# US 8,465,407 B2 · Systems and methods for delivering radiation therapy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,465,407 B2 - Document ID: US8465407B2 - Status: Granted - Kind: B2 - Application number: 12/395,622 - Filed: 2009-02-27 - Published: 2009-09-17 - Granted: 2013-06-18 - 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/US8465407B2 ## 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 foam matrix defining a conformable elongate body having a proximal end, a distal end, a central passage at least partially therethrough, and at least one peripheral passage at least partially therethrough, 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, a central catheter at least partially residing in the central passage, at least one peripheral catheter at least partially residing in the at least one peripheral passage within the elongate body, and an inflation/deflation catheter received in the elongate body configured to infuse or withdraw an inflation medium to allow the elongate body to expand or collapse between the expanded deployed configuration and the unexpanded configuration; wherein the elongate body provides a collapsible and expandable matrix of support to stabilize a position and spacing of the central catheter and the at least one peripheral catheter within the elongate body. ### Claim 2 (depends on 1) The gynecological brachytherapy applicator of claim 1, wherein the foam comprises an open cell foam. ### Claim 3 (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 4 (depends on 3) The gynecological brachytherapy applicator of claim 3, wherein the foam comprises a polyurethane foam. ### Claim 5 (depends on 1) The gynecological brachytherapy applicator of claim 1, wherein the distal end comprises a central opening in communication with the central passage for advancement of a tandem therethrough. ### Claim 6 (depends on 5) The gynecological brachytherapy applicator of claim 5, wherein the tandem comprises a radiation source. ### Claim 7 (depends on 1) The gynecological brachytherapy applicator of claim 1, wherein the distal end of the elongate body is rounded. ### Claim 8 (depends on 1) The gynecological brachytherapy applicator of claim 1, wherein the distal end of the elongate body is funnel shaped. ### Claim 9 (depends on 1) The gynecological brachytherapy applicator of claim 1, wherein the distal end of the elongate body is flat. ### Claim 10 (depends on 1) The gynecological brachytherapy applicator of claim 1, wherein the elongate body has a plurality of peripheral passages extending at least partially through the elongate body and the applicator further comprises a plurality of peripheral catheters residing in the plurality of peripheral passages within the elongate body. ### Claim 11 (depends on 10) The gynecological brachytherapy applicator of claim 10, wherein the plurality of peripheral catheters are oriented substantially parallel to the longitudinal axis of the elongate body. ### Claim 12 (depends on 10) The gynecological brachytherapy applicator of claim 10, wherein the plurality of peripheral catheters are symmetrically positioned within the elongate body. ### Claim 13 (depends on 10) The gynecological brachytherapy applicator of claim 10, wherein the plurality of peripheral catheters are asymmetrically positioned within the elongate body. ### Claim 14 (depends on 10) The gynecological brachytherapy applicator of claim 10, wherein the plurality of peripheral catheters are equally spaced within the elongate body. ### Claim 15 (depends on 10) The gynecological brachytherapy applicator of claim 10, wherein the elongate body has at least four peripheral passages and the applicator contains at least four peripheral catheters at least partially residing in the at least four passages. ### Claim 16 (depends on 10) The gynecological brachytherapy applicator of claim 10, wherein the elongate body has at least six peripheral passages and the applicator contains at least six peripheral catheters at least partially residing in the at least six passages. ### Claim 17 (depends on 1) The gynecological brachytherapy applicator of claim 1, further comprising a membrane substantially surrounding the elongate body. ### Claim 18 (depends on 17) The gynecological brachytherapy applicator of claim 17, wherein the membrane comprises a polymeric material. ### Claim 19 (depends on 18) The gynecological brachytherapy applicator of claim 18, wherein the polymeric material is selected from the group consisting of fluoropolymers, natural and synthetic latex, polyurethane, silicone, and combinations thereof. ### Claim 20 (depends on 19) The gynecological brachytherapy applicator of claim 19, wherein the polymeric material comprises a natural or synthetic latex. ### Claim 21 (depends on 17) The gynecological brachytherapy applicator of claim 17, wherein the membrane is inflatable around a portion of the elongate body. ### Claim 22 (depends on 17) The gynecological brachytherapy applicator of claim 17, 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 23 (depends on 1) The gynecological brachytherapy applicator of claim 1, further comprising a hub fixed to the proximal end of the elongate body, the hub having a plurality of openings through which the central catheter and the at least one peripheral catheter are threaded. ### Claim 24 (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 25 (depends on 24) The gynecological brachytherapy applicator of claim 24, wherein the ratio of the expanded deployed to the initial expanded diameters is between about 1.3:1 to about 2:1. ### Claim 26 (depends on 24) The gynecological brachytherapy applicator of claim 24, wherein the ratio of the initial expanded to unexpanded diameters is between about 1.3:1 to about 3:1. ### Claim 27 (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 28 (depends on 27) The gynecological brachytherapy applicator of claim 27, wherein the one or more gynecological tissue surfaces comprises at least one tissue surface of the cervix. ### Claim 29 (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 30 (depends on 1) The gynecological brachytherapy applicator of claim 1, wherein the applicator is disposable. ### Claim 31 (depends on 1) The gynecological brachytherapy applicator of claim 1, further comprising a radiation source within the central catheter, the at least one peripheral catheter, or a combination thereof. ### Claim 32 (depends on 31) The gynecological brachytherapy applicator of claim 31, wherein the radiation source comprises a radioactive liquid, an x-ray source, a radiation seed, or combinations thereof. ### Claim 33 (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 34 (depends on 33) The gynecological brachytherapy applicator of claim 33, wherein the radiation source comprises iridium. ### Claim 35 (depends on 1) The gynecological brachytherapy applicator of claim 1 further comprising a plurality of peripheral catheters surrounded by the matrix of support, the plurality of peripheral catheters remains in direct contact with the matrix of support in the initial expanded configuration, the unexpanded configuration, and the expanded deployed configuration. ### Claim 36 (depends on 1) The gynecological brachytherapy applicator of claim 1 further comprising a layer of a 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 foam material provided with the central passage and the at least one peripheral passage within the unitary piece. ### Claim 38 (depends on 1) The gynecological brachytherapy applicator of claim 1 wherein the foam is configured to be in direct fluid communication with an inflation medium and expandable and collapsible by infusing and withdrawing the inflation medium. ### Claim 39 A system for delivering radiation therapy to a gynecological tissue comprising: one or more gynecological brachytherapy applicators, the brachytherapy applicators comprising a foam matrix defining a conformable elongate body having a proximal end, a distal end, a central passage at least partially therethrough, and at least one peripheral passage at least partially therethrough, 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; a central catheter at least partially residing in the central passage; at least one peripheral catheter at least partially residing in the at least one peripheral passage within the elongate body; and an inflation/deflation catheter received in the elongate body configured to infuse or withdraw an inflation medium to allow the elongate body to expand or collapse between the expanded deployed configuration and the unexpanded configuration, wherein the elongate body provides a collapsible and expandable matrix of support to stabilize a position and spacing of the central catheter and the at least one peripheral catheter within the elongate body; one or more removable sheaths for housing the one or more brachytherapy applicators during advancement to the target tissue; one or more removable handles for positioning or repositioning the one or more brachytherapy applicators; and instructions for using the one or more brachytherapy applicators. ### Claim 40 (depends on 39) The system of claim 39, comprising a plurality of brachytherapy applicators. ### Claim 41 (depends on 40) The system of claim 40, wherein the plurality of brachytherapy applicators vary in length, shape at the distal end, number of peripheral passages and catheters, initial expanded diameter, unexpanded diameter, expanded deployed diameter, or a combination thereof. ### Claim 42 (depends on 39) The system of claim 39, further comprising one or more radiation sources. ### Claim 43 (depends on 42) The system of claim 42, wherein the one or more radiation sources comprise a radioactive liquid, an x-ray source, a radiation seed, or combinations thereof. ### Claim 44 A method for delivering radiation therapy to a gynecological tissue comprising: advancing a gynecological brachytherapy applicator adjacent to a target tissue, the gynecological brachytherapy applicator comprising a foam matrix defining a conformable elongate body having a proximal end, a distal end, a central passage at least partially therethrough, and at least one peripheral passage at least partially therethrough, wherein the elongate body has an initial expanded configuration, an unexpanded configuration for advancement of the applicator to the target tissue, and an expanded deployed configuration; a central catheter at least partially residing in the central passage; at least one peripheral catheter at least partially residing in the at least one peripheral passage within the elongate body, and an inflation/deflation catheter received in the elongate body configured to infuse or withdraw an inflation medium to allow the elongate body to expand or collapse between the expanded deployed configuration and the unexpanded configuration, wherein the elongate body provides a collapsible and expandable matrix of support to stabilize a position and spacing of the central catheter and the at least one peripheral catheter within the elongate body; and delivering radiation therapy to the target tissue using the brachytherapy applicator. ### Claim 45 (depends on 44) The method of claim 44, further comprising collapsing the elongate body from the initial expanded configuration to the unexpanded configuration. ### Claim 46 (depends on 44) The method of claim 44, further comprising expanding the elongate body to the expanded deployed configuration. ### Claim 47 (depends on 44) The method of claim 44, further comprising removing the brachytherapy applicator from a vaginal canal. ### Claim 48 (depends on 44) The method of claim 44, wherein the radiation therapy is delivered by a radiation source. ### Claim 49 (depends on 48) The method of claim 48, wherein the radiation source comprises a radioactive liquid, an x-ray source, a radiation seed, or combinations thereof. ### Claim 50 (depends on 48) The method of claim 48, 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 51 (depends on 50) The method of claim 50, wherein the radiation source comprises iridium. ### Claim 52 (depends on 48) The method of claim 48, wherein the radiation source is loaded into the central catheter, at least one peripheral catheter, or a combination thereof, using an afterloader. ### Claim 53 (depends on 48) The method of claim 48, wherein the radiation source is used to treat a gynecological cancer. ### Claim 54 (depends on 53) The method of claim 53, wherein the gynecological cancer is selected from the group consisting of cervical cancer, endometrial cancer, uterine cancer, ovarian cancer, and vaginal cancer. ### Claim 55 (depends on 53) The method of claim 53, wherein the gynecological cancer is endometrial cancer. ### Claim 56 (depends on 55) The method of claim 55, wherein the radiation source delivers a radiation dose of about 10 Gy to about 30 Gy to the target tissue to treat the endometrial cancer. ### Claim 57 (depends on 53) The method of claim 53, wherein the gynecological cancer is cervical cancer. ### Claim 58 (depends on 57) The method of claim 57, wherein the radiation source delivers a radiation dose of about 30 Gy to about 45 Gy to the target tissue to treat the cervical cancer. ### Claim 59 (depends on 44) The method of claim 44, wherein the target tissue is the uterus. ### Claim 60 (depends on 44) The method of claim 44, wherein the target tissue is the cervix. ### Claim 61 (depends on 44) The method of claim 44, wherein the target tissue is tissue of the vaginal cuff.