Disposable Radiolucent Marker Foil for Surgical Navigation
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Solution Overview
Problem
Conventional optical tracking markers for intra-operative navigation in surgery are cumbersome to sterilize and reuse, leading to reduced navigation accuracy and increased surgical time due to the need for frequent replacement and precise fixation.
Innovation Solution
A disposable, radiolucent reference array in the form of an unsymmetric marker foil device, comprising a support foil and markers made of materials like Mylar™ that dissolve under steam sterilization, allowing for easy disposal and reducing the complexity of marker placement, with a carrier device designed for secure attachment and detection by navigation systems.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of substance
If conventional markers are sterilized and reused, then cost is reduced, but navigation accuracy deteriorates and surgical time increases
Solution Approach 1:
The patent implements disposable markers made of radiolucent material that can be discarded after single use, eliminating the need for sterilization and ensuring consistent navigation accuracy. The markers are designed to be inexpensive enough to justify single-use disposal, preventing accuracy degradation from repeated sterilization cycles.
Solution Approach 2:
The patent changes the material parameters of markers to be radiolucent (X-ray transparent), allowing direct visualization and tracking by navigation systems without requiring complex sterilization protocols. This material parameter change enables both disposability and maintained accuracy.
2Measurement precision
If multiple markers are precisely fixed to objects, then tracking accuracy is improved, but surgical time increases
Solution Approach 1:
The patent merges multiple individual marker fixation tasks into a single integrated marker array that can be attached as one unit to the surgical object. This combining approach maintains the geometric precision needed for accurate tracking while reducing the cumulative time required for multiple separate fixation operations.
Solution Approach 2:
The patent prepares the marker array with pre-defined geometric configurations and pre-attached positioning features before surgery begins. This preliminary preparation eliminates the need for time-consuming precise measurements and adjustments during the surgical procedure, while maintaining tracking accuracy through factory-calibrated geometries.
3Ease of operation
If retro-reflective coating is used on markers, then passive marker functionality is achieved, but sterilization capability is lost
Solution Approach 1:
The patent eliminates the need for sterilization by making markers disposable, removing the constraint that prevented use of simple retro-reflective coatings. The markers are designed for single use only, so complex sterilization-resistant materials are unnecessary, allowing use of easier-to-manufacture retro-reflective coatings.
Solution Approach 2:
The patent extracts the sterilization requirement from the marker design by implementing a disposable approach. This removes the constraint that previously forced use of sterilization-resistant materials, allowing simpler retro-reflective coatings to be used without compromising the sterilization process.
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 solution simplifies image-guided surgery by eliminating the need for frequent marker replacement and sterilization, reducing surgical time, and ensuring precise tracking without compromising navigation accuracy.
Implementation Method 1
The marker foil device is made of a material that dissolves under steam sterilisation if it is laminated with PE (polyethylene)
Implementation Method 2
Passive markers usually contain a retro-reflective coating which is very sensitive
Data Source
AI summary
A reference foil comprises an unsymmetric marker foil device which advantageously includes spatially separated pieces of a marker material foil in unsymmetric arrangement and/or at least one unsymmetric integral piece of the marker material foil. The reference foil and a carrier device for the same may be used for example in image-guided surgery.