# US 2014/0200646 A1 · Compressible device

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- Number: US 2014/0200646 A1
- Document ID: US20140200646A1
- Status: Published application
- Kind: A1
- Application number: 13/964,825
- Filed: 2013-08-12
- Published: 2014-07-17
- Earliest claimed: 2005-11-24
- Assignees: Femeda Ltd
- Applicants: Femeda Ltd
- Inventors: Graham Peter Boyd; Ian Gregson; Julia Heather Herbert; Edward Michael French
- Web page: https://patentgrep.com/patent/US20140200646A1

## CPC

- A61N 1/3756: {Casings with electrodes thereon, e.g. leadless stimulators}
- A61N 1/0512: {Anal electrodes}
- A61N 1/0524: {Vaginal electrodes}
- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- 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 treatment of anterior and posterior pelvic floor muscle dysfunction is reversibly compressible and 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. In the compressed state the device may be of tampon proportions and after use may easily be removed. The device utilizes a compressible electrode component.

## Claims

### Claim 1

A self-contained vaginal or anal electro-stimulation device, which device comprises a body being reversibly compressible in at least one dimension and at least two electro-conductive elements located at or on an external surface of the body, an internal power source and internal means for the generation and control of electrical pulses for the neuromuscular electro-stimulation of the musculature of the pelvic floor complex via the electro-conductive elements and wherein the device is conformable during its use.

### Claim 2 (depends on 1)

A device as claimed in claim 1 wherein the dimensions of the device in its non-compressed form are such that, when the device is in-situ in the desired location in the vagina or anus, the external surface of the device and the electro-conductive elements located at or on the surface of the device body are in contact with one or more surfaces of the vagina or anus.

### Claim 3 (depends on 1)

The device of claim 1, wherein the body is manufactured from resiliently deformable/compressible material.

### Claim 4 (depends on 1)

The device of claim 1, wherein the body may be compressible due to a combination of the use of a resiliently deformable/compressible material for its manufacture and the nature of the device structure.

### Claim 5 (depends on 4)

The device of claim 4, wherein the body is manufactured from resiliently deformable/compressible material and the interior of the electro-stimulation device body is hollow.

### Claim 6 (depends on 1)

The device of claim 1, wherein the body of the device is moulded around the interior components of the electro-stimulation device to encapsulate them.

### Claim 7

(canceled)

### Claim 8 (depends on 1)

The device of claim 1, wherein the shape of the electro-stimulation device, when viewed in a cross-section taken perpendicular to the axis of insertion into the anus or vagina, is such that the electro-stimulation device may not be freely rotated about that axis when in-situ.

### Claim 9 (depends on 8)

The device of claim 8, wherein the shape of the electro-stimulation device when viewed in a cross-section taken perpendicular to the axis of insertion into the anus or vagina is non-circular.

### Claim 10

(canceled)

### Claim 11 (depends on 1)

The device of claim 1, wherein the electro-stimulation device may be compressed to relative dimensions that are different in proportion to the dimensions of the device in the non-compressed state.

### Claim 12 (depends on 1)

The device of claim 1, wherein the device has at least two dimensions perpendicular to the axis of insertion that have different degrees of compressibility.

### Claim at position 13

13-15. (canceled)

### Claim 16 (depends on 1)

The device of claim 1, wherein at least one of the dimensions of the electro-stimulation device perpendicular to the axis of insertion may be reduced on compression by at least 20%.

### Claim 17

(canceled)

### Claim 18 (depends on 1)

The device of claim 1, wherein the volume of the device in the compressed state is reduced by at least 20% compared to that in the non-compressed state.

### Claim at position 17

19-22. (canceled)

### Claim 23 (depends on 1)

A device for the electro-stimulation of the musculature of the pelvic floor complex which comprises an electro-stimulation device according to claim 1 in combination with an applicator comprising an outer member and an inner member, the electro-stimulation device being located within the outer member.

### Claim at position 19

24-28. (canceled)

### Claim 29 (depends on 1)

The device of claim 1, wherein the output from the circuitry is a pre-defined waveform that is used to provide neuromuscular electro-stimulation of the musculature of the pelvic floor complex.

### Claim 30 (depends on 29)

The device of claim 29, wherein the waveform characteristics of the electrical stimulation signal are not alterable by the user, the waveform being pre-determined and pre-programmed.

### Claim at position 22

31-54. (canceled)

### Claim 55 (depends on 1)

A method of stimulating 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 56 (depends on 55)

A method as claimed in claim 55 wherein the stimulation is for the treatment of anterior and posterior pelvic floor muscle dysfunction.

### Claim 57 (depends on 55)

A method as claimed in claim 55, wherein the device is utilized with an applicator.

### Claim 58 (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 59 (depends on 1)

A device as claimed in claim 1, wherein the electro-stimulation device comprises one-time activation/deactivation mechanisms associated with the internal components.

### Claim at position 28

60-62. (canceled)
