GB2411961A - Wearable physiological parameter change monitoring device - Google Patents

Wearable physiological parameter change monitoring device Download PDF

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Publication number
GB2411961A
GB2411961A GB0405516A GB0405516A GB2411961A GB 2411961 A GB2411961 A GB 2411961A GB 0405516 A GB0405516 A GB 0405516A GB 0405516 A GB0405516 A GB 0405516A GB 2411961 A GB2411961 A GB 2411961A
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body parameter
computer
recording means
measurement values
state change
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GB0405516D0 (en
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Richard Harwood
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0012—Ovulation-period determination
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A61B5/0008—Temperature signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A61B5/02055—Simultaneously evaluating both cardiovascular condition and temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0531—Measuring skin impedance
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Physiology (AREA)
  • Cardiology (AREA)
  • Business, Economics & Management (AREA)
  • Dermatology (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Business, Economics & Management (AREA)
  • Epidemiology (AREA)
  • Primary Health Care (AREA)
  • Radiology & Medical Imaging (AREA)
  • Pulmonology (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

A wearable (or partially wearable) body parameter recorder measures one or more physiological parameters (e.g. temperature, skin resistivity, pulse rate) and stores the measured values. The stored values are transferred to a computer (provided separately from, or incorporated with the recorder) which determines if any change in the measured parameters satisfies predetermined criteria. A warning is provided if the change in the parameters, indicating a change in physiological state, satisfies the criteria. The device may be used for example to warn of impending hypoglycaemic shock, ovulation, the incubation of a bacterium or virus. Methods, computers, computer programs and a reader are also disclosed.

Description

209UKPD 2004.03.01 Specification 241 1 961
A wearable body parameter recording means, computer, program and method for the same.
This invention relates to a wearable body parameter recording means, a method and computer program for the same, and a method of use of the same. It is applicable to the fields of healthcare, medical insurance, exercise and fitness, patient monitoring, and day to day health monitoring.
In the past various types of body parameter measurement means have been nown including the thermometer and the electronic thermometer which car' be used to help determine whether a user or patient is incubating a virus or other infection. A means is needed to detect a change of a body parameter without requiring regular tests to be performed, sometimes more often than every hour, and involving;,pious elt)i, aJILi orgai.isa.ior, as wc'l as rcgutar'y wakA.g the patient. Fig. 1 is a diagram of a known health state detector.
Proposed solutions include various types of monitoring equipment which can monitor vital signs or body parameters such as pulse rate and body temperature. Such equipment is placed on a trolley next to a patient in a hospital ward and may sound an alarm 6 if for example a pulse rate cannot be detected.
Such equipment is expensive to purchase, bulky to move around, and entirely unsuitable to carry at all times.
It is an object of the present invention to provide a means to detect a change in a body parameter of a patient or user.
It is another object of the present invention to provide a means to alert a user or caret to a change in a body parameter of a patient or user.
It is a further object of the present invention to provide a portable means to alert a user or cater to a change in a body parameter of a patient or user.
It is a further object of the present invention to aid a carer or user to determine health state changes in a easier manner than previously possible.
It is a further object of the present invention to aid a cater or user to determine health state changes in faster than previously possible.
It is a further object of the present invention to aid a carer or user to determine health state changes requiring less human intervention than previously possible.
According to a first aspect of the present invention there is provided an at least partially wearable body parameter recording means 1 adapted to measure at least one body parameter to store measurement values thereof and to provide
209UKPD2004.03.0] Specification
stored measurement values to a computer 4, 5 adapted to determine a physiological state change from body parameter measurement values.
According to a second aspect of the present invention there is provided a computer 4, 5 for the at least partially wearable body parameter recording means 1 ofthe first aspect adapted to receive measurement values therefrom, to determine a physiological state change therefrom and to trigger a warning signal in the event of a positive determination of said physiological state change.
According to a third aspect of the invention there is provided the at least partially wearable body parameter recording means 1 of the first aspect and the computer 4, 5 of the second aspect.
According to a fourth aspect of the invention there is provided a computer program for the computer 4, 5 of the second aspect adapted to control said computer 4, 5 to determine a physiological state change from body parameter measurement values Irom an al icasi partially weaiable body para...e.el rccord...g means 1, and to trigger a warning signal in the event of a positive determination of said physiological state change.
According to a fifth aspect of the invention there is provided the at least partially wearable body parameter recording means I of the first aspect comprising a computer 4, 5 of the second aspect.
According to a sixth aspect of the invention there is provided a computer program for the computer 4, 5 of the second aspect or the fourth aspect, adapted to control said computer 4, 5 to determine a physiological state change from body parameter measurement values from an at least partially wearable body parameter recording means 1, and to trigger a warning signal in the event of a positive determination of said physiological state change.
According to a seventh aspect of the invention there is provided a reader for reading measurement values from the recording means of any one of the first aspect, the second aspect or the fifth aspect, adapted to read measurement values therefrom for use in determining a physiological state change such that in the event of a positive determination of said physiological state change a warning signal may be triggered.
According to an eighth aspect of the invention there is provided a band, watch, clasp, strap, bracelet or anklet for an arm or a leg for the recording means of one of the first aspect and the third aspect or for the recorder and computer 4, 5 comprised therein of the fifth aspect.
According to a ninth aspect of the invention there is provided a method of use of the at least partially wearable body parameter recording means I of the first aspect and the computer 4, 5 of the second aspect having the steps of:
209UKPD 2004.03.0] Specification
removably attaching said wearable body parameter recording means I to a body; activating said wearable body parameter recording means I to take measurements of at least one body parameter and to store measured body parameter measurements; allowing said wearable body parameter recording means 1 to provide body parameter measurements to said computer 4, 5; allowing said computer 4, 5 to determine a physiological state change from the provided stored body parameter measurements and to trigger a warning signal in the event of a positive determination of said physiological state change.
According to a tenth aspect of the invention there is provided a method of operation of the at least partially wearable body parameter recording means 1 of the first aspect and the computer 4, 5 of the second aspect having the steps of: taking measurements of at least one body parameter and storing respective measurement values with said wearable i)ouy paiarl.e.ei- -.-ecordi-l;g,I.ea..s 1; providing stored measurement values to said computer 4, 5; reading said provided stored measurement values with said computer 4, 5; determining a physiological state change from said provided stored measurement values; and generating an alarm 6 signal in the event of a positive determination of said physiological state change.
According to an eleventh aspect of the invention there is provided a computer program for controlling a computer 4, 5 of the second aspect to perform the method having the steps of: reading stored body parameter measurement values from an at least partially wearable body parameter recording means] adapted to take body parameter measurements and to store said body parameter measurements; determining a physiological state change from said provided stored measurement values; and generating an alarm 6 signal in the event of a positive determination of said physiological state change for a user.
According to a twelfth aspect of the invention there is provided a computer program for controlling the at least partially wearable body parameter recording means 1 of the first aspect to perform the method having the steps of: taking body parameter measurements; storing body parameter values relating to the body parameter measurements; permitting the computer 4, 5 of the second aspect to access the at least partially wearable body parameter recording means 1; and permitting said computer 4, 5 to obtain stored body parameter values.
209UKPD 2004.03.01 Specification
According to a thirteenth aspect of the invention there is provided a computer 4, 5 interface for the computer program of the fourth aspect, adapted to provide at least a graphical representation of body parameter values and at least a graphical or audio signal in the event of a positive determination of a physiological state change.
According to a fourteenth aspect of the invention there is provided at least one computer 4, 5 readable medium having the computer program of any one of the fourth aspect, the sixth aspect, the eleventh aspect and the twelfth aspect encoded therein.
According to a fifteenth aspect of the invention there is provided at least one network data signal having the computer program of any one of the fourth aspect, the sixth aspect, the eleventh aspect and the twelfth aspect encoded therein.
According to a sixteenth aspect of the invention there is provided at least one data signal from the at least parriaily wearanie body parameter rc;orohl, means] of the first aspect.
According to a seventeenth aspect of the invention there is provided a method of use of the at least partially wearable body parameter recording means I of the first aspect and the computer 4, 5 of the second aspect having the steps of: removably attaching said wearable body parameter recording means I to a body; activating said wearable body parameter recording means 1 to take measurements of at least one body parameter and to store measured body parameter measurements; allowing said wearable body parameter recording means 1 to provide body parameter measurements to said computer 4, 5; allowing said computer 4, 5 to determine a body parameter change from the provided stored body parameter measurements and to trigger a warning signal in the event of a positive determination of said body parameter change.
For a better understanding of the invention and to show how the same may be carried into effect, reference will now be made, by way of example, to the accompanying drawings, in which: Figure I is a diagram of a body parameter recording means I and a computer 4, 5 4 according to one embodiment of the invention; Figure 2 is a diagram of a body parameter recording means I comprising a computer 4, 5 4 according to one embodiment of the invention; Figure 3 is a circuit diagram of a body parameter recording means according to one embodiment of the invention;
209UKPD 2004.03.01 Specification
Figure 4 is a circuit diagram of a body parameter recording means according to another embodiment of the invention; Figure 5 is a flow diagram illustrating a method of operation of a body parameter recording means according to one embodiment of the invention; Figure 6 is a flow diagram illustrating a method of operation of a body parameter! recording means according to one embodiment of the invention; Figure 7 is a flow diagram illustrating a method of operation of a computer 4, 5 for a body parameter recording means according to one specific embodiment of the invention; and Figure g is a flow diagram, .lluslating a mchod of operation of a computer 4, 5 for a body parameter recording means according to another specific embodiment of the invention.
According to a general embodiment of the first aspect there is provided an at least partially wearable body parameter recording means i adapted to measure at least one body parameter to store measurement values thereof and for providing stored measurement values to a computer 4, 5 adapted to determine a physiological state change from body parameter measurement values.
According to a pre-visit embodiment of the invention there is provided an at least partially wearable body parameter recording means I for permitting determination of a physiological state change prior to planned health care, adapted to measure at least one body parameter to store measurement values thereof and to provide stored measurement values to a computer 4, 5 adapted to determine a physiological state change by a determination of a change in body parameter measurement values.
According to a post-visit embodiment of the invention there is provided an at least partially wearable body parameter recording means I for permitting determination of a physiological state of a patient during health care, adapted to measure at least one body parameter to store measurement values thereof and to provide stored measurement values to a computer 4, 5 adapted to determine a physiological state change by a determination of a change in body parameter measurement values, the computer 4, 5 being a portable computer 4, 5 or being adapted accept provided stored measurement values by means of a portable computer 4, 5.
According to a user embodiment of the invention there is provided an at least partially wearable body parameter recording means I for permitting determination of a physiological state change as and when desired, adapted to measure at least one body parameter to store measurement values thereof and to provide stored measurement values to a computer 4, 5 adapted to determine a
209UKPD 2004.03.01 Specification
physiological state change by a determination of a change in body parameter measurement values.
According to an emergency embodiment of the invention there is provided an at least partially wearable body parameter recording means I for permitting determination of a physiological state change as and when desired, adapted to measure at least one body parameter to store measurement values thereof and to provide stored measurement values to a computer 4, 5 adapted to determine a physiological state change by a determination of a change in body parameter measurement values, the computer 4, 5 being carryable or wearable and being connected to said w earable body parameter recording means I According to a donor embodiment of the invention there is provided a blood or organ parameter recording means for providing a temperature audit trail by means of a computer 4, 5 adapted to display at least a graph of recorded _. . . . . . , 1 _. _1 _ _ 1 _ _ temperatures or preferably aeermme a warmng Slate and a;;ola'l'y u>ay a warning.
According to any of the embodiments the at least partially wearable body parameter recording means l may comprise a thermistor adapted to provide a temperature measurement, the at least partially wearable body parameter recording means l being adapted to measure at least a skin surface body temperature or more preferably at least a basal body temperature directly or indirectly, to store measurement values thereof and to provide stored measurement values including stored temperature measurement values to a computer 4, 5 adapted to determine a physiological state change by determination of a change in body parameter measurement values including stored temperature measurement values.
According to any of the embodiments the wearable body parameter recording means I may comprise a surface resistance or resistivity meter adapted to provide a surface resistance or resistivity measurement, the at least partially wearable body parameter recording means I being adapted to measure at least a skin surface resistance or resistivity, to store measurement values thereof and to provide stored measurement values including stored skin surface resistance or resistivity measurement values to a computer 4, 5 adapted to determine a physiological state change by determination of a change in body parameter measurement values including stored temperature measurement values.
According to any of the embodiments the at least partially wearable body parameter recording means 1 may comprise a pulse rate meter adapted to provide a pulse rate measurement, the at least partially wearable body parameter recording means I being adapted to measure a pulse rate, to store measurement values thereof and to provide stored measurement values including pulse rate
209UKPD2004.03.01 Specification
measurement values to a computer 4, 5 adapted to determine a physiological state change by determination of a change in body parameter measurement values including pulse rate measurement values.
According to any of the embodiments the at least partially wearable body parameter recording means I may comprise a Thermochron adapted to provide a body temperature measurement via the 1-Wire data transfer protocol, the at least partially wearable body parameter recording means I being adapted to measure a body temperature, to store measurement values thereof and to provide stored measurement values including body temperature measurement values via the l-Wi.e data transfer protocol to a computer 4, 5 adapted to determine a physiological state change by determination of a change in body parameter measurement values including body temperature measurement values.
According to any of the pre-visit, post-visit and user embodiments, the computer it, 5 may be provideci as a remote computer 4, suen as pcrsolla; computer 4, 5, adapted to operate software, to accept measurement values from an at least partially wearable body parameter recording means 1, to be directed by said software to analyse said measurement values, to determine whether a pre- determined criteria of change of measurement values has been fulfilled, and to trigger or provide a warning being at least one of an audio warning or a visual warning in the event of such determination being positive.
There may be provided a computer program for controlling a computer 4, 5 to perform the method having the steps of: reading or accepting a plurality of measurement values from an at least partially wearable body parameter recording means 1; analysing said measurement values to determine whether a predetermined criteria of change of measurement values has been fulfilled; and triggering or providing a warning in the event of such determination being positive.
According to any of the embodiments a determination of a physiological state change from body parameter measurement values includes substantially determining whether any measurement value being within a predetermined time range or measurement value range, is within a predetermined measurement value range relative to any other measurement value being within a predetermined relative time range or measurement order range to the measurement value.
According to any of the embodiments a determination of a physiological state change from body parameter measurement values includes substantially determining whether any substantially recent measurement value is different by at least a predetermined value to any other measurement value being substantially
209UKPD 20Q4.03.0 1 Specification
recent thereto, where the tern-. recent means passing a predeterrr.ined time or measurement value criteria relative in the first usage to a current time, and relative to in the second usage to the time of the respectively compared measurement value.
According to any of the embodiments a determination of a physiological state change from body parameter measurement values includes firstly substantially smoothing said body parameter measurement values according to a predetermined smoothing routine to form substantially smoothed measurement values, and secondly substantially determining whether any substantially srnoo+.hed measurement value being within a predetermined time range or measurement value range, is within a predetermined measurement value range relative to any other smoothed measurement value being within a predetermined relative time range or measurement order range to the smoothed measurement value.
According to any of the embodiments a determination of a physiological state change from body parameter measurement values includes smoothing the measurement values to form smoothed measurement values, substantially determining whether any substantially recent smoothed measurement value is different by at least a predetermined value to any other smoothed measurement value being substantially recent thereto, where the term recent means passing a predetermined time or measurement value criteria relative in the first usage to a current time, and relative to in the second usage to the time of the respectively compared measurement value.
According to any of the embodiments a determination of a physiological state change from body parameter measurement values includes substantially determining whether any measurement value being within a predetermined time range or measurement value range, is within a predetermined measurement value range relative to any other measurement value being within a predetermined relative time range or measurement order range to the measurement value, may be specifically determining a rise in measurement values.
According to any of the embodiments a determination of a physiological state change from body parameter measurement values includes substantially determining whether any measurement value being within a predetermined time range or measurement value range, is within a predetermined measurement value range relative to any other measurement value being within a predetermined relative time range or measurement order range to the measurement value, may be specifically determining a fall in measurement values.
209UKPD 2004.03.01 Specification
Figure I shows a diagram of a wearable body parameter measurement means] according to an embodiment of the present invention associated with a computer 4, 5 4.
The wearable body parameter measurement means 1 may preferably be attachable to an arm or a leg or may be provided in a loop or band shape so as to encircle an arm or a leg.
The wearable body parameter measurement means I is provided with at least one sensor 3 for measuring at least one body parameter and a storage medium 2 for storing body parameter measurements.
The computer 4, 5 4 which may be a personal computer 4, 5 and which.
may be a carryable computer 4, 5, comprises a processor 5 for reading body parameter measurement values from the storage medium 2. The processor may transfer such measurement values into a computer 4, 5 storage medium 2. The processor analyses read body parameter measurement values tO determine a physiological state change by determining whether at least one predetermined body parameter measurement value change criterion has been passed.
In the event that the at least one predetermined body parameter measurement value change criterion has been passed the processor may activate an alarm 6 or display device 6 to generate a warning signal which may be visual, audio or even tactile.
Figure 2 shows a diagram of a wearable body parameter measurement means I according to an embodiment of the present invention comprising a computer 4, 5 4. In this case the processor may perform movement of data from the sensor 3 to the storage medium 2 in addition to analysing such data to determine at least one predetermined body parameter measurement value change criterion.
Figure 3 shows a circuit diagram of a wearable body parameter measurement means according to one embodiment of the invention.
Figure 4 shows a circuit diagram of a wearable body parameter measurement means according to another embodiment of the invention.
Figure 5 shows a diagram of a method of operating a computer 4, 5 for a wearable body parameter measurement means 1. The computer 4, 5 accesses 50 a storage unit and receives 51 measurement value data therefrom. The computer 4, 5 then analyses the data 52 according to one embodiment, or according to another analyses a smoothed version of the received data. The analysis is performed to determine whether a change in the measurement values has occurred substantially recently and whether such a change passes at least one criterion including a change amount criterion and a change duration criterion. Preferably these criteria are
209UKPD 2004.03.01 Specification
combined into a criterion that the change must exceed a predetermined relationship or function or change amount versus change duration. Such a relationship may be either discrete or preferably continuous. Such a relationship may either specify a relationship between change amount, change duration and the time between the change and either a present time or a most recent measurement.
In such a case such a time may be measured from substantially the end of the change or substantially the middle of the change or preferably substantially from the beginning of the change.
If such an at least one criterion is passed then the computer 4, 5 activates or Diggers 55 ar alarm 6 which may be at least an audio signal, may be a tactile signal, or may be a visual signal displayed preferably on a visual display. If such an at least one criterion has not been passed then no such warning is triggered or activated.
Accorciing to an embocimem oupi;icu ir, Our; o if Me a. leas. one criterion is not passed then the computer 4, 5 waits 54 preferably a predetermined time before repeating the method. Such an embodiment is important in the case of such a computer 4, 5 connected continuously to or within a wearable body parameter measurement means such as one for detecting or predicting a hypoglycaemic shock.
Figure 7 shows a flow diagram of a method for determining a physiological state change according to one embodiment of the invention. A procedure begins with turning on a power, and may include a power on delay to stabilise a timer oscillator.
After ascertaining an acceptable battery or parasitic capacitor level interrupts are set so as to control how often a waking or value obtaining procedure is performed. As an example waking and value obtaining may preferable be set to be performed more than once per 130 minutes, more preferably more than once per 40 minutes, yet more preferably more than once per 25 minutes, further preferably more than once per 12 minutes, even more preferably more than once per 6 minutes, still further more preferably more than 3 minutes, even more preferably more than once per 120 seconds, even more preferably more than once per 90 seconds, still more preferably more than once per 45 seconds, yet more preferably more than once per 20 seconds, yet more preferably more than once per 12 seconds, and most preferably more than once per 6 seconds. Such preferential limits may be applied to any of the embodiments.
Analogue to digital communications channels may be opened either on power on or more preferably on wake up. On wake up a time is recorded, and at least one temperature value is obtained. The at least one temperature value is
209UKPD2004.03.01 Specification
stored in a storage medium 2 which may be any data storage medium 2 and more preferably a permanent storage medium 2. The data storage medium 2 may he in the form of any type of physical or virtual memory or more preferably any type of non-volatile physical or virtual memory.
A determination may be made of a change in such measurement values according to at least one change criterion as described elsewhere herein. In the event of such a positive determination set interrupts may disabled. Furthermore a further measurement type value may be read or more preferably a further measurement type may be performed. Such a further measurement type may be preferably a pulse rate or skin resistance or resistivity or more preferably a skin resistance or resistivity. A further at least one change criterion may be determined based upon at least said further measurement type or more preferably based upon said further measurement type and the original measurement type which may be a _ _ _A 4 A_ 4_ P_ _ Llilpl"LUI IIIOUJ11111L pip - . If any such further determination is also positive then data from said data storage medium 2 may be re-read to confirm current data. If these two data match then an alarm 6 may be activated.
Figure 8 shows a flow diagram of a method for determining a physiological change according to another embodiment of the invention. This method follows substantially from that of figure 7 however use is made of the 1wire data protocol to extract data from a data storage medium 2. As such particularly in this embodiment more than one measurement value may be read therefrom by each reading thereof. In such a case a frequency of measuring temperature may be greater than a frequency of reading temperature measurement values.
According to any of the embodiments there may be provided a temperaturesensor 3 adapted to be worn substantially against a skin surface and provided with an insulation means therefore to insulate the temperature sensor 3 from an ambient temperature.
According to any of the embodiments the at least one apparatus or method may be for determining or predicting at least an incubation of a virus or bacteria.
According to any of the embodiments the at least one apparatus or method may be for determining or predicting at least a fertile period in an ovulation cycle.
According to any of the embodiments the at least one apparatus or method may be for determining or predicting at least a hypoglycaemic shock.
According to any of the embodiments the at least one apparatus or method may be for determining or predicting at least an incubation of a virus or bacteria, or a hypoglycaemic shock. 1 1
209UKPD 2004.03.01 Specification
According to any OT the embodiments the at least one apparatus or method may be for determining or predicting at least a fertile period in an ovulation cycle or an incubation of a virus or bacteria.
According to any of the embodiments the at least one apparatus or method may be for determining or predicting at least a hypoglycaemic shock or a fertile period in an ovulation cycle.
According to any of the embodiments there may be provided at least one apparatus or method for determining or predicting, any of at least an incubation of a virus or bacteria, a fertile period in an ovulation cycle, or a hypoglycaemic shock.
According to any of the embodiments the wearable apparatus may be provided with an inbuilt computer 4, 5 or a computer 4, 5 attached thereto to automatically perform repeated determinations and to provide a warning of a positive such determination.
According to any of the embodiments the wearable apparatus may be provided with a means whereby a computer 4, 5 may connect thereto to obtain data and to make a determination as and when required to by a user and to provide a warning of a positive such determination.
According to any of the embodiments the at least partially wearable body parameter recording means I may be a fully wearable body parameter recording means 1.
According to any of the embodiments the at least partially wearable body parameter recording means I may be a fully wearable body parameter recording means l excluding any computer 4, 5 for determining a physiological state change from data therefrom.
According to any of the embodiments the at least partially wearable body parameter recording means 1 for determination of a physiological state change may be for determination of a physiological state change relating to a change in health.
According to any of the embodiments the at least partially wearable body parameter recording means I for determination of a physiological state change may be for determination of a physiological state change relating to a change in fertility.
According to any of the embodiments any computer 4, 5 adapted to receive body parameter measurement values from an at least wearable body parameter recording means l may be adapted to electronically request or obtain such values.
According to any of the embodiments a measuring action may be performed as often or more frequently than a measurement value receiving,
209UKPD 2004.03.01 Specification
requesting or obtaining action, or provided apparatus may be provided to perform as such. In this case such measurements may at least as frequently as such value transactions by a ratio of at least], more preferably at least 1.5, more preferably at least 1.9, more preferably at least 2, more preferably at least 3, more preferably at least 5, more preferably at least 9, and most preferably at least 19.
According to any of the embodiments the wearable body parameter recording means I may be provided with a substantially thermally insulating portion thereof. Such a wearable body parameter recording means I may further be provided with a means for substantially preventing or limiting ambient temperature air from entering any gap between said substantially thermally insulating portion and a skin surface. Such a provision may include a substantially retentive skirt. Further such a provision may include a retaining means adapted to retain such a substantially thermally insulating portion substantially against a skin surface. Further such prL,vision inlay n,cl-uue a s-ulus,ai;.,a.ly- expar.dable bou..da.y portion adapted to fill any such gap.
According to any of the embodiments body temperature parameter recording may be performed with a temperature resolution of at least] C, preferably at least 0.5 C, and most preferably at least 0.25 C.
According to any of the embodiments a computer may access a wearable body parameter recording means worn or previously worn by a user or a patient for at least one day prior to planned substantially non-urgent surgery or medical treatment, any warning generated or triggered by said computer may be used to avoid performing such substantially non-urgent surgery or medical treatment at a time when said user or patient is incubating a virus or bacterium. It has been found that a rise in body temperature may be indicative of such incubation. Further, such a temperature rise coupled with a change in skin resistivity may further be used to determine such incubation.
According to any of the embodiments a computer may access a wearable body parameter recording means worn by a user or a patient after or during medical treatment, such access, determination, and any warnings therefrom are provided without disturbing said user or patient and reduce the time needed for a health care provider or cater to perform routine patient status checking. In this embodiment there particularly may be provided a reader which may or may not be connected directly to the computer. Such a reader may be a l-Wire protocol enabled reader. Such a reader may alternatively be a wireless enabled reader, the wearable body parameter recorder being wirelessly linkable thereto. It is known that a rise in body temperature may be indicative of such incubation. Further it has
209UKPD 2004.03.0] Specification
been found that such a temperature rise coupled with a change in skin resistiv.ty may further be used to determine such incubation.
According to any of the embodiments a computer may access a wearable body parameter recording means worn by a user substantially at risk in the event of an infection for early detection of thereof, any warning generated or triggered by said computer may provide advance notice that the user is incubating a virus or bacterium. Such an embodiment may be important for users with a low or dysfunctional auto immune system such as transplant patients and HIV sufferers.
It is known that a change in body temperature may be indicative of such incubation. Further it has been found the+ such a change coupled vanish a change in skin resistivity may further be used to determine such incubation.
According to any of the embodiments a computer may access a wearable body parameter recording means worn by a user substantially at risk of a hypoglycaemic shock, especially a user who is aware that such a shock may occur without warning, any warning generated or triggered by said computer may be used to provide sufficient warning to a user to take appropriate action. Such action may include injecting insulin, consuming sugar or ceasing any potentially dangerous activity such as driving a car. It has been found that a change in body temperature over a period of 5 to 70 minutes may be indicative of such a shock or impending shock. Further such a change coupled with a change in skin resistivity may further be used to determine such incubation.
According to any of the embodiments a computer may access a wearable body parameter recording means worn by a user, any warning generated or triggered by said computer may be used to provide notice that a fertile period in a menstrual cycle has been reached. It is known that a rise in body temperature over a period of 1 day to 5 days may be indicative of such a fertile period in a menstrual cycle. Further such a temperature rise coupled with a change in skin resistivity may further be used to determine such a fertile period.
According to any of the embodiments the wearable body parameter recording means may be provided substantially as a watch. Such a device may be provided with a display adapted to show at least one of a current time and an alarm status.
According to any of the embodiments the wearable body parameter recording means may be provided with a pulse rate measuring means.
According to any embodiment relating to a Thermochron l-button A, such an l-button may be the DS1921H/Z Thermochron I-button A. According to any of the embodiments the wearable body parameter recording means may be provided with a calorie measuring means.
209UKPD 2004.03.01 Specification
According to any of the embodiments the apparatus is for use on the specifically human body.
According to any of the embodiments the apparatus is for determining a change in at least one body parameter such that a user or carer may perform a diagnosis.
According to any of the embodiments the apparatus is for determining a change in a health state.
According to any of the embodiments the apparatus is for providing stored body parameter measurement values thereof to a computer 4, 5 adapted to determine a bodes parameter value change from said stored body parameter measurement values for alerting at least a user or a cater to said body parameter value change.
Note that where in the description the terms 'wearable' and 'at least partially wearav;e' ;,ave beet, used, ;. is,r''.enueu ha.I;ey be.i;.erc'; a,lgcabic i.. so far as that the main embodiments relate to a portable body parameter recording means being at least partially connected to a skin surface, and which may also be partially carryable (For example in a pocket or a backpack), but where the intention is that the whole body parameter recording means be preferably wholly wearable.
Note that where either or both options of 'resistance' or 'resistivity' is or are used hereinbefore and hereafter, it or they are intended to include both electrical resistance and electrical resistivity, as a determination of one with a meter of predetermined size could generally be used to make a determination of the other.
Note that where the term 'fertility' is used it is intended to include the likelihood of insemination leading to pregnancy.
Note that where the term 'wearable' is used it is intended to include adhesively wearable.
Description of the Preferred Embodiment.
An embodiment of this invention will now be explained with reference to the drawings. This invention is for use as a personal health state change detector.
There is provided an at least partially wearable body parameter recording means I adapted to measure at least one body parameter, to store measurement values thereof, and for providing stored body parameter measurement values thereof to a computer 4, 5 adapted to determine a physiological state change from body parameter measurement values.
209UKPD 2004.03.01 Specification
In this embodiment the at least partially wearable body parameter recording means I is fully wearable in so far as excluding said computer 4, 5 which is controlled by a computer program and which may be an otherwise unrelated personal computer 4, 5. There is also provided a reader for obtaining body parameter measurement values from the wearable body parameter recording means 1.
The wearable body parameter recording means I is adapted to frequently, and in this preferred case regularly, measure at least one body parameter and record such measurements as body parameter measurement values.
Said computer 4, 5 is controlled by a provided computer program to obtain via said reader, said body parameter measurement values. In this preferred case such a measuring and storing action is performed as often as or more frequently than such an obtaining action.
Tutu weaFalebOdy pal-atete 1CCG. .n...,s 1.aa+c..eas"e skin temperature values and in this preferred embodiment also skin resistivity values, and to store measurement values thereof.
In this preferred embodiment the obtaining action is performed by means of a l-wire protocol and is performed via the reader which is provided as a l-wire protocol enabled reader. In this embodiment the wearable body parameter recording means I comprises a Thermochron I-button and is provided as a bracelet, armlet, anklet or like means for wearing on a limb. In this embodiment the wearable body parameter recording means I is provided with a substantially thermally insulating portion thereof adapted to thermally insulate the Thermochron l-button from an ambient temperature.
Said computer 4, 5 is controlled by the computer program to determine a physiological state change by determining at least one predetermined body parameter measurement value change criterion. Such an at least one criterion may in this preferred embodiment include a criterion that a change in a measurement value must have occurred within a predetermined time from a present time being a change greater than a predetermined change and having occurred in a time less than a predetermined time. More specifically there is a predetermined relationship of maximum change as a function of duration of change and of time between the change and a current time. Such a time of a change may be defined in a predetermined manner such as the time of the change being the time of the end of the change. The predetermined relationship in the preferred embodiment allows larger changes of greater durations and vice versa. The predetermined relationship may also define a maximum time of a change from a current time to be analysed.
This may preferably be based on the frequency of determinations and hence an
209UKPD 2004.03.01 Specification
assumption that a predetermined time ago a sirr.ilar determination divas made and thus it would not be necessary to re-analyse the earlier data. Alternatively a predetermined maximum time may be defined irrespective of such.
On determination of a change in excess of a predetermined relationship of maximum change as a function of duration of change and of time between the change and a current time the computer 4, 5 activates or triggers an alarm 6 or generates a warning signal. In the preferred embodiment such a warning signal includes a text message on a visual display such as a computer 4, 5 monitor.

Claims (36)

209UKPD 2004.03.01 Specification CLA IMS
1. An at least partially wearable body parameter recording means (1) adapted to measure at least one body parameter, to store measurement values thereof, and for providing stored body parameter measurement values thereof to a computer (4, 5) adapted to determine a physiological state change from said stored body parameter measurement values.
2. An at least partially wearable body parameter recording means ( l) according to claim I, said wearable body parameter recording means ( I) being for providing said stored body parameter measurement values to a computer (4, 5) adapted to ueierilliiic a pl-lysio:ogica: state change Coral body pa.arrlc.c1 measurement values by determining whether the provided body parameter measurement values pass at least one predetermined change criterion.
3. An at least partially wearable body parameter recording means ( l) according to claim 1 or claim 2, said at least one body parameter including at least a body temperature.
4. An at least partially wearable body parameter recording means (1) according to claim 3, comprising a Thermochron l-button adapted to measure at least a body temperature with said Thermochron I-button, to store measurement values thereof within said Thermochron I-button, and to provide, by means of a l-wire data protocol, stored measurement values to a computer (4, 5) adapted to determine a physiological state change from body parameter measurement values.
5. An at least partially wearable body parameter recording means (1) according to one of claims I to 4, said at least one body parameter including a skin resistivity or skin resistance.
6. An at least partially wearable body parameter recording means (l) according to one of claims I to 5, said at least one body parameter including a skin resistivity or skin resistance.
7. An at least partially wearable body parameter recording means ( I) according to one of claims I to 6, comprising a parasitic capacitor. It
209UKPD 2004.03.01 Specification
8. An at least partially wearable body parameter recording means (1) according to one of claims I to 7 adapted to accept a request for data from a processor and to provide requested data on such request.
9. An at least partially wearable body parameter recording means ( 1) according to one of claims I to 8, for providing stored body parameter measurement values to said computer (4, 5) adapted to determine a physiological state change from body parameter measurement values, said physiological state change relating to a change in bodily health or fertility.
10. An at least partially wearable body parameter recording means (1) according to one of claims 1 to 8, being fully wearable in so far not necessarily including said computer (4, 5).
11. An at least partially wearable body parameter recording means (1) according to one of claims I to 8, being fully wearable and including said computer (4, 5).
12. An at least partially wearable body parameter recording means (1) according to one of claims I to I I, for providing stored body parameter measurement values to said computer (4, 5) adapted to determine a physiological state change from body parameter measurement values, said physiological state change relating to at least one of an incubation of a virus or bacterium, or to a change in fertility or to a hypoglycaemic shock.
13. A computer (4, 5) for the at least partially wearable body parameter recording means (1) of any one of claims I to 12, adapted to receive measurement values therefrom, to determine a physiological state change therefrom and to trigger a warning signal in the event of a positive determination of said physiological state change.
14. A computer (4, 5) of claim 13 adapted to trigger an at least audio, visual or tactile warning signal to indicate a determined physiological state change, in the event of a positive determination of said physiological state change.
209UKPD 2004.03.0] Specification
15. A computer (4, 5) of one of claims 13 to 14 adapted to determine a physiological state change from said measurement values by determining whether said measurement values pass at least one measurement value change criterion.
16. A computer (4, 5) of claim 15, said at least one measurement value change criterion including a measurement value change exceeding a predetermined change limit, and such measurement value change being measurement value change limit duration, and within a predetermined change time limit of at least a current time or a most recent measurement value.
] 7. A computer (4, 5) of claim 15, said at least one measurement value change criterion including a measurement value change exceeding a predetermined limit relationship of measurement value change versus measurement value change duration within a predetermined change time limit of at least a current time or a most recent measurement value.
18. A computer (4, 5) of one of claims 13 to 17 adapted to perform substantially a smoothing of said received data or determining a data trend from said received data, analysis thereof being performed on smoothed data or a data trend therefrom.
19. An at least partially wearable body parameter recording means (]) of any one of claims 1 to 12, and the computer (4, 5) of any one of claims 13 to 18.
20. A computer program for the computer (4, 5) of any one of claims 13 to 18, adapted to control said computer (4, 5) to determine a physiological state change from body parameter measurement values from an at least partially wearable body parameter recording means (1), and to trigger a warning signal in the event of a positive determination of said physiological state change.
21. The at least partially wearable body parameter recording means (1) of anyone ofclaims I to 12 comprising acomputer(4,5)ofany one ofclaims 13to 18.
22. A computer program for the computer (4, 5) of any one of claims 13 to 18 or for the computer (4, 5) ol recording means of the claim 21, adapted to control said computer (4, 5) to determine a physiological state change from body parameter measurement values from an at least partially wearable body parameter
209UKPD 2004.03.01 Specification
recording means ( T), and to trigger a warning signal in the event of a positive determination of said physiological state change.
23. A reader for reading measurement values from the recording means of any one of any one of claims I to 12 or claim 21, or to the computer (4, 5) of any one of claims 13 to 18 adapted to read measurement values therefrom for use in determining a physiological state change such that in the event of a positive determination of said physiological state change a warning signal may be triggered.
24. A band, watch, clasp, strap, bracelet or anklet for an arm or a leg for the recording means of one of any one of claims I to] 2 and claim 19 or for the recorder and computer (4, 5) comprised therein of claim 21.
25. A method of use of the at least partially wearable body parameter recording means ( I) of any one of claims] to 12, and the computer (4, 5) of any one of claims 13 to 18, having the steps of: removably attaching said wearable body parameter recording means (1) to a body; activating said wearable body parameter recording means (l) to take measurements of at least one body parameter and to store measured body parameter measurements; allowing said wearable body parameter recording means (1) to provide body parameter measurements to said computer (4, 5); allowing said computer (4, 5) to determine a physiological state change from the provided stored body parameter measurements and to trigger a warning signal in the event of a positive determination of said physiological state change.
26. A method of operation of the at least partially wearable body parameter recording means (1) of any one of claims I to 12 and the computer (4, 5) of any one of claims 13 to l 8 having the steps of: taking measurements of at least one body parameter and storing respective measurement values with said wearable body parameter recording means (l); providing stored measurement values to said computer (4, 5); reading said provided stored measurement values with said computer (4, 5); determining a physiological state change from said provided stored measurement values; and in\
209UKPD2004.03.0] Specification
generating an alarm signal in the event of a positive determination of said physiological state change.
27. A computer program for controlling a computer (4. 5) of any one of claims 13 to 18 to perform the method having the steps of: reading stored body parameter measurement values from an at least partially wearable body parameter recording means ( 1) adapted to take body parameter measurements and to store said body parameter measurements; determining a physiological state change from said provided stored measurement values; and generating an alarm signal in the event of a positive determination of said physiological state change for a user.
-0 -_ _ 1 1 _ _ Lie _ _ 1 _ _ _ 1 1 _.... _ _ to l L _ 40. UIIIIJULl plut;lalil lUI UIIUU11111 Ills aL JaOL pallally vr"lavl vvv' parameter recording means (1) of any one of claims I to 12 to perform the method having the steps of: taking body parameter measurements; storing body parameter values relating to the body parameter measurements; permitting the computer (4, 5) of the second aspect to access the at least partially wearable body parameter recording means ( I); and permitting said computer (4, 5) to obtain stored body parameter values.
29. A computer (4, 5) interface for the computer program of claim 20, adapted to provide at least a graphical representation of body parameter values and at least a graphical or audio signal in the event of a positive determination of a physiological state change.
30. At least one computer (4, 5) readable medium having the computer program of any one of claim 20, claim 22, claim 27 and claim 28 encoded therein.
31. At least one network data signal having the computer program of any one of claim 20, claim 22, claim 27 and claim 28 encoded therein.
32. At least one data signal from the at least partially wearable body parameter recording means ( 1) of any one of claims I to 12. 2-
209UKPD 2004.03.()1 Specification
33. An at least partially wearable body parameter recording means (1) for providing a warning in the event of a physiological health state change as hereinbefore described with reference to figures lto 8.
34. A computer (4, 5) adapted to receive body parameter data and provide a warning in the event of a physiological health state change as hereinbefore described with reference to figures l to 8.
35. The at least partially wearable body parameter recording means (1) of claim 33 'it}h the computer t4, 5> of clairr 34.
36. A computer program for the computer (4, 5) of claim 34.
3 /. T he al icasl parciaily wearable body pa,aii.ici,-ecoi-di-,lg r;, eals (. J O1 claim 33 with the computer program of claim 34 38. At least one computer (4, 5) readable medium or signal having the computer program of claim 36 stored thereon. -2 3
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