Abstract: A therapeutic strand implant, for use in brachytherapy and deliverable to an implant site by way of a needle, includes a plurality of radioactive sources, and a polymeric material molded to encapsulate the radioactive sources. A space is defined by the polymeric material between each adjacent pair of the radioactive sources. A plurality of protrusions is defined by an outer surface of the encapsulating polymeric material.

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: Spacers for use in brachytherapy, radiotherapy, and other medical therapy, which can be used to improve a patient's outcome, assist in treating difficult cases and/or combine multiple modalities that are currently performed separately into a single procedure. In accordance with an embodiment, a spacer is formed of an encapsulating material in a generally cylindrical or elongated shape. One or more regions are formed within the spacer for receiving and retaining therapeutic loads, such as radiation sources and/or pharmaceutical therapeutic loads, and/or any other substances that a physician might select to treat a patient, such as drug liquids, powder or particles (e.g., microparticles or nanoparticles), with the particles or powders combined with binders, such as polyacrylamide, that are selected to retain and gradually disperse the powder or particles at a desired rate.

Abstract: In an embodiment, an implantable marker, which is adapted to be implanted into patient tissue using a hollow needle, includes a marker body including a radiopaque material and a polymeric material that encapsulates at least a portion of the marker body. In an embodiment, an outer surface of the encapsulating material includes one or more protrusions to reduce a tendency of the marker to migrate and rotate within a patient's body after implantation.

Abstract: In one embodiment an after-loader for providing an implant to a hollow needle, the after-loader comprising a body having a distal end including a bevel for receiving a hub of a seed lock needle, and a bore therethrough for receiving a hub of a MICK® needle; a proximal end having a funnel shaped opening; a shield adapted to be provided over the body; and wherein the distal end further includes a taper along a portion of a distance from the distal end to the proximal end for providing a friction fit to a shield. This abstract is not intended to be a complete description of the invention.

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.

Abstract: An anchor mechanism includes a sleeve to fit around a structure such as a radioactive source, a thermal ablation implant, a spacer, a strand or a radiopaque marker. The sleeve has a bore that extends an entire longitudinal length of the sleeve, and through which the structure fits, such that the structure can extend out from both longitudinal ends of the sleeve. One or more protrusion extends from an outer surface of the sleeve to engage surrounding patient tissue after implantation of the structure into a patient, to thereby reduce a tendency for the structure to migrate and rotate after implantation.

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: 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 and a method for making the strand 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 axial length, an outer surface and an inner surface. A chamber is formed along the axial length, the chamber being defined by the inner surface. The chamber is adapted to improve ultrasound visibility relative to the spacer.

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 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: In one embodiment a therapeutic member includes a radioactive source and a material (e.g., a bio-absorbable polymeric material) that encapsulates the radioactive source. An outer surface of the encapsulating material includes a plurality of protrusions to reduce a tendency of the member to migrate and rotate within a patient's body after implantation. In an embodiment, the encapsulating material includes an anchor mechanism that extends from at least one of the longitudinal ends of the radioactive source to reduce a tendency of the member to migrate and rotate within a patient's body after implantation. Embodiments of the present invention are also directed to strands that include similar protrusions and/or anchor mechanisms. Additionally, embodiments of the present invention are directed to spacers that resist migration and rotation. Embodiments are also directed to radiopaque markers that resist migration and rotation. This abstract is not intended to be a complete description of the invention.

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: 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: Provided herein are bio-absorbable strands for use in brachytherapy. In an embodiment, a plurality of discrete hollow bio-absorbable segments spaced apart from one another and encapsulated using a bio-absorbable material to form an elongated member configured to be implantable in patient tissue using a hollow needle. Each hollow bio-absorbable segment has a length, an outer periphery and an inner channel. Radioactive material is within at least a portion of the inner channel or coating at least a portion of the outer periphery of each hollow bio-absorbable segment. Contrast material is within at least a portion of the inner channel or coating at least a portion of the outer periphery of each hollow bio-absorbable segment.

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: In an embodiment a therapeutic member includes a single radioactive seed and is adapted to be implanted into patient tissue using a hollow needle. The seed includes a metallic housing with radioactive material contained within the metallic housing. A polymeric bio-adherent and/or bio-adhesive material surrounds at least a portion the housing of the single radioactive seed. The polymeric bio-adherent and/or bio-adhesive material reduces a tendency of the member to migrate and rotate within a patient's body after implantation of the member.

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.