RF Electrode Assembly for Meibomian Gland Heating

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Solution Overview

Problem

Current treatments for evaporative dry eye associated with Meibomian Gland Dysfunction (MGD) are either expensive, inefficient, or unable to raise gland temperature to the required levels, and existing technologies do not address periorbital skin laxity effectively.

Innovation Solution

A radiofrequency (RF) electrode assembly is used to deliver RF energy to the skin around the eye, stimulating nerve tissue and heating it to 42-45°C to improve Meibomian gland function and reduce periorbital skin laxity, with a temperature measuring feature to monitor and regulate temperature and a protective element for good contact.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Temperature

If superficial heat delivery methods (masks, hot washcloths) are used, then the treatment is simple and inexpensive, but the gland temperature cannot reach required levels

Engineering Contradiction:
Improvegland temperatureVSAvoidtreatment method complexity
Core Design Contradiction:
TemperatureVSDevice complexity

Solution Approach 1:

The patent replaces conventional mechanical heat delivery methods (hot packs, washcloths) with radiofrequency electromagnetic energy delivery. The RF electrode assembly delivers RF energy that penetrates tissue to heat the meibomian glands directly, achieving therapeutic temperatures (40-43°C) that superficial methods cannot reach.

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

Solution Approach 2:

The patent introduces an RF electrode assembly as an intermediary device that bridges the gap between external heat sources and internal gland tissue. The electrode assembly with its specific configuration (contact element, spacer, conductive material) serves as a mediator to deliver energy efficiently to the target glands while maintaining safety.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Use of energy by moving object

If transcutaneous heat delivery (MiBo ThermoFlo) is used, then the treatment is simpler than transconjunctival methods, but heat delivery efficiency to meibomian lipids is reduced

Engineering Contradiction:
Improveheat delivery efficiencyVSAvoidheating method complexity
Core Design Contradiction:
Use of energy by moving objectVSDevice complexity

Solution Approach 1:

The patent applies local quality by positioning the RF electrode assembly to deliver energy specifically to the meibomian gland region. The electrode can be positioned externally or internally (transconjunctivally) to target the glands precisely, ensuring localized heating of the meibomian lipids while minimizing heat diffusion to surrounding tissues.

Inventive Principle:
Principle #3Local quality

3Reliability

If LipiFlow treatment is used, then effective heating and massaging is achieved, but treatment cost is high and the unit is not intended for reuse

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidtreatment cost
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The RF electrode assembly is designed as a multi-functional device that can deliver both thermal energy (heating) and mechanical energy (massaging/vibration) to the meibomian glands. This combination replicates the dual-action effectiveness of LipiFlow while using a simpler, potentially reusable RF-based platform that may reduce overall treatment costs.

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

Solution Approach 2:

The patent changes the energy delivery parameter from conventional thermal conduction (hot packs) to radiofrequency electromagnetic energy. This parameter change enables deeper tissue penetration and more efficient heating of the meibomian glands, achieving therapeutic效果 with potentially lower overall energy consumption and treatment cost.

Inventive Principle:
Principle #35Parameter changes

4Ease of operation

If RF energy is applied to stimulate nerve tissue, then Meibomian gland function improves, but risk of nerve tissue damage increases if temperature is not controlled

Engineering Contradiction:
Improvegland stimulation effectivenessVSAvoidnerve tissue damage risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent incorporates temperature monitoring and control mechanisms to provide feedback during RF energy delivery. Temperature sensors monitor the tissue temperature in real-time, and the RF energy delivery is adjusted or terminated based on temperature thresholds to prevent nerve tissue damage while maintaining effective stimulation of the meibomian glands.

Inventive Principle:
Principle #23Feedback

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 RF energy treatment effectively stimulates Meibomian gland secretion, improves evaporative dry eye symptoms, and reduces periorbital skin laxity, demonstrating significant improvements in dry eye symptoms and ocular surface health without the need for direct application to the eyelid.

Implementation Method 1

The ThermiEye system delivers radiofrequency energy deep into the skin causing heat to build up where the skin and fat layer meet

Methodology Applied
Scientific EffectResistive heating: Joule Heating

Implementation Method 2

the electrode coupled to the treatment tip is configured to transfer radiofrequency energy to the skin surrounding the eye in such a way that nerve tissue is stimulated and/or strengthened around the eye

Methodology Applied
Scientific EffectElectromagnetic energy conversion: Electromagnetic Induction

Data Source

PatentUS10695219B2Apparatus and method for treatment of dry eye using radio frequency heating
Publication Date: 2020.06.30 THERMIGEN LLC
  • US10695219B2 patent drawing
  • US10695219B2 patent drawing
  • US10695219B2 patent drawing

AI summary

The present disclosure is related to a treatment probe and method for treating dry eye. The treatment probe may include a thin stainless steel tip, a spacer to ensure proper contact and protect the skin of a patient, a sensor to provide temperature feedback to the power supply providing RF energy to the treatment probe. The treatment focuses on a patient's temple and periorbital area.