# US 9,039,593 B2 · Systems and methods for delivering radiation therapy

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- Number: US 9,039,593 B2
- Document ID: US9039593B2
- Status: Granted
- Kind: B2
- Application number: 12/395,624
- Filed: 2009-02-27
- Published: 2009-09-24
- Granted: 2015-05-26
- Earliest claimed: 2008-02-29
- Assignees: Varian Medical Systems, Inc.
- Applicants: Gail S. Lebovic; George D. Hermann; Douglas S. Sutton
- Inventors: Gail S. Lebovic; George D. Hermann; Douglas S. Sutton
- Web page: https://patentgrep.com/patent/US9039593B2

## CPC

- A61N 5/1016: {Gynaecological radiation therapy}
- A61N 2005/1004: {having expandable radiation 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)

## Abstract

Described here are conformable brachytherapy applicators. The conformable brachytherapy applicators generally follow the contour of tissue surfaces so that distances between radiation sources and target tissues can be precisely determined and radiation dose clouds can be readily shaped. Systems and methods for using the conformable brachytherapy applicators are also described.

## Claims

### Claim 1

A gynecological brachytherapy applicator comprising:
a porous and compliant matrix in the form of a substantially cylindrical conformable elongate body having a proximal end and a distal end,
a central catheter at least partially received in the porous and compliant matrix, and at least one pair of opposed peripheral catheters at least partially received in the porous and compliant matrix;
wherein the maximum distance between the at least one pair of opposed peripheral catheters being in a range from 70% to equal to or smaller than 100% of the outer diameter of the elongate body, wherein the elongate body has an initial expanded configuration, an unexpanded configuration for advancement of the applicator to a target tissue, and an expanded deployed configuration, wherein the conformable elongate body is imageable by computed tomography,
wherein the elongate body provides a collapsible and expandable matrix of support such that a position and spacing of the central catheter relative to the at least one pair of opposed peripheral catheters within the porous and compliant matrix are stabilized in the expanded deployed configuration and the initial expanded configuration, and wherein the elongate body is made of a material comprising a foam.

### Claim 2 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the maximum distance between the at least one pair of opposed peripheral catheters is at least about 72% of the outer diameter of the elongate body.

### Claim 3 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the maximum distance between the at least one pair of opposed peripheral catheters is at least about 75% of the outer diameter of the elongate body.

### Claim 4 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the maximum distance between the at least one pair of opposed peripheral catheters is at least about 80% of the outer diameter of the elongate body.

### Claim 5 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the maximum distance between the at least one pair of opposed peripheral catheters is at least about 85% of the outer diameter of the elongate body.

### Claim 6 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the maximum distance between the at least one pair of opposed peripheral catheters is at least about 90% of the outer diameter of the elongate body.

### Claim 7 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the applicator contains at least two pairs of opposed peripheral catheters at least partially received in the porous and compliant matrix.

### Claim 8 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the applicator contains at least three pairs of opposed peripheral catheters at least partially received in the porous and compliant matrix.

### Claim 9 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the elongate body is constructed from a material comprising a compliant material.

### Claim 10 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the foam comprises an open cell foam.

### Claim 11 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the foam is selected from the group consisting of polyester foam, polyurethane foam, silicone foam, thermoplastic elastomer foam, and combinations thereof.

### Claim 12 (depends on 11)

The gynecological brachytherapy applicator of claim 11, wherein the foam comprises a polyurethane foam.

### Claim 13 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the distal end comprises a central opening in communication with the central catheter for advancement of a tandem therethrough.

### Claim 14 (depends on 13)

The gynecological brachytherapy applicator of claim 13, wherein the tandem comprises a radiation source.

### Claim 15 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the distal end of the elongate body is rounded.

### Claim 16 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the distal end of the elongate body is flat.

### Claim 17 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the distal end of the elongate body is funnel shaped.

### Claim 18 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein at least portions of the at least one pair of opposed peripheral catheters are oriented substantially parallel to the longitudinal axis of the elongate body.

### Claim 19 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the at least one pair of opposed peripheral catheters is symmetrically spaced around the circumference of the elongate body.

### Claim 20 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the at least one pair of opposed peripheral catheters is asymmetrically spaced around the circumference of the elongate body.

### Claim 21 (depends on 1)

The gynecological brachytherapy applicator of claim 1, further comprising a membrane surrounding the elongate body.

### Claim 22 (depends on 21)

The gynecological brachytherapy applicator of claim 21, wherein the membrane comprises a polymeric material.

### Claim 23 (depends on 22)

The gynecological brachytherapy applicator of claim 22, wherein the polymeric material is selected from the group consisting of fluoropolymers, natural and synthetic latex, polyurethane, silicone, and combinations thereof.

### Claim 24 (depends on 21)

The gynecological brachytherapy applicator of claim 21, wherein the membrane is inflatable around a portion of the elongate body.

### Claim 25 (depends on 21)

The gynecological brachytherapy applicator of claim 21, wherein one or more of the membrane, central catheter, at least one peripheral catheter, and elongate body, or portions thereof, are radiopaque, or combinations thereof are radiopaque.

### Claim 26 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the elongate body has an initial expanded diameter, an unexpanded diameter, and an expanded deployed diameter.

### Claim 27 (depends on 26)

The gynecological brachytherapy applicator of claim 26, wherein the ratio of the expanded deployed to the initial expanded diameters is between 1.3:1 to about 2:1.

### Claim 28 (depends on 26)

The gynecological brachytherapy applicator of claim 26, wherein the ratio of the initial expanded to unexpanded diameters is between 1.3:1 to about 3:1.

### Claim 29 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the distal end of the elongate body in its initial deployed configuration or expanded deployed configuration is conformable to one or more gynecological tissue surfaces.

### Claim 30 (depends on 29)

The gynecological brachytherapy applicator of claim 29, wherein the one or more gynecological tissue surfaces comprises at least one tissue surface of the cervix.

### Claim 31 (depends on 1)

The gynecological brachytherapy applicator of claim 1, wherein the elongate body in its expanded deployed configuration is configured to secure the applicator within the vaginal canal or against the cervix.

### Claim 32 (depends on 1)

The gynecological brachytherapy applicator of claim 1, further comprising a radiation source within the central catheter, at least one peripheral catheter of the at least one pair of opposed peripheral catheters, or a combination thereof.

### Claim 33 (depends on 32)

The gynecological brachytherapy applicator of claim 32, wherein the radiation source comprises a radioactive liquid, an x-ray source, a radiation seed, or combinations thereof.

### Claim 34 (depends on 32)

The gynecological brachytherapy applicator of claim 32, wherein the radiation source comprises radionuclides selected from the group consisting of cesium, iridium, iodine, cobalt, palladium, strontium, yttrium, gold, ruthenium, californium, and combinations thereof.

### Claim 35 (depends on 34)

The gynecological brachytherapy applicator of claim 34, wherein the radiation source comprises iridium.

### Claim 36 (depends on 1)

The gynecological brachytherapy applicator of claim 1 further comprising a layer of noncompressible material coupling the at least one peripheral catheter to an outer surface of the elongate body.

### Claim 37 (depends on 1)

The gynecological brachytherapy applicator of claim 1 wherein the elongate body comprises a unitary piece of a compliant material.

### Claim 38 (depends on 1)

The gynecological brachytherapy applicator of claim 1 wherein the elongate body is made of a material comprising a foam, and the foam is configured to be expandable and collapsible by infusing and withdrawing an inflation medium into and from the foam.
