Reusable EM Sensor with Segmented Adhesive Marker
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Solution Overview
Problem
Current electromagnetic tracking systems for medical procedures are costly due to the expense of disposable sensors and cables, and they cannot be easily reused or repositioned accurately for image fusion and guidance applications.
Innovation Solution
A reusable active marker device with a 6DOF electromagnetic sensor and a frame assembly that can be securely attached to the patient's skin using adhesive disks, featuring visualizable elements for accurate image registration and a socket for the sensor, allowing for reproducible placement and reuse.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If electromagnetic sensors and cables are permanently embedded in disposable markers, then patient-to-patient contamination is avoided, but the expense increases significantly
Solution Approach 1:
The marker system is divided into two segments: a disposable marker body that contacts the patient and a reusable electromagnetic sensor that does not. The disposable marker includes adhesive backing and visualizable elements, while the reusable sensor is attached via a connector. This segmentation allows the expensive sensor to be reused across multiple patients while only the inexpensive marker portion is discarded, resolving the contradiction between contamination prevention and cost reduction.
2Reliability
If markers are designed for single use to avoid contamination, then patient safety is ensured, but the ability to reuse and reposition markers for accurate image fusion is lost
Solution Approach 1:
The marker system separates the disposable adhesive marker portion from the reusable sensor portion. The disposable marker can be safely discarded after single use to prevent contamination, while the reusable sensor can be sterilized and reused for subsequent procedures requiring accurate image fusion and registration. This resolves the contradiction by allowing each component to fulfill its optimal function.
Solution Approach 2:
A connector serves as an intermediary between the disposable marker and reusable sensor. This connector allows for reliable attachment and detachment, enabling the sensor to be reused while maintaining the sterile barrier of the disposable marker. The intermediary facilitates the separation of concerns between single-use and reusable components.
3Reliability
If expensive sensors are discarded after single use, then contamination is prevented, but the cost per procedure increases
Solution Approach 1:
The system segments the expensive sensor from the inexpensive disposable marker. Only the marker portion is discarded after single use, while the sensor is reused across multiple procedures. This dramatically reduces the cost per procedure while maintaining contamination prevention, as the expensive component is not discarded with each use.
Solution Approach 2:
The disposable marker is discarded after single use while the reusable sensor is recovered and sterilized for subsequent use. This recovery of the expensive sensor component significantly reduces waste and lowers the cost per procedure while still preventing contamination through the disposable marker barrier.
4Reliability
If markers are made disposable, then contamination is avoided, but the precision and accuracy of electromagnetic tracking may be compromised
Solution Approach 1:
The system segments the tracking function (performed by the reusable precision sensor) from the disposable marker portion. The reusable sensor maintains high measurement precision and tracking accuracy across multiple uses, while the disposable marker ensures contamination prevention. This segmentation allows both requirements to be satisfied simultaneously.
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 reduces costs per procedure by allowing the expensive sensor to be reused and enables precise image registration across different imaging sessions, improving the efficiency and accuracy of medical procedures like biopsies and ablations.
Implementation Method 1
releasably securable attachment members (e.g., adhesive disks)
Implementation Method 2
The sensor also contains two or three orthogonal coils, which measure the strength of the signal from the current source coil
Data Source
AI summary
A device for use in an image-guided procedure on a patient is disclosed. The device includes an EM sensor assembly, a frame assembly (e.g., a base portion from which a plurality of legs project upward to a common point) and a plurality of attachment members. Each attachment member is arranged to be releasably (e.g., adhesively) secured to the skin of a patient and to be coupled to the frame assembly to secure the frame assembly on the skin of the patient. The EM sensor assembly is arranged to be releasably secured to the frame assembly (e.g., pivotably snap-fit into a socket in the frame assembly). The device additionally includes plural visualizable elements (e.g., metal balls) that are adapted to be readily imaged to establish imaging reference points and a plurality of asymmetrically disposed apertures to enable tattooing indicia on the skin of the patient through the apertures.