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.

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 delivery system and method for interstitial radiation therapy uses a seed strand composed of a plurality of tubular shaped, hollow radioactive seeds with a bore. The seed strand as assembled with a material provided in the bore and between the spaced seeds is axially stiff and radially flexible and is bioabsorbable in living tissue.

Abstract: An apparatus for implanting an element within a tissue a cannula having a sharpened tip at a beveled distal end, and a stylet. The stylet is configured to engage the element within a hollow bore of the cannula, so that the element is pushed through the hollow bore out of the beveled distal end onto the tissue, when the cannula is moved relative to the stylet along an axis. A bevel-shaped insert member has a bevel angle that matches the bevel angle of the cannula distal end. The outer surface of the insert member supports the tissue, to prevent the tissue from prolapsing into the interior of the beveled distal end during penetration of the tissue by the sharpened tip. A protruding structure extends from the outer surface of the member, and frictionally holds the member in place along the interior surface of the hollow bore during the penetration.

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 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 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 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 process is provided for sterilizing brachythearpy 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 normal system 100 for sterilizing, transporting and preparing radioactive seed strands for use in brachytherapy is provided. The system 100 is lightweight and can carry a plurality of seed strands and strand of spacer material, and can be sterilized by Ethylene Oxide Gas. Radioactive seed strands remain shielded from the user until the user is ready to retrieve each individual seed strand for measuring and cutting on an integrated cutting board.

Abstract: An ultrasonic probe 10 includes an elongated housing 12 which contains a window 24 surrounding a ultrasonic transducer 32. The ultrasonic transducer 32 is mounted on a first platform 36. The first platform 36 is in turn mounted on a second platform 38. A motor 44 and linkage arrangement 48 is provided for pivoting the transducer 32. A thumb wheel 16 can rotatably position the transducer 32 as it pivots, allowing ultrasonic imaging of bodily tissue through three hundred and sixty degrees. Further, a position sensor 78 allows for accurate sensing of the position of the transducer 32 as the transducer 32 pivots and rotates.