Abstract: Utilization of a contact device placed on the eye in order to detect physical and chemical parameters of the body as well as the non-invasive delivery of compounds according to these physical and chemical parameters, with signals being transmitted continuously as electromagnetic waves, radio waves, infrared and the like. One of the parameters to be detected includes non-invasive blood analysis utilizing chemical changes and chemical products that are found in the conjunctiva and in the tear film. A transensor mounted in the contact device laying on the cornea or the surface of the eye is capable of evaluating and measuring physical and chemical parameters in the eye including non-invasive blood analysis. The system utilizes eye lid motion and/or closure of the eye lid to activate a microminiature radio frequency sensitive transensor mounted in the contact device. The signal can be communicated by wires or radio telemetered to an externally placed receiver.

Abstract: Apparatus, systems, and methods are provided for delivering brachytherapy into a target tissue region, e.g., a breast. In some embodiments, a flexible brachytherapy device is implanted that includes a therapy delivery portion having one or more radioactive sources securely retained thereto, and a tail portion extending from the therapy delivery portion. The brachytherapy device may be implanted in a helical configuration within the target tissue region. To assist in placement and removal of the brachytherapy device, a tubular sheath may be implanted by attaching (e.g., sliding over) a helically coiled needle that is advanced into the body by screw-like rotation. Once implanted, the sheath and the brachytherapy device may extend outside the body, where they may be folded and secured flat against the skin. The device and sheath may be removed at therapy completion.

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 method of removing lesions by implanting a radioactive seed at the location of the lesion, locating the lesion with the radioactive seed, and removing the lesion with the radioactive seed.

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: 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 stranded brachytherapy product and methods of forming a stranded brachytherapy product. The methods includes the step of applying an adhesive to a carrier containing at least one brachytherapy seed so as to, upon curing of the adhesive, impart substantial rigidity to the carrier. Alternatively, the adhesive may be selectively applied so as to provide a deflectable brachytherapy product.

Abstract: A computerized system 40 for locating a device. System 40 includes a sensor module 20 and a CPU 42. A radioactive source 38, associated with the device, produces a signal in the form of radioactive disintegrations. Module 20 includes a radiation detector 22 capable of receiving a signal from source 38 attached to the device. Module 20 produces an output signal 34. CPU 42 receives output signal(s) 34 and translates output 34 into directional information relating to a position of source 38.

Abstract: Methods and apparatuses for the delivery of bioactive substances into the prostate. The present invention encompasses the release of bioactive substances into the prostate of a patient. Preferably, the present invention employs either a sustained-release or depot formulation of the bioactive substance to release the substance over an extended period of time. In particularly-preferred embodiments, the apparatuses of the present invention release of anti-inflammatory agents into the prostate. The anti-inflammatory agents preferably reduce the inflammation that is associated with brachytherapy and other conditions of the prostate. In particular, corticosteroid anti-inflammatory agents are employed in the context of the present invention.

Abstract: Provided are methods and apparatus for the use of magnetic traction to maintain the patency of a tubular anatomical structure, whether a vessel, duct, the trachea, bronchus, bile duct, ureter, vas deferens, fallopian tube, or portions of the digestive tract, as to constitute means for extraluminal stenting. An extraluminal stent consists of a perimedial or medial intravascular and an extravascular component. The intravascular component consists of ferromagnetic spherules implanted aeroballistically or stays implanted by means of a special hand tool, while the extravascular component consists of a pliant jacket or mantle that has magnets mounted about its outer surface.

Abstract: A flexible or elastic brachytherapy strand that includes an imaging marker and/or a therapeutic, diagnostic or prophylactic agent such as a drug in a biocompatible carrier that can be delivered to a subject upon implantation into the subject through the bore of a brachytherapy implantation needle has been developed. Strands can be formed as chains or continuous arrays of seeds up to 50 centimeters or more, with or without spacer material, flaccid, rigid, or flexible.

Abstract: A method of preparing a material for use in a manufactured seed is provided. The method includes providing the material having a melting temperature. The method also includes subjecting the material to a heat treatment at a temperature about 10% below the melting temperature for a predetermined period of time.

Abstract: A flexible or elastic brachytherapy strand that includes an imaging marker and/or a therapeutic, diagnostic or prophylactic agent such as a drug in a biocompatible carrier that can be delivered to a subject upon implantation into the subject through the bore of a brachytherapy implantation needle has been developed. Strands can be formed as chains or continuous arrays of seeds up to 50 centimeters or more, with or without spacer material, flaccid, rigid, or flexible.

Abstract: Radioactive sources for implanting in tissue to treat tumors and to provide a directional dose to allow improved dose placement, particularly at the interface between healthy and diseased tissue.

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: Apparatus, systems and methods for delivering brachytherapy to a target tissue region of a human or other mammalian body. In some embodiments, a flexible brachytherapy device is implanted that includes a therapy delivery portion having one or more radioactive sources securely retained thereto, and a tail portion extending from the therapy delivery portion. Once implanted, the tail portion may extend outside the body, where it may be folded and secured flat against the skin. The device may be removed at therapy completion. Other embodiments of the invention are directed to systems and methods for delivering brachytherapy devices to the body.

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: Hollow metal and polymeric containers (or seeds) are provided having a therapeutic agent encapsulated therein, e.g., a nucleic acid or cytokine, that diffuses out of the seeds via one or more holes disposed therein and is thereby delivered to target sites, e.g., tumor cells. These hollow seeds can be precisely delivered to garget cites, e.g., within a tumor, preferably by use of stereotactic guidance, ultrasound, CT or MRI.

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 low dose rate brachytherapy seed having activity in the range between 0.5 and 10 millicurie, preferably less than 3 millicurie, comprising thulium-170 placed within a casing and at least one layer of a radiation emission modifying metal, said layer being provided either internally within the casing or on the outer surface thereof. The radiation emission modifying metal is preferably gold.

Abstract: A catheter-based deployment system for deploying cellular material (22) into the heart muscle (25). The deployment system includes a guiding catheter (19) and a needle assembly (31) capable of sliding within the guiding catheter. The needle assembly (31) terminates in a tip (34) having at least one side with an opening (43) in communication with a lumen (20) disposed within the needle assembly (31). Once the guiding catheter (19) is positioned the needle assembly (31) is advanced until the tip (34) penetrates the muscle wall (25). At a predetermined depth the cellular material (22) may be deployed into the muscle wall (25) via a push rod (46) disposed through the lumen of the needle assembly (31).

Abstract: A system, method and device for treating tumor cells utilizing a resorbable therapy seed made up of microspheres containing a beta-particle-emitting radiation source and a resorbable polymer matrix. These seeds are implanted within the tumor and then rapidly dissolved or broken so as to release the microspheres. These microspheres then spread within a preselected target area and provide radiation therapy in a predetermined amount and at a preselected rate according the specific needs and necessities of the users. The configuration of the microspheres, the types of radiation provided and the location and use of these microspheres provides desired localized treatment to target cells while preferentially avoiding undesired damage to surrounding tissue. The present invention provides a method for making the seeds, as well as a method for utilizing the seeds as a part of the treatment method.

Abstract: A system, method and device for treating tumor cells utilizing a resorbable therapy seed made up of microspheres containing a beta- or alpha-particle-emitting radiation source and a resorbable polymer matrix. These seeds are implanted within the tumor and then rapidly dissolved so as to release the microspheres from the polymer matrix. These microspheres then spread within a preselected target area and provide radiation therapy in a predetermined amount and at a preselected rate according the specific needs and necessities of the users. The configuration of the microspheres, the types of radiation provided and the location and use of these microspheres provides desired localized treatment to target cells while preferentially avoiding or minimizing undesired damage to surrounding tissue. The present invention provides a method for making the seeds, as well as a method for utilizing the seeds as a part of the treatment method.

Abstract: Medical devices can include a lubricious echogenic coating that is slippery when wet and provides visibility during ultrasonic imaging.

Abstract: Methods of forming a low-dose-rate (LDR) brachytherapy device include depositing a solution comprising a soluble form of a radioactive material on a substrate. A water-insoluble form of the radioactive material is formed on the substrate by chemical precipitation and/or thermal decomposition.

Abstract: A brachytherapy device for the provision of brachytherapy is disclosed. The brachytherapy device has at least one source lumen located outside a movable surface of the device. The source lumen may be secured to the movable outer surface in a manner whereby relative movement of the source lumen relative to the movable outer surface is permitted. The brachytherapy device is inserted into a body cavity. After insertion, the movable surface is moved to position the at least one source lumen closer to the tissue boundary of the cavity. One or more sources of radiation are then placed within the at least one source lumen to provide a customizable treatment. Also disclosed are methods for providing brachytherapy via body cavities.

Abstract: Apparatus, systems and methods for delivering brachytherapy to a target tissue region of a human or other mammalian body. In some embodiments, a flexible brachytherapy device is implanted that includes a therapy delivery portion having one or more radioactive sources securely retained thereto, and a tail portion extending from the therapy delivery portion. Once implanted, the tail portion may extend outside the body, where it may be folded and secured flat against the skin. The device may be removed at therapy completion. Other embodiments of the invention are directed to systems and methods for delivering brachytherapy devices to the body.

Abstract: A radioactive implant for brachytherapy includes a composite radioactive source having at least two different types of radionuclides.

Abstract: A radioactive seed and method for making a radioactive seed with selective magnetic imaging characteristics are provided. The seed comprises a housing which may include a metal shell for at least partially enclosing a radioactive material. The shell encloses a rod having a nickel layer with a phosphorous content, wherein the phosphorous content comprises a level of phosphorous sufficient, when the seed is implanted in tissue, to provide a defined magnetic resonance signature of the seed while substantially eliminating gross artifacts in the magnetic resonance image.

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 selectively loadable/sealable bioresorbable carrier assembly for retaining and positioning elements used in brachytherapy procedures comprises a bioresorbable tube having a closed distal end and a proximal open end. The bioresorbable tube is loaded with a selectable arrangement of elements, including at least one radioactive seed, through the proximal open end. After the bioresorbable tube is selectably loaded, the bioresorbable tube is heat sealed at a sealing position adjacent a proximalmost element. Once sealed, the bioresorbable tube maintains the arrangement of elements throughout the treatment duration.

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 method of removing lesions by implanting a radioactive seed at the location of the lesion, locating the lesion with the radioactive seed, and removing the lesion with the radioactive seed.

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: An implantable medical marker, the marker comprising a marker body adapted for insertion via a needle and adapted to define a volume with a smallest dimension larger than an inner diameter of the needle; and a radiation source—characterized by gamma emissions sufficient to exit the human body.

Abstract: The present disclosure relates to an implant comprising at least two sheets of a biocompatible material, and at least one radioactive seed disposed between said sheets of material. The disclosure also relates to a method for treating a patient, comprising fixing to the tissue of the patient at least one implant comprising at least two sheets of a biocompatible material, and at least one radioactive seed disposed between said sheets of material.

Abstract: Radioactive sources are manufactured for treating a tumor or cancerous area occurring around a conduit or duct in the body by emitting X-rays to destroy or reduce the tumors. The sources contain ytterbium which is substantially enriched in 168Ytterbium and which is activated by exposure to neutron flux so as to contain a minor, but significant, fraction of X-ray and gamma-emitting 169Ytterbium. The radioactive 169Ytterbium source is inserted through a catheter or applicator or needle to the site of the cancer where it is maintained in position for a period of time to reduce the occurrence of cancer. The ytterbium also acts as an X-ray-opaque marker to facilitate external visualization of the sources during their delivery to the treatment site. The sources are encased in a shell to prevent direct contact of the radioactive material with human tissue. This encapsulation may be formed by welding a pair of end caps to a tubular member.

Abstract: In an embodiment a therapeutic member includes a solitary radioactive seed. The seed includes a metallic housing with radioactive material contained within the metallic housing. The metallic housing has a first longitudinal end and a second longitudinal end and a longitudinal length between the first and second longitudinal ends. A polymeric material is molded to completely and monolithically encapsulate the metallic housing of the solitary radioactive seed. The implantable therapeutic member is adapted to be implanted into patient tissue using a hollow needle. A portion of the molded polymeric material extends from one of the first and second longitudinal ends of the metallic housing to reduce a tendency of the seed to migrate and rotate within a patient's body after implantation of the member.

Abstract: An interstitial marker for localization of organs, biopsy sites, tumors or tumor beds, is comprised of a fluid marker material which is visible under at least one imaging modality. The fluid marker material is injected at the desired location to create a marker having a desired size and configuration. The configuration includes combinations of straight and curved lines, spheres and blank spaces. The fluid marker material includes a high density metal such as bismuth, gold, or iridium suspended in a liquid, in colloidal form or made into a solution.

Abstract: A hybrid multi-radionuclide sealed source for use in brachytherapy comprising a plurality of radionuclides is disclosed. The differing decay rates of the radionuclides in the hybrid multi-radionuclide sealed source combine a large initial dose of radiation followed by an extended dose of radiation contained within the single source. The sealed source may comprise a seed, a flexible strand, a rigid strand, a wire, a coil or a catheter.

Abstract: A fiducial marker which is visible to a wide range of imaging techniques, comprises a radiopaque material, such as barium sulphate or a metal wire, encapsulated in a biocompatible polymeric material, for example a polyaryletherketone such as polyetheretherketone.

Abstract: This invention includes methods of fabricating brachytherapy implant seeds, methods of fabricating brachytherapy implant seed cores, and brachytherapy implant seeds independent of method of fabrication. In one implementation, a brachytherapy implant seed includes a sealed inorganic metallic cylinder having a radioactive core received therein. The radioactive core includes an inorganic amorphous silicate glass tube having an exterior surface extending axially along the tube. An inorganic crystalline ceramic coating is received on at least a portion of the inorganic amorphous glass tube exterior surface. The coating includes a therapeutic dose of radioactive material. A radiographic marker is received within the sealed inorganic metallic cylinder. Other aspects and implementations are contemplated.

Abstract: Devices and methods are provided for controlled application of a treatment to tissue adjacent a body cavity, such as after removal of tissue, e.g. cancer. A device embodying features of the invention includes one or more radiation shielding components to control emitted radiation from a radiation source to minimize radiation damage to healthy portions of the body cavity. A device embodying features of the invention can include a sealing member at a location on a shaft of the device proximal to a treatment location therein to seal the passageway leading to the body cavity. Methods for treating a body cavity include methods for delivering a radiation source to a body cavity while minimizing damaging irradiation of healthy tissue.

Abstract: Provided herein is a method of producing europium-152 as a radiotherapeutic source for external beam radiation therapy and brachytherapy using existing containment or capsule devices for the radionuclide. The method comprises irradiating a europium-151 enriched target with neutrons confined to a range of neutron energies effective to drive the reaction 151Eu(n,?)152Eu. Also provided are methods of treating a subject using external beam radiation therapy or brachytherapy using europium-152.

Abstract: The present invention provides a method of preparing Cesium-131 (Cs-131) as a dispersed radioisotope. Uses of the dispersed Cs-131 prepared by the method include cancer research and treatment, such as for the use in brachytherapy. Cs-131 is particularly useful in the treatment of faster growing tumors.

Abstract: A radiation source device. The radiation source device has a radiolucent window portion, such as formed of beryllium, with a front window and a sleeve portion having an outer surface and a window portion cavity therein. A primary element, e.g., a metal wire, is provided that has a radioactive end, which primary element is received in the window portion cavity with its radioactive end adjacent to the front window and a seal is located between an outer wall of the primary element and an inner wall of the window portion. A radiopaque capsule is provided and has an open end that is sized to receive the sleeve portion of the radiolucent window portion and the primary element. A secondary seal between the capsule and the radiolucent window portion is provided.

Abstract: The invention relates to a method for producing a radioactive brachytherapy source material comprising indium-114m in radioactive equilibrium with indium-114 as main radioactive isotopes. A new radioactive brachytherapy source material comprises indium-114m in radioactive equilibrium with indium-114 as main radioactive isotopes. A new encapsulated radioactive brachytherapy source comprises the new radioactive brachytherapy source material.

Abstract: A surgical device for localized delivery of beta radiation in surgical procedures, particularly ophthalmic procedures. Preferred surgical devices include a cannula with a beta radiotherapy emitting material at the distal end of the cannula. The surgical device is particularly suitable for use in the treatment of treat Age Related Macular Degeneration (AMD).

Abstract: The present invention relates to an anti-thrombogenic, physically well-tolerated polymer and its use for manufacturing sheaths and films as a component of therapeutic devices for preventing excessive cell proliferation. Furthermore, it relates to films made from the polymer as well as wrappings for medical devices such as stents. It also relates to medical devices that are enclosed by a film or wrapping according to the invention.