Traitement en cours

Veuillez attendre...

Paramétrages

Paramétrages

Aller à Demande

1. WO2020157751 - PROCÉDÉS ET DISPOSITIF DE DÉTERMINATION DE L'EFFICACITÉ DE LA LACTATION

Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

[ EN ]

CLAIMS:

1. A method for determining inadequate lactation in a female subject, the method comprising:

-determining an expression of a physicochemical parameter of a breast milk sample obtained from the subject at a time point after delivery, and

-determining whether the subject is inadequately lactating by comparing the expression of the physicochemical parameter of the breast milk sample with an expression of the physicochemical parameter of breast milk sample(s) obtained from adequately lactating subjects at the same time point after delivery or by comparing a change in expression of a physicochemical parameter of two or more breast milk samples obtained at two or more time points, with a change of an expression of the physicochemical parameter of breast milk sample(s) obtained from adequately lactating subjects, at the two or more time points;

wherein inadequate lactation comprises or is associated with reduced lactation efficiency, delayed lactogenesis II (DLII), inadequate lactogenesis III or reduced milk production.

2. A method for determining inadequate lactation in a female subject, the method comprising:

-determining an expression of a physicochemical parameter of a breast milk sample obtained from the subject at a time point after delivery,

-determining an expression of the physiochemical parameter of breast milk sample(s) obtained from adequately lactating subjects at the time point, and

-determining whether the subject is inadequately lactating;

wherein inadequate lactation comprises or is associated with reduced lactation efficiency, delayed lactogenesis II (DLII), inadequate lactogenesis III or reduced milk production.

3. A method for determining inadequate lactation in a female subject, the method comprising

-determining an expression of a physicochemical parameter of a breast milk sample obtained from the subject at a time point after delivery, and

-determining whether the subject is inadequately lactating by comparing the expression of the physicochemical parameter of the breast milk sample with an expression of the physicochemical parameter of breast milk sample(s) obtained from adequately lactating subjects at the time point or by comparing a change in expression of a physicochemical parameter of two or more breast milk samples obtained at two or more time points, with a change of an expression of the physicochemical parameter of breast milk sample(s) obtained from adequately lactating subjects, at the two or more time points, wherein when the expression of the physicochemical parameter measured for the breast milk sample and the expression of the physicochemical parameter predetermined for the control population at the same time point after delivery are not the same, the female subject has inadequate lactation;

wherein inadequate lactation comprises or is associated with reduced lactation efficiency, delayed lactogenesis II (DLII), inadequate lactogenesis III or reduced milk production.

4. A method for determining inadequate lactation in a female subject, the method comprising

-determining an expression of a physicochemical parameter of a breast milk sample obtained from the subject at a time point after delivery, and

-determining whether the subject is inadequately lactating by comparing the expression of the physicochemical parameter of the breast milk sample with an expression of the physicochemical parameter of breast milk sample(s) obtained from adequately lactating subjects at the time point or by comparing a change in expression of a physicochemical parameter of two or more breast milk samples obtained at two or more time points, with a change of an expression of the physicochemical parameter of breast milk sample(s) obtained from adequately lactating subjects, at the two or more time points; wherein when the expression of the physicochemical parameter measured for the breast milk sample and the expression of the physicochemical parameter predetermined for the control population are same, or the physicochemical parameter for the breast milk sample is within 1.285SD (standard deviation) of the expression of the same physicochemical parameter predetermined for the control population for the same time point, the female subject has adequate lactation;

wherein inadequate lactation comprises or is associated with reduced lactation efficiency, delayed lactogenesis II (DLII), inadequate lactogenesis III or reduced milk production.

5. A method for determining status of lactation in a female subject at a time point after delivery, the method comprising:

-determining whether an expression of a physicochemical parameter of a breast milk sample obtained from the subject at a time point after delivery is different from an expression of the physicochemical parameter of breast milk sample(s) obtained from a control population of lactating subjects at the same time point,

wherein if the expression of the physicochemical parameter of the breast milk sample obtained from the subject is different from the expression of the same physicochemical parameter of breast milk sample(s) obtained from the control population, the female subject is regarded as having reduced lactation efficiency, delayed lactogenesis II (DLII), inadequate lactogenesis III or reduced milk production.

6. The method according to any one of claims 1 to 5, comprising obtaining at least one breast milk sample from a female subject or obtaining at least one breast milk sample from one or both breasts of the female subject.

7. The method according to claim 6, comprising obtaining multiple milk samples from the subject at different time points, optionally wherein at least some of the multiple samples obtained at different time points are obtained from either or both breasts of the female subject.

8. The method according to any one of claims 1 to 7, comprising measuring the physicochemical parameter of the milk sample obtained from the female subject at a time point between delivery and 14 days after delivery.

9. The method according to any one of claims 1 to 8, wherein the physicochemical parameter is at least one of (i) electrical resistivity, (ii) electrical conductivity, (iii) an amount of an electrolyte, (iv) an amount of a protein and (v) an amount of a sugar.

10. The method according to claim 9, wherein the at least one physicochemical parameter is electrical resistivity or electrical conductivity.

11. The method according to any one of claims 1 to 10, comprising calibrating and/or normalization the measured physicochemical value.

12. The method according to any one of claims 1 to 5, for early diagnosis of inadequate lactation.

13. The method according to claim 12, for early diagnosis of at least one of reduced lactation efficiency, delayed lactogenesis II (DLII), inadequate lactogenesis III or reduced milk production, the method comprising

- determining an expression of at least one of electrical resistivity or electrical conductivity of a breast milk sample obtained from the subject at a time point between delivery and 14 days after delivery, and

- determining whether the subject is suffering from at least one of reduced lactation efficiency, delayed lactogenesis II (DLII), inadequate lactogenesis III or reduced milk production, by comparing the expression of at least one of electrical resistivity or electrical conductivity of the breast milk sample with an expression of at least one of electrical resistivity or electrical conductivity of breast milk sample(s) obtained from adequately lactating subjects at the time point,

- wherein when the expression of least one of electrical resistivity or electrical conductivity measured for the breast milk sample and the expression of the of least one of electrical resistivity or electrical conductivity predetermined for the control population are not the same, the female subject is suffering from at least one of reduced lactation efficiency, delayed lactogenesis II (DLII), inadequate lactogenesis III or reduced milk production.

14. The method according to claim 12, for early diagnosis of at least one of reduced lactation efficiency, delayed lactogenesis II (DLII), inadequate lactogenesis III or reduced milk production, the method comprising

- determining an expression of at least one of electrical resistivity or electrical conductivity of a breast milk sample obtained from the subject at a time point between delivery and 5 days after delivery, and

- determining whether the subject is suffering from at least one of reduced lactation efficiency, delayed lactogenesis II (DLII), inadequate lactogenesis III or reduced milk production, by comparing the expression of at least one of electrical resistivity or electrical conductivity of a breast milk sample with an expression of at least one of electrical

resistivity or electrical conductivity of breast milk sample(s) obtained from adequately lactating subjects at the same time point,

wherein when the expression of the at least one of electrical resistivity or electrical conductivity measured for the breast milk sample and the expression of the at least one of electrical resistivity or electrical conductivity predetermined for the control population are different, or the physicochemical parameter for the breast milk sample is outside a range defined by a standard deviation value of 1.285SD of the expression of the same physicochemical parameter predetermined for the control population, the female subject is suffering from at least one of reduced lactation efficiency, delayed lactogenesis II (DLII), inadequate lactogenesis III or reduced milk production.

15. The method according to claim 1 , wherein the female subject is suffering from pain, swelling or fever.

16. The method according to claim 15, for determining whether the pain, swelling or fever are associated with inflammation.

17. The method according to claim 15, for determining the likelihood of developing inadequate lactation in a female subject, the method comprising:

-determining an expression of a physicochemical parameter of a breast milk sample obtained from the subject at a time point after delivery and after the development of pain, swelling or fever, and

-determining whether the subject is likely to develop inadequate lactation by comparing the expression of the physicochemical parameter of the breast milk sample with an expression of the physicochemical parameter of breast milk sample(s) obtained from adequately lactating subjects not suffering from pain, swelling or fever, at the same time point after delivery.

18. A device for carrying out a method according to any one of claim 1 to 17.

19. A device for measuring at least one physicochemical parameter in a breast milk sample, the device comprising a chamber configured for holding a breast milk sample, a detector for determining an expression of at least one physicochemical parameter of the breast milk sample, a signal transmitting module and optionally a user interface.

20. The device according to claim 19, comprising a processor and user interface.

21. The device according to any one of claims 18 to 20, wherein the at least one physicochemical parameter is at least one of (i) electrical resistivity, (ii) electrical conductivity, (iii) an amount of an electrolyte, (iv) an amount of a protein and (v) an amount of a sugar.

22. The device according to any one of claims 18 to 21, being a two-part device.

23. The device according to claim 22, comprising an electrical sensor comprising at least one electrode assembly and a reader.

24. The device according to claim 22, comprising a power supply.

25. The device according to claim 23 or 24, wherein the electrode assembly is operably connected to a measurement compartment or any component thereof in a manner that allows transmission of signals between the electrode assembly and the reader.

26. The device according to claim 21, wherein the electrode assembly is configured to measure electrical conductivity or electrical resistivity.

27. A system for determining inadequate lactation in a female subject, the system comprising a device according to any one of claims 18 to 26, a data processing unit and a data interface unit, wherein the data processing unit is configured for data communication with the device and the data interface unit being in data communication with the data processing unit;

wherein the data processing unit comprising data relating to at least one expression of at least one of electrical conductivity or electrical resistivity at various time points after infant birth and is adapted to receiving from the device information relating to at least one expression of electrical conductivity or electrical resistivity of a breast milk sample obtained at the various time point, and provide an indication of adequate or inadequate lactation.

28. A kit for determining inadequate lactation in a female subject, the kit comprising a chamber configured for holding a breast milk sample, a device according to any one of claims 18 to 16 and instruction for use.