If standard implants are used, then manufacturing cost and ease of manufacture are improved, but implant precision and patient-specific fit deteriorate
Solution Approach 1:
Patient-specific implant designs are created preoperatively using imaging data and computational planning, allowing customization without intraoperative fabrication. The implant design is finalized before surgery, enabling precise patient-specific geometry to be manufactured in advance while avoiding time-consuming intraoperative customization.
Solution Approach 2:
The system allows selective customization of implant portions while maintaining standard sections. Only specific regions of the implant are customized to match patient anatomy, while other portions remain as standard components, optimizing both precision and manufacturing efficiency.
2Manufacturing precision
If patient-specific implants are fabricated in advance, then implant precision is improved, but lead time and availability deteriorate
Solution Approach 1:
Complete preoperative planning including implant design selection is performed before surgery. The system retrieves pre-designed patient-specific implant options from a database, eliminating the need for intraoperative customization and reducing lead time while maintaining precision.
Solution Approach 2:
The system changes the state of implant customization from intraoperative to preoperative by implementing digital planning and virtual implant positioning. This parameter change in the timing of customization activities reduces lead time while maintaining manufacturing precision through advanced manufacturing techniques.
3Adaptability or versatility
If intraoperative customization is performed manually, then adaptability is improved, but manufacturing precision and time efficiency deteriorate
Solution Approach 1:
The system incorporates real-time feedback through intraoperative imaging and verification processes. Implant positioning and customization are verified using imaging data, allowing adjustments to be made with precise feedback on positioning accuracy, thereby improving both adaptability and precision.
Solution Approach 2:
Manual sculpting and mechanical customization tools are replaced with automated positioning systems and computer-controlled implant placement. The system uses digital models and imaging guidance to achieve precise customization without manual manipulation, improving both precision and time efficiency.
4Adaptability or versatility
If manual sculpting tools are used intraoperatively, then adaptability is improved, but time efficiency and productivity deteriorate
Solution Approach 1:
All implant customization decisions and design selections are made preoperatively through digital planning. The surgical team reviews and finalizes the implant design before entering the operating room, eliminating time-consuming intraoperative sculpting and improving surgical efficiency while maintaining adaptability through pre-planned customization options.
Solution Approach 2:
Digital copies and virtual models of patient-specific anatomy are created preoperatively from imaging data. These digital models are used for planning and selecting implant configurations, replacing the need for physical manipulation and sculpting during surgery, thereby improving time efficiency while maintaining full adaptability to patient-specific anatomy.
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
Enables rapid, precise, and cost-effective customization of implants within a sterile surgical environment, reducing lead times and inventory needs, and ensuring sterility throughout the customization process.
Implementation Method 1
The implant can then be manufactured using an additive manufacturing system, which deposits material in a layer-by-layer fashion to build a three-dimensional structure
Implementation Method 2
The system employs a laser to remove material from a build platform in a layer-by-layer fashion
Data Source
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AI summary
Disclosed herein are apparatuses and methods for intraoperative on-demand implant customization in a surgical setting. An apparatus may include a storage portion, an implant customization portion and an interface. The storage portion may house implant blanks and implant accessories. The implant customization portion may customize the implant blanks. The interface may be configured to receive implant customization information and utilize the same to intraoperatively manipulate the implant blank to a patient-specific implant within a sterile environment. A method to customize an implant in a surgical care environment may include the steps of obtaining information related to the implant location, selecting an implant blank based on the information, and customizing the implant blank in a surgical care setting with a customization apparatus.