Technological and Clinical Evidence of Effectiveness

Physics and Clinical Evidence of BioElectronics V10

Electro-therapy has been used for decades to reduce pain and swelling following injury.  The clinical evidence of its efficacy is overwhelming.   Now the science is catching up with the clinical evidence and we are reaching a better understanding of electro-therapy’s mechanism of action and learning that very low power levels, when used chronically, can produce equivalent results to the high power, transient treatments associated with cumbersome traditional machines.

Lower power levels allow us to pack the power of electro-therapy into a wearable, affordable patch. ActiPatch® Therapy eliminates major barriers for patients considering plastic surgery by reducing the long recovery time caused by the swelling and bruising of the incision.

How Skin Cells React to Incisions – Every incision is a wound that stimulates the body’s natural responses to prevent an infection.  This response, inflammatory process, consists of a rapid onset tissue destruction phase followed by a longer duration tissue repair phase.   It is during this initial destruction phase that the patient experiences redness, heat, swelling, and pain in the tissue.  These characteristics of inflammation result from injured cells releasing agents such as nitric oxide (NO), which leads to the rapid dilation of blood vessels in the immediate vicinity of the injury and increased leakiness of these vessels.  This rapid response permits fluid and protein to flow into the region (edema), resulting in a disruption of communication among the cells of the tissue.

Under infectious conditions, tissue edema serves to disconnect the cells within the tissue thereby preventing the spread of infection. In the case of non-infected trauma or aseptic surgical procedures, inflammatory responses cause discomfort and pain without contributing to the healing process.   In fact, for surgical wounds, inflammation is usually more damaging than helpful.

How ActiPatch Therapy Restores Tissues – ActiPatch Therapy  is directed towards re-establishing cell communication, and suppressing the vasodilatory response.  Tissues are composed of cell networks in which cell-cell communication relies extensively on cell-cell proximity. In edematous tissues, cell-cell communication is greatly reduced resulting in poor coordination and delayed healing.  In the absence of normal cell contact, ActiPatch Therapy can be used as a coordinating signal to synchronize the activity of the cells within a tissue, thereby returning tissues to normal function in a shorter period of time¹.

The therapeutic goal is to induce the tissue to rapidly pass through, or bypass, the tissue-damaging phase of the inflammatory process and move to the mode of tissue repair.

How electro-healing operates — ActiPatch Therapy uses a modulated radio frequency (RF) electromagnetic field to induce an extremely low frequency electric field into the body tissue.  Because ActiPatch Therapy is placed right on the skin, we are able to use a lower energy field than traditional diathermy machines.  A 27 MHz field, similar to that used in diathermy, permits non-invasive transmission of the treatment into the tissue, and treatment penetration to a depth greater than 1 cm.

The 1 KHz modulation (pulsation) constitutes the physiologically active component of the signal²³. It is the pulsing or modulation component of the therapy, which exerts the electromechanical force on the cell population.  Recent measurements indicate that less than 1 % of the treatment energy is responsible for cell synchronization.  The magnitude of the induced 1 KHz electric field in the tissue during ActiPatch Therapy treatment is on the order of 100 µV/cm.  The area of effective treatment of an ActiPatch device mirrors the size and shape of the area of the patch and antenna.

The primary cause of pain in post-surgical recovery is the swelling of the tissues caused by the inflammation phase.  Swelling mechanically disrupts nerve endings producing acute pain, and also results in the cellular secretion of pain producing substances, which result in chronic pain in the inflamed region. By truncating the inflammation phase through its cellular influence on vasodilatory agents such as nitric oxide⁴⁵, induced electric fields reduce the swelling, and significantly reduces pain.

Forms of Cell Communication –The action of ActiPatch Therapy applies an induced current across the cells.  This restores the cell communication in three ways:

Cell Contact Communication — The electro-mechanical force produced by the induced current mechanically perturbs, in unison, the cells of the tissue, mimicking the behavior of cells in uninjured tissue, which are in cell-cell contact.

Gap Junctional Communication — The space between cells increases during the inflammation stage inhibiting normal gap junctional communication, which permits chemical ion communication between cells.  The induced current of ActiPatch Therapy produces transmembrane potentials in the cells, which serve to synchronize ion channel opening, mimicking aspects of intercellular gap junctions.

Synaptic/Chemical Communication — Injury and edema sensitize the surrounding tissue to pain, with cells of the injured tissue secreting pain producing substances (PPS), which interact with peripheral nerves.  ActiPatch Therapy stabilizes the cells in the injured region, reducing their production of PPS, leading to a rapid decrease in pain.