Disposable Insulating Shield for Capacitive RF Electrodes
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Solution Overview
Problem
Capacitive radiofrequency delivery devices face safety issues due to potential skin burns from electrode integrity failures, cytotoxic insulation materials, and contamination risks, limiting their application to intact skin and preventing treatment of damaged tissues like ulcers and sores.
Innovation Solution
A non-cytotoxic, ISO 10993-certified protective insulating shield is interposed between the insulated electrode and the skin to restore integrity and prevent contamination, allowing safe capacitive RF delivery on non-intact skin, made from materials like PVC or POM, and designed as a cap or membrane to ensure effective electrical insulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an insulated electrode is used for capacitive RF delivery, then skin regeneration is achieved, but safety risks arise from potential insulator fractures and direct RF discharge
Solution Approach 1:
A protective insulating shield made of non-cytotoxic dielectric material is introduced as an intermediary layer between the insulated electrode and the skin. This shield prevents direct contact and potential RF discharge while maintaining the capacitive coupling effect, thereby eliminating skin burn risks without compromising the regenerative action.
Solution Approach 2:
The protective insulating shield serves as a pre-established protective barrier that prevents harmful effects before they can occur. By placing this shield beforehand, the system proactively prevents insulator fractures from causing direct RF discharge and skin burns, rather than relying on post-failure responses.
2Reliability
If conventional insulation materials are used on the electrode, then electrical insulation is provided, but cytotoxicity risks arise
Solution Approach 1:
The material properties of the insulating shield are specifically selected to change the safety parameters of the system. The shield is made from non-cytotoxic dielectric materials with appropriate electrical resistance properties, transforming the electrode system from potentially harmful to safe for prolonged skin contact while maintaining electrical insulation functionality.
3Productivity
If the same insulated electrode is reused across multiple patients, then device availability is maintained, but contamination risks increase
Solution Approach 1:
The electrode system is segmented into two distinct components: a reusable insulated electrode core and a disposable protective insulating shield. The shield can be sterilized or replaced between patients, allowing the expensive electrode core to be reused while maintaining hygiene standards and preventing cross-contamination.
Solution Approach 2:
The protective insulating shield is designed as a disposable component that can be sterilized or replaced between patients. This disposable element protects the reusable electrode core from contamination while maintaining device availability, as the shield is inexpensive compared to the electrode core and can be readily replaced.
4Adaptability or versatility
If capacitive RF is applied to non-intact skin, then treatment of ulcers and sores becomes possible, but direct RF discharge and skin damage risks increase
Solution Approach 1:
The protective insulating shield acts as a mediator that enables safe application of capacitive RF to non-intact skin. By providing a consistent insulating layer between the electrode and compromised skin, the shield prevents direct RF discharge while allowing the capacitive coupling effect to stimulate tissue regeneration in ulcers and sores.
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 shield enhances safety and efficacy by enabling capacitive RF treatment on previously inaccessible tissues, such as ulcers, by maintaining non-cytotoxicity and preventing contamination, while ensuring effective electrical insulation and preventing skin damage.
Implementation Method 1
the high resistance stratum corneum is the insulator
Implementation Method 2
an insulating protective shield made of a non-cytotoxic dielectric material
Implementation Method 3
activates ion exchange in relation to the electrical charge present inside the insulated electrode
Implementation Method 4
capacitive radiofrequency performs said regenerative action by applying an action similar the that of a capacitor to the skin
Implementation Method 5
Capacitive radiofrequency (RF) is known in the state of the art for its ability to regenerate skin
Data Source
AI summary
A disposable device designed to enhance the safety of capacitive radiofrequency therapies is described that is able to prevent risks arising from lesions present on the dielectric surface of the insulated electrode or on the stratum corneum of the skin, as well as risks arising from the use of technologies placed on the market before the certification of non-cytotoxicity of the parts applied to the patient (ISO 10993: 2018) was required, as well as the risks of contamination of parts applied in therapies previously performed on other patients.