Portable TMS Headpiece with Image-Guided Positioning
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Solution Overview
Problem
Current TMS systems lack the necessary portability and functionality for patient-administered point-of-care (POC) treatment of neurologic or psychiatric disorders requiring repetitive transcranial magnetic stimulation (rTMS), and fail to address safety and regulatory requirements for conditions like major depressive disorder (MDD).
Innovation Solution
A system comprising a prescribing subsystem and a treatment subsystem, where the treatment subsystem includes a headpiece with a secure magnetic coil configuration and image recording device to ensure proper positioning and subject verification, enabling operation based on stored stimulation parameters and image data, allowing for portable and safe administration of rTMS therapy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If TMS systems are made portable for point-of-care treatment, then ease of operation and accessibility are improved, but reliability and safety control deteriorate
Solution Approach 1:
The system is divided into two separate subsystems: a prescribing subsystem that remains at the clinical facility and a treatment subsystem that can be transported to the patient's location. The prescribing subsystem performs comprehensive safety evaluations and generates treatment protocols, while the treatment subsystem executes these protocols with built-in safety constraints. This segmentation allows the treatment device to be portable while safety-critical functions remain under controlled environment supervision.
Solution Approach 2:
A communication interface and data transmission system act as an intermediary between the prescribing subsystem and treatment subsystem. The prescribing subsystem sends authenticated treatment parameters, patient data, and safety constraints to the treatment subsystem, which cannot operate without receiving valid instructions from the prescribing subsystem. This intermediary mechanism ensures that portability does not compromise safety control.
2Ease of operation
If TMS systems are simplified for patient administration, then ease of operation is improved, but measurement precision and positioning accuracy deteriorate
Solution Approach 1:
The treatment subsystem incorporates automated functions that allow the patient to independently position and secure the headpiece using visual feedback from the image recording device. The system captures images to verify positioning accuracy and provides real-time guidance, enabling patients to achieve proper positioning without requiring clinician assistance during each treatment session.
Solution Approach 2:
The prescribing subsystem pre-configures optimal headpiece positioning parameters and treatment protocols based on comprehensive patient evaluation performed at the clinical facility. These pre-determined settings are transmitted to the treatment subsystem, which then guides the patient through positioning using stored reference images and positioning criteria, eliminating the need for complex real-time adjustments during patient-administered sessions.
3Reliability
If comprehensive safety monitoring is implemented, then reliability is improved, but device complexity increases
Solution Approach 1:
Safety monitoring functions are segmented between the prescribing subsystem and treatment subsystem. The prescribing subsystem handles comprehensive safety evaluations, patient assessments, and protocol development with full monitoring capabilities. The treatment subsystem implements streamlined safety checks and verification functions that reference pre-established safety parameters from the prescribing subsystem, distributing complexity across both subsystems rather than concentrating it all in one device.
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 effective, portable, and safe point-of-care TMS therapy for conditions like MDD by ensuring proper subject identification, headpiece positioning, and adherence to treatment protocols, addressing the limitations of existing systems in terms of portability and regulatory compliance.
Implementation Method 1
the stimulator delivers electric pulses to the magnetic coil, which induces a changing magnetic field
Implementation Method 2
The magnetic field causes an electric current to be induced in the target region of the brain, resulting in stimulation of the corresponding neurological tissue
Data Source
AI summary
A magnetic stimulation system may include a prescription system and a treatment system. The prescription system may include a first processor configured to determine stimulation parameter data for a subject. The treatment system may include a stimulator, a headpiece, a coil mounted to the headpiece body, an image recording device, and a second processor configured to: receive first image data for one or more first images of the subject and headpiece; receive, from the image recording device, second image data for one or more second images of the subject and headpiece; determine, using the first and second image data, that the headpiece is at a pre-determined position relative to a target anatomy of the subject.