Patent No. US11878167 (titled "Device And Method For Unattended Treatment Of A Patient") was filed by Btl Healthcare Technologies As on May 19, 2022.
’167 is related to the field of non-invasive cosmetic treatment devices, specifically those that use electromagnetic energy, such as radiofrequency (RF) energy , and electrical stimulation to rejuvenate skin and underlying tissue. The background acknowledges the limitations of manual energy delivery, which can lead to inconsistent results and potential risks like burns, especially on uneven areas like the face. Existing solutions, like LED masks, offer safety but lack the thermal effects needed for effective rejuvenation.
The underlying idea behind ’167 is to provide a device that can deliver both RF energy for heating and electrical stimulation for muscle contraction in a controlled, unattended manner, even on uneven surfaces. The key inventive insight is to use a flexible pad with embedded active elements (electrodes) that can conform to the patient's body, ensuring consistent contact and energy delivery. This allows for homogeneous treatment without manual manipulation, improving reproducibility and safety.
The claims of ’167 focus on a device comprising a first generator for electromagnetic energy, a second generator for electric current, and a pad with a flexible substrate. The independent claims specify that the pad has a surface area between 0.1 cm² and 150 cm² and is configured to attach to a body part. The pad includes an electrode with a surface area between 1 cm² and 25 cm², coupled to both generators via a conductive lead. The control unit manages both generators, enabling the electrode to heat the skin and stimulate muscle contractions.
In practice, the device uses a flexible pad, often with an adhesive layer, to maintain contact with the skin. The pad contains multiple electrodes that can deliver RF energy to heat the tissue and electric current to stimulate muscle contractions. Thermal sensors monitor the temperature, and the control unit adjusts the energy output to prevent overheating. The device can switch between different electrodes or groups of electrodes to ensure even energy distribution across the treatment area. The flexible nature of the pad allows it to conform to uneven surfaces like the face, ensuring consistent contact.
’167 differentiates itself from prior approaches by combining RF heating and electrical stimulation in a single, unattended device. Unlike manual RF devices, it offers consistent energy delivery and reduces the risk of operator error. Unlike low-energy LED masks, it provides therapeutic thermal effects. The flexible pad design addresses the challenge of treating uneven surfaces, making it suitable for facial rejuvenation. The device also incorporates safety features like thermal sensors and impedance monitoring to prevent burns and ensure proper contact, enhancing both efficacy and safety compared to existing solutions.
In the early 2020s when ’167 was filed, electromagnetic energy was commonly delivered for cosmetic procedures such as skin rejuvenation and wrinkle removal, at a time when manually controlled radiofrequency or light devices were typically used for facial tissue heating, while unattended LED facial masks were based on phototherapy rather than thermal effects. Ensuring homogeneous energy distribution was non-trivial when treating uneven areas, and maintaining consistent contact between the energy generator and the tissue was challenging.
The application was subject to a non-final office action. Claims were rejected under 35 U.S.C. 102 and 103. The applicant's arguments were found persuasive regarding election/restrictions, leading to the withdrawal of a restriction requirement. Claims 5-6, 8-10, 12-18, 21-25, and 27-31 were objected to as being dependent upon a rejected base claim. The prosecution record describes claim changes and technical reasoning that led to the rejections.
This patent includes 30 claims, with independent claims numbered 1, 10, 18, and 25. The independent claims generally focus on devices for patient treatment using a combination of electromagnetic energy or radiofrequency energy and electric current delivered through a pad with electrodes. The dependent claims elaborate on specific features, materials, dimensions, and configurations of the device components, such as the adhesive, electrodes, and substrate.
Definitions of key terms used in the patent claims.
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