# US 2012/0142992 A1 · Applicator for use in a brachytherapy radiation treatment

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- Number: US 2012/0142992 A1
- Document ID: US20120142992A1
- Status: Published application
- Kind: A1
- Application number: 13/372,447
- Filed: 2012-02-13
- Published: 2012-06-07
- Earliest claimed: 2007-06-04
- Assignees: Xoft, Inc.
- Inventors: Paul A. Lovoi
- Web page: https://patentgrep.com/patent/US20120142992A1

## CPC

- A61N 5/1015: {Treatment of resected cavities created by surgery, e.g. lumpectomy}
- A61B 2018/00291: {using suction}
- A61N 2005/1094: {Shielding, protecting against radiation}
- 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

In brachytherapy radiation treatment, particularly on the breast following a tumor resection, adequate skin to balloon distance must be maintained, to avoid damage to the skin. Often the distance is too small in certain areas or at a single point. The disclosed procedures and devices are effective to manipulate the skin-to-balloon distance to increase that distance when necessary, using vacuum, friction or other means to grip, move and “bunch” the breast tissue from regions of larger balloon-skin distance to regions with inadequate balloon-skin distance. The apparatus can include a ring or ring shaped array that fits around the breast, larger than the balloon, a circular vacuum device, or a cup which is pushed over the breast to move tissue toward a thin tissue region. In many cases only a few millimeters of added distance are needed to meet minimum requirements so that the radiation procedure can commence.

## Claims

### Claim 1

An applicator for use in brachytherapy radiation treatment for positioning overlying or adjacent to a resection cavity, the applicator comprising:
a support manifold having at least one port for coupling to a vacuum source;
an array of individual vacuum tubes mounted from the support manifold and extending distally therefrom;
a compacting ring disposed about and in contact with the array of tubes;
the compacting ring constructed and arranged to be controlled so as to bunch the skin and tissue overlying the resection cavity with an attendant increase in the skin-to-cavity tissue thickness.

### Claim 2 (depends on 1)

The applicator of claim 1 including attaching the distal ends of the tubes to the skin by applying vacuum, followed by compacting the array by advancing the ring distally.

### Claim 3 (depends on 1)

The applicator of claim 1 wherein the compacting ring comprises a belt tightened so as to compact the array.

### Claim 4 (depends on 1)

The applicator of claim 1 wherein the manifold forms a common vacuum chamber to facilitate concurrent vacuum application.

### Claim 5 (depends on 1)

The applicator of claim 1 wherein each tube has its own vacuum source or can be individually valved to permit sequential application of vacuum for attachment to the patient's skin.

### Claim 6

An applicator for use in brachytherapy radiation treatment for positioning overlying or adjacent to a resection cavity, the applicator comprising:
a proximal portion having a vacuum port leading to a source of vacuum;
a distal portion, defining with the proximal portion, a maifold vacuum chamber therebetween;
the distal portion having undulations or corrugations extending from a distal outer surface thereof and rising substantially into the manifold vacuum chamber.

### Claim 7 (depends on 6)

The applicator of claim 6 wherein the proximal portion has radially extending undulations functioning as downward ridges.

### Claim 8 (depends on 7)

The applicator of claim 7 wherein the proximal portion includes a proximal outer wall, and the undulations extend downwardly in the proximal outer wall into the manifold vacuum chamber.

### Claim 9 (depends on 8)

The applicator of claim 8 wherein the proximal and distal undulations nearly abut, but are not joined together.

### Claim 10 (depends on 8)

The applicator of claim 8 wherein the undulations of the proximal portion are disposed radially and the undulations of the distal portion are disposed concentrically.

### Claim 11 (depends on 7)

The applicator of claim 7 wherein the proximal and distal undulations are formed os at least one of spacer strips, molded solid ridges and convolutions.

### Claim 12 (depends on 6)

The applicator of claim 6 wherein each of the distal portions have concentric undulations with a through port in each undulation, these ports facilitating application of vacuum between the skin of the patient and concentric vacuum chambers formed by the concentric undulations.

### Claim 13 (depends on 6)

The applicator of claim 6 wherein the distal portion has a belt or draw string to assist in compacting the undulations of the distal portion, bunching the tissue overlying the treatment cavity.

### Claim 14 (depends on 6)

The applicator of claim 6 further including a substantially rigid element that lies proximally of the proximal portion.

### Claim 15 (depends on 14)

The applicator of claim 14 wherein the rigid element is constructed and arranged so as to create a secondary vacuum chamber proximal of the proximal portion.

### Claim 16 (depends on 15)

The applicator of claim 15 wherein the rigid element is constructed and arranged to produce a desired contour at the skin surface once the distal portion is secured to the skin and the secondary chamber is evacuated.

### Claim 17 (depends on 14)

The applicator of claim 14 wherein the distal portion has a belt or draw string to assist in compacting the undulations of the distal portion, bunching the tissue overlying the treatment cavity.

### Claim 18 (depends on 14)

The applicator of claim 14 wherein the distal portion has concentric undulations each with a port and the rigid element also has a port for drawing vacuum.

### Claim 19

An applicator for use in brachytherapy radiation treatment for positioning overlying or adjacent to a resection cavity, the applicator comprising:
a cup shaped structure defining an internal chamber;
a separate vacuum chamber disposed about a rim of the cup shaped structure;
the rim adapted to be placed against the patient's skin while the the rim chamber is evacuated, securing the cup to the skin;
the internal chamber being evacuated, drawing the skin into conformance with the internal chamber, causing the tissue underlying the skin to bunch into the cup, increasing its thickness and drawing the resection cavity toward the cup.

### Claim 20 (depends on 19)

The applicator of claim 19 including a groove for a drawstring or belt to facilitate compaction of tissue, and wherein the vacuum chamber is annular in shape having a semi-circular cross-section.
