Abstract: A breast brachytherapy applicator providing a stable semi permanent/permanent in dwelling platform that is configured to replicate anatomically the excised cancer bed and allows for a more precise anatomically correct delivery of limited field radiation treatment. This device may be used to reconstitute a resected tissue space to its pre-operative size and shape to 1) facilitate the accurate and precise delivery of adjunctive breast brachytherapy following breast cancer surgery and 2) prevent/decrease post-operative deformity as a result of surgical resection, whether for benign or malignant disease, and in particular after radiation treatment of malignant disease in the post lumpectomy patient.

Abstract: Methods and apparatus are described for irradiating living tissue via a cavity or lumen, using an inflatable balloon applicator. In a preferred embodiment the applicator balloon has a balloon skin with x-ray contrast material in relatively low concentration, so that an outline of the balloon will appear sharply when imaged externally. In another preferred embodiment the balloon catheter has a drain for withdrawing liquids from the cavity, which may include channels or texture on the exterior of the balloon. Methods are described for using a switchable miniature x-ray tube, variable as to voltage and current, to achieve accuracy in an isodose profile.

Abstract: A balloon brachytherapy applicator has either a single or double chambers, with the capability of “blistering” outwardly at a specified area on one side of the balloon. This is useful to move sensitive tissue farther away from a radiation source within a source guide inside the balloon. In one case a secondary compartment is formed on the primary balloon, and is separately inflatable so as to allow blistering as desired when needed. In another form the balloon comprises a single chamber but with a “window” or area in which the balloon wall is elastic, or substantially more elastic than the main balloon wall, so that inflation of the balloon up to a certain point forms a substantially regular balloon shape, and the addition of further pressure will blister out the elastic area to increase the distance between the shaft and the sensitive tissue in a desired orientation of the balloon.

Abstract: A customized gynecological brachytherapy applicator is formed by placing a molded balloon, which is secured to a handle, into a vaginal cavity and then filling the mold balloon with a settable liquid material. The material may be an expanding foam or any other form of curable material that becomes solid, rigid or pliable, when set by chemical action, temperature change, oxidation, a curing means such as a light, or other curing regime. The mold balloon can be elastic or inelastic, depending on the degree to which the applicator is to conform its external surfaces to the vaginal contours. One or more lumina are provided in the set filler material to receive a radiation source, with additional lumina optionally provided for purposes such as drainage or administration of therapeutic agents. The applicator may be withdrawn and reinserted into the vagina during treatment, and selected tissues adjacent to the applicator are irradiated in accordance with a radiation prescription.

Abstract: Methods and applicator apparatus are disclosed for brachytherapy treatment of tissue surrounding a cavity in a patient, particularly a resection cavity. In treatment regimes requiring recovery time between successive radiation treatments, applicators of the invention are retained under the skin, with the skin allowed to at least partially heal, and are re-accessed later for one or more subsequent treatments. To reduce patient discomfort an anesthetic agent can be infused through the applicator to patient tissue, for insertion, balloon inflation or removal of the applicator.

Abstract: A flexible, relatively flat and thin patch, optionally made of biodegradable material, substantially attenuates ionizing radiation from normal but sensitive anatomy during radio-therapy, particularly breast brachytherapy. The patch is of such a thickness as to substantially attenuate radiation by distance or consists of a material that has been formulated with radio-attenuating filler or is of radio-attenuating material. An alternative version consists of a thin patch that is coated with radio-attenuating material.

Abstract: Brachytherapy applicators incorporate various forms of selective shielding devices for controlling the direction and intensity of radiation directed at a patient's tissue. In some forms the applicators include a retractable sheath, in some a series of retractable fingers. In other forms the applicator, having an inflatable balloon, has a shield which is retractable from a position adjacent to the balloon or retracted from the balloon, or a shield can itself be inflatable, separately or together with the balloon.

Abstract: A customized gynecological brachytherapy applicator is formed by placing a molded balloon, which is secured to a handle, into a vaginal cavity and then filling the mold balloon with a settable liquid material. The material may be an expanding foam or any other form of curable material that becomes solid, rigid or pliable, when set by chemical action, temperature change, oxidation, a curing means such as a light, or other curing regime. The mold balloon can be elastic or inelastic, depending on the degree to which the applicator is to conform its external surfaces to the vaginal contours. One or more lumina are provided in the set filler material to receive a radiation source, with additional lumina optionally provided for purposes such as drainage or administration of therapeutic agents. The applicator may be withdrawn and reinserted into the vagina during treatment, and selected tissues adjacent to the applicator are irradiated in accordance with a radiation prescription.

Abstract: Applicators for ionizing radiation therapy and their methods of use are provided for expedient preparation of precise treatment plans and for quantitative assessment of therapy delivered to natural or surgically-created, intra-corporeal cavities or lumina. Feedback capability is provided for timely treatment control and for verification of treatment to plan using sensors on the applicators.

Abstract: A system and method to position and orient an excised breast tissue specimen on a support structure in a duplicate anatomic orientation relative to the operated breast is provided. One embodiment of the system includes an anatomically representative map of the breast under investigation. The system allows a surgeon to suture, ink, or otherwise fix the excised specimen on the map in accordance to its original position and orientation in the operated breast or organ. A radiogram of the excised specimen can be taken that shows the location of calcifications on a grid with radiopaque markers. The system allows a pathologist to cut through the specimen utilizing the map as a template in order to perform histological analysis and correlate the position and orientation of each slice to its anatomic position in the breast and thereby direct a precise and anatomically accurate re-excision by the surgeon if so required.

Abstract: A radiation therapy system and method, especially for brachytherapy, monitors and verifies dose delivered at a plurality of points at or near the region to be irradiated, integrating verification with radiation delivery. In one procedure, mapping is used to determine the shape and location of the region to be irradiated. A treatment plan is developed using the mapping information and a dose prescription. As radiation is delivered to the target region internally, preferably using an electronic radiation source, the dose received at plural points is monitored and continually fed to a central processor. As needed based on feedback, the system modifies the treatment plan and delivery of radiation accordingly, to arrive substantially at the prescribed dose at all locations in the region. In a modified procedure the treatment is done according to a prescription dose but without a treatment plan by multiple iterations of source pullback and feedback and analysis of dose received in the tissue.

Abstract: Age-related macular degeneration is treated by radiation delivered from a miniature x-ray tube inserted via a catheter around the globe of the eye, to a position behind the macula. The process can employ an applicator with several parallel guides, inserted around the eye to receive the catheter with x-ray tube (or an isotope) at a matrix of different positions. Methods are described for properly locating the catheter and x-ray tube, using illumination on the catheter and viewing through the front of the eye, or sensors on the catheter and a scanned beam shone from the front of the eye. Fluorescent material excited by x-rays can also be used. Also described are methods and devices for immobilizing the probe once properly located in the eye, for standoff of the x-ray tube from the target tissue, and for achieving prescription radiation dose in the choroid while eliminating dose to adjacent tissues. The x-ray treatment can be enhanced using a radiosensitizing drug, and can be combined with PDT.

Abstract: A vaginal brachytherapy applicator is versatile to different anatomies and more comfortable to the patient than prior applicators. An inflatable balloon on a shaft may be inelastic or elastic. In one embodiment the shaft is rotatable relative to the balloon for enabling a ring or band of dose delivery, for versatility in radiation placement. Alternatively, the source can be rotated and pulled back within a stationary shaft. An adjustment is provided for reducing the length of balloon that inflates, to accommodate different anatomies and positions. Although isotope radiation sources can be used in the applicator, an electronic source is preferred, and the system and method include procedures for using the applicator with an electronic source.

Abstract: Breast cancer patients are treated intraoperatively with radiation shortly after excision of a tumor. Pathology of the tissue is determined with a nearly instantaneous method, further excision is performed if needed, and the patient, still anesthetized and preferably unmoved, is then treated with radiation therapy. In a preferred embodiment an applicator is inserted into the excision cavity, the cavity is three-dimensionally mapped using radiation sources and a sensor, a radiation treatment plan is developed using a radiation prescription and the determined shape and location of the cavity, and the treatment plan is executed, all while the patient remains under anesthesia.

Abstract: A miniature x-ray tube has an anode assembly capable of transmitting x-rays through the anode and over a wide angular range. The anode is in the shape of a cone or truncated cone with an axis on the x-ray tube frame axis, formed of low-Z material with high thermal conductivity for heat dissipation. A target material on the anode body is in a thin layer, which may be approximately 0.5 to 5 microns thick. In one embodiment a tube evacuation exhaust port at the tail end of the anode assembly forms a cavity for a getter, with a pinched-off tubulation at the end of the cavity.

Abstract: Methods for connecting electrical potential to an extractor cup at the cathode of a miniature x-ray tube are disclosed. The various connection schemes are designed to form a rugged and conveniently manufacturable connection between the metal extractor cup and one side of the cathode filament, so that the extractor cup shapes the path of electrons as desired en route to the anode of the tube. Some of the disclosed connections involve evaporation of conductive metal or other materials off the filament when the filament is first activated. Others involve applying a paste or paint conductive precursor directly to a base to connect a post and the extractor, the paste being heat-cured after the completion of assembly. Others involve a fine wire or spring strip from one filament post to the walls of the extractor cup. Other schemes include welded or brazed wires or foil, crimping, pinching, swaging and other connections, all made inside the tube enclosure.

Abstract: Methods for connecting electrical potential to an extractor cup at the cathode of a miniature x-ray tube are disclosed. The various connection schemes are designed to form a rugged and conveniently manufacturable connection between the metal extractor cup and one side of the cathode filament, so that the extractor cup shapes the path of electrons as desired en route to the anode of the tube. Some of the disclosed connections involve evaporation of conductive metal or other materials off the filament when the filament is first activated. Others involve applying a paste or paint conductive precursor directly to a base to connect a post and the extractor, the paste being heat-cured after the completion of assembly. Others involve a fine wire or spring strip from one filament post to the walls of the extractor cup. Other schemes include welded or brazed wires or foil, crimping, pinching, swaging and other connections, all made inside the tube enclosure.

Abstract: A miniature x-ray tube is cooled using a catheter preferably having multiple small lumens for inflow and outflow of coolant. Inflow may be through an outer lumen(s) in a concentric-extrusion catheter, the liquid turning back at the distal end of the catheter to a proximal flow over the anode end of the x-ray tube and through an inner lumen within which the x-ray tube is positioned. A coolant distribution head may engage with the anode end of the x-ray tube, with small orifices so as to distribute coolant essentially evenly over the anode surface. Temperature and flow rate of the inflowing coolant liquid are balanced so as to optimize heat transfer while efficiently carrying coolant through small lumens without the need for high pressures. Some embodiments use the inflation liquid in an applicator balloon as the coolant, with the liquid actively flowing or, in a simplified system, with the liquid static.

Abstract: The present invention provides improved devices, methods, and kits for inhibiting restenosis and hyperplasia after intravascular intervention. In particular, the present invention provides controlled immunomodulator delivery in combination with ionizing radiation to selected locations within a patient's vasculature to reduce and/or inhibit restenosis and hyperplasia rates with increased efficacy. In one embodiment, the combination radiation and immunomodulator delivery catheter for inhibiting hyperplasia comprises a catheter body having a proximal end and distal end, an ionizing radiation source coupleable to the catheter body for applying a radiation dose to a body lumen, and a porous material, matrix, membrane, barrier, coating, infusion lumen, stent, graft, or reservoir for releasing an immunomodulator to the body lumen.

Abstract: The present invention provides improved devices, methods, and kits for inhibiting restenosis and hyperplasia after intravascular intervention. In particular, the present invention provides controlled radiosensitizer delivery in combination with ionizing radiation to selected locations within a patient's vasculature to reduce and/or inhibit restenosis and hyperplasia rates with increased efficacy. In one embodiment, the combination radiation and radiosensitizer delivery catheter for inhibiting hyperplasia comprises a catheter body having a proximal end and distal end, an ionizing radiation source coupleable to the catheter body for applying a radiation dose to a body lumen, and a porous material, matrix, membrane, banier, coating, infusion lumen, stent, graft, or reservoir for releasing an radiosensitizer to the body lumen.