Device to measure analytes in the skin

• US 20150335287A1
• Filed: 12/20/2013
• Published: 11/26/2015
• Est. Priority Date: 01/02/2013
• Status: Active Grant

• Current Assignee: Fibrotx Oue
• Original Assignee: Fibrotx Oue
• Inventors: Neuman, Toomas, Kazarjan, Aram
• Granted Patent: US 11,389,114 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0035 Vaccination diagnosis other than by injuring the skin, e.g. allergy test patches
• CPC Class Codes: A61B 10/0064 for taking sweat or sebum samples measuring sweat production A61B5/4266
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/443 Evaluating skin constituents, e.g. elastin, melanin, water
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61F 13/00051 Accessories for dressings
• CPC Class Codes: A61F 13/00055 Saturation indicators
• CPC Class Codes: A61F 13/00063 comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic drug delivery dressings A61K9/70; chemical aspect of the additives A61L15/00
• CPC Class Codes: A61F 13/0206 with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings
• CPC Class Codes: A61F 2013/0028 applying of mechanical pressure; passive massage
• CPC Class Codes: A61F 2013/0037 for cosmesis
• CPC Class Codes: A61F 2013/00544 form or structure
• CPC Class Codes: A61F 2013/0094 for sensing physical parameters plasters for conducting test A61F2013/00429
• CPC Class Codes: A61F 2013/8473 for diagnostic purposes
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper

Abstract

The present invention provides a dermal patch for selectively retaining one or more analyte(s) from a body of a subject comprising: a membrane layer (101) for retaining one or more analyte(s) from a body of a subject, with a first and a second side, wherein the first side is adapted to be in fluid communication with the skin of the subject; optionally holding means for securing the membrane layer in place; an adhesive layer (104); and a backing layer; wherein between the backing layer and the membrane layer (101) there is an expandable layer (103) for applying pressure to the membrane layer.

Claims

1. A dermal patch for selectively retaining one or more analyte(s) from a body of a subject comprising:

a membrane layer (101, 601) for retaining one or more analyte(s) from a body of a subject, with a first and a second side, wherein the first side is adapted to be in fluid communication with the skin of the subject, wherein the membrane is configured so as not to be expandable;

optionally holding means for securing the membrane layer in place;

an adhesive layer (104);

a backing layer (606);

characterized in that between the backing layer (606) and the membrane layer (101) there is an expandable layer (103) for applying pressure to the membrane layer.

2. The dermal patch according to claim 1, characterized in that the holding means (102, 602) is made out of the same material as the membrane layer (101, 601), and where the holding means is not attached to expandable layer (103, 603).

3. The dermal patch according to claim 1 wherein that the expandable layer (103, 603) is for applying pressure and moisture to the membrane layer.

4. The dermal patch according to claim 1 wherein that there is a moisture layer (605) for applying moisture to the membrane layer (101, 601).

5. The dermal patch according to claim 4, wherein the moisture layer is in fluid communication with the membrane layer (101, 601) is the same layer as the expandable layer (103, 603).

6. The dermal patch according to claim 1 wherein the expandable layer (103, 603) contains compressed cellulose.

7. The dermal patch according to claim 1 wherein the backing layer (606) has an aperture (610) that allows liquid added through the aperture (610) to be in fluid communication with the expandable layer (103, 603) and/or the moisture layer (605).

8. The dermal patch according to claim 1 wherein the area of the expandable layer (103, 603) completely encompass the membrane layer (101, 601) and where the area of the expandable layer (103, 603) is equal to or larger than the area of the membrane layer (101, 601).

9. The dermal patch according to claim 1 wherein the area of the membrane layer (101, 601) is 1 cm² or less.

10. The dermal patch according to claim 1 wherein the membrane layer (101, 601) comprise one or more distinct capture section(s) with affinity molecule(s) for selectively retaining one or more analyte(s), preferably where the area of the capture section is less than 0.01 cm², preferably less than 0.003 cm².

11. The dermal patch according to claim 1 wherein the membrane layer (101, 601) comprise at least four distinct capture sections for selectively retaining the analyte where in each of the at least four distinct capture sections, at least four different affinity molecules have been immobilized.

12. The dermal patch according to claim 1 for use in medicine.

13. Method for measuring the concentration of one or more analytes in a sample comprising the following steps:

a) selecting one or more analytes to be measured;

b) immobilizing onto a membrane in a patch according to claim 1 one or more zones of specific affinity molecules for the selected one or more analytes, and one or more positive and/or negative controls;

c) removably securing the patch of step b) onto the skin of a subject and activate the pressure means;

d) leaving the patch on the skin for the duration of the sampling period;

e) removing the patch from the skin and analysing the membrane to determine the concentration(s) of the selected one or more analytes, and one or more positive and/or negative controls by analysing the one or more zones.

14. Method according to claim 13 additionally comprising:

f) normalising the concentration(s) determined in step e) with the concentration determined for the one or more positive controls

g) comparing the normalised concentration determined under step f) with normalised concentrations from a reference group of subjects.

15. The method according to claim 13 wherein the one or more analytes to be measured comprise at least one or more of the following group of analytes:

extracellular matrix protein (affecting a skin feature), AMP, interleukins, growth factors and chemokines.

16. A kit for determining the effect of a topical treatment comprising at least two patches according to claim 1, and optionally an activation liquid for activating the expandable layer, and wetting the membrane.