# US 11,998,302 B2 · Thermographic device for measurement of differential temperatures in tissue

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- Number: US 11,998,302 B2
- Document ID: US11998302B2
- Status: Granted
- Kind: B2
- Application number: 17/947,512
- Filed: 2022-09-19
- Published: 2023-06-29
- Granted: 2024-06-04
- Earliest claimed: 2017-12-08
- Assignees: Welwaze Medical Inc.
- Applicants: Welwaze Medical Inc.
- Inventors: Samir Mousa
- Web page: https://patentgrep.com/patent/US11998302B2

## CPC

- A61B 5/015: {By temperature mapping of body part}
- A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20)
- A61B 5/4312: {Breast evaluation or disorder diagnosis (optical mammography A61B5/0091)}
- G01K 11/06: using melting, freezing, or softening
- G01K 11/16: of organic materials
- G01K 13/20: Clinical contact thermometers for use with humans or animals
- A61B 10/0041: {Detection of breast cancer (mammography by transillumination A61B5/0091, by X-rays A61B6/502, by ultrasonic means A61B8/0825)}
- A61B 2562/0276: comprising a thermosensitive compound
- A61B 2562/046: in a matrix array
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G01K: MEASURING TEMPERATURE; MEASURING QUANTITY OF HEAT; THERMALLY-SENSITIVE ELEMENTS NOT OTHERWISE PROVIDED FOR (radiation pyrometry G01J5/00)

## Abstract

A thermographic sensing device for measuring temperatures at one or more regions of the human body, particularly the breast, utilizes a thermographic composition deposited into linear arrays of recesses formed in the lobes of a conformable medium which is disposable against the skin. The thermographic composition includes a binary solvent system and at least one colorant, wherein the compositions in each array are formulated to melt at precise temperatures, within a diagnostically temperature relevant range, to change from a first visible color to a second visible color.

## Claims

### Claim 1

A device for measuring temperatures at one or more regions on a human, the device comprising:
a platform having a first surface and a second surface, wherein the platform is shaped to define a plurality of lobe areas wherein each of the plurality of the lobe areas is conformable to a shape of a human breast;
a temperature sensing module disposed on each lobe area of the first surface of the platform, the module comprising:
a heat conducting substrate comprising metallic foil, the substrate having a top surface and a plurality of linear arrays, each array comprising a plurality of spaced apart recesses, defined in the top surface;
a thermographic composition disposed in each recess; and
wherein the thermographic composition comprises:
a binary solvent system comprising relative amounts of ortho-chloronitrobenzene (OCNB) and ortho-bromonitrobenzene (OBNB);
a first dye comprising crystal violet lactone which is present in an amount of 0.1% to 0.3% by weight, based on the total weight of the thermographic composition;
a second dye comprising (1-methylamino)anthraquinone which is present in an amount of 0.04% to 0.05% by weight, based on the total weight of the thermographic composition, or 1-[[4-(phenylazo)phenyl]azo]-2-naphthalenol which is present in an amount of 0.03% to 0.05% by weight, based on the total weight of the thermographic composition; and
an activator comprising bisphenol A and 2,2′, 4′4′-tetrahydroxybenzophenone, each of which is present in an amount of 0.1% to 0.3% by weight, based on the total weight of the thermographic composition, and
wherein the activator also comprises arachidic acid in an amount of 0.01% to 0.03% by weight, based on the total weight of the thermographic composition; and
wherein the relative amounts of OCNB and OBNB determine a melting point of the thermographic composition, and wherein the linear array of spaced apart recesses are radially arranged with respect to a center of the platform, wherein the thermographic compositions in the recesses in any one linear array are identical and have the same melting point, and wherein not all linear arrays have the same melting point
wherein the thermographic composition, when in a solid state, exhibits a first color and, when in a liquid state, exhibits a second color, distinct from the first color, each of the first and second colors being visible to the naked eye.

### Claim 2 (depends on 1)

The device of claim 1, wherein a difference between respective thermographic composition melting points of adjacent linear arrays is in a range of 0.2° F. to 1.0° F.

### Claim 3 (depends on 1)

The device of claim 1, wherein the temperature sensing module covers less than all of the first surface of the platform.

### Claim 4 (depends on 1)

The device of claim 1, wherein alternate linear arrays of recesses have different numbers of recesses.

### Claim 5 (depends on 1)

The device of claim 1, wherein the activator comprises an organic acid having a pKa of about 4 to about 12.

### Claim 6 (depends on 5)

The device of claim 5, wherein the organic acid is selected from the group consisting of phenol, bisphenol A, arachidic acid, pyrocathechol and 3-nitrophenol, and combinations of two or more thereof.

### Claim 7 (depends on 1)

The device of claim 1, wherein the second dye is (1-methylamino)anthraquinone.

### Claim 8 (depends on 1)

The device of claim 1, wherein the second dye is 1-[[4-(phenylazo)phenyl]azo]-2-naphthalenol.

### Claim 9 (depends on 1)

The device of claim 1, further comprising:
a releasable cover layer, having a shape corresponding to the platform, provided over the device and releasably attached to the first surface of the platform by the adhesive at the periphery.

### Claim 10 (depends on 1)

The device of claim 1 in combination with a second device and instructional materials for using the device, wherein the device and second device and instructional materials are packaged as a kit.

### Claim 11 (depends on 1)

The device of claim 1 further comprising a readable data structure disposed on one of the first and second surfaces of the platform.

### Claim 12

A device for measuring temperatures at one or more regions on a human, the device comprising:
a heat conducting substrate comprising metallic foil, the substrate having a top surface and a plurality of linear arrays comprising a plurality of spaced apart recesses defined in the top surface;
a protective layer of material disposed on the top surface of the heat conducting substrate;
a thermographic composition disposed in each recess the thermographic composition comprising:
a binary solvent system comprising relative amounts of ortho-chloronitrobenzene (OCNB) and ortho-bromonitrobenzene (OBNB);
a first dye comprising crystal violet lactone which is present in an amount of 0.1% to 0.3% by weight, based on the total weight of the thermographic composition;
a second dye comprising (1-methylamino)anthraquinone which is present in an amount of 0.04% to 0.05% by weight, based on the total weight of the thermographic composition, or 1-[[4-(phenylazo)phenyl]azo]-2-naphthalenol which is present in an amount of 0.03% to 0.05% by weight, based on the total weight of the thermographic composition; and
an activator comprising bisphenol A and 2,2′, 4′4′-tetrahydroxybenzophenone, each of which is present in an amount of 0.1% to 0.3% by weight, based on the total weight of the thermographic composition, and wherein the activator also comprises arachidic acid in an amount of 0.01% to 0.03% by weight, based on the total weight of the thermographic composition;
wherein the relative amounts of OCNB and OBNB determine a melting point of the thermographic composition, and
wherein the thermographic composition, when in a solid state, exhibits a first color and, when in a liquid state, exhibits a second color, distinct from the first color, each of the first and second colors being visible to the naked eye.

### Claim 13 (depends on 12)

The method of claim 12, wherein the thermographic compositions in the recesses in any one linear array are identical and have a same melting point within a diagnostically relevant temperature range.

### Claim 14 (depends on 12)

The method of claim 12, wherein no two linear arrays contain thermographic compositions with the same melting point.

### Claim 15 (depends on 12)

The method of claim 12, wherein the linear arrays are arranged in an order corresponding to sequentially increasing thermographic composition melting points.

### Claim 16 (depends on 12)

The method of claim 12, wherein the different thermographic composition melting points in the plurality of linear arrays define the diagnostically relevant temperature range.

### Claim 17 (depends on 12)

The device of claim 12, wherein the platform is shaped to define three lobe areas.

### Claim 18 (depends on 12)

The device of claim 12, wherein the number of recesses in the linear arrays alternates between 7 and 15 recesses.

### Claim 19 (depends on 12)

The device of claim 12, wherein the number of recesses in the linear arrays alternates between 8 and 14 recesses.

### Claim 20 (depends on 12)

The device of claim 12, wherein the plurality of linear arrays of recesses comprises 18 linear arrays of recesses.
