Biofeedback device for an incontinent person

• US 6,266,557 B1
• Filed: 06/29/1999
• Issued: 07/24/2001
• Est. Priority Date: 06/29/1998
• Status: Expired due to Fees

• Current Assignee: The Procter & Gamble Company
• Original Assignee: The Procter & Gamble Company
• Inventors: Roe, Donald C., Coles, Peter
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/342,289
• Time in Patent Office: 756 Days
• Field of Search: 607/40, 607/41, 607/139, 600/29, 600/30, 600/546, 600/595, 600/587, 604/361, 128/905
• US Class Current: 600/546
• CPC Class Codes: A61F 13/42 with wetness indicator or alarm
• CPC Class Codes: A61F 13/495 with faecal cavity
• CPC Class Codes: A61F 13/82 with means for attaching to the body
• CPC Class Codes: A61F 2013/8473 for diagnostic purposes
• CPC Class Codes: A61F 2013/8479 including electric or magnetic devices
• CPC Class Codes: A61L 15/18 containing inorganic materials
• CPC Class Codes: A61L 15/20 containing organic materials
• CPC Class Codes: A61L 15/24 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof A61L15/225 takes precedence
• CPC Class Codes: A61L 15/26 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof A61L15/225 takes precedence
• CPC Class Codes: A61L 15/56 Wetness-indicators or colourants
• CPC Class Codes: G01N 33/5308 for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites
• CPC Class Codes: Y10S 128/905 Feedback to patient of biological signal other than brain electric signal

Abstract

A biofeedback device for predicting an impending elimination of bodily waste in an incontinent person includes a sensing element in contact with an area of a user so as to detect electrical activity of a sphincter muscle associated therewith and a signaling element operatively connected to the sensing element that provides a signal upon an occurrence of a predetermined electrical activity for the sphincter muscle. The biofeedback device is able to predict an impending elimination of bodily waste for an incontinent person, as well as assist the incontinent person in achieving a contraction of his/her sphincter muscle.

Claims

1. A biofeedback device for signaling an impending elimination of bodily waste, the biofeedback device comprising:

a) a sensing element adapted to be in contact with a body so as to detect an electrical activity of a sphincter muscle surrounding a bodily opening;

the sensing element comprising a receiving unit adapted to;

(i) establish a basal electrical activity for the sphincter muscle by monitoring the electrical activity over a specified time period;

(ii) identify a correlation between a change in the basal electrical activity and an impending elimination of bodily waste, the change constituting a specified electrical activity;

(iii) determine whether the specified electrical activity recurs during continued monitoring; and

b) a signaling element operatively connected to the receiving unit, the signaling element adapted to provide a signal upon the determination by the receiving unit that the specified electrical activity has recurred.

2. The biofeedback device of claim 1, wherein said sensing element is able to detect electrical activity of said sphincter muscle in a frequency range of approximately 5 Hertz to approximately 500 Hertz.

3. The biofeedback device of claim 1, said sensing element further comprising an electrode adapted to be positioned on the skin of said body adjacent said sphincter muscle, the receiving unit operatively connected to said electrode, said receiving unit being configured to receive signals from said electrode corresponding to electrical activity of said sphincter muscle.

4. The biofeedback device of claim 1, wherein said specified electrical activity is preset within said receiving unit.

5. The biofeedback device of claim 1, wherein said specified electrical activity is programmed within said receiving unit.

6. The biofeedback device of claim 1, wherein said specified electrical activity is stored within said receiving unit as a function of the basal electrical activity for said sphincter muscle.

7. The biofeedback device of claim 1, said specified electrical activity of said sphincter muscle being equivalent to an increase of the basal electrical activity of said sphincter muscle in a range of at least about 2-5 times.

8. The biofeedback device of claim 1, said specified electrical activity of said sphincter muscle being equivalent to a decrease of the basal electrical activity of said sphincter muscle in a range of at least about 50-95%.

9. The biofeedback device of claim 1, said specified electrical activity of said sphincter muscle being equivalent to the electrical activity having a designated electrical level in a range of at least about 200-600 microvolts.

10. The biofeedback device of claim 1, said specified electrical activity of said sphincter muscle being equivalent to the electrical activity having a designated electrical level for a time period in a range of at least about 1-5 seconds.

11. The biofeedback device of claim 1, wherein said sensing element is adapted to be in contact with a perianal area of said body to detect electrical activity of an external anal sphincter muscle.

12. The biofeedback device of claim 1, wherein said sensing element is adapted to be in contact with a urethral area of said body to detect electrical activity of an external urethral sphincter muscle.

13. The biofeedback device of claim 1, said signaling element providing at least one of the following upon occurrence of said specified electrical activity for said sphincter muscle:

a visual signal, an aural signal, and a tactile signal.

14. The biofeedback device of claim 1, wherein the signal provided by said signaling element increases and decreases in intensity as said sphincter muscle increases and decreases, respectively, in electrical activity.

15. The biofeedback device of claim 1 further comprising a conductive element directly connecting said signaling element and said sensing element.

16. The biofeedback device of claim 1, said signaling element being separate from the receiving unit of said sensing element.

17. The biofeedback device of claim 16, said sensing element further comprising a transmitter and said signaling element further comprising a receiver so that said sensing element is able to telemetrically communicate with said signaling element.

18. The biofeedback device of claim 1, wherein the biofeedback device is used in an environment having an article of clothing, a piece of furniture, or a table, wherein said signaling element is adapted to be attached to or carried on the article of clothing, adapted to be attached to or set on the piece of furniture, or is adapted to be set on the table.

19. A method of predicting an impending elimination of bodily waste in a person, comprising the following steps:

a) identifying a specified electrical activity for a sphincter muscle of said person correlating to a contraction thereof;

b) monitoring electrical activity of said sphincter muscle;

c) determining whether said specified electrical activity occurs for said sphincter muscle; and

d) predicting the impending elimination of bodily waste based on the determination.

20. The method of claim 19, wherein said specified electrical activity is equivalent to the electrical activity having a designated electrical level in a range of at least about 200-600 microvolts.

21. The method of claim 19, wherein said specified electrical activity is equivalent to the electrical activity having a designated electrical level for a time period in a range of at least about 1-5 seconds.

22. The method of claim 19, said identifying step further comprising:

a) sensing electrical activity of said sphincter muscle for a specified time period;

b) establishing a basal electrical activity for said sphincter muscle;

c) identifying changes in said basal electrical activity for said sphincter muscle correlating to said contraction of said sphincter muscle.

23. The method of claim 22, wherein said specified electrical activity corresponds to an increase in the basal electrical activity of said sphincter muscle in a range of at least 2-5 times.

24. The method of claim 22, wherein said specified electrical activity corresponds to a decrease in a range of at least about 50-95% of said basal electrical activity for said sphincter muscle.

25. The method of claim 22, wherein said sensing step occurs at a perianal area of said person to detect electrical activity of an external anal sphincter muscle.

26. The method of claim 22, wherein said sensing step occurs at a urethral area of said person to detect electrical activity of an external urethral sphincter muscle.

27. The method of claim 19, further comprising the step of providing a signal upon the occurrence of said prediction of the impending elimination of bodily waste.

28. The method of claim 27, wherein the signal provided upon the occurrence of said prediction of the impending elimination of bodily waste is at least one of the following:

a visual signal, an aural signal, and a tactile signal.

29. The method of claim 28, wherein the signal provided upon the occurrence of said prediction of the impending elimination of bodily waste increases and decreases in intensity as said sphincter muscle increases and decreases, respectively, in electrical activity.

30. The method of claim 28, wherein the signal provided upon the occurrence of said prediction of the impending elimination of bodily waste is provided at a location remote from said person.