# US 10,245,446 B2 · Marker-flange for MRI-guided brachytherapy

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- Number: US 10,245,446 B2
- Document ID: US10245446B2
- Status: Granted
- Kind: B2
- Application number: 13/826,873
- Filed: 2013-03-14
- Published: 2014-09-18
- Granted: 2019-04-02
- Earliest claimed: 2013-03-14
- Assignees: University of Iowa Research Foundation
- Applicants: University of Iowa Research Foundation
- Inventors: Yusung Kim
- Web page: https://patentgrep.com/patent/US10245446B2

## CPC

- A61N 5/1007: {Arrangements or means for the introduction of sources into the body}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61B 2090/3954: {magnetic, e.g. NMR or MRI}
- A61N 5/1016: {Gynaecological radiation therapy}
- A61N 2005/1012: {Templates or grids for guiding the introduction of sources}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Disclosed herein is a marker-flange for use with a brachytherapy applicator, having a flange body with a first face, a second face, and a hollow chamber positioned between the first and second faces. A cavity extending through the flange body is dimensioned to receive a tandem in a brachytherapy applicator in a press-fit connection, so as to affix the flange-marker to an outside surface of the tandem. The hollow chamber includes an MR imaging responsive marker agent that provides strong signal intensities and a high geometric accuracy in MR imaging.

## Claims

### Claim 1

A marker-flange for use with a brachytherapy applicator, comprising:
a flange body having a first face and a second face, with a hollow chamber positioned in the flange body between the first and second faces;
a cavity comprising a first cavity opening on the first face and a second cavity opening on the second face, the cavity extending through the flange body and dimensioned to receive a tandem in a brachytherapy applicator in a press-fit connection;
a port comprising a port opening positioned on one of the first and second faces of the flange body, the port being configured to communicate with the hollow chamber; and
a sealing agent contained within the port opening, the sealing agent providing an air-tight seal between the hollow chamber and an external environment outside the flange body.

### Claim 2 (depends on 1)

The marker-flange of claim 1, further comprising:
a marker agent contained within the hollow chamber.

### Claim 3 (depends on 2)

The marker-flange of claim 2, wherein:
the marker agent is a liquid, magnetic resonance (MR) imaging responsive marker agent.

### Claim 4 (depends on 3)

The marker-flange of claim 3, wherein:
the marker agent is chosen from the group consisting of: saline; an iothalamate meglumine composition; liquid vitamin E; fish oil; 1% Agarose Gel; and C4 cobalt-chloride complex.

### Claim 5 (depends on 1)

The marker-flange of claim 1, wherein:
the sealing agent contained in the port opening comprises an elastomeric material having a sufficient elasticity to exhibit a self-resealing characteristic after having been penetrated by a syringe.

### Claim 6 (depends on 1)

The marker-flange of claim 1, wherein:
the cavity is cylindrically shaped and has a diameter between 3.0 and 7.0 mm in a cross-section.

### Claim 7 (depends on 1)

The marker-flange of claim 1, further comprising
a shaft extending from one of the first and second faces of the flange body, wherein the shaft has a narrower width than the flange body.

### Claim 8 (depends on 7)

The marker-flange of claim 7, wherein:
the shaft includes a channel that communicates with the cavity in the flange body.

### Claim 9 (depends on 7)

The marker-flange of claim 7, further comprising:
channels formed in the flange body, the channels being dimensioned to receive a suture thread for suturing the flange body to the outer surface of a cervix.

### Claim 10

A brachytherapy applicator, comprising:
a marker flange comprising a flange body having a first face and a second face, with a hollow chamber positioned in the flange body between the first and second faces, the hollow chamber configured to receive and retain magnetic resonance (MR) imaging responsive marker agent; and
a cavity extending through the flange body and dimensioned to receive a tandem in the brachytherapy applicator, without the outer surface of the tandem contacting a surface of the flange body that defines the cavity, wherein
the brachytherapy applicator is a tandem-and-ring applicator, and the marker-flange is an integrated ring portion in the tandem-and-ring applicator, with one of the first and second faces of the flange body configured to abut a cervix upon use of the tandem-and-ring applicator with insertion of the tandem into a cervical OS.

### Claim 11 (depends on 10)

The brachytherapy applicator of claim 10, wherein:
the marker agent is a liquid marker agent.

### Claim 12 (depends on 11)

The brachytherapy applicator of claim 11, wherein:
the marker agent is chosen from the group consisting of: saline; an iothalamate meglumine composition; liquid vitamin E; fish oil; 1% Agarose Gel; and C4 cobalt-chloride complex.

### Claim 13 (depends on 10)

The brachytherapy applicator of claim 10, wherein:
the flange body is formed from an elastomeric material having a sufficient elasticity to exhibit a self-resealing characteristic after having been penetrated by a syringe.

### Claim 14 (depends on 10)

The brachytherapy applicator of claim 10, wherein:
the marker flange further comprises a port positioned on one of the first and second faces of the flange body, the port communicating with the hollow chamber and containing a sealing agent so as to provide an air-tight seal between the hollow chamber and an external environment outside the flange body.

### Claim 15 (depends on 14)

The brachytherapy applicator of claim 14, wherein:
the sealing agent contained in the port is an elastomeric material having a sufficient elasticity to exhibit a self-resealing characteristic after having been penetrated by a syringe.

### Claim 16 (depends on 10)

The bracytherapy applicator of claim 10, wherein
the flange body further comprises a source pathway cavity for insertion of a radiation source into the flange body.

### Claim 17 (depends on 16)

The brachytherapy applicator of claim 16, wherein
the source pathway cavity and the hollow chamber extend around the flange body cavity on a common plane transverse to a central axis of the flange body cavity.

### Claim 18 (depends on 1)

A method for performing a brachytherapy procedure, including:
introducing magnetic resonance (MR) imaging responsive marker agent into the hollow chamber of the marker-flange of claim 1; and
inserting a tandem of a brachytherapy applicator into the cavity of the marker-flange, so as to affix the marker-flange to an outside surface of the tandem.

### Claim 19 (depends on 18)

The method for performing a brachytherapy procedure of claim 18, wherein:
the sealing agent contained in the port opening is composed of an elastomeric material having a sufficient elasticity to render it self-resealing after penetration by a syringe, and
introducing a marker agent into the hollow chamber includes using a syringe to inject a liquid marker agent through the port.

### Claim 20 (depends on 18)

The method for performing a brachytherapy procedure of claim 18, wherein:
inserting a tandem into the cavity of the marker-flange includes affixing the marker-flange at a position on the tandem for use as a cervical flange for abutting a cervix upon the insertion of the tandem into a cervical os.

### Claim 21 (depends on 18)

The method for performing a brachytherapy procedure of claim 18, wherein:
the marker-flange includes a shaft extending from one of the first and second faces of the flange body, with the shaft having a channel that communicates with the cavity of the flange body,
the marker-flange further includes channels formed in the flange body, the channels being dimensioned to receive a suture thread for suturing the flange body to the outer surface of a cervix,
inserting a tandem into the cavity of the marker-flange includes affixing the marker-flange at a position on the tandem for use as a cervical sleeve for abutting a cervix upon the insertion of the tandem into a cervical os; and
the method further includes inserting the shaft of the marker-flange into a cervical OS, and suturing the marker-flange to the cervix.

### Claim 22 (depends on 18)

The method for performing a brachytherapy procedure of claim 18, wherein:
inserting a tandem into the cavity of the marker-flange includes inserting a titanium tandem into the cavity; and
the method further includes using three-dimensional imaging to guide the titanium tandem, with the marker flange affixed to an outside surface thereof, into an intracavitary treatment region,
wherein the three-dimensional imaging is performed using only an MR imaging modality.
