Processing

Please wait...

Settings

Settings

Goto Application

1. WO2018150168 - ANALYTE-MONITORING DEVICE

Considered void:  31.07.2019
Note: Text based on automatic Optical Character Recognition processes. Please use the PDF version for legal matters

[ EN ]

CLAIMS

1. An analyte-monitoring device comprising:

a porous membrane layer;

an analyte monitoring means; and

an enzyme deposited on the porous membrane layer and/or the analyte monitoring means;

wherein, when placed on the skin of a patient the membrane layer is an interface between the skin of the patient and the analyte monitoring means.

2. The device of Claim 1 wherein the porous membrane layer comprises or consists of nylon.

3. The device of Claim 1 or 2, wherein the analyte is glucose or lactate.

4. The device of any preceding claim, wherein the device does not comprise a gel.

5. The device of any preceding claim, wherein the device does not comprise a hydrogel.

6. The device of Claims 4 or 5, wherein the porous membrane layer does not include a gel and/or a hydrogel.

7. The device of any preceding claim, wherein the device is configured to continuously monitor the concentration of the analyte in a patient.

8. The device of any preceding claim, wherein the enzyme is glucose oxidase or lactase dehydrogenase.

9. The device of any preceding claim, wherein the enzyme has a concentration range in the porous membrane layer of 0.45 to 0.60 mg/cm2 of membrane surface area for a membrane thickness of 158 to 192 μηι thickness, or 0.45 mg to 0.60 mg per 0.158 μηι3 to 0.192μηι3 of the 3-dimensional porous membrane.

10. The device of any preceding claim wherein the analyte monitoring means includes an electrode, the enzyme being deposited on the electrode.

1 1. The device of any one of Claims 1 to 9, wherein the enzyme is deposited on the membrane layer by being either physically adsorbed on the porous membrane layer or chemically bonded to the porous membrane layer.

12. The device of Claim 1 , wherein the porous membrane layer is a porous hydrophilic polymer layer, optionally wherein the polymer is nylon, preferably nylon 6,6, and more preferably amphoteric nylon 6,6.

13. The device of Claim 1 , wherein the porous membrane layer is a porous hydrophobic, or partially hydrophobic layer, optionally wherein the polymer is chemically or physically treated nylon 6,6, or surface functionalised polyethersulfone.

14. The device of Claim 1 , wherein the porous membrane layer is a 3-dimensional matrix, optionally wherein the 3-dimensional matrix is nylon 6,6, or surface functionalised polyethersulfone.

15. The device of any preceding claim, wherein the porous membrane layer has a thickness of less than 300 μηι.

16. The device of any preceding claim, wherein the pores of the porous membrane layer have an average size of from about 0.1 μηι to about 2.0 μηι, such as from about 0.2 μηι to about 1.0 μηι, preferably from about 0.3 μηι to about 0.5 μηι.

17. The device of any preceding claim, wherein the porous membrane layer and analyte monitoring means are contiguous.

18. The device of any preceding claim, wherein when placed on the surface of the skin of a patient, the porous membrane layer and the surface of the skin are contiguous.

19. The device of any preceding claim, wherein the device comprises means for performing iontophoresis, ultrasound, and/or micro-poration using microneedles or laser light.

20. The device of any preceding claim, wherein the analyte monitoring means comprises a counter electrode and a working electrode, and a reference electrode.

in a patient.

22. A method of monitoring the concentration of an analyte in a patient comprising the steps of:

a) applying a device according to any of Claims 1 to 20 to the skin of the patient such that the porous membrane layer of the device is hydrated and in contact with the skin; b) receiving analyte from the skin into the porous membrane layer;

c) converting the received analyte via the enzyme deposited in the porous membrane layer and/or on the analyte monitoring means; and

d) generating a signal representative of the level of received analyte via the analyte monitoring means.

23. The method of Claim 22, wherein the method involves the step of providing a porous membrane layer comprises or consists of nylon.

24. The method of Claim 22 or 23, wherein the method involves the step of performing iontophoresis or applying ultrasound to the skin, or poration of the skin by laser light or micro needles, in order to receive analyte.

25. The method of Claim 24 wherein the step of performing iontophoresis or applying ultrasound to the skin, or poration of the skin by laser light or micro needles is performed prior to application of the device to the skin.

26. The method of any one of Claims 22 to 25, wherein the analyte is glucose or lactate, comprising the step of oxidising the received glucose or lactate to produce hydrogen peroxide.

27. The method of Claim 26, comprising the step of detecting the level of hydrogen peroxide produced by the analyte monitoring means.