Compressible device

• US 9,042,987 B2
• Filed: 08/12/2013
• Issued: 05/26/2015
• Est. Priority Date: 11/24/2005
• Status: Active Grant

• Current Assignee: Femeda Limited
• Original Assignee: Femeda Limited
• Inventors: Boyd, Graham Peter, Gregson, Ian, Herbert, Julia Heather, French, Edward Michael
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US13/964,825
• Publication Number:
  US 20140200646A1
• Time in Patent Office: 652 Days
• Field of Search: 607/41, 607115-116, 607/138, 607/148, 600/373
• US Class Current: 607/41
• CPC Class Codes: A61N 1/0512 Anal electrodes
• CPC Class Codes: A61N 1/0524 Vaginal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

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

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 and the control means are not alterable by a user of the device.

2. 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.

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

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

5. 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.

6. 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.

7. 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 is not freely rotated about that axis when in-situ.

8. The device of claim 7, 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.

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

10. 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.

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

12. 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.

13. 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.

14. 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.

15. The device of claim 14, wherein the waveform characteristics of the electrical stimulation signal are not alterable by the user, the waveform being pre-determined and pre-programmed.

16. 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.

17. A method as claimed in claim 16 wherein the stimulation is for the treatment of anterior and posterior pelvic floor muscle dysfunction.

18. A method as claimed in claim 16, wherein the device is utilized with an applicator.

19. 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.

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