# US 8,540,639 B2 · Ultrasonographic identification of a sentinel lymph node

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- Number: US 8,540,639 B2
- Document ID: US8540639B2
- Status: Granted
- Kind: B2
- Application number: 12/766,420
- Filed: 2010-04-23
- Published: 2010-10-28
- Granted: 2013-09-24
- Earliest claimed: 2009-04-23
- Applicants: Roberto Kusminsky
- Inventors: Roberto Kusminsky
- Web page: https://patentgrep.com/patent/US8540639B2

## CPC

- A61B 8/481: {involving the use of contrast agents, e.g. microbubbles introduced into the bloodstream}
- A61B 8/0833: {involving detecting or locating foreign bodies or organic structures}
- A61B 10/0041: {Detection of breast cancer (mammography by transillumination A61B5/0091, by X-rays A61B6/502, by ultrasonic means A61B8/0825)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A method of detecting at least one axillary sentinel lymph node using ultrasonography is described. The method comprises injecting an iron hydroxide compound into a patient at or near a suspected tumor site in the breast and waiting an amount of time required for the iron hydroxide compound to enter cells of the sentinel lymph node. The axillary area near the injection site may then be analyzed using ultrasonography to identify at least one sentinel lymph node. Once identified, a small sample of tissue from the identified sentinel lymph node may be taken for pathological analysis to aid in determination of the stage or extent of breast cancer.

## Claims

### Claim 1

A method of detecting at least one sentinel lymph node, comprising:
injecting an iron hydroxide-sucrose complex into a patient;
waiting an amount of time;
analyzing an area in which the at least one sentinel lymph node is suspected to exist using ultrasonography; and
identifying the at least one sentinel lymph node by detecting the injected iron hydroxide-sucrose complex in the at least one sentinel lymph node by the ultrasonography.

### Claim 2 (depends on 1)

The method of claim 1, further comprising:
removing a sample of tissue from the identified sentinel lymph node for pathological analysis.

### Claim 3 (depends on 1)

The method of claim 1, wherein the iron hydroxide-sucrose complex is a brown, sterile, aqueous complex of polynuclear iron (III)-hydroxide in sucrose.

### Claim 4 (depends on 1)

The method of claim 1, wherein the at least one sentinel lymph node is an axillary lymph node in a breast of which breast cancer is suspected to exist.

### Claim 5 (depends on 4)

The method of claim 4, wherein the injection is made in a subareolar location.

### Claim 6 (depends on 4)

The method of claim 4, wherein the injection is made in close proximity to the areola.

### Claim 7 (depends on 1)

The method of claim 1, wherein the amount of time is the time required for the iron hydroxide-sucrose complex to enter cells of the at least one sentinel lymph node.

### Claim 8 (depends on 7)

The method of claim 7, wherein the amount of time is about fifteen minutes.

### Claim 9 (depends on 1)

The method of claim 1, wherein identifying the at least one sentinel lymph node includes looking for a region of the lymph being analyzed by ultrasonography which appears brighter than the surrounding tissue.

### Claim 10 (depends on 2)

The method of claim 2, wherein the pathological analysis is used to determine at least one of presence and extent of a disease.

### Claim 11 (depends on 10)

The method of claim 10, wherein the disease is breast cancer.

### Claim 12

A method of detecting at least one axillary sentinel lymph node in a breast cancer patient, comprising:
injecting an iron hydroxide-sucrose complex into a patient;
waiting the iron hydroxide-sucrose complex to enter cells of the at least one axillary sentinel lymph node;
analyzing an area in which the at least one axillary sentinel lymph node is suspected to exist using ultrasonography; and
identifying the at least one axillary sentinel lymph node by detecting the injected iron hydroxide-sucrose complex in the at least one axillary sentinel lymph node by the ultrasonography.

### Claim 13 (depends on 12)

The method of claim 12, further comprising:
removing a sample of tissue from the identified axillary sentinel lymph node for pathological analysis.

### Claim 14

A sonographic scanner configured to be directed toward a patient in which an iron hydroxide-sucrose complex has been infused to locate a sentinel lymph node.

### Claim 15 (depends on 14)

The sonographic scanner of claim 14, wherein the sonographic scanner is directed at a portion of the patient in which the sentinel lymph node is suspected to exist.

### Claim 16

A system for detecting at least one sentinel lymph node, comprising:
an iron hydroxide-sucrose complex configured to be injected into a patient and allowed to enter cells of at least one sentinel lymph node; and
an ultrasonographic device configured to an area in which the at least one sentinel lymph node is suspected to exist to identify the at least one sentinel lymph node detecting the injected iron hydroxide-sucrose complex in the at least one sentinel lymph node.

### Claim 17 (depends on 16)

The system for detecting at least one sentinel lymph node of claim 16, wherein the iron hydroxide-sucrose complex is an iron compound to be injected into a patient and allowed to enter cells of at least one sentinel lymph node that is an axillary lymph node in a breast of which breast cancer is suspected to exist.

### Claim 18 (depends on 16)

The system for detecting at least one sentinel lymph node of claim 16, wherein the sentinel lymph node appears brighter than the surrounding tissue on the ultrasonographic device.
