# US 9,358,383 B2 · Self contained device with treatment cycle for electrostimulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,358,383 B2 - Document ID: US9358383B2 - Status: Granted - Kind: B2 - Application number: 12/094,941 - Filed: 2006-11-24 - Published: 2009-09-03 - Granted: 2016-06-07 - Earliest claimed: 2005-11-24 - Assignees: Femeda Ltd - Applicants: Graham Peter Boyd; Ian Gregson; Julia Heather Herbert - Inventors: Graham Peter Boyd; Ian Gregson; Julia Heather Herbert - Web page: https://patentgrep.com/patent/US9358383B2 ## CPC - A61N 1/0524: {Vaginal electrodes} - A61N 1/0512: {Anal electrodes} - A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control} - A61N 1/0521: {Genital electrodes} - A61N 1/3605: {Implantable neurostimulators for stimulating central or peripheral nerve system} - A61N 1/36053: {adapted for vagal stimulation (A61N1/36114 takes precedence)} - A61N 1/36146: {specified by the stimulation parameters} - A61N 1/36167: {Timing, e.g. stimulation onset} - A61N 1/36171: {Frequency} - A61N 1/36175: {Pulse width or duty cycle} - A61N 1/36178: {Burst or pulse train parameters} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract 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. ## Claims ### Claim 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. ### Claim 2 (depends on 1) An electro-stimulation device as claimed in claim 1 wherein the waveform used comprises two or more components each component being a train of regularly spaced pulses and each component having different pulse repetition frequencies. ### Claim 3 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein the second component is combined with the first component but the second component has spacing between successive pulses that is less than the spacing between successive pulses in the first component. ### Claim 4 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein there is a third component being a train of regularly spaced pulses and the third component having a different pulse repetition frequency that has spacing between successive pulses that is less than the spacing between successive pulses in the second component. ### Claim 5 (depends on 4) An electro-stimulation device as claimed in claim 4 wherein the third component has a pulse repetition frequency between 80 and 300 Hz. ### Claim 6 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein there are periods of relaxation between sets of pulse trains. ### Claim 7 (depends on 6) An electro-stimulation device as claimed in claim 6 wherein the periods of relaxation are equal to or greater than the periods of stimulation. ### Claim 8 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein the treatment cycle is 3 hours or less. ### Claim 9 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein the treatment cycle is 2 hours or less. ### Claim 10 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein the treatment cycle is 1 hour or less. ### Claim 11 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein the treatment cycle is less than 1 hour. ### Claim 12 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein the treatment cycle is 45 minutes or less. ### Claim 13 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein the first component has a pulse repetition frequency between 1 and 15 Hz. ### Claim 14 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein the second component has a pulse repetition frequency between 30 and 60 Hz. ### Claim 15 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein the pulses have a pulse width of 50 to 350 microseconds. ### Claim 16 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein the pulse width is varied during use of the device. ### Claim 17 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein the amplitude of the pulses for each component is of the same magnitude. ### Claim 18 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein the amplitude of the pulses for each component is of different magnitude. ### Claim 19 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein the pulse amplitude for one or more of the components is varied at one or more points in time throughout the treatment cycle. ### Claim 20 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein at least one component consists of a series of pulses of pulse width 150 to 350 microseconds at a maximum voltage of 60 volts, and between each sequence of pulses there is a period of rest of between 5 to 10 seconds. ### Claim 21 (depends on 2) An electro-stimulation device as claimed in claim 2 wherein the current is applied regulated and increased throughout a treatment period. ### Claim 22 (depends on 1) A device as claimed in claim 1 in which the circuitry incorporates a delay after activation to ensure that the electrode surfaces are in place before the treatment cycle commences. ### Claim 23 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 two or more components each component being a train of regularly spaced pulses and each component having different pulse repetition frequencies. ### Claim 24 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein the second component is combined with the first component but the second component has spacing between successive pulses that is less than the spacing between successive pulses in the first component. ### Claim 25 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein there is a third component being a train of regularly spaced pulses and the third component having a different pulse repetition frequency that has spacing between successive pulses that is less than the spacing between successive pulses in the second component. ### Claim 26 (depends on 6) An electro-stimulation device as claimed in claim 6 wherein the third component has a pulse repetition frequency between 80 and 300 Hz. ### Claim 27 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein there are periods of relaxation between sets of pulse trains. ### Claim 28 (depends on 27) An electro-stimulation device as claimed in claim 27 wherein the periods of relaxation are equal to or greater than the periods of stimulation. ### Claim 29 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein the treatment cycle is 3 hours or less. ### Claim 30 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein the treatment cycle is 2 hours or less. ### Claim 31 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein the treatment cycle is 1 hour or less. ### Claim 32 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein the treatment cycle is less than 1 hour. ### Claim 33 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein the treatment cycle is 45 minutes or less. ### Claim 34 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein the first component has a pulse repetition frequency between 1 and 15 Hz. ### Claim 35 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein the pulses have a pulse width of 50 to 350 microseconds. ### Claim 36 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein the pulse width is varied during use of the device. ### Claim 37 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein the amplitude of the pulses for each component is of the same magnitude. ### Claim 38 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein the amplitude of the pulses for each component is of different magnitude. ### Claim 39 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein the pulse amplitude for one or more of the components is varied at one or more points in time throughout the treatment cycle. ### Claim 40 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein at least one component consists of a series of pulses of pulse width 150 to 350 microseconds at a maximum voltage of 60 volts, and between each sequence of pulses there is a period of rest of between 5 to 10 seconds. ### Claim 41 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein the current is applied regulated and increased throughout a treatment period. ### Claim 42 (depends on 23) A device as claimed in claim 23 in which the circuitry incorporates a delay after activation to ensure that the electrode surfaces are in place before the treatment cycle commences. ### Claim 43 (depends on 23) An electro-stimulation device as claimed in claim 23 wherein the second component has a pulse repetition frequency between 30 and 60 Hz. ### Claim 44 (depends on 23) A method of stimulation of the musculature of the pelvic floor complex, which method comprises providing electro-stimulation to the musculature of the pelvic floor complex using a device according to claim 23. ### Claim 45 (depends on 44) A method as claimed in claim 44 wherein the stimulation is for the treatment for anterior and posterior pelvic floor muscle dysfunction. ### Claim 46 (depends on 44) A method as claimed in claim 44 wherein the device is utilized with an applicator. ### Claim 47 (depends on 1) A method of stimulation of the musculature of the pelvic floor complex, which method comprises providing electro-stimulation to the musculature of the pelvic floor complex using a device according to claim 1. ### Claim 48 (depends on 47) A method as claimed in claim 47 wherein the stimulation is for the treatment for anterior and posterior pelvic floor muscle dysfunction. ### Claim 49 (depends on 47) A method as claimed in claim 47 wherein the device is utilized with an applicator.