Female External Incontinence Device

• US 20110028922A1
• Filed: 07/31/2009
• Published: 02/03/2011
• Est. Priority Date: 07/31/2009
• Status: Abandoned Application

• Current Assignee: BioDerm Inc.
• Original Assignee: BioDerm Inc.
• Inventors: Babb, Steven J., Underwood, David W., Kay, Dennis M.
• Application Number:
  US12/533,343
• Publication Number:
  US 20110028922A1
• Time in Patent Office: Days
• US Class Current: 604/329
• CPC Class Codes: A61F 5/443 having adhesive seals for securing to the body, e.g. of hydrocolloid type, e.g. gels, starches, karaya gums adhesives or sealing pads therefor A61L24/00
• CPC Class Codes: A61F 5/455 for collecting urine or discharge from female member
• CPC Class Codes: A61F 5/4553 placed in the vagina, e.g. for catamenial use pessaries A61F6/08; absorbent cups A61F13/2045

Abstract

A female external incontinence device includes a housing formed of a soft, pliable, membranous, elastomeric material defining a flange for adhesive securement to the intralabial parameatal surface to create a parameatal seal around the urethral meatus, a urine collection channel and an outlet tube and an applicator having a tray component for holding the housing to facilitate securement of the housing to the intralabial parameatal surface.

Claims

1. A female external incontinence device comprising

a housing having a flange for attachment to tissue in the vaginal opening, a urine collection channel depending from said flange and an outlet tube communicating with said urine collection channel, said flange having a configuration to define a margin surrounding an elongated opening for alignment with the urethral meatus;

an intravaginal component extending from said flange at an angle to be inserted in the vagina; and

an adhesive layer carried on said flange margin for securing said housing in a sealing manner around the urethral meatus.

2. A female external incontinence device as recited in claim 1 wherein said outlet tube has a diametrical dimension and said housing includes a bulging formation disposed between, and communicating with, said urine collection channel and said outlet tube, said bulging formation having a diametrical dimension greater than the diametrical dimension of said outlet tube.

3. A female external incontinence device as recited in claim 1 wherein said tongue is formed of a flexible membrane, is connected with said flange and terminates at a distal end forming a pocket between layers of said flexible membrane to facilitate deployment of said housing and said intravaginal component.

4. A female external incontinence device as recited in claim 3 wherein said pocket is formed on an outer side of said intravaginal component and an adhesive layer is carried on an inner side of said intravaginal component opposite said outer side.

5. A female external incontinence device as recited in claim 1 wherein said housing is formed of a single piece of soft, membranous, flexible, pliable elastomeric material whereby said flange, said urine collection channel and said outlet tube are unitarily formed as a single part.

6. A female external incontinence device as recited in claim 5 wherein said soft, membranous, flexible, pliable elastomeric material has a durometer of Shore A 30 or less.

7. A female external incontinence device as recited in claim 6 wherein said housing has a longitudinal dimension and a lateral dimension and said flange has at least a partial lateral curvature about the longitudinal dimension in a resting state.

8. A female external incontinence device as recited in claim 7 wherein said curvature of said flange is formed by opposing lateral sides of said margin curving toward said urine collection channel.

9. A female external incontinence device as recited in claim 1 wherein said flange of said housing has a longitudinal dimension defining a midline for said housing and an anterior portion with a shape defining a fold line aligned with said midline whereby said housing is biased to collapse along said midline.

10. A female external incontinence device as recited in claim 9 wherein said urine collection channel has an inner surface adjacent said opening in said flange and protuberances extending from said inner surface to enhance urine flow.

11. A female external incontinence device as recited in claim 1 wherein said urine collection channel and said outlet tube have inner surfaces and protuberances extending from said inner surfaces to enhance urine flow.

12. A female external incontinence device as recited in claim 1 wherein said housing and said intravaginal component are formed of a single piece of soft, membranous, flexible, pliable elastomeric material whereby said flange, said urine collection channel, said outlet tube and said intravaginal component are unitarily formed as a single part.

13. A female external incontinence device comprising

a unitary housing made of an elastomer forming, as a single part, a flange for attachment to parameatal tissue in the vaginal opening,

a urine collection channel depending from said flange and an outlet tube communicating with said urine collection channel;

an intravaginal component extending from said flange at an angle to be inserted in the vagina; and

an applicator including a tray component supporting said housing and said intravaginal component and disposed under said flange.

14. A female external incontinence device as recited in claim 13 wherein said intravaginal component terminates at a distal end forming a pocket and said tray component of said applicator terminates posteriorly at a distal end received in said pocket to facilitate deployment of said housing.

15. A female external incontinence device as recited in claim 13 wherein said tray component includes a concavity receiving said urine collection channel and said outlet tube.

16. A female external incontinence device as recited in claim 13 wherein said applicator includes a retainer component disposed over said flange and detachably coupled with said tray component to sandwich said housing therebetween.

17. A female external incontinence device as recited in claim 16 wherein said flange has an outer surface carrying an adhesive layer for adhesive attachment of said housing to the intralabial parameatal surface surrounding the urethral meatus and further comprising a release film covering said adhesive layer of said flange and coupled with said retainer component of said applicator so as to be removed from said flange when said retainer component of said applicator is withdrawn.

18. A female external incontinence device as recited in claim 13 wherein said flange has an outer surface carrying an adhesive layer for adhesive attachment of said housing to the intralabial parameatal surface surrounding the urethral meatus and further comprising a release film covering said adhesive layer of said flange and removable for adhesive deployment of said housing.

19. A female external incontinence device as recited in claim 18 wherein said release film cooperates with said tray component to retain said housing on said tray component.

20. A female external incontinence device as recited in claim 13 wherein said flange has an outer surface carrying an adhesive layer for adhesive attachment of said housing to the intralabial parameatal surface surrounding the urethral meatus and further comprising a release film having a U-shape with a free end extending along said tray component such that said release film can be removed to expose said adhesive layer by pulling said free end.

21. A female external incontinence device as recited in claim 13 wherein said flange has an outer surface carrying an adhesive layer for adhesive attachment of said housing to the intralabial parameatal surface surrounding the urethral meatus and said intravaginal component has an outer surface carrying an adhesive layer for adhesive attachment of said housing to the anterior wall of the vagina and further comprising a release film covering said outer surface of said flange and said outer surface of said intravaginal component and coupled with said retainer component of said applicator so as to be removed from said flange and said intravaginal component when said retainer component of said applicator is withdrawn.

22. A female external incontinence device comprising

a housing made of soft, pliable, elastomeric, membranous material configured to define a flange having an opening therein with said opening having a longitudinal dimension greater than a width dimension of said opening to provide an elongated shape for surrounding the urethral meatus;

a urine collection channel communicating with said opening to collect urine exiting from the urethra;

an outlet tube communicating with said urine collection channel; and

an elastic layer of adhesive carried by said flange and surrounding said opening to contact tissue adjacent the urethral meatus to provide a urethral parameatal seal,

said housing and said layer of adhesive being sufficiently soft and pliable to be elastically compressed during use thereby permitting comfortable use of the female external incontinence device.

23. A female external incontinence device as recited in claim 22 wherein said housing has an inner wall surface carrying inwardly extending protuberances whereby when said housing is compressed during use said protuberances prevent said inner wall surface from occluding passage of urine through said housing.

24. A female external incontinence device as recited in claim 22 wherein said wine collection channel and said outlet tube have inner wall surfaces carrying inwardly extending protuberances whereby when said housing is compressed during use said protuberances prevent said inner wall surfaces from occluding passage of urine through said urine collection channel and said outlet tube.

25. A method of using a female external incontinence device comprises the steps of

providing a housing made of soft, pliable, membranous, elastomeric material formed to provide a flange for creating a seal surrounding the parameatal urethral meatus and to provide a urine collection channel;

providing an intravaginal component coupled with the housing;

inserting an applicator carrying the housing and the intravaginal component between the labia to spread the labia;

rotating the applicator to contact the anterior vaginal wall to spread and flatten the rugae in the introitus; and

removing the applicator leaving the housing in place.

26. The method of using a female external incontinence device as recited in claim 26 and further comprising the step of adhesively securing the flange to the intralabial surface to create the seal surrounding the parameatal urethral meatus.