Classifications

• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/02—Food
  • G01N33/04—Dairy products
  • G01N33/06—Determining fat content, e.g. by butyrometer
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/42—Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
  • A61B5/4261—Evaluating exocrine secretion production
  • A61B5/4288—Evaluating exocrine secretion production mammary secretions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
  • A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
  • A61B5/4312—Breast evaluation or disorder diagnosis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J13/00—Breast-nipple shields
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/06—Milking pumps
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01J—MEASUREMENT OF INTENSITY, VELOCITY, SPECTRAL CONTENT, POLARISATION, PHASE OR PULSE CHARACTERISTICS OF INFRARED, VISIBLE OR ULTRAVIOLET LIGHT; COLORIMETRY; RADIATION PYROMETRY
  • G01J3/00—Spectrometry; Spectrophotometry; Monochromators; Measuring colours
  • G01J3/46—Measurement of colour; Colour measuring devices, e.g. colorimeters
  • G01J3/50—Measurement of colour; Colour measuring devices, e.g. colorimeters using electric radiation detectors
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
  • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
  • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
  • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
  • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
  • G01N21/59—Transmissivity
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/0045—Devices for taking samples of body liquids
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/33—Controlling, regulating or measuring
  • A61M2205/3306—Optical measuring means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2230/00—Measuring parameters of the user
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N2201/00—Features of devices classified in G01N21/00
  • G01N2201/06—Illumination; Optics
  • G01N2201/061—Sources
  • G01N2201/06113—Coherent sources; lasers
  • G01N2201/0612—Laser diodes

Definitions

• This invention relates to a method of providing an indication as to the amount of milk remaining in a breast during lactation based on a determined fat content of milk that has been expressed from the breast.
• the invention also relates to a unit for carrying out the method that is attachable to a breast pump and, to a breast pump incorporating such a unit.
• breast milk is a solution with 87% ⁇ 88% water, ⁇ 4% fat, ⁇ 7% lactose and ⁇ 1% protein and other minerals.
• the fat is insoluble in water and so takes the form of fat globules suspended in the water.
• the fat globules have an average diameter of 4 ⁇ . These are the largest particles present in breast milk.
• Proteins, such as casein protein, are also present in particle form, but much smaller 0.005 ⁇ -0.3 ⁇ . Other constituents of the breast milk are dissolved in the water and so have no significant particle presence.
• Another method of determining when a breast is empty is to estimate the breast volume using a breast imaging technique.
• the shape of the breasts will naturally change as they are emptied and this is a difference visible from the exterior.
• centrifuge nor the breast imaging methods are suitable for regular, everyday use as they require equipment and processes that are complex, costly and inconvenient and which cannot be carried out quickly and easily in real time and on a sample of milk that has only just been expressed from the breast and whilst the breast pump is still in use.
• a method of providing an indication as to the amount of milk remaining in a breast during lactation based on a determined fat content of milk that has been expressed from said breast wherein the method of determining said fat content comprises measuring an optical characteristic of milk during expression and by comparing said measured optical characteristic with data representing a corresponding optical characteristic of a sample of milk having a known fat content to determine the fat content of said expressed milk, and determining an indication of the amount of milk remaining in the breast from the determined fat content of said expressed milk.
• the method includes the step of applying an algorithm to determine the fat content of expressed milk based on said comparison of the measured optical characteristic and said corresponding optical characteristic of a sample of milk having a known fat content to determine the fat content of said expressed milk.
• the step of measuring an optical characteristic of the expressed milk comprises the step of illuminating a portion of milk using a light source and using an RGB sensor to detect the color of the expressed milk and subsequently comparing said measured color with the color of a sample of milk having a known fat content to determine the fat content of said expressed milk which is indicative of the amount of milk remaining in the breast.
• the step of measuring an optical characteristic of the expressed milk comprises the step of illuminating milk following expression using a light source and using a sensor to detect the amount of light that is absorbed by said expressed milk, and subsequently comparing said measured absorption with data representing the absorption of a sample of milk having a known fat content to determine the fat content of said expressed milk which is indicative of the amount of milk remaining in the breast.
• the step of using a sensor to detect the amount of light that is absorbed by the expressed milk comprises the step of illuminating the expressed milk with light of a predetermined wavelength and which is known to be scattered or absorbed by globules of fat contained in expressed milk, detecting the amount of light transmitted through said milk and comparing said measured amount of transmitted light with data representing the amount of light transmitted through a sample of milk having a known fat content to determine the fat content of said expressed milk which is indicative of the amount of milk remaining in the breast.
• This embodiment may further include the step of illuminating a portion of expressed milk with multiple light sources that emit light of different wavelengths and using multiple sensors to detect the amount of light of each wavelength that is transmitted through the expressed milk, and comparing said measured amount of transmitted light with the amount of light transmitted through a sample of milk having a known fat content to determine the fat content of said expressed milk which is indicative of the amount of milk remaining in the breast.
• the step of measuring an optical characteristic of the expressed milk comprises the step of illuminating a portion of expressed milk using a light source and using a sensor to detect attenuation of the light by said expressed milk, and subsequently comparing said measured attenuation with data representing the attenuation of a sample of milk having a known fat content to determine the fat content of said expressed milk which is indicative of the amount of milk remaining in the breast.
• multiple sensors may be used to detect light transmitted through the expressed milk and light which is scattered by said expressed milk and comparing the detected light with light received by a control detector that has not been incident on the expressed milk.
• This embodiment may include a beam splitter positioned in the path of the light emitted from the light source such that a portion of the light emitted therefrom towards the expressed milk is directed towards the control detector.
• the method includes the step of informing the user of the determined fat content of the expressed milk or other indicia representative of the amount of milk remaining in said breast based on the determined fat content, such that the user may control pumping in dependence on said information.
• the method may further comprise the step of supplying a signal representative of the determined fat content of the expressed milk to a control unit, said control unit being operable to automatically control pumping in dependence on said signal.
• a device for providing an indication as to the amount of milk remaining in a breast during lactation based on a determined fat content of milk that has been expressed from said breast said device being releasably attachable to a breast pump and operable to measure an optical characteristic of milk as it is expressed from a breast and for comparing said measured optical characteristic with a corresponding optical characteristic of a sample of milk having a known fat content to determine the fat content of said expressed milk and determine an indication of the amount of milk remaining in the breast from the determined fat content of said expressed milk.
• a breast pump may be provided which comprises the unit.
• the breast pump comprises a breast shield for insertion of a breast into the breast pump during use, said unit being releasably attachable to said breast shield.
• the breast shield may have a bulge or recess therein to receive and temporarily retain or buffer a sample of milk, said unit being operable to measure an optical characteristic of the milk in said bulge or recess when said unit is attached to said breast pump.
• Fig. 1 shows a method drawing of a light source and an optical sensor adjacent to a fluid flow.
• Fig. 2 shows a method of using a pair of light sources and a corresponding pair of optical sensors located on opposite sides of a fluid flow.
• Fig. 3 shows a method comprising a light sources and a plurality of optical sensors located around a fluid flow.
• Fig. 4 shows a perspective view of a typical breast pump assembly.
• One of the results of this is a change in color of the breast milk as the fat content changes.
• Figure 1 shows a light source 2, an optical sensor 3 and fluid flow 1.
• the fluid flow 1 represents breast milk that has just been expressed from a breast and has entered a breast pump (not shown).
• the light source 2 may be any electrical device that can produce the required light, such as a white (broad spectrum) LED.
• the optical sensor 3 is configured to detect the color composition of the light after it has been reflected by the fluid flow 1 and can be any type of color sensing element, such as an RGB sensor which outputs numerical data relating to the composition of the color in terms of the red, green and blue elements of the light.
• the output signal from the optical sensor 3 is transmitted to a control unit (not shown), which compares the signal to known data and informs the user as to the amount of milk remaining in their breast based on the data comparison, thereby enabling them to vary pumping accordingly.
• the breast pump may be controlled automatically in dependence on the output from the sensor 3 and comparison with known data.
• the light source 2 and the optical sensor 3 are shown as separate parts and are positioned alongside the fluid flow, adjacent to each other. However, it will be appreciated that the light source 2 and optical sensor 3 might be arranged differently, anywhere in the area around the fluid flow 1 , and may even be combined into one component with a dual function of emitting light and detecting the color of the fluid flow.
• Figure 2 shows another embodiment of the method comprising two light sources 4, 5 with two optical sensors 6, 7 positioned on an opposite side of the fluid flow 1 from the light sources 4, 5.
• the light sources 4, 5 produce light, with a controlled wavelength respectively, directed towards the fluid flow 1.
• the optical sensors 6, 7, positioned on the opposite side of the fluid flow 1, detect the light after it has passed through the fluid flow 1. It is configured such that the first optical sensor 6 exclusively detects light from the first light source 4, and the second optical sensor 7 exclusively detects light from the second light source 5.
• the fluid flow 1 is representative of breast milk that has just been expressed from a breast and has entered a breast pump (not shown).
• the wavelengths of the light emitted by the light sources so that they are particularly vulnerable to absorption or scattering by the fat globules in the breast milk, but avoid, as much as possible, scattering by other constituents of the breast milk.
• the fat globules are typically 1.5 ⁇ - 12 ⁇ in diameter, with an average of 4.5 ⁇ .
• Breast milk also contains casein protein particles which can scatter or absorb light. However, casein particles cannot be used to give an indication of the emptiness of the breasts because the percentage casein content of breast milk is fairly constant throughout a feeding session.
• the wavelengths of the light emitted from the light sources 4, 5 can be selected such that the absorption and scattering caused by the fat globules can be distinguished from the absorption and scattering caused by the casein particles.
• the first and second light sources 4, 5 comprise laser diodes and the first and second optical sensors 6, 7 comprise photodiodes.
• the first and second laser diodes 4, 5 emit light of different wavelengths to increase the reliability of the readings and account for the variation in fat globule size.
• the first and second photodiodes 6, 7 detect the light, after it has been altered by the breast milk 1, and in cooperation with a control unit (not shown); can identify the amount of light that has been absorbed by the fat globules in the breast milk 1.
• the control unit can compare the measurements to empirical results and use an algorithm to determine the fat content of the breast milk. This information can be used to detect the amount of milk remaining in the breast and inform the user or actuate some control action in the breast pump.
• Figure 3 shows a third embodiment of the method, comprising one light source 8, four optical sensors 9,10,11,12 and a beam splitter 16, arranged around the fluid flow 1.
• the light source 8 is a laser diode and the optical sensors 9,10,11,12 are photodiodes.
• the fluid flow 1 is breast milk expressed from a breast and having entered a breast pump (not shown).
• the optical sensors 9,10,11,12 are configured to detect the light scattering rate caused by the fat globules in the breast milk 1 - the turbidity of the breast milk 1.
• Turbidity is an optical characteristic that indicates haziness or cloudiness of a fluid caused by individual particles. It is known to measure the turbidity of a fluid by measuring the attenuation and/or scattering of light, as the light is transmitted through the fluid. As described earlier, breast milk contains fat globules and so the amount of light scattered as the light passes through the breast milk will give a measurement of the fat content of the breast milk. If more fat globules are present, more light will be scattered.
• the laser diode 8 and the beam splitter 16 are configured such that the light emitted from the laser diode 8 is split into two portions, one of which is directed into the first photodiode 9, the other of which is directed towards the flow of breast milk 1.
• the measurement value of the first photodiode 9, detecting the first part of the split portion of light from the laser diode 8, acts as a control measurement.
• the second photodiode 10 is configured to give a measurement of the attenuation of the light, compared to the
• the turbidity, and therefore fat content, of the breast milk 1 can be determined by comparing the following ratios to each other and to empirically derived constants:
• Figure 4 shows a typical breast pump assembly 13 having a breast receiving shield 15 that narrows to a cylindrical portion 14 which connects the breast receiving shield 15 to the body 20 of the breast pump and a milk collecting container 21.
• the cylindrical portion 14 may have a deformity, bulge or other formation 14a to which an optical sensor, such as a sensor described with reference to Figures 1 to 3 can be attached.
• an optical sensor such as a sensor described with reference to Figures 1 to 3 can be attached.
• This is the preferred location for the sensor, as it is advantageous for the breast milk to be analyzed by the sensor immediately upon, or very shortly after, leaving the breast and before it is mixed with the breast milk already in the milk collecting container 21 to allow changes in breast milk fat content to be detected with the greatest degree of accuracy.
• the sensors may be removably mounted to the breast pump to allow their removal prior to cleaning of the breast pump.
• breast milk flows along the cylindrical portion 14 and a sample of it will pass through the deformity or bulge 14a which provides a buffer area because the milk that passes through this region may be less turbulent relative to the milk passing through the cylindrical portion 14, making it easier to analyses.
• the device for measuring a change in the optical characteristic of the expressed milk is mounted to the outside of the breast shield, then the breast shield, or at least a portion of the breast shield in the vicinity of the bulge 14a, must be formed from a transparent material that will have little or no effect on the light passing through it into the milk being analyzed.
• the sensors generate a signal which is fed back to either the user or to a breast pump control unit.
• a user interface might inform the user when the amount of milk remaining in the breast is low or empty. For example, a series of lights or other indicia may be displayed to indicate the amount of milk remaining in the breast based on the determined measurements.
• the breast pump control unit might use the measurements to determine if the pumping power is sufficient and to increase or decrease the power as appropriate. It may also automatically stop pumping if the measurements indicate that the breast is empty or only a small amount of milk remains in the breast.

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• Health & Medical Sciences (AREA)
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• Endocrinology (AREA)
• Gynecology & Obstetrics (AREA)
• External Artificial Organs (AREA)
• Investigating Or Analysing Materials By Optical Means (AREA)
• Measuring And Recording Apparatus For Diagnosis (AREA)
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Citations (8)

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• 2011
  • 2011-12-22 EP EP11195114.1A patent/EP2606816A1/en not_active Withdrawn
• 2012
  • 2012-12-14 RU RU2014130083A patent/RU2621397C2/ru active
  • 2012-12-14 WO PCT/IB2012/057314 patent/WO2013093739A1/en not_active Ceased
  • 2012-12-14 EP EP12818618.6A patent/EP2793686B1/en active Active
  • 2012-12-14 EP EP20172626.2A patent/EP3721791B1/en active Active
  • 2012-12-14 IN IN4969CHN2014 patent/IN2014CN04969A/en unknown
  • 2012-12-14 JP JP2014548283A patent/JP6185480B2/ja not_active Expired - Fee Related
  • 2012-12-14 BR BR112014015151A patent/BR112014015151A2/pt not_active Application Discontinuation
  • 2012-12-14 CN CN201280070401.3A patent/CN104271032B/zh active Active
  • 2012-12-14 US US14/367,491 patent/US9535047B2/en active Active

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