Translucent Fiducial Device with Mechanical Interface for Surgical Guidance

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Solution Overview

Problem

Current skull fixation devices for scan-guided surgical operations are cumbersome and require multiple steps, prolonging anesthesia time due to the need for precise registration of fiducial markers and drill trajectories, which complicates the surgical procedure and reduces accuracy.

Innovation Solution

A device with a translucent material for electromagnetic scans, incorporating a fiducial marker that can be fixed to a surgical instrument with a well-defined mechanical interface, using protrusions and indentations for stable coupling, and bone screws with sleeves to prevent skin damage, allowing direct referencing of scan data to the surgical instrument's position.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional fiducial markers and multiple registration steps are used, then the surgical procedure can be performed with established methods, but the surgery time is prolonged and the procedure becomes more complex

Engineering Contradiction:
Improveestablished methodsVSAvoidsurgery time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent combines the fiducial marker and the mechanical interface device into a single integrated component. The fiducial marker is embedded within the device that also provides the mechanical interface for the surgical instrument, eliminating the need for separate fiducial markers and reducing the number of registration steps required.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The device serves multiple functions simultaneously: it acts as a fiducial marker for image guidance, provides a mechanical interface for instrument attachment, and establishes the coordinate system transformation. This multi-functionality reduces the overall complexity and time of the surgical procedure while maintaining reliability.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Measurement precision

If multiple registration steps are performed to ensure accurate drill trajectory, then the drilling accuracy can be maintained, but the surgical procedure is complicated and anesthesia time is extended

Engineering Contradiction:
Improvedrilling accuracyVSAvoidprocedure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The coordinate system transformation is pre-established through the rigid mechanical connection between the device and the surgical instrument. The fiducial marker is positioned and registered before the actual drilling operation, allowing the trajectory to be accurately transferred without requiring multiple registration steps during the procedure.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The device acts as an intermediary element that bridges the image space (fiducial marker) and the physical surgical instrument. This intermediary provides a stable, well-defined mechanical connection that maintains the coordinate transformation throughout the procedure, ensuring drilling accuracy while simplifying the overall process.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If a well-defined mechanical interface is used to couple the device to the surgical instrument, then the position referencing accuracy is improved, but the device structure becomes more complex

Engineering Contradiction:
Improveposition referencing accuracyVSAvoiddevice structure
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The device is segmented into distinct functional components: the fiducial marker portion, the mechanical interface portion with protrusions and indentations, and the bone attachment portion. This segmentation allows each component to be optimized for its specific function while maintaining an overall simple and effective structure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The mechanical interface with protrusions and indentations provides self-aligning and self-locking functionality. The geometric features automatically ensure proper orientation and secure coupling between the device and the surgical instrument without requiring additional adjustment mechanisms or complex assembly procedures.

Inventive Principle:
Principle #25Self-service

4Strength

If bone screws are used to fixate the device to the skull, then the device can be securely attached, but skin damage may occur without proper protection

Engineering Contradiction:
Improveattachment strengthVSAvoidskin damage
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

A protective element is introduced as an intermediary between the bone screw and the skin. This element distributes the mechanical stress and prevents direct contact between the screw and soft tissue, thereby maintaining secure attachment strength while eliminating the harmful effect of skin damage.

Inventive Principle:
Principle #24Intermediary (Mediator)

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 the surgical procedure by enabling direct referencing of scan data to the surgical instrument's position, reducing anesthesia time and improving accuracy, while preventing skin damage and minimizing imaging artifacts with a contrast agent-filled cavity.

Implementation Method 1

The device comprises a material translucent for the applied electromagnetic waves of the scan

Methodology Applied
Scientific EffectElectromagnetic wave transmission: Absorption (EM radiation)

Data Source

PatentUS11464600B2Mechanical interface device to bone structure with an integrated targeting reference, allowing for surgical device attachment
Publication Date: 2022.10.11 EINDHOVEN MEDICAL ROBOTICS BV
  • US11464600B2 patent drawing
  • US11464600B2 patent drawing
  • US11464600B2 patent drawing

AI summary

Device 1 for fixation to the skull 2 of a patient that can serve as a fiducial marker in scan guided surgical operations using a surgical instrument. The device 1 comprises a material translucent for the applied electromagnetic waves of the scan and a fiducial marker and where the device 1 comprises means to fixate the device in a well-defined manner to the surgical instrument.