Self contained device with treatment cycle for electrostimulation

摘要

An electro-stimulation device for the stimulation of the musculature of the pelvic floor complex e.g. for the treatment of anterior and posterior pelvic floor muscle dysfunction is fully self-contained. The device requires no external power sources or control and may be inserted into the vagina or anus through the use of an applicator. The device uses a pre-programmed treatment cycle of stimulating pulses. The cycle comprises either a waveform with an initial phase where the current of the device is ramped from an initial level to a higher level, a second phase where the current is ramped from the higher level from the first phase to a second higher level and a third phase where the current is maintained at the second higher level, or a waveform comprising two or more components each component being a train of regularly spaced pulses or a combination of these two waveforms.

主权项

1. A self-contained vaginal or anal electro-stimulation device, which comprises a device body and at least two electrodes located at or on the external surface of the device body, components internal to the device body comprising an internal power source and internal microprocessor controlled circuitry to control the generation of electrical pulses for the neuromuscular electro- stimulation of the musculature of the pelvic floor complex via the device electrodes and a one-time device activation/deactivation mechanism within the body of the device, the internal controlling means within the device body being pre-programmed with an electro-stimulating treatment cycle waveform not alterable by the user, wherein the device does not include means for reprogramming the internal microprocessor controlled circuitry, and wherein the waveform comprises a series of ramps with an initial phase where the current is ramped from an initial level to a higher level, a second phase where the current is ramped from the higher level from the first phase to a second higher level and a third phase where the current is maintained at the second higher level.