Abstract: Described here are brachytherapy applicators that comprise a modular support matrix. The modular support matrix may define the arrangement of radiation source lumens within the brachytherapy applicator. The modular support matrix can be adjusted to position the radiation sources to obtain a certain dose and dose profile. A series of modular support matrices may be operably connected according to patient anatomy or dosing requirements. Systems and methods for using such modular brachytherapy applicators are also described.

Abstract: The invention relates to a source guide apparatus for guiding and locating a radiation source in a human body, wherein a catheter is provided in a body and connected to the apparatus, and wherein the proximal end is kept in a predetermined position with respect to the body. According to the invention, a treatment window is set, which is situated within the body, within which the source can be kept in respective positions, wherein the treatment window has a fixed window width and a reference position situated at a predetermined distance with respect to the proximal end of the catheter. The source guide apparatus guides the source through the catheter to a predetermined position in the body, measured relative to the treatment window.

Abstract: Brachytherapy treatment apparatus are provided that include an elongate body including a core member and an outer member surrounding and movable relative to the core member. One or more helical catheters are provided on a distal portion of the elongate body, e.g., including distal ends coupled to the core member and proximal ends coupled to the outer member. The outer member is movable relative to the core member, e.g., axially and/or rotationally, to direct the helical catheters between a collapsed configuration for introduction through a tissue tract to a target location, e.g., a lumpectomy cavity, and an expanded configuration. Each helical catheter includes a lumen, and, after expansion to the expanded configuration, a source of radiation may be introduced along the helical catheters and/or a lumen of the core member for delivering radiation to the target location. Optionally, the apparatus may include a balloon surrounding or within the helical members.

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: The present invention provides an integral source material, the integral source material has at least one nuclide that is an integral source material having at least one nuclide that is activatable by exposure to radiation, the nuclide is a chemically bound constituent of a polymer of the integral source material, wherein the integral source material is configured before activation to provide a device.

Abstract: Packaged systems for implanting a marker in a patient and methods for manufacturing and using such systems. In one embodiment, a packaged system comprises an introducer having a cannula and a stylet configured to be received in the cannula, a marker in the cannula, and a package having a sterile compartment. The marker can have a casing configured to be implanted in a patient and a resonating circuit in the casing. The resonating circuit can comprise a coil configured to wirelessly transmit a target signal in response to a wirelessly transmitted excitation signal. The introducer is contained within the sterile compartment. In another embodiment, the marker is not loaded in the introducer within the compartment of the package.

Abstract: A radioactive member for use in brachytherapy comprising a hollow elongate bioabsorbable suture member with radioactive seeds and spacer members without different coloration and diameter from the radioactive seeds alternately disposed therein, and methods for the manufacture and the use thereof. The radioactive members may be used in the treatment of, for example, prostate cancer.

Abstract: A magazine for chain components of a chain with radiation sources comprises a housing as well as a first means for receiving chain components that is mounted in a pivotal manner in the housing and has recesses for receiving the chain components, a tension spring for driving the means for receiving the chain components, a sprocket being coupled in a pivotal manner to the means for receiving the chain components and being mounted in a pivotal position in the housing, and an ejector for ejection of the radiation sources. Furthermore, the magazine comprises an ejection lever which is mounted in a pivotal manner in the housing, whereby, in a first position, the ejection lever engages the sprocket, and in a second position it blocks the ejector.

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: Apparatus for delivering brachytherapy to a target tissue region includes an elongate body including a proximal end, a distal end sized for introduction into a tissue tract and carrying a plurality of elongate members including pathways for receiving a source of radiation. The elongate members are movable between collapsed and expanded configurations. During use, a tract is created through tissue, and the elongate body carrying the elongate members is advanced through the tract into a target location with the elongate members in the collapsed configuration. The elongate members are directed to the expanded configuration at the target location, and radiation is delivered to treat tissue at the target location, e.g., by introducing one or more radiation sources along the pathways.

Abstract: A stabilization device that may be used in connection with a radiation therapy procedure such as a breast brachytherapy procedure to stabilize one or more tubular members of a brachytherapy device between treatment sessions. The device includes a base member for placement over a body site of a patient and a cover member that may be positioned over the base member. The one or more tubular members may be locatable between the base and cover members and thereby stabilized relative to at least one of the base and cover members. In some embodiments, the base member may be in the form of a sheet member, and the stabilization device may include one or more resilient members that may be placed under the tubular members to limit lateral movement of the tubular members and provide a cushioning effect for the patient.

Abstract: A real time radiation treatment planning system for use in effecting radiation therapy of a pre-selected anatomical portion of an animal body. A processor is provided with a three-dimensional imaging algorithm and a three-dimensional image segmentation algorithm for at least the specific organs within the anatomical portion and the needles. The processor converts the image data into a three-dimensional image of the anatomical portion using at least one single or multi-objective anatomy based genetic optimization algorithm. The processor determines in real time the optimal number and position of the hollow needles, the position of the energy emitting source within each hollow needle and the dwell times of the energy emitting source at each position. For post planning purposes, the processor determines, based on three-dimensional image information in real time, the real needle positions and the dwell times of the energy emitting source for each position.

Abstract: A system comprising a catheter having an expandable element, which when expanded, has an annular shape surrounding a passageway. The expandable element in the expanded state is rollable along at least a portion of the shaft of the catheter without slipping. The system may be used for delivering an object to a site in the body, retrieving an object from a body, removing debris and/or other particulate matter from a blood vessel, and distending and/or expanding a pathologically-involved region of a blood vessel wall.

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: 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 method for producing uniform activity targets according to an embodiment of the invention may include arranging a plurality of targets in a holding device having an array of compartments, each target being assigned to a compartment based on a known flux of a reactor core so as to facilitate an appropriate exposure of the targets to the flux based on target placement within the array of compartments. The holding device may be positioned within the reactor core to irradiate the targets. The method may be used to produce brachytherapy and/or radiography targets (e.g., seeds, wafers) in a reactor core such that the targets have relatively uniform activity.

Abstract: A method for performing intraocular brachytherapy and an apparatus for performing the same is disclosed. The apparatus preferably comprises a hand-held delivery device that advances a radiation source into an associated cannula or probe that is positioned adjacent the target tissue. The handpiece provides for shielded storage of the radiation source when retracted from the cannula and includes a slider mechanism for advancing and retracting the radiation source. The radiation source is mounted to a wire that has a flexible distal end and a relatively stiffer proximal end. A positioning system for the cannula is also disclosed.

Abstract: Apparatus for delivering brachytherapy to a target tissue region includes an elongate body including a proximal end, a distal end sized for introduction into a tissue tract and carrying a plurality of elongate members including pathways for receiving a source of radiation. The elongate members are movable between collapsed and expanded configurations. During use, a tract is created through tissue, and the elongate body carrying the elongate members is advanced through the tract into a target location with the elongate members in the collapsed configuration. The elongate members are directed to the expanded configuration at the target location, and radiation is delivered to treat tissue at the target location, e.g., by introducing one or more radiation sources along the pathways. The apparatus may include features to prevent overexpansion of the elongate members and/or to facilitate rapid collapse of the elongate members.

Abstract: Disclosed herein is a system for transferring brachytherapy elements to a needle, such as seeds, connectors, spacers, and strands. The system comprises a transfer device and, optionally, a stylet and a rack configured to hold one or more transfer devices.

Abstract: A mechanism to facilitate the insertion of radioactive sources/source strands into soft tissue, such as breast tissue, and a method that utilizes this mechanism with the goal of improving the reproducibility of the procedure and ensuring that the sources are reliably and consistently inserted in an exact position per a patient prescription treatment plan from patient to patient as well as improve the ease-of-use of the device and procedure are provided.

Abstract: Methods and apparatus for intraocular brachytherapy are disclosed in which a cannula is introduced into the eye for delivery of radiation to a target tissue. Techniques for properly locating the cannula with respect to the target tissue, for protecting non-target tissue, for regulating heat generated by x-ray emitters, and for combining therapies are disclosed.

Abstract: Tools for accessing tissue are described for use with a locatable guide of a navigation system. In preferred embodiments, said tools are attachable to a distal tip of a locatable guide, such that the location of the tool, preferably in six degrees of freedom, is known while the tool is being used.

Abstract: Combined brachytherapy and ablation devices and methods. A combined brachytherapy and cryotherapy method, includes: inserting an ablation device into tissue of a subject; ablating tissue within an ablation zone of the device; detaching and removing a first part of the device while leaving a second part of the device in the tissue, the first part contacting the ablation zone; and inserting a brachytherapy rod into the second part of the device when the second part is detached from the first part, the brachytherapy rod connected to base at one end and retaining at least one radioactive seed at an opposing end, the brachytherapy rod configured and dimensioned so that when it is inserted into the device up to the base, the at least one radioactive seed is in the ablation zone.

Abstract: There is provided herein a brachytherapy delivery system for the internal delivery and positioning of therapeutic agent, most particularly, a discrete radiation emitting particulate, within or in proximity to a vertebral or other bony tumor. The system comprises an elongated bone cannula having a proximal and a distal end, the distal end being suitable for disposition within bone. The bone cannula further comprises a bore disposed longitudinally therethrough suitable to axially and slidably receive an elongated and cannulated therapy delivery apparatus through which the therapeutic agent is delivered.

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: The present disclosure relates to an implant comprising at least one sheet of a biocompatible material, at least one shielding apparatus fixed to the biological material, and at least one radioactive seed partially disposed in the shielding apparatus. 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 one sheet of a biocompatible material, at least one shielding apparatus fixed to the biological material, and at least one radioactive seed partially disposed in the shielding apparatus.

Abstract: A rough, bio-absorbable strand is provided. More specifically, a bio-absorbable strand having a central body and a rough or irregular outer surface capable of securing the placement of the strand inside a patient is provided. The strand has one or more radioactive seeds embedded in the central body of the strand. The rough outer surface of the strand may include one or more prongs, ridges, strips, grooves, or texture. Additionally, the strand may be capable of being dispensed from an implant needle.

Abstract: A method for brachytherapy in a lumpectomy cavity of a breast including, positioning a distal end of a brachytherapy device within the cavity, expanding an expandable surface portion located between proximal and distal ends of the device within the cavity, the source lumen tubes defining a curved configuration within the cavity; and positioning a source of radiation sequentially within one or more source lumens of the source lumen tubes according to a brachytherapy treatment plan. The device includes an inner tube, and a plurality of source lumen tubes located around the inner tube and including distal ends secured together with the inner tube at the distal end disposed within the body cavity, the source lumen tubes comprising proximal portions sufficiently long to extend outside the breast.

Abstract: Embodiments of passive vent valve devices are disclosed. One of the novel aspects of the invention is its ability to transform from a packaging configuration to a use configuration. The packaging configuration allows sterilization gases to penetrate into the device through standard valve openings as well as through vented mesh openings. Passage of gas into the device, in turn, provides a means of sterilizing all surface areas in the device. Alternatively, when the valve is placed in a use configuration, the passage of gas through the vented mesh is inhibited providing a sealed environment that functions as a valve. The invention is useful in manufacturing sterile medical devices by allowing all surfaces to communicate with the sterilizing agent when the valve is in a packaging configuration or when it is in a use configuration.

Abstract: A brachytherapy implant includes a plurality of protrusions to reduce a tendency of the implant to migrate and rotate within a patient's body after implantation. Embodiments of the present invention are directed to spacers that resist migration and rotation. This abstract is not intended to be a complete description of the invention.

Abstract: Brachytherapy devices and methods that may allow high doses of radiation to be applied to areas in need of treatment, while reducing damage to healthy tissue that may be in the vicinity. The devices and methods may utilize an expansion device and a treatment device. The expansion device may include an outer expandable assembly that is implanted into a post-surgical cavity. The treatment device may include an inner expandable assembly that is mated to the expansion device during treatment fractions, and provides a pathway for the radiation source, for example an HDR (high dose rate) afterloader source.

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: Apparatus for delivering brachytherapy to a target tissue region includes an elongate body including a proximal end, a distal end sized for introduction into a tissue tract and carrying a plurality of elongate members including pathways for receiving a source of radiation. The elongate members are movable between collapsed and expanded configurations. During use, a tract is created through tissue, and the elongate body carrying the elongate members is advanced through the tract into a target location with the elongate members in the collapsed configuration. The elongate members are directed to the expanded configuration at the target location, and radiation is delivered to treat tissue at the target location, e.g., by introducing one or more radiation sources along the pathways.

Abstract: A brachytherapy device for treating tissue within a cavity of a body. The device may include a first set of tubes configured to be inserted into the cavity through an opening at the surface of the body. Each of the tubes may have an external end and an interior channel beginning at the external end that is configured to receive radioactive material. The external ends of the tubes may be bundled together. The tubes may be of a length that causes the external ends to be near the opening in the surface of the body while the tubes are in the cavity. A seal may be configured to prevent fluid that originates from the cavity from entering into the external ends of the tubes while they are near the opening in the surface of the body. The seal may include a gasket that is pressed against the external ends of the tubes. The gasket may have openings that align with channels within the external ends of the tubes.

Abstract: Embodiments of an apparatus and method to track and identify radioactive sources are described. In one embodiment, a device includes first housing for a radioactive source having a first electronic tag, a second housing for the radioactive source having a second electronic tag, and a guide tube that couples the first housing with the second housing. The guide tube includes a third electronic tag. The first, second, and third electronic tags communicate with each other to confirm automatically a delivery path for the radioactive source. In one embodiment, the electronic tags may be a radio frequency identification device (RFID).

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 biopsy marker deployment device is provided herein. According to one exemplary embodiment, the deployment device includes a deployment assembly and an actuator configured to selectively actuate the deployment assembly. The deployment assembly is configured to selectively deposit a marker in a biopsy site through at least one aperture and to substantially reduce space between the aperture and the deployment assembly.

Abstract: System, including apparatus and methods, for positioning medical material in living tissue using hollow elements that are formed unitarily from a synthetic bioabsorbable material. The hollow elements are optionally filled with a core material and a heat shrink process is performed so that the hollow elements are tightened around the core material.

Abstract: A system for treating tissue includes a cannula having a proximal end, a distal end, and a lumen extending between the proximal and the distal ends, and an array of delivery tubes at least partially disposed within the lumen, each of the delivery tube having a lumen, wherein each of the delivery tubes is slidable relative to the cannula, and has a first configuration when inside the lumen, and a second configuration when outside the lumen. A system for treating tissue includes a treatment device having a distal end, and an indexing device for controlling a longitudinal position of the distal end of the treatment device relative to a target tissue region, the indexing device having a tubular portion for receiving the treatment device.

Abstract: An in-vivo dose detector (41) for an HDR brachytherapy system (1; 31), wherein the detector is insertable into and movable through a catheter (15), and comprises a sensor (53) operable to detect radiation from a source (52) used to irradiate a tissue to be treated (9) in the course of an HDR brachytherapy treatment. A brachytherapy system and a method of dose monitoring are also disclosed.

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 gynecological balloon apparatus has a first balloon and a second balloon disposed with a gynecological brachytherapy applicator. The first and second balloons are each movable between an inflated condition and a deflated condition. The first and second balloons may conform to a shape of a vaginal cavity when in their inflated conditions. A radiation detecting sensor and a motion detecting sensor may be positioned with the apparatus.

Abstract: A spinal implant configured to facilitate focused treatment of spinal tumors includes a plurality of irradiated implant seeds configured to concentrate the dosage and duration of radiation treatment of tumors.

Abstract: Systems and methods for stabilizing a target location within a human body. One embodiment of the system provides a tissue anchor for holding a tissue mass within a human body. The tissue anchor may include a lead; a tissue fastener coupled to the lead; and a marker which can be detected by a position detection system to facilitate placement of the anchor. The tissue anchor can be used to help stabilize tissue in a surgical procedure, e.g., in excising a lesion in amorphous, pliable tissue (e.g., breast tissue) or other body parts.

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: Embodiments of an apparatus and method to track and identify radioactive sources are described. In one embodiment, a device includes first housing for a radioactive source having a first electronic tag, a second housing for the radioactive source having a second electronic tag, and a guide tube that couples the first housing with the second housing. The guide tube includes a third electronic tag. The first, second, and third electronic tags communicate with each other to confirm automatically a delivery path for the radioactive source. In one embodiment, the electronic tags may be a radio frequency identification device (RFID).

Abstract: A brachytherapy device including an elongate member comprising a proximal portion and a distal portion. The device also includes a movable surface portion surrounding at least the distal portion of the elongate member and a plurality of source lumen tubes defining respective source lumens, the source lumen tubes being located around the elongate member, distal ends of the source lumen tubes coupled to the distal portion of the elongate member, the source lumen tubes extending a sufficient distance in a proximal direction such that the source lumen tubes extend outside a body when distal portions of the source lumen tubes are positioned in a body cavity for brachytherapy.

Abstract: Apparatus for delivering brachytherapy to a target tissue region includes an elongate body including a proximal end, a distal end sized for introduction into a tissue tract and carrying a plurality of elongate members including pathways for receiving a source of radiation. The elongate members are movable between collapsed and expanded configurations. During use, a tract is created through tissue, and the elongate body carrying the elongate members is advanced through the tract into a target location with the elongate members in the collapsed configuration. The elongate members are directed to the expanded configuration at the target location, and radiation is delivered to treat tissue at the target location, e.g., by introducing one or more radiation sources along the pathways. The apparatus may include features to prevent overexpansion of the elongate members and/or to facilitate rapid collapse of the elongate members.