Incontinence management system and diaper

• US 7,977,529 B2
• Filed: 05/02/2007
• Issued: 07/12/2011
• Est. Priority Date: 11/03/2004
• Status: Active Grant

• Current Assignee: Fred Bergman Healthcare Pty Ltd.
• Original Assignee: Fred Bergman Healthcare Pty Ltd.
• Inventors: Bergman, Frederick, Barda, David Albert, Guibert, Remi, Eitzen, Guy, Weinstock, Daniel, Rodda, Maria C.
• Primary Examiner(s): Zalukaeva; Tatyana
• Assistant Examiner(s): Chapman; Ginger T
• Application Number:
  US11/797,352
• Publication Number:
  US 20070270774A1
• Time in Patent Office: 1,532 Days
• Field of Search: 604/361, 604/385.01, 702/177, 702/180, 702/181, 702/188, 702/189, 703/11, 703/16, 703/17, 705/2, 705/3
• US Class Current: 604/361
• CPC Class Codes: A61F 13/42 with wetness indicator or alarm
• CPC Class Codes: A61F 13/505 with separable parts, e.g. combination of disposable and reusable parts, A61F13/20, A61F13/49003 take precedence; supporting or fastening means A61F13/56; belts or the like A61F13/64
• CPC Class Codes: A61F 2013/15121 for mild incontinence
• CPC Class Codes: A61F 2013/15146 for urine collection
• CPC Class Codes: A61F 2013/15154 for hospitalised patients
• CPC Class Codes: A61F 2013/425 being also a toilet training aid
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices

Abstract

An incontinence management system for monitoring wetness in one or more absorbent articles, includes input for receiving one or more sensor signals indicative of a presence of wetness in an absorbent article, processor for processing the one or more sensor signals and for performing an analysis of the signals to characterise wetness events occurring in an absorbent article and user interface for communicating with a user of the system. A mathematical model is used to characterise wetness events, receiving as inputs variables derived from sensor signals and optionally, patient and demographic data. The mathematical model can be configured and/or re-configured utilising observation data obtained while monitoring a patient for wetness. A diaper for use with such as system is also disclosed.

Claims

1. A moisture monitoring system for monitoring wetness in one or more absorbent articles, the system including:

an input for receiving one or more sensor signals indicative of a presence of wetness in an absorbent article;

a processor; and

user interface for communicating with a user of the system;

wherein the processor executes an algorithm to analyze the one or more sensor signals by applying the one or more received sensor signals to a pre-determined mathematical model to characterize a wetness event in an absorbent article; and

wherein the system has devised the pre-determined mathematical model using sensor signal data previously received by the system, the mathematical model representing a relationship between one or more variables obtainable from the received sensor signals and a characteristic used to characterise a wetness event.

2. A moisture monitoring system according to claim 1 wherein the processor executes the algorithm to characterise a wetness event in an absorbent article by determining one or more of:

(i) an estimated volume of exudate in a wetness event; and

(ii) the nature of exudate in a wetness event.

3. A moisture monitoring system according to claim 1 wherein the system uses the received sensor signals and/or variables derived from the received sensor signals to derive one or more parameters suitable for use in the mathematical model.

4. A moisture monitoring system according to claim 3 wherein the system applies variables derived from the one or more received sensor signals to optimize the mathematical model for characterizing a wetness event.

5. A moisture monitoring system according to claim 1 wherein the one or more sensor signals are indicative of one or more of:

(i) conductivity of the exudate;

(ii) temperature of the exudate;

(iii) location of the exudate;

(iv) pH of the exudate;

(v) pressure within the absorbent article;

(vi) odour within the absorbent article;

(vii) presence of a gas in the absorbent article;

(viii) presence of blood and/or a biological marker and/or a chemical marker in the exudate.

6. A moisture monitoring system according to claim 1 wherein variables derived from the sensor signals are selected from the group including:

(i) area under a sensor signal curve;

(ii) highest sensor signal value in a predetermined time period;

(iii) maximum value of a leading edge of the sensor signal;

(iv) rate of decay of sensor signal after a leading edge;

(v) a volume estimated in a previous wetness event;

(vi) time of onset of a wetness event;

(vii) time of termination of a wetness event; and

(viii) duration of a wetness event;

(ix) time of day of a wetness event; and

(x) time elapsed since last wetness event.

7. A moisture monitoring system according to claim 1 wherein the processor is configured to determine one or more of:

(a) a likelihood of an imminent wetness event;

(b) an estimate of when a wetness event is likely to occur;

(c) an estimate of a degree of fullness of an absorbent article; and

(d) an estimate of when an absorbent article is likely to reach its absorbent capacity.

8. A moisture monitoring system according to claim 1, wherein the user interface includes a wireless transmitter configured to transmit a signal to a user of the system to indicate that a predetermined volume of wetness has been detected in an absorbent article.

9. A moisture monitoring system according to claim 1 wherein the system is configurable to provide a toileting or voiding diary.

10. A moisture monitoring system according to claim 1 wherein the system is configurable to derive a toileting or voiding schedule for an individual, based on wetness events monitored using the monitoring system.

11. A moisture monitoring system according to claim 10 wherein the system is configured to predict, based on a derived toileting or voiding schedule, when an individual is likely to experience a wetness event which meets pre-defined criteria for manual checking.

12. A moisture monitoring system according to claim 1 wherein the system is further adapted to communicate automatically, an alert to a carer when one or more pre-defined criteria for manual checking are satisfied.

13. A moisture monitoring system according to claim 1 wherein the system is configured to classify a possible form of incontinence suffered by a patient monitored by the system, the form of incontinence being selected from the group including urinary, fecal, dribble, stress, overflow, urge, mixed urinary (MUI), total and functional incontinence.

14. A moisture monitoring system according to claim 1 wherein the system is configured to perform one of recognizing and predicting the occurrence of lingering wetness in a region of an absorbent article.

15. A moisture monitoring system according to claim 1 wherein the processor is affixable to a sensor, an absorbent article or to a garment worn by a wearer of an absorbent article.

16. A moisture monitoring system according to claim 1 wherein the processor is incorporated into a central monitoring station adapted to receive sensor signals from a plurality of sensors associated with one or more absorbent articles.

17. A moisture monitoring system according claim 1 wherein the processor includes a pre-processor associated with a sensor of an absorbent article.

18. A moisture monitoring system according to claim 2, adapted to reconfigure the mathematical model for use with one or more of a particular individual being monitored, a different sensor type and a different absorbent article type, by:

for a training period using the particular individual, the different sensor type or the different absorbent article type, monitoring wetness at regular intervals by obtaining sensor signals and obtaining observation data; and

reconfiguring the mathematical model so that there is satisfactory correlation between wetness estimates produced using the sensor signals and the reconfigured mathematical model, and wetness observations from the observation data obtained during the training period.

19. A moisture monitoring system according to claim 18 wherein reconfiguring a mathematical model involves determining one or more new parameters for the mathematical model.

20. A moisture monitoring system according to claim 18 wherein reconfiguring a mathematical model involves application of a linear regression algorithm.

21. A moisture monitoring system according to claim 18 wherein the observation data includes measurements indicating an amount of wetness in the absorbent article and time of measurement.

22. A moisture monitoring system according to claim 18 wherein the observation data includes one or more of:

demographic information; and

patient information.

23. A moisture monitoring system according to claim 1 further including one or more sensors for use with an absorbent article being monitored for wetness, the sensor including a plurality of sensor elements arranged in a pattern which provides an improved ability to detect wetness.

24. A moisture monitoring system according to claim 23 wherein the sensor elements are arranged in a pattern in which there are more sensor elements in regions having higher propensity for variable moisture or temperature.

25. A moisture monitoring system according to claim 23 wherein, when applied to or incorporated into an absorbent article, one or more sensor elements extend beyond an edge thereof.

26. A moisture monitoring system according to claim 25 wherein, when applied to or incorporated into an absorbent article, one or more sensor elements extend beyond a front edge thereof.

27. A moisture monitoring system according to claim 23 further including, for each absorbent article being monitored, a signal receiver unit and a connector for connecting sensor elements associated with an absorbent article to an associated signal receiver unit.

28. A moisture monitoring system according to claim 23 further including, for each absorbent article being monitored, a cover layer over the sensor elements, the cover layer extending beyond an edge of the absorbent article and including means for enclosing a signal receiver unit attachable to one or more of the sensor elements.

29. A moisture monitoring system according to claim 23 wherein, when applied to or incorporated into an absorbent article, one or more sensor elements are arranged for connection to a signal receiver unit outside the absorbent article.

30. A moisture monitoring system according to claim 27 wherein the signal receiver unit includes storage means for storing sensor signals collected over a period of time.

31. A moisture monitoring system according to claim 27 wherein the signal receiver unit includes means for receiving data relating to a patient'"'"'s toileting activities.

32. A moisture monitoring system according to claim 23 wherein the pattern includes sensor elements positioned toward the sides of the absorbent article, near an opening for receiving a leg of the wearer.

33. A moisture monitoring system according claim 23 wherein the pattern includes sensor elements located at two or more depths of the absorbent article.

34. A moisture monitoring system according to claim 23 wherein the sensor includes a sensor substrate, the sensor substrate having one or more channels arranged between adjacent elements of the sensor.

35. A moisture monitoring system according to claim 34 for use with an absorbent article having super absorbent material arranged in the article so as to draw fluid from the one or more channels in the sensor substrate.

36. A moisture monitoring system according to claim 23 wherein the sensor is provided on a flexible substrate affixable, by adhesive or other means, to an absorbent article wearable by a user.

37. A moisture monitoring system according to claim 23 wherein the sensor elements detect wetness at various identifiable locations with respect to the absorbent article, the locations selected from the group including:

(a) toward the front of the absorbent article;

(b) toward the rear of the absorbent article;

(c) toward a side of the absorbent article; and

(d) substantially centrally of the absorbent article.

38. A moisture monitoring system according to claim 23 wherein the pattern of sensor elements facilitates improved detection of moisture from a user in a range of positions including standing, sitting, lying prone, lying supine and lying on the side.

39. A moisture monitoring system according to claim 23 wherein the sensor elements are arranged to detect spread of moisture from a wetness event in two or more directions.

40. A moisture monitoring system according to claim 23 wherein the sensor pattern includes one or more of:

elongate sensor elements;

sensor elements arranged in a grid; and

an array of sensor element dots.

41. A moisture monitoring system according to claim 23 wherein the sensor includes sensor elements for detecting one or more of electrical conductivity, temperature, pressure, pH, odour, gas and presence of a biological or chemical marker in exudate and location of exudate.

42. A diaper for a person to wear, for use with the moisture monitoring system of claim 1 wherein said diaper includes a sleeve for the insertion of a diagnostic strip.

43. A diaper according to claim 42 characterised in that said sleeve is located on said diaper close to, in use, the pubic area of a wearer.

44. A diaper according to claim 42, characterised in that said diaper has means designed to direct fluids excreted by said person, to said sleeve.

45. A diaper according to claim 42, characterised in that said sleeve is provided with a V-shaped notch to facilitate the insertion of a diagnostic strip.

46. A diaper according to claim 42, characterised in that said sleeve is attachable to said diaper by adhesive material.

47. A diaper according to claim 44, characterised in that said means designed to direct fluids excreted by said person, to said sleeve, is constituted by pores and/or channels.

48. A diaper according to claim 47, characterised in that said pores and/or channels are located around the periphery of said sleeve.

49. A diaper according to claim 42, characterised in that sleeve is adapted to retain a predetermined amount of exudate to facilitate contact of said exudate with said strip.

50. A diaper for a person to wear, for use with the moisture monitoring system of claim 1 wherein said diaper is provided with a plurality of sensors at different locations in said diaper.

51. A diaper according to claim 50, characterised in that said sensors are wetness sensors.

52. A diaper according to claim 51, characterised in that said sensors are adapted to permit the estimation of the volume of exudate flowing from the patient in real time.

53. A diaper according to claim 52, characterised in that the volume of exudate passed by the person wearing said diaper, preferably in a unit of time, is established using the mathematical model and computed by using such factors as the distance between said sensors, the rate of transfer of moisture between said sensors, and the absorption properties of the materials used, such as polymer fibres, natural fibres and combinations of polymer fibres and natural fibres.

54. A diaper according to claim 53, characterised in that data from said sensors is transmitted using radio technology, and in that said data is processed using software running the aforementioned mathematical model.

55. A diaper according to claim 50, characterised in that each of said sensors is constituted by conductive inks.

56. A diaper according to claim 50, characterised in that the spacing of said sensors is at different thicknesses in material forming at least a part of said diaper.

57. A pad for use with a diaper, and the moisture monitoring system of claim 1, wherein said pad is associated with transmitting means, for transmitting signals representative of an aspect of fluids absorbed by said pad, to a remote location.

58. A diaper according to claim 57, characterised in that said pad includes a chamber for collection of said fluids.

59. A diaper according to claim 58, characterised in that said chamber is removable.

60. A moisture monitoring system according to claim 1 configurable to adapt a mathematical model to characterise a wetness event in an absorbent article being monitored using one or more of a new sensor type, new sensor element and a new type of absorbent article not previously used with the moisture monitoring system.

61. A moisture monitoring system according to claim 1 wherein the processor is configured to receive automatically data pertaining to known features of an absorbent article selected from a group including:

volume capacity, type, brand and location of sensors embedded therein.