# US 2020/0393384 A1 · pH RESPONSIVE MATERIALS FOR OPTICAL MONITORING OF WOUND STATUS

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- Number: US 2020/0393384 A1
- Document ID: US20200393384A1
- Status: Published application
- Kind: A1
- Application number: 16/901,241
- Filed: 2020-06-15
- Published: 2020-12-17
- Earliest claimed: 2019-06-14
- Applicants: Qualizyme Diagnostics GmbH & Co. KG
- Inventors: Clemens GAMERITH
- Web page: https://patentgrep.com/patent/US20200393384A1

## CPC

- A61B 5/445: {Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore}
- G01N 21/80: Indicating pH value
- A61F 13/00051: {Accessories for dressings}
- A61L 15/225: {Mixtures of macromolecular compounds}
- A61L 15/42: Use of materials characterised by their function or physical properties (liquid bandages A61L26/00)
- A61L 15/56: Wetness-indicators or colourants
- C07F 7/0836: {Compounds with one or more Si-OH or Si-O-metal linkage}
- A61B 10/0045: {Devices for taking samples of body liquids}
- A61B 2010/0006: {involving a colour change}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- C07F: ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM (metal-containing porphyrins C07D487/22)

## Abstract

The disclosed technology relates to materials for the detection of wounds, e.g., chronic wounds or infected wounds, including compositions, substrates, kits, dressing materials, and articles, and systems containing such compounds. The disclosed technology further relates to methods of using these compositions, kits and systems in the diagnosis and/or detection of chronic or infected wounds based measurement of pH. Additional disclosure relates to methods of characterizing wounds based on pH of wounds or wound fluids and using such information to treat, manage, and follow-up patients suffering from chronic or infected wounds.

## Claims

### Claim 1

A pH responsive material, comprising;
an anchor material;
a linking moiety; and
a pH responsive element.

### Claim 2 (depends on 1)

The pH responsive material of claim 1, wherein the linking moiety connects the anchor material and the pH responsive element via covalent bonds.

### Claim 3 (depends on 1)

The pH responsive material of claim 1, wherein the anchor material comprises OH-bearing surfaces.

### Claim 4 (depends on 1)

The pH responsive material of claim 1, wherein the anchor material comprises a polysaccharide, a cellulose, or a monomer thereof, an oligomer thereof, a derivative thereof, a mixture or a combination thereof.

### Claim 5 (depends on 1)

The pH responsive material of claim 1, wherein the anchor material comprises a polysaccharide selected from hydroxypropyl methylcellulose (HPMC), hydroxyethyl cellulose, hydroxymethyl cellulose, D-galactopyranoside, or a derivative thereof.

### Claim 6 (depends on 1)

The pH responsive material of claim 1, wherein the anchor material is a solid support formed from one or more of cotton, paper, filter paper, a chip, a pin, a slide, a membrane, a bead, a cotton swab, a wound dressing, or a particle.

### Claim 7 (depends on 1)

The pH responsive material of claim 1, wherein the anchor material is a solid support comprising a cellulose particle formed from a particle size of up to about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, or 100 μm.

### Claim 8 (depends on 1)

The pH responsive material of claim 1, wherein the linking moiety is a siloxane monomer or polymer thereof that comprises one or more monomers selected from GPTMS, Diethoxy(3-glycidyloxypropyl)methylsilane, 3-Glycidoxypropyldimethoxymethylsilane, 2-(3,4-epoxycyclohexyl)ethyltriethoxysilane, 2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane, or combinations thereof.

### Claim 9 (depends on 1)

The pH responsive material of claim 1, wherein the pH responsive element presents a visible color change at a pH of about 7.0.

### Claim 10 (depends on 1)

The pH responsive material of claim 1, wherein the pH responsive element is selected from thymol blue, bromophenol blue, bromocresol green, bromocresol purple, bromothymol blue, phenol red, napththolpthalein, cresol red, cresolpthalein, phenolphthalein, or thymolpthalein.

### Claim 11 (depends on 1)

The pH responsive material of claim 1, wherein the pH responsive element is a pH indicator comprising multiple phenol functional groups.

### Claim 12

A pH responsive material having the structure:
wherein;
A is cellulose or a cellulose polymer; and
each R1 is independently H or one or more functionalized or non-functionalized GPTMS monomers or a combination thereof.

### Claim 13 (depends on 12)

The pH responsive material of claim 12, wherein the cellulose or cellulose polymer is a cellulose particle having a particle size of about 20 μm.

### Claim 14 (depends on 12)

The pH responsive material of claim 12, wherein the cellulose or cellulose polymer is a cellulose particle incorporated into a medical or diagnostic device by spraying, printing, or depositing the cellulose particle.

### Claim 15 (depends on 26)

The pH responsive material of claim 26, wherein the cellulose or cellulose polymer is a cellulose particle sprayed, printed, or deposited on a solid phase of the medical or diagnostic device, the solid phase comprising a dressing, a wound dressing, a bandage, filter paper, or a test strip.

### Claim 16

A method of making a pH responsive material comprising the steps of:
dissolving a linking moiety in an acidic solution;
immersing an anchor material in the acidic solution;
drying the anchor material; and
soaking the anchor material in a solution comprising a pH responsive element.

### Claim 17 (depends on 16)

The method of claim 16, wherein the linking moiety is a silane reagent comprising an epoxide functional group.

### Claim 18 (depends on 16)

The method of claim 16, further comprising a silane reagent selected from GPTMS, Diethoxy(3-glycidyloxypropyl)methylsilane, 3-Glycidoxypropyldimethoxymethylsilane, 2-(3,4-epoxycyclohexyl)ethyltriethoxysilane, 2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane, or combinations thereof.

### Claim 19 (depends on 16)

The method of any of claim 16, wherein the anchor material is immersed in the acidic solution for at least about 5, 10, 15, 20, 25, or 30 minutes.

### Claim 20 (depends on 16)

The method of any of claim 16, wherein the acidic solution is at a temperature of at least about 60, 70, 80, 90, 100, 110, or 120° C.