Patent No. US11679255 (titled "Device And Method For Unattended Treatment Of A Patient") was filed by Btl Healthcare Technologies As on Sep 9, 2022.
’255 is related to the field of aesthetic medical devices, specifically those used for skin rejuvenation, wrinkle removal, and body contouring. Traditional methods often rely on manual operation, leading to inconsistent results and potential risks like burns. Unattended devices exist, but struggle with uneven surfaces like the face, requiring consistent contact or distance. This patent addresses the need for a safe and reproducible unattended treatment for uneven areas, particularly the face, by combining electromagnetic energy and electrical stimulation.
The underlying idea behind ’255 is to use a flexible pad with embedded active elements (electrodes) that can conform to the contours of uneven body parts like the face. These elements deliver both radiofrequency energy for heating the tissue and pulsed electric current for muscle stimulation , allowing for unattended treatment. The flexible pad ensures good contact, while the combination of heating and muscle stimulation enhances visual appearance.
The claims of ’255 focus on a device comprising a flexible pad with an electrode, where the pad is configured to be attached to a body part of a patient during treatment, specifically the face, neck, or submentum. The electrode applies radiofrequency energy in the range of 400 kHz to 80 MHz to heat the skin to a temperature in the range of 37.5° C. to 65° C. The electrode also applies a pulsed electric current with a duration in the range of 0.1 μs to 10 s to cause electric muscle stimulation. A control unit manages both the radiofrequency energy and the pulsed electric current.
In practice, the flexible pad is adhesively attached to the patient's face or neck. The control unit then activates the electrodes, delivering radiofrequency energy to heat the skin and pulsed electric current to stimulate the underlying muscles. Thermal sensors within the pad provide feedback to the control unit, allowing it to adjust the energy delivery to maintain a safe and consistent temperature. The pulsed electric current causes muscle contractions, further enhancing the rejuvenating effect.
This approach differs from prior solutions by combining two treatment modalities (heating and muscle stimulation) in a single, flexible, unattended device. Existing devices often require manual operation or are not well-suited for uneven surfaces. The flexible pad ensures consistent contact, while the combination of radiofrequency and pulsed electric current provides a more comprehensive treatment for skin rejuvenation and muscle toning. The unattended nature of the device also reduces the risk of operator error and improves treatment reproducibility.
In the early 2020s when ’255 was filed, electromagnetic energy was commonly delivered for medical and cosmetic purposes at a time when systems typically relied on manual movement of a handheld device by an operator. At that time, unattended skin delivery systems were emerging, but maintaining consistent contact with uneven treatment areas remained non-trivial.
The application was subject to a restriction requirement, dividing the claims into three groups: a device for treatment, a device comprising a radiofrequency generator and pad, and a method of treating a patient. A provisional election was made without traverse to prosecute the first group of claims. Claims 1-15 were rejected under 35 U.S.C. 103. Claims 16-30 were withdrawn from consideration.
This patent contains 22 claims, with independent claims 1, 8, and 16. The independent claims are directed to a device for treating a patient using radiofrequency energy and pulsed electric current, involving a pad with an electrode and a control unit. The dependent claims generally specify further details and variations of the device, such as modulation of the pulsed electric current, inclusion of adhesives or sensors, preprogrammed treatment protocols, and specific body parts or muscles targeted.
Definitions of key terms used in the patent claims.
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