Device to measure analytes in the skin

• US 11,389,114 B2
• Filed: 12/20/2013
• Issued: 07/19/2022
• Est. Priority Date: 01/02/2013
• Status: Active Grant

• Current Assignee: Fibrotx Oue
• Original Assignee: FIBROTX OU{umlaut over ( )}
• Inventors: Neuman, Toomas, Kazarjan, Aram
• Primary Examiner(s): Cheng, Jacqueline
• Assistant Examiner(s): Portillo, Jairo H
• Application Number:
  US14/655,850
• Publication Number:
  US 20150335287A1
• Time in Patent Office: 3,133 Days
• Field of Search: None
• 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 comprising layers in the following order:

a membrane layer (101, 601) for retaining one or more analyte(s) from a body of a subject with skin, the membrane layer (101, 601) having a first and a second side, wherein the first side is in fluid communication with the skin of the subject, wherein the membrane layer (101, 601) has an area and is non-expandable, and wherein the membrane layer (101, 601) comprises one or more distinct capture section(s) with affinity molecule(s) for selectively retaining one or more analyte(s);

an expandable layer (103, 603), wherein said expandable layer applies a pressure, which is evenly distributed over the entire membrane layer;

an adhesive layer (104);

which ensures that the patch can be reversibly fastened to the skin of a subject;

a backing layer (606);

wherein said membrane layer is facing the skin and said backing layer (606) is facing away from the skin; and

wherein said adhesive layer is protected by a peelable layer (611).

2. The dermal patch according to claim 1 wherein the expandable layer (103, 603) presses and moisturizes the membrane layer (101, 601).

3. The dermal patch according to claim 1 wherein a moisture layer (605) is in fluid communication with the membrane layer (101, 601).

4. The dermal patch according to claim 3, wherein the moisture layer (605) is in fluid communication with the membrane layer (101, 601) and is the same layer as the expandable layer (103, 603).

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

6. 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).

7. The dermal patch according to claim 6 wherein the backing layer will not absorb aqueous liquid.

8. The dermal patch according to claim 1 wherein the expandable layer (103, 603) has an area that completely encompasses the membrane layer (101, 601) and wherein the expandable layer (103, 603) has an area that 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 at least four distinct capture sections for selectively retaining the one or more analyte wherein each of the at least four distinct capture sections immobilize at least four different affinity molecules.

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

12. A 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 a subject'"'"'s skin and activating the expandable layer of the patch;

d) leaving the patch on the skin for a period of time;

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.

13. A method according to claim 12 additionally comprising:

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

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

14. The method according to claim 12 wherein the one or more analytes to be measured comprise at least one or more of the following group of analytes:

extracellular matrix protein, anti-microbial peptides (AMP), interleukins, growth factors and chemokines.

15. A kit for determining the effect of a topical treatment comprising at least two patches according to claim 1, and an activation liquid wherein the activation liquid activates the expandable layer and wets the membrane layer.

16. The dermal patch according to claim 1, further comprising a membrane holding layer (102, 602).

17. The dermal patch according to claim 16, wherein the membrane holding layer (102, 602) is made out of the same material as the membrane layer (101, 601), and where the membrane holding layer (102, 602) is not attached to the expandable layer (103, 603).

18. The dermal patch according to claim 16, wherein the membrane holding layer (102, 602) is an adhesive.

19. The dermal patch according to claim 1 wherein the one or more distinct capture section(s) has an area that is less than 0.01 cm².

20. The dermal patch according to claim 1 wherein the one or more distinct capture section(s) has an area that is less than 0.003 cm².