Abstract:
A therapeutic member for use in brachytherapy deliverable to an implant site by way of a needle comprises a single radioactive source encapsulated by a bio-absorbable material having an outer surface including one or more ribs encircling the single radioactive source, a leading edge endcap rib and a trailing edge endcap rib. The one or more ribs reduces a tendency of the member to migrate and rotate within a patient's body after implantation. The encapsulating material further includes a first rail formed from the bio-absorbable material extending at least from opposite sides of the outer surface of the encapsulating material along the longitudinal axis of the therapeutic member, and a second rail formed from the bio-absorbable material extending at least from opposite sides of the outer surface of the encapsulating material along the longitudinal axis of the therapeutic member, the second rail arranged in a plane substantially perpendicular to a plane in which the first rail is arranged.
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:
Therapeutic members and strands for use in brachytherapy are designed to reduce the tendency for the members and strands (and thus the radioactive sources, thermal ablation implants and/or radiopaque makers, etc. therein) to migrate and/or rotate within a patient's body. In one embodiment a member includes a radioactive source and a material that encapsulates the radioactive source. Such encapsulating material, which is preferably, but not necessarily, bioabsorbable, is likely polymeric or some other plastic material. An outer surface of the encapsulating material includes at least one protrusion, and preferably a plurality of protrusions, to reduce the tendency of the member to migrate and rotate within a patient's body after implantation. Other embodiments are also provided.
Abstract:
A process is provided for sterilizing brachytherapy devices (10) with Ethylene Oxide gas and releasing the devices (10) on a parametric release basis. Devices that can be sterilized with this process include interstitial radiation seed strand (12) implants and the needles (14) used for implantation. In order to be sterilized effectively by EtO gas, the devices (10) 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 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 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 predeterrnined 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 substantially axially stiff and radially flexible elongated members made of material which is bioabsorbable in linving 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 is also provided. The delivery system and method further customize the member based on a prescription.
Abstract:
Vaginal dilators include an incrementally inflatable, optionally curved balloon mounted onto a flexible, elongated shaft having a soft rubber tip.
Abstract:
After-loader devices, kits, and methods for using the same are provided. Such after-loader devices are useful for loading implants into hollow needles, especially after the needles are inserted into patient tissue. The after-loader devices can be pre-loaded with implants, before the after-loaders are connected to hubs of hollow needles, or loaded thereafter.