Abstract: The present disclosure provides a brachytherapy apparatus, system and method that delivers partial breast irradiation treatment for post-lumpectomy patients via introduction of a catheter-like device through a trocar. The apparatus may be introduced post-surgically with local anesthesia under image guidance into the previous excision site and into a cavity by a surgeon. The brachytherapy apparatus includes one or more thin-walled tubes, each of said thin-walled tubes being configured to contain one or more radioactive sources, at least one radiation source configured to deliver a prescribed dose of radiation, a whisk adjuster configured to permit adjustment of each of the one or more thin-walled tubes so that the tubes substantially conform to a size of the body cavity; and an expansion element configured to expand outwardly said one or more thin-walled tubes within the cavity so that the thin-walled tubes substantially conform to a shape and/or size of the body cavity.

Abstract: A brachytherapy device may include an expandable outer cage, an expandable inner cage positioned within the outer cage and configured to receive radioactive material at its perimeter, and a movable actuator configured to cause the outer and inner cages to expand simultaneously in response to movement of the actuator between certain positions while maintaining a substantially constant separation distance between the outer and inner cages.

Abstract: The present disclosure provides a brachytherapy apparatus that delivers a low dose, partial breast irradiation treatment for post-lumpectomy patients via introduction of a catheter-like device through a cannula. The apparatus may be introduced post-surgically with local anesthesia under image guidance into the previous excision site and into a cavity by a surgeon. The brachytherapy apparatus includes a seed containment device configured to contain a plurality of low-dose radioactive seeds therein. The seed containment device may be one or more thin-walled tubes. The apparatus is further configured to expand so that at least a portion of the seed containment device is positioned against the remaining tissue and the plurality of radioactive seeds are disposed at the perimeter of the seed containment device. Also described are various clamps for the apparatus, and sleeves for adjusting the size of the device to fit a cavity when the apparatus is in use.

Abstract: A delivery system and method for interstitial radiation therapy comprising substantially axially stiff and longitudinally flexible elongated members made of material which is bioabsorbable in living tissue and a plurality of radioactive seeds dispersed in a predetermined array within the elongate member. The radioactive seeds can be dispersed within assembled half-shells made of the same material. The housing for the radiation seeds can also be manufactured from extruded material. A system for manufacturing the interstitial radiation therapy seed strands that automatically makes the seed strands at the patient's bedside. The delivery system and method further customize the member based on a prescription.

Abstract: A prescription method of treating tissue comprises the steps of accepting a prescription tissue treatment plan for the tissue to be treated, positioning seeds relative to each other per the prescription tissue treatment plan such that the positions of seeds relative to each other is only established by the prescription tissue treatment plan, and creating a treatment strand by heating and cooling a material to position the plurality of treatment seeds in the material. The prescription tissue treatment plan specifies a number and a spacing of the seeds to be provided in the treatment strand, the spacing of the treatment seeds being unrestricted by any use of spacers and independently set by and according to the prescription tissue treatment plan.

Abstract: A delivery system and method for interstitial radiation therapy comprising a substantially axially stiff and longitudinally flexible elongated member made of material, which is bio-absorbable in living tissue and a plurality of radioactive seeds dispersed in a predetermined array within the member. The delivery system and method further customize the member based on a prescription.

Abstract: Echogenic strands and spacers are provided for use in brachytherapy. Methods of making the strands and spacers are also provided. An echogenic strand for use in brachytherapy includes an encapsulating material, a seed disposed within the encapsulating material, and a spacer disposed within the encapsulating material and arranged adjacent to the seed. The spacer has an external length and a chamber formed along the external length, the chamber being adapted to improve ultrasound visibility relative to the spacer.

Abstract: A brachytherapy device may include a plurality of rods, each configured to move between a straightened position and a bowed position, the plurality of rods configured to collectively form a shaft while each rod is in the straightened position and to collectively form at least one cage while at least some of the rods are in the bowed position, at least some of the rods having lumens that are configured to receive and hold radioactive material. A brachytherapy device may further include a rotatable mechanism configured to cause at least some of the plurality of rods to move between the straightened position and the bowed position upon rotation of the rotatable mechanism.

Abstract: A brachytherapy device may include an expandable outer cage, an expandable inner cage positioned within the outer cage and configured to receive radioactive material at its perimeter, and a movable actuator configured to cause the outer and inner cages to expand simultaneously in response to movement of the actuator between certain positions while maintaining a substantially constant separation distance between the outer and inner cages.

Abstract: A delivery system and method for interstitial radiation therapy comprising a substantially axially stiff and longitudinally flexible elongated strand made of material, which is bio-absorbable in living tissue and a plurality of radioactive seeds dispersed in a predetermined array within the strand. The delivery system and method further customize the strand based on a prescription. The strands can have custom end spacings, which allow the optimal placing of seeds within the treatment tissue by implanting a plurality of strands to the same depth. A plurality of these strands can be implanted at the same time by the use of a guiding device.

Abstract: A delivery system and method for interstitial radiation therapy comprising a strand made of material, which is bio-absorbable in living tissue and a plurality of radioactive seeds dispersed in a predetermined array within the strand. The strands can have custom end spacings, which allow the optimal placing of seeds within the treatment tissue by implanting a plurality of strands to the same depth. A plurality of these strands can be implanted at the same time by the use of a guiding device. In certain embodiments, a custom end spacing within a needle is not attached to the strand in the needle. In certain embodiments, the custom end spacing, seeds and spacers within a needle are loose, i.e., not part of a strand.

Abstract: A prescription method of treating tissue comprises the steps of accepting a prescription tissue treatment plan for the tissue to be treated, positioning seeds relative to each other per the prescription tissue treatment plan such that the positions of seeds relative to each other is only established by the prescription tissue treatment plan, and creating a treatment strand by heating and cooling a material to position the plurality of treatment seeds in the material. The prescription tissue treatment plan specifies a number and a spacing of the seeds to be provided in the treatment strand, the spacing of the treatment seeds being unrestricted by any use of spacers and independently set by and according to the prescription tissue treatment plan.

Abstract: The present disclosure provides a brachytherapy apparatus, system and method that delivers partial breast irradiation treatment for post-lumpectomy patients via introduction of a catheter-like device through a trocar. The apparatus may be introduced post-surgically with local anesthesia under image guidance into the previous excision site and into a cavity by a surgeon. The brachytherapy apparatus includes one or more thin-walled tubes, each of said thin-walled tubes being configured to contain one or more radioactive sources, at least one radiation source configured to deliver a prescribed dose of radiation, a whisk adjuster configured to permit adjustment of each of the one or more thin-walled tubes so that the tubes substantially conform to a size of the body cavity; and an expansion element configured to expand outwardly said one or more thin-walled tubes within the cavity so that the thin-walled tubes substantially conform to a shape and/or size of the body cavity.

Abstract: A process is provided for sterilizing brachytherapy devices with Ethylene Oxide gas and releasing the devices on a parametric release basis. Devices that can be sterilized with this process include interstitial radiation seed strand implants and the needles used for implantation. In order to be sterilized effectively by EtO gas, the devices are constructed such that surfaces not readily infused with EtO gas are made to be gas permeable, and will not retain the gas after the sterilization process. Performance qualification of the sterilization process is performed through physical and microbiological studies, and set of established physical process parameters. Maintaining the physical process parameters in subsequent sterilization cycles will consistently yield the desired sterility assurance level without having to test the devices for sterility.

Abstract: A delivery system and method for interstitial radiation therapy comprising a substantially axially stiff and longitudinally flexible elongated member made of material, which is bio-absorbable in living tissue and a plurality of radioactive seeds dispersed in a predetermined array within the member. The delivery system and method further customize the member based on a prescription.

Abstract: A brachytherapy device may include an expandable outer cage, an expandable inner cage positioned within the outer cage and configured to receive radioactive material at its perimeter, and a movable actuator configured to cause the outer and inner cages to expand simultaneously in response to movement of the actuator between certain positions while maintaining a substantially constant separation distance between the outer and inner cages.

Abstract: A brachytherapy device may include a plurality of rods, each configured to move between a straightened position and a bowed position, the plurality of rods configured to collectively form a shaft while each rod is in the straightened position and to collectively form at least one cage while at least some of the rods are in the bowed position, at least some of the rods having lumens that are configured to receive and hold radioactive material. A brachytherapy device may further include a rotatable mechanism configured to cause at least some of the plurality of rods to move between the straightened position and the bowed position upon rotation of the rotatable mechanism.

Abstract: A brachytherapy device may include an expandable outer cage, an expandable inner cage positioned within the outer cage and configured to receive radioactive material at its perimeter, and a movable actuator configured to cause the outer and inner cages to expand simultaneously in response to movement of the actuator between certain positions while maintaining a substantially constant separation distance between the outer and inner cages.

Abstract: A brachytherapy device may include an expandable outer cage, an expandable inner cage positioned within the outer cage and configured to receive radioactive material at its perimeter, and a movable actuator configured to cause the outer and inner cages to expand simultaneously in response to movement of the actuator between certain positions while maintaining a substantially constant separation distance between the outer and inner cages.

Abstract: A brachytherapy apparatus and method are provided for treating tissue forming an internal body cavity, such as an excised breast or brain tumor bed. The apparatus has at least one outer wall that is movable between (i) a retracted position spaced inwardly relative to tissue forming the internal body cavity, and (ii) an expanded position spaced outwardly and contiguous to tissue forming the internal body cavity. The outer wall is formed by a stent, a balloon catheter, or a plurality of axially-elongated solid or hollow flexible members that are angularly spaced relative to each other. A plurality of radiation sources are carried by the at least one outer wall and movable therewith between the retracted and expanded positions for transmitting radiation in the expanded position into the tissue forming the internal body cavity.