Subcutaneous Transcranial FUS System for Chronic Neuromodulation

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Solution Overview

Problem

Current focused ultrasound (FUS) techniques for treating neurological disorders like major depression are limited by the need for external devices, repeated clinic visits for recalibration, and the resulting cost, time, and effort for patients, leading to non-compliance and practical challenges for depressed patients.

Innovation Solution

The development of a subcutaneous transcranial FUS system, where ultrasound transducers and sensors are implanted under the skin, allowing for accurate and effective treatment without the need for repeated recalibrations, enabling continuous and chronic neuromodulation and monitoring.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If external FUS devices are used with CT and MRI imaging for recalibration, then treatment accuracy is improved, but patient burden and treatment cost increase due to repeated clinic visits

Engineering Contradiction:
Improvetreatment accuracyVSAvoidpatient burden
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The system divides the recalibration process into two parts: initial calibration using CT/MRI imaging at the clinic, and subsequent use of onboard sensors for monitoring and adjustment. This segmentation allows the patient to complete the complex imaging portion once, then use simpler sensor-based monitoring at home, reducing repeated clinic visits while maintaining treatment accuracy.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Onboard sensors act as intermediaries between the external FUS device and the brain target. These sensors monitor acoustic properties and provide real-time feedback, enabling the system to compensate for skull and tissue variations without requiring repeated CT/MRI scans, thus reducing patient burden while preserving treatment precision.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If external FUS devices require repeated recalibration sessions, then treatment precision is maintained, but device complexity and operational difficulty increase

Engineering Contradiction:
Improvetreatment precisionVSAvoidoperational difficulty
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The system implements self-service through onboard sensors that automatically monitor acoustic properties and enable real-time compensation for tissue and skull variations. This automation eliminates the need for manual recalibration by operators, maintaining treatment precision while significantly reducing operational complexity and making the system easier to use.

Inventive Principle:
Principle #25Self-service

3Reliability

If FUS treatment requires repeated clinic visits, then treatment effectiveness is maintained through recalibration, but patient compliance decreases due to cost and time requirements

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidpatient compliance
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The system performs preliminary calibration using CT/MRI imaging during the initial clinic visit. After this one-time setup, the onboard sensors enable the system to maintain treatment effectiveness without requiring repeated complex recalibration sessions, making the treatment more adaptable to patient schedules and improving compliance.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system replaces the mechanical/imaging-based recalibration system (CT/MRI scans) with a sensor-based acoustic monitoring system. This substitution maintains treatment effectiveness through continuous acoustic property monitoring while eliminating the need for repeated expensive and time-consuming imaging sessions, thereby improving patient compliance.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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 approach provides a stable and effective means of delivering FUS therapy, reducing the burden on patients by eliminating the need for frequent clinic visits and allowing for remote treatment sessions, thereby improving compliance and treatment outcomes.

Implementation Method 1

Focused ultrasound (FUS) is a non-invasive brain stimulation technique with neuromodulation of specific brain circuits

Methodology Applied
Scientific EffectUltrasound: Ultrasound

Implementation Method 2

Ultrasound includes a pressure wave of frequencies above an audible range. As a propagating wave, ultrasound can penetrate biological tissues including a skull

Methodology Applied
Scientific EffectAcoustic wave propagation: Sound

Implementation Method 3

The human skull attenuates ultrasounds by a factor of 4.5 to 64 depending on the individual and skull segment. Hair, acoustic coupling to the head, and entrapped bubbles or air pockets results in severe and highly variable attenuation

Methodology Applied
Scientific EffectAcoustic attenuation: Acoustic Absorption

Data Source

PatentUS20250135238A1Subcutaneous transcranial focused ultrasound
Publication Date: 2025.05.01 BLACKROCK MICROSYST LLC
  • US20250135238A1 patent drawing
  • US20250135238A1 patent drawing
  • US20250135238A1 patent drawing

AI summary

Apparatuses, systems, and methods are disclosed for subcutaneous transcranial functional ultrasound technique. An example apparatus includes a substrate and a device configured to be disposed under skin. The device includes one or more transducers disposed on the substrate and provides a pressure wave that propagates a body part under the skin. The pressure wave has a fundamental frequency within a range approximately from 10 Hz to 10 GHz.