Incontinence management system and diaper

• US 20070270774A1
• Filed: 05/02/2007
• Published: 11/22/2007
• 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, Guibert, Remi, Bergman, Ari, Eitzen, Guy, Weinstock, Daniel, Rodda, Maria, Barda, David
• Granted Patent: US 7,977,529 B2
• Time in Patent Office: Days
• 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 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.

2. A moisture monitoring system according to claim 1 wherein the processor executes an algorithm to devise a mathematical model for characterising a wetness event in an absorbent article.

3. A moisture monitoring system according to claim 1 wherein the processor executes an algorithm to perform the analysis and wherein the algorithm applies uses the sensor signals and a pre-determined mathematical model 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.

4. A moisture monitoring system according to claim 1 wherein the processor uses sensor signals and/or variables derived from the sensor signals to derive one or more parameters suitable for use in a mathematical model for characterising a wetness event.

5. A moisture monitoring system according to claim 3 wherein the algorithm applies variables derived from the one or more sensor signals to a pre-determined mathematical model to characterise a wetness event.

6. A moisture monitoring system according to claim 3 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 or chemical marker in the exudate.

7. A moisture monitoring system according to claim 4 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.

8. 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.

9. A moisture monitoring system 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.

10. A moisture monitoring system according to claim 1 wherein the processor is configured to provide a toileting or voiding diary.

11. A moisture monitoring system according to claim 3 wherein the processor is configured to derive a toileting or voiding schedule for an individual, based on wetness events monitored using the monitoring system.

12. A moisture monitoring system according to claim 11 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.

13. 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.

14. A moisture monitoring system according to claim 1 wherein the processor 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.

15. A moisture monitoring system according to claim 1 wherein the processor is configured to recognise and/or predict lingering wetness in a region of an absorbent article.

16. 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.

17. 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.

18. A moisture monitoring system according claim 1 including a pre-processor associated with a sensor of an absorbent article.

19. A moisture monitoring system according to claim 3, adapted to reconfigure the one or more mathematical models 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 the estimates produced using the sensor signals and the reconfigured mathematical model, and the observation data obtained during the training period.

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

21. A moisture monitoring system according to claim 19 wherein reconfiguring a mathematical model involves application of a linear regression algorithm.

22. A moisture monitoring system according to claim 19 wherein the observation data includes measurements indicating an amount of wetness in the absorbent article and time of measurement.

23. A moisture monitoring system according to claim 19 wherein the observation data includes one or more of:

demographic information; and

patient information.

24. A sensor 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.

25. A sensor according to claim 24 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.

26. A sensor according to claim 24 wherein, when applied to or incorporated into an absorbent article, one or more sensor elements extend beyond an edge thereof.

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

28. A sensor according to claim 24 further including a connector for connecting the sensor elements to a signal receiver unit.

29. A sensor according to claim 24 further including 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.

31. A sensor according to claims 28 wherein the signal receiver unit includes storage means for storing sensor signals collected over a period of time.

32. A sensor according to claims 28 wherein the signal receiver unit includes means for receiving data relating to a patient'"'"'s toileting activities.

33. A sensor according to claim 24 wherein the pattern includes sensor elements positioned toward the sides of the absorbent article, near an opening for receiving a leg of the wearer.

34. A sensor according claim 24 wherein the pattern includes sensor elements located at two or more depths of the absorbent article.

35. A sensor according to claim 24 wherein the sensor includes a sensor substrate, the sensor substrate having one or more channels arranged between adjacent elements of the sensor.

36. A sensor according to claim 35 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.

37. A sensor according to claim 24 wherein the sensor is provided on a flexible substrate affixable, by adhesive or other means, to an absorbent article wearable by a user.

38. A sensor according to claim 24 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.

39. A sensor according to claim 24 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.

40. A sensor according to claim 24 wherein the sensor elements are arranged to detect spread of moisture from a wetness event in two or more directions.

41. A sensor according to claim 24 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.

42. A sensor according to claim 24 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.

30. A sensor according to claim 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.

43. A method for monitoring moisture in an absorbent article including the steps of:

(a) receiving one or more sensor signals associated with the absorbent article, the sensor signals indicating wetness in the absorbent article;

(b) applying one or more sensor signals to a predetermined mathematical model for characterising a wetness event; and

(c) based on the mathematical model, characterising a wetness event in the absorbent article.

44. A method for monitoring moisture according to claim 43 wherein characterising a wetness event involves ascertaining one or more of an estimated volume of exudate in a wetness event and the nature of the exudate.

45. A method for monitoring moisture according to claim 43 further including the step of automatically notifying a user if one or more predetermined notification criteria are met.

46. A method for monitoring moisture according to claim 43 wherein the predetermined mathematical model has variables derived from the one or more sensor signals.

47. A method for monitoring moisture according to claim 43 wherein the 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; and

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

48. A method for monitoring moisture according to claim 46 wherein the 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.

49. A method for monitoring moisture according to claim 43 further including the step of maintaining a toileting or voiding diary, being a log of monitored wetness events.

50. A method of monitoring moisture according to claim 43 further including the step of deriving a toileting or voiding schedule for an individual, based on wetness events monitored using the monitoring system.

51. A method of monitoring moisture according to claim 50 further including the step of predicting, based on a derived toileting or voiding schedule, when an individual is likely experience a wetness event which meets pre-defined criteria for manual checking.

52. A method of monitoring moisture according to claim 43 further including the step of reconfiguring 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 and/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 the estimates produced using the sensor signals and the reconfigured mathematical model, and the observation data obtained during the training period.

53. A method of monitoring moisture according to claim 52 wherein reconfiguring a mathematical model involves determining new parameters for the mathematical model.

54. A method of monitoring moisture according to claim 52 wherein reconfiguring a mathematical model involves application of a linear regression algorithm.

55. A method of monitoring moisture according to claim 52 wherein the observation data includes measurements indicating an amount of wetness in the absorbent article and time of measurement.

56. A method of monitoring moisture according to claim 52 wherein the observation data includes one or more of demographic information and patient information.

57. A diaper for a person to wear, for use in an incontinence management system or a system for the management of exudates from the body of a person, characterised in that said diaper includes a sleeve for the insertion of a diagnostic strip.

58. A diaper according to claim 57 characterised in that said sleeve is located on said diaper close to, in use, the pubic area of a wearer.

59. A diaper according to claim 57, characterised in that said diaper has means designed to direct fluids excreted by said person, to said sleeve.

60. A diaper according to claim 57, characterised in that said sleeve is provided with a V-shaped notch to facilitate the insertion of a diagnostic strip.

61. A diaper according to claim 57, characterised in that said sleeve is attachable to said diaper by adhesive material.

62. A diaper according to claim 59, characterised in that said means designed to direct fluids excreted by said person, to said sleeve, is constituted by pores and/or channels.

63. A diaper according to claim 62, characterised in that said pores and/or channels are located around the periphery of said sleeve.

64. A diaper according to claim 57, characterised in that sleeve is adapted to retain a predetermined amount of exudate to facilitate contact of said exudate with said strip.

65. A diaper for a person to wear, for use in an incontinence management system or a system for the management of exudates from the body of a person, characterised in that said diaper is provided with a plurality of sensors at different locations in said diaper.

66. A diaper according to claim 65, characterised in that said sensors are wetness sensors.

67. A diaper according to claim 66, characterised in that said sensors are adapted to permit the estimation of the volume of exudate flowing from the patient in real time.

68. A diaper according to claim 67, characterised in that the volume of exudate passed by the person wearing said diaper, preferably in a unit of time, is established using a mathematical model 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.

69. A diaper according to claim 65, 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.

70. A diaper according to claim 65, characterised in that each of said sensors is constituted by conductive inks.

71. A diaper according to claim 65, characterised in that the spacing of said sensors is at different thicknesses in material forming at least a part of said diaper.

72. A pad for use with a diaper, said pad being associated with transmitting means, for transmitting signals representative of an aspect of fluids absorbed by said pad, to a remote location.

73. A diaper according to claim 72, characterised in that said pad includes a chamber for collection of said fluids.

74. A diaper according to claim 73, characterised in that said chamber is removable.

75. An incontinence management system or a system for the management of other exudates from the body of a person, characterised by an article adapted to be worn by the person, sensing means associated with said article and adapted to sense a condition, and transmitting means adapted to transmit a signal generated by said sensing means to a location.

76. An incontinence management system according to claim 75, characterised in that said system also includes means for processing said signal.

77. An incontinence management system according to claim 75, characterised in that said sensing means is a plurality of sensors, arranged spatially in said article.

78. An incontinence management system according to claim 77, characterised in that said spatial arrangement includes the spacing of sensors at different thicknesses in material forming at least a part of said article.

79. An incontinence management system according to 75, characterised in that said article is a diaper.